A multilayered silicone nasal tampon containing cannabidiol, coated with silver nanoparticles and chitosan, developed for use in the treatment of septal perforations.

Abstract

This invention relates to a nasal tampon that is inserted into the nasal cavity for the management and treatment of septal perforations that develop after nasal surgery.

Description

1 TARIFF FOR USE IN THE TREATMENT OF SEPTAL PERFORATIONS ENHANCED, CANNABIDIOL-CONTAINING, SILVER NANOPARTICLE AND CHITOSAN COATED MULTILAYER SILICONE NASAL TAMPON Technical Area 5 This invention is relevant to the management of septal perforations developing after nasal surgery and It refers to a nasal tampon that is placed inside the nasal cavity for use in treatment. Previous Technique Septal perforations can be caused by septoplasty, septal surgeries, trauma, infections, or inflammation. nasal congestion can develop due to illnesses or long-term intranasal drug use. symptoms such as bleeding, crusting, dryness, impaired airflow, infection, and difficulty breathing. These are nasal septum defects that can cause clinical problems. Septal perforations In its treatment, conservative approaches and surgical methods are used together. In terms of technique, silicone-based nasal tampons, septal buttons, and various other devices are used for conservative treatment. Intranasal splints and topical care products are used. Silicone nasal tampons are the main 15 as well as controlling postoperative bleeding, supporting the nasal cavity, and It is applied to ensure tissue stabilization during the healing process. Septal The buttons mechanically close the perforation opening, regulating the airflow and It aims to reduce symptoms. In addition, antibiotic ointments and moisturizers are used to promote mucosal healing. Gels, hyaluronic acid-containing preparations, and various topical agents can be used. However... These products are generally applied independently of tampon or septal button and are single-use. They are unable to provide mechanical support to their heads. In more advanced cases, local flaps, free grafts, and cartilage are used to close the perforation. or surgical reconstruction is performed using fascia grafts. With this 25 surgical methods in combination with other methods have long operation times, technical application difficulties, and graft issues. failure, the possibility of recurrence of perforation, and the risk of postoperative complications. For these reasons, it cannot offer a suitable solution for every patient. 2 Current nasal tampon systems are mostly biocompatible silicone-based structures, and the basic It performs mechanical support and bleeding control functions. Some While absorbent sponge structures or hemostatic materials can be used in tampons, antibacterial properties, controlled drug release, and support of mucosal epithelialization, etc. multilayered integrated 5 in which biological functions are performed together within the same structure No such systems are encountered. In addition, reducing the risk of infection in existing products, Active ingredients used to control bleeding and promote tissue healing. The components are mostly administered as separate treatment applications. Therefore, nasal tampons, septal buttons, and other intranasal devices used in the current technique treatment products, mechanical support that may be needed in the treatment of septal perforation, 10 Antibacterial protection, hemostatic effect and epithelialization support are provided by a single biocompatible intranasal solution. The device cannot provide all of these simultaneously. This situation leads to a longer treatment process and the need for additional treatment. This can lead to the need for additional procedures and a decrease in patient comfort. Document GB2553260A discusses filling body cavities such as nasal cavities. A ready-to-use, hydrophilic, self-dispersing porous sponge 15 This is explained. Sponges can be made from synthetic and natural materials such as polyvinyl alcohol, gelatin, chitosan, and alginate. It consists of a lyophilized mixture of polymers. The sponge is used in medicines and growth. as a carrier for the controlled release of therapeutic agents such as factors or cells It has also been stated that it can be used. Document US11083634B2 states that filling body cavities such as nasal cavities is permissible under 20 a device that enables the controlled application of pharmaceutical compounds to a targeted area It is related to. The device is an absorbent tube with cavities on at least one of its surfaces that serve as a medicine reservoir. It contains elements. This structure stops bleeding by mechanical pressure while simultaneously... It enables the direct release of agents held in reservoirs to the target mucosal region. The device is largely made of absorbent materials such as PVA and cellulose, although the handle and outer casing are 25. Components such as these can be manufactured from materials like silicone and polyethylene. Document US2019254961A1 describes methods for stopping bleeding in the nasal cavities. A nasal plug with a hemostatic coating is described. According to the document, in one application... Polymeric sponges, cellulosic materials, or porous and flexible materials like cotton. Iron sulfate, aluminum 30, with a compressible inner layer, has hemostatic properties. A coating consisting of compounds such as sulfate, tannic acid, and zinc chloride is described. (Plug) 3 Its contents include clotting factors such as thrombin, antibiotics, and antimicrobial agents. It has also been noted that antihistamines and decongestants may be added. Document US11684520B1 describes the control and treatment of nasal bleeding. A device for this purpose is described. The device consists of a sponge-like upper section that enters the nose, and... a supporting stem, a 5-inch upper section impregnated with a drug that causes blood clotting. It contains one layer. Therefore, septal technology provides a solution to the aforementioned problems encountered in the current technique. An improved version that increases effectiveness in treating perforations and supports the healing process. The development of nasal packing has become necessary. Purposes and Brief Description of the Invention 10 The aim of this invention is to manage septal perforations that develop after nasal surgery. and a nasal tampon that is placed inside the nasal cavity for use in treatment It is the development of. Another aim of the invention is to provide antibacterial and hemostatic effects within a single nasal tampon structure. By combining features and mucosal epithelialization support, the postoperative healing process is improved by 15 The goal is to create a multi-layered structure that provides support. Another aim of the invention is to reduce the risk of infection and bleeding with the developed nasal tampon. It has a multilayered structure that supports control and accelerates mucosal tissue healing. It is the fact that. Detailed Description of the Invention 20 This invention is used in the treatment of septal perforations in order to achieve its objectives. a multi-purpose product containing cannabidiol, coated with silver nanoparticles and chitosan, developed for use in... Layered silicone nasal packing is shown in the attached figures. Figure 1: Perspective view of the complete nasal septal perforation tampon from the invention. 25 It is the appearance. 4 Figure 2: Perspective section showing the layered structure of the nasal septal perforation tamponade. It is the appearance. Figure 3: Cross-sectional view of nasal septal perforation tamponade. Figure 4: Nasal septum perforation and the tampon of the invention within the nasal cavity. This is a representative sagittal view of the location. 5 The parts shown in the figures are individually numbered, and their corresponding numbers are listed below. It has been given. 1. Base support layer 2. CBD-bearing layer 3. Chitosan layer 10 4. Nanocomposite layer containing silver nanoparticles The invention relates to the management of septal perforations developing after nasal surgery and This relates to a nasal tampon that is inserted into the nasal cavity for use in treatment, - non-porous, medical-grade material that allows for shaping and internal airflow. Basic support layer made of silicone (1), 15 - cannabidiol applied by co-extrusion onto the base support layer (1) (CBD) containing CBD carrier layer (2), - Chitosan layer applied by liquid immersion method onto CBD-bearing layer (2) (3), - Nanocomposite 20 containing silver nanoparticles applied on chitosan layer (3) layer (4) It includes its parts. The base support layer (1) is made of non-porous medical grade silicone and is the innermost part of the structure. It is located in this section. This layer forms the backbone of the tampon and is tubular. It possesses the mechanical strength necessary to maintain its shape. Shape retention, 25 It helps the nasal passage to take on the desired shape during the healing process. CBD-carrying layer (2), making silicon nano-microporous by chemical methods and coated onto the basic support layer (1) by co-extrusion method is formed. After the application of the CBD-carrying layer (2), the buffer is heated to approximately 50 °C. The patient is placed in a CBD bath at a certain temperature. The pores are opened in a vacuum-assisted unit at a low temperature. It is filled with CBD formulation using a liquid impregnation method under pressure. The CBD formulation to be used will be subjected to the same temperatures in subsequent production steps. It is selected in a way that will maintain its stability, and this feature is confirmed by analytical tests. 5 CBD-carrying layer (2) provides controlled exposure to the mucosal surface when the tampon is placed in the nasal cavity. It is formulated to release large amounts of CBD. The released CBD... Thanks to its anti-inflammatory and antioxidant properties, it reduces the inflammatory response. supporting mucosal healing and accelerating the epithelialization process is intended. 10 The chitosan layer (3) is coated onto the CBD-bearing layer (2) by liquid immersion method and It is cured in a tunnel oven operating at a low temperature, below 70 °C. Chitosan layer (3), It has a biocompatible biopolymer structure and properties that support bleeding control. This indicates that the layer in question forms a localized layer in the areas where the tampon contacts the nasal mucosa. It contributes to the restoration of hemostasis, improves the adaptation of the tampon to the mucosa, and 15 It supports tissue stabilization during the healing process. In addition, the CBD-carrying layer (2) It supports the controlled release of CBD into the tissues. Chitosan layer (3), By creating an interface between the tissue and the CBD-carrying layer (2), CBD can be transported only to the CBD-carrying layer. It reduces the risk of entrapment within layer (2). A nanocomposite layer containing silver nanoparticles (4) has cross-linking capability. The coating is applied onto a chitosan layer (3) using a polymer carrier. three-dimensional effect through liquid spraying system located at the extrusion line outlet. This is carried out. Then, the product is passed through a tunnel oven on the line and heated to 70 °C. It is dried at a temperature below this level, and the coating is fixed to the surface by cross-linking. The nanocomposite layer containing silver nanoparticles (4) is located on the outermost surface of the buffer 25 This coating prevents bacterial colonization on the buffer surface. reducing biofilm formation and lowering the risk of infection is the goal. Base support layer (1), CBD-bearing layer (2), chitosan layer (3) and silver nanoparticle nanocomposite layer (4) containing 30 layers connected to each other through structural integration between layers They are connected. Structural integration allows layers to be separated from each other during use. It prevents and increases mechanical strength. The bond between the layers is co-extrusion. 6 Lamination combined with thermal bonding, chemical bonding, or biocompatible adhesives. This can be achieved using one of the suitable production methods, such as systems. The external geometry of the nasal tampon is based on a form factor that ensures stable placement in the nasal cavity. It is created by taking into account the form factor, allowing the tampon to slide in the perforation area. will prevent it, ensure its stable positioning within the nasal cavity, and provide comfort to the patient. 5 It is anatomically shaped to provide this. Thus, the tampon remains in place throughout the treatment period. It is possible for the active layers to remain in an active position and for them to be in continuous contact with the mucosal surface. is happening. The tampon body is adapted to different nasal cavity anatomies and clinical application needs. In order to meet this requirement, it can be produced in different sizes. In this context, the bumper body has 10... The outer diameter can be selected between approximately 8–20 mm and the inner lumen diameter between approximately 3–10 mm. The diameter and inner lumen diameter values ​​ensure sufficient mechanical support of the tampon within the nasal cavity. This is determined by considering the need to ensure durability and maintain internal airflow. The sizing of the tampon body depends on the patient's nasal cavity anatomy, age, and septal status. Considering the size of the perforation and its location within the nasal cavity... This can be achieved by taking different types of buffers. Accordingly, buffers are available in different lengths, outer diameters, and inner lumens. Produced in diameter combinations to suit different patient and perforation conditions. It is adaptable. Thus, the tampon can be placed appropriately in the perforation area. Stable positioning within the nasal cavity and anatomical considerations for the patient during use. It is ensured that it adapts to its structure. 20 Nasal tampons, produced in tubular and long continuous forms, are suitable for various clinical settings. The tampon is cut into lengths of approximately 2–8 cm to suit the applications. Both ends are designed to prevent damage to surrounding tissues during insertion into the nose. in a conical, rounded, or beveled form without sharp edges is being shaped. This process involves the use of suitable cutting and edge forming equipment. 25 This is accomplished using [method / technique]. In the final stage, the products are sterilized using one of the known and validated methods. Products are preferably packaged in double packs and then placed on pallets ready for shipment. It is sterilized by irradiation. All raw materials to be used are medical grade. 30 that are biocompatible, non-toxic, and do not cause unacceptable levels of migration. It has this characteristic. 7 In one application of the invention, the base support layer (1), the CBD-carrying layer (2), chitosan layer (3), nanocomposite layer containing silver nanoparticles (4), interlayer A form factor that ensures structural integration and stable placement in the nasal cavity. A multi-layered nasal tampon is created by bringing together these layers. The aforementioned nasal tampon... tampon, used in otolaryngology surgery, to the septal perforation area or 5 Following nasal surgery, the implant is placed in the nasal cavity where the treatment will be applied. The buffer provides antibacterial protection thanks to the silver nanoparticles on its outer surface, It supports bleeding control through the chitosan layer (3) and the CBD-carrying layer (2) with the controlled release of cannabidiol, mucosal healing and epithelialization process It contributes to mechanical support, infection control, hemostasis and tissue 10 The healing process is achieved together within a single intranasal medical device. 20

Claims

8 REQUESTS 1. The invention relates to the management of septal perforations developing after nasal surgery and a nasal tampon placed inside the nasal cavity for use in treatment related to, - non-porous medical grade 5 that allows for shaping and internal airflow. Basic support layer made of silicone (1), - CBD-bearing containing cannabidiol (CBD) located on the basic support layer (1) layer (2), - Chitosan layer (3) located on top of CBD-bearing layer (2), - Nanocomposite containing silver nanoparticles applied on chitosan layer (3) 10 layer (4) It is characterized by containing its components.

2. Multilayer nasal tampon according to claim 1, with a non-porous base support layer (1). Made of medical-grade silicone, it preserves the tubular form and nasal cavity. It is characterized by being designed to adapt to its anatomy. 15 3. Multilayer nasal tampon according to claim 1, with a CBD-carrying layer (2) having nano-micro It is made of porous silicone structure and co- on the basic support layer (1) It is characterized by its application via the extrusion method.

4. Multilayer nasal tampon according to claim 1, with chitosan layer (3) carrying CBD. Application to the layer (2) by liquid immersion method and working below 70°C 20 It is characterized by curing in a tunnel oven.

5. Multilayer nasal tampon according to claim 1, in tubular form and long continuous structure. The bumper body, which is produced in this way, can be cut into lengths of approximately 2–8 cm, and The bumper should be tapered or rounded at both ends so that they do not have sharp edges. It is characterized by its beveled, fractured form. 25 6. Multilayer nasal tampon according to claim 1, tampon body approximately 8–20 mm It is produced in different sizes with an outer diameter of approximately 3–10 mm and an inner lumen diameter of approximately 3–10 mm. It is characteristic.

7. According to claim 1, it is a multi-layered nasal tampon, and the tampon body is positioned in the patient's nasal passages. 30 different depending on cavity anatomy, age, and size and localization of septal perforation. It is characterized by being produced in various lengths, outer diameters, and inner lumen diameters. 9 8. Multilayer nasal tampon according to claim 1, with base support layer (1) carrying CBD. layer (2), chitosan layer (3) and nanocomposite layer containing silver nanoparticles By combining (4) in such a way as to create structural integrity between the layers It is characterized by... 10 20

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