KR0144573B1 - Adhesive bandage and sealing unit consisting of one fragment - Google Patents

Abstract

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Description

Adhesive bandage and sealing unit consisting of one fragment

1 is a plan view of an open or unfolded film dressing according to the present invention.

2 is a side view of the folded film dressing of FIG.

3 is an enlarged side view of an alternative embodiment of the film dressing according to the present invention.

4 is a plan view of the film dressing manufacturing method of FIG.

FIG. 5 is a plan view of the film dressing of FIG. 3 additionally sealed to several portions cut to show some layers.

6 is a plan view of the dressing of FIG. 3 further comprising a label.

7 is a cross-sectional view of the film dressing of FIG. 6 taken along lines 7-7.

The present invention relates to a pressure sensitive adhesive composite having a backing coated on one surface with an adhesive. More specifically, the present invention relates to pressure sensitive adhesive composites having improved means for applying to and handling the surface. The invention has particular advantages when used in backing, which is a very thin, adhesive-coated transparent film widely used as a medical dressing.

Although the present invention is useful for any adhesive composite that requires a transition system, the present invention has particular advantages with respect to transparent film dressings and surgical bandages. These dressings and bandages serve as barriers to contaminating liquids and bacteria and serve as a protective layer at the wound site, facilitating treatment in wet environments. These types of dressings are ^{Tegaderm TM (3M, St. Paul,} Minnesota), Bioclusive TM (Johnson Johnson, New Brunswick, New Jersey), Op-Site TM (TJ Smith Nephew, Hull, England) and Uniflex ^TM (Howmedica, Largo , Florida).

The polymer film used in such dressings should be comfortable. This means that these films are extremely thin, soft and flexible. This is provided by a peelable protective liner overlying the adhesive coated surface of the film. When the liner is removed, the adhesive coated film tends to wrinkle and stick to itself, preventing the gentle application of the sterile dressing or bandage to the skin. In order to solve this problem, various transition systems have been proposed.

One such transition system is to use a three-part liner model. US Pat. No. 4,614,183 discloses a composite having a relatively thin polymeric film that can be peeled off to two liners with a central gap therebetween.

These two liner sites have a short J-fold located next to the central gap. The third liner fragment covers the central gap on the adhesive coated surface of the backing and extends beyond the J-fold to facilitate removal. In order to apply such a dressing, the user must first remove the center liner piece, apply the middle part of the backing to the substrate, then hold the pliers J-folded to the side of the dressing and remove the liner piece from the backing.

U.S. Patent No. 3,018,881 discloses a folded adhesive bandage seal unit having at least three liner pieces, wherein the adhesive-coated surface of the backing is in contact with the inner surface of the cover panel. Such seals have a finger tab that, when applied to the skin, spreads the bandage and falls off when the user pulls. The seal forming panel is separated from the adhesive bandage after being applied to the skin by continuing to pull the finger tab.

US Pat. No. 4,598,004 discloses an adhesive composite having an adhesive coated backing on at least a portion and a separate liner fragment on the adhesive. At least one edge of the backing is a transition fragment that is firmly adhered to the liner and can be separated from the rest of the backing. The bond between the liner fragment and the transition fragment on the backing must be strong enough to separate from the rest of the backing before the transition fragment is separated from the liner.

US Pat. No. 4,050,121 discloses a diaper tab that is folded in a Y shape around the diaper and does not have a liner that provides additional strength in holding the diaper. A portion of the tab used to fasten the diaper is wrapped around the edge of the diaper and adhered to the securing portion of the storage tab prior to use. US Pat. No. 4,127,132 discloses a disposable diaper tape fastener that has a tape tab folded about itself and that can be unfolded twice or more to expose a new adhesive. In at least one model, the tape piece is held in a folded shape by appropriate means, such as a specific point of adhesive.

The adhesive composite of the present invention has a backing in which the central portion is joined on the face by the side. The central portion has a pressure sensitive adhesive coated on at least a portion of one side of the backing. This adhesive-coated side of the backing center is adhered to be able to peel off at least one of the sides of the backing while providing one piece label, tape or dressing at a lower cost than the previous soluble adhesive composite.

The adhesive composite may also include separating means for separating the central portion of the backing from the side of the backing. Preferably, the separation stage is a parallel pair of perforations provided in the backing so that the sides can be teared off along the cut lines after the composite is transferred to the substrate.

In one model, the center of the backing can be glued so that only one of the sides of the backing can be peeled off by folding the backing along a line in one backing side, which side can be completely covered with the adhesive coated side of the center. Long enough to be.

In a preferred embodiment, the central portion of the backing is folded in two parts such that the non-adhesive side of this part is in close proximity or contact. Such folds may be referred to as outward folds because the adhesive coating is on the outward side of the folded central portion of the backing. The backing is then folded back at each side, whereby the side of the backing is glued so that it can be peeled off to the corresponding adhesive coating surface of the center portion. This folding is called inward folding because the adhesive coating is on the inward side of the folded backing.

The backing is preferably an adhesive coating that is moisture and vapor permeable and must pass wet steam. When using a wet vapor high permeability film, the adhesive is preferably biocompatible. The pressure sensitive adhesive composite is a wet vapor high permeability film, a wet vapor high permeability biocompatible adhesive, and most preferably transparent.

1 and 2 show the dressing composite 10 of the present invention, wherein like numerals refer to like parts. FIG. 1 shows an unfolded dressing 10 comprising a backing 11 made of a thin transparent polymer film that is moisture permeable and water and bacterial impermeable, such as a polyester or polyurethane film. The backing 11 has a central portion 12 which is attached on the face by the sides 14 and 16. The central portion 12 is coated on one side with a pressure sensitive adhesive which is a hypoallergenic adhesive to the skin, preferably a low allergic acrylate copolymer bioadhesive. The side 16 is coated on one side with a release material 15 that can be selected from a low energy surface coating material that reduces the degree of adhesion of the adhesive to the backing, as indicated by the backing material and adhesive properties. In certain cases of selecting the backing material and adhesive, a release coating may not be required. Perforation lines 18 and 20 were made to allow the dressing to be delivered to the skin and then to separate the central portion 12 from the sides 14 and 16. The central portion 12 is bonded along the fold line 22 so that it can be peeled off to the side by the fold backing 11.

FIG. 2 illustrates aspects to the folded dressing embodiment of FIG. 1. In transferring the composite, the user grabs the adhesive uncoated ends 24 and 26 and pulls them in the opposite circular direction, thereby exposing the adhesive-coated side of the central portion 12. Next, the user separates the side portions 14 and 16 from the center portion 12 by applying the center portion to the skin and pulling along the porous cut lines 18 and 20.

3 is an enlarged side view of an alternative dressing composite 30 of the present invention. In this embodiment, the backing 31 has a central portion 32 and sides 34 and 36. The adhesive 37 is coated on one side of the central portion 32. Porous cut lines 38 and 40 are made in the central portion 32 so that the central portion 32 is transferred to the skin and the central portion 32 is separated from the sides 34 and 36. Preferably, the adhesive 37 extends beyond the porous cut lines 38 and 40 such that the portion of the dressing composite 30 remaining on the skin after application is adhered around the edge of the dressing without any edges peeling off. do. The central portion 32 and the side portions 34 and 36 are provided with the central portion 42 and the side portions 45 and 46, respectively, so that the adhesive-coated side of the center portion 32 is peeled off the side portions 34 and 36. Make sure that they stick together. In this three-step fold embodiment, the adhesive uncoated side of the portion of the central portion 32 on the opposite side of the central fold 42 is brought into contact or proximate. In another embodiment, the side portions 34 and 36 are bordered and additional folds are provided with the central fold 42 omitted, such that the non-folded distal portions 50 and 52 extend from the center portion 32. And thus can be easily grabbed by the user. A backing union means 48, such as a viscous or rectangular body of adhesive, is located between the uncoated adhesive side of the central portion 32 portion on either side of the central contact 42 so that the dressing composite 30 is not previously unfolded. Make it easier to handle. In use, the user grabs one of the unbonded ends 50 and 52 in one hand and pulls in the opposite circle direction. Through this action, the adhesive coated surface of the central portion 32 is exposed and settled on the skin. After transferring the central portion 32 to the required position on the skin, the side portions 34 and 36 are removed by intruding the porous cut lines 38 and 40.

4 is a plan view of a method of making the dressing embodiment of FIG. In manufacturing the dressing embodiment 30, a rectangular cutout 62 is placed at regular intervals on the backing sheet 60, which is optionally unwound from the roll, to make the backing sheet 60 into an individual dressing. After dividing, the width of the central portion 32 is made narrower than the sides 34 and 36. The backing sheet 60 is made with parallel continuous porous cut lines 38 and 40. However, the cut lines are preferably bent to provide rounded corners for the final fixed dressing. The central portion 32 of the backing sheet 60 is coated with an adhesive 37 and the sides 34 and 36 of the backing sheet are coated with a release material 47. The adhesive and release material may be coated in any order, but it is more convenient to coat the release material first to the backing and then to overlay coat the adhesive. The dressing embodiment 30 may be separated from the backing sheet 60 by die cutting along a lengthwise line through the rectangular cutout 62. The dressing subject 30 may be folded in the form of the sheet 60, or may first cut the dressing and subsequently the individual dressing. The above-described steps can be interchanged in order, eventually yielding the same final product. Thus, for example, rectangular cutout 62 may be implemented at the final stage of folding.

FIG. 5 is a plan view showing the dressing of FIG. 3, a portion of which is cut to show the layer. It also includes a heat seal 64 around the periphery of the dressing, and a first heat seal 66 entered from the periphery, to allow the user to more easily grip the non-bonded distal ends 50 and 52. To help. As shown, the heat seal 66 is chevron in shape, but may be of any shape as long as it can hold the non-bonded distal ends 50 and 52. Instead of using heat seals 64 and 66, the edges of the dressing 30 may be secured by means such as adhesives.

FIG. 6 is a top view of the dressing embodiment of FIG. 3 further comprising a label 70 that can be removed and optionally re-restricted. The label 70 may be comprised of any relatively strong material, such as paper or any material suitable for use as a backing material. The label 70 is a reinforcing means to provide a writing surface, as well as to improve the handling aptitude of the dressing 30. The label 70 can be of any size as long as it does not interfere with the transfer of the dressing 30 to the skin. For example, the label 30 may cover the sides 34 and 36 as a whole and extend to the edges of the perforated cut lines 38 and 40. The label 70 is adhered to be peeled off the sides 34 and 36 by the presence of the material on which the film backing 31 is extruded or cast, or peeled off to the backing 31 by an adhesive. And can be glued to be reconsidered.

7 is a cross-sectional view taken along the line 7-7 of the dressing of FIG.

In the case of using an extremely soft material in the adhesive composite of the present invention as a backing, it is difficult to handle because the corner portion of the side is curled and the entire composite can be twisted. In this state, it may be particularly desirable to introduce reinforcement means on the sides to improve handling aptitude. Such means may consist of, for example, elongated labels, papers or fibers as described above, dual materials of liners at dressing specific sites, and the like.

Terms such as folds, folds, etc. in the foregoing are to be understood as being used because they are convenient for indicating a particular portion of the composite and the relative spatial shape of such portion. It is evident that the actual wrinkles in the backing and liner are not necessary to obtain the composite of the present invention. In practice, however, it is desirable that the backing have wrinkles.

The transition system of the present invention is useful for any backing coated with a pressure sensitive adhesive. Representative backings are nonwoven fiber webs, fiber webs, knits and other similar backing materials. Preferred backing materials are polymer films. The present invention is particularly useful for pressure sensitive adhesive composites having wet vapor highly permeable films. U.S. Patent Nos. 3,645,835 and 4,595,001 disclose methods of making the moisture / vapor permeable films and testing the permeability of these films.

The film / adhesive composite should be passed through the wet steam to the at least 300g / m ^2/24 sigan / 37 ℃ / speed of 100-10% RH. Preferably, the adhesive coated film is passed through the wet steam to the at least 700g / m ^2/24 sigan / 37 ℃ / speed of 100-10% RH.

The complex is preferably comfortable on the tissue surface. It is preferred that when the complex is applied to the surface of the animal tissue, the surface adapts even when the surface is moving. Preferred backings are also comfortable to animal tissue joints. When bending the joint, the backing must be stretched to conform to the bending of the joint, and when the joint is returned to its original position, it must be elastic enough to continue to fit into the joint.

The measure of consistency is represented by the value of F, which is a measure of the elongation taken at the specified percent elongation of the material (given by subscript). The value of F ₁₀ was obtained using ASTM Test Method D3759 using Interlect II from Instrument Company (Philadelphia, PA), except that the force measurement was taken at 10% stretching. The cross-head speed of Intelect II was set at 10 inches per minute and the chart speed was set at 10 inches per minute (25.4 cm). The test sample was tested 1 inch (2.54 cm) wide with a gauge length of 2 inches (5.1 cm).

The F ₁₀ value is an approximation of the motion of the body surface and the ability of the material to be drawn to this body deformation. The value for backing should not exceed about 1 pound (454 grams), preferably less than about 0.8 pounds (363 grams). In a preferred embodiment of the wound dressing or bandage, a backing having a F ₁₀ value of at least 2.5 pounds (1135 grams) may be used. However, as the F ₁₀ value increases, the consistency decreases and likewise the backing's ability to perform comfort as a medical dressing falls.

In addition, the consistency depends to some extent on thickness, so the thinner the backing, the more comfortable it is. Typically, the film is 12 to 25 microns thick. In the present invention, examples of suitable polymers for use as wound dressing films include polyurethanes such as Estane ^™ (BF Goodrich, Cleveland, Ohio); elastomeric polys such as duPont Hytrel ^™ polyester elastomers (Wilmington, Delaware). Esters; polyethylene; mixtures of polyurethanes and polyesters; chlorinated polyethylene; thermoplastic rubbers of the Kraton ^™ brand (Shell Chemical Company, Houston, Texas), Pebax ^™ polyether block amides (Rilsan Corp., Glen Rock, New Jersey) Such as styrene / butadiene / block copolymers; And polyvinyl chloride.

Preferred backings are polyurethane and elastomeric polyester films. These films have properties that combine desirable properties of elasticity, wet vapor high permeability and transparency. Particularly preferred backings are porous polyethylene films, which have higher wet vapor permeability and elasticity than polyurethane and elastomeric polyester films. Porous polyethylene and polypropylene films useful in the present invention are disclosed in US Pat. No. 4,539,256.

The aforementioned porous polyethylene films are known to be useful as liner materials. Thus, in adhesive composites having an adhesive coated backing covered by a highly flexible and elastic liner, coated porous polyethylene or polypropylene films can be ideally used. Liners made of porous polyethylene or polypropylene are both very comfortable and have a very large internal strength. Therefore, this material is resistant to pulling out when applied from the adhesive coating surface. Such materials are particularly useful as release materials in applications that require progressively controlled delamination because they are able to withstand a 180 ° peel angle and have very little residual at the time the liner is restored. An example of such an application is automotive pinstriping tape.

Preferred pressure sensitive adhesives that can be used as preferred wound dressing embodiments are applied to the skin, such as the acrylate copolymers disclosed in US Pat. No. 24,906, specifically the iso-octyl acrylate: acrylamide copolymer of 97: 3. Conventional adhesives. Other useful adhesives are block copolymers having three or more polymer block structures of the general shape -ABA-, which are disclosed in US Pat. No. 3,389,827, each one block having an average molecular weight of about 500 to 125,000. The thermoplastic polymer has a glass transition temperature of at least room temperature (ie at least about 20 ° C.) and the B block is a polymer of conjugated diene having an average molecular weight of about 15,000 to 250,000. Another example of a useful adhesive is iso-octyl acrylate / n-vinylpyrrolidone copolymer adhesive, and crosslinked acrylate adhesive, for example, as disclosed in US Pat. No. 4,112,213. This adhesive contains agents such as iodine and antimicrobial agents that are effective in wound healing and infection prevention. U.S. Patent Nos. 4,310,509 and 4,323,557 disclose such antimicrobial adhesives.

Various combinations of adhesives and release coatings are feasible. Those skilled in the art are familiar with the process of testing new adhesives for different release coatings or new coatings for different adhesives in order to obtain the desired amount of combination in the final product. Handbook of Pressure-Sensitive Adhesive Technology, Chapter 18 Silicon Release Coatings Van Nostrand-Reinhold, 1982, pp. 384-403, discloses a reference to selecting a perfluoropolyether release coating. In preferred wound dressing embodiments of the present invention, the choice of adhesive is limited to those that are safe for use on the skin, preferably those of a class known to be hypoallergenic. Preferred for this class of adhesives are acrylate copolymers.

Low-adhesive backsize (LAB) is suitable for use in conjunction with nonwoven backings or certain films, while LAB alone is not suitable for use with porous polyethylene or polypropylene films. By varying the proportions of polydimethylsiloxane polymer silicone resins, siloxane crosslinkers and catalysts known in the art, suitable silicone release coatings having desirable peeling properties when used with selected backings and adhesives can be prepared. Alternative release coatings such as silicone / LAB mixtures may also be used.

The composites of the present invention can be prepared by conventional techniques familiar to those skilled in the art (e.g., extraction, solvent casting, rolling and lamination, etc.) (Modern Plastics Encyclopedia McGraw Hill, 1984-85; Coating and Laminating Machines, Weiss) Coverting Technology Co. 1977). The composite preparation method is also illustrated by the following non-limiting examples.

Example 1

7.3 cm wide adhesive coating of a 97: 3 mixture of iso-octyl acrylate: acrylamide copolymer on a 19 cm x 70 cm porous polyethylene sheet (prepared according to Example 23 of US Pat. No. 4,539,256) with a thickness of 7.6 mm Water was coated. Correspondingly sized liner pieces were placed on the adhesive to protect the adhesive from contamination during subsequent manufacturing steps. On one side of the liner fragment, the backing was polydimethylsiloxane polymer / catalyst mixture (SS4300 available from General Electric Company, Waterford, New York) 95 parts, silicone resin (SR545 available from GE) and 5 parts crosslinked It was coated with a 4.9 cm wide silicone release material which was a mixture of 2 parts binder (commercially available at 4300 C by GE). The release coating was cured by heat treatment at a relatively low temperature of 65 ° C. to prevent shrinkage of the backing.

Porosity was applied to the backing at the edge of the adhesive coating so that the adhesive was completely coated in the area between the two porous cut lines. At this time, the protective liner fragment was removed from the adhesive. The dressing was cut to the appropriate size and the product was folded outwardly folded at the center and inwardly folded at the side of the outer portion adjacent the perforated cut line, so that half of the adhesive coating center was laminated to each peel surface coating side.

Example 2

An adhesive composition was prepared as in Example 1 except that the backing consisted of a nonwoven backing and release material (Mead Release Products, West Chicago. IL (Nonwoven N7601-ST3A)). The thickness of the composite was 0.15 mm. The central part containing the release material was sanded to allow the applied adhesive to adhere to the backing.

Example 3

The backing was prepared using an elastomeric polyester film (Hytrel ^™ , manufactured by duPont, Wilmington, Delaware), and the adhesive composite was prepared as in Example 1, except that the release coating was a urethane low adhesive backsize. Prepared.

Example 4

An adhesive composite was prepared as in Example 3, except that the center had a width of 6 cm and the side had a width of 7 cm. All four edges were sealed by heat sealing the edges of the composite using a heat sealing machine Model 12AS (Packaging Industries, Inc., Hyannis, Mass.). This produced a single package.

Example 5

The adhesive composite was prepared as in Example 4, except that the center had a width of 5.5 cm and was sealed with 4 mm fragments of a 97: 3 mixture of iso-octyl acrylate: acrylamide copolymer adhesive rather than by heat sealing. Prepared.

It is to be understood that the specific preferred embodiments described above are provided for purposes of illustration and description, and that the present invention may be modified in many ways by those skilled in the art without departing from the principles of the present invention. For example, the composite can further enhance wet vapor permeability by additionally including absorbent pad or adhesive pores.

Claims (2)

A backing having a central portion having sides coupled to opposite sides, the central portion having a pressure sensitive adhesive coated on at least a portion of one side of the backing, wherein the adhesive coated side of the central portion has one or more sides; An adhesive composite detachably bonded to the center portion, wherein the center portion is separated from the side portion by a separating means. A backing having a central portion having sides coupled to opposite sides, the central portion having a pressure sensitive adhesive coated on at least a portion of one side of the backing, the adhesive coated side of the central portion having two sides An adhesive composite that is peelably adhered to.

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