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 at the level of the Upper Airway (UAS) of the human being, when he is suffering from ronchopathies 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 that none of these therapies are perfectly satisfactory.

[0013] Only the insufflation into the upper airways of air pulsed by a turbine machine, currently provides a reliable result to counter involuntary respiratory arrests occurring during sleep. This is why PPC (Continuous Positive Airway Pressure) or CP AP (Continuous Positive Airway Pressure), remains, in 2024, the strategy rightly favored by the Medical Corps, despite the inconveniences, disadvantages and high cost of this technique.

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

[0015] * CURRENTLY EXHAUSTIVE LIST OF PRIOR ART

[0016] Given the heterogeneous results of each of these treatment 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 THE DEPTH OF SLEEP

[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 glossectomy by radiofrequency

[0034] - partial glossectomy by cervicotomy

[0035] -advancement of the 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 uvulectomy

[0044] -radiofrequency uvulopalatopharyngoplasty

[0045] -velar sclerosing injections

[0046] 6-PHYSIOTHERAPY

[0047] - tubovelotympanic rehabilitation

[0048] -pharyngeal and lingual rehabilitation

[0049] -temporo-maxillary 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-ORAL OCCLUSION

[0056] -chin straps

[0057] -perforated or non-perforated adhesive bandages

[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 AIR 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-quontroleur z3)

[0077] 15-POSITIONAL THERAPY

[0078] -balls

[0079] -pajama-orthesis

[0080] - anti-snoring pillow

[0081] 16-TRACHEOTOMY

[0082] C- STATEMENT OF THE INVENTION

[0083] Our theoretical research into the laws of AEROELASTICITY led us to believe that snoring was 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 for physicists).

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

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

[0087] Just as the skipper adjusts his ropes to avoid abnormal fluttering 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 avoid apnea.

[0088] The dysfunction of these muscles (around 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 mode of this muscular stimulation was first considered by an electronic route, 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 process of computer composition and organization of the stimulator would be for the pharynx, infinitely more complex than for the heart, a unique 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 nervous circuits constituted by the anastomoses between the cranial nerves which intervene directly or indirectly on the airways (V VIIIX X XII th pairs), their ganglia (interconnected groups of afferent and efferent neurons) and their nuclei of origin located at the level of the brain stem. All differently controlled, according to the phases of deep or superficial sleep, by the circuits of the overlying brain.

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

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

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

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

[0101] -in alterations of consciousness during certain head traumas, cerebrovascular accidents or degenerative neuropathies

[0102] - in the unconscious state of sleep, this reflex is reactivated without inconvenience throughout the night in normal adults.

[0103] D-MEANS OF THE INVENTION

[0104] The reflexogenic orthosis is made up of 3 specific elements:

[0105] 1-THE MOUTH 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-bandage type sheet has in its middle (5) [Fig.l] a reinforced non-adhesive zone (5+1) [Fig.l] 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 make it possible to reach the most fixed lines of the facial skin through their perimeter due to their underlying linear aponeurotic adhesions.

[0111] These are natural furrows of the face: nasolabial furrow above (14) [Fig.4], labiomental furrow below (17) [Fig.5], nasolabial furrow (15) and labiomental furrow (16) [Fig.4] laterally.

[0112] The vermilion border (19) [Fig.4] and the mucous surface 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 thus prohibit mandibular lowering which induces retropulsion of the tongue 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 detachment tabs (13) [Fig.2] allow the applicator to be easily removed.

[0116] 2-THE “AREOLO-NIPPLE” ORTHOSIS:

[0117] It 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 of the post partum. Its diameter is 11 mm and its height 17 mm

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

[0119] This “nipple” column (7) [Fig.3] is fixed, implanted within a rounded, circular “areolar” base (2[Fig.l],ll[Fig.3]).

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

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

[0122] This base has 8 small elevations (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 Morgani mounds of the female breast.

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

[0125] 3-BREATHING SAFETY VALVES

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

[0127] The orthosis would therefore be poorly tolerated in patients with deficient nasal permeability:

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

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

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

[0131] After several prototype tests we have chosen 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, in line with 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] -back and up by the lower face of the upper lip (21) [Fig.5] in its mucous part.

[0138] -back and down by the upper face of the lower lip (22) [Fig.5] in its mucous part.

[0139] - Upon deep inspiration in a patient with good nasal permeability, this sural committed tunnel collapses, preventing oral airflow. This disaccustoms the patient to pathological exclusive mouth breathing and prevents xerostomia.

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

[0141] Furthermore, the presence of these two lateral zones (6) [Fig.l] of the mask, free from adhesion, allows the patient to use them very easily as pull tabs (right or left depending on their predominant hand) to remove the mask.

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

[0143] E-EMPLOYMENT OF THE INVENTION

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

[0145] 1-for the mouth mask:

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

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

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

[0149] 2-for the central part:

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

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

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

[0153] It is not useful to manufacture the orthosis with a scented, sweet or fruity aromatic impregnation. However, depending on the patient's wishes, 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 meets a need that has existed since the 1960s and 1970s, when Sleep Apnea Hypopnea Syndrome (SAH) was discovered by the medical profession. This nocturnal ventilation disorder, due to the abnormally frequent occurrence of respiratory pauses, affects 5 to 8% of the population. OSAHS significantly increases the individual's risk of cardiovascular disorders, high blood pressure and accident-prone daytime sleepiness. The main current anterior techniques (Continuous Positive Airway Pressure and mandibular advancement devices) are uncomfortable and expensive (400 million euros in France in 2019). PPC alone has become such an economic issue for Health Insurance that the latter requires remote monitoring of compliance data before reimbursement renewals. The orthosis which is the subject of the invention, comfortable and inexpensive, acts in a natural, physiological way, of reflexogenic origin. Thanks to this orthosis, the vortices and other turbulence responsible for snoring and apnea dissipate if the invented device is worn all night, every night and all year round. The only contraindications for wearing this orthosis are the total absence of nasal permeability, allergy to the components or very severe respiratory insufficiency.

[0156] G-POSITIVE INDICATIONS OF THE INVENTION

[0157] 1-Advantages: The advantages of this innovative orthosis are evaluated by comparison with the previous therapeutic technical means listed in chapter B. -Ease of installation: The application is easy for the patient to do 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 permeability is satisfactory, the patient does not feel any respiratory discomfort. -Discretion:

[0159] The volume of the orthosis box is very small. When traveling, there is no need for a power supply point. The room remains silent: no turbine noise like PPC (25 decibels)

[0160] - Possibility of conversing with the spouse:

[0161] It is preserved; the voice is a little 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 in the form of a small-diameter lollipop. The resulting symbolism is much less unfavorable than that of PPC artificial respiration devices, nasal dilators and orthoses or chin straps and their attachments. -Sleep quality: The disappearance of apnea thanks to the orthosis reduces the micro-awakenings and night-time getting ups that are so unpleasant and exhausting for the patient. The sucking reflex induced by wearing the orthosis causes the brain to secrete endorphins during the night, hormones that provide a feeling of well-being. These molecules, called "happy hormones," are anxiolytic, analgesic, and relaxing. The night, extended in duration and quality, leaves the subject with the feeling of restorative sleep. -Restoration of physiological oral humidification: The reflex, of correlated sucking and swallowing, activates the physiological secretion of saliva and dental rinsing. -Prevention of glaucoma. This ophthalmological pathology 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 teeth, is greatly improved by the nocturnal dental interposition of the tip of the tongue induced by the orthosis.

Claims

[Claim 1] Claims 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 oral orifice, carrying in its center a curved column (7) [Fig 3] and flexible comparable to a pacifier, characterized in that the free end of this column has at least several small non-perforated recesses (4) [Fig 1] and in that its base (2) [Fig 1], or “pseudo-areolar” plate (11) [Fig 3], has at least several bosses (3) [Fig 1] distributed concentrically.

Images