Note: Descriptions are shown in the official language in which they were submitted.
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TITLE
METHOD AND APPARATUS FOR DELIVERING AN AGENT
TO THE ABDOMEN*
BACKGROUND OF THE INVENTION
FIELD OF THE INVENTION
This invention relates to treating gases delivered into body cavities, spaces
or
body surfaces of an animal. More specifically, it relates to a device for, and
method of,
treating gases with one or more agents to be carried by the gas stream to an
animal.
RELATED ART
The delivery of gas into the body of a patient is well known for many
purposes.
Gas is delivered into a body cavity, such as the abdomen, to distend a
compliant surface
or create pressure for a specific purpose. Distention of the abdomen using gas
creates a
pneumoperitoneum that achieves a space in which one can examine, repair,
remove and
surgically manipulate. The space created by gas insufflation is a basic
component of
laparoscopic surgery. Within the space of the body created by the gas flow and
pressure, tissue surfaces and organs can be visualized safely and instruments
placed
that are used for diagnostic and therapeutic purposes. Examples of such uses
include,
but are not limited to, coagulation, incision, grasping, clamping, suturing,
stapling,
inoving, retracting and morcelizing. The quality of the gas stream can be
modified and
conditioned by filtering, heating and hydrating. U.S. Patent No. 5,411,474 and
the
aforementioned U.S. patent application disclose methods for conditioning gas
in this
matter.
There is room for further improvement and advancement. During a procedure
that instills gas to a body cavity, body space or body surface, the addition
of
pharmacologically active or inert materials (organic or inorganic) can enhance
tissue
healing, reduce infection, reduce adhesion formation, modify the immunologic
response, treat neoplasm, treat specific disease processes, reduce pain and
assist in
diagnosis. It is desirable to provide an apparatus and method suitable for
treating gas in
such a manner.
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SUMMARY OF INVENTION
Briefly, the present invention is directed to a method and apparatus for
treating
gas with one or more agents for delivery to a body cavity, body space or body
surface.
The gas is received into the apparatus from a gas source. The apparatus
comprises a
housing defining at least one chamber having an entry port and an exit port,
the entry
port for receiving a gas stream from a gas source. A quantity of one or more
agents is
released into the chainber to be admixed in the gas stream that is delivered
to the
animal by a delivery device. The gas stream is optionally humidified and/or
heated in
the housing.
The above and other objects and advantages of the present invention will
become more readily apparent when reference is niade to the following
description
taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a schematic view of an apparatus according to the present
invention.
Figure 2 is a cross-sectional view of the gas treater of the apparatus
according to
the present invention.
Figure 3 is schematic diagram of a gas treater housing according to an
embodiment of the present invention comprising a plurality of distinct
chambers.
Figure 4 is an end view of the gas treater housing according to the embodiment
of Figure 3.
Figure 5 is an internal view of the gas treater housing according to another
embodiment featuring one or more bag members inside the housing.
Figure 6 is an internal view of the gas treater housing according to still
another
embodiment featuring one or more bag members outside the housing.
Figure 7 is an internal view of the gas treater housing according to yet
another
embodiment featuring a tube member disposed within the housing and having a
restrictive opening at a distal end thereof.
Figure 8 is an internal view of the gas treater housing according to another
embodiment featuring a tube member disposed within the housing and having a
plurality of openings on a length portion thereof.
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Figure 9 is a schematic diagram of still another embodiment featuring an
inlcjet
printhead for controllably releasing a quantity of one or more agents into the
chamber
of the gas treater housing.
Figure 10 is a schematic diagram of a heating element used in the gas treater.
Figure 11 is a cross-sectional view of the gas treater chamber and showing the
fluted gas inlet and outlet of the chamber.
Figure 12 is an internal view of a gas treater housing showing a container for
releasing a quantity of a solid phase agent into the chamber.
Figure 13 is a view of a gas treater housing, similar to Figure 12, but
showing
the container positioned outside of the chamber.
Figure 14 is a schematic diagram showing a circuit for controlling the
temperature of the gas and for monitoring the humidity of the gas.
Figure 15 is a schematic diagram showing a circuit for monitoring humidity of
the gas according to an alternative embodiment.
Figure 16 is a schematic diagram of an alternative einbodiment of the present
invention, wllich can deliver treated or untreated gas and an agent into body
cavities,
spaces, or surfaces.
Figure 17 is a schematic diagram of a further alternative embodiment of the
present invention which can deliver treated or untreated gas and an agent into
body
cavities, spaces, or surfaces.
Figure 18 is a schematic diagram of a further alternative embodiment of the
present invention which can deliver treated or untreated gas and an agent into
body
cavities, spaces, or surfaces.
Figure 19 is a schematic diagram of a further alternative embodiment of the
present invention which can deliver treated or untreated gas and an agent into
body
cavities, spaces, or surfaces.
Figure 20 is a schematic diagram of a further alternative einbodiinent of the
present invention which can deliver treated or untreated gas and an agent into
body
cavities, spaces, or surfaces.
Figure 21 is an elevational view showing how an agent may be introduced into
the agent chamber used in some embodiments of the invention.
Figure 22 is an elevational view showing another way in which an agent may be
introduced into an agent chamber.
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Figure 23 is an elevational view showing still another way in which an agent
may be introduced into an agent chamber.
Figure 24 is an elevational view showing still another way in which an agent
may be introduced into an agent chamber.
Figure 25 is an elevational view showing how a syringe may be used as an
agent chamber in the present invention.
t..
Figure 26 is an elevational view showing how a pump may be used as an agent
chamber in the present invention.
Figure 27 is an elevational view showing how a pressurized chainber may be
used as an agent chamber in the present invention.
Figure 28 is an elevational view showing how a bag may be used as an agent
chamber in the present invention.
Figure 29 is an elevational view showing how a piezoelectric chainber may be
used as an agent chamber in the present invention.
Figure 30 shows a further embodiment of the present invention.
Figure 31 is an elevational view of a two inlet trocar forming part of the
present
invention.
Figure 32 is a modification of the construction shown in Figure 31
Figure 33 is a further modification of the construction shown in Figure 31.
Figure 34 is a flow chart showing a series of steps that may be used in
operating
various embodiments of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
DEFINITIONS
As used in the claims, "a" can mean one or more.
As used herein, "a predetermined temperature" or "a predetermined temperature
range" is one that has been preset or programmed by the user during a
procedure. For
example, a desirable temperature range may be physiological body temperature,
i.e.,
approximately 35-40 C. As explained hereinafter, the temperature of the gas
may be
adjusted by a "dial" type or other similar adjustment.
As used herein, the term "humidifying solution" means water, normal saline,
lactated Ringers, any buffered liquid or solution, an aqueous solution, a non-
water
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based solution, a coinbination of water or non-water solutions and other
substances, or
a gel substance containing water or non-water solutions and other substances.
As used herein, the term "agent" means any organic substance, inorganic
substance, inert or biologically active substance of pharmacologic material,
that may
5 effect or enhance tissue healing, reduce infection, reduce adhesions
formation, modify
the immunologic response, treat specific disease processes, reduce pain or be
used for
any tllerapeutic or diagnostic purpose. This includes materials in solid,
liquid or gas
phase, and materials that are water (aqueous) based, colloid and non-colloid
suspensions, mixtures, solutions, hydrogels, lyophilized materials,
hydrophobic,
hydropliilic, aiiionic, cationic, surface active agents, surgical adjuvants,
anticoagulants,
antibiotics, immunologic stimulators, iinmunologic suppressants, growth
inhibitors,
growtll stimulators, diagnostic materials, anesthetic agents, analgesic
agents, and
materials by themselves or dissolved or based in other materials, such as, but
not
limited to, alcohols, ethers, esters, lipids and solvents. The agent can be
dry, such as in
a power form. Any material that can be carried by the flow of gas into a body
cavity or
onto a surface for therapeutic or diagnostic purposes can be delivered in
accordance
with this invention. It is not intended to limit the present invention to the
above
examples of agents. Furthermore, the gas stream may be treated with any type
or
combination of agents in accordance with the present invention. An example is
to treat
the gas stream witll a humidifying solution for hydration to prevent
desiccation, an
antibiotic to reduce infection, an anti-inflammatory to reduce inflammation
a.nd an anti-
adhesive to reduce adhesions and improve healing. Agents such as those sold
under the
trademarks Adept manufactured by ML Laboratories, Adcon manufactured by
Gliatech
and Atrisol manufactured by Atrix Laboratories can be used to reduce
adhesions.
As used herein, the term "gas" includes any gas or combination or mixture of
gases in any proportion that occurs naturally or can be manufactured or placed
or
created in a container.
The term "treating" used in connection with treating of the gas stream means
to
inject or release one or more agents into the gas stream so that the gas
stream is a fume
or dust in the case of a solid phase agent, or a mist or spray in the case of
a liquid phase
agent. In some embodiments, such as where the agent is in liquid form, the
agent is
wicked off or dislodged from a container. In other cases, the agent is
injected or
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released into the gas stream. In general, the gas stream to be treated with
one or more
agents is also humidified.
The terms "cavity" or "space" mean any body cavity or space including the
interthoracic cavity, the pericardiuin, the peritoneal cavity or abdomen,
plural cavity,
knee space, shoulder space, eyeball, stomach arid lung.
The term "aerosol" means a suspension of liquid or solid particles in a gas.
The term "spray" means a jet of liquid dispersed by a sprayer.
The term "mist" meains liquid in the form of particles suspended in a gas.
The term "fog" means vapor condensed to fine particles of liquid suspended in
a
gas.
The term "vapor" means a gas dispersion of molecules of a substance.
The basic tenet of the present invention is to treat a flowing gas stream with
one
or more agents so that the agent(s) actively or passively are injected into
the gas stream
and are made part of the gas stream as a result of the dynamics of flow, vapor
pressure
and/or rate of evaporation. The gas streain thereby is modified to contain
additives that
are determined desirable by the user for purposes of enhancing the outcome of
a gas
delivery event in connection with, for example, a pat-ticular treatment or
diagnostic
procedure or prevention.
The term "body surface" means any surface of the body, whether internal or'
external, and whether exposed naturally or by way of surgical procedure.
Referring to Figure 1, the apparatus for treating or conditioning gas is shown
generally at reference numeral 100. The apparatus 100 is adapted to receive
gas from a
gas regulator 10 (high or low pressure, high or low flow rate), such as an
insufflator.
The apparatus comprises a gas treater 120, an optional filter 110 and an
optional control
module 140. Tubes are provided to connect the various components of the
apparatus
together. Specifically, a first tube segment 160 connects the outlet of the
gas regulator
10 to the inlet tubing of the filter 110 via a male Luer lock 166 or any
appropriate
adapter compatible with the insufflator outlet port. A second tube segment 162
connects the outlet of the filter 110 to the inlet of the gas treater 120. A
third tube
segment 164 connects the outlet of the gas treater 120 by a male Luer lock 168
(or
other appropriate fitting adapter) to a gas delivery device (not shown), such
as a trocar,
Veres needle, endoscope or a tube that enters a body cavity or space that
delivers the
treated gas into the body of an animal. Alternatively, if the gas is to be
delivered to a
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body surface, the gas delivery device may be shaped, formed or otherwise
configured
to direct or spread the flow of gas onto a surface.
The tubing of the tube segments 160, 162 and 164 is preferably flexible and
sufficiently long to permit the gas regulator 10 a.iid control module 140 to
be placed at a
convenient distance from an animal undergoing procedure requiring gas
deliveiy. For
applications of the apparatus 100 where the temperature of the gas stream
should be
within a desired range when delivered, the gas treater 120 is preferably
placed
immediately adjacent to that location where the gas is to be delivered.
The filter 110 is an optional element and consists of a high efficiency,
1lydrophobic filter (for example Gelman Sciences Metricel M5PU025, having a
pore
size preferably small enougll to exclude all solid particles and bacterial or
fungal agents
that may have been generated in a gas supply cylinder or the gas regulator 10
(i.e., 0.5
micron or less and preferably about 0.3 micron). A preferable filter is a
hydrophobic
filter, such as a glass fiber-type filter, e.g., Metrigard by Gelman Sciences
or Porous
Media Ultraphobic filter, Model DDDF 4700 M02K-GB. Other suitable filters
include
polysulfone (Supor, HT Tuffrin, Gelman Sciences) and mixed cellulose esters
(GN-6
Metricel, Gelman Sciences), for example. Decreasing the pore size of filter
110 below
0.1 micron causes a concomitant increase in pressure drop of gas, and tlius
flow rate is
reduced significantly. If the procedure to be performed requires a relatively
high
pressure and/or flow rate of gas to the aniinal, such as laparoscopy, the pore
size should
preferably not decrease below 0.2 micron. A hydrophobic filter is preferable
to a
hydrophilic one, as a hydrophobic filter is less likely to tear under water
pressure
caused by accidentally suctioning or siphoning peritoneal or irrigation
fluids.
In some applications, it is desirable that the gas treater 120 be connected
immediately adjacent to a gas delivery device so that the gas travels a
miniinuin
distance from the outlet of the gas treater 120 to the conduit or connection
to the
interior of an animal. The purpose of this arrangement is to allow gas to be
delivered to
the animal while still at a temperature and water content sufficiently close
to the
physiological interior body temperature or other body surface. That is, for
some
applications, the apparatus according to the invention prevents thermodynamic
cooling
of gases in transit to the animal, because it provides a highly efficient
treatment
chamber that, as a result of its efficiency, can be quite compact and thus be
positioned
very near to the animal.
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The control module 140 is contained within an electrical housing 210 and is
connected to the gas treater 120 by several wire pairs contained within an
insulated
electrical cable 170. In particular, the cable 170 has a connector 172 at one
end that
electrically comlects into a circuit connector 212 of the housing 210 for the
control
module 140, and at the other end it is electrically connected to the gas
treater 120 by a
sealed electrical feed through 174. The cable 170 is attached to the tube
segment 162
by a plastic tape or clip 176. Alternatively, the cable 170 is attached to the
tube
segment 162 by heat seal, extrusion, ultrasonic welding, glue or is passed
through the
interior of tube segment 162.
The control module 140 and associated components in the gas treater 120 are
preferably powered by an AC-DC converter 180. The AC-DC converter 180 has an
output that is connected by a plug connector 182 into a power receptacle 214
of the
circuit within the control module 140, and has a sta.ndard AC wall outlet plug
184 that
can be plugged into standard AC power outlets. For example, the AC-DC
converter
180 is plugged into an AC power strip that is provided on other equipment in
an
operating room. Alternatively, electrical power for the apparatus is provided
by a
battery or photovoltaic source. Another alternative is to provide circuitry in
the control
module 140 that operates on AC signals, as opposed to DC signals, in which
case the
control module 140 could be powered directly by an AC outlet. The control
module
140 and the heating and liydrating components inside the gas treater 120 will
be
described in more detail hereinafter.
In some embodiments, the gas treater 120 has a charging port 190 that is
capable of receiving a supply of an agent and/or humidifying solution. For
example, a
syringe 200 containing a predetermined volume of liquid-based agent is
introduced into
the charging port 190 to inject it into the gas treater 120 for an initial
charge or re-
charge thereof. The apparatus 100 may be sold with the gas treater 120 pre-
charged
with a supply of an agent and/or humidifying solution such that an initial
charge is not
required for operation.
Turning to Figure 2, the gas treater 120 will be described in greater detail.
The
gas treater 120 comprises a housing 122 having an (entry port) gas inlet 124
and an
(exit port) gas outlet 126. The housing 122 defines a chamber 128 that
contains a
treatment subchamber for treating the gas supplied through the inlet with an
agent, and
in some einbodiments, contains elements for substantially simultaneously
heating and
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hydrating (hmnidifying), as well as ineans 136 for sensing the temperature of
the gas
and means 138 for sensing the relative huinidity of the gas as it exits the
chamber 128.
Specifically, in the einbodiment of Figure 2, within the chamber 128, there is
provided a subchamber that comprises of one or more layers of liquid-retaining
or
absorbing padding or sponge material, shown at reference numerals 130, 131 and
132.
It should be understood that the number, spacing and absorbency of the liquid-
retaining
layers 130, 131 and 132 varies according to specific applications. Three
layers are
shown as an example. The material of the layers 130, 131 and 132 can be any
desirable
liquid retaining or absorbent material, such as a rayon/polyester formed
fabric (e.g., NU
GAUZETM, manufactured and sold by Johnson & Johnson Medical, Inc.). The pore
size of the selected material should be chosen according to a balance of
liquid-retaining
capabilities and low pressure drop considerations. The larger the pore size,
the greater
the liquid retention capability for gas contact for aerosolizing the gas.
Other fonns of the treatment subchamber may consist of an empty chamber, a
subcontainer or subchamber of liquid within the chainber 128 (without
absorbent
layers) having a semi-permeable membrane on opposite ends to allow gas to pass
there
through. The agent in the chamber is optionally heated by a heating jacket
placed
around the chamber.
The heating means in the gas treater 120 consists of at least one heating
element
134 positioned in the housing, such as between the absorbent layers 130 and
131. The
heating element 134 is an electrically resistive wire, f6r example. The
heating element
134 is placed preferably between absorbent layers or en-meshed within the
layers of
material (in the fabric). The heating element 134 heats the gas supplied
through the
inlet, under control of a heat control signal supplied by the control module
140,
substantially simultaneous with the treatment of the gas as the gas passes
through the
chamber 128. Additional heating elements may be disposed within the chamber.
In order to sense the temperature and humidity of the gas as it exits the gas
treater 120, a temperature sensor 136 and a relative humidity sensor 13 8 are
provided.
The temperature sensor 136 may be provided anywhere within the flow of gas in
the
chamber 128, but is preferably positioned on the downstream side of the
heating
element 134 between liquid-retaining layers. The temperature sensor 136 is a
thermistor (for example, Theimometrics MA100 Seres chip therinistor, or
Thermometrics Series BR23, Thermometrics, Inc., Edison, New Jersey). It is
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preferable that the temperature sensor 136 be accurate to within about 0.2 C.
In the
present invention, the temperature of the gas is preferably sensed after the
gas has been
treated (and optionally humidified) so that any change in the temperature of
the gas as
it is treated is corrected at that point in the apparatus, thereby
compensating for
5 enthalpy changes.
The humidity sensor 138 is positioned in the flow path of gas exiting the
chamber 128, preferably downstream from the heating element 134 either between
liquid-retaining layers or on the downstream side of the absorbent layers,
proximate the
exit port 126 of the housing 122. The humidity sensor 13 8 is preferably not
in contact
10 with a layer. Figure 2 shows the humidity sensor 138 distal to the
absorbent layers,
separated from the liquid-retaining layer 132 by a porous mesh (plastic or
metal) layer
133 that extends across the interior of the housing 122. The humidity sensor
138
actually is generally not in contact with the porous mesh layer 133, but is
spaced there
from as well. The huinidity sensor 138 is, in one einbodiment, a huinidity-
sensitive
capacitor sensor, such as a capacitive humidity sensor manufactured by Philips
Corporation, which changes capacitance in response to humidity changes. The
humidity sensor 13 8 measures the relative humidity of the gas as it passes
through the
chamber 128 to enable monitoring of the gas humidity, and in order to provide
an
indication of the amount of humidifying solution remaining in the gas treater
120, i.e.,
in layers 130, 131 and 132. As will be explained hereinafter, in one
einbodiment, a
timer/divider integrated circuit (IC) 145 (Figure 5), is connected to the
humidity sensor
138 and is preferably disposed within the housing 122 togetlier and
substantially co-
located with the humidity sensor 138. Other means of determining the humidity
of the
gas are well within the scope of the present invention.
One way to treat a gas stream with one or inore agents using the embodiment of
the gas treater 120 shown in Figure 2 is to inject from a syringe 200 a liquid-
based
agent into the chamber 128 through the charging port 190 for absorption onto
one of
the layers 130-132. When the gas stream flows over the layers 130-132, the gas
stream
will become treated with agent and thereby carry the agent out of the gas
treater 120
into an animal. Depending on the dimensions and type of absorbent pad or pads
used,
there is a capacity to the amount of agent that can be introduced into the
chamber 128.
The size of the chamber 128 can be increased to allow for larger pads, and
therefore
greater capacity.
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Several additional embodiments of the invention will now be described in
conjunction witll Figures 3-9, and 12-15. In these embodiments, other
configurations
of the housing 122 of the gas treater 120 are described that are useful to
treat the gas
stream flowing through the gas treater housing 122 with one or more agents.
These
embodiments show different types of containers for containing an agent and
releasing it
into the gas stream in a chamber of the gas treater 120.
Figures 3 and 4 illustrate an embodiment for the gas treater housing 122
featuring multiple chambers, for example, three chainbers 128A, 128B and 128C
that
extend a certain length portion (not necessarily all) of the housing 122.
These
chambers are separated by walls or partitions 2021/ 204 and 206.- Associated
with each
chamber 128A, 128B and 128C is a charging port 190A, 190B and 190C,
respectively
to receive a supply of agent froin a respective source, such as an external
bag, syringe,
etc. The agent is delivered under pressure into a chamber through its
respective
charging port, or is wicked off from a small opening of a bag (Figs. 5 and 6)
placed
through the charging port into a chamber. Alternatively, within each chamber
128A,
128B and 128C is one or more absorbent pads or layers similar to that shown in
Figure
2, onto which a quantity of an agent is absorbed. Still a further alternative
is to provide
a separate semi-permeable membrane in each chamber filled with a different
agent.
Each of the chambers can be charged with a different agent. For example,
chamber 128A may be charged with a humidifying solution, chamber 128B may be
charged with agent A and chamber 128C may be charged with agent B. Though not
sliown in Figures 3 and 4, it should be understood that the heating elements,
temperature sensor and humidity sensor shown in Figure 2 may optionally be
included
in their various configurations in the embodiment of the housing shown in
Figures 3
and 4. In the embodiment of Figures 3 and 4, when the gas stream flows through
the
housing 122, the gas stream wicks off or dislodges the humidifying solution
from
chamber 128A, is mixed with agent A from chamber 128B and is mixed with agent
B
from chamber 128C. Thus, the gas stream that exits the housing 120 is hydrated
and
treated with the agents, for delivery to an animal.
Figures 5 and 6 illustrate another embodiment where the agents to be carried
by
the gas stream are contained within bags. In Figure 5, there are, for example,
two bags
220 and 230 each of which are to contain a quantity of an agent. The apparatus
may be
shipped with the bags 220 and 230 pre-loaded or pre-charged with a quantity of
agents,
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or they may be filled with a quantity of agents prior to use. The bags 220 and
230 are
formed of flexible material such as, polyethylene or other similar material.
In one
configuration, the bags 220 and 230 are foirned of semi-permeable membrane
material
such that the agent contained therein can be wiclced off by the flowing gas
stream over
the surface of the bags through the housing 122. In another configuration, at
the end bf
each bag 220 and 230 inside the housing 122 is a restrictive orifice, nozzle
or hole 222
and 232, respectively, such as a spray hole or atomizer hole to allow for
contact with
the gas stream to be adinixed therewith. At the other end of each bag 220 and
230 is an
optional charging port 224 and 234, respectively, to allow the introduction of
a quantity
of an agent into the bags 220 and 230. Openings are made in the housing 122 to
allow
a length of the bags 220 and 230 to pass there through and into the chamber.
As the bags are filled, they expand inside the chamber 128. The pressure of
the
quantity of agent in the bags 220 and 230 and/or capillary action at the holes
222 and
232 forces the agent to drip out of the holes 222 and 232 to be wicked off or
dislodged
by the flowing gas stream through the chamber 128 and carried out of the exit
port of
the housing 122. In the configuration where the bags 220 and 230 are formed of
a
semi-perineable membrane material, the pressure of the quantity of agent in
the bags
facilitates the wicking off of the agent through the membrane. The bags 220
and 230
are deployed within the chamber 128 so that when they are filled, they expand
and are
substantially confined to a predetermined region of the chamber so as not to
interfere
with gas flow over the other bag. For example, a heating coil 124 or an
absorbent pad
can be used to separate the bags 220 and 230 in the chamber 128.
Figure 5 shows only two bags 220 and 230, but it should be understood that one
or any number of bags may be suitable depending on the number of agents to be
carried
by the gas stream.
Figure 6 shows a variation of the embodiment of Figure 5 wherein the bags 220
and 230 are located on the outside or exterior of the housing 122. In this
configuration,
openings are made in the housing 122 and the holes 222 and 232 of the bags are
located
just inside the housing 122 at these openings. The agents bead out of the
holes 222 and
232 and are wiclced off or dislodged by the flowing gas stream through the
chamber
128. In addition, there will be a natural tendency for the agent in the bags
220 and 230
to enter the flowing gas stream from the holes 222 and 232 due to the change
in vapor
pressure. Because the gas stream is relatively dry and by contrast, the agent
in the bags
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220 and 230 may have soine degree of moisture, a natural mechanism occurs by
which
the moist agent will wick out of the bags in an attempt to reach a vapor
pressure
equilibrium. The greater the rate of flow of the gas stream, the less of the
agent in the
bags 220 and 230 that will bead into the gas streain. The same theory of
operation
applies to the embodiment of Figure 5.
Even if deployed on the outside of the housing 122, the bags 220 and 230 can
be filled through their respective charging ports 224 and 234 in the same
manner as
described in conjunction with Figure 5. The number of bags may vary on a
particular
application, and two are shown in Figures 5 and 6 only as an example. All
other
features concerning the heating, humidification and sensing in the housing 122
are
applicable to the embodiments shown in Figures 5 and 6.
A still further variation on the embodiments of Figures 5 and 6 is to provide
the
optional tubing meinber 250 that extends from a bag to an optional absorbent
pad 130
that is positioned within the housing 122.
Further embodiments for deploying one or more agents into the gas stream are
shown in Figures 7 and 8. Figure 7 shows an elongated tubing member 300 that
is
disposed in the chamber 128 of the housing 122. The tubing member 300 is
extremely
long and winds throughout the chamber 128; Figure 7 is over-simplified in this
respect.
The tubing member 300 is, for example, a polyamide tubing product manufactured
by
MicroLumen of Tampa, Florida. The impoi-tant characteristics of the tubing
material
are that the sides or walls of the tubing member 300 are as thin as possible
so that the
volume of agent that the tubing member 300 can carry is maximized. At the tip
or end
of the tubing member 300 is a restrictive orifice or hole 310 through which
the agent
may bead and be wicked off or dislodged into the gas strean, then multiple
tubing
members each containing a different agent is provided. A charging port 312 is
also
provided on the proximal end of the tubing member 300 just outside the housing
122 to
supply a quantity of the agent into the tubing member 300.
Figure 8 illustrates a variation of the embodiment shown in Figure 7, wherein
a
tubing member 400 is provided that includes one or a plurality of holes or
perforations
410 along the length of the tubing member 400 through which the agent is
allowed to
release into the chamber 128. The gas stream flowing tlirough the chamber 128
will
wick off or dislodge the agent from the holes 410 and carry the agent in the
gas stream.
The tubing member 400 has a charging port 412 similar to charging port 300 for
tubing
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14
member 300. Also, multiple tubing members 400 may be provided in the chamber
to
release inultiple types of agents into the gas stream. The length of each
tubing member
400 and the quantity and size of the holes 412 therein may be selected to
control the
rate at which different agents from different tubing meinbers 400 are wicked
off or
dislodged by the gas stream flowing through the chamber 128.
In the embodiments shown in Figures 2-8, the size of the chamber 128 of the
gas treater housing 122 may vary depending on the intended use, gas flow, type
of
agent, whetlier and how many absorbent pads are provided, etc. There is no
limit,
either relative small, or relatively large, to the size of the chamber for
purposes of
carrying out the present invention.
Turning to Figure 9, yet another einbodiment is shown wherein an inlcjet
printhead cartridge 500 is used to release vapor bubbles containing a quantity
of one or
more agents into the chainber 128 of the housing 122. The inkjet printhead
cartridge
500 may be one of any lcnown inlcjet printheads such as those used in inlcjet
printers
sold by Hewlett-Packard, Canon, etc.
As is well known in the art, an inkjet printhead cartridge, such as that shown
at
reference numeral 500, coinprises a reservoir 510, a printhead 520 and a
plurality of
contact pads 530. Conductive traces in the cartridge 500 are terininated by
the contact
pads 530. The contact pads are designed to normally interconnect with a
printer so that
the contact pads 530 contact printer electrodes that provide externally
generated
energization signals to the printhead 520 to spray ink onto paper. Thennal
inkjet
printheads create vapor bubbles by elevating the inlc temperature, at the
surface of a
plurality of heaters, to a superheat limit. This same process can be used to
create vapor
bubbles of one or more agents. The printhead 520 comprises a plurality of
nozzles 522
from which the vapor bubbles are released when heaters are energized to heat
the
quantity of agent contained in the reservoir.
According to the present invention, the inkjet printhead cartridge 500 is
connected to a control circuit 600 by way of connector 610 having contacts to
match
the contact pads 530. The control circuit 600 may be contained within the
control
module 140 shown in Figure 1 and coupled to the cartridge 500 by one or more
electrical conductors contained in the electrical cable 170. The reservoir 510
is filled
with a quantity or volume of one or more agents to be released into the
chamber 128.
For example, a color inlcjet printhead cartridge contains multiple chambers or
reservoirs
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for each of three colors of ink. Using this same type of device, an inkjet
printhead
cartridge may contain a quantity or voluine of several different agents to be
separately
or simultaneously delivered into the chamber in controlled amounts. The
control
circuit 600 generates appropriate control signals that are coupled to the
cartridge 500
5 via the connector 610 to drive the heaters in the printhead 520 and release
vapor
bubbles of one or more agents into the chamber from the nozzles 522.
When the one or more agents are released into the chamber 128, the gas stream
that flows through the chamber and carries the agent out the exit port of the
housing
122 and into the animal. Each of the different agents can be released into the
chamber
10 128 at different rates or volumes. Furthermore, it is possible that a
different inkjet
printhead cartridge is provided for each of separate subchambers inside
chamber 128 to
keep the agents from mixing for a period of time before delivered into the
animal.
Referring back to Figure 2, electrical connections to the components inside
the
housing 122 of the gas treater 120 are as follows. A ground or reference lead
(not
15 specifically shown) is provided that is connected to each of the
temperature sensor 136,
heating element 134 and humidity sensor 138-timer/divider 145. A wire 175 (for
a
positive lead) electrically connects to the hearing element 134 and a wire 176
(for a
positive lead) electrically connects to the temperature sensor 136. In
addition, three
wires 177A, 177B and 177C electrically connect to the hw.nidity sensor 138-
timer/divider circuitry, wllerein wire 177A carries a DC voltage to the
timer/divider
145, wire 177B carries an enable signal to the timer/divider 145, and wire
177C carries
an output signal (data) from the timer/divider 145. All of the wires are fed
from the
insulated cable 170 into the feedthrough 174 and through small holes in the
housing
122 into the chainber 128. The feedthrough 174 is sealed at the opening 178
around the
cable 170.
The charging port 190 is attached to a lateral extension 139 of the housing
122.
The charging port 190 comprises a cylindrical body 192 containing a resealable
member 194. The resealable member 194 permits a syringe or similar device to
be
inserted there tlirough, but seals around the exterior of the syringe tip.
This allows a
volume of liquid agent or humidifying solution to be delivered into the
chamber 128
without releasing the liquid already contained therein. The resealable member
194 is,
for example, Baxter InterLinkTM injection site 2N3379. Alternatively, the
charging port
may be embodied by a one-way valve, a sealable port, a screw cap, a cap with a
slit to
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16
permit the introduction of a syringe or other device, such as a SafelineTM
injection site,
part number NF9 100, manufactured by B. Braun Medical Inc., or any other
covering
material or member capable of permitting the introduction of a syringe and
preventing
the backflow of contained liquid or gas. The control module 140 will issue a
waa.=ning
when the humidity of the gas being treated by the gas treater 120 drops below
a
predetermined or user programmable relative liumidity, as explained
hereinafter.
As an alternative, or in addition to the sensing and monitoring features
described above, a baclcup or reserve supply container for liquid agent and/or
humidifying solution is provided. Referring back to Figure 1, one form of a
backup
supply container is a container 800 that hangs free of the apparatus 100 and
is
connected with an access tubing 810 to the charging port 190. The container
800 is, for
example, a bag such as an intravenous fluid bag and the access tubing 810 is
an
intravenous type tubing.
Another form of a backup supply container is a container 850 that attaches to
a
portion of the apparatus 100. For exainple, the container 850 is a reservoir
tube, bag,
syringe or tank that is attached to the tubing segment 162 or is strapped or
fastened to
the tubing segment 162 close to the gas treater 120. Another alternative would
be to
strap or fasten it to the outside of the housing 122 of the gas treater 120.
The container
850 is connected to an access tubing 860 that connects into the charging port
190,
similar to access tubing 810 described above.
Access tubing 810 and 860 have a penetrating member (not shown) at their
distal ends to penetrate the charging port 190 to gain access to the chamber
128 of the
gas treater housing 122. Alternatively, instead of the access tubing 860, the
container
850 has at the end proximate the charging port 190 a tip member similar to
that of the
syringe 200 to penetrate and directly couple to the charging port 190.
The containers 800 and 850 can be pre-charged or charged prior to use
according to techniques well knovtni in the art. For example, container 850
has an
injection site 862 to enable injection of liquid into the container 850.
Preferably, the access tubing 810 or 860 of the backup supply containers 800
and 850, respectively, (or the integral penetrating tip of the container 850)
extend far
enough through the charging port 190 so as to malce contact with one of the
layers 130-
132 so that the liquid therein is wicked off on to one of the layers 130-132
due to
capillary forces. Alternatively, the access tubing 810 or 860 (or integral
penetrating tip
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17
of the container 850) stops short of one of the layers 130-132, and the
pressure
differential created by the flowing gas stream through the housing 122 will
wiclc off the
liquid agent and/or humidifying solution from the end of these members to
contribute
to the treatment of the gas.
With reference to Figure 2, another variation is to provide an extension tube
870
that leads from the charging port 190 where the access tubing 810 or 860 (or
the
integral penetrating tip member of the container 850) terminates, to the
treatment
subchamber inside the chamber 128, i.e., to contact one or more of the layers
130-132.
Liquid agent and/or humidifying solution is continuously wicked out from the
end of
the extension tube 870 onto one of the layers 130-132.
In either form of the backup supply container, the basic principle is the
same.
The backup supply container provides is coupled through the charging port 190
to the
treatment subchamber inside the chamber 128 to constantly replenish the
treatment
subchamber, e.g., one or more of the layers 130, 131 or 132. Consequently, the
treatinent subchamber will have an initial amount of liquid agent and/or
humidifying
solution (pre-charged or charged prior to use) and a backup supply from the
baclcup
supply container is constantly supplied to the treatment subchamber to
constantly
replenish it as gas flows through the chamber. The overall time of sufficient
gas
humidification and/or treatment is thereby lengthened to a duration that is
suitable for
all or nearly all gas delivery applications. As a result, there is no need to
be concerned
about decreasing humidity of the gas delivered. The baclcup supply container
acts as a
backup to provide gas humidification and/or treatinent for an entire
procedure.
Therefore, some fonns of the apparatus 100 need not include the humidity and
temperature sensing and monitoring features, or the recharge alert, described
herein.
The features provide another type of backup that may be useful in certain
applications,
instead of, or in addition to the baclcup supply container.
The desirable width and diameter of the gas treater is dependent upon many
factors, including the intended use, the rate of gas flow from the gas source
and the
pressure desired to be maintained, which is affected more by the diaineter of
chamber
128 than by its length. A person of ordinary skill in the art, given the
teachings and
examples herein, can readily determine suitable dimensions for chamber 128
without
undue experimentation. It should also be noted, however, that upon activating
the
apparatus or changing the demand on the apparatus (e.g., flow rate or
pressure), there is
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a lag time of only several tenths seconds for sensing the temperature of gas
and
adjusting the hearing element to achieve the proper gas or desired
temperature. Such a
fast start-up time is extremely beneficial.
Referring to Figure 10, the heating element 134 is shown in more detail. The
heating element 134 is an electrically resistive wire that is disposed in the
housing 128
in a concentrical coil configuration having a number of turns, such as 6-8
turns.
Alternatively, a second heating element 134' is provided that is arranged with
respect to
the heating element 134 such that its coils are offset from those of the first
heating
element, relative to the direction of gas flow through the chamber. If two or
more
heating elements are employed, they are preferably spaced from each other in
the
chamber of the gas treater by approximately 3-4 mm. The first and second
heating
elements 134 and 134' can be coiled in opposite directions relative to each
other. This
arrangement allows for maximum contact of the gas flowing through the chamber
with
a heating element. Other non-coiled configurations of the heating element 134
are also
suitable.
Turning to Figure 11, another feature of the gas treater 120 is illustrated.
At the
inlet and/or outlet of the housing 122, fluted surfaces 123 may be provided to
facilitate
complete dispersion of gas as it is supplied to the gas treater 120. This
improves the
fluid dynamics of the gas flow through the chamber 128 to ensure that the gas
is
uniformly heated and humidified as it flows through the chamber 128.
Figures 12 and 13 illustrate embodiments of the apparatus to treat the gas
stream with a solid phase agent. Figure 12 shows a container 700 of a solid
phase
agent, such as in power form, that is positioned in the chamber 128 of the gas
treater
housing 122. The container 700 includes a check valve 710 and a pressurizer
720, such
as a carbon dioxide cartridge. When the pressurizer 720 is activated, pressure
inside
the container 700 is caused to rise, such that the bias of the check valve 710
is
overcome, releasing the agent into the chamber 128. A button 730 on the
exterior of
the housing 122 is coupled by a wire or other means to pressurizer 720 to
activate it
remotely.
Figure 13 shows a container 700 of solid phase agent positioned outside of the
housing 122. The check valve 710 of the container 700 is fed through an
opening in the
housing 122 into the chamber 128. The button 730 for activating the
pressurizer is
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19
optionally positioned on the exterior of the container 700. Operation of the
configuration shown in Figure 13 is similar to that of Figure 12.
In the embodiment of Figures 12 and 13, the rate at which the solid phase
agent
is released into the chainber 128 is dependent upon the pressure created in
the container
700 by the pressurizer 720 and the size of the check valve 710. It may be
desirable to
deliver short bursts of the solid phase agent into the gas stream, or to
deliver it into the
gas stream on a continuous basis. If necessary, a separate backup source of
pressure
may be coupled to the container 700 to provide for longer term treatment of
the gas
stream. In any case, the gas stream flowing through the housing 122 will carry
the
solid phase agent with through the exit port.
Referring to Figure 14, the control module 140 will be described in detail.
The
control module 140 contains monitoring circuitry and control circuitry for the
apparatus
100. It is understood that some forms of the apparatus 100 need not include
the
humidity (and heating) sensing, monitoring, temperature control and recharge
alert
fiuictions. The control module 140 comprises a voltage regulator 141, a
microcontroller 142, an A/D converter 143, a dual operational amplifier
(hereinafter
"op-amp") module 144, and a timer/divider 145. The monitoring circuit portion
of the
control module 140 consists of the combination of the microcontroller 142 and
timer/divider 145. The control circuit portion of the control module 140
consists of the
microcontroller 142, A/D converter 143 and op-amp module 144. The monitoring
circuit monitors the relative humidity of gas exiting the chamber based on a
signal
generated by the timer/divider 145. The control circuit monitors the
temperature of the
gas exiting the chamber and in response, controls electrical power to the
heating
element to regulate the temperature of the gas to a user programmable or fixed
teinperature or temperature range. While the temperature of the gas exiting
the
chamber is actively controlled, the relative humidity of the gas in the
chainber is not
actively controlled; rather it is monitored and an alert is generated when it
drops below
a corresponding threshold so that appropriate action can be taken, such as
replenishing
the gas treater 120 with liquid agent or humidifying solution.
Figure 14 shows that several components are preferably located within the
electrical housing 210 (Figure 1), whereas other components are located within
the
housing of the gas treater 120 (Figure 2). In particular, the timer/divider
145 and the
associated resistors R4 and R5 are preferably located inside the housing 122
of the gas
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treater 120, togetlier with the humidity sensor 138 in a circuit package that
includes the
humidity sensor 138 exposed on one or more surfaces thereof. More
specifically, the
timer/divider 145 is co-located with humidity sensor 138. This configuration
minimizes timing error by stray wiring inductance and capacitance (sensor kept
close to
5 active circuits of timer/divider 145). In addition, by co-locating the
timer/divider 145
and humidity sensor 138, the need for interconnecting wires is eliminated,
thereby
avoiding'undesirable signal radiation.
The voltage regulator 141 receives as input the DC output of the AC-DC
converter 180 (Figure 1), such as for example, 9V DC, that is suitable for use
by the
10 analog components of the control module. The voltage regulator 141
regulates this
voltage to generate a lower voltage, such as 5V DC, for use by the digital
components
of the control module. The capacitor Cl at the output of the voltage regulator
141
serves to filter out any AC components, as is well known in the art.
Alternatively, a
suitable DC voltage is provided by a battery or photovoltaic source shown at
reference
15 numeral 149.
The microcontroller 142 is a PIC16C84 integrated circuit microcontroller that
controls system operation. A ceramic resonator 146 (4 MHz) is provided to
supply a
raw clock signal to pins 15 and 16 of the microcontroller 142, which uses it
to generate
a clock signal for the signal processing functions explained hereinafter.
20 The op-amp 144 module is coupled (by wire 176) to the temperature sensor
136
(thermistor) mounted in the housing of the gas treater. The op-amp module 144
is, for
example, a LTC1013 dual low-input-offset-voltage operational amplifier
integrated
circuit that includes two op-ainps, referred to hereinafter as op-amp A and op-
amp B.
The non-inverting input of the op-amp A of the op-amp module 144 is pin 3, and
pin 2
is the inverting input. The output of op-amp A is pin 1. Op-ainp A of the op-
amp
module 144 is used to buffer the output voltage of the voltage divider formed
by
resistors Rl and R2. The buffered output voltage, referred to as Vx in Figure
5, is
applied to op-amp B in the op-amp module 144. Op-amp B is configured as a non-
inverting-with-offset amplifier with a gain of 21.5, and also receives as
input the output
of the temperature sensor 136, adjusted by resistor R3, shown as voltage Vy in
the
diagram. The output voltage of op-amp B is at pin 7, referred to as Vo in
Figure 5.
The output voltage Vo is equal to 21.5Vy - 20.5Vx, which is inversely
proportional to
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21
the gas temperature in the housing of the gas treater. The output voltage Vo
ranges
between 0-5V DC, depending on the temperature of the gas in the chamber.
The A/D converter 143 is an ADC 0831 integrated circuit analog-to-digital
converter that receives as input at pin 2, the output Vo of the op-amp module
144. The
A/D converter 143 generates a multi-bit digital word, consisting of 8 bits for
example,
that represents the output voltage Vo, and is supplied as output at pin 6,
which in turn is
coupled to I/O pin 8 of the microcontroller 142. The microcontroller 142
commands
the A/D converter 143 to output the digital word by issuing a control signal
on I/O pin
which is coupled to the cliip select pin 1 of the A/D converter 143. Moreover,
the
10 microcontroller 142 controls the rate at which the A/D converter 143
outputs the digital
word by supplying a sequence of pulses on pin 9 applied to clock input pin 7
of the A/D
converter 143. The "unbalanced bridge" values of resistors Rl, R2 and R3 are
chosen
to produce a 0-5V DC output over gas temperatures from approximately 20 C to
approximately 45 C. Since the bridge and the reference for the A/D converter
143 are
provided by the same 5V DC source, error due to any reference voltage shift is
eliminated.
The timer/divider 145 is, for example, a MC 14541 precision timer/divider
integrated circuit. The humidity sensor 138 is connected to pin 2 and to
resistors R4
and R5 as shown. In response to an enable signal output by the microcontroller
142 on
pin 12 that is coupled to timer/divider pin 6, the timer/divider 145 generates
an output
signal that oscillates at a rate determined by the value of the resistor R4,
the capacitance
of the humidity sensor 13 8(which varies according to the relative liumidity
of the gas
inside the gas treater housing) and a predetermined divider constant. For
example, the
divider constant is 256. Specifically, the output signal of the timer/divider
145 is a
square wave oscillating between OV ("low") and 5V ("high") at a frequency of
approximately 1/[256*2.3*R4t*Ct]Hz, where R4t is, for example, 56 kOhms, and
Ct is
the capacitance at some time (t) of the relative humidity sensor 138 depending
on the
relative humidity of the gas in the chamber. For example, the humidity sensor
manufactured by Phillips Electronics, referred to above, can measure between
10-
90%RH (relative humidity), where Ct at 43%RH is 122 pF (+/- 15%), with a
sensitivity
of 0.4 +/- 0.5 pF per 1%RH. The output signal of the timer/divider 145 appears
at pin
8, which is coupled to the 1/0 pin 13 of the microcontroller 142. Thus, the
timer/divider 145 is essentially an oscillator circuit connected to the
humidity sensor
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22
that generates an output signal with a frequency dependent on a capacitance of
the
humidity sensor. Any oscillator circuit that can generate as output a signal
whose
frequency is dependent on a variable capacitance may be suitable for the
timer/divider
145.
The microcontroller 142 computes a measure of the relative humidity of the gas
inside the gas treater housing by timing or measuring a characteristic of the
output
signal of the timer/divider 145. Specifically, microcontroller measures the
time
duration of one of the phases of the output signal of the timer/divider 142,
such as the
"high" phase which is approximately 1/Z*[256*2.3*R4t*Ct]. This time duration
is
indicative of the relative humidity of the gas in the chamber of the gas
treater since the
rate of the oscillation of the timer/divider depends on the capacitance of the
humidity
sensor 138, as explained above. For example, for a change in RH of 10-50%
and/or 50
to 90%, there is a 13% change in the duration of the "high" phase of the
timer/divider
output signal. The microcontroller 142 monitors the relative humidity of the
gas
exiting the chamber in this manner and when it drops below a predetennined
relative
humidity threshold (indicated by a corresponding predetermined change in the
oscillation rate of the timer/divider 145), the microcontroller 142 generates
a signal on
pin 17, called a recharge signal, that drives transistor Q3 to activate an
audible alarm
device, such as buzzer 147. The buzzer 147 generates an audible sound which
indicates
that the relative humidity of the gas in the gas treater has dropped below the
predetennined threshold and that it is necessary to recharge the gas treater
with liquid.
The predetermined relative humidity threshold corresponds to a minimum level
for a
desirable relative humidity range of the gas exiting the gas treater, and may
be 40%, for
example. The predetermined relative humidity threshold is an adjustable or
programmable parameter in the microcontroller 142. Optionally, the
microcontroller
142 may generate another warning signal at the output of pin 7 to illuminate a
light
emitting diode (LED) 148A, thereby providing a visual indication of the
humidity
dropping below the predetermined relative humidity threshold in the gas
treater, and the
need to recharge the gas treater 120 with liquid. Further, the microcontroller
142
generates a trouble or warning signal output at pin 6 to drive LED 148B (of a
different
color than LED 148A, for example) when there is either a "code fault" in the
microcontroller 142 (an extremely unlikely occurrence) or when the relative
lzumidity
of the gas in the gas treater is less than a critical relative humidity
threshold (lower than
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23
the predetermined relative humidity threshold), such as 10%. In eitlier case,
power to
the heating element 134 is terminated in response to the warning signal.
The microcontroller 142 also controls the heating element 134 in order to
regulate the temperature of the gas inside the gas treater. Accordingly, the
microcontroller 142 processes the digital word supplied by the A/D converter
143 to
determine the temperature of the gas inside the gas treater housing. In
response, the
microcontroller 142 generates a heat control signal on the output pin 11 that
drives
transistor Q1, which in turn drives the MOSFET power transistor Q2, that
supplies
current to the heating element 134. The temperature of the gas inside the gas
treater is
regulated by the microcontroller 142 so that it is within a predetermined
temperature
range as it exits the gas treater for delivery into the bodyof a patient. The
predetermined temperature range that the gas is regulated to is approximately
35 -
40 C, but preferably is 37 C. As meiitioned above, when the relative humidity
inside
the gas treater falls below a critical threshold as determined by the
monitoring circuit
portion of the control module 140, the control circuit portion in response
terminates
- power to the heating element 134 to prevent the delivery of warm gas that is
extremely
dry.
The circuitry for monitoring the relative humidity of the gas can be embodied
by other circuitry well known in the art. In addition, while the control
module 140 has
been described as having a single microcontroller 142 for monitoring signals
representing temperature and relative humidity of the gas exiting the chamber,
and for
controlling the heating element to control the temperature of the gas, it
should be
understood that two or more microcontrollers could be used dedicated to the
individual
functions. In addition, the functions of the microcontroller 142 could be
achieved by
other circuits, such as an application specific integrated circuit (ASIC),
digital logic
circuits, a microprocessor, or a digital signal processor.
Figure 15 illustrates an alternative embodiment for monitoring relative
humidity
of the gas, in which a humidity sensitive resistor is used, instead of a
humidity sensitive
capacitor 138. The hu.inidity sensing scheme employing a resistive humidity
sensor
does not require the timer/divider circuit 145 shown in Figure 14. The
humidity
sensitive resistor 900 is located inside the gas treater housing in a suitable
location for
sensing the relative humidity of the gas stream flowing through the gas
treater 120. A
suitable humidity sensitive resistor is a model UPS600 resistor by Ohmic,
which at
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24
45% RH is approximately 30.7 k Ohms. A resistor R10 is coupled in a voltage
divider
configuration with the humidity sensitive resistor 900. Three pins of the
microcontroller 142 couple to the voltage divider formed by resistor R10 and
humidity
sensitive resistor 900.
Pin 910 of the microcontroller 142 is coupled to one terminal of the resistor
R10, pin 912 is coupled to one terminal of the humidity sensitive resistor 900
and pin
914 is coupled to the terininal between the resistor R10 and the humidity
sensitive
resistor 900. The humidity sensitive resistor 900 may be a type that requires
AC
excitation. Accordingly, the microcontroller 142 excites the humidity
sensitive resistor
900 by applying an alternating pulse, such as a 5-volt pulse, to pins 910 and
912, such
that pin 912 is "high" for a period of time and pin 910 is low. As a result,
the average
excitation voltage to the humidity sensitive resistor 900 is zero. During the
time period
when pin 910 is "high", the microcontroller 142 senses the humidity of the gas
by
determining if the tap voltage pin 914 is a logic "zero" or a logic "one". If
it is a logic
zero (low voltage), the resistance of the humidity sensitive resistor 900 is
low,
indicating that the relative huinidity of the gas is still high. If it is a
logic one (high
voltage), then the resistance of the humidity sensitive resistor 900 is high,
indicating
that the relative humidity of the gas is low. The value of the resistor R10 is
chosen to
yield a transition at pin 914 at a desired humidity tliresllold, such as 45%
RH, witli a 2.5
V transition from a low voltage to a higll voltage. For example, resistor R10
is a 30k
ohm resistor. In the embodiment employing a resistive humidity sensor, a
microcontroller that is suitable is a PIC 16C558 in place of the
microcontroller model
referred to above in conjunction with Figure 14. This sensing scheme can be
simplified
even further if a relative humidity sensor that allows DC excitation is used.
In this
case, only one pin of the microcontroller 142 need be associated with humidity
sensing.
A resistive humidity sensor has certain advantages over a capacitive humidity
sensor. It has been found that the specific type of resistive humidity sensor
referred to
above can tolerate immersion in water in the gas treater 120 if a user
accidentally over-
fills the gas treater 120. In addition, the sensing scheme using a resistive
sensor does
not require a relatively high frequency square wave signal, which may be
undesirable in
some environments where the apparatus is used. Finally, the resistive sensor
affords
better accuracy for relative humidity sensing in some applications.
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Other variations or enhancements to the circuitry shown in Figure 14 are
possible. The type of microcontroller used can be one, such as the PIC16C715,
that
incorporates the functions of the A/D converter 143. The PIC16C715
microcontroller
incorporates a multichannel A/D converter. In addition, a more feature rich
5 microcontroller of this type will allow for the addition of a display, such
as a liquid
crystal display (LCD) or LED display. The microcontroller could generate
information
on a periodic basis to be displayed to the user, such as gas temperature and
relative
humidity. In addition, the microcontroller may directly drive an audible alert
device,
rather than indirectly driving it througli a transistor as shown in Figure 14.
These are
10 examples of the types of modifications or variations that are possible
depending on the
type of microcontroller that is selected for use in the control module 140.
With reference to Figures 1 and 2, the setup and operation of the apparatus
100
will be described. The AC/DC converter 180 is plugged into a 110V AC power
source,
such as a wall outlet or a power strip. The control module 140 is connected to
the
15 AC/DC converter 180. Alternatively, the apparatus 100 may be powered by a
battery
or photovoltaic source. The heater/hydrating tubing set is then installed by
attaching
one end of the tube segment 160 to the outlet of the insufflator 10 by the
Luer lock 166.
The tube segments 160, 162 and 164 may be pre-attached to the filter 110 and
the gas
treater 120 for commercial distribution of the apparatus 100. The cable 170 is
installed
20 into the electrical housing 210 of control module 140 by the connector 172.
The gas treater 120 is charged with a supply of liquid agent and/or
humidifying
solution by the syringe 200. The syringe 200 is then inserted into the
charging port 190
so that a needle or cannula of the syringe 200 penetrates the resealable
member 194
(Figure 2) and the liquid is injected into the gas treater 120 to be absorbed
by the
25 absorbent layers. The syringe 200 is then removed from the charging port
190, and the
charging port 190 seals itself. The free end of the tube segment 164 is
attached to a gas
delivery device by the Luer lock 168 or other appropriate connector.
Alternatively, the
gas treater 120 may be pre-charged with liquid, thus not requiring a charge
prior to
operation.
If the embodiment of Figure 5 or 6 is employed, then the bags 220 and 230 are
charged (unless they are pre-charged) with a quantity of one or more agents.
Likewise,
if the embodiment of Figure 7 or 8 is employed, the tube member 300 or tube
member
400 is charged (unless it is pre-charged) with a quantity of one or more
agents. The
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26
nozzles 522 of the printhead 520 are positioned in alignment with an opening
to the
housing 122. Finally, if the embodiment of Figures 12 or 13 is employed, the
container
700 is prepared for use as described above in conjunction with Figures 12 and
13.
Once the gas regulator 10 is activated, it receives gas from a gas supply
cylinder
and regulates the pressure and flow rate of the gas, both of which can be
adjusted by the
operator. The pressure and volumetric flow rate are controlled by adjusting
controls
(not shown) on the gas regulator 10. Gas then flows through the tube segment
160 into
the optional filter 110 where it is filtered, and then through tube segment
162 into the
gas treater 120. In the gas treater 120, gas comes into contact with the
optional
electrical lieating element 134 and the optional humidifying liquid-retaining
layer(s)
130-132 which are positioned within the flow path of the gas, as shown in
Figure 2.
Depending on which gas treater embodiment of Figures 2-9, 12, or 13 is
employed, the gas stream is treated with a quantity of one or more agents so
that the
one or more agents is carried out of the gas treater 120 for delivery to an
animal. For
some applications and temperature range requirements, it may be desirable to
position
the gas treater 120 immediately adjacent the location to which the treated gas
is to be
delivered.
In the event that heating and humidification of the gas is also desired and
the
appropriate components are also deployed in the gas treater 120, then in
chamber 128,
the gas is also simultaneously heated and humidified to the proper
physiological range
by regulation of the heating element 134 and liquid content of the layers 130-
132 such
that the temperature of gas exiting chamber 128 is within a preselected
physiological
temperature range (preferably 35 to 40 C, though any desired temperature
range can
be preselected), and within a preselected range of relative humidity
(preferably above
40% relative humidity, such as in the range of 80-95% relative humidity). If
the
apparatus is operated with the gas treater 120 not charged with liquid agent
and/or
humidifying solution either because the user forgot to manually charge it
before
initiating operation, or the apparatus was sold without a pre-charge of liquid
(i.e., in a
dry state), the relative humidity of the gas in the chamber of the gas treater
120 will be
detected to be below the predetermined threshold and the alarm will be
activated,
alerting the user that the gas treater 120 requires charging of liquid. The
apparatus will
automatically issue an alarm to alert a user to the need for charging the gas
treater 120
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with liquid agent and/or humidifying solution, thereby avoiding further
delivery of
unhydrated gas into an animal.
With further reference to Figure 5, the control module 140 monitors the
relative
humidity of the gas exiting the chamber and further regulates the temperature
of the gas
in the chamber 128. In particular, the microcontroller 142 generates a
recharge signal
when the relative humidity of the gas in the chamber drops below the
predetermined
relative humidity threshold, indicating that the liquid supply in the gas
treater 120
requires replenishing. An audible alarm is issued by the buzzer 147 and/or a
visual
alarm is issued by LED 148A to warn the medical attendant or user that the gas
treater
120 requires recharging. Preferably, the microcontroller 142 continues the
alarm until
the humidity in the chamber returns to a level above the predetermined
relative
humidity threshold, which will occur when the gas treater 120 is recharged
with liquid.
Moreover, the microcontroller 142 will issue a second alarm, such as by
energizing
LED 148B, when the relative humidity level of gas in the gas treater 120 drops
below
the critical relative humidity threshold, at which point electrical power to
the heating
element 134 is terminated. In addition, the microcontroller 142 controls the
temperature of the gas by controlling electrical power supplied to the heating
element
134.
In some cases, the controlled humidity of the gas stream is more important
than
controlled heating. For those applications, the apparatus would include only
those
components necessary to treat the gas stream with one or more agents
(according to the
embodiments of Figures 7-13) and to liumidify the gas stream. Furthermore,
monitoring the humidity of the gas stream is also optional for certain
applications. For
example, treating the gas stream with a dry agent may not normally require
heating or
humidification.
The method and apparatus of this invention can be utilized for many medical
procedures requiring the provision of heated and humidified gas. The optional
filtration may also be utilized according to the sterility of gas required for
the
procedure. The gas is chosen according to the procedure to be performed and
can be
any medically useful gas, such as carbon dioxide, oxygen, nitrous oxide,
argon, helium,
nitrogen and room air and other inert gases. Preferable gases for endoscopy
are carbon
dioxide and nitrous oxide. A combination of the above gases can also be used,
i.e.,
100% of a single gas need not be used. The procedure is preferably endoscopy
such as
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laparoscopy, colonoscopy, gastroscopy, bronchoscopy, and thoracoscopy.
However, it
may also be utilized for providing heated and humidified oxygen or any
anesthetic
gases or combination of gases for breathing, for example, or'to administer
anesthesia or
breathing therapy. In particular, the compact size of the apparatus make the
invention
portable and thus suitable for uses requiring portability. The gas delivery
device that
provides the direct contact to the patient should be selected according to the
medical
procedure to be performed as known to those skilled in the art. The gas that
is
conditioned by the apparatus may be pressure controlled, volumetrically
controlled or
both.
In some cases, it is desired to supply some agents of pharmacologic material,
separate from other agents (which, as discussed above, could be pharmacologic
agents)
which may be supplied by the heater/hydrator 120. Depending upon the agent, it
may
be desirable to use the heater/hydrator to humidify and heat the insufflation
gas, and
supply the agent separately. Alternatively, one or more agents could be
supplied using
a heater/hydrator while one or more additional agents could be supplied into
the gas
stream separately.
Agents can be supplied through a gas stream, for example, during a
laparoscopy, colonoscopy, gastroscopy, and/or thoracoscopy, or any other
procedure
that requires distention. For example, wllile these procedures are presently
done under
general anesthesia, where uses of therapeutic doses of anesthesia
administered, by way
of example, and not of limitation, into the abdomen during surgery, less, or
no general
anesthesia may be needed, making for faster surgeries, and quicker patient
recovery.
For example, an appendectomy, cholycysectomy, or tubal ligation might be done
without general anesthesia.
While any type of agent could be delivered using the invention, examples of
particular agents that might be delivered in a gas stream during a procedure
include
anesthetic agents, analgesic agents, chemotherapy agents, anti-infective
agents, and
anti-adhesion agents.
Anesthetic agents include, but are not limited to, alcohol, Bupivacaine,
Chloroprocaine, Levobupivacaine, Lidocaine, Mepivacaine, Procaine, Ropivacaine
and
Tetracaine.
Analgesic agents may include, but are not limited to, respiratory agents such
as
Excedrin, Tylenol, DayQuil, NyQuil; centrally acting analgesics such as,
Duraclon,
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Ultrocet and Ultram; miscellaneous analgesics agents such as, Carbatrol,
Hyalgan,
Lidoderm, Nuropin, Neurontin, Phenegran, and Tegretol; as well as narcotics
such as,
Nubain, Darvocet, Dilaudid, Lortab, OxyContin, Percocet, and Vicodin.
Chemotherapy agents, also known as antineoplastic agents, may include, but not
be limited to, Altretamine, Asparaginase, BCG, Bleomycin sulfate, Busulfan,
Carboplatin, Cannustine, Chlorambucil, Cisplatin, Cladribine,
Cyclophosphamide,
Cytarabine, Decarbazine imidazole carboxamide, Dactinomycin, Daunorubicin-
daunomycin, Dexamethasone, Doxorubicin, Etoposide-epipodophyllotoxin,
Floxuridine, Fluorouracil, Fluoxymesterone, Flutamide, Fludarabine, Goserelin,
Hydroxyurea, Idarubicin HCL, Ifosfamide-Isophosphamide, Interferon alfa,
Interferon
alfa 2a, Interferon alfa n3, Irinotecan, Leucovorin calcium, Leuprolide,
Levamisole,
Lomustine, Megestrol, Melphalan-L-phenylalanine mustard, L-sarcolysin,
Melphalan
hydrochloride, MESNA, Meclilorethamine, nitrogen mustard, Methylprednisolone,
Methotrexate-Amethopterin, Mitomycin-Mitomycin C, Mitoxantrone,
Mercaptopurine,
Paclitaxel, Plicamycin-Mithramycin, Prednisone, Procarbazine, Streptozocin-
Streptozotocin, Tamoxifen, 6-thioguanine, Thiotepa-triethylene
thiophosphoramide,
Vinblastine, Vincristine and Vinorelbine tartrate.
Anti-infective agents include those agents classed as antihelminics and
antibiotics. Antibiotics may be further classified as aminoglysosides, anti-
fungal
antibiotics, cephalosporins, b-lactam antibiotics, cl-doramphenical,
macrolides,
penicillins, tetracyclines, miscellaneous antibiotics, antituberculosis
agents, anti-virals,
anti-retrovirals, antimalarials, ouinolones, sulfonainides, sulfones, urinary
anti-
infectives and miscellaneous anti-infectives.
Antihelminics may include by way of example, but not of limitation to,
Thiabendazole.
Aminoglycosides may include by way of example, but not of limitation to,
Amikacin, Gentamicin, Neomycin, Streptomycin and Tobramycin.
Antifungal antibiotics may include by way of example, but not of limitation
to,
Amphotericin B, Amphotericin B, Lipid fonnulation T.E., Fluconazole,
Flucytosine,
Griseofulvin, Itraconazole, Ketoconazole, Nystatin, and Terbinafine.
Cephalosporins may include by way of exainple, but not of limitation to,
Cefaclor, Cefazolin, Cefepime, Cefixime, Cefonicid, Cefotaxine, Cefpodoxine,
Cefprozil, Ceftazidine, Ceftriaxone, Cefuroxime, Cephalexin, and Cephradine.
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B-Lactam antibiotics may include by way of example, but not of limitation to,
Aztreonam, Cefotetan, Cefoxitin, and Imipenem/Cilastatin.
Chloroamphenicol may include by way of example, but not of limitation to,
Chloramphenicol, Chloramphenicol Palmitate, and Chloramphenicol Succinate.
5 Macrolides may include by way of example, but not of limitation to,
Azithromycin, Clarithromycin, Eryth.romycin, Erythromycin Ethyl Succinate and
Erythromycin Lactobionate.
Tetracyclines may include by way of example, but not of limitation to,
Demeclocycline, Doxycycline, Minocycline and Tetracycline.
10 Miscellaneous antibiotics may include by way of exainple, but not of
limitation
to, Bacitracin, Clindamycin, Polymyxin B, Spectinomycin and Vancomycin.
Antituberculosis agents may include by way of example, but not of limitation
to, Ethambutol, Isoniazid, Pyrazinainide, Rifabutin and Rifampin
Antivirals may include by way of example, but not of limitation to, Acyclovir,
15 Amantadine, Famciclovir, Foscarnet, Ganciclovir, Ribavirin, Valacyclovir
and
Valganciclovir.
Antiretrovirals may include by way of example, but not of limitation to,
Abacavir, Amprenavir, Didanosine, Efavirenz, Indinavir, Lamivudine,
Loopinavir,
Nelfinavir, Nevirapine, Ritonavir, Saquinavir, Stavudine, Zalcitabine and
Zidovudine.
20 Antimalarials may include by way of example, but not of limitation to,
Chloroquine, Hydroxychloroquine, Pyrimethamine and Quinine.
Quinolones may include by way of example, but not of limitation to,
Gatifloxacin, Levofloxacin and Ofloxacin.
Sulfonamides may include by way of example, but not of limitation to,
25 Sulfadiazine, Sulfamethoxazole, Sulfasalazine and Sulfisoxazole.
Sulfones may include by way of example, but not of limitation to, Dapsone.
Urinary anti-infectives may include by way of example, but not of limitation
to,
Nitrofurantoin.
Miscellaneous anti-infectives may include by way of example, but not of
30 limitation to, Clofazamine, Co-trimoxazole, Metronidazole and Pentamidine.
Anti-adhesions agents may include by way of example, but not of limitation to,
Aspirin, Calcium channel blockers, Carboxymethylcellulose, Chondroitin
sulfate,
Corticosteroids, Chymase inhibitors, Dextran, Dialysis solution,
Diphenhydramine,
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Fibrin glue, Haparin, Hyaluronic acid, L-Arginine, Methylene blue,
Mifepristone,
Mitomycin C, NSAIDs, Octreotide, Pentoxifylline, Peritoneal transplant,
Photopolymerized hydrogel, Polyethylene glycol, Polyoxamer, Ringers lactate,
Saline,
Surfactant and tissue plasminogen activator.
Also known are solutions or gels such as Hyaluronic acid, Hyalutronate-
carboxymetliylcellulose, Carboxymethylcellulose, Polyethylene glycol, Dextran
70 and
Icodextrin 4%.
The preceding are liquids, solutions or gels which it is believed within the
skill
of those in the art to use in the present invention. Also known are commercial
anti-
adhesion barriers such as hyaluronate-carboxymethylcellulose, oxidized
regenerated
cellulose, polyethylene oxide-oxidized regenerated cellulose, expanded
polytetrafluoroethylene and pericardial patch.
The use of these in the present invention may require shredding, pulverizing
or
powdering togetller with mixing them with a liquid to make them usable in the
present
invention.
The present invention contemplates use of yet to be invented agents of the
above classes, as well as any of those drugs of the above classes which have
not been
listed.
Referring to Figures 16-20, there are shown embodiments of the present
invention which are thought to be particularly useful in providing agents to
be
delivered, along with insufflation gas, whether treated or not, to the abdomen
of a
patient. There is shown an insufflation device, at least one structure
defining at least
one fluid flow path extending at least a portion of the distance between the
insufflation
device and the abdomen of a patient, and a chamber adapted to be coupled to
the at
least one structure and adapted to supply an agent to the interior of the
abdomen
through the at least one structure.
Figure 16 shows an apparatus comprising an insufflation device 915, which may
be such as the Stortz Mode126012 mentioned above, or any other insufflation
device
that supplies insufflation gas to a surgical site. The insufflation device 915
has an
outlet 916 through which it supplies insufflation gas.
There is optionally provided downstream of the insufflation device 915, and in
fluid communication therewith, the heater/hydrator 120 of the present
invention. The
heater/hydrator 120 has an inlet 917 and an outlet 918. A first conduit 919
connects the
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32
insufflation device outlet 916 with the inlet 917 of the heater/hydrator 120,
thus placing
the insufflation device 915 in fluid communication with the heater/hydrator
120.
In any of the embodiments set forth herein, conduits may be short or long,
wide
or narrow. In some cases, the conduits may be separate pieces from devices
they are in
fluid communication with, while in other cases the conduit may be formed
together
with such devices. In some cases, various devices may be connected or coupled
together without conduits between them. In some cases, various devices may be
formed as a single device with multiple chambers. All such einbodiments are
within
the scope of the invention.
The addition of an agent into the gas stream which is going into the patient's
abdomen may be beneficial whether or not the insufflation gas is dry or
humidified, or
warm or cold. The scope of the present invention covers the addition of an
agent under
any conditions. The preferred method is one in which the insufflation gas is
heated and
humidified.
A second conduit 920 is connected at its first end 920A to the outlet 918 of
the
lieater/hydrator 120, and is open at its second end 920B. Either end may
include one or
more connectors, such as, for example, a Luer lock. During surgery, the second
conduit may be connected to, or placed in fluid communication with trocar
assembly
921 which has previously been placed into the abdomen 922 of the patient P,
thus
placing the heater/hydrator in fluid communication with the patient's abdomen.
A
Veres needle or other device could also be used to provide access to the
abdomen
without departing from the scope of the present invention. The first conduit
919, or
second conduit 920, may have a filter attached thereto.
In this embodiment of the present invention, an agent chamber 925 is provided
external and separate of the heater/hydrator 120. The agent chamber 925 has at
least an
outlet 926. A third conduit 927 is connected at its first end 927A to the
outlet 926 of
the agent chamber. The third conduit 927, at its other en&927B, may be in flow
communication with the trocar assembly 921 (or could be in flow communication
with
conduit 920 if an appropriate connector was used).
A two-inlet trocar assembly 930 (Figure 31) may be provided. Or, if desired, a
modified trocar 933 (Figure 32) may be provided. Since the third conduit is
open to
atmosphere, some pressure source, other than the insufflation device 915, is
employed
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to drive the agent in the agent chamber 925 into the insufflation gas stream.
An
example pressure source is described below.
A dispersion device 948 may be used to promote the entry of the agent into the
abdomen 922 of the patient P as an aerosol spray, mist, fog or vapor. It is
believed that
the dispersion device will promote the effectiveness of the agent.
The dispersion device placement may depend on where and how the agent is
introduced to the insufflation gas stream. It is believed that when the agent
chamber
925 is not connected in line, the dispersion device may be anywhere in the
third conduit
927 or in the trocar 921.
Referring now to Figure 17, a modification of the construction shown in Figure
16 is provided. In this embodiment, the insufflation device 915 having outlet
916 is
again provided. The lieater/hydrator 120 has its inlet 917 connected to the
outlet 916 of
insufflation device 915 by the first conduit 919. However, in this embodiment,
the
modified agent chamber 935 (referred to as modified because of having an inlet
and an
outlet), having an inlet 936, and an outlet 937, is placed in-line with the
heater/hydrator
120 and connected thereto by second conduit 920. Therefore, the pressure of
the
insufflation gas may be used to drive the agent, if desired. The term
"modified agent
chamber" is used for convenience and is not meant to create a special
definition of
either "agent chamber" or "modified agent chamber" in the claims. As used in
the
claims, the term "agent chamber" is meant to refer broadly to any chamber that
may
contain an agent.
A fourth conduit 938 is connected to the outlet 937 of agent chamber 935. The
fourth conduit 938 may be used to place the agent chamber 935 in fluid
communication
with the trocar assembly 921 in the abdomen 922 of a patient P during a
surgical
procedure. The dispersion device 948 may be anywhere downstream of the
modified
agent chamber 935, such as interposed or connected to the fourth conduit 938.
As
discussed above, a device other than a trocar 921 could be used to provide
access to the
abdomen, such as, for example, a Veres needle.
One skilled in the art will appreciate that, depending on the nature of the
dispersion device 948, it may be placed in the conduits described herein, with
the fluid
flowing through the dispersion device 948, or around it, or, the dispersion
device 948
could surround the conduit. Depending on the application, for any particular
conduit,
there may be a dispersion device both, in a conduit, and external to it.
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In Figure 18, the agent chamber 925 is connected upstream of the
heater/hydrator 120. It is connected in flow communication with the
heater/hydrator
120 by fifth conduit 940. Fifth conduit 940 may be connected anywhere between
the
outlet 916 of the insufflation device 915 and the inlet 917 of the
heater/hydrator 120 to
place the agent chamber 925 in flow communication with the heater/hydrator
120. As
before, second conduit 920 is connected to the outlet 918 of the
heater/hydrator 120,
and places the heater/hydrator 120 in fluid communication with the patient's
abdomen
through trocar asseinbly 921. As discussed above, a device other than a trocar
921
could be used to provide access to the abdomen, such as, for example, a Veres
needle.
Since the agent chamber 925 is connected in parallel with the insufflation
device 915, the dispersion device 948 may be connected or placed anywhere
downstream of the agent chamber 925, for example, in the second conduit 920.
The embodiment shown in Figure 19 is similar to that shown in Figure 17,
except that the modified agent chamber 935 having inlet 936 and outlet 937 is
placed
upstream of the heater/hydrator 120, instead of downstream thereof. First
conduit 919
may now be connected between the outlet 916 of the insufflation device 915 and
the
inlet 936 of the modified agent chamber, thus placing the modified agent
chamber 935
in fluid communication with the insufflation device 915.
A sixth conduit 941 connects the outlet 937 of the modified agent chamber 935
to the inlet 917 of the heater/hydrator 120. A seventh conduit 942 is
connected to the
outlet 918 of the heater/hydrator 120. Seventh conduit 942 may be placed in
fluid
communication with a trocar 921 assembly which has previously been placed in
the
abdomen 922 of a patient P during a surgical procedure. As discussed above, a
device
other than a trocar 921 could be used to provide access to the abdomen, such
as, for
example, a Veres needle. When gas is flowing from the insufflation device 915,
and
there is agent remaining in the modified agent chamber 935, the agent may be
delivered
into the abdomen 922 of the patient P. As before, dispersion device 948 may be
placed
anywhere downstream of the agent chamber, such as interposed in, or connected
to
seventh conduit 942.
The embodiment shown in Figure 20 is similar to the embodiment shown in
Figure 18, except that the agent chamber 925, having outlet 926 is connected
downstream of the heater/hyd.rator 120, instead of upstream. First conduit 919
is
connected between the outlet 916 of the insufflation device 915 and the inlet
917 of the
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heater/hydrator, thereby placing heater/hydrator 120 in fluid or flow
communication
with the insufflation device 915.
Second conduit 920 is connected to the outlet 918 of the heater/hydrator 120.
As before, second conduit 920 may be placed in flow cominunication with a
trocar
5 assembly 921 that has been placed into the abdomen 922 of a patient P during
a
surgical procedure. As discussed above, a device other than a trocar 921 could
be
used to provide access to the abdomen, such as, for example, a Veres needle.
The
outlet 926 of the agent chamber 925 has an eighth conduit 943 connected
thereto. The
other end of eiglith conduit 943 may be connected in flow communication with
the gas
10 stream coming from the heater/hydrator anywhere between the outlet 918 of
the
heater/hydrator 120 and the trocar assembly 921. Dispersion device 948 may be
placed
anywhere downstream of the agent chamber 925, such as being interposed in, or
connected to, second conduit 920. When pressure is applied to the agent in the
agent
chamber 925, whether or not gas is flowing from the insufflation device 915,
agent may
15 be supplied into the abdomen 922 of the patient P.
Depending on the application, the constructions shown in Figs. 1-20 may be
combined or duplicated to achieve the desired results. For example, one or
more agents
may be introduced through the heater/hydrator 120, and one or more agents may
be
introduced through one or more agent chambers (925,935). Also, any of the
chambers
20 shown may be single or multiple chambers, so as to provide for the addition
of multiple
agents. The gas may be heated and/or humidified, as desired. The chambers may
be
empty chambers, or have various means to absorb or adsorb liquid in them.
Referring now to Figure 21, there is shown one way in wliich agent may be
introduced into an agent chamber (925,935). Although modified agent chamber
935 is
25 illustrated in Figure 21, the apparatus shown will also work with agent
chamber 925.
An external port 950 is provided, which may have a closure member 968 to
regulate
flow through the port 950, into which syringe 951 containing the desired
amount of
agent may be inserted. At the proper time, the surgeon, anesthetist, or other
medical
personnel, will open the closure member 968, if present, and depress the
plunger 952 of
30 syringe 951 to inject the agent into the agent chamber (925,935), where it
will travel to
the patient's abdomen in the manner previously described.
Referring now to Figure 22, there is shown another device that may serve to
introduce agent into an agent chamber (925,935) in various embodiments of the
present
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36
invention. In this embodiment, pump 954 is used to deliver the agent to the
agent
chamber (925,935). An external port 950 is provided to which pump 954, such as
a
peristaltic or other suitable type pump, is connected. A closure member 968
may be
provided to regulate the flow into the port 150. A reservoir (not shown)
containing at
least the desired amount of agent is provided.
At the proper time, the surgeon, anesthetist, or other medical personnel, will
open the closure member 968, if present, activate the pump 954 to supply the
desired
amount of the agent into the agent chamber (925, 935), where it will travel to
the
patients abdomen in the manner previously described. Note that in any of the
embodiment discussed lierein, closure member 968 could be an adjustable valve.
Referring now to Figure 23, there is shown a still further device that may
serve
to introduce agent into an agent chamber (925, 935) in embodiments of the
present
invention. In this einbodiment, a pressurized cylinder 956 which has been pre-
charged
with a desired amount of agent is used to deliver the agent to the agent
chamber (925,
935). An external port 950 is provided to which pressurized cylinder 956 is
connected.
A closure member 968 is interposed between cylinder 956 and port 950. The pre-
charged cylinder, in addition to having a desired amount of agent contained
therein,
may have a predetermined amount of a pressurizing agent, such as an inert gas,
contained therein, and may have apparatus (e.g. an electronically controlled
valve) to
cause the release of the agent at the desired time. At the proper time, the
surgeon,
anesthetist, or other medical personnel, may open the closure member 968, if
present,
and activate the release apparatus to supply the desired amount of the agent
into the
agent chamber, where it will travel to the patients abdomen in the manner
previously
described.
Referring now to Figure 24, there is shown yet another device which may serve
to introduce agent into an agent chamber (925, 935) of the present invention.
In this
embodiment, a flexible bag 958 containing a desired amount of agent is
connected by
tubing 959 to the external port 950. Apparatus (e.g. an adjustable valve) to
control the
release of the agent from the flexible bag 958 may, or may not, be provided,
depending
on the application. The closure member 968 may serve as the release apparatus.
At the
desired time in the surgery, the flexible bag 958 will be squeezed, the
release apparatus,
if present, will be operated, and the agent will be forced into the agent
chamber (925,
935).
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It should be understood that all of the ways of introducing the agent into the
agent chamber (925, 935) shown in Figures 21-24 will work with any of the
embodiments of the invention shown in Figures 16-20. It should further be
understood
that other methods of introducing agent into the chamber (925, 935) may be
used
without departing from the scope of the invention.
Referring now to Figures 25-28, if a separate agent chamber is not desired for
whatever reason, the syringe 951, pump 954, pressurized cylinder 956 and
flexible bag
958 may be used by themselves to supply agent to the embodiments of the
invention
shown in Figures 16-20. An appropriate external port or connector 965 may be
placed
in line in the appropriate conduit so that the external port or connector 965
will be in
the flow path of the insufflation gas. The operation of the various devices
will be as
just described with regard to Figures 21-24.
Refer-ring now to Figure 29, there is shown an additional device that may
serve
as the agent chamber (925, 935) of the present invention. Piezoelectric
chamber 961
comprises a hollow chamber 962 having an inlet 963 and an outlet 964. The
piezoelectric chamber is connected in flow communication witli the appropriate
conduit
to place it in the stream of the insufflation gas 970 when the insufflation
device is in
operation. In the hollow chamber 962 is placed a desired quantity of agent 966
in
liquid form. The agent 966 will be placed in the chamber with the
piezoelectric crystal
965. Piezoelectric crysta1965 may then be energized to activate the crystal..
Activation of the crysta1965 may cause the molecules of the agent to vibrate
at such
speeds as to produce an agent fog 967, which may be drawn into the
insufflation gas
stream 970 and delivered to the patient's abdomen.
With reference to Figure 30, there is shown a furtller alternative embodiment
of
the invention which is believed useful for the administration of agent into
the abdomen
of a patient. This embodiment of the invention involves the use of a modified
syringe
971 being used with a trocar 972. The trocar 972 has a tubular portion 973 and
an
enlarged top portion 974. The modified syringe 971 has a normally sized hollow
body
portion 978 which sealingly accepts the plunger 979 for reciprocal movement in
the
body portion 978. Attached to, or integral with, the body portion 978 is an
elongated,
hollow, tubular, lower portion 980 having a dispersion device 948 mounted at
the distal
end thereof.
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38
In use, agent is drawn into the modified syringe assembly 971, either through
a
needle, or the lower tubular portion 980. If not already attached, the lower
tubular
portion 980 is attached, and the modified syringe 971 is placed into the
trocar assembly
972, with the lower tubular portion 980, and the dispersion device 948,
slidably fitting
in the tubular portion of the trocar 972.
The elongated tubular portion 980 of the modified syringe should be long
enough so that when the modified syringe 971 is inserted in the trocar, the
distal end
980A of the lower tubular portion 980 extends past the end of the tubular
portion 973 of
the trocar 972. In this manner, during surgery, when it is desired to add
agent to the
abdomen, and the modified syringe 971 is fully inserted into the trocar 972,
the
dispersion device 948 may actually be inside the pneumoperitoneum. Therefore,
when
the plunger 979 is depressed, the agent that has previously been drawn into
the
modified syringe 971 may be forced through the dispersion device 948, and may
directly enter the abdomen as an aerosol, spray, mist, fog or vapor, depending
on the
dispersion device 948 used, and the agent. Some agents may not be capable of
being
dispersed in all forms.
Referring now to Figure 31, there is shown a two-inlet trocar 930. Two-inlet
trocar 930 is similar in some respects to trocars known in the art in that it
has a tubular
body portion 975, having an enlarged top portion 975A and has a single inlet
976 for
the admission of insufflation gas, such as that which may be supplied from
insufflation
device 915. Due to the potential desirability of introducing the agent into
the
insufflation gas stream right at the trocar, two-inlet trocar 930 with second
inlet 977
may be desirable. When desired, the insufflation gas stream may enter the two-
inlet
trocar 930 through first inlet 976, and the agent gas stream may enter the
trocar through
the second inlet 977 (or vice versa).
A modification of the trocar construction shown in Figure 31 is shown in
Figure
32. Modified trocar 933 is shown. Modified trocar 933 has a tubular body
portion 975
and enlarged top portion 974 as before. In addition, it has inlet 976.
However, instead
of having a second inlet 977, it has a branch inlet 934 which branches off the
inlet 976
to provide for the agent stream to be connected directly to the modified
trocar 933, but
without the provision of an entirely separate second inlet. A dispersion
device 948 is
optionally provided at the distal end of the branch outlet 934. Closure
members 968 are
optionally provided.
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Referring now to Figure 33, a further embodiment of the invention, which is,
in
some respects similar to the embodiment shown in Figure 32, is shown. This
embodiment of the invention uses most of the construction of Figure 32 in that
the
modified trocar 933 having a lower tubular portion 975 and enlarged top
portion 974 is
used with a single inlet 976 and a branch outlet 934. In this modification,
the branch
inlet is sized and shaped to accommodate a pressurized aerosol spray can
981which has
a desired amount of agent and propellant contained therein.
The pressurized container or spray can 981 has a nozzle 982 with an orifice
that
sliould be chosen, depending on the agent being used, to create an aerosol
spray, mist,
fog, or vapor, if possible. The nozzle 982 may be adapted to be press fit onto
the
branch inlet 934. Because the nozzle may create the desired dispersion,
dispersion
device 948 may be omitted in this embodiment of the invention, but could also
be
included, if desired.
Referring now to Figure 34, there is shown a flow chart illustrating a series
of
steps in which various embodiments of the invention may be used. At Box 1000,
the
first step is to gain access to the abdomen 922 of the patient P. This may be
done by
any of several well known surgical techniques known to those skilled in the
art of
surgery, and will usually involve making a surgical incision in the patient's
abdomen
and inserting a trocar therein.
Next (Box 1010) a gas stream of insufflation gas may be introduced into the
patient's abdomen 922. This will involve the steps of providing an
insufflation device
120, creating a flow path between the insufflation device and the trocar, and
initially
inflating the patient's abdomen with about 2-3 liters of insufflation gas.
After the
initial inflation of the patient's abdomen, insufflation gas may continue to
flow into the
abdomen at the desired rate or may cease to flow depending upon the particular
circumstances.
The agent, or agent stream may then be introduced into the pneumoperitoneum
along with the insufflation gas (Box 1020). A predetermined concentration
suitable for
a particular procedure may be cliosen.
Once the desired concentration of agent has been determined for the surgical
procedure being performed, there are several ways the agent may be introduced
into the
pneumoperitoneum, as described above.
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Regardless of the method used, when the desired amount of agent has been
introduced, the flow of agent or agent stream will be shut off (Box 1030).
Throughout this application, various patents publications are referenced. The
disclosures of these,publications in their entireties are hereby incorporated
by reference
5 into this application in order to more fully describe the state of the art
to which this
invention pertains.
Although the present process has been described with reference to specific
details of certain embodiments thereof, it is not intended that such details
should be
regarded as limitations upon the scope of the invention except as and to the
extent that
10 they are included in the accompanying claims.
25
