Source: http://www.allindianpatents.com/patents/240783-a-surgical-instrument-reprocessor-to-measuring-a-property-of-a-sterilant-solution-and-a-system-therefor
Timestamp: 2018-01-21 00:44:19
Document Index: 635276936

Matched Legal Cases: ['art 202', 'art 202', 'art\n202', 'art 202', 'art 202', 'art 202', 'art 202', 'art 338']

Indian Patents. 240783:A SURGICAL INSTRUMENT REPROCESSOR TO MEASURING A PROPERTY OF A STERILANT SOLUTION AND A SYSTEM THEREFOR
A SURGICAL INSTRUMENT REPROCESSOR TO MEASURING A PROPERTY OF A STERILANT SOLUTION AND A SYSTEM THEREFOR
This invention relates to a surgical instrument reprocessor configured to measure a property of a sterilant solution used for washing and sterilization of the surgical instrument, the surgical instrument reprocessor comprising; a reservoir (14a, 14b) configured to receive the sterilant solution (86) having bubbles therein; a cuvette (344) configured to receive an at least substantially bubble-free sample of the sterilant solution (86); a light source (350) for passing light through the sample; a light sensing mechanism (356,358) for sensing the light passing through the sample; a pump (70) configured to move the sterilant solution (86) from the reservoir (14a, 14b) through the cuvette (344) until the sample of the sterilant solution within the cuvette (344) is at least substantially bubble-free; and a controller (360) associated with the light sensing mechanism (356, 358), wherein the light sensing mechanism is configured to detect the light passing through the at least substantially bubble-free sample of the sterilant solution (86).
The present invention relates to the decontamination arts including the
sterilization arts. It finds particular application in conjunction with the decontamination
of medical devices, especially medical devices such as endoscopes and other devices
having channels or lumens that must be decontaminated after use.
Endoscopes and similar medical devices having channels or lumens formed
therethrough are being used on an ever increasing basis in the performance of medical
procedures. The popularity of these devices has led to calls for improvements in the
decontamination of these devices between use, both in terms of the speed of the
decontamination and the effectiveness of the decontamination.
One popular method for cleaning and disinfection or sterilization of such
endoscopes employs an automated endoscope reprocessor which both washes and then
disinfects or sterilizes the endoscope. Typically such a unit comprises a basin with a
selectively opened and closed cover member to provide access to the basin. Pumps
connect to various channels through the endoscope to flow fluid therethrough and an
additional pump flows fluid over the exterior surfaces of the endoscope. Typically, a
detergent washing cycle is followed by rinsing and then a sterilization or disinfection
cycle and rinse.
To insure adequate washing and sterilization it may be desirable to measure the
strength of fluids used for washing and sterilization. In particular, it is desirable to
make sure that the proper concentration has been achieved in the circulating fluid.
An endoscope processor according to the present invention incorporates a
solution measuring system. The measuring system comprises a cuvette for holding a
sample of the solution, a light source for passing a light through the cuvette and the
sample, and a light sensing mechanism for sensing light passing through the cuvette
and the sample. A reservoir is provided for receiving a quantity of the solution
containing bubbles. A pump associated with the reservoir allows pumping of a quantity
of solution out of the reservoir through a first path from the reservoir and/or a second
path from the reservoir to the cuvette. A control; system associated with the pump is
programmed to first direct the pump to move a portion of the quantity of fluid in the
reservoir out through the first path, whereby to drive bubbles therein out of the
reservoir, and then to direct a sample of the liquid into the cuvette.
Preferably, the solution comprises an aldehyde., as for instance
orthophthalaldehyde.
Preferably, a light path through the sample in the cuvette is between 1 mm and 5
mm, more preferably between 1 mm and 3 mm.
Preferably, the first path leaves the reservoir from an upper portion thereof The
first path can be the same as the second path with the bubbles being removed through
cuvette. The control system is then preferably programmed to pump fluid out of the
reservoir for a time period sufficient to pump substantially all of the bubbles in the
solution out through the cuvette whereby to leave a quantity of solution in the cuvette
substantially free of bubbles.
Preferably, the control system is programmed to delay pumping of fluid out of
the reservoir for a time period after the reservoir is filled sufficient to allow the bubbles
in the solution to float to the surface.
A method according to the present invention in an endoscope processor
provides for measuring a property of a solution to be applied to the endoscope. The
method comprises: collecting a quantity of the solution in a reservoir; directing a
portion of the solution out from the reservoir through a first path to carry bubbles in the
solution out of the reservoir; then directing a sample of the solution from the reservoir
to a cuvette; measuring the property of the solution in the sample in the cuvette by
passing light through the cuvette and the sample and reading said light passing through
said light and said sample.
Preferably, the property of the solution being measured is the level of sterilant
BRIEF DESCRIPTION OF THE ACCOMPANYING RAWINGS
The invention may take form in various components and arrangements of
components and in various steps and arrangements of steps. The drawings are for
purposes of illustrating preferred embodiments only, and are not to be construed as
FIG. 1 is a front elevational view of a decontamination apparatus in accordance
FIG. 2 is a diagrammatic illustration of the decontamination apparatus shown in
FIG. 1, with only a single decontamination basin shown for clarity;
FIG. 3 is a cut-away view of an endoscopie suitable for processing in the
decontamination apparatus of FIG. 1;
FIG. 4 is a diagrammatic illustration of spectroscopic fluid measuring
subsystem of the decontamination apparatus of FIG. 2; and
FIG. 5 is a perspective view of the spectroscopic fluid measuring subsystem of
FIG. 1 shows a decontamination apparatus for decontaminating endoscopes and
otiier medical devices which include channels or lumens formed therethrough; FIG. 2
shows the apparatus in block diagram form. The decontamination apparatus generally
includes a first station lo and a second station 12 which are at least substantially similar
in all respects to provide for the decontamination of two different medical devices
simultaneously or in series. First and second decontamination basins 14a, 14b receive
the contaminated devices. Each basin 14a, l!4b is selectively sealed by a lid 16a, 16b,
respectively, preferably in a microbe-blocking relationship to prevent the entrance of
environmental microbes into the basins 14a, 14b during decontamination operations.
The lids can include a microbe removal or HEPA air filter formed therein for venting.
A control system 20 includes one or more microcontrollers, such as a
programmable logic controller (PLC), for controlling decontamination and user
interface operations. Although one control system 20 is shown herein as controlling
both decontamination stations lo, 12, those skilled in the art will recognize that each
station lo, 12 can include a dedicated control system. A visual display 22 displays
decontamination parameters and machine conditions for an operator and at least one
printer 24 prints a hard copy output of the decontamination parameters for a record to
be filed or attached to the decontaminated device or its storage packaging. The visual
display 22 is preferably combined with a touch screen input device. Alternatively, a
keypad or the like is provided for input of decontamination process parameters and for
machine control. Other visual gauges 26 such as pressure meters and the like provide
digital or analog output of decontamination or medical device leak testing data.
FIG. 2 diagrammatically illustrates one station lo of the decontamination
apparatus. Those skilled in the art will recognize that the decontamination station 12 is
preferably similar in all respects to the station lo illustrated in FIG. 2. However, the
station 12 has not been shown in FIG. 2 for clarity. Further, the decontamination
apparatus can be provided with a single decontamination station or multiple stations.
The decontamination basin 14a receives an endoscope 200 (see FIG. 3) or other
medical device therein for decontamination. Any internal channels of the endoscope
200 are connected with flush lines 30. Each flush line 30 is connected to an outlet of a
pump 32. The pumps 32 are preferably peristaltic pumps or the like that pump fluid,
such as liquid and air, through the flush lines 30 and any internal channels of the
medical device. Specifically, the pumps 32 either can draw liquid from the basin 14a
through a filtered drain 34 and a first valve SI, or can draw decontaminated air from an
air supply system 36 through a valve S2. The air supply system 36 includes a pump 38
and a microbe removal air filter 40 that filters microbes from an incoming air stream. It
is preferable that each flush line 30 be provided with a dedicated pump 32 to ensure
adequate fluid pressure and to facilitate the individual monitoring of the fluid pressure
in each flush line 30. A pressure switch or sensor 42 is in fluid communication with
each flush line 30 for sensing excessive pressure in the flush line. Any excessive
pressure sensed is indicative of a partial or complete blockage, e.g., by bodily tissue or
dried bodily fluids, in a device channel to which the relevant flush line 30 is connected.
The isolation of each flush line 30 relative to the others allows the particular blocked
channel to be easily identified and isolated, depending upon which sensor 42 senses
The basin I4a is in fluid communication with a water source 50 such as a utility
or tap water connection including hot and cold inlets and a mixing valve 52 flowing
into a break tank 56. A microbe removal filter 54, such as a 0.2 µm or smaller absolute
pore size filter, decontaminates the incoming water which is delivered into the break
tank 56 through the air gap to prevent backflow. A pressure type level sensor 59
monitors liquid levels within the basin 14a. An optional water heater 53 can be
provided if an appropriate source of hot water is not available.
The condition of the filter 54 can be monitored by directly monitoring the flow
rate of water therethrough or indirectly by monitoring the basin fill time using a float
switch or the like. When the flow rate drops below a select threshold, this indicates a
partially clogged filter element that requires replacement.
A basin drain 62 drains liquid from the basin 14a through an enlarged helical
tube 64 into which elongated portions of the endoscope 200 can be inserted. The drain
62 is in fluid communication with a recirculation pump 70 and a drain pump 72. The
recirculation pump 70 recirculates liquid from the basin drain 62 to a spray nozzle
assembly 60 which sprays the liquid into the basin 14a and onto the endoscope 200.
Coarse and fine screens 71 and 73, respectively, filter out particles in the recirculating
fluid. The drain pump 72 pumps liquid from; the basin drain 62 to a utility drain 74. A
level sensor 76 monitors the flow of liquid from the pump 72 to the utility drain 74.
The pumps 70 and 72 can be simultaneously operated such that liquid is sprayed into
the basin 14a while it is being drained to encourage the flow of residue out of the basin
and off of the device. Of course, a single pump and a valve assembly could replace the
dual pumps 70, 72.
An inline heater 80, with temperature sensors 82, downstream of the
recirculation pump 70 heats the liquid to optimum temperatures for cleaning and
disinfection. A pressure switch or sensor 84 measures pressure downstream of the
circulation pump 70.
Detergent solution 86 is metered into the flow upstream of the circulation pump
70 via a metering pump 88. A float switch 90 indicates the level of detergent available.
Typically, only a small amount of disinfectant 92 is required. To more accurately
meter this, a dispensing pump 94 fills a pre-chamber 96 under control of a hi/low level
switch 98 and of course the control system 20. A metering pump lo0 meters a precise
quantity of disinfectant as needed.
Endoscopes and other reusable medical devices often include a flexible outer
housing or sheath surrounding the individual tubular members and the like that form
the interior channels and other parts of the device. This housing defines a closed
interior space, which is isolated from patient tissues and fluids during medical
procedures. It is important that the sheath be maintained intact, without cuts or other
holes that would allow contamination of the interior space beneath the sheath.
Therefore, the decontamination apparatus includes means for
testing the integrity of such a sheath.
An air pump, either the pump 38 or another pump 1lo,
pressurizes the interior space defined by the sheath of the device
through a conduit 112 and a valve S5. Preferably, a HEPA or other
microbe-removing filter 113 removes microbes from the
pressurizing air. An overpressure 114 prevents accidental over
pressurization of the sheath. Upon full pressurization , the
valve S5 is closed and a pressure sensor 116 looks for a drop in
pressure in the conduit 112 which would indicate the escape of
air through the sheath. A valve S6 selectively vents the conduit
112 and the sheath through an optional filter 118 when the
testing procedure is complete. An air buffer 120 smoothes out
pulsation of pressure from the air pump lo.
Preferably, each station lo and 12 each contain a drip basin
130 and spill sensor 132 to alert the operator to potential
An alcohol supply 134 controlled by a valve S3 can supply
alcohol to the channel pumps 32 after rinsing steps to assist in
removing water from the endoscope channels.
Flow rates in the supply lines 30 can be monitored via the
channel pumps 32 and the pressure 42. The channels pumps 32 are
peristaltic pumps which supply a constant flow. If one of the
pressure sensors 42 detects too high a pressure the associated
pump 32 cycles off. The flow rate of the pumps 32 and its
percentage on time provide a reasonable indication of the flow
rate in an associated line 30. These flow rates are monitored
during the process to check for blockages in any of the
endoscope channels. Alternatively, the decay in the pressure from
the time the pump 32 cycles off can also be used to estimate the
flow rate, with faster decay rates being associated with higher
A more accurate measurement of flow rate in an individual
channel may be desirable to detect more substle blockages. A
metering tube 136 having a plurality of level indicating sensors
138 fluidly connects to the inputs of the channel pumps 32.
One preferred sensor arrangement provides a reference connection at a low point in the
metering tube and a plurality of sensors 138 arranged vertically thereabove. By passing
a current from the reference point through the fluid to the sensors 138 it can be
determined which sensors 138 are immersed and therefore determine the level within
the metering tube 136. Other level sensing techniques can be applied here. By shutting
valve SI and opening a vent valve S7 the channel pumps 32 draw exclusively from the
metering tube. The amount of fluid being drawn can be very accurately determined
based upon the sensors 138. By running each channel pump in isolation the flow
therethrough can be accurately determined based upon the time and the volume of fluid
emptied from the metering tube.
In addition to the input and output devices described above, all of the electrical
and electromechanical devices shown are operatively connected to and controlled by
the control system 20. Specifically, and without limitation, the switches and sensors
42, 59, 76, 84, 90, 98, 114, 116, 132 and 136 provide input I to the microcontroller 28
which controls the decontamination and other machine operations in accordance
therewith. For example, the microcontroller 28 includes outputs O that are operatively
connected to the pumps 32, 38, 70, 72, 88, 94, lo0, 1lo, the valves S1-S7, and the
heater 80 to control these devices for effective decontamination and other operations.
Turning also to FIG. 3, an endoscope 200 has a head part 202, in which
openings 204 and 206 are formed, and in which , during normal use of the endoscope
200, an air/water valve and a suction valve are arranged. A flexible insertion tube 208
is attached to the head part 202, in which tube a combined air/water channel 2lo and a
combined suction/biopsy channel 212 are accommodated.
A separate air channel 213 and water channel 214, which at the location of a
joining point 216 merge into the air/water channel 2lo, are arranged in the head part
202. Furthermore, a separate suction channel 217 and biopsy channel 218, which at the
location of the joining point 220 merge into the suction/biopsy channel 212, are
accommodated in the head part 202.
In the head part 202, the air channei 213 and the water
channel 214 open into the opening 204 for the air/water valve.
The suction channel 217 opens into the opening 206 for the
suction valve. Furthermore, a flexible feed hose 222 connects to
the head part 202 and accommodates channels 213', 214' and 217'
which via the openings 204 and 206, are connected to the air
channel 213, the water channel 214 and the suction channel 217,
respectively. In practice, the feed hose 222 is also referred to
as the high—conductor casing.
The mutually connecting channels 213 and 213» 214', 217 and
217' will be referred to below overall as the air channel 213,
the water channel 214 and the suction channel 217.
A connection 226 for the air channel 213, connects 228 and
228a for the water channel 214 and a connection 230 for the
suction channel 217 are arranged on the end section 224 (also
referred to as the light conductor connector) of the flexible
hose 22'2. When the connection 2'26 is in use, connection 22aa is
closed off. A connection 232 for the biopsy channel 21B is
arranged an the head part 202.
A channel separator 240 is shown inserted into the openings
204 and 206. It comprises a body 242) and plug members 244 and
246 which occlude respectively openings 204 and 206. A coaxial
insert 248 on the plug member 244 extends inwardly of the opening
204 and terminates in an annular flange 250 which occludes a
portion of the opening 204 to separate channel 213 from channel
214. By connecting the lines 30 to the openings 226) 228, 228a,
230 and 232, liquid for cleaning and disinfection can be flowed
through the endoscope channels 213) 214) 217 and 218 and out of a
distal tip 252 of the endoscope 200 via channels 2lo and 212. The
channel separator 240 ensures that such liquid flows all the way
through the endoscope 200 without leaking out of openings 204 and
206 and isolates channels 213 and 214 from each other so that
each has its own independent flow path. One of skill in the art
will appreciate that various endoscopes having differing
arrangements of channels and openings will likely require
modifications in the channel separator 240 to accommodate such
differerjces while occluding ports in the head 202 and keeping
channels separated from each other so that each channel can be
flushed independently of the other channels) Otherwise a blockage
in one channel might merely redirect flow to a connected
unblocked channel.
A leakage port 254 on the end suction 224 leads into an
interior portion 236 of the endoscope 200 and is used to check
for the physical integrity thereof, namely to ensure that no
leakage has formed between any of the channels and the interior
256 or from the exterior to the interior 256.
Turning also now to FIBS. 4 and 5, a concentration monitor 300
monitors concentration of the. disinfecting solution circulating
through the basis 14a or 14b. An inlet valve 302 connects through
its A port 304 to the circulating fluid downstream of the main
circulation pump 70. Its B port 306 leads either to waste or back
to the basin 14a or 14b such as through the air gap 56. Its C
port 30B leads to a sampling valve 3lo through its A port 312.
Its B port 314 leads to a piston chamber 316 liquid side 318 and
its C port 320 to a drain valve 322, A piston 324 operates within
the piston chamber 316. With the piston 324 all the way down, the
liquid side 318 should have a volume of about 15 to 50 ml or
larger to promote floation of entrained bubbles. A reservoir size
of 30 to 35 ml has been shown to work well with OPA. Its diameter
should be 13 to 26 mm, or preferably 18 to 20 mm, to promote
bubble flotation. A larger size could also be used. The air pump
3B connects to an air side 326 of the piston chamber 316 through
an air valve 32B at its A port 330. The air valve 32B B port 332
connects to the piston chamber air side 326 and its C port 334
opens to atmosphere.
On the drain valve 322, its A port 336 leads to the sampling
valve 3lo, its B part 338 to drain and its C port 340 to an inlet
342 of a cuvette 344. An outlet 346 of the cuvette 344 leads
preferably to drain, but can lead to a sample collection
container (now shown) for further periodic testing of the fluid,
or back to the basin 14a or 14b.
The cuvette 344 is preferably holds a sample of about 5 ml
and is 2mm wide having optical grade glass or quarts side windows
348 through which light may pass for spectroscopically measuring
a property of the liquid in the cuvette 344. A UV lamp 350
passes light through a filter 352., collimator 353 and a beam-
splitter 354 passes a portion of the light through the cuvette
344 and liquid therein to a first detector 356 and relects
another portion of the light toward a second, reference, detector
358. The lamp emits in the 150 mm to 600 nm range and the filter
passes light to 254 nm for measuring concentration of OFA. Other
wavelengths would be appropriate for different solutions and ar
easily determined by those of skill in the art. A controller 360
ties into the valves, lamp and detectors to control the operation
thereof and it itself links into the main controller 28.
In use, a sample of the circulating liquid is drawn in
through the inlet valve 302 and sample valve 3lo into the liquid
side 318 of the piston chamber 316. The air side 326 of the
piston chamber 316 is open to atmosphere through the air valve
328 to allow the piston 34 to move as the liquid enters the piston
chamber 316. After filling the liquid side 318 and moving the
piston all the way down, the liquid is allowed to rest to allow
any bubbles therein to float to the surface. For an OPA solution
a rest time of 30 to 40 seconds should be sufficient. Then the
sample valve 3lo and air valve 328 are cycled allowing air to
enter the air side 326 driving the piston upwards and expelling
the bubbles out of the liquid side 318 toward the drain valve
322 and out its B port 338 to drain. After a time period
sufficient to expel the bubbles, the drain valve 322 is cycled to
direct the liquid out of the A port 336 to the cuvette 344.
Alternatively, the drain valve 322 can be omitted with the
bubbles being passed out through the cuvette 344 by passing a
sufficient quantity of liquid therethrough to obtain a bubble
free sample within the cuvette 344. With a sample in the cuvette
344, light is passed thoough to spectroscopically measure the
concentration of the OPA or other component therein.
The entire cleaning and sterilization cycle in detail
Btep 1, Open the Lid
Pressing a foot pedal (not shown) opens the basin lid 16a.
There is a separate foot pedal for each side. If pressure is
removed from the foot pedal, the lid motion stops.
The insertion tube 208 of the endoscope 200 is inserted into the helical circulation
tube 64. The end section 224 and head section 202 of the endoscope 200 are
situated within the basin 14a, with the feed hose 222 coiled within the basin 14a
with as wide a diameter as possible.
The flush lines 30, preferably color-coded, are attached, one apiece, to the
endoscope openings 226, 228, 228a, 230 and 232. The air line 112 is also
connected to the connector 254. A guide located on the on the station lo provides a
reference for the color-coded connections.
Depending on the customer-selectable configuration, the control system 20 may
prompt for user code, patient ID, endoscope code, and/or specialist code. This
information may be entered manually (through the touch screen) or automatically
such as by using an attached barcode wand (not shown).
Closing the lid 16a preferably requires the user to press a hardware button and a
touch-screen 22 button simultaneously (not shown) to provides a fail-safe
mechanism for preventing the user's hands from being caught or pinched by the
closing basin lid 16a. If either the hardware button or software button is released
while the lid 16a is in the process of closing the motion stops.
The user presses a touch-screen 22 button to begin the washing / disinfection
The air pump is started and pressure within the endoscope body is monitored.
When pressure reaches 250 mbar, the pump is stopped, and the pressure is allowed
to stabilize for 6 seconds. If pressure has not reached 250 mbar in 45 seconds the
program is stopped and the user is notified of the leak. If pressure drops to less than
lo0 mbar during the 6-second stabilization period, the program is stopped and the
user is notified of the condition.
Once the pressure has stabilized, the pressure drop is monitored over the course of
60 seconds. If pressure drops more than lo mbar within 60 seconds, the program is
stopped and the user is notified of the condition. If the pressure drop is less than lo
mbar in 60 seconds, the system continues with the next step. A slight positive
pressure is held within the endoscope body during the rest of the process to prevent
fluids from leaking in.
A second leak test checks the adequacy of connection to the various ports 226, 228,
228a, 230, 232 and the proper placement of the channel separator 240. A quantity
of water is admitted to the basin 14a so as to submerge the distal end of the
endoscope in the helical tube 64. Valve SI is closed and valve S7 opened and the
pumps 32 are run in reverse to draw a vacuum and to ultimately draw liquid into the
endoscope channels 2lo and 212. The pressure sensors 42 are monitored to make
sure that the pressure in any one channel does not drop by more than a
predetermined amount in a given time frame. If it does, it likely indicates that one
of the connections was not made correctly and air is leaking into the channel. In
any event, in the presence of an unacceptable pressure drop the control system 20
will cancel the cycle an indicate a likely faulty connection, preferably with an
indication of which channel failed.
The purpose of this step is to flush water through the channels to remove waste
material prior to washing and disinfecting the endoscope 200.
The basin 14a is filled with filtered water and the water level is detected by the
pressure sensor 59 below the basin 14a.
The water is pumped via the pumps 32 through the interior of the channels 213,
214, 217, 218, 2lo and 212 directly to the drain 74. This water is not recirculated
around the exterior surfaces of the endoscope 200 during this stage.
Step lo. Drain
As the water is being pumped through the channels, the drain pump 72 is activated
to ensure that the basin 14a is also emptied. The drain pump 72 will be turned off
when the drain switch 76 detects that the drain process is complete.
During the drain process sterile air is blown via the air pump 38 through all
endoscope channels simultaneously to minimize potential carryover.
The basin 14a is filled with warm water (35 °C ). Water temperature is controlled
by controlling the mix of heated and unhealed water. The water level is detected by
the pressure sensor 59.
The system adds enzymatic detergent to the water circulating in the system by
means of the peristaltic metering pump 88. The volume is controlled by controlling
the delivery time, pump speed, and inner diameter of the peristaltic pump tubing.
The detergent solution is actively pumped throughout the internal channels and over
the surface of the endoscope 200 for a predetermined time period, typically of from
one to five minutes, preferably about three minutes, by the channel pumps 32 and
the external circulation pump 70. The inline heater 80 keeps the temperature at
about 35 °C.
After the detergent solution has been circulating for a couple of minutes, the flow
rate through the channels is measured. If the flow rate through any channel is less
than a predetermined rate for that channel, the channel is identified as blocked, the
program is stopped, and the user is notified of the condition. The peristaltic pumps
32 are run at their predetermined flow rates and cycle off in the presence of
unacceptably high pressure readings at the associated pressure sensor 42. If a
channel is blocked the predetermined flow rate will trigger the pressure sensor 42
indicating the inability to adequately pass this flow rate. As the pumps 32 are
peristaltic, their operating flow rate combined with the percentage of time they are
cycled off due to pressure will provide the actual flow rate. The flow rate can also
be estimated based upon the decay of the pressure from the time the pump 32 cycles
The drain pump 72 is activated to remove the detergent solution from the basin 14a
and the channels. The drain pump 72 turns off when the drain level sensor 76
indicates that drainage is complete.
During the drain process sterile air is blown through all endoscope channels
simultaneously to minimize potential carryover.
The basin 14a is filled with warm water (35 °C). Water temperature is controlled
The rinse water is circulated within the endoscope channels (via the channel pumps
32) and over the exterior of the endoscope 200 (via the circulation pump 70 and the
sprinkler arm 60) for 1 minute.
As rinse water is pumped through the channels, the flow rate through the channels
is measured and if it falls below the predetermined rate for any given channel, the
channel is identified as blocked, the program is stopped, and the user is notified of
The drain pump is activated to remove the rinse water from the basin and the
Steps 18 through 22 are repeated to ensure maximum rinsing of enzymatic
detergent solution from the surfaces of the endoscope and the basin.
The basin 14a is filled with very warm water (53 °C). Water temperature is
controlled by controlling the mix of heated and unheated water. The water level is
detected by the pressure sensor 59. During the filling process, the channel pumps
32 are off in order to ensure that the disinfectant in the basin is at the in-use
concentration prior to circulating through the channels.
A measured volume of disinfectant 92, preferably CIDEX OPA orthophalaldehyde
concentrate solution, available from Advanced Sterilization Products division
Ethicon, Inc., Irvine, CA, is drawn from the disinfectant metering tube 96 and
delivered into the water in the basin 14a via the metering pump lo0. The
disinfectant volume is controlled by the positioning of the fill sensor 98 relative to
the bottom of the dispensing tube. The metering tube 96 is filled until the upper
level switch detects liquid. Disinfectant 92 is drawn from the metering tube 96
until the level of the disinfectant in the metering tube is just below the tip of the
dispensing tube. After the necessary volume is dispensed, the metering tube 96 is
refilled from the bottle of disinfectant 92. Disinfectant is not added until the basin
is filled, so that in case of a water supply problem, concentrated disinfectant is not
left on the endoscope with no water to rinse it. While the disinfectant is being
added, the channel pumps 32 are off in order to insure that the disinfectant in the
basin is at the in-use concentration prior to circulating through the channels.
The in-use disinfectant solution is actively pumped throughout the internal channels
and over the surface of the endoscope, ideally for a minimum of 5 minutes, by the
channel pumps and the external circulation pump. The temperature is controlled by
the in-line heater 80 to about 52.5 °C. During this process a sample of the
circulating liquid is taken and tested for proper concentration using the
concentration monitor 300. If the concentration is low, additional sterilant can be
added and the timer for this step reset.
During the disinfection process, flow through each endoscope channel is verified by
timing the delivering a measured quantity of solution through the channel. Valve
SI is shut, and valve S7 opened, and in turn each channel pump 32 delivers a
predetermined volume to its associated channel from the metering tube 136. This
volume and the time it takes to deliver provides a very accurate flow rate through
the channel. Anomalies in the flow rate from what is expected for a channel of that
diameter and length are flagged by the control system 20 and the process stopped.
As disinfectant in-use solution is pumped through the channels, the flow rate
through the channels is also measured as in Step 15.
The drain pump 72 is activated to remove the disinfectant solution from the basin
The basin is filled with sterile warm water (45 °C ) that has been passed through a
0.2 |;x filter.
32) and over the exterior of the endoscope (via the circulation pump 70 and the
is measured as in Step 15.
The drain pump 72 is activated to remove the rinse water from the basin and the
Steps 31 through 35 are repeated two more times (a total of 3 post-disinfection
rinses) to ensure maximum reduction of disinfectant residuals from the endoscope
200 and surfaces of the reprocessor.
From the time of program completion to the time at which the lid is opened,
pressure within the endoscope body is normalized to atmospheric pressure by
opening the vent valve S5 for lo seconds every minute.
Depending on customer-selected configuration, the system will prevent the lid from
being opened until a valid user identification code is entered.
Information about the completed program, including the user ID, endoscope ID,
specialist ID, and patient ID are stored along with the sensor data obtained
If a printer is connected to the system, and if requested by the user, a record of the
disinfection program will be printed.
Once a valid user identification code has been entered, the lid may be opened (using
the foot pedal as in step 1, above). The endoscope is then disconnected from the
flush lines 30 and removed from the basin 14a. The lid can then be closed using
both the hardware and software buttons as described in step 4, above.
understanding the preceding detailed description. It is intended that the invention be
construed as including all such modifications and alterations insofar as they come
within the scope of the appended claims or the equivalents thereof
1. A surgical instrument reprocessor configured to measure a property of a
sterilant solution used for washing and sterilization of the surgical
instrument, the surgical instrument reprocessor comprising:
a reservoir configured to receive the sterilant solution having bubbles
a cuvette configured to receive an at least substantially bubble-free
sample of the sterilant solution;
a light source for passing light through the sample;
a light sensing mechanism for sensing the light passing through the
a pump configured to move the sterilant solution from the reservoir
through the cuvette until the sample of the sterilant solution within the
cuvette is at least substantially bubble-free; and
a controller associated with the light sensing mechanism, wherein the light
sensing mechanism is configured to detect the light passing through the
at least substantially bubble-free sample of the sterilant solution.
2. The surgical instrument processor as claimed in claim 1, comprising a
valve in fluid communication with the reservoir and the cuvette.
3. The surgical instrument processor as claimed in claim 2, wherein the
valve comprises:
an inlet port in fluid communication with the reservoir;
a first outlet port; and
a second outlet port in fluid communication with the cuvette, wherein the
valve is selectively controllable such that the valve is configured to
selectively direct the sterilant solution away from the cuvette through the
first outlet port, and wherein the valve is configured to selectively direct
the sterilant solution toward the cuvette through the second outlet port.
4. The surgical instrument processor as claimed in claim 3, wherein the first
outlet port is in fluid communication with a drain.
5. The surgical instrument processor as claimed in claim 3, wherein the first
port is in fluid communication with a vent such that the bubbles can be
directed to the vent before the at least substantially bubble-free sample of
the solution is directed to the cuvette.
6. A system for measuring a property of a sterilant solution adaptable in a
surgical instrument reprocessor, the reprocessor having a reservoir
configured to received a solution having bubbles therein, the system
sample of the solution;
a separation assembly comprising :
a piston chamber; and
a piston movably positioned within the piston chamber, wherein the piston
chamber is configured to receive a quantity of the solution such that at
least a portion of the bubbles can separate from the quantity of the
solution, and wherein the piston is configured to expel the bubbles from
the piston chamber and move the at least substantially bubble-free
sample of the solution into the cuvette.
7. The system as claimed in claim 6, comprising a valve in fluid
communication with the piston chamber and the cuvette.
8. The system as claimed in claim 6, wherein the valve comprises :
an inlet port in fluid communication with the piston chamber;
a second outlet in fluid communication with the cuvette, wherein the valve
is controllable such that the valve is configured to selectively direct the
solution away from the cuvette through the first outlet port, and wherein
the valve is configured to selectively direct the solution toward the cuvette
through the second outlet port,
9. The system as claimed in claim 6, wherein the first outlet port is in fluid
communication with a vent such that the bubbles can be directed to the
vent before the at least substantially bubble-free sample of the solution is
directed into the cuvette.
lo,The system as claimed in claim 8, comprising a controller, wherein the
controller is configured to direct the valve between a first configuration for
directing the solution to the first outlet port and a second configuration for
directing the solution to the second outlet port.
11.The system as claimed in claim 6, wherein the piston within the piston
chamber defines a first portion configured to received the quantity of the
solution and a second portion configured to receive a compressed gas for
moving the piston within the piston chamber.
12.The system as claimed in claim 9 or lo, wherein the controller is
configured to control the valve to first vent the bubbles from chamber and
then control the valve to direct the at least substantially bubble-free
This invention relates to a surgical instrument reprocessor configured to measure a property of a sterilant solution used for washing and sterilization of the surgical instrument, the surgical instrument reprocessor comprising; a reservoir (14a, 14b) configured to receive the sterilant solution (86) having bubbles therein; a
cuvette (344) configured to receive an at least substantially bubble-free sample of the sterilant solution (86); a light source (350) for passing light through the sample; a light sensing mechanism (356,358) for sensing the light passing through the sample; a pump (70) configured to move the sterilant solution (86)
from the reservoir (14a, 14b) through the cuvette (344) until the sample of the sterilant solution within the cuvette (344) is at least substantially bubble-free; and a controller (360) associated with the light sensing mechanism (356, 358), wherein the light sensing mechanism is configured to detect the light passing through the at least substantially bubble-free sample of the sterilant solution
00805-kol-2006-abstract.pdf
00805-kol-2006-claims.pdf
00805-kol-2006-correspondence others.pdf
00805-kol-2006-correspondence-1.1.pdf
00805-kol-2006-correspondence-1.2.pdf
00805-kol-2006-correspondence-1.3.pdf
00805-kol-2006-description(complete).pdf
00805-kol-2006-drawings.pdf
00805-kol-2006-form-1.pdf
00805-kol-2006-form-2.pdf
00805-kol-2006-form-26.pdf
00805-kol-2006-form-3.pdf
00805-kol-2006-form-5.pdf
00805-kol-2006-priority document.pdf
805-KOL-2006-ABSTRACT.pdf
805-KOL-2006-CLAIMS_1.0.pdf
805-KOL-2006-CLAIMS_1.1.pdf
805-KOL-2006-DESCRIPTION COMPLATE.pdf
805-KOL-2006-DRAWINGS.pdf
805-KOL-2006-FORM 1.pdf
805-KOL-2006-FORM 2.pdf
805-KOL-2006-FORM-27.pdf
805-kol-2006-granted-abstract.pdf
805-kol-2006-granted-assignment.pdf
805-kol-2006-granted-claims.pdf
805-kol-2006-granted-correspondence.pdf
805-kol-2006-granted-description (complete).pdf
805-kol-2006-granted-drawings.pdf
805-kol-2006-granted-examination report.pdf
805-kol-2006-granted-form 1.pdf
805-kol-2006-granted-form 18.pdf
805-kol-2006-granted-form 2.pdf
805-kol-2006-granted-form 26.pdf
805-kol-2006-granted-form 3.pdf
805-kol-2006-granted-form 5.pdf
805-kol-2006-granted-priority document.pdf
805-kol-2006-granted-reply to examination report.pdf
805-kol-2006-granted-specification.pdf
805-KOL-2006-OTHERS-1.1.pdf
805-KOL-2006-OTHERS.pdf
805-KOL-2006-PETITION UNDER RULE 137.pdf
805-KOL-2006-REPLY TO EXAMINATION REPORT-1.1.pdf
805-KOL-2006-REPLY TO EXAMINATION REPORT.pdf
abstract-00805-kol-2006.jpg
805/KOL/2006
U. S. ROURTE 22, SOMERVILLE, NJ
1 NICK NGOC NGUYEN 29131 LATIGA CANYON ROAD, SILVERADO, CA 92676
2 RICHARD JACKSON 3372 SPARKLER DRIVE HUNTINGTON BEACH, CA 92649
B 01B 1/00
1 11/212,955 2005-08-26 U.S.A.