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United States Patent [w]
Quacquarella et al.
US005989235A [ii] Patent Number: 5,989,235  Date of Patent: *Nov. 23,1999
 OSTOMY BAG
 Inventors: Cesare Quacquarella; Livio
Buongiorno, both of Milan; Vittorio
Perego, Busto Arsizio, all of Italy
 Assignee: Cryovac, Inc., Duncan, S.C.
[ * ] Notice: This patent issued on a continued prosecution application filed under 37 CFR 1.53(d), and is subject to the twenty year patent term provisions of 35 U.S.C. 154(a)(2).
 Appl. No.: 08/903,570
 Filed: Jul. 31, 1997
 Foreign Application Priority Data
Jan. 29, 1999 [EP] European Pat. Off 96112399
 Int. C I. A61F 5/44
 U.S. CI 604/332; 604/338
 Field of Search 604/332-345,
604/327; 427/189, 200, 206; 156/279
 References Cited
U.S. PATENT DOCUMENTS
4,816,027 3/1989 Gilchrist et al 604/339
5,316,607 5/1994 Johnsen et al 156/212
5,423,782 6/1995 Wolrich 604/339
5,545,154 8/1996 Oberholtzer 604/336
5,591,144 1/1997 Smith et al 604/327
5,672,163 9/1997 Ferreira et al 604/333
5,722,965 3/1998 Kuczynski 604/344
5,785,695 7/1998 Sato et al 604/339
Primary Examiner—-John G. Weiss
Assistant Examiner—Dennis Ruhl
Attorney, Agent, or Firm—Elda DeCarli; Thomas C. Lagaly  ABSTRACT
The invention provides a drainage bag (colostomy, ileostomy or urostomy bag) comprising a bag of thermoplastic material having means to define an opening for receiving waste material from a stoma and means to secure the bag in place with the opening connected to the stoma, characterized in that at least the surface of the bag in contact with the skin of the wearer is flocked. Also described is an ostomy appliance comprising a re-usable outer bag and a disposable inner bag, means for securing the two bags together and to the stoma, means for inserting and removing the inner bag from the outer one, and means for closing, the outer bag once the inner one is in place, characterized in that at least the surface of the outer bag in contact with the skin of the wearer is flocked.
4,490,145 12/1984 Campbell
11 Claims, 2 Drawing Sheets
The present invention relates to ostomy bags that can be confortably worn by the patients.
An ostomy bag is a pouch that is employed to collect 5 waste material that exits a person's body through a stoma, i.e. through an artificial, permanent, opening, surgically created in the ostomate's skin and connected to the intestine or to the bladder.
Colostomy, ileostomy, and urostomy bags, herein collectively referred to as ostomy bags, typically comprise a pouch of plastic, moisture-impermeable and odor-barrier, material; an opening in said bag to allow waste material to enter into the plastic envelope; and means to secure the bag in place with the opening connected to the stoma. This can be obtained by means of a tape that is heat bonded to the 15 ostomy bag around the opening; said tape has an opening which is positioned in-line with the opening of the bag and the side of said tape which is adjacent to the ostomate's body is coated with an adhesive which allows adhesion of the ostomy appliance to the "peristomal area", i.e., the skin area 20 surrounding the stoma.
Preferably the means to secure the ostomy bag to the stoma and the ostomy bag itself, are constructed as two separable parts which are connected and disconnected by the user as desired. This is achieved for instance by applying to 25 the ostomate's skin by means of a suitable adhesive a tape that bears on its outer surface a semi-rigid plastic snap ring, bonded by conventional means to the tape, that surrounds the opening. The ostomy bags then bear a second complementary snap ring mating with the tape one; said comple- 30 mentary snap ring is bonded to the ostomy bag and surrounds the opening therein. The user can therefore apply and remove the ostomy bag from the stoma without peeling off from the skin the means for securing the bag to the stoma. When assembled the snap ring provides a tight leak-free 35 seal.
For the sake of clarity, FIGS. 1 and 2 in the attached drawings illustrate a conventional design for ostomy bags.
In FIG. 1, (1) represents the odor-barrier thermoplastic pouch, (2) is the opening in the pouch that needs to be in-line 40 with the stoma in order to receive the body's waste material, and (3) is the tape that is welded to the pouch and is used to secure the pouch in place by adhering to the ostomate's peristomal skin. In a preferred aspect, as indicated above, the ostomy bag and the means to secure it to the patient's skin 45 are constructed as two separate parts. In such a case, in FIG. 1, (3) represents a ring-shaped flange of semi-rigid plastic as better described in FIG. 2. This pouch strap ring, that preferably has clip retainers (4) spaced thereon, is used to secure the pouch to a tape, applied to the ostomate's skin 50 through its adhesive surface, said last tape bearing a mating ring on its outer surface (not shown in the drawings).
In all events the ostomy bag, which has a surface larger than that of the tape for attachment, lies on the ostomate's skin, conforming the abdominal contours and moving with 55 the skin as the skin moves.
The most common plastic films that are ordinarily employed in the manufacture of ostomy bags, being essentially impermeable to moisture vapor, do not allow the skin to breathe and frequently give rise to irritation of the user's 60 skin, particularly in case of a consistent and prolonged contact therewith.
Different solutions have been proposed to solve this problem, such as the use of a fabric material as the skin contact layer (as in CA-A-1,060,749) or the use of a com- 65 posite thermoplastic with a skin contact layer of a thermoplastic non-woven material (as in EP-A-433,060).
A great challenge still exists however to further improve the ostomates' comfort providing ostomy bags that not only meet functional requirements such as good mechanical resistance, easy sealability, and adequate odor barrier properties, but also are as much comfortable for the patient to wear as possible.
It has now been found that by using in the manufacture of an ostomy bag, at least for the surface thereof which is in contact with the patient's skin, a thermoplastic material which has been flocked, the discomfort which is associated with prolonged contact of moisture impermeable material with the patient's skin is remarkably alleviated.
Flocking (flock coating or flock lining) is a technique that allows the coating of a substrate with a high number of short fibers to give to the finished article a suede- or velvet-like appearance and touch.
In said process, the substrate to be flocked is first coated with a suitable glue or adhesive; then, in an electrostatic field, a great number of individual fibers (flock) are shot vertically into the thick adhesive coating; the flocked surface is then dried and cooled; and the excess flock is sifted out. Electrostatic flocking is based on the law of physics. The rod-shaped flocks take over the charge at one pole (due to either ionization or electrostatic induction) and then travel to the counterpole (the substrate coated with the adhesive) aligning themselves along the lines of force that always enter the substrate vertically.
Flocking machines and production lines for flocking that can be used in the manufacture of the flocked material for the ostomy bag of the present invention are commercially available. An example of a suitable flocking machine is Flocking machine GFS manufactured by Maag Flockmaschinen GmbH.
For the use according to the present invention the substrate or base to be flocked is a thermoplastic mono- or multi-layer film.
Widely differing kinds of fibers can be employed, such as polyamides, polyesters, acrylic polymers, and natural fibers, e.g. cotton and viscose. In a preferred embodiment of the present invention a natural fiber is employed, and even more preferably cotton fibers are used. The length of these fibers is typically less than 5 mm and generally of from about 0.1 to about 3.0 mm. Fibers of from about 0.3 to about 1.5 mm are preferred. The amount of flock fibers distributed per m2 of substrate may vary depending on the type of fibers employed, on the line speed and on the more-or-less heavy loading of the substrate which is desired. For the purposes of the present invention, optimum results are obtained with from about 10 to about 100 g/m2 and particularly with from about 30 to about 70 g/m2 of flock fibers, because a remarkable improvement in hand-feel and appearance is obtained with little increase in weight or stiffness. Fibers of different thickness can also be employed in the manufacture of the ostomy bag according to the present invention. The difference in thickness of the fibers is indicated as the titer which is measured in dtex or grams per 10,000 m length of the individual fiber. For the purpose of the present invention fibers with a titer of from about 2 to about 20 can suitably be employed.
Suitable adhesives will be selected depending on the type of substrate and flock fibers employed. In general said adhesive must be electrically conductive and must remain adhesive on the substrate surface for a time sufficient to allow the vertical fibers to penetrate. It is typically applied to the substrate with a sprayer or by brush, roller, pad or squeegee. Acrylic adhesives, such as polyacrylates or polyacrylates modified with epoxy resins, and urethane adhe