A device, method, and a system for treating respiratory conditions

Abstract

A device, method and a system for treating a respiratory conditions The present invention relates to the field of mandibular repositioning as a measure to treat the respiratory conditions not limited to OSA (Obstructive Sleep Apnea). The device comprises an upper splint with a nasal dilator; and a lower splint comprising a lingual bud. The device is a metal free mandibular advancement device (MAD) with a locking mechanism comprising an interchangeable insert for incremental advancement of the mandible. The locking arrangement is a side–to-side arrangement of the bilateral inserts and the bilateral flanges for the adjustable coupling of the splints. The device provides a method to prevent airway obstruction and enhance airflow in respiratory condition such as sleep apnea, snoring, nasal obstruction, and upper airway resistance syndrome. It further provides a system having a sensor and feedback mechanism for monitoring airflow, pressure, or tongue position during use.

Description

[0001] FIELD OF THE INVENTION:

[0002] The present invention relates to the field of mandibular repositioning as a measure to treat respiratory conditions not limited to OSA (Obstructive Sleep Apnea). The device (100) comprises an upper splint (10) with a nasal dilator (30); and a lower splint (20) comprising plurality of lingual bud (50). More particularly, the device is a metal free mandibular advancement device (MAD) with a locking mechanism comprising an interchangeable insert (60A) for incremental advancement of the mandible.

[0003] BACKGROUND OF THE INVENTION:

[0004] India has a huge population suffering from OSA, causing co -morbidities like cardiac diseases including high blood pressure, heart attack, stroke and diabetes. In this condition, the upper airway becomes blocked during sleep, reducing or completely stopping airflow. The consequences are fatal if remain unattended. The existing solution to OSA is a technology based on CPAP (Continuous Positive Airway Pressure) therapy and the oral devices for same. Other alternatives are the clip-on and anti-snoring devices. Further, the custom fit oral appliances and the surgical option is effective only in the limited cases. However, the CPAP has limitations, so not used by the majority of OS. A patients. The CPAP known are incompatibility and not user friendly, so leaving OSA untreated causing the life-threatening condition and co-morbidities. Therefore, there is a dire need for the MAD as a highly recommended alternative to the CPAP-intolerant patients.

[0005] A reference may be made to US2021315728 for a dental device that has metal wire supported nasal dilators and lingual buttons. It discloses adjustable dental hinge system for the mandible positioning. In particular, it provides a mandibular attachment wire encased within an outer circumference of the mandibular tray. However, there are limitations due to rigid mechanical connection, including limited jaw movement, potential for breakage, and the increased risk of specific dental and joint pain. The rigid metal connection limits the natural side- to-side (lateral) and vertical (opening) jaw movements during sleep. This can lead to a feeling of constriction and may increase discomfort for some patients.

[0006] A reference “US9254219B2” provides snoring and obstructive sleep apnea prevention and treatment device. 'The document focuses anti-snoring and anti¬ obstructive sleep apnea oral device disposed in a retro molar space and between a last molar tooth of an oral cavity. It has a nasal dilator, along with the mouth guard. However, the significant variation in retromolar space depth between patients leads to poor compatibility. Further, constant contact with soft tissues (retromolar pad, buccal mucosa) causes irritation, soreness, and ulceration. In some situation, continuous contact with the distal gingiva of the last molar may result in periodontal pocketing or gingival recession.

[0007] A reference may be made to CA3039295 disclosing device having a maxillary splint. In addition to the mandibular splint, the device has set of removable adjustment spacers. However, such devices suffer drawback of breakage of parts that can cause choking. Also, the devices are poor fit, and so have limited adjustability. Thus, the higher incidence of side effects leads to reduced effectiveness and poor patient adherence. This prior-art configuration in the reference above positions a wide dorsal spacer on a bracket. Such placement is producing a cam-out lifting force during natural mandibular closure, which causes loosening, fracture, loss of protrusive control and increased stress on the temporomandibular joint (TMJ), and may also create an aspiration hazard if the spacer detaches intraorally.

[0008] There is, therefore, felt a need that mitigates the drawbacks mentioned hereinabove or at least provide a suitable alternative to overcome the health impact of obstructive sleep apnea, in particular.

[0009] SUMMARY OF THE INVENTION

[0010] The present application relates to device (100), a method and a system for treating a respiratory condition. The device comprises an upper splint (10) and a lower splint (20). The upper splint comprises a nasal dilator (30) and bilateral flanges (40) at a pre-determined position. The nasal dilator (30) is M-shaped and is to be positioned in the nasolabial fold for improved breathing through the nasal cavity. The lower splint (20) comprises plurality of lingual buds (50) and bilateral insert (60A). The lingual bud (50) stimulates the proprioceptors and keeps the tongue in a forward position. The insert (60A) is configured relative to the respective flange (40) for a locking arrangement during use.

[0011] The method to prevent airway obstruction and enhance airflow in respiratory condition comprises the steps of positioning an upper splint having a nasal dilator for improved breathing through the nasal cavity; and positioning a lower splint having a lingual bud (50) within the oral cavity. Further, the method involves engaging a locking mechanism between the upper and lower splint to maintain a predetermined orientation and mandibular advancement. The device is then maintained in the position during respiration to prevent airway obstruction and enhance airflow in the respiratory conditions.

[0012] The system comprises a device, a sensor and a feedback mechanism tor monitoring airflow, pressure, or tongue position during use.

[0013] BRIEF DESCRIPTION OF THE DRAWINGS:

[0014] The above and still further features and advantages of embodiments of the present invention will become apparent upon consideration of the following detailed description of embodiments thereof, especially when taken in conjunction with the accompanying drawings, and wherein:

[0015] The present disclosure will now be described with the help of the accompanying drawing, in which:

[0016] Figure I illustrates a front view the device (100) in a locked configuration in accordance with the present disclosure: Figure 2 illustrates the interior of the device (100) in accordance with the present disclosure;

[0017] Figure 3 illustrates the side view of the device (100) in an open configuration, in accordance with the present disclosure;

[0018] Figure 4 (A-B) illustrates the locking arrangement, and position of insert of the device (100) in accordance with the present disclosure; and

[0019] Figure 5 illustrates a graph of total AHI values at baseline; AHI values from conventional device, and the device in accordance with the invention.

[0020] Figure 6 illustrates block diagram of the sensor-feedback control system in accordance with the invention.

[0021] Legends for the drawing:

[0022] Details Legends

[0023] Upper splint 10

[0024] Lower splint 20

[0025] Nasal dilator 30

[0026] Flange / fin 40

[0027] Lingual button / tongue 50

[0028] button

[0029] Insert 60A

[0030] Build-in slot for inserts 60B

[0031]

[0032] DETAILED DESCRIPTION OF THE DRAWINGS FIG. 1-3 illustrates the perspective views of device (100) worn by a user, showing the relative positioning of the upper splint and the lower splint within the oral cavity, and the nasal dilator positioned external to or partially within the nostrils. In particular, the nasal dilator (30) is M-shaped to be positioned in the nasolabial fold for improved breathing through the nasal cavity. The upper splint and the lower splint are in an engaged position. The anatomical alignment ensures that the nasal dilator remains centrally positioned regardless of slight mandibular adjustments permitted by the locking mechanism.

[0033] The enlarged view of the upper splint includes a dental tray shaped to conform to the maxillary dental arch. It is extending interiorly from the tray body to the nasal dilator. The upper splint comprising a single rigid structure positioned in the labial sulcus. The nasal dilator is the dimensioned to gently expand the user’s nasal valve region, lifting the thereby improving nasal airflow during inhalation.

[0034] The lingual bud projects upward into the tongue space and encourages anterior tongue positioning. The nasal dilator simultaneously expands the nasal passages, enabling dual-action airway support through both nasal and oral anatomical mechanisms.

[0035] FIG. 4 provides a detailed view of the locking mechanism associated with the lower splint. The locking mechanism includes insert housed in a build-in slot formed along the anterior surface of the lower splint and a corresponding engagement member / bilateral flange projecting from the upper splint at a pre¬ defined angle. In the engaged configuration, the bilateral flanges couples with insert housed in a build-in slot, thereby stabilizing the relative position of the upper and lower splints for the mendibular adjustment.

[0036] The device in a locked configuration, with the latch (i.e. inserts) securely nested within the Unit. This keeps the mandible in an ideal forward position to keep the airway open during sleep during sleep while allowing controlled microadjustments necessary for comfort. The locking mechanism may employ a sliding, snap-fit, magnetic, or ratchet-type interface depending on the embodiment.

[0037] The upper splint with the nasal dilator is a single unit without any prongs. The M shape connector bridge attaches to an upper mounting pad located on the labial surface of the upper splint. An alternate embodiment of the lingual bud wherein the protrusion includes surface texturing or air channels to support saliva flow and minimize tongue irritation. The bud is flexible or semi-rigid to enhance the user comfort. The airflow pathways facilitated by the combined operation of the nasal dilator and lingual bud.. Arrows indicate improved nasal airflow through the dilator and improved oropharyngeal patency due to forward positioning of the tongue induced by the lingual bud.

[0038] The present disclosure relates to relates to a device, a method and a system for treating a respiratory condition, in particular obstructive Sleep Apnea (OSA).

[0039] Embodiments, of the present disclosure, will now be described with reference to the accompanying drawing.

[0040] Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well- known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0041] The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure.. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," ‘■‘including;' and “having;' are open-ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and / or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.

[0042] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed elements.

[0043] CPAP devices force a patient's airway open during the sleep i.e. based on a flow of pressurized air into the throat of the patient. However, the CPAP has limitations, so not used by the majority of OSA patients. The devices known are incompatibility and not user friendly, so leaving OSA untreated causing the life¬ threatening condition and co-morbidities. Other alternatives are the inserts clip-on and anti-snoring device. The device of the present invention repositions the lower jaw and tongue in a downward and forward position during sleep and keeps the central airway open. In the device, the forward position of the mandible can be adjusted as required.

[0044] In an aspect, the present disclosure envisages a device for treating a respiratory condition.

[0045] In an embodiment, the device comprises an upper splint comprising a nasal dilator for improved breathing through the nasal cavity; and a lower splint comprising a lingual bud.

[0046] In an embodiment, the device comprises:

[0047] a. an upper splint (10) comprising:

[0048] i. a nasal dilator (30), wherein the nasal dilator (30) is M-shaped to be positioned in the nasolabial fold for improved breathing through the nasal cavity;

[0049] ii. bilateral flanges (40) at a pre-determined position; and b. a lower splint (20) comprising plurality of lingual bud (50) and bilateral insert (60A).

[0050] In an embodiment, the insert (60A) is configured relative the respective flange (40) for a locking arrangement during use.

[0051] In an embodiment, the upper splint comprising a metal free nasal dilator of predefined shape and size.

[0052] In an embodiment, the lower component comprising metal free lingual bottoms / bud.

[0053] In an embodiment, the device is a metal free mandibular advancement device with a locking mechanism comparing an insert.

[0054] In an embodiment, the pre-determined position bilateral flanges (40) is the pre¬ defined angle, geometry and condylar closing trajectory to guide restrict and synchronize mandibular' movement to support unobstructed opening and closing of mouth in-use configuration of the device.

[0055] In an embodiment, the locking arrangement comprises an side-to-side arrangement of the bilateral inserts and the bilateral flanges (40) for adjustable coupling configured to vary the distance between the splints (10 and 20) to provide mandibular advancement unobstructed airflow through the nasal and oral airways.

[0056] In an embodiment, the device is a mandibular advancement device comprising interchangeable inserts for incremental advancement of the mandible.

[0057] The mandibular closure produces a resultant force vector directed exclusively into the insert and into the block cavity, thereby generating a purely compressive, self¬ locking engagement between the fin and insert with substantially no upward or outward shear force. This provides the reduced stress concentration while in use. The forces generated during nocturnal bruxism act primarily along the axis of fin- and-insert engagement and are absorbed by the enclosing block walls, thereby enhancing durability and reducing mechanical fatigue. Therefore, the device has superior durability under bruxism.

[0058] In an embodiment, the insert (60A) is housed in a build-in slot (60B).

[0059] The insert is supported by three loads- bearing block walls that distribute functional forces uniformly, thereby reducing stress concentration and minimizing risk of breakage compared to bracket-mounted dorsal spacers.

[0060] The pre-determined position of the flange (40) supports unobstructed opening and closing of mouth in closed configuration of the device.

[0061] The pre-determined position of the bilateral flanges (40) is the pre-defined angle; geometry and Condylar closing trajectory to guide restrict and synchronize mandibular movement of the flange (40).

[0062] “Condylar closing trajectory,” as used herein, refers to the three-dimensional path followed by the mandibular condyle as the mandible moves from an open position toward a closed or occluded position. The trajectory represents the spatial movement of the condyle within the temporomandibular joint (TMJ), including both rotational and translational components, and characterizes how the condyle returns to its seated or functional position during mandibular closure. This term encompasses the geometry, angle, curvature, and displacement pattern of the condylar pathway, which may be utilized to guide, restrict, or synchronize mandibular movement in the disclosed device.

[0063] The upper fin / flange is oriented at a predefined anterior-inferior angle corresponding to the physiological condylar closing trajectory such that mandibular closure causes the fin to advance the mandible along its natural hinge¬ path, thereby producing passive, anatomically guided protrusion without generating unnatural anterior thrust forces. The condyle-aligned fin-and-insert engagement reduces temporomandibular joint (TMJ) loading by avoiding posterior shear forces and by allowing the mandible to follow its natural rotational-anterior closing arc during protrusive positioning.

[0064] The flange / fin engages the insert in a passive gliding manner during closure without abrupt contact, thereby improving patient comfort and enabling natural mandibular movement without forcing the joint into non-physiological positions. Therefore, the passive closure and enhanced comfort is thereby achieved.

[0065] In an embodiment, the bilateral Inserts are the interchangeable inserts. In an exemplary embodiment, the insert is a set in the range of 6 to 14 inserts having an incremental increase of width.

[0066] In an embodiment, the incremental increase of width of the inserts (60A) is 0.2 to 0.8 mm.

[0067] In an embodiment, the incremental increase of width of the inserts is 0.5 mm, thus can give an advancement of 5.0 mm in total.

[0068] The geometry of the fin / flange and insert eliminates cam-out forces characteristic of dorsal-fin spacer designs, thereby preventing lifting, loosening, or fracture of the insert or fin under functional or bruxism-related loads. Therefore, there is elimination of Cam-Out Forces too. The elimination of Cam-Out Force ensures stable coupling, improved mechanical reliability, and consistent functional performance during repeated use.

[0069] The insert is retained within a three- sided block cavity (I.e. a build-in- block) in a manner preventing the insert from lifting, rotating, or exiting the cavity under occlusal, protrusive, or bruxism forces, thereby inherently protecting against intraoral aspiration or ingestion of components. Therefore, device has an aspiration- safe captive insert.

[0070] The fin / flange remains engaged within the block-seated insert across a range of mandibular opening movements, thereby maintaining stable protrusion during partial mouth opening and preventing posterior relapse of the mandible. This provides stability during mouth opening, while in use.

[0071] In an embodiment, the inserts are unique color coded, and also numbered for identification purpose.

[0072] In accordance with the present disclosure, the inserts are retained by mechanism, not limited to a frictional resistance.

[0073] In an embodiment, the inserts are placed in an open chamber of the lower splint that permits better cleansing of the build-in slot.

[0074] The locking mechanism of the present invention is structurally and biomechanically superior to the dorsal- fin spacer system that may be known.

[0075] The device employs a narrow, downward-projecting upper fin / flange engaging a narrow-neck insert seated within a deep three-sided block cavity, the fin being angled precisely to follow the physiological condylar closing trajectory. As the patient closes the mouth, the bilateral fin / flange slides passively along this anatomical path and gently advances the mandible without any forcible or unnatural protrusive thrust, thereby reducing TMJ loading and enhancing comfort.

[0076] The condyle- aligned geometry converts all closing forces into inward, compressive, self-locking engagement with no upward shear, eliminating cam-out behaviour, preventing dislodgement, minimizing stress concentration, reducing breakage risk, maintaining stable protrusion throughout mouth opening movements, and inherently protecting against aspiration by ensuring that no component can detach into the oral cavity.

[0077] In second aspect, the present disclosure envisages a method for managing OSA.

[0078] The method is based on Mandibular advancement device of the present invention.

[0079] In an embodiment, the method is to prevent airway obstruction and enhance airflow in respiratory condition. In an embodiment, the method comprises the steps of:

[0080] i) positioning an upper splint having a nasal dilator within or adjacent to a user's nasal cavity;

[0081] ii) positioning a lower splint with a tongue button within the oral cavity; iii) engaging a locking mechanism between the upper and lower splint to maintain a predetermined orientation and mandibular advancement; and i v) maintaining the device in position during respiration to prevent airway obstruction and enhance airflow in the respiratory conditions.

[0082] In a third aspect, the invention provides a system for treating a respiratory condition.

[0083] The system comprises a device, and a sensor and feedback mechanism for monitoring airflow, pressure, or tongue position during use.

[0084] In an embodiment, the system comprises a sensor input selected from nasal airflow sensors, microcontrollers and the feedback output means. The sensors are the tongue-position / pressure sensor; jaw position sensor; and lock-status sensor. 'The microcontroller is with signal conditioning unit. The feedback outputs are the vibratory cueing, acoustic biofeedback, illumination indicator, and data transmission to the sleep-monitoring applications.

[0085] In an embodiment, the system comprises:

[0086] » an upper splint with an interiorly projecting nasal dilator,

[0087] « a lower splint with a lingual bud,

[0088] « a locking mechanism between the two splints, and

[0089] • a sensor and feedback module configured to monitor airway parameters and provide responsive feedback.

[0090] The airflow sensor measures bidirectional nasal airflow and detects reductions associated with snoring or hypopneas. In an embodiment the system block diagram description of the sensor-feedback control.

[0091] In an embodiment, the sensors of the system provide the following:

[0092] • Flow / pressure sensor at mask or airway (detects inspiratory / expiratory airflo w, apneas / hypopneas).

[0093] « SpO2sensor (finger / wrist) for oxygen desaturation monitoring.

[0094] ® Respiratory sound (microphone) for snoring detection.

[0095] • Position sensor / accelerometer (supine detection).

[0096] » Mandibular position sensor / hall sensor (if device moves jaw).

[0097] » Battery & device health monitors.

[0098] In an embodiment, the Actuators / Outputs of the system provide the following:

[0099] « Mandibular advancement actuator (linear motor / stepper) or mechanical stop.

[0100] » Nasal dilator inflation / valve (micro-pump).

[0101] » Vibratory haptic alarm to prompt repositioning.

[0102] « Audible alarm + LED.

[0103] « Wireless comms (BLE / Wi-Fi) module.

[0104] In an embodiment, the Sensor interface / preprocessing of the system provide the following:

[0105] • Anti-alias filter, ADC, gain stages, motion / artefact rejection.

[0106] » Breath segmentation (detect inhale / exhale), moving window RMS, envelope detection.

[0107] In an embodiment, the Estimation & Feature Fusion of the system provides the following:

[0108] « Derive features: tidal volume estimate, apnea duration, SpO2drop rate, snore intensity.

[0109] • Fuse multiple sources to reduce false positives (e.g., require both airflow drop + desaturation or snore pattern). In an embodiment, the Control Logic of the system provides the following:

[0110] ® Real-time loop (e.g., 10–50 Hz for flow, slower for SpO2~0.5–1 Hz). » Two layers: fast loop (respond to breathing within breaths) and supervisory layer (episode classification, therapy adjustments).

[0111] « Safety interlocks (max jaw travel, force limits, alarm escalation).

[0112] In an embodiment, the Telemetry / UI of the system provide the following:

[0113] • Event logs, daily AHI estimate clinician remote tuning, firmware updates.

[0114] In an embodiment, the nasal dilator includes dilator prongs for nasal valve expansion, bridge connecting the prongs, and a sensor mount carrying a nasal airflow sensor.

[0115] In accordance with the present disclosure, the method involves reposition the lower jaw and the tongue in downward and forward position during sleep keeping the central airway open using device of the present invention.

[0116] The device having the fin-insert-block mechanism is a carefully engineered, condylar-aligned, self- locking system that stabilizes the jaw passively, protects the TMJ, virtually eliminates breakage and aspiration risk, and is clearly superior to Panthera’s dorsal-fin spacer both mechanically and clinically. The locking mechanism offers mechanically as well as bio mechanic ally superiority to the panthera’s dorsal-fin spacer.

[0117] The foregoing description of the embodiments has been provided for purposes of illustration and is not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment but are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

[0118] TECHNICAL. ADVANCEMENTS: The present disclosure described hereinabove has several technical advantages including, but not limited to, the realization of an invention that:

[0119] * is simple;

[0120] « Scalable;

[0121] « metal free;

[0122] « locking and advancement mechanism,

[0123] « custom titratable;

[0124] * components can be 3D printed;

[0125] * light in weight and user friendly,

[0126] « Solves multiple real technical problems simultaneously including the cam- out, breakage, instability, TMJ overload, and the aspiration risk.

[0127] « is efficient;

[0128] « treats Obstructive Sleep Apnea (OSA);

[0129] * continuous monitoring,

[0130] * Data evaluation for effective OSA treatment lines.

[0131] The embodiments herein and the various features and advantageous details thereof are explained with reference to the non- limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein.. Accordingly, the examples should not be construed as limiting the scope of the embodiment s herein.

[0132] EXPERIMENTAL:

[0133] Examples: Device Efficiency study

[0134] Example 1: AHI (Apnea hypopnea Index) measures of the device in accordance with the invention (PRANA Elite™) The device is tested on the patients suffering OSA. The parameters Total AHI, REM AHI, NREM AHI, ODI and Mean SpOz (%) is recorded. The details are provided herein below as Table 1:

[0135] Table 1:

[0136] PRANA

[0137] Elite™

[0138] Baseline Traditional (Mean + % Improvement % Improvement Parameter (Mean + MAD (Mean SD) in vs. vs. Traditional SD) + SD) accordance Baseline MAD with the

[0139] invention

[0140] Total AHI 12.9 + 12.1 11.8 + 14.2 1.7 + 1.2 86.7% 1 85.6% |

[0141] REM AHI 22.5 + 28.6 21.7 + 23.7 5.2 + 3.8 77.0%; 76.2% j

[0142] NREM

[0143] 9.6 + 6.8 10.0 + 12.7 1.0 + 0.9 89.7% 1 90.2% 1 AHI

[0144] 12.5 + 10.2 12.4 + 7.7

[0145] ODI 2.4 + 1.9 81.3%; 81.0%;

[0146] (n-5) (n-5)

[0147] Mean

[0148] 92.6 + 3.7 93.3 + 1.9 96.1 + 1.7 +3.7% (~+3.5 pp) +3.0% (~+2.8 pp) SpOz (%)

[0149] Minimum 77.4 + 9.5 72.4 + 5.4 87.4 + 3.3 + 12.9% (-+10.0 +20.7% (-+1.5.0 SpO’ (%) (n=5) (n=5) (n=5) PP) PP)

[0150]

[0151] 5

[0152] Example 2: Data for the BP controlled in hypertensive volunteers PRANA Elite™

[0153] PRANA Elite™

[0154] Baseline (Traditional - Early

[0155] Parameter - Long-Term (6 Medication Status MAD) Response (Day

[0156] Months)

[0157] 4)

[0158] No drug change at Day 4; diuretic Blood Pressure

[0159] 142 / 88 118 / 77 124 / 82 (Eplerenone) (mmHg)

[0160] stopped by 6 months Cilnidipine 10

[0161] - Cilnidipine 10 mg BD mg BD - - Telmisartan 40 mg Same regimen Telmisartan 40 Antihypertensives......

[0162] BD Eplerenone 25 mg (no changes) mg BD

[0163] OD Eplerenone

[0164] stopped

[0165] ASBP (drop in — Significant -24 mmHg -18 mmHg

[0166] systolic) reduction ADBP (drop in — Significant -11 mmHg -6 mmHg

[0167] diastolic) reduction Maintained

[0168] Rapid improvement

[0169] Suggests genuine Hypertensive despite normalization despite de- Notes PRANA Elite- triple therapy within 4 days of escaiation of

[0170] linked BP benefit PRANA Elite™ antihypertensive

[0171] therapy

[0172]

[0173] Example 3: Compliance, Comfort & Tolerability of PRANA Elite™ (n =

[0174] 6 Volunteers)

[0175] Average Comfort Comfort

[0176] Side Effects / Overall Volunteer Usage Nights / Week Duration (Your Score

[0177] Benefits Satisfaction (h / night) Words) (0-3)

[0178] 6-7 6 Excellent Better sleep

[0179] p-Piiot 7 / 7 3 Very satisfied h / night months comfort refreshing

[0180] 6-7 4 Very

[0181] Y-Vl 7 / 7 3 None Satisfied h / night months comfortable

[0182] 6-7 4 Mild initial

[0183] Y-V2 7 / 7 1-2 None Satisfied h / night months discomfort

[0184] Good

[0185] 6-7 4 Better sleep

[0186] Y-V3 7 / 7 comfort Very satisfied h / night months refreshingness

[0187] overall

[0188] 6-7 7 / 7 Excellent

[0189]

[0190] y-V4 4 3 None Very satisfied Average Comfort Comfort

[0191] Side Effects / Overall Volunteer Usage Nights / Week Duration (Your Score

[0192] Benefits Satisfaction (h / night) Words) (0-3)

[0193] h / night months comfort

[0194] 6 -7 4 Very

[0195] y-V5 7 / 7 3 None Satisfied h / night months comfortable

[0196]

[0197] Inference:

[0198] All six volunteers demonstrated complete night time adherence (6-7 hours / night, 7 nights / week) with excellent overall comfort and tolerability. No adverse events were reported, and improvements in sleep refreshingness were noted in two cases. 5 Importantly, satisfaction levels were consistently high (four ‘Very satisfied’ and two ‘Satisfied’ responses). Such uniformly high compliance and comfort indicate that PRANA Elite™ overcomes the discomfort -related limitations of conventional mandibular advancement devices, enabling sustained long-term use — a critical prerequisite for both therapeutic efficacy and systemic benefits such as blood- 10 pressure reduction.

[0199] The superior comfort and natural nocturnal tolerability of the PRANA Elite™ device directly resulted in exceptionally high compliance across all users (6-7 hours per night, 7 nights per week), a level of adherence not achievable with conventional mandibular advancement devices, which are often discontinued due 15 to discomfort, dental pressure, or temporomandibular joint strain. This unprecedented compliance enabled sustained, uninterrupted upper-airway stabilization and autonomic recalibration during sleep, producing systemic therapeutic effects that are neither taught nor suggested in the prior art.

[0200] In a hypertensive volunteer who remained uncontrolled on triple therapy 20 (Cilnidipine, Telmisartan 40 mg BD, and Eplerenone), PRANA Elite™ reduced blood pressure from 142 / 88 mmHg to 118 / 77 mmHg within four days without, any change in medication, and the improvement persisted at six months (124 / 82 mmHg) despite withdrawal of the diuretic.

[0201] Such rapid and durable normalization of blood pressure-arising solely from a 25 novel oral device used comfortably throughout the night ---constitutes an unexpected physiological advantage and establishes a direct technical link between the inventive comfort-oriented design features of PRANA Elite™, sustained nightly compliance, and systemic cardiovascular benefit. This chain of effects demonstrates a non-obvious and inventive step over existing devices, which fail to produce comparable adherence or measurable systemic improvement.

Claims

WE CLAIM:

1. A device (100) for treating a respiratory condition comprising:a. an upper splint (10) comprising:i. a nasal dilator (30), wherein the nasal dilator (30) is M- shaped to be positioned in the nasolabial fold for improved breathing through the nasal cavity;ii. bilateral flanges (40) at a pre-determined position of the upper splint; andb. a lower splint (20) comprising plurality of lingual bud (50); and bilateral inserts (60A),wherein the insert (60A) is configured relative to the respective flange (40) for a locking arrangement during use.

2. The device as claimed in claim 1 wherein the pre-determined position bilateral flanges (40) is the pre-defined angle, geometry and condylar closing trajectory to guide restrict and synchronize mandibular movement to support unobstructed opening and closing of mouth in-use configuration of the device.

3. The device as claimed in claim 1 wherein the bilateral insert (60A) is having size in the range of 1mm to 7mm for the adjustable coupling of the splints; and is housed in a build-in slot (60B).

4. The device as claimed in claim 1 wherein the insert (60A) is configured relative to the respective flange (40) bilaterally for a locking arrangement that allows incremental anterior displacement and reposition of the lower splint (20) relative to the upper splint (10); and for positioning of the nasal dilator (30) and the lingual bud (50) during use.

5. The device as claimed in claim 1 wherein the locking arrangement is for the symmetric forward positioning of the lower jaw to provide airway diameter for an improved airflow.

6. The device as claimed in claim 1 wherein the lingual bud (50) is a curve surface configured for stabilizing and stimulating the proprioceptors to keeps the tongue in a forward position, thereby preventing the tongue from falling back and blocking the airways during use.

7. The device as claimed in claim 1 wherein the locking arrangement comprises an side-to-side arrangement of the bilateral inserts (60A) and the bilateral flanges (40) for the adjustable coupling configured to vary the distance between the splints (10 and 20) to provide mandibular advancement and unobstructed airflow through the nasal and oral airways.

8. The device for treating a respiratory condition as claimed in claim 1 wherein the condition is sleep apnea, snoring, nasal obstruction, and upper airway resistance syndrome.

9. A method to prevent airway obstruction and enhance airflow in respiratory condition comprising the steps of:i. positioning the upper splint (10) having M-shaped nasal dilator for improved breathing through the nasal cavity;ii. positioning the lower splint (20) having a lingual bud (50) within the oral cavity;iii. engaging a locking arrangement between the upper and lower splints integrated with the bilateral inserts (60A) for the adjustable coupling to maintain a predetermined orientation and mandibular advancement; andiv. maintaining the position during respiration to prevent airway obstruction and enhance airflow in the respiratory conditions.

10. A system for treating a respiratory condition wherein the system comprises a device as claimed in claim 1, a sensor and feedback mechanism for monitoring airflow, pressure, or tongue position during use.

Images