JP2019514822A - Device, system and method for treating medical devices having passageways with ozone gas - Google Patents

Abstract

The present disclosure relates generally to devices, methods and systems for cleaning, disinfecting and / or sterilizing medical devices, medical hoses and tubes and accessories thereof with ozone gas, and in particular, the disclosure relates to ozone gas to the internal passageways and external compartments of medical devices. The present invention relates to devices, methods and systems having a plurality of receptacles that provide a closed loop fluid passage for fluid communication. The device according to the disclosed embodiments comprises two or more receptacles for circulating ozone gas, a gastight compartment, an ozone operating system, and one or more connector units configured to fluidly move ozone in a closed loop processing system. And. [Selected figure] Figure 1

Description

  The present disclosure relates generally to ozone gas treatment of medical devices, and more particularly, to medical devices such as hoses and / or tubes, medical devices, and one or more receptacles to facilitate cleaning, disinfection and sterilization of medical passageways. The invention relates to a device, system and method using a substance or gas such as ozone gas which cleans, disinfects and sterilizes a medical device with a plurality of cleaning, disinfecting and sterilizing ozone devices provided with a socket and a chamber.

  Medical devices, medical devices and medical accessories (collectively "medical devices"), to prevent the accumulation of bacteria and molds, and for the safe use and reuse of the device in the same patient and between patients Require varying degrees of cleaning, disinfecting and / or sterilizing. Several pieces and accessories that require cleaning, disinfection and / or sterilization, including but not limited to hoses, tubes, face masks, probes, compartments, reservoirs, irrigation systems, pumps and other accessories There are many types of medical devices that have. Current devices, systems and methods for preparing medical devices for use and / or reuse have proven to be awkward and difficult for users, hospitals and other medical device provisioning services. The device often requires daily and weekly maintenance steps to prevent bacterial and fungal buildup, requiring each part of the device to be cleaned individually, which can be daily or weekly for the user It is difficult and time consuming. Other cleaning methods include immersing the component parts of the medical device in a solvent or a mixture of, for example, vinegar and water to disinfect the component parts. Due to the inherent nature of collecting bacteria and mold in many medical devices, safer use of the medical devices includes, but is not limited to, sprays, UV light devices, cleaning sheets and cleaning brushes Several other products are available to consumers.

  Ozone gas is powerful and effective in removing odors, impurities and dangerous germs, and acts by exchanging electronic charge from unstable ozone O3 with particles that ozone contacts to form oxygen O2 . This process is particularly useful for purifying air and water, and for killing bacteria and microbes that ozone contacts. An ozone generator can be used to generate ozone from molecular oxygen, often by exposing ultraviolet light to oxygen. Ozone gas consists of oxygen molecules ionized by radiation to form a group O3 of three oxygen atoms, for example, in devices such as an ozone generator, applying ultraviolet light to convert air and oxygen into ozone gas It can be generated using. However, while ozone gas is a powerful cleaning, disinfecting and sterilizing gas, ozone gas must be contained and controlled since it is not safe for the user to absorb ozone gas until it is safely converted back to oxygen. The amount of time required for ozone to be safely converted from ozone to oxygen varies significantly based on the amount of ozone used in the treatment cycle, ranging from 1 minute to 24 hours in some embodiments Do.

  Needs minimal decomposition and part-specific processing, all built into one or more connected closed loop systems for safe use processing with ozone gas and for ease of use by the user The provision of devices, systems and methods capable of treating medical devices and medical device pathways with one device using ozone gas is a long-standing need in the art. There is a further need to provide a connector unit that connects various medical devices and medical device pathways for treatment with ozone gas.

  Other systems, methods and 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.

  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. Further, in the drawings, like reference numerals represent corresponding parts throughout the several views.

FIG. 1 is a perspective view of an ozone treatment device according to an embodiment of the present disclosure. FIG. 1 is a perspective view of an ozone treatment device having a connector unit according to an embodiment of the present disclosure. FIG. 1 is a schematic view of an ozone process, according to an embodiment of the present disclosure. FIG. 1 is a schematic view of an ozone process, according to an embodiment of the present disclosure. FIG. 10 is a perspective view of an ozone treatment device coupled to a hose and a medical device according to an embodiment of the present disclosure. FIG. 1 is a perspective view of an ozonation device having an ozone flow line for recirculating ozone into the device, according to an embodiment of the present disclosure.

  The present disclosure relates to devices, systems and methods for cleaning, disinfecting and sterilizing medical devices, the system comprising: a device having an ozone operating system; and a distribution line fluidly connected to the ozone operating system for distributing ozone gas. A first receptacle of the device, the first receptacle of the device having a flow line fluidly coupled to release ozone gas, and in one embodiment, a fluid connection to the first receptacle of the device at the proximal end And fluidly connected at the distal end to the proximal end of the hose, in another embodiment, to the second receptacle of the device, and in another embodiment, to the proximal end of the medical device Connector unit configured as described above, and a hose for ozone gas to be discharged through the fluid passage And a exhaust port configured to be fluidly coupled to the distal end.

  FIG. 1 is a perspective view of an ozone treatment device 100 for treating medical device tubes or hoses 115, medical devices and medical device accessories with ozone. The medical device may include, but is not limited to, any medical device with a passageway including tubes and hoses. Treatment with ozone as used herein refers to the use of ozone for cleaning, disinfecting and / or sterilizing. According to this embodiment, the ozone operating system is incorporated into the bottom of the device 100 behind the compartment door for easy access by the user. The ozone operating system of this embodiment includes an air pump, such as a water pump that pumps air, and an ozone generator that receives air and produces ozone gas. In this embodiment, as shown in FIG. 1, the ozone flow line 140 is coupled to the ozone operating system, and the flow line 140 releases ozone into the first ozone delivery receptacle 105. According to this embodiment, the first receptacle 105 is configured to fluidly couple to the proximal end of a medical device hose 115, such as a continuous positive airway pressure device hose. The second ozone receiving receptacle 130 of the device 100 allows the medical device hose 115 to engage so that the tab 131 engages the second receptacle and forms a tight seal around the hose 115 when the upper lid 132 is in the closed position. Designed to engage the distal end of the According to this embodiment, the second receptacle is fluidly coupled to an air tight compartment 135 in which the vent 125 is integrated. The hermetic compartment 135 can be used to clean, disinfect and / or sterilize medical devices and accessories consisting of materials that do not degrade in the presence of ozone, such as, by way of example, CPAP face masks, whereby the closed loop ozone process Close As such, ozone gas passes from the ozone operating system, through the distribution line, the first receptacle, the hose, through the second receptacle, and into the hermetic purification chamber, the exhaust port. The vent 125 according to this embodiment is coupled to the hermetic compartment 135 and exhausts ozone from the fluid passages described in this embodiment for reuse and / or release. According to this embodiment, an oxidation catalyst is coupled to exhaust 125 for collecting ozone gas and decomposing it to oxygen for safe release. According to this embodiment, ozone generated by the device 100 is released from the ozone operating system into the first receptacle 105 and ozone gas passes from the device 100 into the hose 115 and is released through the exhaust 125 Be done.

  According to the embodiment shown in FIG. 1, the device further comprises a third receptacle 130 a, wherein both the second receptacle 130 and the third receptacle 130 a have a removable seal 107. According to this embodiment, the removable seal 107 of the second receptacle 130 and the third receptacle 130a maintain a closed loop system, wherein the ozone gas is released from the closed loop system before the ozone gas is converted back to oxygen. While at the same time allowing the medical device hose 115 to be fluidly connected into the second receptacle 130 or the third receptacle 130a. According to this embodiment and the closed loop system described, ozone gas is released into the air tight compartment 135 to process the medical devices and accessories located in the air tight compartment 135 of the device 100. According to this embodiment, the medical devices and accessories can be placed in the airtight compartment and can be cleaned, disinfected and / or sterilized, while the hoses and tubes operate in the closed loop system as described. The ozone gas from the system, through the first receptacle, into the hose and into the exhaust is flushed, disinfected and / or disinfected. According to this embodiment, movement of ozone gas from the ozone operating system to the second receptacle 130 and / or the third receptacle 130a can be accomplished with one or more hoses, flow lines or connectors.

  According to the embodiment shown in FIG. 1, the ozone treatment device 100 also includes a user interface 160 coupled to the ozone operating system, a timer coupled to the ozone operating system, a hose 115, a gas tight compartment 135 and / or a closed loop system A sensor 145 to detect any ozone gas left somewhere on, and a safety switch to prevent the start of the ozone process or the use of medical devices during the ozone process and an oxidation coupled to the exhaust 125 for collecting and decomposing ozone And a catalyst.

  FIG. 1A is a perspective view of an ozone treatment device 100 for cleaning, disinfecting and sterilizing medical device tubes or hoses 115, medical devices and medical device accessories. According to this embodiment, the ozone operating system is incorporated into the device 100, the ozone operating system of this embodiment comprising an air pump such as a water tank pump that pumps air and an ozone generator that receives air and produces ozone gas. Including. In this embodiment, as shown in FIG. 1A, the ozone flow line 140 is coupled to the ozone operating system, and the flow line 140 releases ozone into the first receptacle 105. According to this embodiment, the first receptacle 105 is configured to be fluidly coupled to the proximal end of the connector unit 110. The connector unit is sized to be fluidly coupled to the proximal end of the hose 115 at the distal end of the connector unit. According to this embodiment, the second receptacle 130 of the device 100 engages the second receptacle with the tabs 131, 131a forming a tight seal around the hose 115 when the upper lid 132 is in the closed position. As such, it is designed to engage the distal end of the hose 115. According to this embodiment, the second receptacle 130 is fluidly coupled to the exhaust 125 through an air tight compartment 135 with an exhaust 125 incorporated into the device 100 in this example. The hermetic compartment 135 can be used to clean, disinfect and / or sterilize medical devices and accessories consisting of materials that do not degrade in the presence of ozone, such as, by way of example, CPAP face masks, whereby the closed loop ozone process Close As such, ozone gas passes from the ozone operating system, through the distribution line 140, the first receptacle 105, the hose 115, through the second receptacle in the hose 115, into the hermetic compartment 135, and into the exhaust port 125. . The exhaust 125 according to this embodiment is coupled to the hermetic compartment 135 and exhausts the ozone from the fluid passages described in this embodiment for reuse and / or release. According to this embodiment, an oxidation catalyst is coupled to exhaust 125 for collecting ozone gas and decomposing it to oxygen for safe release. According to this embodiment, ozone generated by the device 100 is released from the ozone operating system into the first receptacle 105, and ozone gas passes from the device 100 through the hose 115 and is released through the exhaust 125.

  According to the embodiment shown in FIG. 1A, the connector unit 110 enables the device 100 to be coupled to any device hose by providing a first receptacle 105 of the device fluidically coupled to the connector unit 110. . For example, in one embodiment, the connector unit 110 may be sized to couple to the first receptacle 105 at the proximal end, to the CPAP hose 115 at the distal end. In another embodiment, the connector unit 110 may be sized to couple to the endoscope at the proximal end, to the hose, at the distal end, and to the endoscope. Similarly, an adapter and means for altering the distal end of the connector unit 110 to fit various sized tubes of any medical device are disclosed herein.

  2 and 2A are schematic diagrams illustrating a closed loop ozone process according to embodiments of the present disclosure. According to this embodiment, an ozone treatment system 200 is described that uses a reverse loop ozone process, and the device is in fluid communication with the medical device hose 215 to provide a closed loop ozone process according to an embodiment of the present disclosure. And a second receptacle 230. According to this embodiment, the ozone processing system 200 includes an ozone operating system 202 including an ozone pump 201 coupled to the ozone generator 203 for generating ozone gas, and a flow for transporting the ozone gas to the first receptacle 205. And a line 240. The ozone gas, in this embodiment, travels through the coupled hose 215 and exits the hose into the exhaust port 225 prior to the ozone gas being released or recirculated from the described closed loop system.

  Similar to FIG. 2, FIG. 2A shows the ozone operating system 202 fluidly coupled to the first receptacle 205 using a flow line 240, wherein ozone gas is released or recaptured from the closed loop system through the exhaust port 225. Prior to being circulated, the medical device and accessories in the hermetic chamber are moved into the hermetic chamber through the second receptacle 230 of the device 100 within the hose 215 in order to clean, disinfect and / or sterilize medical devices and accessories in the hermetic chamber. In this embodiment, an oxide filter 270 is further shown for collecting and decomposing ozone gas to oxygen.

  According to the method disclosed in FIGS. 2 and 2A, a method of treating a medical device with ozone gas is disclosed, said method producing ozone gas with a device having an ozone operating system, the ozone gas, the distribution line of the device The ozone process is described as passing through the first receptacle and moving into the hose of the medical device to discharge ozone gas from the hose of the medical device. According to this method, the second receptacle of the device is vented and / or vented so that ozone gas may be recirculated into the device prior to being removed, released or recirculated from the system in a closed loop ozone process. It may be used in a device having an airtight compartment coupled and housed in the device.

  FIG. 3 shows a perspective view of an ozone device having an ozone operating system according to an embodiment of the present disclosure. In this embodiment, the flow line 340 passes through the first receptacle 305 and connects to the connector unit 310 at the distal end. In this embodiment, the flow line traverses within the connector unit 310, the connector unit 310 being coupled to the medical device 350 at the proximal end, to the medical device hose 315 at the distal end, and ozone being , Into the hose and / or into the cavity of the medical device 350. In this embodiment, a hose 315 is connected through the second receptacle 330 as shown so that the seal 307 can be released so as to release ozone gas into the airtight compartment 335 and exhaust it through the exhaust outlet 325. A second receptacle 330 and a third receptacle 330a are provided. According to this embodiment, a sensor 345 is provided in the hermetic compartment 335 to detect the amount of ozone gas in the closed loop system described herein. In this embodiment, the sensor 345 is coupled to a user interface 360 that provides the user with ozone process information including, but not limited to, ozone levels remaining in the gas tight compartment 335, ozone cycle time and ozone safety signal. According to this embodiment, the device 300 and the described method and system further comprise a user interface 360 coupled to the ozone operating system, a timer coupled to the ozone operating system, initiation of the ozone process or during the ozone process And a oxidation switch such as a magnesium oxide filter coupled to exhaust 325 for collecting and decomposing ozone.

  As such, according to one embodiment of the present disclosure, a device 300 having an ozone operating system, a flow line 340 fluidly connected to the ozone operating system for receiving ozone gas, and a first receptacle 305 of the device. And a connector unit configured to be fluidly connected to the first receptacle 305 and to the medical device 350 and to the medical device hose 315, wherein the flow line 340 traverses the first receptacle and connects to the connector unit 310. A system is described that includes 310 and a second receptacle 330 that engages the hose 315 when the lid 332 is in the closed position and the free end is embedded in the hermetic compartment 335 of the device 300.

  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. According to this embodiment, the ozone operating system is incorporated into the device 400, the ozone operating system of this embodiment comprising an air pump such as a water tank pump that pumps air and an ozone generator that receives air and generates ozone gas. It is included. In this embodiment, as shown in FIG. 4, the ozone flow line 440 is coupled to the ozone operating system, and the flow line 440 traverses the first receptacle 405. According to this embodiment, the first receptacle 405 engages a second receptacle fluidly coupled to the air-tight compartment 435 in which the flow line 440 traverses the first receptacle 405 and the exhaust 425 is integrated therein. Configured to allow matching. The hermetic compartment 435 can be used to clean, disinfect and / or sterilize medical devices and accessories consisting of materials that do not degrade in the presence of ozone, such as, by way of example, a CPAP face mask, whereby the closed loop ozone process And so doing, ozone gas passes from the ozone operating system, through the distribution line, the first receptacle and the second receptacle, into the hermetic chamber and into the exhaust. An exhaust 425 according to this embodiment is coupled to the hermetic compartment 435 and exhausts ozone from the fluid passages described in this embodiment for reuse and / or release. According to this embodiment, an oxidation catalyst is coupled to exhaust 425 for collecting ozone gas and cracking it to oxygen for safe release.

  According to yet another embodiment of the present disclosure, a first receptacle adapted to fluidly transfer ozone gas from an ozone operating system to a hose, and fluid to move ozone gas from the hose to an outlet. A device is described having an ozone operating system comprising a second receptacle. According to this embodiment, the device further comprises an airtight compartment to which the exhaust is coupled. The device of this embodiment further comprises a connector unit, wherein the first end of the connector unit is configured to fluidly couple to the first receptacle, and the second end is fluidically coupled to the first end of the hose Configured to According to this embodiment, the second receptacle of the device engages the second end of the hose to allow ozone gas to be released from the hose through the second receptacle and into the hermetic compartment Configured as. The device of the present embodiment is further coupled to a user interface coupled to the ozone operating system, a timer coupled to the ozone operating system, and an ozone operating system for detecting remaining ozone in the medical device. A sensor, an air pump coupled to the ozone operating system, and an oxidation catalyst coupled to the exhaust for collecting and decomposing ozone.

  In addition to the devices, systems and methods shown in the prior examples, the described closed loop system, in some embodiments, delays the start of the ozone process for a period of time from the previous ozone process for consumer safety including. The step of delaying the start time may be in the range of about 30 seconds to about 24 hours, depending on the device being processed and the level of cleaning, disinfection and / or sterilization required. In addition, detecting the remaining ozone in the medical device being processed further enhances the security of the present processing system and method to the user, and the medical device follows the user guidelines and the number of ozone exposures required. It also indicates to the user that it has been completely processed. As such, the user interface is not limited to the following for the convenience of the user, but is not limited to ozone cycle time, devices being processed, ozone levels detected by sensors, bacteria of the devices being processed, molds Various ozone process information may be displayed to the user, including treatment levels required based on the assessment of dirt, or other criteria, light or voice indicators and consumable product indicators.

  The present disclosure discloses devices, systems and methods that use ozone gas in a closed loop system for cleaning, disinfecting and / or sterilizing medical devices, medical device hoses and tubes and accessories. Examples of medical devices that can be cleaned, disinfected and / or sterilized according to embodiments described in the present disclosure include, but are not limited to: surgical instruments, irrigation systems for sterile instruments in sterile tissue, endoscopes and the like Endoscopic biopsy accessories, duodenum endoscopes, endotracheal tubes, bronchoscopes, laryngoscope blades and other respiratory devices, esophagus manometry probes, diaphragm fitting rings and gastroendoscopes, drip pumps, ventilators, and A continuous positive airway pressure device (CPAP) is included that tends to accumulate mold on contact with moist air and the patient's mouth. Many of the devices listed above include passageways that are difficult to clean, disinfect and sterilize, such as endoscopes, probes, ventilators, CPAP devices and any of the associated hoses.

  Thus, the present disclosure discloses a unique cleaning, disinfecting and sterilizing device having one or more receptacles and connector units for cleaning, disinfecting and / or sterilizing a plurality of medical devices, medical tubes and accessories. The devices, systems and methods described comprise a plurality of connector units of different sizes and shapes, a plurality of ozone flow lines from devices which may be of any size and shape, a timer, ozone in a closed loop system A sensor that detects the pressure, a cycle parameter and information, a display that displays the medical device cycle level, a cycle time, a controller that controls the release of ozone into the closed loop system, a locking mechanism that locks the device, An oxidation catalyst coupled to the exhaust and a specially designed connector unit connected to the plurality of medical devices may be included.

  It should be emphasized that the above-described embodiments of the present disclosure, in particular any "preferred" embodiments, are only possible examples of implementations and are merely described for a clear understanding of the principles of the disclosure. is there. 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 variations and modifications are intended to be included herein and within this disclosure within the scope of this disclosure and protected by the following claims.

Claims (22)

With the ozone operating system,
A first receptacle fluidically coupled to the ozone operating system, configured to receive ozone gas from the ozone operating system and fluidly coupled to a proximal end of an ozone delivery line, the ozone delivery line A first receptacle, further comprising a distal end;
An airtight compartment,
A base comprising a lid and at least one wall, wherein the lid and the at least one wall define a cavity;
A second receptacle configured to receive and engage an intermediate portion of the ozone delivery line to form a hermetic seal with the distal end of the ozone delivery line disposed within the cavity. An airtight compartment comprising a second receptacle between the proximal end and the distal end of the hose;
The ozone operating system generates ozone gas for delivery by the ozone delivery line to the cavity of the hermetic compartment such that the ozone gas flows directly from the first receptacle into the ozone delivery line. Composed of an ozone treatment system.   The ozone treatment system according to claim 1, wherein the second receptacle is at least partially defined by at least one wall of the plurality of walls.   The ozone treatment system according to claim 1, wherein the second receptacle is at least partially defined by the at least one wall and the lid. The lid is movable between an open position and a closed position,
The at least one wall comprises a lid sealing surface and a delivery line sealing surface;
The ozone treatment system according to claim 1, wherein the second receptacle is at least partially defined by the delivery line sealing surface. When the lid is in the closed position,
The first portion of the lid engages the lid sealing surface,
5. The ozone treatment system of claim 4, wherein a second portion of the lid defines at least a portion of the second receptacle.   6. The ozone treatment system of claim 5, wherein the second portion of the lid and the lid sealing surface form the hermetic seal with the middle portion of the ozone delivery line. The lid further comprises a sealing element,
When the lid is in the closed position,
The first portion of the lid engages the lid sealing surface,
The sealing element engages at least a portion of the middle portion of the ozone delivery line such that the second receptacle is at least partially defined by the delivery line sealing surface and the sealing element. The ozone treatment system according to claim 4.   The ozone treatment system according to claim 7, wherein the sealing element extends from the downward side of the lid when the lid is in the closed position. The second receptacle defines a passageway into the cavity of the hermetic compartment;
The ozone treatment system according to claim 1, wherein the distal end of the ozone delivery line is larger than the passage.   The ozone treatment system according to claim 1, wherein the ozone delivery line is a hose of a medical device.   The ozone treatment system according to claim 10, wherein the hose is a hose of a continuous positive airway pressure device.   11. The ozone treatment system of claim 10, further comprising a mask coupled to the distal end of the hose.   The ozone treatment system according to claim 1, further comprising an exhaust port fluidly coupled to the hermetic compartment, wherein the exhaust port exhausts ozone gas from the cavity.   The ozone treatment system according to claim 11, further comprising an oxidation catalyst downstream of the exhaust port, wherein the oxidation catalyst is configured to decompose the ozone gas exhausted by the exhaust port.   15. The ozone treatment system of claim 14, wherein the oxidation catalyst comprises magnesium oxide.   The ozone treatment system according to claim 1, further comprising an ozone sensor in the cavity.   The ozone treatment system according to claim 1, wherein a hermetic compartment is integral with the ozone operating system.   The ozone treatment according to claim 1, further comprising a base, wherein the ozone operating system and the hermetic compartment are coupled to the base such that the position of the ozone operating system is fixed relative to the position of the hermetic compartment. system.   The ozone treatment system of claim 1, further comprising an air pump fluidly coupled to the ozone operating system. An ozone operating system configured to fluidly couple to a proximal end of a medical device hose, the hose further comprising a distal end;
An airtight compartment at least partially defined by a plurality of walls and a lid, said lid being movable between an open position and a closed position,
The plurality of walls comprises a first wall configured to receive an intermediate portion of the hose to form a hermetic seal, the intermediate portion being between the proximal end and the distal end And
The ozone operating system is configured to generate ozone gas for delivery by the hose to the hermetic compartment such that the ozone gas flows directly into the ozone delivery line from the first receptacle. Processing system. The first wall comprises an upward facing surface and a hose seal;
When the lid is in the closed position and the middle portion is disposed within the hose seal,
The first portion of the lid engages the upward surface,
The second portion of the lid engages at least a portion of the middle portion of the hose;
21. The ozone treatment system of claim 20, wherein the hose seal engages at least a portion of the intermediate portion of the hose to form the hermetic seal.   22. The ozone treatment system of claim 21, wherein when the middle portion of the hose is disposed within the hose seal, at least a portion of the middle portion of the hose is below the lid seal.

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