WOUND DRESSING, KIT AND PRODUCTION METHOD

Abstract

The invention is a biocompatible hydrogel-based wound dressing (100) that can be applied to the wound surface, consisting of a hydrogel layer (110) that forms the biocompatible matrix in direct contact with the wound and provides a moist healing environment by producing or releasing NO under light; a NO module (120) to ensure controlled release; an optical lock layer (130) to suppress unwanted activation in ambient light and allow only the passage of target wavelengths; an adhesive frame (150) to fix the aforementioned wound dressing (100) to the surrounding healthy skin; a light source (200) to enable controlled activation of the NO module (120); and an LED array (210) that produces light at the required wavelength to carry out the activation process.

Description

1 TARIFF WOUND DRESSING, KIT AND PRODUCTION METHOD TECHNICAL FIELD The invention relates to a biocompatible hydrogel-based wound dressing that can be applied to the wound surface. STATE OF THE ART 5 In chronic wound treatment, nitric oxide (NO) increases vasodilation and supports angiogenesis. It is an important biological agent due to its antimicrobial activity and accelerated tissue regeneration. It is considered one of the signaling molecules. Therefore, NO emissions have been monitored in recent years. Numerous studies have been conducted on wound dressings and biomaterials that can perform this function. In current technology, the majority of NO release systems are based on passive diffusion-controlled release. These systems utilize various mechanisms. In these systems, the NO donor is pre-loaded into the wound dressing. and are released over time through diffusion or chemical decomposition. However, this approach is mostly flawed. Initially, a high amount of the active substance is released, after which it is rapidly depleted, and This makes it difficult to maintain therapeutic levels for a long time. The literature also proposes wound dressing systems activated by external energy. For example, 15 In patent document number US10543293B2 titled "Medical dressing," it is stated that light emitted from a light module... a modular system that enables the degradation of photolabile nitric oxide donors by electromagnetic radiation The wound dressing is explained. Thus, nitric oxide release is achieved by the application of light. However, the system in question features an optical lock architecture that prevents unwanted activation in ambient light. 20 features such as repeatable dose control over multiple sessions and user-controlled on-demand dosing. It does not include these features. Therefore, it lacks a significant technical infrastructure in terms of light-activated NO emissions. Although it offers something different, it differs structurally and functionally from the existing invention. Similarly, patent document number KR101725374B1 describes fiber structures based on natural polymers. It describes a patch system that enables the controlled release of biomolecules or drugs. Its mechanism is passive controlled release based on ionic interactions, and light-triggered nitric oxide production 25 or does not include any solution to prevent activation under ambient light. On the other hand, patent number CN117794521A describes activation by various external stimuli (such as heat or radiation). Possible local application patch systems are described. However, these systems use light-selective nitric oxide. 2 hydrogel structure that enables release, optical lock layer and multi-session controlled dosing mechanism They do not offer them together. Patent number US6773699B1 describes a light-energy device that uses laser energy to enhance tissue adhesion. It describes biological patch systems. Here, the purpose of the light is not to produce nitric oxide, but biological... It is the activation of the adhesive. Therefore, although light is used, the technical problem and solution are 5. His approach differs from the existing invention. In addition, patent number US11389410B2 enables controlled drug release over multiple days. It describes a transdermal patch system. The system is based on a long-term, stable release principle, and light-controlled activation, nitric oxide production, or activation performed at a time desired by the user. It does not involve a multi-session dosing approach. 10 Apart from this, in the literature US2004167461A1, CN114668748A, US2025134829A1, US2020129669A1, Numerous patents such as US2022087948A1, US2005255150A1, US2013204191A1 and KR20080014461A The document describes patch structures containing active agents and various external triggering mechanisms. However, light-selective nitric oxide release suppresses unwanted activation in ambient light through optics. An integrated system offering both key architecture and multi-session user-controlled dosing capabilities. 15 It has not been revealed. Therefore, the current technology uses devices that can only be activated by light when desired, remaining passive in ambient light. Portable light that provides repeatable therapeutic doses in multiple sessions and is implanted with a hydrogel wound dressing. There is still a need for a solution that offers the module as a single system. THE PURPOSE OF THE INVENTION 20 The main objective of the invention is to create a biocompatible hydrogel-based wound dressing that can be applied to the wound surface. By enabling the controlled and safe release of nitric oxide (NO), it supports the wound healing process. The goal is to develop a new biomaterial system. One aim of the invention is to create a hydrogel structure containing a nitric oxide donor that is applied only by the user. 25 that can initiate NO emission at a desired time by activating it with light of a specific wavelength. It is to offer a wound dressing. Another purpose of the invention is to address potential issues that may arise under ambient light or everyday lighting conditions. By developing an optical lock architecture that prevents unwanted activations, NO within the hydrogel. The goal is to increase the stability of the donor during storage, transport, and use. 3 Another aim of the invention is to enable multiple treatment sessions spread throughout the day following a single application. a dosing mechanism capable of delivering repeatable and user-controlled nitric oxide release to provide. Another aim of the invention is to provide predictable and controlled results within the therapeutic range after each light activation. By releasing nitric oxide, the initial high emission rate is reduced and the active ingredient is 5 The aim is to ensure it is used more efficiently. Another objective of the invention is to create an integrated portable light source that works in conjunction with a hydrogel wound dressing. The aim is to create a kit that provides ease of clinical use and standardized application. Another objective of the invention is to allow the user to adjust the light application duration, light intensity, and application time. by enabling control, it allows for optional and personalized treatment. 10 to make it possible. Another objective of the invention is to create an integrated wound dressing, optical locking structure, and portable light module. by creating a system, solutions that are currently offered as separate components in the existing technology are brought together on a single platform. to unite under one. Another aim of the invention is to treat chronic wounds, diabetic foot ulcers, pressure ulcers, venous ulcers and similar conditions. In types of wounds that are difficult to heal, controlled nitric oxide release supports tissue regeneration. The goal is to provide a reliable treatment platform. BRIEF DESCRIPTION OF THE FIGURES Figure 1 shows the kit / system: wound dressing, light source module, instruction manual, and protective sterile packaging. A general overview showing its components is provided. 20 Figure 2 shows a layered cross-sectional view of the wound dressing; hydrogel layer, NO modulus, optical locking layer, The carrier / support layer and adhesive frame components are shown. Figure 3 shows the multi-session activation protocol; activation windows (S1–S5), session interval (Δt), and basal values. Periods (B) and an example timeline are shown. Figure 4 shows the NO emission profile; basal emission region, triggered emission region, peak emission, and integrated emission region. 25 (IA) indicators. 4 EXPLANATION OF REFERENCES IN THE FIGURES B. Basal region A. Activation zone P. Peak release IA. Integrated emission area 5 100. Wound dressing 110. Hydrogel layer Module 120. NO 121. NO donor 122. NO Carrier 10 130. Optical lock layer 131. Permeable filter film 132. Pigment 133. Layered dielectric structure 140. Carrier 15 150. Adhesive frame 160. Separator 200. Light source 210th LED array 220. Optical collimator 20 230. Controller 240. Ambient light sensor 250. Power supply 300. IFU 400. Protector 900. Kit DETAILED DESCRIPTION OF THE INVENTION 5 The invention shown in Figure 1 and Figure 2 is a wound dressing developed for general application to wound surfaces. A Kit that enables the controlled activation of the wound dressing (100) with the wound dressing (100). (900) relates to the structure. Kit (900); wound dressing (100), light source (200), IFU (300) and protective (400) components are included. Wound dressing (100) has low basal nitric acid unless trigger light is applied. It will release oxide, and when light of a specific wavelength is applied, it will be activated in a controlled manner. It is structured in such a way that nitric oxide release during the wound healing process is controlled by the user. It is left to their control and involves the execution of multiple tasks spread throughout the day. It provides. Wound dressing (100) is formed as a layered structure. This structure is directly in contact with the wound. contacting hydrogel layer (110), NO module (120) located inside the hydrogel layer (110), optical lock 15 layer (130), optional carrier (140), adhesive frame (150) and pre-use It includes the separating (160) components that protect the system. These layers work together to provide controlled nitric It forms a wound dressing capable of releasing oxide. The hydrogel layer (110) forms the biocompatible active layer that is in direct contact with the wound surface. The hydrogel layer (110) supports the healing environment by keeping the wound surface moist and 20 It also forms a carrier medium for the NO module (120). Hydrogel layer (110); hyaluronic acid, alginate, chitosan, gelatin derivatives (including GelMA), PEG, PVA or their derivatives They can be prepared from combinations of ionic, covalent, photochemical or enzymatic processes. It forms a three-dimensional hydrogel network with increased mechanical strength by cross-linking using various methods. Thus, it provides a suitable structure in terms of both biocompatibility and controlled substance release. 25 NO module (120), the active part which forms or releases nitric oxide when light is applied. It consists of. The NO module (120) contains at least one NO donor (121). NO donor (121); RSNO class, NONOate class, nitrite / nitrate precursors or NO loaded porous systems It can be selected. NO donor (121) dispersed directly in the hydrogel layer (110). As can be found, 30 NO carriers (122) are also added to increase controlled release. 6 It can be placed. NO carrier (122) ensures that the active substance remains stable during storage, under controlled conditions. This ensures that it is activated in this way and maintains its effectiveness across multiple applications. The optical lock layer (130) constitutes one of the key innovative elements of the invention. Optical lock layer (130), which is present in ambient light and causes unwanted activation on NO module (120). It is structured to suppress possible wavelengths. In contrast, only target 5 This allows the activation wavelengths to reach the hydrogel layer (110). Thus uncontrolled nitric oxide emissions that may occur during storage, transport and daily use In user-controlled lighting applications, the NO module blocks access. It ensures that (120) is activated as desired. Optical lock layer (130); at least one permeable filter film (131), pigment (132) and layered dielectric 10 The structure (133) can include components. The permeable filter film (131) can only contain the specified wavelengths. It provides selective permeability allowing the passage of unwanted wave. Pigment (132) By absorbing their lengths, it reduces the involuntary activation that may occur on the NO module (120). Layered dielectric structure (133) regulates the optical properties of light and high at target wavelengths. It provides high transmittance and blocking at other wavelengths. These structures alone provide 15 or they can be used together. The carrier (140) increases the mechanical strength of the wound dressing (100) and holds the layers together. It forms the structural element that provides the carrier (140), the hydrogel layer (110) and the optical lock layer. (130) ensures that it maintains its integrity without deformation during application. Adhesive frame (150), wound dressing (100) securely onto healthy skin around the wound 20 It ensures that it is fixed. The separator (160) that protects the system before use is used during application. This allows the wound dressing (100) to be used sterilely by removing it. The light source (200) included in the kit (900) enables the controlled activation of the NO module (120). It constitutes the electronic component that provides the light source (200); at least one LED array (210), optical Collimator (220), controller (230), optional ambient light sensor (240) and power supply (250) 25 It can include its components. The LED array (210) produces light at the required wavelength for activation. The optical collimator (220) directs the generated light onto the wound dressing (100) in a homogeneous and controlled manner. It ensures the direction of the light application time, application time and the controller (230). It controls the operating parameters. Ambient light sensor (240), in the applications where it is located By sensing the ambient light level, the system can provide warnings to the user or activate its safety functions. 30 It provides support. The power supply (250) provides the electricity required for the operation of the light source (200). It provides its energy. 7 During use, the user must adjust the light source in accordance with the application protocol specified in IFU (300). (200) places the wound dressing (100) on it. NO module during the time the trigger light is not applied. (120) remains at a low basal emission level. With the application of light at the determined wavelength The NO module (120) is activated and nitric oxide release begins. The application of light Upon termination, the system returns to a low basal release level. Thus, nitric 5 Oxide emissions are only released when needed and in a controlled manner. Figure 3 illustrates the principle of multi-session application. A specific time interval is required between each application session. By releasing it, the NO module (120) is reactivated. Thus, the same wound dressing (100) Multiple applications can be run on it throughout the day, and each application is controlled. Nitric oxide release is obtained. 10 In the nitric oxide emission profile shown in Figure 4, the absence of light application is denoted as the basal region (B). System activation occurs when the user initiates the lighting application. It passes into region (A) and nitric oxide emissions increase. The highest value reached is peak emission (P). It is defined as follows. The total nitric oxide emission that occurs during the activation period is integrated. This is shown as the emission area (IA). Thus, both the instantaneous performance and the total emissions of the system are shown. It enables a joint assessment of their capacities. After use, the wound dressing (100) can be left on the wound for an appropriate period of time or used for treatment. It can be changed according to the protocol. Unused products are kept in protective (400) containers. It is thus protected against ambient light. In this way, the NO module (120) is protected during storage and transport. It does not activate unintentionally and maintains its stability until the moment of use. 20

Claims

8 REQUESTS 1. The invention is a biocompatible hydrogel-based wound dressing (100) that can be applied to the wound surface, feature;  A biocompatible matrix that comes into direct contact with the wound and provides a moist healing environment. to provide hydrogel layer (110); 5  By producing or releasing NO under light; to achieve controlled release. NO module (120);  By suppressing unwanted activation in ambient light, it activates only the target wavelengths. optical lock layer to allow passage (130);  To secure the mentioned wound dressing (100) to the surrounding healthy skin, use adhesive 10 frame (150);  Light source (200) to enable controlled activation of the NO module (120);  Light at the required wavelength to enable the activation process to take place LED array producing (210);  To direct the light onto the wound dressing (100) in a homogeneous and controlled manner 15 optical collimator (220);  To enable control of light application duration, time, and operating parameters. controller (230);  Power to meet the electrical energy needs of the light source module source (250); 20  To protect the product from ambient light and prevent unintentional activation during storage and transport. protective measures to prevent (400); It is characterized by its inclusion.

2. A biocompatible hydrogel-based wound dressing (100) conforming to Claim 1, whose characteristic is light showing the low emission level when no application is made; the emission profile from the beginning and 25 It includes the basal region (B) to define the resting level.

3. A biocompatible hydrogel-based wound dressing (100) conforming to Claim 1, whose characteristic is; trigger light By showing the region where NO emissions increase when applied; controlled activation behavior. It contains the activation region (A) to express this.

4. A biocompatible hydrogel-based wound dressing (100) conforming to Claim 1, with the characteristic of activation 30 It includes peak emission (P) to show the highest NO emission reached during the process. 9 5. A biocompatible hydrogel-based wound dressing (100) conforming to Claim 1, whose characteristic is activation. Integrated release to measure total dose capacity by showing total NO emissions over time. It includes the area (IA).

6. A biocompatible hydrogel-based wound dressing (100) in accordance with Claim 1, whose characteristic is; NO production. It contains the chemical source No donor (121). 5 7. A biocompatible hydrogel-based wound dressing (100) in accordance with Claim 1, whose characteristic is; donor NO carrier (122) to keep stable during storage and support controlled activation It includes.

8. A biocompatible hydrogel-based wound dressing (100) conforming to Claim 1, whose characteristic is; selected wave It contains a permeable filter film (131) to provide spectral selectivity by passing their lengths through. 10 9. A biocompatible hydrogel-based wound dressing (100) in accordance with Claim 1, whose characteristic is; unwanted It contains pigment (132) to reduce involuntary activation by absorbing wavelengths.

10. A biocompatible hydrogel-based wound dressing (100) in accordance with Claim 1, whose characteristic is; target wave designed to provide high transmittance at one wavelength and high blocking at other wavelengths. It contains a layered dielectric structure (133). 15 11. A biocompatible hydrogel-based wound dressing (100) conforming to Claim 1, whose characteristic is that the layers It contains a carrier (140) to maintain its mechanical integrity and reduce deformation.

12. A biocompatible hydrogel-based wound dressing (100) conforming to Claim 1, whose characteristic is; light-sensitive wound dressing Optical collimator (220) for directing homogeneously and in a controlled manner onto (100). It includes. 20 13. A biocompatible hydrogel-based wound dressing (100) in accordance with Claim 1, its feature is; multiple sessions and It includes IFU (300) to inform the safe use protocol and the sequence of application.

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