US 3177871 A
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April 1965. P. H. MEYERS 3,177,871
DISPOSABLE SANITARY CONTAINER FOR RADIOGRAPHIC ENEMAS Filed Feb. 24, 1961 PHILUP H. MEYERS MD.
INVENTOR United States Patent This invention relates to a new method of preparing and using sanitary preparations of radiopaque substances; such as barium sulphate, and its variant compounds, in the radiographic visualization of the lower gastrointestinal tract so that a physician can make a medical diagnosis. This new method may save the physician both time and money in the administration of radiopaque enemas. This new method, when used in place of conventional techniques, will eliminate contamination from patient to patient as shown in a scientific paper by P. H. Meyers, J.A.M.A., August 6, 1960, entitled Contamination of the Barium Enema During Its Use.
The current method of administrating radiopaque substances involves the mixing of these substances, such as barium sulphate, with water in a suitable mechanical mixer. The mixer provides the vigorous agitation necessary to bring the barium sulphate into suspension. This suspension must be very fine, and free of large agglomerates of unwetted barium sulphate. A suspension agent, such as carboxyme-thylcellulose, is sometimes used to increase the viscosity of the aqueous phase of the suspension, and thereby decrease the settling out of suspension of the solids. The aqueous suspension is usually then poured into an enema can, which is usually of metal with a rubber tube leading from the bottom of the can terminating in a tip which is inserted into the patient.
The process of mixing and pouring the barium sulphate suspension is time consuming and messy. This diagnostic procedure is often reluctantly used because of the trouble and mess involved. Generally the metal enema can is not sterilized between use, nor is the rubber tubing changed or sterilized. Many doctors do, however, use plastic disposable enema tips. Meyers, in the article cited above, showed that it is possible to transmit fecal matter from one patient to the next when using the above conventional method of preparing and administering a barium enema.
Another diagnostic method usually used in conjunction with a barium enema is that of air contrast. Here, air is pumped into a patient after he has evacuated the bulk of the radiopaque suspension, but while the walls of the lower colon are still coated with the radiopaque substance. A rubber balloon :or bulb is usually used to pump the air into patient. These balloons are usually not sterilized or changed from patient to patient. Meyers has shown that these items are also subject to contamination.
The principal object of this invention is to provide a sanitary method of administrating radiopaque substances through the rectum without possibility of contamination from one patient to the next, and without the need of sterilizing bulky metal enema cans. It is a further object of this invention to provide a sanitary, water tight container which is made of inexpensive materials so that it may be disposed of after use. It is a further object of this invention to provide a disposable sanitary, water tight container which contains the radiopaque substance and to Which-the doctor has to merely add water and shake, thus eliminating the messy and tedious steps involved in the preparation of barium enemas.
It is a further object of this invention to provide a prepackaged device which contains the proper amount of barium sulphate and suspension agent in a suitable inexpensive plastic container. The doctor has to merely 3,177,871 Patented Apr-.13, 1965 add Water to this package and then vigorously shake it so as to bring the barium sulphate into suspension. This device can include a filter, .or strainer, or similar multiple outlet device so as to prevent large agglomerates of the barium sulphate which are not in proper suspension from being carried from the disposable container through the tubing and into the patient. If this were not done, either the tubing could clog, or undesirable artifacts would be introduced into the patient, thereby clouding the diagnosis.
It is a further object of this invention that this container, having been used on a patient for the introduction of radiopaque substances, can, when empty, be used to pump air into the same patient under controlled conditions of pressure and rate of flow so that an air contrast of the lower gastrointestinal tract may be obtained in a manner designed to eliminate contamination'from one patient to the .next and to maximize the convenience to the doctor. a
Other and further objects and advantages of the invention will be pointed out in the following more detailed description and by reference to the accompanying drawing, which illustrates one embodiment of the invention and wherein the figure indicates a disposable sanitary container which is constructed of an inexpensive flexible transparent plastic material. The numeral '1 indicates generally the bag, as supplied to the doctor, 3 is a grommet suitable for handling the apparatus from a convenient hook on the X-ray machine. 2 is a tube of plastic which is heat sealed closed during the manufacturing of the apparatus. 4 is the radiopaque substance, such as barium sulphate, mixed in the dry state with a suitable suspension agent as well as other chemicals such as tannic acid and salt. These chemicals other than the radiopaque substance, may or may not be present, either all or in part. -5 is the filter, strainer, or other suitable multiple outlet device which projects appreciably into the disposable sanitary container. This prevents any clumps or aggregates of radiopaque material from clogging the tubing or being a medical artifact on the X-ray diagnostic film by entering the gastrointestinal tract. A plastic dis posable rectal tip 7 is attached to a thin walled plastic tube 6. The plastic tube 6 is heat sealed to the flexible plastic bag during the manufacturing operation so that it is joined to the bag with the filter 5, in place, but so that a passage remains between the tubing and the bag. The disposable rectal tip may be permanently attached to the tube, or it may be attached separately, the tube being heat sealed shut during the manufacture of thisdevice.
In the preferred embodiment of this invention, the disposable bag 1, filled with a suitable amount of barium sulphate 4, which may be between 8 and 14 ounces, and enough suspension agent, such as 1% by weight of thoroughly mixed-in carboxymethylcellulose, to keep the radiopaquesubstance in suspension during the examination, is supplied to the doctor with a suitable length of thin walled plastic tubing 6, such as between 4 and 7 feet, heat sealed to the bag, so that passage between the bag and the tubing is not obstructed. A rectal tip 7, may be attached to the lower end of the tubing 6, or it may be attached by the doctor just prior to use. To attach the rectal tip, the heat seal at the loose end of the tube 6 is cut, and the tube 6 is slipped over the tip 7 until a snug fit is obtained. The lower tubing 6, is
tightly clamped just below the filter. The upper, shorter length of tubing 2, is then opened with a knife, razor, or other sharp instrument. Enough water of a suitable temperature is then added to the bag through the shorter, wider upper tube 2. The amount of water may vary between one and three quarts; and the water temperature is usually about body temperature. The upper tube water, barium sulphate and suspension agent, is vigor-.
ously shaken, kneaded, and squeezed so as to eflYect thorough mixing of the ingredients. Thus, the messy, time consuming, and tedious method of preparing a barium sulphate enema such as is now in use maybe supplanted with a clean, quick, and easy method by taking advantage of this invention. Of necessity, the walls. and seams of this disposable sanitary container must be of high strength and good quality so as to withstand the vigorous handling during the mixing operation. The enema is administered to the patent by hanging it from a suitable. hook by grommet 3 and by insertion of the disposable tip 7 into the rectum. The clamp is then removed from the lower tube. 'The enema may now be given, with pressure controlled by the doctor, by squeezing the bag. Or, if preferred, theenema may be given utilizing gravity flow by removing the clamp from the upper tube 2.
On completion of the enema, and subsequent evacuation of the radiopaque material from the patient, this apparatus may be used for an air contrast study. The tip is reinserted into the patients rectum. The botttom tube 6 is again clamped. The bag 1 is now drawn apart so that air may enter via tube 2. Tube 2 is then clamped, tube 6 is opened, and air administered to the patient by squeezing bag 1. Should more air be desired, this procedure can be repeated by clamping tube 6, opening tube 2, filling the bag with air, closing tube 2, and opening tube 6. Air is then again squeezed into the patient in a novel manner which precludes contamination from one patient to the next. After use, the apparatus may be thrown away, thereby totally eliminating the possibility of contamination between patients. .In the preferred embodiment of this invention, as described above, an easy to use, inexpensive, sanitary, and convenient device is provided. Other embodiments; of this invention may become obvious to one skilled in art based on the teachings of this invention. Changes in'construction and design of this invention may therefore be made without departing from the scope of the invention as defined by the appended claims.
Having thus described my invention, I claim:
1. A disposable applicator for administering a radiopaque suspension comprising a sealed bag of water-insol- 4, uble plastic containing a water-insoluble, water dispersible radiopaque material and an outlet tube of flexible plastic having one end adapted for attachment to a rectal tip and the other end secured to and opening into one end of said bag. l
2. A disposable applicator as claimed in claim 1 wherein a filter is located at the opening of said outlet tube into said splastic bag to prevent clumps of radiopaque material from passing into said outlet tube.
3. A disposable applicator as claimed in claim 1 in which said radiopaque material is barium sulphate.
4. A disposable applicator as claimed in claim 3 wherein a filter is located at the opening of said outlet tube into said plastic bag to prevent clumps of barium sulphate from passing into said outlet tube.
5. A disposable applicator as claimedin claim 3 wherea in said sealed plastic bag contains a suspension agent in addition to said barium sulphate. V
6. .A disposable applicator for administering a radiopaque suspension comprising a sealed bag of waterinsoluble plastic containing barium sulphate and a suspension agent; a sealed inlet tube secured to one end of said plastic bag, said inlet tube being adapted to admit liquid into said plastic bag when the seal on said inlet tube is opened; an outlet tube of flexible plastic having one end attached to a rectal tip and the other end secured to and opening into the opposite end of said plastic bag from said inlet tube; and a filter located at the opening of said outlet tube into said plastic bag to prevent clumps of radiopaque material from passing. into said outlet tube.
References Cited by the Examiner UNITED STATES PATENTS 2,625,264 1/5 3- Edwards 20669 2,664,891 1/54 Kempel 128-224 2,923,296 2/60 Adams et a1 128-227 2,936,757 5/60 Trace 128376 OTHER REFERENCES Medicines May Be Packaged by Doses, article from the Washington Post, August 18, 1960.
ADELE M. EAGER, Primary Examiner.