US 2902036 A
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United States lPatentV 2,9o2g036 y IRRIGATOR ASSEMBLY Murle Perry, Minneapolis, Minn. Application December 20, '1954, Serial-VNO. 476,456
7 claims. (ci. 12s- 253)v This invention relates to irrgators and particularly to an irrigator bag permitting the use of a thin flexible disposable bag unit.
For many years it has been a problem to provide-an irrigator which would permit the use of a relatively inexpensive disposable bag. This, of course, has many advantages among which is the use of irrigators in hospitals where it is obviously desirable to provide entirely new and prevously unused bag units for each patient.
It is an object of my present invention to provide an irrigator which can be quickly and easily mounted on the body of a wearer and which permits the use of a disposable bag made from inexpensive thin waterproof sheet material.
It is another object to provide an irrigator assembly providing means for reinforcingnot only the stoma receiving opening through the bag to permit secure and positive attachment of the bag to the body of a wearer but also for reinforcing an opening in the outerportion of the bag to permit an irrigator tube to be extended therethrough.
It is still a further object to provide a pair of reinforcing and clamping elements fortightlyl clamping the These and other objects and advantages of my inven- Fig. 3 is a front elevational view of the structure shown in Fig. 2; and
Fig. 4 is a rear elevational View ofthe bag per se.
As illustrated vinthe `accompanying drawings Iprovide a clamping assembly for converting into an irrigator, a Colostomy or ileostomy appliance using a disposable bag made from suitable thin waterproof sheet material such as polyethylene plastic. The polyethylene bag is mounted on the body of the wearer in position fto surround and receive from the stoma as shown in Fig. 2. A clamping and mounting assembly generally similar to that disclosed in my copending application Serial No. 476,465, filed December 20, 1954 for United States Letters Patent entitled Improved Colostomy and Ileostomy Appliance and now Patent No. 2,787,270, is provided incorporating clamping elements or rings 10 and 11 wherein an insert ring 10 is received in tightly clamped relation within an outer clamping ring 11. The ring 11 is of course, provided with -an annular flange portion and an outwardly extending substantially cylindrical attachment and clamping portion. The outer pe- ICC riphery ofthe insert ring 10 and the inner periphery of the clampingr ring 11 are slightly tapered to insure a positive clamped fit and the two rings may be positively locked together by suitable clips such as the pivotally mounted clips 12. A retaining ring 13 to which anchoring belts 14 are connected surrounds the outwardly extending cylindrical portion of the clamping ring 11 and permits rotation thereof while positively holding said ring and insert member clamped therein to the body of the wearer. The bag illustrated is designated by the numeral 15 and is, of course, closed at the top and has a releasable closure assembly 16 for sealing the lower end thereof.
A pair of clamping elements made from any suitable rigid easily cleaned material are provided and are adapted to securely clamp a portion of the outer layer of the bag therebetween yas best shown in Figs. l and 2. As best shown in Fig. 4, the upper portions of the two layers of the bag have a pair of openings respectively formed therethrough. The opening through the inner layer is designated by the numeral 15a and is larger than the opening 15b through the outer layer and is only slightly smaller than the outer diameter of the insert member 10. The two outer clamping members are respectively designated by the numerals 17 and 18. The inner member 17 has an outwardly extending sleeve element 17a andan inwardly disposed clamping flange 17b fixed therearound. The outer member 18 has a passage therethrough adapted to receive the sleeve 17a in tight fitting relation with an enlarged recess 18a surrounding the inner portion of said passage and having a size to tightly receive and clamp the enlarged flange portion 17b of the inner member. The opening 15b through the outer layer of the bag 15 is of a size to permit the sleeve 17a to be received therethrough but is substantially smaller than the outside diameter of the clamping flange 17b so that the marginal portion of the material surrounding said opening may be tightly clamped between both the peripheral and annular portions of the ange 17b when said inner member is received within said outer member as shown in Fig. 2. While the marginal portion of the bag material surrounding the opening 15b is tightly clamped in Sealed relation between the flange portion 171) and the wall defining the recess 18a, the two clamping members 17 and 18 are seceurely held together by the frictional resistance between the outside surface of the sleeve 17a and the inside surface of the outer member 18 which defines the sleeve receiving passage. The sleeve 17a has a tapered passage formed therethrough to receive the irrigator tube -in sealed relation therethrough and is also adapted to receive the tapered plug member 19 to positively seal and close said passage.
The opening through the sleeve portion 17a is adapted to receive an irrigator tube such as the catheter 26 which is then inserted into the stoma for irrigation purposes. Fig. 2 shows the outer reinforcing assembly before the same has been pressed inwardly against the stoma to form a seal against the outer end thereof. It is well known that stomas may vary greatly in length and protrusion from the body and it is, therefore, necessary to provide an opening through insert member 10 which is suiciently large to permit the outer reinforcing member 13 to be received ytherethrough and pressed tight against the portion of the body of the wearer surrounding the stoma if necessary to provide the required seal around the catheter tube and prevent leakage around the stoma opening. Obviously the inside diameter of the sleeve 17a is suiciently small to form a relatively tight seal fit with the -outside diameter of an irrigator tube such as the catheter tube 20.
It will be seen that I have provided a highly efficient yet relatively simple means for converting a Colostomy appliance into an irrigator having. a disposable bag made from relatively inexpensive thin exible sheet material such as the polyethylene plastic bag illustrated. The bag f5 which'. is shown in the drawing isk considerablyI more ilexible than the bag shown in my previously issued United States Patent No. 2,504,572,4 wherein. a rubber bag is disclosed. Obviously! it is' Well known: that; the rubber bags are considerably more expensive andV also that rubber is somewhat more porous than is polyethylfene plastic or other suitable inexpensive sheet materials which are now available. However, since these inexpensive sheet materials are not as strong and resilientas rubber, it is necessary to provide a suitable reinforcing assembly around each ofthe openings made in the bag side walls and after considerable experimentation, I have found that the clamping seal formed by two cooperating members securely anchoring a portion of the sheet material therebetween is the mostv suitable Way of providing this reinforcing. In hospital use, it is, of course, desirable to use a fresh new bag for each patient rather than using a sterilized rubber bag which has previously been used by others and upon such use has become discolored toI a substantial extent. With the inexpensive sheet materials such as are ypresently available, it isV obviously possible from the economic standpoint to provide fresh new bags for each individual' patient.
It will, of course, be understood thatvarious changes may be made in the form, details, arrangement, and proportions of the parts without departing from the scope of my invention which generally stated consists Vin the matter set forth in the appended claims. While other mak terials may be suitable for the clamping members 17- and 18 as well as the inner insert ring 10, Il have found that methyl methacrylate resin provides the best results ofany of the materials with which I amy familiar since it is relatively hard and unbreakableI as well as being capable of being easily cleaned.
What is claimed is: 1
l. An irrigator comprising abag made from thin flexible Waterproof sheet material having an opening through the inner layer thereof and a second opening through the outer layer thereof in generally opposed relation tothe inner opening, mounting means connected to the" inner layer of said bag around said` inner opening for connecting the bag to the body of a wearer in position4 to receive through said inner opening from the` stoma, tube receiving means surrounding the opening in said outer layer and having clamping connection with the outer layer adjacent the opening periphery, and said tube-receiving means having an aperture to permit an irrigator' tube to be inserted therethrough in substantial alignment with the stoma to permit irrigation.
2. An irrigator comprising. a bag made from thin flexible waterproof sheet material having a pair of generally opposed openings formed through the upper portion thereof, a pair of cooperating intertting annular members positively clamped around one of the openings to define a stoma receiving opening on` the inner side of said bag, means interconnecting said members to the body of a wearer, a pair of clamping elements surrounding the other opening and positively clamped to the portion of the material surrounding said aperture, an opening through said clamping means to permit an irrigation tube to be inserted therethrough, thewinnensurface of one of said members adjacent the stoma receiving opening being constructed to sealingly engage the outer extremity of the stoma to prevent leakage around, said tubel during the irrigation operation.
3. The structure set forth in` claim 2' andl the opening defined by the annular members being larger than the dimensions of the exterior clamping elements to permit said elements to be received within said inner members and pressed tightly against the body of the wearer if necessary to form the required seal. v
4".V An irrigator comprisinga bag made from-thinhighly diexiblev waterproof material having al pair ofv generally aligned openings therethrough, Areinforcing means clamped to-the bagV peripherally of both of saidy openings, attachment means connected with one of saidl reinforcing means to attach the same to the -body of a wearer and the other t thin flexible Waterproof sheet matealhaving an opening through the inner layer thereofv and a second opening throughl the outer layer thereof in' generally opposed relation to said inner opening, an annular mounting member having an inwardly projecting peripheral rib constructed to surround the stoma of the wearer in radially spaced relation therefrom, clamping means for sealingly attaching the bag to said mount-ing member, tensioning means for positively holding said mounting member with the peripheral inwardly protruding portion securely engaging the body of the wearer to form a peripheral seal against theV wearersv body, means surrounding the outer opening in said bag to reinforce` the same and -dening an irrigator tube receiving passage therethrough to sealingly embrace a tube' inserted through saidpassage and permit irrigation.
'6ry The structure set forth in claim 5 and said clamping means consisting in an annular clamping ring closely surrounding said annularl mounting member to sealingly anchorv the portion of said bag surrounding the inner opening and` positively reinforce the same.
7'. The structure set forth in claim 5 anda cooperating femaleY clamping member constructed for cooperation with said reinforcing member to positively clamp the mar'- ginal .portion of the bag material therebetweenV and form a peripheral seal therearound.
References Cited in the file of this patent UNITED STATES PATENTS