JP4546772B2 - Anti-adhesion material with release sheet - Google Patents

Description

  The present invention relates to an adhesion preventing material for preventing adhesion after surgery. More specifically, the present invention relates to an adhesion preventing material comprising a biodegradable film or sheet attached to a release sheet.

  Tissue adhesion, which is a physiological effect that occurs after surgery, is defined as abnormal binding between surrounding tissues and organs caused by production of collagen fibers by fibroblasts caused by tissue damage. Such adhesions are said to occur 90% after the operation, and in the case of causing pain, biological dysfunction, etc., it is a problem accompanied by mental and physical pain for the patient.

  A lot of research has been done to solve the problem. For example, in order to minimize adhesion formation, water-soluble anti-adhesion materials such as sodium alginate aqueous solution and sodium hyaluronate aqueous solution have been used. However, although these have some effects, they are water-soluble, so they flow not only at sites where adhesion prevention is required, but they may not only stay where they are needed, but also cause adhesion at normal sites. It was.

Therefore, in order to separate damaged tissue from other tissues, materials such as silicon, petrolatum, and polytetrafluoroethylene have been studied as adhesion preventing materials as physical barriers. Since these materials are non-bioabsorbable materials, they have a sufficient function as a barrier, but the risk of an immune reaction due to long-term persistence in the body and the need for reoperation to remove them after healing, etc. I had a problem.
In order to solve this problem, an anti-adhesion material using a natural polymer that is a bioabsorbable material has been developed.

  Specifically, an anti-adhesion material using oxidized cellulose is known, but if a sponge or knit made of oxidized cellulose is used in the presence of blood, it may not promote hemostasis and may promote adhesion more. . In addition, an anti-adhesion material comprising sodium hyaluronate and carboxymethyl cellulose has been developed and used. However, the anti-adhesion material using these materials has a high water absorption property, and thus has a problem that it is difficult to handle because it adheres to the water of the surgical instrument and organs other than the affected part. In order to avoid this, currently, it is recommended to use a method in which the anti-adhesive material is sandwiched and held between papers, the paper on the sticking side is removed during use, and the other paper is peeled off after sticking. However, the protection of the adhesion preventing material by paper has a problem that the paper and the adhesion preventing material are not easily attached to each other, so that the paper and the adhesion preventing material are easily separated and shifted.

  Further, the structure of the adhesion preventing material is desired to have a shape in which the distribution of fibrin cells from one tissue to another tissue is not desired, and a biodegradable and highly manipulable material is desired.

  Japanese Patent Application No. 2003-106186 discloses an adhesion preventing material using a honeycomb structure film made of a biodegradable polymer. Since this adhesion preventing material has a difference in structure between the front and back, it is necessary to distinguish the front and back, and it is required that the front and back can be more easily distinguished.

  It is necessary to protect the surface until just before use, and in the laminate in which both sides of the anti-adhesive material having a difference in the structure of the front and back surfaces of the anti-adhesive material are protected with the release sheet, the protective release sheet on the use surface can be easily peeled off Provided is an anti-adhesive material that can easily peel the remaining release sheet after the use surface is applied to the wound surface as an application site.

  An anti-adhesive material and a laminate in which release sheets are pasted on both sides of the anti-adhesion material, wherein the anti-adhesion material has a smooth surface and a rough surface, and the rough surface is applied to a wound surface. An anti-adhesive material characterized in that the adhesive force between the rough surface and the other release sheet is smaller than the adhesive force between the smooth surface and one release sheet, to solve the previous problem. The headline and the present invention were completed.

  That is, the present invention relates to an adhesion preventing material composed of a film or sheet having a rough surface structure on one side attached to a release sheet.

  The anti-adhesion material of the present invention can protect the surface of the anti-adhesion material for a required period and can easily expose the use surface during use. The anti-adhesion effect is stable and stable over the period.

  In a preferred embodiment of the invention, a film or sheet having a rough structure on one side is placed as a physical barrier between the surgical site and its adjacent tissue to limit tissue apposition, thereby preventing post-surgical adhesion. Reduce formation.

  The adhesion preventing material according to the present invention is characterized in that one surface has a rough surface structure and the other surface has a smooth structure. The rough surface preferably has irregularities of 0.1 μm to 200 μm in the depth direction, and more preferably 0.5 μm to 150 μm. The surface roughness of the rough surface structure is preferably Ra = 20 nm or more. The rough surface structure is not particularly limited, but includes not only a non-uniform structure but also a uniform structure such as a honeycomb structure. For example, in the case of a honeycomb structure, if the size of the void inner diameter is 0.1 to 20 μm, it can be suitably used as an adhesion preventing material.

  The thickness of the adhesion preventing material is not particularly limited, but is preferably 500 μm or less and more preferably 200 μm or less from the viewpoint of flexibility. From the viewpoint of handleability, it is preferably 1 μm or more, more preferably 3 μm or more.

  The material of the anti-adhesion material must be biodegradable in order to be embedded in the body. It is not particularly limited as long as it has biodegradability. For example, biodegradable synthetic polymers composed of polylactic acid, polyglycolic acid and the like, natural polymers such as collagen and gelatin, alginic acid, chitosan, hyaluron Examples thereof include polymers derived from natural products such as acid and cellulose. Among these, polylactic acid, polylactic acid-polyglycolic acid copolymer, and polycaprolactone are desirable from the viewpoint of availability and price.

  It is preferable that the release sheet of the present invention is flexible enough to be introduced into an endoscope. For example, any one of paper, a plastic film, a silicon sheet, and a vinyl sheet is included, and it is not particularly defined as long as it has flexibility enough to be introduced into an endoscope. You may use the paper which apply | coated silicon like release paper.

  In the release sheet of the present invention, the inner diameter of the trocar for passing the endoscope is from 3 mm to several tens of millimeters. Therefore, during the endoscopic operation, these release sheets are rolled up with an anti-adhesive material attached, and the inside of the cylinder. It will be shaped to pass through. Therefore, it is desirable that the release sheet is as thin as possible. Specifically, the thickness is preferably 20 μm to 200 μm, more preferably 30 μm to 150 μm. If the thickness of the release sheet is less than 20 μm, the release sheet becomes too thin to maintain the shape of the anti-adhesion material, making it difficult to release the release sheet, and workability may be reduced. On the other hand, if the thickness of the release sheet exceeds 200 μm, it is not preferable because flexibility is applied and workability during surgery is deteriorated.

  Since the adhesion preventing material of the present invention has a rough surface structure on one side, the adhesiveness is different on both sides of the film. In many cases, the antiadhesive material and the release sheet of the present invention are bonded to each other by a frictional force or an electric force on the surfaces of both materials without using an adhesive or the like.

  The adhesion force between the rough surface of the anti-adhesion material and the release sheet is determined by laminating the anti-adhesion material and the release sheet on the rough surface side of the anti-adhesion material and holding the laminate horizontally with the release sheet facing down. In addition, it is desirable that the release sheet does not peel off due to its own weight.

  The adhesion between the smooth surface of the anti-adhesion material and the release sheet is such that when the anti-adhesion material is applied to the wound surface, the release sheet easily peels from the anti-adhesion material, and the adhesion preventive material from the wound surface. It is desirable that it does not peel off again and does not damage the shape of the anti-adhesion material, such as tearing of the anti-adhesion material.

  The adhesion of the smooth surface of the anti-adhesive material to the release sheet with a smooth surface is high, and it has the property of being difficult to slip once applied. On the other hand, since the rough surface has higher adhesive force to the affected area than the adhesive force between the release sheet and the smooth surface of the adhesion preventing material, the release sheet can be easily peeled off during the operation. The anti-adhesion material takes a form in which both sides of the anti-adhesion material are covered in order to protect the sticking surface on the packaging. Therefore, when one release paper is peeled off during use, the smooth surface is always attached to the release sheet, so that the rough surface, which is the application surface to the affected area, is always attached to the front surface. Thereby, it becomes possible to affix a rough surface to an affected part, without distinguishing front and back.

  The release sheet of the present invention may be colored. By changing the color on both sides of the anti-adhesion material, it becomes easier for the user to distinguish between rough and flat surfaces. Although the color is not particularly defined, colors that are easy to distinguish from others, such as white, yellow, light blue, blue, green, and purple, are preferred to prevent forgetting at the time of surgery rather than colors that are close to the organ such as skin color.

  The adhesion-preventing material of the present invention is suitably used particularly for preventing adhesion during surgery. For example, the surface of living tissue that has been damaged by surgery during laparotomy or endoscopic surgery for a disease such as the liver, spleen, pancreas, kidney, uterus, ovary, or sutures of the Achilles tendon, hand tendon, nerve, etc. Used to prevent this.

  As a method of using the adhesion preventing material of the present invention, after attaching the rough surface of the adhesion preventing material to the affected area, moisture such as blood and tissue fluid is adsorbed and fixed on the affected area, and then the release sheet is peeled off. Since moisture such as blood and tissue fluid is adsorbed to the rough surface portion and the anti-adhesion material is fixed to the affected area, it is not necessary to suture the affected area.

  Furthermore, the anti-adhesion material of the present invention can be sterilized by, for example, ethanol sterilization, γ-ray sterilization, electron beam sterilization, ethylene oxide gas sterilization, etc., and safety can be enhanced by applying these treatments. .

  Hereinafter, although an example explains an embodiment of the present invention, these do not restrict the invention of the present invention.

[Example 1]
A phosphatidylethanolamine-dioleoyl as a surfactant is mixed with a chloroform solution (5 g / L) of polylactic acid (molecular weight: 100,000) in a ratio of 200: 1, cast on a glass substrate, and allowed to stand at room temperature and humidity of 70%. And a film having a honeycomb structure was prepared by gradually removing the solvent. The pore inner diameter of each of the pores constituting the honeycomb structure in the structure thus obtained is about 5 μm, the film thickness is 13 μm, a non-penetrating film, the surface is a rough surface structure, and the back surface is a smooth structure. A film was obtained. The surface roughness of the rough surface was Ra = 585 nm. Next, white release sheets (glassine paper coated with silicon) were pasted on both sides of the film-like adhesion preventing material prepared above.

  When both release sheets were held and one release sheet was peeled off, the adhesion-preventing material was peeled off with the rough side facing up. When the adhesive was applied to the abdomen of the rat with the rough side up, the anti-adhesive material was applied to the abdomen and only the release sheet could be easily peeled off.

[Comparative Example 1]
A cast solution with smooth both sides was prepared by casting a chloroform solution (100 g / L) of polylactic acid (molecular weight 100000) on a glass substrate, leaving it at room temperature, and removing the solvent by natural drying. Next, white release sheets (those coated with silicon on glassine paper) were pasted on both surfaces of the film-like anti-adhesive material prepared above.

  Holding both sides of the release sheet and peeling off one release sheet, the anti-adhesion material was peeled off when applied to one side, but when the adhesive was applied to the abdomen of the rat with the rough side up, After applying to the abdomen, it was difficult to peel off the release sheet.

[Comparative Example 2]
As a release sheet, a white release sheet (glassine paper coated with silicon) was attached to both sides of Sepra film (adhesion prevention material, Kaken Pharmaceutical Co., Ltd.). However, there was no adhesive force between the Sepra film and the release sheet, and when the Sepra film was placed on the release sheet and the release sheet was held and inverted, the Sepra film fell off.

It is a schematic diagram of the laminated body of the adhesion preventing material of this invention, and a peeling sheet.

Explanation of symbols

1 Release paper attached to the rough side of the anti-adhesion material 2 Release paper attached to the smooth side of the anti-adhesion material 3 Adhesion prevention material

Claims (7)

An anti-adhesive material and a composite in which release sheets are attached to both sides of the anti-adhesion material,
(1) The adhesion preventing material has a smooth surface and a rough surface, and the adhesion preventing material applies the rough surface to a wound surface,
(2) An adhesion preventing material characterized in that the adhesive force between the rough surface and the other release sheet is smaller than the adhesive force between the smooth surface and one release sheet. The adhesion preventing material according to claim 1, wherein the release sheet includes any one of paper, a plastic film, a silicon sheet, and a vinyl sheet. The adhesion preventing material according to claim 1 or 2, wherein the release sheet has a thickness of 20 to 200 µm.   The adhesion preventing material according to any one of claims 1 to 3, wherein the rough surface structure of the adhesion preventing material has irregularities of 0.1 µm to 200 µm in the depth direction.   The adhesion preventing material according to any one of claims 1 to 3, wherein the surface roughness of the rough surface structure of the adhesion preventing material is Ra = 20 nm or more. 6. The adhesion preventing material according to claim 1, wherein the rough surface structure of the adhesion preventing material is a honeycomb structure. Material該癒adhesion prevention material, polylactic acid, polyglycolic acid, collagen, gelatin, alginate, chitosan, hyaluronic acid, claim 1 is at least one polymer selected from cellulose scan or Ranaru group 6 of The adhesion prevention material according to any one of the above.

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