Reflexogenic orthosis regulating the aeroelasticity of the pharynx

Abstract

Device to combat sleep apnea: Reflexogenic orthosis regulating the aeroelasticity of the pharynx. FIGURES

Description

Title of the invention: Reflexogenic orthosis regulating the aeroelasticity of the pharynx

[0001] Device for combating sleep apnea

[0002] Reflexogenic orthosis regulating the aeroelasticity of the pharynx

[0003] DESCRIPTION of the invention

[0004] A-TECHNICAL FIELD OF THE INVENTION

[0005] The present invention is a medical device, of the orthotic type, which makes it possible to support and restore several deficient muscular functions in the Upper Airways (UA) of the human being, when suffering from snoring and sleep apnea (Obstructive Sleep Apnea-Hypopnea Syndrome SAHOS) or (OSA Obstructive Sleep Apnea).

[0006] According to the International Patent Classification, the technical field of this invention is as follows:

[0007] -Section A: Common necessities of life.

[0008] -Class 61: Medical or veterinary sciences; hygiene.

[0009] -Subclass F: Devices maintaining the passage or preventing the collapse of tubular body structures.

[0010] -CIB:A61F

[0011] B-STUDY OF PRIOR TECHNOLOGY

[0012] To date, there are more than thirty different methods for treating OSAHS, which shows how none of these therapies is perfectly satisfactory.

[0013] To date, only the insufflation of air pulsed by a turbine machine into the upper airways provides a reliable result for counteracting involuntary respiratory arrests occurring during sleep. This is why CPAP (Continuous Positive Airway Pressure) remains, in 2024, the preferred strategy, and rightly so, for the medical community, despite the discomfort, drawbacks, and high cost of this technique.

[0014] We have set ourselves the objective of designing a medical device that could become an alternative treatment to CPAP.

[0015] * CURRENTLY EXHAUSTIVE LIST OF PRIOR TECHNIQUES

[0016] Given the heterogeneous results of each of these care techniques, their classification on criteria of effectiveness or on statistical criteria of frequency of use would have been questionable.

[0017] We therefore preferred to list these therapeutic means in alphabetical order, whether they are essential or adjuvant.

[0018] 1-WEAKENING OF SLEEP DEPTH

[0019] -sound sensors triggering stimuli

[0020] -bracelet

[0021] -frontal contact

[0022] -perfume

[0023] -sounds

[0024] 2-INCREASED NASAL PERMEABILITY

[0025] -Lubricants and decongestants

[0026] -vasoconstrictors in spray

[0027] -nasal dilators

[0028] -nasal tube

[0029] -electric air blower (micro blower)

[0030] -nasal valve plastic surgery

[0031] 3-TONGUE SURGERY

[0032] - anteriorization of the lingual insertions on the mandible

[0033] -partial intraoral radiofrequency glossectomy

[0034] -partial glossectomy by cervicotomy

[0035] -Advanced insertion of the genioglossus muscle

[0036] 4-NASAL SURGERY

[0037] -septoplasty

[0038] -turbinectomy

[0039] -polypectomies

[0040] 5-SURGERY OF THE SOFT PALATE

[0041] -palatine tonsillectomy

[0042] -uvulectomy

[0043] -laser uvuloplasty

[0044] -radiofrequency uvulopalatopharyngoplasty

[0045] -velar sclerosing injections

[0046] 6-PHYSIOTHERAPY

[0047] -tubovelotympanic rehabilitation

[0048] -pharyngeal and lingual rehabilitation

[0049] -temporomandibular joint rehabilitation

[0050] -oromyo-functional rehabilitation

[0051] -phoniatric rehabilitation

[0052] 7-BIOCHEMICAL MEDICATION

[0053] -80 mg of atomoxetine (noradrenergic)

[0054] -+5 mg of oxybutyrine (antimuscarinic)

[0055] 8-OCCLUSION MOUTH

[0056] -chin straps

[0057] -perforated or non-perforated diachylons

[0058] -sleep strips

[0059] 9-MANDIBULAR ADVANCEMENT ORTHOSES

[0060] -standard orthosis

[0061] -molded orthosis

[0062] -articulated orthosis (retrognathia)

[0063] 10-REFLEXOGENIC ORTHOSES

[0064] -face former therapy

[0065] -dragon pearl

[0066] 11 - LINGUAL PROTRUSION ORTHHESIS

[0067] -lingual blocking orthosis (mouthguard + vacuum)

[0068] 12-ASSISTED BREATHING / CONTINUOUS POSITIVE PRESSURE (CPAP)

[0069] -nasal mask

[0070] -nasobuccal mask

[0071] 13-REMOTE-CONTROLLED LANGUAGE STIMULATION

[0072] -stimulation of the XII (hypoglossal)

[0073] -surgically implanted material

[0074] -INSPIRE IV (Inspire Medical Systems)

[0075] 14-PERCUTANEOUS MUSCLE STIMULATION

[0076] -correlated to a percutaneous sensor (SomniusXY3-controller z3)

[0077] 15-POSITIONAL THERAPY

[0078] -balls

[0079] -pajama-orthosis

[0080] -anti-snoring pillow

[0081] 16-TRACHEOTOMY

[0082] C-STATEMENT OF THE INVENTION

[0083] Our theoretical research in the laws of AEROELASTICITY has led us to believe that snoring is due to an aeroelastic instability of the soft palate and the base of the tongue.

[0084] These two organs are subjected during each respiratory phase to vibrations induced by the movement of the nasal or bucco-nasal airflow (movement induced vibration or MIV of physicists).

[0085] In our opinion, the muscular walls of the oropharynx are particularly sensitive to certain frequencies. According to the laws of aeroelasticity, when the frequency RESONANCE occurs, the system is the site of increasingly significant oscillations (snoring) until blockage (apnea).

[0086] In patients suffering from snoring and apnea due to flaccidity of their oropharyngeal muscular walls, our aim is to stimulate the muscles of the tongue, soft palate and pharynx.

[0087] Just as the skipper adjusts his ropes to avoid abnormal luffing of his sail, the desired medical device must stimulate the tensor and elevator muscles of the soft palate and the propulsive muscles of the tongue, to prevent apnea.

[0088] The dysfunction of these muscles (about thirty....) is the cause of the nocturnal collapse of the diameter of the highly deformable tubular structure that represents the posterior part of the upper airways.

[0089] The method of this muscle stimulation was first considered by an electronic means, in the same conceptual scheme as micro pacemakers.

[0090] This route quickly proved impractical:

[0091] -on a biological level: the upper airways are a hyperseptic environment.

[0092] The risk of infection from implantation at this level is unavoidable.

[0093] -on the electronic level: the computer composition and organization process of the stimulator would be infinitely more complex for the pharynx than for the heart, a single muscle, whose contraction is of a monomorphic rhythm.

[0094] During our interprofessional and interdisciplinary medical discussions, we were struck by a surprising similarity between:

[0095] -on the one hand the computer organization of a programmable pulse generator.

[0096] - on the other hand, the anatomical neural circuits constituted by the anastomoses between the cranial nerves that act directly or indirectly on the airways (V, VIII, X, X, XII cranial nerves), their ganglia (interconnected groups of afferent and efferent neurons) and their nuclei of origin located in the brainstem. All of this is controlled differently, depending on the phases of deep or light sleep, by the circuits of the overlying brain.

[0097] The aim of the invention is therefore to stimulate the only human anatomical structure that can trigger automatic, unconscious, coordinated and repeated muscular reactions: THE POLYSYNAPTIC NEURAL CHAIN ​​OF A REFLEX ARC.

[0098] It is precisely at the level of the aerodigestive intersection which concerns us that the reflex arcs are most numerous (swallowing, phonation, salivation, coughing, sneezing, hiccups, yawning, nausea, vomiting.....)

[0099] The only reflex that pleasantly triggers tongue protrusion and tensioning of the soft palate is the SUCTION REFLEX.

[0100] This primitive or archaic reflex of the newborn is masked in the adult but it re-emerges spontaneously:

[0101] -in altered states of consciousness during certain head injuries, strokes or degenerative neuropathies

[0102] -in the unconsciousness of sleep, this reflex reactivates without inconvenience throughout the night in a normal adult.

[0103] D-MEANS OF THE INVENTION

[0104] The reflexogenic orthosis consists of 3 specific elements:

[0105] 1-THE FACE MASK:

[0106] It consists of a flexible sheet (10) [Fig.3], covered with a layer of hypoallergenic adhesive product (9) [Fig.3].

[0107] This diachylon-dressing type sheet has in its middle (5) [Fig.1] a reinforced non-adhesive zone (5+1) [Fig.1] to support its axial part.

[0108] This mask is roughly rectangular in shape: Dimensions, Width 70 mm Height 50 mm.

[0109] These measurements correspond to those of the perioral area of ​​an average-sized adult.

[0110] These dimensions allow us to reach, by their perimeter, the most fixed facial skin lines due to their underlying linear aponeurotic adhesions.

[0111] These are natural furrows of the face: nasolabial sulcus at the top (14) [Fig.4], labiomental sulcus at the bottom (17) [Fig.5], nasolabial sulcus(15) and labiogenal sulcus(16) [Fig.4] laterally.

[0112] The vermilion border (19) [Fig.4] and the mucous face of the lips (21,22) [Fig.5] are not in contact with the adhesive surface of the mask.

[0113] The mask has sufficient resistance to prevent naso-mental separation (14,17) [Fig.4] and thereby prohibit mandibular lowering which induces tongue retraction generating apnea.

[0114] After peeling off the protective film from the adhesive (8) [Fig.3] the mask is applied to the perioral skin.

[0115] To facilitate this application, the rear face of the mask is reinforced with a polyester applicator frame (12) [Fig.2]. Two release tabs (13) [Fig.2] allow the applicator to be easily removed.

[0116] 2-THE "AREOLO-NIPPLE" ORTHOSIS:

[0117] Consists of a curved and flexible cylindrical column (7) [Fig. 3] whose entasis and dimensions are equal to the average dimensions of the female nipple in its thelotic phase postpartum. Its diameter is 11 mm and its height 17 mm

[0118] The free end of the column is blunt around its entire circumference and has about ten small, unperforated indentations (4) [Fig.O] 1.5 mm in diameter. These small hollows simulate the galactophoric pores.

[0119] This "mammary" column (7) [Fig.3] is fixed, implanted within a domed, circular "areolar" base (2[Fig.1],ll[Fig.3]).

[0120] The thickness of this basal plate is identical in its centre (11) [Fig.3] to the average thickness of the female areola postpartum: 3 mm.

[0121] The diameter of this pseudo-areola is 30 mm.

[0122] This base has 8 small raised areas (3) [Fig.l] of 1.5 mm in diameter and 1.5 mm in height distributed according to a concentric circle of 17 mm in diameter.

[0123] These bumps simulate the Morgoni mounds of the female breast.

[0124] These recesses (4) [Fig.1] and bumps (3) [Fig.1] are slightly hypertrophied compared to their natural size to facilitate their perception by the discriminative sensitivity of the tip of the tongue.

[0125] 3-RESPIRATORY SAFETY VALVES

[0126] Due to its complete peripheral skin adhesion, the mask, which is impermeable, prevents all mouth breathing. However, nocturnal mouth breathing is almost always predominant in patients suffering from snoring and sleep apnea.

[0127] The orthosis would therefore be poorly tolerated in patients with impaired nasal patency:

[0128] -either permanently through hypertrophy of the turbinates, inflammatory or allergic episodes....

[0129] -either intermittently, according to the phases of the nasal erectile cycle in patients with only one patent nasal cavity.

[0130] This drawback is mitigated in certain earlier strip sleep techniques by single or multiple perforations of the mask. However, experimentation has shown that these perforations facilitate oral airflow too much and allow oropharyngeal turbulence and xerostomia to persist.

[0131] After several prototype trials, we settled on a simple and effective solution:

[0132] Leave two gap areas (6) [Fig.l] non-adhesive in the polyurethane film, self-adhesive everywhere else.

[0133] Their topography is bilateral, right and left, directly above each labial commissure (18 [Fig.4],25 [Fig.5]).

[0134] Their dimension is 10 mm in height.

[0135] This results in a limited triangular tunnel:

[0136] -forward through the non-adherent area of ​​the mask (24) [Fig.5]

[0137] -backwards and upwards through the lower face of the upper lip (21) [Fig.5] in its mucous part.

[0138] -backwards and downwards through the upper surface of the lower lip (22) [Fig.5] in its mucous part.

[0139] - During deep inspiration in a patient with good nasal patency, this sural tunnel collapses, preventing oral airflow. This weans the patient from their pathological exclusive mouth breathing and prevents xerostomia.

[0140] -On expiration, these right and left tunnels open and constitute two large air evacuation valves.

[0141] Moreover, the presence of these two lateral areas (6) [Fig.l] of the mask, free from adhesion, allows the patient to use them very easily as traction tabs (right or left depending on his dominant hand) to detach the mask.

[0142] This facility may be useful in case of emergency (severe cough, vomiting, intercurrent dyspnea).

[0143] E-REALIZATION OF THE INVENTION

[0144] The development of the orthosis prototypes used in preclinical trials was inspired by the pharmaceutical industry.

[0145] 1-for the face mask:

[0146] -self-adhesive transparent polyurethane film with polyester applicator system.

[0147] -Hypoallergenic acrylic emulsion adhesive mass, hydrofilm type R

[0148] -absence of latex, absence of rosin.

[0149] 2-for the central part:

[0150] -the periareolar plate (5) [Fig.1] must have a hydrophobic non-woven polypropylene outer layer and an absorbent or wadding inner layer.

[0151] -the nipple and areola can be made of either silicone or woven compress-type material, resistant and hypoallergenic synthetic or plant-based fabric.

[0152] The material forming the center of the orthosis must have an AO hardness on the SHORE ISO 48-4 scale, identical to the hardness of human cutaneous and adipose tissue in a flaccid zone. This hardness must be lower than that of the silicone used in pediatric pacifiers and soothers.

[0153] Manufacturing the orthosis with perfumed, sweet or fruity aromatic impregnation is not necessary. However, at the patient's request, such a production cannot be excluded.

[0154] Unlike a bandage, this orthosis does not need to be sterilized.

[0155] F-INDICATIONS FOR USE OF THE INVENTION This invention addresses a need that has existed since the 1960s-1970s, when the medical community discovered Sleep Apnea-Hypopnea Syndrome (SAHOS). This nocturnal ventilation disorder, due to the abnormally frequent occurrence of respiratory pauses, affects 5 to 8% of the population. OSA significantly increases the individual's risk of cardiovascular disorders, high blood pressure, and accident-causing daytime sleepiness. The main current previous techniques (Continuous Positive Pressure and mandibular advancement orthotics) are uncomfortable and expensive (400 million euros in France in 2019). The PPC alone becomes such an economic issue for the Health Insurance that the latter requires remote monitoring of compliance data before renewal of reimbursements. The orthosis that is the subject of the invention, comfortable and inexpensive, acts by a natural, physiological, reflexogenic mode. Thanks to this orthosis, the vortices and other turbulences responsible for snoring and apnea dissipate if the invented device is worn all night, every night, all year round. The only contraindications for wearing this orthosis are total nasal obstruction, allergy to its components, or very severe respiratory failure.

[0156] G-POSITIVE INDICATIONS OF THE INVENTION

[0157] 1-Advantages: The advantages of this innovative orthosis are evaluated by comparison with the previous therapeutic techniques listed in Chapter B. -Ease of installation: The pose is easy for the patient to perform themselves in front of a mirror. -Comfort :

[0158] Less than one minute after implantation of the perioral adhesive mask, its presence is no longer perceived. If nasal patency is satisfactory, the patient experiences no respiratory discomfort. -Discretion:

[0159] The orthotic case is very compact. When traveling, there is no need for a power outlet. The chamber remains silent: no turbine noise like a CPAP machine (25 decibels).

[0160] - Possibility of conversing with the spouse:

[0161] It is preserved; the voice is slightly distorted but remains understandable thanks to the presence of the two respiratory safety valves. -Symbolic perception by the spouse: The orthosis is barely visible. The translucent adhesive film mask is invisible once applied to the face. Only the central part is clearly visible, shaped like a small lollipop. The symbolism conveyed is much less unfavorable than that of CPAP-type artificial respiration devices, nasal dilators and orthotics, or chin straps and their fixings. -Sleep quality: The disappearance of apneas thanks to the orthosis reduces micro-awakenings and nighttime awakenings which are so unpleasant and exhausting for the patient. The sucking reflex induced by wearing the orthosis triggers the release of endorphins in the brain during the night, hormones that produce a feeling of well-being. These molecules, known as "happy hormones," are anxiolytic, analgesic, and relaxing. The night, lengthened in duration and quality, leaves the subject with the feeling of restorative sleep. -Restoration of physiological oral lubrication: The reflex, of sucking and correlated swallowing, activates the physiological secretion of saliva and dental rinsing. -Glaucoma prevention. This ophthalmological condition can be triggered by apnea. In cases of primary glaucoma, apneas always have an aggravating effect.

[0162] 2-Unexpected effects: -Xerostomia, or dry mouth, is, as we have seen, greatly improved by the orthosis in patients accustomed to sleeping with their mouth open. -Bruxism, grinding, friction or clenching of the teeth, is greatly improved by the nocturnal dental interposition of the tip of the tongue induced by the orthosis.

Claims

[Claim 1] Demands Claim 1 Device intended to stimulate the sucking reflex and regulate the aeroelasticity of the pharynx comprising an adhesive mask (1) [Fig 1] occluding the mouth opening, carrying in its center a curved column (7) [Fig 3] and flexible comparable to a teat, characterized in that the free end of this column has at least several small unperforated recesses (4) [Fig 1] and in that its base (2) [Fig 1], or “pseudo-areolar” plate (11) [Fig 3], has at least several concentrically distributed bumps (3) [Fig 1].

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