JP7714964B2 - Hydrocolloid tape for skin application to wounds - Google Patents

Description

The present invention relates to a hydrocolloid tape for application to the skin, which is applied to a wound .

One method of treating wounds is to cover the wound with gauze. In this case, the gauze is secured to the wound with tape or the like (see, for example, Patent Document 1). Recently, hydrocolloid skin adhesives have become known that can be applied directly to the wound to perform moist wound healing (see, for example, Patent Document 2).

Patent No. 4940385 JP 2017-39706 A

Because hydrocolloid-type skin adhesives are applied directly to the wound, they are required to have the function of preventing exudate gushing from the wound from leaking outward. Therefore, when hydrocolloid-type skin adhesives are made into, for example, long tapes that can be cut to the length appropriate for the size of the wound, if perforations are provided to make them easier to cut with fingers, the slits in the perforations will cause exudate to leak. Therefore, it has been practically difficult to provide perforations in tape-shaped hydrocolloid-type skin adhesives to make them easier to cut with fingers.

This application therefore discloses a hydrocolloid tape for application to the skin that minimizes the possibility of exudate leaking through perforations.

To solve the above problem, the present invention laminates a hydrocolloid material onto a film, and the individual cut portions of the perforations in the film are at least 2.0 mm long.

In detail, the present invention relates to a hydrocolloid tape for application to the skin, comprising a tape-shaped film substrate, a hydrocolloid material laminated to one side of the film, and perforations in the film, each consisting of alternating cut portions that penetrate the film and non-cut portions that do not penetrate the film, with each cut portion having a length of at least 2.0 mm.

The length of each cut portion of the perforations may be 1.5 mm or less.

Furthermore, the length of each cut portion of the perforation may be 1.0 mm or less.

Furthermore, the length of each uncut portion of the perforation may be less than 3.0 mm.

Furthermore, the length of each uncut portion of the perforation may be 2.0 mm or less.

Furthermore, the length of each uncut portion of the perforations may be 1.5 mm or less.

Furthermore, the total length of the uncut portion of the perforations may be 25% or more of the tape width.

Furthermore, the total length of the uncut portion of the perforations may be 48% or more of the tape width.

The hydrocolloid tape for skin application may have a value of 4.3×10 ⁻¹ or more, calculated by dividing the tensile strength by the peel strength at the perforation.

The hydrocolloid tape for application to the skin may have a maximum shear stress at the perforations of less than 2.1×10 ¹ N.

This invention makes it possible to minimize the possibility of exudate leaking through perforations.

FIG. 1 is a diagram showing a hydrocolloid tape for application to the skin according to an embodiment. FIG. 2 is a diagram showing an example of how to use the hydrocolloid tape. FIG. 3 is an enlarged view of the perforations. FIG. 4 is a diagram showing the routes through which exudate leaks. FIG. 5 shows the evaluation results.

The following describes a hydrocolloid tape for application to the skin according to an embodiment of the present invention, with reference to the drawings. Note that the configurations of the following embodiments are illustrative, and the present invention is not limited to the configurations of these embodiments.

Figure 1 shows a hydrocolloid tape for application to the skin according to an embodiment. In Figure 1, the hydrocolloid tape 1 is shown in roll form, with a long tape wound around a core, but it is not limited to a roll shape and may be, for example, in the form of a long, thin strip.

Hydrocolloid tape 1 comprises a tape-shaped film 2 serving as a base material and a hydrocolloid material 3 laminated to one side of film 2 (the back side of film 2 in the drawing of Figure 1). Hydrocolloid tape 1 is not limited to a form in which hydrocolloid material 3 is not present on the other side of film 2. For example, hydrocolloid tape 1 may have hydrocolloid material present on a portion of the surface of film 2 (the side not laminated with hydrocolloid material 3). Multiple perforations 4 are provided in the film 2 at predetermined intervals along its length. Hydrocolloid tape 1 is a hydrocolloid-type skin adhesive that can be applied directly to a wound to perform moist wound healing. Therefore, the perforations 4 are provided so that hydrocolloid tape 1 can be cut with the user's fingers to an appropriate length depending on the size of the wound. Therefore, it is preferable that the perforations 4 be provided in film 2 at intervals that allow the user to aim at a specific perforation 4 and cut with their fingers, and that the perforations can be adjusted to an appropriate size for the wound. The spacing between such perforations 4 is preferably 5 to 80 mm, more preferably 10 to 70 mm, and even more preferably 20 mm.

Because the hydrocolloid tape 1 is a skin adhesive that is applied directly to the wound, it is preferable to use an adhesive material for the hydrocolloid material 3 that is unlikely to adhere to the wound and also unlikely to cause maceration of the skin surrounding the wound. Examples of materials for the hydrocolloid material 3 include hydrophilic synthetic or natural polymers selected from the group consisting of alginic acid and its salts and derivatives, chitin and its derivatives, chitosan and its derivatives, pectin, cellulose and its derivatives, such as cellulose ether or cellulose ester, cross-linked or non-cross-linked carboxyalkyl cellulose or hydroxyalkyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, agar, guar gum, and gelatin. The hydrocolloid material 3 may be in the form of a semi-solid gel or fiber, or a gel containing particles and fibers. The hydrocolloid material 3 may also be in the form of a polymer containing hydrocolloid particles.

The film 2 is preferably made of a material that allows the hydrocolloid material 3 to be easily peeled from the film 2 even when the hydrocolloid tape 1 is rolled up and the hydrocolloid material 3 comes into contact with the surface of the film 2, and has sufficient strength so that the perforations 4 do not easily tear even when a slight load is applied to the perforations 4 when the film is attached to the skin. Suitable materials for the film 2 include, for example, PE film containing a release agent, PE film coated with a release agent, or PE film laminated with a release agent by lamination.

Figure 2 shows an example of how to use hydrocolloid tape 1. When applying hydrocolloid tape 1 to a wound on the skin, remove the required amount of hydrocolloid tape 1 from the roll, as shown in Figure 2(A). Then, as shown in Figure 2(B), hold the area near a specific perforation 4 with your fingers and pull, cutting the hydrocolloid tape 1 with the force of your fingers. Then, as shown in Figure 2(C), place the hydrocolloid tape 1 cut from the roll over the wound T on the skin S. Then, as shown in Figure 2(D), apply the hydrocolloid tape 1 to the skin S so that the wound T on the skin S is completely covered with the hydrocolloid tape 1.

The hydrocolloid tape 1 has perforations 4 spaced at predetermined intervals, allowing the hydrocolloid tape 1 to be prepared according to the size of the wound T without using cutting tools such as scissors. However, because the hydrocolloid tape 1 has perforations 4 spaced at predetermined intervals, the perforations 4 may overlap the position of the wound T. Since exudate may leak from the wound T, if the perforations 4 overlap the position of the wound T, there is a risk of exudate leaking from the gaps where the perforations 4 are cut.

Figure 3 is an enlarged oblique view of the perforation 4. As shown in Figure 3, the perforation 4 is composed of alternating cut sections 41, which are cut portions that penetrate the film 2, and uncut sections 42, which are uncut portions that do not penetrate the film 2. Due to the processing of the perforation 4, the cut sections 41 that penetrate the film 2 are designed to penetrate not only the film 2 but also the hydrocolloid material 3. Therefore, if the perforation 4 overlaps the position of the wound T, there is a possibility that exudate will leak through the gaps in the cut sections 41. However, with the hydrocolloid tape 1 of this embodiment, the dimensions of the cut sections 41 and uncut sections 42 are appropriately set as described below, minimizing the possibility of exudate leaking through the cut sections 41 of the perforation 4.

FIG. 4 is a diagram showing the paths through which exudate leaks. For ease of explanation, the same reference numerals are used in both the embodiment shown in FIG. 4(A) and the comparative example shown in FIG. 4(B). In this embodiment, in which the dimensions of the cut portion 41 and the uncut portion 42 are appropriately set, even if the cut portion 41 is provided in the film 2, the flow path of the exudate F through the cut portion 41 is blocked by the hydrocolloid material 3, as shown in FIG. 4(A). Therefore, in this embodiment, the possibility of the exudate F leaking from the cut portion 41 is minimized. On the other hand, in the comparative example in which the dimensions of the cut portion 41 and the uncut portion 42 are not appropriately set, the flow path of the exudate F through the cut portion 41 is not sufficiently blocked by the hydrocolloid material 3,
A gap 43 is formed, and exudate may leak out through the cut portion 41 of the perforation 4.

Several prototypes were prepared with alternating dimensions for the cut and uncut sections 41 and 42, and various evaluations were conducted. The results are shown below. Figure 5 shows the evaluation results.

For this evaluation, a roll of hydrocolloid tape measuring 25 mm wide and 3 m long was prepared. This hydrocolloid tape consisted of a 40 μm-thick PE film containing a release agent, which served as the base film for laminating the hydrocolloid material. A hydrocolloid material of 80 to 104 μm thick was then laminated onto this film. Methods for laminating the hydrocolloid material onto the film include direct coating onto the film, application of a coating to a substrate other than film and then affixing it to the film (transfer), and various other methods. The hydrocolloid tape was perforated at approximately 20 mm intervals, with the cut and uncut sections alternately sized. Four different cut section sizes were available: 1.0 mm, 1.5 mm, 2.0 mm, and 3.0 mm. Four different uncut section sizes were available: 1.0 mm, 1.5 mm, 2.0 mm, and 3.0 mm. From these, appropriate combination patterns were prepared, and as shown in Figure 5, six types were prepared for this evaluation, labeled "Prototype Name (Cut Dimensions/Uncut Dimensions)": "Prototype 1 (1.0mm/1.0mm)," "Prototype 2 (1.0mm/1.5mm)," "Prototype 3 (1.0mm/3.0mm)," "Prototype 4 (1.5mm/1.5mm)," "Prototype 5 (2.0mm/2.0mm)," and "Prototype 6 (3.0mm/1.0mm)." Because the width of the hydrocolloid tape is 25mm, the total dimensions of the cut portions (total cut portions) and the total dimensions of the uncut portions (total uncut portions) for each prototype are as shown in Figure 5.

In this evaluation, the following three items were evaluated.
<Hard to tear when unwinding>
This is an evaluation item to check that the hydrocolloid tape does not unintentionally tear at the perforations while being unwound from the roll.
<Easy to tear by hand>
This is an evaluation item to check whether the hydrocolloid tape can be easily cut with fingers at the perforations.
<Leakage>
This is an item to check whether exudate is unlikely to leak during use. In this evaluation, instead of exudate, hydrocolloid tape was applied to the position of a drop of water placed on the back of the hand so that the perforation overlapped, and the presence or absence of a drop of water adhering to the finger was confirmed by pressing the perforation with a finger (sensory evaluation). Since exudate is a secretion, it is thought to have a higher viscosity than water. Therefore, it is thought that water is more likely to leak from small areas than exudate. Therefore, in this application, if there is no water leakage at the perforation, it is considered that there is no leakage of exudate at the perforation.

As can be seen from the evaluation results in Figure 5, when the total length of the uncut portions was 6 mm, it was found that the tape would tear when unwound. Furthermore, when the total length of the uncut portions was 12 mm or more, it was found that the tape would not tear when unwound, and would not pose any practical problems. From these results, it can be said that the total length of the uncut portions needs to be at least 25% of the tape width, and more preferably 48% or more of the tape width.

Furthermore, as can be seen from the evaluation results in Figure 5, when the length of each uncut portion is 3.0 mm or more, it was found that it was not easy to tear the perforations with fingers. Furthermore, when the length of each uncut portion is 2.0 mm, it was found that it was possible to tear the perforations with fingers. Furthermore, when the length of each uncut portion is 1.5 mm or less, it was found that it was easy to tear the perforations with fingers. From these results, it can be seen that the length of each uncut portion needs to be at least less than 3.0 mm, preferably 2.0 mm or less, and more preferably 1.5 mm or less.

Furthermore, as can be seen from the evaluation results in Figure 5, it was found that when the individual length of the cut portions is 2.0 mm or more, water easily leaks through the gaps in the cut portions. It was also found that when the individual length of the cut portions is 1.5 mm, water may leak through the gaps in the cut portions. It was also found that when the individual length of the cut portions is 1.0 mm, water does not leak through the gaps in the cut portions. From these results, it can be said that the individual length of the cut portions must be at least less than 2.0 mm, preferably 1.5 mm or less, and more preferably 1.0 mm or less.

Therefore, from the results of this evaluation, it can be said that in the case of a hydrocolloid tape in which a hydrocolloid material having a thickness of 80 to 104 μm is laminated to a 40 μm thick PE film containing a release agent, if the total length of the uncut portions of the perforations is at least 25% of the tape width, the length of each uncut portion is at least 3.0 mm, and the length of each cut portion is at least 2.0 mm, the perforations can be torn and cut with fingers without tearing when unwinding, and water will not easily leak through the gaps in the cut portions. Furthermore, the results of this evaluation show that in the case of a hydrocolloid tape in which a hydrocolloid material having a thickness of 80 to 104 μm is laminated to a 40 μm thick PE film containing a release agent, if the total length of the uncut portions of the perforations is at least 48% of the tape width, the length of each uncut portion is 1.0 mm or less, and the length of each cut portion is 1.0 mm or less, the perforations can be easily torn off with fingers without tearing when unwinding, and water will not leak through the gaps in the cut portions. For this reason, in this evaluation, prototypes 1, 2, and 4 shown in Figure 5 can be said to be suitable embodiments.

These evaluation results will vary depending on the material and thickness of the film, as well as the composition and thickness of the hydrocolloid material laminated to the film. However, taking into account that exudate is less likely to leak than water, it is believed that a hydrocolloid tape made using, for example, a 20-60 μm thick PE film with a release agent and a 40-200 μm thick hydrocolloid material laminated thereon would also be effective as in the above test.

In this evaluation, the physical properties of the hydrocolloid tape, such as tensile strength, peel force, and maximum shear stress, were also measured, as shown in Figure 5. For reference, the physical properties of a commercially available plastic tape and a commercially available adhesive bandage that can be torn by hand were also measured. Therefore, the results of these measurements are described in detail below.

First, we will explain the physical properties related to resistance to tearing when unwinding. The resistance of a roll of hydrocolloid tape to tearing when unwinding it from the roll is thought to be closely related to the tensile strength of the tape itself and the peel force when the tape separates from the roll (peels off). For example, if the tensile strength is sufficient against the peel force, the tape will be less likely to tear at the perforations when unwinding it from the roll. Therefore, as shown in the table in Figure 5, when evaluating resistance to tearing when unwinding, we also measured the tensile strength and peel force when unwinding the roll of hydrocolloid tape from the roll. Because the tensile strength of the tape varies depending on the state of the perforations (the length of the cut and uncut portions), the values shown in the table in Figure 5 are alternating for prototypes 1 to 6. On the other hand, the peel force of the tape is consistent regardless of the state of the perforations, so prototypes 1 to 6 all show the same value, as shown in the table in Figure 5.

As can be seen from the evaluation results in Figure 5, for prototype 6, which tore when unwound, the value obtained by dividing the tensile strength by the peel force was 0.43. On the other hand, for prototypes 1 to 5, which did not tore when unwound, the value obtained by dividing the tensile strength by the peel force was 0.64 to 0.82, all of which were greater than the 0.43 obtained for prototype 6. Therefore, from these measurement results, it can be said that for resistance to tearing when unwound, the value obtained by dividing the tensile strength by the peel force (= tensile strength/peeling force) needs to be 4.3 x ^10-1 or greater, and more preferably 6.4 x ^10-1 or greater.

Next, we will explain the physical properties related to hand tearability. The ease with which hydrocolloid tape can be cut with fingers at the perforations is thought to be closely related to the shear stress applied to the tape at the perforations. For example, if the maximum shear stress of the tape at the perforations is too high, it will not be easy to cut with fingers. Therefore, as shown in the table in Figure 5, when evaluating hand tearability, the maximum shear stress of the tape at the perforations was also measured. The maximum shear stress of the tape at the perforations varies depending on the state of the perforations (the length of the cut and uncut sections), and therefore, as shown in the table in Figure 5, prototypes 1 to 6 show alternating values.

As can be seen from the evaluation results in Figure 5, in Prototype 3, where the perforations could be torn off with fingers (each uncut portion had a length of 3.0 mm or more), the maximum shear stress was 2.2 N. In contrast, in Prototypes 1, 2, 4 to 6, where the perforations could be torn off easily with fingers (each uncut portion had a length of 2.0 mm or less), the maximum shear stress was 0.8 to 1.4 N. Furthermore, in Prototypes 1, 2, 4, and 6, where the perforations could be torn off more easily with fingers (each uncut portion had a length of 1.5 mm or less), the maximum shear stress was 0.8 to 1.4 N. Furthermore, for a commercially available adhesive bandage that is advertised as being tearable by hand, the maximum shear stress was 20.6 N. Therefore, from these measurement results, it can be said that the maximum shear stress for hand tearability is at least less than 2.1 x 10 ¹ N, preferably less than 2.2 x 10 ⁰ N, and more preferably less than 1.3 x 10 ⁰ N.

The numerical ranges for these physical properties can be said to be independent of the individual thicknesses of the film and hydrocolloid material that make up the hydrocolloid tape. For example, the numerical ranges for physical properties related to resistance to tearing when unwound are relative values obtained by dividing tensile strength by peel force. Therefore, from an engineering perspective, unless there is a significant difference in the strength of the film material itself, the thickness of the film does not affect the numerical range. Furthermore, for example, the numerical ranges for hand tearability are absolute values that determine whether a person can tear the tape by hand. Therefore, regardless of the film thickness, it is sufficient that the film breaks somewhere within the thickness, and the numerical range for the maximum shear stress at which hand tearing is possible does not depend on the film thickness.

Therefore, regardless of the individual thicknesses of the films and hydrocolloid materials that make up the hydrocolloid tape, hydrocolloid tapes in which the value obtained by dividing the tensile strength by the peel force at the perforation (=tensile strength/peeling force) is 4.3 x ^10-1 or more, and more preferably 6.4 x ^10-1 or more, can be said to be less likely to tear when unwound. Furthermore, regardless of the individual thicknesses of the films and hydrocolloid materials that make up the hydrocolloid tape, hydrocolloid tapes in which the maximum shear stress at the perforation is at least less than 2.1 x ¹⁰¹ N, preferably less than 2.2 x ¹⁰⁰ N, and more preferably less than 1.3 x ¹⁰⁰ N can be said to be easily torn by hand.

S: Skin T: Wound F: Exudate 1: Hydrocolloid tape 2: Film 3: Hydrocolloid material 4: Perforation 41: Cut portion 42: Uncut portion 43: Gap

Claims (10)

a tape-like film as a base material;
a hydrocolloid material laminated to one side of the film;
perforations provided in the film, in which cut portions penetrating the film and non-cut portions not penetrating the film are arranged alternately;
The perforations are provided for cutting to an appropriate length for the wound site, and each of the cut portions has a length of at least 2.0 mm or less;
The hydrocolloid material seals the exudate that flows out from the wound site to perform moist wound healing.
A hydrocolloid tape for application to the skin that is attached to the wound. The perforations have individual cut portions each having a length of 1.5 mm or less.
2. The hydrocolloid tape for application to the skin according to claim 1, which is applied to a wound site. The perforations have individual cut portions each having a length of 1.0 mm or less.
3. A hydrocolloid tape for application to the skin, which is applied to a wound site according to claim 1 or 2. The perforations have an individual length of the uncut portion of less than 3.0 mm.
A hydrocolloid tape for application to the skin, which is applied to a wound site according to any one of claims 1 to 3. The perforations have an individual length of the uncut portion of 2.0 mm or less.
A hydrocolloid tape for application to the skin, which is applied to a wound site according to any one of claims 1 to 4. The perforations have an individual length of the uncut portion of 1.5 mm or less.
A hydrocolloid tape for application to the skin, which is applied to a wound site according to any one of claims 1 to 5. The total length of the uncut portion of the perforation is 25% or more of the tape width.
A hydrocolloid tape for application to the skin, which is applied to a wound site according to any one of claims 1 to 6. The total length of the uncut portions of the perforations is 48% or more of the tape width.
A hydrocolloid tape for application to the skin, which is applied to a wound site according to any one of claims 1 to 7. The value obtained by dividing the tensile strength by the peel force at the perforation is 4.3 × 10 ⁻¹ or more;
A hydrocolloid tape for application to the skin, which is applied to a wound site according to any one of claims 1 to 8. The maximum shear stress at the perforation is less than 2.1 × 10 ¹ N;
A hydrocolloid tape for application to the skin, which is applied to a wound site according to any one of claims 1 to 9.