CA1186579A - Surgical adhesive dressing - Google Patents

Surgical adhesive dressing

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Publication number
CA1186579A
CA1186579A CA000426901A CA426901A CA1186579A CA 1186579 A CA1186579 A CA 1186579A CA 000426901 A CA000426901 A CA 000426901A CA 426901 A CA426901 A CA 426901A CA 1186579 A CA1186579 A CA 1186579A
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CA
Canada
Prior art keywords
dressing
water
adhesive
film
contact
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
Application number
CA000426901A
Other languages
French (fr)
Inventor
David A. Rawlings
William D. Potter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew PLC
Original Assignee
Smith and Nephew Associated Companies PLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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Application filed by Smith and Nephew Associated Companies PLC filed Critical Smith and Nephew Associated Companies PLC
Priority to CA000426901A priority Critical patent/CA1186579A/en
Application granted granted Critical
Publication of CA1186579A publication Critical patent/CA1186579A/en
Expired legal-status Critical Current

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Abstract

A B S T R A C T

A surgical dressing is described which consists essentially of a film which carries an adhesive layer for securing the dressing to the body characterised in that (a) the film is continuous and comprises a polymer which in contact with water has a higher MVP than when in contact with moisture vapour but not water (b) the adhesive layer is adapted to allow access of water to the film when water is in contact with the adhesive layer so that (c) said surgical dressing has a MVP of not less than 2500g/m2 when the adhesive layer is in contact with water and has a MVP of not more than 2000g/m2 when the adhesive is in contact with moisture vapour but not water;
whereby the dressing is suitable for use on exuding wounds and on non-exuding wounds.

Description

SURC-ICAL ADHESIVE DRESSING

The present invention relates to adhesive dressings for use on the human body. More particularly this invention relates to adhesive surgical dressin~s suitable for use on bo-th exuding wounds and non-exuding wounds.

Moisture vapour permeable thin :Eilms coated with adhesive were disclosed in British Pa-tent No. 1,280,631 and ~.S. Patent No. 3,645,835 as being suitable for use as surgical dressings. In recent years one such film has come to prominence under the trade mark "Qp-Site" and has found use as a surgical dressin~, for example for covering burns, donor sites, surgical incisions, intra-venous catheter sites and the like. The known dressings have proved usetul because tney keep out bacteria owing to the microscopically continuous nature of -the film and adhesive layer but do not cause maceration of -the skin to which it is applied because both the film and the adhesive layer have high moisture vapour permeability (~5VP). One problem with presently available high ~VP dressings is that ~ 7~7~

the ~I~7P is not high enough ior some uses such as covering exuding wounds when an unsightly blister can occur.
However it has not been thought prac-ticable simply to increase the MVP of the product overall since this wou]d lead to drying out of some wounds with a consequent reduction in the rate Or healing. It has now been discovered that it is possible to alleviate the known disadvantages of conventional surgical dressings by providing dressings which transmit substantially more moisture vapour when in contact with a wetter wound than they do when in contact with a dryer wound.

Accordingly the present invention provicles a surgical dressing which consists essentially of a film which carries an adhesive layer for securing the dressing to the body characterised in that (a) the film is continuous and comprises a polymer which in contact with water has a higher MVP than when in contact with moisture vapour but not water (b) the adhesive layer is adapted to allow access of water to the film when water is in contact with the adhesivelayer so that (c) said surgical dressing has a MVP of not less than 2500g/m2 when the adhesive layer is in contact with water and has an ~P of no-t more than 2000g/m2 when the adhesive is in contact with moisture vapour but not water; whereby the dressing is suitable for use on exuding wounds and on non-exuding wounds.

3~

~ hen used herein with reference to "contact" the term "water" means liquid water (as opposed to moisture vapour) unless otherwise specified When used herein MVP units are g/m2/24hrs/37C/]00-10~, rela-tive humidity and are generally abbreviated -to g/m .

Suitable test methods for determining -the MVP of a dressing or its components are set forth in the Description hereinafter. U~hen MVP values quoted therein-after are referred to as "wet-~P" they refer to values obtained with the adhesive face in contac-t wi-th water and when referred to as "dry-~VP" they refer to values ob-tained with -the adhesive -face not in con-tac-t wl-th wa-ter.

More suitably the dressing of this invention will have a wet-MVP of not less than 3000g/m2, most suitably will have a wet-~'P of not less than 3200g/m2 and preferably will have a wet-MVP of not less than 5000g/m2.
More suitably the dressing of this invention will have a dry-MVP of not more than ~500g/m2, most suitably will have a dry-MVP o not more than l~OOg/m2 and preferably will have a dry-MVP of not more than 1200g~m2.

- The film used in this invention may comprise any synthetic or modified natural polymer which has a sufficiently higher wet-~lVP than dry-MVP to produce the desired ~IVP parameters in the dressing. The method set out in the Descriptions may be employed to determine whether the film materlal exibits the desired ~.~P when in contact with water. Most aptly the film comprises a synthetic polymer although modified natural polymers such as regenerated cellulose or cellulose acetate may be employed if sufficiently plasticised to conform to the movements of the body when adhered thereto. Preferably the synthetic polymer employed is an elastomer so that it readily conforms to the movement of the skin when the dressing is in use.

~ lost suitably the film used in this invention will be hydrophilic, that is will absorb water when immersed therein. Aptly the film material when hydrated will contain 5~v to 50% water (w/w at 20C), more aptly from 10~3 to 40~c~ of water and favourably from 20~ to 30~3 of water.

Suitable hydrophilic film material will include polyurethanes, polyether polyamide block copolymers, polyether polyester block copolymers, cross-linked polyvinyl alcohols, acrylic copolymers, polyamides, regenerated cellulose, cellulose acetate and the like, provided said film material are highly conformable ( whether per se or by plasticisation) and that the material used most suitably has the preceeding water contents when hydrated.

7;'~7 ~

The -film employed will be a continuous fllm, -that is it will be free of holes (whether microporolls or macroporous) which allow the passage of bacteria.

The desirable properties of this invention may be best obtained by employing a film of hydrophilic polyurethane in combination with an adhesive layer adapted to allow access of water to the film when water is presented to the adhesive face of the dressing.

~'ost suitably the film will be from 15 to 80 I n microns -thic~i, will more usually be from 20 to 60 microns thick and will pre-Lerably be :from 25 to 50 microns thick, for example 30, 35 or 40 microns thick.

Aptly the film will be formed from a hydrophilic polyurethane which when hydrated contains from 5C~ to 50C1c of water, more aptly from lOC,~', to 40C7/ of water and favourably from 20C7~c~ to 30C,'~ water.

In order to enable visual observation of the wound it is desirable :For the film used in this invention to be transparent. This in turn requires tha-t the film should 20 be capable of being self supporting, that is sufficiently coherent when we-t or dry to be used without recourse to additional support such as a fabric, for example a gau~e, net or the like. It has been -found that polyether polyurethanes are particularly sui-table for use in the formation of such films. Favoured polyether polyurethanes are essentially free of reactive substituents such as hydroxyl or carboxyl groups. It has been found that certain apt polyurethanes for use in this invention are random polymers containing units derived from diolic compounds and di-isocyanates.

Suita~le polyurethanes may be ~rocluced by the methods described in British Patent Specification No.
20~3190~ at ~a~Je 6 line 35 to na~e 8, line 41.

The adhesive layer present on the body contacting surface of the film is favourably an interrupted layer so that areas of the film are free of adhesive, aptly 20 to 75% of the film is free of adhesive, more aptly 30 to 70ch of the film face is free of adhesive and preferably 40 to 60~ of the film face is free of adhesive. The use of an interrupted layer in such a manner has been found to be highly beneficial in allowing the desirable variabilit~v of ~P to be achieved.

The adhesive is generally emnloyed at a mass per unit area of lO to 80g/m2, m~re a~tly 20 to 45g/m2 and favourably from 25 to 35g/m2.

The adhesive may be applied around the periphery of -the dressings, in lines over the face oI -the dressing (parallel, at right angles, forming diamond pa-ttern or the like) or in combina-tions of such sys-tems.

The adhesive is preferably one which itself transmits water vapour, for example one which if present as a film 25 microns thick would have a ~qV~ of at least 300g/m2, more suitably at least 500g/m2 and preferably a-t least 700g/m2. Such permeabilities may be achieved by using a non-porous or porous (including microporous)pattern spread adhesive but generally it is preferred to employ a non-rorous pattern spread adhesive, Suitable adhesives include nol yvinyl ethyl ether adhesive and acrylate surgical adhesives. Preferred adhesives include those described in European Patent Application No. 31300~47 (Publication No. 0035399)-The dressings of the invention may be made by any convenient process, for example a film of, for example hydrophilic polyurethane may be roller printed or hand printed with a pattern of adhesive. Alternatively any o-ther convenient method o~ providing a non-continuous adhesive may be employed. The coated films may then be cut, packaged and sterilised in conventional manner, for example by irradiation, heat or ethylene oxide.

~ L&~5~

In a favoured aspect this inventi.on provides a dressing as hereinbefore described in sterile form.
~.lost aptly the sterile dressing is pac~aged i.n a bacteria-proof package such as a paper or aluminium foil pouch.

Suitable polyurethane may be produced by the methods described in British ~atent .Specification No. 20~3190 at ~age 6, line 35 to page 6, line ~1 thereof.

Normally the dressings are provided for use with a silicone release paper to protect the adhesive which protector is removed prior to use of the dressing.

The following Examples illustrate the invention:

_g_ Description "Dry" MVP Determination Discs of the material under test are clamped over Payne Permeability Cups (flanged metal cups) using sealing rings and screw clamps. The exposed surface area of the test sample is lOcm2, Each cup contains approximately lOml, of distilled water.

After weighing the cups are placed in a fan assisted electric oven which is maintained at 37 - 1C.
The relative humidity within the oven is maintained at approximately 10~ by placing l~g. O:e anhydrous 3-~ mesh calcium chloride on the :Eloor O:e :the oven.

The cups are removed after 24 hours, allowed to cool for 20 minutes and re-weighed. The MVP of the test material is calculated -erom the weight loss and expressed in units of grams of weight per square metre per 24 hours.

"Wet" MVP determination The method described above is employed except that the Payne Cups are inverted in the oven so that the water within the cups is in contact with the test material.

E_ample 1 Preparation of Eilm A solution of a hydrophilic polyurethane (of Example
2 of ~K No. 2093190A) :in industrial methylated spiri-ts (18~? solids) was cast using a doctor blade on-to a silicone treated release paper to produce a coa-ting weight after drying of 30 - 3g/m2. The cast film was dried at 80C
to remove solvent.

Pattern Spreading of Film with Adhesive A solution O-r acrylic adhesive in acetone (solids con-tent 35,J) was coated directly onto the :ri lm ol`
hydrophilic polyurethane using an en~raved roller so as to produce ~ reticulated ~cross hatched) coatlng O r adhesive.
After coating the adhesive was all.owed to dy in air before a silicone treated paper protector was applied. The average weight of the adhesive coating was 30 - 3g/m2.
The area of film covered by the adhesive was approximately 50% of the total available area. (The adhesive was tha-t of Example 1 of European Patent Application No. 813008~7.1).

The dry-MVP of the product of this Example was 1250g/m2 and the wet-MVP was 3600g/m'' (compare corresponding values o-f about llOOg/m2 and about 1250g/m2 for an analogous material which employed Estate 571~ - a non-hydrophilic polyurethane in place of the hydrophilic polyurethane).

Example 2 The product of Example 1 was cut into 10 x 10cm squares and sealed into pouches. The product was sterilised using ethylene oxide. The resulting sterile dressing may be emp]oyed to cover wounds.

Example 3 The procedures of Examples 1 and 2 may be carried out replacing the hydrophilic polyurethane by those of British Patent Specification No. 2093190A at page 6 line 35 to page 7 line 25. The resulting dressings are suitable for covering wounds.

:EYamP1e ~
The procedures of Examples 1 and 2 may be repeated using a vinyl ethyl ether adhesive in place of the acrylic adhesive. The resulting dressings may be employed to cover wounds.

Example 5 A 25 micron film of polyether polyamide blocls copolymer (Pebax ~011 supplied by ATO Chemical Products, NewL~ury, UK) had applied thereto by roller a cross hatched pattern of polyvinyl ethyl ether adhesive. The adhesive covered about 75,~. of area of the film surface and the diamond shaped interstices accounted for about 25% of the area of -the film. The average weight of the adhesive layer was approximately 60gsm. The resulting material was cut into 15cm x 15cm squares, placed on silicone release paper (adhesive side to release layer), placed in pouches and sterilised using ethylene oxide.

The dressing had a dry-~P of about 1800g/m2 and a wet-MVP of greater than 5000g/m2.

Claims (10)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY
OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A surgical dressing which consists essentially of a film which carries an adhesive layer for securing the dressing to the body characterised in that (a) the film is continuous and comprises a polymer which in contact with water has a higher MVP than when in contact with moisture vapour but not water (b) the adhesive layer is adapted to allow access of water to the film when water is in contact with the adhesive layer so that (c) said surgical dressing has a MVP of not less than 2500g/m2 when the adhesive layer is in contact with water and has a MVP of not more than 2500g/m2 when the adhesive is in contact with moisture vapour but not water; whereby the dressing is suitable for use on exuding wounds and on non-exuding wounds,
2. A dressing as claimed in claim 1 wherein the MVP
is not more than 1500g/m2 when the adheisve layer is in contact with moisture vapour but not water.
3. A dressing as claimed in claim 2 wherein the MVP is not less than 3200g/m2 when the adhesive layer is in contact with water.
4 A dressing as claimed in claim 1 wherein the film comprises a hydrophilic polyurethane which when hydrated contains 5% to 50% of water and is from 15 to 80 microns thick.
5. A dressing as claimed in claim 4 wherein the film comprises a hydrophilic polyurethane which when hydrated contains 10% to 40% of water and is from 20 to 60 microns thick.
6. A dressing as claimed in claim l wherein the film is a hydrophilic polyurethane which is a hydrophilic polyether polyurethane.
7. A dressing as claimed in claim 1 wherein the adhesive is an interrupted layer which leaves 30% to 70% of the film free of adhesive.
8. A dressing as claimed in claim l wherein the adhesive comprises a polyvinyl ethyl ether or an acrylate surgical adhesive.
9. A dressing as claimed in claim 1 in which the average weight per unit area of adhesive is 20g/m2 to 45g/m2.
10. A dressing as claimed in claim l in sterile form packaged in a bacteria proof package.
CA000426901A 1983-04-28 1983-04-28 Surgical adhesive dressing Expired CA1186579A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA000426901A CA1186579A (en) 1983-04-28 1983-04-28 Surgical adhesive dressing

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA000426901A CA1186579A (en) 1983-04-28 1983-04-28 Surgical adhesive dressing

Publications (1)

Publication Number Publication Date
CA1186579A true CA1186579A (en) 1985-05-07

Family

ID=4125117

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000426901A Expired CA1186579A (en) 1983-04-28 1983-04-28 Surgical adhesive dressing

Country Status (1)

Country Link
CA (1) CA1186579A (en)

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