Note: Descriptions are shown in the official language in which they were submitted.
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FLUID MANAGEMENT SYSTEM
Background of the Invention
[0001] The present invention is directed to fluid management
systems and, more
particularly, to fluid management systems providing one or more functions
associated with
suction, irrigation, distention, deficit monitoring, infusion, fluid warming,
and the like.
Summary of the Invention
[0002] Exemplary embodiments may include surgical fluid
management systems and
methods of operating surgical fluid management systems, which may provide one
or more
functions associated with suction, irrigation, distention, deficit monitoring,
infusion, fluid
warming, and the like. Some example embodiments may include infrared lamps
arranged
to warm fluid flowing through a disposable cartridge. Some example embodiments
may
provide a three-dimensional fluid path through the cartridge and/or multi-
stage heating
capabilities. Some example fluid management systems may be selectable between
pressure control and flow control modes.
[0003] In an aspect, a surgical fluid management system may
include a pump
configured to deliver a fluid to a surgical site; and a control system, the
control system
being user-selectable between a pressure control mode and a flow control mode.
The
pressure control mode may include controlling the pump to deliver the fluid to
the surgical
site at approximately a target pressure, and the flow control mode may include
controlling
the pump to deliver the fluid to the surgical site at approximately a target
flow rate.
[0004] In a detailed embodiment, a surgical fluid management
system may include at
least one pressure sensor configured to generate a pressure signal associated
with a
pressure of the fluid and/or the control system may be configured to control
the pump in
the pressure control mode based at least in part upon the pressure signal. In
a detailed
embodiment, the at least one pressure sensor may include at least a first
pressure sensor
and a second pressure sensor, the first pressure sensor and the second
pressure being
configured to generate respective pressure signals associated with the
pressure of the fluid.
In a detailed embodiment, the control system may be configured to compare the
first
pressure signal and the second pressure signal and/or may be configured such
that if the
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first pressure signal and the second pressure signal differ by an amount in
excess of an
acceptable tolerance band, the control system may automatically stop the pump.
[0005] In a detailed embodiment, the pump may include a positive
displacement
pump, a fluid flow rate through the pump may be substantially directly related
to a speed
of operation of the pump, and/or the control system may be configured to
control the pump
in the flow control mode based at least in part upon a flow rate calculated
based upon the
speed of the pump.
[0006] In a detailed embodiment, a surgical fluid management system
may include a
heater assembly configured to heat the fluid between a fluid supply container
and the
surgical site. In a detailed embodiment, a surgical fluid management system
may include a
touch screen interface configured to display at least one operating parameter
and to receive
at least one command, and the control system may be selectable between the
pressure
control mode and the flow control mode using the touch screen. In a detailed
embodiment,
the touch screen may be configurable with respect to at least one of content
and layout.
[0007] In an aspect, a surgical fluid management device may include
a pump
configured to propel fluid from a fluid supply container to a surgical site; a
heater
assembly configured to heat the fluid as it is propelled from the fluid source
to the surgical
site; and a control system operatively connected to the pump and the heater
assembly. The
control system may be configured to control the pump and the heater assembly
in at least a
distention mode and an irrigation mode, the distention mode may include
operation of the
pump to maintain a fluid pressure within a predetermined pressure band, the
irrigation
mode may include operation of the pump to provide a fluid flow rate within a
predetermined flow rate band, and/or the control system may be configured to
control the
heater to maintain a temperature of the fluid delivered to the surgical site
within a
predetermined temperature band in at least the distention mode and/or the
irrigation mode.
[0008] In a detailed embodiment, the distention mode may include
calculation of a
fluid deficit associated with a difference between a volume of fluid delivered
to the
surgical site and a volume of fluid returned from the surgical site. In a
detailed
embodiment, a surgical fluid management device may include at least one load
cell
configured to generate an electrical signal associated with a weight of a
fluid supply
container and/or at least one load cell configured to generate an electrical
signal associated
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with a weight of a fluid collection container. The control system may be
operative to
calculate a difference between an initial total system weight including an
initial weight of
the fluid supply container and an initial weight of the fluid collection
container and current
total system weight including the current weight of the fluid supply container
and the
current weight of the fluid collection container.
[0009] In a detailed embodiment, the control system may be operative to
control the
pump and the heater in an infusion mode. The infusion mode may include
operating the
pump to infuse the fluid at a desired flow rate while monitoring at least one
bubble
detector, the bubble detector being operatively connected to the control
system such that
detection of a bubble results in stopping the pump.
[0010] In a detailed embodiment, a surgical fluid management device may
include a
tubing and cartridge set including a cartridge configured to be received
within the heater
assembly, the cartridge including an internal fluid path, a first section of
tubing extending
at least partway from the source of fluid to the cartridge, and a second
section of tubing
extending from the cartridge at least partway to the surgical site.
[0011] In a detailed embodiment, the pump may include a positive
displacement
pump. In a detailed embodiment, the positive displacement pump may include a
peristaltic
pump configured to receive at least a portion of the first section of tubing.
[0012] In an aspect, a surgical fluid management system may include a pump
configured to deliver fluid to a surgical site; a heater configured to heat
the fluid prior to
delivery to the surgical site; and a control system operatively connected to
the pump and
the heater, the control system being configurable to control the pump to
deliver the fluid to
the surgical site at at least one of a desired flow rate and a desired
pressure, and to control
the heater to warm the fluid to a desired temperature.
[0013] In a detailed embodiment, the control system may be configured to
control the
pump by adjusting a speed of the pump to maintain the desired flow rate. In a
detailed
embodiment, the control system is configured to control the heater by
adjusting the heater
to maintain the desired fluid temperature based on an inlet fluid temperature,
an outlet fluid
temperature, and the flow rate.
[0014] In an aspect, a disposable tubing and cartridge set for a surgical
fluid
management may include a connector adapted to couple with a fluid supply
container; a
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heating cartridge configured to be received within a heater assembly of a
surgical fluid
management system; a trumpet valve; an upstream irrigation tubing section
fluidicly
coupling the connector and the heating cartridge; a downstream irrigation
tubing section
fluidicly coupling the heating cartridge and the trumpet valve; and a suction
tubing section
fluidicly coupled to the trumpet valve and including an end configured for
coupling to a
fluid collection container.
[0015] In a detailed embodiment, the trumpet valve may include a tip
configured for
suction and irrigation. In a detailed embodiment, the probe may include an
electrosurgical
tip.
[0016] In an aspect, a surgical fluid management system may include a pump
configured to deliver fluid to a body cavity for distention of the body
cavity; a remote
pressure sensor configured for placement in the body cavity; and a control
system
operatively connected to the pump and the remote pressure sensor, the control
system
being configured to receive, from the remote pressure sensor, a signal
associated with a
pressure of the fluid within the body. The control system may be configured to
adjust a
speed of the pump to maintain a desired fluid pressure based at least in part
upon the signal
from the remote pressure sensor.
[0017] In a detailed embodiment, the control system may be configured to
receive at
least one of a pneumatic signal or an electrical signal from the remote
pressure sensor.
[0018] In an aspect, a method for operating surgical fluid management
system may
include delivering fluid from a fluid supply container to a surgical site via
a tubing set;
sensing a system fluid pressure in the tubing set between the fluid supply
container and the
surgical site; sensing a surgical site fluid pressure using a remote pressure
sensor disposed
approximate the surgical site; and controlling a pressure of the fluid
delivered to the
surgical site based at least in part upon at least one of the sensed system
fluid pressure and
the sensed surgical site fluid pressure.
[0019] In a detailed embodiment, controlling the pressure of the fluid
delivered to the
surgical site may be based at least in part upon both the sensed system fluid
pressure and
the sensed surgical site fluid pressure. In a detailed embodiment, the tubing
set may
include a disposable tubing set including a pressure relief valve.
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[0020] In an aspect, a suction container support assembly may include a
suction
container support including a plurality of openings, each of the plurality of
openings being
configured to receive an individual suction container therein; and a base
comprising at
least three spaced-apart load cells, the suction container support being
substantially
supported by the at least three spaced-apart load cells. The plurality of
openings may be
arranged such that individual centers of mass of the suction containers
received within the
openings may be disposed inwardly with respect to the spaced-apart load cells.
[0021] In a detailed embodiment, the base may include four substantially
symmetrically spaced-apart load cells and/or the suction container support may
include
four substantially symmetrically arranged openings.
[0022] In a detailed embodiment, individual ones of the plurality of
openings may be
independently adjustable to receive suction containers of a plurality of
sizes. In a detailed
embodiment, a suction container support assembly may include, for each of the
plurality of
openings, a generally radially slidable adjuster, the adjusting being
selectively securable in
a desired position by a respective knob.
[0023] In an aspect, a method of operating a surgical fluid management
system may
include delivering fluid to a surgical site using a pump; and controlling
operation of the
pump based at least in part upon a pressure trend, the pressure trend
including a current
measured pressure as compared to a set point pressure and a previous measured
pressure as
compared to the set point pressure.
[0024] In a detailed embodiment, controlling operation of the pump may
include
classifying the previous measured pressure as compared to the set point
pressure as
corresponding to one of a plurality of zones and/or classifying the current
measured
pressure as compared to the set point pressure as corresponding to one of the
plurality of
zones.
[0025] In a detailed embodiment, the plurality of zones may include a first
zone less
than a lowest value of a set point tolerance band, a second zone between the
lowest value
of the set point tolerance band and the set point, a third zone between the
set point and the
highest value of the set point tolerance band, a fourth zone between the
highest value of the
set point tolerance band and a high pressure alarm level, and/or a fifth zone
above the high
pressure alarm level. In a detailed embodiment, controlling operation of the
pump may
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include selecting one of a plurality of control modes based at least in part
upon the zone
corresponding to the current measured pressure and the zone corresponding to
the previous
measured pressure.
[0026] In a detailed embodiment, the plurality of control modes may include
at least
one of a slope mode, the slope mode including calculating a desired rate of
pressure
change, and adjusting operation of the pump to achieve the desired rate of
pressure change;
an integral control mode, the integral control mode including calculating an
integral of a
pressure error over time, the pressure error being determined by subtracting a
respective
measured pressure from the set point pressure, and adjusting operation of the
pump to
incrementally adjust a fluid flow rate based at least in part upon the
integral of the pressure
error; a coast mode, the coast mode including substantially maintaining a
speed of the
pump; a reduction mode, the reduction mode including, if the current measured
pressure is
less than the previous measure pressure, substantially maintaining the speed
of the pump,
and, if the current measured pressure is not less than the previous measured
pressure,
reducing the speed of the pump; and/or a reverse mode, the reverse mode
including
reversing operation of the pump until a subsequent measured pressure is below
a desired
pressure level.
[0027] In a detailed embodiment, in the integral control mode, adjusting
operation of
the pump to incrementally adjust the fluid flow rate may include adjusting
operation of the
pump to change the fluid flow rate in increments of about +1 ml/min. In a
detailed
embodiment, in the reduction mode, if the current measured pressure is not
less than the
previous measured pressure, reducing the speed of the pump based at least in
part upon a
difference between the current measured pressure and the set point pressure.
[0028] In a detailed embodiment, selecting one of the plurality of control
modes based
at least in part upon the zone corresponding to the current measured pressure
and the zone
corresponding to the previous measured pressure may include, if the current
measured
pressure corresponds to the second zone and the previous measured pressure
corresponds
to the first zone, selecting the slope control mode; if the current measured
pressure
corresponds to the third zone and the previous measured pressure corresponds
to the
second zone, selecting the integral control mode; if the current measured
pressure
corresponds to the fourth zone and the previous measured pressure corresponds
to the third
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zone and if the fluid flow rate is greater than 0, selecting the reduction
mode; if the current
measured pressure corresponds to the fourth zone and the previous measured
pressure
corresponds to the third zone and if the fluid flow rate is not greater than
0, selecting the
reverse mode; if the current measured pressure corresponds to the fifth zone
and the
previous measured pressure corresponds to the fourth zone and if the fluid
flow rate is not
greater than 0, selecting the reduction mode; if the current measured pressure
corresponds
to the fifth zone and the previous measured pressure corresponds to the fourth
zone and if
the fluid flow rate is not greater than 0, selecting the reverse mode; if the
current measured
pressure corresponds to the fourth zone and the previous measured pressure
corresponds to
the fifth zone and if the fluid flow rate is not greater than 0, selecting the
reduction mode;
if the current measured pressure corresponds to the fourth zone and the
previous measured
pressure corresponds to the fifth zone and if the fluid flow rate is not
greater than 0,
selecting the reverse mode; if the current measured pressure corresponds to
the third zone
and the previous measured pressure corresponds to the fourth zone or the fifth
zone,
selecting the coast mode; if the current measured pressure corresponds to the
second zone
and the previous measured pressure corresponds to the third zone, selecting
the integral
control mode; and/or if the current measured pressure corresponds to the
second zone and
the previous measured pressure corresponds to the fourth zone or the fifth
zone, selecting
the slope mode.
[0029] In an aspect, a method of operating a surgical fluid management
system may
include delivering fluid to a surgical site using a pump; and controlling
operation of the
pump including selecting one of a plurality of pressure control modes based at
least in part
upon measured conditions, and adjusting operation of the pump using the
selected control
mode.
[0030] In a detailed embodiment, the plurality of pressure control modes
may include
at least one of a slope mode, the slope mode including calculating a desired
rate of pressure
change, and adjusting operation of the pump to achieve the desired rate of
pressure change;
an integral control mode, the integral control mode including calculating an
integral of a
pressure error over time, the pressure error being determined by subtracting a
respective
measured pressure from the set point pressure, and adjusting operation of the
pump to
incrementally adjust a fluid flow rate based at least in part upon the
integral of the pressure
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error; a coast mode, the coast mode including substantially maintaining a
speed of the
pump; a reduction mode, the reduction mode including, if the current measured
pressure is
less than the previous measure pressure, substantially maintaining the speed
of the pump,
and, if the current measured pressure is not less than the previous measured
pressure,
reducing the speed of the pump; and/or a reverse mode, the reverse mode
including
reversing operation of the pump until a subsequent measured pressure is below
a desired
pressure level.
[0031]
In a detailed embodiment, in the integral control mode, adjusting
operation of
the pump to incrementally adjust the fluid flow rate may include adjusting
operation of the
pump to change the fluid flow rate in increments of about +1 ml/min. In a
detailed
embodiment, in the reduction mode, if the current measured pressure is not
less than the
previous measured pressure, reducing the speed of the pump based at least in
part upon a
difference between the current measured pressure and the set point pressure.
[0032]
In a detailed embodiment, selecting the one of the plurality of pressure
control
modes based at least in part upon measured conditions may include classifying
a previous
measured pressure as compared to a set point pressure as corresponding to one
of a
plurality of zones;
classifying a current measured pressure as compared to the set point
pressure as corresponding to one of the plurality of zones; and/or selecting
the one of the
plurality of pressure control modes based at least in part upon the zone
corresponding to
the current measured pressure and the zone corresponding to the previous
measured
pressure.
[0033]
In a detailed embodiment, the plurality of zones may include a first zone
less
than a lowest value of a set point tolerance band, a second zone between the
lowest value
of the set point tolerance band and the set point, a third zone between the
set point and the
highest value of the set point tolerance band, a fourth zone between the
highest value of the
set point tolerance band and a high pressure alarm level, and a fifth zone
above the high
pressure alarm level.
[0034]
In a detailed embodiment, selecting the one of the plurality of pressure
control
modes may include, if the current measured pressure corresponds to the second
zone and
the previous measured pressure corresponds to the first zone, selecting the
slope control
mode; if the current measured pressure corresponds to the third zone and the
previous
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measured pressure corresponds to the second zone, selecting the integral
control mode; if
the current measured pressure corresponds to the fourth zone and the previous
measured
pressure corresponds to the third zone and if the fluid flow rate is greater
than 0, selecting
the reduction mode; if the current measured pressure corresponds to the fourth
zone and
the previous measured pressure corresponds to the third zone and if the fluid
flow rate is
not greater than 0, selecting the reverse mode; if the current measured
pressure corresponds
to the fifth zone and the previous measured pressure corresponds to the fourth
zone and if
the fluid flow rate is not greater than 0, selecting the reduction mode; if
the current
measured pressure corresponds to the fifth zone and the previous measured
pressure
corresponds to the fourth zone and if the fluid flow rate is not greater than
0, selecting the
reverse mode; if the current measured pressure corresponds to the fourth zone
and the
previous measured pressure corresponds to the fifth zone and if the fluid flow
rate is not
greater than 0, selecting the reduction mode; if the current measured pressure
corresponds
to the fourth zone and the previous measured pressure corresponds to the fifth
zone and if
the fluid flow rate is not greater than 0, selecting the reverse mode; if the
current measured
pressure corresponds to the third zone and the previous measured pressure
corresponds to
the fourth zone or the fifth zone, selecting the coast mode; if the current
measured pressure
corresponds to the second zone and the previous measured pressure corresponds
to the
third zone, selecting the integral control mode; and/or if the current
measured pressure
corresponds to the second zone and the previous measured pressure corresponds
to the
fourth zone or the fifth zone, selecting the slope mode.
[0035] In an aspect, a tubing and cartridge set for a surgical
fluid management system
configured to receive fluid from a fluid supply container and to deliver the
fluid to a
surgical instrument may include a heating cartridge configured to be
releasably received in
a heater assembly, the heating cartridge including a three-dimensional fluid
path
therethrough; an upstream tubing section fluidicly interposing a fluid supply
container and
the heating cartridge; and a downstream tubing section fluidicly interposing
the heating
cartridge and a surgical instrument.
[0036] In a detailed embodiment, the three-dimensional fluid path
may include a first
fluid channel oriented in a first direction, a second fluid channel oriented
in a second
direction, the second direction being substantially opposite the first
direction, and a port
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fluidicly connecting the first fluid channel to the second fluid channel. The
first fluid
channel may be disposed on a first side of a main body of the heating
cartridge, the second
fluid channel may be disposed on a second side of the main body of the heating
cartridge,
the first fluid channel may face outwardly from the first side of the heating
cartridge,
and/or the second fluid channel may face outwardly from the second side of the
heating
cartridge.
[0037] In a detailed embodiment, the three-dimensional fluid path
may include a third
fluid channel on the second side of the main body and generally adjacent to
the second
fluid channel, the third fluid channel being oriented generally in the first
direction. The
three-dimensional fluid path may include a fourth fluid channel on the first
side of the
main body and generally adjacent to the first fluid channel, the fourth fluid
channel being
oriented generally in the second direction. The third fluid channel may face
outwardly
from the second side of the heating cartridge and/or the fourth fluid channel
may face
outwardly from the first side of the heating cartridge.
[0038] In a detailed embodiment, the heating cartridge may include
a first side sheet
affixed to the first side of the main body and a second side sheet affixed to
the second side
of the main body. The first side sheet may at least partially define outwardly
facing
aspects of the first fluid channel and the fourth fluid channel and/or the
first fluid channel
and the fourth fluid channel may be disposed substantially against the first
side sheet. The
second side sheet may at least partially define outwardly facing aspects of
the second fluid
channel and the third fluid channel and/or the second fluid channel and the
third fluid
channel may be disposed substantially against the second side sheet.
[0039] In a detailed embodiment, a tubing and cartridge set may
include a fitting
configured to releasably couple with a corresponding fitting associated with
the heater
assembly upon insertion of the heating cartridge into the heater assembly
and/or the fitting
may be fluidicly connected to the fluid path. In a detailed embodiment, a
tubing and
cartridge set may include a hydrophobic filter fluidicly interposing the
fitting and the fluid
path, the hydrophobic filter being operative to prevent fluid from flowing
from the fluid
path through the fitting.
[0040] In a detailed embodiment, the heating cartridge may include
at least one
bubble trap configured to vent gas from the fluid path. In a detailed
embodiment, the
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bubble trap may include an umbrella valve arranged to allow the gas to escape
the fluid
path without allowing air to enter the fluid path.
[0041] In an aspect, a cartridge for a surgical fluid management
system may include
an internal fluid path including a first channel extending along a first side
of the cartridge,
a first through-port to a second side of the cartridge, a second channel
extending along the second side of the cartridge, a turn section, a third
channel extending
along the second side of the cartridge, a second through-port to the first
side of the
cartridge, and a fourth channel extending along the first side of the
cartridge.
[0042] In a detailed embodiment, the first channel, the second
channel, the third
channel, and the fourth channel have generally flattened shapes. In a detailed
embodiment,
the first channel, the second channel, the third channel, and the fourth
channel have lengths
and heights which are substantially greater than their thicknesses.
[0043] In a detailed embodiment, a cartridge may include an inlet
fitting fluidicly
connected to the first channel, and an outlet fitting fluidicly connected to
the fourth
channel. In a detailed embodiment, a cartridge may include a first bubble trap
between the
inlet fitting and the first channel. In a detailed embodiment, a cartridge may
include a
second bubble trap between the fourth channel and the outlet fitting. In a
detailed
embodiment, at least one of the first bubble trap and the second bubble trap
may include a
hydrophobic membrane. The hydrophobic membrane may be disposed within the
cartridge such that the hydrophobic membrane is canted with respect to
vertical when the
cartridge is in use, the hydrophobic membrane being canted towards a fluid-
contacting
side.
[0044] In a detailed embodiment, a cartridge may include a
substantially rigid main
body and two relatively flexible side sheets, the main body and the side
sheets defining the
first channel, the second channel, the third channel, and the fourth channel.
In a detailed
embodiment, the main body may include molded polycarbonate; the side sheets
may be
constructed from polycarbonate and welded to the main body.
[0045] In a detailed embodiment, a cartridge may include a pressure
sensor fitting
configured to couple with a corresponding fitting in a heater assembly upon
insertion of
the cartridge into the heater assembly. The pressure sensor fitting may be
fluidicly
connected to the internal fluid path. In a detailed embodiment, a cartridge
may include a
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hydrophobic filter fluidicly interposing the pressure sensor fitting and the
internal fluid
path, the hydrophobic filter being operative to prevent fluid from flowing
through the
pressure sensor fitting. In a detailed embodiment, a cartridge may include a
pressure
sensor fluid path fluidicly connecting the internal fluid path and the
hydrophobic filter.
The pressure sensor fluid path may be configured to retain a volume of gas
adjacent to the
hydrophobic filter.
[00461 In an aspect, a heater assembly for a surgical fluid
management device may
include a slot configured to receive a cartridge slidably therein; a first
infrared lamp
mounted adjacent a first side of the slot; a second infrared lamp mounted
adjacent the first
side of the slot; a third infrared lamp mounted adjacent a second side of the
slot; and a
fourth infrared lamp mounted adjacent the second side of the slot. The first
infrared lamp
may be substantially elongated and/or may be configured to heat fluid within a
first flow
channel of the cartridge, the second infrared lamp may be substantially
elongated and/or
may be configured to heat fluid within a second flow channel of the cartridge,
the third
infrared lamp may be substantially elongated and/or may be configured to heat
fluid within
a third flow channel of the cartridge, and/or the fourth infrared lamp may be
substantially
elongated and/or may be configured to heat fluid within a fourth flow channel
of the
cartridge. At least one of the first infrared lamp, the second infrared lamp,
the third
infrared lamp, and/or the fourth infrared lamp may be mounted generally
parallel with a
respective one of the first flow channel, the second flow channel, the third
flow channel,
and/or the fourth flow channel.
[00471 In a detailed embodiment, the first infrared lamp and the
second infrared lamp
may be operatively connected to be controlled as a pair; the third infrared
lamp and the
fourth infrared lamp may be operatively connected to be controlled as a pair;
and fluid may
flow through the cartridge from the first flow channel to the second flow
channel, from the
second flow channel to the third flow channel, and from the third flow channel
to the
fourth flow channel.
[0048] In a detailed embodiment, a heater assembly may include an
inlet temperature
sensor, an intermediate temperature sensor, and/or a outlet temperature
sensor. The first
flow channel and the second flow channel may be fluidicly between the inlet
temperature
sensor and the intermediate temperature sensor, and the third flow channel and
the fourth
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flow channel may be fluidicly between the intermediate temperature sensor and
the outlet
temperature sensor. A level of power applied to the first infrared lamp and
the second
infrared lamp may be determined at least in part by a signal from the inlet
temperature
sensor and/or a level of power applied to the third infrared lamp and the
fourth infrared
lamp may be determined at least in part by a signal from the outlet
temperature sensor.
[0049] In a detailed embodiment, a heater assembly may include a first
reflector
associated with the first infrared lamp and arranged to direct infrared energy
emitted by the
first infrared lamp onto the first flow channel, a second reflector associated
with the second
infrared lamp and arranged to direct infrared energy emitted by the second
infrared lamp
onto the second flow channel, a third reflector associated with the third
infrared lamp and
arranged to direct infrared energy emitted by the third infrared lamp onto the
third flow
channel, and/or a fourth reflector associated with the fourth infrared lamp
and arranged to
direct infrared energy emitted by the fourth infrared lamp onto the fourth
flow channel. In
a detailed embodiment, at least a portion of at least one of the first
reflector, the second
reflector, the third reflector, and/or the fourth reflector may be shaped, in
cross-section,
generally as at least a portion of an ellipse. In a detailed embodiment, one
of the first
infrared lamp, second infrared lamp, third infrared lamp, and/or fourth
infrared lamp may
be located proximate a first foci of the ellipse and/or at least a portion of
at least one of the
first flow channel, the second flow channel, the third flow channel, and/or
the fourth flow
channel may be located proximate a second foci of the ellipse.
[0050] In an aspect, a surgical fluid management system may include a
heater
assembly including elongated infrared lamps located adjacent to a slot; a
heating cartridge
incorporating a three-dimensional fluid path including a plurality of fluid
channels, the
heating cartridge being receivable within the slot such that the elongated
infrared lamps are
disposed generally adjacent to the fluid channels; and a control system
operatively
connected to the elongated infrared lamps, the control system being configured
to adjust
power to the elongated infrared lamps based on fluid temperature and flow rate
to heat the
fluid to a desired temperature.
[0051] In a detailed embodiment, the control system may be operative to
adjust power
to the elongated infrared lamps using pulse width modulation. In a detailed
embodiment,
the heater assembly may include an individual elongated infrared lamp located
generally
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adjacent to each of the fluid channels. In a detailed embodiment, each
individual elongated
infrared lamp may be mounted generally parallel to its respective fluid
channel. In a
detailed embodiment, the control system may be configured to supply different
levels of
power to different lamps, thereby applying different levels of power to
different fluid
channels in response to fluid temperature and flow rate conditions.
[0052] In a detailed embodiment, a surgical fluid management system may
include at
least one reflector arranged to direct infrared energy emitted by at least one
of the
elongated infrared lamps towards at least one of the fluid channels. In a
detailed
embodiment, the at least one reflector may be arranged to minimize exposure of
portions
of the heating cartridge other than the fluid channels. In a detailed
embodiment, the at
least one reflector may be integrated with the elongated lamp. In a detailed
embodiment,
the at least one reflector may include a reflector shroud mounted generally
adjacent to the
elongated infrared lamp.
[0053] In an aspect, a surgical fluid management system may include a
heater
assembly including a slot including a first side and a second side, a first
elongated infrared
lamp mounted generally adjacent to the first side of the slot, a second
elongated infrared
lamp mounted generally adjacent to the second side of the slot, a third
elongated infrared
lamp mounted generally adjacent to the second side of the slot, a fourth
elongated infrared
lamp mounted generally adjacent to the first side of the slot; a heating
cartridge receivable
within the slot and including a first fluid channel and a second fluid channel
arranged such
that when the heating cartridge is received within the slot, the first fluid
channel may be
disposed between the first elongated infrared lamp and the second elongated
infrared lamp
and/or the second fluid channel may be disposed between the third elongated
infrared lamp
and the fourth elongated infrared lamp; and a control system configured to
independently
control at least a first group including the first elongated infrared lamp and
the second
elongated infrared lamp and a second group including the third infrared lamp
and the
fourth infrared lamp, so as to selectively apply different levels of power to
the first fluid
channel and the second fluid channel.
[0054] In a detailed embodiment, the control system may be operative to
selectively
apply different levels of power to the first fluid channel and the second
fluid channel based
at least in part upon fluid temperature and/or flow rate.
CA 02905825 2016-12-15
[0055] In an aspect, a heating cartridge for a surgical fluid management
system may
include a three-dimensional fluid path including a plurality of fluid
channels, each of the
plurality of fluid channels being exposed to an exterior of the heating
cartridge to receive
infrared energy therein. A first one of the fluid channels may be disposed
adjacent to a
second one of the fluid channels to permit heat transfer from the first fluid
channel to the
second channel through an interposing wall.
[0056] In an aspect, a heating cartridge for a surgical fluid management
system may
include a substantially rigid main body at least partially defining at least
one fluid channel;
and a substantially flexible side sheet affixed to the main body, the side
sheet at least
partially defining the at least one fluid channel, such that the main body and
side sheet
together define the at least one fluid channel.
[0057] In a detailed embodiment, the side sheet may be sufficiently
flexible to
substantially dampen pulsatile fluid flow through the fluid channel. In a
detailed
embodiment, the side sheet may be sufficiently flexible to substantially
dampen pulsatile
fluid flow produced by at least one of a peristaltic pump or a piston pump.
[0058] In an aspect, a surgical fluid management system may include a
heater
assembly including a slot and a heater assembly pressure sensor fitting; a
heater cartridge
receivable within the slot, the heater cartridge including a heater cartridge
pressure sensor
fitting configured to couple with the heater assembly pressure sensor fitting
upon insertion
of the heater cartridge into the heater assembly, the heater cartridge
pressure sensor fitting
being fluidicly connected to at least one fluid channel within the heater
cartridge; and at
least one fluid pressure sensor fluidicly connected to the heater assembly
pressure sensor
fitting, the pressure sensor being operative to measure a pressure of a column
of air trapped
between fluid in the at least one fluid channel and the pressure sensor.
[0059] In an aspect, a method of operating a surgical fluid management
system may
include delivering fluid to a surgical site via a heater assembly, the heater
assembly
including at least a first heater and a second heater, the fluid flowing past
the first heater
and then flowing past the second heater; supplying power to the first heater
based at least
in part upon an estimated power requirement, the estimated power requirement
being
substantially proportional to a flow rate of the fluid and a total desired
temperature change
of the fluid; and supplying power to the second heater, including, if a
current outlet
CA 02905825 2016-12-15
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temperature is less than a set point outlet temperature by greater than a
predetermined
threshold, supplying power to the second heater based upon a first heater
control
algorithm, and, if the current outlet temperature is less than the set point
outlet temperature
by less than a predetermined threshold, supplying power to the second heater
based upon a
second heater control algorithm.
[0060] In a
detailed embodiment, supplying power to the first heater may include
supplying power to the first heater based at least in part upon a load factor
multiplied by
the estimated power requirement. In a detailed embodiment, supplying power to
the
second heater may include cutting off power to the second heater if a
predetermined
threshold rate of pressure increase is reached.
[0061] In a
detailed embodiment, the first heater control algorithm may include a
proportional control algorithm, the proportional control algorithm including
multiplying
the estimated power requirement by a proportional control factor, the
proportional control
factor varying with the temperature error, the temperature error being a
difference between
a set point outlet temperature and a current outlet temperature. In a detailed
embodiment,
temperature _error 2
the proportional control factor may be given by k1 + ,
where k1 and
k2
k2 are constants.
[0062] In a
detailed embodiment, the second heater control algorithm may include an
integral control algorithm, the integral control algorithm including
calculating an integral
of the temperature error over time, the temperature error being a difference
between a set
point outlet temperature and a current outlet temperature; if the integral of
the temperature
error over time is less than a predetermined negative value, incrementally
reducing the
power supplied to the second heater; if the integral of the temperature error
over time is
greater than a predetermined positive value, incrementally increasing the
power supplied to
the second heater; and if the integral of the temperature error over time is
between the
predetermined negative value and the predetermined positive value, maintaining
the power
supplied to the second heater.
[0063] In a
detailed embodiment, incrementally reducing the power supplied to the
second heater and incrementally increasing the power supplied to the second
heater may
include adjusting the power supplied to the second heater in increments of
about 1% of a
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17
maximum power of the second heater. In a detailed embodiment, supplying power
to the
second heater based upon the integral control algorithm may include applying a
reduction
factor to the power supplied to the second heater, the reduction factor
decreasing from
about 1.0 to about 0 as the current outlet temperature increases to reach and
exceed the set
point outlet temperature.
[0064] In an aspect, a method of monitoring a fluid deficit in a
surgical fluid
management system may include measuring an initial weight held by a fluid
supply
container support, the fluid supply container support supporting a first fluid
supply
container; measuring an initial weight held by a fluid collection container
support, the fluid
collection container support supporting a first fluid collection container;
calculating an
initial reference total weight, the initial reference total weight including a
sum of the initial
fluid supply container support weight and the initial fluid collection
container support
weight; supplying fluid from the first fluid supply container to a surgical
site; collecting at
least some of the fluid from the surgical site into the first fluid collection
container;
measuring a first current weight held by the fluid supply container support;
measuring a
first current weight held by the fluid collection container support;
calculating a first current
total weight, the first current total weight including a sum of the first
current weight held
by the fluid supply container support and the first current weight held by the
fluid
collection container support; and calculating a first fluid deficit by
subtracting the first
current total weight from the initial reference total weight.
[0065] In a detailed embodiment, a method may include, prior to
measuring the initial
weight held by the fluid supply container support and prior to measuring the
initial weight
held by the fluid collection container support, priming a tubing set.
[0066] In a detailed embodiment, a method may include, after
calculating the first
fluid deficit, supplying fluid from the first fluid supply container to the
surgical site and
collecting at least some of the fluid from the surgical site into the first
collection container;
measuring a second current weight held by the fluid supply container support;
measuring a
second current weight held by the fluid collection container support;
calculating a second
current total weight, the second current total weight including a sum of the
second current
weight held by the fluid supply container support and the second current
weight held by
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the fluid collection container support; and calculating a second fluid deficit
by subtracting
the second current total weight from the initial reference total weight.
[0067] In a detailed embodiment, a method may include, after
calculating the second
fluid deficit, accounting for replacement of the first fluid supply container
with a second
fluid supply container by prior to replacement of the first fluid supply
container with the
second fluid supply container, measuring a pre-replacement weight held by the
fluid
supply container support; after replacement of the first fluid supply
container by the second
fluid supply container, measuring a post-replacement weight held by the fluid
supply
container support; calculating a fluid supply container weight difference by
subtracting the
pre-replacement weight from the post-replacement weight; and calculating an
updated
reference total weight, the updated reference total weight including the sum
of the initial
reference total weight and the fluid supply container weight difference.
[0068] In a detailed embodiment, a method may include, after
calculating the updated
total reference weight, supplying fluid from the second fluid supply container
to the
surgical site and collecting at least some of the fluid from the surgical site
into the first
collection container; measuring a third current weight held by the fluid
supply container
support; measuring a third current weight held by the fluid collection
container support;
calculating a third current total weight, the third current total weight
including a sum of the
third current weight held by the fluid supply container support and the third
current weight
held by the fluid collection container support; and calculating a third fluid
deficit by
subtracting the third current total weight from the updated reference total
weight.
[0069] In a detailed embodiment, a method may include detecting
replacement of the
first fluid supply container by the second fluid supply container by
ascertaining a
substantial weight difference between the pre-replacement weight and the post-
replacement weight. In a detailed embodiment, the substantial weight
difference may
correspond approximately to a predetermined expected fluid supply container
replacement
weight difference. In a detailed embodiment, ascertaining the substantial
difference may
include waiting for a period of time to allow dissipation of transient weight
signals present
due to inadvertent motion of the surgical fluid management system. In a
detailed
embodiment, detecting replacement of the first fluid supply container by the
second fluid
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supply container may include detecting replacement of a partially depleted
first fluid
supply container by a substantially full second fluid supply container.
[0070] In a detailed embodiment, a method a method may include, after
calculating
the second fluid deficit, accounting for replacement of the first fluid
collection container
with a second fluid collection container by prior to replacement of the first
fluid collection
container with the second fluid collection container, measuring a pre-
replacement weight
held by the fluid collection container support; after replacement of the first
fluid collection
container by the second fluid collection container, measuring a post-
replacement weight
held by the fluid collection container support; calculating a fluid collection
container
weight difference by subtracting the pre-replacement weight from the post-
replacement
weight; and calculating an updated reference total weight, the updated
reference total
weight including the sum of the initial reference total weight and the fluid
collection
container weight difference.
[0071] In a detailed embodiment, a method may include, after calculating
the updated
total reference weight, supplying fluid from the first fluid supply container
to the surgical
site and collecting at least some of the fluid from the surgical site into the
second
collection container; measuring a third current weight held by the fluid
supply container
support; measuring a third current weight held by the fluid collection
container support;
calculating a third current total weight, the third current total weight
including a sum of the
third current weight held by the fluid supply container support and the third
current weight
held by the fluid collection container support; and calculating a third fluid
deficit by
subtracting the third current total weight from the updated reference total
weight.
[0072] In a detailed embodiment, a method may include detecting replacement
of the
first fluid collection container by the second fluid collection container by
ascertaining a
substantial weight difference between the pre-replacement weight and the post-
replacement weight. In a detailed embodiment, the substantial weight
difference may
correspond approximately to a predetermined expected fluid collection
container
replacement weight difference.
[0073] In an aspect, a method of monitoring a fluid deficit in a surgical
fluid
management system may include measuring an initial weight held by a fluid
supply
container support, the fluid supply container support supporting at least one
fluid supply
CA 02905825 2016-12-15
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container; measuring an initial weight held by a fluid collection container
support, the fluid
collection container support supporting at least one fluid collection
container; calculating
an initial reference total weight, the initial reference total weight
including a sum of the
initial fluid supply container support weight and the initial fluid collection
container
support weight; supplying fluid from the at least one fluid supply container
to a surgical
site; collecting at least some of the fluid from the surgical site into the at
least one fluid
collection container; monitoring a current weight held by the fluid supply
container
support; monitoring a current weight held by the fluid collection container
support;
calculating a current total weight, the current total weight including a sum
of the current
weight held by the fluid supply container support and the current weight held
by the fluid
collection container support; and calculating a current fluid deficit by
subtracting the
current total weight from the initial reference total weight.
[0074] In a detailed embodiment, a method may include accounting
for replacement
of the at least one fluid supply container with a new fluid supply container
including
sensing a significant difference between a pre-replacement fluid supply
container support
weight and a post-replacement fluid supply container support weight;
calculating a fluid
supply container weight difference by subtracting the pre-replacement fluid
supply
container support weight from the post-replacement fluid supply container
support weight;
calculating an updated reference total weight, the updated reference total
weight including
the sum of the initial reference total weight and the fluid supply container
weight
difference; and using the updated reference total weight in subsequent deficit
calculations.
[0075] In a detailed embodiment, a method may include accounting
for replacement
of the at least one fluid collection container with a new fluid collection
container including
sensing a significant difference between a pre-replacement fluid collection
container
support weight and a post-replacement fluid collection container support
weight;
calculating a fluid collection container weight difference by subtracting the
pre-
replacement fluid collection container support weight from the post-
replacement fluid
collection container support weight; calculating an updated reference total
weight, the
updated reference total weight including the sum of the initial reference
total weight and
the fluid collection container weight difference; and using the updated
reference total
weight in subsequent deficit calculations.
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[0076] In a detailed embodiment, a method may include repeating the
monitoring the
current weight held by the fluid supply container support, monitoring the
current weight
held by the fluid collection container support, calculating the current total
weight, and
calculating the current fluid deficit operations to provide a substantially
continuously
updated fluid deficit calculation.
[0077] In an aspect, a method of operating a surgical fluid
management device may
include calculating an initial reference total weight, the initial reference
total weight
including a sum of an initial weight of a fluid supply container and an
initial weight of a
fluid collection container; supplying fluid from the fluid supply container to
a surgical site;
collecting at least some of the fluid from the surgical site into the fluid
collection
container; calculating a current total weight, the current total weight
including a sum of a
current weight of the fluid supply container and a current weight of the fluid
collection
container; and calculating a deficit by subtracting the current total weight
from the initial
reference total weight.
[0078] In a detailed embodiment, a method may include detecting
replacement of the
fluid supply container by a replacement fluid supply container by ascertaining
a substantial
weight difference between a pre-replacement weight of the fluid supply
container and a
post-replacement weight of the replacement fluid supply container; calculating
an updated
reference total weight, the updated reference total weight including the sum
of the initial
reference total weight and a difference between the post-replacement weight of
the
replacement fluid supply container and the pre-replacement weight of the fluid
supply
container.
[0079] In a detailed embodiment, a method may include supplying
fluid from the
replacement fluid supply container to the surgical site; collecting at least
some of the fluid
from the surgical site into the fluid collection container; calculating an
updated current
total weight, the updated current total weight including a sum of an updated
current weight
of the replacement fluid supply container and an updated current weight of the
fluid
collection container; and calculating an updated deficit by subtracting the
updated current
total weight from the updated reference total weight.
[0080] In a detailed embodiment, a method may include detecting
replacement of the
fluid collection container by a replacement fluid collection container by
ascertaining a
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substantial weight difference between a pre-replacement weight of the fluid
collection
container and a post-replacement weight of the replacement fluid collection
container; and
calculating an updated reference total weight, the updated reference total
weight including
the sum of the initial reference total weight and a difference between the
post-replacement
weight of the replacement fluid collection container and the pre-replacement
weight of the
fluid collection container.
[0081] In a detailed embodiment, a method may include supplying fluid from
the fluid
supply container to the surgical site; collecting at least some of the fluid
from the surgical
site into the replacement fluid collection container; calculating an updated
current total
weight, the updated current total weight including a sum of an updated current
weight of
the fluid supply container and an updated current weight of the replacement
fluid
collection container; and calculating an updated deficit by subtracting the
updated current
total weight from the updated reference total weight.
[0082] In an aspect, a method of operating a multi-functional fluid
management
system may include receiving, via a user interface, at least one of a surgical
discipline
selection and a surgical procedure selection; and setting at least one default
operating limit
based at least in part upon the at least one of the surgical discipline
selection and the
surgical procedure selection.
[0083] In a detailed embodiment, a method may include allowing user-
directed
operation below the default operating limit; requiring additional affirmative
action via the
user interface for operation above the default operating limit at less than a
maximum limit;
and precluding operation above the maximum limit.
[0084] In an aspect, a method of operating a surgical fluid management
system may
include receiving, via a user interface, identification of information to be
gathered by a
surgical fluid management system during a surgical procedure; electronically
storing the
information during the surgical procedure; and receiving, via the user
interface, an
instruction pertaining to at least one of printing, storing, and/or
electronically transmitting
the information.
[0085] In an aspect, a method of operating a multi-functional surgical
fluid
management system may include receiving, via a user interface, identification
of at least
one of a surgical discipline and a surgical procedure; setting default
operating parameters
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based upon the at least one of the surgical discipline and the surgical
procedure and
receiving, via a user interface, input to adjust the operating parameters.
[0086] In a detailed embodiment, a method may include receiving,
via the user
interface, input pertaining to desired alarm levels and alarm types; and
overriding an alarm
received during the surgical procedure based on input received via the user
interface, if
conditions have not exceeded pre-established maximum levels.
[0087] In a detailed embodiment, the alarm types may include at
least one of visible
and audible.
[0088] In an aspect, a method of operating a surgical fluid
management system may
include receiving, via a user interface, preferred operating settings
associated with at least
one of a surgical discipline and a surgical procedure, the preferred operating
settings also
being associated with an identity of at least one of a surgeon and an
operator; and setting
operating parameters at the preferred operating settings upon receiving an
input, via a user
interface, associated with at least one of the surgeon and the operator and at
least one of the
surgical discipline and the surgical procedure.
[0089] In an aspect, a surgical fluid management system may include
a touch screen
interface, the touch screen interface being configured to receive user input
pertaining to
operating parameters and to display information.
[0090] In an aspect, a method of controlling a surgical fluid
management device may
include receiving, via a user input, identification of information which must
be entered
prior to operation of a surgical fluid management device; requesting entry of
the
information; if the information has not been entered, precluding operation of
the of the
surgical fluid management device; and if the information has been entered,
allowing
operation of the surgical fluid management device.
[0091] In accordance with another aspect of the present invention,
there is provided a
fluid management system for supplying fluids of at least two types, said
system
comprising: at least one fluid supply container; at least one fluid collection
container; a
pump configured to deliver a fluid from the at least one fluid supply
container to a site,
said site being a surgical site or a patient; a control system for operating
the fluid
management system in at least one of (1) a pressure control mode, wherein said
control
system controls the pump to deliver fluid to the site at approximately a
target pressure or
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(2) a flow control mode, wherein the control system controls the pump to
deliver fluid to
the site at approximately a target flow rate. The control system includes a
user interface
for communication between the control system and a user, including inputting
data to the
control system and outputting data from the control system; a fluid deficit
monitoring
function for determining a fluid deficit that is a difference between (i) a
volume of fluid
delivered to the site from the at least one fluid supply container and (ii) a
volume of fluid
returned from the site to the at least one fluid collection container; and a
fluid deficit alarm
function for activating a fluid deficit alarm when a fluid deficit exceeds a
fluid deficit
alarm limit indicative of a maximum fluid deficit associated with a type of
fluid
communicated to the control system.
[0092] In accordance with still another aspect of the present
invention, there is
provided a method of operating a fluid management system for supplying fluids
of at least
two types, wherein said system includes at least one fluid supply container,
at least one
fluid collection container, a pump configured to deliver a fluid from the at
least one fluid
supply container to a site, said site being a surgical site or a patient; and
a control system
for controlling operation of the fluid management system. The method includes
the steps
of: inputting data to the control system and outputting data from the control
system via a
user interface; selecting a medical procedure that requires (1) a pressure
control mode,
wherein said control system controls the pump to deliver fluid to the site at
approximately
a target pressure or (2) a flow control mode, wherein said control system
controls the pump
to deliver fluid to the site at approximately a target flow rate; determining
a fluid deficit
that is a difference between (i) a volume of fluid delivered to the site from
the at least one
fluid supply container and (ii) a volume of fluid returned from the site to
the at least one
fluid collection container; associating a fluid deficit alarm limit with a
type of fluid being
supplied by the at least one fluid supply container; and activating a fluid
deficit alarm
when the fluid deficit exceeds the fluid deficit alarm limit associated with
the type of fluid
being supplied by the at least one fluid supply container.
Brief Description of the Drawings
[00931 The detailed description refers to the following figures in
which:
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[0094] FIG. 1 is a perspective view of an exemplary surgical fluid
management
system;
[0095] FIG. 2 is a front elevation view of an exemplary surgical
fluid management
system with the door open;
[0096] FIG. 3 is a front elevation cross-section view of an
exemplary surgical fluid
management system;
[0097] FIG. 4 is a perspective view of an exemplary fluid bag
hanger assembly;
[0098] FIG. 5 is a perspective view of an exemplary suction
container hanger
assembly;
[0099] FIG. 6 is a cross-sectional view of an exemplary suction
container hanger
assembly;
[00100] FIG. 7 is a bottom view of an exemplary suction container
hanger assembly;
[00101] FIG. 8 is a perspective view of an exemplary load cell base;
[00102] FIG. 9 is a schematic illustration of an exemplary trumpet
valve tubing set;
[00103] FIG. 10 is an exploded perspective view of an exemplary
heating cartridge;
[00104] FIG. 11 is a perspective view of an exemplary heating
cartridge;
[00105] FIG. 12 is a perspective view of an exemplary heating
cartridge;
[00106] FIG. 13 is a perspective view of a heating cartridge
illustrating an exemplary
three-dimensional fluid flow path;
[00107] FIG. 14 is a perspective view of a heating cartridge
illustration an exemplary
bubble trap;
[00108] FIG. 15 is a perspective view of an exemplary heater
assembly;
[00109] FIG. 16 is a side view of an exemplary heater assembly;
[00110] FIG. 17 is a side view of an exemplary heater assembly;
[00111] FIG. 18 is a cross-sectional view of an exemplary heater
assembly;
[00112] FIG. 19 is a cross-sectional view of an exemplary heater
assembly;
[00113] FIG. 20 is a schematic illustration of an exemplary power
and control system;
[00114] FIG. 21 is a schematic illustration of an exemplary
equipment setup utilizing
multi-stage heating;
[00115] FIG. 22 is a schematic diagram of an exemplary equipment
setup for use with
a trumpet valve;
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[00116] FIG. 23 is a schematic diagram of an exemplary equipment
setup for use with
an electrosurgical device;
[00117] FIG. 24 is a schematic diagram of an exemplary equipment
setup for use with
a tubing set including one or more connectors for connecting to a surgical
instrument;
[00118] FIG. 25 is a schematic diagram of an exemplary equipment
setup for infusion;
[00119] FIG. 26 is a perspective view of an alternative exemplary
heating cartridge;
[00120] FIG. 27 is an exploded perspective view of an alternative
exemplary heating
cartridge;
[00121] FIG. 28 is an exploded perspective view of an alternative
exemplary heating
cartridge;
[00122] FIG. 29 is a screen shot of an exemplary setup screen;
[00123] FIG. 30 is a screen shot of an exemplary tubing set
selection screen;
[00124] FIG. 31 is a screen shot of an exemplary surgical discipline
selection screen;
[00125] FIG. 32 is a screen shot of an exemplary procedure selection
screen;
[00126] FIG. 33 is a screen shot of an exemplary physician selection
screen;
[00127] FIG. 34 is a screen shot of an exemplary operator selection
screen;
[00128] FIG. 35 is a screen shot of an exemplary control mode
selection screen
[00129] FIG. 36 is a screen shot of an exemplary priming screen;
[00130] FIG. 37 is a screen shot of an exemplary secondary display
and printer control
screen;
[00131] FIG. 38 is a screen shot of an exemplary run screen;
[00132] FIG. 39 is a screen shot of an exemplary summary screen;
[00133] FIG. 40 is a screen shot of an exemplary supervisor screen;
[00134] FIG. 41 is a flowchart illustrating an example method of
operating a surgical
fluid management system;
[00135] FIG. 42 is a flowchart illustrating an example method of
operating a surgical
fluid management system;
[00136] FIG. 43 is a flowchart illustrating an example method of
operating a surgical
fluid management system;
[00137] FIG. 44 is a flowchart illustrating an example method of
operating a surgical
fluid management system;
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[00138] FIG. 45 is a flowchart illustrating an example method of monitoring
a fluid
deficit in a surgical fluid management system;
[00139] FIG. 46 is a flowchart illustrating an example method of monitoring
a fluid
deficit in a surgical fluid management system;
[00140] FIG. 47 is a flowchart illustrating an example method of operating
a surgical
fluid management system;
[00141] FIG. 48 is a flowchart illustrating an example method of operating
a multi-
functional fluid management system;
[00142] FIG. 49 is a flowchart illustrating an example method of operating
a surgical
fluid management system;
[00143] FIG. 50 is a flowchart illustrating an example method of operating
a multi-
functional surgical fluid management system;
[00144] FIG. 51 is a flowchart illustrating an example method of operating
a surgical
fluid management system;
[00145] FIG. 52 is a flowchart illustrating an example method for of
controlling a
surgical fluid management device;
[00146] FIG. 53A illustrates a tubing set having detachable proximal and
distal
portions, according to a first embodiment;
[00147] FIG. 53B illustrates a tubing set having detachable proximal and
distal
portions, according to a second embodiment; and
[00148] FIG. 54 is a block diagram illustrating an embodiment of the
control system
for the fluid management system that includes an RFID interface.
Detail Description of the Invention
[00149] The present disclosure includes, inter alia, surgical fluid
management systems
and methods for using surgical fluid management systems.
[00150] The present disclosure contemplates that various fluids (such as
irrigation
fluids) may be employed during surgical procedures for many purposes, such as
(and
without limitation) to wash away blood and/or debris from a surgical site to
provide the
surgeon with an improved view and/or to distend a surgical site (such as
during some
gynecological, urological, and orthopedic procedures, for example). In
addition, the
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present disclosure contemplates that fluids may be infused into a patient. For
example,
various fluids (including fluids comprising pharmaceuticals and/or blood
components) may
be intravenously infused into a patient.
[001511 Further, the present disclosure contemplates that a
patient's core body
temperature may be reduced if a low-temperature irrigation and/or infusion
fluid is
employed. Thus, the use of low-temperature fluids (which may refer to fluids
at
temperatures less than a patient's body temperature) may contribute to
hypothermia, which
may be a reduction in a patient's body temperature of about 2 C or more. For
example, the
use of low-temperature irrigation fluid during a surgical procedure may
contribute to
intraoperative hypothermia. Similarly, the present disclosure contemplates
that infusion of
low temperature fluids may contribute to patient hypothermia. The present
disclosure
contemplates that hypothermia may result in adverse patient outcomes and/or
increased
medical costs. Similarly, the present disclosure contemplates that some
procedures may
include intentionally lowering a patient's body temperature, and, in such
circumstances,
further lowering of the patient's body temperature below the desired
temperature may
result in adverse patient outcomes and/or increased medical costs.
[00152] An exemplary fluid management system according to the
present disclosure
may provide one or more functions, including irrigation, distention, deficit
monitoring,
and/or infusion functions, and/or may warm the fluid. An exemplary embodiment
may
allow a user to select between fluid pressure or flow rate control, to enable
or disable fluid
warming, to control various operating parameters (such as desired fluid
pressure or fluid
flow rate, fluid temperature (if the fluid warming feature is enabled), and
the like), may
display information (such as desired and/or actual fluid pressure, fluid flow
rate, and fluid
temperature, as well as fluid volume, volumetric deficit, and the like),
and/or may provide
one or more alarms (such as an over pressure alarm, over temperature alarm,
low fluid
supply alarm, fluid deficit alarm, perforation alarm, and the like). Some
exemplary
devices may provide data logging and/or printing capabilities and/or the
ability to
electronically transmit data to a central data collection or information
system. An
exemplary embodiment may warm a fluid to a temperature selected by a user
(such as a
temperature approximate a patient's body temperature) and/or may deliver the
fluid to the
surgical site at a pressure and/or flow rate selected by a user.
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29
_
[00153] FIG. 1 is a perspective view of an exemplary fluid
management system 10
including a fluid management unit 100. An exemplary fluid management unit 100
may
include one or more fluid container supports, such as fluid bag hangers 102,
104, each of
which may support one or more fluid bags 902, 904 (and/or other fluid supply
containers).
Fluid bag hangers 102, 104 may receive a variety of sizes of fluid bags 902,
904, such as 1
L to 5 L bags. An exemplary embodiment may include fluid bag hangers 102, 104
at
approximately shoulder height, which may minimize the difficulty of hanging
fluid bags
902, 904, particularly when large volume fluid bags 902, 904 are employed.
[00154] An exemplary fluid management unit 100 may include one or
more user
interface components, such as a touch screen display 106. As will be described
in detail
below, the user interface provides communication between a control system and
a user,
including inputting data to the control system and outputting data from the
control system.
The user interface may provide information to the user in visual and/or
audible forms.
Some exemplary embodiments may employ switches, knobs, dials, and the like as
user
interface components in addition to or instead of one or more touch screen
displays 106.
User interface components, such as touch screen display 106, may enable the
user to select
fluid pressure or flow rate control, to enable or disable fluid warming
functions, to
configure operating parameters and alarms, to configure information to be
displayed,
and/or to configure information to be stored, printed, or transmitted after
the procedure for
record keeping purposes.
[00155] An exemplary fluid management system 10 may include a
secondary display
106A, which may be mounted to a display pole 20A. Display pole 20A may be
configured
to be extendable (e.g., telescopically) to allow adjustment of the height of
secondary
display 106A. Such an embodiment may be useful during procedures in which the
surgeon
is sitting and/or must look over an obstruction to view the fluid management
system 10.
Similarly, some exemplary embodiments may include one or more remote displays
which
may be located away from the fluid management unit 100 for the convenience of
a user.
[00156] Some exemplary fluid management units 100 may include a
door 108 or other
closure which may at least partially cover various components. In some
exemplary
embodiments including a door 108 or other closure, the position (e.g., shut
and/or open) of
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the door 108 or other closure may be utilized as an interlock to prevent
and/or allow certain
operations of the device.
[00157] An exemplary fluid management system 10 may include a
suction container
hanger assembly 200. An exemplary suction container hanger assembly 200 may
support
one or more suction canisters 906, 908, 910, 912 (and/or other fluid
collection containers)
from a suction canister hanger 202. Other exemplary embodiments may employ
suction
container support assemblies other than suspension-type assembles. For
example, an
assembly supporting a suction container from below may be utilized instead of
or in
addition to a suspension-type assembly. In an exemplary embodiment, one or
more
suction canisters 906, 908, 910, 912 may be coupled to a suction or vacuum
source, such
as any of those commonly found in a surgical suite. An exemplary suction
container
hanger assembly 200 may be adapted to accommodate different sizes of suction
containers
and may be adjustable to accommodate such containers.
[00158] An exemplary surgical fluid management unit 100 may be
mounted on a
rolling stand, which may include a pole 20 and/or a base 22, which may include
a plurality
of castered wheels 26 mounted to a respective plurality of legs 24. The base
22 may also
include a storage basket 28 other similar storage component. Some exemplary
embodiments may be mounted to other mobile devices, such as a cart. Some
exemplary
embodiments may be mounted in a fixed location, such as an operating room, by
being
affixed to a wall, mounted to other fixed equipment, mounted on a boom, etc.
[00159] An exemplary fluid management unit 100 may be utilized
with tubing sets that
fluidicly connect various components. Tubing sets may be disposable (to comply
with
health standards associated with items contacting bodily fluids, for example),
and may be
provided sterile and ready for use. Different tubing sets may be utilized for
performing
different surgical functions. For example, an exemplary irrigation tubing set
for
laparoscopic procedures may include generally parallel suction and irrigation
tubing,
and/or may include a valve device (such as a trumpet valve) for controlling
flow of
irrigation fluid and/or suction. An exemplary tubing set for distention
procedures may
include generally parallel delivery and return tubing, which may couple to a
surgical
instrument, such as via standard Luer-lock fittings. Such tubing sets for
distention
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31
procedures may incorporate a pressure relief valve to guard against over-
pressurization of
the body cavity being distended.
[00160] FIG. 2 is a detailed front elevation view of an exemplary fluid
management
unit 100. In FIG. 2, door 108 is open and slot 310 for fluid heating cartridge
410 is visible.
An exemplary cartridge 410, described in further detail below, may be utilized
with one or
more heat transfer devices (e.g., heaters) to change the temperature of a
fluid prior to
delivery to a surgical site and/or prior to infusion into a patient. In an
exemplary
embodiment, cartridge 410 may be fully enclosed (except for the connections
described
below) and/or may be provided as part of a disposable tubing set. By providing
a
disposable cartridge 410 (and/or other patient or fluid-contacting components)
as part of a
disposable tubing set, an exemplary fluid management system 10 may provide
components
requiring sterilization prior to use and/or which may contact bodily fluids as
disposable
components, and/or other components may be durable. Thus, only minimal
cleaning of the
non-disposable components of fluid management system 10 may be required
between
patients.
[00161] An exemplary embodiment may include a data recording device, such
as a
printer 111. An exemplary data recording device may create a permanent and/or
temporary record of important information regarding the use of the fluid
management
system 10 during a surgical procedure, such as the identity of the surgeon,
identity of the
operator, identity of the patient (usually by patient number), procedure
performed, and
procedure duration, as well as various operating conditions such as total
fluid volume
utilized, average fluid temperature, minimum and/or maximum fluid
temperatures, alarm
conditions, and the like. Those of ordinary skill will recognize that
alternate and/or
additional data recording and/or storage mechanisms may be utilized, such as
electronic
storage components.
[00162] An exemplary fluid management unit 100 may include a handle 110.
[00163] An exemplary fluid management unit 100 may include one or more
fluid
pressurization or transfer devices, such as a pump 112. An exemplary pump 112
may
include an electrically driven peristaltic pump. Some exemplary peristaltic
pumps may
operate at speeds between about 4 and 400 revolutions per minute and/or may
deliver fluid
up to approximately 1.4 L/min, for example. Some exemplary embodiments may
include
CA 02905825 2016-12-15
32
other types of positive displacement and/or non-positive displacement pumps
known in the
art. Further, some exemplary embodiments may utilize alternative power
sources, such as
compressed air, vacuum, etc. to drive a pump. Exemplary electrically driven
pumps may
receive power from a line source (such as a wall outlet) and/or one or more
external and/or
internal electrical storage devices (such as a disposable or rechargeable
battery). Some
exemplary electrically driven pumps may include stepper motors, DC brush
motors, AC or
DC brushless motors, and/or other similar devices known in the art.
[00164] In an exemplary embodiment, fluid bag hangers 102, 104 may include
one or
more hooks 114, 116 from which one or more fluid bags 902, 904 may be
suspended. In an
exemplary embodiment, door 108 may include one or more hinges 117 and/or a
latch
component 118, which may have a corresponding latch component 120 on the fluid
management unit 100.
[00165] Various fluid paths are visible in FIG. 2. For example, a tubing
set may
include irrigation tubing, which may include tubing extending from one or more
fluid
containers (such as fluid bags 902, 904 shown in FIG. 1), through opening 122,
through
pump 112, into cartridge 410 (which may be provided as part of the tubing
set), out of the
cartridge into path 124, and to a hand piece via opening 126. A tubing set may
include
suction tubing, which may include tubing extending from a hand piece into
opening 126,
through path 128, out of opening 130, and to one or more suction sources
and/or
containers, such as suction canisters 906, 908, 910, 912.
[00166] Some exemplary embodiments may include one or more bubble
detectors,
such as ultrasonic bubble detector 132, which may be provided along a fluid
path.
Exemplary embodiments may include other types of bubble detectors and/or
liquid
detectors (such as optical bubble detectors, infrared bubble detectors, and
the like) in place
of or in addition to ultrasonic bubble detector 132. One or more bubble
detectors 132 may
be utilized for various purposes as discussed below, such as to detect liquid
during priming
and/or to detect a bubble in tubing leading to a surgical and/or infusion
site. In some
exemplary embodiments, one or more bubble detectors 132 may be used to detect
fluid
within the tubing, thus indicating that cartridge 410 may be substantially
filled with fluid
and, therefore, heater assembly 309 may be safely activated, In some exemplary
embodiments, two or more bubble detectors 132 may be utilized to detect
bubbles (e.g., in
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33
distention and/or infusion applications), which may provide redundant bubble
detection
capability. For example, in some distention and/or infusion applications, if
any bubble
detector 132 detects a bubble, pump 112 may be stopped to reduce the risk of
introducing
air into the body cavity being distended (which could obstruct viewing) or
infusing air into
a patient.
[00167] Some exemplary embodiments may include one or more
temperature sensors,
such as thermal cut off sensor(s) 2048, which may include one or more bimetal
switches,
infrared temperature sensors, and/or other temperature sensors known in the
art. Bubble
detector(s) 132 and thermal cut off sensor(s) 2048 may be mounted such that
they may be
in contact with tubing extending through path 124, for example.
[00168] In some exemplary embodiments, door 108 may be arranged such
that it may
not be fully shut unless the tubing of the tubing set is properly inserted
into the appropriate
flow paths. For example, door 108 may be arranged such that it will not fully
shut unless
cartridge 410 is fully inserted into slot 310 and/or tubing associated with a
tubing set is
properly installed in fluid management unit 100. Fingers 108A on the inside of
door 108
may be configured to prevent door 108 from fully shutting if pump 112 is not
in its
operational configuration (e.g., door 108 may be prevented from closing if the
pump head
is not closed). Similarly, finger 108C may be configured to press tubing into
path 124 to
promote contact between the tubing and bubble detector 132. Likewise, finger
108B may
be configured to press tubing into path 124 to promote contact between the
tubing and
thermal cut off sensor(s) 2048.
[00169] FIG. 3 is a cross-sectional view of an exemplary fluid
management unit 100.
Some exemplary fluid bag hangers 102, 104 may include rods 134, 136 which may
be
pivotably joined at pivots 138, 140, respectively. In an exemplary embodiment,
rods 134,
136 may include a journal 139, 141 through which the respective pivot 138, 140
extends.
Rods 134, 136 may be supported by one or more load cells 142, 144, which may
output
electrical signals associated with the weight of the fluid containers
suspended from the
fluid bag hangers. In an exemplary embodiment, load cells 142, 144 may include
button-
type compression cells. Other exemplary embodiments may utilize load cells of
other
types, such as beam-type load cells and/or strain gauges. An exemplary
embodiment may
utilize a signal provided by one or more load cells 142, 144 to determine a
volume of one
CA 02905825 2016-12-15
34
or more bags of fluid 902, 904 attached to the unit 100 (e.g., whether a given
bag of fluid
902 is a 1 L bag, or a 5 L bag), to determine an amount of fluid remaining in
one or more
bags of fluid 902, 904, and/or to sense when a bag of fluid 902, 904 has been
replaced, for
example. In an exemplary embodiment in which a fluid bag hanger 102, 104 is
utilized to
hang a single fluid bag 902, 904, each load cell 142, 144 may provide a signal
associated
with the weight of a single fluid bag 902, 904.
[00170] In some exemplary embodiments, providing one or more integral fluid
bag
hangers 102, 104 may reduce the complexity and/or cost of the fluid management
system
because wiring associated with the load cells 142, 144 may be located within
the
housing of fluid management unit 100, as compared to embodiments including
fluid bag
hangers mounted to a supporting structure (such a pole and cross bar assembly)
extending
upwardly from the fluid management unit 100. Specifically, integral fluid bag
hangers
102, 104 may obviate the need to run wiring associated with one or more load
cells along
or within an upwardly extending supporting structure.
[00171] In an exemplary embodiment, a heater assembly 309 may include one
or more
heat sources, such as infrared (IR) lamps 312, 314, 316, 318, which may be
mounted near
slot 310. In other exemplary embodiments, other sources of IR energy may be
utilized,
such as halogen lamps, light emitting diodes (LEDs), quartz lamps, carbon
lamps, and the
like. In an exemplary embodiment, IR lamps 312, 314, 316, 318 may draw up to
about
500 W each, for a total of up to approximately 2 kW, which may provide
approximately a
25 C temperature rise (or greater) at a flow rate of approximately 500 mL/min
or greater.
Reflector shrouds 320, 322, 324, 326 may be mounted to direct IR energy
emitted by
lamps 312, 314, 316, 318 towards cartridge 410, which may be received in slot
310.
[00172] FIG. 4 is a detailed perspective view of an exemplary fluid bag
hanger
assembly.
[00173] FIGS. 5-8 illustrate an exemplary suction container hanger assembly
200.
Suction canister hanger 202 may include one or more receiving openings 201A,
201B,
201C, 201D into which one or more suction canisters 906, 908, 910, 912 may be
placed.
Openings 201A, 201B, 201C, 201D may be adapted to receive suction canisters of
various
sizes.
CA 02905825 2016-12-15
[00174] In some exemplary embodiments, receiving openings 201A, 201B, 201C,
201D may be arranged generally symmetrically. In some exemplary embodiments,
receiving openings 201A, 201B, 201C, 201D of different sizes may be provided
and/or
adjusters 216A, 216B, 216C, 216D may be adjusted to accommodate canisters 906,
908,
910, 912 of one or more sizes and/or shapes, as best seen in FIG. 7. In an
exemplary
embodiment, each adjuster 216A, 216B, 216C, 216D may be individually
adjustable. In
an exemplary embodiment, receiving openings 201A, 201B, 201C, 201D and their
associated adjusters 216A, 216B, 216C, 216D may be capable of receiving
suction
canisters 906, 908, 910, 912 with diameters up to about 6.6 inches.
[00175] Adjusters 216A, 216B, 216C, 216D may be slidable generally radially
inward
and/or outward with respect to the opening 201 (e.g., as shown by arrow A). In
an
exemplary embodiment, adjusters 216A, 216B, 216C, 216D may include a shaped
end,
such as curved end 218A, 218B, 218C, 218D, which may be adapted to interface
with a
suction canister 906, 908, 910, 912. Knobs 220A, 220B, 220C, 220D may be
threadedly
engaged with suction canister hanger 202 and/or adjusters 216A, 216B, 216C,
216D to
allow adjusters 216A, 216B, 216C, 216D to be secured in position relative to
suction
canister hanger 202. For example knobs 220A, 220B, 220C, 220D may include
threaded
rods which may be received in corresponding threaded openings on suction
canister hanger
202. In such an exemplary embodiment, rotation of knobs 220A, 220B, 220C, 220D
may
tighten knobs 220A, 220B, 220C, 220D against adjusters 216A, 216B, 216C, 216D
and/or
may loosen knobs 220A, 220B, 220C, 220D away from adjusters 216A, 216B, 216C,
216D, thereby allowing a user to selectively secure and release an adjuster
216A, 216B,
216C, 216D for adjustment. In other exemplary embodiments, various types of
retainers
known in the art may be substituted for knobs 220A, 220B, 220C, 220D, such as
other
arrangements of threaded retainers, cam-type retainers, clips, etc.
[00176] In an exemplary embodiment, adjusters 216A, 216B, 216C, 216D may be
initially positioned and secured using knobs 220A, 220B, 220C, 220D.
Subsequent
installation and removal of canisters 906, 908, 910, 912 may be accomplished
by lowering
canisters 906, 908, 910, 912 into pre-adjusted receiving openings 201A, 201B,
201C,
201D and raising canisters 906, 908, 910, 912 out of pre-adjusted receiving
openings
201A, 201B, 201C, 201D. Adjustment of knobs 220A, 220B, 220C, 220D may only be
CA 02905825 2016-12-15
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_ 36
necessary when a canister 906, 908, 910, 912 of a different size is utilized.
In other
exemplary embodiments, one or more adjusters 216A, 216B, 216C, 216D may be
adjusted
more frequently during use, such as with each canister replacement.
[00177] An exemplary suction canister hanger 202 may include a
collar 203, which
may receive pole 20 (which is shown in FIG. 2) therethrough. Suction canister
hanger 202
may be supported by a load cell base 204, which may include a housing 212 for
receiving
pole 20 therethrough and/or a pin 214 which may extend through pole 20. Some
exemplary load cell bases 204 may be constructed of metal, such as steel.
[00178] In some exemplary embodiments, suction canister hanger 202
may be
supported on load cell base 204 substantially by load cells 206A, 206B, 206C,
206D,
which may be mounted on arms 204A, 204B, 204C, 204D. Load cells 206A, 206B,
206C,
206D may be adapted to provide electrical outputs associated with the weight
carried by
the suction canister hanger 202. In an exemplary embodiment, load cells 206A,
206B,
206C, 206D may include button-type compression cells. Other exemplary
embodiments
may utilize load cells of other types, such as beam-type load cells and/or
strain gauges.
[00179] In some exemplary embodiments, the total weight supported
by load cells
206A, 206B, 206C, 206D may be about equal to sum of the weight of suction
canister
hanger 202, the empty weights of canisters 906, 908, 910, 912, and the weight
of any
contents of canisters 906, 908, 910, 912. An exemplary embodiment may utilize
signals
provided by one or more load cells 206A, 206B, 206C, 206D to determine a
volume of
liquid collected in one or more suction canisters 906, 908, 910, 912 and/or to
determine
when one or more suction canisters 906, 908, 910, 912 has been replaced.
[00180] In some exemplary embodiments, load cells 206A, 206B,
206C, 206D may be
positioned on load cell base 204 such that suction canisters 906, 908, 910,
912 are located
generally towards collar 203 with respect to load cells 206A, 206B, 206C,
206D. In other
words, load cells 206A, 206B, 206C, 206D may be positioned radially farther
from collar
203 than the centers of mass of suction canisters 906, 908, 910, 912. Put
another way, the
centers of mass of suction canisters 906, 908, 910, 912 may be disposed
inwardly with
respect to spaced-apart load cells 206A, 206B, 206C, 206D. In some exemplary
embodiments, load cell base 204 may include three or more load cells 206A,
206B, 206C,
206D. Such an arrangement may be useful when it is desired for the sum of the
load cell
CA 02905825 2016-12-15
37
readings to be representative of the total weight of the canisters 906, 908,
910, 912.
Further, such an arrangement may be useful when uneven canister 906, 908, 910,
912
loading may occur.
[00181] FIG. 9 is a schematic diagram of an exemplary trumpet valve tubing
set 3010,
which may include cartridge 410. In an exemplary embodiment, trumpet valve
tubing set
3010 may include irrigation tubing 3013 and suction tubing 3027. Irrigation
tubing 3013
may include one or more connecters, such as spikes 3014, which may be adapted
to couple
with one or more fluid containers (such as fluid bags 902, 904). Exemplary
tubing sets
may be provided with single or multiple spikes 3014 in various exemplary
embodiments.
Irrigation tubing 3013 may include an upstream section 3013A, which may be
fluidicly
upstream of cartridge 410, and/or a downstream section 3013B, which may be
fluidicly
downstream of cartridge 410.
[00182] In an exemplary embodiment, one or more clamps 3016, 3018 may be
provided downstream of the spikes 3014. Some exemplary embodiments may include
a Y-
connector 3020 and/or other similar device joining a plurality of sections of
tubing. In an
exemplary embodiment, cartridge 410 may be provided as part of tubing set
3010.
Trumpet valve 3022 may be fluidicly connected to cartridge 410 (e.g., via
tubing 3013B)
and may include one or more valves for controlling flow of irrigation fluid
and/or suction.
Trumpet valve 3022 may include a tip 3024, which may be utilized for suction
and/or
irrigation. In some exemplary embodiments, tip 3024 may include
electrosurgical
components, such as an electrocautery tip. An exemplary suction tubing 3027
may include
a suction connection 3026, which may be coupled to a source of suction via one
or more
suction containers (such as suction canisters 906, 908, 910, 912), for
example. In such an
exemplary embodiment, the one or more suction containers may be connected to a
hospital's central suction and/or a standalone suction device, for example.
[00183] An example trumpet valve 3022 may comprise a single-use suction and
irrigation device intended for use in surgical procedures, such as
laparoscopic surgical
procedures. An example trumpet valve 3022 may include two push-button operated
valves, one for irrigation fluid and one for suction, that may be connected to
a probe
attachment port. The body of the suction valve may include a manually
adjustable false air
regulator. Various probes may be attached to the probe attachment port, such
as 5 mm
CA 02905825 2016-12-15
38
single-lumen probes and probes including monopolar or bipolar electrosurgical
tips. Some
example electrosurgical probes may include electrical cables that are
coupleable to external
electrosurgical generators. U.S. Patent No. 6,234,205 describes an example
trumpet valve
and is incorporated by reference.
[00184] FIGS. 10-14 illustrate an exemplary cartridge 410 according to the
present
disclosure. Some exemplary cartridges may include a main or center body 410X
(which
may be substantially rigid) and/or one or more side sheets 410Y, 410Z (which
may be
relatively flexible). An exemplary cartridge may be generally L-shaped and
substantially
flattened, having a generally horizontally extending fluid IR exposure section
415 and a
generally vertically extending elevated section 417, extending vertically up
from the fluid
heat transfer section 415. An exemplary cartridge 410 may include inlet and/or
outlet
connections, such as inlet fitting 412 and outlet fitting 414 positioned at
the side of the
cartridge with the vertically extending elevated section 417, where the inlet
fitting 412
extends generally downward and the outlet fitting 414 extends generally upward
from a tab
section 419 extending from a side of the generally vertically extending
elevated section
417. In an exemplary embodiment, inlet fitting 412 and/or outlet fitting 414
may include
barb fittings; however, other exemplary embodiments may utilize other
connection devices
such as compression fittings, Luer-lock fittings, glue joints, and other
connection devices
known in the art. In an exemplary embodiment, cartridge 410 may include
additional
connections, such as fitting 430, which may connect to a pressure sensor
(and/or a pressure
transducer).
[00185] In an exemplary embodiment, cartridge 410 may include an internal
flow path
through which fluid may flow from inlet fitting 412 to outlet fitting 414. A
front portion of
an exemplary flow path is visible in FIGS. 11 and 14: lower, front fluid
channel 420, port
424, port 426, and upper front fluid channel 422. In an exemplary embodiment,
one or
more walls (such as wall 428) may separate various fluid channels 420, 422. A
back
portion of the exemplary flow path is visible in Fig. 12: lower, back fluid
channel 432,
upper, back fluid channel 434 and turn section 436. In an exemplary
embodiment, the
internal flow path may direct fluid through and/or past one or more bubble
traps 416, 418
(which may also be referred to as air venting chambers). In an exemplary
embodiment, the
bubble trap 416 nearer the inlet fitting 412 may be larger than the bubble
trap 418 nearer
CA 02905825 2016-12-15
39
the outlet fitting 414. In some exemplary embodiments, a larger bubble trap
416 near the
inlet fitting 412 may remove bubbles delivered to cartridge 410 resulting from
a
replacement of a fluid bag 902, 904. In some circumstances, such bubbles may
be
relatively large. In some exemplary embodiments, a smaller bubble trap 418
near the
outlet fitting 414 may remove bubbles not removed by bubble trap 416 and/or
bubbles
created during fluid warming within cartridge 410. In some exemplary
embodiments,
bubble traps 416, 418 may include hydrophobic membranes 416A, 418A as
described in
detail below.
[00186] Fluid channels 420, 422, 432 and 434 may include generally
horizontally
extending fluid channels having the following dimensions in an example
embodiment:
about 9.5" long by about 2" high by about 0.25" thick. In some example
embodiments, the
dimensions of fluid channels 420, 422, 432, 434 may be configured to provide a
substantial
amount of outwardly facing surface area relative to the internal volume to
promote
efficient warming of the fluid using IR lamps 312, 314, 316, 318.
[00187] In an exemplary embodiment, fluid may enter cartridge 410 at inlet
fitting 412,
may flow past bubble trap 416, and into lower, front fluid channel 420. Then,
the fluid
may flow through port 424 and into lower, back fluid channel 432. The fluid
may
generally reverse direction in turn section 436 and may flow into upper, back
fluid channel
434. Turn section 436 may include one or more ribs 436A. Fluid may then flow
through
port 426, through upper, front fluid channel 422, past bubble trap 418, and
out of cartridge
410 via outlet fitting 414. Fluid channels 432, 434 may be separated by a
horizontal wall
438. Thus, such an exemplary embodiment may provide a three-dimensional fluid
flow
path P (e.g., the fluid flow path causes the fluid to flow in the X, Y, and Z
directions), as
best seen in FIG. 13.
[00188] As illustrated in FIG. 13, an elongated, three-dimensional,
convoluted path P
may be defined in cartridge 410 between inlet fitting 412 and outlet fitting
414.
[00189] Cartridge 410 may be designed such that path sections, defined by
fluid
channels 420, 432, 434, and 422 are substantially aligned and/or substantially
in registry
with IR lamps 312, 318, 316, 314, respectively, when cartridge 410 is inserted
into slot 310
of heater assembly 309, as illustrated in FIG. 19.
CA 02905825 2016-12-15
[00190] In some exemplary embodiments, increasing the length of the fluid
flow path
within the cartridge may increase the time the fluid is subjected to heating
by the IR lamps
and, thereby, enable increased fluid warming at increased fluid flow rates. A
cartridge
including a three-dimensional flow path with multiple fluid channels exposed
to IR lamps
may enable efficient fluid warming and cost effective designs of both the
cartridge and
heater assembly. A two-dimensional flow path wherein the fluid is subjected to
heating by
the IR lamps for the same amount of time may result in a larger, less cost
effective
cartridge and a larger, less cost effective heater assembly and/or less
efficient fluid
warming.
[00191] In some exemplary embodiments, one or more fluid channels may be
arranged
such that they are capable of transferring heat to one or more other fluid
channels. For
example, heat transfer from fluid channel 432 to fluid channel 420 may occur.
Similarly,
heat transfer from fluid channel 422 to fluid channel 434 may occur. Heat
transfer between
channels may aid in dissipating heat from warmer sections, particularly during
stagnant or
low flow conditions (such as when pump 112 is not running). Such heat transfer
may not
be possible with a two-dimensional fluid path.
[00192] A main body 410X of an exemplary cartridge 410 may be constructed
of
polycarbonate, which may be substantially rigid. In some exemplary
embodiments, the
main portion of cartridge 410 may be molded as a single piece. In some
exemplary
embodiments, various fittings, such as inlet fitting 412, outlet fitting 414,
and fitting 430
may be integrally molded with the main portion of the cartridge 410, while
such fittings
may be separately installed pieces in other exemplary embodiments. In some
exemplary
embodiments, utilizing a single-piece molded cartridge main body may reduce
the
potential for fluid leakage because of a reduced number of joints. Similarly,
employing
integrally molded components, such as fittings 412, 414, 430 may reduce the
potential for
fluid leakage. In addition, integrally molded fittings (and other components)
may be less
expensive to manufacture and may require less labor (e.g., they do not need to
be
separately installed); thus, integrally molded construction may reduce the
cost of cartridge
410.
[00193] Front and/or back sides of an exemplary cartridge may be covered by
one or
more sheets 410Y, 410Z of polycarbonate (such as LEXANS polycarbonate), which
may
CA 02905825 2016-12-15
41
have a thickness in the range of approximately 0.010-0.030 inches, for
example. In an
exemplary embodiment, both the front and back sides are covered with
polycarbonate
sheets 410Y, 410Z having a thickness of approximately 0.020 inches. In an
exemplary
embodiment, one or more polycarbonate sheets 410Y, 410Z may be attached and/or
sealed
to the cartridge 410 using ultrasonic welding, for example. In some exemplary
embodiments, rib 436A may simplify ultrasonic welding of polycarbonate sheets
410Y,
410Z to cartridge 410 by diffusing some energy which may be directed generally
at the
projecting portion of wall 438. The
present disclosure contemplates that such
polycarbonate materials may be highly transparent to IR energy (e.g.,
approximately 85%
transmissive). Utilizing highly IR transparent materials may allow a
relatively high
percentage of the energy emitted by the IR lamps to directly warm fluid within
the
cartridge.
[00194] In an
exemplary embodiment, materials from which various components are
constructed (such as polycarbonate) may be substantially free of polyvinyl
chloride (PVC)
and/or bis(2-ethylhexyl)phthalate (DEHP). Such materials may be advantageous
for
environmental and/or patient safety reasons.
[00195] The
present disclosure contemplates that positive displacement pumps of
various types may provide advantages, such as an easily calculated flow rate.
The present
disclosure also contemplates that, due to their nature, certain types of
positive
displacement pumps may provide a pulsed flow. In some exemplary embodiments,
it may
be desirable to provide a non-pulsatile flow. An exemplary embodiment may
include
sheets 410Y, 410Z, which may be somewhat flexible and/or elastic. When
utilized in
connection with a pulsed fluid flow, such as that produced by some peristaltic
and piston-
type pumps, a cartridge 410 including one or more flexible sheets 410Y, 410Z
may operate
to at least partially dampen the pulses and/or to provide more continuous
fluid flow and/or
pressure.
[00196] An
exemplary embodiment may include a cartridge 410 and a slot 310 (see,
e.g., FIGS. 3 and 15) having complementary shapes, which may prevent insertion
of the
cartridge 410 in slot 310 in an improper orientation. For example, an
exemplary cartridge
may generally have an L-shape (see, e.g., the portion of cartridge 410
including bubble trap
418), and the slot 310 may prevent full insertion of the cartridge 410 in an
inverted
CA 02905825 2016-12-15
42
orientation by only accommodating the L-shape in the proper orientation. An
exemplary
embodiment may include one or more ridges, such a upper ridge 440 and/or a
lower ridge
442, which may be arranged to engage one or more corresponding grooves in slot
310. In
some exemplary embodiments, upper ridge 440 and lower ridge 442 may have
different
widths (and/or shapes), and their corresponding grooves in slot 310 may be
sized such that
cartridge 410 cannot be inserted into slot 310 in an inverted orientation.
Upper ridge 440
and/or lower ridge may extend at least part of the length of cartridge 410
and/or may be
discontinuous. In some exemplary embodiments, one or both of upper ridge 440
and lower
ridge 442 may include an engagement feature, such as notch 410A, which may be
used to
releasably retain cartridge 410 within slot 310 of heater assembly 309.
[00197] FIG. 14 is a detailed perspective view of a portion of an exemplary
cartridge
410. An exemplary bubble trap 418 may be provided in the elevated section 417
of the
cartridge and may include a plurality of vertically extending ridges 421
and/or one or more
central openings 419A. The bubble trap 418 may be covered with a hydrophobic
membrane adapted to vent bubbles of gas from fluid. Ridges 421 (and/or similar
structures) may provide support for the hydrophobic membrane against the fluid
while
allowing gas to pass through the hydrophobic membrane. Gas may exit through
openings
419A, which may be covered by a closure, such as an umbrella valve, which may
be
arranged to operate as a one-way valve. Thus, gas may exit through openings
419A but air
may be prevented from entering through openings 419A.
[00198] In an exemplary embodiment, at least a portion of the bubble trap
covered by
the hydrophobic membrane may be canted towards the fluid side of the membrane.
Such
an arrangement may increase the contact between a bubble and the membrane,
which may
encourage the gas to pass through the membrane. More specifically, a bubble
trap may
include a generally vertically oriented chamber through which fluid may flow.
At least
one side of the chamber may include the hydrophobic membrane, which may be
angled
downwardly inward such that a rising bubble may be pressed against the
hydrophobic
membrane. The present disclosure contemplates that a relatively larger chamber
may
provide a relatively lower fluid velocity; thus, a larger chamber may increase
the
probability that a bubble may remain in the chamber and/or may exit through
the
CA 02905825 2016-12-15
43
hydrophobic membrane, as opposed to being swept away by the fluid flow prior
to exiting
through the hydrophobic membrane.
[00199] In an exemplary embodiment, fitting 430 may connect to the internal
fluid path
of the cartridge 410 via pressure sensor fluid path 431 provided in the
vertical portion of
the cartridge adjacent to the bubble trap 418, which may include a hydrophobic
filter
431A. Pressure sensor fluid path 431 may include a narrowed opening 431B into
a
vertically disposed cavity 433, which may provide fluidic communication with
fluid
channel 422. The hydrophobic filter 431A may be provided in an upper portion
of the
cavity 433. In such an embodiment, fitting 430 (which may be connectable to a
pressure
sensing device) may convey substantially only gas, and fluid may be
substantially retained
within cartridge 410. Because the gas may pass through hydrophobic filter
431A, the gas
may be exposed to the pressure of the fluid, and the gas may transmit the
pressure to the
pressure-sensing device. Thus, the pressure-sensing device may remain dry
while sensing
the fluid pressure. Additionally, hydrophobic filter 431A may assist in
maintaining
sterility of cartridge 410, such as by preventing infiltration of foreign
matter into cartridge
410 through fitting 430.
[00200] The present disclosure contemplates that pressure readings may
become
inaccurate if fluid comes into contact with hydrophobic filter 431A. Some
exemplary
embodiments may be constructed such that the volume of gas downstream of
hydrophobic
filter 431A (e.g., fittings, conduits, and/or pressure sensors) and/or the
volume of air
upstream of hydrophobic filter 431A (e.g., in pressure sensor fluid path 431)
may reduce
the likelihood that fluid may contact hydrophobic filter 431A. For example,
pressure
sensor fluid path 431 may be configured to retain a volume of gas (e.g., air)
in the cavity
433 sufficient to prevent fluid from contacting hydrophobic filter 431A during
expected
pressure excursions (e.g., the level of the fluid within pressure sensor fluid
path 431 will
not rise to hydrophobic filter 431A).
[00201] Some exemplary embodiments may include one or more pressure sensors
and/or transducers fluidicly coupled to fitting 430, via heater assembly 309,
as shall be
described in greater detail below. For example, some exemplary embodiments may
include two or more pressure sensors and/or transducers, the outputs of which
may be
compared. Comparisons of the outputs of a plurality of pressure sensors may
aid in the
CA 02905825 2016-12-15
44
identification of a faulty pressure sensor and/or an inaccurate pressure
reading. For
example, if pressure readings from at least two pressure sensors agree within
an acceptable
tolerance band, operation may continue. If the pressure readings from two
pressure
sensors differ by an amount in excess of the acceptable tolerance band, heater
assembly
309 and/or pump 112 may be shut down and/or an alarm may be actuated.
[00202] FIGS. 15-19 are views of an exemplary heater assembly 309. An
exemplary
heater assembly 309 may include a slot 310 for receiving cartridge 410. In
some
exemplary embodiments, a portion of slot 310 may be defined by a guide 334
(see, e.g.,
FIG. 15), which may assist a user in inserting cartridge 410 into slot 310. An
exemplary
embodiment may include temperature sensors, such as IR temperature sensors
338, 340,
which may be adapted to sense the temperature of fluid within cartridge 410.
For example,
IR temperature sensors 338, 340 may detect IR energy emitted by fluid within
cartridge.
By ascertaining the wavelength of the emitted energy, IR temperature sensor
338, 340 may
provide an output associated with the temperature of the fluid adjacent the IR
temperature
sensor 338, 340. An exemplary heater assembly 309 may also include one or more
intermediate temperature sensors as discussed below.
[00203] Some exemplary heater assemblies 309 may include a downwardly
angled
trough 309C, which may be mounted generally below slot 310 and/or which may be
configured to catch fluid leakage from cartridge 410 in slot 310. In a lower
portion, the
trough 309C may include a drain fitting 309D and/or a fluid detector 2060
(such as an
optical liquid detector, resistance liquid detector, continuity liquid
detector, ultrasound
liquid detector, infra-red liquid detector, and the like), which may output an
electrical
signal associated with detection of leakage from the cartridge. In some
example
embodiments, fluid detector 2060 may be located proximate a lowest level of
trough 309C.
In some exemplary embodiments, trough and/or drain fitting 309D may be sized
to allow
drainage of fluid at a rate greater than would be expected in the event of a
catastrophic
failure of cartridge 410 (e.g., the maximum flow rate delivered by pump 112).
In some
example embodiments, detection of fluid in trough 309C by fluid detector 2060,
which
may indicate a leak from cartridge 410, may result in an alarm and/or
automatic shutdown
of pump 112 and/or heater assembly 309.
CA 02905825 2016-12-15
[00204] Some exemplary embodiments may include a secondary drain fitting
309F,
which may be coupled to a source of vacuum to remove fluid from trough 309C.
More
specifically, some drain fittings 309D may extend upwards from the floor of
trough 309C,
which may prevent complete draining of trough 309C through drain fitting 309D.
Fluid
detector 2060 may be mounted such that it may detect even minimal amounts of
fluid
within trough 309C. Thus, secondary drain fitting 309F may be used to withdraw
residual
fluid from trough 309C which may be at a level below drain fitting 309D but
above fluid
detector 2060.
[00205] Some exemplary heater assemblies 309 may include a blower 309A,
which
may be configured to draw cooling air through the heater assembly 309. In some
exemplary embodiments, such cooling air may prevent an over temperature
condition
within heater assembly 309, such as at low fluid flow rates. In some exemplary
embodiments, blower 309A may be attached to a plenum 309B, which may be
connected
to an upper portion of slot 310, such that air may be drawn upwards past
cartridge 410.
More specifically, some heater assemblies 309 may be configured such that
blower 309A
may be operative to draw air in around trough 309C, upward through slot 310
past
cartridge 410, through plenum 309B, and away from heater assembly 309 through
blower
309A. Some exemplary blowers 309A may be configured to run at more than one
speed
and/or the speed of the blower 309A may vary with temperature (e.g., such that
the airflow
is increased when the temperature is higher).
[00206] In some exemplary embodiments, temperature sensors 338, 340 may be
mounted such that they detect the temperature of fluid flowing through
cartridge 410
fluidicly near inlet fitting 412 and outlet fitting 414, respectively. In an
exemplary
embodiment, temperature sensors 338, 340 may be mounted such that they detect
the
temperature of fluid flowing through cartridge 410 prior to the fluid entering
fluid channel
420 and after the fluid exits fluid channel 422. Some exemplary temperature
sensors may
be mounted such that they detect the temperature of fluid in cartridge 410 at
positions that
are unlikely to include stagnant areas, such that the detected temperatures
are
representative of the temperatures of the fluid flowing through cartridge 410.
Some
exemplary embodiments may include shields, such as rings 338A, 340A, which may
reduce the effect of airflow caused by blower 309A on temperatures detected by
CA 02905825 2016-12-15
46
temperature sensors 338, 340. Rings 338A, 340A may include tapered ramps 338B,
340B,
which may assist in guiding cartridge 410 into slot 310. In an exemplary
embodiment, a
temperature sensor, such as an IR temperature sensor 342, may be mounted such
that it
senses the temperature of fluid in cartridge 410, such as fluid at an
intermediate point in
the internal flow path through cartridge 410. For example, IR temperature
sensor 342 may
be mounted within heater assembly 309 such that it measures the temperature of
the fluid
in cartridge 410 proximate turn section 436.
[00207] An exemplary heater assembly 309 may include a fitting 336 that may
be
fluidicly connected to fitting 430 on cartridge 410 when cartridge 410 is
installed in the
heater assembly. Connection of fitting 430 to fitting 336 may create a sensor
fluid path
that connects path (chamber) 431 in cartridge 410 to pressure sensors 2068,
2070,
schematically illustrated in FIG. 18. In some exemplary embodiments, a
hydrophobic
filter mounted within cartridge 410 may be utilized to prevent liquid from
flowing through
fitting 430, while allowing gas flow through the sensor fluid path.
[00208] A first set of IR lamps 312, 318 may be mounted on one side of slot
310, and a
second set of IR lamps 314, 316 may be mounted on the other side of slot 310.
Thus, IR
lamps 312, 318 may be directed towards one side of cartridge 10, and IR lamps
314, 316
may be directed towards the other side of cartridge 410. As shown in the
figures, in an
example embodiment, the IR lamps 312, 314, 316, 318 may be generally
cylindrical and
may have axes running generally along the horizontal direction of the
cartridge. In some
exemplary embodiments, individual IR lamps 312, 314, 316, 318 may include a
reflective
coating (e.g., gold or aluminum oxide), such as on about 60% of the surface
area so as to
direct IR energy toward cartridge 410. Some exemplary embodiments including IR
lamps
312, 314, 316, 318 having reflective coatings may or may not include reflector
shrouds
320, 322, 324, 326 running along the length of a respective IR lamp 312, 314,
316 and 318.
In some exemplary embodiments, utilizing IR lamps 312, 314, 316, 318 with
reflective
coatings may provide improved efficiency over uncoated IR lamps 312, 314, 316,
318.
[00209] In some exemplary embodiments, individual IR lamps 312, 314, 316,
318 may
be mounted within and/or behind protective covers, such as quartz glass tubes
312A,
314A, 316A, 318A. In some exemplary embodiments, quartz glass tubes 312A,
314A,
316A, 318A may prevent leakage of fluid from cartridge 410 from contacting IR
lamps
CA 02905825 2016-12-15
=
- 47
312, 314, 316, 318. Some exemplary embodiments may not include quartz glass
tubes
312A, 314A, 316A, 318A (or other covers) and/or IR lamps 312, 314, 316, 318
may be
substantially directly exposed to cartridge 410, which may increase fluid
warming
efficiency.
[00210] The present disclosure contemplates that an ellipse
includes two foci, and that
rays emitted by a source at one of the foci are reflected to the other foci.
In an exemplary
embodiment, one or more reflector shrouds 320, 322, 324, 326 may include at
least a
partial substantially elliptical shape (in cross section) with an IR lamp 312,
314, 316, 318
located at or near one of the foci and with a portion of cartridge 410 located
at or near the
other foci. Accordingly, IR energy emitted by the IR lamp 312, 314, 316, 318
may be
reflected to the portion of the cartridge 410. For example, reflector 324 and
cartridge 410
may be arranged in relation to an ellipse 3320 and its two foci 3321, 3322. In
an
exemplary embodiment, IR lamp 316 may be located at or near foci 3321 and/or
fluid
channel 434 is located at or near foci 3322. One or more of reflector shrouds
320, 322,
324, 326 may have a similar arrangement.
[00211] In an exemplary embodiment, one or more reflector shrouds
320, 322, 324,
326 may be arranged to direct IR energy at particular locations on cartridge
410 and to
limit the amount of IR energy directed at other locations on cartridge 410.
For example,
one or more reflector shrouds 320, 322, 324, 326 may be arranged to limit the
IR energy
directed at portions of cartridge 410 where limited IR exposure may be
desired. For
example, limited IR exposure may be desired for portions of cartridge 410
including little
or no fluid and/or portions that are not substantially transparent to IR
energy. For example,
reflector shrouds 320, 322, 324, 326 may be arranged to limit the IR energy
directed at
various seams and/or welds. In some exemplary embodiments, such use of
reflector
shrouds 320, 322, 324, 326 may obviate a need to employ a cartridge 410
including
substantially reflective portions to prevent absorption of IR energy in
undesired locations.
In some exemplary embodiments, directing a greater proportion of the IR energy
towards
desired positions on the cartridge 410 may increase the efficiency of the
device.
[00212] In some exemplary embodiments, reflector shrouds including
other shapes
may be employed. For example, a reflector shroud having a parabolic shape in
cross-
section may be utilized, and an IR lamp may be located approximately at the
focal point of
CA 02905825 2016-12-15
48
the parabola, and the IR energy may be directed towards at least a portion of
a cartridge.
In some exemplary embodiments, parabolic reflector shrouds may obviate a need
to
employ a cartridge 410 including substantially reflective portions to prevent
absorption of
IR energy in undesired locations (such as seams and/or welds). In some
exemplary
embodiments, directing a greater proportion of the IR energy towards desired
positions on
the cartridge 410 may increase the efficiency of the device.
[00213] In an exemplary embodiment, reflector shrouds 320, 322, 324, 326
may be
constructed from aluminum and/or another reflective material. In some
exemplary
embodiments, reflector shrouds 320, 322, 324, 326 may include a polished
surface. For
example, reflector shrouds 320, 322, 324, 326 may be constructed of aluminum
and may
include polished surfaces. In some exemplary embodiments, reflector shrouds
320, 322,
324, 326 may be plated or otherwise coated with a reflective material (such as
gold or
aluminum oxide). For example, a steel reflector may include a gold-plated
reflective
surface.
[00214] In some exemplary embodiments, heater assembly 309 may include one
or
more engagement features, such as ball detent 310A. Ball detent 310A may
releasably
engage notch 410A of rib 440, thereby releasably retaining cartridge 410 in
slot 310.
Some exemplary embodiments may include one or more cartridge switches 2046,
which
may open or shut when a cartridge 410 is fully installed in slot 310.
[00215] FIG. 20-is a schematic diagram of an exemplary power and control
system 8
for an exemplary fluid management system 10. It is to be understood that some
exemplary
embodiments may include various appropriate power supplies, circuit breakers,
fuses,
terminal boards, and the like, as would be apparent to one of skill in the
art.
[00216] In an exemplary embodiment, electrical power may be supplied to a
fluid
management system 10 via a detachable power cord 2010, a line filter 2012, and
appropriate fuses and/or circuit breakers. One or more power supply units may
provide
appropriate voltages and currents to the various electrical loads. In some
exemplary
embodiments, some components may receive power from more than one power
supply.
For example, a component utilizing two voltages may receive power from two
power
supplies.
CA 02905825 2016-12-15
49
[00217] An exemplary embodiment may include one or more fans and/or blowers
(such as blower 309A and/or chassis fan 2018), one or more IR lamps 312, 314,
316, 318
(IR lamps 312, 314 may comprise a first group 313, and IR lamps 316, 318 may
comprise
a second group 317), a pump motor 2042 associated with pump 112, a printer
111, an
isolation board 2034, and/or one or more remote display devices 2038 (such as
a liquid
crystal display, LED display, organic light-emitting diode display, and the
like). For
example, secondary display 106A may include a remote display 2038. Relays
2020, 2021,
2040 may selectively supply power to one or more components.
[00218] An exemplary isolation board 2034 may provide control signals to
one or more
solid state relays 2076, 2078, which may selectively supply power to IR lamps
312, 314,
316, 318, and/or controller 2074, which may be operatively coupled to pump
motor 2042.
In an exemplary embodiment, isolation board 2034 may include one or more
digital-to-
analog (D/A) converters which may supply an analog control signal (such as a 0-
5V
control signal for controller 2074). Isolation board 2034 may operate to
isolate high
voltages supplied to certain components (e.g., pump motor 2042 and/or IR lamps
312, 314,
316, 318), which may improve patient safety.
[00219] An exemplary embodiment may include one or more interlocks
associated
with certain conditions that may be operative to allow or prevent operation of
various
components of a fluid management unit 100. For example, a door switch 2044 may
open
if door 108 is opened, thereby cutting off power to IR lamps 312, 314, 316,
318 and/or
pump motor 2042 via relays 2020, 2021, 2040. In some exemplary embodiments,
door
108 may not be fully shut unless the cartridge 410 is properly installed, the
tubing set is
properly installed, and/or the pump head is properly shut. Thus, door 108 may
function as
a primary safety device by only allowing door switch 2044 to shut when these
conditions
are satisfied. In an exemplary embodiment, switch 2044 may be integrated with
one or
more of latch component 118 and corresponding latch component 120.
[00220] In an exemplary embodiment, a cartridge switch 2046 may shut when a
cartridge 410 is fully inserted into heater assembly 309, thereby allowing
relays 2020,
2021, 2040 to supply power to IR lamps 312, 314, 316, 318 and/or pump motor
2042. It is
to be understood that in some exemplary embodiments, one or more switches
2044, 2046
may be configured to open when a condition is satisfied. In an exemplary
embodiment,
CA 02905825 2016-12-15
- 50
thermal cut off sensor(s) 2048 may open when a predetermined fluid temperature
is
exceeded, which may cause the cutting off of power to IR lamps 312, 314, 316,
318 and/or
pump motor 2042.
[00221] An exemplary embodiment may include a main processor 2050,
which may
perform various functions (such as computing, calculation, control, interface,
display,
logging, and the like). Main processor 2050 may be operatively connected to
one or more
user interface components, such as touch screen 106 and/or remote display
device 2038.
An exemplary main processor 2050 may be operatively connected to one or more
speakers
2052 and/or one or more universal serial bus ("USB") devices 2054 via one or
more USB
interfaces 2056. In an exemplary embodiment, data such as data pertaining to
operations
of the device and/or software updates may be transferred via the USB interface
2056, for
example.
[00222] Some exemplary embodiments may provide network communication
capabilities, such as by including an Ethernet port 2056A through which the
device may be
connected to a network, such as a local area network. Data transfer for any
purpose may
be accomplished via the network, such as providing software updates,
transferring data
pertaining to operations of the device, and/or transmitting error codes, for
example.
[00223] An exemplary embodiment may include an input/output (I/O)
board 2058
which may be operatively connected to main processor 2050 and/or which may
receive
signals from one or more sensors, such as IR temperature sensors 338, 340,
342. I/O board
2058 may be operatively connected to one or more switches associated with
certain
conditions, such as bubble detector 132 and/or leakage detector 2060, which
may be
associated with trough 309C. I/O board 2058 may receive signals from one or
more
sensors, such as load cells 142, 144, 206A, 206B, 206C, 206D and/or pressure
sensors
2068, 2070.
[00224] Some exemplary embodiments may include various safety
switches, such as
cabinet over-temperature switch 2062A (which may detect a high temperature
condition in
fluid management unit 100), current sensor 2062B (which may sense whether
electrical
current is flowing to IR lamps 312, 314, 316, 318), blower-on switch 2062C
(which may
sense whether blower 309A is running), canister connected switch 2062D (which
may
CA 02905825 2016-12-15
51
sense whether suction container hanger assembly 200 is present), and/or fan-on
switch
2062E (which may sense whether chassis fan 2018 is running).
[00225] In some exemplary embodiments, fluid management unit 100 may be
user
selectable between a pressure control mode and a flow control mode. In an
exemplary
pressure control mode, pump 112 may be controlled (e.g., started, stopped, and
its speed
adjusted) to maintain a fluid pressure delivered to a surgical site at about a
target pressure
and/or within a predetermined pressure band. In an exemplary flow control
mode, pump
112 may be controlled (e.g., started, stopped, and its speed adjusted) to
deliver fluid to a
surgical site at a about target flow rate and/or within a predetermined flow
rate band. In
both pressure and flow control modes, heater assembly 309 may be controlled
(e.g., IR
lamps 312, 314, 316, 318 may be energized, deenergized, and/or the power level
supplied
to IR lamps 312, 314, 316, 318 may be adjusted) to maintain the temperature of
the fluid
delivered to the surgical site at about a target temperature and/or within a
predetermined
temperature band if the fluid warming feature has been enabled by the user.
[00226] FIG. 21 is a schematic diagram of an exemplary equipment setup
utilizing
multi-stage heating. In an exemplary embodiment, one or more of IR lamps 312,
314, 316,
318 may be controlled in association with one or more others of IR lamps 312,
314, 316,
318. For example, IR lamps 312, 314 may comprise a first group 313, and IR
lamps 316,
318 may comprise a second group 317. In an exemplary embodiment, fluid may
flow past
the IR lamps associated with one group prior to flowing past the IR lamps
associated with
a second group, and the first and second groups may be controlled
independently. For
example, the fluid flow path in cartridge 410 including channels 420, 432,
434, 422 (in that
order) may direct fluid past lamps 312, 314, 316, 318 (in that order).
[00227] In an exemplary embodiment, the first group 313 may be control
based at least
in part on a sensed inlet temperature (such as sensed by temperature sensor
338), and the
second group 317 may be controlled based at least in part on a sensed
temperature of the
fluid between the first and second groups, which may be referred to as a
midpoint
temperature (such as sensed by temperature sensor 342), and/or a sensed outlet
temperature
(such as sensed by temperature sensor 340). An outlet temperature, which may
be the
temperature of the fluid after it has passed the second group (such as sensed
by
CA 02905825 2016-12-15
52
temperature sensor 340), may also be used to vary one or more power scaling
factors
associated with the power applied to one or more groups of IR lamps.
[00228] In some exemplary embodiments, the amount of power applied to one
or more
stages (e.g., groups 313, 317) may be based at least partially on a flow rate
of fluid through
heater assembly 309. In some exemplary embodiments, a flow rate may be
determined
using a known flow rate per rotation of the pump 112 and the rotational speed
of the pump
112, for example. In some other exemplary embodiments including other types of
positive
displacement pumps, the flow rate may be determined in a similar manner. In
some
exemplary embodiments, a flow rate sensor may be utilized to measure a flow
rate.
[00229] Some exemplary embodiments may be configured to account for one or
more
of the following conditions: variations in incoming fluid temperature during a
procedure,
variations in flow rate to maintain constant pressure, changes to temperature
set point by
the user, interruptions and/or changes in flow rate during a procedure caused
by
opening/closing of external valves (e.g., trumpet valves, valves in surgical
instruments,
etc.), and/or resuming warming when stopped flow resumes.
[00230] In some exemplary embodiments, the first group 313 may be powered
based at
least in part upon an estimated power requirement, which may be directly
proportional to a
total desired temperature change of the fluid (e.g., outlet temperature minus
inlet
temperature) and/or a flow rate of the fluid. In some example embodiments, the
estimated
power requirement may be multiplied by a load factor, which may determine a
fraction of
the estimate power that is to be delivered to the first group. In some
exemplary
embodiments, the first group may be deenergized whenever pump 112 is stopped.
[00231] In some exemplary embodiments, the second group 317 may be powered
based at least in part upon a proportional control algorithm and/or an
integral control
algorithm. In an example proportional control algorithm, the estimated power
may be
multiplied by a proportional factor whose value varies with the temperature
error (desired
outlet temperature ¨ current outlet temperature). For example, the
proportional factor may
be given by 1.1+ temperature _error 2
. In some exemplary embodiments, the constants
400
may be selected such that the desired outlet temperature may be achieved
reasonably
quickly with limited overshoot. In addition, some constants may be selected to
at least
CA 02905825 2016-12-15
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partially compensate for older lamps that may have begun to exhibit
performance
degradation. In an exemplary embodiment, the value of 1.1 results in a power
at the
desired outlet temperature that is about 10% above the estimated power. In an
exemplary
embodiment, the value of 400 ( 202) may be based on the notion that an
expected initial
error may be on the order of 20 C which would result in proportional factor
of 2.1.
[00232] In an example integral control algorithm, the power
applied to the second
group 317 may be adjusted in small increments (e.g., about 1% per increment)
based on
the integral of the temperature error. For example, if the integral of the
temperature error
is less than a predetermined negative value (e.g., fluid temperature is high),
the power
applied to the second group may be reduced by one increment. Similarly, if the
integral of
the temperature error is greater than a predetermined positive value (e.g.,
fluid temperature
is low), the power applied to the second group 317 may be increased by one
increment.
The predetermined negative value and the predetermined positive value may vary
based at
least in part upon the flow rate of the fluid.
[00233] Some example embodiments may provide a pressure curve
override, which
may reduce heating when the pump 112 is running but little or no fluid is
flowing. For
example, if the irrigation valve on a trumpet valve is rapidly shut, pump 112
may continue
to run until the fluid reaches a predetermined maximum pressure. In such a
situation, it
may be desirable to reduce the power supplied to the second group 317, or to
deenergize
the second group entirely. For example, if the sensed pressure increases at a
rate in excess
of 2 mmHg/second, the second group 317 may be deenergized.
[00234] Algorithm selection may be based at least in part upon the
current deviation
from the desired outlet temperature. For example, when the current outlet
temperature is
substantially below the desired outlet temperature, the proportional control
algorithm may
be used. As the current outlet temperature approaches the desired outlet
temperature,
integral control may be used. At some temperature deviations, a power
reduction factor
may be applied to reduce the power supplied to the second group 317 to prevent
overshooting the desired outlet temperature. In some exemplary embodiments,
the power
reduction factor may vary from about 1.0 (no reduction) down to about 0 (no
power
applied) as the current outlet temperature reaches and/or exceeds the desired
outlet
temperature.
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[00235] In an exemplary embodiment, pulse width modulation may be employed
to
vary the power applied to one or more IR lamps 312, 314, 316, 318. For
example,
processor 2050, via I/O board 2058 and/or isolation board 2034, may direct
SSRs 2076,
2078 to selectively energize and deenergize first group 313 and/or second
group 317. The
duty cycle (e.g., the ratio of on time to the sum of the on and off times in
an on/off cycle)
may be varied to deliver more or less power to the first group 313 and/or
second group 317
as desired. More specifically, if it is desired to increase the amount of
power delivered to
first group 313, the first group's duty cycle may be adjusted by causing SSR
2076 to
increase the on time and reduce the off time in each on/off cycle. Similarly,
if it is desired
to reduce the amount of power delivered to the second group 317, the second
group's duty
cycle may be adjusted by causing SSR 2078 to reduce the on time and increase
the off time
in each on/off cycle.
[00236] Some exemplary embodiments may utilize pressure control modes for
distention applications, and some pressure control modes may be referred to as
distention
modes although the fluid is likely being used for both distention (body cavity
expansion)
and irrigation (blood and debris removal) purposes. Some exemplary embodiments
may
utilize flow control modes for irrigation applications, and some flow control
modes may be
referred to as irrigation modes.
[00237] FIG. 22 is a schematic diagram of an exemplary equipment setup for
use with
a trumpet valve. In an exemplary embodiment, irrigation tubing 3013 may extend
through
pump 112 such that pump 112 is operative to pressurize and/or propel liquid in
irrigation
tubing 3013.
[00238] FIG. 23 is a schematic diagram of an exemplary equipment setup for
use with
an electrosurgical device. In some exemplary embodiments, an electrosurgical
tip 3024
may receive electrical power from an external power source 3036, such as an
electrosurgical generator.
[00239] FIG. 24 is a schematic diagram of an exemplary equipment setup for
use with
a tubing set including one or more connectors 3028, 3030 for connection to one
or more
surgical instruments 3032. For example, Luer connectors may be provided.
Exemplary
surgical instruments which may be utilized with exemplary fluid management
units 100
may include arthroscopes, hysteroscopes, and/or cystoscopes, and the like.
Similar devices
CA 02905825 2016-12-15
. 55
may be employed in other procedures, such as transurethral resection of the
prostate
(TURP). The present disclosure contemplates that other surgical instruments
known in the
art may be utilized in connection with various exemplary embodiments.
[00240] Any tubing set and/or equipment setup used in connection
with exemplary
fluid management units 100 according to the present disclosure may include one
or more
relief valves. For example, one or more relief valves 3013R may be fluidicly
connected in
and/or to irrigation line 3013 downstream of pump 112. In such embodiments, if
the fluid
pressure downstream of pump 112 exceeds the set pressure of the relief valve
3013R for
any reason, including a failure in fluid management system 100, the relief
valve 3013R
may discharge fluid until the fluid pressure falls below the re-seat pressure
of the relief
valve 3013R. Such a pressure relief valve 3013R may be completely independent
of the
microprocessor-based control system for fluid management unit 100 and,
therefore, may
comprise a substantially redundant safety mechanism.
[00241] Some exemplary embodiments may include one or more remote
pressure
sensors 2069A. For example, a remote pressure sensor 2069A may be placed at
least
partially in a body cavity 3052A being distended, such as a uterus or a
bladder, and such
remote pressure sensor 2069A may provide a pressure signal to fluid management
unit
100. For example, a remote pressure sensor 2069A located in a body cavity
being
distended may provide an electrical (e.g., analog and/or digital) and/or
pneumatic signal
indicative of fluid pressure within the cavity. Such analog, digital, and/or
pneumatic signal
may be conveyed to fluid management unit 100 directly and/or via the heating
cartridge
410. Fluid management unit 100 may use such signal from remote pressure sensor
2069A
indicating fluid pressure in the body cavity 3052A being distended in place
of, or in
addition to, the signal indicating fluid pressure in cartridge 410 to control
fluid pressure at
the desired level selected by the user and, if necessary, to trigger alarms or
shut down the
pump 112 to prevent unsafe conditions.
[00242] FIG. 25 is a schematic diagram of an exemplary equipment
setup for infusion.
Such a device may be utilized with any fluids to be infused into a patient,
including
pharmaceuticals and/or blood components. Some exemplary embodiments may
include
one or more bubble detectors 132 (FIG. 2) within unit 100 and/or one more
bubble
detectors 3050 external to fluid management unit 100. In some exemplary
embodiments,
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the fluid may be gravity fed, and the tubing may bypass pump 112. In some
exemplary
embodiments, an in-line filter 3051 may be employed, such as when blood is
being
infused. Such tubing sets used for infusion may also include a pressure relief
valve 3013R
to reduce the likelihood of infusing fluids into a patient at excess pressures
for any reason,
including a failure of fluid management system 100.
[00243] FIGS.
26 and 27 illustrate an alternative example cartridge 2410. Cartridge
2410 may be generally similar to cartridge 410, except that cartridge 2410 may
include a
two-dimensional fluid flow path. Specifically, in some example embodiments,
fluid may
enter cartridge 2410 at an inlet fitting which may be generally similar to
inlet fitting 412,
may flow past bubble trap 2416, and into lower fluid channel 2420. Then, fluid
may
generally reverse direction in turn section 2436 and may flow into upper fluid
channel
2434. Fluid may then flow past bubble trap 2418 and out of cartridge 2410 via
an outlet
fitting which may be generally similar to outlet fitting 414. Cartridge 2410
may include
any other features discussed herein with reference to cartridge 410, such as
fitting 2430.
[00244] Some
example cartridges 2410 may comprise two sections 2410A, 2410B,
which may be joined together using adhesive, solvent bonding, ultrasonic
bonding, and/or
RF welding, or the like. Sections 2410A, 2410B may be constructed by vacuum
forming
thin plastic to form the desired features. Unlike cartridge 410, some
exemplary cartridges
2410 may not include a substantially rigid center section. In
some exemplary
embodiments, one section (e.g., section 2410A) may be flat and/or flatter than
another
section (e.g., 2410B). For example, certain fluid flow paths and/or fluid
channels (lower
fluid channel 2420 and/or upper fluid channel 2434) may be formed in one
section (e.g.,
section 2410B) while at least some of the other section (e.g., section 2410A)
may be
substantially flat and/or configured to lie against section 2410B to form
certain features.
[00245] An
example cartridge 2410 may be configured for use in connection with
heater assembly 309 described herein. Accordingly, fluid within cartridge 2410
may be
warmed by IR lamps 312, 314, 316, 318. In some example embodiments, lower
fluid
channel 2420 may be warmed from one side by IR lamp 312 and from the opposite
side by
IR lamp 314. Similarly, upper fluid channel 2434 may be warmed from one side
by IR
lamp 318 and from the opposite side by IR lamp 316.
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[00246] FIG. 28 illustrates an alternative example cartridge 1410. Similar
to cartridge
2410 described above, some example cartridges 1410 may comprise two sections
1410A,
1410B. In some exemplary embodiments, section 1410A may include bubble traps
1416,
1418, which may be generally similar to bubble traps 416, 418 described above.
In some
exemplary embodiments, cartridge 1410 may include one or more fluid channels
1422 to
which fluid may be supplied to or discharged from via one or more fluid
conduits 1422A.
Some exemplary fluid conduits 1422A may be formed in one or more of sections
1410A,
1410B in a manner similar to fluid channel 1422. In some exemplary
embodiments, fluid
may enter cartridge 1410 through in inlet fitting generally similar to inlet
fitting 412, flow
through bubble trap 1416, flow through fluid conduit 1422A, flow through fluid
channel
1422, flow through bubble trap 1418, and/or may exit cartridge 1410 via an
outlet fitting
generally similar to outlet fitting 414. Some exemplary cartridges 1410 may
include a
pressure tap and/or fluid path generally similar to those of cartridge 410.
[00247] In some exemplary embodiments, only one or more IR lamps 312, 314,
316,
318 may be used in connection with cartridge 1410. For example, upper lamps
316, 318
may be used in connection with cartridge 1410, while lower lamps 312, 314 may
remain
deenergized. Some exemplary fluid management units 100 may be configured for
such
operations by entry of a part number corresponding to the cartridge type by a
user.
[00248] Some exemplary cartridges 1410 may have a lower internal volume
that
cartridge 410 described above, which may utilize a smaller volume of fluid for
priming
than cartridge 410. Some exemplary cartridges 1410 may provide relatively
lower fluid
flow rates than some exemplary cartridges 410. Thus, some exemplary cartridges
1410
may be used in place of some exemplary cartridges 410 in some procedures in
which lower
fluid flow rates may be expected.
[00249] Some exemplary embodiments may include a remote control device,
such as a
pneumatic remote control device. For example, a pneumatic signal may be
produced by a
pneumatic actuator (such as a bulb, button, bellows, piston, or the like),
which may be
mounted near or on, or integrated with a hand piece and/or surgical
instrument. The
pneumatic signal may be conveyed to the fluid management unit 100. For
example, a the
pneumatic signal may be conveyed via tubing extending from the pneumatic
actuator to a
fitting on a cartridge, through a passage in the cartridge, and to a pressure
transducer (or
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other device capable of producing an electrical signal based at least
partially upon the
pneumatic signal) via a fitting which releasably engages a corresponding
fitting in heater
assembly 309. As another example, a pneumatic signal may be conveyed via
tubing
extending from the pneumatic actuator, to a fitting on fluid management unit
100, and to a
pressure transducer (or other device capable of producing an electrical signal
based at least
partially upon the pneumatic signal). The pneumatic signal may be utilized to
cause an
adjustment in a desired pressure, flow rate, or other operating parameter, for
example.
Such an adjustment may be a momentary or a sustained incremental adjustment,
for
example.
[00250] Some exemplary embodiments may provide a perforation
alarm, which may be
particularly useful in hysteroscopic procedures and the like, for example. An
exemplary
perforation alarm may be based on an increased rate of change of the deficit.
For example,
an alarm may be triggered when the deficit is increasing at a rate in excess
of 200 mL/min.
In exemplary embodiments, the set point of one or more perforation alarms may
be
programmed by a user.
[00251] Some exemplary embodiments may be capable of warming
fluids from a
storage temperature to an appropriate temperature for use without pre-warming
in a
warming cabinet, for example.
[00252] Some exemplary embodiments may include a user interface
allowing a user to
specify a particular type of tubing set that is being utilized. In some
exemplary
embodiments, the device may automatically determine a particular type of
tubing set that is
being installed by, for example, using one or more bar codes (or other optical
codes),
radio-frequency identification (RFID) transponders, color-coding, and the
like. In some
exemplary embodiments, default parameters may be automatically set based upon
a sensed
tubing set type.
[00253] Some exemplary embodiments may include a user-configurable
interface,
which may be provided using touch screen 106. In exemplary embodiments, user
may be
able to specify the data (such as temperature, pressure, flow rate, deficit,
etc.) that are
displayed, and may be able specify a manner of display (e.g., numeric value,
graphical
representation of a single value or a value over time, etc.). In some
exemplary
embodiments, the user interface may be adapted to provide instructions (such
as startup
CA 02905825 2016-12-15
59
instructions, cleaning instructions, and/or operating instructions) to a user
via touch screen
106, for example. In some exemplary embodiments, a language used on a display
may be
user-selectable. In some exemplary embodiments, the touch screen interface may
be
configured to display error codes, conditions, and/or descriptions and may
also be
configured to display preventative maintenance notifications.
[00254] FIGS. 29-40 are screen shots of an exemplary touch screen 106.
These screen
shots are described with reference to "buttons," which may comprise portions
of touch
screen 106 configured to appear like buttons and/or which may provide
functionality
similar to physical buttons. FIG. 29 illustrates an example setup screen,
which may
include a setup button 4002, a supervisor mode button 4004, and/or a date/time
display
4006. Setup button 4002 may be used to initiate setup of fluid management unit
100 for a
procedure, supervisor mode button 4004 may be used to enter a supervisor mode
(which is
discussed in detail below), and/or the date and/or time may be adjusted using
date/time
display 4006.
[00255] FIG. 30 illustrates an exemplary tubing set selection screen, which
may
include setup instructions 4008, a tubing set list 4010, and/or a continue
button 4012.
Tubing set list 4010 (which may include one or more tubing set types) and/or
continue
button 4012 may be used to specify a particular type of tubing set that will
be used.
[00256] FIG. 31 illustrates an exemplary surgical discipline selection
screen, which
may include a discipline list 4014, a continue button 4016, and/or a back
button 4018.
Discipline list 4014 (which may include one or more surgical disciplines)
and/or continue
button 4016 may be used to specify a surgical discipline associated with a
desired
procedure. Discipline list 4014 may be automatically populated based at least
in part upon
the previously selected type of tubing set. Back button 4018 may return the
user to the
tubing set selection screen.
[00257] FIG. 32 illustrates an exemplary procedure selection screen, which
may
include a procedure list 4020, a continue button 4022, and/or a back button
4024.
Procedure list 4020 (which may include one or more procedures) and/or continue
button
4022 may be used to specify a desired surgical procedure. Procedure list 4020
may be
automatically populated based at least in part upon the previously selected
type of tubing
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set and/or the previously selected surgical discipline. Back button 4024 may
return the
user to the discipline selection screen.
[00258] FIG. 33 illustrates an exemplary physician selection
screen, which may
include a physician list 4026, an add button 4028, a delete button 4030, a
move up button
4032, a move down button 4034, an edit button 4036, a continue button 4038,
and/or a
back button 4040. Physician list 4026 (which may include one or more
physicians) and/or
continue button 4038 may be used to specify a physician. Physician names may
be added
to, deleted from, or reordered on physician list 4026 using the add button
4028, the delete
button 4030, the move up button 4032, and/or the move down button 4034. Back
button
4040 may return the user to the procedure selection screen.
[00259] FIG. 34 illustrates an exemplary operator selection
screen, which may include
an operator list 4042, an add button 4044, a delete button 4046, a move up
button 4048, a
move down button 4050, an edit button 4052, a continue button 4054, and/or a
back button
4056. Operator list 4042 (which may include one or more operators) and/or
continue
button 4054 may be used to specify a operator. Operator names may be added to,
deleted
from, or reordered on operator list 4042 using the add button 4044, the delete
button 4046,
the move up button 4048, and/or the move down button 4050. Back button 4056
may
return the user to the procedure selection screen.
[00260] FIG. 35 illustrates an exemplary control mode selection
screen. Pressure mode
button 4058 and/or flow mode button 4060 may allow toggling between a pressure
control
mode and a flow control mode. Option buttons, such as deficit monitoring
button 4062
and/or heater button 4064 may allow selection of optional functions. Continue
button
4066 may advance the interface to the next screen. In some exemplary
embodiments, the
control mode (e.g., pressure or flow) and/or optional functions may be
selected by default
based at least in part upon previously entered information. For example, if
the entered
discipline and procedure utilize pressure mode, the system may assume that
pressure
mode, deficit monitoring, and/or heater should be enabled. Similarly, if the
entered
discipline and procedure utilize flow mode, the system may assume that flow
mode and/or
heater should be enabled and/or that deficit monitoring should be disabled.
These defaults
may be accepted by pressing the continue button 4066, or the settings may be
adjusted as
desired prior to pressing the continue button 4066.
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[00261] FIG. 36 illustrates an exemplary priming screen, which may
include priming
instructions 4068, and automatic prime button 4070, a manual prime button
4072, a remote
button indicator button 4074, a continue button 4076, and a flow rate
indicator 4078. In
some exemplary embodiments, the automatic prime button 4070 may cause pump 112
to
run for a predetermined time sufficient to prime tubing set assuming the user
has opened
the irrigation valve on the trumpet valve or surgical instrument to vent air
that would
otherwise be trapped in the tubing set, where the predetermined time may vary
based upon
the tubing set type selected previously. In some exemplary embodiments, the
manual
prime button 4072 may cause pump 112 to run while it is depressed and pump 112
may
stop running when it is released. Manual prime button 4072 may be depressed
until fluid
has substantially filled the tubing set. In some exemplary embodiments, flow
rate indicator
may display the current flow rate of fluid.
[00262] FIG. 37 illustrates an exemplary secondary display and
printer control screen.
A secondary display control box 4080 may allow a user to select parameters
that will be
displayed on secondary display 106A, such as temperature, pressure, volume,
and/or
deficit. A printer control box 4082 may display information related to printer
111 (e.g.,
whether printer 111 is out of paper) and/or may allow a user to select
information to be
printed at the end of a procedure (e.g., temperature, pressure, volume,
deficit, and the like).
Continue button 4084 may be used to advance to the next screen.
[00263] FIG. 38 illustrates an exemplary run screen for a
procedure requiring fluid
pressure control, which may include a temperature section 4086, a pressure
section 4088, a
deficit monitoring section 4090, a flow section 4092, a fluid remaining
indicator 4094
(which may indicate an approximate amount of fluid remaining in fluid bag
902), a fluid
remaining indicator 4096 (which may indicate an approximate amount of fluid
remaining
in fluid bag 904), a start/stop button 4098, an end procedure button 5000,
and/or a back
button 5002. An exemplary temperature section 4086 may include current
temperature
5004, setpoint temperature 5006 (e.g., target temperature), temperature alarm
setpoint
5008, and/or temperature alarm action settings 5010 (e.g., what actions, in
addition to a
visual alarm, will automatically be taken upon actuation of the temperature
alarm, such as
sounding an audio alarm and/or stopping fluid flow). An exemplary pressure
section 4088
may include current pressure 5012, setpoint pressure 5014 (e.g., a target
pressure), pressure
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alarm setpoint 5016, pressure alarm action settings 5018 (e.g., what actions,
which may be
in addition to a visual alarm, will automatically be taken upon actuation of
the pressure
alarm, such as sounding an audio alarm and/or stopping flow), and/or a flow
limit 5020
(e.g., a maximum allowable flow rate). An exemplary deficit monitoring section
4090 may
include current deficit 5022, deficit alarm limit 5024, perforation alarm
limit 5026, and/or
perforation alarm action settings 5028 (e.g., what actions will automatically
be taken upon
actuation of the perforation alarm, such as sounding an audio alarm and/or
stopping flow).
Start/stop button 4098 may be used to start and/or stop the fluid management
unit 100
without terminating the procedure, the end procedure button 5000 may be used
to
terminate the procedure, and/or back button 5002 may be used to return to the
secondary
display and printer control screen.
[00264] In some exemplary fluid pressure control embodiments, default
operating
parameters (e.g., one or more of setpoint temperature 5006, temperature alarm
setpoint
5008, temperature alarm action settings 5010, setpoint pressure 5014, pressure
alarm
setpoint 5016, pressure alarm action settings 5018, flow limit 5020, deficit
alarm limit
5024, perforation alarm limit 5026, and/or perforation alarm action settings
5028) may be
set based at least in part upon the selected discipline and/or selected
procedure. In some
exemplary embodiments, these operating parameters may be adjusted by touching
the
corresponding portion of the touch screen 106. Some exemplary embodiments may
allow
adjustment of these operating parameters up to predetermined maximum limits,
which may
be associated with safety considerations. If a condition exceeds an operating
parameter
when the operating parameter is below its respective maximum limit, the
resulting alarm
may be overridden and operation may continue provided that the maximum limit
is not
reached. Some exemplary embodiments may stop operation upon reaching a maximum
limit, which may not be overridden.
[00265] FIG. 39 illustrates an exemplary summary screen, which may display
procedure information 5030. A print button 5032 may cause printer 111 to print
the
procedure information 5030. A new procedure button 5034 may return the user to
the
setup screen described above to prepare fluid management unit 100 for use in a
new
procedure.
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[00266] FIG. 40 illustrates an exemplary supervisor screen, which may
include an
input type selection section 5036. Input type selection section 5036 may allow
a
supervisor to select information that will be gathered during the setup
process. For
example, physician and/or operator identities may be gathered as described
above.
Similarly, patient identifying information and/or other information may be
gathered in a
similar fashion. An exemplary supervisor screen may allow a supervisor to
perform other
functions, such as calibrating one or more of load cells 142, 144, 206A, 206B,
206C, 206D
via calibrate button 5038, resetting a password via password reset button
5040, and/or
importing or exporting data via import/export button 5042.
[00267] An exemplary embodiment may be operated as follows. An operator may
hang one or more fluid bags 902, 904 on one or more of fluid bag hangers 102,
104. The
operator may install one or more suction canisters 906, 908, 910, 912 into
suction canister
hanger 202. The operator may connect a tubing set (e.g., trumpet valve tubing
set 3010) to
the fluid bags 3 902, 904, load a section of tubing into pump 112, load
cartridge 410 into
heater assembly 309, load a section of irrigation tubing 3013 into path 124,
connect suction
tubing 3027 to one or more suction canisters 906, 908, 910, 912,=and shut door
108. The
operator may then utilize touch screen 106 to set up the fluid management unit
100, which
may include selecting the tubing set, a surgical discipline, procedure type,
set point fluid
temperature, set point fluid pressure (in pressure control mode), set point
fluid flow rate (in
flow control), and/or other parameters (such as display content and/or
arrangement, alarm
set points and/or indications, and the like).
[00268] An exemplary embodiment may be operated in a pressure control mode.
The
pressure of the fluid may be sensed via a tap (which may be a fluid
connection) in fluid
communication with the fluid flow path (such as fitting 430) and/or via a
pressure sensor
located at or in the surgical site (e.g., remote pressure sensor 2069A). In an
exemplary
embodiment where the fluid is sensed via a tap in fluid communication with the
fluid flow
path, the pressure of the fluid may be sensed by more than one pressure sensor
2068, 2070
for redundancy purposes.
[00269] An exemplary pressure control mode may be configured to pump fluid
at
about a flow rate that establishes and maintains the pressure within an
acceptable range
corresponding to the set point established by the user. In an exemplary
embodiment, the
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manner in which pressure is controlled is determined may be based at least in
part on the
relationship of actual pressure to the set point pressure. Accordingly, the
system may
determine if actual pressure is in Zone 0 (which may be defined as actual
pressure between
0 and the pressure at the lowest value of the set point tolerance band which
may be referred
to as Low Tolerance Level), Zone 1 (which may be defined as actual pressure
between the
Low Tolerance Level and the desired pressure level which may be referred to as
Set Point
Level), Zone 2 (which may be defined as actual pressure between the Set Point
Level and
the pressure at the highest value of the set point tolerance band which may be
referred to as
High Tolerance Level), Zone 3 (which may be defined as actual pressure between
the High
Tolerance Level and the pressure level that triggers alarms which may be
referred to as the
Alarm Level), and/or Zone 4 (which may be defined as pressure exceeding the
Alarm
Level).
[00270] Some example fluid management units 100 may be configured
to employ
multiple modes of pressure control. In an exemplary Slope mode, the desired
minimum
slope of pressure (rate of pressure increase) may be calculated and the fluid
flow rate may
be adjusted at least in part based on the actual slope of the pressure
increase. In an
exemplary Control mode, the fluid flow rate may be adjusted incrementally
(e.g., by about
+1 ml/min) based at least in part upon a sum of errors methodology. For
example, an
integral Control mode may include calculating an integral of a pressure error
(e.g., set
point pressure ¨ actual pressure) over time and adjusting operation of the
pump 112 to
incrementally adjust a fluid flow rate based at least in part upon the
integral of the pressure
error. In an exemplary Coast mode, pump speed may be substantially maintained.
In an
exemplary Reduction mode, the fluid flow rate may be monitored and left
substantially
unchanged if actual pressure is decreasing, but may be aggressively reduced if
pressure is
not decreasing with the amount of the reduction based, at least in part, upon
the deviation
between actual pressure and Set Point Level. In an exemplary Reverse mode,
pump
rotation may be reversed (e.g., at a fluid flow rate of about 130 ml/min)
until actual
pressure is reduced to the appropriate Zone.
[00271] In some exemplary embodiments, the control scheme
employed at a particular
time may depend on current and previous Zones of actual pressure as set forth
in the
following table:
CA 02905825 2016-12-15
Current Previous Mode
Zone Zone
0 Slope
1 0 Slope
2 1 Control
3 2 Reduction (if flow rate > 0); Otherwise Reverse
4 3 Reduction (if flow rate > 0); Otherwise Reverse
3 4 Reduction (if flow rate > 0); Otherwise Reverse
2 3 or 4 Coast
1 2 Control
1 3 or 4 Slope
[00272] In some exemplary embodiments, an overpressure alarm may be delayed
for a
short period (e.g., 5 seconds) to allow reversal of pump 112 to correct an
overpressure
condition.
[00273] An exemplary embodiment may provide automatic and/or manual priming
functions. For example, an exemplary automatic priming function may be
initiated by a
user after installing a tubing set and connecting the tubing set to one or
more fluid bags
902, 904. An exemplary automatic priming sequence may include running pump 112
until
liquid is detected by bubble detector 132, and may include continuing to run
pump 112
after liquid is detected by bubble detector 132. For example, pump 112 may
continue to
run after liquid is detected by bubble detector 132 to deliver a predetermined
volume to fill
the remainder of the tubing set provided the user has opened the irrigation
valves in the
downstream trumpet valve or surgical instrument to vent air. In some exemplary
embodiments, the predetermined volume pumped after liquid is detected by
bubble
detector 132 may vary depending on the type of tubing set being utilized. For
example, the
fluid management system 10 may be programmed to automatically prime certain
known
types of tubing sets. An exemplary manual priming function may include a user
starting
and stopping the pump 112 using a user interface, such as pressing and
releasing a button
on touch screen display 106. A user may employ the manual priming function to
prime a
tubing set for which the fluid management system 10 is not programmed for
automatic
CA 02905825 2016-12-15
66
priming, to perform additional priming subsequent to automatic priming, and/or
whenever
it is desired to manually prime a tubing set, for example.
[00274] In some exemplary embodiments, detection of fluid by bubble
detector 132
during automatic and/or manual priming may result in initiation of fluid
warming by
heating assembly 309. In some exemplary embodiments, fluid may be warmed
during
priming subsequent to detection of fluid by bubble detector 132 to reduce the
amount of
unwarmed fluid in the tubing set. In such embodiments, overheating of
cartridge 410
(such as may occur if heating was initiated without fluid in cartridge 410)
may be avoided
by utilizing the detection of liquid by bubble detector 132 as an indication
of proper
priming.
[00275] An exemplary embodiment may be operated in a flow control mode. A
flow
rate may be determined using a known flow rate per rotation of the pump 112
and the
rotational speed of the pump 112, for example. In some other exemplary
embodiments
including other types of positive displacement pumps, the flow rate may be
determined in a
similar manner. In some exemplary embodiments, a flow rate sensor may be
utilized to
measure a flow rate. In an exemplary flow control mode, the rotational speed
(or
equivalent for other types of pumps) may be increased or decreased to minimize
or reduce
a deviation between a set point flow rate and the flow rate determined from
the pump
speed, flow rate sensor, etc. An example flow control mode may employ pressure
sensors
2068, 2070 to prevent an overpressure condition. For example, the user may
select a
maximum allowable pressure, which may be approximately 3x the actual fluid
pressure in
the "open valve" configuration of the trumpet valve or surgical instrument
necessary to
achieve the desired fluid flow rate and pump 112 may be operated to provide
the desired
flow rate, without exceeding the maximum allowable pressure. Thus, if fluid
flow is
obstructed (e.g., by shutting the irrigation valve on a trumpet valve), pump
112 will stop
operating prior to reaching the maximum allowable pressure. Once the pressure
is reduced
(e.g., by opening the irrigation valve on the trumpet valve), pump 112 may
resume
operation to deliver the desired flow rate.
[00276] In some exemplary embodiments, fluid management unit 100 may be
operated
in an infusion mode. An example infusion mode may be generally similar to the
flow
control mode described above. For example, an infusion mode may allow a user
to input a
CA 02905825 2016-12-15
67
desired flow rate, such as by using touch screen 106. Similar to the flow
control mode
described above, an example infusion mode may include a maximum allowable
pressure.
Pump 112 may be stopped or slowed if the output pressure approaches and/or
reaches the
maximum allowable pressure. In addition, as mentioned above, one or more
bubble
detectors 132 may monitor fluid being delivered to the patient. Pump 112 may
be stopped
if a bubble is detected by one or more bubble detectors 132.
[00277] In
some example embodiments, fluid management unit 100 may be configured
to perform a deficit monitoring function. In some example embodiments, deficit
monitoring may be based at least partially upon an assumption that fluid may
be one of
four places: in the fluid supply containers (e.g., fluid bags 902, 904), in
the tubing set, in
the patient, and/or in the fluid collection containers (e.g., canisters 906,
908, 910, 912).
Any fluid that is not in the fluid supply containers, the tubing set, or in
the fluid collection
containers is assumed to be in the patient. Thus, some example embodiments may
utilize
total system weights (e.g., the weight of the fluid supply containers plus the
fluid collection
containers) to calculate the amount of fluid that may be in the patient (e.g.,
the deficit).
For example, after the tubing has been primed, an "initial total system
reference weight"
may be calculated from the initial weight of the fluid supply containers
(e.g., fluid bags
902, 904), as determined by load cells 142, 144 and from the initial weight of
the fluid
collection containers (e.g., canisters 906, 908, 910, 912), as determined by
load cells 206A,
206B, 206C, 206D. The "initial total system reference weight" may be
determined (e.g., at
the beginning of a procedure when the "run" button is pressed) by summing the
initial
weight of the fluid supply containers and the initial weight of the fluid
collection
containers. As the fluid management unit 100 operates, the weight of the fluid
supply
containers and the weight of the fluid collection containers are monitored by
controller at
periodic time intervals. At each time interval, a deficit may be calculated by
subtracting
the combined weights of the fluid supply containers and the fluid collection
canisters, as
measured at that time, from the initial total system reference weight. In some
exemplary
embodiments, the periodic time intervals may be sufficiently short (e.g., a
fraction of a
second) such that the deficit is effectively continuously monitored (e.g., a
plurality of times
per second). The calculated deficit is an indication of fluid that may be
within the patient
at the time the deficit is calculated. The calculated deficit at a time
interval may be
CA 02905825 2016-12-15
. 68
displayed on displays 106, 106A when calculated by the controller for
observation by a
user of fluid management unit 100.
[00278] Some exemplary fluid management units may be configured to
automatically
detect fluid supply container and/or fluid collection container replacements.
For example,
replacement of a fluid supply container (e.g., an empty or near empty fluid
supply
container with a full fluid supply container) may be detected by observation
of a
substantial increase in the sensed weight of the fluid supply containers.
Similarly,
replacement of a fluid collection container (e.g., a full or nearly full fluid
collection
container with an empty fluid collection container) may be detected by
observation of a
substantial decrease in the sensed weight of the fluid collection containers.
Bumping or
shaking of fluid management unit 100 to may cause momentary weight errors, so
some
example fluid management units 100 may be configured to allow a period of time
for any
transient conditions to dissipate. Thus, transient weight errors may be
automatically
corrected when the transient ends.
[00279] Some example fluid management units 100 may automatically
account for
fluid supply container replacements by noting the change in fluid supply
container weight
when the replacement occurs. The change in weight may then be added to the
system total
reference weight to provide an updated total system reference weight for use
in subsequent
deficit determinations. Similarly, some example fluid management units 100 may
automatically account for fluid collection container replacements by noting
the change in
fluid collection container weight when the replacement occurs. The change in
weight may
then be subtracted from the system total reference weight to provide an
updated total
system reference weight for use in subsequent deficit determinations. Some
example
systems may automatically account for a plurality of fluid supply container
replacement
and/or fluid collection container replacement in this manner on an ongoing
basis by
updating the reference total system weight each time a replacement occurs.
[00280] FIG. 41 illustrates an example method 4100 of operating a
surgical fluid
management system. Operation 4102 may include delivering fluid from a fluid
supply
container to a surgical site via a tubing set. Operation 4104 may include
sensing a system
fluid pressure in the tubing set between the fluid supply container and the
surgical site.
Operation 4106 may include sensing a surgical site fluid pressure using a
remote pressure
CA 02905825 2016-12-15
69
sensor disposed approximate the surgical site. Operation 4108 may include
controlling a
pressure of the fluid delivered to the surgical site based at least in part
upon at least one of
the sensed system fluid pressure and the sensed surgical site fluid pressure.
[00281] FIG. 42 illustrates an example method 4200 of operating a surgical
fluid
management system. Operation 4202 may include delivering fluid to a surgical
site using
a pump. Operation 4204 may include controlling operation of the pump based at
least in
part upon a pressure trend, the pressure trend including a current measured
pressure as
compared to a set point pressure and a previous measured pressure as compared
to the set
point pressure.
[00282] FIG. 43 illustrates an example method 4300 of operating a surgical
fluid
management system. Operation 4302 may include delivering fluid to a surgical
site using
a pump. Operation 4304 may include controlling operation of the pump including
selecting one of a plurality of pressure control modes based at least in part
upon measured
conditions, and adjusting operation of the pump using the selected control
mode.
[00283] FIG. 44 illustrates an example method 4400 of operating a surgical
fluid
management system. Operation 4402 may include delivering fluid to a surgical
site via a
heater assembly, the heater assembly including at least a first heater and a
second heater,
the fluid flowing past the first heater and then flowing past the second
heater. Operation
4404 may include supplying power to the first heater based at least in part
upon an
estimated power requirement, the estimated power requirement being
substantially
proportional to a flow rate of the fluid and a total desired temperature
change of the fluid.
Operation 4406 may include supplying power to the second heater, including, if
a current
outlet temperature is less than a set point outlet temperature by greater than
a
predetermined threshold, supplying power to the second heater based upon a
first heater
control algorithm, and if the current outlet temperature is less than the set
point outlet
temperature by less than a predetermined threshold, supplying power to the
second heater
based upon a second heater control algorithm.
[00284] FIG. 45 illustrates an example method 4500 of monitoring a fluid
deficit in a
surgical fluid management system. Operation 4502 may include measuring an
initial
weight held by a fluid supply container support, the fluid supply container
support
supporting a first fluid supply container. Operation 4504 may include
measuring an initial
CA 02905825 2016-12-15
weight held by a fluid collection container support, the fluid collection
container support
supporting a first fluid collection container. Operation 4506 may include
calculating an
initial reference total weight, the initial reference total weight including a
sum of the initial
fluid supply container support weight and the initial fluid collection
container support
weight. Operation 4508 may include supplying fluid from the first fluid supply
container
to a surgical site. Operation 4510 may include collecting at least some of the
fluid from
the surgical site into the first fluid collection container. Operation 4512
may include
measuring a first current weight held by the fluid supply container support.
Operation
4514 may include measuring a first current weight held by the fluid collection
container
support. Operation 4516 may include calculating a first current total weight,
the first
current total weight including a sum of the first current weight held by the
fluid supply
container support and the first current weight held by the fluid collection
container support.
Operation 4518 may include calculating a first fluid deficit by subtracting
the first current
total weight from the initial reference total weight.
[00285] FIG.
46 illustrates an example method 4600 of monitoring a fluid deficit in a
surgical fluid management system. Operation 4602 may include measuring an
initial
weight held by a fluid supply container support, the fluid supply container
support
supporting at least one fluid supply container. Operation 4604 may include
measuring an
initial weight held by a fluid collection container support, the fluid
collection container
support supporting at least one fluid collection container. Operation 4606 may
include
calculating an initial reference total weight, the initial reference total
weight including a
sum of the initial fluid supply container support weight and the initial fluid
collection
container support weight. Operation 4608 may include supplying fluid from the
at least
one fluid supply container to a surgical site. Operation 4610 may include
collecting at
least some of the fluid from the surgical site into the at least one fluid
collection container.
Operation 4612 may include monitoring a current weight held by the fluid
supply container
support. Operation 4614 may include monitoring a current weight held by the
fluid
collection container support. Operation 4616 may include calculating a current
total
weight, the current total weight including a sum of the current weight held by
the fluid
supply container support and the cuiTent weight held by the fluid collection
container
CA 02905825 2016-12-15
71
support. Operation 4618 may include calculating a current fluid deficit by
subtracting the
current total weight from the initial reference total weight.
[00286] FIG. 47 illustrates an example method 4700 of operating a surgical
fluid
management system. Operation 4702 may include calculating an initial reference
total
weight, the initial reference total weight including a sum of an initial
weight of a fluid
supply container and an initial weight of a fluid collection container.
Operation 4704 may
include supplying fluid from the fluid supply container to a surgical site.
Operation 4706
may include collecting at least some of the fluid from the surgical site into
the fluid
collection container. Operation 4708 may include calculating a current total
weight, the
current total weight including a sum of a current weight of the fluid supply
container and a
current weight of the fluid collection container. Operation 4710 may include
calculating a
deficit by subtracting the current total weight from the initial reference
total weight.
[00287] FIG. 48 illustrates an example method 4800 of operating a multi-
functional
fluid management system. Operation 4802 may include receiving, via a user
interface, at
least one of a surgical discipline selection and a surgical procedure
selection. Operation
4804 may include setting at least one default operating limit based at least
in part upon the
at least one of the surgical discipline selection and the surgical procedure
selection.
[00288] FIG. 49 illustrates an example method 4900 of operating a surgical
fluid
management system. Operation 4902 may include receiving, via a user interface,
identification of information to be gathered by a surgical fluid management
system during
a surgical procedure. Operation 4904 may include electronically storing the
information
during the surgical procedure. Operation 4906 may include receiving, via the
user
interface, an instruction pertaining to at least one of printing, storing, and
electronically
transmitting the information.
[00289] FIG. 50 illustrates an example method 5000A of operating a multi-
functional
surgical fluid management system. Operation 5002A may include receiving, via a
user
interface, identification of at least one of a surgical discipline and a
surgical procedure.
Operation 5004A may include setting default operating parameters based upon
the at least
one of the surgical discipline and the surgical procedure. Operation 5006A may
include
receiving, via a user interface, input to adjust the operating parameters.
CA 02905825 2016-12-15
= 72
[00290] FIG. 51 illustrates an example method 5100 of operating a
surgical fluid
management system. Operation 5102 may include receiving, via a user interface,
preferred
operating settings associated with at least one of a surgical discipline and a
surgical
procedure, the preferred operating settings also being associated with an
identity of at least
one of a surgeon and an operator. Operation 5104 may include setting operating
parameters at the preferred operating settings upon receiving an input, via a
user interface,
associated with at least one of the surgeon and the operator and at least one
of the surgical
discipline and the surgical procedure.
[00291] FIG. 52 illustrates an example method 5200 of controlling
a surgical fluid
management device. Operation 5202 may include receiving, via a user input,
identification
of information which must be entered prior to operation of a surgical fluid
management
device. Operation 5204 may include requesting entry of the information.
Operation 5206
may include if the information has not been entered, precluding operation of
the of the
surgical fluid management device. Operation 5208 may include if the
information has
been entered, allowing operation of the surgical fluid management device.
[00292] As has been described above, the present invention is
directed to a fluid
management system 10 for managing fluids used in connection with a wide
variety of
"medical procedures" that may be performed in connection with humans and
animals. As
should be apparent from the invention disclosure provided above, the term
"medical
procedure" as used in the present application refers to procedures, including,
but not
limited to: surgical procedures, irrigation procedures, and infusion
procedures, said
procedures performed on humans or animals. It should be understood that a
medical
procedure may be comprised of multiple elements, wherein each element is an
individual
medical procedure. In other words, a plurality of individual medical
procedures may be
carried out in succession to complete a comprehensive medical procedure. Thus,
"medical
procedure" may refer to an individual medical procedure or a comprehensive
medical
procedure comprised of a plurality of individual medical procedures.
[00293] The medical procedures may be associated with such medical
disciplines,
including but not limited to: gynecology, obstetrics, urology, orthopedics,
general surgery
and trauma. Examples of medical procedures, include but are not limited to,
hysteroscopy,
CA 02905825 2016-12-15
73
cystoscopy, ureteroscopy, laparascopy, arthroscopy, and infusion. These
medical
procedures are identified in general or specific terms.
[00294] The medical procedures carried out with use of fluid management
system 10
disclosed herein may involve one or more of the following fluid delivery
functions,
including but not limited to: fluid irrigation, distention of a body cavity,
and fluid infusion
into a patient. Fluid management system 10 of the present invention may also
provide
additional functions with respect to the medical procedures, including, but
not limited to:
fluid deficit monitoring associated with delivery and return of fluid to/from
a site (wherein,
the site is a surgical site or a patient), fluid warming, fluid pulsation, and
circulation of
fluid (e.g., into and out of a body cavity).
[00295] Depending upon the selected medical procedure, fluid management
system 10
operates in either a pressure control mode (wherein control system 8 controls
pump 112 to
deliver fluid to the site at approximately a target pressure), or in a flow
control mode
(wherein control system 8 controls pump 112 to deliver fluid to the site at
approximately a
target flow rate).
[00296] in order to safely and effectively deliver fluid for carrying out
the medical
procedure, several "default" operating parameters are established in
accordance with the
medical procedure selected by the user. These default operating parameters
include, but
are not limited to, a target pressure and a target flow rate. A range of
acceptable pressures
and flow rates are respectively defined by minimum and maximum pressures and
minimum and maximum flow rates. By maintaining the pressure within the
acceptable
pressure range and maintaining the flow rate within the acceptable flow rate
range, fluid
management system 10 of the present invention safely and effectively delivers
fluid to the
site in connection with the selected medical procedure.
[00297] Described below are additional features of the present invention.
Certain
aspects of these features have been described in the preceeding sections of
the
specification.
[00298] Heating Suspension
[00299] In accordance with one embodiment of the present invention, heater
assembly
309 is disabled when pump 112 is inactive (i.e., not rotating), unless fluid
management
system 10 is in an "idle" state. This disablement of heater assembly 309
prevents any
CA 02905825 2016-12-15
74
dangerous conditions that could arise from heating stagnant fluid in cartridge
410. Control
system 8 is programmed to deactivate pump 112 when a threshold fluid pressure
(Pthreshoid)
is detected by control system 8 (e.g., using pressure sensors 2068, 2070). The
threshold
fluid pressure (P
\-- threshold) is typically achieved when a user closes an inflow or outflow
valve
on a surgical instrument, or tubing downstream of cartridge 410 is
intentionally or
unintentionally occluded.
[00300] However, it is recognized that if tubing located upstream of
cartridge 410 is
occluded or the fluid supply source (i.e., fluid supply container(s); fluid
bags 902, 904)
have become depleted, then pump 112 continues to be activated due to the fact
that the
threshold fluid pressure (Pthreshoid) cannot be achieved. As a result, heater
assembly 309
continues to be enabled (even though the fluid in cartridge 410 is stagnant).
This situation
may result in undesirable conditions, such as overheating of the fluid in
cartridge 410.
[00301] According to an aspect of the present invention, control system 8
is
programmed to monitor the weight of the fluid supply source when pump 112 is
in an
activate state, and thereby determine whether or not fluid is "flowing." As
discussed
above, one or more load cells 142, 144, may output electrical signals
associated with the
weight of the fluid supply containers suspended from the fluid bag hangers.
Control
system 8 determines whether the weight of the fluid supply source is
decreasing. If the
weight of the fluid supply source is not decreasing, then control system 8
determines that
tubing upstream of cartridge 410 is occluded, or that the fluid supply source
has become
depleted, and thus disables heater assembly 309 to prevent any further heating
of the fluid.
[00302] If a user selects a medical procedure that allows fluid heating and
the user has
enabled the fluid heating function (e.g., by selecting heater button 4064 as
shown in FIG.
35), then heater assembly 309 will continue to be enabled if (a) pump 112 is
activated; (b)
bubble detector 132 is sensing the presence of fluid; and (c) the weight of
the fluid supply
source is decreasing. If any one of the conditions (a), (b) or (c) is not
present, then heater
assembly 309 will be disabled to stop further heating of the fluid in
cartridge 410.
[00303] In accordance with an alternative embodiment, control system 8 does
not
monitor the weight of the fluid supply source, but instead, receives a signal
from a flow
sensor located along a fluid path upstream of cartridge 410 indicative of
whether fluid is
flowing along the fluid path.
CA 02905825 2016-12-15
[00304] Manual Lost Fluid Estimator
[00305] In accordance with certain medical procedures (such as operative
hysteroscopy), fluid absorption by a patient must be carefully monitored to
guard against
excess fluid absorption, which may result in complications. The amount of
fluid that can
be safely absorbed by the patient is dependent upon a number of factors,
including the type
of fluid being used.
[00306] In some fluid management systems, the fluid deficit is monitored by
measuring the amount of fluid delivered to a site and the amount of fluid
returned from the
site (e.g., via suction or gravity). Such fluid management systems may provide
an alarm
when the fluid deficit is approaching an unsafe level, and prevent any further
fluid delivery
to the site when the fluid deficit has reached an unsafe limit. However, such
fluid
management systems are not able to measure the amount of fluid that is "lost"
including,
but not limited to, fluid that has spilled onto the floor and/or has been
absorbed by surgical
drapes, gowns, and/or blankets. As a result, such "lost" fluid is deemed by
the fluid
management system to have been absorbed by the patient, and thereby results in
an
artificially high fluid deficit. Consequently, the user may experience
corresponding false
fluid deficit alarms, procedure interruptions, and/or premature terminations
of procedures.
[00307] According to an aspect of the present invention, control system 8
is
programmed to present the user with a data entry screen (via touch screen 106)
that allows
the user to manually enter a value that is an estimate of the amount of fluid
"lost" during a
medical procedure. This value may be entered in units of volume or weight.
[00308] Control system 8 incorporates the "lost" fluid estimate into the
fluid deficit
calculations (such as those described in detail above), thus providing the
user with a fluid
deficit having greater accuracy. For example, the "lost" fluid estimate may be
incorporated
into the fluid deficit calculations by subtracting the weight of the estimated
"lost" fluid
from the initial total system weight, or by adding the weight of the estimated
"lost" fluid to
the current total system weight.
[00309] To minimize the risk associated with "lost" fluid estimates and to
ensure
accountability for users making and manually entering the "lost" fluid
estimates, control
system 8 may also be programmed to provide one or more of the following
features:
CA 02905825 2016-12-15
76
1. Visually and/or audibly providing a warning (via touch screen 106 and/or
speaker 2052) to the user against overestimating the "lost" fluid due to
inaccurate
fluid deficit monitoring and corresponding adverse consequences that could
result
from overestimations;
2. Visually and/or audibly providing a warning (via touch screen 106 and/or
speaker 2052) to the user against entering "lost" fluid estimates considered
nominal
in nature (e.g., less than 100m1);
3. Providing a "lost" fluid estimate on a printed procedure summary that
may be
printed by printer 111 at the completion of a medical procedure to provide a
printed
record of the medical procedure. Printer control box 4082 may provide a user
with
a selection for printing the "lost" fluid estimate at the end of a medical
procedure
(see FIG. 37); and
4. Programming control system 8 to prohibit the "lost" fluid estimate from
being
incorporated into fluid deficit calculations during the medical procedure in
order to
eliminate the possibility of a user manipulating or effectively raising the
fluid
deficit alarm limit by overestimating the amount of "lost" fluid. In this
case, the
only purpose for manual entry of the "lost" fluid estimate would be to have
such
estimate printed in the procedure summary for a more accurate record of the
fluid
deficit occurring during the medical procedure.
[00310] Default Maximum Fluid Deficit by Fluid Type
[00311] As discussed above, the amount of fluid that can be safely absorbed
by a
patient is dependent upon a several factors, including the type of fluid being
used.
However, some fluid management systems default to a fluid deficit alarm limit
that is
independent of the type of fluid being used, and thus allows a user to adjust
the fluid
deficit alarm limit within a range inclusive of all permissible levels of
fluid absorption for
all types of fluids that could be used during a medical procedure. As a
result, a user may
program the fluid management system with a fluid deficit alarm limit set to a
high limit
(e.g., 2500m1) when the fluid management system is being used to supply a
fluid that
requires a lower fluid deficit alarm limit (e.g., 1500m1).
[00312] In accordance with an aspect of the present invention, where
deficit
monitoring is enabled, control system 8 is programmed to prompt a user to
enter or select a
CA 02905825 2016-12-15
77
"type" of fluid to be used in connection with the medical procedure, via touch
screen 106.
Control system 8 defaults to an appropriate/safe fluid deficit alarm limit for
the entered or
selected fluid "type" and allows the user to adjust such fluid deficit alarm
limit within a
range deemed safe for that particular "type" of fluid. The "type" of fluid
indicated by the
user, the fluid deficit alarm limit set by the user, and the total fluid
deficit may be provided
on a printed procedure summary at the conclusion of the medical procedure.
[00313] Alternatively, control system 8 may default to a fluid deficit
alarm limit
deemed safe for all possible fluids and only prompt the user to enter or
select the fluid
"type" if the user desires to increase the fluid deficit alarm limit above the
initial default
fluid deficit alarm limit or other low fluid deficit alarm limit.
[00314] Deficit Monitoring by Type of Fluid Used and Purge Button
[00315] During certain medical procedures, including operative hysteroscopy
having
both hysteroscopic and laparoscopic elements, it may be necessary to change
the tubing set
and the type of fluid being used during the procedure to accomplish the
respective
distention and/or irrigation functions. For example, in the hysteroscopic
element, an
endoscopic tubing set and saline fluid may be used. In the laparoscopic
element, a
laparoscopic tubing set and a non-conductive fluid (such as glycine) may be
used in order
to perform electrocautery. It may also be necessary to return to the
hysteroscopic element
(i.e., endoscopic tubing and saline) to complete the procedure.
[00316] Fluid management system 10 is operable in both pressure and flow
control
modes, and includes tubing sets that facilitate the transition between to two
or more
elements of a procedure (e.g. between hysteroscopic and laparoscopic
elements). These
tubing sets include a proximal portion that includes cartridge 410, and a
distal portion
downstream of cartridge 410 that terminates in a connector, such as a luer
lock connector
(e.g., for hysteroscopic use) or a surgical instrument, such as a trumpet
valve (e.g., for
laparoscopic use). For example, see FIGS. 9 and 24. It is contemplated that
other types of
connectors and instruments may be used in connection with the present
invention.
[00317] In one embodiment of the present invention, the distal portion is
adapted to be
interchangeable, i.e., a distal portion terminating in a first type of
connector (e.g., a luer
lock connector) can be interchanged with a distal portion terminating a
surgical instrument
(e.g., a trumpet valve) or a second type of connector. This allows a luer lock
connector to
CA 02905825 2016-12-15
78
be interchanged with a trumpet valve, thereby facilitating a transition
between different
medical procedures (e.g., laparoscopic and hysteroscopic procedures).
Interchangeable
distal portions are discussed in detail below.
[00318] If the fluid used during a second element of a procedure is
different from the
fluid used during a first element of the procedure, then a user must ensure
that the fluid
used in the first element of the procedure is completely purged from fluid
management
system 10 prior to commencing the second element of the procedure. This
requires the
user to manually estimate the amount of fluid that must be pumped to
completely purge the
fluid used in the first element of a procedure. Moreover, the user must
manually track the
fluid deficit associated with the first element of the procedure and the fluid
deficits
associated with any subsequent elements of the procedure in order to have an
accurate total
fluid deficit.
[00319] In accordance with another aspect of the present invention, control
system 8 is
programmed to present the user with a prompt or data entry screen (via touch
screen 106)
that allows the user to indicate a transition from a first element of a
procedure to a second
element of the procedure (e.g., from a hysteroscopic element to a laparoscopic
element).
Upon such indication, control system 8 uses touch screen 106 to prompt the
user to select
the procedure associated with the second element; instruct the user to change
the distal
portion of tubing; and query the user whether a different fluid will be used
for the second
element of the procedure and, if so, prompts the user to enter or select the
"new" fluid via
touch screen 106. If the user indicates that a different fluid will be used
for the second
element of the procedure, control system 8 is programmed to display a "purge"
button that,
when pressed, causes control system 8 to activate pump 112 in order to pump a
sufficient
volume of the "new" fluid to thereby completely purge the "old" fluid from the
proximal
portion of the tubing set before connecting the new distal portion.
[00320] Control system 8 is further programmed to incorporate the above-
described
"purge" function into the fluid deficit monitoring calculations (described
above) in order to
avoid artificially high fluid deficit and corresponding false alarms,
procedure interruptions,
and/or early procedure terminations. For example, the volume of "purged" fluid
may be
incorporated into the fluid deficit calculations by subtracting the weight of
the "purged"
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fluid from the initial total system weight, or by adding the weight of the
"purged" fluid to
the current total system weight.
[00321] Control system 8 is also programmed to present the user
with the "purge"
button if the user indicates to control system 8 that a fluid change is going
to be made
during a single element of the procedure (e.g., during a hysteroscopic
element). In this
situation the distal portion remains unchanged. As a result of selecting the
"purge" button,
control system 8 performs the fluid "purge" and adjusts the fluid deficit
monitoring levels
accordingly.
[00322] Control system 8 is further programmed to automatically
track and display (a)
the fluid deficit associated with the "old" fluid used during the first
element of the
procedure; (b) the fluid deficit associated with the "new" fluid used during
the second
element of the procedure; and (c) the total fluid deficit for the entire
procedure (i.e., all
elements of the procedure). Furthermore, if there is a third (or subsequent)
element(s) of
the procedure (e.g., hysteroscopic element changing to laparoscopic element
changing
back to hysteroscopic element), control system 8 is programmed to track and
display the
fluid deficits based on the fluid used during that element.
[00323] Change Canister Prompt
[00324] Fluid management unit 100 is capable of sensing a
significant weight change
indicative of the replacement of a fluid collection container. A user may be
presented with
a "change canister" button displayed on touch screen 106 to eliminate
potential errors that
can be caused by movement or vibration of fluid management unit 100 (e.g.,
shifting of
fluid inside canisters 906, 908, 910, 912). However, if the user fails to
press the "change
canister" button, the volume of the fluid associated with the full fluid
supply container that
was removed is no longer accounted for and, therefore, deemed by control
system 8 to
have been absorbed by the patient. This situation can result in an
artificially high fluid
deficit calculation and display, as well as accompanying false alarms,
procedure
interruptions, or early procedure terminations.
[00325] According to an aspect of the present invention, control
system 8 is
programmed to sense a large decrease in weight on load cell base 204
indicative of the
removal of a full or substantially full fluid supply container, without the
user having
pressed the "canister change" button. Furthermore, control system 8 is
programmed to
CA 02905825 2016-12-15
store the weight determined prior to the significant weight change, and
displays a query on
touch screen 106 to request the user to confirm that a fluid supply container
has been
removed (e.g., "Did you just remove a canister? If so, please press canister
change button
now"). As described above, the total weight supported by load cells 206A,
206B, 206C,
206D is about equal to the sum of the weight of suction canister hanger 202,
the empty
weights of canisters 906, 908, 910, 912, and the weight of any contents of
canisters 906,
908, 910, 912.
[00326] Bolus Button
[00327] During certain medical procedures (e.g., ureteroscopy), a user may
need a
bolus of higher pressure fluid to carry out a particular mechanical function
(such as move
kidney stones, separate tissue, expand passageways, etc.). The bolus can be
achieved via a
syringe or bulb that is manually operated by the user. This approach may
result in unsafe
fluid pressure levels or volumes, and often requires a separate tubing set
which can be
inefficient and costly.
[00328] In accordance with an aspect of the present invention, when a user
selects a
medical procedure where a "bolus" of fluid might be necessary (e.g.,
ureteroscopy), control
system 8 is programmed to display (via touch screen 106) a "bolus" button that
can be
selected by the user at any time during the procedure. Upon selection of the
"bolus"
button, control system 8 is programmed to provide a "bolus" of fluid. The user
may set
parameters associated with the "bolus" including, but not limited to, a
desired fluid
pressure level and a desired duration (in either time or fluid volume). It is
also
contemplated that control system 8 may be programmed to display numerous
"bolus"
buttons, wherein each button is associated with a specific pressure and
duration
combination. This feature enables the user to more efficiently employ the
correct "bolus"
without having to "reprogram" a single "bolus" button for different pressure
and duration
combinations.
[00329] Intra-Procedure Multi-Functionality
[00330] In the medical discipline of gynecology, the associated procedures
may
involve both hysteroscopic and laparoscopic elements of a procedure.
Typically, these
procedures will commence with diagnostic or operative hysteroscopy and
progress to
gynecologic and/or abdominal laparoscopy. Fluid management systems that
require the
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use of multiple devices and/or multiple tubing sets to complete such types of
multi-element
procedures decrease efficiency, increases the costs associated with such
procedures, and
might potentially adversely affect patient safety.
[00331] In hysteroscopy, irrigation fluid is circulated into and out of the
uterine cavity
at a pressure deemed optimal to maintain proper distention and to achieve good
visualization by washing out blood and debris resulting from the procedure.
Due to the
dangers associated with intravasation, the fluid deficit (i.e., the difference
in volume
between the amount of fluid delivered to a site and the amount of fluid
returned from the
site), must be closely monitored by the fluid management system. Also, due to
procedural
requirements and/or the adverse outcomes associated with intraoperative
hypothermia,
warming of the irrigation fluid to approximately body temperature may be
necessary or
desired.
[00332] In laparoscopy, the irrigation fluid is delivered to the site at a
flow rate deemed
appropriate to clear the site of blood and debris and to maintain good
visualization. Again,
due to procedural purposes and/or the adverse outcomes associated with
intraoperative
hypothermia, warming of the irrigation fluid to approximately body temperature
may be
desired or necessary.
[00333] Due to functional limitations of certain existing fluid management
systems,
procedures that include multiple elements (e.g., hysteroscopic and
laparoscopic elements)
may require the use of multiple fluid management systems during such
procedures. These
functional limitations, include, but are not limited to: single operating mode
(i.e., operable
in a pressure control mode or a fluid control mode, but not both modes); lack
of tubing sets
that can be configured for hysteroscopic and laparoscopic use (i.e., requiring
the use of
separate tubing sets for each element of a procedure); lack of automated
deficit monitoring
capabilities; lack of user-selectable on-demand fluid warming capabilities;
and lack of
trumpet valves with suction/irrigation and electrocautery capability.
[00334] According to an aspect of the present invention there is provided a
"multi-
functional" fluid management system 10 that includes a fluid management unit
100 that
operates in fluid pressure control mode or flow control mode depending upon a
selected
medical procedure, monitors fluid deficits, provides on-demand fluid warming;
and
provides a tubing set that is configurable for various different medical
procedures, such as
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hysteroscopy and laparoscopy (suction/irrigation alone or in combination with
electrocautery).
[00335] FIG. 53A illustrates a trumpet valve tubing set 3010 useable in
connection
with a first medical procedure (e.g., a laparoscopic procedure), while FIG.
53B illustrates a
luer lock connector (single lumen) tubing set 3010' useable in connection with
a second
medical procedure (e.g., a hysteroscopic procedure). Each tubing set 3010,
3010' is
comprised of a cartridge or proximal portion 3015 and a distal portion 3017,
3017'. The
proximal portion includes dual spikes 3014 with clamps 3016, 3018, a "Y"
connector
3020, a first section 3013A of tubing connecting "Y" connector 3020 and a
cartridge 410
(fluid inflow), cartridge 410, and a second section 3013C of tubing (with a
clamp 3015B)
that connects cartridge 410 and a connector 3015A (fluid outflow).
[00336] Distal portions 3017, 3017' are adapted for use with a particular
medical
procedure. In the illustrated embodiment, distal portion 3017 provides a
trumpet valve,
while distal portion 3017' provides a single lumen terminating in a luer lock
connection or
other connection to a surgical instrument. It is contemplated that the distal
portion may be
adapted for use with devices other than those illustrated herein.
[00337] Distal portion 3017 includes a tubing section 3013D (irrigation
line) and a
connector 3017A for connection to proximal portion 3015 of tubing set 3010. In
the
illustrated embodiment, tubing section 3013D terminates at the distal end in a
trumpet
valve 3022 and a conjoined suction tubing or line 3027 that terminates in a
standard
suction connector 3026.
[00338] Distal portion 3017' includes a tubing section 3013E (irrigation
line) and a
connector 3017A with an optional clamp 3017B for connection to proximal
portion 3015
of tubing set 3010'. In the illustrated embodiment, tubing section 3013E
terminates at the
distal end in a luer lock 3019 with a clamp 3019A
[00339] For example, fluid management system 10 may be configured for a
hysteroscopy procedure by selecting the hysteroscopy procedure from a medical
procedure menu (e.g., see FIG. 32), which automatically puts fluid management
system 10
in a pressure control mode. A user installs proximal portion 3015 of tubing
set 3010'
(FIG. 53B) that includes dual bag spikes 3014 and "y" connector 3020, a
cartridge 410 that
is inserted 410 into slot 310 (see FIG. 2), and a segment 3013C of tubing
extending from
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cartridge 410 to a male or female connector 3015A for enabling coupling to
distal portion
3017' of tubing set 3010' outside of fluid management unit 100. Distal portion
3017'
includes mating connector 3017A and segment 3013E of tubing for delivering
fluid from
fluid management unit 100 to the site. Segment 3013E of tubing terminates in
luer lock
connector 3019 for coupling to a hysteroscope or other instrument.
[00340] Control system 8 facilitates transitions between two different
elements of a
procedure. For example, when the hysteroscopic element of the procedure is
complete, or
it becomes necessary to interrupt the hysteroscopic element of the procedure
to perform a
laparoscopic element, the user indicates to control system 8, via touch screen
106, a change
in the medical procedure to laparoscopy. As a result, control system 8
automatically
transitions the fluid management unit 100 to a flow control mode.
[00341] The user disconnects distal portion 3017' of the tubing used for
hysteroscopy
from proximal portion 3015, and connects distal portion 3017 (FIG. 53A) to
proximal
portion 3015. Proximal portion 3015 includes mating connector 3015A that
couples to
connector 3017A of distal portion 3017. Distal portion 3017 includes segment
3013D of
tubing that terminates in trumpet valve 3022, for delivering fluid from fluid
management
system 10 to the site. Trumpet valve 3022 has a standard suction/irrigation
probe or a
combination probe that includes suction/irrigation and electrocautery. When
the distal
portion substitution has been completed by the user, the user will indicate to
control system
8 (via touch screen 106) that fluid management system 100 is properly
configured to start
the laparoscopic element of the procedure. If a different fluid is being used,
then the
"purge" function described above may be implemented.
[00342] Although fluid deficit is less of a concern during laparoscopy,
control system 8
is programmed to prompt the user (via touch screen 8) to indicate whether the
user wants
to continue fluid deficit monitoring. If the user elects to continue the
deficit monitoring,
control system 8 will regard the laparoscopy element as a continuation of the
same
procedure (i.e., the originally selected procedure) for purposes of the
deficit monitoring
function. If the user elects to discontinue the deficit monitoring, control
system 8 will
regard the laparoscopy element as a "new" procedure. Accordingly, the deficit
monitoring
function of control system 8 is adapted to facilitate changes between elements
of a
procedure.
CA 02905825 2016-12-15
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[00343] When the laparoscopic element of the procedure is complete, or when
it
becomes necessary to interrupt the laparoscopic element to perform an
additional
hysteroscopic element, the user indicates to control system 8, via touch
screen 106, a
change in the procedure to return back to hysteroscopy. As a result, control
system 8
automatically transitions the fluid management unit 100 back to a pressure
control mode.
Fluid management unit 100 indicates, via touch screen 106, that the fluid
deficit
monitoring calculations from the previous hysteroscopic element of the
procedure will be
restored and comprise the basis for continuing the fluid deficit monitoring
calculations.
The user changes the distal portion of tubing from the laparoscopic tubing
(FIG. 53A) to
the hysteroscopic tubing (FIG. 53B), and then indicates to control system 8
(via touch
screen 106), that fluid management system 100 is properly configured to return
to the
hysteroscopic element of the procedure.
[00344] It should be appreciated that the following features of fluid
management
system 10 enable performance of the functions described above: operates in a
pressure
control mode or a flow control mode depending on the selected procedure;
tubing sets are
configurable for different procedures (e.g., hysteroscopic and laparoscopic
procedures);
microprocessor-based fluid deficit monitoring (for storing, recalling and
computing fluid
deficit calculations); selectable on-demand fluid warming; and combination
suction/irrigation electrocautery trumpet valve probes.
[00345] Fluid management system 10 as described above has several
advantages,
including, but not limited to:
a. only one fluid management system is needed to perform a procedure
involving multiple elements (e.g. hysteroscopic and laparoscopic elements),
thereby saving time since only one fluid device has to be set up, reducing
costs since only one device has to be acquired and maintained, and
minimizing space requirements in the operating room (OR);
b. only one tubing set is needed, with appropriate accessories, thereby
reducing costs over separate tubing sets needed for hysteroscopic and
laparoscopic elements;
CA 02905825 2016-12-15
c. the ability of fluid management system 10 to function for multiple
elements
(e.g., both hysteroscopy and laparoscopy elements) increases the efficiency
of the procedure;
d. the ability of fluid management system 10 to store, retrieve, and build
upon
fluid deficit calculations from a first element (e.g., a hysteroscopic
element)
performed earlier in a procedure increases patient safety by reducing
possible recording errors;
e. the "selectable" on-demand fluid warming feature of fluid management
system 10 enables the use of fluid management system 10 in a variety of
situations, i.e., when there are procedural requirements for fluid warming
(such as the warm fluid indication in certain hysteroscopic sterilization
procedures), when there are concerns with intraoperative hypothermia that
require on-demand fluid warming, and when there are procedural
requirements or other clinical issues that require room-temperature or cool
irrigation fluid; and
f. the trumpet valve of fluid management system 10 can receive a standard
suction/irrigation probe or a combination suction/irrigation and
electrocautery probe, thereby saving time and money, and eliminating the
need for two separate ports into an insufflated surgical site.
g. the purge function when transitioning from a first fluid to a second fluid.
[00346] According to another embodiment of the present invention, fluid
management
system 10 includes an automatic tubing detection feature and allows control
system 8 to
automatically detect changes in tubing sets in use with fluid management
system 10. In
this regard, control system 8 is programmed to automatically recognize a
change between a
distal portion 3017' of tubing set 3010' (e.g., used for hysteroscopy) and a
distal portion
3017 of tubing set 3010 (e.g., used for laparoscopy), and automatically
respond to such
detected change by making a corresponding change to system operation, e.g.,
changing
between pressure mode control and flow control mode, and adjusting alarm
limits. The
automatic recognition contemplated herein may be accomplished using detection
technology well know in the art, including but not limited to RFID tagging, or
a variety of
other electrical (wired and wireless communication devices), mechanical,
optical, or
CA 02905825 2016-12-15
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pneumatic means. An illustrated embodiment of the present invention will be
described
with reference to a fluid management system 10 that includes radio frequency
identification device (RFID) tagging as an electrical communication device.
[00347] As will be described in detail below, a readable memory
such as an RFID is
integral with the distal portion of the tube set. The RFID includes a memory
that stores
data identifying characteristics of the distal portion of the tube set. An
interface unit reads
the data in the RFID memory. Based on this data, the control system 8 then
regulates
operation of fluid management system 10 according to a pressure control mode
or a flow
control mode in accordance with the type of distal portion that has been
detected using the
RFID.
[00348] Control system 8 also controls pump 112 such that fluid,
when required, is
delivered at a pressure level or flow rate according to the data read out from
the RFID
memory. This data is also used by the control system 8 to regulate priming of
pump 112
so that when fluid management system 10 is initially setup, a head of
irrigation fluid can be
pumped close to the end of the hand piece tool from which the fluid is to be
discharged.
[00349] Referring now to FIGS. 53A and 53B, respective distal
portion 3017, 3017' of
tube sets 3010, 3010' include an RFID 3142. RFID 3142 includes a memory in
which data
is stored that identifies characteristics of distal portion 3017, 3017' (e.g.,
which type(s) of
medical procedure(s) use the distal portion, whether the distal portion is
used in connection
with a pressure control mode or a flow control mode, and associated pressure
level or flow
rate). RFID 3142 also includes the following components that facilitate the
reading of data
to and the writing of data from the memory: a coil, a signal
modulator/demodulator; a
processor; and a rechargeable power supply.
[00350] With reference to FIG. 54, control system 8 is modified to
include an RFID
interface unit 3122 for communicating with RFID 3142. In this regard,
interface unit 3122
reads data from and writes data to RFID 3142. Interface unit 3122 includes an
antenna that
is positioned such that when the distal portion 3017 or 3017' is positioned
for connection
with proximal portion 3015, the antenna and the coil integral with RFID 3142
are close
enough to facilitate inductive signal transfer therebetween. Interface unit
3122 also
includes a modulator/demodulator for encoding the signals for forwarding data
to RFID
3142 and decoding received signals received from RFID 3142. Once a distal
portion 3017
CA 02905825 2016-12-15
87
or 3017' is connected with proximal portion 3015, data is read out of the RFID
memory. It
should be appreciated that interface unit 3122 may alternatively be located at
cartridge 410
and communicate with processor 2050 via wireless or wired communications.
[00351] A manual process (as described above) may be used as the primary
means for
indicating to fluid management unit 100 that a change in the type of procedure
is
occurring, and the automatic tubing detection feature serving as a secondary
redundant
safety check. For example, if the user manually indicates, via touch screen
106, that a
change to a laparoscopy procedure was going to occur, but mistakenly couples a
distal
portion of tubing intended for a hysteroscopy procedure, control system 8 is
programmed
to identify this error, and notify the user of the mistake via the touch
screen 106 and
preclude operation of fluid management system 10 until the correct distal
portion of tubing
is attached.
[00352] It should be further noted that a configurable tubing set allows
for the use of
specialized distal portions. For example, a distal portion with an integrated
pressure relief
valve may be used for patient safety to guard against overpressurization of
the cavity
during hysteroscopy, and a distal portion without a pressure relief valve may
be used for
laparoscopy. Inclusion of the pressure relief valve for laparoscopy would
involve
unnecessary costs and could be problematic due to higher required fluid
pressures needed
to deliver the required flow rates for laparoscopy.
[00353] Apparatus and methods according to the present disclosure may be
utilized in
a wide variety of settings, such as surgical and/or other procedures performed
on humans
and/or animals, dental surgeries and/or other procedures, and/or any other
medical and/or
veterinary procedures, such as those involving irrigation, distention, and/or
infusion.
[00354] While exemplary embodiments have been set forth above for the
purpose of
disclosure, modifications of the disclosed embodiments as well as other
embodiments
thereof may occur to those skilled in the art. Accordingly, it is to be
understood that the
disclosure is not limited to the above precise embodiments and that changes
may be made
without departing from the scope. Likewise, it is to be understood that it is
not necessary
to meet any or all of the stated advantages or objects disclosed herein to
fall within the
scope of the disclosure, since inherent and/or unforeseen advantages of the
may exist even
though they may not have been explicitly discussed herein.
