CA1198334A

CA1198334A - Combined wound dressing and delivery means composite

Info

Publication number: CA1198334A
Application number: CA000426465A
Authority: CA
Inventors: Donald J. Therriault
Original assignee: Kendall Co
Current assignee: Kendall Co
Priority date: 1982-05-20
Filing date: 1983-04-21
Publication date: 1985-12-24
Also published as: GB2120104A; FR2527075A1; DE3317929A1; GB8313783D0; BE896805A

Abstract

ABSTRACT OF THE DISCLOSURE

A wound dressing and delivery means laminate composite is described comprising contiguously oriented and coplanary arranged discrete layers. A
centrally-disposed wound dressing layer is in separable and releasable contiguous adhesive contact through an adhesive surface with an adjacent surface of a release liner layer. A non-adhesive surface of the wound dressing layer is in separable and releasable contiguous adhesive contact with an adhesive surface of the delivery means layer. In using, the release liner layer is first peelably separated from the adhesive surface of the centrally disposed wound dressing layer within which it is in releasable contact. Next, the remaining adherent wound dressing layer and delivery means layer of the wound dressing composite are positioned over the wound application site and applied to the site by contact adhesion. Finally, the delivery means layer is peelably separated from the adjacently contiguous adhering surface of the wound dressing layer.

Description

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BACKGRO~ND OF THE INVENTION

The present invention relates to bandage constructions and to wound closure constructions in general.
This invention also relates to laminated wound closure systems and, more particularly, relates to polymeric intravenous wound closure membranes.
jl The present invention further relates to a pre or post-surgical wound closure polymeric membrane that is also transparent, durable and conformable.
The present invention most particul~rly relates to ; an împroved positioning or delivery sys~em for ~
polymeric wound closure membrane to a wound site.
~ Surgeons have been concerned from the beginnings of surgery to the present time with wound closure techniques. Traditional skin sutures passing through the skin in-troduces bacteria into the deeper layers of the wound, resulting in troublesome wound infections.
Il Other complications of skin suturing are localised , tension and ischemia that results in cross-hatching of the wound scar, with resultant discomfort and cosmetic disfigurations.
Sutureless wound closures utilizing soft-tissue forces, improves the early healing of wounds, reduces wound infections produced by sutures, and other nocosomial infections, decreases the cosmetic disfigurations and eliminates suture removal complications and attendant anxiety.

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The instant invention provides for sterility oE the wound dressing layer during application, and wound site contamination will not occur during application of the wound dressing composite. Further, the tape tab removal via perforations insures aseptic conditions adjacent to the wouncl application site.
It is therefore an object of the present invention to provide a wound dressing and delivery means composite which is at once economical to produce, simple to use, and will maintain its initial sterile condi-tions during and subse~uent to its application to the wound site.
SUMMARY OF THE INVENTION
According to the invention there is provided a wound dressing and delivery system composite comprising: a polymeric, moist~re-vapor permeable wound dressing layer; said wound dressing layer having an adhesive-coated surface and a non-adhesive coated surface on the opposite side thereof; said wound dressing layer having opposed outer peripheral regions which incorporate perforations so as to define removable tabs disposed therefrom; said tabs having an adhesive-coated surface on one surface thereof; a release liner layer being oriented coplanarly ad-jacent to and releasably secured to said wound dressing layer adhesive-~O coated surface; a dclivery means for delivering said wound dressing to a ~ound application site disposed over said wound dressing layer and com-prlsing a continuous sheet-like layer structure; said delivery means further having an adhesive-coated surface and a non-adhesive-coated surface on the opposite sida thereof; said wound dressing layer being centrally disposed between said release liner layer and said delivery means; and said wound dressing layer being oriented coplanarly adjacent to and releasably secured to said adhesive surface of said delivery means.

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After removal of the entire pre-packaged wound closure laminate from its enclosure, the release liner layer, if present, is peeled away from the pressure-sensitive adhesive of the centrally disposed wound dressing layer. The remaining two adherent layers of the laminate are now pre-positioned over the wound application site, that has been previously prepared and selected for the application of the wound closure. The il semi-rigid combined delivery means layer and its associated wound dressing layer being generally transparent, will permit careful prepositioning of the ', wound closure layer along with i~s still a &erent i, delivery means layer. The generally transparent and subs-tantially non-~lexible, semirigid continuous layer structure of the delivery means layer, also aids in both the wound site visibility characteristics and the maintenance of the modulus of rigidity of the wound dressing composite. A good application and conformability of the wound dressing layer to the 20 ; selected wound application site results through the modulus of rigidity of the delivery means layer, and the inherent stretchability of the polymeric wound dressing layer. When the wound dressing layer is finally placed I in contact with the skin surface, a gentle rubbing across the top surface of the delivery system layer will create a completely smooth wrinkle-free contact between the skin and the polymeric wound closure adhesive 33~

surfaces. The final step in the wound dressing application process, is a peeling away of the delivery means layer from its releasably adherent wound dressing layer, starting at a corner of the delivery means layer 9 uncovering the now firmly attached polymeric wound closure layer. The adhered thin, transparent, extremely elastic, polymeric wound closure film is wo~md sealing, occclusive and waterproof. Although non-porous~
, moisture vapor and gases are freely permeable across the wound dressing membrane, allowing the interchange of these gases to aid healing, while protecting the site from bacterial contamina~ion.
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BRIEF DESCRIPTION OF THE DRAWINGS

In order that the invention be more readily understood, and so that further features thereof may be appreciated, the inven~ion will now be described by way of example with reference to the accompanying drawings, in which:
Figure 1 is a perspective, partially open view, of the wound dressing composite in accordance with the ; prevent invention.
Figure 2 is an exploded view of the wound dressing composite in accordance with the present invention.

Figures 3A-3I are top plan views of the wound dressing composite alternate embodiments of the present invention.
Figure 4 is a cross-sec~ional view of the wound S dressing composite in accordance with the present invention taken along lines A-A of Figure 1.
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Figures 5A-5D are schematic views of several operational stages in the application of the present `, invention to a wound application site.

,' DETAILED DESCRIPTION OF TXE PREFERRED EMBODIMENT
., Referring now to Figures 1, 2, and 4 of the accompanying drawings, a composite wound dressing and delivery means construction in accordance with the present invention is depicted as 10. The wound dressing lS composite 10 is depicted having a generally rectangular shape, although it is to be noted that essentially any desired configuration can be achieved during the construction of the present invention. A release liner ; layer 12 is shown, and may be referred to here as the wound dressing composite lower outer layer merely for distinguishing purposes. The release liner layer 12 has two major coplanar surfaces. The release liner inner surface 14 is shown as being adjacent to the centrally 3~

disposed wound dressing layer adhesive surface Z0. The release liner outer surface 16 is seen to be the outermost surface of the wound dressing and delivery means composite 10.
The centrally disposed wound dressing layer 18, which preferably ~ay be a flexible, conformable polymeric membrane, has two major surfaces. An adhesive lower surface that i5 in releasable adhesive contact with the release liner inner surface 14, is the wound dressing layer adhesive surface 20. This wound dressing layer adhesive surface 20 is coated wi~h an adhesive material 21, such as a pressure sensitive adhesive, that allows for the easy separability by peeling, of the ~ release liner layer 12 from the adherent adjacent, centrally-disposed and coplanarly arranged wound dressing layer 18. The wound dressing layer upper surface is depicted as 22. This wound dressing layer non-adhesive upper surface 22 is located adjacent and contiguous to the lower adhesive surface 24 of the ; top-mounted and upper situated delîvery me~ns layer 26.
A pressure sensitive adhesive material, or the like, 23 is coated onto the delivery means layer adhesive surface 24. The delivery means layer 26 is easily releasable . and peelably separable from the contiguous and adherent wound dressing layer upper surface 22 by means of a gentle peeling movement.

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The overall structural coniguration of the delivery means layer 26 is seen to be that of a continuous substantially transparent sheet-like structure, as depicted in Figure 1 and in the exploded view of Figure

2.
The modulus of rigidity of the delivery means layer 26 is to be variable within the limits of the modulus of rigidity or coeffecient of elasticity required for the , delivery means layer 26 to maintain the wound dressing ~;
layer 18 in a relatively rigid and substantially ; non-flexible planar configuration following the removal " or absence cf the release liner layer 12 from the wound dressing composite 10.
; Several alternate exemplary embodiments of the wound dressing composite 10 of the present invention are seen in top plan view in Figures 3A-3I.
The presence of perforatiGns, depicted here as 28, incorporated in either or both the release liner layer 12, and the contiguosly-oriented wound dressing layer 18, is shown in several of the alternate exemplary embodiments depicted therein. More detailed specifics concerning the function of the perforations 28 will : follow later in the disclosure.

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The perforations 28 in selected depicted embodiments of the present invention are arranged in essentially a linear pattern and are shown as bein$
located in the peripheral regions of the wound dressing layer 18, and/or the release liner layer 12, and being oriented substantially parallel to the outer edges 30 of the wound dressing composite 10 of the present invention. It is to be noted that the use of only one row of perforations 28, as seen in Figure 3 in embodiments B,D, and H, or two rows of the perforations , 28, as in embodiments A,C and G, can be employed in ! various exemplary embodiments.
It is also to be noted that perforations 28 may in selected embodiments be present only in the wound lS dressing layer 18, and not in the release liner layer 12 ; of the wound dressing composite 10 of ~he presen~
invention. In relation to the above, further various selected embodiments of the present invention depicted as E, F and I, are shown where no rows of perforations 20 , 28 are incorporated in either the release liner layer 12 or the wound dressing layer 18 of the wound dressing composite 10.
The presence of tape tabs 32, mounted on either or both the wound dressing layer 26 or delivery means layer 18, is also depicted in Figure 3 in selected exemplary embodiments, i.e. A,B,C,D,E, and F. Other exexmplary embodiments of the present invention, i.e. G,H, and I, _9_ ~83391t are shown without wound dressing layer 26, or delivery means layer 18, tape tabs 32, being incorporated thereon. These edge-oriented tape tabs 32, are essentially elongated, substantially rectangular, parallell-aligned tape tabs, that are situated in the peripheral regions of the wound dressing layer 18, and/or the release liner layer 12, and are adjacent to the outer edges 30 of the wound dressing composite 10.
, When present, the tape tabs 32 serve to facilitate handling and separability of ~he layers of wound dressing composite 10.
As further seen in Figure 4, a cross-sectional view , through the wound dressing composite 10 of the present : invention taken through lines A-A of Figure 1, the wound 15 : dressing tape tabs 32, when present in an exemplary embodiment of the present invention, are located along either one or both of the peripheral regions situated parallel and adjacent ~o the outer edges 30 of the wound dressing layer 18 and/or the delivery means layer 26.
The tape tabs 32 are essentially elongated and substantially rectangularly-shaped defined discrete strips of tape that are applied to either of the outer surfaces of the wound dressing layer 18 or the delivery means layer 26. The area of the wound dressing layer 18 situated beneath a top-mounted tape tab 32 is generally characterized by the absence of the adhesive coating 21 on the wound dressing layer adhesive surface 20, in the 33~

defined tape tab region. The entire wound dressing layer 18 is preferrably transparent for positioning purposes. However, if an opaque wound dressing layer 18 is preferred to be employed, this may be an alternate exemplary embodiment. In order to clearly distinguish the tape tab 32 when present, from the adjacent regions of ~he wound dressing layer 18, or delivery means layer 26, it is preferable to color the tape tab 32 with a il dis~inctive color.
It is also to be noted that various exemplary embodiments of the present invention are contemplated in which no wound dressing layer or delivery means layer tape tabs 32 are to be incorporated in the wound dressing composite 10.
Referring now to figure 5 which is a schematic view of the wound dressing composite 10 wound site application procedure, the wound dressing application steps are described below. During use of an exemplary embodimen-t of the present invention, the wound dressing composite 10 t iS first removed from an optionally provided conventional protective carrier. View A of figure S shows the release liner layer 12, if present in the particular embodiment, being peelably separated from the releasably adherent contiguously adjacent wound 2~ dressing layer adhesive surface 20. View ~ shows the now remaining layers of the wound dressing composite, i.e. the wound dressing layer 18 and the ~9833~

contiguously-adjacent, separably adherent delivery means layer 26, being carefully positioned over the wound application site 40, utilizing, i present, the tape tabs 32, and further aided in the locationing by ~he transparent nature of the s~ill adheren~ly associated wound dressing layer 18 and delivery means layer 26 composite.
As indicated previously in the disclosure, ~he modulus of rigidity 9 or the non-elasticity of the delivery means layer 26, aids in maintaining the relatively rigid and planar configuration of the `, combined wound dressing layer 18 and delivery means layer 26, until the final positioning and adhesion to the wound application site 40. A minimal digitally 15 : applied pressure across the top of the non-adhesive surface 17 of the just applied wound dressing delivery means layer 26, at this point, insures adequate skin contact and adhesion of the wound dressing layer 18 without unwanted trapped air pockets or contact flaws at the wound application site 40. At this point, the delivery means layer 26 is readily separated from the adjacent and contiguous non-adhesive surface 22 of the wound dressing layer 18, by lifting a corner of the delivery means layer 26, and peeling it away from the underlying adherent wound dressing layer 18 (see view C
of figure 5). In the exemplary embodiments discussed above that incorporate rows of perforations 28 within the wound dressing layer 18, the final step in the process of wound dressing application is the removal of the peripheral regions of the perforated wound dressing layer 18, by peeling the tape tab regions away from the remaining adhered wound dressing layer 18 (see view D of Fig. 5). The entire wound dressing application process is now complete and a sterile physically intact protective wound dressing is conformably affixed to the - wound application ~ite 40.
The foregoing detailed description o the preferred ` embodiments of the present invention is given for purposes of clarity of understanding only, and no unnecessary limitations should be understood or implied therefrom, as modifications may be obvious to those skilled in the art.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A wound dressing and delivery system composite com-prising:
a polymeric, moisture-vapor permeable wound dressing layer;
said wound dressing layer having an adhesive-coated surface and a non-adhesive coated surface on the opposite side thereof;
said wound dressing layer having opposed outer peripheral regions which incorporate perforations so as to define removable tabs disposed therefrom;
said tabs having an adhesive-coated surface on one surface thereof;
a release liner layer being oriented coplanarly adjacent to and releasably secured to said wound dressing layer adhesive-coated surface;
a delivery means for delivering said wound dressing to a wound application site disposed over said wound dressing layer and comprising a continuous sheet-like layer structure;
said delivery means further having an adhesive-coated surface and a non-adhesive-coated surface on the opposite side thereof;
said wound dressing layer being centrally disposed between said release liner layer and said delivery means; and said wound dressing layer being oriented coplanarly adjacent to and releasably secured to said adhesive surface of said delivery means.