Nostril retainer device

Abstract

The embodiments herein describe a nostril retainer device (1) comprising a nostril stent assembly (3) and a wing assembly (2), detachably attached to the nostril stent assembly The wing assembly includes a body having a set of holes positioned at a centre of the wing assembly to hold the nostril stent assembly and an attachment member to secure the nostril retainer device into a nose of an individual to assist the individual to perform a nasal activity by the individual. The nostril stent assembly and the wing assembly are made of a biocompatible material comprising at least one of a medical-grade silicone, a Liquid Silicone Rubber (LSR), a rubber, a thermoplastic urethane, elastomers and thermoplastic elastomer.

Description

“NOSTRIL RETAINER DEVICE”The following specification particularly describes the invention and the manner in which it is to be performed: -FIELD OF INVENTION

[0001] The present application is based on and claims priority from an Indian Provisional Application Number 202541003683 filed on 16th January 2025, the disclosure of which is hereby incorporated by reference herein. The proposed embodiments relate to medical instruments and, more particularly, to providing a nostril retainer device with detachable wing assembly to prevent post-surgical and post-traumatic scar contracture of the nostril.BACKGROUND

[0002] Rhinoplasty, including aesthetic and restorative procedures such as cleft lip nose repair and septorhinoplasty, is a surgical intervention aimed at modifying the shape and size of the nose for cosmetic enhancement or functional improvement. Post-operatively, it is common practice to employ nostril splints, retainers, or conformers to stabilize and protect the nose during the healing period. These devices are essential in maintaining the newly sculpted shape, minimizing swelling, and safeguarding against accidental trauma.

[0003] Conventional nostril retainer devices are generally crafted from a single piece of relatively thin, malleable material designed to contour snugly to the individual's nose, thereby ensuring the desired shape is preserved during recovery. However, current nostril retainer device designs predominantly fall into two categories: those without wing assembly and those with fixed wing assembly. The inclusion of wing assembly is intended to enhance the security of the retainer on the patient's nose, yet this design feature is not without its drawbacks.

[0004] Retainers with fixed wing assembly can present significant challenges. The fixed wing assembly, while providing stability, may lead to irritation or discomfort within the nostrils. As the nasal tissues undergo the healing process, the wing assembly can exert friction against the delicate mucosal lining,potentially resulting in soreness or abrasions. Furthermore, if the retainer is not optimally fitted or if the wing assembly applies excessive pressure on the nostril walls, patients may experience heightened pain, pressure, or tenderness, with prolonged use.

[0005] Another concern associated with fixed-wing retainers is their propensity to trap moisture and mucus within the nostril cavity. Inadequate cleaning or infrequent replacement of the retainer can create a favorable environment for bacterial proliferation, thereby increasing the risk of infection.

[0006] These issues highlight the need for improvements in nostril retainer device design to mitigate discomfort, enhance fit, and reduce the likelihood of infection while still effectively supporting the healing process.

[0007] It is desired to address the above-mentioned disadvantages or other short comings or at least provide a useful alternative.OBJECT OF INVENTION

[0008] The principal object of the invention herein is to provide a nostril retainer device consisting of a nostril stent assembly and a wing assembly detachably attached to the nostril stent assembly to prevent post-surgical and post-traumatic scar contracture of the nostril and is customized to enhance comfort and with enhanced customization for patient- specific needs.

[0009] Another object of the invention herein is to provide a locking mechanism that engages with the nostril retainer device, providing an additional layer of security against accidental dislodgement.

[0010] Yet another object of the invention herein is to provide a nostril retainer device with a detachable wing assembly where the wing assembly includes an adhesive tape affixed over the strap area where the adhesive tape is applied horizontally or vertically at the ends of the wing assembly.

[0011] Yet another object of the invention herein is to provide a nostril retainer associated with the wing assembly with two holes to facilitate breathing and a tiny hole in between the two holes to hold the stent assembly.

[0012] Yet another object of the invention herein is to provide a nostril retainer device associated with the wing assembly affixed with the strap to hold the nostril retainer device in place.

[0013] Yet another object of the invention herein is to provide a nostril retainer device that includes a wing assembly having two holes to facilitate breathing and a central opening in between the two holes to hold the stent assembly where the stent assembly is designed with a tiny projection to fit into the central opening.

[0014] Yet another object of the invention herein is to provide a wing assembly specially designed for the individuals with choanal atresia or deviated septum or heminose condition where the wing assembly is provided with a single opening for holding stent and a pair of openings at ends to hold the strap.

[0015] Yet another object of the invention herein is to provide a wing assembly with two holes perfectly designed to insert the nasal stent assembly in place without the strap.SUMMARY

[0016] In an aspect the objectives are achieved by providing a nostril retainer device. The nostril retainer device includes a nostril stent assembly and a wing assembly, detachably attached to the nostril stent assembly. The wing assembly includes a body having a set of holes positioned at a centre of the wing assembly to hold the nostril stent assembly and an attachment member to secure the nostril retainer device into a nose of an individual to assist the individual to perform a nasal activity by the individual.

[0017] In an embodiment, the nostril stent assembly and the wing assembly are made of a biocompatible material comprising at least one of a medical-grade silicone, a Liquid Silicone Rubber (LSR), a rubber, thermoplastic urethane elastomers, and thermoplastic elastomer.

[0018] In an embodiment, the nostril stent assembly adapts to different anatomical measurements of the nose of individuals. The anatomical measurement includes the length of the nose of the individual, the diameter of a nasal passage of the individual, and the length of a nasal septum of the nose of the individual.

[0019] In an embodiment, the attachment member comprises two slots, each of which is positioned at opposite ends of the wing assembly to hold the nostril retainer device on the face of the individual using a strap. The strap comprises a first end comprising a first clip and a second end with a second clip configured to hold a nostril retainer device. The first clip and the second clip are adapted to be inserted into the two slots situated at the ends of the wing assembly.

[0020] These and other aspects of the embodiments will be better understood with the following description and drawings. The descriptions indicate preferred embodiments and specific details for illustration, not limitation. Many changes and modifications can be made within the scope of the embodiments without departing from their spirit, and all such modifications are included.BRIEF DESCRIPTION OF FIGURES

[0021] These and other features, aspects, and advantages of the present embodiments are illustrated in the accompanying drawings, throughout which like reference letters indicate corresponding parts in the various figures. The embodiments herein will be better understood from the following description with reference to the drawings, in which:

[0022] Fig. 1 illustrates schematic of the nostril retainer device, according to the embodiments as disclosed herein.

[0023] Fig. 2 illustrates a wing assembly along with a holding strap, according to the embodiments as disclosed herein.

[0024] Fig. 3a illustrates the wing assembly, according to the embodiments as disclosed herein.

[0025] Fig. 3b illustrates the nostril stent assembly, according to the embodiments as disclosed herein.

[0026] Figs. 4a and 4b illustrates cross sectional views of the nostril stent assembly detachably attached to the wing assembly, according to the embodiments as disclosed herein.

[0027] Figs. 5a-5b illustrates cross sectional views of the nostril stent assembly detachably attached to the wing assembly, according to the embodiments as disclosed herein.

[0028] Fig. 6 illustrates an example dimensions of wing assembly, according to the embodiments as disclosed herein.

[0029] Fig. 7a illustrates a wing assembly with adhesive tape, according to the embodiments as disclosed herein.

[0030] Fig. 7b illustrates the wing assembly, according to the embodiments as disclosed herein.

[0031] Fig. 8 illustrates a wing assembly with the strap attached to the wing assembly, according to the embodiments as disclosed herein.

[0032] Fig. 9a illustrates a nostril retainer device, according to the embodiments as disclosed herein.

[0033] Fig. 9b illustrates the wing assembly of the nostril retainer device, according to the embodiments as disclosed herein.

[0034] Fig. 9c illustrates the nostril stent assembly, according to the embodiments as disclosed herein.

[0035] Fig. 10a illustrates the nostril retainer device featuring a wing assembly with a rectangular slot, according to the embodiments disclosed herein.

[0036] Fig. 10b illustrates the wing assembly with the rectangular slot, according to the embodiments disclosed herein.

[0037] Fig. 10c illustrates nostril stent assembly, according to the embodiments as disclosed herein.

[0038] Fig. 11 illustrates a nostril retainer device designed to accommodate unique anatomies, according to the embodiments as disclosed herein.

[0039] Fig. 12 illustrates a nostril retainer attached with an adhesive backing, according to the embodiments as disclosed herein.

[0040] It may be noted that to the extent possible, like reference numerals have been used to represent like elements in the drawing. Further, those of ordinary skill in the art will appreciate that elements in the drawing are illustrated for simplicity and may not have been necessarily drawn to scale. For example, the dimension of some of the elements in the drawing may be exaggerated relative to other elements to help to improve the understanding of aspects of the invention. Furthermore, the elements may have been represented in the drawing byconventional symbols, and the drawings may show only those specific details that are pertinent to the understanding the embodiments of the invention so as not to obscure the drawing with details that will be readily apparent to those of ordinary skill in the art having benefit of the description herein.DETAILED DESCRIPTION OF INVENTION

[0041] The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and details in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. Also, the various embodiments described herein are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments. The term “or” as used herein, refers to a non-exclusive or, unless otherwise indicated. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein can be practiced and to further enable those skilled in the art to practice the embodiments herein. Accordingly, the examples are not be construed as limiting the scope of the embodiments herein.

[0042] As is traditional in the field, embodiments are described and illustrated in terms of blocks that carry out a described function or functions. These blocks, which referred to herein as managers, units, modules, hardware components or the like, are physically implemented by analog and / or digital circuits such as logic gates, integrated circuits, microprocessors, microcontrollers, memory circuits, passive electronic components, active electronic components, optical components, hardwired circuits and the like, and optionally be driven by firmware and software. The circuits, for example, be embodied in one or more semiconductor chips, or on substrate supports such as printed circuit boards and the like. The circuits constituting a block be implemented by dedicated hardware, or by a processor (e.g., one or more programmed microprocessors and associated circuitry), or by a combination of dedicated hardware to perform some functions of the block and a processor to perform other functions of the block. Each block of the embodimentsbe physically separated into two or more interacting and discrete blocks without departing from the scope of the proposed method. Likewise, the blocks of the embodiments be physically combined into more complex blocks without departing from the scope of the proposed method.

[0043] The accompanying drawings are used to help easily understand various technical features and it is understood that the embodiments presented herein are not limited by the accompanying drawings. As such, the proposed method is construed to extend to any alterations, equivalents and substitutes in addition to those which are set out in the accompanying drawings. Although the terms first, second, etc. used herein to describe various elements, these elements are not be limited by these terms. These terms are generally used to distinguish one element from another.

[0044] In existing nostril retainer devices, keeping the nostril retainer clean and ensuring it is properly positioned can be challenging. If the retainer is not kept clean, there is a risk of infection, which can complicate the healing process. Some users may experience difficulty breathing through their nose, especially if the retainer is not fitted properly.

[0045] The proposed nostril retainer device includes a wing assembly and a nostril stent assembly, where the wing assembly is detachably attached to the nostril retainer device. The nostril retainer device is configured to maintain nasal airway patency, support post-surgical healing following rhinoplasty, septoplasty, or other nasal procedures, and provide structural stability to the nasal passages while allowing unobstructed airflow. The wing assembly includes two central holes designed to hold the nostril stent assembly, as well as two holes at the ends for holding the nostril retainer device in place and to attach the nostril retainer device to the face. These holes ensure proper alignment and stability of the wing assembly within the nostril retainer device, facilitating secure attachment and maintaining the overall integrity of the nostril retainer device. The wing assembly facilitates the attachment of the nostril retainer device and keeps the nostril retainer device in place.

[0046] The nostril retainer device with a detachable wing assembly prevents post-surgical and post-traumatic scar contracture of the nostril. The proposed nostril retainer device is a U-shaped nostril stent assembly made of medical-grade silicone to improve nostril breathing and support the nostril structure. The nostril retainer devices are designed to be anatomically analogous and help give the best post-surgical correction to the nose. The nostril retainer device is the device having two symmetrical nostril stent assemblies connected with a common bridge. Further, the nostril stent assemblies are laterally connected to the holding wing assembly, which helps secure the nostril retainer device to the patients’ nose. The wing assemblies are detachable, which are customized to enhance comfort, and the detachable wing assembly makes it easier to clean the retainer.

[0047] Referring now to the drawings and more particularly to Figs. 1 through 12, where similar reference characters denote corresponding features consistently throughout the figure, these are shown preferred embodiments.

[0048] Fig. 1 illustrates a schematic of the nostril retainer device (1) according to the embodiments as disclosed herein. The nostril retainer device (1) includes a wing assembly (2) and a nostril stent assembly (3). The nostril stent assembly (3) is detachably attached to the wing assembly (2). The wing assembly (2) is designed with a flexible yet durable material that can withstand repeated attachment and detachment cycles without degrading. Unlike existing nostril retainer devices, the proposed nostril retainer (1) incorporates a locking mechanism that ensures a secure fit between the wing assembly (2) and the nostril stent assembly (3), preventing accidental dislodgement. The proposed design inherently extends the operational lifespan of the nostril retainer device (1). The ability to replace the wing assembly (2) individually means the nostril retainer device (1) can maintain optimal functionality for longer periods, avoiding premature replacement cycles. Such durability is especially advantageous in high-usage environments where reliable and lasting performance is essential. This improvement in longevity translates to better resource utilization and increased efficiency as the core device remains functional with minimal need for full replacement.

[0049] The wing assembly (2) includes a body having a set of holes (a & b) positioned at the center of the wing assembly (2) to hold the nostril stent assembly (3) and an attachment member to secure the nostril retainer device (1) into the nose of an individual to assist the individual in performing a nasal activity. The nostril stent assembly (3) and the wing assembly (2) are made of a biocompatible material comprising at least one of a medical-grade silicone, a Liquid Silicone Rubber (LSR), a rubber, thermoplastic urethane elastomers, and thermoplastic elastomer.

[0050] In an embodiment, the body has a length ranging from approximately 70 to 90 millimeters. The set of holes comprises a pair of holes positioned for insertion of the nostril stent assembly. Each hole of the pair of holes comprises a diameter of 8-16 millimeters and is separated by a distance of approximately 6-16 millimeters, with a total width of the holes including the separation being 18-27 millimeters. Further, the attachment member at the ends has a length of 11 millimeters and a width of 5 millimeters, and the ends of the wing assembly (2) narrow to a width of 7-32 millimeters and then enlarge to a width of 15-32 millimeters, and wherein the wing assembly (2) is curved to fit the pair of holes.

[0051] In an embodiment, the nostril stent assembly (3) adapts to different anatomical measurements of the nose of individuals. The anatomical measurement includes the length of the nose of the individual, the diameter of a nasal passage of the individual, and the length of a nasal septum of the nose of the individual.

[0052] In an embodiment, the nostril stent assembly (3) includes two tubular stent assemblies (g & h), a hollow passage associated with the two tubular stent assemblies (g & h) for air passage. The hollow passage includes a smooth inner surface to minimize resistance and turbulence, thereby optimizing the breathing efficiency of the individual. Further, the nostril stent assembly (3) includes a bridge connecting two tubular stent assemblies (g & h). The bridge (i) ensures that the two tubular stent assemblies (g & h) remain aligned and symmetrically positioned within the nostrils of the individual.

[0053] In an embodiment, the nostril stent assembly (3) has a hardness rating of 0 Shore A to 60 Shore A to provide an optimal balance between flexibility and structural support.

[0054] In an embodiment, the attachment member comprises two slots, each of which is positioned at opposite ends of the wing assembly (2) to hold the nostril retainer device (1) on the face of the individual using a strap (8). The strap (8) comprises a first end comprising a first clip (8a) and a second end with a second clip (8b) configured to hold a nostril retainer device (1). The first clip (8a) and the second clip (8b) are adapted to be inserted into the two slots situated at the ends of the wing assembly (2).

[0055] In an embodiment, the strap is provided with elasticity to ensure a snug fit without being too tight. The wing assembly (2) is adjustable to different tension levels to allow for personalized comfort settings. The clips are adjustable to ensure a perfect fit. The strap is made from materials selected from the group consisting of polyester, nylon, elastane, spandex, and Lycra. The attachment member includes a seamless uninterrupted loop that securely wraps around the head of the individual. The seamless uninterrupted loop provides even tension distribution to enhance comfort and maintain the nostril retainer device (1) position during use.

[0056] In an embodiment, the attachment member comprises a strap area over which an adhesive tape is affixed. The adhesive tape is applied either vertically or horizontally at the ends of the wing assembly (2) and is configured to adhere directly to the cheeks of the individuals, thereby facilitating the placement of the nostril retainer device (1) without the need for holes or loops on the wing assembly (2). The wing assembly (2) is color-coded or labeled to facilitate identification and matching of different sizes of the nostril stent assembly. The wing assembly (2) includes visual or tactile indicators to guide proper attachment and alignment of the nostril stent assembly (3) into the set of holes of the wing assembly (2).

[0057] In an embodiment, the set of holes on the wing assembly (2) includes two holes and a tiny hole in between the two holes. The nostril stent assembly (3) includes an elongated structure configured to fit inside the nostrils, built-in channelsor holes for air passage, and a tiny projection at the center configured to fit through the tiny hole of the wing assembly (2). The wing assembly (2) is configured to allow rotation of the nostril stent assembly (3) along a central axis of the wing assembly (2), thereby providing adaptability to accommodate a wide range of anatomical variations and ensuring a secure fit.

[0058] In an embodiment, the wing assembly (2) is secured to the nostril stent assembly (3) using at least one of a snap-fit joint, friction-lock mechanism, magnetic coupling, interlocking groove system, hook-and-loop fastener, or adhesive bonding, providing secure and adjustable positioning without compromising stability or ease of removal. The snap-fit joint in the nostril retainer device (1) could be used to connect the nostril stent assembly (3) and the wing assembly (2) and to ensure that the nostril retainer device (1) maintains its shape when deployed in the body. The snap-fit joint relies on the elasticity of the material, which allows the parts to interlock by snapping together. The flexible snap-fit designs could allow the nostril retainer device (1) to adjust its size or shape during deployment. Cantilever or annular snap-fit joints could provide secure yet detachable connections, enabling easy adjustments during placement and reducing the risk of dislodgement. Further, the materials used for the snap-fit joints could be biocompatible polymers or metals with memory properties, ensuring that the device can withstand the physiological conditions within the nasal cavity.

[0059] Further, the friction-lock mechanisms rely on surface friction to hold the nostril stent assembly (3) and the wing assembly (2) in place. The friction-lock mechanism could be used to adjust the length or diameter of the nostril retainer device (1) or to lock the nostril stent assembly (3) and the wing assembly (2) together securely. The mechanism would work by creating friction between the nostril stent assembly (3) and the wing assembly (2), providing resistance to movement. The friction-lock mechanism allows for easy adjustability, ensuring that the nostril retainer device (1) remains in place and does not slip or shift after deployment. The surfaces involved in the friction-lock mechanism could be textured or coated with materials that enhance grip, such as silicone or rubber, to improve the stability of the connection.

[0060] Furthermore, the magnetic coupling uses magnets to create a secure connection between the nostril stent assembly (3) and the wing assembly (2) of the nostril retainer device (1) together without physical contact, especially in cases where the nostril retainer device (1) has multiple segments that need to align or lock into place once deployed. Magnets embedded within the nostril retainer device (1) would interact to secure or adjust parts. The primary advantage of magnetic coupling is its ability to allow for non-invasive, tool-free adjustments and ensure a firm connection without friction or wear over time. It can also be used for repositioning the nostril retainer device (1) post-deployment if needed. The magnets could be coated with biocompatible materials to prevent any adverse reactions and ensure long-term safety within the nasal cavity.

[0061] Further, the interlocking groove system could be employed to enable the nostril retainer device (1) components to mesh securely. This mechanism involves grooves or teeth that fit into corresponding channels, allowing the nostril retainer device (1) to hold its shape or lock parts together after deployment. The grooves and channels could be designed with precision to ensure a tight fit, preventing any unintended movement or disassembly. Whereas the hook-and-loop fasteners could be used in certain nostril retainer device (1) designs to allow for a removable or adjustable positioning system. This might be used to temporarily secure the nostril retainer device (1) to the surrounding tissue or to enable easy removal or repositioning. The hook-and-loop fasteners could be made from medical-grade materials that are gentle on the skin and reduce the risk of irritation. The adhesive bonding involves chemical adhesion between surfaces. The adhesive bonding offers the advantage of a permanent, non-invasive solution to keep the stent fixed in position, eliminating the need for mechanical fasteners. The adhesives used could be biocompatible and designed to withstand the moist environment of the nasal cavity, ensuring long-term stability.

[0062] In an embodiment, the strap (8) comprises a self-adjusting tension mechanism selected from an elastic retention system, sliding lock, ratcheting buckle, or micro-adjustable fastening system, enabling a secure and customizable fit while maintaining user comfort. The elastic retention system relies on materialslike elastomers or springs to maintain tension. These systems can adjust dynamically to fit varying sizes or pressures, ensuring comfort and security. Elastic bands may stretch to accommodate different shapes and return to their original form, offering a snug yet adaptive fit. The elastomers used could be hypoallergenic and designed to maintain their elasticity over extended periods of use. A sliding lock mechanism uses sliding components that can be fixed at specific positions to adjust tension. Users can slide the lock to tighten or loosen the fit. Once set, the lock remains in place until intentionally adjusted. The sliding components could be designed with smooth surfaces to ensure easy operation and prevent any accidental adjustments.

[0063] The ratcheting buckles involve a toothed strap and a locking mechanism that allows incremental adjustments. The toothed strap could be made from durable materials that resist wear and tear, ensuring long-term reliability. The micro-adjustable fastening system allows for fine, precise adjustments. This could involve mechanisms like small screws, dials, or other fine-tuned systems that can make incremental adjustments to the tension or fit of the device. The micro-adjustable components could be designed to provide tactile feedback, allowing users to feel each adjustment and achieve the desired fit with precision. These mechanisms ensure that the nostril retainer device (1) can be customized to fit a wide range of nasal anatomies, providing both comfort and stability.

[0064] In an embodiment, the nostril stent assembly (3) is designed as a premoulded anatomical variant tailored for at least one of ethnic nasal variations, post-traumatic nasal reconstruction, cleft lip repair, revision rhinoplasty, or other specialized nasal surgical procedures, ensuring a precise fit for diverse patient anatomies. People from different ethnic backgrounds can have distinct nasal features, such as variations in nasal bridge height, width, nostril shape, and skin thickness. A pre-moulded anatomical variant can be designed to align with these specific features. The design process could involve the use of 3D scanning and printing technologies to create highly accurate models that match the unique nasal structures of different ethnic groups. After a nasal injury or trauma, the pre-moulded device can help restore the natural shape and function of the nose. The nostrilretainer device (1) could be designed to fit the patient’s post-injury anatomy, including any loss of tissue or structural abnormalities. These variants can be custom-made to fit the deformed or injured nasal structure, supporting the healing process and maintaining correct nasal alignment. The pre-moulded variants accelerate recovery, providing optimal structural support while reducing the risk of complications such as malpositioning or improper healing of the nasal tissues.

[0065] For patients undergoing cleft lip repair, the nasal anatomy is often impacted, and the pre-moulded variant can be designed to fit around the unique anatomical requirements of a cleft- affected nose. The nostril retainer device (1) incorporates adjustable supports to accommodate the asymmetry of the nasal structure in cleft patients. It would help to stabilize the repaired nose while also maintaining nasal patency. The device could be designed with soft, flexible materials to ensure comfort and reduce the risk of irritation in the delicate tissues of cleft- affected patients. Revision rhinoplasty is performed to correct previous rhinoplasty surgeries that did not achieve the desired outcome. Pre-moulded anatomical variants can be used to support the nasal framework while it heals and provide adjustments for any remaining imperfections from the previous surgery. The pre-moulded variant can be designed to fit the altered nasal anatomy postsurgery, whether correcting issues with the nasal tip, bridge, or airway. It can help stabilize the structure, preventing collapses or shifts in the nasal framework. The device could be designed with modular components that allow for easy adjustments and fine-tuning during the healing process.

[0066] In an embodiment, the nostril stent assembly comprises a multi-layer or dual-density material structure with an inner soft flexible layer for enhanced patient comfort and an outer firmer layer for structural reinforcement and septal stability, providing an optimal balance between flexibility and support. The inner soft flexible layer could be made from medical-grade silicone or other biocompatible elastomers that conform to the nasal anatomy, reducing pressure points and enhancing comfort. The outer firmer layer could be constructed from rigid polymers or metals that provide the necessary structural support to maintain the shape and position of the nostril stent assembly. This dual-layer design ensuresthat the device can adapt to the dynamic movements of the nasal tissues while providing the stability needed to support the healing process. The materials used for both layers could be selected for their durability and resistance to degradation in the moist environment of the nasal cavity.

[0067] In an embodiment, the nostril stent assembly is treated with a surface coating or infused with an antimicrobial agent, hydrophobic layer, or frictionreducing finish to minimize bacterial colonization, enhance hygiene, and improve patient comfort during extended wear. The antimicrobial agent could be silver nanoparticles or other biocompatible substances that inhibit the growth of bacteria and reduce the risk of infection. The hydrophobic layer could be applied to the surface of the nostril stent assembly to repel moisture and prevent the accumulation of mucus and other fluids, enhancing hygiene and reducing the need for frequent cleaning. The friction-reducing finish could be a smooth, low-friction coating that minimizes irritation and discomfort during insertion and removal of the device. These surface treatments ensure that the nostril stent assembly remains clean, comfortable, and effective throughout its use, providing a safer and more pleasant experience for the patient.

[0068] In the medical field, strict adherence to hygiene standards is paramount, during post-surgery. The option to detach the wing assembly (2) facilitates more thorough cleaning and sterilization processes, ensuring that the device remains free from contaminants that could compromise patient safety. The materials used in the wing assembly (2) are resistant to high -temperature sterilization methods such as autoclaving, which is used for maintaining sterility. Further, detachable wing assembly (2) simplify re- sterilization protocols for reused devices, contributing to an environment of optimal hygiene. Patients and medical staff alike benefit from the easy maintenance as it reduces the potential for post-surgical infections and promotes overall recovery. The design also allows for the use of disposable covers or sleeves that can be easily replaced, further enhancing the hygiene of the device.

[0069] The option to replace only the wing assembly (2) rather than the entire nostril retainer device (1) reduces the generation of medical waste. In anindustry striving toward more sustainable practices, detachable wing assembly (2) represent an eco-conscious choice by limiting disposal to individual components. The materials selected for the wing assembly (2) are recyclable, aligning with environmental sustainability goals. This approach aligns with current environmental priorities, supporting a reduced ecological footprint while also benefiting medical institutions in meeting sustainability goals. By minimizing waste, detachable wing assembly (2) not only improve device functionality but also contribute to broader environmental and resource conservation efforts. This modular approach also allows for the customization of the device to fit different patient anatomies, reducing the need for multiple device sizes and further decreasing waste.

[0070] Since the wing assembly (2) is not fixed to the nostril retainer device (1) itself, any movement of the wing assembly (2) on the face does not impact the position of the nostril retainer device (1) within the nose. This independent movement allows the nostril retainer device (1) to maintain a stable, snug fit inside the nostril without shifting or causing discomfort due to external forces acting on the wing assembly (2). The wing assembly (2) is designed with a soft hypoallergenic material that conforms to the contours of the face, providing additional comfort. This design enhancement ensures that the retainer (1) remains securely in place, providing consistent support and alignment, which is especially beneficial for patients requiring stable, prolonged nostril support during recovery. The secure fit also minimizes the risk of the device becoming dislodged during sleep or physical activity, ensuring continuous therapeutic benefits.

[0071] The detachable nature of the wing assembly (2) allows for reduced bulk within the nostril device, preventing unnecessary pressure against sensitive nostril tissues. The wing assembly (2) can be adjusted to different tension levels, allowing for personalized comfort settings. Because the wing assembly (2) does not have to be worn if unnecessary for certain patients, irritation and discomfort are minimized. This design respects the delicate post-operative condition of nostril structures, offering a gentler healing experience and reducing the risk of inflammation caused by a fixed bulky device. This is advantageous in the earlystages of recovery, where minimal contact can lead to greater patient comfort and faster healing. The ability to customize the fit and pressure of the wing assembly (2) also aids in reducing the risk of pressure sores or skin irritation.

[0072] The modular design of the nostril retainer device (1) with detachable wing assembly (2) offers additional logistical advantages. The wing assembly (2) can be color-coded or labelled for easy identification and matching with the appropriate nostril stent assembly (3). Because the wing assembly (2) and the nostril retainer device (1) can be stored separately, the device requires less space during packaging and storage. Medical facilities benefit from this reduced footprint as it eases inventory management and minimizes the space required for storage. Further, this modularity supports more straightforward distribution and handling, in settings where surgical kits must be organized efficiently, ultimately streamlining supply chains for hospitals and medical practices. The modular design also allows for easy upgrades or modifications to the device without the need for complete replacement, ensuring that the latest advancements can be incorporated seamlessly.

[0073] The detachable wing assembly (2) allows for a simplified training process for medical professionals and caretakers learning to fit and adjust nostril retainer devices (1). The modular aspect of the wing assembly encourages a more intuitive understanding of the device's components and their individual functions, improving training. The wing assembly (2) can be designed with visual or tactile indicators to guide proper attachment and alignment. The caretakers can become proficient with the device more quickly, reducing the potential for error and improving patient outcomes. This adaptability also empowers physicians to make quick adjustments mid-procedure without compromising the integrity or fit of the retainer itself. Further, the patients are more likely to adhere to using a medical device that they find comfortable and unobtrusive. The freedom to detach the wing assembly (2) and adjust them to personal preference contributes to a more comfortable experience, thereby increasing patient compliance with post-operative instructions. This flexibility ultimately results in higher satisfaction and a greater likelihood of positive recovery outcomes as patients experience less discomfort and are more inclined to consistently wear the device as prescribed.

[0074] The proposed nostril retainer device has a unique design, which is based on cutting-edge technology, provides a number of benefits to the patient, including keeping the septum in a vertical position, erasing the memory of the ectopic cartilage, and allowing nostril breathing in the immediate postoperative period without obstructing airflow. The device incorporates advanced materials that are biocompatible and resistant to degradation over time, ensuring long-term effectiveness. Further, the nostril retainer device is simple to sanitize and sterilize, making the post-operative procedure smooth and ensuring consistent results. The design also includes features such as adjustable tension settings and customizable fit options, allowing for tailored support that meets the specific needs of each patient. The combination of these features makes the nostril retainer device a versatile and effective solution for post-operative care, enhancing patient comfort and promoting optimal healing.

[0075] The proposed nostril retainer device (1) is a U-shaped nostril stent assembly made of medical-grade silicone to improve nostril breathing and support the nostril structure. The nostril retainer devices are designed to be anatomically analogous and help give the best post-surgical correction to the nose. The nostril retainer device is the device having two symmetrical nostril stent assemblies connected with a common bridge, which provides structural integrity and ensures even distribution of pressure across the nasal passages. Further, the nostril stent assembly is laterally connected to the holding wing assembly, which helps secure the nostril retainer device to the patients’ nose. The wing assembly is detachable and can be customized to enhance comfort by adjusting the width and curvature to match the patient’s nasal anatomy. Further, the detachable wing assembly makes it easier to clean the retainer as it can be disassembled and sanitized separately. Regular cleaning of the detachable parts can extend the life of the nostril retainer device by preventing the buildup of residues that might degrade the material over time, ensuring consistent performance and hygiene. Further, the detachable feature of the wing assembly (2) prevents the growth of commensal bacteria and other harmful organisms, which can potentially lead to infections at the newly operated region.

[0076] The present disclosure introduces a novel device designed to overcome existing challenges, providing a number of benefits to the patient, including keeping the septum in a vertical position, erasing the memory of the ectopic cartilage, enhanced customization for patient- specific needs, costeffectiveness through component replacement, extended device longevity and durability, improved maintenance and enhanced hygiene, reduced environmental impact through minimization of medical waste, stability and snug fit with independent wing movement, reduced risk of patient irritation and discomfort, streamlined device packaging and storage, increased patient compliance and satisfaction, and allowing nostril breathing in the immediate postoperative period without obstructing airflow, among others. The device’s design incorporates feedback from both patients and healthcare professionals to ensure it meets the highest standards of comfort and functionality. The use of eco-friendly materials and manufacturing processes further underscores the commitment to sustainability, while the compact design facilitates easy transport and storage, making it ideal for both clinical and home use.

[0077] The wing assembly (2) includes visual or tactile indicators to guide proper attachment and alignment of the nostril stent assembly (3) into the set of holes of the wing assembly. The indicators comprise raised ridges, embossed markings, or color-coded sections that provide feedback to ensure correct positioning of the nostril stent assembly within the wing assembly (2), allowing for accurate and secure placement by the user or medical professional.

[0078] Fig 2 illustrates a wing assembly (2) along with a holding strap (8) according to the embodiments as disclosed herein. The holding strap (8) includes a pair of clips (8a and 8b) one on each end to hold the nostril retainer device (1). The clips (8a and 8b) can be inserted into the two slots (c & d) situated at the ends of the wing assembly (2). The holding strap (8) is made from strong and long-lasting materials like polyester, Nylon, Elastane, spandex, Lycra, and other lightweight materials to avoid unnecessary weight. The adjustable clips (8a and 8b) are customized at the ends of the holding strap (8) to ensure a perfect fit. The holding strap (8) is provided with some elasticity to provide flexibility and to ensure a snugfit without being too tight. Further, the holding strap (8) is available in various colors and designs to match personal preferences or specific applications. The holding strap (8) forms a seamless uninterrupted loop that securely wraps around the user’ s head. This innovative design eliminates the need for multiple components or connectors, ensuring a uniform and stable fit. The holding strap (8) provides even tension distribution, enhancing user comfort while maintaining the device’s position during use. This design is advantageous for users requiring prolonged wear as it minimizes pressure points and ensures reliable placement without frequent adjustments. The strap's elasticity is calibrated to balance between providing sufficient tension to hold the device in place and allowing enough give to prevent discomfort or skin irritation.

[0079] Fig 3a illustrates the wing assembly (2) according to the embodiments as disclosed herein. The wing assembly (2) features two central holes (a and b) designed to hold the nostril stent assembly (3), which is used for maintaining the patency of the nasal passage during the healing process. These central holes (a & b) are precisely engineered to accommodate the nostril stent assembly (3) with minimal friction, ensuring that the stent remains securely in place without causing undue pressure on the surrounding tissue. The material of the wing assembly (2) is selected for its biocompatibility and flexibility, allowing it to conform to the unique anatomical contours of the nasal cavity while providing sufficient rigidity to support the stent assembly (3). The material of the wing assembly (2) includes but is not limited to silicone, Liquid Silicone Rubber (LSR), rubber, thermoplastic urethane elastomers, and the like. The silicone, LSR, and rubber thermoplastic urethane elastomers are versatile materials with thermal stability, flexibility, and resistance to environmental factors. The silicone is highly biocompatible, where it can perform with an appropriate host response in a specific situation. This makes it suitable for long-term implants. Further, the LSR is a versatile and synthetic elastomer used for its remarkable durability, thermal stability, and resistance to environmental factors, making it suitable for a diverse range of applications. Being biocompatible, the thermoplastic urethane offers excellent flexibility and durability, making it suitable for designing the nostrilretainer (1). Further, the wing assembly (2) includes two slots (c and d) at the ends for holding the nostril retainer device (1) in place. These slots (c and d) are used for ensuring proper alignment and stability of the wing assembly (2) within the nostril retainer device (1), facilitating secure attachment and maintaining the overall integrity of the nostril retainer device (1). The precise positioning of these holes is determined through computational modeling to optimize the distribution of mechanical forces, thereby reducing the risk of displacement during use. The design also incorporates a locking mechanism that engages with the nostril retainer device (1), providing an additional layer of security against accidental dislodgement. The wing assembly (2) facilitates the attachment of the nostril retainer device (1) and keeps the nostril retainer device (1) in place. The length, width, and height of the nostril retainer device (1) are carefully selected to ensure it stays in place and provides necessary support to prevent collapse and promote optimal healing. The dimensions are tailored to accommodate a range of nasal anatomies with adjustable features that allow for customization to individual patient needs. The wing assembly (2) is designed to be lightweight and unobtrusive, ensuring that it does not interfere with the user's daily activities or sleep.

[0080] Fig 3b illustrates the nostril stent assembly according to the embodiments as disclosed herein. The nostril stent assembly (3) is designed to provide structural support while allowing airflow through the nostril passages. The stent is constructed from a biocompatible material such as medical-grade silicone, LSR, rubber, thermoplastic urethane elastomers, or thermoplastic elastomer, which ensures both flexibility and durability. The hollow passage (e and f) associated with the tubes (g and h) is designed to facilitate airflow, featuring a smooth inner surface to minimize resistance and turbulence, thereby optimizing the breathing. The bridge (i) connects the two tubular nostril stent assemblies, ensuring that they remain aligned and symmetrically positioned within the nostrils. This bridge (i) is made from a flexible yet sturdy material that can accommodate slight movements of the nostrils without compromising the stent's position. The ends of the nostril retainer device (1) are expanded and extended outward to provide anchorage of the device in place, preventing it from moving or slipping deeper into the nostril cavity or otheranatomical spaces. The nostril stent assembly (3) is designed with a focus on patient comfort, incorporating soft edges and a contoured shape to minimize irritation. The materials used are selected for their hypoallergenic properties, reducing the risk of allergic reactions or skin sensitivities. The stent assembly is also designed to be easy to clean and maintain, ensuring that it remains hygienic and safe for prolonged use.

[0081] Figs 4a and 4b illustrate cross-sectional views of the nostril stent assembly (3) detachably attached to the wing assembly (2) according to the embodiments as disclosed herein. The nostril stent assembly (3), which is made of medical-grade silicone, is sterilized using an autoclave process to ensure it is free from any microbial contamination. The silicone material is chosen for its biocompatibility and flexibility, which allows it to conform to the unique contours of a patient's nasal passage. The wing assembly (2), which typically consists of openings or slots designed to hold the nostril stent assembly (3), is also cleaned and sterilized using a similar process to maintain a sterile environment. The nostril stent assembly (3) is carefully aligned with the holes in the wing assembly (2) using alignment guides or markers to ensure precise placement. The nostril stent assembly (3) is gently pushed or guided into the holes of the wing assembly (2). Once the nostril stent assembly (3) is inserted, it may be secured in place within the wing assembly (2) using a locking mechanism or friction fit to prevent accidental dislodgement during use. The nostril retainer devices (1) are manufactured from medical-grade silicone to sustain the insertion of the device into the user’s nostril based on the strength and surface qualities. The silicone with a hardness rating of Shore Hardness of 0 shore A to 60 Shore A is used to manufacture the nostril retainer device (1), providing an optimal balance between flexibility and structural support. The proposed nostril retainer devices (1) are designed using cutting-edge technology like 3D scanners, which capture the precise anatomical features of the nasal cavity, and 3D printers, which produce prototypes for testing and refinement. Powerful computer simulations are employed to predict the performance of the device under various conditions, while advanced CAD modeling programs allow for iterative design improvements to enhance fit and function. The inclusion of thewing assembly (2), which is detachable, offers unparalleled adaptability in patient care. Physicians can tailor the use of the nostril retainer device (1) to each patient’s unique anatomy and specific post-operative requirements, allowing for greater precision in treatment. This capability helps achieve better alignment and minimizes discomfort by permitting adjustments in response to the patient’s evolving needs throughout recovery. The wing assembly (2) can be adjusted in terms of angle and tension, providing a customizable fit that accommodates swelling and changes in nasal structure over time. The choice to utilize or remove the wing assembly (2) results in a truly patient-centered approach, significantly enhancing both comfort and compatibility. This modular design also facilitates easier training for medical staff, as they can quickly adapt the device to suit different patient profiles. Further, the detachable wing assembly (2) reduces the need for full device replacement in the event of damage, offering a pragmatic and cost-efficient solution. If the wing assembly (2) experiences wear and tear, it can be replaced individually, avoiding the expense of an entirely new nostril retainer device (1). This feature is beneficial for both medical institutions and patients by lowering costs and providing a more economical solution over time. The wing assembly (2) is designed with durable materials that resist deformation and degradation, ensuring long-term reliability. By maintaining the quality and functionality of the device without complete replacement, the detachable wing assembly (2) offers an effective balance of performance and cost-saving. Further, the modular nature of the device allows for easy upgrades or modifications as new materials and technologies become available. The design also supports the integration of additional features, such as antimicrobial coatings or enhanced airflow channels, to further improve patient outcomes.

[0082] Figs 5a and 5b illustrate a real-life scenario where an infant is wearing the nostril retainer device (1) according to the embodiments as disclosed herein. The device is shown to fit securely and comfortably, demonstrating its effectiveness in maintaining nasal patency while accommodating the delicate anatomy of an infant. The images highlight the device's unobtrusive design, which allows for normal facial expressions and movements without causing discomfort.The nostril retainer device (1) is designed to be easy to apply and remove, ensuring that caregivers can manage the device with minimal training. The device's materials are selected to be gentle on the infant's skin, reducing the risk of irritation or allergic reactions. The real-life scenario underscores the device's practical application and its potential to improve the quality of life for infants requiring nasal support.

[0083] Fig 6 illustrates an example dimensions of wing assembly (2) according to the embodiments as disclosed herein. The wing assembly (2) ranges from around 70 to 90 millimeters. The wing assembly (2) illustrated in the Fig 5 is of 8004 millimeters long with two central holes for the insertion of the nostril stent assembly (3) each of diameter 816 millimeters and are separated by 616 millimeters. The total width of holes include 1827 millimeters including the separation between the holes. Further, the wing assembly features two holes at the ends to facilitate the holding of the nostril retainer device and to attach to the face. The length of the holes at the ends is 11 millimeters whereas the width associated with the holes is 5 millimeters. The wing assembly (2) from the ends gets narrowed to around 732 millimeters and gets enlarged again to around 1532 millimeters and is curved to fit the central holes. The curvature of the wing assembly is designed to conform to the natural contours of the user's face, ensuring a snug and comfortable fit. The material used for the wing assembly is a flexible yet durable polymer that can withstand repeated use without losing its shape. Further, the wing assembly is coated with a hypoallergenic layer to prevent skin irritation during prolonged wear.

[0084] Fig 7a illustrates a wing assembly (5) with adhesive tape (6) according to the embodiments as disclosed herein. The wing assembly (5) includes an adhesive tape (6) which needs to be affixed along or across the strap area facilitating the proper placement and securement of the nostril retainer device. Further, the wing assembly (5) shown in the Fig 6a eliminates the need for holes or loops for tape attachment. The adhesive tape (6) is applied strategically either vertically or horizontally at the ends of the wing assembly (5) and adhered directly to the user's cheeks. This approach ensures compatibility with the user’s unique anatomy, offering a more versatile and universally accommodating design, for individuals who cannot utilize loop-based configurations. The adhesive used is amedical-grade, skin-friendly adhesive that provides a strong bond without causing discomfort or allergic reactions. The tape is designed to be breathable, allowing air to circulate and preventing moisture buildup, which can lead to skin irritation. The adhesive tape can be easily removed and replaced, making it convenient for users to maintain hygiene and ensure a secure fit at all times.

[0085] Fig 7b illustrates the wing assembly (5) according to the embodiments as disclosed herein. The wing assembly includes two holes (j and k) in the center designed to hold the nostril stent assembly (3). The holes (j and k) are precisely designed with little friction ensuring that the stent remains firmly in position without placing unnecessary strain on the surrounding tissue. The holes are reinforced with a slightly raised edge to prevent the stent from slipping out of place. The material around the holes is slightly thicker to provide additional support and stability. This design ensures that the nostril stent assembly remains securely in place even during vigorous activities or movements. The wing assembly is also designed to be lightweight, reducing the overall burden on the user's face and enhancing comfort during extended use.

[0086] Fig 8 illustrates a wing assembly (7) with the strap (7c) attached to the wing assembly (7) according to the embodiments as disclosed herein. The wing assembly (7) includes a stretchable strap (7c) to hold the nostril retainer device in place. The strap (n) is designed such that it extends and contracts depending on the needs and fits precisely. The wings assembly (7) further includes two holes (1 and m) to accommodate the nostril stent assembly (3). The strap (7c) forms a seamless uninterrupted loop that securely wraps around the user’s head. This innovative design eliminates the need for multiple components or connectors, ensuring a uniform and stable fit. The continuous band provides even tension distribution, enhancing user comfort while maintaining the device's position during use. This design is advantageous for users requiring prolonged wear as it minimizes pressure points and ensures reliable placement without frequent adjustments. The strap is made from a high-elasticity material that retains its shape and elasticity over time, ensuring consistent performance. The material is also breathable and moisture -wicking, preventing discomfort from sweat buildup during extended use.

[0087] Fig 9a illustrates a nostril retainer device (9) according to the embodiments as disclosed herein. The nostril retainer device (9) includes a wing assembly (11) and nostril stent assembly (10) where the nostril stent assembly (10) is attached to the wing assembly (11). The wing assembly (11) is designed to provide a stable base for the nostril stent assembly (10), ensuring that it remains securely in place. The nostril stent assembly (10) is designed to fit comfortably inside the nostrils, providing support and maintaining the shape of the nasal passages. The materials used for both the wing assembly and the nostril stent assembly are hypoallergenic and biocompatible, ensuring that they do not cause irritation or allergic reactions. The design of the nostril retainer device (9) allows for easy insertion and removal, making it convenient for users to use on a daily basis.

[0088] Fig 9b illustrates the wing assembly (11) of the nostril retainer device (9) according to the embodiments as disclosed herein. The wing assembly (11) consists of two holes (lid & lie) for easy air flow facilitating breathing. Further, the wing assembly (11) includes a tiny hole (Ila) at the center to hold the nostril retainer device (9). Further, the wing assembly (11) includes a pair of holes (11) at the ends to hold the nostril retainer device (9) in place. The figure illustrates the nostril retainer device (9) with a unique strap design that features a tiny hole (Ila) paired with a pin on the nostril retainer device (9) for attachment. This configuration allows the strap to be securely affixed to the nostril retainer device (9) while enabling rotation along the central axis. This rotational capability provides enhanced adaptability, ensuring the device can accommodate a wide range of unique anatomical variations. By allowing precise adjustments to the strap's angle and positioning, this intelligent design choice ensures a secure fit, superior comfort, and an improved user experience. The wing assembly is made from a flexible yet durable material that can withstand repeated use without losing its shape. The holes are reinforced to prevent tearing and ensure long-lasting performance.

[0089] Fig 9c illustrates the nostril stent assembly (10) according to the embodiments as disclosed herein. The nostril stent assembly (10) as illustrated in the figure is an elongated structure that fits inside the nostrils and helps maintainthe shape of the nasal passages. This has built-in channels or holes that allow air to pass through, ensuring that the patient can breathe comfortably while wearing the nostril retainer device (9). Further, the nostril stent assembly (10) includes a tiny projection (11c) at the center to fit the nostril stent assembly (10) through the tiny hole (Ila) provided in the wing assembly (10). The channels or holes are strategically placed to maximize airflow while maintaining the structural integrity of the stent. The material used for the nostril stent assembly is a soft, flexible silicone that conforms to the shape of the nasal passages, providing a comfortable fit. The tiny projection (11c) is designed to lock securely into the hole (Ila), preventing the stent from slipping out of place during use.

[0090] In an embodiment, the tiny hole (1 la) at the center is provided as an example only. The shape of the hole at the center designed to hold the wing assembly can vary. The hole can be circular, oval, or any other shape that provides a secure fit for the nostril stent assembly. The design of the hole can be customized to accommodate different sizes and shapes of nostril stent assemblies, ensuring a secure and comfortable fit for a wide range of users. The flexibility in the design of the hole allows for greater versatility and adaptability, making the nostril retainer device suitable for a broader range of anatomical variations.

[0091] Fig 10a illustrates the nostril retainer device (12) featuring a wing assembly (12a) with a rectangular slot according to the embodiments disclosed herein. The nostril retainer device (12) includes the wing assembly (12a) with the rectangular slot and a corresponding pin on the nostril stent assembly (12b) for attachment. This innovative design ensures the wing assembly (12a) remains parallel to the nostril stent assembly (12b) at all times, providing superior stability and alignment. The rectangular slot (12c) prevents unintended rotation, ensuring consistent positioning and a secure fit. This precise alignment accommodates a wide range of unique anatomical needs, delivering optimal comfort, enhanced usability, and an improved overall experience for the user. The rectangular slot is designed to provide a snug fit for the pin, preventing any movement or slippage during use. The materials used for the wing assembly and the nostril stent assembly are chosen fortheir durability and biocompatibility, ensuring long-lasting performance and user safety.

[0092] Fig 10b illustrates the wing assembly (12a) with the rectangular slot according to the embodiments disclosed herein. The wing assembly (12a) consists of two holes (12e) for easy air flow facilitating breathing. Further, the wing assembly (12a) includes a rectangular slot (12c) at the center to hold the nostril retainer device (12). Further, the wing assembly (12a) includes a pair of holes (12f) at the ends to hold the nostril retainer device (12b) in place. The figure illustrates the nostril retainer device (12) with a unique wing assembly (12a) that features a central hole (12c) paired with the rectangular pin (12d) on the nostril retainer device (12) for attachment. This configuration allows the nostril stent assembly (12b) to be securely affixed to the nostril retainer device (12) while enabling rotation along the central axis. The rectangular slot is designed to provide a secure fit for the pin, preventing any movement or slippage during use. The materials used for the wing assembly and the nostril stent assembly are chosen for their durability and biocompatibility, ensuring long-lasting performance and user safety. The holes (12e) are strategically placed to maximize airflow while maintaining the structural integrity of the wing assembly.

[0093] Fig 10c illustrates nostril stent assembly (12b) according to the embodiments as disclosed herein. The nostril stent assembly (12b) as illustrated in the figure is an elongated structure that fits inside the nostrils and helps maintain the shape of the nasal passages. This has built-in channels or holes that allow air to pass through, ensuring that the patient can breathe comfortably while wearing the nostril retainer device (12). Further, the nostril stent assembly (10) includes a tiny projection (11c) at the center to fit the nostril stent assembly (10) through the tiny hole (Ila) provided in the wing assembly (10). The channels or holes are strategically placed to maximize airflow while maintaining the structural integrity of the stent. The material used for the nostril stent assembly is a soft, flexible silicone that conforms to the shape of the nasal passages, providing a comfortable fit. The tiny projection (11c) is designed to lock securely into the hole (Ila), preventing the stent from slipping out of place during use. The design of the nostrilstent assembly ensures that it remains securely in place while providing optimal airflow and comfort for the user.

[0094] Fig 11 illustrates a nostril retainer device (13) designed to accommodate unique anatomies according to the embodiments as disclosed herein. The figure illustrates the nostril retainer device (13) featuring a wing assembly (13) with a single hole or a modified bridge design (13c). This adjustment is intentionally engineered to accommodate a broader range of anatomical variations. The singlehole configuration or the customized bridge shape allows for precise alignment and better adaptability to unique facial structures. By reducing unnecessary complexity, this design focuses on creating a tailored fit, enhancing comfort, and ensuring optimal functionality for individuals with varying nasal anatomies. This solution prioritizes versatility without compromising on stability or usability. The conditions like choanal atresia, heminose, or deviated septum and others result in anatomical variation with single hole configuration. The proposed nostril retainer device helps in perfect alignment for optimal functionality. The materials used for the nostril retainer device are chosen for their durability and biocompatibility, ensuring long-lasting performance and user safety. The design of the nostril retainer device allows for easy insertion and removal, making it convenient for users to use on a daily basis.

[0095] Fig 12 illustrates a nostril retainer (14) attached with an adhesive backing according to the embodiments as disclosed herein. The adhesive backing eliminates the need for external mountings like wing assembly, strap hooks, or slots. This intelligent design simplifies application by adhering directly to the skin, ensuring a secure and stable fit. The adhesive backing is strategically formulated to maintain strong adherence while being gentle on the skin, reducing irritation and improving user comfort. This streamlined solution is especially beneficial for users with unique anatomies, offering universal adaptability, enhanced ease of use, and a discreet profile. The adhesive used is a medical-grade, skin-friendly adhesive that provides a strong bond without causing discomfort or allergic reactions. The adhesive backing is designed to be breathable, allowing air to circulate and preventing moisture buildup, which can lead to skin irritation. The adhesive backingcan be easily removed and replaced, making it convenient for users to maintain hygiene and ensure a secure fit at all times.

[0096] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.

Claims

We claim:

1. A nostril retainer device (1), comprising:a nostril stent assembly (3); anda wing assembly (2) detachably attached to the nostril stent assembly (3), wherein the wing assembly (2) comprises a body having a set of holes (a & b) positioned at a centre of the wing assembly (2) to hold the nostril stent assembly (3) and an attachment member to secure the nostril retainer device (1) into a nose of an individual to assist the individual to perform a nasal activity.

2. The nostril retainer device (1) as claimed in claim 1, wherein at least one of the nostril stent assembly (3) and the wing assembly (2) are made of a biocompatible material comprising at least one of a medical-grade silicone, a Liquid Silicone Rubber (LSR), a rubber, a thermoplastic urethane, elastomers and thermoplastic elastomer.

3. The nostril retainer device (1) as claimed in claim 1,wherein the body having a length ranging from approximately 70 to 90 millimetres,wherein the set of holes comprises a pair of holes positioned for insertion of the nostril stent assembly (3), each hole of the pair of holes (a & b) comprises a diameter of 8.16 millimetres and separated by a distance of approximately 6.16 millimetres, with a total width of the holes including the separation being 18.27 millimetres,wherein the attachment member at ends have a length of 11 millimetres and a width of 5 millimetres, andwherein the ends of the wing assembly (2) narrow to a width of 7.32 millimetres and then enlarge to a width of 15.32 millimetres, and wherein the wing assembly (2) being curved to fit the pair of holes.

4. The nostril retainer device ( 1 ) as claimed in claim 1 , wherein the nostril stent assembly (3) adapts different anatomical measurements of the nose of individuals, wherein the anatomical measurement comprises a length of thenose of the individual, a diameter of a nasal passage of the individual, and a length of a nasal septum of the nose of the individual.

5. The nostril retainer device ( 1 ) as claimed in claim 1 , wherein the nostril stent assembly (3) comprises:two tubular stent assemblies (g & h);a hollow passage associated with the two tubular stent assemblies (g & h) for air passage, wherein the hollow passage comprises a smooth inner surface to minimize resistance and turbulence, thereby optimizing breathing efficiency of the individual; anda bridge (i) connecting two tubular stent assemblies (g & h), wherein the bridge (i) is ensuring that the two tubular stent assemblies (g & h) remain aligned and symmetrically positioned within the nostrils of the individual.

6. The nostril retainer device ( 1 ) as claimed in claim 1 , wherein the nostril stent assembly (3) has a hardness rating of 0 Shore A to 60 Shore A to provide an optimal balance between flexibility and structural support.

7. The nostril retainer device (1) as claimed in claim 1, wherein the attachment member comprises two slots (c & d) each of which is positioned at opposite ends of the wing assembly (2) to hold the nostril retainer device (1) on a face of the individual using a strap (8), wherein the strap (8) comprises a first end comprising a first clip (8a) and a second end with a second clip (8b) configured to hold a nostril retainer device (1), and wherein the first clip (8a) and the second clip (8b) are adapted to be inserted into the two slots (c & d) situated at the ends of the wing assembly (2).

8. The nostril retainer device (1) as claimed in claim 7, wherein the strap is provided with elasticity to ensure a snug fit without being too tight, wherein the wing assembly (2) is adjustable to different tension levels to allow for personalized comfort settings, and wherein the clips (8a & 8b) are adjustable to ensure a perfect fit.

9. The nostril retainer device (1) as claimed in claim 7, wherein the strap (8) is made from materials selected from the group consisting of polyester, nylon, elastane, spandex, and Lycra.

10. The nostril retainer device (1) as claimed in claim 1, wherein the attachment member comprises a seamless uninterrupted loop that securely wraps around a head of the individual, wherein the seamless uninterrupted loop provides even tension distribution to enhance comfort and maintain the nostril retainer device position during use.

11. The nostril retainer device (1) as claimed in claim 1, wherein the attachment member comprises a strap area over which an adhesive tape is affixed, wherein the adhesive tape is applied either vertically or horizontally at ends of the wing assembly (2) and is configured to adhere directly to cheeks of the individuals, thereby facilitating placement of the nostril retainer device (I) without need for holes or loops on the wing assembly (2).

12. The nostril retainer device (1) as claimed in claim 1, wherein the wing assembly (2) is color-coded or labelled to facilitate identification and matching of different sizes of the nostril stent assembly (3).

13. The nostril retainer device (1) as claimed in claim 1, wherein the wing assembly (2) includes visual or tactile indicators to guide proper attachment and alignment of the nostril stent assembly (3) into the set of holes of the wing assembly (2).

14. The nostril retainer device (1) as claimed in claim 1,wherein the set of holes on the wing assembly (11) comprises two holes (lid and 1 le) and a tiny hole (Ila) in between the two holes (lid and lie); andwherein the nostril stent assembly (10) comprises an elongated structure configured to fit inside the nostrils, built-in channels or holes for air passage, a tiny projection (11c) at a centre configured to fit through the tiny hole (1 la) of the wing assembly (11),wherein the wing assembly (11) is configured to allow rotation of the nostril stent assembly (10) along a central axis of the wing assembly (II), thereby providing adaptability to accommodate a wide range of anatomical variations and ensuring a secure fit.

15. The nostril retainer device (1) as claimed in claim 1, wherein the wing assembly (2) is secured to the nostril stent assembly (3) using at least one of a snap-fit joint, friction-lock mechanism, magnetic coupling, interlocking groove system, hook- and-loop fastener, or adhesive bonding, providing secure and adjustable positioning without compromising stability or ease of removal.

16. The nostril retainer device (1) as claimed in claim 7, wherein the strap comprises a self-adjusting tension mechanism selected from at least one of elastic retention system, sliding lock, ratcheting buckle, or micro-adjustable fastening system, enabling a secure and customizable fit while maintaining user comfort.

17. The nostril retainer device (1) as claimed in claim 1, wherein the nostril stent assembly (3) is designed as a pre-moulded anatomical variant tailored for at least one of ethnic nasal variations, post-traumatic nasal reconstruction, cleft lip repair, revision rhinoplasty, ensuring a precise fit for diverse patient anatomies.

18. The nostril retainer device (1) as claimed in claim 1, wherein the nostril stent assembly (3) comprises a multi-layer or dual-density material structure, with an inner soft, flexible layer for enhanced patient comfort and an outer firmer layer for structural reinforcement and septal stability, providing an optimal balance between flexibility and support.

19. The nostril retainer device (1) as claimed in claim 1, wherein the nostril stent assembly (3) is treated with a surface coating or infused with an antimicrobial agent, hydrophobic layer, or friction-reducing finish, to minimize bacterial colonization, enhance hygiene, and improve patient comfort during extended wear.

Images