US 3221742 A
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Description (OCR text may contain errors)
Dec. 7, 1965 E. OROWAN 3,221,742
RECEPTACLE FOR ENTEROSTOMY APPLIANCE Filed Jan. 9, 1962 INVENTOR.
EGO N OROWA N FIG. 5
lattice of a metal but never a molecule.
iferous substances present in' intestinal or urinary dis U nitcd States Patent 6) 3,221,742 RECEPTACLE FOR ENTEROSTOMY APPLIANCE Egon Orowan, 44 Payson Terrace, Belmont, Mass. Filed Jan. 9, 1962, Ser. No. 165,193 17 Claims. (Cl. 128283) The present invention relates to an improvement in enterostomy appliances, i.e., appliances for ileostomy, uretherostomy, colostomy, and similar types of surgically made or natural fistulas discharging through the surface of the body, usually of the abdomen. These appliances are attached to the body adhesively or by means of a belt; they comprise a receptacle to collect the discharge, provided with an opening through which the stoma discharges into the receptacle. At present, the receptacle is practically always a flexible envelope made of thin sheets of natural or synthetic rubber, polyethylene, polyvinylidene chloride, polyvinylchloride, or some other organic polymer. Compared with the rigid receptacles of aluminum or celluloid earlier in use, these flexible envelopes have the advantage of being comfortable and inconspicuous. I-Iowever,-their great disadvantage is that they are far from being odorproof. Rubberlike materials consist of a largely disordered array of long chain-molecules, with relatively large open intermolecular spaces through which molecules of odorous substances can diffuse easily. Polyethylene can be largely crystalline, and its crystalline regions are less permeable; however, they also make the material much stifler, so that very thin foils have to be used which are even more permeable to odor than the thicker sheets of equally flexible rubber.
The present invention eliminates this defect of the flexible receptacle by the use of multi-layered flexible sheets containing one or more thin layers of non-polymeric crystalline material. Particularly suitable among such crystalline materials are metals which can be used in the form of very thin foils sandwiched between thin sheets of polymeric material, for instance, rubber, either in the form of a solid sheet or of a fabric composed of fibers of a polymeric material, such as cotton or nylon. Such thin foils of metal such as aluminum or tin are practically completely impermeable to odoriferous molecules; the atoms of metal are so closely packed in their crystal lattice that only single atoms such as hydrogen, nitrogen, or carbon atoms can diffuse through the crystal Since all odorcharge are chemical compounds consisting of molecules, they cannot diffuse through a layer of metal, however thin. The grain boundaries of polycrystalline metals contain somewhat larger atomic interstices than the interior of the crystal grains; even these interstices, how ever, are of atomic dimensions, too small to permit the passage of any of the molecules of the troublesome odorous substances present in the discharge.
Although a thin metal foil is impermeable and flexible, it is not strong enough by itself for use as a receptacle wall. According to the invention, adequate strength is achieved by backing the thin metal foil with a thin sheet of polymeric material, for instance, rubber or those mentioned above, or sandwiching it between thin sheets of polymeric material. In this way, a composite sheet is obtained which combines the impermeability of the metal foil with the strength of a much thicker layer of polymer while still retaining adequate pliability.
The metal foil-rubber sheet sandwich is impermeable and pliable but it cannot be stretched substantially without tearing the foil and creating cracks in it which reduce the impermeability of the composite sheet. To provide extensibility and prevent tearing, the metal foil can be provided according to the invention with wavelike cor- 3,221,742 Patented Dec. 7, 1965 rugations; the polymeric sheets enclosing it may or may not be provided with corresponding corrugations. It is of advantage to corrugate the composite sheet as a whole, thereby obtaining more extensibility, reducing the area of contact between the skin and the receptacle, and providing better ventilation of the skin.
Instead of a metal foil, a layer of powdered metal or some other powdered crystalline material, preferably with flake-like grains, can be used. The grains should be bonded with a suitable polymeric bonding material and their concentration should be very high in order to achieve practically adequate impermeability. The use of crystalline powders, such as clay, mica flour, carbon or a metal powder as a filler in rubber is well known. However, the concentration of crystalline material in accordance with the present invention can be much higher than is possible in the manufacture of rubber for use in a conventional manner as a flexible receptacle in enterostomy appliances. The limitations imposed on the quantity of filler by the requirement of adequate mechanical strength are avoided in the present invention by sandwiching the highly filled layer between sheets of unfilled or less highly filled polymeric material of sufficiently high strength and resistance to cracking. In this way, concentrations of the non-polymeric crystalline powder in the odor-insulating layer can be attained so high that they would make a single layer of such material far too weak, liable to cracking and generally useless for an enterostomy receptacle.
The principle of the invention is demonstrated in the enclosed drawings of which:
FIGS. la and 1b represent an embodiment of the invention as applied to a conventional form of an ileostomy appliance. FIG. 1a is a vertical section of the appliance perpendicular to the surface of the body of the user. FIG. 1b is an enlargement of the area outlined with a broken line in FIG. 1a.
FIG. 2 is a front view of a receptacle of the invention provided with corrugations for increasing the extensibility of the walls.
FIG. 3 is a horizontal section taken along the line 33 of FIG. 2..
FIG. 4 is an enlargement of the area outlined with broken lines in FIG. 3.
FIG. 5 is a view like FIG. 2 with a part of the outer layer of the front wall of the receptacle removed.
In FIGS. 1a and lb an embodiment of the invention as applied to a conventional type of ileostomy appliance is shown. In FIG. 1a, 1 is the receptacle which is provided with a spout 2 for emptying at the bottom; the top is attached to a disc 3 which is cemented to the body with one of the conventional cements or vegetable gums used for this purpose, and/ or pressed to the body mechanically, for instance, with a belt. The receptacle may be integral with the disc, or it may be attached to the disc with any of a number of mechanical means, for example, as disclosed in my co-pending application Serial No. 856,446 now U.S. Patent No. 3,100,488. The disc contains an orifice 4 for accommodating the stoma and receiving the discharge. Alternatively, the disc may be omitted and the receptacle provided with an orifice for the stoma and an adhesive surface around the orifice for adhering to the skin. The present invention relates to the construction of the receptacle alone, and it can be applied to all types of appliances having a receptacle.
FIG. 1b is an enlargement of the area outlined with a broken line in FIG. 1a. It shows a cross-section of the receptacle wall according to the invention. 5 and 6 are pliable sheets of a polymeric material which can be a natural or synthetic rubber or a partly crystalline polymer such as polyethylene. Sandwiched between 5 and 6 and adhesively bonded to them is a thin odor insulating layer 7 of non-polymeric substantially crystalline material. This can be a metal foil, such as tinfoil, aluminum foil, indium foil, etc., or a layer of metal lamina, or lamina of other non-polymeric crystalline materials, such as mica. Alternatively, the odor insulating layer may be a composite material consisting of a fine grained substantially crystalline powder, such as clay, bentonite, carbon black, mica powder, or a metal powder, preferably of flake-shaped grains, bonded in a matrix of a polymeric material, such as rubber. In such case, the concentration of crystalline powder in the odor insulating layer can be much higher than the maximum permitted by the requirement of mechanical strength and crack resistance if the material is used alone. The thinness of the odor insulating layer makes it pliable independently of its material. The outer layers 5 and 6 insure the mechanical strength of the composite sheet while the inner layer 7 reduces the permeability of the sheet to the required magnitude.
FIG. 2 shows a receptacle made of a composite sheet as described above, provided with wavy corrugations 8 over a part or all of its wall area.
FIG. 3 is a horizontal cross section 33 of the receptacle of FIG. 2 showing the corrugations of the walls.
FIG. 4 is an enlarged section of the wall across the corrugations showing the metal foil 7 sandwiched between polymeric sheets 5 and 6. The corrugations make the wall of the receptacle extensible in spite of the relative inextensibility of the metal foil it contains. An additional advantage of the corrugations is that they prevent the inner wall of the receptacle from being in contact with a large area of the skin and hindering the evaporation of the perspiration. The corrugations act as ventilating channels for the skin.
FIG. 5 shows a design in which the metal foil does not extend over the entire area of the walls but terminates inside the circumference of the receptacle and/or outside the circumference of its receiving orifice 4. The marginal areas left unprotected by the odor insulating layer can be made so small that the odor transmission through them is practically unimportant, and at the same time making the seam in a seamed receptacle may be facilitated by terminating the odor insulating layer just inside the margins of the receptacle walls. In addition, the attachment of the receptacle to the disc may be easier if the odor insulating layer terminates outside the circumference of the receiving orifice.
The receptacle can also be made seamless by the economical process of latex dipping or solution dipping which, however, in itself gives walls of very inferior odor resistance, and then sheets of metal foil preferably backed with a thin protective layer can be bonded to the walls of the latex-dipped or solution-dipped receptacle. The dipped receptacle forms one of the layers 5 and and the backing layer forms the other layer 6. It is of advantage to provide the protective backing layer with a margin extending beyond the odor insulating layer and bonded directly to the wall of the receptacle, thus enclosing the odor insulating layer completely and protecting it from chemical attack.
Naturally, a receptacle as described in the present invention can also be used as a loose cover fitted over any other type of receptacle. Loose covers of fabric are widely used for promoting evaporation from the skin which is inhibited by direct contact with the wall of a rubber or other conventional receptacle. The use of the receptacle according to the present invention as a loose cover fitting over another type of receptacle provides odor insulation; in addition, it can promote evaporation of perspiration if the outer surface of the skin-contacting wall is covered with a fabric forming the layer 6 of the wall. Evaporation is also promoted by the corrugation of the walls as described above and illustrated in FIGS. 2, 3 and 4. The receptacle as shown in these figures and in FIG- 5 can be used directly or as a loose cover fitted over any other receptacle for achieving odor insulation.
1. An enterostomy appliance comprising a receptacle and a disc, said disc having an opening therein and having means for attaching said disc to the body with said opening of said disc located over the stoma of the patient, said receptacle comprising two pliable walls joined along at least the major part of their margins to form a pliable enevlope-like container, one wall containing an opening for receiving the discharge from the stoma of the patient, means connecting said receptacle with said disc with said opening of said receptacle in communication with said opening of said disc and with said receptacle lying generally flat against the body, each of said walls comprising a multi-layered sheet in which at least one layer comprises a substantially crystalline non-polymeric material.
2. A receptacle according to claim 1, said layer of material comprising metal.
3. A receptacle for an enterostomy appliance according to claim 2 in which said layer consists of a metal foil.
4. A receptacle for an enterostomy appliance according to claim 2 in which said layer consists of tin foil.
5. A receptacle for an enterostomy appliance according to claim 2 in which said layer consists of aluminum foil.
6. A receptacle for an enterostomy appliance according to claim 1 in which said layer comprises flakes of a crystalline material.
7. A receptacle for an enterostomy appliance according to claim 1 in which said layer consists of a nonpolymeric crystalline powder bonded with a polymeric material.
8. A receptacle for an enterostomy appliance according to claim 7 in which the grains of said powder have the shape of flakes.
9. A receptacle for an enterostomy appliance according to claim 1, said layer being sandwiched between two other layers of different material.
10. A receptacle according to claim 9, at least one of said layers comprising a fabric.
11. A receptacle for an enterostomy appliance according to claim 1, said walls containing marginal parts free from said substantially crystalline layer.
12. A receptacle for an enterostomy appliance according to claim 1, at least a part of one of said walls being provided with wavy corrugations.
13. A receptacle for an enterostomy appliance according to claim 1, comprising a rubbery receptacle produced by dipping and a substantially crystalline non-polymeric odor insulating layer bonded to the wall of the dipped receptacle.
14. A receptacle for an enterostomy appliance according to claim 13, in which the odor insulating layer is a metal foil.
15. A receptacle for an enterostomy appliance according to claim 13 comprising a protective backing bonded to the odor insulating layer.
16. A receptacle for an enterostomy appliance according to claim 15 in which the protective backing of the odor insulating layer extends beyond the margin of said layer and is bonded to the clipped part of the receptacle.
17. An enterostomy appliance comprising a receptacle and a disc, said disc having an opening therein and having means for attaching said disc to the body with said opening of said disc located over the stoma of the patient, said receptacle comprising two pliable walls joined along at least the major part of their margins to form a pliable envelope-like container, one wall containing an opening for receiving the discharge from the stoma of the patient, means connecting said receptacle with said disc with said opening of said receptacle in communication with said opening of said disc and with said receptacle lying generally fiat against the body, each of said walls comprising a multi-layered sheet in which at least one layer comprises a substantially crystalline non-polymeric material,
References Cited by the Examiner UNITED STATES PATENTS 1,580,857 4/1926 Richards 128132 X 1,819,147 8/1931 Bronson 117133 1,944,323 1/1934 Kilchling 117--127 Ruofl? 117-127 Reynolds 117-127 Nelson 128283 Perry 128283 Clark 20684 RICHARD A. GAUDET, Primary Examiner. RICHARD J. HOFFMAN, Examiner.