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EP-4736899-A1 - INCISE DRAPE AND MANUFACTURING METHOD THEREOF

EP4736899A1EP 4736899 A1EP4736899 A1EP 4736899A1EP-4736899-A1

Abstract

Proposed is an incise drape including a base layer, and an adhesive layer formed on the base layer and containing acid-treated chitosan, povidone-iodine, and acrylate copolymer, wherein the adhesive layer contains less than 1 part by weight of povidone-iodine, and acid-treated chitosan in an amount of 1.5 to 5 parts by weight relative to povidone-iodine.

Inventors

  • JUNG, MIN HO

Assignees

  • Endovision Co., Ltd.

Dates

Publication Date
20260506
Application Date
20251030

Claims (11)

  1. An incise drape comprising: a base layer; and an adhesive layer formed on the base layer and configured to contain acid-treated chitosan, povidone-iodine, and acrylate copolymer, wherein the adhesive layer contains the povidone-iodine in an amount of less than 0.7 to 1 part by weight based on a total weight of the adhesive layer, and the acid-treated chitosan in an amount of 1.5 to 5 parts by weight relative to the povidone-iodine.
  2. The drape of claim 1, wherein the chitosan includes mushroom-derived chitosan.
  3. The drape of claim 2, wherein the mushroom-derived chitosan has a molecular weight between 3,000 to 30,000 Da.
  4. The drape of claim 1, wherein the acrylate copolymer comprises at least one selected from the group consisting of vinyl acrylate copolymer, methacrylate copolymer, stearyl acrylate copolymer, butyl acrylate copolymer, alkyl acrylate copolymer, acrylic acid and acrylate copolymer, acrylate-polyester copolymer, acrylate-polyurethane copolymer, and acrylate-silicone copolymer.
  5. The drape of claim 1, wherein the base layer comprises a polyurethane layer formed atop a polyolefin film.
  6. The drape of claim 1 comprises a release liner film on one or both sides thereof.
  7. A manufacturing method of an incise drape, the method comprising: S1) preparing a base layer; S2) manufacturing an adhesive layer by preparing a mixed solution containing acid-treated chitosan, povidone-iodine, and acrylate copolymer and applying the mixture to the base layer; and S3) drying, wherein the mixed solution contains acid-treated chitosan, povidone-iodine, and acrylate copolymer in a weight ratio of 0.1 to 5: 0.1 to 10: 75 to 99.
  8. The method of claim 7, wherein the step S1) comprises: forming the base layer by applying 40 to 60 mL of polyurethane per 1 m 2 of polyolefin film.
  9. The method of claim 7, wherein the step S2) comprises: S2-1) preparing the mixed solution by combining the acid-treated chitosan, povidone-iodine, and acrylate copolymer and stirring the mixture at 30 to 40 °C for 80 to 100 minutes; S2-2) heating the mixed solution to 70 to 90 °C and mixing for an additional 50 to 90 minutes; and S2-3) forming the adhesive layer by stirring the mixed solution for 1 to 10 hours by reducing temperature to 30 to 40 °C and then applying 80 to 110 mL of the stirred mixed solution per 1 m 2 of the base layer.
  10. The method of claim 7, wherein the acid-treated chitosan is prepared by immersing mushroom-derived chitosan in an acid solution to form an acid-treated chitosan mixture, followed by washing with at least one of an alcohol or a surfactant, and then drying the resulting material.
  11. The method of claim 7, wherein the acrylate copolymer comprises at least one selected from the group consisting of vinyl acrylate copolymer, methacrylate copolymer, stearyl acrylate copolymer, butyl acrylate copolymer, alkyl acrylate copolymer, acrylic acid and acrylate copolymer, acrylate-polyester copolymer, acrylate-polyurethane copolymer, and acrylate-silicone copolymer.

Description

CROSS REFERENCE TO RELATED APPLICATION The present application claims priority to Korean Patent Application No. 10-2024-0154587, filed November 04, 2024 and Korean Patent Application No. 10-2025-0082432, filed June 23, 2025, the entire contents of which are incorporated herein for all purposes by this reference. BACKGROUND Technical Field The present disclosure relates to a surgical incise drape with improved antimicrobial activity, and a manufacturing method thereof. Description of the Related Art Incise drapes are used during surgery to protect the incision area from infection and other factors. Typically, an incise drape is composed of a base layer and an adhesive surface formed on one side of the base layer. An incise drape configured as above has an adhesive surface to be adhered to the skin and be cut through along with the skin by means of a surgical instrument. The primary purpose of surgical incise drapes is to create a sterile barrier that prevents germs and bacteria from reaching the incision site. Because the skin is typically disinfected rather than sterilized during surgical preparation, bacteria can still remain on the skin and be transferred to the incision site during the incision. Incise drapes can be used to reduce infection at the surgical site by trapping skin microorganisms and providing a lasting antimicrobial effect. Furthermore, by stabilizing the skin and securing the incision site, the incise drapes can prevent an incision from opening or damage to the underlying tissue. Surgical incise drapes use povidone-iodine (PVP-I) or chlorhexidine to provide antimicrobial properties. Chlorhexidine has high antibacterial and antifungal activity with low skin irritation, making it a common alternative or supplement to povidone-iodine. However, chlorhexidine has limitations against some viruses and fungi on its own. Povidone-iodine is a broad-spectrum antimicrobial that is effective against germs, bacteria, viruses, and fungi. Povidone-iodine's strong sterilizing power and rapid action speed allow it to exert a powerful sterilizing effect within seconds to minutes. Povidone-iodine is a versatile antiseptic used for disinfection, wound care, and medical instrument sterilization. Povidone-iodine has different antimicrobial effects and clinical uses depending on its concentration. Povidone-iodine at lower concentrations has a milder antimicrobial effect, but it causes less skin irritation and leaves no residue on the skin after use, and does not significantly interfere with wound healing. Because of these properties, it is widely used in wound treatment patches, wound dressings, and skin disinfectants. High concentrations of povidone-iodine exhibit strong antimicrobial effects, making it used for surgical drapes and medical device disinfection to prevent surgical site infections. However, the high concentration can cause skin irritation, and prolonged use may lead to adverse effects such as burns and cytotoxicity. For surgical incise drapes, high concentrations of povidone-iodine need to be used to enhance the antimicrobial effect since the incise drapes are used by directly adhering to the skin. However, using high concentrations of povidone-iodine for long periods can cause skin irritation like dryness, redness, or stinging, as described above, and its powerful antimicrobial action can be toxic to both bacteria and normal cells, potentially delaying wound healing if it penetrates open wounds or incisions. Moreover, some patients have been reported to develop allergic reactions to iodine. To address these issues, various formulation strategies have been explored to maintain a low concentration of povidone-iodine while still achieving high antimicrobial efficacy by combining povidone-iodine with other antimicrobial agents. However, in most of these formulations, the concentration of povidone-iodine has not been reduced to below 1%, which is the threshold typically associated with minimal skin irritation. Thus, incise drapes still contain high concentrations of povidone-iodine, which carries the risk of skin irritation and inflammation. Accordingly, there is a need to develop an incise drape that can have high antimicrobial activity even with low concentrations of povidone-iodine while minimizing skin irritation. SUMMARY The present disclosure aims to provide an incise drape that has high antimicrobial activity even with low concentrations of povidone-iodine by containing acid-treated chitosan, and a method of manufacturing the incise drape. In order to achieve the above objective, according to an aspect of the present disclosure, there is provided an incise drape including: a base layer; and an adhesive layer formed on the base layer and configured to contain acid-treated chitosan, povidone-iodine, and acrylate copolymer, wherein the adhesive layer may contain less than 1 part by weight of povidone-iodine based on the total weight of the adhesive layer, and acid-treated chitosan in an amount of 1