WO2016151510A1 - Dispositif de traitement du ronflement et procédé et kit de production associés - Google Patents

Dispositif de traitement du ronflement et procédé et kit de production associés Download PDF

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Publication number
WO2016151510A1
WO2016151510A1 PCT/IB2016/051646 IB2016051646W WO2016151510A1 WO 2016151510 A1 WO2016151510 A1 WO 2016151510A1 IB 2016051646 W IB2016051646 W IB 2016051646W WO 2016151510 A1 WO2016151510 A1 WO 2016151510A1
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WO
WIPO (PCT)
Prior art keywords
dental arch
patient
support
model
treatment
Prior art date
Application number
PCT/IB2016/051646
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English (en)
Inventor
Pier Paolo MAGAGNOLI
Original Assignee
Magagnoli Pier Paolo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Magagnoli Pier Paolo filed Critical Magagnoli Pier Paolo
Publication of WO2016151510A1 publication Critical patent/WO2016151510A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A61F5/566—Intra-oral devices

Definitions

  • This invention relates to a device for the treatment of snoring and the relative production method and kit.
  • Rhonchopathy or pathological chronic snoring is a series of symptoms associated with intermittent snoring, sometimes particularly loudly, accompanied by breathing abnormalities or by interrupted sleep.
  • Snoring or rhonchopathy is a disorder that affects around one Italian in four, although the inconvenience connected with this type of disorder indirectly involves the quality of sleep of partners and family members.
  • Snoring is normally the noise caused by the vibration of the organs involved in breathing, including the soft palate, the uvula, the rear wall of the throat, the tonsils and the tongue (and the epiglottis).
  • Snoring and nocturnal apneas are annoying sleep disorders caused by the weakening of the muscle tone of the throat and the retreat of the rear section of the tongue, which cause a reduction in size of the pharyngeal orifice through which air passes, triggering turbulence and vibration of the flexible part of the palate and of the pharynx (snoring).
  • a more severe obstruction of air flow may occur, characterised by breathing pauses of variable intensity, or involuntary sleep apnea or asphyxia.
  • MADs Microbular Advance Devices
  • voluminous devices that encumber the oral cavity so much that they stimulate a sensation of vomiting and/or create the feeling of suffocation and oral claustrophobia.
  • the technical purpose which forms the basis of this invention is to propose a device for the treatment of snoring and the relative production method which overcomes one or more of the above- mentioned drawbacks of the prior art. More specifically, the aim of this invention is to provide a device for the treatment of snoring which is structurally simple, easy and ready to use, and which has limited dimensions, ensuring a low degree of invasiveness in the patient's mouth.
  • this invention comprises a method for the production of the device for the treatment of snoring that allows rapid and effective treatment based on the dental features and individual biomechanical and functional parameters of the patient.
  • the patient can simply insert the device according to the invention inside his/her oral cavity and hook the device onto the upper dental arch and the lower dental arch so that the mandible and the maxilla are kept in the correct therapeutic position, allowing sufficient breathing during sleep and preventing snoring and/or nocturnal apnea.
  • the device once inserted in the mouth, the device needs no further adjustment and is immediately ready to perform the function for which it is designed.
  • the device when the patient has to open his/her mouth, the device can advantageously remain connected to just one of the two dental arches to allow opening and then be re-attached to the detached dental arch, thus re-establishing the therapeutic position without having to extract the device from the mouth.
  • the method and the kit make it possible to obtain a device for the treatment of snoring which complies with the gnathology of the patient, respecting the anatomical and functional parameters of the various dental structures belonging to the different human dental classes, providing a personalised ad hoc device for the patient that has to use it.
  • the method and the kit allow the construction of a gnathological oral device, which respects the articulo-occlusal parameters, for mandibular repositioning, designed to widen the tissutal area of the human hypopharynx in order to permeabilize the part of the upper airways not supported either by bone or cartilage structures.
  • This device consists of two heat-moulded supports reproducing the upper and lower dental arches of the patient, appropriately arranged in a working position according to the individual biomechanical and functional parameters, stably and irremovably joined by interconnecting means in order to keep the patient's teeth in a therapeutic position during sleep which prevents snoring and/or apnea.
  • FIG. 1 is a schematic perspective view of a portion of the human skull
  • Figure 2 is a schematic representation of a phase of adjustment of the models of upper and lower dental arches of a patient in order to place them in centric relationship
  • FIG. 3 is a schematic representation of a phase of adjustment of a preferred embodiment of the device for the treatment of snoring according to this invention
  • Figure 4 is a partly exploded view of Figure 3
  • FIG. 5 is a perspective schematic view of the device of Figure 3.
  • the numeral 1 denotes as a whole a device for the treatment of snoring, hereinafter simply the device 1 .
  • Figure 1 shows a portion of a human skull in which it is possible to see a mandible M, the lower dental arch Ai and the mandibular condyles O.
  • the mandibular condyle O is a process of the mandibular bone that extends in an olive shape at the upper end of each ramus and represents the articular portion of the mandible M that articulates with the glenoid fossa of the temporal bone, not shown.
  • the protrusive movements of the mandible M are all bicondylar since the articulations on both sides are always simultaneously engaged.
  • the movements can take place by rotation and/or translation with respect to the centre of the condyles O in the three planes of the space defined by the median sagittal plane YZ, the frontal plane XZ and the horizontal plane XY, all at right angles to each other.
  • the median sagittal plane YZ is defined by the intersection of the sagittal axis Y and the vertical axis Z
  • the frontal plane XZ is defined by the intersection of the horizontal axis X and the vertical axis Z
  • the horizontal plane is defined by the intersection between the sagittal axis Y and the horizontal axis X.
  • mandible M There are three types of basic movements of the mandible M, which are: 1 ) mandibular lowering and raising, also called, respectively, opening and closing;
  • the protrusion and retrusion movements are movements that take place in the horizontal plane XY, with sliding of the lower dental arch Ai below the upper arch, not shown.
  • the movement takes place by simple translation of the condyles O, with minimum rotation (less than 1 °).
  • the heads of the condyles and articular disc, not shown slide on the surface of the articular tubercle of the temporal bone, not shown, moving forward and down, as far as the apex of the tubercle.
  • the condylar movements are bilateral and simultaneous.
  • the normal translation of the condyles O in protrusion is around 10 mm, while the maximum opening width of the mandible M is 40- 42 mm.
  • condylar protrusion the movement wherein the condyles O which translate on the horizontal plane XY towards the front part of the skull, disregarding the low negative value of rotation (gamma angle) preferably along the sagittal axes Y
  • condylar retrusion the movement wherein the condyles O translate on the horizontal plane XY towards the rear part of the skull (disregarding the low value of rotation, preferably along the sagittal axes Y).
  • the device 1 allows the patient to maintain the lower dental arch Ai of the mandible M in condylar protrusion with respect to the upper dental arch in order to obtain an increase of the pharyngeal space which ensures correct oxygenation of the patient during sleep, preventing the onset of rhonchopathy and apnea.
  • the device 1 comprises a lower support 2 that can be associated with at least one part of the lower dental arch Ai of a patient and an upper support 3 that can be associated with at least one part of the upper dental arch of a patient.
  • the lower support 2 and the upper support 3 preferably respectively comprise a lower cavity 2a shaped against the lower dental arch Ai of the patient and an upper cavity 3a shaped against the upper dental arch of the patient.
  • the supports 2, 3 are personalised on the basis of the morphology of the patient's teeth and define, respectively, a cast of the lower dental arch Ai and of the upper dental arch of the patient.
  • the lower support 2 and the upper support 3 are preferably made by means of resin moulding.
  • the lower support 2 and the upper support 3 are preferably transparent.
  • the device 1 also comprises interconnection means 4 configured to stably and unmovably interconnect the lower support 2 with the upper support 3 along a plane of contact 5 corresponding to the dental occlusion plane of the patient.
  • the interconnection means preferably comprise a layer of thermosetting resin 4a configured to weld the upper support 3 to the lower support 2.
  • the lower support 2 and the upper support 3 are reciprocally positioned along the plane of contact 5 in a working position wherein during use of the device 1 inside the oral cavity of the patient, in which the lower dental arch Ai is engaged with the lower support 2 and the upper dental arch is engaged with the upper support 3 of the device 1 , the lower dental arch Ai and the upper dental arch are held in a therapeutic position in which the lower dental arch Ai is in a projected position along the occlusion plane with respect to a rest position of the lower dental arch Ai during non-use of the device 1 .
  • the term "rest position" means the posture mainly assumed by the mandible M of the patient during the day, when not swallowing, maintained by the tone of the elevator muscles of the mandible.
  • the mandible M is typically advanced by a few millimetres with respect to the maxilla, that is to say the lower dental arch Ai protrudes with respect to the upper dental arch along the horizontal plane XY.
  • the patient inserts the device 1 according to the invention in his/her mouth (when using the device 1 ) and engages his/her dental arches with the supports 2, 3 of the device 1 thus inserting his/her teeth in the shaped cavities 2a, 3a of the supports 2, 3, thereby placing his/her dental arches in a therapeutic position, wherein the lower dental arch Ai is in a personalized protrusion position; the presence of the rest position in intermaxillary blocking allows the patient to activate the elevator muscles with a mandibular lock, an important protective function of cerebral hyperactivity or stress.
  • the protrusion position of the lower dental arch Ai preferably corresponds to a therapeutic condylar protrusion equal to a value of between 60% and 70% of the maximum condylar protrusion of the patient.
  • the method for the production of the device 1 comprises, first of all, the preparation of a model of the lower dental arch 6 and a model of the upper dental arch 7 of the patient, shown in figures 2, 3 and 4.
  • This step preferably comprises the step of preparing a cast of the upper dental arch and a cast of the lower dental arch Ai of the patient, not shown in the figures, and a step of filling these casts with a setting material, preferably plaster, in order to obtain the two models 6, 7.
  • a setting material preferably plaster
  • the method then comprises the step of preparing the lower supports 2 and the upper supports 3.
  • This step preferably comprises a step of moulding a thermosetting material, preferably resin, on the models of the lower 6 and upper 7 dental arches.
  • the method then comprises the step of preparing an average value articulator 8, substantially known and schematically indicated in figures 2, 3 and 4, that is to say an instrument able to reproduce the movements of the mouth.
  • the method also comprises the step of mounting the models 6, 7 on the articulator 8 so that the respective assembly portions of the models 6a, 7a are inserted in the receiving portions 8a of the articulator 8, as shown in exploded view in figure 4.
  • the bite 9 is guided in the sense that, in a known way, an operator positions the patient's mandible with respect to the maxilla in the centric relationship to obtain this impression.
  • This step preferably comprises the step of making this bite impression 9 by insertion of a wax impression in the oral cavity of the patient and subsequent guided dental occlusion of the lower dental arch Ai against the upper dental arch.
  • the impression of the bite 9 is now present between the models 6, 7 of the patient and the articulator 8 is adjusted so that the models 6, 7 are aligned on the bite impression 9 along the dental occlusion plane according to the TMJ centric relationship of the patient, as shown in figure 2.
  • this makes it possible to correctly reproduce the reciprocal position of the two dental arches of the patient in the rest position, in particular in the centric relationship of the temporomandibular joint.
  • the bite impression 9 must then be removed in order to proceed with the subsequent steps for creation of the device 1 .
  • the preferred therapeutic position foresees a therapeutic condylar protrusion equal to a value of between 60% and 70% of the maximum condylar protrusion of the patient preferably on the basis of the dental class to which the patient belongs.
  • the two models of the lower 6 and upper 7 dental arches are therefore mounted on the articulator 8 according to a therapeutic condylar protrusion equal to a value of between 60% and 70% of the maximum condylar protrusion of the patient starting from the centric relationship.
  • the average value articulator 8 preferably comprises two condylar baskets 8b designed to accommodate inserts 10 configured to define a reciprocal position between the lower dental arch model 6 and the upper dental arch model 7, in order to set a working position of the lower 2 and upper 3 supports, which will be engaged and joined in a subsequent step.
  • the step of adjusting the average value articulator 8 to set the working position of the two lower 2 and upper 3 supports preferably comprises a step of selecting the inserts 10 from a plurality of different inserts and positioning them in the condylar baskets 8b.
  • the plurality of inserts 10 preferably comprises at least two inserts that differ in shape and/or size in order to define at least two different reciprocal positions between the lower dental arch model and the upper dental arch model Ai.
  • the inserts 10 that can be inserted in the condylar baskets 8b determine this preferred protrusion position, corresponding to a determined dental class and to a group of average functional parameters obtained statistically from a data population relative to adult individuals. In this way, it is possible to quickly set the correct therapeutic position that the patient must assume when using the device by merely selecting the appropriate inserts 10, according to the patient's stomatognathic features and on the basis of previously sampled and classified functional parameters, using them to adjust the models 6, 7 of the patient with the help of the articulator 8.
  • the preferred therapeutic protrusion of the models of the dental arches in the articulator is set by means of the appropriate inserts that are positioned according to the dental class of the patient and the group of functional parameters.
  • the result of these steps described so far is a reproduction on the models 6, 7 of the therapeutic position that the lower Ai and upper dental arches of the patient must be in when the device 1 is used.
  • the method now foresees the step of engaging the lower support 2 on the lower dental arch model 6 and the upper support 3 on the upper dental arch model 7 so that they are arranged in the working position.
  • the supports 2, 3 are inserted in the respective models 6, 7 so that they match perfectly, simulating their use in the patient's mouth.
  • the method proceeds with the step of preparation of the interconnection means 4 to stably and unmovably interconnect and/or block the upper support 3 to the lower support 2 previously placed in a working position, as shown in figure 3.
  • the two supports 2, 3 are welded together in order to create the device 1 which can thus be removed from the articulator 8 and be ready for use.
  • the step of preparing the interconnection means 4 preferably comprises a step of inserting or injecting thermosetting resin to produce a layer of thermosetting resin 4a between the lower support 2 and the upper support 3 positioned at a determined distance perpendicular to the plane of contact 5.
  • Figure 5 shows a possible embodiment of the device 1 according to this invention, preferably made according to the method described in this invention and preferably using a kit comprising:
  • a lower support 2 that can be associated with at least one part of the lower dental arch Ai of a patient and an upper support 3 that can be associated with at least one part of the upper dental arch of a patient, - an impression preferably in wax of the guided bite 9 of the patient in the centric relationship,
  • an average value articulator 8 designed to accommodate and adjust the position of the dental arch models 6, 7, comprising two condylar baskets
  • this invention makes it possible to obtain a device for the treatment of snoring 1 , also known as a Nocturnal Anti-asphyxia Bite, that can offer a beneficial and therapeutic increase in pharyngeal space to effectively reduce and prevent nocturnal asphyxia and the annoying noise of snoring while a patient is asleep.
  • snoring 1 also known as a Nocturnal Anti-asphyxia Bite
  • the device 1 easy to use and specific for the patient, needs only to be inserted in the patient's mouth; by immediately hooking the supports 2, 3 of the device onto the dental arches, the patient can go to sleep without worrying about snoring or being suffocated while asleep.
  • the device 1 uses and includes in its construction the specific mandibular advancement based on the dental class, the relative condylar inclination with respect to the occlusal plane and the rest position with which it is associated as a means of cerebral function protection.
  • the device 1 can advantageously be produced with very reduced dimensions and thicknesses of the supports 2, 3 preferably less than a millimetre, for example 0.8 mm.
  • the device 1 advantageously allows the absence of harmful metallic restraints that are potentially dangerous over time for the wear of the dental enamel, and the use of construction materials that are quick and easy to clean.
  • the device 1 ensures non-invasiveness of the oral cavity and thus the absence of the stimulation of the vomiting reflex, allowing complete liberty for movement of the tongue and for swallowing.
  • the device 1 offers stability during occlusion but at the same time freedom of movement in mandibular opening and closing at the wish of the patient.
  • the method described above advantageously concludes by obtaining the device 1 , substantially made from a single piece and without rocking movements, and which on removal from the mouth maintains the working position of the supports 2, 3.
  • the device 1 is particularly useful also to prevent the occlusal damage caused by grinding of the teeth or dynamic bruxism, but allows static bruxism or locking as already described for cerebral protection.
  • the present invention therefore achieves the preset aims, overcoming the drawbacks of the prior art.

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  • Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un dispositif de traitement du ronflement (1) et un procédé et un kit de production associés, comprenant : un support inférieur (2) et un support supérieur (3) positionnés en alternance le long du plan de contact (5) correspondant au plan d'occlusion dentaire d'un patient dans la position de fonctionnement, dans lequel au cours de l'utilisation du dispositif (1) à l'intérieur de la cavité buccale du patient, dans laquelle l'arcade dentaire inférieure (Ai) est en contact avec le support inférieur (2) et l'arcade dentaire supérieure est en contact avec le support supérieur (3), les arcades dentaires sont maintenues dans une position thérapeutique dans laquelle l'arcade dentaire inférieure (Ai) est dans une position en saillie le long du plan d'occlusion par rapport à une position de repos de l'arcade dentaire inférieure (Ai) lorsque le dispositif (1) n'est pas utilisé ; des moyens d'interconnexion (4) conçus pour interconnecter de façon stable et fixe les supports (2, 3).
PCT/IB2016/051646 2015-03-26 2016-03-23 Dispositif de traitement du ronflement et procédé et kit de production associés WO2016151510A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITBO2015A000146 2015-03-26
ITBO20150146 2015-03-26

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WO2016151510A1 true WO2016151510A1 (fr) 2016-09-29

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109124857A (zh) * 2018-07-18 2019-01-04 兴康明科技（深圳）有限公司 制备阻鼾器的方法及阻鼾方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5003994A (en) * 1989-10-10 1991-04-02 Cook George W Oral appliance for improving breathing and methods of using and making same
US5267862A (en) * 1993-01-08 1993-12-07 Parker Jonathan A Intraoral appliance
WO1994023674A1 (fr) * 1993-04-21 1994-10-27 Gary John Jacobsen Dispositif ameliorant la qualite du sommeil
US20120103345A1 (en) * 2010-11-02 2012-05-03 Maxwell Harold Gay Sleeping Aid

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5003994A (en) * 1989-10-10 1991-04-02 Cook George W Oral appliance for improving breathing and methods of using and making same
US5267862A (en) * 1993-01-08 1993-12-07 Parker Jonathan A Intraoral appliance
WO1994023674A1 (fr) * 1993-04-21 1994-10-27 Gary John Jacobsen Dispositif ameliorant la qualite du sommeil
US20120103345A1 (en) * 2010-11-02 2012-05-03 Maxwell Harold Gay Sleeping Aid

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109124857A (zh) * 2018-07-18 2019-01-04 兴康明科技（深圳）有限公司 制备阻鼾器的方法及阻鼾方法

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