WO2015049800A1 - Film médical bioadhésif - Google Patents

Film médical bioadhésif Download PDF

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Publication number
WO2015049800A1
WO2015049800A1 PCT/JP2013/077146 JP2013077146W WO2015049800A1 WO 2015049800 A1 WO2015049800 A1 WO 2015049800A1 JP 2013077146 W JP2013077146 W JP 2013077146W WO 2015049800 A1 WO2015049800 A1 WO 2015049800A1
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WIPO (PCT)
Prior art keywords
film
thickness
bioadhesive
central portion
medical film
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PCT/JP2013/077146
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English (en)
Japanese (ja)
Inventor
田畑泰彦
豊島永実子
深野兼司
Original Assignee
ニチバン株式会社
田畑泰彦
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Application filed by ニチバン株式会社, 田畑泰彦 filed Critical ニチバン株式会社
Priority to PCT/JP2013/077146 priority Critical patent/WO2015049800A1/fr
Publication of WO2015049800A1 publication Critical patent/WO2015049800A1/fr

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    • 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01008—Non-adhesive bandages or dressings characterised by the material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/222—Gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • 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
    • A61F2013/00089—Wound bandages
    • A61F2013/00217—Wound bandages not adhering to the wound
    • A61F2013/00221—Wound bandages not adhering to the wound biodegradable, non-irritating

Definitions

  • the present invention relates to a bioadhesive medical film that can be applied to uses such as an adhesion preventing material, a wound dressing material, a transplanted cell sheet material, or a biomedical drug-containing sheet material.
  • the bioadhesive medical film is used in various medical applications such as an adhesion prevention material, a wound dressing material, a transplanted cell sheet material, or a biomedical drug-containing sheet material.
  • Anti-adhesive materials are used in clinical fields such as cardiac surgery, orthopedic surgery, neurosurgery, abdominal surgery, and obstetrics and gynecology to prevent the affected living tissue from adhering after various surgical operations or due to trauma.
  • Patent Document 1 When adhesion of living tissue occurs, it causes pain and dysfunction. In severe cases, an operation for separating the adhesion is necessary, and it may be difficult to re-operate for the original disease. Therefore, in order to prevent adhesion of living tissue, an adhesion preventing material that covers and protects tissue that may cause adhesion has been developed, and it is known to use a bioadhesive film.
  • the wound dressing can be applied to the affected area in the living body to promote wound healing or protect the wound or affected area from physical irritation. Moreover, the healing effect can be further enhanced by including a drug such as a hemostatic agent in the wound dressing.
  • a wound dressing a sheet-like structure having high biocompatibility such as carboxyethyl cellulose is known (Patent Document 2).
  • Patent Document 3 As a transplanted cell culture sheet used for the field of regenerative medicine, treatment of damage or defect of cartilage tissue or bone tissue, a sheet having good biological tissue adhesion is known (Patent Document 3).
  • Patent Document 4 a biomedical drug-containing sheet material that contains a physiologically active factor such as a hepatocyte growth factor or an anticancer agent and that is embedded in a living body and releases the physiologically active factor is known (Patent Document 4).
  • bioadhesive medical films used for anti-adhesion materials and wound dressing materials cannot be visually confirmed if the surgical site is closed after application.
  • in-vivo adhesive medical films sometimes move out of the affected area of the target organ or the like, and a solution has been demanded. That is, since the organ itself, often an adjacent organ or a neighboring tissue (for example, abdominal lining, abdominal organ, tendon, etc.) can move to some extent, the bioadhesive medical film is If it is not sufficiently fixed in the living body and moves from the initial position, the expected effect may not be obtained.
  • the shielding effect is not exhibited at a site where adhesion prevention or the like is required, and as a result, adhesion may occur.
  • the displacement of the bioadhesive medical film from the affected area also occurs when the medical film comes into contact with an organ or the like.
  • a medical film may be delivered into a body cavity through a hole that has been cut through a small body surface, and flexibility and bending resistance may be required. Therefore, if the thickness of the bioadhesive medical film is increased in order to improve the workability of applying the medical film or increase the drug content per sheet, There is a problem that the contact with the medical film is likely to occur, and the displacement movement from the affected part becomes large.
  • the bioadhesive medical film such as an antiadhesive material to perform a desired function such as an antiadhesion function
  • the bioadhesive medical film is used for a necessary period (usually 1). For about one month to about one month), and in the affected area such as the application site, after acting as a barrier between the tissues of the application site and protection of the wound, finally, for example, by decomposing, It must disappear and be absorbed by the living body.
  • the bioadhesive medical film such as the anti-adhesion material is required to be excellent in biocompatibility, bioabsorbability and the like.
  • bioadhesive medical film used for anti-adhesion materials, wound dressings, etc. moderate tissue adhesiveness (to the extent that the material does not peel from the organ), moderate operability (flexibility and bending resistance) Etc.), moderate biodegradability, etc., and usually maintain in vivo adherence during the pasting period of 1 week or longer, stays in the affected area without causing displacement of the film, and A bioadhesive medical film that is flexible, flexible, easy to handle and bioabsorbable has been desired.
  • An object of the present invention is to provide a bioadhesive medical film that stays in an affected area without causing displacement of the film during the sticking period and has good handleability.
  • the present inventors have reduced the chance of contact with an organ or the like by adjusting the thickness of the peripheral portion, or the ability to follow the organ or the like in the peripheral portion of the film. It has been found that the force applied from an organ or the like can be reduced by increasing the value of the value, thereby solving the problem, and the present invention has been completed.
  • the bioadhesive medical device comprising a peripheral portion formed including an end portion defining the outline of the film and a central portion formed continuously inward of the peripheral portion.
  • a bioadhesive medical film characterized in that it is provided with an area extending inward from the outline of the film and having a thickness smaller than that of the central part.
  • the following bioadhesive medical films (1) to (10) are provided.
  • the cross-sectional shape of the region extending inward from the contour of the film and having a thickness smaller than the central portion is stepped, and the thickness of the stepped step portion is 50% or less with respect to the thickness of the central portion.
  • the cross-sectional shape of the region extending inward from the contour of the film and having a thickness smaller than the central portion is a stepped shape having two or more stepped portions, and the thickness of the stepped portion farthest from the central portion is the central portion
  • the bioadhesive medical film described above which is 50% or less with respect to the thickness of the body.
  • the bioadhesive medical film as described above wherein the total area of the region extending inward from the contour of the film and having a thickness smaller than that of the central portion is less than 40% of the entire area.
  • the bioadhesive medical film as described above wherein the thickness of the central part when dried is 3 to 5000 ⁇ m.
  • an adhesion preventing material for treating a wound dressing material, a transplanted cell sheet material or a biomedical drug-containing sheet material comprising the above-mentioned bioadhesive medical film.
  • the said bioadhesive medical film provided with the process of extending inward from the outline of a film in a peripheral part by cutting, and forming the area
  • the above-described bioadhesive method comprising the steps of: forming a region having a thickness that is inwardly extended from the contour of the film and having a smaller thickness than the central portion by laminating a plurality of films.
  • a method of manufacturing a medical film is provided.
  • the method includes the step of forming an area extending inward from the contour of the film and having a thickness smaller than that of the central portion in the peripheral portion by casting and drying the film material on the mold.
  • a method for producing an in vivo adherent medical film is provided.
  • a bioadhesive medical film comprising a peripheral portion formed including an end portion that defines the contour of a film and a central portion formed continuously inward of the peripheral portion.
  • the film during the application period is a bioadhesive medical film characterized in that it has a region extending inward from the outline of the film in the peripheral portion and having a smaller thickness than the central portion.
  • a bioadhesive medical film that stays in the affected area without causing any displacement movement, and has good handleability, and further comprises an antiadhesive material and a wound covering comprising the bioadhesive medical film.
  • the material, the sheet material for transplanted cells, or the biomedical drug-containing sheet material is provided.
  • a step of forming a region extending inward from the contour of the film and having a smaller thickness than the central portion, or a plurality of films is laminated on the peripheral portion by cutting such as slicing
  • the film extends inward from the contour of the film and forms a region having a thickness smaller than that of the central part, or the film material is cast on the mold and dried to dry the film on the peripheral part.
  • the in-adhesive medical film manufacturing method includes a step of forming an area extending inward from the contour of the inward and having a thickness smaller than that of the central portion.
  • FIG. 2 is a schematic cross-sectional view taken along the line XX of FIG. 1 in a region including a peripheral portion of one specific example of the bioadhesive medical film of the present invention.
  • FIG. 7 is a schematic cross-sectional view taken along the line XX of FIG. 1 in a region including a peripheral portion of another specific example of the bioadhesive medical film of the present invention.
  • FIG. 7 is a schematic cross-sectional view taken along the line XX of FIG. 1 in a region including a peripheral portion of still another specific example of the bioadhesive medical film of the present invention.
  • FIG. 1 is a schematic cross-sectional view taken along the line XX of FIG. 1 in a region including a peripheral portion of still another specific example of the bioadhesive medical film of the present invention.
  • FIG. 7 is a schematic cross-sectional view taken along the line XX of FIG. 1 in a region including a peripheral portion of still another specific example of the bioadhesive medical film of the present invention.
  • FIG. 7 is a schematic cross-sectional view taken along the line XX of FIG. 1 in a region including a peripheral portion of still another specific example of the bioadhesive medical film of the present invention.
  • FIG. 7 is a schematic cross-sectional view taken along the line XX of FIG. 1 in a region including a peripheral portion of still another specific example of the bioadhesive medical film of the present invention.
  • FIG. 7 is a schematic cross-sectional view taken along the line XX of FIG.
  • FIG. 7 is a schematic cross-sectional view taken along the line XX of FIG. 1 in a region including a peripheral portion of still another specific example of the bioadhesive medical film of the present invention. It is typical sectional drawing of the cross section which passes along the center part of the film of FIG. 1 of the further another specific example of the bioadhesive medical film of this invention.
  • Bioadhesive medical film The bioadhesive medical film of the present invention can be applied to uses such as anti-adhesion materials, wound dressings, transplanted cell sheets or biomedical drug-containing sheet materials. It is a medical film that adheres to a living body.
  • the bioadhesive medical film is present in an affected area such as an application site for a necessary period (usually about 1 week to 1 month) in order to perform an intended function such as an adhesion prevention function, After acting as a barrier between tissues at the application site and protection of wounds, bioabsorbability that eventually disappears in the living body and is absorbed by the living body is required.
  • the bioadhesive medical film of the present invention is usually formed from a bioabsorbable polymer, specifically, a biodegradable polymer that can be degraded in an in vivo environment, Or it is preferable to form from the water-soluble polymer which can melt
  • the biodegradable polymer and the water-soluble polymer are not mutually exclusive concepts.
  • the biodegradable polymer that can form the bioadhesive medical film of the present invention is not particularly limited as long as it is a biocompatible biodegradable polymer. Specifically, collagen-derived proteins such as gelatin, glycosaminoglycans such as hyaluronic acid, fibrin, chitin, chitosan, oxidized cellulose, polyglycolic acid, polylactic acid, lactic acid-glycolic acid copolymer, polycaprolactone, hydroxybutyric acid -Hydroxyvaleric acid copolymer, poly-p-dioxane and the like.
  • collagen-derived proteins such as gelatin, glycosaminoglycans such as hyaluronic acid, fibrin, chitin, chitosan, oxidized cellulose, polyglycolic acid, polylactic acid, lactic acid-glycolic acid copolymer, polycaprolactone, hydroxybutyric acid -Hydr
  • the water-soluble polymer capable of forming the bioadhesive medical film of the present invention is not particularly limited as long as it is a water-soluble polymer having biocompatibility. Specific examples include sodium alginate, carboxymethylcellulose, acrylic acid copolymer, acrylamide-sodium acrylate copolymer, and the gelatins previously mentioned as biodegradable polymers as described later. Some are classified into water-soluble polymers.
  • biodegradable polymers or water-soluble polymers the biocompatibility is excellent, and biodegradability and water solubility can be easily adjusted.
  • a bioadhesive medical film formed from gelatin for example, gelatin extracted from bones, tendons, skins, fish scales, etc. of mammals such as cows, pigs, horses, birds such as chickens, fishes such as salmon, etc. it can.
  • gelatins may be prepared by, for example, extracting from the above animals, but usually commercially available products can be used.
  • the extraction method is not particularly limited, and examples thereof include conventionally known methods such as acid treatment and alkali treatment.
  • gelatins are further purified to preferably satisfy, for example, Japanese Pharmacopoeia gelatin or purified gelatin standards, and gelatin obtained by heat denaturation of commercially available collagen can also be used. Furthermore, a derivative obtained by chemically modifying the side chain of gelatin is also included. The chemical modification includes carboxymethylation, carboxyethylation, methylation, hydroxyethylation, acetylation and the like.
  • alkali-treated gelatin having an extremely low endotoxin content and excellent in safety is preferable.
  • bovine-derived alkali-treated gelatin pig-derived alkali-treated gelatin manufactured by Nitta Gelatin Co., Ltd. Can be illustrated.
  • glycerin, polyethylene glycol, hyaluronic acid or the like may be added to the gelatin used for forming the bioadhesive medical film.
  • additives such as antibacterial agents and anti-inflammatory agents may be used in anticipation of medicinal effects.
  • the bioadhesive medical film formed from gelatin may be used as it is for anti-adhesion materials, etc., but it is possible to lengthen the in vivo degradation time or adjust it to a desired time. Therefore, a bioadhesive medical film formed from crosslinked gelatin is more preferable.
  • thermal crosslinking thermal dehydration
  • chemical crosslinking using a crosslinking agent energy beam crosslinking by ultraviolet rays, ionizing radiation, and the like are known, and the combination of these is also known.
  • Thermal crosslinking is usually a crosslinking reaction by heating at a temperature of 140 to 160 ° C.
  • aldehyde crosslinking agents such as glutaraldehyde and formaldehyde
  • isocyanate crosslinking agents such as hexamethylene diisocyanate
  • carbodiimide crosslinking agents such as 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide hydrochloride
  • a polyepoxy-based crosslinking agent such as diethylene glycol diglycidyl ether
  • a crosslinking reaction such as a crosslinking agent such as diethylene glycol diglycidyl ether
  • energy beam crosslinking examples include ultraviolet rays; ionizing radiation such as ⁇ rays, electron rays ( ⁇ rays), X rays ( ⁇ rays), heavy ion rays, etc., and medical treatment by adjusting the crosslinking density. From the viewpoint of easy adjustment of the decomposition time of the film and uniformity of crosslinking, ionizing radiation is more suitable, and an electron beam is most suitable.
  • the electron beam crosslinking can be performed using a general-purpose electron beam irradiation apparatus, and the irradiation dose is usually selected from the range of 5 to 10000 kGy.
  • the irradiation dose is related to the crosslink density of the cross-linked gelatin. The greater the irradiation dose, the greater the crosslink density.
  • the irradiation dose depends on the acceleration voltage and the thickness of the resulting gelatin film (in-vivo adhesive medical film), but when the acceleration voltage is 200 to 1000 kV and the film thickness is about 3 to 5000 ⁇ m, It is preferably 10 to 5000 kGy, more preferably 15 to 2000 kGy.
  • the acceleration voltage can be increased or the irradiation dose can be increased.
  • a gelatin derivative in which a functional group having an electrical or steric hindrance is added to the side chain of gelatin is inferior in crosslinking efficiency. Therefore, it is preferable to select a relatively large irradiation dose.
  • the atmosphere in which the irradiation of the electron beam may be in air, or to avoid the generation of ozone, in order to raising the reaction efficiency, generally, is often performed in an inert gas atmosphere such as nitrogen.
  • additional irradiation is performed while adjusting the acceleration voltage so as not to change the cross-linking degree inside the cross-linked gelatin film (for example, low voltage). It may be processed.
  • the bioadhesive medical film of the present invention is usually a flat film, but may be used in the form of a cylinder, porous (sponge), non-porous, or cloth.
  • the shape of the film or the like may be a quadrangle (square, rectangle, rhombus, etc.), circle, polygon or the like, but a rectangle or square is preferred.
  • the bioadhesive medical film of the present invention is a film having an outline such as a quadrangle (square, rectangle, rhombus, etc.), a circle, or a polygon.
  • the size of the bioadhesive medical film is not particularly limited, and can be appropriately determined according to the site to be applied. For example, in the case of a quadrangular shape, the width (sometimes referred to as “vertical”) 0.3 to 20 cm, the length (sometimes referred to as “horizontal”) 0.5 to 50 cm, preferably 0.4 mm wide. -15 cm, length 0.7-30 cm, more preferably width 0.5-10 cm and length 1-20 cm. When a film is circular, it can determine according to this. If the size of the film is too small, functions such as anti-adhesion and wound covering may be insufficient, and handling may be reduced. A region having a smaller thickness may be too small, and the effect of preventing movement may be insufficient. If the size of the film is too large, the handleability may be reduced, or an organ other than the target organ may be contacted.
  • the thickness of the bioadhesive medical film at the time of drying can be appropriately determined according to the desired decomposition time, etc. Usually, it is in the range of 3 to 5000 ⁇ m, preferably 4 to 3000 ⁇ m, more preferably 5 to 1000 ⁇ m, still more preferably 5 to 100 ⁇ m, and particularly preferably 5 to 30 ⁇ m.
  • the thickness of the film is, for example, less than 3 ⁇ m, strength, bending resistance and the like may be insufficient, or handling properties may be deteriorated.
  • the thickness of the center part of a film uses the dial type thickness gauge [Ozaki Mfg. Co., Ltd., PEACOCK (registered trademark) DIALTHICKNESS GAUGE (0.001 ⁇ 1 mm), measuring element 5 mm ⁇ flat type]
  • the thickness is measured at three points in the central portion other than the portion, and the average value is the thickness of the central portion when the film is dried (unit: ⁇ m.
  • Thickness (dry) simply referred to as “thickness (dry)”. It is measured by the method.
  • the thickness of the swelled film was determined by immersing the dried film in distilled water at a temperature of 37 ° C. for 24 hours, then removing the wiped water from the surface and flattening it on a polypropylene flat plate. Measure the thickness including the polypropylene plate at three points at the center other than the periphery of the film using a digital caliper (manufactured by Mitutoyo Corporation, Digimatic Caliper CD-15C). The average value of the values obtained by subtracting the thickness of the polypropylene plate from the obtained numerical value is measured by a method of setting the thickness of the film in a swollen state (unit: ⁇ m or less, sometimes simply referred to as “thickness (swelling)”). be able to.
  • a bioadhesive medical film having an area extending inward from the contour of the film in the peripheral portion and having a thickness smaller than that of the central portion.
  • the bioadhesive medical film of the present invention defines the contour of the film.
  • a bio-adhesive medical film comprising a peripheral portion formed including an end portion and a central portion formed continuously inward of the peripheral portion, from the contour of the film to the peripheral portion It is characterized by having a region extending inward and having a thickness smaller than that of the central portion.
  • the peripheral part means a part of the bioadhesive medical film that includes an end part that defines the outline of the film. Is the area near the edge that defines the contour of the film, usually the width or length of the film (if the shape of the film is square) or the diameter of the film (if the shape of the film is circular) On the other hand, the size of the film (the width of the film) from the edge defining the film outline toward the inside of the film, that is, toward the center of the film (the center of gravity of the film; the same applies hereinafter). Or a length included in a region separated by a distance of less than 10%.
  • the central portion includes a region continuously formed inward of the peripheral portion, and includes a region other than the peripheral portion including the central portion of the film. means.
  • the peripheral part includes an area extending inward from the outline of the film and having a thickness smaller than that of the central part
  • the peripheral part that is, the outline of the film
  • the peripheral part In the region near the edge that defines the edge of the film, it extends inward from the contour of the film and has a smaller thickness than the central portion, i.e., the edge that defines the contour of the film.
  • a region having a thickness smaller than that of the central portion is provided.
  • the end portion that defines the outline of the bioadhesive medical film of the present invention is included in a region having a thickness smaller than that of the central portion, and forms the tip portion of the region.
  • the region having a thickness smaller than that of the central portion may be formed over the entire contour of the peripheral portion of the film, or may be formed with respect to a part of the contour of the film.
  • the peripheral portions 21 to 24 of the film extend from the contour L of the film to the film. In the direction of the central portion C, the thickness is smaller than that of the central portion 1.
  • Peripheral portions 21 to 24 that are regions extending from the contour L and having a smaller thickness than the central portion 1 may have the same cross-sectional shape and size, or may have different cross-sectional shapes and sizes.
  • the cross-sectional shapes of the peripheral portions 21 and 23 can be tapered, and the cross-sectional shapes of the peripheral portions 22 and 24 can be stepped.
  • FIG. 1 is intended to help understanding of the present invention, and the display of dimensions is not strict. The same applies to the other figures.
  • the bioadhesive medical film of the present invention extends inward from the contour of the film from the viewpoint of bioadhesiveness, the effect of suppressing displacement of the film and ease of manufacture, and from the center. It is preferable that the cross-sectional shape of the region having a small thickness is at least one of a taper shape or a step shape.
  • the cross-sectional shape of the region extending inward from the contour of the film and having a thickness smaller than that of the central part is prepared by preparing a frozen section having a thickness of 10 ⁇ m by the freeze embedding method and observing the specimen prepared by eosin staining with an optical microscope. And can be confirmed.
  • the cross-sectional shape of the region extending inward from the contour of the film and having a thickness smaller than that of the central portion can be tapered as shown in the schematic cross-sectional view of FIG.
  • the apex angle ⁇ of the taper is more preferably 5 ° or more and less than 90 °, more preferably the apex angle is 8 to 60 °, and particularly preferably the apex angle is 10 to 45. It is in the range of °.
  • the apex angle ⁇ of the taper is less than 5 °, the area of the region extending inward from the contour of the film and having a thickness smaller than the central portion becomes too large. As a result, the strength of the bioadhesive medical film is increased. There is a risk of shortage or loss in vivo in a short period of time.
  • the cross-sectional shape of the region extending inward from the outline of the film and having a thickness smaller than that of the central portion can be stepped as shown in the schematic cross-sectional view of FIG.
  • the thickness h of the stepped step portion is more preferably 50% or less with respect to the thickness H of the central portion, and more preferably the thickness ratio is 10 to 10%.
  • the range is 45%, particularly preferably 20 to 40%.
  • the corner is bent at a right angle and then extends downward in the vertical direction, but the corner is chamfered with a straight line or a curve ( It may be a shape with a corner cut out.
  • the tip of the region extending inward from the outline of the film having a step-like cross-sectional shape and having a smaller thickness than the central portion FIG. 4 to FIG.
  • One or both of the shape of the left end portion in FIG. 6 and the shape of the stepped portion may be tapered.
  • the sectional shape of the region extending inward from the contour of the film and having a thickness smaller than the central portion is stepped, as shown in the schematic sectional view of FIG. It is a staircase having a step shape in which the cross-sectional shape of the region extending and having a thickness smaller than the central portion includes two or more step portions, and the thickness h of the step portion farthest from the center portion is 50% or less with respect to the thickness H of the center portion. It is good also as what is.
  • the cross-sectional shape of the region extending inward from the contour of the film and having a thickness smaller than the central portion is a tapered cross-sectional shape having no apex angle.
  • a substantially arc-shaped taper shape, an exponential function taper shape, or a parabolic taper shape may be used.
  • a region extending inward from the contour of the film and having a thickness smaller than the central portion may be a central portion of the bioadhesive medical film. It can also be provided near C.
  • the bioadhesive medical film of the present invention extends inward from the contour of the film from the viewpoint of more surely preventing misalignment due to the displacement of the film during the sticking period to the tissue in the living body.
  • the total area of the regions having a thickness smaller than that of the central part is preferably less than 40% of the total area of the bioadhesive medical film, more preferably less than 20%, still more preferably 10% or less, Particularly preferably, it is 5% or less.
  • the total area of the regions having a thickness smaller than that of the central portion may be 2% or less, further 1% or less depending on the application.
  • the strength of the bioadhesive medical film is insufficient, or it disappears in vivo in a short period of time.
  • the lower limit of the total area of the region having a small thickness varies depending on the cross-sectional shape of the region having a small thickness and the thickness of the medical film, but in many cases is about 0.2%.
  • bioadhesive medical film In vivo comprising a peripheral part formed including an end part defining the contour of the film of the present invention and a central part continuously formed inward of the peripheral part
  • An adhesive medical film having an area extending inward from the contour of the film and having a thickness smaller than that of the central part at the peripheral part.
  • a biomedical drug may be contained by a method known per se, such as impregnating a bioadhesive medical film with an aqueous solution of a biomedical drug.
  • the bioadhesive medical film of the present invention has an in vivo structure comprising a peripheral portion formed including an end portion that defines the contour of the film and a central portion formed continuously inward of the peripheral portion.
  • Adhesive medical film which has a region extending inward from the contour of the film and having a thickness smaller than that of the central portion at the peripheral portion, thereby causing the tissue in the living body to shift during the sticking period. In this case, it is possible to stay in the affected area without fail for a required period of time, and after the elapse of the required period, it can be decomposed or absorbed in the living body and disappear.
  • the film is provided in the peripheral portion and extends inwardly from the contour of the film, and the region other than the region where the thickness is smaller than the central portion, that is, the thickness of the central portion can be relatively thick, This makes it easy to perform the disposition operation and improves the handleability, and can increase the amount of the biomedical drug contained in the bioadhesive medical film if desired.
  • the positional shift due to the shift movement of the film during the application period of the bioadhesive medical film of the present invention to the tissue in the living body can be evaluated according to the following method. That is, the abdomen of a 9-week-old Wistar rat is shaved under anesthesia, the abdomen is disinfected, and then the abdominal skin and muscle tissue are incised at the midline. The inside of the abdominal wall is incised about 2 cm with a scalpel and sutured with silk thread. A quadrilateral (rectangular) bioadhesive medical film 2 cm long and 3 cm wide is applied to the abdominal wall so as to cover the abdominal wall incision and the silk suture part, and the abdomen is closed.
  • the film is not fixed by sewing or the like.
  • the abdomen was opened, and the degree of positional deviation of the film from the applied site was visually observed and evaluated.
  • the evaluation of misalignment is performed by the following three-stage evaluation. If the evaluation of the position shift of the bioadhesive medical film is less than 1, it can be said that the film does not move during the application period, and preferably the position of the bioadhesive medical film.
  • the evaluation of deviation is less than 0.9, more preferably less than 0.8.
  • a bioadhesive medical film comprising a peripheral portion formed including an end portion defining the contour of the film of the present invention and a central portion formed continuously inward of the peripheral portion, A film having a bioadhesive medical film having an area extending inward from the outline of the film and having a thickness smaller than that of the central part in the peripheral part, the film having no displacement movement during the application period.
  • the peripheral portion includes an area extending inward from the contour of the film and having a smaller thickness than the central portion.
  • a bioadhesive medical film comprising a peripheral portion formed including an end portion defining the contour of the film of the present invention and a central portion formed continuously inward of the peripheral portion,
  • the bioadhesive medical film is characterized in that it has a region extending inward from the contour of the film and having a thickness smaller than that of the central portion in the peripheral portion.
  • a bioadhesive medical film provided with a laminate of a reinforcing layer formed from a biodegradable polymer.
  • the biodegradable polymer that forms the reinforcing layer examples include biodegradable polymers that can form the bioadhesive medical film of the present invention.
  • the form of the reinforcing layer is preferably a nonwoven fabric, a woven fabric or a knitted fabric, or a porous or nonporous film.
  • the basis weight of the reinforcing layer is preferably in the range of 5 to 200 g / m 2
  • the thickness is preferably in the range of 10 to 500 ⁇ m.
  • the reinforcing layer may be laminated on the whole surface or a part of the bioadhesive medical film.
  • the bioadhesive medical film of the present invention includes a peripheral part formed including an end part that defines the contour of the film, and an inward part of the peripheral part.
  • a medical film having an in-vivo adhesive property comprising a central portion formed in a peripheral portion, the peripheral portion having an area extending inward from the contour of the film and having a smaller thickness than the central portion.
  • the production method is not particularly limited as long as the bioadhesive medical film can be obtained.
  • a film material that is, a raw material containing a film-forming polymer such as a biodegradable polymer or a water-soluble polymer is converted into a normal film production method, for example, a casting method or extrusion molding.
  • a film having a predetermined thickness is produced.
  • the produced film is cut into a predetermined shape and size as necessary.
  • the thickness of the film to be produced is usually an in vivo attachment consisting of a peripheral part formed including an end part that defines the outline of the film and a central part formed continuously inward of the peripheral part.
  • a dry thickness of the bioadhesive medical film characterized in that it has a region extending inward from the contour of the film and having a thickness smaller than that of the central portion in the peripheral portion. The same, but as will be described later, by laminating several films, it is formed continuously around the periphery that includes the edge that delineates the outline of the film and inside the periphery.
  • a bioadhesive medical film comprising a central portion, wherein the peripheral portion includes an area extending inward from a contour of the film and having a smaller thickness than the central portion.
  • a gelatin solution is prepared by dissolving gelatin, such as alkali-treated gelatin, and a raw material containing an additive to be added, if desired, in a heated solvent.
  • a solvent distilled water, dimethyl sulfoxide (DMSO) or the like, a mixed solution thereof or the like can be used, and distilled water is preferable in terms of handling.
  • the content of gelatin in the gelatin solution is usually in the range of 0.1 to 50% by mass, preferably 1 to 30% by mass, more preferably 2 to 20% by mass.
  • the dissolution temperature is usually in the range of 10 to 80 ° C., preferably 30 to 70 ° C., more preferably 40 to 60 ° C.
  • the dissolution time is not particularly limited as long as the gelatin can be dissolved, but is, for example, in the range of 1 minute to 100 hours, preferably 5 minutes to 50 hours, more preferably 10 minutes to 24 hours.
  • the prepared gelatin solution is poured into a mold such as a petri dish made of polystyrene or fluororesin, for example, to form a uniform solution, and then dried to produce a gelatin film.
  • the size of the mold such as a petri dish is not particularly limited. The size of the mold may be set according to the desired length, width and thickness of the gelatin film. Further, after the gelatin film is manufactured, it may be cut into a desired size. For example, a cylindrical petri dish having a diameter of 50 to 100 mm and a depth of 5 to 20 mm can be used.
  • the amount of gelatin solution poured into a mold such as a petri dish can be appropriately selected according to the desired thickness of the gelatin film, etc., but is usually 0.01 to 5 mL per 1 cm 2 area of the mold such as a petri dish, preferably It is in the range of 0.03 to 3 mL, more preferably 0.05 to 1 mL.
  • the drying method is not particularly limited, and can be performed by, for example, natural drying, heat drying, vacuum drying (vacuum drying), forced exhaust drying, forced circulation convection, or the like.
  • the drying temperature is usually in the range of ⁇ 40 to 90 ° C., preferably 0 to 50 ° C., more preferably 5 to 30 ° C.
  • the drying time is usually in the range of 1 to 200 hours, preferably 3 to 100 hours, more preferably 5 to 48 hours.
  • the series of film production steps is preferably performed aseptically in, for example, a clean bench or a clean room. This is to prevent the gelatin film produced from being contaminated by the propagation of various bacteria during the operation. Therefore, it is preferable to use the manufacturing instrument to be sterilized by, for example, an autoclave, EOG (ethylene oxide gas), dry heat, electron beam or the like.
  • EOG ethylene oxide gas
  • the gelatin solution is also preferably subjected to each step after, for example, conventionally known filter filtration sterilization.
  • the prepared gelatin film can be used as a bioadhesive medical film as it is, but as described above, the degradation time in the living body can be lengthened or adjusted to a desired time. Since it is possible, it is preferable to further form a bioadhesive medical film formed from gelatin which has been subjected to a crosslinking treatment.
  • a crosslinking method thermal crosslinking; chemical crosslinking using a crosslinking agent; energy ray crosslinking by ultraviolet rays, ionizing radiation, or the like; these methods may be used in combination.
  • energy beam crosslinking particularly electron beam crosslinking.
  • the timing for crosslinking is not particularly limited, and the prepared gelatin solution may be poured into a mold such as a petri dish to form a uniform solution and then dried or may be dried.
  • a mold such as a petri dish
  • a method for forming a region extending inward from the contour of the film and having a smaller thickness than the central portion which is a feature of the bioadhesive medical film of the present invention, has a predetermined shape. There is no particular limitation as long as the region can be formed.
  • the peripheral portion of the film is subjected to cutting processing such as slicing using a slicer or the like on the peripheral portion.
  • the film outline is formed by slicing (cutting) the film in an oblique direction with respect to the thickness direction of the film, and extending inward from the outline of the film in the peripheral portion and forming a region having a smaller thickness than the central portion.
  • a bioadhesive medical film comprising a peripheral part including an end part to be defined and a central part continuously formed inward of the peripheral part, wherein the contour of the film is formed in the peripheral part.
  • the bioadhesive medical film of the present invention having a region extending inward from the center and having a thickness smaller than that of the central portion can be produced.
  • a method for producing a bioadhesive medical film comprising a step of forming a region extending inwardly from the contour of a film and having a thickness smaller than that of a central portion by cutting such as slicing.
  • the film extends inward from the contour of the film provided at the periphery of the film, and has a thickness greater than the center. What has various cross-sectional shapes of a small area
  • region can be obtained.
  • the cross-sectional shape of the region extending inward from the contour of the film and having a thickness smaller than the central portion is stepped, and the thickness of the stepped step portion is 50% of the thickness of the central portion.
  • a bioadhesive medical film which is the following, by laminating a plurality of films, an area extending inward from the outline of the film and having a smaller thickness than the central part is laminated. It can depend on the manufacturing method of the bioadhesive medical film provided with the process to form.
  • a peripheral portion is provided with a region having a smaller thickness than the central portion in which the cross-sectional shape is stepped as described above.
  • a method of laminating a required number of films may be used.
  • the size and thickness of the laminated films may be the same or different.
  • the bioadhesive medical film of the present invention can be easily produced.
  • one or both of the above-described method by cutting and the method by laminating a plurality of films are combined. It can also be done.
  • a cutting process such as a slicing process is performed so that each of the two opposing sides has a tapered shape with different cross-sectional angles. It is also possible to combine cutting and laminating a plurality of films.
  • the bioadhesive medical film of the present invention is obtained by casting a film material (that is, a raw material containing a film-forming polymer such as a biodegradable polymer or a water-soluble polymer) in a mold. By drying, it can be obtained by a method for producing a bioadhesive medical film comprising a step of forming a region extending inward from the contour of the film and having a thickness smaller than that of the central portion. .
  • a film material that is, a raw material containing a film-forming polymer such as a biodegradable polymer or a water-soluble polymer
  • a mold such as a petri dish made of polystyrene or fluororesin
  • it is provided in the peripheral part, extends inward from the outline of the film, and from the center part.
  • a mold having an inner surface shape corresponding to a region having a small thickness can be used.
  • the method of casting the film material on the mold and the drying method can be performed according to a conventional method as described above for the production of a film by the casting method.
  • the thickness of the central part of the film (dry state) was measured by the following method. That is, using a dial-type thickness gauge [manufactured by Ozaki Mfg. Co., Ltd., PEACOCK (registered trademark) DIALTHICKNESS GAUGE (0.001 ⁇ 1 mm), measuring element 5 mm ⁇ flat type], three points in the central portion other than the peripheral portion of the film The thickness of the film was measured, and the average value was defined as the thickness of the central part when the film was dried (unit: ⁇ m. Hereinafter, it may be simply referred to as “thickness (dry)”).
  • the thickness of the swollen film was measured by the following method. That is, the dried film was immersed in distilled water at a temperature of 37 ° C. and allowed to swell for 24 hours, then taken out, wiped off moisture adhering to the surface, flattened on a flat plate made of polypropylene, and digital caliper. (Mitutoyo Co., Ltd., Digimatic Caliper CD-15C) was used to measure the thickness including the polypropylene plate at the three points in the center other than the periphery of the film, and the thickness of the polypropylene plate was determined from the obtained values. The average value of the values obtained by subtracting was used as the thickness of the film in the swollen state (unit: ⁇ m or less, sometimes simply referred to as “thickness (swelling)”).
  • Example 1 On the inner bottom surface of a mold (polystyrene container; diameter 86 mm ⁇ depth 12 mm), beef bone-derived type I collagen alkali-treated gelatin [manufactured by Nitta Gelatin Co., Ltd .; isoelectric point 5.0, molecular weight 100,000] An aqueous solution (concentration: 5% by mass) was cast to form a coating layer having a predetermined thickness.
  • a cross-linked gelatin film having a taper shape with an apex angle of 15 °, a region extending inward from the contour of the film and having a smaller thickness than the central portion (hereinafter sometimes referred to as “taper region”).
  • the ratio of the area of the area extending inward from the outline of the film provided in the peripheral part and having a thickness smaller than that of the central part to the total area of the crosslinked gelatin film was calculated to correspond to about 0.62%. .
  • the dry thickness and swelling thickness of the produced crosslinked gelatin film were measured.
  • Each of the prepared crosslinked gelatin films was sealed in a sterilization bag (Medic Roll R-02, Sanko Chemical Co., Ltd.) and sterilized with ethylene oxide gas.
  • the cross-linked gelatin film was taken out of the sterile bag and attached to the abdominal wall of the rat.
  • the film could be smoothly applied to the abdominal wall.
  • Table 1 shows the results of measurement and evaluation of the thickness [thickness (dry)] of the central part during drying of the film, the thickness [thickness (swelling)] of the swollen state, and the positional deviation.
  • Example 1 A cross-linked gelatin film (tapered region at the periphery) was obtained in the same manner as in Example 1 except that the four sides of the rectangular cross-linked gelatin film having the predetermined size after being taken out from the mold were not sliced. Was prepared.). Table 1 shows the results of measuring and evaluating the thickness (dry), thickness (swelling), and displacement of this crosslinked gelatin film.
  • Example 2 A crosslinked gelatin film having a tapered region at the periphery was prepared in the same manner as in Example 1 except that the thickness of the coating layer of the alkali-treated gelatin aqueous solution was adjusted so that the dry thickness was 17 ⁇ m. .
  • Table 1 shows the results of measuring and evaluating the thickness (dry), thickness (swelling), and displacement of this crosslinked gelatin film.
  • the crosslinked gelatin film of Example 2 could be smoothly removed from the sterilized bag and applied to the abdominal wall of the rat.
  • Example 2 A cross-linked gelatin film (tapered region around the periphery) was obtained in the same manner as in Example 2 except that the four sides of the rectangular cross-linked gelatin film having the predetermined size after removal from the mold were not sliced. Was prepared.). Table 1 shows the results of measuring and evaluating the thickness (dry), thickness (swelling), and displacement of this crosslinked gelatin film.
  • the bioadhesive medical film comprising a peripheral part formed including an end part that defines the outline of the film and a central part formed continuously inward of the peripheral part.
  • Each of the cross-linked gelatin films of Examples 1 and 2 having a taper region extending inward from the contour of the film and having a thickness smaller than that of the central portion in the peripheral portion is a cross-linked gelatin from a sterile bag.
  • the cross-linked gelatin films of Comparative Examples 1 and 2 that do not have a tapered region in the peripheral part both have an evaluation value of positional deviation of 1.0 or more, and cover the abdominal wall incision part and silk suture part. It was found that a position shift occurred in
  • the bioadhesive medical film is composed of a peripheral part formed including an end part that defines the outline of the film and a central part formed continuously inward of the peripheral part.
  • the bioadhesive medical film of the present invention is characterized in that it comprises a region extending inward from the outline of the film in the peripheral portion and having a thickness smaller than that of the central portion.
  • the affected tissue to which the film is applied has no risk of shifting the film during the application period, and it can be smoothly removed from the sterilization bag and applied to the affected area, providing excellent handling. It was inferred that
  • the present invention is a bioadhesive medical film comprising a peripheral part formed including an end part defining the outline of a film and a central part formed continuously inward of the peripheral part.
  • the bioadhesive medical film is characterized in that it has a region extending inward from the outline of the film in the peripheral portion and having a thickness smaller than that of the central portion.
  • the present invention also includes a step of forming a region extending inward from the contour of the film and having a smaller thickness than the central portion, or a plurality of films, by cutting such as slicing.
  • a step of forming a region extending inward from the contour of the film and having a smaller thickness than the central portion, or a plurality of films by cutting such as slicing.
  • the in-adhesive medical film manufacturing method includes a step of forming a region extending inward from the center and having a thickness smaller than that of the central portion, thereby causing the film to shift during the application period. Therefore, it is possible to provide a method capable of easily producing a bioadhesive medical film that stays in an affected area without fail and is easy to handle. There is a high possibility.
  • Central portion 21 to 24 Peripheral portion (region extending inward from the outline of the film and having a smaller thickness than the central portion)
  • L film contour
  • C film center
  • ⁇ taper apex angle
  • h thickness of step (thickness in a region extending inward from the film contour and smaller than the center)
  • H thickness of the center of the film

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Abstract

La présente invention concerne un film médical bioadhésif de préférence formé à partir d'un polymère biodégradable ou d'un polymère hydrosoluble, la périphérie du film étant pourvue d'une région qui s'étend vers l'intérieur depuis le bord du film et est plus mince que la section centrale, de préférence, une région dans laquelle la forme de section transversale est conique ou à gradins. L'invention concerne en outre un matériau de prévention d'adhésion, un matériau de couverture de plaie, un matériau de feuille de cellules transplantées ou un matériau de feuille contenant un médicament in vivo obtenu à partir dudit film médical bioadhésif. L'invention concerne en outre un procédé de fabrication dudit film médical bioadhésif, le procédé comprenant un processus pour former une région sur la périphérie qui s'étend vers l'intérieur depuis le bord du film et est plus mince que la section centrale par un processus de coupe tel qu'une découpe, le laminage de films multiples, ou une coulée dans un moule et un séchage.
PCT/JP2013/077146 2013-10-04 2013-10-04 Film médical bioadhésif WO2015049800A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019001948A (ja) * 2017-06-19 2019-01-10 澁谷工業株式会社 ゼラチン架橋体の製造方法および製造装置

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05503871A (ja) * 1990-10-01 1993-06-24 ジェンセン、オール・アール 輪郭形成された接着層を有する傷用被包材
JP2003199781A (ja) * 2001-10-24 2003-07-15 Daiya Seiyaku Kk パッド材及び携帯用パッド材
JP2007044080A (ja) * 2005-08-05 2007-02-22 Gunze Ltd 癒着防止膜
WO2008016163A1 (fr) * 2006-08-01 2008-02-07 Nichiban Co., Ltd. Structure multicouche à gel de gélatine réticulée, vecteur de facteur bioactif, préparation de libération du facteur bioactif et leurs procédés de production
WO2013018864A1 (fr) * 2011-08-03 2013-02-07 グンゼ株式会社 Membrane anti-adhésion

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05503871A (ja) * 1990-10-01 1993-06-24 ジェンセン、オール・アール 輪郭形成された接着層を有する傷用被包材
JP2003199781A (ja) * 2001-10-24 2003-07-15 Daiya Seiyaku Kk パッド材及び携帯用パッド材
JP2007044080A (ja) * 2005-08-05 2007-02-22 Gunze Ltd 癒着防止膜
WO2008016163A1 (fr) * 2006-08-01 2008-02-07 Nichiban Co., Ltd. Structure multicouche à gel de gélatine réticulée, vecteur de facteur bioactif, préparation de libération du facteur bioactif et leurs procédés de production
WO2013018864A1 (fr) * 2011-08-03 2013-02-07 グンゼ株式会社 Membrane anti-adhésion

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019001948A (ja) * 2017-06-19 2019-01-10 澁谷工業株式会社 ゼラチン架橋体の製造方法および製造装置
JP6989757B2 (ja) 2017-06-19 2022-02-03 澁谷工業株式会社 ゼラチン架橋体の製造方法および製造装置

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