WO2014003002A1 - マイクロニードルパッチの保護離型シート - Google Patents
マイクロニードルパッチの保護離型シート Download PDFInfo
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- WO2014003002A1 WO2014003002A1 PCT/JP2013/067387 JP2013067387W WO2014003002A1 WO 2014003002 A1 WO2014003002 A1 WO 2014003002A1 JP 2013067387 W JP2013067387 W JP 2013067387W WO 2014003002 A1 WO2014003002 A1 WO 2014003002A1
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- WIPO (PCT)
- Prior art keywords
- release sheet
- protective release
- microneedle
- hole
- protective
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
-
- 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
- A61F13/00051—Accessories for dressings
- A61F13/00072—Packaging of dressings
- A61F13/00076—Packaging of adhesive dressings
- A61F13/0008—Packaging of adhesive dressings having means for facilitating the removal of the packaging and release liner
-
- 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
- A61F13/00051—Accessories for dressings
- A61F13/00072—Packaging of dressings
- A61F13/00076—Packaging of adhesive dressings
-
- 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
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/56—Supporting or fastening means
- A61F13/5605—Supporting or fastening means specially adapted for sanitary napkins or the like
- A61F13/5616—Supporting or fastening means specially adapted for sanitary napkins or the like using flaps, e.g. adhesive, for attachment to the undergarment
-
- 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
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/56—Supporting or fastening means
- A61F13/58—Adhesive tab fastener elements
- A61F13/60—Adhesive tab fastener elements with release means associated with tab fasteners
-
- 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
- A61F2013/00361—Plasters
- A61F2013/00795—Plasters special helping devices
- A61F2013/008—Plasters special helping devices easy removing of the protection sheet
-
- 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
- A61F2013/00361—Plasters
- A61F2013/00795—Plasters special helping devices
- A61F2013/008—Plasters special helping devices easy removing of the protection sheet
- A61F2013/00812—Plasters special helping devices easy removing of the protection sheet perforate or breakable zones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0046—Solid microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/06—Packaging for specific medical equipment
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- F04C2270/00—Control; Monitoring or safety arrangements
- F04C2270/04—Force
- F04C2270/042—Force radial
- F04C2270/0421—Controlled or regulated
Definitions
- the present invention relates to a protective release sheet for microneedle patches.
- Non-Patent Document 1 There are two methods for administering drugs to the human body: oral administration and transdermal administration.
- a typical transdermal administration method is injection, but since injection is painful and may cause infection, it is an unwelcome technique.
- a transdermal administration method using a microneedle array without causing pain has recently attracted attention (Patent Document 1, Non-Patent Document 1).
- the skin stratum corneum acts as a barrier for drug permeation, and simply applying the drug to the skin surface does not allow the drug to permeate sufficiently.
- a microneedle by perforating the stratum corneum using a fine needle, that is, a microneedle, the drug permeation efficiency can be remarkably improved as compared with the coating method.
- a microneedle array is a large number of microneedles integrated on a substrate.
- the product is easy to use with an adhesive sheet for attaching the microneedle array to the skin and a protective release sheet for protecting the adhesive sheet and supporting the microneedle array on the skin. This is called a microneedle patch.
- the pressure-sensitive adhesive sheet refers to a film, cloth or paper coated with a pressure-sensitive adhesive.
- a microneedle is made of a material that dissolves in the body and disappears by metabolism, such as carbohydrates, even if the needle breaks and remains in the skin, no accident will occur.
- the drug is contained in the sugar, the inserted microneedle is dissolved in the body, so that the drug can be easily administered intracutaneously or subcutaneously (Patent Document 2).
- the protective release sheet is attached to the adhesive surface of the microneedle patch.
- the microneedle patch is attached to the back of the adhesive sheet (the surface without the adhesive) and the protective release sheet with your fingers. Hold it and apply it to the skin while peeling off the protective release sheet.
- peeling off the protective release sheet the finger should not be brought into contact with the microneedle.
- a protective release sheet is usually pasted on the entire surface of the adhesive. At this time, a cutting line is put in the protective release sheet, the protective release sheet is held by hand, the entire patch is bent outwardly, and the protective release sheet is peeled off and the patch is applied to the skin. Yes.
- the substrate of the microneedle array was hard and could not be bent outwardly, it was impossible to peel off the protective release sheet while bending.
- a microneedle array having a flexible substrate has been developed, and a device for facilitating the skin application of the microneedle patch is required.
- the protective release sheet and the back surface of the adhesive sheet are sandwiched between fingers, and the protective release sheet is peeled off from the microneedle patch and applied to the skin.
- the protective release sheet is peeled off, there is a risk that the finger comes into contact with the adhesive surface or the microneedle and the microneedle is soiled.
- the protective release sheet of the microneedle patch according to the present invention made to solve the above problems has a hole on the inside, and one or more cutting lines from the outer edge of the protective release sheet toward the hole. It is characterized by having.
- the protective release sheet has holes because it is difficult to cover the microneedle with the protective release sheet, and the microneedle patch requires different considerations from ordinary patches that do not use microneedles. It is.
- the size of the hole in the protective release sheet is preferably larger than that of the microneedle patch so as not to damage the needle of the microneedle patch, and the microneedle array preferably fits completely in the hole.
- the hole is preferably smaller than the pressure-sensitive adhesive sheet and covers the periphery of the pressure-sensitive adhesive sheet.
- the hole in the protective release sheet can be made slightly larger than the microneedle array.
- a plurality of microneedle arrays can be held by one protective release sheet.
- the cutting lines are arranged symmetrically on both sides of the hole.
- the cutting line basically connects the outer edge of the protective release sheet and the hole, and it does not matter whether it is connected linearly or curvedly.
- the number of cutting lines is typically two for one hole, but can be one or three.
- the cutting line does not need to be accurately directed toward the center of the hole, and may be at a position or direction slightly deviated from the center of the hole. In some cases, it is convenient to have a cutting line from one hole to another.
- the cutting line may be a slit that has already been cut, or may be a line that can be easily cut off with perforations.
- the cut may be linear or curved.
- the microneedle of the present invention is made of a substance dissolved in a living body such as hyaluronic acid or collagen, and the length of the microneedle is typically 30 to 1000 ⁇ m.
- the size of the substrate of the microneedle array is not particularly limited, but is typically a substrate area of 0.5 to 40 cm 2 and a substrate thickness of 10 to 2000 ⁇ m.
- the shape can be various shapes such as a circle, an ellipse, a ball shape, and a face mask.
- the protective release sheet polyester, polyolefin, paper, or the like that has been subjected to release treatment can be used, and the shape is not limited, but a hole larger than the microneedle patch in the center and smaller than the adhesive sheet is used. It is necessary to be.
- the thickness is 30 to 1,000 ⁇ m, preferably 50 to 500 ⁇ m. If the thickness is less than 30 ⁇ m, it is inconvenient to handle, and if it is 1,000 ⁇ m or more, it is too thick to make it difficult to peel off the protective release sheet.
- the adhesive sheet of the microneedle patch can be made of polyurethane, polyethylene, polyester, paper or the like as a base material, and is an acrylic or rubber adhesive applied to a film of 5 to 50 ⁇ m in thickness to 5 to 50 ⁇ m.
- the shape is not particularly limited, a circular shape, an elliptical shape, a slanted ball shape, and a face shape are preferable in a manner similar to the shape of the microneedle array.
- a symbol indicating that the protective release sheet should be peeled off from the position may be put on one side or both sides of the cutting line of the protective release sheet. As the symbol, an arrow is suitable for easy understanding.
- the microneedle patch is stored in a protective case and stored and transported as a microneedle patch system. It is necessary to use a protective case with a lid that has a structure in which the needle surface is floated and fixed so that the protective case is protected and not damaged. As a specific method for that purpose, it is preferable to sandwich the protective release sheet between the first and second case members from above and below to support the microneedle patch.
- the protective case is preferably prepared by heat compression molding of a polyester sheet.
- microneedle patch When attaching the microneedle patch to the skin by providing a cutting line on the protective release sheet, hold both sides of the cutting line of the protective release sheet in both hands and bend the microneedle patch outward with one hand.
- the microneedle patch with an adhesive sheet can be peeled off from the protective release sheet and easily applied to the skin. As a result, it is possible to prevent accidents such as contacting the microneedles with a finger and soiling the microneedle.
- microneedle array By providing a gap between the protective release sheet and the microneedle array, it is possible to prevent the microneedle array from being torn when the protective release sheet is vigorously peeled off. Thereby, a microneedle patch can be handled safely.
- ⁇ Handling of the microneedle patch is facilitated by providing a cut at the position of the cutting line at the outer edge of the protective release sheet or by attaching an arrow. As a result, even a person unaccustomed to handling the microneedle patch can easily apply the microneedle array to the skin.
- FIG. 1 is a view of a protective release sheet for one microneedle array.
- FIG. 1A is a cross-sectional view
- FIG. 1B is a plan view.
- FIG. 2 is an illustration of a microneedle patch having a protective release sheet with longitudinal cut lines on both sides of the microneedle array.
- FIG. 3 is a diagram of a microneedle patch in which the cutting line of the protective release sheet is perforated and arrows are inserted on both sides of the cutting line.
- FIG. 4 is a view of a protective release sheet for two microneedle arrays.
- FIG. 5 is a diagram of another example of a protective release sheet for two microneedle arrays.
- FIG. 6 is a diagram of a third example of a protective release sheet for two microneedle arrays.
- FIG. 7 is a diagram of a fourth example of a protective release sheet for two microneedle arrays.
- FIG. 8 is a diagram of a fifth example of a protective release sheet for two microneedle arrays.
- FIG. 9 is a diagram of a sixth example of a protective release sheet for two microneedle arrays.
- FIG. 10 is a schematic cross-sectional view in which a microneedle patch is housed in a protective case.
- Example 1 The microneedle patch of this example is shown in FIG. As shown in FIG. 1, the microneedle array 11 has an elliptical planar shape, and has a width of about 65 mm and a length of 30 mm. The microneedle 11a is provided on a flexible microneedle array substrate 11b, and the entire microneedle array can be deformed according to the unevenness of the skin.
- the size of the microneedle is not limited, but about 50 to 500 needles / cm 2 with a length of 30 to 1000 ⁇ m are provided.
- the main component is hyaluronic acid, but it may contain a component effective for wrinkle removal and rejuvenation activation of the skin.
- the microneedles are omitted in the plan view of FIG. 1 (b), and the number is simplified in the cross-sectional view of FIG. 1 (a).
- the pressure-sensitive adhesive sheet 13 is provided on the back surface of the microneedle array (in FIG. 1, the back side of the paper surface) and has an elliptical shape that is slightly larger than the microneedle array 11. As shown in the plan view of FIG. 1B, there is an elliptical hole in the center of the adhesive tape, and the center of the microneedle array is not covered with the adhesive tape.
- the width of the adhesive tape is 100 mm.
- the outline of the adhesive tape 13 is indicated by a dotted line in the plan view in order to indicate that it is attached to the back surface.
- the protective release sheet 12 has a rectangular shape with a width of 120 mm and a length of 70 mm, and has a hole 14 in the center. The size of the hole is larger than that of the microneedle array, and as shown in the cross-sectional view of FIG. 1A, there is a gap 16 between the microneedle array and the release sheet, and part of the adhesive surface of the adhesive tape. Is exposed.
- the protective release sheet is larger than the pressure-sensitive adhesive sheet and spreads beyond the pressure-sensitive adhesive sheet.
- the cutting line 15 of the protective release sheet is provided on the left and right sides of the release sheet from the outer edge toward the hole.
- the protective release sheet is divided into two by a cutting line.
- the adhesive sheet can be easily removed from the protective release sheet by holding both ends of either side of the protective release sheet 12 and peeling the protective release sheet from the adhesive sheet along the cutting line.
- the microneedle array 11 can be attached to the skin with the adhesive sheet 13. Thereafter, the surface of the microneedle array 11 is lightly pressed to insert the microneedle into the skin stratum corneum. There is almost no pain due to this insertion.
- FIG. 2 shows the microneedle patch used in this example.
- the material and method of use are the same as in Example 1 except that the shape of the microneedle array 21 is a ball shape.
- FIG. 2 represents the surface of the microneedle as a table, and the adhesive sheet 22 is indicated by a broken line because it is attached to the back surface of the microneedle array and the protective release sheet.
- the pressure-sensitive adhesive sheet 22 of this embodiment is attached with the microneedle array of the pressure-sensitive adhesive sheet as close to the eyes as possible, and therefore the width of the bottom portion is narrow.
- the holes of the protective release sheet 23 of this embodiment are in close contact with the microneedle array 21 and no gap is provided therebetween.
- the protective release sheet 23 has cutting lines 24 in the vertical direction, and the cutting lines 24 are symmetrically arranged on both sides of the hole. Moreover, it has a triangular cut near the outer edge of the cutting line. This cutting makes it easier to peel off the protective release sheet. Note that the shape of the cut is not limited to a triangular shape, and may be an arc shape, an elliptical arc shape, or the like.
- the cutting line 24 is provided at the upper and lower parts of the center of the protective release sheet 23, the both ends of the protective release sheet are sandwiched, and the protective release sheet is cut. If the pressure-sensitive adhesive sheet with the microneedle array peeled off while spreading so as to open the line is brought into contact with the application site (under the eyes), the pressure-sensitive adhesive sheet 22 adheres. Thereafter, the surface of the microneedle array 21 is lightly pressed to insert the microneedle into the skin stratum corneum.
- Example 3 In the protective release sheet of this example, as shown in FIG. 3, the cutting line of the protective release sheet is a perforation. If the cutting line is perforated, it is possible to prevent an accident in which the protective release sheet is cut carelessly and the microneedle patch is dropped before the microneedle patch is attached.
- arrows indicating the start position of the protective release sheet peeling are attached to both sides of the cutting line. Even a user who is unfamiliar with the use of the microneedle patch can easily determine the peel-off start position of the protective release sheet by this arrow.
- the symbol indicating the peeling start position is not limited to an arrow, and may be a star mark or the like.
- Example 4 The protective release sheet of the present embodiment includes two circular microneedle arrays 31 as shown in FIG. Adhesive sheets 32 are respectively provided on the back surfaces of the microneedle array and the protective release sheet 33. One cutting line is provided for each microneedle array and can be applied to the skin one by one in the same manner as the microneedle patches of Examples 1 to 3.
- the protective release sheet of this example includes two array type microneedle arrays 41 in one hole.
- Each microneedle array includes an adhesive sheet 42 on the back surface, but this adhesive sheet does not cover the entire back surface of the microneedle array.
- the protective release sheet 43 is provided with two cutting lines 44. Similar to the microneedle patch of Example 4, it can be applied to the skin one by one.
- the protective release sheet of this example includes one microneedle array 51 in each of two holes.
- Each microneedle array includes an adhesive sheet 52 on the back surface that covers the entire back surface of the microneedle array.
- the protective release sheet 53 includes two cutting lines 54. One of the two cutting lines is characterized by going from the outer edge of the protective release sheet to the upper hole, and the other one going from the upper hole to the lower hole.
- the hole in the protective release sheet is slightly larger than the microneedle array, and a gap is provided between the protective release sheet and the microneedle array to facilitate removal of the microneedle patch.
- the protective release sheet of this example includes one slanted ball type microneedle array 61 in each of two holes.
- Each microneedle array includes an adhesive sheet 62 that covers the entire back surface of the microneedle array on the back surface.
- the protective release sheet 63 includes two cutting lines 64. Both are from the outer edge of the protective release sheet toward the hole. Similarly to the microneedle patches of Examples 4 to 6, the protective release sheet is cut from the cutting line, and the microneedle patches can be taken out and stuck to the skin one by one.
- the protective release sheet of this example includes one microneedle array 71 in each of two holes.
- Each microneedle array includes an adhesive sheet 72 that covers the entire back surface of the microneedle array on the back surface.
- the protective release sheet 73 includes two cutting lines 74. The positions of the two cutting lines on the protective release sheet are different from those in Example 6.
- the hole in the protective release sheet is slightly larger than the microneedle array, and a gap is provided between the protective release sheet and the microneedle array to facilitate removal of the microneedle patch.
- the protective release sheet is cut from the cutting line, and the microneedle patches can be taken out and applied to the skin one by one.
- the protective release sheet of this example includes one microneedle array 81 in each of two holes.
- Each microneedle array includes an adhesive sheet 82 covering the entire back surface of the microneedle array on the back surface.
- the protective release sheet 83 includes two cutting lines 84. The positions of the two cutting lines on the protective release sheet are different from those in Examples 6 and 8.
- the hole in the protective release sheet is slightly larger than the microneedle array, and a gap is provided between the protective release sheet and the microneedle array to facilitate removal of the microneedle patch.
- the protective release sheet is cut from the cutting line, and the microneedle patches can be taken out and applied to the skin one by one.
- the microneedle patch must be handled in a special protective case to prevent contamination and needle breakage from manufacture to use.
- the protective case is preferably formed of a microneedle patch and first and second case members holding the protective release sheet from above and below.
- the dedicated protective case holds the microneedle patch only with the protective release sheet and should not contact the needle portion of the microneedle patch.
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- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Informatics (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Dermatology (AREA)
- Vascular Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
本実施例のマイクロニードルパッチを図1に示す。マイクロニードルアレイ11は、図1に示すように、楕円形の平面形状をしており、横幅約65mm、縦幅30mmである。このマイクロニードル11aは柔軟なマイクロニードルアレイ基板11b上に設けられており、マイクロニードルアレイ全体として皮膚の凹凸に合わせて変形させることができる。
本実施例に用いたマイクロニードルパッチを図2に示す。マイクロニードルアレイ21の形状が勾玉型となっている点を除き、材質や使用方法は実施例1と同じである。図2はマイクロニードルの面を表として表記しており、粘着シート22はマイクロニードルアレイ及び保護離型シートの裏面に付されているので破線で記載している。実施例3~9でも同様である。本実施例の粘着シート22は、粘着シートのマイクロニードルアレイをなるべく目に近づけて貼付するため、底の部分の幅が狭くなっている。本実施例の保護離型シート23の穴はマイクロニードルアレイ21に密着しており、間に隙間を設けていない。
本実施例の保護離型シートは、図3に示すように、保護離型シートの切断線がミシン目である。切断線がミシン目であると、マイクロニードルパッチ貼付前に保護離型シートが不用意に切断されてマイクロニードルパッチを落下させるような事故を防止できる。
本実施例の保護離型シートは、図4に示すように、2個の円形のマイクロニードルアレイ31を備えている。それぞれ粘着シート32がマイクロニードルアレイと保護離型シート33の裏面に備えられている。切断線は各マイクロニードルアレイに1個づつ備えられており、実施例1~3のマイクロニードルパッチと同様に1個づつ皮膚に貼付することができる。
本実施例の保護離型シートは、図5に示すように、1個の穴の中に2個のアレイ型マイクロニードルアレイ41を備えている。各マイクロニードルアレイは、背面に粘着シート42を備えているが、この粘着シートはマイクロニードルアレイの背面全体を覆ってはいない。保護離型シート43には切断線44が2本備えられている。実施例4のマイクロニードルパッチと同様に、1個づつ皮膚に貼付できる。
本実施例の保護離型シートは、図6に示すように、2個の穴の中にそれぞれ1個のマイクロニードルアレイ51を備えている。各マイクロニードルアレイは、背面にマイクロニードルアレイの背面全体を覆う粘着シート52を備えている。保護離型シート53は、切断線54を2本備えている。2本の切断線の内1本は保護離型シートの外縁から上の穴に向かい、他の1本は上の穴から下の穴に向かっているのが特徴である。この保護離型シートの穴はマイクロニードルアレイより若干大きく、保護離型シートとマイクロニードルアレイの間に隙間を設け、マイクロニードルパッチの取り出しを容易としている。
本実施例の保護離型シートは、図7に示すように、2個の穴の中にそれぞれ1個の勾玉型マイクロニードルアレイ61を備えている。各マイクロニードルアレイは、背面にマイクロニードルアレイの背面全体を覆う粘着シート62を備えている。保護離型シート63は、切断線64を2本備えている。2本とも保護離型シートの外縁から穴に向かっている。実施例4~6のマイクロニードルパッチと同様に、切断線から保護離型シートを切断してマイクロニードルパッチを取り出し1個づつ皮膚に貼付できる。
本実施例の保護離型シートは、図8に示すように、2個の穴の中にそれぞれ1個のマイクロニードルアレイ71を備えている。各マイクロニードルアレイは、背面にマイクロニードルアレイの背面全体を覆う粘着シート72を備えている。保護離型シート73は、切断線74を2本備えている。2本の切断線の保護離型シート上の位置が実施例6とは異なっている。この保護離型シートの穴はマイクロニードルアレイより若干大きく、保護離型シートとマイクロニードルアレイの間に隙間を設け、マイクロニードルパッチの取り出しを容易としている。
本実施例の保護離型シートは、図9に示すように、2個の穴の中にそれぞれ1個のマイクロニードルアレイ81を備えている。各マイクロニードルアレイは、背面にマイクロニードルアレイの背面全体を覆う粘着シート82を備えている。保護離型シート83は、切断線84を2本備えている。2本の切断線の保護離型シート上の位置が実施例6、8とは異なっている。この保護離型シートの穴はマイクロニードルアレイより若干大きく、保護離型シートとマイクロニードルアレイの間に隙間を設け、マイクロニードルパッチの取り出しを容易としている。
11a…マイクロニードル
11b…マイクロニードルアレイ基板
13、22、32、42、52、62、72、82…粘着テープ
12、23、33、43、53、63、73、83…保護離型シート
14…穴
15、24、34、44、54、64、74、84…切断線
16…隙間
17…第1のケース部材
18…第2のケース部材
Claims (10)
- マイクロニードルパッチの保護離型シートであって、内側に穴を有すると共に、前記保護離型シートの外縁から前記穴に向かう1ないし複数の切断線を有することを特徴とする、マイクロニードルパッチの保護離型シート。
- 前記穴内に、マイクロニードルアレイ基板を配置するように形成されている、マイクロニードルパッチの保護離型シートであって、前記穴の内周縁と前記マイクロニードルアレイ基板との間に隙間を設けるように前記穴が形成されている、請求項1に記載の保護離型シート。
- 前記切断線の外縁部分に、切り込みが付されていることを特徴とする、請求項1又は2に記載の保護離型シート。
- 前記切断線が、前記穴の両側に対称的に配置されていることを特徴とする請求項1~3のいずれか1項に記載の保護離型シート。
- 前記穴が一つであり、かつ前記穴内に複数のマイクロニードルパッチを保持できるように前記穴が形成されていることを特徴とする、請求項1~4のいずれか1項に記載の保護離型シート。
- 前記穴が複数であることを特徴とする、請求項1~4のいずれか1項に記載の保護離型シート。
- 前記複数の穴のうち1つの穴から他の穴に向かう切断線をも有することを特徴とする、請求項6に記載の保護離型シート。
- 前記切断線がミシン目であることを特徴とする、請求項1~7のいずれか1項に記載の保護離型シート。
- 請求項1から請求項8のいずれか1項に記載の保護離型シートと、該保護離型シートの穴内に配置されているマイクロニードルアレイ基板とを備える、マイクロニードルパッチ。
- 請求項9に記載のマイクロニードルパッチと、前記マイクロニードルパッチの保護離型シートを上下から挟んで保持している第1,第2のケース部材とを備える、マイクロニードルパッチ保護ケース。
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AU2013281871A AU2013281871B2 (en) | 2012-06-27 | 2013-06-25 | Protective release sheet for microneedle patch |
CN201380031586.1A CN104363951A (zh) | 2012-06-27 | 2013-06-25 | 微针贴片的离型保护膜 |
KR1020207028782A KR102229689B1 (ko) | 2012-06-27 | 2013-06-25 | 마이크로니들 패치의 보호 이형 시트 |
EP13810059.9A EP2868341B1 (en) | 2012-06-27 | 2013-06-25 | Microneedle patch comprising a protective release sheet |
KR1020217007641A KR102289132B1 (ko) | 2012-06-27 | 2013-06-25 | 마이크로니들 패치의 보호 이형 시트 |
US14/410,300 US10821275B2 (en) | 2012-06-27 | 2013-06-25 | Protective release sheet for microneedle patch |
CA2876569A CA2876569C (en) | 2012-06-27 | 2013-06-25 | Protective release sheet for microneedle patch |
KR1020147035927A KR102165648B1 (ko) | 2012-06-27 | 2013-06-25 | 마이크로니들 패치의 보호 이형 시트 |
US17/065,475 US11998712B2 (en) | 2012-06-27 | 2020-10-07 | Protective release sheet for microneedle patch |
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JP2012195509A JP5903016B2 (ja) | 2012-06-27 | 2012-08-21 | マイクロニードルパッチの保護離型シート |
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US17/065,475 Division US11998712B2 (en) | 2012-06-27 | 2020-10-07 | Protective release sheet for microneedle patch |
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JPWO2016017439A1 (ja) * | 2014-07-30 | 2017-04-27 | 凸版印刷株式会社 | マイクロニードルユニット |
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US10589077B2 (en) | 2014-12-05 | 2020-03-17 | Hisamitsu Pharmaceutical Co., Inc. | Microneedle device system |
EP3246066A4 (en) * | 2015-01-16 | 2018-06-20 | Toppan Printing Co., Ltd. | Transdermal-administration-device accommodating body |
US10561831B2 (en) | 2015-01-16 | 2020-02-18 | Toppan Printing Co., Ltd. | Transdermal administration device packaged body |
JP2017143965A (ja) * | 2016-02-16 | 2017-08-24 | 凸版印刷株式会社 | 経皮投与デバイス収容体 |
WO2021246301A1 (ja) * | 2020-06-01 | 2021-12-09 | コスメディ製薬株式会社 | 美容用マイクロニードルアレイ |
CN115461081A (zh) * | 2020-06-01 | 2022-12-09 | 考司美德制药株式会社 | 美容用微针阵列 |
CN116270422A (zh) * | 2023-05-19 | 2023-06-23 | 优微(珠海)生物科技有限公司 | 微针贴 |
CN116270422B (zh) * | 2023-05-19 | 2023-09-05 | 优微(珠海)生物科技有限公司 | 微针贴 |
Also Published As
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US20150335870A1 (en) | 2015-11-26 |
EP2868341B1 (en) | 2018-08-08 |
KR20200118250A (ko) | 2020-10-14 |
US10821275B2 (en) | 2020-11-03 |
KR102229689B1 (ko) | 2021-03-18 |
AU2013281871B2 (en) | 2017-04-13 |
KR102165648B1 (ko) | 2020-10-14 |
CA2876569A1 (en) | 2014-01-03 |
CN107412946A (zh) | 2017-12-01 |
KR102289132B1 (ko) | 2021-08-13 |
EP2868341A1 (en) | 2015-05-06 |
CN104363951A (zh) | 2015-02-18 |
EP2868341A4 (en) | 2016-03-30 |
US20210016072A1 (en) | 2021-01-21 |
CA2876569C (en) | 2019-10-15 |
JP2014028108A (ja) | 2014-02-13 |
JP5903016B2 (ja) | 2016-04-13 |
AU2013281871A1 (en) | 2015-01-22 |
KR20210031787A (ko) | 2021-03-22 |
KR20150028248A (ko) | 2015-03-13 |
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