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IE46487B1 - Improvements relating to drainage pouches - Google Patents

Improvements relating to drainage pouches

Info

Publication number
IE46487B1
IE46487B1 IE538/78A IE53878A IE46487B1 IE 46487 B1 IE46487 B1 IE 46487B1 IE 538/78 A IE538/78 A IE 538/78A IE 53878 A IE53878 A IE 53878A IE 46487 B1 IE46487 B1 IE 46487B1
Authority
IE
Ireland
Prior art keywords
attachment
ring
adhesive
adhesive patch
patch
Prior art date
Application number
IE538/78A
Other versions
IE780538L (en
Original Assignee
Hollister Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=25128926&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=IE46487(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hollister Inc filed Critical Hollister Inc
Publication of IE780538L publication Critical patent/IE780538L/en
Publication of IE46487B1 publication Critical patent/IE46487B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/445Colostomy, ileostomy or urethrostomy devices
    • A61F5/448Means for attaching bag to seal ring

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nursing (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Laminated Bodies (AREA)
  • External Artificial Organs (AREA)
  • Bag Frames (AREA)

Abstract

SEALING AND ATTACHMENT ASSEMBLY FOR MEDICAL DRAINAGE POUCH A medical drainage pouch is provided with a breathable microporous adhesive patch for attaching the pouch to the body of a patient. The pouch includes a moisture-impermeable plastic bag having a drainage opening. A plastic annular retainer ring ` may be secured to the bag around the drainage opening. The adhesive patch has a thin non-woven porous backing sheet which is relatively easy to tear, and the patch is attached to the bag by a flexible annular attaching ring. The attaching ring may comprise a first layer of plastic and a second layer of hot melt adhesive. The plastic layer of the attaching ring is heat-sealed to the retainer ring or to the bag around a generally circular area of attachment, and the adhesive patch is heat-sealed to the adhesive layer of the attaching ring around a generally circular area of attachment which extend radially outwardly beyond the first area of attachment. The outward extension of the attaching ring provides a flexible, shock-absorbing connection between the tearable adhesive patch and the retainer ring or bag, and forces which are exerted on the adhesive patch, e.g., by the weight of the bag, are directed linearly with respect to the adhesive patch so that the tendency of the patch to tear is minimized.

Description

This invention relates to medical drainage pouches, and, more particularly, to an improved sealing assembly for such drainage pouches, which include surgical pouches for stoma or wound drainage, fecal collectors, enema bags, urostomy bags, etc.
Certain surgery, such as abdominal surgery known as colostomy, ileostomy, ureterostomy and the like, results in an opening, for example, in the abdominal wall, which permits drainage from the interior of a body cavity. The patient cannot control the drainage, and therefore a surgical drainage appliance in the form of a pouch or bag is used to contain the drainage.
United States Patent Nos. 3,302,647 and 3,822,704 disclose prior art surgical drainage pouches, as used particularly for stoma or wound drainage. Each of these pouches includes a plastics bag for containing the fluid which is drained from the body and a relatively rigid plastics retainer ring which is heat-sealed to the bag around the drainage opening in the bag. The drainage pouch described in US Patent Ko. 3,302,647 includes a sealing pad or ring formed from a mixture of karaya powder and glycerol. The drainage pouch described in US Patent No. 3,822,704 includes an adhesive patch which is secured to the relatively rigid retaining ring. A release paper covers the adhesive surface of the adhesive patch, and when the release paper is removed, the adhesive patch can be adhesively secured to the patient's body.
Current commercial surgical drainage pouches are similar to the pouch described in US Patent No. 3,822,704. The adhesive patch is formed from a nonporous surgical tape. This tape may comprise a backing sheet of nonporous polyethylene coated with a layer of pressure-sensitive adhesive. The relatively rigid retainer ring can be formed of polyethylene, and the adhesive patch secured to the retainer ring by heat-sealing the polyethylene backing of the adhesive patch to the polyethylene retainer ring. Alternatively, the nonporous adhesive patch can be heat-sealed directly to the pouch around the opening.
Drainage pouches which are provided with such a nonporous polyethylene adhesive patch are sold with and without a karaya sealing ring of the type described in US Patent No. 3,302,647. The adhesive patch is much larger than the karaya sealing ring, which is intended to seal the area adjacent the stoma against irritating fluids. The adhesive patch is adhesively secured to the body radially outwardly of the karaya ring to provide additional mechanical securement.
While such nonporous adhesive patches provide good adhesive and mechanical securement, certain problems have arisen. Since polyethylene or similar patches are not porous, the skin cannot breathe through the patch. The patch traps moisture against the skin and might cause an increase in the skin irritation of the patient.
Porous non-woven surgical adhesive tape is available. For example, a porous non-woven surgical tape is available under the brand name Micropore from Minnesota Mining & Manufacturing Company, of Minneapolis, Minnesota. This tape is formed from a backing layer of porous, non-woven rayon fabric and a layer of hypo-allergenic, synthetic, acrylic pressure-sensitive adhesive. Such tape is essentially continuous in appearance and is non-perforated but exhibits a porosity which permits the skin to breathe through the tape. Because the pores of the tape are quite small and the tape appears to be essentially continuous, the tape is considered microporous.
Our attempts to substitute a porous non-woven surgical adhesive tape for the polyethylene adhesive patch on the drainage pouch were initially unsuccessful. First of all. 6 487 the non-woven fabric backing layer of the tape cannot be satisfactory heat-sealed directly to the plastics retainer ring or to the pouch. We found that some other means of attaching the fabric backing to the retainer ring must be used. We also found that the very thin nonwoven fabric is very easily torn at any concentrated stress point. For example the fabric is easily tearable when it is subjected to a force tending to peel it away from an area of attachment or when it is subjected to a force which is directed angularly with respect to the plane of the fabric. Since the drainage pouch fills with fluid and becomes quite heavy, the force which tends to peel rhe retainer ring away from the adhesive patch which secures the pouch to the skin can become substantial and tear the patch causing leakage.
The invention provides a drainage pouch comprising a moisture-impermeable bag formed of plastics sheet material with a drainage opening in one side thereof, a sealing and attachment assembly including an adhesive patch formed of microporous sheet material with an opening therein which is generally concentric with said opening in the bag, the patch having inner and outer sides and the outer side of the patch being coated with a pressure-sensitive adhesive for attachment to the body of a wearer, an annular attaching ring formed of flexible sheet material, said attaching ring having inner and outer sides and an opening which is generally concentric with the openings in the bag and in the patch, the inner side of the attaching ring being attached to the bag in a first area of attachment and the outer side of the attachment ring being attached to the inner side of the patch in a second area of attachment, the second area of attachment extending radially outwardly beyond the first area of attachment to provide an annular outer portion of the attaching ring which is unconnected to the bag and which is flexible and conformable by forces which are applied to the attaching ring and to the adhesive patch and which tend to remove the adhesive patch from the body so that said annular outer portion of the attaching ring and the portion of the adhesive patch attached thereto extend substantially linearly and the tendency of the adhesive patch to tear as a result of said forces is minimized, the outer periphery of the attaching ring being spaced inwardly of the outer periphery of the adhesive patch to provide a breathable outer portion of the adhesive patch which is uncovered by the attaching ring.
The invention also provides a drainage pouch comprising a moisture-impermeable bag formed of plastics sheet material with a drainage opening in one side thereof, a retainer ring of relatively rigid plastics material having inner and outer sides and an opening which is generally concentric with the opening in the bag, the inner side of the retainer ring being attached to the bag around the bag opening, an annular attaching ring formed of flexible sheet material, said attaching ring having inner and outer sides and an opening which is generally concentric with the opening in the bag and in the retainer ring, the inner side of the attaching ring being attached to the retainer ring in a first area of attachment, an adhesive patch formed of microporous sheet material with an opening therein which is generally concentric with the opening in the attaching ring, the patch having inner and outer sides and the outer side being coated with a pressure-sensitive adhesive for attachment to the body of a wearer, the outer side of the attaching ring being attached to the inner side of the patch in a second area of attachment, the second area of attachment extending radially outwardly beyond the first area of attachment to provide an annular outer portion of the attaching ring which is unconnected to the retainer ring and which is flexible and conformable by forces which are applied to the attaching ring and to the adhesive patch and which tend to remove the adhesive patch from the body so that said annular outer portion of the attaching ring and the portion of the adhesive patch attached thereto extend substantially linearly and the tendency of the adhesive patch A 6 4 8 7 to tear as a result of said forces is minimized, the outer periphery of the attaching ring being spaced inwardly of the outer periphery of the adhesive patch to provide a breathable outer portion of the adhesive patch which is uncovered by the attaching ring.
The invention will be explained, by way of example only, in conjunction with illustrative embodiments shown in the accompanying diagrammatic drawings, in which:Fig. 1 is an elevational view, partially broken away, of a drainage pouch equipped with a sealing assembly formed in accordance with the invention; Fig. 2 is a sectional view taken along the line 2-2 of Fig. 1; Fig. 3 is a fragmentary sectional view showing the pouch secured to the body of a patient; Fig. 4 is an enlarged fragmentary sectional view showing a force applied to the adhesive patch tending to pull the patch away from the skin; Fig. 5 is an enlarged view of a portion of Fig. 4; Fig. 6 is an exploded fragmentary perspective view of the drainage pouch; Fig. 7 is a plan view of the flexible attaching ring; Fig. 8 is a sectional view taken along the line 8-8 of Fig. 7; Fig. 9 is a sectional view of the adhesive patch; Fig. 10 is a fragmentary sectional view similar to Fig. 2 showing a modified embodiment of the sealing assembly; Fig. 11 is a fragmentary sectional view showing a modified method of bonding the adhesive patch to the flexible attaching ring; Fig. 12 is an exploded fragmentary perspective view of a modified drainage pouch of a modified construction in which the attaching ring is heat-sealed directly to the bag; Fig. 13 is a vertical sectional view of the exploded pouch components of Fig. 12, upper and lower portions of the bag being shown broken away; and Fig. 14 is an enlarged detailed sectional view showing the components of the pouch of Figs. 12 and 13 in an assembled relation, the adhesive patch and attachment ring being flexed outwardly.
The invention relates to a sealing and attachment assembly for a drainage pouch having a moisture-impermeable bag formed of thermoplastic sheet material with the drainage opening in one side thereof and including an adhesive patch formed of microporous sheet material with an opening therein generally concentric with the bag opening. The outer side of the adhesive patch is coated with the pressure-sensitive adhesive for attachment to the body of a wearer and the inner side is connected to the bag. The improvement comprises means for connecting the microporous patch to the bag including an annular attaching ring formed of nonporous flexible plastics sheet material. The ring is positioned adjacent the patch inner side and arranged concentrically with respect to the bag anti patch openings. At least the opposed annular outer portion of the ring is adhesively attached to the patch inner side. The annular inner portion of the other side of the ring provides a heat-sealed connection to the bag, either directly or through a retaining ring which in turn is heatsealed to the bag. The annular outer portion of the inside of the attaching ring is unconnected and free to flex with the patch.
Referring first to Figs. 1 and 2, the numeral 15 designates generally a drainage pouch of the type described in US Patent Nos. 3,302,647 and 3,822,704. The pouch includes a bag 16 which is formed from a pair of moistureimpermeable thermo-plastic1 film 17 and 18, such as polyethylene film, which are heat-sealed together around the periphery 19 thereof. The bottom of the bag 16 may be provided with a drainage valve 20, if desired.
The plastics film 17 is provided with a circular drainage opening 22 in the upper portion thereof, and a thermoplastic retainer ring or gasket 23 is secured to the plastics film 17 around the opening 22. The retainer ring 23 is provided with a central opening 24 which is defined by an axially enlarged flange 25 (Fig. 2), and the retainer ring 23 is secured to the plastics film 17 by heat-sealing the film 17 and the retainer ring 23 in an annularly shaped area around the drainage opening of the bag indicated at 26 in Fig. 2. The retainer ring 23 is advantageously formed of polyethylene so that it can be easily heat-sealed to the polyethylene plastics film of the bag 16.
Referring again to Fig. 1, the retainer ring 23 includes a pair of radially outwardly extending wings 27 and 28, each of which is provided with a slotted opening 29 which permits the retainer ring 23 to be attached to the conventional belt which surrounds the patient and helps support the drainage pouch. The retainer ring 23 is relatively thick and rigid and is capable of retaining its shape under the stress imposed by the belt. Λ flexible plastics annular attaching ring 31 is secured to the retainer ring 23 on the side of the retainer ring 23 opposite the plastics bag 16. Preferably, the ring 31 or the inner layer thereof is formed of a thermoplastics film having a thickness not exceeding 10 mils, such as 2-5 mils, thereby being highly flexible. In the particular embodiment illustrated the flexible attaching ring 31 has inside and outside diameters which are slightly greater than - 9 the inside and outside diameters, respectively, of the retainer ring 23 so that an annular outer portion of the attaching ring 31 extends radially outwardly beyond the periphery of the retainer ring 23 (except in the area of the wings 27 and 28). The attaching ring 31 is heat-sealed to the retainer ring 23 by a generally annularly shaped heat-sealed area indicated at 32 in Fig. 2 which is adjacent the inner periphery of the attaching ring 31 and which generally overlies the heat-seal attachment 26 between the retainer ring 23 and the plastics bag 16.
A generally rectilinear patch 34 of porous adhesive tape is secured to the annular attaching ring 31 on the surface of the ring opposite the surface which is bonded to the retainer ring 23. The adhesive patch 34 is provided with an opening 35 having a diameter substantially the same as the inner diameter of the annular attaching ring 31, and the adhesive patch 34 extends substantially outwardly to the attaching ring 31 and retainer ring 23 and terminates in a generally rectilinear periphery 36.
The porous adhesive patch 34 is advantageously formed of non-woven microporous sheet material, such as rayon or paper, coated with a surgical pressure-sensitive adhesive. For example non-woven rayon fabric can be used. Such porous non-woven fabric is available from Minnesota Mining & Manufacturing Company (3M) in Minneapolis, Minnesota. It is sold in roll form under the brand name Micropore by 3M. Similar microporous tape is available from other manufacturers, such as Johnson & Johnson under the brand name Permacel (Registered Trade Mark). Both of these adhesive tapes are porous and breathable but are capable of being torn quite easily. One particular Micropore tape which has been used has a thickness of 0.0045 ± 0.0015 inch. While this tape had a specified tensile breaking strength of at least 5 pounds per inch, the tape could be torn by a force substantially less than 5 pounds.
More specifically, the adhesive tape for the patch 34 may consist of a backing layer of porous non-woven rayon fabric and an adhesive layer of hypo-allergenic, synthetic, acrylic pressure-sensitive adhesive. The pressuresensitive adhesive can be covered by a silicone-coated release paper 37 which has a central opening 38.
In order to provide a good bond between the annular attaching ring 31 and the fabric layer of the adhesive patch 34, the attaching ring 31 can be provided with a layer 40 (Fig. 8) of hot melt adhesive which is extrusion coated to a polyethylene layer 41. Since the adhesive layer 40 is extrusion coated to the polyethylene layer 41 a satisfactory bond is obtained. The polyethylene layer 41 of the attaching ring 31 is easily heat-sealed or fused to the polyethylene retainer ring 23, and when the hot melt adhesive layer 40 of the attaching ring 31 is prebsed against the fabric layer of the adhesive patch 34 under heat, the hot melt adhesive will, flow into the pores.of the iabric and provide a good mechanical and adhesive bond between the attaching ring 31 and the adhesive patch 34. One particular type of hot melt adhesive that has been used is an ethyl vinyl acetate copolymer adhesive. In one embodiment of the annular attaching ring 31, the polyethylene layer 41 was 0.003 inch thick and the adhesive layer 40 was also 0.003 inch thick.
An enlarged sectional view of the adhesive patch 34 is shown in Fig. 9. The patch 34 includes a layer 42 of non-woven fabric (which is bonded to the adhesive layer 40 of the attaching ring 31), a layer 43 of pressure-sensitive adhesive which is intended to be applied to the skin of the patient, and the layer 37 of silicone-coated'release paper.
Referring again, to Fig. 2, the fabric layer of the adhesive patch 34 is bonded to the adhesive-coated attaching ring 31 in an annularly shaped heat-seal area designated 45 which is spaced radially outwardly of the heat-seal 32 between the attaching ring 31 and the retainer ring 23. In one specific embodiment of the invention the width of both - 11 of the annularly shaped heat-seal zones 32 and 45, i.e., the distance between the inner and outer diameters of the heat-seal zones, was 1/8 inch, and the distance between the outer diameter of the inner heat-seal zone 32 and the inner diameter of the outer heat-seal zone 45 on the attaching ring 31 was about 5/32 inch. The heatseal areas 32 and/or 45 can be made wider or made to overlap providing the area 45 extends outwardly a substantial distance beyond area 32.
The particular drainage pouch illustrated in Figs. and 2 includes an annular adhesive sealing pad or ring 47. The sealing pad is formed from a mixture of karaya and glycerol as described in US Patent No. 3,302,647 and is intended to provide a seal around the drainage opening in the body to protect the skin. The sealing pad 47 is provided with a central opening 48 which is concentric with the openings in the retainer ring 23, attaching ring 31, and adhesive patch 34, and the circular outer periphery 49 of the sealing pad 47 has a diameter greater than the diameter of the opening 38 in the release paper 37. The sealing pad 47 is secured to the adhesive patch 34 by the adhesive property of the sealing pad 47 and the adhesive layer of the adhesive patch 34.
Fig. 3 illustrates the drainage pouch secured to the skin 41 of a patient around a drainage opening. The release paper 37 is first removed from the adhesive surface of the adhesive patch 34, and the Karaya sealing pad 47 is pressed against the skin around the drainage opening called the stoma. The Karaya pad 47 is deformable and will be flattened somewhat as it is pressed against the skin. The adhesive patch 34 is then pressed against the skin outwardly of the Karaya pad 47 and adhesively secured thereto. The drainage pouch can be further supported by attachment of a conventional belt to the attaching wings 27 and 28 of the retainer ring 23.
Figs. 4 and 5 illustrate the drainage pouch and sealing assembly when a force tending to pull the adhesive patch away from the skin 51 is applied to the pouch, e.g., by the weight of fluid contained by the plastics bag. The upper portion of the retainer ring 23 tends to pivot about the lower edge thereof, and the adhesive patch 34 is subjected to a force tending to pull the patch away from the skin. However, because both the annular attaching ring 31 and the adhesive patch 34 are flexible, the pulling force A. exerted by the retainer ring 23 on the attaching ring 31 and the adhesive patch 34 tends to straighten the attaching ring 31 and the adhesive patch 34 along a line extending between the attachment of the attaching ring 31 to the retainer ring 23 and the attachment of the adhesive patch 34 to the skin 51 as shown in Fig. 5. Accordingly, the force B, exerted on the adhesive patch 34 in the area of the heat-seal bond 45 is essentially linearly directed, i.e., the force vector lies substantially in the plane of the adhesive patch 34.
Although the adhesive patch 34 can be torn easily, the adhesive patch 34 is sufficiently strong to resist linearly directed forces of the magnitude which would ordinarily be encountered during use of the pouch. The portion of the adhesive patch 34 adjacent the skin 51 curves smoothly into contact with the skin because the skin will be pulled outwardly somewhat, and concentrated stress areas which could tear the patch 34 are thereby avoided in that area.
The force indicated by the arrow A. tends to peel the attaching ring 31 away from the retainer ring 23 and is resisted by the heat-seal bond 32 between the attaching ring 31 and the retainer ring 23. Since the heat-seal bond between the polyethylene layer of the attaching ring 31 and the polyethylene retainer ring 23 is a fusion bond, the bond is extremely strong and is easily capable of resisting this peeling force.
In the embodiment illustrated in Figs. 1 - 4, the diameter of the opening 35 in the adhesive patch 34 is substantially the same as the inside diameter of the annular - 13 attaching ring 31. Accordingly, the adhesive patch 34 extends radially inwardly beyond the outer heat-seal bond 45 and is also bonded to the adhesive layer of the attaching ring 31 in the heat-seal zone 32. However, this inner attachment between the adhesive patch 34 and the attaching ring 31 is not required to withstand any peeling forces since the force tending to separate the adhesive patch 34 and the attaching ring 31 is taken up by the outer heat-seal zone 45.
Fig. 6 illustrates the manner in which the drainage pouch is assembled. The attaching ring 31 is first bonded to the adhesive patch 34, which is covered with the release paper 37, by the outer annular heat-seal ring 45. Thereafter, the attaching ring 31 and adhesive patch 34 are placed over the retainer ring 23 which has already been heat-sealed to the plastics film 17. The attaching ring 31 is then heat-sealed to the retainer ring 23 by the inner heat-seal ring 32 (Fig. 2), which also bonds the adhesive patch 34 to the attaching ring 31. The Karaya sealing pad 47 is then secured to the portion of the adhesive patch 34 which is exposed by the opening in the release paper 37.
If desired, the drainage pouch can be sold without a Karaya sealing pad 47, and the user can apply a Karaya sealing or an equivalent sealing means himself before using the drainage pouch. If the drainage pouch is sold without a Karaya sealing pad, the central opening in the release paper 37 is reduced so that the release paper 37 covers the entire adhesive surface of the adhesive patch 34. For applications other than stoma drainage, the Karaya ring is frequently omitted.
Fig. 10 illustrates a modified embodiment in which the diameter of the central opening 135 of the adhesive patch 134 is greater than the diameter of the inner heatsealing ring 132. The adhesive patch 134 is therefore heat-sealed to the attaching ring 131 only in the area of the outer heat-seal ring 145. The adhesive surface of the adhesive patch 134 is protected by the release paper 137. - 14 The embodiment shown in Fig. 10 will function in the same way as the embodiment shown in Fig. 5. A force which tends to.pull the adhesive patch 134 away from the skin will cause the flexible attaching ring 131 to extend in a substantially straight line between the inner heatseal ring 132 and the area of attachment between the adhesive patch 134 and the skin, and the force tending to pull the adhesive patch 134 and the attaching ring 131 apart will be substantially linearly directed.
Fig. 11 illustrates an alternate method of attaching the adhesive patch 234 to the sealing ring. The attaching ring 231 is formed from a single layer of polyethylene, and a layer 240 of breathable heat-sealable adhesive is impregnated into the non-woven fabric layer 242 of the adhesive patch 234. The adhesive patch 234 is provided with a coating ‘243 of pressure-sensitive adhesive which is protected by a release paper 237. When the adhesive patch 234 Is heat-sealed to the attaching ring 231, the heatsealable adhesive 240 bonds to the polyethylene attaching ring. If desired, the attaching ring 231 can be provided with a layer of hot melt adhesive, as previously described, which will fuse with the impregnated adhesive 240, thereby providing an even more secure attachment.
We have referred to the attachment between the polyethylene retainer ring and the polyethylene layer of the attaching ring as well as the attachment between the heat-sealable adhesive layer of the attaching ring and fabric layer of the adhesive patch as heat-seal bonds. However, these two attachments are different in character.
The inner polyethylene to polyethylene attachment is a fusion bond which is obtained by melting and fusing the confronting thermoplastic surfaces. The outer attachment is both an adhesive and a mechanical bond, being obtained when the hot melt adhesive melts and flows into the pores of the fabric. Moreover, the bond between the polyethylene layer and the hot melt adhesive layer of the attaching ring in the preferred embodiment is obtained when the two layers are extruded 6 487 together under heat, and this is a fusion or a chemical bond so that the two layers are essentially integrated.
In alternate embodiments where no gasket or retainer ring, such as ring 23, is provided around the pouch opening the attaching ring, such as ring 31, can be directly heat-sealed (fusion bonded) to the pouch, which will be formed of a heat-sealable material, such as polyethylene. Such embodiments will find use as wound drainage pouches, fecal collectors, enema bags, urostomy bags, etc. One such embodiment is illustrated in Figs. to 14 of the drawings, wherein the parts corresponding to those of Figs. 1 to 6 have been given the same numbers except that the numbers have been primed.
As shown in Figs. 12 and 13, the inner side of the -. ? ί attaching ring 31' is opposed to the side 17' of the bag 16'.
There is no intervening retaining ring, as in the embodiment ' of Figs. 1 to 6., The. inner layer gf the attaching ring 31' is formed of thin, flexible thermoplastic sheet material, ,, i 1 (· -·» such as polyethylene, and the outer layer 40' is formed of r a hot melt adhesive, as previously described. The bag sides 17' and IS^aire formed of a thermoplastic sheet material such as polyethylene. In the assembly of the components, the inner side 41' of the attaching ring is heat-sealed in an annular area around the bag opening 22' to the bag wall 17', as indicated at 32' in Fig. 14. The inner side of the microporous adhesive patch 34' is heat-sealed fused to the outer side of the attaching ring 31' by means of a hot melt adhesive layer 40', as previously described with respect to the prior embodiments. As shown more clearly in Fig. 14, the adhesive attachment of the patch 34' to the outer side of ring 31' extends substantially across the full width of the ring, the outer attached portion extending beyond the heat-sealed attachment 32'. In other words, the annular outer portion of the inner side of the attaching ring 31' is unconnected to the bag wall 17' and is thereby free to flex with the patch 34', as indicated in Fig. 14. As previously described, this provides a secure connection which minimizes the tendency of the microporous patch to tear - 16 while being worn.
The attaching ring 31', being formed of nonporous plastics sheet material, effectively seals the portion of the microporous adhesive patch 34' which is opposed thereto. Thus any fluids which tend to seep between the inner side of the microporous patch and the patient's body are prevented from passing through the microporous patch material unless the seepage extends to a point outwardly of the outer end of the attaching ring 31'.
Since this is unlikely to occur during normal use of the drainage pouch,· an effective liquid barrier is provided by the construction while at the same time retaining the advantages of the breathable microporous adhesive patch which extends outwardly around the attaching ring 31'.

Claims (12)

1. A drainage pouch comprising a moisture-impermeable bag formed of plastics sheet material with a drainage opening in one side thereof, a sealing and attachment assembly including an adhesive patch formed of microporous sheet material with an opening therein which is generally concentric with said opening in the bag, the patch having inner and outer sides and the outer side of the patch being coated with a pressure-sensitive adhesive for attachment to the body of a wearer, an annular attaching ring formed of flexible sheet material, said attaching ring having inner and outer sides and an opening which is generally concentric with the openings in the bag and in the patch, the inner side of the attaching ring being attached to the bag in a first area of attachment and the outer side of the attaching ring being attached to the inner side of the patch in a second area of attachment, the second area of attachment extending radially outwardly beyond the first area of attachment to provide an annular outer portion of the attached ring which is unconnected to the bag and which is flexible and conformable by forces which are applied to the attaching ring and to the adhesive patch and which tend to remove the adhesive patch from the body so that said annular outer portion of the attaching ring and the portion of the adhesive patch attached thereto extend substantially linearly and the tendency of the adhesive patch to tear as a result of said forces is minimized, the outer periphery of the attaching ring being spaced inwardly of the outer periphery of the adhesive patch to provide a breathable outer portion of the adhesive patch which is uncovered by the attaching ring.
2. A drainage pouch according to claim 1 in which said first and second areas of attachment extend annularly around the opening in the attaching ring.
3. A drainage pouch according to claim 1 or 2 in which X - 18 the attaching ring comprises an inner layer of plastics for providing a heat-sealed connection in said first area of attachment and an outer layer of adhesive which is attached to said adhesive patch in said second area 5 of attachment.
4. A drainage pouch according to claim 3 in which said adhesive is a hot melt adhesive.
5. A drainage pouch according to claim 3 in which said adhesive is an ethyl vinyl acetate copolymer adhesive. 10
6. A drainage pouch according to any one of the preceding claims in which said adhesive patch is formed from a thin microporous non-woven fabric which is relatively easy to tear.
7. A drainage pouch according to any one of the 15 preceding claims in which said adhesive patch has a hot melt adhesive applied to the inner side thereof and the patch and the attaching ring are heat-sealed together in said second area of attachment.
8. A drainage pouch according to any one of the preceding 20 claims in which the second area of attachment overlaps said first area of attachment.
9. A drainage pouch comprising a moisture-impermeable bag formed of plastics sheet material with a drainage opening in one side thereof, a retainer ring of relatively rigid 25 plastics material having inner and outer sides and an opening which is generally concentric with the opening in the bag, the inner side of the retainer ring being attached to the bag around the bag opening, an annular attaching ring formed of flexible sheet material, said attaching ring having inner 30 and outer sides and an opening which is generally concentric with the opening in the bag and in the retainer ring, the inner side of the attaching ring being attached to the 4648? - 19 retainer ring in a first area of attachment, an adhesive patch formed of microporous sheet material with an opening therein which is generally concentric with the opening in the attaching ring, the patch having inner and outer sides and the outer side being coated with a pressure-sensitive adhesive for attachment to the body of a wearer, the outer side of the attaching ring being attached to the inner side of the patch in a second area of attachment, the second area of attachment extending radially outwardly beyond the first area of attachment to provide an annular outer portion of the attaching ring which is unconnected to the retainer ring and which is flexible and conformable by forces which are applied to the attaching ring and to the adhesive patch and which tend to remove the adhesive patch from the body so that said annular outer portion of the attaching ring and the portion of the adhesive patch attached thereto extend substantially ’ ; s , linearly and the tendency of the adhesive patch to tear ΐ as a result of said forces is minimized, the outer periphery of the attaching ring being spaced inwardly of the outer periphery of the adhesive patchito provide a breathable outer portion of the adhesive patch which is uncovered by the attaching ring.
10. A drainage pouch comprising a moisture-impermeable bag having a drainage opening, a sealing assembly comprising an annular attaching ring formed of flexible sheet ! material secured to said pouch by a first area of attachment 1 extending around the pouch opening, and an adhesive patch formed of microporous sheet material, the adhesive patch having an opening therein which is generally concentric with the openings in the attaching ring and the bag, the adhesive patch being secured to the attaching ring by a second area of attachment extending around the attaching ring and extending outwardly beyond said first area of attachment, the adhesive patch being adapted to be - 20 adhesively secured to the body of a patient around a drainage opening, the portion of the flexible attaching ring between the first area of attachment of the attaching ring to the retainer ring and the second area of attachment 5 of the attaching ring to the adhesive patch being conformable by forces which are applied to the attaching ring and the adhesive patch which tend to remove the adhesive patch from the body so that the portions of the attaching ring and the adhesive patch adjacent the 10 attachment therebetween extend substantially linearly and the tendency of the adhesive patch to tear as a result of said forces is minimized.
11. A drainage pouch constructed, arranged and adapted to operate substantially as herein described with
12. 15 reference to and as shown in the accompanying drawings.·.
IE538/78A 1977-03-31 1978-03-16 Improvements relating to drainage pouches IE46487B1 (en)

Applications Claiming Priority (1)

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US78334077A 1977-03-31 1977-03-31

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IE780538L IE780538L (en) 1978-09-30
IE46487B1 true IE46487B1 (en) 1983-06-29

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IE538/78A IE46487B1 (en) 1977-03-31 1978-03-16 Improvements relating to drainage pouches

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JP (1) JPS53123590A (en)
AU (1) AU516180B2 (en)
BR (1) BR7801965A (en)
CA (1) CA1125614A (en)
DE (1) DE2813708C2 (en)
DK (1) DK146466C (en)
ES (1) ES468460A1 (en)
FR (1) FR2385598A1 (en)
GB (1) GB1587604A (en)
IE (1) IE46487B1 (en)
SE (1) SE433167C (en)

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DE3223147A1 (en) * 1981-06-23 1983-01-13 Beiersdorf Ag, 2000 Hamburg Container with a self-adhesive finish
ZA827903B (en) * 1981-11-27 1983-08-31 Squibb & Sons Inc A skin barrier
DK82683A (en) * 1982-02-24 1983-08-25 Matburn Holdings Ltd MEDICAL DRAENAGE POSE
FI67297C (en) * 1983-06-30 1985-03-11 Hantaaki Oy FISTELPAOSE
JPS61100413U (en) * 1984-12-05 1986-06-26
JPS61145524U (en) * 1985-02-27 1986-09-08
GB2185404B (en) * 1986-01-17 1989-10-25 Smiths Industries Plc Wc disposable bags
US4710182A (en) * 1986-12-04 1987-12-01 Hollister Incorporated Ostomy appliance and method of making
ZA94720B (en) * 1993-02-08 1994-08-02 Squibb & Sons Inc Flushable ostomy pouch
GB2290968B (en) * 1994-07-01 1998-06-03 Welland Medical Ltd Ostomy Bags and Laminates for Use therein.
GB2290712B (en) * 1994-07-01 1998-03-25 Welland Medical Ltd Ostomy bag filters
GB2290713B (en) * 1994-07-01 1998-07-08 Welland Medical Ltd Ostomy bag liner
DK172791B1 (en) * 1997-05-26 1999-07-19 Coloplast As An ostomy appliance
WO1998055057A1 (en) * 1997-06-04 1998-12-10 Coloplast A/S An ostomy appliance
US20050177119A1 (en) * 2004-01-21 2005-08-11 Tsai M. L. Pouch for medical use
DE202004002007U1 (en) * 2004-02-11 2005-06-30 Schikorski, Michael, Dr. Drainage device attachable as a plaster, for minor skin cuts and operations, comprises a liquid-tight outer foil sealed along its edge zone to a semipermeable foil which bounds a storage medium
CA2608228A1 (en) * 2005-05-20 2006-11-23 Coloplast A/S An appliance for irrigation and/or drainage
BRPI0712259B8 (en) * 2006-05-24 2021-06-22 Coloplast As layered adhesive construction useful for attaching a collection bag or collection device to the perianal area.
GB2509752B (en) * 2013-01-14 2019-06-26 Pelican Healthcare Ltd An ostomy pouch assembly
US10441690B2 (en) 2014-08-11 2019-10-15 Western Connecticut Health Network, Inc. Systems and methods wound drainage management
USD848608S1 (en) 2016-10-21 2019-05-14 Coloplast A/S Base unit for anal irrigation and controller

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US3302647A (en) * 1964-03-03 1967-02-07 Hollister Inc Sealing pad for a post-surgical drainage pouch
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US3822704A (en) * 1972-11-20 1974-07-09 Hollister Inc Urostomy device
SE7314477L (en) * 1973-10-25 1975-04-28 Gesenta Persson Goesta Fa

Also Published As

Publication number Publication date
AU3447378A (en) 1979-09-27
DK146466C (en) 1984-06-04
JPS6247540B2 (en) 1987-10-08
ES468460A1 (en) 1979-10-01
BR7801965A (en) 1978-10-24
SE433167C (en) 1991-03-18
CA1125614A (en) 1982-06-15
DE2813708C2 (en) 1985-03-28
DK123378A (en) 1978-10-01
JPS53123590A (en) 1978-10-28
FR2385598B1 (en) 1980-09-19
FR2385598A1 (en) 1978-10-27
DE2813708A1 (en) 1978-10-05
IE780538L (en) 1978-09-30
GB1587604A (en) 1981-04-08
SE433167B (en) 1984-05-14
AU516180B2 (en) 1981-05-21
SE7803442L (en) 1978-10-01
DK146466B (en) 1983-10-17

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