Note: Descriptions are shown in the official language in which they were submitted.
84291234
DEVICES, SYSTEMS AND METHODS FOR TREATING MEDICAL DEVICES
HAVING PASSAGEWAYS WITH OZONE GAS
TECHNICAL FIELD
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
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
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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.
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, 02, from the unstable ozone 03. 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, 03, 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.
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
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According to one aspect of the present invention, there is provided an ozone
treatment
system comprising: an ozone operating system; a first receptacle fluidly
coupled to the ozone
operating system, the first receptacle configured to receive ozone gas from
the ozone
operating system and to fluidly couple to a proximal end of medical device
hose, said medical
device hose further comprising a distal end; and a gas tight compaittnent
comprising: a base; a
lid coupled to the base by a hinge, said lid movable between an open position
and a closed
position; and a chamber formed by said lid and said base when said lid is in
the closed
position; and wherein: said base comprises a second receptacle configured to
receive an
intermediate portion of said medical device hose with a distal end of said
medical device hose
.. disposed in said chamber, said intermediate portion being between said
proximal end and said
distal end of said medical device hose; when said medical device is received
within the second
receptacle and said lid is in said closed position, said lid engages said
second receptacle form
a seal around said intermediate portion of said medical device hose; and said
ozone operating
system is configured to generate ozone gas for conveyance to said chamber by
said medical
device hose, wherein said ozone gas flows directly from said first receptacle
into said medical
device hose.
2a
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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
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.
FIG. 1 is a perspective view of an ozone treatment device, in accordance with
an
embodiment of the present disclosure.
FIG. lA is a perspective view of an ozone treatment device with a connector
unit, in
accordance with an embodiment of the present disclosure.
FIG. 2 is a schematic illustration of an ozone process in accordance with an
embodiment
of the present disclosure.
FIG. 2A is a schematic illustration of an ozone process in accordance with an
embodiment of the present disclosure.
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.
FIG. 4 is a perspective view of an ozone treatment device with an ozone
distribution line
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for recirculating the ozone into the device, in accordance with an embodiment
of the present
disclosure.
SUMMARY OF THE DISCLOSURE
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;
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
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
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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.
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In accordance with the embodiment shown in FIG 1, the device further includes
a third
receptacle, 130a, wherein both the second receptacle 130 and the third
receptacle 130a have a
removable seal 107. In accordance with this embodiment, the removable seal 107
on the second
receptacle 130 and third receptacle 130a allows the medical device hose 115 to
be fluidly
connected into the second receptacle 130 or third receptacle 130a 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 130a, can be accomplished with one
or more hoses,
distribution lines or connectors.
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.
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FIG. lA 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,
131a 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
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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.
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.
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
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described.
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.
In accordance with the methods disclosed in FIG. 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.
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
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embodiment a second receptacle 330 and a third receptacle 330a, 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.
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.
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
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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.
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
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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.
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
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treated, light or sound indicators, and consumable product indicators, for the
convenience of
Men.
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.
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
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connect to multiple medical devices.
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.
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