CA1125614A - Sealing and attachment assembly for medical drainage pouch - Google Patents
Sealing and attachment assembly for medical drainage pouchInfo
- Publication number
- CA1125614A CA1125614A CA300,043A CA300043A CA1125614A CA 1125614 A CA1125614 A CA 1125614A CA 300043 A CA300043 A CA 300043A CA 1125614 A CA1125614 A CA 1125614A
- Authority
- CA
- Canada
- Prior art keywords
- ring
- patch
- bag
- adhesive
- adhesive patch
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/445—Colostomy, ileostomy or urethrostomy devices
- A61F5/448—Means for attaching bag to seal ring
Abstract
SEALING AND ATTACHMENT ASSEMBLY
FOR MEDICAL DRAINAGE POUCH
Abstract of the Disclosure 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 adhe-sive 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 adhe-sive 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 tear-able 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.
FOR MEDICAL DRAINAGE POUCH
Abstract of the Disclosure 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 adhe-sive 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 adhe-sive 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 tear-able 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
Background of the Invention 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 1~ 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 dis-close prior art surgical drainage pouches, as used particularly for stoma or wound drainage. Each of these pouches includes a plastic bag for containing the fluid which is drained from the body and a relatively rigid plastic retainer xing which is heat-sealed to the bag around the drainage opening in the bag. The ..
; drainage pouch described in Patent No. 3,302,647 includes a 20 sealing pad or ring formed from a mixture of karaya powder and glycerol. The drainage pouch described in Patent No. 3,822,704 includes an adhesive patch which is secured to the relatively rigid retaining ring. A release paper covers the adhesive sur-face 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 descrihed in Patent No. 3,822,704. The adhesive patch .i ~
~, .,"~ ' ii6~
i. .ormed froM a nonporous surgical adhesive tape. This tape may comprise a backing sheet of nonporous polyethylene coated with a layer oE pressure-sensitive adhesive. The relatively rigid retainer ring can be formed of poly~thylene, and the adhesive patch secured to the retainer ring by 'neat~sealing the polyethylene backing of the adhesive patch to the polyethylene retainer ring. ~lternatively, the nonporous adhesive patch can be heat-sealed directly to the pouch around the opening.
Drainage pouches which are provided with such a nonporous lOpolyethylene adhesive patch are sold with and without a karaya sealing ring of the type described in 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 readially outwardly of the karaya ring to provide additional mechanical securement.
While such nonporous adhesive patches provide good adhe-sive and mechanical securement, certain problems have arisen.
Since polyethylene or similar patches are not porous, the skin 20cannot breathe through the patch. The patch traps moisture against the s]cin 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 ;~"~r`
the brand name "Micropore" from Minnesota Mining & Manufacturing Company, of Minneapolis, Minnesota. This tape is formed from a bac~ing layer o porous t non-woven rayon fabric and a layer of hypo-allergenic, synthètic, acrylic pressure-sensitive adhesive.
Such tape is essentially continuous in appearance and is non-3~perforatecl but exhibits a porosity which permits the skin to breathethrough the tape. Because the pores o the tape are quite small -the tape appears to be essentially continuous, the tape is considered microporous.
Our attempts to substitute a porous non-woven surgical adhesive tape Eor the polyethylene adhesi~e patch on the drainage pouch were initially unsuccessful. First of all, the non-woven fabric backing layer of the tape cannot be satisfactorily heat-sealea directly to the plastic retainer ring or to the pouch.
r~e found that some other means of attaching the fabric backing to the retainer ring must be used. We also found that the very 10thin non~woven fabric is very easily torn at any concentrated stress polnt. 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 ~hich tends to peel the retainer ring away from the adhesive patch which secures the pouch to the skin can become substantial and tear the patch cauSincJ leakage.
Summary o~ the Invention We have been able to overcome the problems of using non-woven porous fabric with drainage pouches by attaching the fabric to the retainer ring of the pouch with a ~lexible attachiny ring.
The flexible attaching ring is made from a material, for example, polyethylene, which can be easily heat-sealed to the retainer ring ~æ~-or to the pouch. The porous non-woven fabric is attached to the flexible at-taching ring or bag in a circular area extending radially outwardly of the heat-sealed~area between the attaching ring and the retainer ring or the bag. The attachment between the micro-porous bac~in~ sheet and the attaching ring can be made by heat- ~-~
30 sealable adhesive, which is applied either to the attaching ring,or to the backing sheet, or both. For example, a hot melt adhesive can be used on the attaching ring which when i6~
ted flows into the pores of the ~abric and provides a good adhesive and mechanical bond between the a-ttaching ring and the microporous sheet. A force which tends to peel the retainer ring of the pouch away from the microporous adhesive patch is resisted by the heat seal attachment between the flexible plastic attaching ring and the plastic retainer ring or bag, and the heat seal bond between these parts is extremely s-trong and will resist normal tearing forces. Since the attaching ring is flexible, the ~ -attaching ring and the fabric will extend linearly or in a plane in the area of the bond between the attaching ring and the fabric.
The force tending to separate the attaching ring and the adhesive patch is essentially a shear force which is aligned with the planes of the attaching ring and the patch in the area of the bond, and even though the microporous backing is easy to tear, it has sufficient streng-th to resist such linearly directed forces of the magnitude which would normally be encountered. We have found that microporous patches provide better adhesion to the skin than nonporous polyethylene tape since the breathable patches do not trap moisture between the patch and tlle s}~in. ~urther, 20the attachillg ring may be utilized as a moisture barrier around the bag opening when no retainer ring is employed.
Descxiption of the Drawing The inven-tion will be explained in conjunction with illustrative embodiments shown in the accompanying drawing, 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 o 30Fig. l;
Fig. 3 is a fragmentary sectional view showing the pouch secured to the body o~ a patient;
Fig. ~ is an enlarged fragmentary sectional view showing a force applied to the adhesive patch tencling to pull the patch away from the skin;
Fig. 5 is an enlarged view of a portion of Fig. 4;
ig. 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 modi-fied method of bonding the adhesive patch to the flexible attaching ring;
Fig. 12 is an exploded fragmentary perspective view of a modifiecl drainage pouch of a modified construction in which the attaching ring is heat sealed directly to l:he bag;
Fig. 13 is a vertical sectional view of the exploded 20 pouch components of Fig. 12, upper and lower portions of the ba~
~ .
being shown broken away; and Fig. 14 is an enlarged detailed sectional view showing the components of the pouch o Figs. 12 and 13 in assembled rela-tion, the adhesive patch and attachment ring being flexed outwardly.
General Description ~, 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 ; 30 opening. The outer side of the adhesive patch is coated with the , ~;essure-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 plastic sheet material. The ring is positioned adjacent the patch inner side and arranged concentrically with respect to the bag and patch openings. At least the opposed annular outer por-tion of the ring is adhesively attached to the patch inner side.
The annular inner portion of the o-ther side of the ring provides a heat-sealed connection to the bag, either directly or through a retaining ring which in turn is heat-sealed to the bag. The annular outer portion of the inside of the attaching ring is unconnected and free to flex with the patch.
Description of Preferred Embodiments .
Referring first to Figs. l and 2, the numeral 15 desig-na-tes generally a drainage pouch of tl-e type described in U.S.
Patent Nos. 3,302,6~7 and 3,822,704. The pouch includes a bag 16 which is Eormed from a pair of moisture-impermeable thermo-~j plastic films 17 and 18~ such as polyethylene film, which are 20 heat-sealed together around the periphery l9 thereof. The bottom of the bag may be provided with a drainage valve 20, if desired.
The plastic film 17 is pro~ided with a circular drainage opening 22 in the upper portion thereof, and a thermoplastic retainer ring or gasket 23 is secured to the plastic film around jr~
the o?ening 22. The retainer ring is provided with a central opening 24 which is defined by an axially enlarged flanc~e 25 - (Fig. 2), and the retainer ring is secured to the plastic film 17 by heat-sealing the film and the retainer ring in an annularly shaped area around the drainag~ opening of the bag indicated at 30 2G in Fig. 2. The retainer ring is advantageously formed of polyethylene so that it can be easily heat-sealed to the poly-ethylene plastic film of the bag.
5~ ~
Referring a~ain to E'ig. 1, the retainer ring includes a pair oE radially outwardly extending wings 27 and 2~, each of which is provided with a slotted opening 29 which permits the retainer ring to be attached to the conventional belt which surrounds the patient and helps support the drainage pouch.
The retainer ring is relatively thick and rigid and is capable of retaining its shape under the stress imposed by the belt.
A flexible ~lastic annular attaching ring 31 is secured to the retainer ring 23 on the side of the retainer ring opposite the plastic bag. Preferably, ring 31 or the inner layer thereof is formed of a thermoplastic film having a thickness of not over 10 mils, such as 2-5 mils, thereby being highly flexible. In the particular embodiment illustrated the flexible attaching ring has inside and outside diameters which are sli~htly greater than the inside and outside diameters, respectively, of the retainer ring 2,3 so that an annular outer portion of the attachihg ring extends radially outwardly beyond the periphery of the retainer ring (except in -the area of the wings 27 and 28). The attaching ring 31 is heat-sealed to the re-tainer rin~ 23 by a generally 20annularly shaped heat sealed area indicated at 32 in Fig. 2 which is adjacent the inner periphery of the attachin~ ring and which generally overlies the heat seal attachment 26 between the retainer ring and the plastic bag.
generally rectilinear patch 34 of porous adhesive tape is secured to the annular attaching ring 31 Oll the surface of the ring oppostie the surface which is bonded to the retainer ring 23.
The adhes~'~e patch is provided with an opening 34 having a dia-meter substantially the same as the inner diameter of the annular attaching ring, and the adhesive patch extends substantially out-30wardly of -the attaching ring and retainer ring and terminates in a generally rectilinear periphery 36.
~2~
The porous adhesive patch is advantageously Eormed of non-woven microporous sheet material such as rayon, paper, etc., 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) of 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". Both o these adhesive tapes Oare porous and breathable but are capable o~ being torn quite easily. One particular "~icropore" tape which has been used has a thickness of 0.00~5 + 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.
~ore speciEically, the adhesive tape for the patch may consist of a backing layer o~ porous non-woven rayon Eabric and an adhesive layer of hypo-allergenic, synt:hetic, acrylic pressure~
sensi-tive adhesive. ~he pressure-sensitive adhesive can be ~ covered by a silicone-coated release paper 37 which has a central opening 3~.
In order to provide a good bond between the annular attaching ring 31 and the fabric layer of the adhesive patch 3~, the attaching ring can be provided with a layer 40 (Fig. 3) of ; hot melt adhesive which is extrusion coated to a polyethylene layer al. Since the adhesive layer is extrusion coated to the polyetl~ylene layer a satisfactorv bond is obtained. The poly-ethylene layer of the attaching ring is easily heat-sealed or fused to the polyethylene retainer ring 23, and when the hot 30 melt adhesive layer oE the at-taching ring is pressed against the fabric layer oE the adhesive patch under heat, the hot melt adhesive will flow into the pores o~ the fabric and provide a good mechanical and adhesive bond between the attaching ring and the adhesive patch. One particular type of hot melt adhe-9 _ ~25ii~
~ e that has been used is an ethyl vinyl acetate copol~mer adhesive. In one embodiment of the annular attachin~ ring, the polyethylene layer 41 was 0.003 inch tnick 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 includes a laYer 42 of non-woven fabric which is bonded to the adhesive layer 40 of the attaching rin~, a layer 43 of pressure-sensitive adhesive which is intended to be applied to the skin of the patient, and the liner 37 of 10 silicone-coated release paper.
Referring again to Fig. 2, the fabric layer of the adhesive ~atch 34 is bonded to the adhesive-coated attaching ring 31 in an annularly shaped heat-seal area designated ~5 which is spaced radially outwardly of the the heat seal 32 between the attaching ring and the retainer ring 23. In one specific embodiment of the invention the width of both 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 20 heat seal zone 32 and the inner diameter of the outer heat seal zone 45 on the attachiny ring was about 5/32 inch. The heat seal areas 32 and/or 45 can be made wider or made to overlap providing the area 45 extends outwardly a subs~antial distance be~ond area 32.
The particular drainage pouch illustrated in Figs. 1 and 2 inc]udes an annular adhesive sealing pad or ring 47. The sealing pacl is formed from a mixture of karaya and glycerol as clescribed in U.S. Patènt ~o. 3,302,647 and is intended to provide a seal around the drainage opening in the body to protect the ~`
30 skin. The sealing pad 47 is provided with a central opening 43 which is concentric with the openings in the retainer ring 23, -- 1 0 -- !~
~taching ring 31, and adhesive patch 34, and the circular outer periphery 49 of the sealing pad has a diame-ter greater than the diameter of -the opening 33 in the release paper 37.
The sealing pad 47 is secured to the adhesive patch by the adhesive property of the sealing pad and the adhesive layer of the adhesive patch.
Fig. 3 illustrates the drainage pouch secured to the skin 51 of a patient around a drainage opening. The release paper 37 is first removed from the adhesive surface of the lO adhesive patch 34, and the Karaya sealing pad 47 is pressed against the skin around the drainage opening called the stoma.
The Karaya pad is deformable and will be flattened somewhat as it is pressed against the skin. The adhesive patch is then pressed against the skin outwardly of the Karaya pad and adhe-sively secured thereto. The drainage pouch can be further supported by attachment of the conventiona] belt to the attaching~
wings 27 and 2g of the retainer ring 23.
Fi~s. 4 and 5 illustrate the drainage pouch and sealing assembly when a force tending to pull the adhesive patch away 20 from ti~e skin is applied to the pouch, e.g., by the weight of fluid contained by the plastic bag. The upper portion of the retainer ring 23 tends to pivot about the lower edge thereof, and the aclhesive patch 3~ 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 flexibler 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 and the adhesive patch along a line extending between the attachment of the a-ttaching ring to the retainer ring -30 and the attachment of the aclhesive patch to the skin as shownin Fig. 5. Accordingly, -the force B exerted on the adhesive patch in the area of the hea-t seal bond 45 is essentially linearly ~ 11. --6:~
rected, l.e., the force vector lies substantially in the plane of the adhesive patch. Although the adllesive patch can be torn easily, the adhesive patch is sufficiently strong to resist linearly directed forces of the magnitude which would ordinarily be encountered during use of the pouch. mhe portion of the adhesive patch adjacent the skin curves smoothly into contact with the skin because the skin will be pulled outwardly somewhat, and concentrated stress areas which could tear the patch are thereby avoided in that area.
The force indicated by the arrow A tends to peel the a-ttaching ring away from the retainer rin~ and is resisted by the heat seal bond 32 between the attaching ring and the retainer ring. Since the heat seal bond between the polyethylene layer of the attaching rint3 and the polyethylene retainer ring is a fusion bond, the bond is extremely strong and is easily capable of resisting this peeling force.
In the embodiment illustrated ln Figs. l-~, the diameter of the opening in the adhesive patch is substantially the same as ~ the inside diameter of the annular attaching ring 31. According-- ~ ly, the adhesive patch extends radially inwardly beyond the outer heat seal bond 45 and is also bonded to the adhesive layer of the attaching ring in the heat seal zone 32. EIowever, this inner attachment between the adhesive patch and the attaching ring is not requlred to withstand any peeling forces since the force tendint~ to separate the adhesive patch and the attaching ring is taken up by the outer heat seal zone 45.
; Fig. 6 illustrates the ~anner 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 ~~
3037, by the outer annular hea-t seal ring 45. Thereafter, the attaching ring and adhesive patch is placed over the retainer ' '..
g 23 which has already been heat sealed to the'plastic film 17. The attaching ring is then heat sealed to the retainer ring by the inner heat seal ring 32 (Fig. 2), which also bonds the adhesive patch to the attaching ring. The Karaya sealing pad 47 is then secured to the portion of the adhesive patch 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 himsel~ before using the 10 drainage pouch. If the drainage pouch is sold without a Karaya sealing pad, the central opening in the release paper is reduced so that the release paper covers the entire adhesive surface of the adhesive patch. 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 ~ -t is greater than the diameter of the inner heat sealing ring 132.
The adhesive patch is therefore heat-sealed to the attaching ring 132 only in the area of the ou-ter heat seal ring 1~5. The ~0 adhesive surface of the adhesive patch is protected by the release paper 137.
The embodiment shown in Fig. 10 will function in the same way as-the embodiment shown in Fig. 5. A ~orce which tends to pull the adhcsive patch away from the s]cin will cause the flexible attaching ring to extend in a substantially straight line between the inner heat seal ring 132 and the area of attachment between the adhesive patch and the s]cin, and the force tending to pull the adhesive pa-tch and the attaching ring apart will be substantially linearly directed. --.
Fig. 11 illustrates an alternate method of attaching the adhesive patch to the sealing ring. The attaching ring 231 Z~Gl~
formed Erom a single layer of polyethylene, and layer 240 of breathable heat-sealable adhesive is impregnated into the non-woven fabric layer 242 of the adhesive patch 234. The adhesive patch 23~ is provided with a coating 2~3 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 heat-sealable adhesive 240 bonds to the poly-ethylene attaching ring. If desired, the attaching ring 231 can be provided with a layer o 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 poly-ethylene retainer ring and the polyethylene layer of the attach-ing ring as well as the attachment between the heat-sealable adhesive layer of the attaching ring and the fabric layer of the adhesive patch as "heat seal" bonds. However, these two attach- ~, ' ments 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 20 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 poly-ethylene layer and the hot melt adhesive layer of the attaching ring in the preferred embodiment is obtained when the two layers are extruded together under heat, and this is a fusion or a --chemical bond so that the two layers are essentially integrated.
ln 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 30 (fusion bonded) -to the pouch, which will be formed of a heat-sealable material, such as polye-t11ylene. Such embodiments will find use as wound drainage pouches, ecal collectors, enema bags, urostomy bags, etc. One such embodiment is illustrated
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 1~ 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 dis-close prior art surgical drainage pouches, as used particularly for stoma or wound drainage. Each of these pouches includes a plastic bag for containing the fluid which is drained from the body and a relatively rigid plastic retainer xing which is heat-sealed to the bag around the drainage opening in the bag. The ..
; drainage pouch described in Patent No. 3,302,647 includes a 20 sealing pad or ring formed from a mixture of karaya powder and glycerol. The drainage pouch described in Patent No. 3,822,704 includes an adhesive patch which is secured to the relatively rigid retaining ring. A release paper covers the adhesive sur-face 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 descrihed in Patent No. 3,822,704. The adhesive patch .i ~
~, .,"~ ' ii6~
i. .ormed froM a nonporous surgical adhesive tape. This tape may comprise a backing sheet of nonporous polyethylene coated with a layer oE pressure-sensitive adhesive. The relatively rigid retainer ring can be formed of poly~thylene, and the adhesive patch secured to the retainer ring by 'neat~sealing the polyethylene backing of the adhesive patch to the polyethylene retainer ring. ~lternatively, the nonporous adhesive patch can be heat-sealed directly to the pouch around the opening.
Drainage pouches which are provided with such a nonporous lOpolyethylene adhesive patch are sold with and without a karaya sealing ring of the type described in 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 readially outwardly of the karaya ring to provide additional mechanical securement.
While such nonporous adhesive patches provide good adhe-sive and mechanical securement, certain problems have arisen.
Since polyethylene or similar patches are not porous, the skin 20cannot breathe through the patch. The patch traps moisture against the s]cin 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 ;~"~r`
the brand name "Micropore" from Minnesota Mining & Manufacturing Company, of Minneapolis, Minnesota. This tape is formed from a bac~ing layer o porous t non-woven rayon fabric and a layer of hypo-allergenic, synthètic, acrylic pressure-sensitive adhesive.
Such tape is essentially continuous in appearance and is non-3~perforatecl but exhibits a porosity which permits the skin to breathethrough the tape. Because the pores o the tape are quite small -the tape appears to be essentially continuous, the tape is considered microporous.
Our attempts to substitute a porous non-woven surgical adhesive tape Eor the polyethylene adhesi~e patch on the drainage pouch were initially unsuccessful. First of all, the non-woven fabric backing layer of the tape cannot be satisfactorily heat-sealea directly to the plastic retainer ring or to the pouch.
r~e found that some other means of attaching the fabric backing to the retainer ring must be used. We also found that the very 10thin non~woven fabric is very easily torn at any concentrated stress polnt. 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 ~hich tends to peel the retainer ring away from the adhesive patch which secures the pouch to the skin can become substantial and tear the patch cauSincJ leakage.
Summary o~ the Invention We have been able to overcome the problems of using non-woven porous fabric with drainage pouches by attaching the fabric to the retainer ring of the pouch with a ~lexible attachiny ring.
The flexible attaching ring is made from a material, for example, polyethylene, which can be easily heat-sealed to the retainer ring ~æ~-or to the pouch. The porous non-woven fabric is attached to the flexible at-taching ring or bag in a circular area extending radially outwardly of the heat-sealed~area between the attaching ring and the retainer ring or the bag. The attachment between the micro-porous bac~in~ sheet and the attaching ring can be made by heat- ~-~
30 sealable adhesive, which is applied either to the attaching ring,or to the backing sheet, or both. For example, a hot melt adhesive can be used on the attaching ring which when i6~
ted flows into the pores of the ~abric and provides a good adhesive and mechanical bond between the a-ttaching ring and the microporous sheet. A force which tends to peel the retainer ring of the pouch away from the microporous adhesive patch is resisted by the heat seal attachment between the flexible plastic attaching ring and the plastic retainer ring or bag, and the heat seal bond between these parts is extremely s-trong and will resist normal tearing forces. Since the attaching ring is flexible, the ~ -attaching ring and the fabric will extend linearly or in a plane in the area of the bond between the attaching ring and the fabric.
The force tending to separate the attaching ring and the adhesive patch is essentially a shear force which is aligned with the planes of the attaching ring and the patch in the area of the bond, and even though the microporous backing is easy to tear, it has sufficient streng-th to resist such linearly directed forces of the magnitude which would normally be encountered. We have found that microporous patches provide better adhesion to the skin than nonporous polyethylene tape since the breathable patches do not trap moisture between the patch and tlle s}~in. ~urther, 20the attachillg ring may be utilized as a moisture barrier around the bag opening when no retainer ring is employed.
Descxiption of the Drawing The inven-tion will be explained in conjunction with illustrative embodiments shown in the accompanying drawing, 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 o 30Fig. l;
Fig. 3 is a fragmentary sectional view showing the pouch secured to the body o~ a patient;
Fig. ~ is an enlarged fragmentary sectional view showing a force applied to the adhesive patch tencling to pull the patch away from the skin;
Fig. 5 is an enlarged view of a portion of Fig. 4;
ig. 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 modi-fied method of bonding the adhesive patch to the flexible attaching ring;
Fig. 12 is an exploded fragmentary perspective view of a modifiecl drainage pouch of a modified construction in which the attaching ring is heat sealed directly to l:he bag;
Fig. 13 is a vertical sectional view of the exploded 20 pouch components of Fig. 12, upper and lower portions of the ba~
~ .
being shown broken away; and Fig. 14 is an enlarged detailed sectional view showing the components of the pouch o Figs. 12 and 13 in assembled rela-tion, the adhesive patch and attachment ring being flexed outwardly.
General Description ~, 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 ; 30 opening. The outer side of the adhesive patch is coated with the , ~;essure-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 plastic sheet material. The ring is positioned adjacent the patch inner side and arranged concentrically with respect to the bag and patch openings. At least the opposed annular outer por-tion of the ring is adhesively attached to the patch inner side.
The annular inner portion of the o-ther side of the ring provides a heat-sealed connection to the bag, either directly or through a retaining ring which in turn is heat-sealed to the bag. The annular outer portion of the inside of the attaching ring is unconnected and free to flex with the patch.
Description of Preferred Embodiments .
Referring first to Figs. l and 2, the numeral 15 desig-na-tes generally a drainage pouch of tl-e type described in U.S.
Patent Nos. 3,302,6~7 and 3,822,704. The pouch includes a bag 16 which is Eormed from a pair of moisture-impermeable thermo-~j plastic films 17 and 18~ such as polyethylene film, which are 20 heat-sealed together around the periphery l9 thereof. The bottom of the bag may be provided with a drainage valve 20, if desired.
The plastic film 17 is pro~ided with a circular drainage opening 22 in the upper portion thereof, and a thermoplastic retainer ring or gasket 23 is secured to the plastic film around jr~
the o?ening 22. The retainer ring is provided with a central opening 24 which is defined by an axially enlarged flanc~e 25 - (Fig. 2), and the retainer ring is secured to the plastic film 17 by heat-sealing the film and the retainer ring in an annularly shaped area around the drainag~ opening of the bag indicated at 30 2G in Fig. 2. The retainer ring is advantageously formed of polyethylene so that it can be easily heat-sealed to the poly-ethylene plastic film of the bag.
5~ ~
Referring a~ain to E'ig. 1, the retainer ring includes a pair oE radially outwardly extending wings 27 and 2~, each of which is provided with a slotted opening 29 which permits the retainer ring to be attached to the conventional belt which surrounds the patient and helps support the drainage pouch.
The retainer ring is relatively thick and rigid and is capable of retaining its shape under the stress imposed by the belt.
A flexible ~lastic annular attaching ring 31 is secured to the retainer ring 23 on the side of the retainer ring opposite the plastic bag. Preferably, ring 31 or the inner layer thereof is formed of a thermoplastic film having a thickness of not over 10 mils, such as 2-5 mils, thereby being highly flexible. In the particular embodiment illustrated the flexible attaching ring has inside and outside diameters which are sli~htly greater than the inside and outside diameters, respectively, of the retainer ring 2,3 so that an annular outer portion of the attachihg ring extends radially outwardly beyond the periphery of the retainer ring (except in -the area of the wings 27 and 28). The attaching ring 31 is heat-sealed to the re-tainer rin~ 23 by a generally 20annularly shaped heat sealed area indicated at 32 in Fig. 2 which is adjacent the inner periphery of the attachin~ ring and which generally overlies the heat seal attachment 26 between the retainer ring and the plastic bag.
generally rectilinear patch 34 of porous adhesive tape is secured to the annular attaching ring 31 Oll the surface of the ring oppostie the surface which is bonded to the retainer ring 23.
The adhes~'~e patch is provided with an opening 34 having a dia-meter substantially the same as the inner diameter of the annular attaching ring, and the adhesive patch extends substantially out-30wardly of -the attaching ring and retainer ring and terminates in a generally rectilinear periphery 36.
~2~
The porous adhesive patch is advantageously Eormed of non-woven microporous sheet material such as rayon, paper, etc., 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) of 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". Both o these adhesive tapes Oare porous and breathable but are capable o~ being torn quite easily. One particular "~icropore" tape which has been used has a thickness of 0.00~5 + 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.
~ore speciEically, the adhesive tape for the patch may consist of a backing layer o~ porous non-woven rayon Eabric and an adhesive layer of hypo-allergenic, synt:hetic, acrylic pressure~
sensi-tive adhesive. ~he pressure-sensitive adhesive can be ~ covered by a silicone-coated release paper 37 which has a central opening 3~.
In order to provide a good bond between the annular attaching ring 31 and the fabric layer of the adhesive patch 3~, the attaching ring can be provided with a layer 40 (Fig. 3) of ; hot melt adhesive which is extrusion coated to a polyethylene layer al. Since the adhesive layer is extrusion coated to the polyetl~ylene layer a satisfactorv bond is obtained. The poly-ethylene layer of the attaching ring is easily heat-sealed or fused to the polyethylene retainer ring 23, and when the hot 30 melt adhesive layer oE the at-taching ring is pressed against the fabric layer oE the adhesive patch under heat, the hot melt adhesive will flow into the pores o~ the fabric and provide a good mechanical and adhesive bond between the attaching ring and the adhesive patch. One particular type of hot melt adhe-9 _ ~25ii~
~ e that has been used is an ethyl vinyl acetate copol~mer adhesive. In one embodiment of the annular attachin~ ring, the polyethylene layer 41 was 0.003 inch tnick 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 includes a laYer 42 of non-woven fabric which is bonded to the adhesive layer 40 of the attaching rin~, a layer 43 of pressure-sensitive adhesive which is intended to be applied to the skin of the patient, and the liner 37 of 10 silicone-coated release paper.
Referring again to Fig. 2, the fabric layer of the adhesive ~atch 34 is bonded to the adhesive-coated attaching ring 31 in an annularly shaped heat-seal area designated ~5 which is spaced radially outwardly of the the heat seal 32 between the attaching ring and the retainer ring 23. In one specific embodiment of the invention the width of both 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 20 heat seal zone 32 and the inner diameter of the outer heat seal zone 45 on the attachiny ring was about 5/32 inch. The heat seal areas 32 and/or 45 can be made wider or made to overlap providing the area 45 extends outwardly a subs~antial distance be~ond area 32.
The particular drainage pouch illustrated in Figs. 1 and 2 inc]udes an annular adhesive sealing pad or ring 47. The sealing pacl is formed from a mixture of karaya and glycerol as clescribed in U.S. Patènt ~o. 3,302,647 and is intended to provide a seal around the drainage opening in the body to protect the ~`
30 skin. The sealing pad 47 is provided with a central opening 43 which is concentric with the openings in the retainer ring 23, -- 1 0 -- !~
~taching ring 31, and adhesive patch 34, and the circular outer periphery 49 of the sealing pad has a diame-ter greater than the diameter of -the opening 33 in the release paper 37.
The sealing pad 47 is secured to the adhesive patch by the adhesive property of the sealing pad and the adhesive layer of the adhesive patch.
Fig. 3 illustrates the drainage pouch secured to the skin 51 of a patient around a drainage opening. The release paper 37 is first removed from the adhesive surface of the lO adhesive patch 34, and the Karaya sealing pad 47 is pressed against the skin around the drainage opening called the stoma.
The Karaya pad is deformable and will be flattened somewhat as it is pressed against the skin. The adhesive patch is then pressed against the skin outwardly of the Karaya pad and adhe-sively secured thereto. The drainage pouch can be further supported by attachment of the conventiona] belt to the attaching~
wings 27 and 2g of the retainer ring 23.
Fi~s. 4 and 5 illustrate the drainage pouch and sealing assembly when a force tending to pull the adhesive patch away 20 from ti~e skin is applied to the pouch, e.g., by the weight of fluid contained by the plastic bag. The upper portion of the retainer ring 23 tends to pivot about the lower edge thereof, and the aclhesive patch 3~ 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 flexibler 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 and the adhesive patch along a line extending between the attachment of the a-ttaching ring to the retainer ring -30 and the attachment of the aclhesive patch to the skin as shownin Fig. 5. Accordingly, -the force B exerted on the adhesive patch in the area of the hea-t seal bond 45 is essentially linearly ~ 11. --6:~
rected, l.e., the force vector lies substantially in the plane of the adhesive patch. Although the adllesive patch can be torn easily, the adhesive patch is sufficiently strong to resist linearly directed forces of the magnitude which would ordinarily be encountered during use of the pouch. mhe portion of the adhesive patch adjacent the skin curves smoothly into contact with the skin because the skin will be pulled outwardly somewhat, and concentrated stress areas which could tear the patch are thereby avoided in that area.
The force indicated by the arrow A tends to peel the a-ttaching ring away from the retainer rin~ and is resisted by the heat seal bond 32 between the attaching ring and the retainer ring. Since the heat seal bond between the polyethylene layer of the attaching rint3 and the polyethylene retainer ring is a fusion bond, the bond is extremely strong and is easily capable of resisting this peeling force.
In the embodiment illustrated ln Figs. l-~, the diameter of the opening in the adhesive patch is substantially the same as ~ the inside diameter of the annular attaching ring 31. According-- ~ ly, the adhesive patch extends radially inwardly beyond the outer heat seal bond 45 and is also bonded to the adhesive layer of the attaching ring in the heat seal zone 32. EIowever, this inner attachment between the adhesive patch and the attaching ring is not requlred to withstand any peeling forces since the force tendint~ to separate the adhesive patch and the attaching ring is taken up by the outer heat seal zone 45.
; Fig. 6 illustrates the ~anner 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 ~~
3037, by the outer annular hea-t seal ring 45. Thereafter, the attaching ring and adhesive patch is placed over the retainer ' '..
g 23 which has already been heat sealed to the'plastic film 17. The attaching ring is then heat sealed to the retainer ring by the inner heat seal ring 32 (Fig. 2), which also bonds the adhesive patch to the attaching ring. The Karaya sealing pad 47 is then secured to the portion of the adhesive patch 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 himsel~ before using the 10 drainage pouch. If the drainage pouch is sold without a Karaya sealing pad, the central opening in the release paper is reduced so that the release paper covers the entire adhesive surface of the adhesive patch. 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 ~ -t is greater than the diameter of the inner heat sealing ring 132.
The adhesive patch is therefore heat-sealed to the attaching ring 132 only in the area of the ou-ter heat seal ring 1~5. The ~0 adhesive surface of the adhesive patch is protected by the release paper 137.
The embodiment shown in Fig. 10 will function in the same way as-the embodiment shown in Fig. 5. A ~orce which tends to pull the adhcsive patch away from the s]cin will cause the flexible attaching ring to extend in a substantially straight line between the inner heat seal ring 132 and the area of attachment between the adhesive patch and the s]cin, and the force tending to pull the adhesive pa-tch and the attaching ring apart will be substantially linearly directed. --.
Fig. 11 illustrates an alternate method of attaching the adhesive patch to the sealing ring. The attaching ring 231 Z~Gl~
formed Erom a single layer of polyethylene, and layer 240 of breathable heat-sealable adhesive is impregnated into the non-woven fabric layer 242 of the adhesive patch 234. The adhesive patch 23~ is provided with a coating 2~3 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 heat-sealable adhesive 240 bonds to the poly-ethylene attaching ring. If desired, the attaching ring 231 can be provided with a layer o 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 poly-ethylene retainer ring and the polyethylene layer of the attach-ing ring as well as the attachment between the heat-sealable adhesive layer of the attaching ring and the fabric layer of the adhesive patch as "heat seal" bonds. However, these two attach- ~, ' ments 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 20 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 poly-ethylene layer and the hot melt adhesive layer of the attaching ring in the preferred embodiment is obtained when the two layers are extruded together under heat, and this is a fusion or a --chemical bond so that the two layers are essentially integrated.
ln 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 30 (fusion bonded) -to the pouch, which will be formed of a heat-sealable material, such as polye-t11ylene. Such embodiments will find use as wound drainage pouches, ecal collectors, enema bags, urostomy bags, etc. One such embodiment is illustrated
2~6: L~
ln Figs. 12 to 14 of the drawings, whereln 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 attaching ring 31 prime is opposed to side 17 prime of bag 16 prime. There is no intervening retaining ring, as in the embodiment of Figs.
1 to 6. The inner layer of attachinc3 ring 31 prime is formed of thin, flexible thermoplastic sheet material, such as polyethylene, and the outer layer 40 prime is formed of a hot melt adhesive, as 10 previously described. The bac~ sides17 prime and 18 prime are formed of a thermoplastic sheet material such as polyethylene.
In the assembly oE the components, inner side 41 prime of the attaching riny is heat sealed in an annular area around bag opening 22 prime to bag wall 17 prime, as indicated at 32 prime in Fig. 14. The inner side of microporous adhesive patch 34 prime is heat-sealed fused to the outer side of attachinc3 ring ~ -~31 prime by means of hot melt adhesive layer 40 prime, as pre-viously described with respect to the prior embodiments. As shown more clearly in Fig. 14, the adhesive attachment of patch 20 34 prime to the outer side of ring 31 prime extends substantially across the full width of the ring, the outer attached portion extending beyond the heat sealed attachment 32 prime. In other words, -the annular outer portion of the inner side of attaching ring 31 prime is unconnected to bag wall 17 prime and is thereby free to flex with patch 34 prime, as indicated in Fig. 14. As ~ ~~
previously described, this provides a secure connection which minimizes the tendency of the microporous patch to tear while being worn.
Attaching ring 31 prime, being ~ormed o nonporous 30 plastic sheet material, effectively seals the portion of micro-porous adhesive patch 34 prime which is opposed thereto. Thus ~æ~
any fluids which tend to seep be-tween 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 attaching ring 31 prime. Since this ia 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 attaching ring 31 prime.
ln Figs. 12 to 14 of the drawings, whereln 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 attaching ring 31 prime is opposed to side 17 prime of bag 16 prime. There is no intervening retaining ring, as in the embodiment of Figs.
1 to 6. The inner layer of attachinc3 ring 31 prime is formed of thin, flexible thermoplastic sheet material, such as polyethylene, and the outer layer 40 prime is formed of a hot melt adhesive, as 10 previously described. The bac~ sides17 prime and 18 prime are formed of a thermoplastic sheet material such as polyethylene.
In the assembly oE the components, inner side 41 prime of the attaching riny is heat sealed in an annular area around bag opening 22 prime to bag wall 17 prime, as indicated at 32 prime in Fig. 14. The inner side of microporous adhesive patch 34 prime is heat-sealed fused to the outer side of attachinc3 ring ~ -~31 prime by means of hot melt adhesive layer 40 prime, as pre-viously described with respect to the prior embodiments. As shown more clearly in Fig. 14, the adhesive attachment of patch 20 34 prime to the outer side of ring 31 prime extends substantially across the full width of the ring, the outer attached portion extending beyond the heat sealed attachment 32 prime. In other words, -the annular outer portion of the inner side of attaching ring 31 prime is unconnected to bag wall 17 prime and is thereby free to flex with patch 34 prime, as indicated in Fig. 14. As ~ ~~
previously described, this provides a secure connection which minimizes the tendency of the microporous patch to tear while being worn.
Attaching ring 31 prime, being ~ormed o nonporous 30 plastic sheet material, effectively seals the portion of micro-porous adhesive patch 34 prime which is opposed thereto. Thus ~æ~
any fluids which tend to seep be-tween 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 attaching ring 31 prime. Since this ia 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 attaching ring 31 prime.
Claims (13)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A sealing and attachment assembly for a drainage pouch having a moisture-impermeable bag formed of thermoplastic sheet material with a drainage opening in one side thereof and including an adhesive patch formed of microporous sheet material with an opening therein generally concentric with said bag opening, the outer side of said patch being coated with a pressure-sensitive adhesive for attachment to the body of a wearer and the inner side thereof being connected to said bag, wherein the improve-ment comprises means for connecting said microporous patch to said bag including an annular attaching ring formed of nonporous flexi-ble plastic sheet material, said ring being adjacent said patch inner side and arranged concentrically with respect to said bag and patch openings, at least the opposed annular outer portion of said ring being adhesively attached to said patch inner side, the annular inner portion of the outer side Of said ring pro-viding a heat-sealed connection to said bag, the annular outer portion of said other side being unconnected to said bag and free to flex with said patch.
2. The structure of claim 1 in which a retainer ring of relatively rigid thermoplastic material is interposed between said bag and said attaching ring with the opening therein generally concentric with said bag and ring openings, the inner side of said retainer ring being heat-sealed to said bag around said bag open-ing and the outer side thereof being heat-sealed to the inner side of said attaching ring to provide said connection to said bag.
3. The structure of claim 1 in which said inner portion of said other ring side is heat-sealed directly to said bag around said bag opening.
4. The structure of claim 1 in which the attaching ring comprises an inner layer of plastic for providing said heat-sealed connection, and an outer layer of adhesive which is attached to said adhesive patch.
5. The structure of claim 2 in which said attaching ring comprises an inner layer of flexible thermoplastic which is heat-sealed to the retainer ring, and an outer layer of adhesive which is attached to said adhesive patch.
6. The structure of claim 5 in which the adhesive of said attaching ring is a hot melt adhesive and the attaching ring is heat-sealed to said adhesive patch.
7. The structure of claim 1 in which said adhesive patch is formed from a thin microporous non-woven fabric which is rela-tively easy to tear.
8. The structure of claim 1 in which said adhesive patch has a hot melt adhesive applied to the inner side, the patch and the said outer portion of said attaching ring being heat-sealed together.
9. The structure of claim 8 in which the annular inner portion of the attaching ring outer side is also heat-sealed to said patch.
10. The structure of claim 2 in which the diameter of said opening in the adhesive patch is greater than the diameter of the area of attachment between said retainer ring and the attaching ring.
11. The structure of claim 2 in which only said annular outer portion of said ring is attached to said patch, and the area of attachment therebetween is spaced radially outwardly from the area of said heat-sealed connection to said retainer ring.
12. A sealing assembly for a drainage pouch, the drainage pouch including a moisture-impermeable bag having a drainage opening, the sealing assembly comprising an annular attaching ring formed of flexible sheet material secured to said pouch by a first area of attachment 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 out-wardly beyond said first area of attachment, the adhesive patch being adapted to be 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 of the attaching ring to the adhesive patch from the body so that the portions of the attaching ring and the adhesive patch adjacent the attachment therebetween extend substantially linearly and the tendency of the adhesive patch to tear as a result of said forces is minimized.
13. A sealing assembly for a drainage pouch, the drainage pouch including a moisture-impermeable bag having a drainage open-ing and an annular retainer ring secured to the bag around the drainage opening, the sealing assembly comprising an annular attaching ring formed of flexible sheet material secured to the retainer ring by a first area of attachment extending around the attaching ring, 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, the retainer, and the bag, the adhesive patch being secured to the attaching ring by a second area of attachment extending around the attaching ring and spaced outwardly of the first area of attachment, the adhesive patch being adapted to be 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 of the attaching ring to the adhesive patch being conformable by forces which are applied to the attach-ing 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 attachment therebetween extend substantially linearly and the tendency of the adhesive patch to tear as a result of said forces is minimized.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US78334077A | 1977-03-31 | 1977-03-31 | |
| US783,340 | 1977-03-31 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1125614A true CA1125614A (en) | 1982-06-15 |
Family
ID=25128926
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA300,043A Expired CA1125614A (en) | 1977-03-31 | 1978-03-30 | Sealing and attachment assembly for medical drainage pouch |
Country Status (11)
| Country | Link |
|---|---|
| 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) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10441690B2 (en) | 2014-08-11 | 2019-10-15 | Western Connecticut Health Network, Inc. | Systems and methods wound drainage management |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA1146829A (en) * | 1977-10-17 | 1983-05-24 | James L. Chen | Stomal faceplate and skin barrier |
| 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 |
| FR2523839A1 (en) * | 1982-02-24 | 1983-09-30 | Matburn Holdings Ltd | Plastics surgical drainage bag - has microporous fixing flange and overlying impervious mounting ring around rear wall inlet |
| 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 | ||
| DE3642150C2 (en) * | 1986-01-17 | 1993-12-23 | Smiths Industries Plc | Ostomy bags for body waste |
| 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 |
| GB2290712B (en) * | 1994-07-01 | 1998-03-25 | Welland Medical Ltd | Ostomy bag filters |
| GB2290968B (en) * | 1994-07-01 | 1998-06-03 | Welland Medical Ltd | Ostomy Bags and Laminates for Use therein. |
| 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 |
| EP0991382B1 (en) * | 1997-06-04 | 2004-04-28 | 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 |
| WO2006122562A2 (en) * | 2005-05-20 | 2006-11-23 | Coloplast A/S | An appliance for irrigation and/or drainage |
| US7862878B2 (en) * | 2006-05-24 | 2011-01-04 | Coloplast A/S | Layered adhesive construction useful for attaching a collecting bag or collecting device to the perianal area |
| GB2509752B (en) * | 2013-01-14 | 2019-06-26 | Pelican Healthcare Ltd | An ostomy pouch assembly |
| USD848608S1 (en) | 2016-10-21 | 2019-05-14 | Coloplast A/S | Base unit for anal irrigation and controller |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK126967A (en) * | ||||
| CH340582A (en) * | 1955-12-31 | 1959-08-31 | Sorensen Elise | Colotomy pouch |
| US3302647A (en) * | 1964-03-03 | 1967-02-07 | Hollister Inc | Sealing pad for a post-surgical drainage pouch |
| DK116151B (en) * | 1967-03-10 | 1969-12-15 | Pharma Plast As | Colostomy bandage. |
| US3822704A (en) * | 1972-11-20 | 1974-07-09 | Hollister Inc | Urostomy device |
| SE7314477L (en) * | 1973-10-25 | 1975-04-28 | Gesenta Persson Goesta Fa |
-
1978
- 1978-03-16 IE IE538/78A patent/IE46487B1/en not_active IP Right Cessation
- 1978-03-20 DK DK123378A patent/DK146466C/en not_active IP Right Cessation
- 1978-03-21 GB GB11052/78A patent/GB1587604A/en not_active Expired
- 1978-03-23 AU AU34473/78A patent/AU516180B2/en not_active Expired
- 1978-03-28 SE SE7803442A patent/SE433167C/en not_active IP Right Cessation
- 1978-03-29 JP JP3654178A patent/JPS53123590A/en active Granted
- 1978-03-30 BR BR7801965A patent/BR7801965A/en unknown
- 1978-03-30 CA CA300,043A patent/CA1125614A/en not_active Expired
- 1978-03-30 DE DE2813708A patent/DE2813708C2/en not_active Expired
- 1978-03-31 ES ES468460A patent/ES468460A1/en not_active Expired
- 1978-03-31 FR FR7809466A patent/FR2385598A1/en active Granted
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10441690B2 (en) | 2014-08-11 | 2019-10-15 | Western Connecticut Health Network, Inc. | Systems and methods wound drainage management |
Also Published As
| Publication number | Publication date |
|---|---|
| SE433167C (en) | 1991-03-07 |
| SE433167B (en) | 1984-05-14 |
| AU516180B2 (en) | 1981-05-21 |
| DK146466B (en) | 1983-10-17 |
| JPS6247540B2 (en) | 1987-10-08 |
| DK146466C (en) | 1984-06-04 |
| IE46487B1 (en) | 1983-06-29 |
| FR2385598B1 (en) | 1980-09-19 |
| GB1587604A (en) | 1981-04-08 |
| JPS53123590A (en) | 1978-10-28 |
| FR2385598A1 (en) | 1978-10-27 |
| DE2813708A1 (en) | 1978-10-05 |
| BR7801965A (en) | 1978-10-24 |
| AU3447378A (en) | 1979-09-27 |
| SE7803442L (en) | 1978-10-01 |
| IE780538L (en) | 1978-09-30 |
| DK123378A (en) | 1978-10-01 |
| DE2813708C2 (en) | 1985-03-28 |
| ES468460A1 (en) | 1979-10-01 |
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| MKEX | Expiry |