The present invention relates to a method of manufacturing a wound treatment medical tape for a physiological tension, and more particularly, to a method of manufacturing a wound treatment medical tape having an internal stress holding portion.
A hurt formed by damaging part of a human body is called “injury”. The “injury” can be roughly classified into a “wound” which is an opened injury formed by cutting with a sharp knife or the like and “bruise” which is a closed injury formed by hitting with a blunt instrument or the like. Conventionally, in the field of the medical services, when a bottom of a wound which is an opened damage is shallow, treatment of closing and fixing the wound with an adhesive plaster, bandage, or the like is employed. When the wound bottom is deep, treatment of closing and fixing the wound with a suture thread or the like is widely employed.
In addition, the skin can be classified into three layers of the epidermis, the dermis, and the subcutaneous tissue from the upper layer. In general skin suturing, the three layers are sutured at once. Therefore, when a thick suture thread is used, a conspicuous scar is left on the skin surface in many cases. When a thin suture thread is used, wound dehiscence caused by an external force tends to increase. In order to prevent such a problem, “dermis suturing” has been selected and widely used as a suturing method. The dermis suturing is a suturing method in which the epidermis as a first layer of the skin is not sutured, but the dermis as a second layer and the subcutaneous tissue as a third layer are sutured. A suturing method in which only the epidermis as a first layer is sutured after dermis suturing is called “epidermis suturing”. In addition, in the dermis suturing, a thick suture thread (absorbent thread) that does not require thread removal is used, and a thin suture thread is selected for the epidermis suturing to minimize a scar on the skin surface.
However, even when the wound is closed and fixed through this treatment, the wound is re-opened often. Hereinafter, an event that “the wound that has been closed and fixed once is re-opened” will be referred to as “wound dehiscence”. One of the causes of the wound dehiscence is a “physiological and static sustained tension” (hereinafter, referred to as a “physiological tension”) caused by the skin and underlying muscles of the tissue surrounding the wound or the like, which acts on the tissue around the wound in the “direction of re-opening the wound” (hereinafter, referred to as a “dehiscence direction”).
Here, the wound dehiscence or the physiological tension will be described. Note that, in order to compare whether or not there is a physiological tension, “non-deteriorated tanned leather (animal hide)” is used as a sample not having the physiological tension. A non-deteriorated tanned leather having a length of 15 cm, a width of 10 cm, and a thickness of about 2 mm is prepared, and an incision having a straight line shape is made in the central part of the tanned leather with a surgical scalpel to a length of about 3 cm and a depth of about 1.5 mm. Then, the incision is sutured with a suture thread as in the case where a “skin of a living body” has an equivalent incision wound. In this case, when the suture thread is pulled with a strong force, the suture thread is broken, or the tanned leather is torn. This is also similarly applied to a case where the “skin of a living body” has an equivalent incision. When the suture thread is pulled with a strong force, the suture thread is broken, or the skin of a living body is torn. This is due to an immature stitching technique in the case of tanned leather, and an immature suturing technique in the case of skin. This problem is addressed by mastering a correct technique.
Even when the incised part of the tanned leather is stitched and closed on the basis of an appropriate stitching technique, the suture thread is broken, or the tanned leather is torn by pulling the tanned leather with a strong force perpendicularly to the close direction. Similarly, even when the incised wound of the skin is sutured with an appropriate suturing technique to close the wound, the suture thread is broken, or the skin of a living body is torn by applying a strong force to the wound in the dehiscence direction. When this happens unintentionally, the cause is an accident caused by an external force, and this is addressed by a preventive measure. This is a common phenomenon between the non-deteriorated tanned leather and the skin of a living body.
Here, the physiological tension will be visualized with reference to
Next, the shape of the incision will be compared. In the case of tanned leather, the part incised with a surgical scalpel in a straight line shape is broken, but the shape of the incision remains linear in a straight line shape. In contrast, when the skin of a living body is incised in a straight line shape with a surgical scalpel, the wound shape is not limited to the straight line shape, and becomes an oval open shape as shown in the wound surface 7 of
In addition, comparing a thread spacing or a tightening state between the stitching of tanned leather and the suturing of the skin of a living body, in the case of the suturing of skin of a living body, the coarse spacing of the sutured thread of the skin around wound produces a better prognosis than the dense spacing. Therefore, the spacing becomes inevitably coarser, and the tightness of the suture thread is loosened to prevent overtightening. For this reason, when a wound that has been successfully sutured undergoes dehiscence several days later, the patient may easily attribute the cause to the doctor’s immature suturing technique, and the doctor may easily attribute it to the patient’s carelessness. Therefore, they do not think that the cause is the physiological tension, and a trouble often occurs between the patient and the doctor. Accordingly, presence of the physiological tension in the suturing causes the doctor’s annoyance. Note that, for wound dehiscence caused by necrosis of the skin or the like around the sutured wound due to poor circulation of blood or the like (medical tool compression wound caused by a suture thread), no effect is expected even by performing suturing again, and it is necessary to switch to conservative treatment in which all suture threads are removed, necrotic tissues are excised, the wound is covered with a covering to expect autotherapy in many cases. This is caused by the physiological tension acting on the skin around the wound, and is addressed by preventing the physiological tension acting on the skin around the wound. However, it is not easy to eliminate or reduce the physiological tension acting on the skin around the wound. Therefore, it was difficult to prevent wound dehiscence caused by the physiological tension acting in the dehiscence direction.
In some documents, a dehiscence prevention assistance tool having a function of consistently reducing the physiological tension in the dehiscence direction received by the tissue around the sutured wound and the tension acting on the suture thread associated with the physiological tension has been proposed (for example, see Patent Document 1). In this technique, a dehiscence prevention portion formed of elastic bare woven fabric (89% cotton and 11% polyurethane) is applied to the forearm by a holding portion having a function of holding the dehiscence prevention portion in close contact with the wound and the tissue around the wound by virtue of friction generated between the sutured part and the skin around the sutured part in order to reduce the physiological tension acting in the dehiscence direction. However, in the example of the dehiscence prevention assistance tool described in Patent Document 1, a twill weave fabric using cotton threads having no elastic function is thinned and is used as a string. Therefore, when the string is too strongly tightened, it will cause a pain to the patient. When the string is too weakly tightened, it is difficult to efficiently reduce the physiological tension acting in the dehiscence direction. Accordingly, it is not easy to efficiently reduce the physiological tension with a conventional dehiscence prevention assistance tool, and there has been no means for appropriately addressing such a disadvantage in the current situation.
Patent Document 1: Japanese Patent No. 4790091
In view of the aforementioned problems, it is therefore an object of the present invention to provide a method of manufacturing a wound treatment medical tape capable of providing a high effect of preventing wound dehiscence by reducing a physiological tension acting on a wound and skin around the wound in a dehiscence direction, and easy to use and apply regardless of whether the wound is sutured or not.
In order to address the aforementioned problems, the inventor made diligent studies over and over and completed the present invention as a result. Specifically, a wound treatment medical tape obtained through the manufacturing method according to the present invention has an elastic base member portion that covers a wound and a skin around the wound and has an elastic function, an adhesion portion having a function of applying and holding the elastic base member portion to the skin, a release portion having a function of protecting the adhesion portion, and an internal stress holding portion having a function of holding an effective shrink force in the elastic base member portion. The internal stress holding portion, the elastic base member portion, the adhesion portion, and the release portion are provided in this order from a bottom layer. In addition, a method of manufacturing the medical tape obtained through the manufacturing method according to the present invention includes, in a manufacturing process of the medical tape, a step of applying a solution polymer for making the elastic base member portion to an upper layer of the internal stress holding portion; a step of subsequently holding the effective shrink force in the elastic base member portion with the internal stress holding portion by completing a film formation of the solution polymer with the effective shrink force being held in the elastic base member portion and concurrently completing a lamination of the elastic base member portion and the internal stress holding portion; and a step of subsequently laminating the adhesion portion and the release portion on a surface of the elastic base member portion opposite to the internal stress holding portion. In addition, the method releases the effective shrink force existing in the elastic base member portion by removing the internal stress holding portion at a time of use. In the medical tape manufacturing method according to the present invention, any step other than those described above may be arbitrarily added without a particular limitation as long as the effects of the present invention can be obtained. Note that the effective shrink force refers to a shrink force, which can be obtained through the manufacturing process according to the present invention, is held in the elastic base member portion by a function of the internal stress holding portion, and can be released by removing the internal stress holding portion at the time of use, so that the elastic base member portion is shrunken by the released shrink force in a direction resisting the physiological tension to reduce the physiological tension.
In the wound treatment medical tape obtained through the manufacturing method according to the present invention, a means for consistently reducing the physiological tension acting on the sutured wound and the skin around the wound in the dehiscence direction is incorporated as a function of the wound treatment medical tape, and particularly, its shape is a tape. As a result, it is possible to apply the medical tape by covering the sutured wound and the skin around the wound, efficiently reduce the physiological tension, and provide a function of consistently reducing the physiological tension acting on the sutured wound and the skin around the wound in the dehiscence direction. In addition, in the medical tape manufacturing process, a function of holding the effective shrink force in the elastic base member portion is provided. At the time of use, the medical tape can be applied to the skin with the effective shrink force being held in the elastic base member portion. Furthermore, by removing the internal stress holding portion after applying the adhesion portion to the skin, the effective shrink force held in the elastic base member portion is released to the wound and the skin around the wound to which the adhesion portion is applied. The released effective shrink force efficiently acts in the direction resisting the physiological tension applied in the dehiscence direction, so that the elastic base member portion is shrunken in the direction resisting the physiological tension, and the wound and the skin around the wound are shrunken in the direction resisting the physiological tension applied in the dehiscence direction. As a result, it is possible to slightly loosen the skin around the sutured wound from the direction resisting the dehiscence direction to the sutured wound and consistently reduce the physiological tension acting on the skin around the sutured wound in the dehiscence direction and the tension acting on the suture thread in association with the physiological tension. Furthermore, since the medical tape has a function of reducing the physiological tension on the entire surface, and can be applied by covering the skin as a surface, the released effective shrink force acts not only on the wound and the skin around the wound covered with the medical tape, but also on the skin around a medical tape application portion, so as to generate a force of attracting the skin around the wound caused by the effective shrink force. As a result, it is possible to stably retain the wound and its surrounding tissue, consistently reduce the physiological tension, prevent wound dehiscence, and remove necessity of suturing depending on the wound condition in some cases. In addition, it is possible to prevent dehiscence of a wound that is generally difficult to suture, such as a contusion or bite wound. Furthermore, it is possible to stably retain the wound and its surrounding tissues and accelerate autotherapy regardless of whether the wound is sutured or not. According to the medical tape manufacturing method according to the present invention, it is possible to efficiently manufacture the medical tape.
In the process of diligent studies, the inventor found that it is important to consistently reduce the physiological tension acting on a skin around the sutured wound or the suture thread in the dehiscence direction in order to prevent dehiscence of the sutured wound. In addition, it is also necessary to stably hold the skin around the sutured wound in order to accelerate autotherapy after suturing. However, it is difficult to stably hold the suture thread because the skin around the sutured wound is consistently subjected to the physiological tension in the dehiscence direction.
Here, consistently reducing the physiological tension acting on the skin around the sutured wound in the dehiscence direction and the tension acting on the suture thread associated with the physiological tension by slightly loosening the skin around the sutured wound for the sutured wound from the direction resisting the dehiscence direction becomes an effective means for preventing the wound dehiscence caused by suture thread cutting subsequent to the suturing and the wound dehiscence caused by necrosis or the like of the skin around the sutured wound by the suture thread. By incorporating this effective means into a function of the wound treatment medical tape in the form of a surface covering to the skin, it is possible to provide a function of reducing the physiological tension on the entire surface and apply the tape by covering the sutured wound and the skin around the wound as a surface. Therefore, it is possible to consistently reduce the physiological tension acting on the skin around the sutured wound in the dehiscence direction and the tension acting on the suture thread associated with the physiological tension and prevent wound dehiscence caused by suture thread cutting subsequent to suturing and wound dehiscence caused by necrosis or the like of the skin around the sutured wound by the suture thread. In addition, since it is possible to consistently reduce the physiological tension acting on the dehiscence direction, it is possible to eliminate necessity of the suturing depending on the wound condition and expect dehiscence prevention for a wound generally difficult to suture, such as a contusion or bite wound. Furthermore, it is possible to stably hold the skin around the wound regardless of whether the wound is sutured or not and accelerate autotherapy. From this point of view, it is recognized that, in the conventional dehiscence prevention assistance tool, the physiological tension acting on the tissue around the sutured wound or the physiological tension acting on the suture thread in the dehiscence direction has not been considered.
In this regard, in order to provide a wound treatment medical tape formed by incorporating a function of consistently reducing the physiological tension acting on the skin around the sutured wound in the dehiscence direction and the tension acting on the suture thread associated with the physiological tension into the manufacturing process, the inventor selected materials of this medical tape as follows. That is, the inventor selected, as a material of the elastic base member portion that covers the wound and the skin around the wound and has an elastic function, a solution polymer material that is usable for a medical purpose and capable of providing an elastic function after a film formation and having an effective shrink force generated by an internal stress associated with forming shrinkage, resisting the physiological tension acting on the skin around the sutured wound in the dehiscence direction. In addition, as a material of the internal stress holding portion, an inelastic material to an upper layer of which the solution polymer for making the elastic base portion was applied in the manufacturing procedure and which had a function of holding the effective shrink force in the elastic base portion was selected. Then, as a material of the adhesion portion, a medical adhesive that has a function of applying and holding the elastic base member portion to the skin and has less adhesive residue and keratin damage at the time of releasing was selected. In addition, as the material of the release portion, a release sheet having a function of protecting the adhesion portion was selected. The inventor proposed an idea for a method of manufacturing the wound treatment medical tape by using functions having each material.
In the manufacturing process for the wound treatment medical tape by combining these materials, the wound treatment medical tape is obtained through a step of applying a solution polymer for making the elastic base member portion to the upper layer of the internal stress holding portion, a step of subsequently completing the film formation of the solution polymer with the effective shrink force being provided in the elastic base member portion, and completing a lamination of the elastic base member portion and the internal stress holding portion to hold the effective shrink force in the elastic base member portion with the internal stress holding portion, and a step of subsequently laminating the adhesion portion and the release portion on a surface of the elastic base member portion opposite to the internal stress holding portion.
The medical tape obtained through the manufacturing method according to the present invention has the internal stress holding portion, the elastic base member portion, the adhesion portion, and the release portion sequentially from the bottom. At the time of use of the wound treatment medical tape according to the present invention, the release portion is removed, the wound and the skin around the wound are covered with the elastic base member portion, and the adhesion portion is applied to the skin. Then, the internal stress holding portion is removed. Since the internal stress holding portion has a role of holding the effective shrink force existing in the elastic base member portion inside the elastic base member portion, the effective shrink force held in the elastic base member portion is released to the wound and the skin around the wound to which the adhesion portion is applied by removing the internal stress holding portion. In this case, the released effective shrink force efficiently acts in the direction resisting the physiological tension applied in the dehiscence direction to shrink the elastic base member portion in the direction resisting the physiological tension and shrink the wound and the skin around the wound in the direction resisting the physiological tension applied in the dehiscence direction. In addition, this makes it possible to consistently reduce the physiological tension acting on the skin around the sutured wound in the dehiscence direction and the tension acting on the suture thread associated with the physiological tension by slightly loosening the skin around the sutured wound from the direction resisting the dehiscence direction to the sutured wound. Therefore, it is possible to incorporate the means for consistently reducing the physiological tension acting on the skin around the sutured wound or the suture thread into the manufacturing process as a function of the wound treatment medical tape and cover and apply the medical tape onto the sutured wound and the skin around the wound as a surface by providing a function of reducing the physiological tension on the entire surface. Therefore, it is possible to efficiently reduce the physiological tension. In addition, it is possible to prevent wound dehiscence by slightly loosening the skin around the sutured wound from the direction resisting the dehiscence direction to the sutured wound and consistently reducing the physiological tension acting on the skin around the sutured wound in the dehiscence direction and the tension acting on the suture thread associated with the physiological tension by virtue of the effective shrink force. The inventor completed the present invention on the basis of such knowledge. The term “slightly loosening the skin around the wound” as used herein does not necessarily mean a visually recognizable level, but also includes an insignificant level recognizable by using a magnification lens or microscope. In addition, the term “tape” as used herein refers to a thin band-shaped tape having a narrow width, but the shape is not limited thereto depending on the use purpose.
In the wound treatment medical tape obtained by the manufacturing method according to the present invention, a solution polymer for making the elastic base member portion is applied to the upper layer of the internal stress holding portion. In this case, focusing on the cross-sectional shape of the solution polymer, an upper base of the solution polymer not attached to the internal stress holding portion and a lower base of the solution polymer appropriately attached to the internal stress holding portion in a laminated state have the same length and a rectangular shape (
Examples of the present invention will be described hereinafter in details with reference to the accompanying drawings, but the present invention is not limited thereto. According to the present invention, in a process of appropriately selecting, combining, and manufacturing materials of the wound treatment medical tape, an inelastic plate-shaped plastic film having a function of holding an internal stress associated with forming shrinkage in the elastic base member portion is selected as the internal stress holding portion. A solution polymer (urethane resin liquid and cross-linking agent liquid) as a material of a polyurethane film for making the elastic base member portion is applied to the upper layer of the internal stress holding portion (
According to the first embodiment of the present invention as illustrated in
In the manufacturing process of the wound treatment medical tape, as shown in
Specifically, according to the first embodiment of the present invention, the urethane resin liquid and the cross-linking agent liquid are selected as the solution polymer 1, the polyurethane film formed of the solution polymer 1 to cover the wound and the skin around the wound and provide an elastic function is selected as the elastic base member portion 2, an acrylic adhesive having a function of applying and holding the elastic base member portion 2 to the skin is selected as the adhesion portion 3, a release sheet obtained by coating a release agent on a surface of high-quality paper having a function of protecting the adhesion portion 3 is selected as the release portion 4, and an inelastic plate-shaped plastic film having a function of holding the internal stress associated with forming shrinkage in the elastic base member portion 2 is selected as the internal stress holding portion 5. In the manufacturing process, the urethane resin liquid and the cross-linking agent liquid as the solution polymer 1 are applied to the upper layer of the inelastic plate-shaped plastic film as the internal stress holding portion 5. Then, in order to complete the film formation of the solution polymer 1 with the effective shrink force being provided in the elastic base member portion 2, the film formation is performed by rapidly curing the solution polymer 1 so that the elastic base member portion 2 is obtained. Concurrently, a lamination of the elastic base member portion 2 and the internal stress holding portion 5 is completed, so that the effective shrink force is held in the elastic base member portion 2 by the internal stress holding portion 5. As a result, the upper base 1a of the solution polymer is not attached to the internal stress holding portion 5, so that it is slightly shrunken as the solution polymer 1 is cured. The lower base 1b of the solution polymer appropriately attached while being laminated with the internal stress holding portion 5 concurrently with the film formation of the elastic base member portion 2 is not shrunken along with the curing. In addition, the cross-sectional shape of the elastic base member portion 2 after the film formation is trapezoidal such that the upper base 2a of the elastic base member portion is slightly shorter than the lower base 2b of the elastic base member portion. This shows that the upper base 1a of the solution polymer is not freely shrunken by rapidly curing and a film formation of the solution polymer 1, the film formation of the solution polymer 1 is completed with the effective shrink force being provided in the elastic base member portion 2, and a lamination of the elastic base member portion 2 and the internal stress holding portion 5 is completed concurrently, so that the effective shrink force can be held in the elastic base member portion 2 by the internal stress holding portion 5. Then, the acrylic adhesive as the adhesion portion 3 and the release sheet obtained by coating a release agent on a surface of high-quality paper as the release portion 4 are provided sequentially on the surface of the elastic base member portion 2 opposite to the internal stress holding portion 5.
The urethane resin liquid and the cross-linking agent liquid are used as a material of the solution polymer in the first embodiment. Alternatively, any solution polymer material or other new materials may be employed, or another solution polymer material may be mixed or laminated, as long as the effective shrink force can be held in the elastic base member portion by the internal stress holding portion by applying it to the upper layer of the internal stress holding portion, completing the film formation of the solution polymer with the effective shrink force being provided in the elastic base member portion, and concurrently completing a lamination of the elastic base member portion and the internal stress holding portion. In addition, an inelastic plate-shaped plastic film formed in the flat shape having a function of holding the effective shrink force in the elastic base member portion is employed as a material of the internal stress holding portion. Alternatively, a cut may be inserted into the plate-shaped plastic film depending on application or convenience, a band-shaped tape covering the cut may be employed, or any material or shape may be employed without a limitation as long as it has a function of holding the effective shrink force in the elastic base member portion. In addition, an acrylic adhesive is employed as a material of the adhesion portion. Alternatively, any adhesive may be employed as long as it has a function of applying and holding the elastic base member portion to the skin and is usable for medical purposes. In addition, a portion to which the adhesive is applied may be a part or the entire surface depending on application, and its material, shape, or the like is not limited. Furthermore, while a release sheet formed by coating a release agent on a surface of high-quality paper is employed as a material of the release portion, any material may be employed as long as it has a function of protecting the adhesion portion. For example, the release portion may be formed by coating a release agent on a surface of the elastic base member portion opposite to the internal stress holding portion, a package such as a wrapping sheet may be employed as the release portion, and its material, shape, and the like are not limited. Note that the materials of each part of the wound treatment medical tape, a combination of the materials, functions to be added, and the like may be arbitrary depending on the application, design, convenience, or the like, without any limitation as long as the effects of the present invention can be achieved.
Next, a method of manufacturing the wound treatment medical tape according to the second embodiment of the present invention will be described with reference to
All of the medical tapes obtained through the manufacturing methods according to the present invention as shown in
In the first embodiment described hereinbefore, the wound treatment medical tape has a rectangular shape. However, the shape of the medical tape may be selected freely depending on the application. For example, the medical tape may have a roll shape or sheet shape and may be appropriately shaped depending on each part of a patient’s body. In addition, this medical tape basically has the internal stress holding portion, the elastic base member portion, the adhesion portion, and the release portion from the bottom. However, a gauze, pad, or the like may be provided on the upper layer of the adhesion portion depending on the application, design, convenience, and the like. Note that, although the medical tape according to the present invention is basically closely applied to skin, the medical tape may be applied by inserting a protective material for protecting skin from a medical adhesive or the like in some cases.
Next, the physiological tension or the wound dehiscence associated with the suture thread used to suture a wound and a use method or effect of the wound treatment medical tape according to the second embodiment of the present invention will be described with reference to
According to the manufacturing method of the wound treatment medical tape of the present invention, the effective shrink force is held in the elastic base member portion during the manufacturing process, and at the time of use, the medical tape covers the sutured wound and the skin around the wound as a surface with the effective shrink force being held in the elastic base member portion, and is applied to the skin with the adhesion portion, and the internal stress holding portion is removed. As a result, the effective shrink force in the elastic base member portion is released, so as to allow the effective shrink force to efficiently act in the direction resisting the physiological tension applied in the dehiscence direction, reduce the physiological tension acting on the skin around the sutured wound in the dehiscence direction, and provide a high effect in wound dehiscence prevention. Therefore, it is possible to provide a method of manufacturing the wound treatment medical tape easy to use and apply regardless of whether or not the wound is sutured, and the present invention greatly contributes to the medical industry.
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Number | Date | Country | Kind |
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2021-129983 | Aug 2021 | JP | national |
Filing Document | Filing Date | Country | Kind |
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PCT/JP2022/012133 | 3/17/2022 | WO |