Abstract:
The present disclosure is generally related to devices, methods and systems for cleaning, disinfecting and/or sterilizing a medical device, medical hoses and tubes and accessories thereof with ozone gas, in particular the disclosure relates to devices, methods and systems with multiple receptacles for providing closed-loop fluid pathways to distribute ozone gas to inner passageways and the outer compartments of medical devices. The devices in accordance with an embodiment of the disclosure have two or more receptacles for distributing ozone gas, a gas-tight compartment, an ozone operating system, and one or more connector units configured to fluidly migrate ozone in closed-loop treatment systems.

Description:
TECHNICAL FIELD 
       [0001]    The present disclosure generally relates to ozone gas treatment of medical devices and more particularly, is related to devices, systems and methods using agents or gas, such as ozone gas, for cleaning, disinfecting and sterilizing medical devices in a ozone device with multiple cleaning, disinfecting and sterilizing properties, with one or more receptacles, and receiving ports and chambers for ease of cleaning, disinfecting and sterilizing medical devices, medical instruments and medical passageways, such as hoses and/or tubes. 
       BACKGROUND OF THE DISCLOSURE 
       [0002]    Medical devices, medical instruments and medical accessories (collectively “medical devices”) require varying degrees of cleaning, disinfection and/or sterilization to prevent bacteria and mold build-up and for safe use and reuse of devices on the same patient and between patients. There are many types of medical devices that have multiple pieces and accessories that require cleaning, disinfection and/or sterilization including, without limitation, hoses, tubes, facemasks, probes, compartments, reservoirs, irrigation systems, pumps and other accessories. Current devices, systems and methods for preparing medical devices for use and/or reuse have proved to be tiring and difficult for users, hospitals and other medical device provider services. Devices often require daily and weekly maintenance steps to prevent bacteria and mold buildup, requiring each part of the device to be cleaned individually, which is difficult and time consuming for users on a daily or weekly basis. Other cleaning methods include soaking the component parts of a medical device in solvents or mixtures for instance of vinegar and water to disinfect the component parts. Because of the inherent nature for many medical devices to collect bacteria and mold, a number of other products are available for consumers to make medical devices safer to use, including but not limited to sprays, UV light devices, cleaning wipes and cleaning brushes. 
         [0003]    Ozone gas is powerful and effective for removal of odors, impurities and dangerous pathogens, working by exchanging electron charge with particles that ozone comes into contact with to form oxygen, O 2 , from the unstable ozone O3. This process is particularly useful for purifying air and water and for killing bacteria and microorganisms that the ozone comes into contact with. Ozonators can be used to create ozone from oxygen molecules, often by applying ultraviolet light to the oxygen. Ozone gas is made of oxygen molecules that have been ionized by radiation to form groups of three oxygen atoms, O 3 , and may be created, for instance in a device, using an ozonator, air, and the application of ultraviolet light to convert oxygen into ozone gas. However, while ozone gas is a powerful cleaning, disinfecting and sterilizing gas, ozone gas must be contained and controlled as it is not safe for users to breath ozone gas until it has safely converted back to oxygen. The amount of time that is needed for ozone to convert safely from ozone to oxygen varies significantly based on the amount of ozone used in a treatment cycle, in some embodiments ranging from 1 minute to 24 hours. 
         [0004]    It is a long felt need in the art to provide a device, systems and methods that can treat medical devices and medical device passageways with one device using ozone gas, requiring minimum disassembly and yet part specific treatment, all in one or more connected and closed-loop systems for safe use treatment with ozone gas and ease of use by a user. It is further a need to provide connector units to connect a variety of medical devices and medical device passageways for treatment with ozone gas. 
         [0005]    Other systems, methods, apparatus features, and advantages of the present disclosure will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, apparatus features, and advantages be included within this description, be within the scope of the present disclosure, and be protected by the accompanying claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]    Many aspects of the disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views. 
           [0007]      FIG. 1  is a perspective view of an ozone treatment device, in accordance with an embodiment of the present disclosure. 
           [0008]      FIG. 1A  is a perspective view of an ozone treatment device with a connector unit, in accordance with an embodiment of the present disclosure. 
           [0009]      FIG. 2  is a schematic illustration of an ozone process in accordance with an embodiment of the present disclosure. 
           [0010]      FIG. 2A  is a schematic illustration of an ozone process in accordance with an embodiment of the present disclosure. 
           [0011]      FIG. 3  is a perspective view of an ozone treatment device coupled to a hose and a medical device, in accordance with an embodiment of the present disclosure. 
           [0012]      FIG. 4  is a perspective view of an ozone treatment device with an ozone distribution line for recirculating the ozone into the device, in accordance with an embodiment of the present disclosure. 
       
    
    
     SUMMARY OF THE DISCLOSURE 
       [0013]    The present disclosure relates to a device, system and method for cleaning, disinfecting and sterilizing medical devices, the system comprising, a device with an ozone operating system; 
         [0014]    a distribution line fluidly connected to the ozone operating system for receiving and distributing ozone gas; a first receptacle on the device, wherein the distribution line is fluidly coupled to the first receptacle for releasing ozone gas; a connector unit, wherein the connector unit is configured to be fluidly connected at a proximal end to the first receptacle on the device and fluidly connected at a distal end to a proximal end of a hose in one embodiment, in another embodiment to be fluidly connected to a second receptacle on the device, and in another embodiment to be fluidly connected to the proximal end of a medical device; and an exhaust port configured to be fluidly coupled to the distal end of the hose, such that ozone gas passes through the fluid passageway and is exhausted. 
       DETAILED DESCRIPTION 
       [0015]      FIG. 1  is a perspective view of an ozone treatment device  100  for treating a medical device tube or hose  115 , and medical devices and medical device accessories with ozone. The medical devices may include any medical devices with passageways including, without limitation, tubes and hoses. As used herein, treating with ozone refers to the use of ozone to clean, disinfect and/or sterilize In accordance with this embodiment, an ozone operating system is embedded at the bottom of the device  100  behind a compartment door for ease of access by a user. The ozone operating system in this embodiment including an air pump, such as an aquarium pump, for pumping air and an ozone generator for receiving the air and creating ozone gas. In this embodiment an ozone distribution line  140  is coupled to the ozone operating system wherein the distribution line  140  releases ozone into a first ozone delivering receptacle  105 , as shown in  FIG. 1 . In accordance with this embodiment, the first receptacle  105  is configured to fluidly couple to a proximal end of a medical device hose  115 , such as a continuous positive airway pressure device hose. A second ozone receiving receptacle  130  on the device  100  is designed to engage the distal end of the medical device hose  115 , such that when a top lid  132  is in a closed position, tabs  131  engage the second receptacle and form a secure seal surrounding the hose  115 . In accordance with this embodiment, the second receptacle is fluidly coupled to a gas-tight compartment  135  with an exhaust port  125  embedded therein. The gas-tight compartment  135  can be used to clean, disinfect, and/or sterilize medical devices and accessories made of materials that do not degrade in the presence of ozone, such as CPAP facemasks, as an example, thereby closing a closed loop ozone process. As such the ozone gas traverses from the ozone operating system, to a distribution line, to a first receptacle, through a hose, through a second receptacle, into a gas-tight sanitization chamber, and to an exhaust port. The exhaust port  125  in accordance with this embodiment is coupled to the gas-tight compartment  135  and exhausts ozone from the fluid passageway described in the present embodiment for reuse and/or release. In accordance with this embodiment, an oxidizing catalyst is coupled to the exhaust port  125  for collecting and breaking down ozone gas into oxygen, for safe release. In accordance with this embodiment, ozone generated in the device  100  is released from the ozone operating system into the first receptacle  105  and ozone gas traverses from the device  100  into the hose  115  and is released through the exhaust port  125 . 
         [0016]    In accordance with the embodiment shown in  FIG. 1 , the device further includes a third receptacle,  130   a , wherein both the second receptacle  130  and the third receptacle  130   a  have a removable seal  107 . In accordance with this embodiment, the removable seal  107  on the second receptacle  130  and third receptacle  130   a  allows the medical device hose  115  to be fluidly connected into the second receptacle  130  or third receptacle  130   a  while maintaining a closed-loop system and preventing release of ozone gas from the closed-loop system prior to conversion of the ozone gas back to oxygen. In accordance with this embodiment and the closed-loop system described, the ozone gas is released into a gas-tight compartment  135  to treat medical devices and accessories placed in the gas-tight compartment  135  in the device  100 . In accordance with this embodiment, medical devices and accessories can be placed in the gas-tight compartment and cleaned, disinfected and/or sterilized, while hoses and tubes are cleaned, disinfected and/or sterilized with the ozone gas from the ozone operating system, through the first receptacle and into the hose and exhaust port, in a closed-loop system as described. In accordance with this embodiment, the transfer of ozone gas from the ozone operating system to the second and/or third receptacle  130  and  130   a , can be accomplished with one or more hoses, distribution lines or connectors. 
         [0017]    In accordance with the embodiment shown in  FIG. 1 , the ozone treatment device  100  also includes a user interface coupled to the ozone operating system  160 , a timer coupled to the ozone operating system, a sensor  145  for sensing remaining ozone gas in the hose  115 , gas-tight compartments  135  and/or anywhere in the closed loop system, and a safety switch to prevent start of an ozone process or use of a medical devices during an ozone process and an oxidizing catalyst coupled to the exhaust port  125  to collect and break down ozone. 
         [0018]      FIG. 1A  is a perspective view of an ozone treatment device  100  for cleaning, disinfecting and sterilizing a medical device tube or hose  115 , and medical devices and medical device accessories. In accordance with this embodiment, an ozone operating system is embedded in the device  100 , the ozone operating system in this embodiment including an air pump, such as an aquarium pump, for pumping air and an ozone generator for receiving the air and creating ozone gas. In this embodiment an ozone distribution line  140  is coupled to the ozone operating system wherein the distribution line  140  releases ozone into a first receptacle  105 , as shown in  FIG. 1A . In accordance with this embodiment, the first receptacle  105  is configured to be fluidly coupled to a proximal end of a connector unit  110 . The connector unit is sized to be fluidly coupled at the distal end of the connector unit to the proximal end to the hose  115 . In accordance with this embodiment, the second receptacle  130  on the device  100  is designed to engage the distal end of the hose  115 , such that when a top lid  132  is in a closed position, tabs  131 ,  131 a engage the second receptacle and form a secure seal surrounding the hose  115 . In accordance with this embodiment the second receptacle  130  is fluidly coupled to an exhaust port  125 , in this example, through a gas-tight compartment  135  with the exhaust port  125  embedded in the device  100 . The gas-tight compartment  135  can be used to clean, disinfect, and/or sterilize medical devices and accessories made of materials that do not degrade in the presence of ozone, such as CPAP facemasks, as an example, thereby closing a closed loop ozone process. As such, the ozone gas traverses from the ozone operating system, to a distribution line  140 , to a first receptacle  105 , through a hose  115 , through a second receptacle in the hose  115 , into a gas-tight compartment  135 , and to an exhaust port  125 . The exhaust port  125  in accordance with this embodiment is coupled to the to the gas-tight compartment  135  exhausts ozone from the fluid passageway described in the present embodiment for reuse and/or release. In accordance with this embodiment, an oxidizing catalyst is coupled to the exhaust port  125  for collecting and breaking down ozone gas into oxygen, for safe release. In accordance with this embodiment, ozone generated in the device  100  is released from the ozone operating system into the first receptacle  105  and ozone gas traverses from the device  100  into the hose  115  and is released through the exhaust port  125 . 
         [0019]    In accordance with the embodiment shown in  FIG. 1A , the connector unit  110  allows the device  100  to be coupled to any device hose, by providing a first receptacle  105  on the device that fluidly couples to the connector unit  110 . For example, in one embodiment the connector unit  110  may be sized to couple at the proximal end to the first receptacle  105  and on the distal end to a CPAP hose  115 . In another embodiment, the connector unit  110  may be sized to couple at the proximal end to the hose and at the distal end to an endoscope. Similarly adapters and means to change the distal end of the connector unit  110  to fit a variety of sized tubes for any medical device are disclosed herein. 
         [0020]      FIGS. 2 and 2A  are schematic sketches showing closed-loop ozone processes in accordance with an embodiment of the present disclosure. In accordance with this embodiment, an ozone treatment system  200  with a reverse loop ozone process is described, wherein the device has a first receptacle  205  and a second receptacle  230  that fluidly couple to a medical device hose  215  for providing a closed loop ozone process in accordance with an embodiment of the present disclosure. In accordance with this embodiment, the ozone treatment system  200  has an ozone operating system  202  including an ozone pump  201  coupled to an ozone generator  203 , for producing ozone gas, and a distribution line  240  that carries ozone gas to a first receptacle  205 . Ozone gas migrates in this embodiment through the coupled hose  215  and exits the hose into the exhaust port  225 , before the ozone gas is release or recycled from the closed-loop system described. 
         [0021]    Similar to  FIG. 2 ,  FIG. 2A  shows an ozone operating system  202  fluidly coupled to a first receptacle  205  with a distribution line  240 , with ozone gas migrating into the hose  215  and through the second receptacle  230  on the device  100  into a gas-tight chamber for cleaning, disinfecting and/or sterilizing medical instruments and accessories in the gas tight chamber, before the ozone gas is released or recycles from the closed loop system through an exhaust port  225 . In this embodiment an oxide filter  270  is further shown for collecting and breaking down ozone gas into oxygen. 
         [0022]    In accordance with the methods disclosed in  FIGS. 2 and 2A , a method of treating a medical device with ozone gas is disclosed, the method describing an ozone process of producing ozone gas in a device with an ozone operating system, migrating ozone gas through a distribution line through a first receptacle in the device and into a hose of a medical device, and exhausting ozone gas from the hose of the medical device. In accordance with this method, a second receptacle on the device may be used on the device with an exhaust port and/or a gas-tight compartment coupled to an exhaust port and housed in the device, such that the ozone gas is re-circulated into the device before being removed, released or re-circulated from the system, in a closed-loop ozone process. 
         [0023]      FIG. 3  shows a perspective view of an ozone device with an ozone operating system, in accordance with an embodiment of the present disclosure. In this embodiment, a distribution line  340  traverses a first receptacle  305  and attaches at a distal end to a connector unit  310 . In this embodiment the distribution line traverses into the connector unit  310 , which is coupled at a proximal end to a medical device  350  and at the distal end to a medical device hose  315 , and ozone is released into the hose and/or into a cavity in the medical device  350 . In this embodiment a second receptacle  330  and a third receptacle  330   a , with a seal  307  are provided such that the hose  315  can be connected as shown through the second receptacle  330  to release ozone gas into a gas-tight compartment  335  and be exhausted through exhaust port  325 . In accordance with this embodiment, a sensor  345  is provided in the gas-tight compartment  335  to sense the amount of ozone gas in the closed loop system described herein. In this embodiment the sensor  345  is coupled to the user interface  360  for providing ozone process information to a user, including but not limited to ozone levels remaining in the gas tight compartment  335 , ozone cycle time, and ozone safety signals. In accordance with this embodiment, the device  300  and the methods and systems described may further have a user interface  360  coupled to the ozone operating system, a timer coupled to the ozone operating system, a safety switch  365  to prevent start of an ozone process or use of a medical device during an ozone process, and an oxidizing catalyst such as an magnesium oxide filter coupled to the exhaust port  325  to collect and break down ozone. 
         [0024]    As such, in accordance with one embodiment of the present disclosure, a system comprising, a device  300  with an ozone operating system; a distribution line  340  fluidly connected to the ozone operating system for receiving and distributing ozone gas; a first receptacle  305  on the device, wherein the distribution line  340  traverses the first receptacle and connects to a connector unit  310 ; the connector unit  310 , wherein the connector unit  310  is configured to be fluidly connected to a medical device  350  and to a medical device hose  315 ; a second receptacle  330  that engages the hose  315  when the lid  332  is in a closed position with a free end immersed in a gas-tight compartment  335  in the device  300 , is described. 
         [0025]      FIG. 4  is a perspective view of a device  400  with an ozone operating system, showing devices, methods and systems for cleaning, disinfecting and sterilizing medical devices and medical device accessories. In accordance with this embodiment, an ozone operating system is embedded in the device  400 , the ozone operating system in this embodiment including an air pump, such as an aquarium pump, for pumping air and an ozone generator for receiving the air and creating ozone gas. In this embodiment an ozone distribution line  440  is coupled to the ozone operating system wherein the distribution line  440  traverses a first receptacle  405 , as shown in  FIG. 4 . In accordance with this embodiment, the first receptacle  405  is configured to allow the distribution line  440  to traverse through the first receptacle  405  and engage the second receptacle, which is fluidly coupled to a gas-tight compartment  435  with an exhaust port  425  embedded therein. The gas-tight compartment  435  can be used to clean, disinfect, and/or sterilize medical devices and accessories made of materials that do not degrade in the presence of ozone, such as CPAP facemasks, as an example, thereby closing a closed loop ozone process, whereby ozone gas traverses from the ozone operating system, to a distribution line, through a first receptacle and second receptacle, into a gas-tight chamber, and to an exhaust port. The exhaust port  425  in accordance with this embodiment is coupled to the to the gas-tight compartment  435  and exhausts ozone from the fluid passageway described in the present embodiment for reuse and/or release. In accordance with this embodiment, an oxidizing catalyst is coupled to the exhaust port  425  for collecting and breaking down ozone gas into oxygen, for safe release. 
         [0026]    In accordance with yet another embodiment of the present disclosure, a device with an ozone operating system comprising; a first receptacle, wherein the first receptacle is adapted to fluidly transfer ozone gas from the ozone operating system to a hose; and a second receptacle, wherein the second receptacle is adapted to fluidly transfer ozone gas from the hose to an exhaust port, is described. In accordance with this embodiment the device further comprises a gas-tight compartment, wherein the exhaust port is coupled to the gas-tight compartment. The device in the present embodiment further comprises a connector unit, wherein the first end of the connector unit is configured to fluidly couple to the first receptacle and a second end is configured to fluidly couple to a first end of the hose. In accordance with this embodiment second receptacle on the device is configured to engage with a second end of the hose, allowing ozone gas to be released from the hose, through the second receptacle, into the gas-tight compartment. The device in the present embodiment further comprises a user interface coupled to the ozone operating system, a timer coupled to the ozone operating system, a sensor coupled to the ozone operating system for sensing remaining ozone in the medical device, an air pump coupled to the ozone operating system and an oxidizing catalyst coupled to the exhaust port to collect and break down ozone. 
         [0027]    In addition to the devices, systems and methods shown in the proceeding examples, the closed-loop systems described include, in some embodiments, steps for delaying the start of an ozone process of a for a fixed period of time from the last ozone process for the safety of the consumers. The step of delaying the start time may range from may range from about 30 seconds to about 24 hours, depending on the device being treated and the level of cleaning, disinfection and/or sterilization required. In addition the step of sensing remaining ozone in a the medical devices being treated further increases the safety of the present treatment systems and methods for users, while also indicating to users that a medical device has been fully treated in accordance with user guidelines and required ozone exposure numbers. As such, the user interface may display a variety of ozone process information to a user, including but not limited to ozone cycle time, device being treated, ozone levels as detected by sensors, level of treatment required based on an assessment of bacterial, mold, dirt or other criteria on a device being treated, light or sound indicators, and consumable product indicators, for the convenience of users. 
         [0028]    The present disclosure discloses, devices, systems and methods of using ozone gas in closed-loop systems to clean, disinfect and/or sterilize medical devices, medical device hoses and tubes and accessories. Examples of medical devices that may be cleaned, disinfected and/or sterilized in accordance with the embodiments described in the present disclosure include but are not limited to: surgical instruments, irrigation systems for sterile instruments in sterile tissues, endoscopes and endoscopic biopsy accessories, duodenoscopes, endotracheal tubes, bronchosopes, laryngosopes blades and other respiratory equipment, esophageal manometry probes, diaphragm fitting rings and gastrointestinal endoscopes, infusion pumps, ventilators, and continuous positive airway pressure devices (CPAP), prone to bacterial build-up because of humidified air and contact with a patients mouth. Many of the devices listed above include passageways that are difficult to clean, disinfect and sterilize, such as any of the endoscopes, probes, ventilators and CPAP devices and related hoses. 
         [0029]    The present disclosure thus discloses unique cleaning, disinfecting and sterilizing devices with one or more receptacles and connector units for cleaning, disinfecting and/or sterilizing multiple medical devices, medical tubes and accessories. The devices, systems and methods described may include multiple connector units of different sizes and shapes, multiple ozone distribution lines from a device, wherein the devices may be of any size and shape, a timer, a sensor for sensing ozone in the closed-loop systems, a display for displaying cycle parameters and information, medical device cycle levels, cycle times, a controller for controlling release of ozone into the closed-loop systems, a locking mechanism for locking the device, an exhaust port, and a oxygen catalyst coupled to the exhaust port and uniquely designed connector units that connect to multiple medical devices. 
         [0030]    It should be emphasized that the above-described embodiments of the present disclosure, particularly, any “preferred” embodiments, are merely possible examples of implementations, merely set forth for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiments of the disclosure without departing substantially from the spirit and principles of the disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure and the present disclosure and protected by the following claims.