WO2021074877A1 - Sterilization device - Google Patents

Sterilization device Download PDF

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Publication number
WO2021074877A1
WO2021074877A1 PCT/IB2020/059758 IB2020059758W WO2021074877A1 WO 2021074877 A1 WO2021074877 A1 WO 2021074877A1 IB 2020059758 W IB2020059758 W IB 2020059758W WO 2021074877 A1 WO2021074877 A1 WO 2021074877A1
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Prior art keywords
electrodes
enclosure
pair
reactive species
electrode
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PCT/IB2020/059758
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French (fr)
Inventor
Krupakar Murali Subramanian
Original Assignee
Krupakar Murali Subramanian
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Publication of WO2021074877A1 publication Critical patent/WO2021074877A1/en

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Classifications

    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05HPLASMA TECHNIQUE; PRODUCTION OF ACCELERATED ELECTRICALLY-CHARGED PARTICLES OR OF NEUTRONS; PRODUCTION OR ACCELERATION OF NEUTRAL MOLECULAR OR ATOMIC BEAMS
    • H05H1/00Generating plasma; Handling plasma
    • H05H1/24Generating plasma
    • H05H1/2406Generating plasma using dielectric barrier discharges, i.e. with a dielectric interposed between the electrodes
    • H05H1/2439Surface discharges, e.g. air flow control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/14Plasma, i.e. ionised gases
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05HPLASMA TECHNIQUE; PRODUCTION OF ACCELERATED ELECTRICALLY-CHARGED PARTICLES OR OF NEUTRONS; PRODUCTION OR ACCELERATION OF NEUTRAL MOLECULAR OR ATOMIC BEAMS
    • H05H1/00Generating plasma; Handling plasma
    • H05H1/24Generating plasma
    • H05H1/2406Generating plasma using dielectric barrier discharges, i.e. with a dielectric interposed between the electrodes
    • H05H1/2443Generating plasma using dielectric barrier discharges, i.e. with a dielectric interposed between the electrodes the plasma fluid flowing through a dielectric tube
    • H05H1/245Generating plasma using dielectric barrier discharges, i.e. with a dielectric interposed between the electrodes the plasma fluid flowing through a dielectric tube the plasma being activated using internal electrodes
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05HPLASMA TECHNIQUE; PRODUCTION OF ACCELERATED ELECTRICALLY-CHARGED PARTICLES OR OF NEUTRONS; PRODUCTION OR ACCELERATION OF NEUTRAL MOLECULAR OR ATOMIC BEAMS
    • H05H2245/00Applications of plasma devices
    • H05H2245/30Medical applications
    • H05H2245/34Skin treatments, e.g. disinfection or wound treatment

Definitions

  • the present disclosure relates to medical equipments and devices.
  • it pertains to a sterilization device for use in the medical industry.
  • HAI Healthcare associated infections
  • SAL sterility assurance level
  • a sterility assurance level (SAL) of 10 6 is appropriate for items intended to come into contact with compromised tissue, which has lost the integrity of natural body barriers. This would include sterile body cavities, tissues and vascular system.
  • a sterility assurance level (SAL) of 10 6 means that there is less than or equal to one chance in a million that a particular item is contaminated or unsterile following a sterilization process.
  • Reusable medical devices including surgical instruments that enter normally sterile tissue or the vascular system require sterilization before each use. Improperly sterilized or contaminated medical devices utilized in patient care can contribute to surgical site infection and pose a serious risk to the patient’s safety and welfare and can result in a serious life-threatening infection or even death.
  • Achieving sterilization is contingent on right conditions to destroy living organisms, through cleaning of devices to be sterilized and good contact between the sterilant and all surfaces and crevices of the device to be sterilized both physically and for sufficient duration of time to ensure the intended sterilization occurs. Further, it is also important that medical devices are properly inspected, assembled, packaged, and loaded into the sterilizer in accordance with established procedures and techniques.
  • Saturated steam under pressure is the oldest and most widely used, economical, effective and reliable method of sterilization available to health care facilities.
  • Pressurized steam at high temperature is used to kill various microorganisms.
  • due to the very high temperatures and moisture associated with steam sterilization it may only be used with heat and moisture stable medical devices, instruments and compatible materials.
  • Ethylene Oxide is a low temperature sterilization method that has been used for decades. The low temperature process makes it suitable for the sterilization of heat and moisture sensitive medical devices that cannot tolerate the high temperatures and moisture associated with steam sterilization.
  • EO is a colorless gas, which destroys microorganisms by a process called alkylation. The EO penetrates the cells membrane and reacts with the nuclear material rendering it unable to metabolize and reproduce.
  • EO has disadvantages. It has a relatively long sterilization cycle and needs aeration for a specified amount of time. Further, EO is toxic and porous materials exposed to EO will absorb the toxic gas requiring aeration following the sterilization process to allow the residue to escape from the medical devices before they are handled and used. EO is extremely flammable in its pure form and requires that special precautions be taken in its storage and use. Furthermore, EO is also a known carcinogen and known workplace hazard. All this requires for complicated equipment to be used and extensive monitoring to be implemented.
  • Liquid chemical sterilization is utilized for the sterilization of heat sensitive devices that can be immersed.
  • This method employs the use of a germicidal solution and requires the complete immersion of items in the solution for a prescribed period of time to kill microorganisms.
  • Peracetic acid, Glutaraldehyde etc. are used.
  • devices that are sterilized by this method are intended for just-in-time use and have no shelf life.
  • Glutaraldehyde generates toxic fumes, and the process has potential for contamination of sterile devices during rinsing and transfer to the area of use, and no method to biologically monitor the sterilization process.
  • a well-ventilated work environment is required and personal protective equipment such as gloves and face masks must be used.
  • Dry heat sterilization is used to sterilize anhydrous (waterless) items that can withstand high temperatures.
  • the destruction of organisms occurs by oxidation, which is a slow burning up process of coagulating the cells protein. It is not in much use nowadays as it is a long sterilization process due to the length of time it takes for objects to reach required temperatures.
  • Irradiation using Gamma, Beta rays
  • the product to be sterilized is exposed to radiation for 10 to 20 hours, depending on the strength of the source.
  • the highest temperatures reached in gamma sterilization are usually 30-40°C.
  • Gamma radiation is popular for sterilizing before shipment and it can be done through the packaging.
  • Ionizing radiation produces ions by knocking electrons out of atoms. These electrons are knocked out violently and strike an adjacent atom and either attach themselves to it, or dislodge an electron from the second atom. The result is ionic energy that becomes converted to thermal and chemical energy. This energy kills microorganisms by disruption of the DNA molecule, therefore preventing cellular division and propagation of biologic life.
  • the principal sources of ionizing radiation are beta particles and gamma rays. The procedures, however, require high voltage machines and the usefulness of this method in sterilizing an object is limited by the density, thickness of the object and by the energy of the electrons. As said, usage of this method is largely limited to commercial use.
  • Gas Plasma is a low temperature sterilization alternative that has been available for several years and is suitable for many heat sensitive and moisture sensitive or moisture stable medical devices. Unlike EO sterilization, gas plasma sterilization is devoid of the occupational, environmental and patient safety concerns. Gas plasma have total cycle times that are significantly less than EO and medical devices so sterilized are ready for use following sterilization without the need for aeration. However, the major disadvantage of this system is that it is extremely expensive and unaffordable by most medical establishments. Especially in rural settings, this equipment cannot be serviced and is difficult to maintain owing to its complexity.
  • Atmospheric pressure plasma is, as the name suggests, a plasma in which the gas pressure approximately matches that of the surrounding atmosphere (ambient pressure).
  • APP Plasma-activated plasma
  • RF Radio Frequency
  • AC Alternating Current
  • DC Direct Current
  • Microwave excitation RF (Radio Frequency) excitation
  • Some devices using APP have been developed in recent years. They, however, generate plasma only in a limited portion of their electrodes (for example tip of an electrode) and need special gases such as Helium for their operation.
  • the devices available are expensive and use complicated power supplies and/or constructional features. Besides, they are not suitable for sterilizing bulk surgical equipment and cannot be used to sterilize/ decontaminate large surfaces. They need a complex matching power supply network to optimize plasma generation.
  • the numbers expressing quantities or dimensions of items, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
  • the present disclosure relates to medical equipments and devices.
  • it pertains to a sterilization device for use in the medical industry.
  • present disclosure elaborates upon a sterilization device that can include: at least one pair of electrodes, the at least one pair of electrodes at least partially separated by a dielectric material, wherein, upon connecting the electrodes to a high voltage variable frequency power supply, atmospheric pressure plasma can be generated along at least a partial length of the electrodes to further create reactive species for sterilization.
  • the dielectric material can be any or a combination of dry air, a gas, plastic, ceramic, mica and glass.
  • the device can be configured with means to direct flow of the reactive species.
  • the device can be configured in a first enclosure and the reactive species can sterilizeat least partial inner surface of the first enclosure and any items in or around the first enclosure.
  • one of the at least one pair of electrodes can be held inside a second enclosure and another of the least one pair of electrodes can be held outside the second enclosure, and the reactive species can be generated at any or a combination of inside and outside the second enclosure.
  • first electrode of the at least one pair of electrodes can be held at least partially inside a third enclosure, the third enclosure configured to perform as second electrode of the at least one pair of electrodes.
  • first electrode of the at least one pair of electrodes can be held at least partially inside a fourth enclosure, and second electrode of the at least one pair of electrodes can be configured to be at least partially moveable over the fourth enclosure.
  • the dielectric material can be in form of a planar surface and the reactive species can sterilize surface of the planar surface.
  • the device can include a plurality of the at least one pair of electrodes, the plurality of the at least one pair or electrodes receiving same voltage or voltage varying in any or a combination of volts, frequency and phase.
  • the means can include vanes with fixed or variable angles attached to any or combination of the electrodes, the dielectric material, and an enclosure in which the device can be configured.
  • the fourth enclosure can act as the dielectric material separating the electrodes.
  • variation in the any or a combination of volts, frequency and phase can be used to vary flow of the reactive species.
  • At least one electrode of the plurality of the at least one pair of electrodes can be common.
  • At least one of the vanes can be configured with another of the at least one pair of electrodes held at least partially separated by a dielectric material to generate reactive species at the vane.
  • FIGs. 1A and IB illustrate present devices that use atmospheric pressure plasma for sterilization purposes (Prior Art).
  • FIGs. 2A and 2B illustrate how proposed device may be employed in small apertures or tubular structures such as those used in laproscopes, endoscopes, colonoscopes, catheters etc. in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 3 illustrates major components and construction of device disclosed in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 4 illustrates an alternate configuration of the proposed device in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 5A illustrates an embodiment of device disclosed in a flexible tubular structure in accordance with an exemplary embodiment of the present disclosure.
  • FIGs. 5B, 5C, 5D, 6A, 6B, 7A, 7B and 7C illustrate alternate embodiments of device disclosed in accordance with exemplary embodiments of the present disclosure
  • FIGs. 8 and 9 illustrate how the electrode arrangement of the proposed device can be varied to generate varied airflows, in accordance with an exemplary embodiment of the present disclosure.
  • FIGs.lOA and 10B illustrate multi-electrode configuration of device disclosed in accordance with an exemplary embodiment of the present disclosure.
  • FIG.11 illustrates how a multi-electrode configuration of device disclosed can be provided a polyphase power supply in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 12 illustrates a polyphase power supply for use with a multi -electrode configuration of device disclosed in accordance with an exemplary embodiment of the present disclosure.
  • FIG.13 shows various electrodes powered by various power supplies in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 14 shows a flat configuration of the proposed device in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 15 shows how a self-sterilizing tile can be formed using proposed device in accordance with an exemplary embodiment of the present disclosure.
  • FIGs.l6A to 16C show various views of planar arrangement of electrodes on either side of a dielectric tile in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 17 shows direction of flow of air /plasma/reactive species along surface of a tile as elaborated above when the electrodes are energized in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 18 illustrates a way to direct the gases away from the surface by means of vanes that can be configured on the planar of a tile/dielectric substrate surface next to the electrodes in accordance with an exemplary embodiment of the present disclosure.
  • FIGs. 19A to 19C illustrates various electrode arrangements in a planar geometry elaborating upon flow of reactive species away from plane dielectric upon which electrode are configured, in accordance with an exemplary embodiment of the present disclosure.
  • FIGs. 20A to 20B illustrate how adjacent electrodes can be energized differently to generate different flow pattern of reactive species in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 21 shows arrangements of vanes along a cylindrical surface, whose orientation can be varied to achieve the intended reactive gas flow away from the container walls.
  • FIGs. 22A and 22B illustrates electrodes configured on vanes in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 23 illustrates how proposed device can be used to create enclosures wherein surgical devices can be placed for sterilization.
  • FIG.24 illustrates another container configuration that can be achieved by proposed device in accordance with an exemplary embodiment of the present disclosure.
  • present disclosure elaborates upon a sterilization device that can include: at least one pair of electrodes, the at least one pair of electrodes at least partially separated by a dielectric material, wherein, upon connecting the electrodes to a high voltage variable frequency power supply, atmospheric pressure plasma can be generated along at least a partial length of the electrodes to further create reactive species for sterilization.
  • the dielectric material can be any or a combination of dry air, a gas, plastic, ceramic, mica and glass.
  • the device can be configured with means to direct flow of the reactive species.
  • the device can be configured in a first enclosure and the reactive species can sterilizeat least partial inner surface of the first enclosure and any items in or around the first enclosure.
  • one of the at least one pair of electrodes can be held inside a second enclosure and another of the least one pair of electrodes can be held outside the second enclosure, and the reactive species can be generated at any or a combination of inside and outside the second enclosure.
  • first electrode of the at least one pair of electrodes can be held at least partially inside a third enclosure, the third enclosure configured to perform as second electrode of the at least one pair of electrodes.
  • first electrode of the at least one pair of electrodes can be held at least partially inside a fourth enclosure, and second electrode of the at least one pair of electrodes can be configured to be at least partially moveable over the fourth enclosure.
  • the dielectric material can be in form of a planar surface and the reactive species can sterilize surface of the planar surface.
  • the device can include a plurality of the at least one pair of electrodes, the plurality of the at least one pair or electrodes receiving same voltage or voltage varying in any or a combination of volts, frequency and phase.
  • the means can include vanes with fixed or variable angles attached to any or combination of the electrodes, the dielectric material, and an enclosure in which the device can be configured.
  • the fourth enclosure can act as the dielectric material separating the electrodes.
  • variation in the any or a combination of volts, frequency and phase can be used to vary flow of the reactive species.
  • At least one electrode of the plurality of the at least one pair of electrodes can be common.
  • At least one of the vanes can be configured with another of the at least one pair of electrodes held at least partially separated by a dielectric material to generate reactive species at the vane.
  • FIGs.lA and IB illustrate present devices that use atmospheric pressure plasma for sterilization purposes (Prior Art).
  • agas is provided via entrance 106 between two tubes 104 and 106, wherein 104 is a grounded electrode and 106 is an RF electrode.
  • the electrodes are provided suitable power via an RF source.
  • Plasma is generated as shown at 108. Plasma can as well be similarly generated at tip 130 of an inner electrode 128 surrounded by an outer electrode 126.
  • Electrorode 126 also creates a tubular structure in which gas is provided through gas inlet 124 and the electrodes are supplied power from an appropriate power source shown as 122. Similar plasma jet devices have been developed for dental applications.
  • helium gas is required for efficient operation of this device, thus making this device unsuitable for remote rural like settings.
  • the devices are relatively expensive and are not suitable for sterilizing bulk surgical equipment. Furthermore, they cannot be used to decontaminate large surfaces and need a matching power supply network to optimize the plasma, increasing the complexity and thus the cost of the device.
  • present disclosure elaborates upon a new sterilization technique using atmospheric pressure plasma (APP) that achieves same effectiveness as vacuum plasma but at lower cost using a simple, low cost device.
  • APP atmospheric pressure plasma
  • the technique proposed is also effective in places where vacuum plasma fails to penetrate such as inside surfaces of long tubes. It uses RF excitation in less than 1 MHz range. Plasma generated at this frequency is cold to touch and maintains ambient low temperature similar to room temperature.
  • FIGs. 2A and 2B illustrate how proposed device may be employed in small apertures or tubular structures such as those used in laproscopes, endoscopes, colonoscopes and catheters etc. in accordance with an exemplary embodiment of the present disclosure.
  • proposed device uses a dual electrode configuration that can be introduced into small apertures or tubular structures such as those used in laproscopes, endoscopes, colonoscopes and catheters etc. such as those illustrated in FIG.2A and FIG. 2B.
  • small apertures or tubular structures such as those used in laproscopes, endoscopes, colonoscopes and catheters etc.
  • FIG.2A and FIG. 2B As is well known, minimally invasive surgical and diagnostic procedures using such devices are gaining increasing usage. However, such devices get contaminated after each use and need to be sterilized after every such use/ procedure. Usually Hydrogen peroxide, diluted formaldehyde or other such chemical solutions is poured through the tubes to sterilize the surfaces. However, these fluids can be ineffective against certain germs that have developed immunity to chemicals of various kinds. As further elaborated, proposed device can be very effective in quickly and thoroughly sterilizing such devices having small apertures and tubular structures.
  • FIG. 3 illustrates major components and construction of device disclosed in accordance with an exemplary embodiment
  • proposed device can include two wires shown as 302A and 302B (collective termed as electrodes 302) held close to each other (but not touching) each other.
  • the electrodes 302 can be connected to a high power RF power supply 306 and ends of electrodes 302 can be terminated using rounded tips shown as 308 A and 308B.
  • plasma can be generated along length of the electrodes.
  • the plasma can create reactive oxygen and nitrogen gases (interchangeably termed herein as reactive species or gases) from air surrounding the electrodes.
  • the reactive species can be used for sterilization by directing their flow using various means as further elaborated.
  • air within the two electrodes is also acting as a dielectric. Any other dielectric can similarly be used.
  • a plastic tube of a medical device (such as a laproscope) can hold the electrodes, the reactivespecies serving to sterilize the tube and its contents, as further described.
  • proposed device can be used inside tubular medical devices such as laproscopes, endoscopes, colonoscopes and catheters and can serve to sterilize such devices.
  • electrodes 302 can be held within a covering structure (for example, the cylindrical/tubular structure shown as 304) that maybe open at its ends. As the electrodes are supplied power, plasma can be generated all along their length. Reactive species so formed can sterilize all that it gets in contact with. For instance, inner surface of tube 304 and the electrodes themselves can be sterilized. Device disclosed can generate plasma at room temperature and pressure, leading to a less complicated and cheaper device. [00099] In a similar manner, wires similar to electrodes 302 and held close to each other can be wound on external surface of tube 304 and outer surface of tube 304 can as well be sterilized.
  • FIG. 3 elaborates upon a dual electrode configuration, it can be readily appreciated that multiple sets of electrodes can be used in similar configurations.
  • the electrodes can be powered by a high voltage alternating current power supply. Such power supply operating at various voltages, currents, and frequencies can be designed and built by those skilled in the art.
  • the power supply can be tuned to match the impedance of the electrode configuration. For such a tuning a matching circuit can be used or any or a combination of voltage and frequency can be varied.
  • FIG. 4 illustrates an alternate configuration of the proposed device in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 4 illustrates an alternate configuration of the proposed device wherein the tube 304 can be provided with end plugs shown as 402A and 402B, a gas inlet 404 and a gas outlet 406. Inside surface of tube 304 may accordingly be processed. Appropriate gases such as Helium, Argon, Nitrogen etc. can be provided via gas inlet 404 and exhausted via gas outlet 406, while plasma is created in tube 304 to sterilize inner surface of the tube 304and items kept in it.
  • tube 304 can be a catheter or any other tube that needs plasma for cleaning or sterilization applications. Electrodes 302 can be made detachable from tube 304 or held together (with an intervening gap in which plasma will be created) or separately embedded inside tube 304. Only a sealed inlet for gas can be provided while the outlet could remain open.
  • tube 304 is made of insulating material, electrodes 302 can as well be put on its either side. If tube 304 is made of conducting material, an insulation material can be provided between the two electrodes when so placed.
  • FIG.5A illustrates an embodiment of device disclosed in a flexible tubular structure
  • FIGs. 5B to 5D illustrate alternate embodiments of the device disclosed in accordance with exemplary embodiments of the present disclosure
  • electrodes 302 can be flexible, enabling their insertion in a flexible tube (such as tube 502) whereby they can conform to shape of tube used, as shown in FIG. 5.
  • Plasma is generated in between the two insulated electrodes (302) and this plasma permeates in at least some region between the electrodes (302) and the outer tube (502), so sterilization can occur everywhere inside the tube 502.
  • the electrode (302) and the tube (502) is optionally covered by at least some insulating material.
  • FIG. 5B illustrates application of a high voltage variable frequency signal to electrodes 302.
  • the proposed device can have an internal insulated electrode and the high voltage variable frequency signal is applied between the insulated inner electrode (3021) and the conducting outer tube (5021) where the plasma is also generated.
  • This plasma permeates in at least some region between the electrode (3021) and the outer conducting tube (5021) that can also be optionally insulated, so sterilization can occur everywhere inside the tube(5021).
  • the tube (5021) could be a conductor, an insulator or a conductor that is at least partially covered by an insulator.
  • the inner electrode is at least a single insulated electrode and the high voltage variable frequency signal is applied between the insulated inner electrode (3022) and the conducting and moveable outer electrode (5023) placed around the tube (5022), where the plasma is also generated in the region between the inner electrode (3022) and the outer electrode (5023).
  • This plasma permeates in at least some region between the optionally insulated electrode (3022) and the outer electrode (5023) that can also be optionally insulated, so sterilization can occur everywhere inside and outside the tube(5021).
  • the tube (5022) could be a conductor, an insulator or a conductor that is at least partially covered by an insulator.
  • FIG. 5A shows application of high frequency high voltage power between the two inner electrodes that are separated by the insulation.
  • the plasma is thus generated in the area surrounding these two insulated electrodes. This plasma permeates within the surrounding tubular structure and any germs that come in contact with these electrodes will be instantaneously killed.
  • the tubular structure could be both conducting and non-conducting.
  • FIG. 5C illustrates power being applied to a conducting outer tube and an insulated inner electrode. This can generate plasma in between the inner electrode and the inner surface of the outer electrode. The insulation around the inner electrode will act like a dielectric barrier.
  • the inner electrode can be an insulated wire that conforms to the shape of the tube.
  • the outer electrode can be a concentric ring that is slid along the outer surface (from position 1 to position 2 along the path shown). When a high frequency high voltage is applied between the two electrodes plasma is created and this plasma moves along where ever the outer electrode is slid to. All germs that come in contact with the plasma thus created will be instantaneously killed. This configuration would work irrespective of the length of the tubular structure that is being sterilized.
  • FIGs.6A, 6B, 7A, 7B and 7C illustrate alternate embodiments of device disclosed in accordance with exemplary embodiments of the present disclosure.
  • electrodes can be secured directly to walls of tube that can act as dielectric.
  • electrode 602A can be fixed on inside surface of tube 604, and electrode 602B can be fixed on outside surface of tube 604..
  • both electrodes 622 A and 622B can be within tube 624, as shown in FIG.6B.
  • the tube When placed with wall of tube in between, the tube itself can provide necessary insulation between the two electrodes (or such insulation can be provided additionally to the electrodes).
  • the electrodes themselves can be insulated, irrespective of conductance of the tube 624.
  • the electrodes When configured as shown in FIG.6A, the electrodes can be flat and bare with no insulation. Hence in this configuration, tube 604 must itself be a dielectric to provide necessary conductance barrier between electrodes 602A and 602B. In such a configuration, reactive species (gases) created by plasma in tube 604 will be blown along the tube’s inside surface, causing sterilization inside the tube 604. Plasma on outside surface of tube 604, however, will blow in a direction tangential to the tube and hence will not be effective in sterilizing outer surface of the tube 604.
  • the electrodes can as well be embedded in walls of tube 604 either individually or together. However, if another suitable enclosure is used around the outer electrode and the tube, then the reactive gases can be circulated on the outer surface as well to sterilize it.
  • the tube material can be either an insulator or a conductor.
  • the electrodes 622A and 622B can be surrounded by dielectric material and stuck together. The electrodes could also be spaced apart from each other and/or the tube.
  • FIGs. 7A to 7C show more configurations for the electrodes that can be embedded inside the walls of the tubes.
  • FIGs. 7A to 7C show cross section of a tubular structure 710 with electrodes 712A and 712B embedded in it. As indicated, both size and position of electrodes 712 can be varied. By varying these parameters, flow of reactive species (that is, gases) in tube 710 can be varied, as further illustrated.
  • FIGs. 8 and 9 illustrate how the electrode arrangement of the proposed device can be varied to generate varied airflows, in accordance with an exemplary embodiment of the present disclosure.
  • Electrodes can be in shape of thin foils attached to the surface so that tube 810 does not lose its flexibility. This would be very important for flexible medical tubular instruments.
  • electrode arrangement can as well be varied to create an opposing flow of reactive species created by the plasma as indicated by 912. This creates turbulence at the bottom of tube 910and can cause the reactive species to move towards center of tube 910 without continuing to circulate.
  • FIGs.lOA and 10B illustrate multi-electrode configuration of device disclosed in accordance with an exemplary embodiment of the present disclosure.
  • FIG.10A illustrates an isometric view of a tube as elaborated above configured with multiple electrodes
  • FIG.10B illustrates a side view of the tube with multiple electrodes.
  • multiple pair of electrodes such as 1002 A and 1002B can be arranged along the surface of a cylindrical chamber or tube 1004 at different positions. When these electrodes are energized they would all produce plasma. A smooth flow of reactive species can be achieved by proper spacing of electrodes, or by using a polyphase power supply. [000124] In the geometry shown in FIG.10A and 10B, the gases flowing within the tube 1004 would be guided by the surface of the tube and therefore will move in circles.
  • Electrodes with voltages that have a phase difference can help increase the speed of the reactive species/ gases circulating within and around the tubular structure. It is not necessary that all electrode dimensions or their spacing remain equal. Appropriate dimensions can be determined by those skilled in the art through simple trial and error.
  • FIG.11 illustrates how a multi-electrode configuration of device disclosed can be provided a polyphase power supply in accordance with an exemplary embodiment of the present disclosure.
  • outer electrode 1102 can be a foil covering whole of a tube 1104 (the tube also serving as dielectric between two facing electrodes), while inner surface of the tube 1104 can be configured with multiple electrodes 1106. While the outer electrode 1102 can be grounded, a polyphase power supply can be provided to inner electrodes 1106.
  • FIG. 12 illustrates a polyphase power supply for use with a multi -electrode configuration of device disclosed in accordance with an exemplary embodiment of the present disclosure.
  • Polyphase power supply as illustrated in FIG. 12 can be used along with proposed device to create a draft of reactive gases on a planar surface.
  • an outer electrode 1202 can be in the form of a conducting sheet and can be grounded.
  • a dielectric sheet 1204 (that can be for, example, tube 304 cut axially and flattened out) can be interspersed between a common outer electrode 1202 and strips of inner electrodes shown as 1206 that can be configured on top of ( or embedded in ) dielectric sheet 1204.
  • a polyphase power supply shown as 1208 can be configured to deliver voltages off by a fixed phase to adjacent electrodes 1206.
  • Plasma 1210 can be created around each electrode 1206 in such a manner that reactive gases formed move in direction 1212 as indicated.
  • phase angle 0 can be determined as 360 °/ N where N is the number of phases per period.
  • Number of waves generated can be indicated as k, wherein k is equal to 2p/l wherein l is equal to N*L, L being distance between two electrode strips 1206.
  • Adjacent electrodes can be powered by a voltage that is off by a fixed phase.
  • the electrodes could be arranged in spiral configuration.
  • different patterns and directions of reactive species can be formed by varying different parameters pertaining to the electrodes.
  • FIG. 13 shows various electrodes powered by various power supplies in accordance with an exemplary embodiment of the present disclosure.
  • FIG. 14 shows a flat configuration of the proposed device in accordance with an exemplary embodiment of the present disclosure.
  • sets of electrodes shown as 1402A and 1402B can be placed with an insulating substrate 1404 in between in a flat configuration as shown. Electrodes 1402 can be embedded in substrate 1404.
  • the substrate 1404 can be in shape of a flat tile and can hold embedded into it electrodes in such a manner that a set of electrodes is embedded in the tile itself. In such a configuration, plasma will be close to the surface of this tile. The gases such created in this electrode configuration will move along the surface of the tile without the necessity of any moving parts. Even in vacant places on the dielectric surface 1404 where the electrodes are absent, the reactive gases created by distant electrodes arrive due to the momentum imparted to them by the varying electric fields of the electrodes and these reactive gases help sterilize such vacant surfaces.
  • a self-sterilizing tile can be formed.
  • the tile so formed can in turn be used in several structures such as, but not limited to, surgical operation theaters.
  • FIG. 15 shows how a self-sterilizing tile can be formed using proposed device in accordance with an exemplary embodiment of the present disclosure.
  • a tile base 1502 can be used to further support substrate 1404 below electrode 1402B. This can provide further sturdiness to the tile /electrode arrangement. Such an assembly can be well used in operation theaters and other places where the electrodes would also have to bear weight. Necessary grooves and glue to fill these grooves can be designed by those skilled in the art.
  • Surgical equipments may be cleaned first/debris therein removed using soap and alcohol. Thereafter, they can be sterilized simply by holding them in plasma discharge/ reactive species for a few minutes.
  • FIGs. 16A to 16C show various views of planar arrangement of electrodes on either side of a dielectric tile in accordance with an exemplary embodiment of the present disclosure.
  • electrodes 1602 A and 1602B can be configured with a planar dielectric tile 1604 between them.
  • the electrode width/length and the connection of power supply to these electrodes can be appropriately determined by those skilled in the art.
  • FIG. 17 shows direction of flow of air /plasma/reactive species along surface of a tile as elaborated above when the electrodes are energized in accordance with an exemplary embodiment of the present disclosure.
  • direction (1702) of flow of reactive species is dependent on the way the voltages at various frequencies are applied to the electrodes. Similar flow can be achieved on the bottom side of the electrode arrangement as well (when it is exposed to air). [000147] Configuration as in FIG 17 is not useful when access to reactive species is required in the volume above the electrode arrangement plate. In applications such as but not limited to medical equipment sterilization the reactive species need to be away from the surface towards the volume above the electrode arrangement (where, for instance, devices to be sterilized can be kept). This can be done in various ways as further elaborated.
  • FIG. 18 illustrates a way to direct the gases away from the surface by means of vanes that can be configured on the planar of a tile/dielectric substrate surface next to the electrodes in accordance with an exemplary embodiment of the present disclosure.
  • vanes 1802 can be oriented at various angles with respect to plane tile/substrate 1804 to get the gases flow in desired direction. Further, vanes 1802 can even be mechanically swayed from one angle to another to make the gases flow away from the surface of substrate 1804 all desired directions.
  • the angle ‘Q’ between wanes 1802 and planar dielectric/substrate 1804 can be varied anywhere from 0° to 180° and the vanes 1802 can be placed on any side of substrate 1804
  • FIGs. 19A to 19C illustrates various electrode arrangements in a planar geometry elaborating upon flow of reactive species away from plane dielectric upon which electrode are configured, in accordance with an exemplary embodiment of the present disclosure.
  • electrodes can be configured on both sides of a substrate 1904. Gas flow is illustrated on only one side of the electrode arrangement, but such gas movement can be observed on both sides of the electrode arrangement.
  • a single grounded electrode 1902 A is placed at the bottom while the upper electrode 1902B are in different segments.
  • FIG. 19B shows electrodes 1922A and 1922B being placed in an opposite manner, while FIG. 19C shows the lower electrode 1944A filling the gap in between the upper electrodes shown as 1944B.
  • Dielectric substrate 1904 separates the opposite electrodes in all cases.
  • the dimensions of 1944A and 1944B can be varied by those skilled in the art to tune the flow of reactive gases thus generated.
  • Electrode configurations such as these can be used to create reactive species and move it away from surfaceof substrate 1904 into the bulk volume above the electrodes 1902 / 1922 / 1944. When such an arrangement is used and the electrodes are evenly energized, the gases flowing upwards will be mostly in perpendicular direction perpendicular to the planar substrate. Similar flows can be observed on both sides of the substrate 1904. [000154] In order to move the upward draft at an angle the adjacent electrodes have to be energized differently, as further elaborated via FIG. 20.
  • FIGs. 20A to 20B illustrate how adjacent electrodes can be energized differently to generate different flow pattern of reactive species in accordance with an exemplary embodiment of the present disclosure.
  • a single grounded electrode 2002 can be placed at the bottom while upper electrodes 2004 can be segmented with a planar dielectric 2006 in-between electrode 2002 and electrode 2004. Each of these segmented electrodes 2004, or at least the alternating electrodes 2004 can be individually energized to create a flow as shown at 2008.
  • sets of electrodes 2020A and 2020B can be placed in an opposing manner across dielectric 2024 and power supplied to them so that intended reactive species/gas flow is achieved by simply varying the voltage and frequency to vary the velocity of the gas draft produced from each pair of electrodes.
  • Vanes can as well be configured in cylindrical structure as described via FIG. 18, FIG. 21, 22 andFIG.23.
  • FIG. 21 shows arrangements of vanes along a cylindrical surface, whose orientation can be varied to achieve the intended reactive gas flow away from the container walls.
  • the orientation of guide vanes can be determined with reference to radial lines drawn from the tip of the optionally moveable guide vanes in inward direction as shown in FIG.21 at 2102 as Q.
  • the vanes can all be oriented at the same angle with respect to the radial line or can be oriented in different directions to create the desired turbulent mixture.
  • These vanes could be fixed or mounted on moveable hinges. Those skilled in the art can easily determine the mechanism to move these vanes in the desired directions.
  • the vanes need not be parallel and can be randomly arranged, split into further segments to achieve the intended gas mixing.
  • FIGs. 22A to 22B illustrates electrodes configured on vanes in accordance with an exemplary embodiment of the present disclosure. These vanes could be fixed or mounted on moveable hinges. Those skilled in the art can easily determine the mechanism to move these vanes in the desired directions.
  • Electrodes can as well be configured on vanes instead of the planar dielectric surface, or on both of them.
  • FIG.22A illustrates a configuration wherein the electrodes 2202A and 2202B are placed on vanes 2204 and dielectric surface 2206 does not carry any electrodes.
  • FIG. 22B illustrates another configuration wherein electrodes 2202 (collectively termed) are placed both on guide vanes 2204 and planar surface 2206 carries electrodes 2224A and 2224B as shown. These vanes could be fixed or mounted on moveable hinges. Those skilled in the art can easily determine the mechanism to move these vanes in the desired directions.
  • Electrode dimensions, their placement on guide vanes, voltages and phase differences/shifts between electrodes/groups of electrodes can be optimized by those skilled in the art to generate flow of reactive species as required. For instance, placement of electrodes on both guide vanes and planar surface as shown in FIG. 22B can increase the velocity of the reactive species and hence their reach.
  • These vanes could be fixed or mounted on moveable hinges. Those skilled in the art can easily determine the mechanism to move these vanes in the desired directions.
  • FIG. 23 illustrates how proposed device can be used to create enclosures wherein instruments of interest such as but not limited to surgical devices can be placed for sterilization.
  • container 2300 can have a dielectric wall 2302 that can carry external electrodes 2304 with corresponding opposing internal electrodes shown as 2306. Further, it can have dielectric guide vanes 2308 that can as well hold electrodes (one such shown as 2310). Container 2300 can have shelves 2312 upon which items to sterilized can be kept.
  • voltage, frequency and phase difference amongst electrodes can be varied to vary pattern of flow of the reactive species. For instance, voltage to two nearby electrodes can be in opposite phase to generate counter streaming reactive gas flow. Flow/sway of gases can be electronically controlled without using any moving parts.
  • FIG.24 illustrates another container configuration that can be achieved by proposed device in accordance with an exemplary embodiment of the present disclosure.
  • a container 2400 can have dielectric side walls 2406 with a continuous outer electrode shown as 2402. Inside electrodes 2404 can be separate and energized by separate power sources as required. A single common outside electrode 2402 can reduce RF radiation. Shelf 2408can hold items to be sterilized.
  • the term “coupled to” is intended to include both direct coupling (in which two elements that are coupled to each other or in contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms “coupled to” and “coupled with” are used synonymously. .
  • the present disclosure provides for a sterilization device that is simple to operate and maintain.
  • the present disclosure provides for a sterilization device that is inexpensive.
  • the present disclosure provides for a sterilization device that does not need any specific gas for its operation.
  • the present disclosure provides for a sterilization device that can quickly and effectively sterilize flexible medical devices such as catheters, laproscopes, colonoscopes etc. [000177] The present disclosure provides for a sterilization device that can sterilize surgical equipments in bulk as well as large surfaces without needing a specific gas.

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Abstract

A device to sterilize various medical devices is disclosed. The device includes at least one pair of electrodes that are separated by a dielectric material. Upon connecting the electrodes to a high voltage RF power supply plasma is generated along length of the electrodes to further create reactive species for sterilization. The device is configured with means to direct flow of said reactive species and maybe configured in an enclosure when the reactive species sterilize inner surface of the enclosure and any items in the enclosure. Means to vary flow of reactive species are described. In a multi-electrode configuration this is done by a polyphase power supply wherein electrodes are supplied power varying in any or a combination of volts, frequency and phase to vary flow of the reactive species. Various configurations of the proposed device are described.

Description

STERILIZATION DEVICE
FIELD OF DISCLOSURE
[0001] The present disclosure relates to medical equipments and devices. In particular it pertains to a sterilization device for use in the medical industry.
BACKGROUND OF THE DISCLOSURE
[0002] The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Healthcare associated infections (HAI) are a leading cause of death even in developed countries. Most of the HAIs are caused due to lack of reliable sterilization techniques and procedures. Proper sterilization of medical devices, surgical instruments, supplies and equipment utilized in direct patient care and surgery is a critical aspect of the modern health care delivery system and directly impacts patient safety. The Association for the Advancement of Medical Instrumentation (AAMI) defines sterilization as: “A process designed to remove or destroy all viable forms of microbial life, including bacterial spores, to achieve an acceptable sterility assurance level”. Sterility is measured by probability expressed as sterility assurance level (SAL). It is generally accepted that a sterility assurance level (SAL) of 106 is appropriate for items intended to come into contact with compromised tissue, which has lost the integrity of natural body barriers. This would include sterile body cavities, tissues and vascular system. A sterility assurance level (SAL) of 106 means that there is less than or equal to one chance in a million that a particular item is contaminated or unsterile following a sterilization process.
[0004] Reusable medical devices, including surgical instruments that enter normally sterile tissue or the vascular system require sterilization before each use. Improperly sterilized or contaminated medical devices utilized in patient care can contribute to surgical site infection and pose a serious risk to the patient’s safety and welfare and can result in a serious life-threatening infection or even death.
[0005] Achieving sterilization is contingent on right conditions to destroy living organisms, through cleaning of devices to be sterilized and good contact between the sterilant and all surfaces and crevices of the device to be sterilized both physically and for sufficient duration of time to ensure the intended sterilization occurs. Further, it is also important that medical devices are properly inspected, assembled, packaged, and loaded into the sterilizer in accordance with established procedures and techniques.
[0006] Conventional sterilization involves the use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial pores. The major sterilizing agents commonly used in healthcare facilities today are a) saturated steam, b) ethylene oxide gas, c) liquid chemicals d) Dry heat, e) hydrogen peroxide gas plasma f) Ultraviolet light, g) Gamma radiationand h) Ozone. Various conventional sterilization methods presently in use are as elaborated hereunder.
[0007] Saturated steam under pressure is the oldest and most widely used, economical, effective and reliable method of sterilization available to health care facilities. Pressurized steam at high temperature is used to kill various microorganisms. However, due to the very high temperatures and moisture associated with steam sterilization it may only be used with heat and moisture stable medical devices, instruments and compatible materials.
[0008] Ethylene Oxide (EO) is a low temperature sterilization method that has been used for decades. The low temperature process makes it suitable for the sterilization of heat and moisture sensitive medical devices that cannot tolerate the high temperatures and moisture associated with steam sterilization. EO is a colorless gas, which destroys microorganisms by a process called alkylation. The EO penetrates the cells membrane and reacts with the nuclear material rendering it unable to metabolize and reproduce. However, EO has disadvantages. It has a relatively long sterilization cycle and needs aeration for a specified amount of time. Further, EO is toxic and porous materials exposed to EO will absorb the toxic gas requiring aeration following the sterilization process to allow the residue to escape from the medical devices before they are handled and used. EO is extremely flammable in its pure form and requires that special precautions be taken in its storage and use. Furthermore, EO is also a known carcinogen and known workplace hazard. All this requires for complicated equipment to be used and extensive monitoring to be implemented.
[0009] Liquid chemical sterilization is utilized for the sterilization of heat sensitive devices that can be immersed. This method employs the use of a germicidal solution and requires the complete immersion of items in the solution for a prescribed period of time to kill microorganisms. Peracetic acid, Glutaraldehyde etc. are used. However, devices that are sterilized by this method are intended for just-in-time use and have no shelf life. Glutaraldehyde generates toxic fumes, and the process has potential for contamination of sterile devices during rinsing and transfer to the area of use, and no method to biologically monitor the sterilization process. A well-ventilated work environment is required and personal protective equipment such as gloves and face masks must be used.
[00010] Dry heat sterilization is used to sterilize anhydrous (waterless) items that can withstand high temperatures. The destruction of organisms occurs by oxidation, which is a slow burning up process of coagulating the cells protein. It is not in much use nowadays as it is a long sterilization process due to the length of time it takes for objects to reach required temperatures. [00011] Irradiation (using Gamma, Beta rays) is an effective sterilization method, but it is limited to commercial use only. The product to be sterilized is exposed to radiation for 10 to 20 hours, depending on the strength of the source. The highest temperatures reached in gamma sterilization are usually 30-40°C. Gamma radiation is popular for sterilizing before shipment and it can be done through the packaging. Ionizing radiation produces ions by knocking electrons out of atoms. These electrons are knocked out violently and strike an adjacent atom and either attach themselves to it, or dislodge an electron from the second atom. The result is ionic energy that becomes converted to thermal and chemical energy. This energy kills microorganisms by disruption of the DNA molecule, therefore preventing cellular division and propagation of biologic life. The principal sources of ionizing radiation are beta particles and gamma rays. The procedures, however, require high voltage machines and the usefulness of this method in sterilizing an object is limited by the density, thickness of the object and by the energy of the electrons. As said, usage of this method is largely limited to commercial use.
[00012] Gas Plasma is a low temperature sterilization alternative that has been available for several years and is suitable for many heat sensitive and moisture sensitive or moisture stable medical devices. Unlike EO sterilization, gas plasma sterilization is devoid of the occupational, environmental and patient safety concerns. Gas plasma have total cycle times that are significantly less than EO and medical devices so sterilized are ready for use following sterilization without the need for aeration. However, the major disadvantage of this system is that it is extremely expensive and unaffordable by most medical establishments. Especially in rural settings, this equipment cannot be serviced and is difficult to maintain owing to its complexity. [00013] Atmospheric pressure plasma (APP) is, as the name suggests, a plasma in which the gas pressure approximately matches that of the surrounding atmosphere (ambient pressure). In contrast with low-pressure plasma or high-pressure plasma no reaction chamber is needed to ensure the maintenance of a pressure level differing from atmospheric pressure. The need for cost-intensive chambers for producing a partial vacuum as used in low-pressure plasma technology is eliminated, thus making them inherently cost effective. There are several different ways in which APP could be generated such as (1) RF (Radio Frequency) excitation (2) AC (Alternating Current) excitation (3) DC (Direct Current) excitation and(4) Microwave excitation. [00014] Some devices using APP have been developed in recent years. They, however, generate plasma only in a limited portion of their electrodes (for example tip of an electrode) and need special gases such as Helium for their operation. The devices available are expensive and use complicated power supplies and/or constructional features. Besides, they are not suitable for sterilizing bulk surgical equipment and cannot be used to sterilize/ decontaminate large surfaces. They need a complex matching power supply network to optimize plasma generation.
[00015] There is, therefore, a need in the art for a sterilizing device using APP that does not necessarily require any gas for its operation, is simple to operate and maintain, and is inexpensive. The device should be able to sterilize bulk surgical equipment simultaneously, as well as large surfaces without needing a complex matching power supply network to optimize the plasma generated.
[00016] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[00017] In some embodiments, the numbers expressing quantities or dimensions of items, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[00018] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
[00019] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.
OBJECTS OF THE DISCLOSURE
[00020] Some of the objects of the present disclosure, which at least one embodiment herein satisfies are as listed herein below.
[00021] It is an object of the present disclosure to provide for a sterilization device that is simple to operate and maintain.
[00022] It is another object of the present disclosure to provide for a sterilization device that is inexpensive. [00023] It is yet another object of the present disclosure to provide for a sterilization device that does not need any specific gas for its operation.
[00024] It is an object of the present disclosure to provide for a sterilization device that can quickly and effectively sterilize flexible medical devices such as catheters, laproscopes, colonoscopes etc.
[00025] It is another object of the present disclosure to provide for a sterilization device that can sterilize surgical equipments in bulk as well as large surfaces without needing a complex power supply.
SUMMARY
[00026] The present disclosure relates to medical equipments and devices. In particular it pertains to a sterilization device for use in the medical industry.
[00027] This summary is provided to introduce simplified concepts of a sterilization device which are further described below in the Detailed Description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended for use in determining/limiting the scope of the claimed subject matter.
[00028] In an aspect, present disclosure elaborates upon a sterilization device that can include: at least one pair of electrodes, the at least one pair of electrodes at least partially separated by a dielectric material, wherein, upon connecting the electrodes to a high voltage variable frequency power supply, atmospheric pressure plasma can be generated along at least a partial length of the electrodes to further create reactive species for sterilization.
[00029] In another aspect, the dielectric material can be any or a combination of dry air, a gas, plastic, ceramic, mica and glass.
[00030] In yet another aspect, the device can be configured with means to direct flow of the reactive species.
[00031] In an aspect, the device can be configured in a first enclosure and the reactive species can sterilizeat least partial inner surface of the first enclosure and any items in or around the first enclosure.
[00032] In another aspect, one of the at least one pair of electrodes can be held inside a second enclosure and another of the least one pair of electrodes can be held outside the second enclosure, and the reactive species can be generated at any or a combination of inside and outside the second enclosure.
[00033] In yet another aspect, first electrode of the at least one pair of electrodes can be held at least partially inside a third enclosure, the third enclosure configured to perform as second electrode of the at least one pair of electrodes.
[00034] In an aspect, first electrode of the at least one pair of electrodes can be held at least partially inside a fourth enclosure, and second electrode of the at least one pair of electrodes can be configured to be at least partially moveable over the fourth enclosure.
[00035] In another aspect, the dielectric material can be in form of a planar surface and the reactive species can sterilize surface of the planar surface.
[00036] In an aspect, the device can include a plurality of the at least one pair of electrodes, the plurality of the at least one pair or electrodes receiving same voltage or voltage varying in any or a combination of volts, frequency and phase.
[00037] In another aspect, the means can include vanes with fixed or variable angles attached to any or combination of the electrodes, the dielectric material, and an enclosure in which the device can be configured.
[00038] In yet another aspect, the fourth enclosure can act as the dielectric material separating the electrodes.
[00039] In an aspect, variation in the any or a combination of volts, frequency and phase can be used to vary flow of the reactive species.
[00040] In another aspect, at least one electrode of the plurality of the at least one pair of electrodes can be common.
[00041] In yet another aspect, at least one of the vanes can be configured with another of the at least one pair of electrodes held at least partially separated by a dielectric material to generate reactive species at the vane.
[00042] Within the scope of this application it is expressly envisaged that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, in the claims and/or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible. [00043] Various objects, features, aspects and advantages of the present disclosure will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like features.
BRIEF DESCRIPTION OF DRAWINGS
[00044] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure, and wherein:
[00045] FIGs. 1A and IB illustrate present devices that use atmospheric pressure plasma for sterilization purposes (Prior Art).
[00046] FIGs. 2A and 2B illustrate how proposed device may be employed in small apertures or tubular structures such as those used in laproscopes, endoscopes, colonoscopes, catheters etc. in accordance with an exemplary embodiment of the present disclosure.
[00047] FIG. 3 illustrates major components and construction of device disclosed in accordance with an exemplary embodiment of the present disclosure.
[00048] FIG. 4 illustrates an alternate configuration of the proposed device in accordance with an exemplary embodiment of the present disclosure.
[00049] FIG. 5A illustrates an embodiment of device disclosed in a flexible tubular structure in accordance with an exemplary embodiment of the present disclosure.
[00050] FIGs. 5B, 5C, 5D, 6A, 6B, 7A, 7B and 7C illustrate alternate embodiments of device disclosed in accordance with exemplary embodiments of the present disclosure [00051] FIGs. 8 and 9 illustrate how the electrode arrangement of the proposed device can be varied to generate varied airflows, in accordance with an exemplary embodiment of the present disclosure.
[00052] FIGs.lOA and 10B illustrate multi-electrode configuration of device disclosed in accordance with an exemplary embodiment of the present disclosure.
[00053] FIG.11 illustrates how a multi-electrode configuration of device disclosed can be provided a polyphase power supply in accordance with an exemplary embodiment of the present disclosure. [00054] FIG. 12 illustrates a polyphase power supply for use with a multi -electrode configuration of device disclosed in accordance with an exemplary embodiment of the present disclosure.
[00055] FIG.13 shows various electrodes powered by various power supplies in accordance with an exemplary embodiment of the present disclosure.
[00056] FIG. 14 shows a flat configuration of the proposed device in accordance with an exemplary embodiment of the present disclosure.
[00057] FIG. 15 shows how a self-sterilizing tile can be formed using proposed device in accordance with an exemplary embodiment of the present disclosure.
[00058] FIGs.l6A to 16C show various views of planar arrangement of electrodes on either side of a dielectric tile in accordance with an exemplary embodiment of the present disclosure.
[00059] FIG. 17 shows direction of flow of air /plasma/reactive species along surface of a tile as elaborated above when the electrodes are energized in accordance with an exemplary embodiment of the present disclosure.
[00060] FIG. 18 illustrates a way to direct the gases away from the surface by means of vanes that can be configured on the planar of a tile/dielectric substrate surface next to the electrodes in accordance with an exemplary embodiment of the present disclosure.
[00061] FIGs. 19A to 19C illustrates various electrode arrangements in a planar geometry elaborating upon flow of reactive species away from plane dielectric upon which electrode are configured, in accordance with an exemplary embodiment of the present disclosure.
[00062] FIGs. 20A to 20B illustrate how adjacent electrodes can be energized differently to generate different flow pattern of reactive species in accordance with an exemplary embodiment of the present disclosure.
[00063] FIG. 21 shows arrangements of vanes along a cylindrical surface, whose orientation can be varied to achieve the intended reactive gas flow away from the container walls.
[00064] FIGs. 22A and 22B illustrates electrodes configured on vanes in accordance with an exemplary embodiment of the present disclosure.
[00065] FIG. 23 illustrates how proposed device can be used to create enclosures wherein surgical devices can be placed for sterilization. [00066] FIG.24 illustrates another container configuration that can be achieved by proposed device in accordance with an exemplary embodiment of the present disclosure.
DETAILED DESCRIPTION
[00067] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.
[00068] In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. It will be apparent to one skilled in the art that embodiments of the present invention may be practiced without some of these specific details.
[00069] If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.
[00070] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[00071] Exemplary embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. These exemplary embodiments are provided only for illustrative purposes and so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those of ordinary skill in the art. The invention disclosed may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Various modifications will be readily apparent to persons skilled in the art. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Moreover, all statements herein reciting embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.
[00072] Each of the appended claims defines a separate invention, which for infringement purposes is recognized as including equivalents to the various elements or limitations specified in the claims. Depending on the context, all references below to the "invention" may in some cases refer to certain specific embodiments only. In other cases it will be recognized that references to the "invention" will refer to subject matter recited in one or more, but not necessarily all, of the claims.
[00073] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing. [00074] In an aspect, present disclosure elaborates upon a sterilization device that can include: at least one pair of electrodes, the at least one pair of electrodes at least partially separated by a dielectric material, wherein, upon connecting the electrodes to a high voltage variable frequency power supply, atmospheric pressure plasma can be generated along at least a partial length of the electrodes to further create reactive species for sterilization.
[00075] In another aspect, the dielectric material can be any or a combination of dry air, a gas, plastic, ceramic, mica and glass.
[00076] In yet another aspect, the device can be configured with means to direct flow of the reactive species.
[00077] In an aspect, the device can be configured in a first enclosure and the reactive species can sterilizeat least partial inner surface of the first enclosure and any items in or around the first enclosure. [00078] In another aspect, one of the at least one pair of electrodes can be held inside a second enclosure and another of the least one pair of electrodes can be held outside the second enclosure, and the reactive species can be generated at any or a combination of inside and outside the second enclosure.
[00079] In yet another aspect, first electrode of the at least one pair of electrodes can be held at least partially inside a third enclosure, the third enclosure configured to perform as second electrode of the at least one pair of electrodes.
[00080] In an aspect, first electrode of the at least one pair of electrodes can be held at least partially inside a fourth enclosure, and second electrode of the at least one pair of electrodes can be configured to be at least partially moveable over the fourth enclosure.
[00081] In another aspect, the dielectric material can be in form of a planar surface and the reactive species can sterilize surface of the planar surface.
[00082] In an aspect, the device can include a plurality of the at least one pair of electrodes, the plurality of the at least one pair or electrodes receiving same voltage or voltage varying in any or a combination of volts, frequency and phase.
[00083] In another aspect, the means can include vanes with fixed or variable angles attached to any or combination of the electrodes, the dielectric material, and an enclosure in which the device can be configured.
[00084] In yet another aspect, the fourth enclosure can act as the dielectric material separating the electrodes.
[00085] In an aspect, variation in the any or a combination of volts, frequency and phase can be used to vary flow of the reactive species.
[00086] In another aspect, at least one electrode of the plurality of the at least one pair of electrodes can be common.
[00087] In yet another aspect, at least one of the vanes can be configured with another of the at least one pair of electrodes held at least partially separated by a dielectric material to generate reactive species at the vane.
[00088] FIGs.lA and IB illustrate present devices that use atmospheric pressure plasma for sterilization purposes (Prior Art).
[00089] As illustrated in FIG. 1A, agas is provided via entrance 106 between two tubes 104 and 106, wherein 104 is a grounded electrode and 106 is an RF electrode. The electrodes are provided suitable power via an RF source. Plasma is generated as shown at 108. Plasma can as well be similarly generated at tip 130 of an inner electrode 128 surrounded by an outer electrode 126.Electrode 126 also creates a tubular structure in which gas is provided through gas inlet 124 and the electrodes are supplied power from an appropriate power source shown as 122. Similar plasma jet devices have been developed for dental applications.
[00090] However, helium gas is required for efficient operation of this device, thus making this device unsuitable for remote rural like settings. The devices are relatively expensive and are not suitable for sterilizing bulk surgical equipment. Furthermore, they cannot be used to decontaminate large surfaces and need a matching power supply network to optimize the plasma, increasing the complexity and thus the cost of the device.
[00091] In an aspect, present disclosure elaborates upon a new sterilization technique using atmospheric pressure plasma (APP) that achieves same effectiveness as vacuum plasma but at lower cost using a simple, low cost device.
[00092] The technique proposed is also effective in places where vacuum plasma fails to penetrate such as inside surfaces of long tubes. It uses RF excitation in less than 1 MHz range. Plasma generated at this frequency is cold to touch and maintains ambient low temperature similar to room temperature.
[00093] FIGs. 2A and 2B illustrate how proposed device may be employed in small apertures or tubular structures such as those used in laproscopes, endoscopes, colonoscopes and catheters etc. in accordance with an exemplary embodiment of the present disclosure.
[00094] In an aspect, proposed device uses a dual electrode configuration that can be introduced into small apertures or tubular structures such as those used in laproscopes, endoscopes, colonoscopes and catheters etc. such as those illustrated in FIG.2A and FIG. 2B. As is well known, minimally invasive surgical and diagnostic procedures using such devices are gaining increasing usage. However, such devices get contaminated after each use and need to be sterilized after every such use/ procedure. Usually Hydrogen peroxide, diluted formaldehyde or other such chemical solutions is poured through the tubes to sterilize the surfaces. However, these fluids can be ineffective against certain germs that have developed immunity to chemicals of various kinds. As further elaborated, proposed device can be very effective in quickly and thoroughly sterilizing such devices having small apertures and tubular structures. [00095] FIG. 3 illustrates major components and construction of device disclosed in accordance with an exemplary embodiment of the present disclosure.
[00096] As illustrated in FIG. 3, proposed device can include two wires shown as 302A and 302B (collective termed as electrodes 302) held close to each other (but not touching) each other. The electrodes 302 can be connected to a high power RF power supply 306 and ends of electrodes 302 can be terminated using rounded tips shown as 308 A and 308B. Upon providing appropriate power to the electrodes, plasma can be generated along length of the electrodes. The plasma can create reactive oxygen and nitrogen gases (interchangeably termed herein as reactive species or gases) from air surrounding the electrodes. The reactive species can be used for sterilization by directing their flow using various means as further elaborated.
[00097] It can be readily understood that air within the two electrodes is also acting as a dielectric. Any other dielectric can similarly be used. A plastic tube of a medical device (such as a laproscope) can hold the electrodes, the reactivespecies serving to sterilize the tube and its contents, as further described. In this manner, proposed device can be used inside tubular medical devices such as laproscopes, endoscopes, colonoscopes and catheters and can serve to sterilize such devices.
[00098] In an exemplary embodiment, electrodes 302 can be held within a covering structure (for example, the cylindrical/tubular structure shown as 304) that maybe open at its ends. As the electrodes are supplied power, plasma can be generated all along their length. Reactive species so formed can sterilize all that it gets in contact with. For instance, inner surface of tube 304 and the electrodes themselves can be sterilized. Device disclosed can generate plasma at room temperature and pressure, leading to a less complicated and cheaper device. [00099] In a similar manner, wires similar to electrodes 302 and held close to each other can be wound on external surface of tube 304 and outer surface of tube 304 can as well be sterilized.
[000100] While FIG. 3 elaborates upon a dual electrode configuration, it can be readily appreciated that multiple sets of electrodes can be used in similar configurations. The electrodes can be powered by a high voltage alternating current power supply. Such power supply operating at various voltages, currents, and frequencies can be designed and built by those skilled in the art. The power supply can be tuned to match the impedance of the electrode configuration. For such a tuning a matching circuit can be used or any or a combination of voltage and frequency can be varied.
[000101] FIG. 4 illustrates an alternate configuration of the proposed device in accordance with an exemplary embodiment of the present disclosure.
[000102] FIG. 4 illustrates an alternate configuration of the proposed device wherein the tube 304 can be provided with end plugs shown as 402A and 402B, a gas inlet 404 and a gas outlet 406. Inside surface of tube 304 may accordingly be processed. Appropriate gases such as Helium, Argon, Nitrogen etc. can be provided via gas inlet 404 and exhausted via gas outlet 406, while plasma is created in tube 304 to sterilize inner surface of the tube 304and items kept in it. [000103] In various exemplary embodiments, tube 304 can be a catheter or any other tube that needs plasma for cleaning or sterilization applications. Electrodes 302 can be made detachable from tube 304 or held together (with an intervening gap in which plasma will be created) or separately embedded inside tube 304. Only a sealed inlet for gas can be provided while the outlet could remain open.
[000104] In case tube 304 is made of insulating material, electrodes 302 can as well be put on its either side. If tube 304 is made of conducting material, an insulation material can be provided between the two electrodes when so placed.
[000105] FIG.5A illustrates an embodiment of device disclosed in a flexible tubular structure, while FIGs. 5B to 5D illustrate alternate embodiments of the device disclosed in accordance with exemplary embodiments of the present disclosure
[000106] In an aspect, electrodes 302 can be flexible, enabling their insertion in a flexible tube (such as tube 502) whereby they can conform to shape of tube used, as shown in FIG. 5. Plasma is generated in between the two insulated electrodes (302) and this plasma permeates in at least some region between the electrodes (302) and the outer tube (502), so sterilization can occur everywhere inside the tube 502. The electrode (302) and the tube (502) is optionally covered by at least some insulating material. The ability to sterilize flexible tubular structures such as laproscopes etc. is a major advantage of proposed device. FIG. 5B illustrates application of a high voltage variable frequency signal to electrodes 302.
[000107] In another aspect, as shown in FIG. 5C, the proposed device can have an internal insulated electrode and the high voltage variable frequency signal is applied between the insulated inner electrode (3021) and the conducting outer tube (5021) where the plasma is also generated. This plasma permeates in at least some region between the electrode (3021) and the outer conducting tube (5021) that can also be optionally insulated, so sterilization can occur everywhere inside the tube(5021). The tube (5021) could be a conductor, an insulator or a conductor that is at least partially covered by an insulator.
[000108] In another aspect, as shown in FIG. 5Dthe inner electrode is at least a single insulated electrode and the high voltage variable frequency signal is applied between the insulated inner electrode (3022) and the conducting and moveable outer electrode (5023) placed around the tube (5022), where the plasma is also generated in the region between the inner electrode (3022) and the outer electrode (5023). This plasma permeates in at least some region between the optionally insulated electrode (3022) and the outer electrode (5023) that can also be optionally insulated, so sterilization can occur everywhere inside and outside the tube(5021). The tube (5022) could be a conductor, an insulator or a conductor that is at least partially covered by an insulator.
[000109] In this manner, as shown in FIG. 5A, electrodes can be introduced and subsequently removed from the tube 502 after tube/items within the tube have been sterilized. In this way, valuable space inside the tube can be better utilized. FIG. 5B shows application of high frequency high voltage power between the two inner electrodes that are separated by the insulation. The plasma is thus generated in the area surrounding these two insulated electrodes. This plasma permeates within the surrounding tubular structure and any germs that come in contact with these electrodes will be instantaneously killed. The tubular structure could be both conducting and non-conducting.
[000110] FIG. 5C illustrates power being applied to a conducting outer tube and an insulated inner electrode. This can generate plasma in between the inner electrode and the inner surface of the outer electrode. The insulation around the inner electrode will act like a dielectric barrier. As illustrated in FIG. 5D, the inner electrode can be an insulated wire that conforms to the shape of the tube. The outer electrode can be a concentric ring that is slid along the outer surface (from position 1 to position 2 along the path shown). When a high frequency high voltage is applied between the two electrodes plasma is created and this plasma moves along where ever the outer electrode is slid to. All germs that come in contact with the plasma thus created will be instantaneously killed. This configuration would work irrespective of the length of the tubular structure that is being sterilized. [000111] FIGs.6A, 6B, 7A, 7B and 7C illustrate alternate embodiments of device disclosed in accordance with exemplary embodiments of the present disclosure.
[000112] In an exemplary embodiment, electrodes can be secured directly to walls of tube that can act as dielectric. For instance, as shown in FIG. 6A, electrode 602A can be fixed on inside surface of tube 604, and electrode 602B can be fixed on outside surface of tube 604.. Or both electrodes 622 A and 622B can be within tube 624, as shown in FIG.6B. When placed with wall of tube in between, the tube itself can provide necessary insulation between the two electrodes (or such insulation can be provided additionally to the electrodes). When configured inside tube 624 (as in FIG. 6B), the electrodes themselves can be insulated, irrespective of conductance of the tube 624.
[000113] When configured as shown in FIG.6A, the electrodes can be flat and bare with no insulation. Hence in this configuration, tube 604 must itself be a dielectric to provide necessary conductance barrier between electrodes 602A and 602B. In such a configuration, reactive species (gases) created by plasma in tube 604 will be blown along the tube’s inside surface, causing sterilization inside the tube 604. Plasma on outside surface of tube 604, however, will blow in a direction tangential to the tube and hence will not be effective in sterilizing outer surface of the tube 604. In another aspect, the electrodes can as well be embedded in walls of tube 604 either individually or together. However, if another suitable enclosure is used around the outer electrode and the tube, then the reactive gases can be circulated on the outer surface as well to sterilize it.
[000114] In the configuration as shown in FIG.6B, the tube material can be either an insulator or a conductor. The electrodes 622A and 622B can be surrounded by dielectric material and stuck together. The electrodes could also be spaced apart from each other and/or the tube.
[000115] FIGs. 7A to 7C show more configurations for the electrodes that can be embedded inside the walls of the tubes.
[000116] FIGs. 7A to 7C show cross section of a tubular structure 710 with electrodes 712A and 712B embedded in it. As indicated, both size and position of electrodes 712 can be varied. By varying these parameters, flow of reactive species (that is, gases) in tube 710 can be varied, as further illustrated. [000117] FIGs. 8 and 9 illustrate how the electrode arrangement of the proposed device can be varied to generate varied airflows, in accordance with an exemplary embodiment of the present disclosure.
[000118] The plasma could be generated within tube 810 by energizing the electrodes 812A and 812B shown in FIG. 8. Electrodes can be in shape of thin foils attached to the surface so that tube 810 does not lose its flexibility. This would be very important for flexible medical tubular instruments.
[000119] When the electrodes are energized the plasma created would generate a draft of reactive species close to tube 810 in direction 814 illustrated, as shown in FIG. 8. The reactive species/ gases will tend to circulate along the surface of tube 810, guided by the curvature of the walls of tube 810. Direction 814 could be reversed by either changing the polarity or by changing the geometry or alignment of the electrodes.
[000120] As illustrated in FIG.9, electrode arrangement can as well be varied to create an opposing flow of reactive species created by the plasma as indicated by 912. This creates turbulence at the bottom of tube 910and can cause the reactive species to move towards center of tube 910 without continuing to circulate.
[000121] FIGs.lOA and 10B illustrate multi-electrode configuration of device disclosed in accordance with an exemplary embodiment of the present disclosure.
[000122] FIG.10A illustrates an isometric view of a tube as elaborated above configured with multiple electrodes, while FIG.10B illustrates a side view of the tube with multiple electrodes.
[000123] As illustrated in FIG. 10 A, multiple pair of electrodes such as 1002 A and 1002B can be arranged along the surface of a cylindrical chamber or tube 1004 at different positions. When these electrodes are energized they would all produce plasma. A smooth flow of reactive species can be achieved by proper spacing of electrodes, or by using a polyphase power supply. [000124] In the geometry shown in FIG.10A and 10B, the gases flowing within the tube 1004would be guided by the surface of the tube and therefore will move in circles.
[000125] Energizing the electrodes with voltages that have a phase difference can help increase the speed of the reactive species/ gases circulating within and around the tubular structure. It is not necessary that all electrode dimensions or their spacing remain equal. Appropriate dimensions can be determined by those skilled in the art through simple trial and error.
[000126] FIG.11 illustrates how a multi-electrode configuration of device disclosed can be provided a polyphase power supply in accordance with an exemplary embodiment of the present disclosure.
[000127] As illustrated in FIG.11, outer electrode 1102 can be a foil covering whole of a tube 1104 (the tube also serving as dielectric between two facing electrodes), while inner surface of the tube 1104 can be configured with multiple electrodes 1106. While the outer electrode 1102 can be grounded, a polyphase power supply can be provided to inner electrodes 1106. [000128] FIG. 12 illustrates a polyphase power supply for use with a multi -electrode configuration of device disclosed in accordance with an exemplary embodiment of the present disclosure.
[000129] Polyphase power supply as illustrated in FIG. 12 can be used along with proposed device to create a draft of reactive gases on a planar surface.
[000130] As illustrated, an outer electrode 1202 can be in the form of a conducting sheet and can be grounded. A dielectric sheet 1204 ( that can be for, example, tube 304 cut axially and flattened out) can be interspersed between a common outer electrode 1202 and strips of inner electrodes shown as 1206 that can be configured on top of ( or embedded in ) dielectric sheet 1204. A polyphase power supply shown as 1208 can be configured to deliver voltages off by a fixed phase to adjacent electrodes 1206. Plasma 1210 can be created around each electrode 1206 in such a manner that reactive gases formed move in direction 1212 as indicated.
[000131] As known, phase angle 0 can be determined as 360 °/ N where N is the number of phases per period. Number of waves generated can be indicated as k, wherein k is equal to 2p/l wherein l is equal to N*L, L being distance between two electrode strips 1206. Electrostatic wave propagation can be represented by V=V0sin(coi+ kx). This equation and the figure 14 were derived by J. Reece Roth in his book Industrial plasma engineering, vol. 2, Applications of plasma processing, pg. 237, IOP publishing ltd (2001). In this book, only planar movement of gases has been explained and no attempt has been made in literature to direct the gases away from the surface as is done in the present invention, in multiple geometries.
[000132] It can easily be appreciated that such a power supply can as well be used when sheet 1204 is rolled into a cylinder. Adjacent electrodes can be powered by a voltage that is off by a fixed phase. In yet another configuration the electrodes could be arranged in spiral configuration. Further, different patterns and directions of reactive species can be formed by varying different parameters pertaining to the electrodes.
[000133] FIG. 13 shows various electrodes powered by various power supplies in accordance with an exemplary embodiment of the present disclosure.
[000134] As illustrated in FIG. 13, different electrode sets (for instance set 1302, set 1304 etc. as shown) can be powered by different power supplies. The voltage, and frequency of these power supplies can be varied as needed to create draft of gases in the desired directions within the cylinder 1306 shown or any other geometry chosen for this application. The electrodes can be so configured that the gases are forced to move away from surface of cylinder 1306. Furthermore, by adjusting the velocity of the gases one could change the direction of the gases and make them sway from side to side depending on the applied power supply conditions. [000135] FIG. 14 shows a flat configuration of the proposed device in accordance with an exemplary embodiment of the present disclosure.
[000136] As indicated in FIG.14, sets of electrodes shown as 1402A and 1402B (collectively termed as 1402) can be placed with an insulating substrate 1404 in between in a flat configuration as shown. Electrodes 1402 can be embedded in substrate 1404.
[000137] In an exemplary embodiment, the substrate 1404 can be in shape of a flat tile and can hold embedded into it electrodes in such a manner that a set of electrodes is embedded in the tile itself. In such a configuration, plasma will be close to the surface of this tile. The gases such created in this electrode configuration will move along the surface of the tile without the necessity of any moving parts. Even in vacant places on the dielectric surface 1404 where the electrodes are absent, the reactive gases created by distant electrodes arrive due to the momentum imparted to them by the varying electric fields of the electrodes and these reactive gases help sterilize such vacant surfaces.
[000138] In this manner, a self-sterilizing tile can be formed. The tile so formed can in turn be used in several structures such as, but not limited to, surgical operation theaters.
[000139] FIG. 15 shows how a self-sterilizing tile can be formed using proposed device in accordance with an exemplary embodiment of the present disclosure.
[000140] As illustrated FIG.15, a tile base 1502 can be used to further support substrate 1404 below electrode 1402B. This can provide further sturdiness to the tile /electrode arrangement. Such an assembly can be well used in operation theaters and other places where the electrodes would also have to bear weight. Necessary grooves and glue to fill these grooves can be designed by those skilled in the art.
[000141] As can be appreciated, various surfaces being described herein including as elaborated in FIG. 14 and 15 above can be sterilized by simply providing electric power to various electrodes. This can be as simple as flicking one/ more switches and thereafter waiting for a few minutes. This can be a major advantage since conventionally, operation theaters are sterilized infrequently and sometimes only once a month as it takes a couple of days to accomplish sterilization using dangerous gases such as Ethelene Oxide (EtO) gas. Using the tiles as shown in FIG. 15, the entire operation theatre could be sterilized after every operation without any harmful chemicals. As can be readily understood, the ability to sterilize/disinfect the Operation theatre after every surgery can help bring down bacterial load therein and so substantially reduce Healthcare Associated Infections (HAIs). Various configurations of device disclosed can thus address sterilization requirements both in urban and rural /remote areas. [000142] Surgical equipments may be cleaned first/debris therein removed using soap and alcohol. Thereafter, they can be sterilized simply by holding them in plasma discharge/ reactive species for a few minutes.
[000143] FIGs. 16A to 16C show various views of planar arrangement of electrodes on either side of a dielectric tile in accordance with an exemplary embodiment of the present disclosure.
[000144] As shown in FIG. 16, electrodes 1602 A and 1602B (collectively termed as 1602) can be configured with a planar dielectric tile 1604 between them. The electrode width/length and the connection of power supply to these electrodes can be appropriately determined by those skilled in the art.
[000145] FIG. 17 shows direction of flow of air /plasma/reactive species along surface of a tile as elaborated above when the electrodes are energized in accordance with an exemplary embodiment of the present disclosure.
[000146] As can be appreciated, direction (1702) of flow of reactive species is dependent on the way the voltages at various frequencies are applied to the electrodes. Similar flow can be achieved on the bottom side of the electrode arrangement as well (when it is exposed to air). [000147] Configuration as in FIG 17 is not useful when access to reactive species is required in the volume above the electrode arrangement plate. In applications such as but not limited to medical equipment sterilization the reactive species need to be away from the surface towards the volume above the electrode arrangement (where, for instance, devices to be sterilized can be kept). This can be done in various ways as further elaborated.
[000148] FIG. 18 illustrates a way to direct the gases away from the surface by means of vanes that can be configured on the planar of a tile/dielectric substrate surface next to the electrodes in accordance with an exemplary embodiment of the present disclosure.
[000149] As illustrated, vanes 1802 can be oriented at various angles with respect to plane tile/substrate 1804 to get the gases flow in desired direction. Further, vanes 1802 can even be mechanically swayed from one angle to another to make the gases flow away from the surface of substrate 1804 all desired directions. The angle ‘Q’ between wanes 1802 and planar dielectric/substrate 1804 can be varied anywhere from 0° to 180° and the vanes 1802 can be placed on any side of substrate 1804
[000150] FIGs. 19A to 19C illustrates various electrode arrangements in a planar geometry elaborating upon flow of reactive species away from plane dielectric upon which electrode are configured, in accordance with an exemplary embodiment of the present disclosure.
[000151] As illustrated in FIGs. 19A to 19C, electrodes can be configured on both sides of a substrate 1904. Gas flow is illustrated on only one side of the electrode arrangement, but such gas movement can be observed on both sides of the electrode arrangement.
[000152] In Fig. 19 A, a single grounded electrode 1902 A is placed at the bottom while the upper electrode 1902B are in different segments. FIG. 19B shows electrodes 1922A and 1922B being placed in an opposite manner, while FIG. 19C shows the lower electrode 1944A filling the gap in between the upper electrodes shown as 1944B. Dielectric substrate 1904 separates the opposite electrodes in all cases. The dimensions of 1944A and 1944B can be varied by those skilled in the art to tune the flow of reactive gases thus generated.
[000153] Electrode configurations such as these can be used to create reactive species and move it away from surfaceof substrate 1904 into the bulk volume above the electrodes 1902 / 1922 / 1944. When such an arrangement is used and the electrodes are evenly energized, the gases flowing upwards will be mostly in perpendicular direction perpendicular to the planar substrate. Similar flows can be observed on both sides of the substrate 1904. [000154] In order to move the upward draft at an angle the adjacent electrodes have to be energized differently, as further elaborated via FIG. 20.
[000155] FIGs. 20A to 20B illustrate how adjacent electrodes can be energized differently to generate different flow pattern of reactive species in accordance with an exemplary embodiment of the present disclosure.
[000156] As illustrated in FIG. 20A, a single grounded electrode 2002 can be placed at the bottom while upper electrodes 2004 can be segmented with a planar dielectric 2006 in-between electrode 2002 and electrode 2004. Each of these segmented electrodes 2004, or at least the alternating electrodes 2004 can be individually energized to create a flow as shown at 2008. [000157] As illustrated in FIG. 20B, sets of electrodes 2020A and 2020B can be placed in an opposing manner across dielectric 2024 and power supplied to them so that intended reactive species/gas flow is achieved by simply varying the voltage and frequency to vary the velocity of the gas draft produced from each pair of electrodes.
[000158] As can be readily understood, it is not necessary at all that only a planar geometry be adhered to. Vanes can as well be configured in cylindrical structure as described via FIG. 18, FIG. 21, 22 andFIG.23.
[000159] FIG. 21 shows arrangements of vanes along a cylindrical surface, whose orientation can be varied to achieve the intended reactive gas flow away from the container walls.
[000160] In case of a cylindrical surface, the orientation of guide vanes can be determined with reference to radial lines drawn from the tip of the optionally moveable guide vanes in inward direction as shown in FIG.21 at 2102 as Q. The vanes can all be oriented at the same angle with respect to the radial line or can be oriented in different directions to create the desired turbulent mixture. These vanes could be fixed or mounted on moveable hinges. Those skilled in the art can easily determine the mechanism to move these vanes in the desired directions. [000161] The vanes need not be parallel and can be randomly arranged, split into further segments to achieve the intended gas mixing.
[000162] FIGs. 22A to 22B illustrates electrodes configured on vanes in accordance with an exemplary embodiment of the present disclosure. These vanes could be fixed or mounted on moveable hinges. Those skilled in the art can easily determine the mechanism to move these vanes in the desired directions. [000163] Electrodes can as well be configured on vanes instead of the planar dielectric surface, or on both of them.FIG.22A illustrates a configuration wherein the electrodes 2202A and 2202B are placed on vanes 2204 and dielectric surface 2206 does not carry any electrodes. FIG. 22B illustrates another configuration wherein electrodes 2202 (collectively termed) are placed both on guide vanes 2204 and planar surface 2206 carries electrodes 2224A and 2224B as shown. These vanes could be fixed or mounted on moveable hinges. Those skilled in the art can easily determine the mechanism to move these vanes in the desired directions.
[000164] It can be readily appreciated that in order to place electrodes on vanes, the vanes themselves must be made of dielectric material. Electrode dimensions, their placement on guide vanes, voltages and phase differences/shifts between electrodes/groups of electrodes can be optimized by those skilled in the art to generate flow of reactive species as required. For instance, placement of electrodes on both guide vanes and planar surface as shown in FIG. 22B can increase the velocity of the reactive species and hence their reach. These vanes could be fixed or mounted on moveable hinges. Those skilled in the art can easily determine the mechanism to move these vanes in the desired directions.
[000165] FIG. 23 illustrates how proposed device can be used to create enclosures wherein instruments of interest such as but not limited to surgical devices can be placed for sterilization. [000166] As shown in FIG. 23, container 2300 can have a dielectric wall 2302 that can carry external electrodes 2304 with corresponding opposing internal electrodes shown as 2306. Further, it can have dielectric guide vanes 2308 that can as well hold electrodes (one such shown as 2310). Container 2300 can have shelves 2312 upon which items to sterilized can be kept. [000167] As already elaborated, voltage, frequency and phase difference amongst electrodes can be varied to vary pattern of flow of the reactive species. For instance, voltage to two nearby electrodes can be in opposite phase to generate counter streaming reactive gas flow. Flow/sway of gases can be electronically controlled without using any moving parts.
[000168] FIG.24 illustrates another container configuration that can be achieved by proposed device in accordance with an exemplary embodiment of the present disclosure. [000169] As illustrated in FIG.24, a container 2400 can have dielectric side walls 2406 with a continuous outer electrode shown as 2402. Inside electrodes 2404 can be separate and energized by separate power sources as required. A single common outside electrode 2402 can reduce RF radiation. Shelf 2408can hold items to be sterilized. [000170] As used herein, and unless the context dictates otherwise, the term “coupled to” is intended to include both direct coupling (in which two elements that are coupled to each other or in contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms “coupled to” and “coupled with” are used synonymously. .
[000171] Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refers to at least one of something selected from the group consisting of A, B, C ... .and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.
[000172] While some embodiments of the present disclosure have been illustrated and described, those are completely exemplary in nature. The disclosure is not limited to the embodiments as elaborated herein only and it would be apparent to those skilled in the art that numerous modifications besides those already described are possible without departing from the inventive concepts herein. All such modifications, changes, variations, substitutions, and equivalents are completely within the scope of the present disclosure. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims.
ADVANTAGES OF THE INVENTION
[000173] The present disclosure provides for a sterilization device that is simple to operate and maintain.
[000174] The present disclosure provides for a sterilization device that is inexpensive.
[000175] The present disclosure provides for a sterilization device that does not need any specific gas for its operation.
[000176] The present disclosure provides for a sterilization device that can quickly and effectively sterilize flexible medical devices such as catheters, laproscopes, colonoscopes etc. [000177] The present disclosure provides for a sterilization device that can sterilize surgical equipments in bulk as well as large surfaces without needing a specific gas.

Claims

I Claim:
1) A sterilization device comprising: at least one pair of electrodes, said at least one pair of electrodes at least partially separated by a dielectric material, wherein, upon connecting said electrodes to a high voltage variable frequency power supply, atmospheric pressure plasma is generated along at least a partial length of said electrodes to further create reactive species for sterilization.
2) The device of claim 1, wherein said dielectric material is any or a combination of dry air, a gas, plastic, ceramic, mica and glass.
3) The device of claim 1, wherein the device is configured with means to direct flow of said reactive species.
4) The device of claim 1, wherein the device is configured in a first enclosure and said reactive species sterilizes at least partial inner surface of said first enclosure and any items in or around said first enclosure.
5) The device of claim 1, wherein one of said at least one pair of electrodes is held inside a second enclosure and another of said least one pair of electrodes is held outside said second enclosure, and said reactive species are generated at any or a combination of inside and outside said second enclosure.
6) The device of claim 1, wherein first electrode of said at least one pair of electrodes is held at least partially inside a third enclosure, said third enclosure configured to perform as second electrode of said at least one pair of electrodes.
7) The device of claim 1, wherein first electrode of said at least one pair of electrodes is held at least partially inside a fourth enclosure, and second electrode of said at least one pair of electrodes is configured to be at least partially moveable over said fourth enclosure.
8) The device of claim 1 , wherein said dielectric material is in form of a planar surface and said reactive species sterilizes surface of said planar surface.
9) The device of claim 1 , wherein the device comprises a plurality of said at least one pair of electrodes, said plurality of said at least one pair or electrodes receiving same voltage or voltage varying in any or a combination of volts, frequency and phase. 10) The device of claim 3, wherein the means comprise vanes with fixed or variable angles attached to any or combination of said electrodes, said dielectric material, and an enclosure in which said device is configured.
11) The device of claim 7, wherein said fourth enclosure acts as said dielectric material separating said electrodes.
12) The device of claim 9, wherein variation in said any or a combination of volts, frequency and phase is used to vary flow of said reactive species.
13) The device of claim 9, wherein at least one electrode of said plurality of said at least one pair of electrodes is common.
14) The device of claim 10, wherein at least one of said vanesis configured with another of said at least one pair of electrodes held at least partially separated by a dielectric material to generate reactive species at said vane.
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Publication number Priority date Publication date Assignee Title
WO2023242568A1 (en) * 2022-06-17 2023-12-21 The University Of Liverpool Air decontamination system

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101948063B1 (en) * 2018-01-25 2019-02-14 주식회사 프라뱅크 Plasma Sterilize

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101948063B1 (en) * 2018-01-25 2019-02-14 주식회사 프라뱅크 Plasma Sterilize

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023242568A1 (en) * 2022-06-17 2023-12-21 The University Of Liverpool Air decontamination system

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