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.

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.

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.