CA1128681A - Polymeric composition - Google Patents
Polymeric compositionInfo
- Publication number
- CA1128681A CA1128681A CA345,330A CA345330A CA1128681A CA 1128681 A CA1128681 A CA 1128681A CA 345330 A CA345330 A CA 345330A CA 1128681 A CA1128681 A CA 1128681A
- Authority
- CA
- Canada
- Prior art keywords
- polymer
- hydrophilic polymer
- molecular weight
- hydrophilic
- skin
- 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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/06—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/14—Adhesives for ostomy devices
Abstract
ABSTRACT
A polymeric composition is disclosed which has sealant and preferably also adhesive properties and which is suitable for use as a protective dressing for application to the skin.
The composition comprises a chemically cross-linked hydrophilic polymer and a support matrix such as a high molecular weight hydrophobic polymer. The hydrophilic polymer is a water-swellable polymer which absorbs or adsorbs water but which is water-insoluble. The composition preferably includes a tackifyer which may be provided by a low molecular weight fraction of a hydrophobic matrix or by a distinct adhesive component such as a gum or a low molecular weight polymer. The composition is particularly suitable for use as a sealing ring in conjunction with a post-surgical drainage appliance wherein the hydrophilic polymer is incorporated in a form such as to provide a transmission system for liquid.
A polymeric composition is disclosed which has sealant and preferably also adhesive properties and which is suitable for use as a protective dressing for application to the skin.
The composition comprises a chemically cross-linked hydrophilic polymer and a support matrix such as a high molecular weight hydrophobic polymer. The hydrophilic polymer is a water-swellable polymer which absorbs or adsorbs water but which is water-insoluble. The composition preferably includes a tackifyer which may be provided by a low molecular weight fraction of a hydrophobic matrix or by a distinct adhesive component such as a gum or a low molecular weight polymer. The composition is particularly suitable for use as a sealing ring in conjunction with a post-surgical drainage appliance wherein the hydrophilic polymer is incorporated in a form such as to provide a transmission system for liquid.
Description
This invention relates to a polymeric composition and, in particular, to a polymeric composition having sealant properties, and pre-ferably also adhesive properties, and which is suitable for application to the skin.
According to a particular embodiment, the present invention provides a polymeric composition for use as a protective dressing in the form for example, of a ring which is suitable for use as a sealant, preferably also having adhesive properties, with,for example,a drainage bag or pouch which is worn by patients after surgical operation.
Certain surgical operations, e.g. colostomy, ileostomy and urinary diversion, result in the formation of an opening, known as a stoma, in the abdominal wall. A reliable seal between the skin of the patient and an ostomy appliance, such as a drainage bag o~lpouch, is essential in order, inter alia, to prevent leakage and/or irritation of the ~
20 skin. ~ i Similarly, drainage bags or pouches are worn by patients to drain faecal fistulae, urinary fistulae and in conjunction with post-surgical body cavity i drainage. In all cases an effective seal between 25 the skin of the patient and the drainage bag or -,':
pouch is required.
One material which has been commonly used to protect the skin, particularly in conjunction with an ostomy appliance, is a semi-gelatinous ring of the naturally occuring hydrocolloid, Karaya, obtained from tree-sap and normally used together with an oleaginous, non-evaporative carrier such as glycerol. The~e are, however, certain problems ~ associatèd with the use for this purpose of Karaya.
One problem is that conventional ostomy rings of Karaya have a limited life since, when they have absorbed a signiflcant amount of water, the rings lose their shape and strength. There exists, there-fore, a need for a protective dressing which avoids the problems associated with the use of conventional Karaya-based mat~rials.
Various materials have been proposed as sub-stitutes for the~naturally occuring Karaya, in paxt-icular for use with ostomy appliances. However, in general, thes`e materials contain a hydrocolloid and/or a water-soluble pol~mer and it has been ound that these materials lose much of their strength when the hydrocolloid has absorbed a significant quantity of water and, thus, are readily disturbed by move-ment of the ostom~ appliance.
..
~,''~.
.
- We have, thereore, attempted to provide an improved polymerlc composition suitable for use as a protective dressing which is capable of absorbing water, while retaining its shape and strength over a long period of time.
We have now found,-in accordance with the present invention, that these criteria are met by a polymeric composition which comprises at least one chemically cross-linked, hydrophilic polymer and a support matrix.
The term "hydrophilic polymer" is used herein to mean a water-swellable polymer which absorbs or adsorbs water but which is water-insoluble. The chemically cross~linked~, hydrophllic polymer is preferably one ~hich has`the ability to absorb and/or adsorb between 10~ and 90% ~f water, expressed in terms of the wei~ht of water absorbed/adsorbed as a percentage of the weight of water absorbed/adsorbed plus the weight of dry polymer.
The support matrix may be, for example, a `
hydrocolloid, a water-soluble polymer, a hydrophobic polymer or a mixture of these.
We have found that the polymeric compo~ition according to the`invention comprising a hydrophilic polymer will only absorb and/or adsorb a finite amount .
. . ' of water and even when the maximum amount of water has been absorbed and/or adsorbed the polymer still retains its original shape and much of its strength and will not disintegrate. This is in contrast to the use of a hydrocolloid and/or water soluble polymer which continues to absorb water to such an extent that it has no residual strength and wiLl ultimately disintegrate and/or dissolve.
This property, inter alia makes the polymeric composition according to the invention very suitable for use as a protective dressing for application to , the skin. According to one embodiment the protective dressing may be used in the form of a ring as previously described.
Thus, the present invention also provides a sealing ring for use with a post-surgical drainage appliance comprising a bag or pouch adapted to receive ~' drainage from the~body of a patient via a stoma, fistula, lesion or the lik~, the ring having an opening to permit the ring to surround the stoma, fistula, lesion or the like thereby forming a seal between the skin of '-the patient and the drainage appliance and which ring is formed from a polymeric composition comprising a matrix and at least one,chemically crosslinked, hydrophilic ~,' polymer which is lncorporated in the composition in a ' form such as to p~ovide a suitable transmission system lor .
,. . .
~?~ -liquid as herein defined.
By the phrase "suitable transmission system for liquid" we mean that, in use in conjunction with a drainage appliance, the sealing ring has good liquid permeability normal to the skin i.e. normal to the plane of the ring and very low permeability-transverse to the skin i.e. transverse to the plane of the ring. By means of the present invention it is possible to have sub-stantially zero permeability transverse to the skin at the inner edge of the sealing ring which can increase towards the outer periphery.
According to another aspect of the invention the composition is provided in the form of a solid sheet for subsequent adaptation to ring-form as just described ;~
or as a protective dressing for skin lesions, varicose ulcers, pressure sores and the like. According to ;-another embodiment the protective dressing may be employed as a mea~s of retaining an appliance or appendage ;
to the skin e.g. for seCuring a male incontinence sheath to the penis.
The ring or sheet of the polymeric composition according to the invention may be provided as part of -~:
a drainage appliance, such as an ostomy appliance or lt may be provided for subsecuent adaptation for - `
use with a particular drainage appliance or it may be provided as a dressing.
According to a further aspect, the composition according to the invention is provided in the orm of a paste, gel or liquid including a volatile carrier. The composition in paste-, gel- or liquid-form can be applied to the skin and thereafter the carrier is evaporated to leave a film of similar composition to that of the solid ring or s~eet previously described.
According to one aspect of the present invention the polymeric compos-ition according to the invention may be suitable for use as a protective dressing simply having sealant prop-erties without any adhesive properties and ithas been found that it is~sometimes desirable to separate these functions.~ In the case where, for example, the dres~ing is in the form of a sealing ring used in conj~nction with a drainage bag or pouch thèn a separate adhesive material or a mechanical securing aid would be employed~
Accordinq to this aspect of ~he invention, tho , `:
, ` ': ' `
-6~
polymeric composition may comprise the hydro-philic polymer together with a matrix.comprising a high molecu1ar weight hydrophobic polymer such as a polyolefin, especially polyisobutylene having a viscosity average (Mv(S)) molecular weight of between 120,000 and 130,000. Alternatiyely the - hydrophilic pOlymer may be used together with a matrix comprising a water-soluble material. --However, according to a preferred aspect of the present invention, the polymeric composition has both sealant and adhesive properties and is thus particularly suitable for use as a protective dressing suitable for appLication to the skin, 15 optionally in~conjunctlon with an appliance such ~.
as an ostomy ~ppliance. . -~
Thus, according to a particular embodiment, the invention provides a polymerlc composition -~
comprising at least one high molecular welght :~
20. hydrophobic polymer; and at least one chemically .:
. . cross-linked.,~hydrophilic polymer, the polymeric composition including a tackifi2r which can be : :
, . , ` ~ :
_g_ 'provided'by a low molecular weight fraction of the high'molecular weight, hydrophobic polymer and/or by a distinct component preferably comprising a low molecular weight polymer.
The high molecular weight, hydrophobic polymer component acts as a skeleton or backbone to hold the composition together and to give it sufficient mechanical-strength.
In general, the viscosity average molecular weight (Staudinger) (Mv(S)) of the hydrophobic polymer is at least 100,000, preferably from , 100,000 to 150,000. ~~
According to one embodiment, the hydro-phobic polymer includes a tackifier fraction. ,' In this case, the hydrophobic polymer should include at least 5% and preferably at least 10 of a fraction having a high molecular weight and at least lO~f a fraction having a low molecular , ~' weight. The high molecular weight fraction provides the backbone of the compos'ition and gives its strength, as just described, and'the low molecular weight '~
, fraction provides a sufficient deg'ree of tackiness such that the composition will adhere to skin under its own weight. -According to an alternative embodiment, the . .
`'.
. ' ' ' tackifier is provided by a distinct component or mixture of components, which is preferably a low molecular weight polymer, preferably a hydro-phobic polymer, and which is also preferably 5 derived from the same monomer as that from which the high molecular weight, hydrophobic polymer is derived. The low molecular weight polymer provides a sufficient'tackiness to adhere the , composition to the skin. The low molecular weight 10 polymer preferably has a molcular weight (Mv(5)) of between 200 and 30,000. "
, As a further possibility the adhesive component may be or may be augmented by for examp,le, a water-, activated adhesive or a non-aqueous, single or two-15 component adhesive.
According to another embodiment of the ,~
invention a polymeric composition having sealant ,~
and adhesive ~roperties comprises`the hydrophilic polymer, and Qptionally a high molecular`weight - 20 hydrophobic polymer and optionally a tackifier, ;
together with a water-activated adhesive such as karaya. By this means,`'the advantages of the widely ` ' '`
used known material would be combined with the advantages ,-arising from the use of'the hydrophilic polymer ' ::
'.' , according to ~his invention.
-The hydrophilic polymer can also be used in conjunction with a matrix containing a hydrocolloid or a water-soluble material to '5 improve adhesive properties when the composition is used in a situation where substantial amounts of water are present.
In general, the composition according to the invention-comprises at least 10% by weight, based on the weight of the total composition, of the at least one chemically cross-linked, hydro~
philic polymer and pre'ferably from 30 to 70%
by weight. According to a particular embodiment, the composition comprises about 60% by weight, based on the weight of'the total composition, of the chemically cross-linked,'hydrophilic~ polymer or polymers. However, within'these preferred limits a hydrocolloid may replace a portion of the hydro-philic polyme~
The ratio of the proportion of the hlgh molecular weight'hydrophobic polymer relative to '`
the low molecular weight tackifier polymer or to the low molec~lar weight fraction of the hydrophobic polymer is pr~ferably in the range of 1 : l to'l : 5 by ' : .
r . ~ ~A
. ~
weight and in particular approximately 1:3 by weight.
Howeverj where, as preferred, the tackifier is hydrophobic, and where the composition contains a relatively small proportion, i.e. towards the lower preferred limit of lO~, of the hydrophilic polymer, then the composition should include a microporous or water-permeable filler for example, Talc or chalk. The presence of the filler reduces the proportion of the hydrophobic material present ~y~rq~ic and hence maintains the-~=d~: permeability of the composition.
The polymeric composition according to the invention may optionally also include one or more othèr ingredients, for example, medicaments, deodorants and pH controllers.
Further details of the components of the polymeric compositions according to the invention `
are given in ~the following.
The ~hemically cross-linked, hydrophilic polymer may be, for example, a homopolymer of a hydrophilic monomer, for example, a vinyl lactam, such as N-viDyl pyrrolidone; a hydroxy-alkyl acrylate or methacrylate e.g. hydroxyethyl methacrylate acryl- ;~
. .
amide and methacrylamide and N-substituted derivatives thereof or a copolymer of two or more of these .
' ~,.
hydrophilic monomers. Suitable N-substituted derivatives include mono- and di-substituted compounds having alkyl, hydroxyalkyl and amino-alkyl groups e.g. N-methyl acrylamide, N-isopropyl-acrylamide N,N-dimethyl acrylamide, N,N-dimethylaminoethyl acrylamide and N-methylamino-isopropylacrylamide. The chemically cross-linked hydrophilic polymer may also be a copolymer of a ;
hydrophilic monomer, as just exemplified, with a hydrophobic comonomer such as an alkyl or amino-alkyl acrylate or methacrylate, e.g. methyl methacrylate or acrylonitrileor methacrylonitrile.
The preferred hydrophilic polymer is a copolymer of methyl methacrylate and N-vinyl pyrrolidone. This polymer may be prepared - by polymerization using radiation or a chemical agent, in the presence of a chemical cross-linkingj~agent such as a diolefinically un-saturated cr~ss-linking agent e.g. allyl methacrylate Or' an acrylate or methacrylate of a polyhydroxy alcohol:
- The matrix may comprise a high molecular weight, hydrophobic polymer, for example, a poly-olefin such aæ a polyisobutylene, a natural or -synthetic rubber such as polyurethane rubber, a silicon .
.
rubber, a polyi'soprene rubber'or a mixture of these polymers. The preferred high molecular weight, hydrophobic polymer is a polyisobutylene having a viscosity average (Mv(S)) molecul~r weight of between 120,000 and 130,000 e.g. a commercially available product called Vistanex (Trade Mark)L140.
Most preferably this constitutes ~pproximately lO~
by weight of the to,tal composition.
- The low molecular weight polymer which acts as a tackifyer in one embodiment of the composition according to the invention is preferably a poly- , isobutylene having a molecular weight (Mv(S)) within the range of 6,000 to 20,000'and a viscosity within the range of 180,000 to 220,000 SSU at 98.9C. Such a material is exemplified by the commercially available products Hyvis (Trade Mark) , 2000, and Vistanex LM-MS and LM-MH grades. It is most `' preferred fo~ this low molecular wèight polymer to con-stitute appr~ximately 30~ by weight of the total composition.
-' Where the tackifyer is provided by a low molecular weight fraction of the high molecular , ~
weight polyiisobutylene, at least 10% of the ; ,', polylsobutylène should have a molecular weight ~(Mv(S)) of qreater than 100,000 and at least 10%
25 of the polyisobutylene should have a molecular , - weight (Mv(S)) of less'than 30,000. , :~ , - , According to a preferred embodiment of the invention the composition comprises approximately 10% by weight of a polyisobutylene having a molecular weight (Mv(S)) of between 120,000 and 130,000;
approximately 30% by weight of a polyisobutylene h'aving a molecular welght (Mv(S)) within the range of 6,000 to 20,000 and a viscos'ity w'ithin the range of 180,000 to 220,000 SSU at 98.9~C; and 60~ by weight of a chemically cross-linked copolymer of methyl methacrylate and N-vinyl pyrrolidone, all percentages being based on the total weight of the composition.
A poPtion of the hydrophilic polymer in this preferred composition may be replaced by a hydrocolloid or a water-soluble polymer. For example'the composition may contain 30'to 40% by weight of the hydrophilic polymer together with 20'to 30% by weight of a hydrocolloid such as karaya.
The fun~tion of the hydrophilic polymer in a polymeric com~sition applied as a protective dressing 20 to the skin'may be two-fold. First, the hydrophilic ;
polymer may act as a reservoir for liquid, e.g. '' perspiration, if rom the surface of'the skin and, second, the hydrophilic polymer may also act as a transmission system, that ls a direct path for the liquid from 25 the skin to the atmosphere~ These functions render '~
~ ~; . - . ,-, , .
?'~, the composition particularly suitable for use in skin care and especially for use as a sealant with drainage bags or pouches such as those used in ostomy appliances.
In order to fulfil'the second function of providing a suitable transmission system for liquid, the hydrophilic polymer may be incorporated in various forms in the composition, such as granules, filaments or hollow fibres.
Referring to the use of the polymeric `
composition a~ a sealing ring according to`the invention, in a first embodiment the hydrophilic material may be incorporated in`the form of granules at low average volume concentrations with the density Of the granules being controlled such that, at least in-a part of',the composition, the granules provide a path for moisture. For examplej the granules mayl~e incorporated w'ith a higher concentrationïat`the outer periphery of the sealing ring. In thls embodiment, particle-particle contact may allow transmission at the outer edge without , seepage from the`stoma.
Another posslbility is to incorporate the hydrophilic polymer as granules at high average ,~
volume concentrations relative to the h'ydrophobic content, e.g. approximately 60~. In'this embodiment~ ~eservoir , ` .-, . : ' , ' ,; ~; i, ' " ,,., . ., :' ' and transmission effects will occur by particle-particle contact, and some additional means of sealing the edge at the stoma will be required.
Alternatively, according to a second embodiment the hydrophilic polymer may be incorporated as filaments passing through the system normal to the skin. This system automatically -provides high permeability normal to the skin and low permeability around the stoma. In a refinement of this arrangement the hydrophilic polyrrler is incorporated as filaments (as just described) but of variable volume concentration increasing-toward the outer surface or otherwise directed within the material.
Another, although less preferred, possibility may be adopted where the hydrophilic polymer has relatively low permeability. Thi involves the use of hollow fibres or filam~nts of the hydrophilic polymer to provide selecti~e directional transmission of the .
liquid.
According to the first embodiment~of the ~;
invention, the h~drophilic polymer is employed in granular form either in a proportion or an arrangement which ensures that there exists a path for liquid from the skin to the atmosphere.
' .:
In this system, the composition desira~ly incl~ldes a water-soluble adhesive, The adhesi~e may be i-ncorporated into the composition in dry form e.g. by milling and can be activated in situ by moisture from the skin.
Therefore, the hydrophilic polymer also acts as a slow release vehicle for the tackifier whereby the adhesive comp~nent or components are released due to uptake of ~ater by the hydrophilic polymer.
The adhesive properties are thereby maintained over a long period of time.
According to the second embodiment of the , invention, permeability normal to the skin is controlled independently from the other . .
properties o~the polymeric composition by the use of filame~ts of the hydrophilic material whlch are arranged to~extend through the thickness of the sealing ring thereby provid1ng a d1rect path for liquid from the skin to the atmosphere. Hollo~
20 flbres or fiIaments of the hydrophilic material ' may be similarly arranged. According to a particular aspect, the density of the hydrophilic --19- ' fibres or filaments is controlled such that their density, and hence liquid permeability normal to the skin, increases towards the outer periphery of the sealing ring.
In this system the-composition desirabl~ in-cludes a non aqueous adhesive orJ preferably, an aqueous adhesive. Where an aqueous, or water-soluble adhesive is employed the adhesive may conveniently be incorporated into the polymeric composition in dry form e.g. by milling. The adhesive is activated in situ by moisture from the skin which is transmitted via the hydrophilic polymer.
The hydrophilic material may also act as a release system for other optional components 15 of the composltion such as medicaments, pH ~-controllers and deodorants.
That is, the hydrophLlic material controls the rate of release of the adhesive component or ;
components a~ording to the rate of uptake of ' water from the~skin by the hydrophilic material.
By this means the hydrophilic material can act as a sIow release system for the adhesive whereby the adhesive characteristics are maintained over a long period of timeO
In both systems just descrlbed it may be , ~
~- :
; ` ~ ' desirable, in order to assist in inhibition Of transverse permeability of liquid from the stoma, to provide a means for sealing the centre of the - sealing ring. This could be effected, for example by introducing an impermeable layer of plastics material, such as polythene, during production of the sealing ring or by subsequent application of a coating. It is deslrable to obtain a sealing ring wherein ~he percentage by volume of the hydrophilic polymer may increase from substantially zero at the inner edge of the ring to about 60% - -at the outer periphery.
An anisotropic material suitable for use as a~sealing ring may be produced, for example from two or more compositions comprising the matrix such a~ a hydrophobic material with different con~entrations of the hydrophilic material in ~ anular form. The different compositions ~ould be co-extruded; pressed from a central unit~of a composition having a low concentration`of hydrophilic granules and a ring of a composition having a high concentration of hydrophilic granules; or pressed into separate flat sheets and rolled together, one on top of the other, 25 with the discs being cut from a cross section of ;-,:
' ' ! ` ' the resulting roll. Alternatively an anisotropic material may be produced by aligning filaments of the hydrophilic polymer and injecting the hydro-phobic material around them; the desired product could then be sliced off from the stock ~od thus obtained.
In order to prepare an isotropic composition according to the present invention the hydrophilic polymer, pref~rably in a finely ground state, may be dispersed, for example by milling, in the matrix.
The matrix may be premixed with an adhesive component or with any optional components of the polymeric composition optionally in the presence of a solvent e.g. normal hexane or perchloroethylene, which is subsequently removed. Another possibility is to feed the essential components into a high shear mixer.
We h~e found that the composition according to the prese~ invention has particularly good properties whlch make it suitable for use with drainage appliances such as ostomy appliances.
Thus, the composition has the important advantage that it is readily flexible, hence accommodating movement of the patient, while being liable to less flow, than, for example, previous compbsitions ~,, '.
~7~
incorpora~ting a hydrocolloid. In addition, the composition according to this invention does not - readily support bacterial growth and conveniently, the composition may be sterilised. The composition according to the present invention has a longer life since it is capable of ahsorbing water while maintaining its shape and strength, in contrast to compositions in-which the water-absorption capacity is provided by hydrocolloids. Finally the composition - 10 according to the present inve~ion is a more effective sealant and allows the skin to remain in a healthy condition by allowing removal of moisture from the skin while maintaining access of gases to the skin.
The invention is illustrated by the following Examples.
Example 1 Vistanex L140 (80g) is cut into small lumps and fed gradually ~nto a high shear Z-blade mixer loaded with Hyvis 2000 (240g). Finely ground methyl meth-acrylate-N-vinyl pyrrolidone co-polymer t480g) is - then also added gradually to the mix the co-polymer having a particle size of 10~-500 microns. ~ixing is continued until a homogeneous material is obtained (total mixing time approx. 45 mins.). The ' .
mixer is then unoladed and the product pressed into sheets of the desired thickness which are subsequently cut into the required shape.
Example 2 Vistanex L140 (88.8g) is cut into small lumps and fed gradually into a high shear Z-blade mixer loaded with Hyvis 2000 (80g). Methyl methacrylate-N-vinyl pyrrolidone co-polymer (272g) (having the same particle size as in Example 1) is then added slowly, - 10 and the mixer run for a further 30 mins. to qive a homogeneous material. A further quantity of Hyvis 2000 (151g) is then added followed by mixing for a ---further 5 mins. Karaya powder (208g) is then added, with mixing for another 5 mins. After checking for homogeneity the product i9 unloaded from the mixer and pressed and cut as in Example 1.
, ~
- ' ".
According to a particular embodiment, the present invention provides a polymeric composition for use as a protective dressing in the form for example, of a ring which is suitable for use as a sealant, preferably also having adhesive properties, with,for example,a drainage bag or pouch which is worn by patients after surgical operation.
Certain surgical operations, e.g. colostomy, ileostomy and urinary diversion, result in the formation of an opening, known as a stoma, in the abdominal wall. A reliable seal between the skin of the patient and an ostomy appliance, such as a drainage bag o~lpouch, is essential in order, inter alia, to prevent leakage and/or irritation of the ~
20 skin. ~ i Similarly, drainage bags or pouches are worn by patients to drain faecal fistulae, urinary fistulae and in conjunction with post-surgical body cavity i drainage. In all cases an effective seal between 25 the skin of the patient and the drainage bag or -,':
pouch is required.
One material which has been commonly used to protect the skin, particularly in conjunction with an ostomy appliance, is a semi-gelatinous ring of the naturally occuring hydrocolloid, Karaya, obtained from tree-sap and normally used together with an oleaginous, non-evaporative carrier such as glycerol. The~e are, however, certain problems ~ associatèd with the use for this purpose of Karaya.
One problem is that conventional ostomy rings of Karaya have a limited life since, when they have absorbed a signiflcant amount of water, the rings lose their shape and strength. There exists, there-fore, a need for a protective dressing which avoids the problems associated with the use of conventional Karaya-based mat~rials.
Various materials have been proposed as sub-stitutes for the~naturally occuring Karaya, in paxt-icular for use with ostomy appliances. However, in general, thes`e materials contain a hydrocolloid and/or a water-soluble pol~mer and it has been ound that these materials lose much of their strength when the hydrocolloid has absorbed a significant quantity of water and, thus, are readily disturbed by move-ment of the ostom~ appliance.
..
~,''~.
.
- We have, thereore, attempted to provide an improved polymerlc composition suitable for use as a protective dressing which is capable of absorbing water, while retaining its shape and strength over a long period of time.
We have now found,-in accordance with the present invention, that these criteria are met by a polymeric composition which comprises at least one chemically cross-linked, hydrophilic polymer and a support matrix.
The term "hydrophilic polymer" is used herein to mean a water-swellable polymer which absorbs or adsorbs water but which is water-insoluble. The chemically cross~linked~, hydrophllic polymer is preferably one ~hich has`the ability to absorb and/or adsorb between 10~ and 90% ~f water, expressed in terms of the wei~ht of water absorbed/adsorbed as a percentage of the weight of water absorbed/adsorbed plus the weight of dry polymer.
The support matrix may be, for example, a `
hydrocolloid, a water-soluble polymer, a hydrophobic polymer or a mixture of these.
We have found that the polymeric compo~ition according to the`invention comprising a hydrophilic polymer will only absorb and/or adsorb a finite amount .
. . ' of water and even when the maximum amount of water has been absorbed and/or adsorbed the polymer still retains its original shape and much of its strength and will not disintegrate. This is in contrast to the use of a hydrocolloid and/or water soluble polymer which continues to absorb water to such an extent that it has no residual strength and wiLl ultimately disintegrate and/or dissolve.
This property, inter alia makes the polymeric composition according to the invention very suitable for use as a protective dressing for application to , the skin. According to one embodiment the protective dressing may be used in the form of a ring as previously described.
Thus, the present invention also provides a sealing ring for use with a post-surgical drainage appliance comprising a bag or pouch adapted to receive ~' drainage from the~body of a patient via a stoma, fistula, lesion or the lik~, the ring having an opening to permit the ring to surround the stoma, fistula, lesion or the like thereby forming a seal between the skin of '-the patient and the drainage appliance and which ring is formed from a polymeric composition comprising a matrix and at least one,chemically crosslinked, hydrophilic ~,' polymer which is lncorporated in the composition in a ' form such as to p~ovide a suitable transmission system lor .
,. . .
~?~ -liquid as herein defined.
By the phrase "suitable transmission system for liquid" we mean that, in use in conjunction with a drainage appliance, the sealing ring has good liquid permeability normal to the skin i.e. normal to the plane of the ring and very low permeability-transverse to the skin i.e. transverse to the plane of the ring. By means of the present invention it is possible to have sub-stantially zero permeability transverse to the skin at the inner edge of the sealing ring which can increase towards the outer periphery.
According to another aspect of the invention the composition is provided in the form of a solid sheet for subsequent adaptation to ring-form as just described ;~
or as a protective dressing for skin lesions, varicose ulcers, pressure sores and the like. According to ;-another embodiment the protective dressing may be employed as a mea~s of retaining an appliance or appendage ;
to the skin e.g. for seCuring a male incontinence sheath to the penis.
The ring or sheet of the polymeric composition according to the invention may be provided as part of -~:
a drainage appliance, such as an ostomy appliance or lt may be provided for subsecuent adaptation for - `
use with a particular drainage appliance or it may be provided as a dressing.
According to a further aspect, the composition according to the invention is provided in the orm of a paste, gel or liquid including a volatile carrier. The composition in paste-, gel- or liquid-form can be applied to the skin and thereafter the carrier is evaporated to leave a film of similar composition to that of the solid ring or s~eet previously described.
According to one aspect of the present invention the polymeric compos-ition according to the invention may be suitable for use as a protective dressing simply having sealant prop-erties without any adhesive properties and ithas been found that it is~sometimes desirable to separate these functions.~ In the case where, for example, the dres~ing is in the form of a sealing ring used in conj~nction with a drainage bag or pouch thèn a separate adhesive material or a mechanical securing aid would be employed~
Accordinq to this aspect of ~he invention, tho , `:
, ` ': ' `
-6~
polymeric composition may comprise the hydro-philic polymer together with a matrix.comprising a high molecu1ar weight hydrophobic polymer such as a polyolefin, especially polyisobutylene having a viscosity average (Mv(S)) molecular weight of between 120,000 and 130,000. Alternatiyely the - hydrophilic pOlymer may be used together with a matrix comprising a water-soluble material. --However, according to a preferred aspect of the present invention, the polymeric composition has both sealant and adhesive properties and is thus particularly suitable for use as a protective dressing suitable for appLication to the skin, 15 optionally in~conjunctlon with an appliance such ~.
as an ostomy ~ppliance. . -~
Thus, according to a particular embodiment, the invention provides a polymerlc composition -~
comprising at least one high molecular welght :~
20. hydrophobic polymer; and at least one chemically .:
. . cross-linked.,~hydrophilic polymer, the polymeric composition including a tackifi2r which can be : :
, . , ` ~ :
_g_ 'provided'by a low molecular weight fraction of the high'molecular weight, hydrophobic polymer and/or by a distinct component preferably comprising a low molecular weight polymer.
The high molecular weight, hydrophobic polymer component acts as a skeleton or backbone to hold the composition together and to give it sufficient mechanical-strength.
In general, the viscosity average molecular weight (Staudinger) (Mv(S)) of the hydrophobic polymer is at least 100,000, preferably from , 100,000 to 150,000. ~~
According to one embodiment, the hydro-phobic polymer includes a tackifier fraction. ,' In this case, the hydrophobic polymer should include at least 5% and preferably at least 10 of a fraction having a high molecular weight and at least lO~f a fraction having a low molecular , ~' weight. The high molecular weight fraction provides the backbone of the compos'ition and gives its strength, as just described, and'the low molecular weight '~
, fraction provides a sufficient deg'ree of tackiness such that the composition will adhere to skin under its own weight. -According to an alternative embodiment, the . .
`'.
. ' ' ' tackifier is provided by a distinct component or mixture of components, which is preferably a low molecular weight polymer, preferably a hydro-phobic polymer, and which is also preferably 5 derived from the same monomer as that from which the high molecular weight, hydrophobic polymer is derived. The low molecular weight polymer provides a sufficient'tackiness to adhere the , composition to the skin. The low molecular weight 10 polymer preferably has a molcular weight (Mv(5)) of between 200 and 30,000. "
, As a further possibility the adhesive component may be or may be augmented by for examp,le, a water-, activated adhesive or a non-aqueous, single or two-15 component adhesive.
According to another embodiment of the ,~
invention a polymeric composition having sealant ,~
and adhesive ~roperties comprises`the hydrophilic polymer, and Qptionally a high molecular`weight - 20 hydrophobic polymer and optionally a tackifier, ;
together with a water-activated adhesive such as karaya. By this means,`'the advantages of the widely ` ' '`
used known material would be combined with the advantages ,-arising from the use of'the hydrophilic polymer ' ::
'.' , according to ~his invention.
-The hydrophilic polymer can also be used in conjunction with a matrix containing a hydrocolloid or a water-soluble material to '5 improve adhesive properties when the composition is used in a situation where substantial amounts of water are present.
In general, the composition according to the invention-comprises at least 10% by weight, based on the weight of the total composition, of the at least one chemically cross-linked, hydro~
philic polymer and pre'ferably from 30 to 70%
by weight. According to a particular embodiment, the composition comprises about 60% by weight, based on the weight of'the total composition, of the chemically cross-linked,'hydrophilic~ polymer or polymers. However, within'these preferred limits a hydrocolloid may replace a portion of the hydro-philic polyme~
The ratio of the proportion of the hlgh molecular weight'hydrophobic polymer relative to '`
the low molecular weight tackifier polymer or to the low molec~lar weight fraction of the hydrophobic polymer is pr~ferably in the range of 1 : l to'l : 5 by ' : .
r . ~ ~A
. ~
weight and in particular approximately 1:3 by weight.
Howeverj where, as preferred, the tackifier is hydrophobic, and where the composition contains a relatively small proportion, i.e. towards the lower preferred limit of lO~, of the hydrophilic polymer, then the composition should include a microporous or water-permeable filler for example, Talc or chalk. The presence of the filler reduces the proportion of the hydrophobic material present ~y~rq~ic and hence maintains the-~=d~: permeability of the composition.
The polymeric composition according to the invention may optionally also include one or more othèr ingredients, for example, medicaments, deodorants and pH controllers.
Further details of the components of the polymeric compositions according to the invention `
are given in ~the following.
The ~hemically cross-linked, hydrophilic polymer may be, for example, a homopolymer of a hydrophilic monomer, for example, a vinyl lactam, such as N-viDyl pyrrolidone; a hydroxy-alkyl acrylate or methacrylate e.g. hydroxyethyl methacrylate acryl- ;~
. .
amide and methacrylamide and N-substituted derivatives thereof or a copolymer of two or more of these .
' ~,.
hydrophilic monomers. Suitable N-substituted derivatives include mono- and di-substituted compounds having alkyl, hydroxyalkyl and amino-alkyl groups e.g. N-methyl acrylamide, N-isopropyl-acrylamide N,N-dimethyl acrylamide, N,N-dimethylaminoethyl acrylamide and N-methylamino-isopropylacrylamide. The chemically cross-linked hydrophilic polymer may also be a copolymer of a ;
hydrophilic monomer, as just exemplified, with a hydrophobic comonomer such as an alkyl or amino-alkyl acrylate or methacrylate, e.g. methyl methacrylate or acrylonitrileor methacrylonitrile.
The preferred hydrophilic polymer is a copolymer of methyl methacrylate and N-vinyl pyrrolidone. This polymer may be prepared - by polymerization using radiation or a chemical agent, in the presence of a chemical cross-linkingj~agent such as a diolefinically un-saturated cr~ss-linking agent e.g. allyl methacrylate Or' an acrylate or methacrylate of a polyhydroxy alcohol:
- The matrix may comprise a high molecular weight, hydrophobic polymer, for example, a poly-olefin such aæ a polyisobutylene, a natural or -synthetic rubber such as polyurethane rubber, a silicon .
.
rubber, a polyi'soprene rubber'or a mixture of these polymers. The preferred high molecular weight, hydrophobic polymer is a polyisobutylene having a viscosity average (Mv(S)) molecul~r weight of between 120,000 and 130,000 e.g. a commercially available product called Vistanex (Trade Mark)L140.
Most preferably this constitutes ~pproximately lO~
by weight of the to,tal composition.
- The low molecular weight polymer which acts as a tackifyer in one embodiment of the composition according to the invention is preferably a poly- , isobutylene having a molecular weight (Mv(S)) within the range of 6,000 to 20,000'and a viscosity within the range of 180,000 to 220,000 SSU at 98.9C. Such a material is exemplified by the commercially available products Hyvis (Trade Mark) , 2000, and Vistanex LM-MS and LM-MH grades. It is most `' preferred fo~ this low molecular wèight polymer to con-stitute appr~ximately 30~ by weight of the total composition.
-' Where the tackifyer is provided by a low molecular weight fraction of the high molecular , ~
weight polyiisobutylene, at least 10% of the ; ,', polylsobutylène should have a molecular weight ~(Mv(S)) of qreater than 100,000 and at least 10%
25 of the polyisobutylene should have a molecular , - weight (Mv(S)) of less'than 30,000. , :~ , - , According to a preferred embodiment of the invention the composition comprises approximately 10% by weight of a polyisobutylene having a molecular weight (Mv(S)) of between 120,000 and 130,000;
approximately 30% by weight of a polyisobutylene h'aving a molecular welght (Mv(S)) within the range of 6,000 to 20,000 and a viscos'ity w'ithin the range of 180,000 to 220,000 SSU at 98.9~C; and 60~ by weight of a chemically cross-linked copolymer of methyl methacrylate and N-vinyl pyrrolidone, all percentages being based on the total weight of the composition.
A poPtion of the hydrophilic polymer in this preferred composition may be replaced by a hydrocolloid or a water-soluble polymer. For example'the composition may contain 30'to 40% by weight of the hydrophilic polymer together with 20'to 30% by weight of a hydrocolloid such as karaya.
The fun~tion of the hydrophilic polymer in a polymeric com~sition applied as a protective dressing 20 to the skin'may be two-fold. First, the hydrophilic ;
polymer may act as a reservoir for liquid, e.g. '' perspiration, if rom the surface of'the skin and, second, the hydrophilic polymer may also act as a transmission system, that ls a direct path for the liquid from 25 the skin to the atmosphere~ These functions render '~
~ ~; . - . ,-, , .
?'~, the composition particularly suitable for use in skin care and especially for use as a sealant with drainage bags or pouches such as those used in ostomy appliances.
In order to fulfil'the second function of providing a suitable transmission system for liquid, the hydrophilic polymer may be incorporated in various forms in the composition, such as granules, filaments or hollow fibres.
Referring to the use of the polymeric `
composition a~ a sealing ring according to`the invention, in a first embodiment the hydrophilic material may be incorporated in`the form of granules at low average volume concentrations with the density Of the granules being controlled such that, at least in-a part of',the composition, the granules provide a path for moisture. For examplej the granules mayl~e incorporated w'ith a higher concentrationïat`the outer periphery of the sealing ring. In thls embodiment, particle-particle contact may allow transmission at the outer edge without , seepage from the`stoma.
Another posslbility is to incorporate the hydrophilic polymer as granules at high average ,~
volume concentrations relative to the h'ydrophobic content, e.g. approximately 60~. In'this embodiment~ ~eservoir , ` .-, . : ' , ' ,; ~; i, ' " ,,., . ., :' ' and transmission effects will occur by particle-particle contact, and some additional means of sealing the edge at the stoma will be required.
Alternatively, according to a second embodiment the hydrophilic polymer may be incorporated as filaments passing through the system normal to the skin. This system automatically -provides high permeability normal to the skin and low permeability around the stoma. In a refinement of this arrangement the hydrophilic polyrrler is incorporated as filaments (as just described) but of variable volume concentration increasing-toward the outer surface or otherwise directed within the material.
Another, although less preferred, possibility may be adopted where the hydrophilic polymer has relatively low permeability. Thi involves the use of hollow fibres or filam~nts of the hydrophilic polymer to provide selecti~e directional transmission of the .
liquid.
According to the first embodiment~of the ~;
invention, the h~drophilic polymer is employed in granular form either in a proportion or an arrangement which ensures that there exists a path for liquid from the skin to the atmosphere.
' .:
In this system, the composition desira~ly incl~ldes a water-soluble adhesive, The adhesi~e may be i-ncorporated into the composition in dry form e.g. by milling and can be activated in situ by moisture from the skin.
Therefore, the hydrophilic polymer also acts as a slow release vehicle for the tackifier whereby the adhesive comp~nent or components are released due to uptake of ~ater by the hydrophilic polymer.
The adhesive properties are thereby maintained over a long period of time.
According to the second embodiment of the , invention, permeability normal to the skin is controlled independently from the other . .
properties o~the polymeric composition by the use of filame~ts of the hydrophilic material whlch are arranged to~extend through the thickness of the sealing ring thereby provid1ng a d1rect path for liquid from the skin to the atmosphere. Hollo~
20 flbres or fiIaments of the hydrophilic material ' may be similarly arranged. According to a particular aspect, the density of the hydrophilic --19- ' fibres or filaments is controlled such that their density, and hence liquid permeability normal to the skin, increases towards the outer periphery of the sealing ring.
In this system the-composition desirabl~ in-cludes a non aqueous adhesive orJ preferably, an aqueous adhesive. Where an aqueous, or water-soluble adhesive is employed the adhesive may conveniently be incorporated into the polymeric composition in dry form e.g. by milling. The adhesive is activated in situ by moisture from the skin which is transmitted via the hydrophilic polymer.
The hydrophilic material may also act as a release system for other optional components 15 of the composltion such as medicaments, pH ~-controllers and deodorants.
That is, the hydrophLlic material controls the rate of release of the adhesive component or ;
components a~ording to the rate of uptake of ' water from the~skin by the hydrophilic material.
By this means the hydrophilic material can act as a sIow release system for the adhesive whereby the adhesive characteristics are maintained over a long period of timeO
In both systems just descrlbed it may be , ~
~- :
; ` ~ ' desirable, in order to assist in inhibition Of transverse permeability of liquid from the stoma, to provide a means for sealing the centre of the - sealing ring. This could be effected, for example by introducing an impermeable layer of plastics material, such as polythene, during production of the sealing ring or by subsequent application of a coating. It is deslrable to obtain a sealing ring wherein ~he percentage by volume of the hydrophilic polymer may increase from substantially zero at the inner edge of the ring to about 60% - -at the outer periphery.
An anisotropic material suitable for use as a~sealing ring may be produced, for example from two or more compositions comprising the matrix such a~ a hydrophobic material with different con~entrations of the hydrophilic material in ~ anular form. The different compositions ~ould be co-extruded; pressed from a central unit~of a composition having a low concentration`of hydrophilic granules and a ring of a composition having a high concentration of hydrophilic granules; or pressed into separate flat sheets and rolled together, one on top of the other, 25 with the discs being cut from a cross section of ;-,:
' ' ! ` ' the resulting roll. Alternatively an anisotropic material may be produced by aligning filaments of the hydrophilic polymer and injecting the hydro-phobic material around them; the desired product could then be sliced off from the stock ~od thus obtained.
In order to prepare an isotropic composition according to the present invention the hydrophilic polymer, pref~rably in a finely ground state, may be dispersed, for example by milling, in the matrix.
The matrix may be premixed with an adhesive component or with any optional components of the polymeric composition optionally in the presence of a solvent e.g. normal hexane or perchloroethylene, which is subsequently removed. Another possibility is to feed the essential components into a high shear mixer.
We h~e found that the composition according to the prese~ invention has particularly good properties whlch make it suitable for use with drainage appliances such as ostomy appliances.
Thus, the composition has the important advantage that it is readily flexible, hence accommodating movement of the patient, while being liable to less flow, than, for example, previous compbsitions ~,, '.
~7~
incorpora~ting a hydrocolloid. In addition, the composition according to this invention does not - readily support bacterial growth and conveniently, the composition may be sterilised. The composition according to the present invention has a longer life since it is capable of ahsorbing water while maintaining its shape and strength, in contrast to compositions in-which the water-absorption capacity is provided by hydrocolloids. Finally the composition - 10 according to the present inve~ion is a more effective sealant and allows the skin to remain in a healthy condition by allowing removal of moisture from the skin while maintaining access of gases to the skin.
The invention is illustrated by the following Examples.
Example 1 Vistanex L140 (80g) is cut into small lumps and fed gradually ~nto a high shear Z-blade mixer loaded with Hyvis 2000 (240g). Finely ground methyl meth-acrylate-N-vinyl pyrrolidone co-polymer t480g) is - then also added gradually to the mix the co-polymer having a particle size of 10~-500 microns. ~ixing is continued until a homogeneous material is obtained (total mixing time approx. 45 mins.). The ' .
mixer is then unoladed and the product pressed into sheets of the desired thickness which are subsequently cut into the required shape.
Example 2 Vistanex L140 (88.8g) is cut into small lumps and fed gradually into a high shear Z-blade mixer loaded with Hyvis 2000 (80g). Methyl methacrylate-N-vinyl pyrrolidone co-polymer (272g) (having the same particle size as in Example 1) is then added slowly, - 10 and the mixer run for a further 30 mins. to qive a homogeneous material. A further quantity of Hyvis 2000 (151g) is then added followed by mixing for a ---further 5 mins. Karaya powder (208g) is then added, with mixing for another 5 mins. After checking for homogeneity the product i9 unloaded from the mixer and pressed and cut as in Example 1.
, ~
- ' ".
Claims (15)
1. A protective dressing suitable for application to the skin which comprises a polymeric composition consisting essentially of (i) at least one chemically cross-linked hydrophilic polymer selected from the group consisting of homopolymers of hydrophilic monomers selected from the group consisting of vinyl lactams, hydxoxy-alkyl acrylates, hydroxy-alkyl methacry-lates, acrylamide, methacrylamide, M-substituted derivatives of acrylamide, N-substituted derivatives of methacrylamide, co-polymers of at least two of the said hydrophilic monomers and copolymers of at least one of the said hydrophilic monomers with at least one hydrophobic monomer; and (ii) a support matrix for the said hydrophilic polymer.
2. A protective dressing as claimed in claim 1, which comprises a polymeric composition consisting essentially of 30 to 70% by weight of the said chemically cross-linked hydrophilic polymer.
3. A protective dressing as claimed in claim 2, wherein a portion of the said chemically-cross-linked hydrophilic polymer is replaced by a hydrocolloid.
4. A protective dressing as claimed in claim 1, wherein the said chemically cross-linked hydrophilic polymer is a copolymer of methyl methacrylate and N-vinyl pyrrolidone.
5. A protective dressing as claimed in claim 1, wherein the said support matrix comprises at least one high molecular weight hydrophobic polymer.
6. A protective dressing as claimed in claim 5, wherein the said high molecular weight hydrophobic polymer is poly-isobutylene having a viscosity average molecular weight of between 120,000 and 130,000.
7. A protective dressing suitable for application to the skin which comprises a polymeric composition consisting es-sentially of (i) at least one chemically cross-linked hydrophilic polymer selected from the group consisting of homopolymers of hydrophilic monomers selected from the group consisting of vinyl lactams, hydroxy-alkyl acrylates, hydroxy-alkyl metha-crylates, acrylamide, methacrylamide, N-substituted derivatives of acrylamide, N-substituted derivatives of methacrylamide, co-polymers_ of at least two of the said hydrophilic monomers and copolymers of at least one of the said hydrophilic monomers with at least one hydrophobic monomer;
(ii) a support matrix for the said hydrophilic polymer comprising at least one high molecular weight hydrophobic polymer; and (iii) a tackifier comprising a low molecular weight fraction of the high molecular weight hydrophobic polymer.
8. A protective dressing suitable for application to the skin which comprises a polymeric composition consisting essential-ly of (i) at least one chemically cross-linked hydrophilic polymer selected from the group consisting of homopolymers of hydrophilic monomers selected from the group consisting of vinyl lactams, hydroxy-alkyl acrylates, hydroxy-alkyl methacrylates,
(ii) a support matrix for the said hydrophilic polymer comprising at least one high molecular weight hydrophobic polymer; and (iii) a tackifier comprising a low molecular weight fraction of the high molecular weight hydrophobic polymer.
8. A protective dressing suitable for application to the skin which comprises a polymeric composition consisting essential-ly of (i) at least one chemically cross-linked hydrophilic polymer selected from the group consisting of homopolymers of hydrophilic monomers selected from the group consisting of vinyl lactams, hydroxy-alkyl acrylates, hydroxy-alkyl methacrylates,
Claim 8 continued acrylamide, methacrylamide, N-substituted derivatives of acrylamide, N-substituted derivatives of methacryl-amide, copolymers of at least two of the said hydrophilic monomers and copolymers of at least one of the said hydrophilic monomers with at least one hydrophobic monomer;
(ii) a support matrix for the said hydrophilic polymer comprising at least one high molecular weight hydrophobic poly-mer; and (iii) a tackifier comprising a distinct component or mixture of components including a low molecular weight polymer.
(ii) a support matrix for the said hydrophilic polymer comprising at least one high molecular weight hydrophobic poly-mer; and (iii) a tackifier comprising a distinct component or mixture of components including a low molecular weight polymer.
9. A protective dressing as claimed in claim 7 wherein the support matrix (ii) comprises poly-isobutylene having a viscosity average molecular weight of between 120,000 and 130,000 and wherein the tackifier, (iii) comprises polyisobutylene having a viscosity average molecular weight within the range of 6,000 to 20,000 and a viscosity within the range of 180,000 to 220,000 SSU at 98.9°C.
10. A sealing ring for use with a post-surgical drainage appliance comprising a bag or pouch adapted to receive drainage from the body of a patient via a stoma, fistula, lesion or the like, the ring having an opening to permit the ring to surround the stoma, fistula, lesion or the like thereby forming a seal between the skin of a patient and the drainage appliance and which ring is formed from a protective dressing suitable for application to the skin which comprises a polymeric composition consisting essentially of (i) at least one chemically cross-linked hydrophilic polymer selected from the group consisting of homopolymers
10. A sealing ring for use with a post-surgical drainage appliance comprising a bag or pouch adapted to receive drainage from the body of a patient via a stoma, fistula, lesion or the like, the ring having an opening to permit the ring to surround the stoma, fistula, lesion or the like thereby forming a seal between the skin of a patient and the drainage appliance and which ring is formed from a protective dressing suitable for application to the skin which comprises a polymeric composition consisting essentially of (i) at least one chemically cross-linked hydrophilic polymer selected from the group consisting of homopolymers
Claim 10 continued of hydrophilic monomers selected from the group consisting of vinyl lactams, hydroxy-alkyl acrylates, hydroxy-alkyl metha-crylates, acrylamide, methacrylamide, N-substituted derivatives of acrylamide, N-substituted derivatives of methacrylamide copolymers of at least two of the said hydrophilic monomers and copolymers of at least one of the said hydrophilic monomers with at least one hydrophobic monomer; and (ii) a support matrix for the said hydrophilic polymer.
11. A sealing ring as claimed in claim 10, wherein the hydrophilic polymer is incorporated in the composition in a form such as to provide a "suitable transmission system for liquid".
12. A sealing ring as claimed in claim 10, wherein the hydrophilic polymer is incorporated in the composition in the form of filaments or hollow fibres or in the form of granules having a high average volume concentration or having a con-trolled density such that particle-particle contact of the hydrophilic polymer allows transmission of liquid through at least a part of the composition.
13. A sealing ring as claimed in claim 10, which comprises a polymeric composition consisting essentially of 30 to 70%
by weight of the said chemically cross-linked hydrophilic polymer.
by weight of the said chemically cross-linked hydrophilic polymer.
14. A sealing ring as claimed in claim 13, wherein a portion of the said chemically-cross-linked hydrophilic polymer is replaced by a hydrocolloid.
15. A sealing ring as claimed in claim 13, wherein the said chemically cross-linked hydrophilic polymer is a copolymer of methyl methacrylate and N-vinyl pyrrolidone.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB7904485 | 1979-02-08 | ||
| GB7904485 | 1979-02-08 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1128681A true CA1128681A (en) | 1982-07-27 |
Family
ID=10503057
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA345,330A Expired CA1128681A (en) | 1979-02-08 | 1980-02-08 | Polymeric composition |
Country Status (9)
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|---|---|
| US (1) | US4768503A (en) |
| JP (1) | JPS55108446A (en) |
| AU (1) | AU538658B2 (en) |
| CA (1) | CA1128681A (en) |
| DE (1) | DE3004742A1 (en) |
| DK (1) | DK53480A (en) |
| FR (1) | FR2448555B1 (en) |
| GB (1) | GB2046764B (en) |
| IT (1) | IT1145258B (en) |
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| US3980084A (en) * | 1974-01-09 | 1976-09-14 | Hydro Optics, Inc. | Ostomy gasket |
| US3877431A (en) * | 1974-01-09 | 1975-04-15 | Hydro Optics Inc | Ostomy gasket |
| JPS5170190A (en) * | 1974-12-17 | 1976-06-17 | Mitsubishi Petrochemical Co | KOTOKASEIMAKU |
| JPS5818381B2 (en) * | 1974-12-26 | 1983-04-12 | 旭化成株式会社 | Inquiry |
| US4082705A (en) * | 1976-02-05 | 1978-04-04 | Johnson & Johnson | Pressure sensitive adhesive compositions |
| US4078568A (en) * | 1976-10-12 | 1978-03-14 | Northern Illinois Research, Inc. | Plastic composition and method |
| JPS53134876A (en) * | 1977-04-30 | 1978-11-24 | Sumitomo Electric Ind Ltd | Production of hydrophilic composite construction |
| GB1576522A (en) * | 1977-05-24 | 1980-10-08 | Colorplast International A S | Sealing material for ostomy devices |
| US4204540A (en) * | 1977-06-08 | 1980-05-27 | E. R. Squibb & Sons, Inc. | Ostomy composition |
| US4192785A (en) * | 1977-06-08 | 1980-03-11 | E. R. Squibb & Sons, Inc. | Ostomy adhesive |
| US4166051A (en) * | 1977-06-08 | 1979-08-28 | E. R. Squibb & Sons, Inc. | Ostomy composition |
| WO1980001384A1 (en) * | 1978-12-28 | 1980-07-10 | Diamond Shamrock Corp | Crosslinked acrylamide polymer compositions and shaped articles therefrom |
| US4421822A (en) * | 1979-08-20 | 1983-12-20 | Minnesota Mining And Manufacturing Co. | Ultraviolet polymerization of acrylate monomers using oxidizable tin compounds |
-
1980
- 1980-01-30 GB GB8003190A patent/GB2046764B/en not_active Expired
- 1980-02-05 AU AU55227/80A patent/AU538658B2/en not_active Ceased
- 1980-02-06 FR FR8002573A patent/FR2448555B1/en not_active Expired
- 1980-02-06 IT IT47828/80A patent/IT1145258B/en active
- 1980-02-07 DK DK53480A patent/DK53480A/en not_active Application Discontinuation
- 1980-02-08 JP JP1465480A patent/JPS55108446A/en active Pending
- 1980-02-08 DE DE19803004742 patent/DE3004742A1/en not_active Withdrawn
- 1980-02-08 CA CA345,330A patent/CA1128681A/en not_active Expired
-
1985
- 1985-08-01 US US06/761,562 patent/US4768503A/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5633010A (en) * | 1992-10-05 | 1997-05-27 | Minnesota Mining And Manufacturing Company | Adhesive compositions, wound dressings and methods |
Also Published As
| Publication number | Publication date |
|---|---|
| GB2046764B (en) | 1983-04-20 |
| FR2448555A1 (en) | 1980-09-05 |
| AU5522780A (en) | 1980-08-14 |
| DK53480A (en) | 1980-08-09 |
| US4768503A (en) | 1988-09-06 |
| GB2046764A (en) | 1980-11-19 |
| FR2448555B1 (en) | 1986-09-26 |
| JPS55108446A (en) | 1980-08-20 |
| DE3004742A1 (en) | 1980-08-21 |
| AU538658B2 (en) | 1984-08-23 |
| IT1145258B (en) | 1986-11-05 |
| IT8047828A0 (en) | 1980-02-06 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |