WO2015174476A1 - Produit de film pour médicament, et procédé de production de film pour médicament - Google Patents

Produit de film pour médicament, et procédé de production de film pour médicament Download PDF

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Publication number
WO2015174476A1
WO2015174476A1 PCT/JP2015/063847 JP2015063847W WO2015174476A1 WO 2015174476 A1 WO2015174476 A1 WO 2015174476A1 JP 2015063847 W JP2015063847 W JP 2015063847W WO 2015174476 A1 WO2015174476 A1 WO 2015174476A1
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WO
WIPO (PCT)
Prior art keywords
net
film
medical
film product
medical film
Prior art date
Application number
PCT/JP2015/063847
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English (en)
Japanese (ja)
Inventor
公一 緒方
Original Assignee
トイメディカル株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by トイメディカル株式会社 filed Critical トイメディカル株式会社
Priority to JP2016519298A priority Critical patent/JP6593930B2/ja
Publication of WO2015174476A1 publication Critical patent/WO2015174476A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0226—Adhesive bandages or dressings with fluid retention members characterised by the support layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0259—Adhesive bandages or dressings characterised by the release liner covering the skin adhering layer

Definitions

  • the present invention relates to a medical film product and a method for manufacturing a medical film product.
  • Medical film products are used in various situations mainly in applications that are applied to the skin, such as fixing catheter punctures and protecting wound surfaces.
  • Conventionally used medical film products usually consist of three members (Patent Document 1 and Patent Document 2). That is, the release liner and the support (carrier) sandwich the film body, and the film body coated with the adhesive has a release liner attached to the adhesive side and the support on the opposite side. Is affixed (FIG. 1, B).
  • a conventional product composed of such three members is used by peeling off the release liner and sticking it to a target site, and then peeling off the support.
  • the film body used in conventional products is generally coated with adhesive on one side of the film base, 7-30 ⁇ m thick transparent polyurethane film as the base, and acrylic, silicone, urethane, rubber as the adhesive. ing.
  • As the support paper, OPP, or PE is used.
  • the conventional product has such a feature that the polyurethane film allows water vapor to pass through without passing through water or bacteria, so that the pasted part can be kept hygienic and difficult to peel off. It is widely used in medical facilities for fixation of vascular indwelling catheters.
  • the polyurethane film has the advantage of being able to follow the skin because of its elasticity, and to observe the applied site because it is colorless and transparent.
  • the conventional product which consists of three members currently widely used in the medical field, there are also demerits.
  • the 7-30 ⁇ m polyurethane film used in the conventional product is thin and has no stiffness, so the operability of the film alone is poor and a support is essential.
  • the film substrate thicker than 30 ⁇ m.
  • the film base is thickened and stiff, it will become irritated and the followability to the skin will be worsened and blisters will be easily formed, and the moisture permeability will be reduced and it will be easy to swell.
  • the present invention has an object to provide a medical film product that eliminates the disadvantages of the conventional product composed of three members.
  • the inventor has attached a predetermined net-like structure to the film substrate, so that it is not a medical film product consisting of three members in the current technological trend, but a support body is not required.
  • Invented a medical film product consisting of two members, and a release liner, and completed an invention relating to a medical film product consisting of two members and a method for producing the same.
  • the inventor has discovered a new problem in the manufacture of the medical film product.
  • the net shape of the net-like structure attached to the film substrate does not necessarily mean that the production efficiency of the product is high, and this raises the manufacturing cost.
  • the inventor has completed the invention relating to an improved medical film product in which the net shape of the net-like structure is improved and the manufacturing efficiency is improved, and a method for manufacturing the same.
  • the present invention has the following configuration.
  • the first configuration of the present invention is a medical film product that does not require a support and is composed of two members, a film body and a release liner, the film body comprising a transparent or translucent film substrate, It consists of a transparent or translucent net-like structure adhering irreversibly and an adhesive layer, and the release liner is affixed to the adhesive layer surface to which the adhesive layer adheres, and the net-like structure is a circle.
  • It is a medical film product characterized by comprising a repeating structure of any of a shape, an ellipse shape, a polygonal shape, or a combination thereof.
  • a second configuration of the present invention is the medical film product according to the first configuration, wherein the net-like structure has a thickness of 30 to 150 ⁇ m.
  • the length of the maximum axis R is 2 to 10 mm, and the length of the minimum axis r is 1 to 7 mm.
  • a fourth configuration of the present invention is the medical film product according to any one of the first to third configurations, wherein the minimum width of the net line in the net-like structure is 0.2 to 2 mm.
  • the medical film product according to any one of the first to fourth aspects wherein the film substrate has a thickness of 5 to 35 ⁇ m.
  • the net shape in the net-like structure is provided with a maximum axis R along the feeding direction of the film body when manufacturing a medical film product, and the minimum axis r
  • a seventh aspect of the present invention is the medical film product according to the sixth aspect, wherein R is 1.2 to 1.8 with respect to r.
  • the net-like structure is made of any one or a combination of polyurethane, polyethylene, polystyrene, polyester, silicone, polyolefin, ethylene acetate copolymer, and acrylate copolymer.
  • the film base is made of polyurethane
  • the net-like structure is made of polyurethane, polystyrene, or a combination thereof. It is.
  • the tenth configuration of the present invention includes a film forming step in which a film material is formed on a support by forming a film base material, and a net-like structure in which the net-like structure is sent out while being bonded to the film base material. And a release liner application step for attaching the adhesive surface of the release liner with adhesive to the film substrate or net-like structure. It is a manufacturing method of the medical film product characterized by including the support body peeling process which peels a body.
  • the eleventh configuration of the present invention is the medical film product manufacturing according to the tenth configuration, wherein the manufactured medical film product is the medical film product according to claim 1. Is the method.
  • the present invention it has become possible to provide a medical film product that eliminates the disadvantages of the conventional product composed of three members. That is, according to the medical film product comprising the two members of the present invention, the operability, followability to the skin, and visibility are not impaired even though the support is unnecessary. In addition, since a support as a member is unnecessary, the manufacturing method can be simplified and the manufacturing cost can be expected to be suppressed.
  • the medical film product of the present invention does not require a support and consists of two members, a film body and a release liner.
  • One is a mode in which an adhesive is applied to the film base and a net-like structure is attached to the surface opposite to the surface where the adhesive is applied in the film body (FIG. 1, A).
  • the other is a mode in which a net-like structure is attached to a film base material and a pressure-sensitive adhesive is subsequently applied to the film base (FIG. 1, B).
  • the medical film product is composed of four layers of a net-like structure, a film substrate, an adhesive, and a release liner.
  • the film substrate is not particularly limited as long as it is a transparent or translucent film material used for medical purposes, and various film materials can be used.
  • various film materials can be used.
  • polyurethane, polyethylene, polystyrene, polyester, silicone, ethylene acetate A copolymer or the like can be used alone or in combination of these materials.
  • Polyurethane is preferably used as the film substrate.
  • the film substrate may be of a thickness that does not impair the ability to follow the skin as a film body.
  • this guideline for example, 5 to 35 ⁇ m is more preferable. Can be from 7 to 20 ⁇ m.
  • the net-like structure is irreversibly attached to the film body by heat or the like, and has a function capable of giving the film body a hardness (beam) to such an extent that the followability to the skin is not lost.
  • the net-like structure is made of a transparent or semi-transparent material, and is a planar structure divided by a plurality of linear structures, and the divided space is circular, elliptical, polygonal. It is defined as a structure consisting of a repetitive structure of any shape or combination thereof.
  • circles, ellipses, and polygons are shapes that include some kind of treatment, and include similar shapes. Like e and f, chamfered and rounded polygons can be mentioned.
  • the net-like structure is not particularly limited as long as it has irreversible adhesion to the film substrate and has a certain hardness, and various transparent or translucent materials can be used.
  • plastic materials such as rubber and plastic May be used.
  • the material for the net-like structure it is preferable to use polyurethane, polyethylene, polystyrene, polyester, silicone, polyolefin, ethylene acetate copolymer, acrylate copolymer, or the like alone or in combination. As a result, it is possible to give a constant beam without greatly impairing the followability of the film body to the skin, and it is easier to change and adjust the shape of the net-like structure. It has the effect of improving the performance and manufacturing efficiency of film products.
  • the film body is polyurethane
  • the net-like structure is polyurethane, polystyrene, or a combination thereof. This combination can make the performance and economical efficiency of the medical film product of the present invention most effective.
  • FIGS. 2 to 4 Examples of the net shape of the net-like structure include the net shapes illustrated in FIGS. 2 to 4.
  • Figure 2 shows an example of a net shape of a square (a), a rhombus (b), a regular hexagon (c), and a vertically long hexagon (d).
  • the gray part indicates a linear structure, and each is shown in white.
  • the polygon which shows is showing the space part. As shown in the figure, it is a net-like structure with repeated polygons of the same shape.
  • FIG. 3 is an example showing a chamfered regular hexagon (e), a chamfered vertically long hexagon (f), a circle (g), and an ellipse (h) net-like structure.
  • FIG. 4 is an example of a combination of two different types of net shapes. As described above, the net-like structure may be a structure in which a plurality of types of net shapes are repeated.
  • the net-like structure is preferably a polygonal repeating structure.
  • a polygonal repeating structure By adopting these polygonal repeating structures, it becomes possible to efficiently and economically manufacture a net-like structure, which has the effect of reducing the manufacturing cost of the medical film product of the present invention.
  • Such a polygonal shape is not particularly limited, and examples thereof include various polygonal shapes such as a quadrilateral, a pentagon, and a hexagon.
  • the net shape configured in the net-like structure needs to have a certain size (area). Thereby, the net-like structure can be made into a structure having a relatively gap, and the visibility of the film main body can be maintained and a constant beam can be given to the film main body.
  • the maximum axis R is provided along the feed direction of the film body when manufacturing a medical film product, and R> r in relation to the minimum axis r More preferably, r is 1 and R is preferably 1.2 to 1.8. Although details will be described later, this increases and stabilizes the production efficiency of the medical film product of the present invention, and thus has the effect of reducing the production cost of the medical film product of the present invention.
  • the width is preferably 0.2 to 2 mm.
  • the linear structure may have a linear structure having a relatively constant width as shown in FIGS. 2a to 2d and e and f of FIG. 3, or the widths as g and h of FIG. May be different. If it has a linear structure with a relatively constant width, the constant width may be adjusted to 0.2-2mm. For linear structures with different widths, the minimum and maximum values can be adjusted to fall within the range of 0.2 to 2 mm.
  • an adhesive usually used for medical film products may be used, and for example, acrylic, silicone, urethane, rubber, etc. may be used.
  • the medical film product manufacturing method includes a film forming process, a net-like structure sticking process, a release liner sticking process, a support peeling process, and these processes as essential processes.
  • the film-forming step is the first step, but in the subsequent steps, it is possible to perform the production by appropriately changing the order in accordance with the embodiment in which the production is performed.
  • the film forming process is a process of forming a film base material by drawing a film material such as polyurethane on a support.
  • the film forming step is not particularly limited as long as the film can be formed, and a normal film forming operation may be performed.
  • the net-like structure sticking step is a step of feeding while attaching the net-like structure to the film substrate.
  • the net-like structure attaching step is not particularly limited as long as these series of operations are possible, and various methods can be adopted.
  • the net-like structure is bonded to the film substrate and fed out while peeling off the support.
  • the method for producing the medical film product of Embodiment 1 first, the support is peeled off from the film substrate to which the release liner is attached. Then, the net-like structure is superposed on the surface of the film substrate on which the support has been adhered, and the film is fed out in a roll shape, heated, and irreversibly attached.
  • the method for producing a medical film product according to Embodiment 2 first, in a film substrate formed on a support, in a roll shape while a net-like structure is superimposed on the surface opposite to the support. Send it out, apply heat, and apply it irreversibly.
  • the maximum axis R is set in the feed direction and that the maximum axis R> the minimum axis r.
  • the release liner attaching step is a step of attaching the release liner to the film substrate or the net-like structure.
  • the release liner attaching step is not particularly limited as long as the release liner can be attached, and a normal release liner attaching operation may be performed.
  • a release liner to which a pressure sensitive adhesive such as silicone is attached may be attached to the film substrate after the film forming process.
  • an adhesive may be attached to the formed film, and then a release liner may be attached.
  • a release liner to which an adhesive such as silicone is attached may be attached to the net-like structure after the net-like structure attaching step. Even in this case, the adhesive may be attached to the net-like structure, and then a release liner may be attached.
  • FIG. 6 is a prototype of the film main body of the medical film product of the present invention shown in Embodiment 1, in which the left is a chamfered regular hexagon (Example 1), and the right is a chamfered vertically long hexagon. (Example 2).
  • the maximum axis R is about 4 mm and the minimum axis r is about 3.5 mm.
  • the maximum axis R is about 5 mm and the minimum axis r is about 3 mm.
  • the reason for the chamfered regular hexagon is unknown, but when it was manufactured, the line portion was kinked, and things that were not formed as products were scattered (Fig. 7, arrow portion).
  • the film and the net roll of the film are peeled off from the support, peeled off and exposed to the polyurethane surface.
  • Manufacture will be performed by sticking and transferring the adhesive surface of the release liner with the adhesive.
  • the disadvantages of this conventional manufacturing method are as follows. (1) Even if a pattern (matte processing) that improves the slipperiness of the surface when affixed to the skin is put on the support, the net can only be attached to the opposite side of the support, so the matting does not become the surface. Sliding does not improve.
  • the pattern of the support is reflected on the film surface, and the support and the polyurethane after the net-like structure is bonded together. This eliminates the need to worry about film peeling, leading to reduced loss and increased process capability.
  • the process of forming a polyurethane film on a support and the process of applying an adhesive are usually carried out at the same factory, so process loss and round trip transportation costs can be suppressed.
  • the transparency was calculated as the reflectance of the reflected light with respect to the incident light. In other words, the closer the reflectance is to 100%, the higher the transparency. 4).
  • the results are shown in FIG. Example 2 showed substantially the same or slightly higher reflectance in the visible wavelength region of 400 to 800 nm than any of the comparative examples, and its value was close to 100%. From this, it was found that the medical film of the present invention has high transparency and no problem in visibility even when compared with a commercial product.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

[Problème] Fournir un produit de film pour médicament, ledit produit de film résolvant l'inconvénient de produits conventionnels qui comprennent 3 composants. [Solution] La présente invention concerne un produit de film pour médicament, ledit produit de film comprenant deux composants, à savoir un corps de film et un revêtement antiadhésif, sans nécessiter un corps de support, et étant caractérisé en ce que : le corps de film comprend un substrat de film transparent à semi transparent, une structure de type filet transparente à semi-transparente qui adhère de façon irréversible au substrat de film, et une couche adhésive ; le revêtement antiadhésif est fixé à une surface de couche adhésive à laquelle la couche adhésive adhère ; et la structure de type filet comprend une structure formée par la répétition d'une forme circulaire, elliptique ou polygonale, ou d'une combinaison de ces formes.
PCT/JP2015/063847 2014-05-16 2015-05-14 Produit de film pour médicament, et procédé de production de film pour médicament WO2015174476A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2016519298A JP6593930B2 (ja) 2014-05-16 2015-05-14 医療用フィルム製品ならびに医療用フィルム製品の製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2014101946 2014-05-16
JP2014-101946 2014-05-16

Publications (1)

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WO2015174476A1 true WO2015174476A1 (fr) 2015-11-19

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WO (1) WO2015174476A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018030447A1 (fr) * 2016-08-09 2018-02-15 日東電工株式会社 Timbre adhésif pour la peau et corps enroulé de patch adhésif pour la peau.
JP6458193B1 (ja) * 2018-08-13 2019-01-23 阿蘇製薬株式会社 絆創膏

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08294527A (ja) * 1995-04-25 1996-11-12 Taki Chem Co Ltd 創傷被覆材及びその製造方法
JPH09502367A (ja) * 1993-07-21 1997-03-11 スミス アンド ネフュー ピーエルシー 外科用ドレッシング
US20020019602A1 (en) * 2000-03-07 2002-02-14 Geng Lisa Fernandez Wound dressing
JP2002069397A (ja) * 2000-08-29 2002-03-08 Ribateepu Seiyaku Kk 粘着テープ及びこれを用いた救急絆創膏、並びに粘着テープの製造方法
JP2004216098A (ja) * 2003-01-15 2004-08-05 Daio Paper Corp 貼付シートまたはテープ
JP2013022244A (ja) * 2011-07-21 2013-02-04 Nitto Denko Corp 医療用粘着テープもしくはシートの製造方法

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09502367A (ja) * 1993-07-21 1997-03-11 スミス アンド ネフュー ピーエルシー 外科用ドレッシング
JPH08294527A (ja) * 1995-04-25 1996-11-12 Taki Chem Co Ltd 創傷被覆材及びその製造方法
US20020019602A1 (en) * 2000-03-07 2002-02-14 Geng Lisa Fernandez Wound dressing
JP2002069397A (ja) * 2000-08-29 2002-03-08 Ribateepu Seiyaku Kk 粘着テープ及びこれを用いた救急絆創膏、並びに粘着テープの製造方法
JP2004216098A (ja) * 2003-01-15 2004-08-05 Daio Paper Corp 貼付シートまたはテープ
JP2013022244A (ja) * 2011-07-21 2013-02-04 Nitto Denko Corp 医療用粘着テープもしくはシートの製造方法

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018030447A1 (fr) * 2016-08-09 2018-02-15 日東電工株式会社 Timbre adhésif pour la peau et corps enroulé de patch adhésif pour la peau.
JP6458193B1 (ja) * 2018-08-13 2019-01-23 阿蘇製薬株式会社 絆創膏

Also Published As

Publication number Publication date
JPWO2015174476A1 (ja) 2017-04-20
JP6593930B2 (ja) 2019-10-23

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