WO2005102229A1

WO2005102229A1 - Improved ostomy appliance

Info

Publication number: WO2005102229A1
Application number: PCT/CA2005/000618
Authority: WO
Inventors: Wayne Conrad; Brock Masters
Original assignee: Wayne Conrad; Brock Masters
Priority date: 2004-04-26
Filing date: 2005-04-25
Publication date: 2005-11-03

Abstract

An ostomy appliance comprising an ostomy bag and means for attaching the ostomy bag to a user's skin, the attaching means comprising a radially inner layer (4) which provides cushioning and also some degree of adhesion to the user's skin, and a radially outer layer (5) of thin flexible oxygen and water vapour permeable but water and body fluids impermeable material which surround the inner layer and which provides stronger adhesion to the user's skin than the inner layer. The inner layer protects the stoma and the peristomal area from rubbing or chafing, which can cause skin irritation, inflammation or infection leading to poor adhesion of the ostomy appliance. The outer adhesive layer provides more than 50 % of the adhesion that secures the ostomy appliance to the user's skin and also ensures that the inner layer is not adversely impacted or degraded by body fluids or water. The attaching means may include an intermediate adhesive layer (41) between the inner layer and the outer layer.

Description

Title: IMPROVED OSTOMY APPLIANCE

Field of the invention

[0001] The present invention relates to ostomy appliances and in particular to the portion of the ostomy appliance used to attach the appliance to the body of the user.

Background of the invention

[0002] A person whose normal bowel function or bladder is impaired due to a birth defect, injury, disease, or other disorder may undergo a surgery known as an "ostomy." Ostomy surgery typically involves the removal or bypass of impaired or diseased tissue, the creation of a hole in the abdominal wall of the patient, the pulling of a section of the bladder conduit or bowel to the skin surface adjacent the hole and subsequently attaching the section of the bladder conduit to the skin surface. Bowel attachment surgery is termed an "ileostomy" when the small intestine is involved, termed a "colostomy" when the large intestine is involved, and termed a "urostomy" when the bladder is involved.

[0003] The hole in the skin to which the end of the bladder conduit or intestine is attached is called the "stoma," and the surrounding skin area is called the "peristomal area". The ileostomy and colostomy stoma provides an open conduit through which a constant or intermittent efflux of fecal material can occur and the urostomy stoma allows the efflux of urine. The urine or feces is collected in a bag-like ostomy appliance, which is worn by the user and replaced by the user as required every few days. In this application, the word ostomy is used to refer to an ileostomy, colostomy, urostomy or any like procedures, which now exist or which may be developed in the future and which result in the efflux of urine or fecal matter through a surgically created opening in the skin of a person.

[0004] The attachment of the ostomy appliance to the user can be achieved with either a one-piece or a two-piece system. A two-piece system typically consists of a flange, which is adhered to the body of the person who has had an ostomy, and a bag like device positioned to collect feces or urine. The flange and the bag each have a mechanical member, which interact to allow the bag to be removably fastened to the flange and for a plurality of bags to be used with a single flange over a period of 2-7 days. The one-piece system integrates both the means of adhering the bag collection device to the body and the bag collection device.

[0005] A modern adhesive system for ostomy appliances typically consists of an inner hydrocolloid layer over which a protective paper or cloth tape is adhered to provide a barrier through which feces and urine will not pass but which does allow oxygen and water vapor to pass. Current adhesive systems for ostomy appliances often become detached from the body of the user if the user sweats or if the product is exposed to moisture, water or excessive heat. Accordingly, a problem with current ostomy appliances is that sweat, moisture or heat or a combination thereof compromises the integrity of the seal created by the hydrocolloid layer against the body, resulting in users being concerned about the embarrassment and inconvenience of the ostomy appliance leaking or becoming detached.

[0006] Eastman (US Patent # 4,681 ,574) recognized the shortcomings of the existing ostomy appliances and their associated adhesives but their solutions to address these shortcomings are themselves inadequate.

Eastman advocated the elimination of all adhesive materials except for the single layer of oxygen permeable, water vapor permeable, thin flexible adhesive material impermeable to bacteria specified and claimed to be less than 0.010" (ten thousands of an inch thick) made of polyurethane elastomer.

The devices of Eastman, namely the use of adhesive coated membranes

0.010" thick having the desirable properties of thinness, low modulus of elasticity, and permeability, have been in use for over ten years for burn and wound dressings, but not as attachments for ostomy appliances. The dressings specified by Eastman included a number of products offered under the trade names "Op-Site" made by Smith & Nephew, "Tegaderm" made by 3M, "Bioclusive" made by Johnson & Johnson, "Thinfilm" made by Hollister and "Uniflex" made by Howmedica. This type of material is described in U.S. Pat. No. 3,645,835, assigned to Smith & Nephew, issued Feb. 29, 1972. Op- Site is sold by Smith & Nephew under this patent, and Tegaderm and Bioclusive are sold under the same patent by virtue of license agreement with Smith & Nephew. A problem with Eastman is that the membranes taught therein, which have a thickness less than ten thousandths of an inch (0.010") and preferably less than about three thousandths of an inch (0.003"), do not protect the stoma and the nearby skin from abrasion and other injury due to the rubbing and chafing of the bag in the case of one-piece appliances and the rubbing and chafing of the flange and bag rings in addition to the bag in the case of two-piece systems. As such, Eastman addressed the issue of adhesion without adequately considering cushioning of the stoma during every day activities.

Summary of the invention

[0007] The present invention provides an improved means for attaching an ostomy appliance to the body and is applicable to both one-piece and two- piece systems which offers water vapor and oxygen permeability, abrasion and chafing protection for the stoma and the peristomal area while being impermeable to water or body fluids and unaffected by sweat and other skin secretions.

[0008] In accordance with one embodiment of the instant invention, a one piece ostomy appliance comprises a bag made of any known materials used for ostomy appliances, preferably flexible sheet or film material such as polyethylene or PVC incorporating an opening for collecting waste matter that is discharged from the stoma. The appliance is attached to the skin directly adjacent to the stoma by means of a thin layer of hydrocolloid over and around which is attached a layer of thin flexible oxygen and water vapor permeable material which adheres to the skin of a user. The hydrocolloid material protects the stoma and the peristomal area from rubbing or chafing, which can cause skin irritation leading to undesirable poor adhesion of the ostomy appliance, skin inflammation or skin infection.

[0009] In accordance with another embodiment of the instant invention, a two piece ostomy appliance comprises a bag made of any known materials used for ostomy appliances, preferably flexible sheet or film material such as polyethylene or PVC incorporating an opening for collecting waste matter that is discharged from the stoma and a ring which attaches and detaches from a ring on the flange with which it mates. The flange is attached to the stoma and peristomal area by means of a two or three layer adhesive system. The flange may be attached to the skin directly adjacent to the stoma by means of a thin layer of hydrocolloid over and around which is attached a layer of thin flexible oxygen and water vapor permeable material which adheres to the skin of a user. The hydrocolloid material protects the stoma and the peristomal area from rubbing or chafing, which can cause skin irritation leading to undesirable poor adhesion of the ostomy appliance, skin inflammation or skin infection. Alternately, the flange may be attached to the skin directly adjacent to the stoma by means of a thin layer of hydrocolloid over and around which is attached a layer of cloth or paper tape over and around which is attached a thin flexible oxygen and water vapor permeable tape, preferably an elastomeric tape and more preferably elastic urethane tape. The hydrocolloid material serves to protect the stoma and the peristomal area from rubbing or chafing, which can cause skin irritation leading to undesirable poor adhesion of the ostomy appliance, skin inflammation or skin infection. The hydrocolloid also enhances healing if irritation or infection of the peristomal area should occur.

[0010] In the application of either the one piece or the two piece ostomy appliance, the hydrocolloid layer guards against infection and skin irritation and the outer layer or layers of adhesives ensure that the hydrocolloid remains in place and is not adversely impacted or degraded by body fluids or water. The outer urethane tape layer provides a thin flexible oxygen and water vapor permeable but water and body fluids impermeable layer which provides an attachment between the body and the flange for two piece systems and between the body and the bag for one piece systems.

[0011] The optional paper or cloth tape layers and the urethane membrane layer both have an opening which registers with the opening in the flange in the case of a two piece system. The optional paper or cloth tape layers and the urethane membrane layer both have an opening which registers with the opening in the bag. The bag and the urethane membrane are attached together, preferably by being bonded or heat sealed together around the periphery of those registered openings. [0012] The body or skin side of the urethane or similar membrane of both the one piece and two piece products has an adhesive on its surface which adhesive is preferably protected by a cover sheet that is removably affixed so as to expose the adhesive for adhering to the body.

[0013] The urethane or similar membrane of the invention when combined the hydrocolloid inner layer creates a number of properties not found in the attachment systems used with the current ostomfy appliances and which reduces the incidence of leakage and detachment and reduces the problem of skin irritation and disintegration. The combination of a hydrocolloid or inner cushioning layer and one or more outer adhesive layers provides an adhesive layer which is very thin, and may be in the range of a few thousandths of an inch, thereby eliminating the space where waste matter can hang up and pool near the stoma while the hydrocolloid protects the peristomal skin and stoma from trauma.

[0014] The outer adhesive layer is preferably stretchable. For example, urethane incorporating an adhesive is easily stretched making it virtually impossible for the normal stretching and contracting of the skin to set up a shear force sufficient to break the bond between the urethane and the skin. The stretch-ability of the outer adhesive layer is preferably essentially uniform in all lateral directions. Furthermore, because of its preferred extreme thinness, flexibility and stretch-ability, the outer adhesive layer of this invention can be easily molded and adhered to the skin. As the outer adhesive layer of this invention is essentially impervious to liquid water it protects the hydrocolloid from dissolving or melting from the action of external water or waste matter from within the appliance. With the addition of the outer adhesive layer, it will be appreciated that the cushion layer is not the sole member that secures the ostomy appliance to a user. Therefore, the cushion layer may be made from an alternate material other than hydrocolloid, and may be made from any medically safe material that will provide cushioning and preferably also provides some degree of adhesion to skin. The outer adhesive layer may use any substrate that is thin, flexible, stretchable, oxygen and water vapor permeable material and is essentially impermeable to body fluids and liquid water.

[0015] The adhesive which is used on the urethane or similar membrane of this invention is preferably essentially unaffected by water, i.e., it does not dissolve, soften, swell or lose its adhesion when exposed to water to such an extent so as to permit the ostomy appliance to become separated prematurely from the user. At the same time, the adhesive is preferably permeable to water vapor and to oxygen. There are a number of adhesives suited to such application including, but not limited to, acrylate adhesives, vinylacrylate adhesives and polyvinyl ether adhesives. Such adhesives are known in the art and all such adhesives may be used herein. The membrane- adhesive combination of this invention is very moisture and oxygen permeable compared to paper and cloth tapes commonly used against the skin in current ostomy appliances. This permeability allows evaporation of perspiration from the skin beneath the membrane helping the skin to remain dry and healthy and helping to minimize bacterial growth on the skin. This permeability allows oxygen to reach the skin, an important factor in promoting healing of any lesions on the skin and in promoting the bacteria fighting mechanisms of the skin.

[0016] The 3M "Tegaderm" membrane, which is the preferred urethane membrane materials of this invention, is impermeable to bacteria and to viruses such as HIV. In the preferred embodiment of this invention the membrane is a continuous material made of polyurethane elastomer which can be manufactured in a manner which provides the desired thinness, flexibility, stretchability, and permeability to water vapor and oxygen while being compatible for adhesion to and interaction with the hydrocolloid layer. [0017] Adhesive coated membranes having these desirable properties of thinness, low modulus of elasticity, and permeability have been in use for over thirty years for burn and wound dressings and as attachments for some ostomy appliances. Dressings of this general type are sold under a number of trade names including "Op-Site" made by Smith & Nephew, "Tegaderm" made by 3M, "Bioclusive" made by Johnson & Johnson, "Thinfilm" made by Hollister and "Uniflex" made by Howmedica. This type of material is described in U.S. Pat. No. 3,645,835, assigned to Smith & Nephew, issued Feb. 29, 1972, the disclosure of which is incorporated herein by reference. Op-Site is sold by Smith & Nephew under this patent, and Tegaderm and Bioclusive are sold under the same patent by virtue of license agreement with Smith & Nephew. However, previous inventions did not combine this urethane and adhesive system in combination with hydrocolloid to provide complete protection for the stoma and the peristomal skin.

[0018] The membrane or outer adhesive layer can also be a non- continuous material including fabrics. Fabrics to which an adhesive layer maybe applied for use according to this invention include, but are not limited to, non-woven fabrics based on cellulose or synthetic polymer fibers which may be crimped and/or laid down in such a manner as to give an elastic fabric. One type of fabric having the desirable properties of omni-directional stretch combined with high porosity and high strength, even when wet, is fabric based on extruded composite synthetic fibers sold under the trade mark "Heterofil" by Imperial Chemical Industries Limited.

[0019] The skin of the abdomen can readily stretch by 30% although most of the occasions of stretching will be significantly less than that. Accordingly, in accordance with one embodiment of this invention, the attachment system which adheres to the skin is able to be stretched, when attached to the skin by at least 30% in any direction, and preferably is able to do so without exerting undue tugging force on the skin which would be uncomfortable and tend to break the bond on the skin. The membranes of the outer adhesive layer used in this invention preferably have sufficient stretchiness that it takes no more than 1.6 pounds/inch to elongate them substantially elastically by 20% and preferably less than 0.6 pounds/inch for 20% elongation.

[0020] In order for the skin's healing mechanisms to function properly and in order to thwart the growth of anaerobic bacteria on the skin, the skin requires an adequate supply of oxygen. A number of ostomy appliances on the market utilize a fiberous "microporous" tape, which permits oxygen to pass therethrough. However, since these existing systems do not use the outer adhesive layer of the present invention, they are prone to leakage and detachment and the skin to irritation. To alleviate these problems, it has been generally recommended that a skin barrier of Karaya or some other material be inserted between the appliance and the skin, thereby blocking oxygen transmission, as well as water vapor transmission, to the skin in spite of the permeability of such microporous material. In the present invention it is possible to secure the full effect of the oxygen and water vapor permeability to contribute to the health and comfort of the skin.

[0021] A further advantage of the present invention is that the hydrocolloid material acts as a stiffener when the ostomy appliance, whether one piece or two piece, is initially applied. This allows the otherwise very limp and flexible membrane to be properly adhered to the skin. The hydrocolloid also serves to prevent the urethane membrane, with its adhesive, from folding and sticking to itself.

[0022] In accordance with this invention, a layer of hydrocolloid tape with a moderate adhesive quality to promote the health of the stoma and the peristomal skin is preferably utilized. [0023] In accordance with an alternative embodiment of this invention, two rings of urethane tape are utilized. An inner ring of flexible urethane tape is applied adjacent to the stoma and offers only moderate adhesion while an outer ring of urethane tape offers stronger adhesion. In the present invention both layers of the urethane with the adhesive applied are relatively thin, flexible, and permeable to water vapor and oxygen transmission. [0024] The ostomy appliances of the present invention eliminate the need for separate skin barriers, tubes of glue and aerosol dispensers required by the prior art. Moreover, the ostomy appliance of the present invention has been found to be useful for periods of up seven to eleven days for activities which include exercise, swimming, hot tub use, steam room and sauna attendance, martial arts, skiing and many other activities without limitations improved by previous products.

[0025] The attachment system of the present invention includes both protection for the stoma and peristomal skin as well as incorporating a thin, flexible adhesive system with easy stretch-ability, high permeability to water vapor and oxygen which ensures that the appliance will not fall off after a time, does not leak, does not irritate or damage the skin, does not require as frequent change, and is comfortable to wear for all forms of activities including sports and exercise. These features are provided in both one piece and two piece appliances, both disposable and drainable, to meet the needs of various users without the need for additional skin barrier materials or attachment structures such as belts, supplementary adhesives, etc as is often currently the case if the appliance is to be worn for sports or exercise activities. To date, these design features have not been adequately recognized and addressed in the design of existing ostomy appliances. [0026] In accordance with one embodiment of the present invention, there is provided an ostomy appliance comprising: a) a bag having an opening for receiving material from a stoma, b) a connecting layer having a bag side and a skin side, the connecting layer releaseably securing the ostomy appliance to the skin of a user, the connecting layer comprising at least a radially inner component proximal to the stoma and the peristomal skin and a radially outer component distal to the stoma and peristomal area, the radially outer component providing more than 50% of the adhesion that secures the ostomy appliance to the skin of the user.

[0027] In accordance with an alternate embodiment of the present invention, there is provided an attachment system for an ostomy appliance comprising a connecting layer, the connecting layer adapted to releaseably secure the ostomy appliance to the skin of a user, the connecting layer comprising at least a radially inner component proximal to the stoma and the peristomal skin and a radially outer component distal to the stoma and peristomal area, the radially outer component providing more than 50% of the adhesion that secures the ostomy appliance to the skin of the user.

[0028] Preferably, radially outer component provides more than 75% of the adhesion and more preferably the radially outer component provides essentially all of the adhesion. [0029] Preferably, the radially inner component comprises a cushioning layer. The radially inner component may provide a portion of the adhesion. Preferably, the radially outer component provides more than 75% of the adhesion.

[0030] The one embodiment, the inner and outer layers each comprise urethane membranes.

[0031] In another embodiment, the inner layer comprises hydrocolloid and the outer layer comprises a urethane membrane.

[0032] In another embodiment, the radially inner and outer components have a skin side surface and the ostomey appliance further comprises an intermediate layer having a skin side surface wherein the skin side surface of the intermediate layer is positioned between the skin side surfaces of the inner and outer layers and the intermediate layer has an adhesive which is stronger than the adhesive of the inner urethane membrane. Preferably, the adhesive of the intermediate layer has an adhesive which is stronger than the adhesive of the outer urethane membrane. Preferably, the intermediate layer is formed from paper or cloth tape.

[0033] In another embodiment, the radially inner and outer components have a skin side surface and the ostomy appliance further comprises an intermediate layer having a skin side surface wherein the skin side surface of the intermediate layer is positioned between the skin side surfaces of the hydrocolloid and the urethane membrane and the intermediate layer has an adhesive which is stronger than the adhesive of the hydrocolloid. Preferably, the adhesive of the intermediate layer has an adhesive which is stronger than the adhesive of the outer urethane membrane. Preferably, the intermediate layer is formed from paper or cloth tape.

Brief description of the drawings

[0034] These and other advantages of the instant invention will be better understood from the following description of the preferred embodiments and the accompanying drawings in which:

[0035] FIG. 1 is a front elevational view of an individual with a colostomy using a two piece attachment system in accordance with a preferred embodiment of the present invention; [0036] FIG. 2 is a perspective view of the flange of the two piece attachment system shown in Figure 1 ;

[0037] FIG. 2A is a perspective view of a flange according to an alternate preferred embodiment of the present invention;

[0038] FIG. 3 is an exploded view of the flange of Figure 2; [0039] FIGS. 4 is an exploded view of a bag assembly, which may be used with the flange of Figures 2 and 2A;

[0040] FIG. 5 is a perspective view of the bag assembly of Figure 4;

[0041] FIG. 6 is an exploded view of a one piece attachment system according to the present invention; [0042] FIG. 7 is a perspective view of the body side of the one piece attachment system of Figure 6;

[0043] FIG. 8 is a sectional exploded side view of the one piece attachment system of Figure 6; [0044] FIG. 9 is a perspective view of an alternative embodiment of a two piece attachment system wherein multiple layers of urethane tape are employed;

[0045] FIG. 10 is a perspective view of an alternative embodiment of a two piece attachment system of the present invention wherein a hydrocolloid ring is supported by a cloth or paper tape layer over and around which a urethane tape layer is applied;

[0046] FIG. 11 is a perspective view of a flange to which a separate urethane tape layer is applied over and around to provide the breathable waterproof sealing layer; [0047] FIG 12 is a sectional exploded view of a bag in accordance with a further alternate embodiment hereof and a method of use thereof of Figure 11 ;

[0048] FIG 13 is a perspective view of the bag and its method of use as shown in Figure 12; and, [0049]

[0050] FIG 14 is an alternate embodiment of the adhesive tape used in

Figure 13.

Detailed description of the invention [0051] In accordance with one embodiment of the instant invention, an attachment system for an ostomy appliance comprises an inner hydrocolloid layer and an outer adhesive tape layer. One, and preferably both of the two layers are preferably provided with a releasable cover. The hydrocolloid layer and the outer adhesive tape layer may be associated together by any means known in the art. Further, the attachment system may be integrally constructed as part of an ostomy appliance (e.g. an ostomy bag). Alternately, the attachment system may be a separate assembly that is configured for attachment to an ostomy appliance. [0052] Figure 1 shows a person 1 with an ostomy wearing a flange 2 of a preferred embodiment of a two piece version of the instant invention. As shown in Figure 2, an ostomy appliance is attached to flange 2. In this specification, the word attached is used to refer to any mechanical (e.g., male and female engagement members), chemical (e.g., an adhesive) or other method of securing one component to another and includes any means currently known in the ostomy art or which may be used in the future in the ostomy art. The ostomy appliance may be any known ostomy appliance that uses a separate flange or member to attach the ostomy appliance to a person. Such ostomy appliances have an attachment member (typically a ring member, e.g., ring 8 in Figure 4), which is adapted to attach the ostomy appliance to a separate flange. Accordingly, by adapting flange 2 to include a member to mate with the attachment member of an existing ostomy appliance, the novel construction of flange 2 disclosed herein may be used with any existing ostomy appliance that uses a separate flange to attach the ostomy appliance to a person.

[0053] Figure 2 is a perspective view of the flange 2 of a preferred embodiment of the two piece version of the present invention. Figure 3 is an exploded view of the flange 2 of Figure 2. The flange 2 is comprised of a male body flange ring 3, which is affixed to a flat hydrocolloid tape donut 4. Ring 3 is provided with a hole 3A for fluidly connecting with a stoma by any means known in the art. Ring 3 may be attached to donut 4 by any means known in the art, and preferably by heat sealing. Urethane tape 5 has a surface facing the person 1 (the skin side surface, which is shown in Figure 2) and a bag side surface, which faces towards a bag assembly. It will be appreciated that donut 4 may be any other cushioning member known know or in the future in the ostomy art. It will also be appreciated that tape 5 may be any stretchable substrate that is known for use with adhesive bandages and the adhesive that is used on tape 5 may be any adhesive which is known for use with removable adhesive bandages.

[0054] The surface of urethane tape 5 which faces person 1 extends outwardly from the outer perimeter of donut 4 thereby defining an annular section to allow the adhesive of the urethane tape 5 to be adhered directly to the skin of the person 1 while allowing hydrocolloid tape donut 4 to contact the skin of person 1 adjacent a stoma. Urethane tape 5 and hydrocolloid layer may be associated together by any means known in the art. For example, as shown in Figure 8, urethane tape 5 may have a portion that overlies hydrocolloid tape donut 4 so that the radially inner perimeter of urethane tape 5 is positioned radially inwardly from the outer perimeter of hydrocolloid tape donut 4. Urethane tape 5 may be positioned in front of hydrocolloid tape donut 4 so as to overlie the skin side of hydrocolloid tape donut 4, but preferably is rearward of hydrocolloid tape donut 4 so as to overlie the bag side of hydrocolloid tape donut 4. In this latter embodiment, all the skin side surface of hydrocolloid tape donut 4 may contact a person. Accordingly, the adhesive of urethane tape 5 may be used to affix hydrocolloid tape donut 4 to urethane tape 5. [0055] A release layer 6 may be provided to cover one and preferably both of the adhesive or skin side of the hydrocolloid tape donut 4 (i.e. the side facing the person 1 when the ostomy appliance is applied) and the adhesive or skin side of the urethane tape 5 (i.e. the side facing the person 1 when the ostomy appliance is applied) for shipping and handling. The release layer 6 may be constructed from any material known in the art that is releasably attachable to hydrocolloid tape donut 4 or urethane tape 5 and, preferably is releasably attachable to both hydrocolloid tape donut 4 and urethane tape 5. Release layer 6 may be removed by the person 1 after the person has cleaned the stoma and peristomal skin and is ready to attach the flange. [0056] The male body flange ring 3 is configured to attach, and preferably releaseably attach, flange 2 to bag flange female ring 8 of an ostomy appliance, such as bag assembly 7 (see Figure 4). It will be appreciated that if flange 2 is provided as a separate component to bag assembly 7, that ring 3 would be configured to be connectable to ring 8 of any known bag assembly 7. Accordingly, ring 3 may be any ring known in the art. It will be appreciated that if a bag assembly 7 uses a different method to attach bag assembly 7 to a separate flange, then Flange 2 may use any compatible member to attach flange 2 to bag assembly 7.

[0057] Preferably, the adhesive of hydrocolloid tape donut 4 may have an adhesive strength of up to 8 - 14 oz per inch to steel, preferably from 10 oz to 13 oz per inch, more preferably 10 to 12 oz per inch and most preferably about 12 oz per inch

[0058] Figure 2A is a perspective view of the flange 9 of another embodiment of the two piece version of the present invention. The flange 9 is comprised of a center hole 12A in flat hydrocolloid tape donut 10 over which a urethane tape 11 , which is preferably clear, is applied such that the outer perimeter of the urethane tape 11 extends beyond the perimeter of the hydrocolloid tape donut 10 so as to allow the adhesive of the urethane tape to be adhered directly to the skin of the person 1. In this alternate embodiment, as the urethane tape 11 extends radially inwardly on the bag side surface of hydrocolloid tape donut 10, the male body flange ring 12 is heat sealed to both the perimeter urethane tape 11 and to the flat hydrocolloid tape donut 10. The release layer 11A is removed by the person 1 after they have cleaned the stoma and peristomal skin and is ready to attach the flange. The male body flange ring 12 is provided as a means of attachment between the flange 9 and the bag assembly 7 by means of the bag flange female ring 8. Accordingly, it will be understood that the male body flange ring may be heat sealed to one or both of the perimeter urethane tape and the hydrocolloid tape.

[0059] Figure 4 is an exploded view exemplifying a typical construction of a bag portion 7 which may utilize the attachment system of the present invention. Figure 5 is a perspective view of the side of bag portion 7 of Figure 4 that faces a person when the bag assembly 7 is in use. The bag assembly 7 is comprised of a bag flange female ring 8 which is heat sealed to a thin polyethylene or PVC film or sheet 13 in which a hole 14 has been cut such that the center of the bag flange female ring 8 is aligned with the hole 14. The thin polyethylene or PVC film or sheet 13 is then heat sealed around the perimeter 16 to another thin polyethylene or PVC film or sheet 15 to form a closed bag. Three tabs 17, 18, and 19 with respective holes 20, 21 , and 22 are provided as a means of affixing an optional belt to support a hernea or to help support the bag and to provide a means of aiding in the attachment and detachment of the bag 7 with the flange 2. In use, a person 1 may attach flange 2 to bag assembly 7 and then attach flange 2 to themselves. Alternately, person 1 may affix flange 2 to themselves and then repeatedly attach the same or different bag assemblies 7 to flange 2 as the bag assemblies are filled. Any bag assembly 7 may be used with flange 2 provided that ring 8 may be fluidly connected to ring 3. Accordingly, ring 3 is preferably configured to mate with the ring 8 of existing bag assemblies 7.

[0060] Figure 6 is a partial exploded view of a one piece attachment system 23 accordingly to a preferred embodiment of the present invention. Figure 8 is an exploded side view. The one piece attachment system incorporate the inner hydrocolloid layer and an outer adhesive tape layer used with flanges 2, 9 and incorporates them into any ostomy appliance. Accordingly, the one piece attachment system 23 comprises a hydrocolloid tape donut 25 and a larger diameter urethane tape ring 24.

[0061] Openings are preferably provided in ring 24 and donut 25 to align with a hole 26 for the stoma, which is provided in sheet 27. Ring 24 and/or donut 25, and preferably both ring 24 and donut 25, are affixed to sheet 27 by any means known in the art. For example ring 24 and donut 25 may each be heat sealed to sheet 27 (which may be a thin polyethylene or PVC film) along one or more ridges 28 and 29. It will be appreciated that donut 25 may be first affixed to ring 24 such as by heat sealing, RF sealing or an adhesive and the subassembly of ring 24 and donut 25 may then be affixed to sheet 27 such as by heat sealing or an adhesive. Before or subsequent to these operations, and preferably after, sheet 27 may be heat sealed to sheet 30 of the bag 23, which may be comprised of another thin polyethylene or PVC film, along the area 32. The release paper 31 is preferably provided to at least one, and preferably both, of the cover both the adhesive side of the hydrocolloid tape donut 25 and the adhesive side of the urethane tape ring 24 for shipping and handling. The release layer 31 is removed by the person 1 after he has cleaned the stoma and peristomal skin and is ready to attach the bag assembly. For example, FIG. 7 is a perspective view of the body side of the one piece attachment system of Figure 6 with the release paper 31 in the process of being removed.

[0062] FIG. 9 is a perspective view of an alternative embodiment of the flange 33 of a two piece attachment system of the present invention wherein multiple annular bands of urethane tape 34 and 35 are employed. The flange 33 includes two annular bands of urethane film 34 and 35, which may be of different thicknesses, which are preferably adhered to each other and to which a male body flange ring 36 is preferably heat sealed. The inner urethane film donut 34 has a moderate strength adhesive applied to it while the outer urethane ring 35 which is preferably applied on top of and around the inner urethane film 34 has a high strength adhesive applied to it. The outer perimeter of the urethane tape donut 35 extends beyond the perimeter of the urethane tape donut 34 so allow the adhesive of the urethane tape to be adhered directly to the skin of the person 1. It will be appreciated that tape donuts 34, 35 need not overlap each other as they may each be secured to flange 33. Further, a non adhesive gap may be provided between the radially inner end of donut 35 and the radially outer end of donut 34.

[0063] It will be appreciated that layers 34 and 35 and ring 36 may be associated together by any means known in the art or as described herein with respect to any alternate embodiment. For example, one or both of the facing surfaces of layers 34 and 35 may have an adhesive to secure layers 34 and 35 together. Ring 36 may be affixed to one or both of layers 34 and 35 by heat sealing or an adhesive. The body flange ring 36 is provided as a means of attachment between the flange 33 and the bag assembly 7 by means, e.g., of the bag flange female ring 8 as in Figures 4 and 5. A release layer 38 is preferably applied to both the adhesive side of the inner urethane film donut 34 and to the adhesive size of the outer urethane ring 35.

[0064] In accordance with this embodiment, donut 34 is preferably sized to cover the peristomal region around a stoma. Donut 34 may extend radially outwardly of the peristomal region. The skin side of donut 35 extends outwards from a position adjacent or outward of the radial outer end of donut 354 and therefore preferably does not cover the peristomal region around a stoma. The adhesive which is used to attach donut 34 to the skin of a user is less sticky then the adhesive which is used to attach donut 35 to the skin of a user. The adhesive which is used to attach layer 34 to the skin of a user has sufficient adhesive strength so that the stoma of a person remains in fluid connection with the opening of a bag assembly but sufficiently weak to permit layer to be peeled off from the skin of the peristomal region without damaging the skin of the peristomal region or the stoma. The adhesive of donut 34 may have an adhesive strength of up to 8 - 14 oz per inch to steel, preferably from 10 oz to 13 oz per inch, more preferably 10 to 12 oz per inch and most preferably about 12 oz per inch. The adhesive of layer 35 is stronger than the adhesive of layer 34 and may have an adhesive strength of up to 15 - 21 oz per inch to steel, preferably from 17 oz to 20 oz per inch, and more preferably 19 oz per inch. As donut 35 is adhered distal to the stoma, the skin in this region is less traumatized and may be contacted with a stronger adhesive without the skin becoming damages from repeated applications. Donut 35 may therefore support a greater proportion of the weight of bag assembly 7 when full. In particular, in one preferred embodiment, donut 35 has an adhesive strength sufficient to support essentially all of the weight of bag assembly 7 when full and donut 35 has an adhesive strength essentially only sufficient to maintain the stoma of a person in fluid contact with the opening in bag assembly 7. [0065] FIG. 10 is a perspective view of the flange 39 of an alternative embodiment of a two piece attachment system wherein a hydrocolloid ring 40 is supported by a cloth or paper tape layer 41 over and around which a urethane tape layer 42 is applied. The flange 39 is comprised of a layer of urethane film donut 42, which is applied on top of and around a paper or cloth tape donut 41 , which is in turn adhered to a hydrocolloid tape donut 40 to which a male body flange ring 43 is applied. The outer perimeters of each of the urethane tape donut 42 and the cloth or paper tape donut 41 extends beyond the perimeter of the hydrocollid tape donut 40 so as to allow the adhesive of the urethane tape donut 42 and the adhesive of the paper or cloth tape donut 41 to be adhered directly to the skin of the person. Release layer 44 is preferably applied to one or more of, and more preferably, each of the adhesive side of the inner hydrocolloid tape donut 40, to the adhesive size of the paper or cloth tape donut 41 and to the adhesive side of the urethane tape donut 42. The body flange ring 43 is provided as a means of attachment between the flange 39 and the bag assembly 7 by means, e.g., of the bag flange female ring 8 as in Figures 4 and 5. The adhesive of cloth tape 41 is preferably stronger than the adhesive of hydrocolloid ring 40 but weaker than the adhesive of urethane tape donut 42. The adhesive of cloth tape 41 may have an adhesive strength of up to 14 - 19 oz per inch to steel, preferably from 15 oz to 18 oz per inch, and more preferably 17 oz per inch.

[0066] FIG. 11 is a perspective view of a flange 45 adhered to the abdominal skin 46 of a person. Flange 45 may be an existing flange that has been applied around a stoma. Flange 45 is comprised of a male body flange ring 49, a hydrocolloid donut 50 and a paper or cloth tape layer 51. In accordance with this embodiment, a urethane tape donut 47 is applied over flange 45. Donut 47 is preferably provided with release paper 48. Paper 48 is removably affixed to the adhesive side of the urethane film donut 47. When paper 48 is removed, the adhesive side of the urethane film donut 47 may be applied over existing flange 45. The final position of the urethane film donut 47 is shown by the dotted lines 52 and 53, which represent the inner diameter and outer diameter of the urethane film donut 47 respectively. The urethane film donut 47 is applied over a potion of the hydrocollic donut 50 and over and around the paper or cloth tape layer 51 to provide a thin, flexible layer, which is permeable to water vapor and oxygen transmission but impermeable to body fluids or liquid water. The body flange ring 49 is provided as a means of attachment between the flange 45 and the bag assembly 7 by means, e.g., of the bag flange female ring 8 as in Figures 4 and 5.

[0067] FIG. 12 is a side sectional view of the a one piece bag 54, which may be of any typical construction, such as two layers of thin film or sheet polyethylene or PVC 55 and 56 that may be heat or RF sealed to each other along seam 57 and a paper or cloth tape donut 58 fixed in place around the opening 59 in the bag 54 to which a hydrocollic tape donut 60 is attached. Figure 12 also shows the stoma of the user 65 and the skin of the abdominal wall of the user 66 to which the bag 54 is attached by means of the hydrocollid tape donut 60 and the paper or cloth tape donut 58. In accordance with this alternate embodiment, the user may then remove the release papers

63 from the urethane tape donut half 61 and apply donut half 61 in direction 67 to both a portion of the cloth or paper tape donut 58 and to the skin of the abdominal wall of the user 66. The user may then remove the release papers

64 from the urethane tape donut half 62 and apply donut half 62 in direction 68 to both a portion of the cloth or paper tape donut 58 and to the skin of the abdominal wall of the user 66. The bag side of donut halves 61 and 62 may then be secure to an ostomy bag 54.

[0068] Figure 13 shows a view of the attachment side of the bag of

Figure 12 with the user removed from the view. The user would normally affix the bag 54 to the skin of the abdominal wall by removing the release paper 74 which exposes the adhesive side of the hydrocollid tape donut 60 and the paper or cloth tape donut 58 and pressing the bag against the abdominal wall (not shown). In accordance with this alternate embodiment, the user may then remove the release paper 63 from the urethane tape donut half 61 and applie half donut 6 in direction 67 to both a portion of the cloth or paper tape donut 58 and to the skin of the abdominal wall of the user not shown. The user may then remove the release paper 64 from the urethane tape donut half 62 and apply donut half 62 in direction 68 to both a portion of the cloth or paper tape donut 58 and to the skin of the abdominal wall of the user 66. The urethane tape 61 moves to position shown 72 shown as an outline, and the urethane tape 62 moves to position shown 73 also shown as an outline. Thus the user applies the urethane donut halves 61 and 62 sequentially over both the paper or cloth tape donut 58 and onto the abdominal skin of the user not shown.

[0069] Figure 14 shows an alternate embodiment wherein the arc of the urethane donut portions 69 and 70 are sized so that they overlap in areas 75 and 76 to make their application easier and to ensure a water tight seal at their joints. It will be appreciate that the arc of one or both of portions 69 and 70 may be greater than 180 degrees.

[0070] In accordance with any of the preferred embodiments, a release layer may be provided with various stoma diameters printed on it to allow the user to enlarge the center hole to a diameter to match their stoma as the stomas of different people are different sizes.

Claims

Claims:

1. An ostomy appliance comprising: a) a bag having an opening for receiving material from a stoma, b) a connecting layer having a bag side and a skin side, the connecting layer releaseably securing the ostomy appliance to the skin of a user, the connecting layer comprising at least a radially inner component proximal to the stoma and the peristomal skin and a radially outer component distal to the stoma and peristomal area, the radially outer component providing more than 50% of the adhesion that secures the ostomy appliance to the skin of the user.

2. The ostomey appliance as claimed in claim 1 wherein the radially outer component provides more than 75% of the adhesion.

3. The ostomey appliance as claimed in claim 1 wherein the radially outer component provides essentially all of the adhesion.

4. The ostomey appliance as claimed in claim 1 wherein the radially inner component comprises a cushioning layer.

5. The ostomey appliance as claimed in claim 4 wherein the radially inner component provides a portion of the adhesion.

6. The ostomey appliance as claimed in claim 5 wherein the radially outer component provides more than 75% of the adhesion.

7. The ostomey appliance as claimed in claim 1 wherein the inner and outer layers each comprise urethane membranes.

8. The ostomey appliance as claimed in claim 1 wherein the inner layer comprises hydrocolloid and the outer layer comprises a urethane membrane.

9. The ostomey appliance as claimed in claim 7 wherein the radially inner and outer components have a skin side surface and the ostomey appliance further comprises an intermediate layer having a skin side surface wherein the skin side surface of the intermediate layer is positioned between the skin side surfaces of the inner and outer layers and the intermediate layer has an adhesive which is stronger than the adhesive of the inner urethane membrane.

10. The ostomey appliance as claimed in claim 9 wherein the adhesive of the intermediate layer has an adhesive which is stronger than the adhesive of the outer urethane membrane.

11. The ostomey appliance as claimed in claim 10 wherein intermediate layer is formed from paper or cloth tape.

12. The ostomey appliance as claimed in claim 8 wherein the radially inner and outer components have a skin side surface and the ostomey appliance further comprises an intermediate layer having a skin side surface wherein the skin side surface of the intermediate layer is positioned between the skin side surfaces of the hydrocolloid and the urethane membrane and the intermediate layer has an adhesive which is stronger than the adhesive of the hydrocolloid.

13. The ostomey appliance as claimed in claim 12 wherein the adhesive of the intermediate layer has an adhesive which is stronger than the adhesive of the outer urethane membrane.

14. The ostomey appliance as claimed in claim 13 wherein intermediate layer is formed from paper or cloth tape.

15. An attachment system for an ostomy appliance comprising a connecting layer, the connecting layer adapted to releaseably secure the ostomy appliance to the skin of a user, the connecting layer comprising at least a radially inner component proximal to the stoma and the peristomal skin and a radially outer component distal to the stoma and peristomal area, the radially outer component providing more than 50% of the adhesion that secures the ostomy appliance to the skin of the user.

16. The attachment system as claimed in claim 15 wherein the radially outer component provides more than 75% of the adhesion.

17. The attachment system as claimed in claim 15 wherein the radially outer component provides essentially all of the adhesion.

18. The attachment system as claimed in claim 15 wherein the radially inner component comprises a cushioning layer.

19. The attachment system as claimed in claim 18 wherein the radially inner component provides a portion of the adhesion.

20. The attachment system as claimed in claim 19 wherein the radially outer component provides more than 75% of the adhesion.

21. The attachment system as claimed in claim 15 wherein the inner and outer layers each comprise urethane membranes.

22. The attachment system as claimed in claim 15 wherein the inner layer comprises hydrocolloid and the outer layer is a urethane membrane.

23. The attachment system as claimed in claim 21 wherein the radially inner and outer components have a skin side surface and the ostomey appliance further comprises an intermediate layer having a skin side surface wherein the skin side surface of the intermediate layer is positioned between the skin side surfaces of the inner and outer layers and the intermediate layer has an adhesive which is stronger than the adhesive of the inner urethane membrane.

24. The attachment system as claimed in claim 23 wherein the adhesive of the intermediate layer has an adhesive which is stronger than the adhesive of the outer urethane membrane.

25. The attachment system as claimed in claim 24 wherein intermediate layer is formed from paper or cloth tape.

26. The attachment system as claimed in claim 22 wherein the radially inner and outer components have a skin side surface and the ostomey appliance further comprises an intermediate layer having a skin side surface wherein the skin side surface of the intermediate layer is positioned between the skin side surfaces of the hydrocolloid and the urethane membrane, wherein the intermediate layer has an adhesive which is stronger than the adhesive of the hydrocolloid.

27. The attachment system as claimed in claim 26 wherein the adhesive of the intermediate layer has an adhesive which is stronger than the adhesive of the outer urethane membrane.

28. The attachment system as claimed in claim 27 wherein intermediate layer is formed from paper or cloth tape.

29. An attachment system for an ostomy appliance comprising an adhesive layer wherein the adhesive layer comprises first and second portions which, when used to affix an ostomy appliance to a person, are configured to define an annular band.

30. The attachment system of claim 29 wherein the first and second portions are portions of an annulus.