U.S. patent number 3,858,572 [Application Number 05/301,564] was granted by the patent office on 1975-01-07 for insufflation device.
This patent grant is currently assigned to The Kendall Company. Invention is credited to William J. Binard, John F. Dye.
United States Patent |
3,858,572 |
Binard , et al. |
January 7, 1975 |
INSUFFLATION DEVICE
Abstract
A device for insufflating a patient's body from a source of
pressurized gas. The device includes a flexible gas reservoir
having an inlet port, an outlet port, and means for indicating a
preselected volume of gas in the reservoir. Means is provided for
connecting the gas source to the inlet port of the reservoir for
filling the reservoir with the preselected volume of gas from the
gas source. The device has body penetrating means for introducing
gas into the patient's body, and means for pumping a selected
volume of gas from the outlet port of the filled reservoir through
the penetrating means and into the body.
Inventors: |
Binard; William J. (Barrington,
IL), Dye; John F. (Barrington, IL) |
Assignee: |
The Kendall Company (Walpole,
MA)
|
Family
ID: |
23163930 |
Appl.
No.: |
05/301,564 |
Filed: |
October 27, 1972 |
Current U.S.
Class: |
600/560;
604/26 |
Current CPC
Class: |
A61M
5/007 (20130101); A61M 13/003 (20130101) |
Current International
Class: |
A61M
5/00 (20060101); A61b 019/00 () |
Field of
Search: |
;128/2A,184,DIG.13,12,213,266,215,216,349B |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
611,037 |
|
Jun 1926 |
|
FR |
|
594,678 |
|
Jun 1925 |
|
FR |
|
791,947 |
|
Oct 1935 |
|
FR |
|
Primary Examiner: Howell; Kyle L.
Claims
We claim:
1. A device for use with a source of pressurized gas for
insufflating a patient's body, the device comprising
a gas reservoir for retaining a volume of gas at approximately
atmospheric pressure, said reservoir formed from a gas impervious
flexible material and including an inlet port and an outlet
port;
balloon means for automatically releasing gas from said reservoir
to the atmosphere when said gas reaches a predetermined pressure,
thereby preventing overinflation of said reservoir;
first conduit means communicating with said inlet port and
connectable to said source of pressurized gas for the filling of
said reservoir;
body penetrating means for introducing gas into the patient's body;
and
second conduit means connecting said reservoir outlet port and said
body penetrating means and including means for pumping a selected
volume of gas from said reservoir to said body penetrating means.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device for insufflating a
patient's body.
2. Description of the Prior Art
Pneumography is the use of a gas as a contrast medium for
radiographic visualization of the body interstices. When
insufflated into a patient's body, gases separate tissues and
organs in the body, and since they have lower densities than the
surrounding body tissues and organs, they are delineated on X-rays
and outline body organs, cavities, and intestines, to facilitate
radiography. Historically, insufflation has also been utilized to
dissect facial planes of tissues, such as in a tubal ligation
procedure for sterilization, to inflate collapsed body structures,
and for diagnostic and/or treatment of the brain
(pneumoencephalography).
As a particular example of the usefulness of an insufflation
procedure, an iodine based dye has been introduced into the kidneys
in retrograde and intravenous pyelogram procedures to obtain X-rays
of the kidneys. Although the internal structure of the kidneys is
shown in the X-rays during a retrograde or intravenous pyelogram,
the outline of the kidneys does not clearly appear during such a
procedure, and certain problems, such as a tumor on a kidney, will
not necessarily be detected through use of either of these
procedures. Accordingly, a gas has been insufflated into the
retroperitoneal space of the patient to separate the kidneys from
the surrounding tissues and present the outline of the kidneys in
sharp contrast during radiography. Moreover, it has been learned
that an increasing number of patients are allergic to the dye used
in retrograde and intravenous pyelograms, and the above described
perirenal insufflation procedure presents a desired alternative in
such a case.
It has been discovered that insufflation of the patient is best
carried out through the use of carbon dioxide, due to the possible
danger of gas embolism when a different gas is utilized. Since
carbon dioxide is rapidly absorbed and dissolved by the body, the
danger of gas embolism is minimized when carbon dioxide is used. A
larger volume of carbon dioxide, relative to other gases, must be
insufflated into the body due to its rapid absorption by the body
and a sufficient quantity of carbon dioxide must be available for
insufflation. For example, two liters of carbon dioxide is adequate
for a perirenal insufflation procedure. However, it is desirable
that the volume of gas insufflated into the body be known. This
follows since if carbon dioxide is not used, the danger of gas
embolism is present if too much gas is insufflated. If carbon
dioxide is utilized for insufflation, and a given volume of gas,
such as two liters, has been injected into the body without
achieving the desired results, the procedure should be verified to
determine whether some deficiency may be present. For example, a
needle, utilized for insufflating the carbon dioxide, may have been
incorrectly positioned in the patient, or the gas may have escaped
into another part of the body.
In the past, insufflation has usually been accomplished by
injecting gas from a pressurized gas source directly into the
patient. The flow rate of the pressurized gas has been utilized to
estimate the desired amount of gas for the insufflation, which has
proven inadequate since the volume of pressurized gas introduced
from the source is not readily determined by the flow rate of the
gas. Also, the pressurized gas source has been connected to a
syringe, and the pressurized gas is pumped by the syringe from the
source into the patient. However, since the gas is under a
relatively high pressure, relative to atmospheric pressure, the
volume of gas at atmospheric pressure is still not known, and the
pressure may force a plunger in the syringe out of the syringe
during pumping.
SUMMARY OF THE INVENTION
A principal feature of the present invention is the provision of a
device of simplified construction for insufflating a patient's body
from a source of pressurized gas.
The insufflating device of the present invention includes a
flexible gas reservoir having an inlet port, an outlet port, and
means for indicating a preselected volume of gas in the reservoir.
Means is provided for connecting the gas source to the inlet port
of the reservoir for filling the reservoir. The device has body
penetrating means for introducing gas into the patient's body, and
means for pumping a selected volume of gas from the outlet port of
the filled reservoir through the penetrating means and into the
body.
A feature of the invention is that the indicating means designates
when the reservoir is filled with the preselected volume of
gas.
Another feature of the invention is that the indicating means may
be utilized to prevent overinflation of the reservoir.
Still another feature of the invention is that the gas in the
filled reservoir is retained at approximately atmospheric
pressure.
Yet another feature of the invention is that the volume of
insufflated gas may be determined by the pumping means.
Further features will become more fully apparent in the following
description of the embodiments of this invention and from the
appended claims.
DESCRIPTION OF THE DRAWINGS
In the drawings:
FIG. 1 is a fragmentary perspective view, partly broken away, of
the insufflating device of the present invention as connected to a
source of pressurized gas;
FIG. 2 is a sectional view taken substantially as indicated along
the line 2--2 of FIG. 1;
FIG. 3 is a fragmentary perspective view of the device of FIG. 1
during filling of a reservoir in the device from the gas
source;
FIG. 4 is a fragmentary plan view, taken partly in section, of the
device of FIG. 1, during operation of pumping means in the device
to withdraw gas from the filled reservoir;
FIG. 5 is a fragmentary elevational view on an enlarged scale,
taken partly in section, of the device of FIG. 1, during operation
of the pumping means to force gas through the penetrating means in
the device;
FIG. 6 is a fragmentary elevational view of another embodiment of
the penetrating means; and
FIG. 7 is a perspective view, partly broken away, of a package for
the device of FIG. 1.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to FIG. 1, there is shown a device, generally
designated 10, for insufflating a patient's body from a source of
pressurized gas designated generally 12. The insufflating device 10
includes a flexible gas reservoir 14, means 16 connecting the gas
source 12 to the reservoir 14, body penetrating means 18 for
introducing gas into the patient's body, and means 20 for pumping a
selected volume of gas from the reservoir 14 through the
penetrating means 18 and into the body.
The gas source 12 may have a valve 22 for controlling the
introduction of pressurized gas from the source 12 into the
connecting means 16. The connecting means 16 comprises a tube 24
which may have a nipple 26 for convenience in attaching the end of
the tube remote the gas source to the reservoir 14. Any suitable
means, such as a sleeve 28, may be utilized to connect the other
end of the tube 24 to the source 12.
The reservoir 14 is preferably relatively inelastic, and may be
made from a flexible material, such as plastic. As shown, the
reservoir 14 may be constructed from a pair of flexible sheets 30a
and 30b, which are joined at their edges along a line 32, such as
by RF sealing, to form a closed bag having an internal chamber
34.
The reservoir 14 has a push valve 36 of a type well known to the
art, which defines an inlet port 38 to the reservoir. When the
valve is open communication is established between the inlet port
38 and the chamber 34 of the reservoir. The nipple 26 of the tube
24 may be connected to the inlet port 38 of the reservoir, as
indicated by the arrow in the drawing, and the valve is constructed
to open when the nipple 26 is so attached to establish
communication between the gas source 12 and the reservoir chamber
34. When the tube nipple 26 is removed from the inlet port 38, the
valve 36 closes to prevent passage of air out of the reservoir
through the inlet port. The reservoir also has a nipple 40 secured
to the reservoir which defines an outlet port 42 of the
reservoir.
The reservoir includes means 44 for indicating when a preselected
volume of gas is introduced into the reservoir from the gas source
12. As shown in FIGS. 1 and 2, a preferred form of the indicating
means 44 comprises a balloon 45 which is secured to the reservoir
and which communicates with the chamber 34. The balloon may be
secured to the reservoir by a pair of annular members 47a and 47b,
as best shown in FIG. 2. The annular member 47b is secured to the
wall 49 of the reservoir, and the annular member 47a is snugly
received in the inside of the member 47b. The open end 51 of the
balloon 45 is positioned over the outside of the member 47a, as
shown, and the member 47a is depressed into the member 47b to
secure the balloon 45 in place. The inside of the balloon 45 then
communicates with the inside of the reservoir through an aperture
53 in the reservoir wall 49. The operation of the indicating means
44 is described in greater detail below.
As illustrated in FIG. 1, the pumping means 20 includes a valve
assembly 46 and a pump or syringe 48, with the syringe 48 being
removably connected to the valve assembly 46 for use, as indicated
by the direction of the arrow in the drawing. As best shown in FIG.
5, the valve assembly has an inlet opening 50, an outlet opening
52, and a passageway 54 which communicates with the inlet and
outlet openings 50 and 52 through valves. A first one-way valve 56,
such as a flap valve, is secured in the valve assembly 46 adjacent
the inlet opening 50, such that the valve 56 permits the passage of
gas from the inlet opening 50 into the passageway 54, but prevents
passage of gas from the passageway 54 to the inlet opening 50. The
valve assembly also has a second one-way valve 58, such as a flap
valve, adjacent the outlet opening 52. The second valve 58 permits
passage of gas from the passageway 54 to the outlet opening 52, but
prevents passage of gas from the outlet opening 52 to the
passageway 54.
The syringe 48 is of a well-known type, and has an outer body 60, a
cavity 62, a plunger 64 slidably received in the cavity 62, and a
tip 66 removably attached to a flange 68 in the valve assembly 46.
When the syringe 48 is attached to the valve assembly 46, the
syringe cavity 62 communicates with the passageway 54 of the valve
assembly, and the syringe plunger 64 is utilized to withdraw and
force gas from and into the passageway 54.
As shown in FIGS. 1 and 4, a tube 70 communicates between the
outlet port 42 of the reservoir 14 and the inlet opening 50 of the
valve assembly 46, and serves as means connecting the outlet port
42 and the inlet opening 50. If desired, one end 72 of the tube 70
may have a nipple 74 to facilitate connection of the tube 70 to the
valve assembly 46, and the other end 76 of the tube 70 is connected
to the reservoir nipple 40.
As shown in FIGS. 1 and 5, the penetrating means 18 may comprise
hollow needles 78, or, as shown in FIG. 6, a flexible catheter 80
which may be secured to a hollow needle 82 having a relatively
short cannula 84. The particular type of penetrating means utilized
is determined by the type of insufflation procedure performed,
during which the penetrating means is inserted into the patient's
body, and gas is introduced through the penetrating means into the
body.
The type of insufflation procedure performed also determines
whether one or more needles or catheters are needed for the
procedure. If a single needle or catheter is utilized for the
penetrating means, the penetrating means may be connected to the
outlet opening 52 of the valve assembly 46 by a tube having a
sufficient length. However, if the insufflation procedure requires
a pair of needles or cathethers, or combination thereof, a Y-shaped
connector 86 may be removably attached to the valve assembly 46,
such that it communicates with the outlet opening 52, and a pair of
tubes 88a and 88b may be connected between the connector 86 and the
penetrating means 18 to establish communication between the outlet
opening 52 and the penetrating means. If desired, the end of the
tubes 88a and b remote the connector 86 may have nipples 90a and
90b, respectively, in order that the penetrating means 18 may be
conveniently attached to the nipples, as indicated by the direction
of the arrow in FIG. 1. Additionally, a pair of clamps 92a and 92b
of a well-known type are positioned on the tubes 88a and b,
respectively, to selectively open and close the tubes, as
desired.
In operation, the tube 24 is connected to the gas source 12 by the
sleeve 28, and the tube nipple 26 is secured to the inlet port 38
of the reservoir 14, as shown in FIG. 1, to open the valve 36 and
establish communication between the tube 24 and the reservoir
chamber 34. Next, the control valve 22 of the gas source 12, which
is preferably carbon dioxide to prevent the possibility of gas
embolism to the patient, is opened to introduce the gas into the
chamber 34. As the gas fills the chamber 34, the flexible walls of
the reservoir expand and the reservoir inflates, as shown in FIG.
3. Once the reservoir is filled with a preselected volume of gas,
the balloon 45 of the indicating means 44 expands to indicate that
the reservoir has been filled with the desired amount of gas. The
volume of gas retained in the chamber is primarily determined by
the size of the chamber, and may be preselected according to the
requirements of a desired insufflation procedure. For example, the
filled reservoir may retain two liters of gas for a perirenal
insufflation procedure.
The balloon 45 also serves as means to prevent overinflation of the
reservoir, since the balloon will burst prior to rupture of the
reservoir. It is apparent that any suitable device may also be
utilized to prevent overinflation of the reservoir, such as
knock-out plugs.
Once the balloon 45 has inflated, the control valve 22 on the gas
source is closed, and the tube nipple 26 is removed from the inlet
port 38 to close the valve 36 and prevent passage of gas from the
chamber 34 through the inlet port 38. When the balloon 45 is
inflated, gas in the reservoir is retained at a pressure slightly
greater than atmospheric pressure, and the balloon contracts to
force gas from the chamber 34 through the outlet port 42 into the
remainder of the device 10, thus purging air from this part of the
device. When the device has undergone sufficient purging or
bleeding, which may be indicated by deflation of the balloon 45,
the clamps 92a and b may be used to close the tubes 88a and b and
prevent further escape of gas until use of the device on the
patient.
The penetrating means 18 should be properly positioned in the
patient according to the particular insufflation procedure being
performed, and the tube nipples 90a and b may then be connected to
the penetrating means preparatory to use of the device. If the
clamps 92a and b have been used to close the tubes 88a and b, they
are then opened to establish communication between the valve
assembly 46 and the penetrating means 18.
Next, the plunger 64 of the syringe 48 is partially retracted from
the syringe outer body 60, as indicated by the direction of the
arrow in FIG. 4, and gas is then withdrawn from the chamber 34
through the tube 70, the first valve 56, and the passageway 54 into
the syringe cavity 62, as indicated by the direction of the arrows
in the drawing. The second valve 58 prevents passage of gas from
the outlet opening 52 to the passageway 54 when the syringe plunger
64 is retracted. The syringe plunger 64 is then pushed into the
syringe outer body 60, as indicated by the direction of the arrow
in FIG. 5, and gas, previously retained in the syringe cavity 62,
is forced through the passageway 54, the second valve 58, the tubes
88a and b, the penetrating means 18, and into the patient's body,
as indicated by the direction of the arrows in the drawing. When
the syringe plunger 64 is pushed into the syringe body 60, the
first valve 56 prevents passage of gas from the passageway 54 to
the inlet opening 50 and back to the reservoir chamber.
As shown in FIG. 1, the syringe body 60 may be calibrated by
indicia 94, and the indicia 94 may be utilized to withdraw a
selected volume of gas from the reservoir chamber when the syringe
plunger 64 is retracted from the syringe body 60, by retracting the
plunger to a selected indicium 94. The selected volume of gas is
then forced into the patient's body when the syringe plunger is
pushed into the syringe body. The total volume of gas injected into
the patient's body may readily be determined by counting the number
of repetitive plunger strokes of the syringe. Alternatively, if the
total volume of gas retained in the filled reservoir is
approximately equal to the desired amount of gas to be insufflated
into the patient, the pumping means 20 may be used until the
reservoir has collapsed and the gas has been removed from its
chamber.
As pumping of gas from the filled reservoir proceeds, the flexible
walls of the reservoir slowly settle as the gas is removed from its
chamber. During this time, the gas in the reservoir chamber remains
at approximately atmospheric pressure since the reservoir is
relatively inelastic and does not compress the gas in the chamber,
other than that caused by the slight weight of the reservoir walls
itself. Since the gas remains at approximately atmospheric pressure
in the chamber, the volume of gas at atmospheric pressure
introduced into the patient during insufflation may readily be
determined and controlled by the pumping means 20. Although the
pumping means has been described with use of a syringe, it is
apparent that any suitable pump may be utilized which may pump gas
in a manner such that the volume of gas pumped is known.
A package 94 for the insufflation device is shown in FIG. 7, which
comprises a box 95, a tray 96 for retaining components of the
device, and a cover 99 for the box, such as a lid. The reservoir 14
of the device may have a pair of flaps 97 extending from opposing
ends of the reservoir, and the reservoir may be secured in the
lower part of the box 95 by attaching the flaps 97 to opposing
sides of the box by suitable means, such as staples 98. The
component tray 96 is placed in the box 95 over the reservoir 14,
and the cover 99 is closed for the packaging of the device. During
use of the device, the reservoir is conveniently retained in the
box and may be inflated from the gas source in this location.
The foregoing detailed description is given for clearness of
understanding only, and no unnecessary limitations should be
understood therefrom, as modifications will be obvious to those
skilled in the art.
* * * * *