US 3483859 A
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F. E. PITTMAN Dec. 16, 1969 STRING FOR MARKING BLEEDING IN UPPER GASTRO-INTESTINAL TRACT Filed Nov. 29, 1967 INVENTOR. BYFRED E. P/TTMHN ATTORNEY nited States atent O 3,483,859 STRTNG FOR MARKING BLEEDING IN UPPER GASTRO-INTESTINAL TRACT Fred E. Pittman, 1430 Tulane Ave.,
New Orleans, La. 70112 Filed Nov. 29, 1967, Ser. No. 686,503 Int. Cl. A61b 5/10; A61m 25/00 US. Cl. 128-2 4 Claims ABSTRACT OF THE DISCLOSURE ends of the envelope are fastened to the string, so that air blown into the upper end of the tube will issue from the opening therein and inflate the envelope, so as to anchor the string in the stomach. A blood-marker chamical (fluorescein) or radiochemical (such as 1-131 labelled human serum albumin) absorbent covering is disposed over the envelope so as to enable to indicate any bleeding which may take place in that area.
BACKGROUND OF THE INVENTION This invention relates to a string for marking the location of bleeding which may be taking place in the upper gastro-intestinal tract. Patients, such as those reporting in hospitals because of passage of blood through the gastro-intestinal tract, are often diflicult to diagnose with respect to the actual situs of bleeding In recent years, radio-opaque marked strings have been devised as bleeding markers, and have been described in various US. patents. They usually have a hard core covered with an absorptive jacket carrying radio-opaque distance markers. The string is soaked in ice water and the patient is instructed to swallow it gradually wilh the aid f sips of water. Once the desired amount of string is swalowed, a roentgenogram of the upper abdomen is taken. While the patient is lying on the X-ray table, 20 ml of marker chemical (fluorescein) or radiochemical (such as Il3l labelled human serum albumin) are injected into an antecubical vein. The dye or radiochemical is al'owed to circulate for four minutes before the string is removed from the patient through the mouth. After the string is removed, it is examined for fluorescence under ultraviolet light or for radioactivity with a radiation detector. If the patient had been bleeding aciively at the time of the test, both hood and dye (or radiochemical) will be readily found on the tape. The dye is visible as a yellow spot of fluorescence on the tape when eX- amined under ultraviolet light. The radio-opaque marker nearest the dye or radioactivity on the tape is noted by counting back the number of inches from the lower end of the string Then, the comparable marker is found on the roentgenogram by counting back the same number of inches (markers) from the end of the string, thereby fixing the bleeding situs in the gastro-intestinal tract.
Although the aforesaid strings have been found very useful in detecting sites of bleeding in the upper gastrointestinal tract, they require the use of abdominal roentgenography to localize precisely the site of bleeding. Frequently, patients with upper gastro-intestinal tract hemorrhage are bleeding so massively that it is not possibie to obtain an abdominal X-ray.
Patented Dec. 16, 1969 Usually in patients with massive gastro-intestinal hemorrhage, and in particular those with known cirrhosis of the liver or suspected liver disease, the most important diagnostic goal is to determine if the bleeding is or is not from ruptured enlarged esophageal veins at the lower end of the esophagus or upper stomach (esophageal or gastric varices). These varices are almost always caused by cirrhosis of the liver which produces obstruction to the blood flow in the liver and elevated b'ood pressure in the portal venous system. There is great need for an accurate device which may be used with or without rorngenography to detect or rule out rapidly the presence of bleeding from esophageal varices. Strikingly different therapeutic courses, both surgical and medical, are followed, depending on whether the diagnosis is bleeding from esophageal varices or from another source. Often patients wi.h no previous history of cirrhosis of the liver present to the physician for the first time with bleeding esophageal varices. A'so often, patients with known cirrhosis of the liver and even with known e Ophageal varices bleed from sources other than esophageal varices, such as gastric or duodenal ulcer.
SUMMARY OF THE INVENTION The present invention deals with a marker string designed to be used only in the upper gastro-intestinal tract. The purpose for using the string is to accurately detect or rule out the presence of bleeding from the esophageal varices or enlarged veins that appear in people who suffer with cirrhosis of the liver. The main use for the device is in patients who are vomiting blood massively, passing blood per rectum rapidly or who are known to or thought to have cirrhosis of the liver and are bleeding into the intestinal tract.
The device of the present invention comprises a flexible tube covered or coated with a coating or envelope which is blood-absorptive. The lower portion of the string is located in the stomach and the covering and tube are pierced in this area to provide a hole over which is disposed a balloon-like envelope coated or covered with a bloodabsorptive material. When air is injected into the upper end of the tube (after it has been swallowed) it passes through the tube and into the inflatable bag or envelope where it inflates the latter in the upper stomach into a balloon. The latter is pulled snug up to the gastroesophageal junction and then serves to separate the esophagus from the stomach making it much easier to identify more accurately whether the bleeding is or is not coming from the lower esophagus. If an X-ray of the abdomen is obtained prior to removing the device, the bleeding site is determined from the radio-opaque markers on the tube or tube covering, according to the method already outlined. If a roentgenogram (X-ray) cannot be obtained, localization is determined by the relationship of the dye or radioactivity to the balloon. Dye or radioactivity found on the upper portion of the balloon and/or on the covering of the tube just above the balloon suggests that bleeding is coming from the lower esophagus or cardioesophageal junction and would be compatible with bleeding from esophageal varices. The absence of dye or radioactivity at these locations on the device in the presence of active bleeding effectively rules out bleeding esophageal varices as the cause of the hemorrhage. The information obtained by this technique aids greatly the physician in his decision as to precisely which therapeutic measures will be carried out.
Although rubber balloons have been lowered into the esophagus in attempts to stop bleeding by inflating them and using the inflation pressure for this purpose, the present invention involves an entirely different device and technique whereby the balloon serves not only to hold the string in place to prevent movement thereof, so as to avoid location error, but it also has an absorptive coating or covering which can serve to detect bleeding at the balloon site.
BRIEF DESCRIPTION OF THE DRAWING The invention will be more readily understood by reference to the accompanying drawing, in which a preferred embodiment is described, and in which:
FIGURE 1 depicts a slightly enlarged side elevational view of a string of the present invention in idle condition.
FIGURE 2 illustrates a similar side view of the balloon portion of the string, with the balloon in inflated condition.
FIGURE 3 presents a view, similar to that in FIG- URE 2, of a different type of absorptive balloon.
FIGURE 4 shows a side view, in collapsed condition, of another form of balloon portion, with a portion of the outer covering cut away.
The same numerals refer to similar parts in the various figures.
DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to the drawing, numeral 16 indicates generally the string to be swallowed after being wetted with cold water. It comprises an outer absorptive envelope or coating 11 of woven, braided, or otherwise made of cotton textile, paper, non-woven absorptive synthetic fabric, or the like, fitting tightly over a flexible plastic tube 12, which may be made of polyethylene, styrene, polyvinyl chloride, or the like. Tube 12 is rigid enough so that its inner opening 13 will not collapse readily, but flexible enough so as to follow easily the contours of the upper gastro-intestinal tract. The tube 12 or the envelope 11 may have attached along their lengths radio-opaque markers 14 (on the tube) or 15 (on the envelope), for indicating the location of the various parts of the swallowed string in the X-rays.
The upper end of the string, indicated generally by numeral 16, is used for insertion into the inner tube 12 of the inflation means, whereas the bottom end, indicated generally by numeral 17, is closed off by metal grommet 13, or by any other suitable means. Abuot 9", or so, from the bottom of the string, is provided the inflatable means, indicated generally by numeral 19.
A hole 20 is pierced through envelope 11 as well as the wall of inner tube 12, and an inflatable envelope of balloon 21 is mounted over the string and over the area of hole 20 in a manner so as to be inflated when air is forced through hole 20. As shown in FIGS. 1-2, this envelope has its ends 22 and 23 fastened down with cords 24 and 25, respectively, or by other suitable fastening means, in outside sealing relation, so that, when air is pumped into tube 12 in the upper end 16 of the string, it will issue through hole 21, as shown in FIG. 2, and thus enable anchoring of the ballooned portion in the stomach, so that the string 10 is set in place.
Envelope or balloon 21 may be made of rubber, inflatable plastic, or the like. It is provided wtih a bloodabsorptive coating, such as cotton flocking 26, so that, when inflated, it will be able to absorb any blood on the surface of the balloon, if bleeding is taking place in that area. Another type of absorptive coating may be a stretch textile fabric which is coated on the inside with a thin film of rubber, the latter serving as the balloon. A still different coating is that shown in FIG. 3, wherein the inflatable rubber balloon 21 is coated with strips 27 of absorbent stretch fabric or other textile material.
Another coating means for envelope or balloon 21 is a loose collapsed absorptive textile envelope 28 which assumes the shape of the balloon 21 after it is inflated, and serves to absorb away blood released in that area as well as to limit the expansion of the balloon. As is apparent from the foregoing, the inflatable balloon may be coated or covered with any absorptive material. whether it be synthetic textile, or natural material, such as cloth, paper, flock, and the like. A small weight, such as a small bag of mercury may be attached to lower end 17, if desired. It is also possible to coat the surface of the absorptive covering, such as covering 28, with a solid film of water soluble material, such as gelatin, agar, or the like, so that, after the film becomes dissolved in the stomach, the absorptive coating or covering is released to absorb any blood present in the vicinity.
Radio-opaque markers, such as markers 29 may be applied to various portions of the balloon and/or its covering or coating to further serve as reference elements in the location of bleeding in the locus of the balloon.
The balloon feature of the present invention is located near the lower end 18 of the string, and preferably not more than about 9" above said end. It is apparent that the material for balloon 21 should be impervious to liquid and free of air leakage (air impermeable). It is desirably made of thin gum rubber film, such as that used in the manufacture of toy balloons, although use of thin vinyl chloride films, and similar synthetic organic plastic or resin films is not excluded. The material should retract and collapse to near its original shape when the balloon is deflated. Inflation may be effected by an air syringe or other suitable air pumping device, and a pressure gauge in the line may be used to prevent over-inflation. The absorptive flock may be applied to the balloon during its manufacture, before or after vulcanization, while the surface is still wet and sticky, although the flock may be cemented onto the surface after manufacture.
The term cover employed herein includes coatings.
1. A string for marking bleeding in the upper gastrointestinal tract, comprising:
a semi-rigid flexible tube, closed at its lower end, a blood-absorbent cover disposed tightly over said tube, means forming an opening through said cover and the wall of said tube near the lower end thereof and designed to permit flow of air thereout, an inflatable envelope covering the string over the opening area, and attached at both ends to said string in a manner to permit air issuing from said opening to inflate said envelope, and designed to thereafter anchor the lower end of said string in the stomach, and a blood-absorbent cover disposed over said envelope and designed so as to not impede the inflation of said envelope. 2. A string, according to claim 1, said blood-absorbent cover comprising a blood-absorbent coating.
3. A string, according to claim 1, said cover comprising a blood-absorbent stretch fabric.
4. A string, according to claim 1, said cover comprising a loose-fitting blood-absorbent cover designed to serve as limiting means for the expansion of said envelope.
References Cited UNITED STATES PATENTS 2,701,559 2/1955 Cooper.
3,097,636 7/1963 Haynes et al 1282 3,155,091 11/1964 Nissenbaum et al 1282 3,217,705 11/1965 Billings 1282 3,302,634 2/1967 Mazellan 1282 3,302,635 2/1967 Pittman 128-2 3,302,637 2/1967 Mazellan 1282 3,331,371 7/1967 Rocchi et al.
3,421,499 l/1969 Bray et al 128-2 ANTON O. OECHSLE, Primary Examiner PAUL E. SHAPIRO, Assistant Examiner US. Cl. X.R. 1283 48