US 2923296 A
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1 Feb. 2, 1960 D. F. ADAMS EI'AL 2,923,296
ENEMA CONTAINER Filed June 27, 1955 0040 F. 404/145 raw 6. 6055577 Ja l/V 6. #4/IV5J002 77/ INVENTORS United States atet ENEMA CONTAINER Application June 27, 1955, Serial No. 518,194
7 Claims. (Cl. 128227) This invention relates to a ready-to-use enema container and particularly to a collapsible container which is inexpensive and convenient to manufacture, transport, store, and use.
In recent years hospitals have encountered considerable difficulty in maintaining a balanced budget. One of the major reasons for this has been the rising labor costs. To help hospitals reduce labor costs, manufacturers have developed equipment made of low-cost materials so that it can be discarded after a single use. This type of equipment eliminates the tedious washing, sterilizing, and assembly processes previously necessary, and relieves space and personnel for more important functions.
Administration of enema solutions is a commonly used hospital procedure. However, when manufacturers attempted to design expendable equipment for administering such solutions, serious problems. were encountered.
The first of these problems was the need for a convenient method of preventing backflow from the bowel into the container, and for controlling solution flow out of the container. This has sometimes been done by placing a hemostat or other clamping device across the neck of the container during insertion of the dispensing stem. Such a device is awkward, however, and makes the insertion rather diificult. Moreover, after the clamping device is removed, no method of controlling flow is available. Trouble has also been encountered from the loss of water vapor through the thin plastic walls necessary for a collapsible container. When molded containers were used, it was difiicult to maintain a uniform wall thickness at all points. Thin spots allowed rapid escape of moisture vapor and even leakage of the solution to occur. Thick-walled containers reduced the rate of moisture vapor escape but were more difficult to empty because of the reduced fiexibility.
It is the object of this invention to provide a convenient, inexpensive dispensing container for enema solutions. It is the further object of the invention to provide an enema container which can be easily and cheaply filled, stored, transported, and used.
A still further object of the invention is to provide a completely collapsible enema container made of thin, transparent, inexpensive plastic film from which the solution flow can be conveniently controlled.
The enema container of the present invention together with various further objects and advantages of the invention will be apparent from the description of the preferred example of the invention. The description is given in connection with the accompanying drawings in which:
Figure 1 is a front elevation of an enema container made in accordance with this invention;
Figure 2 is a top view of the container of Figure 1;
Figure 3 is a sectional view of the line 3-3 of Figure 2;
Figure 4 is an enlargement of the portion of Figure 3 showing the joint between the stem and body;
Figure 5 is a sectional view on the line 5-5 of Figure 1;
Figure 6 is a sectional view of the line 66 of Figure 1;
Figure 7 is a sectional view on the line 77 of Figure 1, when the container is empty; and
Figure 8 is a sectional view, similar to Figure 3, of a modified form of the invention.
Referring to Figures 1-7, the body 10 of the enema container may be formed by heat sealing two layers of thin plastic film 11 along the sides 17 and the bottom 16 with a flange-type seal 12. The body 10 of the container is preferably small enough to hold conveniently in one hand and may be from 4 to .8 inches in length and 1 to 4 inches in width. When empty, the body is almost completely collapsed as shown in Figure 7. Film 11 may be a calendered, cast or extruded plastic film which is preferably uniform in thickness, very pliable and transmits enough light so that the contents of the container can be readily seen. It may be (1003-0020 inch thick, depending on the composition used and the treatment to which the container will be subjected. The thicker films tend to.be more expensive, less flexible and the sealed edges 12 are stiffer than with thin film. Thin-film containers have soft edges but may not stand up under the rough treatment of transportation. Seal 12 is preferably a flange-type seal so that the container can be easily and completely collapsed, although a lap-type seal might be used. The seal is conveniently made by thermal impulse or electronic, heat sealing. Such seals are stronger than the film itself and are adequate to hold the pressure applied to the flexible container. T hereis no glue or adhesive present to contact the ingredients of the container. The body 10 is heatsealed firmly to the dispensing stem 13 along the top 1?. The annular indentation 21 is formed by blending together of the plastic body 10 and the plastic stem 13 to form an integral seal. This weakened: annular area may be pinched by the thumb and forefinger to act as a flow control device for administration of the container contents.
Stern 13 is a smooth, semiflexible tube havinga bore 23 through which the solution can be administered. The outside diameter of stem 13 may be four to ten millimeters and is preferably uniform throughout its length. The stem 13 is a separate plastic tube sealed into the body 10 so that different lengths or stiifnesses may be easily made for different purposes. For normal use, the stem may be as short as 2 or 3 inches. When the fluid is to be placed in the colon, the stem should be about 3 inches long. The stem should be scalable to the film 11 and therefore may have a composition similar to the film. The stem should have the rigidity and smoothness of a rectal catheter and extruded tubes have been found particularly satisfactory for this use. An extruded tube maybe sufiiciently stiff so that the 5 inch tube may be easily inserted into the rectum, but flexible enough so that no damage can be done during insertion. Tip 18 of the stem 13 is rounded and provided'with a pressure-proof rubber closure 24. The other end 20 of the stem extends into the body 10 of the enema container. Flow of the enema solu-v tion from the container may be reduced or stopped by pressing the layer of filrnllover the'end 20 of the dispensing stem. s
The solution 15 in the body of the container is' a hypertonic solution of a material such as sodium chloride, magnesium sulfate, or sodium phosphate. For example, cc. of an aqueous solution, containing 16% monosodium phosphate monohydrate and 6% sodium phosphate, U.S.P., may be used. A nontoxic preservative such as hydrogen peroxide may be included in the solution to prevent mold growth. When administered rectally, this hypertonic solution brings about prompttevacuation. Such hyperto'nic solutions, are effective in much'lower quantities than the water! or soap-suds enemas often given, and' cause less distention, pain, and discomfort, particularly in obstetrical or abdominal surgery cases.
Figure 8 shows a modified form of the invention in which the end 20 of the stem 13 is provided with a bevel 22 to enhance the control action obtained by pressing the film 11 against the end of the stem. The body ofthe container is provided with dry ingredients 25 from which the solution is made by'adding water. This type of container costs less to ship, pack and store. No preservative is needed andthewater vaportr'ansmission problem is completely eliminated. Mold problems on both the inside and outside of the container are also eliminated. A simple cap 14 maybe used in place of the pressureproof stopper 24 which is more expensive to make and assemble.
An outstanding advantage of the dry enema container is that a thinner film can be used. 'Since there is no problem of moisture vapor transmission, the film needs only to be thick enough to hold the container contents. Films 0.002 to 0.004 inch thick have been highly satisfactory. With the proper plasties, films as thin as 0.0005 inch should be satisfactory. The high degree of flexibility and softness of the thin film eliminates the possibility of sharp or rough edges'alohg the sides 17 and the top 19. The lap seal 12 and layflat body of the container (see Figure 7) allow easy filling of the container with water just before use. If desired, warm water may be used and such enemas are often more effective and cause less discomfort to patients. Such warm enemas are diflicult to prepare when the container has a liquid enema solution because of the insulating effect of the plastic wall. The design of the container allows the dry ingredients, such as powder, pellets, or tablets, to be placed in the body of the container before the stem 13 is sealed into place.
In use, the body 10 of the container is held in one hand with the thumb pressing one layer of the film 11 against the inner end 20 or 22 of the dispensing stem' 13. Cap 14 or 24 is removed, and the stem 13 is lubricated. The stem may then be inserted into the rectum, using the other hand to spread the buttocks or otherwise assist the manipulation. The solution is administered by releasing the film 11 from the inner end 20 or 22 of the dispens ing stem, squeezing the container and finally rolling the container up from the bottom to expel all the fluid. If it is necessary for any reason to halt the injection or release the pressure on the container before completion, back flow can be prevented by again pressing the wall of the container against the end 20 or 22 of the stem. By use of this invention, 75 to 90% of the time required for preparing and administering an enema may be eliminated.
At the same time, the possibility of transmitting typhoid, bacillary dysentery, endamoeba histolytica, or other onteric diseases from one patient to another, is greatly reduced. The tedious, unpleasant, and hazardous task of preparing and cleaning up conventional enema equipment is eliminated.
'1. An enema container comprising: a collapsible, plastic body; a semirigid stem adapted for insertion into the rectum, communicating with the interior of the body, and sealed therein; an extension on said stem extending into the body and having a beveled end to facilitate control of flow through the stern by pressing one wall of the collapsible body against said beveled end; a removable closure on the exterior end of said stem; and ingredients suitable for the preparation of an enema solution in said body.
'2. A collapsible enema administration container comprising: a body of a size convenient to hold in one hand, said body being'for'med from 2 layers of heat-sealable, plastic film sealed in face-toiacerelation by a flange seal around at least 3 sidesof the body; a concentrated enema solution in said body; a semirigid, cylindrical stem 3 to 6 inches long, sealed in said body, said stem having a composition similar to the plastic film and being heatsealable to it, said seal being formed by compressing the film and stem to form an annular section having a smaller diameter than the stem itself; the base of said stem extending into the container and having a beveled end to facilitate control of flow through the stem by pressing the film against said beveled end; a smooth rounded distal end on the stern; and a removable cap on said rounded end.
3. An expendable enema solution container comprising: a collapsible, layflat, plastic bag formed from two layers of polyvinyl chloride film heat-sealed together, one of said layers of polyvinyl chloride having a label printed thereon; an insertion stern heat-sealed to 'the inside of the container walls and having a beveled end extending into the container, said stem consisting of a semi-flexible polyvinyl chloride tube 3-6 inches in length; a rounded end having an inside lip on the distal end of said stern; and a pressure-proof rubber stopper in said rounded end.
4. A collapsible, disposable, enema administration container comprising: a body of a size convenient to hold in one hand, said body being formed from two layers of heat-sealable, plastic film sealed in face-to-face relation by a flange seal along at least two sides of the body; a semirigid, cylindrical stem three to six inches long, said stem having a composition similar to that of the plastic film and being heat sealable to it; a flange seal across the top of the body sealing said stem in the body and extending on each side of said stem; an annular section of said stem having a smaller diameter than the stem itself where the stem and top flange are sealed together and a smooth rounded distal end on the stem.
5. A collapsible enema administration container comprising: a body formed from two layers of heat-sealable, plastic film sealed in face to face relation by a flange seal along at least two sides of the body; a semi-rigid, cylindrical'stem sealed in said body, said stem having a composition similar to that of the plastic film and being heatsealable to it; a flange seal across the top of the body sealing said stem in the body and extending on each side of said stem; and an annular section of said stem having a smaller diameter than the stern itself where the stem and top flange are sealed together. i
6. A disposable enema dispensing container comprising: a normally flat, flexible body composed of two layers of polyvinyl chloride film heat sealed along at least two edges, said film having a thickness of 0.0005 to 0.020; a relatively stiff, hollow, tubular nozzle sealed to the body and in communication with its interior; an extension on said nozzle extending into the body and havin a beveled end to facilitate control of flow through the stern by pressing one wall of the collapsible body against said beveled end; a flange sealed top on said body extending on each side of said nozzle, said top being narrower than said body; rounded shoulders joining said top to said body; and a closure on the open end of said nozzle.
7. A disposable enema dispensing container comprising: a body composed of two layers of thin, translucent, flexible, plastic film sealed along the edges; a relatively stiif, hollow, tubular nozzle sealed to the body and in communication with its interior; an extension on said nozzle extending into the body and having a beveled end to facilitate control of flow through said nozzle by pressing one layer of the film against said beveled end; and a closure means on the open end of said nozzle.
References Cited in the file of this patent UNITED STATES PATENTS 79,742 Faloon July 7, 1868 2,222,267 Schnabel Nov. 19, 1940 2,568,915 Friedman Sept. 25, 1951 2,664,891. Kempel Jan. 5, 1954 2,676,591 Fox Apr. 27, 1954 2,690,181 Boyer Sept. 28, 1954 2,784,716 Brornan Mar. 12, 1957