FI59921B - SURGICAL FOERBAND AVSETT ATT PLACERAS PAO KROPPEN AV EN PATIENT - Google Patents

Description

R3r * 1 ΓβΊ nlv NOTICE OF PUBLICATION COO 0 1 IBJ (11) UTLAGG NINGSSKRI FT 59921.

(S1) K, ik.Vci.3 A 61 B 19/08 // A 61 F 13/00 ENGLISH —FINLAND (21) PtwnttllwiMmu · - Patanttraeknlnt 733010 (22) H »tc * mlsptlv! —Aiweknlnpd * | 20.10.73 ^ '(13) AtkuptWi — Gllti | hM * da | 2Ö.10.75 (41) Interpreters fulkitekil - Bllvlt offantllg 12.05.76

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Patent- ocn registerstyrelsen AiwSkan utkfd och utl. «KrifMn pubiicarad 31-07.81

(32) (33) (31) Pyy4 «tty« * ueik * us — B ^ «rd priorities 11.11.7U

USA (US) 522560 (71) Johnson & Johnson, 501 George Street, New Brunswick, New Jersey, USA (US) (72) Robert E. Kelly, Seabright, New Jersey, USA (US) (7U) Oy Kolster Ab ( This invention relates to a surgical dressing suitable for α-placement on a patient's body and comprising a main membrane having an upper surface and a lower surface having a sticky, pressure-sensitive adhesion. to attach the main membrane to the patient's body.

It is well known that the surgical area, i.e. the general area of the body within or on which the surgical procedure is performed, must be kept as sterile as possible. It is also known that blood or other body fluids that may leak out as a result of surgery should preferably be prevented from touching not only other parts of the patient's body but also the clothing and bodies of the various caregivers in the operating room. It is also important to prevent the possibility that bacteria from a source outside the patient could reach the patient, isolating the patient's skin from contact with various caregivers and / or the clothing they wear during surgery.

2,59921 To accomplish these purposes, surgical dressings, commonly referred to as "incise drapes", have been used in the art in the past and can be affixed to a patient as they are "prepared" for a surgical procedure. These opening bandages comprise a main part, preferably consisting of a thin, transparent plastic film which easily adapts to the contours of the patient's body and through which the surgeon can easily see the surgical area.

According to one method of attaching the opening dressing, a sterile, adhesive is injected onto the patient's skin after the skin has been treated with an antiseptic in the usual manner, and then the opening dressing is attached to the patient's skin to obtain a sterile surgical site. According to another method, the bandage itself carries an adhesive with a release film on it. After the antiseptic is applied to the patient's skin, the release liner is removed from the adhesive and the dressing is attached to the patient to obtain a sterile, surgical site.

The surgical dressing forms a barrier that substantially prevents bacteria and various fluids, such as water, blood, and other body fluids, from passing through the dressing. It is known that opening bandages are made of materials that are easily sterilizable. Sterilization of the dressing may be performed in a hospital or, alternatively, may be performed by the manufacturer when the dressing is properly packaged.

Once the opening bandage is attached to the patient to isolate the surgical site, it is often covered with a larger, apertured, surgical bandage that covers the patient and hangs down from the sides of the operating table. This latter bandage is arranged so that its opening is on the cutting site. The surgeon then cuts through the opening, making the required openings directly through the adhesive bandage attached below. In some cases, the surgeon is not using a larger, slotted bandage. In this case, the opening is made directly through the opening bandage, after which the surgical site is limited, i.e. surrounded by wipes, which enclose and / or absorb other blood and body fluids that may leak out during the operation. The difficulty with these procedures is that the open bandage or towels can quite easily slide off the surface of the opening bandage.

% 59921 3

When an open bandage, towel, etc. slips, its parts are either contaminated or, according to current care practice, considered contaminated. In this case, it may be necessary to interrupt the surgical procedure until the patient is fitted with a new bandage.

Po. according to the invention, a new and improved surgical dressing or cover has been developed, characterized in that the adhesive on the lower surface of the main membrane is placed in an area extending over most of the lower surface of the main membrane and that the sticky, pressure-sensitive adhesive is placed on a limited area of the upper membrane , which limited area of the adhesive forms an attachment base for attaching additional absorbent bandages or laundry to the top surface of the main film.

In addition, the edges of the main film are bordered by an adhesive area on the top surface of the main film, which may also include two parallel, spaced apart adhesive strips, each having release strips at least as wide as the adhesive strips and releasably attached thereto. These adhesive strips thus extend from end to end. The releasably attached release strips extend at least past the edge of the corresponding adhesive strip it covers to form an adhesive portion to facilitate removal of the release strip.

This surgical dressing according to the invention solves a difficult problem previously encountered in the α-field by firmly locking the surgical dressings, towels, etc. in their desired positions on the dressing, thus preventing these e-articles from accidentally slipping and / or slipping off their from desired locations.

The main membrane of the bandage is a substance to be draped, preferably a transparent plastic material that can adapt to the contours of the body. It may also be a woven fabric such as linen or cotton, or a nonwoven fabric such as nonwoven and paper. When such woven or non-woven materials are used, they should be treated in a manner well known in the art to prevent the passage of liquids such as water, blood, etc. The size, number and position of the adhesive strips placed above the bandage depend on e.g. the quality of the cut to be performed and the number, size and weight of the objects to be attached to the top surface of the bandage. ,.

4,59921

According to the invention, it is also preferred that no adhesive is present on the opposite edge portions of the lower surface of the main film. Likewise, according to the invention, separate guide strips can be attached next to the side edges of the main film.

The bandages are generally square or rectangular in shape, but regardless of shape or size, the bandage always has a portion, hereinafter referred to as the "cutting area" (OR), where and through which the cutting is actually performed. Since such a bandage is usually and most easily placed symmetrically on the patient relative to the opening site, the incision area is preferably located in the center of the bandage. In any case, it is clear that for maximum comfort and utility, the topsheet adhesive should be placed close to the incision area of the dressing where it does not interfere with surgery and where it is available to attach other dressings, surgical wipes, etc. to desired locations.

Other advantages of the invention will become apparent from the following detailed description taken in conjunction with the drawings, in which: Figure 1 is a top plan view of po. a preferred embodiment of a surgical dressing of the invention; Fig. 2 shows an enlarged cross-sectional view taken along line 2-2 of Fig. 1; Fig. 3 is an enlarged, fragmentary cross-sectional view taken along line 3-3 of Fig. 1; Fig. 4 is a much enlarged cross-sectional view of a corner portion of the surgical dressing shown in Figs. 1-3 showing the main membrane of the dressing and its protective layer separated from each other; Fig. 5 shows a top plan view po. another embodiment of a surgical dressing of the invention in which certain parts are cut off and others are folded back; Fig. 6 is an enlarged, fragmentary cross-sectional view taken along line 6-6 of Fig. 4; Fig. 7 is a much enlarged cross-sectional view of a corner portion of the surgical dressing of Figs. 5 and 6 showing the main membrane of the dressing and its protective layer separated from each other; Fig. 8 is a much enlarged cross-sectional view of a corner portion of a surgical dressing having guide strips on the upper surface of the main membrane of the dressing; Fig. 9 shows a top plan view po. a third embodiment of a surgical dressing according to the invention; Fig. 10 is an enlarged, fragmentary cross-sectional view taken along line 10-10 of Fig. 9; Fig. 11 is an enlarged cross-sectional view taken along line 11-11 of Fig. 10; Fig. 12 shows an exploded perspective view with the parts turned back, po. a fourth embodiment of a surgical dressing according to the invention; Fig. 13 is a top plan view of the bandage of Fig. 12; and Fig. 14 is a cross-sectional view taken along line 14-14 of Fig. 13.

Although the invention is described in terms of its preferred embodiments, it is to be understood that the invention is not intended to be limited thereto. On the contrary, the invention is intended to encompass all alternatives, modifications and equivalent forms which may fall within the spirit and scope of the invention as defined in the appended claims.

Figures 1-3 show po. an opening bandage in accordance with the teachings of the invention. The opening bandage 10 comprises a substantially rectangular main film 12 having an upper surface 14, a lower surface 16, substantially parallel side edges 18 and 18 ', and substantially parallel end edges 20, 20' that are approximately perpendicular to the side edges 18 and 18 '. From the lower surface of the main film, the main central portion is coated with a contact adhesive 22 extending from the end edge 20 to the end edge 20 '(Fig. 3) and terminating inside the side edges 18,18' (Fig. 2). The opposite edges of the adhesive are parallel to each other and relative to the proximal side edges of the main film, from which they are approximately equidistant. Thus, on the opposite sides of the main film, hollow edge portions 19,19 'are formed, which are free of adhesive.

The adhesive 22 removably carries an adhesive protective cover 26 having the same dimension as the main film 12 and terminating at the same point. Since there is no adhesive in the edge portions 19,19 ', there are adhesive portions on opposite sides of the dressing without adhesive that facilitate removal of the cover 26 from the contacting adhesive 22. After the cover is removed, the dressing is placed on the patient's body so that the bandage is cut ("0R"). in Figure 1) is above the opening location.

The upper surface 14 of the main film 12 carries a limited area of contacting adhesive 30 (compared to the area of film 12 or adhesive 22) which, in the embodiment shown, is a narrow, rectangular strip 6,59921 that is a multiple of its width. This strip of adhesive is parallel to the side edges of the bandage and is located just outside the cutting area OK. The adhesive region 30 is preferably centered between the end edges 20 and 20 'and extends from about 1/16 to about 1/2 of the length of the main film. When the dressing is attached to the patient by the adhesive 22 so that the cutting area OR is on the body to be cut, the adhesive area 30 is immediately adjacent to the opening where it is conveniently used to securely lock an object, e.g., a surgical towel, at the desired surface.

The adhesive region 30 is covered by a release liner 32 that extends past the side edge of the adhesive strip to form a strip 32a. This strip can be easily gripped, which facilitates the removal of the release liner from the adhesive strip. Alternatively, the release member 32 may have the same width as the adhesive region 30, but may be longer to form an adhesive strip at one or both ends thereof. In use, of course, the release member 32 does not need to be completely removed if only a relatively small object is to be attached to the bandage.

In the embodiment shown in Figures 1-3, the main film is a thin, transparent polyethylene film. As previously mentioned, the transparency of the main membrane 12 allows the surgeon to easily inspect the entire surgical area. The main film should also preferably have a non-glare surface; this can be achieved by extrusion on a matte coil roll or silicon resin treated paper. It will be appreciated that flexible films which are other artificial copolymers such as polypropylene, polyvinyl chloride, copolymers of ethylene and vinyl acetate, copolymers of ethylene and acrylate esters such as methyl or ethyl acrylate, etc. should be used instead of polyethylene. the thickness should be from about 0.02539 mm to about 0.12695 mm and preferably from about 0.038085 mm to 0.07617 mm. If the thickness is less than 0.038085 mm, the film may contain small holes formed during manufacture, and if the thickness is greater than about 0.12695 mm, the flexibility of the film may deteriorate. The plastic film may, if desired, contain antioxidants, antistatic agents and plasticizers in conventional amounts, as long as these agents can withstand sterilization and do not pose a risk to the patient.

Woven fabrics such as cotton or linen, nonwovens and even paper can also be used in the main film, as long as they do not substantially pass through the liquid or are treated e.g.

7,59921 with a suitable water-repellent agent such as silicon resin or fluorocarbon resin to obtain this property.

As the adhesive layers 22 and 30, any well-known, normally tacky and contact adhesive can be used. By "contact-acting, adhesive" is meant herein an adhesive known for the property of adhering to the receiving surface of the adhesive (in this case, the patient's skin).

Once such an adhesive has touched the adhesive receiving surface, it can no longer be moved without first removing it from the surface. Contact adhesives must not irritate or otherwise damage the skin and must be capable of being sterilized by standard steam, gas or radiation sterilization methods without compromising their adhesion properties. Useful types of adhesives are well known and do not form part of this invention. Of course, if desired, various contact adhesives can be used as the adhesive layers 22 and 30.

Prior to use, the cover 32 protects the adhesive area 30 and the cover 26 protects the adhesive layer 22. These covers are removable from the contact adhesive they protect and may consist of, e.g., waxed paper, glassine paper, or paper treated with release liner. . Any protective cover that can be removably attached to the adhesive to protect it from dust and premature contact with other surfaces, but that can be easily removed from the adhesive below at the right time, is suitable.

Although the protective cover 32 preferably extends past the adhesive strip 30 of Figures 1 and 2 to form the adhesive strips 32a, it may have the same dimension as the adhesive it covers.

Figure H shows how the protective layer 26 is separated from the contact-acting adhesive on the lower surface 16 of the main film of the dressing before use. With the other hand, the main membrane is gripped at the side edge of the bandage where there is no adhesive. At the same time, the release film 26 is gripped with one hand. The release film is then easily removed from the contact-acting, adhesive tape by moving the hands as shown by the arrows in Fig. 4.

8 59921

Of course, there is no difficulty in separating or adhering the main film and the release film at the side edges of the dressing, because the contact adhesive layer 22 does not cover the empty side portions of the dressing.

Figures 5 and 6 show po. another embodiment of an opening bandage in accordance with the teachings of the invention. The bandage 40 comprises a substantially rectangular main film 42 having an upper surface 44, a lower surface 46, substantially parallel side edges 48 and 48 ', and substantially parallel end edges 50 and 50' that are approximately perpendicular to the side edges 48 and 48 '. The lower surface 46 of the backing layer is completely covered by the contact adhesive 52. A release liner 56 having the same dimension as the main film 42 is positioned over the contact adhesive 52 below the bond.

The guide strips 54, 54 ', which are Mylarx polyester strip strips with a width of 12.7 mm, are attached to the contact adhesive 52 below the main film 42 near the side edges 48 and 48'. The guide strips, which extend longitudinally from end to end of the bandage, inactivate those portions of the contact adhesive 52 to which they are attached so that the main film 42 does not adhere to the protective cover 56 along the sides of the bandage. Since, as shown in Figure 6, the cover 56 does not adhere to the contact adhesive 52 along the sides of the dressing, the surgeon or assistant can easily detach the cover from below the dressing before the dressing is placed on the patient.

Attached to the upper surface 44 of the main film 42 are two strips of contact adhesive 60,60 'of equal length and width, which are covered with removably attached protective covers 62,62'. It can be seen in Figure 6 that these protective covers have been extended past the side edges of the strips of contact adhesive covered by them to form strips 62a, 62'a which can be easily gripped, which facilitates the removal of the release liners from the strips of adhesive. In the embodiment shown in Figures 5-7, the dimension of the bandage 40 is 762 mm between its sides and 609.6 mm between its ends. The adhesive strips 60,60 'have a length of 50.8 mm, a width of 12.7 mm and are arranged centrally and parallel to the sides of the bandage. The strips 60,60 'are 215.9 mm apart (distance between centers) and delimit an incision area 0R of 50.8 mm x 203.2 mm within which the surgeon makes an opening and performs surgical procedures. These dimensions are given as one example and do not limit po in any way. invention. For example, it is clear that the distance between the strips 60 and 60 'can be changed for different purposes. As a general rule, the distance between the strips should be at least 50.8 mm and preferably about 152.4 · to about 254 mm.

Although the release liners 62 and 62 'preferably extend past the adhesive strips 60 and 60' as shown in Figures 5 and 6 to form the adhesive strips 62a and 62'a, it is sufficient for the release liners to have the same dimension as the adhesive they cover.

Figure 7 shows an enlarged cross-sectional view of the lower right portion of the dressing 40 being gripped, showing how the release liner below the dressing is removed before the dressing is placed on the patient. The release liner 56 does not adhere to the contact adhesive 52 on the lower surface of the main membrane because the bandage side has a guide strip 54. A person can thus easily engage the main membrane and the guide strip attached to the adhesive 52 by holding one hand with his thumb and forefinger and the other. The release liner can then peel off the top of the contact adhesive by moving its hands in the direction of the arrows in Figure 7. If desired, the other person working with the first can handle the opposite side of the bandage in the same way.

Thus, it is apparent that the guide strips facilitate the placement of the dressing on the patient, and when the dressing is attached to the patient as a grip, prevent the side of the dressing from curling. Once the operation is performed, the guide strips facilitate removal of the bandage from the patient.

Figure 8 shows another example of an alternative structure using guide strips. In this embodiment, there is no contact adhesive along the empty edge portions of the lower surface of the main film 42 and the guide strip 54 is attached to the upper surface of the main film 42 in some suitable manner (not shown).

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In the embodiment of the invention shown in Figures 9-11, the bandage 70 comprises a main film 72 having an upper surface 74, a lower surface 76, side edges 78,78 'and end edges 80,80'. The main film 72 consists of a 0.0508 mm thick film of clear polyvinyl chloride having a size of 762 mm along its side edges and 609.6 mm along its end edges. The lower surface 76 of the main film 72 is coated at its major portion with a contact adhesive 82. The main film 72 has hollow edge portions 79,79 'extending inwardly from the side edges 78.78' of the bandage. These blank edge portions are made to a width of 88.9 mm without adhesive.

The release liner 86 protects the contact adhesive 82 below the dressing and has the same dimension as the head film. The top surface 74 of the main film has strips 90.90 'of contact adhesive having a width of 12.7 mm and a spacing (center distance) of 152.4 mm. The strips of adhesive are parallel to each other and to the binding sides and extend from one end to the other. Prior to use, the corresponding release covers 92,92 'protect the strips.

The guide strips 94,94 'are made on the upper surface of the main film. These guide strips, consisting of strips of polyethylene terephthalate having a thickness of 0.2539 mm, a width of 19.05 mm and a length of 762 mm, are adhered to the main film 72 close to the respective side edges 78.78 '. In addition to facilitating the removal of the release cover 86 and the placement of the bandage on the patient, the guide strips strengthen the bandage on its sides and prevent it from curling during use.

Any of the materials previously described herein can be used for the main film, the contacting adhesive, the release liners, and the guide strips that form the release liner of Figures 9-11. Once the release liner 86 is removed, the bandage 70 can be placed over the patient so that its sides 78,78 'and its adhesive strips 90,90' extend parallel to the sides of the patient's body. The bandage is secured to the patient by the adhesive 82 so that the opening area is located within the incision area 0R bounded by the adhesive strips 90,90 '.

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Figures 12-14 show a fourth embodiment of a surgical dressing according to the present invention. The bandage 100 comprises a substantially rectangular main film 112 having an upper surface 114, a lower surface 116, opposite side edges 118,118 ', and opposite end edges 120,120'. From the lower surface of the main film, the main central portion is covered with a normally tacky and contact adhesive 122 which terminates inside both the side edges and the end edges of the main film. Thus, there is no adhesive in the voids in the ends and sides of the main film.

The adhesive 122 is protected by a release liner 126 attached to the release liner, which has approximately the same dimension as the main film. Since the entire empty edge portion on the lower surface of the main film is free of adhesive, there are adhesive portions without adhesive on both ends and sides of the bandage. Thus, the separation of the release film from the underside of the bandage can be easily initiated at any point along the circumference of the bandage.

The edge portions of the top surface of the main film are covered with a contact-acting adhesive 130 which po. in the embodiment extends inwardly from the edges of the main film. The upper surface of the main film thus carries an edge formed by an adhesive which is available during use of the bandage for attaching various objects from the operating room to the upper surface of the main film. A suitable width for the edge formed by the adhesive is about 25.4 mm, but this size can be changed if desired.

Prior to use, the edge formed by the contact adhesive is protected by a release film 132, which is a flat type seal. This release liner should be wide enough to cover the adhesive prior to use, but is preferably extended beyond the edge of the adhesive to form an adhesive strip to facilitate removal.

It will be apparent to those skilled in the art that innumerable changes and modifications may be made to the described embodiments. within the scope and spirit of the invention. The overall size of the opening bandage can be changed considerably depending on, for example, the size of the patient and the operation to be performed. Typical sizes of rectangular or rectangular ties are 609.6 mm x 762 mm, 557.2 mm x 508 mm and 254 mm x 254 mm, but these sizes are mentioned by way of example only. For special purposes, other ties can be made in different shapes and dimensions. The number, width and length of the adhesive strips on the upper surface of the bandage can be changed for different purposes. The guide strips can be made of any suitable material which can be attached to the main film, for example by means of an adhesive or by heat sealing, and which, due to its special physical properties or thickness, strengthens the edges of the main film. It is obvious that a single guide strip at any edge of the bandage would facilitate handling during lower release cover removal; however, it is preferred to use two guide strips, one placed on each opposite edge, as this structure facilitates the placement of the dressing on the patient and more effectively prevents the dressing from curling during use.

Po. the bandages of the invention may be rotated into a cylindrical or similar shape or may be folded into a flattened cylindrical shape as shown in Figure 12. In any case, the dressings are placed in packages designed to keep the dressing sterile once sterilized and to allow the dressing to be removed from the package without damaging the asepsis. The folded dressing can be sterilized, for example, by means of gas, steam or radiation. The details of said folding, sterilization and packaging methods are well known to those skilled in the art.

Although po. preferred embodiments of the invention have been described as opening dressings in which the main film comprises a plastic film, it will be apparent to those skilled in the art that the idea of the invention could equally well be applied to other articles such as surgical wipes and dressings commonly used in hospitals. According to the invention, for example, a useful core could be developed, the main film of which consists of a nonwoven fabric. An adhesive on the lower surface of such a dressing would be used to secure the dressing to the underlying surface, with the adhesive on the upper surface being available to attach other objects to the upper surface of the dressing itself.

Claims (10)

A surgical dressing intended to be placed on the body of a patient, comprising a scalp (12, 42, 72 or 112) with an upper surface (14, 44, 74 or 114) and a sub-surface (16, 46, 76 or 116), having a sticky, pressure-sensitive adhesive for adhering the scalp to the patient's body, characterized in that the adhesive on the undersurface of the scalp is applied to a region (22, 52, 82 or 122) extending over most of the lower surface of the scalp. that the sticky, pressure-sensitive adhesive is applied to a limited area of the upper surface of the scalp, which limited adhesive area (30; 60, 60 '; 90, 90' or 130) serves as an anchoring support for attaching absorbent additional dressings or fabrics to the upper surface. of the retina. 2. A dressing as claimed in claim 1, characterized in that the release film (20, 56, 86 or 126) is at least as wide as the bonding area of the lower surface of the main film and releasably adhered thereto, and that the release film (32; 62, 62 '; 92, 92 or 132) are at least as wide as the restricted area of the upper surface of the scalp and releasably adhered thereto. 3. A dressing according to claim 2, characterized in that the bonding area (130) of the upper surface of the scalp is applied to form a strip at the edges of the scalp (Figs. 12 and 13). 4. A dressing according to claim 2, characterized in that the bonding area of the upper surface of the scalp comprises two adhesive strips (60, 60 'or 90, 90'), each of which has a release film (62, 62 'or 92, 92'). ) of at least the same width as the binding strips and detachably adhered thereto. Λ '