U.S. patent number 3,768,484 [Application Number 05/295,725] was granted by the patent office on 1973-10-30 for gastric cooling apparatus.
This patent grant is currently assigned to A. Robert Lawrence. Invention is credited to Andrew Gawura.
United States Patent |
3,768,484 |
Gawura |
October 30, 1973 |
**Please see images for:
( Certificate of Correction ) ** |
GASTRIC COOLING APPARATUS
Abstract
A gastric cooling apparatus which can be used for general
cooling but which is especially adapted for local cooling, to
reduce blood flow in the vessels supplying the stomach wall of a
person. The gastric cooling apparatus includes a flexible,
inflatable bag for insertion into a patient's stomach and to
contain a predetermined amount of distilled water. A water cooling
means, a vacuum operated reservoir means, and a directional flow
control shunt valve are operatively interconnected, whereby when
vacuum is applied to the reservoir means, said vacuum will operate
the reservoir means to withdraw a first predetermined amount of
water from said bag through said shunt valve, and then block off
said vacuum to permit said first predetermined amount of water to
flow by gravity from said reservoir means and through said shunt
valve to said water cooling means while simultaneously forcing a
second predetermined amount of cooled water out of said cooling
means and into said bag.
Inventors: |
Gawura; Andrew (Dearborn,
MI) |
Assignee: |
Lawrence; A. Robert (Oak Park,
MI)
|
Family
ID: |
23138979 |
Appl.
No.: |
05/295,725 |
Filed: |
October 6, 1972 |
Current U.S.
Class: |
607/105;
604/909 |
Current CPC
Class: |
A61F
5/003 (20130101); A61F 5/0036 (20130101); A61F
7/123 (20130101) |
Current International
Class: |
A61F
5/00 (20060101); A61F 7/12 (20060101); A61f
007/00 () |
Field of
Search: |
;128/399-401,303.1,2 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Trapp; Lawrence W.
Claims
What is claimed is:
1. A gastric cooling apparatus comprising:
a. a flexible, inflatable bag for insertion into a patient's
stomach;
b. a water cooling means having an inlet and an outlet;
c. a vacuum operated reservoir means operably connected to a vacuum
source;
d. a directional flow control shunt valve;
e. means operatively interconnecting said shunt valve, said
reservoir means, said water cooling means and said flexible,
inflatable bag, whereby when vacuum is applied to the reservoir
means, said vacuum will operate said reservoir means to withdraw a
first predetermined amount of water from said bag through said
valve, and then block off said vacuum to permit said first
predetermined amount of water to flow by gravity from said
reservoir means and through said valve to said water cooling means
while simultaneously a second predetermined amount of cooled water
is forced out of said cooling means and into said bag.
2. A gastric cooling apparatus as defined in claim 1, wherein:
a. said vacuum operated reservoir means includes a cylindrical
reservoir body having a vacuum passage connected at one end thereof
which is connected to said vacuum source, and the other end thereof
being connected to said shunt valve, and a float valve operatively
mounted in said reservoir body for blocking said vacuum passage
when a predetermined amount of water has been drawn into said
reservoir body.
3. A gastric cooling apparatus as defined in claim 2, wherein:
a. said float valve includes a hollow cylindrical body having a
diaphragm on one end thereof for blocking said vacuum passage and
being open at the other end thereof.
4. A gastric cooling apparatus as defined in claim 3, wherein:
a. said float valve includes a plurality of ports formed through
the wall of said cylindrical body and a weight means movably
mounted inside of said cylindrical body.
5. A gastric cooling apparatus as defined in claim 4, wherein:
a. said reservoir means cylindrical body is provided with a vent
means at said one end thereof.
6. A gastric cooling apparatus as defined in claim 5, wherein:
a. said reservoir means vacuum passage is provided with a check
valve means.
7. A gastric cooling apparatus as defined in claim 1, wherein:
a. said flow control shunt valve includes means for providing a
first circuit therethrough to interconnect said bag with said
reservoir means when said reservoir means is vacuum operated, and a
second circuit therethrough to interconnect said bag with said
water cooling means and said reservoir means when said first
predetermined amount of water flows by gravity from said reservoir
means so as to simultaneously force said second predetermined
amount of cooled water into said bag.
8. A gastric cooling apparatus as defined in claim 1, wherein said
flow control shunt valve includes:
a. a body;
b. a first passage means formed in said body and having one end
interconnected to said bag and the other end connected to the
outlet end of said water cooling means;
c. a second passage means formed in said body and having one end
connected to said reservoir means and the other end connected to
said first passage means at a point intermediate its ends;
d. said connecting means including conduit means connecting the
inlet end of said water cooling means to said second passage means
at a point intermediate its ends; and,
e. a check valve means operatively mounted in each of said first
and second passage means at said other ends for controlling the
flow of water through the water cooling means when the reservoir
means discharges water by gravity and for blocking water flow
through the water cooling means when the reservoir means draws
water from the bag.
9. A gastric cooling apparatus as defined in claim 8, wherein:
a. each of said check valve means comprises a ball check valve.
10. A gastric cooling apparatus as defined in claim 8,
including:
a. a temperature indicating means operatively mounted in said first
passage means in said body for indicating the temperature of the
water flowing therethrough.
Description
SUMMARY OF THE INVENTION
This invention relates generally to a gastric cooling apparatus
especially adapted for hypothermically treating locally a condition
of the human body, as hemorrhages in the upper gastrointestinal
tract.
Upper gastrointestinal hemorrhages continue to be a major threat to
life despite refinements of medical and surgical therapy.
Approximately 16 percent of patients having peptic ulcers of the
duodenum have complications caused by hemorrhages. There are also
many other causes of hemorrhages in the upper gastrointestinal
tract. Mortality due to severe bleeding from duodenal ulcers occurs
in approximately 6 to 13 percent of those cases, and in such cases
treated surgically, the mortality rate is somewhat higher.
The age of the patient, coincident disease, and duration of
bleeding are the principle determining factors in the prognosis.
The age of the patient and the coincident disease are usually known
when the patient is first seen. The crucial question is how long
and how severely the patient will bleed. Conservative therapy is
then directed toward replacing blood and limiting or stopping blood
loss with the realization that mortality and the risk is rising
rapidly if this is not achieved in the first 48 hours. Continued
loss of blood after 48 hours usually constitutes a strong
indication for surgical intervention, and the surgeon is often
presented with a high risk patient.
Local gastric hypothermia has long been a part of the procedure for
treating hemorrhages in the upper gastrointestinal tract. One form
of local gastric hypothermia is the use of ice water lavage by
confining the coolant to a balloon and providing a mechanical means
to circulate the coolant and control its temperature. It has been
found that local cooling reduces blood flow in the vessels
supplying the stomach wall, decreases motility of the stomach and
inhibits the secretion of hydrochloric acid and pepsin from the
gastric mucosa. In addition, there is some local tamponade effect
of the balloon in close apposition to the bleeding site or sites
within the mucosa.
Heretofore, a water lavage method has been used which included the
insertion of a tube into a patient and then injecting a
predetermined amount of ice water into the patient's stomach
through the tube, and after a few minutes, withdrawing the water
with the same device as, for example, a syringe. This procedure was
repeated time and time again until no sign of blood was found along
the Levine tube fastened to the syringe. A disadvantage of this
method is that it is slow and an attendant is constantly
required.
Other methods for cooling a patient's stomach have been employed
which include the use of a ballon having a plurality of conduits
for conducting coolant into the balloon and then out of the
balloon, and with the coolant comprising alcohol. A disadvantage of
the last mentioned method of hypothermia is that there is danger of
freezing the stomach of the patient. Also, if the balloon is broken
or punctured, the alcohol is dumped into the patient's body with a
resultant injurious effect on the patient. Furthermore, a
refrigeration unit is required and a technician is required to be
present at all times to keep continuous watch on the equipment. A
further disadvantage of such prior art devices is that they require
a double tube, and accordingly, it is difficult to pass a double
tube down into the stomach of a patient, and it is very
uncomfortable to the patient.
In view of the foregoing, it is an important object of the present
invention to provide a novel and improved gastric cooling apparatus
which overcomes the aforementioned disadvantages of the prior art
gastric cooling apparatuses.
It is another object of the present invention to provide a novel
and improved gastric cooling apparatus which is simple and compact
in construction, economical to manufacture, and which is efficient
in operation.
It is still another object of the present invention to provide a
novel and improved gastric cooling apparatus which includes a
flexible, inflatable bag for insertion into the stomach of a
patient, a water cooling means, a vacuum operated reservoir means
operatively connected to a vacuum source, a flow control shunt
valve, fluid conduit means operatively interconnecting said shunt
valve, said reservoir means, said water cooling means and said
flexible, inflatable bag, whereby when vacuum is applied to the
reservoir means, said vacuum will operate said reservoir means to
withdraw a first predetermined amount of water from said bag
through said valve, and then block-off said vacuum to permit said
first predetermined amount of water to flow by gravity from said
reservoir means and through said valve to said water cooling means
while simultaneously forcing a second predetermined amount of cool
water out of said cooling means and into said bag. The bag
comprises an ordinary toy plastic balloon which affords an
automatic means of removing gases diffusing into the balloon and to
prevent undetected gastric distension. Accordingly, since the water
is not pumped into the balloon, it is "fail-safe" in that the
patient can only receive an amount of water equal to the contents
of the balloon if the balloon were to break or be punctured. In
case of any failure in the apparatus circuit, the result is merely
the stoppage of the cycle. The use of ice and water affords
excellent control of temperature, as well as freedom from hazard of
thermostatic control failure as might occur in a refrigeration unit
of the prior art apparatuses. The gastric cooling apparatus of the
present invention comprises a single small diameter nasogastric
tube for attachment to the balloon and for passing down through the
nasal passage of the patient so as to avoid the discomfort of a
large double channel tube which is necessary in the continuous flow
methods employed in the prior art devices. Also, the simplicity of
operation of the apparatus of the present invention allows the
nursing staff at the bedside to have full and safe control of the
procedure without the need for any special attendant or nursing
care. The temperature of the water and of the patient is constantly
monitored by a suitable thermistor probe in the circuit and by
rectal temperatures, respectively. A warming blanket may be
employed for comfort as well as prevention of general
hypothermia.
The gastric cooling apparatus of the present invention is also
advantageous because it is soundless and disposable.
Other features and advantages of this invention will be apparent
from the following detailed description, appended claims, and the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a top plan view of a gastric cooling apparatus, made in
accordance with the principles of the present invention.
FIG. 2 is a broken, elevational section view of the structure
illustrated in FIG. 1, taken along the line 2--2 thereof, looking
in the direction of the arrows, and showing the gastric cooling
apparatus in an operative condition for initiating a cycle to
withdraw water from a balloon in a patient's stomach.
FIG. 3 is a horizontal, section view of the structure illustrated
in FIG. 2, taken along the line 3--3 thereof, and looking in the
direction of the arrows.
FIG. 4 is a broken, elevational section view, similar to FIG. 2,
and showing the gastric cooling apparatus in an operative condition
for initiating a cycle to feed cooled water into a balloon in a
patient's stomach.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to the drawings, and in particular to FIG. 2, the
numeral 8 generally designates a flexible, inflatable bag in the
form of an ordinary toy balloon, which is operatively connected to
a directional flow control shunt valve generally indicated by the
numeral 10 and to a vacuum operated fluid reservoir generally
indicated by the numeral 9. The balloon 8 may be made from any
suitable plastic material, and it is porous to the extent that the
acids and gases that accumulate in a patient's stomach will pass
into the balloon and will be sucked out in the next cycle of water
and drawn from the balloon 8.
The balloon 8 is provided with a narrow neck 11 that is provided
with a passage 12 through which is extended one end 13 of a
suitable nasogastric tubing 14. The tubing 14 is made from any
suitable plastic material, as for example, from "TEFLON" or
"DELRIN" plastic. The tubing 14 would be adhered to the outer
surface of the fluid entrance passage 12 by any suitable means, as
by a suitable adhesive. As shown in FIG. 2, the inner end 13 of the
tubing 14 is provided with a plurality of outlet ports 15 and an
end opening 16. The tubing 14 preferably has a 3/16 inch outer
diameter and an 5/8 inch inner diameter to provide a desired flow
of water therethrough.
As shown in FIG. 2, the outer end 17 of the naso-gastric tube 14 is
operatively mounted over the outer end 18 of a fitting 19. The
fitting 19 has an enlarged inner end 20 which is adhered by any
suitable adhesive or cement in one end of an enlarged flow passage
21 in a shunt valve block 22. The fitting 19 is provided with a
passage 23 therethrough for communicating the passage 21 with the
tubing 14. The other end of the valve passage 21 communicates with
a reduced diameter passage 24. A valve seat 25 is formed at the
inner end of the reduced diameter passage 24 for the reception of a
suitable ball check valve 26. The outer end of the passage 24
communicates with an enlarged threaded passage 27 in which is
threadably mounted a suitable tubing fitting 28 which has
operatively connected thereto a suitable plastic tubing 29 made
from the same material as the tubing 14.
The other end of the tubing 29 is operatively connected to the
outlet end 30 of a suitable refrigerated copper tube cooling unit,
generally indicated by the numeral 31. Any conventional suitable
cooling unit may be employed. The inlet end 32 of the cooling unit
31 is operatively connected to one end of a suitable plastic tubing
33 made from the same material as the tubings 14 and 29. The other
end of the tubing 33 is operatively connected to a fitting 34 which
is threadably mounted in a threaded hole 35 in the valve block 22.
The threaded passage 35 is disposed perpendicular to the first
fluid passage 21 and a second fluid passage 37 in the block 22. The
passage 37 communicates with the threaded passage 35 through an
interconnecting bore or passage 36.
One end of the passage 37 communicates with a reduced diameter
passage 38 which in turn communicates with an enlarged passage 38a
that is enclosed by a plug 41. The plug 41 is adhered in place in
the bore 38a by any suitable means, as by a suitable adhesive or
cement. A valve seat 39 is formed at the inner end of the passage
33 and operatively receives a ball check valve 40. The ball check
valves 26 and 40 may be made from steel or any other suitable
material. The bore 38a is in communication with a passage 42 that
is connected to the passage 21.
As shown in FIG. 2, a means for monitoring the temperature of the
fluid in the passage 21 is provided, and it comprises a
conventional thermistor probe 44 which has its inner end 43
disposed in the passage 21. The thermister probe 44 is operatively
mounted in a fitting 45 which is fixedly mounted in a bore 47
inside of the valve block 22, and with the inner end 43 of the
probe extending through an interconnecting passage 43 into the
passage 21.
As shown in FIG. 2, the other end of the passage 37 is enclosed by
the inner end 48 of a fitting 49. Fitting 49 is secured in place by
any suitable means, as by a suitable adhesive or cement. The
fittings 19, 45 and 49, the plug 41, and the valve body or block
22, may be made from any suitable material, as for example, a
suitable plastic material. The fitting 49 is provided with a
reduced outer end 50 and with a passage 51 formed therethrough. The
passage 51 communicates the valve passage 37 with the interior of a
suitable plastic tubing 53. One end 52 of the tubing 53 is fixedly
secured by any suitable means to the fitting outer end 50. The
other end 54 of the tubing 53 is fixedly secured by any suitable
means to the reduced outer end 56 of a suitable fitting 57 on the
reservoir body 55. The fitting 57 has an enlarged inner end which
is secured in a central axial bore in the lower end wall 60 of the
reservoir body 55. A passage 59 through the fitting 57 communicates
the tubing 53 with a interior chamber 61 in the reservoir body
55.
As shown in FIG. 2, the reservoir 9 includes the cylindrical body
55 which is made from a suitable plastic material, and which has
its upper end enclosed by a cap generally indicated by the numeral
62. The cap 62 includes a plate 63, on the inner side of which is
formed a circular, inwardly extended flange 64 that is seated in
the upper end of the cylinder or reservoir body 55. The flange 64
is secured in place by any suitable means, as by a suitable
adhesive or cement. It will be understood that the reservoir cap 62
is made from the same suitable plastic as the cylinder or body 55
and the lower end cover 60. A vent passage 65 is formed through the
cap wall 63 for venting the upper end of the chamber 61.
As shown in FIG. 2, the reservoir cap 62 is provided on the inner
side of the cap wall 63 with an inwardly extended axial projection
66, on the inner end of which is formed a flat valve seat 67 around
the inner end of a vacuum passage 68. The vacuum passage 68
communicates at its outer end with a second vacuum passage 69
formed through a radially and outwardly extended integral
projection 70 formed on the outer side of the cover 62. The outer
end of the passage 69 is enlarged, as indicated by the numeral 71,
and fixedly secured therein is a check valve, generally indicated
by the numeral 72.
As shown in FIG. 2, the valve 72 includes a threaded body which is
provided on its inner end with a passage 73 that communicates with
the vacuum passage 69. The inner end of the valve passage 73
communicates with a spring chamber 74 in which is seated a coil
spring 75. Spring 75 normally biases a steel ball check valve 76
outwardly into operative engagement against a valve seat formed on
the inner end of a threadably mounted plug 77 which is disposed in
the outer end of the spring passage or bore 74. A passage 78 is
formed through the plug 77.
As shown in FIG. 2, the vacuum passage 69 also communicates through
a passage 79 with a passage 80 formed through a tubing fitting,
generally indicated by the numeral 81. The inner end of the tubing
fitting 81 is fixedly mounted by any suitable adhesive or cement in
an enlarged passage 83 that communicates with the passage 79. The
reduced outer end 84 of the fitting 81 has operatively mounted
thereon one end of a suitable tubing, generally indicated by the
numeral 85. The tubing 85 is operatively connected to a suitable
conventional electrically operated vacuum pump.
As shown in FIG. 2, the reservior 9 includes a float valve,
generally indicated by the numeral 86, which is formed as an
elongated cylinder 87 made from a suitable plastic material. The
lower end of the valve cylinder 87 is enclosed by an elongated plug
88 which has formed therethrough an axial passage 89. The plug 88
is fixed in place in the lower end of the cylinder 87, by any
suitable means, as by an adhesive or cement. A plurality of
suitable bumpers or stoppers 90, made from any suitable material,
are operatively mounted on the lower end of the float valve 86.
The upper end 91 of the plug passage 89 communicates with the
interior of the valve cylinder or body 87 and has formed on
opposite sides thereof a pair of angled slots 93, whereby fluid may
pass through these slots when a float ball 92 is seated on the
inner end 91 of the passage 89. The float ball 92 may be made from
any suitable material, as for example, a plastic material, and with
weight added therein, as for example, a fluid, to provide a weight
of approximately 2 or 3 grams for urging the valve 86 downwardly
after it has been raised by vacuum, as described more fully
hereinafter.
As shown in FIG. 2, the valve body or cylinder 87 is provided with
a plurality of ports or openings 94 that communicate the upper end
of the valve body 87 with the reservoir chamber 61. The upper end
of the valve body 87 is enclosed by a suitable diaphragm 95 made
from a suitable plastic or elastic material, and it is held in
place by a suitable circular plastic cap 96 provided with an
opening 97.
In use, the balloon 8 will be in a flat, collapsed and extended
condition, whereby it may be inserted into a patient's nasal
passage and down into the patient's stomach. A predetermined amount
of fluid is inserted through the tubing 14 to the balloon 8, as for
example, approximately 600 to 650 cubic centimeters of distilled
water. The tubing 14 is then connected to the directional flow
control shunt valve fitting 19. It will be understood that the
float valve 86 would be in the lowered position shown in FIG. 2,
and that the other part of the circuit including the cooling means
31 will have been charged with distilled water.
The patient is in a sitting position for the inserting of the
balloon 8, and after this procedure, the patient lies down with the
reservoir being disposed in a position a few feet above the patient
to provide the necessary gravity created pressure head operation of
the cooling apparatus. With the balloon 8 in position in a
patient's stomach, and with the cooling apparatus fully charged and
connected to the vacuum source, the vacuum source is actuated so as
to exert a vacuum on the passages 80, 79, 69 and 68, and the
chamber 61 in the reservoir cylinder 55. The spring 75 maintains
the check valve 76 in the position shown in FIG. 2, so as to close
off the passage 69 from the atmosphere. The vacuum is maintained at
approximately 5 to 7 inches of mercury. The vacuum in the reservoir
chamber 61 will lift a column of water from the balloon 8 in
accordance with the internal dimensions of the reservoir chamber 61
and the other interconnecting structure. It has been determined
that a predetermined amount of water of approximately 50 to 80
cubic centimeters is desirable, to be withdrawn from the balloon 8
and exchanged with an equal amount of cooled water. Accordingly,
the vacuum operating in the chamber 61 will pull this predetermined
amount of water from the balloon 8 through the tubing 14 and thence
through the valve passages 21, 42, 38, 37 and through the tubing 53
into the lower end of the chamber 61.
The water entering the chamber 61 will pass up through the float
valve passage 89 and up to the ports 94 at which point the float
valve 86 will move upwardly and move the diaphragm 95 into the
position shown in FIG. 4, so as to block off the vacuum passage 68.
When the passage 68 is closed by the diaphragm 95, the check valve
76 moves inwardly to the position shown in FIG. 4, and gravity
takes over. The water that has been lifted into the reservoir 9
then flows downwardly through the tubing 53 and into the valve
passage 37. The positions of the check balls 26 and 40 are then
reversed from the position shown in FIG. 2. That is, as shown in
FIG. 4, the check valve 40 blocks off the passage 38 and the check
ball 26 opens so that the predetermined amount of water being
forced out of the reservoir 9 will pass from the passage 37 into
the tubing 33 and through the cooling means 31, while
simultaneously forcing a second predetermined amount of water
upwardly through the tubing 29 into the valve passage 21, and then
to the tubing 14 into the balloon 8. The float ball 92 is provided
as a weight means to ensure that the float valve 86 will move
downwardly and break away from the vacuum valve seat 67 as the
water moves out of the reservoir 9 by gravity.
It will be seen that the cooling apparatus of the present invention
is a simple, compact, efficiently operating apparatus. It can be
made economically, so as to be disposable. The constant
interchanging of a predetermined amount of water in the balloon
maintains a desired temperature. The apparatus can be made to cycle
in a predetermined time interval as, for example, one complete
cycle every 15 seconds. The interchange of the units of cooling
water in the balloon makes it possible to maintain the temperature
of the water in the balloon between certain limits as, for example,
from 3-7.degree. C. The apparatus of the present invention does not
require a technician to control it or to monitor it. The nursing
staff on duty on the hospital floor can look at it frequently and
check it to see that it is working properly. The only step in the
procedure of using the apparatus that requires a physician is the
inserting of the balloon 8 into the stomach of a patient, and in
many cases this can be done by a competent nurse.
Experience has shown that the apparatus of the present invention is
very useful and practical. It has been used in the treatment of
esophageal and gastric hemorrhage in patients with malignancies.
Patients treated with the apparatus of the present invention
comprises three categories, namely, patients bleeding from eroded
arteries in gastric carcinoma; patients bleeding from steroid
induced multiple gastric ulcers or stress ulcers; and, patients
with bleeding from esophageal varicies from portal hypertension
secondary to massive hepatic metastases.
It has been found that it takes from 20 to 30 minutes to obtain the
unit from the place where it may be stored and completely set it up
and instruct the floor nurse in its use if she is not familiar with
it, and to write whatever necessary orders are required. There are
not untoward complications in setting up the apparatus. There is no
detrimental effect if the balloon 8 should rupture inside the
stomach of a patient. Since the water in the balloon 8 is
maintained between 3-7.degree. C, there have been no complications
as caused by the earlier prior art freezing methods.
In actual use, the apparatus of the present invention has given
patients the time needed for use of the specific therapy indicated
in each case, whether surgery, corticoid steroid reduction, high
dose radiation therapy, chemotherapy, etc. The apparatus of the
present invention has been impressive from the standpoint of the
speed with which hemorrhages have been controlled. For example,
hemorrhages have been controlled within 2 hours, and nearly always
within 8 hours. It has been found that a minimal amount of nursing
time is required to supervise the apparatus of the present
invention. As for example, no more than 30 minutes per 8-hour shift
is required. The apparatus of the present invention meets the goal
of therapy which is to control life-threatening hemorrhages.
While it will be apparent that the preferred embodiment of the
invention herein disclosed is well calculated to fulfill the
objects above stated, it will be appreciated that the invention is
susceptible to modification, variation and change.
* * * * *