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Device For Disinfecting And/Or Rinsing Endoscopes With Limited Escape Of Fumes

Abstract: Systems and methods for disinfection and/or water rinsing of endoscopes in which disinfectant fumes can be contained during use (e.g. to limit operator exposure to disinfectants and fumes).

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
09 April 2013
Publication Number
46/2014
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
remfry-sagar@remfry.com
Parent Application

Applicants

HEALTHPOINT LTD.
3909 Hulen St. Fort Worth TX 76107

Inventors

1. MINER Norman
300 County Road 134 Gainesville TX 76240

Specification

CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No.
61/388,210, filed September 30, 2010, which is incorporated by reference in its entirety.
BACKGROUND
1. Field of the Invention
[0002] The present invention relates generally to disinfection and/or rinsing; and more
particularly, but not by way of limitation, to high-level disinfection and/or rinsing of
endoscopes.
2. Description of Related Art
[0003] Endoscopes (e.g., heat-sensitive, semi-critical, and/or flexible fiberoptic
endoscopes such as gastroscopes, colonoscopes, bronchoscopes, laryngoscopes, and
cystoscopes) often must be thoroughly cleaned, rinsed to remove the cleaning agents,
disinfected with high level disinfectants, and rinsed to remove the disinfectants, before use
with each patient. Vapors from high level disinfectants such as alkaline glutaraldehyde,
glutaraldehyde plus isopropanol, ortho-phthalaldehyde, and peracetic acid solutions may
irritate and sensitize the skin, eyes, and mucous membranes of the medical personnel who
work with these disinfectants in open basins to reprocess the flexible endoscopes.
[0004] Automatic endoscope reprocessing machines (AER's) have been developed to
hold the flexible endoscopes in a basin, and hold the high level disinfectant solutions in a
separate reservoir. An endoscope may be placed into the basin of an AER, where disinfectant
solutions and subsequently rinse water can be automatically transferred in and out of the
basin. The endoscope may also be connected to tubing to automatically flush the disinfectants
and rinse water through the internal air, water, and working (biopsy) channels of the
endoscopes. Operation of an AER is typically controlled and performed automatically by a
programmable CPU. The disinfectant reservoir and the basin of the AER may be enclosed,
and may sufficiently contain the vapors of the high level disinfectant in the reservoir and basin
of the AER, to protect the workers from the vapors. However, such AER machines are
generally expensive, and can cost from $30,000 to $40,000. Many are also limited to
disinfecting and rinsing at most two flexible endoscopes at the same time, and often require
about 30 to 40 minutes per reprocessing cycle.
[00051 Because of the expense of known AER machines, and the abundance of
unskilled labor, flexible endoscopes world-wide may be manually disinfected between uses
with each patient. The manual disinfection process is generally similar to the automated
process, i.e., clean, rinse, disinfect, rinse, except the manual process is often performed by a
person using basins of disinfectant and rinse water, often exposed and open to air. High level
disinfectant solution may be held in a basin into which the endoscope is placed. Tubing is
generally attached to the flexible endoscope channels and to a syringe or pump. The operator
may work over the disinfectant basin and the endoscope, and the operator may pump the
disinfectant through the channels of the endoscope. The air space immediately above the
disinfectant solution in the basin may be in the operator's breathing zone, and unless the
operator is wearing a breathing mask (a gas mask) that covers the eyes, nose, and mouth, the
operator may come into contact with the vapors of the disinfectant. Even if the operator is
wearing a breathing mask, vapors of the disinfectant solution may escape into the air of the
reprocessing space such as a chemical fume hood, or the air of the reprocessing room and can
irritate exposed skin or other personnel in the area.
[0006] After the endoscope has been exposed to the high level disinfectant, then the
endoscope is generally transferred to another basin holding fresh rinse water, and may be
manually flushed with the rinse water. This rinsing procedure is generally repeated three
times with fresh rinse water each time to dilute the chemicals of the high level disinfectant to
the level of no observable toxic effect. This process of transfer and rinsing of the endoscope
again has the potential to release fumes of the disinfectant to the surrounding air.
[0007] Glutaraldehyde is a high level disinfectant with a long history of use, and
glutaraldehyde plus 20% w/w isopropanol is another disinfectant that is generally more
antimicrobially effective than Glutaraldehyde. Both of these disinfectant solutions may cause
irritation and sensitization of personnel caused by the fumes/vapors of glutaraldehyde (e.g.,
fumes of glutaraldehyde released during manual disinfection of endoscopes). Solutions of
ortho-phthalaldehyde (OPA) are increasingly used because the relatively low vapor pressure
of OPA reduces the vapors that can escape from solutions of OPA. However, OPA is
generally not considered to be a sterilant, and may not kill at least one common spore-forming
bacteria: Bacillus subtilis. These surviving bacteria may initiate formation of biofilms within
endoscopes, after which the endoscope may be difficult or impossible to disinfect. OPA is
also generally considered to be a potent allergen, and cases of anaphylactic shock have been
reported in scientific literature believed by some to be due to use and re-use of endoscopes
disinfected with OPA. Labels of OPA solutions generally carry a warning against the use of
OPA with certain endoscopes (e.g., cystoscopes, used to monitor bladder cancer patients).
OPA has relatively low solubility in water, and one recent publication demonstrates that OPA
adsorbs onto endoscope surfaces and may not be adequately rinsed away even with excessive
numbers of rinses.
[0008] Examples of apparatuses for disinfecting and/or rinsing endoscopes are
disclosed in: (l) U.S. Patent No. 3,963,438; (2) U.S. Patent No. 4,391,287; (3) U.S. Patent
No. 4,732,187; (4) U.S. Patent No. 4,763,678; (5) U.S. Patent No. 5,494,637; (6) U.S. Patent
No. 5,882,589; and (7) U.S. Patent No. 6,361,751.
SUMMARY
[0009] The present disclosure includes embodiments of systems and methods for
disinfecting and/or rinsing endoscopes (e.g., while reducing user exposure to fumes).
[0010] Some embodiments of the present apparatuses for disinfecting and/or rinsing
an endoscope comprise: a basin including a body and a lid, the body configured to receive an
endoscope such that the endoscope can be submersed in liquid with a headspace in the basin
above the liquid, the lid configured to be coupled to the basin to provide a substantially air¬
tight seal between the lid and the body; a reservoir with a top, the reservoir configured to
receive a liquid with a headspace between the liquid and the top; a disinfectant supply conduit
coupled to the basin and to the reservoir, and configured to communicate liquid from the
reservoir to the basin; and a gas conduit coupled to the basin and to the reservoir, the gas
conduit configured to communicate gas between the headspace of the basin and the headspace
of the reservoir.
[0011] Some embodiments further comprise: a water supply conduit coupled to the
basin, and configured to be coupled to a water source to communicate water to the basin.
Some embodiments further comprise: a filter coupled to the water supply conduit. Some
embodiments further comprise: a disinfectant drain conduit coupled to the basin and to the
reservoir, and configured to communicate liquid from the basin to the reservoir. Some
embodiments further comprise: a disinfectant drain valve coupled to the disinfectant drain
conduit and configured to be actuated to substantially prevent liquid communication between
the basin and the reservoir. Some embodiments comprise a waste drain conduit coupled to the
basin, and configured to communicate liquid out of the basin. Some embodiments further
comprise: a waste drain valve coupled to the waste drain conduit and configured to be
actuated to substantially prevent liquid communication out of the basin through the waste
drain conduit. In some embodiments, the waste drain conduit is configured to communicate
waste from the basin to a waste receptacle or a drain. Some embodiments further comprise: a
waste receptacle coupled to the waste drain conduit.
[0012] In some embodiments, the gas conduit is configured to function at atmospheric
pressure. In some embodiments, the apparatus is configured to maintain the gas conduit at
atmospheric pressure. Some embodiments further comprise a pump coupled to the
disinfectant supply conduit and configured to pump a liquid between the reservoir and the
basin. In some embodiments, the pump is configured to pump the liquid from the reservoir to
the basin. In some embodiments, the reservoir is disposed at a lower elevation than the basin.
In some embodiments, the gas conduit is coupled to the basin at an elevation greater than the
elevation at which the disinfectant supply conduit is coupled to the basin. Some embodiments
further comprise: a valve coupled to the gas conduit and configured to be actuated to
substantially prevent liquid communication between the basin and at least a portion of the gas
conduit. In some embodiments, the gas conduit is coupled to the lid. In some embodiments,
the lid is configured to be coupled to the top of the basin.
[0013] Some embodiments further comprise: a second basin having a second body and
a second lid, the body configured to receive an endoscope such that the endoscope can be
submersed in liquid with a headspace in the basin above the liquid, the second lid configured
to be coupled to the second body to provide a substantially air-tight seal between the second
lid and the second basin; a second reservoir with a top, the second reservoir configured to
receive a liquid with a headspace between the liquid and the top; a second disinfectant supply
conduit coupled to the second basin and to the second reservoir, and configured to
communicate liquid from the second reservoir to the second basin; and a second gas conduit
coupled to the second basin and to the second reservoir, the second gas conduit configured to
communicate gas between the headspace of the second basin and the headspace of the second
reservoir.
[0014] Some embodiments further comprise: a second basin configured to receive an
endoscope such that the endoscope can be submersed in liquid with a headspace in the basin
above the liquid; a second lid configured to be coupled to the second basin to provide a
substantially air-tight seal between the second lid and the second basin; a second disinfectant
supply conduit coupled to the second basin, and configured to communicate liquid from the
reservoir to the second basin; and a second gas conduit coupled to the second basin and to at
least one of the first basin and the reservoir, the second gas conduit configured to
communicate gas between the headspace of the second basin and at least one of the headspace
of the reservoir and the headspace of the first basin.
[0015] In some embodiments, the disinfectant supply conduit is in direct fluid
communication with the basin and the reservoir; and/or the gas conduit is in direct fluid
communication with the basin and the reservoir.
[0016] In some embodiments, at least one of the basin and the lid include an opening
configured such that a tube of an irrigator can extend through the opening while connected to
at least one channel of an endoscope in the basin for supplying disinfectant solution or rinse
water to the at least one channel of the endoscope, the opening configured to substantially
prevent fluid communication through the opening around the tube of the irrigator.
[0017] In some embodiments, the apparatus is configured such that if the lid is
coupled to the body of the basin, the apparatus substantially prevents gas from escaping to the
surrounding atmosphere.
[0018] Some embodiments of the present methods for disinfecting and/or rinsing an
endoscope comprise using an embodiment of the present apparatuses to disinfect one or more
endoscopes.
[0019] Some embodiments of the present methods for disinfecting and/or rinsing an
endoscope comprise: disposing an endoscope in a basin; coupling a lid to a body of a basin
such that a substantially airtight seal is provided between the lid and the body; and
transferring disinfectant solution from a reservoir to the basin through a disinfectant supply
conduit such that the endoscope is submersed in the disinfectant solution, and a headspace is
provided between the disinfectant solution and the lid; where the reservoir includes a top, a
headspace is provided between any disinfectant solution remaining in the reservoir and the top
of the reservoir, and the headspace of the basin is in fluid communication with the headspace
in the reservoir through a gas conduit. In some embodiments, transferring is not electrically
powered. Some embodiments further comprise: transferring the disinfectant solution from the
basin to the reservoir. Some embodiments further comprise: introducing water into the basin.
In some embodiments, the basin is substantially filled with water. In some embodiments, the
gas conduit is coupled to the lid. In some embodiments, a gas valve is disposed in the gas
conduit and configured to be actuated to substantially prevent liquid communication between
the basin and at least a portion of the gas conduit, and the method further comprises: closing
the gas valve when the basin is substantially full of water.
[0020] Some embodiments of the present devices for disinfecting at least one
endoscope comprise: (a) a basin, for receiving the endoscope to be disinfected, with a capacity
sufficient to contain the endoscope such that the endoscope can be completely submerged in a
liquid and a headspace can be maintained above the liquid within the basin; (b) a basin lid
with an air-tight seal, for providing an air-tight closure above the basin; (c) a sealable
reservoir, for containing a disinfectant solution; (d) a disinfectant supply tube connected to the
basin and to the reservoir, for supplying the basin with the disinfectant solution; (e) a
disinfectant supply pump connected in-line with the disinfectant supply tube, for pumping the
disinfectant solution from the reservoir to the basin; (f) a water supply tube connected to the
basin and to a water source, for supplying rinse water to the basin; (g) one or more drain tubes
connected to the basin and to: (1) the reservoir, for returning the disinfectant solution to the
reservoir, or (2) a waste container or drain, for disposing of the disinfectant solution or rinse
water; and (h) an air vent tube in communication with the basin headspace and the reservoir
headspace, for maintaining equal air pressure between the basin and the reservoir. Some
embodiments further comprise: a self-sealing opening in the lid or basin, through which the
tube(s) of an all-channel irrigator can pass and connect to at least one channel of the
endoscope inside the basin and connect to a syringe or to an irrigating pump outside the basin,
for supplying disinfectant solution or rinse water to the channel of the endoscope.
[0021] Any embodiment of any of the present apparatuses and methods can consist of
or consist essentially of - rather than comprise/include/contain/have - any of the described
steps, elements, and/or features. Thus, in any of the claims, the term "consisting of or
"consisting essentially of can be substituted for any of the open-ended linking verbs recited
above, in order to change the scope of a given claim from what it would otherwise be using
the open-ended linking verb.
[0022] The feature or features of one embodiment may be applied to other
embodiments, even though not described or illustrated, unless expressly prohibited by this
disclosure or the nature of the embodiments.
[0023] Details associated with the embodiments described above and others are
presented below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The following drawings illustrate by way of example and not limitation. For
the sake of brevity and clarity, every feature of a given structure is not always labeled in every
figure in which that structure appears. Identical reference numbers do not necessarily indicate
an identical structure. Rather, the same reference number may be used to indicate a similar
feature or a feature with similar functionality, as may non-identical reference numbers. The
figures are drawn to scale (unless otherwise noted), meaning the sizes of the depicted
elements are accurate relative to each other for at least the embodiment depicted in the
figures.
[0025] FIG. 1 a perspective view of an embodiment of the present apparatuses.
[0026] FIG. 2 is a block diagram of a slight variation of the embodiment of FIG. 1.
[0027] FIG. 3 is a block diagram of a second embodiment of the present apparatuses.
DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0028] The term "coupled" is defined as connected, although not necessarily directly,
and not necessarily mechanically; two items that are "coupled" may be unitary with each
other unless the context explicitly requires that they be separate structures. The terms "a" and
"an" are defined as one or more unless this disclosure explicitly requires otherwise. The term
"substantially" is defined as largely but not necessarily wholly what is specified (and includes
what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel
includes parallel), as understood by a person of ordinary skill in the art. In any disclosed
embodiment, the terms "substantially," "approximately," and "about" may be substituted with
"within [a percentage] of what is specified, where the percentage includes .1, 1, 5, and 10
percent.
[0029] The terms "comprise" (and any form of comprise, such as "comprises" and
"comprising"), "have" (and any form of have, such as "has" and "having"), "include" (and
any form of include, such as "includes" and "including") and "contain" (and any form of
contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a
device that "comprises," "has," "includes" or "contains" one or more elements possesses
those one or more elements, but is not limited to possessing only those elements. Likewise, a
method that "comprises," "has," "includes" or "contains" one or more steps possesses those
one or more steps, but is not limited to possessing only those one or more steps.
[0030] Further, a device or system that is configured in a certain way is configured in
at least that way, but it can also be configured in other ways than those specifically described.
[0031] Referring now to the drawings, and more particularly to FIGS. 1 and 2, shown
therein and designated by the reference numeral 10 are two variations of a first embodiment of
the present apparatuses for disinfecting and/or rinsing endoscopes, which for brevity, will be
described together. One example of a disinfectant that can be used is in the present
apparatuses and methods is an aldehyde-based high-level disinfectant solution, such as
ALDAHOL® High-Level Disinfectant Solution available from Healthpoint, Ltd.
[0032] In the embodiment shown, apparatus 10 comprises a basin 14 having a body 16
and a lid 18, a reservoir 22 (e.g., a disinfectant reservoir), a disinfectant supply conduit 26,
and a gas conduit 30 (e.g., air-return conduit). In the embodiment shown, reservoir 22 is
disposed at a lower elevation than basin 14. In some embodiments basin 14 and/or lid 1 can
be transparent (e.g., plastic), such that, for example, liquid levels in the basin can be
monitored, and/or fluid and air expelled from the channels of the endoscope can be observed,
by operating personnel. Basin 14 can comprise any material suitable for holding a
disinfectant solution. In the embodiment shown, basin 14 (e.g., body 16) is configured to
receive an (e.g., loosely coiled) endoscope 34 (e.g., one, two, three, or more endoscopes) such
that the endoscope can be submersed in liquid 38 with a headspace 42 in basin 14 above the
liquid (between liquid 38 and lid 18). In some embodiments, basin 14 is sized such that an
endoscope can be submersed in about two (2) gallons of liquid. In the embodiment shown, lid
18 is configured to be coupled (e.g., pivotally coupled via a hinge or hinges, as shown;
removably coupled via clamps or the like; etc.) to basin 14 is configured to provide a
substantially air-tight seal between lid 18 and body 16 (e.g., to be coupled to the top of the
basin (e.g., and to the top of body 16, as shown)). In the embodiment shown, basin 14 is
configured to be sealable to substantially prevent the disinfectant solution fumes from
escaping into the air outside the device.
[0033] In the embodiment shown, reservoir 22 includes a top 46 (e.g., a fixed or
removable top), and is configured to receive a liquid 50 (which may be substantially similar
and/or the same as liquid 38) with a headspace 54 between liquid 50 and top 46. In the
embodiment shown, disinfectant supply conduit 26 is coupled to basin 14 and to reservoir 22,
and configured to communicate liquid from reservoir 22 to basin 14 (e.g., is in direct fluid
communication with basin 14, as shown). In the embodiment shown, gas conduit 30 is
coupled to basin 14 and reservoir 22, and configured to communicate gas (e.g., air, fumes,
etc.) between headspace 42 of basin 14 and headspace 54 of reservoir 22 (e.g., is in direct
fluid communication with basin 14 and/or reservoir 22, as shown). In the embodiment shown,
gas conduit 30 is configured to function at atmospheric pressure. In the embodiment shown,
apparatus 10 is configured to maintain gas conduit 30 substantially at atmospheric pressure
(e.g., as disinfectant solution is introduced into basin 14, air or other gas in basin 14 is allowed
to flow through gas conduit 30 to reservoir 22. Reservoir 22 may, in some embodiments, be
disposable and/or replaceable. For example, a disinfectant shipping container (e.g., container
in which the disinfectant is shipped) could also serve as the reservoir to eliminate the need to
transfer disinfectant from the shipping container to a reservoir. In at least some embodiments,
reservoir 22 is configured to be coupled to conduits 26 and 30 such that liquid (e.g., and gas)
is substantially prevented from escaping from reservoir 22 except through conduits 26 and 30.
In the embodiment shown, reservoir 22 has a rectangular shape.
[0034] In the embodiment shown, apparatus 10 further comprises a water supply
conduit 58 coupled to basin 14, and configured to be coupled to a water source such as a water
tap 60 (or a water tank, etc.), and to communicate water to basin 14. In some embodiments,
apparatus 10 further comprises a water tank coupled to water supply conduit 58. In the
embodiment shown, apparatus 10 further comprises a filter 62 (e.g., a bacterial filter) coupled
to water supply conduit 58 such that water from a water supply coupled to water supply
conduit 58 will pass through the filter before being communicated to basin 14. In some
embodiments, the water source can provide purified and or substantially bacteria-free water.
[0035] As shown in FIG. 2, apparatus 10 can further comprise a disinfectant drain
conduit 66 coupled to basin 14 and reservoir 22, and configured to communicate liquid (e.g.,
disinfectant) from basin 14 to reservoir 22. For example, disinfectant solution can be
repeatedly used to disinfect endoscopes and returned to reservoir 22 until the disinfectant
solution is exhausted (e.g., reaches its minimum recommended concentration (MRC)). In
some embodiments, reservoir 22 includes a removable dipstick configured to be removed with
a small sample of disinfecting solution (e.g., a few drops) for testing the concentration of the
disinfectant solution (e.g., with a paper test strip or the like). In some embodiments,
disinfectant drain conduit 66 and disinfectant supply conduit 26 are unitary (e.g., a single
conduit is configured to communicate disinfectant or other liquid between basin 14 and
reservoir 22. As also shown in FIG. 2, apparatus 10 can further comprise a disinfectant drain
valve 70 coupled to disinfectant drain conduit and configured to be actuated (e.g., closed) to
substantially prevent liquid (e.g., and gas) communication between basin 1 and reservoir 22.
For example, in the embodiment shown, valve 70 is disposed closer to basin 14 than to
reservoir 22 (e.g., at or in contact with basin 14).
[0036] In the embodiment shown, apparatus 10 further comprises a waste drain
conduit 74 coupled to basin 14, and configured to communicate liquid (e.g., rinse water) out
of basin 14 (e.g., to a drain or a waste receptacle). In some embodiments, the apparatus
further comprises a waste receptacle configured to receive waste from waste drain conduit 74.
In the embodiment shown, apparatus 10 further comprises a waste drain valve 78 coupled to
waste drain conduit 74 and configured to be actuated (e.g., closed) to substantially prevent
liquid communication out of basin 14 through waste drain conduit 74. For example, in the
embodiment shown, valve 78 is disposed closer to basin 14 than to the opposing end of waste
drain conduit 74 (e.g., at or in contact with basin 14). In the embodiment shown, waste drain
conduit 74 is configured to permit wastewater to be forced out of basin 14 by gravity. In other
embodiments, the apparatus further comprises a waste pump coupled to the waste drain
conduit 74, and configured to draw waste liquid (e.g., waste water) from the basin. In some
embodiments, disinfectant drain conduit 66 and waste drain conduit 74 are both coupled to
basin 14 through a single port by way of a diverter valve (not shown) that is configured to
direct liquid from basin 14 to either of disinfectant drain conduit 66 or waste drain conduit 74.
[0037] In the embodiment shown, apparatus 10 further comprises a pump 82 coupled
to disinfectant supply conduit 26, and configured to pump a liquid (e.g., disinfectant solution)
between reservoir 22 and basin 14 (e.g., from reservoir 22 to basin 14 and/or from basin 14 to
reservoir 22). Pump 82 can comprise, for example, a self-priming electric pump (e.g., a rotary
pump, a peristaltic pump, etc.), a hand pump (e.g., a hand-crank rotary pump, a squeeze bulb,
etc.), and or any other pump enabling apparatus 10 to function as described in this disclosure.
In some embodiments, such as those that do not include a disinfectant drain conduit 66, pump
82 can be a bi-directional pump configured to be capable of pumping disinfectant from basin
14 to reservoir 22.
[0038] In the embodiment shown, gas conduit 30 is coupled to basin 14 at an elevation
greater than the elevation at which disinfectant supply conduit 26 is coupled to basin 14. For
example, as shown in FIG. 1, gas conduit 30 can be coupled to body 16; or, as shown in FIG.
2, gas conduit 30 can be coupled to lid 18. In the embodiment shown, apparatus 10 also
comprises a valve 86 coupled to gas conduit 30, and configured to be actuated (e.g., closed) to
substantially prevent liquid (e.g., and gas) communication between basin 14 and at least a
portion of gas conduit 30. For example, in the embodiment shown, valve 86 is disposed
closer to basin 14 than to reservoir 22 (e.g., at or in contact with basin 14). For example, in
the embodiment shown, valve 86 can be coupled to lid 18.
[0039] In the embodiment shown, apparatus 10 further comprises a frame 90 coupled
to and/or configured to support basin 14, reservoir 22, and pump 82 in fixed relation to one
another. In the embodiment shown, frame 90 includes a plurality of wheels or casters 92
configured to permit apparatus to be rolled across a surface. In other embodiments, the frame
can be stationary. In the embodiment shown, frame 90 includes three shelves, with the basin
disposed at the height of the top shelf, the pump disposed on the middle shelf, and the
reservoir disposed on the bottom shelf.
[0040] In the embodiment shown, the apparatus is configured to be manually operated
by actuating the pumps and various valves (e.g., apparatus 10 does not include a controller
configured to sequence the function of the valves and pump to permit the apparatus to operate
or be operated as described in this disclosure.
[0041] In the embodiment shown, apparatus 10 further comprises a fitting 94 (e.g.,
grommet or the like) with an opening configured such that a tube of an irrigator (e.g., an allchannel
irrigator 98 for an endoscope—such as, for example, an OLYMPUS CW-3 All
Channel Irrigator Set available from: Zoi Surgical, Inc., Chesterland, Ohio, USA) can extend
through the opening while connected to at least one channel of an endoscope in the basin for
supplying disinfectant solution or rinse water to the at least one channel of the endoscope, the
opening configured to substantially prevent fluid communication through the opening around
the tube of the irrigator. Fitting 94 can be self-sealing, such that, for example, if an irrigator
does not pass through fitting 94, gases are substantially prevented from escaping through
fitting 94; and if an irrigator does pass through fitting 94, gases are substantially prevented
from escaping through fitting 94 (e.g., between the tube of the irrigator and the fitting).
[0042] In the embodiment shown, apparatus 10 further comprises a second basin 14'
with a body 16' and a lid 18', a second reservoir 22', a second disinfectant supply conduit 26',
and a second gas conduit 30', each of which can be substantially similar in function and/or
construction to the corresponding components described above. In the embodiment shown,
water supply conduit 58 and water supply conduit 58' are configured to be coupled to a
common water supply such that the water supply can provide water to both water supply
conduits 58 and 58'. In other embodiments, apparatus 10 can include more than two of any of
the foregoing components. The various conduits (or tubes) described in this disclose can
comprise or be constructed of any material suitable for contact with disinfectant solutions, and
may be rigid and/or flexible.
[0043] Some embodiments of the present methods for disinfecting and/or rinsing an
endoscope comprise: disposing an endoscope (e.g., 34) in a basin (e.g., 14, 14'); coupling a lid
(e.g., 18, 18') to a body (e.g., 16, 16') of the basin such that a substantially airtight seal is
provided between the lid and the body; and transferring disinfectant solution (e.g., 36, 36', 50,
50') from a reservoir (e.g., 22, 22') to the basin through a disinfectant supply conduit (e.g., 26,
26') such that the endoscope is submersed in the disinfectant solution, and a headspace (e.g.,
42, 42') is provided between the disinfectant solution and the lid. In some embodiments, the
reservoir includes a top (e.g., 46, 46'), a headspace (54, 54') is provided between any
disinfectant solution remaining in the reservoir and the top of the reservoir, and the headspace
of the basin is in fluid communication with the headspace in the reservoir through a gas
conduit (e.g., 30, 30'). Displaced air in the headspace of the basin is permitted to flow to the
headspace of the reservoir through the gas conduit in a substantially closed circuit that
maintains substantially equal pressure between the disinfectant reservoir and the basin, and
substantially prevents escape of disinfectant fumes into the air outside the device. The various
conduits can be coupled to the pump(s), basin(s), reservoir(s), and or other components in
substantially air-tight fashion, such that, for example, gas (e.g., fumes) can be substantially
prevented from escaping apparatus 10. In some embodiments, transferring the disinfectant
solution is not electrically powered (e.g., is done with a manually-actuated pump or siphon).
[0044] Some embodiments further comprise coupling an irrigator to the endoscope
such that the irrigator extends out of the basin (e.g., through fitting 94, 94'). Some
embodiments further comprising introducing disinfectant solution, water, and or air into the
endoscope through the irrigator (e.g., from a pump, syringe, or other source).
[0045] In some embodiments, the endoscope can be kept submersed in the disinfectant
solution for a specified amount of time. For example, a timer can be set (e.g., manually) for
10 or 20 minutes, or any other suitable time period (e.g., an exposure time directed by the
instructions of the disinfectant).
[0046] Some embodiments further comprise transferring the disinfectant solution from
the basin to the reservoir. For example, after the exposure time has elapsed, the disinfectant
solution can be drained from the basin back into the disinfectant reservoir through a
disinfectant drain conduit (e.g., 60, 60'), and a disinfectant drain valve can be closed (e.g., 70,
70'). Once the disinfectant solution is exhausted, i.e. after the disinfectant solution reaches its
minimum recommended concentration (MRC), then the expired solution can be discarded. If
the reservoir is disposable, the expired solution and the reservoir can be disposed of.
[0047] Some embodiments further comprise introducing water into the basin and/or
into the endoscope (e.g., via irrigator 98). In some embodiments, the basin is substantially
filled with water (e.g., such that headspace 42 or 42' is substantially eliminated). Some
embodiments further comprise closing the gas valve (e.g., 86, 86') when the basin is
substantially full of water (e.g., to minimize the amount of gas or fumes remaining in basin
14). The rinse water can then be drained from the basin through a waste drain conduit (e.g.,
74, 74'), and diverted to a waste receptacle or a drain. In some embodiments, this rinsing
procedure is repeated two, three, or more times. After the final rinse, the lid can be opened,
and the endoscope(s) is removed and used immediately or hung up to drip dry prior to use.
[0048] Referring now to FIG. 3, shown therein and designated by the reference
numeral 10' is a second embodiment of the present apparatuses. Apparatus 10' comprises
components that can be substantially similar to the correspondingly numbered components
described above. As such, the differences between apparatus 10 and apparatus 10' are
primarily described here. Apparatus 10' comprises first and second basins 14 and 14' coupled
to a single pump 82 and reservoir 22 via a branched disinfectant supply conduit 26
[0049] The above specification and examples provide a complete description of the
structure and use of exemplary embodiments. Although certain embodiments have been
described above with a certain degree of particularity, or with reference to one or more
individual embodiments, those skilled in the art could make numerous alterations to the
disclosed embodiments without departing from the scope of this invention. As such, the
various illustrative embodiments of the present devices are not intended to be limited to the
particular forms disclosed. Rather, they include all modifications and alternatives falling
within the scope of the claims, and embodiments other than the one shown may include some
or all of the features of the depicted embodiment. Further, where appropriate, aspects of any
of the examples described above may be combined with aspects of any of the other examples
described to form further examples having comparable or different properties and addressing
the same or different problems. Similarly, it will be understood that the benefits and
advantages described above may relate to one embodiment or may relate to several
embodiments.
[0050] The claims are not intended to include, and should not be interpreted to
include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly
recited in a given claim using the phrase(s) "means for" or "step for," respectively.

CLAIMS
1. An apparatus for disinfecting and/or rinsing an endoscope, the apparatus comprising:
a basin including a body and a lid, the body configured to receive an endoscope such
that the endoscope can be submersed in liquid with a headspace in the basin
above the liquid, the lid configured to be coupled to the basin to provide a
substantially air-tight seal between the lid and the body;
a reservoir with a top, the reservoir configured to receive a liquid with a headspace
between the liquid and the top;
a disinfectant supply conduit coupled to the basin and to the reservoir, and configured
to communicate liquid from the reservoir to the basin; and
a gas conduit coupled to the basin and to the reservoir, the gas conduit configured to
communicate gas between the headspace of the basin and the headspace of the
reservoir.
2. The apparatus of claim 1, further comprising:
a water supply conduit coupled to the basin, and configured to be coupled to a water
source to communicate water to the basin.
3. The apparatus of claim 2, further comprising:
a filter coupled to the water supply conduit.
4. The apparatus of claim 1, further comprising:
a disinfectant drain conduit coupled to the basin and to the reservoir, and configured to
communicate liquid from the basin to the reservoir.
5. The apparatus of claim 4, further comprising:
a disinfectant drain valve coupled to the disinfectant drain conduit and configured to
be actuated to substantially prevent liquid communication between the basin
and the reservoir.
6. The apparatus of claim 1, further comprising a waste drain conduit coupled to the
basin, and configured to communicate liquid out of the basin.
7. The apparatus of claim 6, further comprising:
a waste drain valve coupled to the waste drain conduit and configured to be actuated to
substantially prevent liquid communication out of the basin through the waste
drain conduit.
8. The apparatus of claim 6, where the waste drain conduit is configured to communicate
waste from the basin to a waste receptacle or a drain.
9. The apparatus of claim 8, further comprising:
a waste receptacle coupled to the waste drain conduit.
10. The apparatus of claim 1, where the gas conduit is configured to function at
atmospheric pressure.
11. The apparatus of claim 10, where the apparatus is configured to maintain the gas
conduit at atmospheric pressure.
12. The apparatus of claim 2, further comprising:
a pump coupled to the disinfectant supply conduit and configured to pump a liquid
between the reservoir and the basin.
13. The apparatus of claim 12, where the pump is configured to pump the liquid from the
reservoir to the basin.
14. The apparatus of any of claims 1-13, where the reservoir is disposed at a lower
elevation than the basin.
15. The apparatus of any of claims 1-13, where the gas conduit is coupled to the basin at
an elevation greater than the elevation at which the disinfectant supply conduit is coupled to
the basin.
16. The apparatus of claim 15, further comprising:
a valve coupled to the gas conduit and configured to be actuated to substantially prevent liquid
communication between the basin and at least a portion of the gas conduit.
17. The apparatus of claim 16, where the gas conduit is coupled to the lid.
18. The apparatus of claim 17, where the lid is configured to be coupled to the top of the
basin.
19. The apparatus of any of claims 1-13, further comprising:
a second basin having a second body and a second lid, the body configured to receive
an endoscope such that the endoscope can be submersed in liquid with a
headspace in the basin above the liquid, the second lid configured to be
coupled to the second body to provide a substantially air-tight seal between the
second lid and the second basin;
a second reservoir with a top, the second reservoir configured to receive a liquid with a
headspace between the liquid and the top;
a second disinfectant supply conduit coupled to the second basin and to the second
reservoir, and configured to communicate liquid from the second reservoir to
the second basin;
a second gas conduit coupled to the second basin and to the second reservoir, the
second gas conduit configured to communicate gas between the headspace of
the second basin and the headspace of the second reservoir.
20. The apparatus of any of claims 1-13, further comprising:
a second basin configured to receive an endoscope such that the endoscope can be
submersed in liquid with a headspace in the basin above the liquid;
a second lid configured to be coupled to the second basin to provide a substantially air¬
tight seal between the second lid and the second basin;
a second disinfectant supply conduit coupled to the second basin, and configured to
communicate liquid from the reservoir to the second basin;
a second gas conduit coupled to the second basin and to at least one of the first basin
and the reservoir, the second gas conduit configured to communicate gas
between the headspace of the second basin and at least one of the headspace of
the reservoir and the headspace of the first basin.
21. The apparatus of any of claims 1-13, where:
the disinfectant supply conduit is in direct fluid communication with the basin and the
reservoir; and/or
the gas conduit is in direct fluid communication with the basin and the reservoir.
22. The apparatus of any of claims 1-13, where at least one of the basin and the lid include
an opening configured such that a tube of an irrigator can extend through the opening while
connected to at least one channel of an endoscope in the basin for supplying disinfectant
solution or rinse water to the at least one channel of the endoscope, the opening configured to
substantially prevent fluid communication through the opening around the tube of the
irrigator.
23. The apparatus of any of claims 1-13, where the apparatus is configured such that if the
lid is coupled to the body of the basin, the apparatus substantially prevents gas from escaping
to the surrounding atmosphere.
24. A method for disinfecting and/or rinsing an endoscope, the method comprising:
disposing an endoscope in a basin;
coupling a lid to a body of a basin such that a substantially airtight seal is provided
between the lid and the body; and
transferring disinfectant solution from a reservoir to the basin through a disinfectant
supply conduit such that the endoscope is submersed in the disinfectant
solution, and a headspace is provided between the disinfectant solution and the
lid;
where the reservoir includes a top, a headspace is provided between any disinfectant
solution remaining in the reservoir and the top of the reservoir, and the
headspace of the basin is in fluid communication with the headspace in the
reservoir through a gas conduit.
25. The method of claim 24, where transferring is not electrically powered.
26. The method of claim 24, further comprising:
transferring the disinfectant solution from the basin to the reservoir.
27. The method of claim 26, further comprising:
introducing water into the basin.
28. The method of claim 27, where the basin is substantially filled with water.
29. The method of claim 28, where the gas conduit is coupled to the lid.
30. The method of claim 29, where a gas valve is disposed in the gas conduit and
configured to be actuated to substantially prevent liquid communication between the basin
and at least a portion of the gas conduit, the method further comprising:
closing the gas valve when the basin is substantially full of water.
31. A device for disinfecting at least one endoscope comprising:
(a) a basin, for receiving the endoscope to be disinfected, with a capacity sufficient
to contain the endoscope such that the endoscope can be completely submerged in a liquid and
a headspace can be maintained above the liquid within the basin;
(b) a basin lid with an air-tight seal, for providing an air-tight closure above the
basin;
(c) a sealable reservoir, for containing a disinfectant solution;
(d) a disinfectant supply tube connected to the basin and to the reservoir, for
supplying the basin with the disinfectant solution;
(e) a disinfectant supply pump connected in-line with the disinfectant supply tube,
for pumping the disinfectant solution from the reservoir to the basin;
(f) a water supply tube connected to the basin and to a water source, for supplying
rinse water to the basin;
(g) one or more drain tubes connected to the basin and to:
(1) the reservoir, for returning the disinfectant solution to the reservoir, or
(2) a waste container or drain, for disposing of the disinfectant solution or
rinse water; and
(h) an air vent tube in communication with the basin headspace and the reservoir
headspace, for maintaining equal air pressure between the basin and the reservoir.
32. The device of claim 31, further comprising a self-sealing opening in the lid or basin,
through which the tube(s) of an all-channel irrigator can pass and connect to at least one
channel of the endoscope inside the basin and connect to a syringe or to an irrigating pump
outside the basin, for supplying disinfectant solution or rinse water to the channel of the
endoscope.

Documents

Application Documents

# Name Date
1 3130-DELNP-2013-FER.pdf 2019-08-22
1 3130-DELNP-2013.pdf 2013-04-22
2 Form 3 [24-11-2016(online)].pdf 2016-11-24
2 3130-delnp-2013-Form-5.pdf 2013-08-20
3 3130-delnp-2013-Form-3.pdf 2013-08-20
3 3130-delnp-2013-Correspondence Others-(27-09-2013).pdf 2013-09-27
4 3130-delnp-2013-Form-2.pdf 2013-08-20
4 3130-delnp-2013-GPA-(27-09-2013).pdf 2013-09-27
5 3130-delnp-2013-Form-1.pdf 2013-08-20
5 3130-delnp-2013-Correspondence-Others-(29-08-2013).pdf 2013-08-29
6 3130-delnp-2013-Form-3-(29-08-2013).pdf 2013-08-29
6 3130-delnp-2013-Correspondence-others.pdf 2013-08-20
7 3130-delnp-2013-Claims.pdf 2013-08-20
8 3130-delnp-2013-Form-3-(29-08-2013).pdf 2013-08-29
8 3130-delnp-2013-Correspondence-others.pdf 2013-08-20
9 3130-delnp-2013-Form-1.pdf 2013-08-20
9 3130-delnp-2013-Correspondence-Others-(29-08-2013).pdf 2013-08-29
10 3130-delnp-2013-Form-2.pdf 2013-08-20
10 3130-delnp-2013-GPA-(27-09-2013).pdf 2013-09-27
11 3130-delnp-2013-Correspondence Others-(27-09-2013).pdf 2013-09-27
11 3130-delnp-2013-Form-3.pdf 2013-08-20
12 Form 3 [24-11-2016(online)].pdf 2016-11-24
12 3130-delnp-2013-Form-5.pdf 2013-08-20
13 3130-DELNP-2013.pdf 2013-04-22
13 3130-DELNP-2013-FER.pdf 2019-08-22

Search Strategy

1 searchTPO_24-07-2019.pdf