"prosthetic device for assisting an individual with cleft lip and cleft palate conditions"

Abstract

Embodiments disclosed herein provide a prosthetic device (100) for assisting an individual with cleft lip and cleft palate conditions The prosthetic device includes a flap (101) and a strap (102). The flap (101) includes a lip philtrum prosthetic area (104) connected to a palate prosthetic area (105). The lip philtrum prosthetic area (104) configured as a temporary upper lip prosthetic, and the palate prosthetic area (105) is configured as a temporary palate prosthetic. The strap (102) is connected to the lip philtrum prosthetic area (104) of the flap (101), wherein the strap (102) has a pair of slots (107) positioned at opposite ends of the strap (102). The prosthetic device (100), when secured on a face of the individual, enables the individual to form a complete seal around a feeding implement, thereby facilitating a feeding process.

Description

“PROSTHETIC DEVICE FOR ASSISTING AN INDIVIDUAL WITH CLEFT LIP AND CLEFT PALATE CONDITIONS”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 202341075296 filed on 3rdNovember 2023, the disclosure of which is hereby incorporated by reference herein. The proposed embodiments relate to medical devices. More particularly relates to prosthetic device for assisting an individual with cleft lip and cleft palate conditions. BACKGROUND

[0002] Cleft lip and palate represent a significant congenital anomaly characterized by a deformity in the tissue structure of the lip and palate regions of the mouth. This condition poses substantial challenges for infants, particularly in the context of feeding. The structural gap in the lip and palate impedes the infant's ability to create a complete seal around a feeding source, such as a bottle or breast, which is crucial for generating the negative pressure necessary for effective feeding. This deficit in negative pressure generation complicates both breastfeeding and bottle feeding efforts.

[0003] Moreover, the incomplete formation of the palate allows for the free passage of air between the nasal and oral cavities, further undermining the infant's ability to develop the requisite suction for feeding. This anatomical anomaly predisposes infants to several hazards, including aspiration and nasal regurgitation, both of which can have serious implications for the infant's health and safety. The inability to suck and swallow properly can lead to complications such as choking, coughing, milk vomiting, asphyxia, and aspiration pneumonia, all of which adversely affect the growth and development of the infant.

[0004] Infants with cleft conditions are consequently at an elevated risk of malnutrition during critical developmental periods. Conventional feeding methodsoften require the active intervention of a caregiver, who must manually administer nourishment through a lengthy tube to control the milk feed rate. This process is not only labor-intensive but also carries inherent risks associated with improper feeding techniques. Despite the use of specialized feeding bottles designed for cleft palate conditions, they often fall short of meeting the needs of infants with severe cleft palate, necessitating the use of indwelling stomach tubes. This approach introduces inconvenience for families and an increased risk of aspiration for the infant.

[0005] Given these challenges, there is a pressing need to address the limitations associated with current feeding methods for infants with cleft lip and palate. It is imperative to explore solutions that mitigate these disadvantages, enhance the feeding experience, and improve the overall well-being of affected infants.OBJECT OF INVENTION

[0006] The principal object of the embodiments herein is to provide a prosthetic device for assisting an infant with cleft lip and cleft palate conditions to overcome the obstacles with nourishment of the infant, enabling the infants to engage in autonomous natural feeding processes, thereby mitigating the risk of malnutrition and associated developmental setbacks.

[0007] Another object of the embodiments herein is to provide a prosthetic device which forms a temporary palate within the oral cavity, serving as a functional palate, and the device covers the portion of the lip, acting as a temporary lip for the infant affected by cleft syndrome.

[0008] Yet another object of the embodiments herein is to establish a complete seal around the nipple of a feeding implement for the infant, thereby enabling the infant to sufficiently generate negative pressure for breastfeeding or bottle feeding.

[0009] Yet another object of the embodiment herein is to provide a prosthetic device which forms a temporary palate and temporary lip portion, where the device includes an adhesive material or a surgical tape to secure the device onto the infant’s mouth.

[0010] Yet another object of the embodiment herein is to provide a prosthetic device which forms a temporary palate and temporary lip portion, where the device includes a tacky or adhesive material on the top surface of the device for securely fastening the device onto both the lip and palate regions of the mouth.

[0011] Yet another object of the embodiment herein is to provide a prosthetic device which forms a temporary palate and temporary lip portion, where the device includes a flap with no uvula profile. The device feeds the multiple functional requirements and physiological considerations.SUMMARY

[0012] In one aspect, the objects are achieved by providing a prosthetic device for assisting an individual with cleft lip and cleft palate conditions. The prosthetic device includes a flap and a strap. The flap includes a lip philtrum prosthetic area connected to a palate prosthetic area. The lip philtrum prosthetic area is configured as a temporary upper lip prosthetic, and the palate prosthetic area is configured as a temporary palate prosthetic. The strap is connected to the lip philtrum prosthetic area of the flap, wherein the strap has a pair of slots positioned at opposite ends of the strap. The prosthetic device, when secured on a face of the individual, enables the individual to form a complete seal around a feeding implement, thereby facilitating a feeding process.

[0013] In an embodiment, the flap is designed based on anatomical measurements related to oral or facial structures of the individual. The anatomical measurement comprises a philtrum width measurement, an inter-canine width measurement, an inter-tuberosity width measurement, an arch length measurement, and an arch circumference measurement. The philtrum width measurement is measured as a distance between two specific points at a base of a philtrum located at a junction where the vertical ridge of the philtrum meets a red border of an upper lip of the individual. The inter-canine width measurement is measured as a distance between tips of permanent canines in both maxillary and mandibular jaws of the individual. The inter-tuberosity width measurement is measured at a point where a maxillary tuberosity intersects with a crest of a ridge. The arch length measurement is measured from a lowermost point of an upper lip of the individual to a uvula. Thearch circumference measurement is measured as a total distance around an arch of a mouth of the individual, including measurements from maxillary tuberosity, canines, and a front end of an upper lip of the individual on both left and right sides.

[0014] In an embodiment, the flap has a top surface that includes a material with adhesive properties, the material being configured to securely attach the prosthetic device to oral surfaces within the mouth of the individual, thereby minimizing movement or displacement of the prosthetic device during use. The adhesive properties of the material are further configured to assist in an oral function by enabling the individual to engage in the oral function autonomously, reducing or eliminating the need for manual assistance.

[0015] In an embodiment, the flap is designed to traverse over a palatal gap in response to an applied pressure exerted by a tongue of the individual on the feeding implement, thereby culminating in the complete seal and facilitating expulsion of fluids or food.

[0016] In an embodiment, the prosthetic device comprises a band configured to secure the prosthetic device on a face of the individual, the band having a first end and a second end, and the band includes hooks at each of the first end and the second end. The hooks are detachably attachable to the slots of the strap, thereby securing the band to the strap. In an embodiment, the band is adjustable in length to ensure a tight fit of the prosthetic device on the face of the individual, thereby enabling the individual with the cleft lip and the cleft palate condition to form the complete seal around the feeding implement to generate a negative pressure for feeding during the feeding process.

[0017] In an embodiment, the lip philtrum prosthetic area has a cam profile to facilitate alignment, and the lip philtrum prosthetic area is positioned on a lip of the individual. The palate prosthetic area has a uvula profile and is placed around the uvula inside the mouth of the individual to act as a temporary palate prosthetic.

[0018] In an embodiment, the prosthetic device comprises an adhesive tape placed along an end area of the strap, wherein the adhesive tape is configured to adhere to cheeks of the individual for added stability. In an embodiment, the prosthetic device is designed without a uvula cutout to facilitate the feeding processby accommodating an anatomical variability of the cleft lip and cleft palate conditions. In an embodiment, the flap is made from a pliable material selected from silicone and plastic.

[0019] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It is understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.BRIEF DESCRIPTION OF FIGURES

[0020] 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:

[0021] FIG 1 is an example diagram illustrating unilateral cleft lip and cleft lip and cleft palate conditions in infants according to the prior art.

[0022] FIG 2a is a schematic diagram illustrating the structure of a prosthetic device for assisting an individual with cleft lip and cleft palate conditions according to the embodiments as disclosed herein.

[0023] FIG 2b is a schematic diagram illustrating the structure of a flap of the prosthetic device for assisting the individual with the cleft lip and cleft palate conditions according to the embodiments as disclosed herein.

[0024] FIG 2c is a schematic diagram illustrating an elastic band of the prosthetic device for assisting the individual with the cleft lip and cleft palate conditions according to the embodiments as disclosed herein.

[0025] FIG 2d is a perspective view of the prosthetic device for assisting the individual with the cleft lip and cleft palate conditions according to the embodiments as disclosed herein.

[0026] FIG 3 is a schematic diagram illustrating the anatomy of the prosthetic device for assisting the individual with the cleft lip and cleft palate conditions according to the embodiments as disclosed herein.

[0027] FIG 4a is a functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device according to the embodiments as disclosed herein.

[0028] FIG 4b is another perspective view of the functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device according to the embodiments as disclosed herein.

[0029] FIG 5a is a schematic diagram illustrating the structure of a prosthetic device with no uvula cutout for assisting the individual with the cleft lip and cleft palate conditions according to another embodiment as disclosed herein.

[0030] FIG 5b is a functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device with no uvula cutout according to the embodiments as disclosed herein.

[0031] FIG 6a is a schematic diagram illustrating the structure of a prosthetic device with adhesive tape to be placed along a strap area for assisting the individual with the cleft lip and cleft palate conditions according to another embodiment as disclosed herein.

[0032] FIG 6b is a functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device with adhesive tape to be placed along the strap area according to the embodiments as disclosed herein.

[0033] FIG 7a is a schematic diagram illustrating the structure of a prosthetic device with a tacky or adhesive surface for assisting the individual with the cleft lip and cleft palate conditions according to another embodiment as disclosed herein, and

[0034] FIG 7b is a functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device with a tacky or adhesive surface according to the embodiments as disclosed herein.

[0035] 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 by conventional 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

[0036] 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 detailed 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 to be construed as limiting the scope of the embodiments herein.

[0037] 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 particularly set out in the accompanying drawings. Although the terms first, second, etc. used herein to describe various elements, theseelements are not limited by these terms. These terms are generally used to distinguish one element from another.

[0038] Embodiments disclosed herein provide a prosthetic device for assisting an individual with cleft lip and cleft palate conditions. The prosthetic device includes a flap and a strap. The flap includes a lip philtrum prosthetic area connected to a palate prosthetic area. The lip philtrum prosthetic area is configured as a temporary upper lip prosthetic, and the palate prosthetic area is configured as a temporary palate prosthetic. The strap is connected to the lip philtrum prosthetic area of the flap, wherein the strap has a pair of slots positioned at opposite ends of the strap. The prosthetic device, when secured on the face of the individual, enables the individual to form a complete seal around a feeding implement, thereby facilitating a feeding process.

[0039] The design of the prosthetic device addresses the unique challenges faced by individuals with cleft lip and cleft palate conditions, particularly in relation to feeding. These conditions can significantly impact the ability to create a proper seal around a bottle or other feeding implements, which is crucial for effective feeding and nutrition intake. By providing a temporary prosthetic solution, the device aids in bridging the gap until surgical interventions can be performed. The lip philtrum prosthetic area mimics the natural contours of an upper lip, while the palate prosthetic area provides a temporary closure to the gap in the palate, thus enhancing the individual's ability to suckle and swallow efficiently.

[0040] Moreover, the prosthetic device is designed with user comfort and ease of use in mind. The strap, with its pair of slots, allows for adjustable fitting, ensuring that the device can be securely and comfortably positioned on individuals of varying facial sizes and shapes. This adjustability is particularly important for infants and young children, who are the primary users of such devices, as they grow rapidly and require adaptable solutions. The materials used in the construction of the prosthetic device are likely chosen for their softness and flexibility, minimizing irritation and discomfort during prolonged use. Additionally, the device's ability to be easily removed and reapplied makes it convenient for caregivers to manage during feeding times and cleaning routines.

[0041] In essence, this innovative prosthetic device not only improves the immediate quality of life for individuals with cleft conditions by facilitating better feeding practices but also supports their long-term health and development. By ensuring adequate nutrition intake during critical growth periods, the device plays a vital role in the overall care and management of cleft lip and palate conditions. Furthermore, the device may also contribute to the psychological well-being of both the individual and their caregivers by reducing the stress and challenges associated with feeding difficulties. As such, this prosthetic device represents a significant advancement in the field of medical prosthetics, offering a practical and compassionate solution to a common and impactful health issue.

[0042] Referring now to the drawings, and more particularly to FIGS. 2 through 7 where similar reference characters denote corresponding features consistently throughout the figures, there are shown preferred embodiments.

[0043] FIG 1 is an example diagram illustrating unilateral cleft lip and cleft lip and palate conditions in infants according to the prior art. Cleft lip and cleft palate are openings or splits in the upper lip, the roof of the mouth (palate), or both. Cleft lip and cleft palate result when facial structures that are developing in an unborn infant don't close completely. A split in the lip appears as only a small notch in the lip or extends from the lip through the upper gum and palate into the bottom of the nose. Less commonly, the cleft occurs only in the muscles of the soft palate (submucous cleft palate), which are at the back of the mouth and covered by the mouth's lining. Infants with cleft lip and palate find difficulty with sucking and swallowing food. Also, the infants suffer from chronic ear infections and a nasal speaking voice.

[0044] In an embodiment, the present disclosure addresses a critical issue faced by infants afflicted with cleft lip and cleft palate disabilities, wherein conventional feeding methods prove inadequate due to the anatomical anomalies present. The infants encounter challenges in achieving a proper seal for generating negative pressure during feeding from either a bottle or natural breastfeeding, resulting in compromised nutritional intake during crucial developmental phases. Additionally, the absence of a formed palate exacerbates the difficulty in creatingnegative pressure as air passage between the nostril and oral cavity obstructs the process. The present disclosure introduces a novel device designed to overcome the existing challenges, enabling the infants to engage in autonomous natural feeding processes, thereby mitigating the risk of malnutrition and associated developmental setbacks.

[0045] FIG. 2a is a schematic diagram illustrating the structure of a prosthetic device (100) for assisting the individual with the cleft lip and cleft palate conditions, according to the embodiments as disclosed herein. Referring to FIG. 2a the prosthetic device (100) includes a flap (101), a strap (102), and a band (103). The flap (101) includes a lip philtrum prosthetic area (104) connected to a palate prosthetic area (105), the lip philtrum prosthetic area (104) is configured as a temporary upper lip prosthetic. The palate prosthetic area (105) is configured as a temporary palate prosthetic. The palate prosthetic area (105) has a uvula profile(106) configured to be placed around uvula inside the mouth. The strap (102) is connected to the lip philtrum prosthetic area (104) of the flap (101), and the strap(102) has a pair of slots (107) positioned at opposite ends of the strap (102). The prosthetic device (100), when secured on the face of the individual, enables the individual to form a complete seal around the feeding implement, thereby facilitating the feeding process. The band (103) is configured to secure the prosthetic device (100) on the face of the individual, and the band (103) is having a first end and a second end. The band (103) includes hooks (108) at each of the first end and the second end, and the hooks (108) being detachably attachable to the slots(107) of the strap (102) thereby securing the band (103) to the strap (107). The band(103) is adjustable in a length to ensure a tight fit of the prosthetic device (100) on the face of the individual, thereby enabling the individual with the cleft lip and the cleft palate condition to form the complete seal around the feeding implement to generate a negative pressure for feeding during the feeding process. Hence the infant or individual is able to suck and swallow food naturally as a normal newborn infant.

[0046] In an embodiment, the feeding implement may comprise a breast nipple, a feeding bottle, or a spoon designated for food consumption. Theseimplements are designed to cater to the unique needs of infants, particularly those with cleft lip and / or cleft palate conditions. The design of these feeding tools takes into account the anatomical challenges faced by such infants, ensuring that they can feed effectively and comfortably. For instance, a specialized breast nipple may have a unique shape or material composition that allows for easier latching and suction, thereby facilitating better milk flow and reducing the risk of aspiration. Similarly, feeding bottles might be equipped with adjustable flow rates or specially designed nipples that accommodate the infant's oral structure, while spoons may have softer edges or ergonomic handles to aid in the safe delivery of semi-solid foods.

[0047] The term "infant" as used herein encompasses individuals with cleft lip and / or cleft palate conditions, but it also extends to a broader demographic of young children who may experience feeding difficulties due to other congenital or developmental anomalies. The present disclosure recognizes the diverse spectrum of feeding challenges and aims to provide solutions that are not only effective but also adaptable to individual needs. This adaptability is crucial, as it allows caregivers and healthcare providers to tailor feeding strategies to each infant's specific condition and developmental stage. By offering a range of feeding implements, the disclosure ensures that infants receive adequate nutrition, which is vital for their growth and development.

[0048] Additionally, the present disclosure may extend to various other feeding devices and methods suitable for individuals with similar conditions, ensuring adaptability to meet diverse feeding needs and preferences. This includes the development of innovative feeding systems that incorporate technology, such as sensors that monitor feeding patterns or devices that provide real-time feedback to caregivers. Such advancements can enhance the feeding experience by allowing for adjustments based on the infant's response, thereby promoting a more personalized approach to feeding. Moreover, the disclosure emphasizes the importance of collaboration with healthcare professionals, including pediatricians, speech therapists, and nutritionists, to develop comprehensive feeding plans that address both the nutritional and developmental needs of infants with cleft lip, cleft palate, and other related conditions. Through ongoing research and development,the aim is to continually improve the efficacy and accessibility of feeding solutions, ultimately contributing to better health outcomes for affected individuals.

[0049] In this embodiment, the innovative design of the flap (101) addresses a critical need for individuals with cleft lip and palate conditions, particularly focusing on infants and young children who face challenges in feeding due to anatomical gaps. The flap (101) is engineered to traverse over a palatal gap, responding dynamically to pressure exerted by the tongue. This interaction is crucial as it culminates in a complete seal, thereby facilitating the expulsion of fluids or food. The mechanism is akin to a natural feeding process, allowing for a more intuitive and less cumbersome feeding experience for both the caregiver and the individual. The design not only enhances the feeding process but also reduces the risk of aspiration, which is a common concern in individuals with cleft conditions.

[0050] The dual-component design of the flap (101) is a testament to the thoughtful engineering behind the device. The lip philtrum prosthetic area (104) and the palate prosthetic area (105) work in tandem to ensure the flap's stability and functionality. The lip philtrum prosthetic area (104) is crucial in anchoring the flap (101) in its optimal position, ensuring that it does not shift during use. This area can be secured using various attachment options, such as elastic bands (103) or a specialized adhesive tape, which provide flexibility and adaptability to different users' needs. The palate prosthetic area (105), on the other hand, is designed to mimic the uvula profile (106), allowing it to seamlessly integrate with the individual's oral cavity. This integration is vital as it temporarily assumes the role of the functional palate, providing a bridge over the anatomical gap and facilitating effective feeding.

[0051] Further, the flap (101) is meticulously crafted to accommodate anatomical variability, drawing on comprehensive mouth anthropometric data. This ensures that the device can be tailored to fit a wide range of users, from newborns to older children awaiting surgical intervention. By temporarily assuming the roles of the upper lip and the functional palate, the flap (101) offers a non-invasive solution that can significantly improve the quality of life for individuals with cleftconditions. It provides a practical and immediate solution to feeding challenges, allowing caregivers to focus on nurturing rather than struggling with feeding techniques. This embodiment not only highlights the potential for technological innovation in medical devices but also underscores the importance of designing solutions that are user-centric and adaptable to individual needs.

[0052] FIG. 2b is a schematic diagram illustrating the structure of the flap (101) of the prosthetic device (100) for assisting the individual with the cleft lip and cleft palate conditions, according to the embodiments as disclosed herein. In an embodiment, operating in synergy with the individual’s innate feeding reflexes, the flap (101) optimizes the feeding process. When the individual’s natural feeding apparatus or nipple is introduced into the mouth in customary fashion, a secure seal is established. Subsequently, the individual employs his tongue to exert upward pressure on the nipple, instigating the expulsion of fluids or food. This dynamic interaction propels the nipple, in turn urging the flap (101) to traverse over the palatal gap, culminating in a seamless seal.

[0053] In an embodiment, the prosthetic device (100) with ingenious design and material composition, stands poised to revolutionize the feeding experience for the individuals affected by cleft lip and palate conditions. By seamlessly integrating into established feeding routines, the prosthetic device (100) serves as a critical aid in sustaining optimal nutrition during the formative stages of infancy, setting the stage for a smoother transition to subsequent developmental milestones.

[0054] FIG. 2c is a schematic diagram illustrating the elastic band (103) of the prosthetic device (100) for assisting the individual with the cleft lip and cleft palate conditions, according to the embodiments as disclosed herein. The hooks (108) are provided on each end of the band (103) so as attach the band (103) into the slots (107) of the strap (102). The device (100) is secured on the face of the infant using the band (103). Once the device (100) is secured on face of the infant, the infant with the clef palate condition is able to form complete seal around the nipple of a feeding bottle or a breast to generate negative pressure. In an embodiment the elastic band (103) includes but not limited to tape, thread, length adjustable band where the length of the band (103) is adjusted using adjuster so asto tightly fasten the device (100) onto the face of the infant or individual. The elastic band (103) is detachably attached to the slots (107) of the strap (102) using hooks (108).

[0055] FIG. 2d is a perspective view of the prosthetic device (100) for assisting the individual with the cleft lip and cleft palate conditions, according to the embodiments as disclosed herein. The perspective view shown in FIG 2d offers a comprehensive understanding of the prosthetic device (100) in its entirety. This view highlights the ergonomic design of the device, which is intended to accommodate the unique facial structure of individuals with cleft conditions. The device is engineered to be lightweight and unobtrusive, allowing the infant to move freely and comfortably while wearing it. The thoughtful design and engineering behind the prosthetic device (100) underscore its potential to significantly improve the quality of life for infants and individuals with cleft lip and cleft palate conditions by facilitating easier and more effective feeding.

[0056] FIG 3 is a schematic diagram illustrating the anatomy of the prosthetic device (100) for assisting individuals with cleft lip and cleft palate conditions according to the embodiments as disclosed herein. When addressing the needs of individuals bom with cleft conditions, understanding the precise anatomical dimensions becomes paramount. Understanding the anatomical dimensions involves the assessment of five distinct areas within the oral cavity: philtrum width, inter-canine width, inter- tuberosity width, arch length, and arch circumference. Each measurement holds significance, defining crucial aspects of the mouth's structure. From the vertical groove at the base of the nose to the fleshy projection at the back of the throat, these parameters are instrumental in designing the prosthetic device (100) tailored to the unique contours of the infant's cleft condition.

[0057] In an embodiment, the flap (101) is designed based on anatomical measurements related to the oral or facial structures of the individual. The anatomical measurement comprises a philtrum width measurement, an inter-canine width measurement, an inter-tuberosity width measurement, an arch length measurement, and an arch circumference measurement. The philtrum widthmeasurement is measured as a distance between two specific points at the base of a philtrum located at a junction where the vertical ridge of the philtrum meets the red border of the upper lip of the individual. The inter-canine width measurement is measured as a distance between the tips of permanent canines in both maxillary and mandibular jaws of the individual. The inter-tuberosity width measurement is measured at a point where a maxillary tuberosity intersects with a crest of a ridge. The arch length measurement is measured from the lowermost point of the upper lip of the individual to the uvula. The arch circumference measurement is measured as a total distance around an arch of the mouth of the individual, including measurements from the maxillary tuberosity, canines, and the front end of the upper lip of the individual on both left and right sides.

[0058] In an embodiment, in the context of cleft gaps, it's important to note that a cleft can extend from the nose all the way to the soft palate and potentially beyond. There are different types of clefts: they are isolated cleft palate (a gap in the roof of the mouth), unilateral cleft lip and palate (a gap on one side of the lip and in the palate), and bilateral cleft lip and palate (gaps on both sides of the lip and in the palate).

[0059] Considering the purpose of the device (100) is to assist with feeding infants with clefts, the anatomical measurements are crucial. The anatomical measurements allow for the creation of a specialized device that fits the unique anatomical shape of the affected area, ensuring optimal functionality and comfort for the infant during feeding. The anatomical dimensions of the device (100) can vary according to various functional requirements and physiological considerations to form a complete seal around the nipple during the sucking of the milk.

[0060] FIG 4a is a functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device (100) according to the embodiments as disclosed herein. In an embodiment, the device (100) serves a secondary purpose as a protective barrier. The prosthetic device (100) offers a safeguarding solution for individuals spanning from infants to adults who have recently undergone palate surgery. By providing an impermeable shield, theprosthetic device (100) effectively shields the surgical site from potential contamination by food and fluids, ensuring the integrity of the freshly operated area.

[0061] In an embodiment, the prosthetic device (100) acts as a formidable deterrent against foreign bodies inadvertently adhering to the stitches, thereby averting potential complications. The prosthetic device’s (100) design is meticulously engineered to prevent any undue friction between the stitches and food, mitigating the risk of stitch dislodgement and safeguarding the delicate healing process. The dual functionality of the device (100) broadens the scope of the application, rendering the device (100) an invaluable asset in post-operative care for a diverse demographic.

[0062] FIG 4b is another perspective view of the functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device (100) according to the embodiments as disclosed herein.

[0063] The prosthetic device (500) described in FIG 5a is designed with a focus on addressing the unique challenges faced by individuals with cleft lip and cleft palate conditions. The absence of a uvula cutout (106) in the flap (101) is a deliberate design choice that reflects an understanding of the specific anatomical and functional requirements of these individuals. By eliminating the uvula profile, the device (500) achieves a more streamlined structure, which not only simplifies its construction but also enhances its adaptability to the varied contours of an infant's oral cavity. This design decision is informed by extensive research into the physiological characteristics of cleft conditions, ensuring that the prosthetic device (500) provides optimal support and comfort.

[0064] The lip philtrum prosthetic area (104) and the palate prosthetic area (105) are integral components of the flap (101), each serving a distinct purpose in the overall functionality of the device (500). The lip philtrum prosthetic area (104), characterized by its cam profile, is engineered to mimic the natural contours of the lip philtrum, thereby providing a more natural appearance and fit. This area is seamlessly connected to the strap (102), which plays a crucial role in maintaining the stability of the device (500) on the infant's face. Meanwhile, the palate prosthetic area (105) is meticulously designed to align with the lip philtrum prosthetic area(104), ensuring a cohesive and supportive structure that accommodates the absence of a uvula profile (106). This thoughtful integration of components underscores the device's (500) commitment to meeting the functional and aesthetic needs of individuals with cleft conditions.

[0065] The strap (102) and band (103) work in tandem to secure the prosthetic device (500) in place, ensuring that it remains stable and effective during use. The strap (102) features a pair of strategically positioned slots (107), located at opposite ends, which facilitate the attachment of the band (103). This configuration allows for easy adjustment and customization of the fit, accommodating the diverse facial structures of infants. The band (103) is designed to provide gentle yet firm support, ensuring that the device (500) remains securely positioned without causing discomfort or irritation. This secure attachment mechanism is crucial for maintaining the efficacy of the prosthetic device (500), allowing it to perform its intended function of assisting individuals with cleft lip and cleft palate conditions effectively.

[0066] FIG 5b is a functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device (500) with no uvula cutout (106) according to the embodiments as disclosed herein. In an embodiment, a deliberate reduction in the length of the flap (101) has been implemented. Extensive observation has indicated that in a majority of cases, coverage of the soft palate may not be imperative. The device (500) prevents nasal regurgitation occurring beyond the hard palate region. Some infants afflicted with cleft palate conditions manifest a distinct anatomical configuration wherein the palatal gap extends beyond the uvula and reaches towards the posterior region of the throat. Recognizing the variability of the palate condition is pivotal in customizing the device (500) to meet the specific needs of the patient infant. Furthermore, through careful clinical observation, it has been observed that an extended length of the device (500), particularly in the soft palate region, has the potential to induce a gag reflex in the infants.

[0067] FIG 6a is a schematic diagram illustrating the structure of a prosthetic device (600) with an adhesive tape (601) to be placed along a strap areafor assisting the individual with the cleft lip and cleft palate conditions according to other embodiments as disclosed herein. As shown in FIG 6a, the device (600) includes a flap (101), a strap (102), and the adhesive tape (601). The flap (101) includes the lip philtrum prosthetic area (104) and the palate prosthetic area (105). The palate prosthetic area (105) is connected to the lip philtrum prosthetic area (104) and has a uvula profile (106) configured to be placed around the uvula inside the mouth. The adhesive tape (601) is strategically placed along an end area of the strap (102) and affixed onto the cheeks of the infant, adhering to the skin surface for added stability. The device (600) effectively diminishes production costs by eliminating the need for the hooks (108) and elastic components.

[0068] FIG 6b is a functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device (600) with the adhesive tape (601) to be placed along the strap area according to the embodiments as disclosed herein.

[0069] FIG. 7a is a schematic diagram illustrating the structure of a prosthetic device (700) with tacky or adhesive surface for assisting the individual with the cleft lip and cleft palate conditions, according to another embodiments as disclosed herein. As shown in FIG. 7a the device (700) includes the flap (101), where the flap (101) includes the lip philtrum prosthetic area (104) and the palate prosthetic area (105). The palate prosthetic area (105) is connected to the lip philtrum prosthetic area (104) and has uvula profile (106) configured to be placed around the uvula inside the mouth. The palate prosthetic area (105) is inserted into the mouth of the infant and acts as temporary palate (temporary palate prosthetic). The device (700) includes a tacky or an adhesive material on top surface of the flap (101) for securely fastening the device (700) onto both the lip and palate regions of the mouth. The top surface of the flap (101) includes a material with adhesive properties, the material being configured to securely attach the prosthetic device (700) to oral surfaces within the mouth of the individual, thereby minimizing movement or displacement of the device (700) during use. The adhesive properties of the material are further configured to assist in an oral function by enabling theindividual to engage in the oral function autonomously, reducing or eliminating the need for manual assistance.

[0070] FIG. 7b is a functional diagram illustrating a scenario of feeding the infant with the cleft lip and palate condition with the prosthetic device (700) with tacky or adhesive surface, according to the embodiments as disclosed herein.

[0071] In an embodiment, while encompassing a range of potential applications, the primary focus of the device (100) is to revolutionize the feeding experience for infants with cleft lip and palate. The device’s (100) paramount purpose is to facilitate independent feeding, whether through the use of the bottle or natural breastfeeding. By affording the infants the capability to autonomously partake in the feeding process, the device (100) effectively eliminates the necessity for manual intervention by a caregiver.

[0072] In an embodiment, the device (100) presented herein holds significant promise in revolutionizing the feeding experience for the infants afflicted with cleft lip and cleft palate conditions, thereby safeguarding the infant’s nutritional well-being, and fostering optimal developmental outcomes.

[0073] In an embodiment, the proposed device (100), known as the flap (101) is crafted from a pliable material such as silicone, plastic, or similar substances. The material possesses the requisite softness and thinness to conform seamlessly to the unique contours of the lip and palate within the oral cavity. The choice of silicone or other food-grade materials is imperative, given the device's constant exposure to the oral environment, which may potentially harbor contaminants and germs. Consequently, routine sterilization or boiling is essential to ensure device’s safe and hygienic utilization.

[0074] In an embodiment, there can be any number of permutations and combinations possible with the disclosed device, such as but not limited to device with no uvula cutout with tacky adhesive surface, or adhesive tape with no uvula cutout.

[0075] The various actions, acts, blocks, steps, or the like in the method are performed in the order presented, in a different order or simultaneously. Further, in some embodiments, some of the actions, acts, blocks, steps, or the like are omitted,added, modified, skipped, or the like without departing from the scope of the proposed method.

[0076] 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 claim1. A prosthetic device (100) for assisting an individual with at least one of a cleft lip and cleft palate condition, comprising: a flap (101) comprising a lip philtrum prosthetic area (104) connected to a palate prosthetic area (105), wherein the lip philtrum prosthetic area (104) configured as a temporary upper lip prosthetic, and wherein the palate prosthetic area (105) is configured as a temporary palate prosthetic; and a strap (102) connected to the lip philtrum prosthetic area (104) of the flap (101), wherein the strap (102) has a pair of slots (107) positioned at opposite ends of the strap (102), wherein the prosthetic device (100), when secured on a face of the individual, enables the individual to form a complete seal around a feeding implement, thereby facilitating a feeding process.

2. The prosthetic device (100) of claim 1, wherein the flap (101) is designed based on at least one anatomical measurement related to oral or facial structures of the individual, wherein the at least one anatomical measurement comprises the at least one of a philtrum width measurement, an Inter-canine width measurement, an inter-tuberosity width measurement, an arch length measurement, and an arch circumference measurement.

3. The prosthetic device (100) of claim 2, wherein the philtrum width measurement is measured as a distance between two specific points at a base of a philtrum, located at a junction where vertical ridge of the philtrum meets a red border of an upper lip of the individual.

4. The prosthetic device (100) of claim 2, wherein the inter-canine width measurement is measured as a distance between tips of permanent canines in both maxillary and mandibular jaws of the individual.

5. The prosthetic device (100) of claim 2, wherein the inter-tuberosity width measurement is measured at a point where a maxillary tuberosity intersects with a crest of a ridge.

6. The prosthetic device (100) of claim 2, wherein the arch length measurement is measured from a lowermost point of an upper lip of the individual to an uvula.

7. The prosthetic device (100) of claim 2, wherein the arch circumference measurement is measured as a total distance around an arch of a mouth of the individual, including measurements from maxillary tuberosity, canines, and an front end of an upper lip of the individual on both left and right sides.

8. The prosthetic device (100) as claimed in claim 1, wherein the flap (101) having a top surface, wherein the top surface includes a material with adhesive properties, the material being configured to securely attach the prosthetic device (100) to oral surfaces within the mouth of the individual, thereby minimizing movement or displacement of the device (100) during use, and wherein the adhesive properties of the material are further configured to assist in an oral function by enabling the individual to engage in the oral function autonomously, reducing or eliminating the need for manual assistance.

9. The prosthetic device (100) as claimed in claim 1, wherein the flap (101) is designed to traverse over a palatal gap in response to an applied pressure exerted by a tongue of the individual on the feeding implement, thereby culminating in the complete seal and facilitating expulsion of fluids or food.

10. The prosthetic device (100) of claim 1, comprising a band (103) configured to secure the prosthetic device (100) on a face of the individual, wherein the band(103) having a first end and a second end, and wherein the band (103) includes hooks (108) at each of the first end and the second end, and wherein the hooks (108) being detachably attachable to the slots (107) of the strap (102) thereby securing the band (103) to the strap (107).

11. The prosthetic device (100) as claimed in claim 10, wherein the band (103) is adjustable in a length to ensure a tight fit of the prosthetic device (100) on the face of the individual, thereby enabling the individual with at least one of the cleft lip and the cleft palate condition to form the complete seal around the feeding implement to generate a negative pressure for feeding during the feeding process.

12. The prosthetic device (100) of claim 1, wherein the lip philtrum prosthetic area(104) having a cam profile to facilitate alignment and position on a lip of the individual, and wherein the palate prosthetic area (105) having a uvulaprofile and is placed around the uvula inside the mouth of the individual to act as a temporary palate prosthetic.

13. The prosthetic device (100) of claim 1, comprising an adhesive tape placed along an end area of the strap (102), wherein the adhesive tape is configured to adhere to cheeks of the individual for added stability.

14. The prosthetic device (100) of claim 1, wherein the prosthetic device (100) is designed without a uvula cutout to facilitate the feeding process by accommodating an anatomical variability of at least one of the cleft lip and cleft palate conditions.

15. The prosthetic device (100) of claim 1, wherein the flap (101) is made from a pliable material selected comprising at least one of silicone and plastic.

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