Membrane and use thereof in an ileostomy bag

Abstract: A method of making a gas-permeable liquid-impermeable membrane includes the steps of perforating a film (10) of linear low density polyethylene (or other suitable polyolefin) in such a way as to yield an array of holes (12) each having an average diameter of approximately 350 µ (microns), and then solution coating the needled film with a porous polyurethane material (14) having pores of a pore size of 1 to 10 µ. Such a film is advantageously embodied in an ileostomy bag, and is fixed to a bag wall thereof in a location to prevent faecal material contacting the bag filter, by a heat or RF welding operation by which the polyolefin is welded to the bag wall which carries the filter. In use, the polyurethane is exposed to the bag contents, and permits gases to pass but prevents any liquid reaching the filter.

Description: This invention relates to a membrane and a method of making the same, and particularly although not exclusively to a membrane which may be used in an ileostomy bag to prevent faecal material contacting a gas vent and filter in the bag wall, while allowing passage of flatus gases so that these, after being deodorised by passage through the filter, can escape to atmosphere. A membrane useful for this purpose should desirably have holes of diameter (or maximum transverse dimension in the case of a non-circular hole) in the range 1 to 10µ (microns). However, it is extremely difficult to make such small holes in currently available membrane films, and the thicker the film, the more difficult it is to make such small holes. However, the overall strength of the film is reduced to an undesirable level if its thickness is sufficiently small to enable holes of, say, less than 20µ diameter to be made by conventional methods such as needling. U.K. Patent Application No. (GB-A)2,059,797 discloses an odor-adsorbing gas-venting filter assembly (20) for a collection appliance (10), such as an ostomy pouch, which assembly includes a fibrous heat-sealable filter pad (21) containing thermoplastic fibres and adhesively bonded activated carbon and having a gas-pervious liquid barrier (22) heat sealed to one face thereof. The pad (21) and the gas-pervious liquid barrier (22) integrated with it are confined between two panels (23,24) of heat-sealable material joined together (at 27) along their borders. The arrangement of the filter shown in this patent application is such that gas escaping from the appliance (10) cannot by-pass the odor-adsorbing filter pad (21). The other panel (24) is formed of a gas-permeable thermoplastic material to enable the escape of gases from the appliance (10). According to the invention, a method of making a gas-permeable liquid-impermeable membrane is characterised by the steps of perforating a film of linear low density polyethylene (or other suitable polyolefin) in such a way as to yield an array of holes each having a minimum transverse dimension in the range 300 to 400µ and then solution coating the needled film with a porous polyurethane material having pores of a pore size of 1 to 10µ. Also according to a preferred embodiment of the invention, such a film is embodied in an ileostomy bag, and is fixed to a bag wall thereof in a location to prevent faecal material contacting the bag filter, by a heat or RF welding operation by which the polyolefin is welded to the bag wall which carries the filter. In use, the polyurethane is exposed to the bag contents, and permits gases to pass but prevents any liquid reaching the filter. An important advantage of this invention is that such a film prevents the bag contents from contacting the filter and in manufacture the film can be heat welded to the bag walls using the same machinery that is used to join together the walls of the ileostomy bag by a peripheral weld. Hence the resulting bag is more efficient for its intended purpose and yet can be economically made. In a preferred embodiment of the invention, the bag walls are made of a multi-laminate film having at least the layers e.v.a/gas barrier film/e.v.a. The intermediate layer serves two main purposes, firstly it acts as a gas barrier and secondly it increases the strength of the bag wall. The perforation of the film of linear low density polyethylene may alternatively be done to yield holes whose minimum transverse dimension is in the range 300 to 400µ. The polyethylene film may for example be 50µ thick and have about 400 holes per square inch (2.4 million holes per sq.metre). Figure 1 is a cross section through one example of membrane according to the invention. This Figure diagrammatically illustrates the invention. In this Figure, a film 10 of low density linear polyethylene has been provided with holes 12 by a vacuum perforation operation. The holes 12 are preferably approximately circular but could be of other shapes. Their diameter (or minimum transverse dimension) may be in the range 300 to 400µ as stated. Onto this film there is solution coated a porous polyurethane backing 14 which has connecting pores. The pore size is desirably 1 to 10µ and preferably about 3 to 8µ. The resulting composite film may readily be rolled and die cut and, as stated, can be handled by conventional high speed ostomy bag making machinery. The composite film is created by solution coating the vacuum perforated polyolefin with the polyurethane, the coating being such as to create microporous interlinked pores as described above. The two layers are held together using a suitable tie layer to create the finished structure. After drying to remove solvent, the finished construction can be reel wound ready for machine handling. It may be required for the polyurethane side of the finished structure to be treated with flurocarbon to further enhance its fluid repellency. For such treatment one could use a commercially-available water-repellent coating. The coated dried polyurethane coating preferably has a thickness in the range 10 to 15 microns.

Claims: A method of making a gas-permeable liquid-impermeable membrane characterised by the steps of perforating a film of linear low density polyethylene (or other suitable polyolefin) in such a way as to yield an array of holes each having a minimum transverse dimension in the range 300 to 400µm and then solution coating the needled film with a porous polyurethane material having pores of a pore size of 1 to 10µm. A method of making an ileostomy bag comprising fixing a film made by the method according to claim 1 to a bag wall thereof in a location to prevent faecal material contacting the bag filter, by a heat or RF welding operation by which the polyolefin is welded to the bag wall which carries the filter. A method of making an ileostomy bag in which the bag walls are made of a multi-laminate film having at least the layers e.v.a/gas barrier film/e.v.a. An ileostomy bag when made by a method according to claim 1 or 2.

Inventors: STEER GRAHAM EMERY, STEER, GRAHAM EMERY
Applicants: SQUIBB & SONS INC, E.R. SQUIBB & SONS, INC.
Application year: 1991
Main classification: A61F5
IPC codes: A61F13, B01D19, B01D69, A61L26, B01D71, A61F5