Hydrocolloid tape for skin application to be attached to the wound site
The hydrocolloid tape with precise perforation dimensions addresses exudate leakage issues by ensuring easy cutting and minimal leakage, enhancing wound care efficacy.
Patent Information
- Application Number
- JP2021141313
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-08-31
- Publication Date
- 2025-07-30
- Estimated Expiration
- 2041-08-31
AI Technical Summary
Hydrocolloid type skin patches directly attached to wounds face challenges in preventing exudate leakage through perforations made for easy cutting, as conventional perforations can lead to leakage due to their design.
A hydrocolloid tape with perforations less than 2.0 mm in individual length, alternating with non-cut portions, ensuring the tape can be easily cut by hand without significant exudate leakage by setting non-cut portions to at least 25% of the tape width and cut portions to 1.0 mm or less.
The design effectively minimizes exudate leakage through perforations while allowing easy cutting without tools, maintaining integrity during unwinding and use.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to To be attached to the wound site a hydrocolloid tape for skin application.
Background Art
[0002] One of the treatments for wounds is to cover the wound site with gauze. In this case, the gauze is fixed to the wound site with tape or the like (see, for example, Patent Document 1). In recent years, a hydrocolloid type skin patch that can be directly attached to the wound site to perform wet therapy has also been known (see, for example, Patent Document 2).
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Patent Document 2
Summary of the Invention
Problems to be Solved by the Invention
[0004] Since the hydrocolloid type skin patch is directly attached to the wound site, it is required to have a function of preventing the exudate oozing from the wound site from leaking to the outside. Therefore, when the hydrocolloid type skin patch is made into a long tape shape that is cut to a length according to the size of the wound site and used, if a perforation is provided to facilitate cutting with a finger, the cut of the perforation may cause the leakage of the exudate. Therefore, it has been practically difficult to provide a perforation for easy cutting with a finger in a tape-shaped hydrocolloid type skin patch.
[0005] Therefore, the present application discloses a hydrocolloid tape for skin application that suppresses the possibility of exudate leakage from the perforations as much as possible.
Means for Solving the Problems
[0006] In order to solve the above problems, in the present invention, a hydrocolloid material is laminated on a film, and the individual lengths of the perforated cut portions provided in the film are made less than at least 2.0 mm.
[0007] Specifically, the present invention is a hydrocolloid tape for skin attachment, comprising a tape-shaped film serving as a base material, a hydrocolloid material laminated on one side of the film, a cut portion provided in the film and penetrating the film, and a perforation in which non-cut portions that do not penetrate the film are alternately arranged, wherein the perforation has an individual length of the cut portion of less than at least 2.0 mm.
[0008] Note that the perforation may have an individual length of the cut portion of 1.5 mm or less.
[0009] Further, the perforation may have an individual length of the cut portion of 1.0 mm or less.
[0010] Further, the perforation may have an individual length of the non-cut portion of less than 3.0 mm.
[0011] Further, the perforation may have an individual length of the non-cut portion of 2.0 mm or less.
[0012] Further, the perforation may have an individual length of the non-cut portion of 1.5 mm or less.
[0013] Further, the perforation may have a total length of the non-cut portions of 25% or more of the tape width.
[0014] Further, the perforation may have a total length of the non-cut portions of 48% or more of the tape width.
[0015] Further, in the above hydrocolloid tape for skin attachment, the value obtained by dividing the tensile strength by the peel force at the perforation is 4.3×10 -1 or more.
[0016] In addition, the above hydrocolloid tape for skin application may have a maximum shear stress at the perforations of less than 2.1×10 1 N.
Advantages of the Invention
[0017] According to the present invention, it is possible to suppress as much as possible the possibility of exudate leaking from the perforations.
Brief Description of the Drawings
[0018]
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Embodiments for Carrying Out the Invention
[0019] Hereinafter, a hydrocolloid tape for skin application according to an embodiment of the present invention will be described with reference to the drawings. Note that the configurations of the following embodiments are examples, and the present invention is not limited to the configurations of these embodiments.
[0020] FIG. 1 is a diagram showing a hydrocolloid tape for skin application according to an embodiment. In FIG. 1, the hydrocolloid tape 1 is illustrated in a roll form in which a long tape is wound around a core, but it is not limited to the roll form and may be, for example, in the form of an elongated strip.
[0021] The hydrocolloid tape 1 includes a tape-shaped film 2 serving as a base material and a hydrocolloid material 3 laminated on one side of the film 2 (the back surface of the film 2 in the plane of FIG. 1). The hydrocolloid tape 1 is not limited to a form in which the hydrocolloid material 3 does not exist at all on the other surface of the film 2. For example, a part of the surface of the film 2 (the surface where the hydrocolloid material 3 is not laminated) may have the hydrocolloid material. A plurality of perforations 4 are provided in the film 2 at predetermined intervals in the longitudinal direction of the film 2. The hydrocolloid tape 1 is a hydrocolloid type skin patch that can be directly attached to a wound site to perform wet therapy. Therefore, the perforations 4 are provided for cutting the hydrocolloid tape 1 with a finger to an appropriate length according to the size of the wound site. Accordingly, it is preferable that the perforations 4 can be cut with a finger by aiming at a specific perforation 4 by the user and are provided in the film 2 at intervals that can be adjusted to an appropriate size for the wound site. As such an interval of the perforations 4, 5 to 80 mm is preferable, 10 to 70 mm is more preferable, and for example, 20 mm is even more preferable.
[0022] Since the hydrocolloid tape 1 is a skin patch that is directly attached to a wound site, it is preferable to use an adhesive material for the hydrocolloid material 3 that is less likely to cause wound adhesion and less likely to cause maceration of the skin around the wound. Examples of the material of the hydrocolloid material 3 include argi Examples of hydrophilic synthetic polymers or natural polymers selected from the group consisting of phosphoric acid and its salts and derivatives thereof, chitin or its derivatives, chitosan or its derivatives, pectin, cellulose or its derivatives such as cellulose ether or cellulose ester, crosslinked or non-crosslinked carboxyalkyl cellulose or hydroxyalkyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, agar, carrageenan or gelatin. Further, the hydrocolloid material 3 may be in a semi-solid gel form or fibrous form, or may be in a form in which particles and fibers are mixed in the gel. Further, the hydrocolloid material 3 may be in a form having hydrocolloid particles in a sticky polymer.
[0023] For the film 2, it is preferable to use a material such that the hydrocolloid tape 1 is in a roll form and the hydrocolloid material 3 can be easily peeled off from the film 2 even when the hydrocolloid material 3 contacts the surface of the film 2, and the perforation 4 does not easily cut even when a certain load is applied to the perforation 4 in a state of being adhered to the skin. Examples of suitable materials for the film 2 include, for example, a PE film blended with a release agent, a PE film coated with a release agent, or a PE film laminated with a release agent by laminating.
[0024] FIG. 2 is a diagram showing an example of a method of using the hydrocolloid tape 1. When it is desired to attach the hydrocolloid tape 1 to a wound site on the skin, as shown in FIG. 2(A), take out the necessary amount of the hydrocolloid tape 1 from the roll. Then, as shown in FIG. 2(B), while pressing the vicinity of a specific perforation 4 with a finger, pull and cut the hydrocolloid tape 1 with the force of the finger. Then, as shown in FIG. 2(C), place the hydrocolloid tape 1 cut out from the roll on the wound T of the skin S. Then, as shown in FIG. 2(D), attach the hydrocolloid tape 1 to the skin S so that the wound T of the skin S is completely covered with the hydrocolloid tape 1.
[0025] Since the perforations 4 are provided at predetermined intervals in the hydrocolloid tape 1, the hydrocolloid tape 1 corresponding to the size of the wound T can be prepared without using a cutting tool such as scissors. However, since the perforations 4 are provided at predetermined intervals in the hydrocolloid tape 1, the perforations 4 may overlap the position of the wound T. Since exudate may gush out from the wound T, if the perforations 4 overlap the position of the wound T, there is a possibility that the exudate may leak out from the gap at the cut portion of the perforations 4.
[0026] FIG. 3 is an enlarged view of the perforations 4 as seen obliquely. As shown in FIG. 3, the perforations 4 are perforations in which the cut portions 41 that penetrate the film 2 and the uncut portions 42 that do not penetrate the film 2 are arranged alternately. For convenience of processing the perforations 4, the cut portions 41 that penetrate the film 2 are formed in such a form that they penetrate not only the film 2 but also the hydrocolloid material 3. Therefore, if the perforations 4 overlap the position of the wound T, there is a possibility that the exudate may leak out from the gap at the cut portion 41. However, in the hydrocolloid tape 1 of the present embodiment, since the dimensions of the cut portion 41 and the uncut portion 42 are appropriately set as described later, the possibility that the exudate leaks out from the cut portion 41 of the perforations 4 is suppressed as much as possible.
[0027] FIG. 4 is a diagram showing the path through which the exudate leaks out. In FIG. 4, for convenience of explanation, the same reference numerals are given in both the embodiment shown in FIG. 4(A) and the comparative example shown in FIG. 4(B). In the present embodiment in which the dimensions of the cut portion 41 and the uncut portion 42 are appropriately set, as shown in FIG. ********(A), even if the cut portion 41 is provided in the film 2, the flow path of the exudate F passing through the cut portion 41 is blocked by the hydrocolloid material 3. Therefore, in the present embodiment, the possibility that the exudate F leaks out from the cut portion 41 is suppressed as much as possible. 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 passing through the cut portion 41 is not sufficiently blocked by the hydrocolloid material 3, a gap 43 is formed, and there is a possibility that the exudate may leak out from the cut portion 41 of the perforations 4.
[0028] A plurality of types of prototypes with alternating dimensions of the cut portion 41 and the uncut portion 42 were prepared and various evaluations were conducted, and the results are shown below. FIG. 5 is a diagram showing the evaluation results.
[0029] In this evaluation, a roll-shaped hydrocolloid tape with a width of 25 mm and a total length of 3 m was prepared. This hydrocolloid tape uses a release agent-containing PE film with a thickness of 40 μm as the film serving as the base material when laminating the hydrocolloid material, and a hydrocolloid material with a thickness of 80 to 104 μm is laminated on this film. As methods for laminating the hydrocolloid material on the film, there are methods such as directly coating the film, attaching a material coated on a base material other than the film to the film (transfer), and various other methods. On this hydrocolloid tape, perforations with alternating dimensions of the cut portion and the uncut portion were provided at intervals of approximately 20 mm. As the dimensions of the cut portion, four types of 1.0 mm, 1.5 mm, 2.0 mm, and 3.0 mm were set. Also, as the dimensions of the uncut portion, four types of 1.0 mm, 1.5 mm, 2.0 mm, and 3.0 mm were set. Appropriate combination patterns were prepared from these, and as shown in FIG. 5, in the notation of "Prototype Name (Dimension of Cut Portion / Dimension of Uncut Portion)", six types of "Prototype 1 (1.0 mm / 1.0 mm)", "Prototype 2 (1.0 mm / 1.5 mm)", "Prototype 3 (1.0 mm / 3.0 mm)", "Prototype 4 (1.5 mm / 1.5 mm)", "Prototype 5 (2.0 mm / 2.0 mm)", and "Prototype 6 (3.0 mm / 1.0 mm)" were prepared in this evaluation. Since the width of the hydrocolloid tape is 25 mm, the total dimension of the cut portion (total cut portion) and the total dimension of the uncut portion (total uncut portion) in each prototype are as shown in FIG. 5.
[0030] In this evaluation, evaluations were conducted on the following three items. <Difficulty of Tearing During Unwinding This is an evaluation item to confirm that the hydrocolloid tape does not accidentally tear at the perforation part while the roll-shaped hydrocolloid tape is being unwound from the roll. <Ease of cutting> This is an evaluation item to confirm that the hydrocolloid tape can be easily cut with a finger at the perforation part. <Leakage resistance> This is an item to confirm that exudate is less likely to leak during use. In this evaluation, instead of exudate, a hydrocolloid tape was attached so that the perforations overlapped the position of the water droplet on the back of the hand, and the presence or absence of water droplets adhering to the finger was confirmed by pressing the perforations with a finger (sensory evaluation). Since exudate is a secretion, it is considered to be more viscous than water. Therefore, it is considered that water is more likely to leak from fine parts than exudate. Therefore, in this application, if there is no water leakage at the perforations, it is considered that there is no exudate leakage at the perforations.
[0031] As can be seen from the evaluation results in Fig. 5, when the total length of the uncut part was 6 mm, it was found that it would tear during feeding. Also, when the total length of the uncut part was 12 mm or more, it was found that there was no problem in practical use as it did not tear during feeding. From this result, it can be understood that the total length of the uncut part needs to be at least 25% or more of the tape width, and more preferably 48% or more of the tape width.
[0032] Also, as can be seen from the evaluation results in Fig. 5, when the individual length of the uncut part was 3.0 mm or more, it was found that it was not easy to cut the perforations with a finger. Also, when the individual length of the uncut part was 2.0 mm, it was found that it was possible to cut the perforations with a finger. Also, when the individual length of the uncut part was 1.5 mm or less it was found that it was easy to cut the perforations with a finger. From this result, it can be understood that the individual length of the uncut part needs to be at least less than 3.0 mm, preferably 2.0 mm or less, and more preferably 1.5 mm or less.
[0033] Also, as can be seen from the evaluation results in Fig. 5, it was found that when the individual length of the cut portion was 2.0 mm or more, water easily leaked from the gap of the cut portion. Also, when the individual length of the cut portion was 1.5 mm, it was found that water might leak from the gap of the cut portion. Also, when the individual length of the cut portion was 1.0 mm, it was found that water did not leak from the gap of the cut portion. From these results, it can be understood that the individual length of the cut portion needs to be at least less than 2.0 mm, preferably 1.5 mm or less, and more preferably 1.0 mm or less.
[0034] Therefore, from this evaluation result, in the case of a hydrocolloid tape in which a hydrocolloid material with a thickness of 80 to 104 μm is laminated on a PE film with a release agent having a thickness of 40 μm, for the perforations, if the total length of the uncut portions is at least 25% or more of the tape width, the individual length of the uncut portions is at least less than 3.0 mm, and the individual length of the cut portions is at least less than 2.0 mm, it can be understood that the tape can be cut by finger-shearing the perforations without tearing during feeding, and water does not easily leak from the gaps of the cut portions. Also, from this evaluation result, in the case of a hydrocolloid tape in which a hydrocolloid material with a thickness of 80 to 104 μm is laminated on a PE film with a release agent having a thickness of 40 μm, for the perforations, if the total length of the uncut portions is at least 48% or more of the tape width, the individual length of the uncut portions is 1.0 mm or less, and the individual length of the cut portions is 1.0 mm or less, it can be understood that the tape can be easily cut by finger-shearing the perforations without tearing during feeding, and water does not leak from the gaps of the cut portions. Therefore, in this evaluation, it can be said that Prototypes 1, 2, and 4 shown in Fig. 5 are qualified as embodiments.
[0035] This evaluation result depends on the material and thickness of the film, and the composition and thickness of the hydrocolloid material laminated on the film. However, considering that the exudate is less likely to leak than water, for example, even in the case of a hydrocolloid tape using a PE film with a release agent having a thickness of about 20 to 60 μm and laminating a hydrocolloid material with a thickness of about 40 to 200 μm, it is considered that the same effect as the above verification is exhibited.
[0036] In this evaluation, as shown in Fig. 5, the physical properties of the hydrocolloid tape such as tensile strength, peel strength, and maximum shear stress were also measured. Also, for reference, the physical properties of a commercially available plastic tape and a commercially available adhesive bandage that can be torn by hand were measured. Therefore, the measurement results will be described in detail below.
[0037] First, the physical properties related to the difficulty of tearing when unwinding will be explained. The difficulty of tearing when unwinding a roll-shaped hydrocolloid tape from the roll is considered to be greatly related to the tensile strength of the tape itself and the peel strength when the tape separates from the roll (peels off) as physical properties. For example, if the tensile strength is sufficient with respect to the peel strength, it can be said that the tape is difficult to tear at the perforations when unwinding from the roll. Therefore, as shown in the table of Fig. 5, in the evaluation of <difficulty of tearing when unwinding>, the tensile strength and peel strength when pulling out the roll-shaped hydrocolloid tape from the roll were also measured. Since the tensile strength of the tape varies depending on the state of the perforations (the length of the cut part and the uncut part), as shown in the table of Fig. 5, Prototypes 1 to 6 show alternating values. On the other hand, since the peel strength of the tape is uniform regardless of the state of the perforations, as shown in the table of Fig. 5, all of Prototypes 1 to 6 show the same value.
[0038] As can be seen from the evaluation results in Fig. 5, for Prototype 6 that was torn when unwinding, the value obtained by dividing the tensile strength by the peel strength was 0.43. On the other hand, for Prototypes 1 to 5 that were not torn when unwinding, the values obtained by dividing the tensile strength by the peel strength were 0.64 to 0.82, all of which were larger than 0.43 of Prototype 6. Therefore, from this measurement result, regarding the difficulty of tearing when unwinding, the value obtained by dividing the tensile strength by the peel strength (=tensile strength / peel strength) needs to be -1 4.3×10 or more, and more preferably 6.4×10 -1 or more.
[0039] Next, the physical properties related to tearability will be described. When cutting a hydrocolloid tape with a finger at the perforation part, the ease of cutting is considered to be greatly related to the shear stress applied to the tape at the perforation part as a physical property. For example, if the maximum shear stress of the tape at the perforation part is too high, it can be said that it is not easy to cut with a finger. Therefore, as shown in the table of Fig. 5, in the evaluation of <tearability>, the maximum shear stress of the tape at the perforation part was also measured. Since the maximum shear stress of the tape at the perforation part varies depending on the state of the perforation (the lengths of the cut part and the uncut part), as shown in the table of Fig. 5, Prototypes 1 to 6 show alternating values.
[0040] As can be seen from the evaluation results in Fig. 5, in Prototype 3 (the individual length of the uncut part is 3.0 mm or more) where it was possible to cut the perforation with a finger, the maximum shear stress was 2.2 N. On the other hand, in Prototypes 1, 2, 4 to 6 (the individual length of the uncut part is 2.0 mm or less) where it was easy to cut the perforation with a finger, the maximum shear stress was 0.8 to 1.4 N. Also, in Prototypes 1, 2, 4, 6 (the individual length of the uncut part is 1.5 mm or less) where it was even easier to cut the perforation with a finger, the maximum shear stress was 0.8 to 1.4 N. Also, for a commercially available adhesive bandage that is touted as being tearable by hand, the maximum shear stress was 20.6 N. Therefore, from this measurement result, regarding tearability, the maximum shear stress is at least less than 2.1×10 1 N, preferably less than 2.2×10 0 N, and more preferably less than 1.3×10 0 N.
[0041] And it can be said that such numerical ranges of physical properties do not depend on the individual thicknesses of the film and hydrocolloid material that constitute the hydrocolloid tape. For example, since the above numerical range of the physical property related to the difficulty of tearing during unwinding is a relative value obtained by dividing the tensile strength by the peel force, if there is no significant difference in the strength of the film material itself, the thickness of the film, whether large or small, cannot affect the numerical range from an engineering perspective. Also, for example, since the above numerical range related to the ease of manual cutting is an absolute value indicating whether a person can cut the tape with hand force, regardless of whether the film thickness is large or small, it is sufficient that breakage occurs at any location within the film thickness, and the numerical range of the maximum shear stress that allows for manual cutting cannot be affected by the film thickness.
[0042] Therefore, regardless of the individual thicknesses of the film and hydrocolloid material that constitute the hydrocolloid tape, the value obtained by dividing the tensile strength at the perforation by the peel force (= tensile strength / peel force) is 4.3×10 -1 or more, and more preferably 6.4×10 -1 or more. Such a hydrocolloid tape can be said to be difficult to tear during unwinding. Also, regardless of the individual thicknesses of the film and hydrocolloid material that constitute the hydrocolloid tape, the maximum shear stress at the perforation is at least 2.1×10 1 N or less, preferably 2.2×10 0 N or less, and more preferably 1.3×10 0 N or less. Such a hydrocolloid tape can be said to have good ease of manual cutting.
Explanation of Symbols
[0043] 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
1. A tape-shaped film serving as a base material, a hydrocolloid material laminated on one side of the film, and perforations provided in the film, in which cut portions penetrating the film and non-cut portions not penetrating the film are arranged alternately, wherein the perforations are provided for cutting to an appropriate length with respect to a wound site, and an individual length of the cut portions is less than at least 2.0 mm, wherein the hydrocolloid material confines exudate oozing from the wound site for performing wet therapy, A hydrocolloid tape for skin attachment to be attached to a wound site.
2. In the perforations, an individual length of the cut portions is 1.5 mm or less, The hydrocolloid tape for skin attachment to be attached to a wound site according to Claim 1.
3. In the perforations, an individual length of the cut portions is 1.0 mm or less, The hydrocolloid tape for skin attachment to be attached to a wound site according to Claim 1 or 2.
4. In the perforations, an individual length of the non-cut portions is less than 3.0 mm, The hydrocolloid tape for skin attachment to be attached to a wound site according to any one of Claims 1 to 3.
5. In the perforations, an individual length of the non-cut portions is 2.0 mm or less, The hydrocolloid tape for skin attachment to be attached to a wound site according to any one of Claims 1 to 4.
6. In the perforations, an individual length of the non-cut portions is 1.5 mm or less, The hydrocolloid tape for skin attachment to be attached to a wound site according to any one of Claims 1 to 5.
7. In the perforations, a total length of the non-cut portions is 25% or more of a tape width, The hydrocolloid tape for skin attachment to be attached to a wound site according to any one of Claims 1 to 6.
8. In the perforations, a total length of the non-cut portions is 48% or more of a tape width, The hydrocolloid tape for skin attachment to be attached to a wound site according to any one of Claims 1 to 7.
9. The value obtained by dividing the tensile strength by the peel force at the perforation is 4.3×10 -1 or more. The hydrocolloid tape for skin attachment to be attached to a wound site according to any one of Claims 1 to 8.
10. The maximum shear stress at the stitch is less than 2.1×10 1 N, The hydrocolloid tape for skin attachment to be attached to a wound site according to any one of Claims 1 to 9.
Citation Information
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