Patent Application
20210236676
This disclosure relates to an automated apparatus for processing medical instruments. In particular, the apparatus is configured for automatically cleaning, drying, packaging, and sterilizing reusable medical instruments.
Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include surgical forceps, restorative spatulas, dental mirrors, periodontal scalers, endoscopes, and stethoscopes
When used on patients, reusable instruments become soiled and contaminated with microorganisms and blood. To avoid any risk of infection by a contaminated instrument, reusable instruments undergo “reprocessing,” which is a detailed multistep process to clean, dry, pack, and sterilize the instruments. Adequate reprocessing of reusable medical instruments is vital to protecting patient safety. Inadequate cleaning between patient uses can result in the retention of blood, tissue, and other biological debris (soil) in certain types of reusable instruments. This debris can allow microbes to survive the subsequent disinfection or sterilization process, which could then lead to Health Care-Associated Infections (HAIs).
Inadequate cleaning and the presence of debris can compromise the sterilization of reusable instruments. Cleaning should always occur before sterilization. Currently, there are a few solutions for management of reusable medical and dental instruments. Some of these solutions attempt to clean (e.g., manually brush) and dry, or to pack, or to sterilize, but these solutions fail to meet the needs of the dental and medical offices because they have to rely on people/employers. In addition, sometimes these solutions do not follow the correct protocol established by the CDC. Also, there is a lack of verification and process reports. Other solutions attempt to automatically clean and dry reusable instruments (e.g., ultrasonic cleaners, instrument washers, washer-disinfectors, and the like), but these solutions are similarly unable to meet the needs of the industry because they still require a user to pack, load, and unload the autoclave machine. A typical sterilization center in a dental office, for example, may take up an entire room and require a user to move the instruments from one module to the next. This results in user error, inadequate cleaning and sterilizing, and a lot of wasted space and time.
Another common problem involves overloading the autoclave. Overloading results in inadequate sterilization. In addition, overloading may cause instrument packs to retain moisture and come out of the autoclave wet. As such, there is a need for solution that adequately and efficiently cleans, dries, packages, and sterilizes instruments for re-use.
It is desirable to have a fully automated system that will manage reprocessing of reusable instruments in dental and medical offices or hospitals. Such a system would increase efficiency, reduce work time, and decrease the risk of injury to a user during management of infected instruments. Furthermore, it is desirable to have a system that will have sensors to identify any failure of the process. Still further, it is desirable to have a system that will automatically follow all recommendations from the CDC about how to manage reusable instrument in medical and dental facilities, resulting in increased safety to employers and to patients. The disclosed system advantageously fills these needs and addresses the aforementioned deficiencies by providing a compliant, fully automated system to manage reusable instruments.
One advantage of the disclosed system is that it is compact and yet it performs all the functions necessary to clean, dry, package, and sterilize medical instruments. In particular, the system is about the size of a cabinet unit typically found in a medical or dental office.
Another advantage of the system is that it is fully automated. A user only needs to pack the dirty instruments in a cassette, place the cassette into the machine, and retrieve the cleaned, sterilized, packaged cassette at the end of the cycle.
In one embodiment, the present invention includes an apparatus for processing medical instruments. The apparatus includes an enclosure having an entrance door and an exit door. The entrance door and exit door may open and close automatically. The enclosure is arranged so that a cassette containing dirty instruments is deposited into the enclosure through the entrance door, the dirty instruments are cleaned, packaged, and sterilized inside the enclosure, and the clean, packaged, sterilized instruments are removed from the enclosure through the exit door. The enclosure includes a plurality of stations therein. The stations may be arranged in a linear row. Each station has sidewalls and a bottom surface. Each station has at least one slot that is sized and shaped to hold only one cassette. Each slot in each station includes a wire frame so that the cassette, when positioned in the slot, does not contact the sidewalls or bottom surface of the station. Each station may include at least two or three slots, with each slot being sized and shaped to hold only one cassette.
One of the stations is a jet washing and drying station. The jet washing and drying station may have a door that is configured to be closed during washing and drying, and is further configured to be open before and after the washing and drying. The jet washing and drying station door may be configured to open and close automatically.
Another one of the stations is a packaging station. The packaging station may include a roller of packaging material, an air blower for opening the package before the cassette is positioned in the package, and a heat sealer for sealing the package after the cassette is positioned therein.
Yet another one of the stations is an autoclave station. The autoclave station may include a lid that closes to seal the autoclave station closed during operation of the autoclave station. The autoclave station lid may be configured to open and close automatically.
The jet washing and drying station may be adjacent to the packaging station, and the packaging station may be disposed between the jet washing and drying station and the autoclave station.
The apparatus may further include an ultrasound cleaning station, which may be configured to automatically turn on when the cassette is positioned therein. An instrument cleaning solution reservoir may be coupled to the ultrasound cleaning station. The ultrasound cleaning station may be configured for being coupled to a water source. The apparatus may further include a filter for filtering water that enters the ultrasound cleaning station. The ultrasound cleaning station may include a door that is configured to be closed during cleaning, wherein the door opens to provide access to the ultrasound cleaning station for depositing the cassette into, or removing the cassette from, the ultrasound cleaning station. The ultrasound cleaning station door may be configured to open and close automatically.
The apparatus may further include a holding area in the enclosure, and the holding area may be adjacent to the exit door. Still further, the apparatus may include a receiving area in the enclosure, wherein the receiving area is positioned adjacent to the entrance door so that a user has access to the receiving area through the entrance door in order to position the instrument cassette through the entrance door an into the receiving area. The apparatus may further include a fluid sprayer adapted to be coupled to a pre-cleaning solution for spraying the pre-cleaning solution on the external surfaces of the dirty instruments. The fluid sprayer may be within, or adjacent to, the receiving area.
The apparatus may further include a robotic arm in the enclosure. The robotic arm may be coupled to a linear track positioned above the stations in the enclosure. The robotic arm may be configured to traverse the linear track in the y-direction. The robotic arm may further be configured to move in the z-direction towards and away from the stations in the enclosure. The robotic arm may include a gripper that closes and opens for grasping and releasing the cassettes. Further, a second gripper may be attached to the robotic arm. The apparatus may further include two robotic arms in the enclosure, wherein a first robotic arm is configured for engaging with the cassette containing dirty instruments, and a second robotic arm is configured for engaging with the cassette after the instruments have been cleaned.
The apparatus may further include a camera and a processor configured for automatically determining whether the medical instruments are clean. The camera and processor may be positioned adjacent to the jet washing and drying station in order to determine whether the instruments are clean prior to packaging. The processor may include artificial intelligence capability for determining whether the instruments are clean.
The apparatus may further include a UV light in the enclosure for sterilizing the inside of the enclosure.
In another embodiment, the present invention includes an apparatus for processing medical instruments. The apparatus includes an enclosure having an entrance door and an exit door. The enclosure is arranged so that a cassette containing dirty instruments is deposited into the enclosure through the entrance door, the dirty instruments are cleaned, sterilized, and packaged inside the enclosure, and the clean, sterilized, packaged instruments are removed from the enclosure through the exit door. The enclosure includes a plurality of stations arranged in a linear row. Each station has sidewalls, a bottom surface, and at least one slot that is sized and shaped to hold only one cassette. Each slot in each station includes a wire frame configured to hold the cassette in a position that is spaced apart from the sidewalls and bottom surface of the station so that all sides of the instruments are fluidly accessible through the cassette and the wire frame. The plurality of stations may include an ultrasound cleaning station, a jet washing and drying station, a packaging station, and an autoclave station. A receiving area may be adjacent to the entrance door and a holding area may be adjacent to the exit door.
Other and further aspects, advantages, and features of the disclosed embodiments will become apparent from the ensuing detailed description in view of the accompanying drawings.
The accompanying drawings illustrate several embodiments and, together with the description, serve to explain the principles of the invention according to the embodiments. It will be appreciated by one skilled in the art that the particular arrangements illustrated in the drawings are merely exemplary and are not to be considered as limiting of the scope of the invention or the claims herein in any way.
Disclosed and depicted herein are systems and devices for automatically reprocessing medical instruments. In one embodiment, a compact apparatus for reprocessing medical instruments includes a cleaning station, a drying station, a packaging station, and/or a sterilizing station. The apparatus may further include a storage area for dirty, contaminated instruments that need to be processed, and a storage area for the clean, sterilized instruments that have been processed.
The instruments are disposed in a sterilization cassette and the cassette is automatically moved from one station to the next station with a robotic arm, conveyor belt, or the like. Each station includes at least one slot that is sized and shaped to hold only one sterilization cassette to avoid over-crowding of the cassettes in each station. The apparatus is compact relative to other sterilization centers that are typically found in dental or medical offices. For example, the apparatus is about the size of a standard cabinet unit that is typically present in dental or medical offices.
The invention is described by reference to various elements herein. It should be noted, however, that although the various elements of the inventive apparatus are described separately below, the elements need not necessarily be separate. The various embodiments may be interconnected and may be cut out of a singular block or mold. The variety of different ways of forming an inventive apparatus, in accordance with the disclosure herein, may be varied without departing from the scope of the invention.
Generally, one or more different embodiments may be described in the present application. Further, for one or more of the embodiments described herein, numerous alternative arrangements may be described; it should be appreciated that these are presented for illustrative purposes only and are not limiting of the embodiments contained herein or the claims presented herein in any way. One or more of the arrangements may be widely applicable to numerous embodiments, as may be readily apparent from the disclosure. In general, arrangements are described in sufficient detail to enable those skilled in the art to practice one or more of the embodiments, and it should be appreciated that other arrangements may be utilized and that structural changes may be made without departing from the scope of the embodiments. Particular features of one or more of the embodiments described herein may be described with reference to one or more particular embodiments or figures that form a part of the present disclosure, and in which are shown, by way of illustration, specific arrangements of one or more of the aspects. It should be appreciated, however, that such features are not limited to usage in the one or more particular embodiments or figures with reference to which they are described. The present disclosure is neither a literal description of all arrangements of one or more of the embodiments nor a listing of features of one or more of the embodiments that must be present in all arrangements.
Headings of sections provided in this patent application and the title of this patent application are for convenience only and are not to be taken as limiting the disclosure in any way.
Devices and parts that are connected to each other need not be in continuous connection with each other, unless expressly specified otherwise. In addition, devices and parts that are connected with each other may be connected directly or indirectly through one or more connection means or intermediaries.
A description of an aspect with several components in connection with each other does not imply that all such components are required. To the contrary, a variety of optional components may be described to illustrate a wide variety of possible embodiments and in order to more fully illustrate one or more embodiments. Similarly, although process steps, method steps, or the like may be described in a sequential order, such processes and methods may generally be configured to work in alternate orders, unless specifically stated to the contrary. In other words, any sequence or order of steps that may be described in this patent application does not, in and of itself, indicate a requirement that the steps be performed in that order. The steps of described processes may be performed in any order practical. Further, some steps may be performed simultaneously despite being described or implied as occurring non-simultaneously (e.g., because one step is described after the other step). Moreover, the illustration of a process by its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, does not imply that the illustrated process or any of its steps are necessary to one or more of the embodiments, and does not imply that the illustrated process is preferred. Also, steps are generally described once per aspect, but this does not mean they must occur once, or that they may only occur once each time a process, or method is carried out or executed. Some steps may be omitted in some embodiments or some occurrences, or some steps may be executed more than once in a given aspect or occurrence.
When a single device or article is described herein, it will be readily apparent that more than one device or article may be used in place of a single device or article. Similarly, where more than one device or article is described herein, it will be readily apparent that a single device or article may be used in place of the more than one device or article.
The functionality or the features of a device may be alternatively embodied by one or more other devices that are not explicitly described as having such functionality or features. Thus, other embodiments need not include the device itself.
Techniques and mechanisms described or referenced herein will sometimes be described in singular form for clarity. However, it should be appreciated that particular embodiments may include multiple iterations of a technique or multiple instantiations of a mechanism unless noted otherwise. Alternate implementations are included within the scope of various embodiments in which, for example, functions may be executed out of order from that shown or discussed, including substantially concurrently or in reverse order, depending on the functionality involved, as would be understood by those having ordinary skill in the art.
The apparatus of the present invention is for processing medical and dental instruments that are positioned inside a sterilization cassette. The apparatus includes an enclosure having an entrance door and an exit door. Within the enclosure are several stations. In one embodiment, the stations include a jet washing and drying station, a packaging station, and an autoclave station. Each station has sidewalls and a bottom surface. A wire frame slot in each station is sized and shaped to hold one cassette in a position that is spaced apart from the sidewalls and bottom surface of the station.
The present invention is directed to a fully automated machine to clean, dry, pack, and sterilize medical and dental instruments. The machine can be of all sizes and can support various sizes and quantities of cassettes of instruments. Also, instruments can be of all types, such as pliers, forceps, scissors, burs, hand pieces, etc.
In one embodiment, the present invention comprises a fully automated machine to clean (e.g., with ultrasound and/or power wash), dry, pack, and heat sterilize medical and dental instruments. More particularly, the invention is a complete automation of the management of reusable instrument in dental facilities, medical facilities, and hospitals. The machine may include a dirty/infection door, where dental and medical assistants may load the machine with cassettes containing dirty reusable instruments. A mechanical/robotic arm may be used to move the cassette through different compartments inside the machine, such as ultrasound cleaning, power washing, drying system, automated packing, and/or heat sterilization. Finally, the robotic arm may transport the cleaned instruments to the clean door on the other side of the machine where the clean instruments inside the cassette will be ready to be used or stored.
The compartments of the machine may include storage for uncleaned cassettes, ultrasonic cleaning, power wash and dry, packaging, autoclave, and/or storage for clean cassettes. A mechanical arm may be used to move around the machine to transport cassettes inside the machine. The machine may have several other compartments and be provided in a variety of different size ranges. For example, depending on the desired size range, some of the compartments may be eliminated for a smaller apparatus, or some of the compartments may be duplicated for a larger apparatus. In one particular example, a user may require an apparatus having an additional autoclave compartment. In another example, a user may require an apparatus having only a power wash and dry compartment. Regardless of the configuration or number of compartments within the apparatus, it is important to note that each compartment includes at least one slot for holding only one sterilization cassette. In this manner, the sterilization cassettes being processed are held in a position that is spaced apart from the sidewalls and bottom surface of the compartment and from other sterilization cassettes, which results in instruments that are more efficiently and effectively cleaned and sterilized.
The medical instrument reprocessing apparatus 100 includes an upper enclosure 102 having an entrance door 104 and an exit door 106. The enclosure 102 is small enough to fit on top of a counter 103. In particular, the enclosure 102 may be about 3-6 feet wide, about 3-6 feet high, and about 2-3 feet deep. A lower enclosure 105 conceals the bottom portion of the apparatus 100. The entrance door 104 provides access to the inside of the upper enclosure 102 so that a user can place dirty, contaminated instruments in the apparatus 100 through the entrance door 104. As explained in further detail below, there are several stations inside the enclosure 102, and the dirty instruments are processed through each station to clean, dry, package, and/or sterilize the instruments. After the instruments have been processed, a user can retrieve the clean, sterilized instruments from the enclosure 102 via the exit door 106. The entrance door 104 and the exit door 106 may be opened and closed manually or may open and close automatically or with the push of a button.
As shown in
Before the dirty, contaminated instruments are placed inside the enclosure 102, the instruments are packed in a cassette 120, such as those depicted in
Next to the receiving area 200 is an ultrasound cleaning station 300. In one embodiment, the ultrasound cleaning station 300 is configured to turn on automatically when a cassette 120 is positioned in the ultrasound cleaning station 300. A water source is coupled to the ultrasound cleaning station 300, and a filter may be positioned between the water source and the ultrasound cleaning station 300 in order to filter the water that enters the ultrasound cleaning station 300. The ultrasound cleaning station 300 may include a cover or door (not shown) that may open and close automatically so that the ultrasound cleaning station 300 can be closed while cleaning is taking place and can be open during non-operating times. In this manner, the ultrasound cleaning station 300 can be open in order to position a cassette 120 therein, or remove a cassette 120 therefrom, and can be closed during ultrasonic cleaning of the cassette 120. The ultrasound cleaning station 300 is optional.
Next to the ultrasound cleaning station 300 is a jet washing and drying station 400. The jet washing and drying station 400 preferably includes a door 402 that closes during washing and drying and opens when a cassette 120 is being added to, or removed from, the jet washing and drying station 400. The door 402 on the jet washing and drying station 400 may be configured to open and close automatically. The jet washing and drying station 400 is configured to power wash the cassette 120 disposed therein at an elevated pressure. For example, the pressure wash may be at a pressure of about 500-1300 Psi. The jet washing and drying station 400 is further configured to dry the cassette 120 after the power washing.
More details of one embodiment of the jet washing and drying station 400 are described with reference to
The jet washing and drying station depicted in
In one embodiment, the apparatus 100 includes a camera and processor (not shown) that are configured to automatically determine whether the instruments in the cassette 120 are clean. For example, the camera is configured to capture images of the instruments after the cleaning procedure, and the processor is configured to process the images to determine whether the instruments are clean. The processor may include artificial intelligence, or machine learning, capabilities for determining whether the instruments are free of debris. The camera and processor are preferably positioned within, or adjacent to, the jet washing and drying station 400. In this manner, the apparatus 100 is able to automatically confirm that the instruments are free of debris before the instruments are packaged and/or sterilized.
Next to the jet washing and drying station 400 is a packaging station 500, as shown in
The packaging station 500 is described in more detail with reference to
The invention is not limited to the packaging station depicted in
Referring back to
The apparatus 100 further includes a holding area 700.
Indeed, as shown in
It should be readily understood by one of ordinary skill in the art that the apparatus 100 may be customized with more or fewer stations, depending on the needs of the user. For example, the user may want to eliminate the ultrasound cleaning station 300, add an additional jet washing and drying station 400, add an additional packaging station 500, or the like. Similarly, the receiving area 200 and holding area 700 may be eliminated for a more compact apparatus.
In one embodiment, the apparatus for reprocessing medical instruments includes only one station. For example, the apparatus may include only the jet washing and drying station. Similar to the embodiments described above, this embodiment may include an enclosure disposed on top of a counter, and a jet washing and drying station inside the enclosure. As discussed above, the jet washing and drying station has power washing capability. As such, the jet washing and drying station is quicker, more efficient, and more effective than conventional washer/disinfectors that are currently used to process medical devices. In other embodiments, the one or more stations may be arranged in a different configurations as would be apparent to a person of ordinary skill in the art without departing from the scope of the invention.
A cassette 120 containing instruments is automatically moved from one station to the next. For example, the apparatus may include a robotic arm that picks up the cassette 120 and moves the cassette 120 down the line to the next station. The distal end of the robotic arm includes a mechanism for holding and lifting the cassette 120 while transporting the cassette 120. For example, the robotic arm may include a gripper, grabber, claw, magnetic mechanism, electromagnetic mechanism, or the like. In other embodiments, the cassette 120 is moved from one station to the next by a conveyor belt, actuator, or other motorized transport mechanism. In yet another embodiment, the cassette 120 is moved from one station to the next manually, which requires a user to have access to the upper enclosure 102 and move the cassette 120 from one station to the next station.
One embodiment of the apparatus 100 including a robotic arm mechanism is depicted in
The distal ends of the robotic arms 804, 806 are equipped with grabbers, graspers, or claws 810 (shown in
In another embodiment, depicted in
In yet another embodiment (not shown), the apparatus may include a single robotic arm having one or two grabbers coupled to the distal end of the robotic arm. One of the grabbers may be designated for handling the cassettes 120 as they enter the apparatus, and the other grabber may be designated for handling the cassettes 120 that have been cleaned and/or sanitized. As such, cross-contamination of the cassettes 120 can be avoided.
Still further, in another embodiment, the apparatus 100 includes a UV light (not shown) disposed inside the enclosure. The UV light may be configured to sterilize the inside of the enclosure 102. For example, during a time when the apparatus 100 is not in use (such as at night when the dental or medical office is closed), the UV light may be activated to clean the inside of the enclosure 102.
In yet another embodiment, the apparatus 100 is configured to automatically perform spore tests to confirm sterilization per CDC guidelines.
As used herein any reference to “one embodiment” or “an embodiment” means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment.
Some embodiments may be described using the expression “coupled” and “connected” along with their derivatives. For example, some embodiments may be described using the term “coupled” to indicate that two or more elements are in direct physical or electrical contact. The term “coupled,” however, may also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other. The embodiments are not limited in this context.
As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Further, unless expressly stated to the contrary, “or” refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).
In addition, use of the “a” or “an” are employed to describe elements and components of the embodiments herein. This is done merely for convenience and to give a general sense of the invention. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise.
Upon reading this disclosure, those of skill in the art will appreciate still additional alternative structural and functional designs for a system and an apparatus for reprocessing medical devices through the disclosed principles herein. Thus, while particular embodiments and applications have been illustrated and described, it is to be understood that the disclosed embodiments are not limited to the precise construction and components disclosed herein. Various apparent modifications, changes and variations may be made in the arrangement, operation and details of the method and apparatus disclosed herein without departing from the spirit and scope defined in the appended claims.
This application claims priority from U.S. Provisional Patent Application No. 62/967,659, filed Jan. 30, 2020, entitled “Fully Automated Machine to Clean Dry Pack and Sterilize Medical and Dental Instruments,” which is hereby incorporated by reference herein for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 62967659 | Jan 2020 | US |
