IE47662B1 - Ostomy appliance including a stomal faceplate and skin barrier - Google Patents

Abstract

A faceplate-skin barrier combination which permits the removal and attachment of pouches includes as the skin barrier portion an adhesive layer 11 and a thin flexible polymeric film layer 12, and has a semi-rigid flat polymeric faceplate 13. The product fits around the stoma and an ostomy pouch is adhesively attached to the semi-rigid polymeric faceplate, a hole being cut through the skin barrier, and when necessary the faceplate, for placement round the stoma.

Description

Major abdominal surgery for a number of diseases involving different parts of the gastro-intestinal and urinary tract can result in the patient being left with an abdominal stoma. The three most common types of abdominal stoma are the colostomy, the ilesotomy, and the ileal conduit. In the case, of an ileostomy, ileal conduit, and many colostomy operations, the patient is unable to control the passage of bodily waste material and must rely upon an appliance attached to their body to collect this material.

Several systems have been employed in the past for this purpose. Colostomates normally employ a disposable appliance which is either a one-piece or two-piece unit. The term disposable refers to the fact that the pouch or bag portion of the unit can be disposed of after a single use.

A closed end pouch sealed along all of its edges with only an opening for the stoma is suitable for this purpose.

Suitable one-piece disposable units consist of a disposable pouch or bag having an adhesive faceplate which is attached directly to body as shown in U.S. Patent Specification No. 3,055,368, a disposable bag having a mounting gasket which is supported by a belt and can include a sealing ring of karaya and glycerol as shown in U.S. Patent Specification No. 3,302,647 or a disposable bag supported by a sealing ring of karaya and glycerol, and adhesive ring, and a belt as shown’in U.S. Patent Specification No. 3,351,061.

Two-piece disposable units consisting of a disposable pouch and a reusable mounting ring or flange which is affixed to the body adhesively and/or by a belt. The pouch has an open mouth that fits over the flange and is held in place by an elastic band as shown for example in U.S. Patents Specifications Nos. 3,906,951 and 3,762,412.

Persons having an ilesotomy or urinary stoma normally employ a permanent (i.e. reusable) system or a semi-permanent system. -247662 This refers to the fact that the waste collecting bag or pouch has a valve or other type of closure means to the bottom. This permits the unit to remain on the body for several days. Again, these systems are available as either a one-piece or two-piece unit.

The one-piece reusable unit consists of a bag having a bottom valve or other closure means and a permanently bonded rubber or plastics faceplate. The faceplate has a centrally located opening for the stoma and can be attached directly to the body by means of latex cement or a double sided pressure sensitive adhesive disk. It is also common to adhesively attach the faceplate to a skin barrier which fits around the stoma rather than directly to the skin. For added security, a pressure plate having a belt attachment and a plasticsor metal ring that fits between the faceplate and the bag can be employed. After several days the adhesive bond between the faceplate and the body or skin barrier will weaken and the unit will be removed. The unit is cleaned and residual adhesive is removed from the faceplate so that it can be reapplied Eventually, the entire unit except for the pressure plate will have to he discarded due to erosion or odor build-up in the bag.

One-piece semi-permanent units for use with an ileostomy stoma having a karaya sealing ring bonded to the faceplate are commercially available.

The two-piece reusable unit consists of a rubber or plasticsflange having an opening for the stoma which is adhesively attached directly to the body or to a skin barrier and a separate bag having a bottom drain valve or other closure means which fits tightly over the flange. -347662 Chen in U.S. Patent Specification No.3,339,546 describes a bandage having an adhesive layer consisting of a mixture of gelatin, pectin, sodium carboxymethylcellulose and polyisobutylene,and a water insoluble polyethylene film. This bandage is currently employed as a skin barrier by ostomates and is also available with a permanently attached flange.

Other commercially available skin barriers contain a cloth mesh layer or polyethylene web sandwiched between two adhesive layers. The adhesive layers comprise a conventional pressure sensitive adhesive and a hydrocolloid.

The specification of Patent Application No. 538/78 discloses a drainage 10 pouch provided with a flexible plastics attaching ring. The specification states that the ring or the inner layer thereof is preferably formed of a thermoplastics film having a thickness not exceeding 10 mils and mentions a thickness of 2 to 5 mils.

According to our invention, there is provided an ostomy appliance 15 comprising a pouch, a skin barrier and a faceplate, said skin barrier including an adhesive layer one side of which is intended to contact the body of the wearer and a flexible polymeric film covering the opposite side of said adhesive layer, in which said faceplate is formed from semi-rigid polymeric material as herein defined and has a substantially flat smooth surface for the adhesive attachment of the ostomy pouch, in which said faceplate is bonded to the exposed surface of said flexible polymeric film and in which said faceplate is formed from low density polyethylene of a thickness of from 15 to 60 mils (381 to 1524 microns) or from high density polypropylene or polyethylene of a thickness of more than 10 mils (254 microns) and up to 40 mils (1016 microns), the pouch being adhesively bonded to the faceplate and the bond being strong enough to support the weight of a filled pouch and yet such as to permit the pouch to be manually peeled away from the faceplate without dislodging the faceplate from the body. - 4 1 In this Specification, the words semi-rigid when applied to the polymeric faceplate mean a faceplate which is sufficiently rigid so as not to wrinkle or bend substantially when in place on the body for several days, and yet which is not so rigid that it digs painfully into the external surface of the skin as the wearer moves or bends.

There is particularly described herein a stomal faceplate and skin barrier combination which permits the removal and attachment of pouches, particularly disposable pouches having an adhesive mounting disk.

Figure 1 is a top view of the stomal faceplate and skin barrrier product. Figure 2 is an enlarged front view of device of Figure 1 taken along the line 2-2 of Figure 1. Figure 3 is a top view of an alternative device. 15 Figure 4 is an enlarged front view of the device of Figure 4 taken along the line 5-5 of Figure 3. In order to alleviate and prevent problems of skin excoriation and irritation ostomates employ skin barrhrs such as that taught by Chen in U.S. Patent Specification No. 3,339,546. Such skin barriers have proven very popular with ileostomates who leave the barrier and appliance attached for several days. However, colostomates who employ disposable pouches have been reluctant to employ such skin barriers for economic reasons. The colostomate requires a skin barrier that will remain in place around the stoma for several days and yet permit the easy removal of a filled pouch and the leak-proof attachment of a new pouch. -547662 Other colostomates are able to control the passage of bodily waste materials by the use of irrigation techniques. However, for added security, they will employ a pouch between irrigations. When they irrigate, the pouch is removed and discarded even if empty since the adhesive on the pouch does not enable it to be reattached to the skin. However, by use of the skin barrier and faceplate combination the colostomate is able to reattach an empty pouch onto the semi-rigid flat polymeric faceplate.

The alternative presently available to the colostomate is the use of a mounting flange which is attached to a skin barrier and permits the pouch to be attached and removed by use of an elastic band or by use of a pouch having elastic properties. However, such pouches are themselves expensive and the flange results in an unsightly bulge beneath the clothing.

As shown in Figures 1 and 2 the combination 10 includes a skin barrier including adhesive layer 11 that contacts the body and a thin flexible polymeric film layer 12 and an outer semi-rigid flat polymeric faceplate 13. The pouch (not shown) is adhesively attached to faceplate 13. In order to have a secure attachment between the pouch and the faceplate the minimum width of faceplate 13 at the area of attachment represented in the figures as 14 should be equal to or greater than about 0.75 inches (19.05 millimetres).

The pouch when adhesively attached should not cover all of faceplate 13. This enables the ostomate to press down on this uncovered portion of faceplate 13 with one hand to securely hold the faceplate in place -647668 on the body while the filled pouch is peeled away from faceplate 13 with the other hand. In the preferred embodiment shown in Figures 1 and 2 this is accomplished by extending faceplate 13 on two sides beyond adhesive layer 11 and flexible film layer 12. However, this result can also be achieved by extending faceplate 13 on only one side or by dimensioning faceplate 13 so that a portion is not adhesively attached to the pouch even though faceplate 13 does not extend heyond adhesive layer 11 and film 12.

Optionally, openings 15 can be provided in the portions of 10 faceplate 13 that extend beyond adhesive layer 11 and film 12 for the attachment to a belt to aid in securing the appliance to the body.

As shown in Figures 1 and 2, the preferred semi-rigid polymeric faceplate 13 is of a closed loop configuration and does not cover the entire surface of film 12. Preferably, film layer 12 and adhesive layer 11 are rectangular with each side being from about 3 to about 5 inches (76.2 to 127 mm. ) in length and semi-rigid polymeric faceplate 13 is preferably of an elliptical external shape. The particular geometric configuration of the combination 10 is not critical and may vary. For example, adhesive layer 11 and film layer 12 may be circular or elliptical rather than rectangular and polymeric faceplate 13 may be circular rather than elliptical.

The inner circular area of film 12 that is not covered by (i.e. is exposed through a hole in) the polymeric faceplate 13 can vary in diameter from about 0.5 to about 2.5 inches (i.e. 12.7 to 63.5 mm.).

The ostomate cuts a hole through this portion of adhesive layer 11 and -747662 film 12 according to the circumference of the stoma. The maximum size of this opening is represented by dashed line 16 in Figure 1. There should be a border of at least about 0.125 inches (0.318 cms.) of film and adhesive layer 11 between the inner circumference of faceplate and the stoma. If the semi-rigid polymeric material of faceplate 13 were to contact or rub against the stoma it would cause discomfort and possible injury. Optionally, a starter hole can he proyided through adhesive layer 11 and film 12.

The polymeric film 12 in this area contiguous with the stoma acts to minimize disintegration of adhesive layer 11 by the hodily effluent that passes through the stoma into the attached pouch.

The adhesive layer 11 is formed from materials known to he compatible with the skin and capable of forming a sufficiently strong bond to support the weight of an ostomy appliance. Suitable adhesive compositions can include a pressure sensitive adhesive component and one or more hydrocolloid materials. Karaya based adhesive compositions such as that taught in U.S. Patent Specification No. 3,302,647 can also be employed. Other suitable adhesive compositions containing guar gum are taught by Chen et al. in U.S. Patent Specification No. 4192785 filed on June 8, 1977. The preferred adhesive composition is taught by Chen in U.S. Patent Specification No. 3,339,546 and is a homogeneous blend on a weight percent basis of 40% polyisobutylene, 20% pectin, 20% gelatin, and 20% sodium carboxymethylcellulose. The adhesive layer 11 can vary in thickness from about 20 to about 90 mils (508 to 2286 microns), preferably from about 55 to about 65 mils (1397-1651 microns). -847662 The thin flexible polymeric film layer 12 is formed from any substantially water insoluble material such as polyethylene, polypropylene, copolymers of vinylidene chloride, etc., with polyethylene being preferred. The film 12 can vary in thickness from 0.5 to about 5 mils (12.7 to 127 microns), preferably from about 1 to about 3 mils (25.4 to 76 microns).

The flat polymeric faceplate 13 is formed from semi-rigid material. It has been found that the surface to which the pouch is attached must have sufficient rigidity so as not to wrinkle or bend when in place on the body for several days. If wrinkles form, it becomes difficult to achieve the leak-proof attachment of subsequent pouches. However, if the polymeric faceplate 13 is too rigid it becomes uncomfortable as the portions that extend beyond the adhesive layer 11 can dig into the skin. The faceplate is formed from low density polyethylene of a thickness of from 15 to 60 mils (381 to 1524 microns) or high density polyethylene or polypropylene of a thickness of more than 10 mils and upto 40 mils (1016 microns) (254 microns) /with low density polyethylene of from 20 to 30 mils (508 to 762 microns) being preferred.

The adhesive bond formed between the faceplate 13 and the pouch is critical. It must be strong enough to support the weight of a filled pouch and yet permit the pouch to be peeled away from faceplate 13 with relative ease for disposal without dislodging the faceplate from the body. The tenacity of this bond can be altered by changing the adhesive on the pouch or by altering the surface characteristics of faceplate 13. For example, where a pouch having a very strong adhesive is employed the top surface of polymeric faceplate 13 can be -947662 coated with silicone so as to increase peelability. For use with a pouch having less tenacious adhesive it is preferred that polymeric faceplate 13 be formed from non-corona treated material and with a pouch having a relatively weak adhesive it is preferred that the top surface of polymeric faceplate 13 be corona treated.

An alternative embodiment of the skin barrier/faceplate combination is shown in Figures 3 and 4. The combination 40 differs from that shown in Figures 1 and 2 in that the semi-rigid outer polymeric faceplate 43 is not annular shaped but extends across the surface of film layer 12. The central area of semi-rigid polymeric faceplate 43 contains a series of circular grooves 44 cut to a depth of approximately 2/3 the thickness of faceplate 43. The grooves function as a cutting guide so that the ostomate can cut or tear an opening in the device 40 slightly greater than the circumference of the stoma. The area between the stoma and the inner edge of the opening can be packed with various ointments, powders or paste products known to be useful for this purpose. The area of polymeric faceplate 43 to which the pouch is attached is substantially flat and the faceplate is again dimensioned so that a portion will not be bonded to the pouch. As explained above, this portion of the faceplate can be employed by the ostomate in holding the faceplate in place while peeling off a pouch. In the preferred form of this embodiment shown in Figures 3 and 4, the faceplate extends beyond the skin barrier and can include openings 15 for the attachment of a belt.

As a further alternative to this embodiment, the faceplate 43 -1047662 can be annular shaped and the central grooved section can be a separate molded piece of polyethylene adapted to fit within this central opening of faceplate 43. Again the grooves will function as a cutting guide so that the ostomate can cut or tear an opening in the faceplate slightly greater than the circumference of the stoma.

The skin barrier/faceplate combinations 10 and 40 are assembled as follows. The skin contacting portion of the skin barrier, i.e. the adhesive layer 11, is prepared according to known methods and then covered by the thin flexible polymeric film layer 12. The semi-rigid faceplate of either configuration 13 or 43 is stamped, die cut or molded into the desired shape. The faceplate then is adhesively attached to the flexible polymeric film 12. Numerous types of adhesives are suitable for this purpose, the only requirement being that the bond between the faceplate 13 or 43 and the film 12 must be strong enough so that the faceplate is not dislodged when a pouch is peeled off. One particularly suitable method of bonding employs commercially available pressure sensitive transfer adhesive tape. This material is in roll form with silicone coated release paper on both sides of the tape.

The faceplate and skin barrier when packaged will include a sheet of release agent coated paper on the exposed bottom surface of adhesive layer 11 that contacts the body. Silicone coated paper is preferred. If desired this paper can be imprinted with a cutting guide so as to aid the ostomate in fitting these parts around his -1147662 stoma.

The faceplate and skin barrier as disclosed herein have been described as being employed along-with disposable colostomy pouches.

Such pouches can have a pressure sensitive adhesive coating directly on a portion of the pouch or can include a collar that is heat sealed to the pouch around the stomal opening with a coating of pressure adhesive on the outer side of the collar. The faceplate and skin barrier as disclosed herein could also be employed by ostomates using a nondisposable pouch that includes a bottom drain or other opening. Also, pouches without an adhesive area can be attached to the device by means of a separate double sided pressure sensitive adhesive coated disk or by the use of transfer tape. The surface of the pouch or collar should be corona treated or primed so that the adhesive will remain on the pouch when it is peeled off from the semi-rigid faceplate.

Claims (10)

1. CLAIMS:1. An ostomy appliance comprising a pouch, a skin barrier and a faceplate, said skin barrier including an adhesive layer one side of which is intended to contact the body of the wearer and a

2. The appliance of claim 1 wherein said faceplate is dimensioned so that a portion of said faceplate will not be adhesively 20 bonded to said ostomy pouch.

3. The appliance of claim 2 wherein the first-mentioned adhesive layer comprises a homogeneous mixture of a pressure sensitive adhesive and one or more hydrocolloid materials.

4. The appliance of claim 1 wherein the thickness of the 25 first-mentioned adhesive layer is substantially from 508 to 2286 microns -1347662 (20 to90 mils) and the thickness of said flexible polymeric film is substantially from 12.7 to 127 microns (0.5 to 5 mils).

5. The appliance of claim 4 wherein said skin barrier is substantially rectangularly shaped and said faceplate is approximately elliptically shaped and extends beyond the surface of said skin barrier. 5 flexible polymeric film covering the opposite side of said adhesive layer, in which said faceplate is formed from semi-rigid polymeric material as herein defined and has a substantially flat smooth surface for the adhesive attachment of the ostomy pouch, in which said faceplate is bonded to the exposed surface of said flexible polymeric film, in 10 which said faceplate is formed from low density polyethylene of a thickness of from 15 to 60 mils (381 to 1524 microns) or from high density polypropylene or polyethylene of a thickness of more than 10 mils microns) (254 microns) and upto 40 mils (1016/ the pouch being adhesively bonded to the faceplate and the bond being strong enough to support 15 the weight of a filled pouch and yet such as to permit the pouch to be manually peeled away from the faceplate without dislodging the faceplate from the body.

6. The appliance of claim 5 wherein the first-mentioned adhesive layer is substantially from 1397 to 1651 microns (55 to 65 mils) in thickness, said flexible polymeric film layer is substantially from 25.4 to 76 microns (1 to 3 mils) in thickness, said semi-rigid polymeric faceplate is low density polyethylene of substantially from 508 to 762 microns (20 to 30 mils) in thickness.

7. The appliance of claim 6 wherein said semi-rigid low density polyethylene faceplate is of a substantially elliptical external configuration with an inner substantially circular hole so that a central portion of said skin barrier is not covered by said faceplate, whereby, in use of the device, the ostomate can cut a hole through this portion of said skin barrier in order to fit the appliance around the stoma.

8. The appliance of claim 7 wherein the minimum dimension of said faceplate between its periphery and the boundary of its said hole is equal to or greater than substantially 19.05 millimetres (0.75 ins.).

9. The appliance of claim 5 wherein the first-mentioned adhesive layer substantially comprises a homogeneous blend of 40% by weight polyisobutylene, 20% by weight pectin, 20% by weight gelatin, and 20% by weight sodium carboxymethylcellulose. 10. The appliance of claim 9 wherein said semi-rigid polyethylene -1447662 faceplate is formed from a non-corona treated material. 11. The appliance of claim 9 wherein the surface of said semirigid faceplate is corona treated. 12. The appliance of claim 9 wherein said semi-rigid faceplate 5 has a silicone coating upon which the second-mentioned adhesive is placed to attach the pouch to the faceplate. 13. The appliance of claim 9 wherein the portions of said faceplate that extend beyond said skin barrier include openings for the attachment of a belt.

10. 14. An ostomy appliance according to claim 1 and substantially as herein described with reference to the accompanying drawings.