Dry Heat Sanitizer and Method of Use
20190046671 ยท 2019-02-14
Assignee
Inventors
Cpc classification
A61B90/70
HUMAN NECESSITIES
A61C19/002
HUMAN NECESSITIES
International classification
Abstract
A sanitizer system and method of use is disclosed. The sanitizer system quickly sanitizes and cools targeted objects and secures the targeted sanitized objects for later use, without the need to transfer the objects to a separate container. In one embodiment, the sanitizer system comprises a cassette having a body and a removable lid that, when joined, form an airtight chamber for containing an object for sterilization. A pressure control element of the system is configured to fluidly engage with the cassette to produce a pressure-controlled environment within the airtight chamber. A heating element of the system, which is interconnected and in thermal communication with the airtight chamber, is configured to provide heat to the airtight chamber. The chamber temperature is raised to a desired temperature for a period of time sufficient to sanitize the object. A cooling element of the system is configured to cool the chamber and the object.
Claims
1. A method of sanitizing an object comprising: providing an object for sanitization; placing the object for sanitization within a cassette comprising a body and a removable lid such that the object for sanitization is in surface contact with the cassette; joining the body and removable lid of the cassette to form an airtight chamber containing the object for sanitization; controlling a pressure in the airtight chamber by forcing fluid into the airtight chamber to increase the pressure and to produce a pressurized environment therein; heating the airtight chamber using a heating element to raise the temperature within the airtight chamber and thereby sanitizing the object for sanitization contained within the airtight chamber; maintaining the temperature for a designated period of time sufficient to sanitize the object for sanitization; and cooling the object for sanitization, wherein cooling the object for sanitization further comprises contacting a surface of the cassette with a cooling element; and moving one of the heating element or the cooling element relative to the other of the heating element or cooling element such that the cassette is only in surface contact with either the heating element or the cooling element.
2. The method of claim 1, wherein said heating the airtight chamber comprises heating the airtight chamber through thermal conduction.
3. The method of claim 1, wherein said heating the airtight chamber comprises heating the airtight chamber through thermal convection.
4. The method of claim 1, wherein said heating the airtight chamber comprises heating with the heating element disposed inside the cassette.
5. The method of claim 1, wherein said controlling the pressure in the airtight chamber comprises evacuating fluid from the airtight chamber to decrease the pressure and to produce a vacuum environment therein.
6. The method of claim 5, further comprising controlling or monitoring the vacuum environment within the airtight chamber after the object for sanitization has been sanitized by using an audible or visual indicator that the cassette is still under vacuum.
7. A method of sanitizing an object comprising: providing an object for sanitization; placing the object for sanitization within a cassette comprising a body and a removable lid; joining the body and removable lid of the cassette to form an airtight chamber containing the object for sanitization; forcing fluid into the airtight chamber to increase the pressure therein; heating the airtight chamber using a heating element to raise the temperature within the airtight chamber and thereby sanitizing the object for sanitization contained within the airtight chamber; maintaining the temperature for a designated period of time sufficient to sanitize the object for sanitization; cooling the object for sanitization, wherein cooling the object for sanitization further comprises contacting a surface of the cassette with a cooling element; wherein the cassette comprises an input valve and an output valve, and wherein the method further comprises: opening the input valve, opening the output valve, passing sanitized fluid through the input valve into the airtight chamber, forcing fluid from the airtight chamber through the output valve, pressurizing the airtight chamber, and closing both valves; and moving one of the heating element or the cooling element relative to the other of the heating element or cooling element such that the cassette is only in surface contact with either the heating element or the cooling element.
8. The method of claim 7, wherein said heating the airtight chamber comprises heating the airtight chamber through thermal conduction.
9. The method of claim 7, wherein said heating the airtight chamber comprises heating the airtight chamber through thermal convection.
10. The method of claim 7, wherein said heating the airtight chamber comprises heating with the heating element disposed inside the cassette.
11. The method of claim 7, further comprising stacking the cassette on top of an adjacent cassette.
12. The method of claim 7, further comprising sterilizing the object for sanitization to a level suitable for dental use or surgical use.
13. The method of claim 7, wherein said cooling the object for sanitization comprises actively cooling the object for sanitization.
14. A method of sanitizing an object comprising: providing an object for sanitization; placing the object for sanitization within a cassette comprising a body and a removable lid such that the object for sanitization is in surface contact with the cassette; joining the body and removable lid of the cassette to form an airtight chamber containing the object for sanitization; evacuating fluid from the airtight chamber to decrease the pressure and to produce a vacuum environment therein; monitoring the vacuum environment within the airtight chamber by using an audible or visual indicator; heating the airtight chamber using a heating element to raise the temperature within the airtight chamber and thereby sanitizing the object for sanitization contained within the airtight chamber; maintaining the temperature for a designated period of time sufficient to sanitize the object for sanitization; and cooling the object for sanitization, wherein cooling the object for sanitization further comprises contacting a surface of the cassette with a cooling element; and moving one of the heating element or the cooling element relative to the other of the heating element or cooling element such that the cassette is only in surface contact with either the heating element or the cooling element.
15. The method of claim 14, further comprising forcing fluid into the airtight chamber to increase the pressure therein.
16. The method of claim 14, wherein said heating the airtight chamber comprises heating with the heating element disposed inside the cassette.
17. The method of claim 14, further comprising stacking the cassette on top of an adjacent cassette.
18. The method of claim 14, further comprising sterilizing the object for sanitization to a level suitable for dental use or surgical use.
19. The method of claim 14, wherein said cooling the object for sanitization comprises actively cooling the object for sanitization.
20. The method of claim 14, wherein said heating the airtight chamber comprises heating the airtight chamber through thermal convection.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and together with the general description of the invention given above, and the detailed description of the drawings given below, serve to explain the principals of this invention.
[0031]
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[0040]
[0041] It should be understood that the drawings are not necessarily to scale unless specifically so indicated. In certain instances, details that are not necessary for an understanding of the invention or that render other details difficult to perceive may have been omitted. It should be understood, of course, that the invention is not necessarily limited to the particular embodiments illustrated herein.
DETAILED DESCRIPTION OF THE INVENTION
[0042] Generally, a sanitizer system and method of use that sanitizes, cools, and stores medical equipment using conduction and a removable cassette is disclosed. The system and method for sanitizing and storing instruments minimizes the potential for contamination during and post-sanitization while also providing a reduced cool-to-cool sanitization total cycle time. In one embodiment, the disclosed system reduces total cycle time from, for example, from between 50-60 minutes to between 15-20 minutes, preferably from between 35-40 minutes to between 12-15 minutes, and more preferably from between 30-35 minutes to between 9-10 minutes, allowing an office to manage its patient flow with fewer instruments resulting in a reduction in instrument cost.
[0043] The disclosed system may comprise a cassette having a removable lid and a cassette body joined to form an enclosed airtight chamber configured to hold objects or instruments for sanitization. The pressure within the cassette may be varied from the ambient environment by pulling air out of the chamber through a valve, or by disposing air, an inert gas, or some other fluid into the chamber to form a pressurized environment, essentially creating a mini vacuum or pressurized chamber. Once the objects or instruments have been placed in the cassette and a vacuum or pressurized chamber has been created, the cassette may be heated in the sanitizer system to an appropriate temperature for a time sufficient to sanitize the objects or instruments to a level suitable for the desired use. After sanitization of the objects or instruments, the cassette may be actively cooled, preferably to a temperature cool enough for a user to handle comfortably, and more preferably to room temperature, for either immediate use or for storage. To open and remove the objects or instruments post sanitization, a valve on the cassette may be turned from closed to open. After opening the valve, air may rush into the chamber through the valve producing an audible sound signifying that the chamber has been kept isolated from the ambient environment and is therefore uncontaminated post sterilization. Once the pressure inside the cassette has reached equilibrium with the ambient environment, the lid may be removed from the cassette body and the instruments, still disposed in the cassette, may be accessed for use. The disclosed device and method may be used in a variety of fields to include sanitization of medical, dental, pharmaceutical, cosmetic, surgical, and orthodontic objects or instruments.
[0044]
[0045] As shown in
[0046]
[0047] In an exemplary embodiment, the sanitizer system may use thermoelectric cooling that may actively cool a hot container or cassette thereby reducing the cool-to-cool total cycle time. The cooling element of the sanitizer system may comprise a cooling block 103, which may be comprised of any material with a high enough thermal conductivity for effective heat transfer. In a preferable embodiment, the cooling block may be comprised of brass. The cooling block 103 may be actively cooled via thermoelectric coolers 130, which in turn, may have their heat dissipated into heat sinks 131. The cooling block 103 may be one solid piece that extends through an opening into the enclosed environment 119.
[0048] The cooling element may be configured to be in surface contact with the cassette such that the cooling element reduces the temperature of the cassette. In addition, the cooling element may comprise a plurality of elongated cooling members separated by alternating gaps forming a cooling platform having a substantially planar cooling surface.
[0049] The pressure control element 110 may be configured to fluidly engage, through for example, pressure control engagement element 130 and valve 120, with cassette 101 in order to produce a pressure-controlled environment within an airtight chamber enclosed by the cassette. The pressure control element may comprise a vacuum or insertion element 110 configured to fluidly engage with cassette 101 and evacuate or insert fluid from the airtight chamber enclosed by the cassette to produce a vacuum or pressurized environment therein. The fluid may comprise a liquid or a gas, including but not limited to air, an inert gas, such as argon or neon, or a non-oxidizing gas, such as nitrogen. Vacuum or insertion element 110 may also comprise a valve (not shown) to control or monitor the chamber environment, wherein the valve is configured to provide an audible or visual indication that an airtight seal has been broken by actuating the valve from a closed position to an open position. Sanitizer system 100 may further comprise an indicator 150, such as, for example, a pressure gauge, having indicia that indicate a degree of vacuum or pressure established in the airtight chamber.
[0050]
[0051]
[0052]
[0053]
[0054] Valve 520 may be a ball valve that may be opened and connected to a pressure control element to create a vacuum or pressurized environment within the closed cassette shown in
[0055] The cassettes and their respective chambers may vary in shape, size, and material. A cassette may be made in any shape or geometry (e.g. cylindrical, spherical, box-shaped, or some other contoured or irregular shape having an internal volume) depending on the instruments and devices to be sanitized. A cassette may also be any size (e.g. large, medium, or small) suitable for containing the objects for sanitization or as required by the end user. For example, small cassettes may be used to hold one standard set or even one tool if desired and the cassettes may have locations where individual instruments may latch into or be secured onto the base of the cassette. Cassettes may also be large enough to house several commercially available containers. Additionally, a cassette may be made of any material suitable to be heated and cooled. For example, the removable lid and potentially even the sides of the cassette body may be constructed of a polymer or polymeric material, provided that the polymer can withstand higher temperatures as needed for sanitization, with only the base, which is in surface contact with the instruments, constructed of metal to allow heat to be conducted through the base to the instruments. The time required to cool the base of the cassette and instruments to a temperature appropriate for use of the instruments may be decreased if plastic or some other appropriate non-metallic material is used to construct portions of the cassette provided that there is less mass to cool as compared with a completely metallic cassette.
[0056] A preferable embodiment of a sanitizer system may further comprise a filter (not shown), which may sanitize the fluid within the airtight chamber 504. Cassette 501 may comprise both an input valve 520 and an output valve 521, wherein the input and the output valve may each have an open and a closed position, and wherein when both the input and the output valve are in the open position, filtered fluid may be configured to be delivered through the input valve filling the cassette with filtered fluid and forcing unfiltered fluid out of the output valve. The fluid may comprise a liquid or a gas, including but not limited to air, an inert gas, such as argon or neon, or a non-oxidizing gas, such as nitrogen.
[0057] The heating element for a sanitizer system may be in surface contact with the cassette and may also further comprise a plurality of elongated heating members separated by alternating gaps forming a heating platform having a substantially planar heating surface, wherein the heating platform conducts heat in a substantially even manner over a surface of the cassette. The heat provided by the heating element may raise the temperature within the airtight chamber of the sanitizer system to a temperature and for a period of time sufficient to sterilize the object for sanitization to a level suitable for dental use or surgical use.
[0058]
[0059] A heating element or cooling element in an embodiment of a sanitizer system as disclosed herein is not limited to the examples shown and may take various forms, shapes, configurations and sizes as known in the art.
[0060]
[0061] One of ordinary skill in the art will appreciate that embodiments of the present disclosure may be constructed of materials known to provide, or predictably manufactured to provide, the various aspects of the present disclosure. For example, an embodiment of a sanitizer system may be manufactured using methods and techniques comprising injection molding, computer-numeric control (CNC) machining, and 3-D printing.
[0062]
[0063] In a preferable embodiment of a method of sanitizing an object, providing an object for sanitization at 810 may comprising taking instruments that have been scrubbed, washed, and chemically treated in accordance with any requirements, laws, and regulations applicable to the respective standard for sanitization employed in the industry and placing them in a cassette (as shown for example in
[0064] Joining the body and removable lid of the cassette to form an airtight chamber may comprise placing the lid (as shown for example in
[0065] Controlling a pressure in the airtight chamber at 840 may comprise evacuating fluid from or disposing fluid into the airtight chamber to either decrease or increase the pressure in order to produce a vacuum or pressurized environment within the airtight chamber. In a preferable embodiment, controlling the pressure may comprise turning a valve 120 as shown in
[0066] The method may further comprise controlling or monitoring the vacuum or pressurized environment within the airtight chamber after the object for sanitization has been sanitized by using an audible or visual indicator that the cassette is still under vacuum or is still pressurized. Additionally, as shown in
[0067] Heating the airtight chamber at 850 may comprise heating the airtight chamber through thermal conduction, through thermal convection, by contacting a surface of the cassette with the heating element, or by heating with the heater element disposed inside the cassette. In a preferable embodiment, the cassette may first be placed on the cooling element 103 of the sanitizer system 100 shown in
[0068] Heating element 102 may be turned on and set to a designated or desired temperature for an appropriate time to sanitize or sterilize the instruments disposed in cassette 101 to a level suitable for dental use or surgical use. Heating may be accomplished in any fashion as long as it is compliant with the allotted amount of time at the appropriate temperature to ensure sanitization or sterilization. Temperature ranges appropriate for sanitizing instruments include 340 F. for a minimum of 60 minutes, preferably 360 F. for a minimum of 30 minutes, and more preferably 375 F. for a minimum of 6 minutes to ensure that the instruments are sterilized. Commercially available indicators may be used to ensure that the temperature of the cassette chamber has reached an appropriate sanitization or sterilization temperature for a sufficient time to sanitize or sterilize the instruments for surgical, dental, or any other desired use. These indicators may be placed on the bottom of the cassette with the instruments. If there is concern about the entire chamber environment being heated, an indicator could be placed on top of a material with a low thermal conductivity that can withstand the higher temperature such as a plastic. The indicator will therefore not be heated via conduction through the base of the cassette but through both convection and radiation within the box ensuring that the entire environment within the cassette has reached a particular temperature indicative of being sanitized or sterilized. The method may also use a controller or any means known to those skilled in the art to monitor and/or control the sanitization process or elements (e.g. the heating element or the cooling element) such as by use of programmable logic controllers.
[0069]
[0070] In a preferable embodiment, cassette 101 may be heated through conduction by surface contact with heating element 102. The required temperature may be maintained for a designated period of time sufficient to sanitize or sterilize the instruments at 860, after which heating element 102 may be turned off and the actuator 111 may be activated to lower cassette 101 down to rest back in its original position on cooling element 103 as shown in
[0071] The instruments for sanitization may be disposed inside the cassette 101, and in particular, may rest on the bottom of cassette 101 and may be heated through conduction via contact with the bottom of cassette 101. Additionally, the cassette may comprise support elements (not shown), including for example, holders or racks for supporting or holding the instruments. The support elements may be used for example to prevent unwanted movement of the instruments, to isolate the instruments from touching one another, or to keep the instruments in a desired order or configuration during the sanitization process or during storage.
[0072] Alternatively, the cassette may be heated in a conventional dry heat convection oven, wherein the cassette is heated by convection and the targeted objects for sanitization (e.g. medical instruments) contained within the cassette are heated by conduction.
[0073] It is also worth noting that cooling the object for sanitization at 870 may be accomplished in a multitude of fashions and need not be separate from the heating element. For example, a cooling jacket may be provided that rests on or is otherwise in communication with the heating element such that when the heating element is turned off, a pneumatic valve opens, allowing coolant fluid to flow into the cooling jacket to cool the cooling element and the cassette. Alternatively, an office water supply, a closed loop water circulation system connected to a refrigerator, or some other coolant fluid source as known in the art may be used to flow coolant fluid through the cooling jacket.
[0074] In a preferable embodiment, the cassette may be metallic and thus, along with being heated via conduction, it may also be actively cooled through conduction reducing the overall cool-to-cool total cycle time. In this case, cooling the object for sanitization at 870 may comprise activating thermoelectric coolers 130 to actively cool the cooling element 103 which is now in surface contact with cassette 101 as shown in
[0075] The thermoelectric coolers 130 may remain on for a time sufficient to allow enough heat to be removed from the cassette as well as the instruments the cassette is housing so that they are at room temperature. Radiative heat sinks 131 may be used to dissipate heat from thermoelectric coolers 130. Both the thermoelectric coolers and heat sinks may be located outside the enclosed environment 119 where the cassette is being heated to ensure that the thermoelectric coolers do not exceed their maximum operation temperature. The heating element, which is mechanically connected to an actuator, remains off at this stage and is disposed below the cooling element.
[0076] Additionally, programmable logic may be used to simplify the end user's experience for the heating and cooling of the cassette chamber in the sanitizer system. For example, the logic may provide error codes in the case of failure to simplify trouble shooting.
[0077] Once cassette 101 and the instruments disposed therein return to room temperature, the cassette may be removed from the sanitizer system. The instruments disposed in the cassette have thus been sanitized and returned to room temperature while still under vacuum or pressure, and are ready for use or storage. The cassette may be stored on top of an adjacent cassette.
[0078] The system may utilize any means known to those skilled in the art to handle the loading and/or unloading of the cassette from or onto the heating element or the cooling element. The sanitizer system may also be used to cool more than one cassette at a time and may be enlarged to sanitize several cassettes.
[0079] The temperature of the cassette may be monitored at all times for safety to ensure that no one picks up a hot cassette. Temperature may be monitored via thermocouples, infrared lasers, color changing indicators which are blue when cold and red when hot, or any other temperature sensing indicator known in the art or commercially available.
[0080] When ready to remove the instruments from the cassette for use, valve 120 may be turned to an open position. Air from the ambient environment will rush into cassette 101 through the nipple of valve 120 until the pressure within the chamber of cassette 101 and the pressure external to cassette 101 are substantially the same, so as to reach equilibrium. A rush of the air into cassette 101 through valve 120 may provide an audible signal that the instruments inside cassette 101 have not been contaminated by the ambient environment. In a preferable embodiment, along with the audible signal, a visual gauge (digital or analog), or tactile signal (i.e. discernable to the touch) may also be provided to indicate that the seal has held and the airtight chamber has not been compromised or otherwise contaminated by the ambient environment. The audible sound may also be enhanced by manipulating the nipple of the valve to make a whistle noise or other audible sound.
[0081] Once valve 120 is open and the chamber of cassette 101 has reached equilibrium by equalizing the pressure in the chamber with the ambient environment, the clamps or other cassette engagement members may be loosened from the removable lid and the lid may be detached from the cassette body. Once the lid has been detached and removed from the cassette body the instruments may be removed from the cassette 101 and are ready for use.
[0082] The sanitizer system may be used to sterilize and/or store dental and/or orthodontic instruments. The sanitizer system may also be configured to comply with or satisfy US government regulatory requirements and/or standards including: ANSI/AAMI/ISO 20857: 2010 (sterilization of health care productsdry heat: requirements for the development, validation and routine control of an industrial sterilization process for medical devices); and ANSI/AAMI ST40:2004/(R) 2010 (Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities, 2.sup.nd ed).
[0083] The cassette used in the sanitizer system isolates the instruments from the ambient environment before, during, and after sanitation. Because the cassette may also be used as a storage unit, there is no need to transfer the sanitized instruments to plastic bags or to any other sterile container known in the art. In addition, the sanitizer system reduces the cool-to-cool total cycle time resulting in faster sanitization turnaround times and a reduction in the number of instruments needed by an office to maintain a desired patient flow.
[0084] One of ordinary skill in the art will appreciate that embodiments of the present disclosure as provided in
[0085] As will be appreciated, any feature may be used alone or in combination with another feature disclosed herein.
[0086] While various embodiment of the present disclosure have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present disclosure, as set forth in the following claims.
[0087] The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.
[0088] Moreover, though the present disclosure has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.
[0089] While preferred embodiments have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.