CA1124154A

CA1124154A - Ostomy appliance

Info

Publication number: CA1124154A
Application number: CA304,753A
Authority: CA
Inventors: John A. Hill; Anthony L. Lavia; Robert W. Loy; William J. Davidson
Original assignee: ER Squibb and Sons LLC
Current assignee: ER Squibb and Sons LLC
Priority date: 1977-07-05
Filing date: 1978-06-05
Publication date: 1982-05-25
Also published as: AU3697278A; DE2829332A1; GB2000683A; JPS5418195A; FR2396542A1

Abstract

SN37 ABSTRACT An ostomy appliance including a bag having a resealable opening at the top just above the stomal opening which permits the ostomate to clean and redress the area conti-guous to the stoma without removing the appliance. The bag can also include a resealable bottom closure for drainage and an adhesive mounting gasket around the stomal opening.

Description

This invention is di.rected to arl ostomy appliance per-miktincJ access to thc stomcl throu~h a resealable openincJ loca~ed at the top of the bag and arl easy to use seal at the bottom of thc bag for draininJ. By means of the top opening the ostomàte is able to examine. and irrigate or clean the skin aroun~1 the stoma and pack this area with medicinal powder or oin~m~nt with-out fixst having to remove the appl.iance. Also, the top opening ena~les the ostomate to fit the appliance around the stoma with greater ease.

Fiyure 1 is a ~ront view o~ the outer side of an ileostomy appliance includi.ng a bag having a resealable opcnin~
across the top and a drainage closure at the bottom.
Figure 2 is an exploded enlarged view o thc reseala~)le top opening shown in figure 1.
Figure 2A is a sectional view taken alorlg lines ~ 2 o~ figure 2.
Figure 3 is a side ele~ation of the appliance shown in : fi~re 1.
Figure 4 is a front view of the skin side of ~n ileos-tomy appliance employing the same type of resealable means asboth the top openiny and bottom closure.
Figure 5 is a side elevation of the appliance shown in f igure 4 .
Ostomy appliance and in particular the one-piece rc-usable or semi-permanent units described above that are com monly used by persons having an ileostomy or urinary stoma present several problems. These units whether a~ixed dircctly to the body or to a skin barrier a.re desj.cJIleld to remain in place for about 7 to 14 days. However, the ~low oi efflucnt from thc stoma can crode the adhesive material of the appliance or o~

~L2~

the skin barrier adjacent to the stoma thus lessening the length of time for which the unit can remaln in place. This breakdown is accelerat~d if the appliance is improperly fitted around the stoma The effluent can ~hen contact the unprotected skin con-ti~uous with the stoma and cause serious irritationA
This invention is directed to means enabling the osto-mate to examine and clean the area o skin contiguous with the storma and, if necessary, redress this area with an ostomy pow-der or ointment without the necessity of first removing the appliance. By so treating, the rate of erosion of the adhesive and the skin barrier are reduced and the appliance can remain - in place for a longer period of time. This result is achieved b~ providing a resealable opening at the top of bag above the stomal opening.
Also, this invention is directed to a bottom closure mealls enahliny the ostomate to easily drain the ka~.
For convenience this invention will be d~scrihed as i~
would be employed with a one-piece semi-permanent ileostomy appliance. However, by modifications that will be described below, the invention is also applica~le to appliances for a colostomy or urinary stoma as well as a one-piece reusable or two-piece ileostomy appliance.
An ileostomy appliance 10 incorporating the features of this invention is shown in figures 1 to 3. The appliance 10 includes a bag having polymeric film surfaces 11 and 12 permanently sealed along a majority of their edges by heat or other means known in the art. Sides 11 and 12 are not joined along either the bottom edge 13 or top ed~3e 1~. Side 1]
is thc skin side of the appliance and side 1~ is thc outer side.

Ther~ i5 an opening 19 in sidewall 11 throu~3h which the s~oma 5~
protrudes.
The film surfaces 11 and 12 can be formed from any suitahle polymeric matcrial which is moisture proof arld odor proof and has the necessary strength. Suitable materials include polyethylene, a copolymer of vinyl chloride and polyvinylidene chloride, etc., and laminates thereof such as a laminate of ethylene vinylacetate or polyethylene and a copolymer of vinyl chloride and polyvinyli-dene chloride. Both polymeric film surfaces 11 and 12 can be clear or opaque or the skin side 11 can be clear and oul:side 12 opaque. The ~hickness of the films 11 and 12 will vary depending upon the particular polymeric material but generally will ranye from about 2 to about 8 mils.
A mounting gasket or faceplate comprising a flexible film 16 of rubber or polymeric material and a pressure sensitive adhe-sive layer 24 (note figure 3) is permanently bonded by heat, adhe-sive, or other known means to skin side 11 around o~ening 19. The area of the bond between the faceplate and side 11 is repres~nted as cross-hatched area 18 in figure 1. As can be seen in figure 3, the outer peripheral edge of the faceplate is free from side 11 and can thus conform to the body- o~ the ostomate.
A starter hole 17 is provided in the faceplate. The ostomat~
increases the size of the starter hole 17 a~cording to the diameter of the stoma. Of course, the bonding area 18 must xemai~ intact. Preferably, the aceplate is a film 16 of pol~-meric material such as polyethylene of from about 1 to about 5 mils in thickness having as the adhesive composition 2~ a homogeneous mixture of polyisobutylene, sodium carboxym~thyl-cellulose, gelatin and pectin as taught by Chen in U.S. Patent 3,339,546 at from about 50 to about 150 mils t~ickness. The faceplate is normally disk shaped as ~hown in figurc 1 but can 5~
be formed in other sh2pcs such as rec~angular i desired.
Optionally, a ring shaped pressure plate (not shown in the drawings) having ~ belt attachment can be itted between thc faceplate and surface 11. Also, during shipping the exposed surface of the adhesive layer 24 is covered by a piece of silicone coated release paper.
The resealable opening means 15 near the stomal opening is shown in figures 1 and 3 and in greater detail in figures 2 and 2A. As shown in figures 2 and 2A, alternate rows of raised ridges separated by grooves are present on the inside of p~ly~
meric surfaces 11 and 12. The rows are aligned so that the raised ridges on the inside of film 12 can be forced by the exertion of a slight amount of pressure into a groove on the inside of surface 11. The seal formed is fluid and odor tigh~.
Methods of forming this and other equivalent types of inter-locking surfaces on polymeric films are taught in various ref-erences such as by Kraus in U.S. Patent 3,380,481, ~usnit in U.S. Patent 3,371,696,by Naito et al. in U.S. Patents 3,198,228 and 3t246,672 and by Goto in U~S. Patent 3,462,332. As shown in figures 2-and 3 the upper edge of film surface 12 extends beyond the upper ed~e of film surface 11 so as to aid in pull ing the two surfaces apart.
~ he appliance 10 includes a resealable closure at the bottom of the bag which permits the bag to be emptied through opening 13. The bottom closure as shown in figures 1 and 3 includes polymeric film member 22 bonded by adhesive or other means to the outer bag surface 12 at the top of the tail por-tion of the bag. A section of hook type male elements 23 are bonded to the inside of film 22 facing bag surface 12 as shown in fig~le 3 and the folded back edye in figure 1. ~ section 5~

of female loop elements 21 are bonded to the-skin sicle of the bag surface 11. The method of forming such male and female elements is taught by deMestral in U.S. Patent 3,009,235.
bar 20 of relatively rigid polymeric material is bonded to the bottom of surface 12. The seal is.formed by bending film 22 bao~ and folding bar 20 over itsel~ so that the loops 21 are facing outward away from the body. Hook elements 23 are then pressed into contact with loops 21 to complete the seal. Of course, the film member 22 and bar 20 can be attached to poly-meric surface 11 and loop elements 21 attached to surfac,~ 12 i~ desired.
An alternativP type of resealable opening at the topof the bag portion of appliance 30 is shown in figuros 4 and 5.
This embodiment employs the same closure at both the ~op and the bottom of the bag. As shown best.in figure 5,a polymoric film 122 is attached to film surface 11 just above the face-plate with male hook elements 123 facing film surface 11. Thc female loop elements are attached to the outside of film sur-face 12 and a r~latively rigid polymeric bar elemen~ is attache~
to the top of ilm surface 11. The seal is formed by bendillg back film 122 and folding bar 120 over itself so that the loops 121 are faci.ng toward the body. Hook elements 123 are then pressed into contact with loops 121 to complete the sea~. This top sealed portion of the bag can then be rolled down 21lCi placed bekween the faceplate and polymeric film surface ll. O~ course, the film member 122 and bar 120 can be attached to polymcric film 12 and loop elements 121 attached to surface 11 if desiro~.
As shown in figure 4, the opening at the top edge 14 of thc bag is of greater width than the bottom opcninc3 13 so that it is easier for the ostomate to reach down into thc bacJ and treat.

the skin contiguous to the stoma.
Ileostomy appliances 10 and 30 are employed in essen-tially the same manner. The ileostomate enlarges the starting hole 17 accordin~ to the size of his stoma. The silicone coated release paper is removed. The area around the s-toma is cleaned, dried, and dressed. The bottom closure is sealed but the top closure near the stoma remains open. The appliance is fitted with the top opening enabling the ileostomate to perform the fit with greater ease. The top closure is then sealed. At any time while the appliance is in place the ileostomate is able ~o - open the top seal and examine the stomal area. If necessary, the area can he cleaned by use of a cotton swab passed down through the opening and the area can also be redressed with ointment or other medication. The opening is then resealed.
Of course, at periodic intervals the bo~tom seal is opened to drain the contents of the bag.
This invention has been described with reference to a semi-permanent one-piece ileostomy appliance. ~Iowever, it is also applicable to other ostomy appliances. For example, the 20 adhesive layer 24 can be omitted so that the faceplate is merely a film of polymeric material and a separate double sided pressure sensitive adhesive disk is employed to mount the appliance. In the case of a urinary stoma, the bottom Velcro type closure can be replaced by a valve means as shown by Nolan in U.S. Patent 3,822,704. In the case of a colostomy, the bottom of the bag would be sealed. Also, the bag can include a deodorizing and/or vent means as disclosed, for example, by Riely in U.S. Patent 3,690,320, by Nolan et al. in U.S. Patent 3,75~,260 and by Elmore et al. in U.S. Patent 3,865,109.

~ ~0

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. An ostomy appliance comprising a bag formed from two polymeric film surfaces permanently sealed along a majority of their length, resealable opening means at both the top and bottom edges of said bag, one of said polymeric film surfaces being the skin side of the bag and having an opening which fits around the stoma, the other polymeric film surface being the outer side of the bag, said resealable bottom opening means comprising a section of male hook elements attached to one of said polymeric film surfaces and a section of female loop elements attached to the other polymeric film surface, and wherein said resealable top opening means is above said stomal opening and provides access for the ostomate to the area con-tiguous to the stoma without the need for removal of the appli-ance.

2. The appliance of claim 1 wherein said resealable top opening means comprises interlocking surfaces on the inside of each polymeric film surface.

3. The appliance of claim 2 wherein said interlocking surfaces are a series of alternating raised ridges and grooves extending across the top of said bag which are aligned so that by the exertion of a small amount of pressure the raised ridge on the inside of one surface will fit within the groove on the inside of the other surface.

4. The appliance of claim 3 including a faceplate of a flexible film of rubber or polymeric material which is per-manently bonded to the skin side of the bag around said stomal opening, said faceplate having a centrally located opening which is expanded by the ostomate to fit snugly around the stoma.

5. The appliance of claim 4 wherein said bottom open-ing means comprises a polymeric film member having male hook elements on its inner surface said polymeric film member per-manently bonded to the outer side of the bag such that the hook elements face the bag, female loop elements permanently bonded to the skin side of the bag, and a bar of relatively rigid poly-meric material permanently bonded to the bottom of the outer side of the bag whereby the seal is formed by bending the bar back over itself so that the female loop and male hook elements can be pressed together.

6. The appliance of claim 5 wherein said faceplate comprises a thin disk shaped film of polymeric material having a layer of pressure sensitive adhesive on its exposed surface and wherein the bond between said disk shaped film and said skin side of the bag does not extend to the outer peripheral edge of said faceplate.

7. The appliance of claim 6 wherein said faceplate comprises a thin film of polyethylene having as the pressure sensitive adhesive a homogeneous mixture of gelatin, pectin, sodium carboxymethylcellulose, and polyisobutylene.

8. The appliance of claim 1 wherein said resealable top opening means comprises a section of male hook elements attached to one of said polymeric film surface and a section of female loop elements attached to the other polymeric film surface.

9. The appliance of claim 8 including a faceplate of a flexible film of rubber or polymeric material which is per-manently bonded to the skin side of the bag around said stomal opening, said faceplate having a centrally located opening which is expanded by the ostomate to fit snugly around the stoma.

10. The appliance of claim 9 wherein said resealable opening comprises a polymeric film member having male hook elements on its inner surface said polymeric film member per-manently bonded to the skin side of the bag just above the face-plate so that the hook elements face the bag, female loop ele-ments permanently bonded to the outer side of the bag, and a bar of relatively rigid polymeric material permanently bonded to the top of the skin side of the bag whereby the seal is formed by bending the bar back over itself so that the female loop and male hook elements can be pressed together.

11. The appliance of claim 10 wherein said bottom opening means comprises a polymeric film member having male hook elements on its inner surface said polymeric film member permanently bonded to the outer side of the bag so that the hook elements face the bag, female loop elements permanently bonded to the skin side of the bag, and a bar of relatively rigid polymeric material permanently bonded to the bottom of the outer side of the bag whereby the seal is formed by bending the bar back over itself so that the female loop and male hook elements can be pressed together.

12. The appliance of claim 11 wherein said faceplate comprises a thin disk shaped film of polymeric material having a layer of pressure sensitive adhesive on its exposed surface and wherein the bond between said disk shaped film and said skin side of the bag does not extend to the outer peripheral edge of said faceplate.

13. The appliance of claim 12 wherein said faceplate comprises a thin film of polyethylene having as the pressure sensitive adhesive a homogeneous mixture of gelatin, pectin, sodium carboxymethylcellulose, and polyisobutylene.