WO2019195579A1 - Dispositif de protection buccale pour le traitement de la sécheresse de la bouche, du grincement des dents, du ronflement et de l'apnée du sommeil et ses procédés d'utilisation - Google Patents

Dispositif de protection buccale pour le traitement de la sécheresse de la bouche, du grincement des dents, du ronflement et de l'apnée du sommeil et ses procédés d'utilisation Download PDF

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Publication number
WO2019195579A1
WO2019195579A1 PCT/US2019/025837 US2019025837W WO2019195579A1 WO 2019195579 A1 WO2019195579 A1 WO 2019195579A1 US 2019025837 W US2019025837 W US 2019025837W WO 2019195579 A1 WO2019195579 A1 WO 2019195579A1
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WIPO (PCT)
Prior art keywords
mouth
valve
treatment device
treatment
range
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Application number
PCT/US2019/025837
Other languages
English (en)
Inventor
Louis T. GERMINARIO
Victoria M. GERMINARIO
Henry G. BRZOSKA
Thomas Stern
Christopher Maurer
Original Assignee
Vms Medical Products, Inc.
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Publication date
Application filed by Vms Medical Products, Inc. filed Critical Vms Medical Products, Inc.
Publication of WO2019195579A1 publication Critical patent/WO2019195579A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0084—Pumps therefor self-reinflatable by elasticity, e.g. resuscitation squeeze bags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • A61M16/049—Mouthpieces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • A61M16/049—Mouthpieces
    • A61M16/0495—Mouthpieces with tongue depressors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • 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
    • A61F2005/563—Anti-bruxisme
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A61M16/0688—Holding devices therefor by means of an adhesive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/07—General characteristics of the apparatus having air pumping means
    • A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
    • A61M2205/075—Bulb type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/07—General characteristics of the apparatus having air pumping means
    • A61M2205/078—General characteristics of the apparatus having air pumping means foot operated
    • A—HUMAN NECESSITIES
    • A63—SPORTS; GAMES; AMUSEMENTS
    • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B23/00—Exercising apparatus specially adapted for particular parts of the body
    • A63B23/18—Exercising apparatus specially adapted for particular parts of the body for improving respiratory function

Definitions

  • Embodiments of the invention relate generally to devices for treatment of conditions such as obstructive sleep apnea (OSA), snoring, dry mouth (xerostomia) and teeth grinding (bruxism) that may be caused by increased airway resistance resulting from partial or complete occlusion of the pharyngeal airways during sleep. More particularly, embodiments of the invention relate to mouth shield devices for regulation and pressurization of exhaled air as a means of providing and maintaining a residual amount of positive expiratory pressure in the upper airways throughout the complete respiratory cycle and for restriction of mouth breathing. Disclosed devices may also be used with CPAP devices and in conjunction with CPR.
  • OSA obstructive sleep apnea
  • snoring dry mouth
  • xerostomia dry mouth
  • bruxism teeth grinding
  • Disclosed devices may also be used with CPAP devices and in conjunction with CPR.
  • Sleep apnea is a relatively widespread problem that affects millions of Americans.
  • the use of intraoral appliances for treatment of obstructive sleep apnea (OSA), and hypopnea events of sleep-disorder breathing (SDB) is therefore an area of great interest owing to the substantial health consequences.
  • OSA obstructive sleep apnea
  • SDB sleep-disorder breathing
  • Sleep apnea is often accompanied with periods of not breathing and an associated decline in blood oxygen and a corresponding increase in carbon dioxide levels.
  • This increasingly common disorder is also characterized by repeated episodes of upper airway narrowing during sleep and collapse of pharyngeal airways.
  • this further reduction or complete blockage of inspiratory airflow and decline in blood oxygen levels also leads to an increased stress on the heart due to low oxygen levels and an increased risk of cardiac failure.
  • a major cause of snoring and OSA is mouth breathing during sleep, especially while sleeping in the supine position.
  • the force of gravity easily pulls the jaw, tongue and surrounding soft tissues and compresses the airway in the oropharynx region.
  • This condition may further restrict the oropharynx region to produce a narrower airway, higher air flow velocity and increased airway resistance.
  • Increased airflow during mouth breathing also induces an increased negative air pressure in the pharyngeal airways which may lead to further constriction by a subsequent collapse and narrowing of the airways. The result may eventually lead to a repetitive collapse and blockage of the pharynx during sleep, resulting in OSA.
  • CPAP continuous positive airway pressure machine
  • PAP positive airway pressure
  • CPAP therapy uses an air compressor or other mechanical device to help a person with OSA breathe more easily during sleep by gently blowing pressurized air into the airways to provide the minimum amount of pressure required to deliver positive air pressure in the client's throat so that the upper airway is much less likely to collapse while breathing.
  • the sleeper wears ei ther a nasal mask, nasal pillow or full-face mask to deliver the air.
  • EPAP controlled mechanical ventilation and expiratory positive airway pressure
  • PEEP positive end expiratory pressure
  • EPAP devices function by building pressure in either the nose or mouth to maintain a positive airway pressure in the lungs to prevent airway narrowing, collapse or blockage during sleep.
  • the application of EPAP during sleep has been shown to decrease the work of breathing by improving diaphragmatic function and thereby reducing the inspiratory effort during sleep.
  • U. S. Pat. No. 4,170,230 who appear to disclose a breathing tube apparatus in the form of a flexible, curved tube which fits between the teeth and cheeks, with openings in the front portion of the curved tube which extend laterally and symmetrically along the teeth line to the back of the molars and mouth to facilitate airflow from the front of the mouth into the rear of the mouth and upper trachea.
  • the stated object of this invention is to reduce or eliminate the drying effect of airflow into the mouth by direct transport and placement of air to the rear of the mouth.
  • Dry mouth during sleep apnea was also noted to be a problem during development of the automatic positive airway pressure (APAP) treatment and is the most common side effect of CPAP.
  • APAP automatic positive airway pressure
  • the principal cause is due to oral venting and the presence of air leaks around the mask.
  • An attempt to resolve the oral venting issue by adaption of a chin strap was not found to be a reliable solution for preventing air leaks.
  • Current treatments for PAP related dry mouth employing full face masks have been shown to increase upper airway obstruction and increased PAP pressure requirements, which may lead to aerophagia and agonizing gas pains due to stomach distension.
  • Mouth opening during sleep may also worsen sleep apnea since the upper airway critical pressure (PCRIT) can be significantly decreased, which may lead to an upper airway collapse and blockage.
  • PCRIT upper airway critical pressure
  • Mouth opening therefore, leads to a preferential increase in negative air pressure in the pharyngeal airways when the mouth is open than when the mouth is closed. This condition often leads to an upper airway collapse and blockage, resulting in dry mouth, snoring and/or OSA.
  • U. S. Pat. No. 1,483,694 appear to disclose use of a membrane that is placed intraorally in the vestibule of the mouth between the gums and lips and extend laterally around the gums as a means of preventing oral breathing by blocking exhale through the mouth.
  • the oval-shaped rubber membrane forms an elliptical concave-convex shape lens held in place by a spring wire frame that is sufficiently flexible to bend and conform to the contours and space between the inner cheeks, lips and the gums.
  • the moldable plastic, celluloid, or metal is formed from a one-piece, flexible piece of material that is sufficiently rigid to retain a curved, oval form and shaped to be placed in the vestibule of the mouth between the teeth and lips.
  • U. S. Pat. Nos. US 2,178,128 and US 6,263,877 Bl appear to disclose designs of a flexible mouthpiece to be worn between the lips and teeth and extend laterally around the gums in order to shield and prevent mouth breathing and to minimize snoring and dry mouth.
  • U. S. Pat. No. US 2,178,128 appear to disclose a flexible mouthpiece design with a plurality of relatively small perforations on the front-center part of the mouthpiece for control and diffusion of an airstream. Also described is a plurality of relatively larger perforations, separate from the airstream zone to permit circulation of saliva while in use.
  • WO2011036658 A9 also appear to disclose the use of one-way valves configured to transfer saliva from the buccal to the lingual side of the shield while also serving as a barrier between the oral cavity and atmospheric pressure.
  • US 6,263,877 B l also appear to disclose oval plate designs for placement between the teeth and lips with an aperture that is centered on the mouthpiece for accommodating airflow into and out of the mouth.
  • a rigid tab is provided that extends outside of the mouth and is positioned above the aperture to provide a separation of the upper and lower lips and to facilitate a flow of air into and out of the mouth when in use.
  • the mouth shield device was reported to be constructed from a plastic material which softens and becomes pliable when heated in order to allow an impression of the inside of the mouth which retains its formed shape upon cooling.
  • U. S. Pat. No. 5,865,170 which appear to describe a moldable, customizable mouthpiece that seals against the user’s gums and teeth, and also provide horizontal bite portions with flanges to stabilize the mouthpiece for a more comfortable fit.
  • U. S. Pat. No. 6,536,424 B2 is a vestibular shield design with retaining wings that conform to the anatomy of a user’s labial and buccal vestibule that extend laterally into the mouth to provide bite features for upper and lower teeth.
  • U. S. Pat. Pub. No. 2002/0069872 Al appear to disclose nasal CPSP system with a vestibular shield design to overlap the user’s teeth and gums and an extra-oral means for sealing the outside lips and prevent both exhale and inhale through the mouth.
  • the device is formed from a flexible polymeric material placed between the teeth, cheek and lips and extends in the oral vestibule laterally around the user’s teeth and gums.
  • a hard-plastic extension is also described to cover parts of the tongue in order to facilitate delivery of gases into the mouth. Further improvements to the vestibular shield design in U.
  • S. Pat. No. 9,155,855 B2 and U. S. Pub. No. 2016/0287831 Al appear to disclose the addition of channels spaced along the diameter of the vestibular shield to allow saliva to be transmitted between the shield buccal side and lingual side.
  • the vestibular shield contains gas diffusing channels to direct gas from the front of the device to the sides of the user’s jaw so that the tongue depressor is eliminating in order to prevent user’s tongue from blocking the air inlet channel and allow swallowing during use.
  • the addition of an integral nasal attachment is also provided to block exhale through the nose.
  • An alternative embodiment describes the addition of an external oral flap to the mouthpiece to eliminate the need of an external head strap to secure the mouthpiece in place.
  • Nasal cannula and nasal puff designs appear to have been disclosed to fit either into the nose or over the nose to improve the comfort of patients during CPAP treatment, (U. S. Pat. Nos. 4,278.082; 4,367,735; 4,782,832; 6,431,172 B l).
  • Other variations in the design of compact oronasal masks for CPAP applications are described in U. S. Pat. Nos. 7,658,189 and 9,220,860 B2, which appear to provide a design for delivery of gases requiring straps and a headgear assembly with a nasal and mouth cushion to provide seals on the outside surfaces of the nose and mouth for CPAP treatment.
  • Still other variations in oronasal mask designs are described in U. S. Pat. Nos. 5,560,354 and 9,027,556 B2, which appear to disclose facial mask designs that include mouth covering and nozzle assemblies which engage either on or within the nasal passage of patients during use.
  • Oral appliances for treatment of OSA are generally designed to either elevate the soft palate, advance the mandible to open the airways, and/or hold the tongue forward.
  • risk factors often identified and associated with the use of intraoral devices for snoring and/or obstructive sleep apnea include intraoral gingival, palatal or dental soreness, tooth movement, or changes in dental occlusion, pain or soreness to the temporomandibular joint, obstruction of oral breathing or may lead to excessive salivation.
  • patients with OSA have an elevated risk of teeth grinding during sleep (sleep bruxism) which may also contribute to tooth wear, fracture, temporomandibular disorders, and pain in the masticatory muscles. (American Academy of Orofacial Pain Guidelines Committee (1996) Orofacial pain: guidelines for assessment, diagnosis and management. Quintessence, Chicago; H.
  • appliances designed for mouth to mouth resuscitation seem to provide either a means to prevent or avoid lip contact between the rescuer and the victim, U.
  • a major challenge is providing an intraoral device that is comfortable and does not irritate or is painful to wear, eliminates development of dry mouth, and provides relief from and control of OSA, snoring, oral dryness and nocturnal teeth grinding.
  • an oral device that maintains the integrity of the upper airways throughout the complete respiratory cycle during sleep, restricts mouth breathing, is non-invasive and comfortable to wear, enables users to sleep free from electrical cords, hoses and noise, demonstrates exceptional levels of acceptance and compliance and supports free breathing during sleep for treatment of dry mouth, snoring, teeth grinding and obstructive sleep apnea.
  • Embodiments of the disclosure relates to mouth shield devices for passive treatment of nocturnal dry mouth, snoring, or sleep apnea.
  • the device may include a polymer piece designed for placement between the gums and lips to create a barrier and shield between the inside and outside regions of the mouth to produce a seal which prevents air leaks and oral venting; a polymer piece having at least one or more openings formed through its thickness; opening and valve designs and structures configured to control air flow and inspiratory and expiratory resistance to reduce oral venting; and valve systems consisting of vertically translating membrane or diaphragm designs to cover an orifice or channel.
  • the mouth shield device may be flexible, easily inserted into the mouth between the lips and gums or dentition and can be easily removed and reinserted into the mouth during use.
  • the mouth shield device is comfortable to wear and designed to reduce or restrict mouth breathing by providing and maintaining an air seal around the device when it is inserted inside the mouth between the lips and dentition.
  • the mouth shield device may be designed to provide methods for regulation and pressurization of exhaled air as a means of providing and maintaining a residual amount of positive air pressure in the upper airways throughout the complete respiratory cycle.
  • the mouth shield device may include a design that conforms to the region between the lips and gums and forms around the gums and dentition to create a barrier between the lips and gums to reduce oral venting and air leakage when the user exhales.
  • the oral barrier aspect of the mouth shield design may further reduce oral venting and prevent air leakage from the inside of the mouth to atmosphere due to an increase in oral air pressure between the mouth shield device and cheeks and lips during exhalation of air.
  • the mouth shield may be configured and designed to increase the contact and adhesion between the lips and mouth to further improve and provide a seal between the lips and mouth to reduce oral venting and air leakage around the device and to minimize or reduce dry mouth symptoms and snoring.
  • the mouth shield design may be custom fitted and configured to promote maximum coverage around the gums, dentition, lips and cheeks to prevent air leaks around the mouth shield device during exhalation and prevent exhaling through the mouth.
  • the mouth shield designs by preventing exhalation through the mouth, may minimize or prevent dry mouth syndrome.
  • the disclosed mouth shield designs may prevent air leaks around the mouth during exhalation therethrough, which may lead to increased pressure against the inner surface of the mouth shield during exhale, thereby reducing loss of exhaled moisture and further minimizing dry mouth syndrome.
  • the disclosed mouth shield designs may prevent exhaling through the mouth while providing and promoting nasal breathing, which may reduce airway resistance, work of breathing relative to mouth breathing, as well as provide increased compliance.
  • the mouth shield device may be formed from hydrophilic polymeric materials consisting of hydrogen bonding-forming groups such as, hydroxyl, carboxy, ketone, aldehyde, carboxylic acid, urethane, ester, amine, imine, amide, imide and nitrile, for example, to further improve contact and provide mucoadhesion for maintaining an air seal around the device and the gums when it is inserted inside the mouth between the lips and dentition.
  • hydrogen bonding-forming groups such as, hydroxyl, carboxy, ketone, aldehyde, carboxylic acid, urethane, ester, amine, imine, amide, imide and nitrile
  • One or more of the openings or channels on the mouth shield device have specific cross-sectional shapes or diameters to provide select airway resistance, pressure gradients and airflow rates that are suitable for providing and maintaining a residual amount of positive expiratory pressure in the upper airways throughout the complete respiratory cycle.
  • the openings in the valving system of the mouth shield device include elastomeric valve elements (membranes or diaphragms) that cover one or more openings formed through the thickness of the mouth shield to create a unidirectional flow in the device.
  • the valving system of the mouth shield device may include elastomeric elements with a low modulus of elasticity and consisting of a vertically translating membrane or diaphragm to cover an orifice or channel which may change shape and cross-sectional area to provide one-way valving action to allow forward flow and prevent backflow.
  • Elastomeric elements of the valve system may be pressure driven and pressure actuated to create an airflow once open when a force is reached to lift the elastomeric elements from the valve openings and provide a unidirectional airflow when opened and close to prevent backflow.
  • the elastomeric membrane elements of the valve designs may be breath actuated and are normally closed and require air pressure to vertically translate the membrane to raise the membrane to open the valve as the user inhales.
  • Valve designs may be configured to create an airflow and force to lift and open the elastomeric membrane elements which expand their cross-sectional area at a given pressure to provide very low resistance and high- volume airflow during inhalation, while providing optimal sealing of valve openings to prevent or minimize exhalation through the mouth and thereby promote nasal breathing during use.
  • the valve system of mouth shield devices may further include designs to provide and promote maximum airflow during inhalation, while increasing airway resistance and maintaining a high pressure drop between the inside and outside regions of the mouth during exhalation.
  • This design may provide and promote a residual high pressure in the upper airways after exhaling and during the period between inhalation and exhalation.
  • the valve system of mouth shield devices may have openings and designs with different cross-sectional shapes, diameters and lengths to control pressure drop and airway resistance to maintain a positive pressure between the upper airways and external environment.
  • the elastomeric valving system provide one-way or two-way valve action that may further control airway resistance, pressure gradients and allow or restrict both forward or backward airflow through the mouth shield device during use.
  • Elastomeric valve systems may provide mechanisms and methods for passive expansion and maximum opening of the valve diameter that is pressure driven during inhalation, to further provide and control airway resistance and allow unrestricted airflow during inhalation while preventing backward airflow through compression and sealing of the elastomeric elements during exhalation.
  • the mouth shield device may also include polymer tabs, i.e., dental guards, located on the ends and sides of the device to keep molars and premolars of the posterior maxillary and mandibular teeth from contacting and function as a protective barrier for individuals who grind their teeth and for treatment of temporomandibular disorders (TMD), bruxism (grinding of teeth) or clenching.
  • the dental guard feature of the mouth shield device may act to further stabilize the mouth shield device and mitigate any possible migration during use.
  • the device may reduce damage to teeth and prevent or minimize noise associated with bruxing or teeth grinding.
  • the device is removable, reusable, replaceable and may be customized for each patient.
  • the dental guard feature of the mouth shield device may contain porous polymer patches attached to the mouth guard for slow release and delivery of active agents, such as but not limited to, breath fresheners, flavors, medicament or other pharmacological agents with activity as, for example, decongestant, anti-histamine, anti-inflammatory, anti-bacterial, analgesic etc., for possible treatment of dry mouth and other common upper respiratory tract infections during use.
  • active agents such as but not limited to, breath fresheners, flavors, medicament or other pharmacological agents with activity as, for example, decongestant, anti-histamine, anti-inflammatory, anti-bacterial, analgesic etc.
  • a comfortable, light weight, compact and miniaturized mask design is provided for delivery of pressurized gases for treatment of sleep disorder breathing conditions such as Obstructive Sleep Apnea (OSA).
  • OSA Obstructive Sleep Apnea
  • Mask designs may include a patient interface which includes a nasal mask or an oral mask or a mask that includes both nasal and oral.
  • the miniaturized mask design may include an integrated mouth shield design that is attached to the external oral, nasal or oronasal mask features.
  • the mouth shield member of the miniature mask design conforms to the region between the lips and around the gums and dentition to create a barrier between the lips and gums in order to reduce oral venting and air leakage when the user exhales.
  • the mask design includes elastomeric membrane elements that are breath actuated and are normally closed and require air pressure to vertically translate the membrane to raise the membrane to open the valve as the user inhales.
  • the mask design may include a tube and passage way that connects the mask to ventilators such as CPAP and the like. Within the tube, that connects the mask assembly to the CPAP device, may be single or multiple valves with features which provide one-way airflow.
  • the valves may be configured to create an airflow and force which lifts and opens the elastomeric membrane elements by expanding their cross-sectional area at a given pressure to thereby provide very low resistance and high- volume airflow during inhalation or for gas delivery for CPAP therapy.
  • the one-way valve design feature also provides optimal sealing of valve openings to prevent or minimize exhalation through the mouth, minimize or prevent air leaks and promote nasal breathing during use.
  • the patient contacting surfaces of the nasal or oronasal mask may be constructed from a soft polymeric material composed of biocompatible, elastomeric materials selected from the group consisting of nylons, polyacrylamide, polyurethanes, acrylics or
  • the soft patient contacting portion of the nasal or oronasal mask may be generally shaped to fit the contour of the nose to fit either on the outside or inside of the nares or cover both nares.
  • the miniaturized mask design may be strapless and due to its light weight is supported by the main body of the mask which consists of a tube that is attached to the polymer shield portion of the mask that is placed inside the mouth between the gums and lips.
  • the polymer shield portion of the mask may be placed inside the mouth between the gums and lips and held in place and stabilized by the lips and front teeth as well as the pressure force exerted inside the mouth which creates an oral pressure that is greater than ambient pressure.
  • the mask may contain bite features onto which molars and premolars of the posterior maxillary and mandibular teeth may bite onto to further support and stabilize the mask structure.
  • Mouth shield designs may be configured for rescue breathing and for applications such as cardiopulmonary resuscitation (CPR) therapy.
  • CPR cardiopulmonary resuscitation
  • the designs may shield the rescuer from the victim to prevent contact and avoid the risk of infection according to guidelines described in,“Updated CDC Recommendations for the Management of Hepatitis B Virus- Infected Health-Care Providers and Students, Morbidity and Mortality Report,
  • the mouth shield designs may provide a means to prevent or avoid lip contact between the rescuer and the victim during CPR therapy.
  • a one-way valve structure may be contained within the breathing tube of the mouth shield that is placed within the victim’s mouth and designed to prevent backflow of air, mist or any liquids which may emerge from the victim’s mouth from coming into contact with the rescuer.
  • a nose-clip may be used to prevent pressure from escaping from the nose during CPR therapy.
  • a bulb or elastic bag may be provided to allow manual application of air into a victim’s passageways thus removing the need for mouth-to-mouth resuscitation.
  • a treatment device including a mouth shield device including a polymer piece configured to fit within a mouth to create a barrier and shield between inside and outside regions of the mouth to reduce oral breathing.
  • the polymer piece includes (i) an oblong shape having a central region and a perimeter surrounding the central region, the perimeter forming indents at a center portion of the shape, (ii) a one-way valve forming an opening through a thickness thereof, the one-way valve having a combination of shape and size configured to provide a differential pressure between the inside and outside regions of the mouth during oral breathing and disposed in the central portion, (iii) a biocompatible, elastomeric material, and (iv) at least one of a length selected from a range of 60 mm to 180 mm, a width selected from a range of 10 mm to 65 mm, or a thickness of about 0.05 mm to about 12 mm.
  • the one-way valve may be formed integrally with the polymer piece.
  • the one-way valve may be inserted into and restricted by the polymer piece.
  • the biocompatible, elastomeric material may be polyurethane, polycaprolactone, nylons, polyacrylamide, acrylics, polyacrylates (PMMA), cellulosic compounds, polyesters, co-polyesters, polycarbonate, fluoropolymers, polyvinylchloride, silicones, PDMS, polyethylene, polystyrene, polypropylene, natural rubbers, synthetic rubbers, thermoplastic elastomers, nitriles, copolymers and/or combinations thereof.
  • the biocompatible, elastomeric material may have a hardness of at least one of (i) a durometer Shore A hardness value selected from a range of 5 to 90 or (ii) a durometer Shore 00 hardness selected from a range of 5 to 100.
  • the biocompatible, elastomeric material may have a Young’s modulus value selected from a range of 0.5 MPa to 4.5 MPa.
  • the treatment device may include a dental guard feature joined to the polymer piece and protruding therefrom, the dental guard feature adapted to prevent teeth grinding, having a thickness sufficient to prevent contact of molars of a user.
  • the thickness of the dental guard feature may be selected from a range of 0.05 mm to 12 mm.
  • the dental guard feature may include an elastomeric material having at least one of (i) a durometer Shore A hardness value selected from a range of 5 to 90 or (ii) a durometer Shore 00 hardness value selected from a range of 5 to 100.
  • the dental guard feature and the polymer piece may each include the same biocompatible, elastomeric material.
  • the treatment device may include a polymer patch including an active agent disposed on the dental guard feature, the polymer patch being adapted to release the active agent for treatment of a medical condition.
  • the polymer patch may include a porous polymeric material, such as selected from the group consisting of carboxymethyl cellulose (CMC), hydroxy propyl methyl cellulose (HPMC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), starch, xanthan gum, acacia gum, guar gum, poly vinylpyrrolidone (PVP), methyl-methacrylate copolymer (MMA), polyvinyl-alcohol, sodium alginate, polyethylene glycol, polyacrylic acid, copolymers, and/or combinations thereof.
  • CMC carboxymethyl cellulose
  • HPMC hydroxy propyl methyl cellulose
  • HEC hydroxyethyl cellulose
  • HPC hydroxypropyl cellulose
  • PVP poly vinylpyrrolidone
  • MMA methyl
  • the active agent may be, e.g., a breath freshener, flavors, a medicament, and/or other pharmacological agents with activity as, for example, decongestant, anti-histamine, anti inflammatory, anti-bacterial, analgesic etc., for possible treatment of dry mouth and other common upper respiratory tract infections during use.
  • a breath freshener e.g., a breath freshener, flavors, a medicament, and/or other pharmacological agents with activity as, for example, decongestant, anti-histamine, anti inflammatory, anti-bacterial, analgesic etc., for possible treatment of dry mouth and other common upper respiratory tract infections during use.
  • the one-way valve may include a valve mechanism having a valve element configured to open and close the valve opening to restrict airflow.
  • the valve mechanism may be pneumatic, breath actuated, and pressure -driven, and oriented to open at a given pressure during inhalation and to close during exhalation.
  • the valve element comprises a valve element biocompatible, elastomeric material.
  • the valve element biocompatible, elastomeric material may have at least one of (i) a durometer Shore A hardness value selected from a range of 5 to 90 or (ii) a durometer Shore 00 hardness value selected from a range of 5 to 100.
  • the treatment device may include a mask, such as a nasal mask, an oral mask, or an oronasal mask, with the polymer piece being attached to the mask to form a one-piece mouth shield / mask module configured for attachment to a breathing assistance device.
  • a mask such as a nasal mask, an oral mask, or an oronasal mask
  • the mouth shield / mask module may be removably couplable to the breathing assistance device.
  • a tube may be attached to the polymer piece, thereby forming a polymer piece/tube module.
  • the tube may be a tongue depressor tube or a long-curved tube and squeeze bulb combination, and the treatment device may be configured for providing CPR therapy.
  • the polymer piece and the one-way valve may be a one-piece injection molded biocompatible, elastomeric material component.
  • the one-way valve may provide one-way airflow to create and maintain sufficient differential pressure between an oral cavity and atmosphere to maintain a residual amount of positive expiratory pressure in upper airways during use.
  • embodiments of the invention relate to a method for treating at least one of dry mouth, teeth grinding, snoring, or sleep apnea in an individual.
  • the method includes
  • the polymer piece includes (i) an oblong shape having a central region and a perimeter surrounding the central region, the perimeter forming indents at a center portion of the shape, (ii) a one-way valve forming an opening through a thickness thereof, the one-way valve having a combination of shape and size configured to provide a differential pressure between the inside and outside regions of the mouth during oral breathing and disposed in the central portion, (iii) a biocompatible, elastomeric material, and (iv) at least one of a length selected from a range of 60 mm to 180 mm, a width selected from a range of 10 mm to 65 mm, or a thickness of about 0.05 mm to about 12 mm.
  • Positioning the treatment device in the mouth of the individual treats the at least one of dry mouth, teeth grinding, snoring, or sleep apne
  • the treatment device may include a dental guard feature joined to the polymer piece and protruding therefrom, the dental guard feature adapted to prevent teeth grinding and for treatment of temporomandibular disorders and having a thickness sufficient to prevent contact of molars of a user.
  • the thickness of the dental guard feature may be selected from a range of 0.05 mm to 12 mm.
  • the dental guard feature may include an elastomeric material having at least one of (i) a durometer Shore A hardness value selected from a range of 5 to 90 or (ii) a durometer Shore 00 hardness value selected from a range of 5 to 100.
  • a polymer patch may be applied to the dental guard feature, wherein (i) the polymer patch comprises an active agent and (ii) is adapted to release the active agent for treatment of a medical condition.
  • the polymer piece may be attached to a mask to form a one-piece shield / mask module configured for attachment to a breathing assistance device.
  • the polymer piece may be custom fitted to the individual to promote coverage around gums, dentition, lips, and cheeks to reduce air leaks around the treatment device during exhaling and to prevent exhalation through the mouth.
  • the one-way valve may include an elastomeric valve element adapted to open at a given pressure to provide a desired airway resistance, pressure-drop, and airflow rates to control and maintain upper airway patency throughout an entire respiratory cycle.
  • the one-way valve may be breath actuated and open at a given pressure to provide one-way airflow to generate and maintain sufficient differential pressure between an oral cavity of the individual and atmosphere to maintain a residual amount of positive expiratory pressure in upper airways during use.
  • Positioning the polymer piece into the mouth to treat the at least one of dry mouth, teeth grinding, snoring, or sleep apnea by reducing oral breathing may include at least one of (i) providing a tight seal between the treatment device and cheeks and lips of the individual or (ii) preventing exhaling through the mouth of the individual through the at least one one-way valve.
  • the treatment device may be connected to a CPAP machine, and air may be provided to the individual through the treatment device by the CPAP machine.
  • a method for providing CPR treatment includes positioning in a mouth of an individual a treatment device including mouth shield device including a polymer piece to create a barrier and shield between inside and outside regions of the mouth to at least reduce oral breathing.
  • the polymer piece includes (i) an oblong shape having a central region and a perimeter surrounding the central region, the perimeter forming indents at a center portion of the shape, (ii) a one-way valve forming an opening through a thickness thereof, the one-way valve having a combination of shape and size configured to provide a differential pressure between the inside and outside regions of the mouth during oral breathing and disposed in the central portion, (iii) a biocompatible, elastomeric material, and (iv) at least one of a length selected from a range of 60 mm to 180 mm, a width selected from a range of 10 mm to 65 mm, or a thickness of about 0.05 mm to about 12 mm.
  • the polymer piece is attached to a tube.
  • the tube is a tongue depressor tube or a long-curved tube and a squeeze bulb combination.
  • the treatment device includes a polymer piece / tube module configured for providing CPR treatment. CPR treatment is provided to the individual while the treatment device is in the individual’s mouth.
  • the tube may be a tongue depressor tube, and an airway of the individual may be cleared with the tube during CPR treatment.
  • the tube may be the long-curved tube and squeeze bulb combination, further rescue air may be provided to the individual by squeezing and releasing the squeeze bulb.
  • FIGS. 1A-1- 1A-3 illustrate a mouth shield device in accordance with an embodiment of the invention, with FIG. 1A-1 being a front view of the mouth shield device while in use by a patient, and FIG. 1A-2 being a front view of the mouth shield device before insertion into the mouth, and FIG. 1A-3 being a front view of the mouth shield device before it is folded for insertion into the mouth.
  • FIGS. 2A-1- 2A-2 illustrate a mouth shield device in accordance with an embodiment of the invention, with FIG. 2A-1 being a side view of the mouth shield device while in use by a patient, and FIG. 2A-2 being a side view of the mouth shield device before insertion into the mouth.
  • FIGS. 3A-1- 3A-2 illustrate a mouth shield device in accordance with an embodiment of the invention, with FIG. 3A-1 being a top view of the mouth shield device before insertion into the mouth, and FIG. 3A-2 being a top view of the mouth shield device after insertion between the cheeks, lips, and gums or dentition.
  • FIGS. 4A-1- 4A-3 illustrate a mouth shield device in accordance with an embodiment of the invention, with FIG. 4A-1 being a face view and FIG. 4A-2 being a cross- sectional view of an exemplary mouth shield device with valves having a triangular-type one- way valve design, in accordance with an embodiment of the invention.
  • FIG. 4A-3 illustrate the normally closed, triangular-type one-way valves which open to allow airflow into the lungs as a patient inhales (arrows), and close to block airflow when the patient exhales.
  • FIGS. 5A-1- 5A-2 illustrate perspective views of a mouth shield device with triangular-type valve system, in accordance with an embodiment of the invention, with FIG. 5A-1 being a front view of the mouth shield device before insertion into the mouth, and FIG. 5A-2 being a view of the triangular-type valve structure as viewed from inside the mouth.
  • FIGS. 6A-1- 6A-3 illustrate a mouth shield device in accordance with another embodiment of the invention, with FIG. 6A-1 being a front view, and FIG. 6A-2 being a perspective view, and FIG. 6A-3 being a cross-sectional view of another embodiment of the invention of a mouth shield device with dome-shaped valves.
  • FIGS. 7A-1- 7B-3 illustrate a mouth shield device in accordance with another embodiment of the invention of a mouth shield device with an butterfly-type valve design
  • FIGS. 7A-1 and 7A-2 being perspective views of butterfly-type valves
  • FIGS. 7B-1 and 7B-2 being a perspective view and cross-section view, respectively, of an exemplary butterfly-type valve design with elastomer-type valve elements which are normally closed and provide a sealing or closure mechanism for valve openings when a patient exhales and flex to lift and open the elastomeric valve elements as the patient inhales, in accordance with an embodiment of the invention
  • FIG. 7B-3 illustrating a top view of a 6-hole butterfly valve.
  • FIG. 8A- 1- 8 A-2 are plots of an exemplary butterfly-type valve design with elastomeric material properties in accordance with an embodiment of the invention, with FIG. 8A-1 being the umbrella valve opening pressure as a function of airflow, and for various valve membrane thickness for valves composed of 50 durometer silicone, and FIG. 8A-2 being a plot of exemplary elastomeric material mechanical properties, Shore A Durometer versus Young’s Modulus.
  • FIGS. 9A-1- 9A-3 illustrate a mouth shield device in accordance with another embodiment of the invention, with FIG. 9A-1 being an exploded view of exemplary membrane-type membrane valve elements which flex to open the valve as the patient inhales and closes as the patient exhales.
  • FIG. 9A-2 and 9A-3 perspective views are illustrated with exemplary membrane valve elements in the normally closed position.
  • FIGS. 10A-1- 10A-4 illustrate a one-way valve open and close action mechanism of an exemplary triangular-type valves, in accordance with an embodiment of the invention, with FIG. 10A-1 being a cross-sectional, side view of an open valve and FIG. 10A-2, a top view of the triangular-type valve design.
  • FIGS. 10A-3 and 10A-4 illustrate a side view and top view of an exemplary triangular-type valve design in the normally closed position.
  • FIGS. 11A-1- 11A-2 illustrate a one-way valve open and close action mechanism of an exemplary dome-type valve, in accordance with an embodiment of the invention, with FIG. 11 A-l being a cross-sectional side view of the action mechanism for opening the valve and FIG. 11 A-2 is the closure mechanism of the normally closed dome-type valve.
  • FIGS. 12A-1- 12A-5 illustrate a one-way valve open and close action mechanism of an exemplary butterfly-type valve, in accordance with an embodiment of the invention, with FIG. 12A-1 being a perspective view of a butterfly-type valve, FIG. 12A-2 being a cross-sectional view, and FIG. 12A-3 being a top view of a 5-hole-type, air inlet, butterfly- type valve.
  • the open and closure mechanism of butterfly-type valves is illustrated in FIG. 12A-4 and FIG. 12A-5.
  • FIGS. 13 A-l- 13A-5 illustrate a one-way valve open and close action mechanism of an exemplary butterfly-type valve with four, air inlet openings, in accordance with an embodiment of the invention, with FIG. 13 A-l being a perspective view of a butterfly valve, FIG. 13 A-2 being a cross-sectional view, and FIG. 13A-3 being a top view of a 4-hole-type, air inlet, butterfly valve.
  • the open and closure mechanism of a butterfly valves is illustrated in FIG. 13A-4 and FIG. 13A-5.
  • FIGS. 14A-1- 14A-5 illustrate a one-way valve open and close action mechanism of a butterfly-type valve with two, air inlet openings, in accordance with an embodiment of the invention, with FIG. 14A-1 being a perspective view of a butterfly valve, FIG. 14A-2 being a cross-sectional view, and FIG. 14A-3 being a top view of a 2-hole-type, air inlet, butterfly valve.
  • the open and closure mechanism of butterfly valves is illustrated in FIG. 14A-4 and FIG. 14A-5.
  • FIGS. 15A-1- 15A-2 illustrate a one-way valve open and close action mechanism of a one -hole-type membrane valve, in accordance with an embodiment of the invention, with FIG. 15 A-l being a cross-sectional view of the valve open state, while FIG. 15 A-2 illustrates the normally closed, valve state.
  • FIG. 16 illustrates the relationship between differential pressure and valve hole diameter, for air flow through circular valves during quiet breathing at 0.3 L/s.
  • FIG. 17 illustrates the relationship between air flow resistance and valve hole diameter, for air flow through circular valves during quiet breathing at 0.3 L/s.
  • FIGS. 18A-1- 18A-3 illustrate a mouth shield device with a dental guard feature in accordance with another embodiment of the invention, with FIG. 18A-1 being a top view of the mouth shield device, before insertion into the mouth, and FIG. 18 A-2 being a top view of the mouth shield device after insertion between the cheeks, lips and gums or dentition by a patient, and FIG.
  • FIGS. 18 A- 3 illustrate the mouth shield device as viewed by the patient, before insertion into the mouth, which contain dental guard features, four triangular-shaped, one way valve designs and notches or slots that are centrally placed above and below the mouth shield device, in accordance with another embodiment of the invention.
  • FIGS. 19A-1- 19A-3 illustrate a mouth shield device in accordance with another embodiment of the invention, with FIG. 19A-1 being a view before insertion into the mouth and FIG. 19A-2 being a cross-sectional view of an exemplary mouth shield device with valves having a triangular-type one-way valve design, in accordance with an embodiment of the invention.
  • FIG. 19A-3 illustrate the normally closed, triangular-type one-way valves which open to allow airflow into the lungs as a patient inhales (arrows), and close to block airflow when the patient exhales.
  • FIGS. 20A-1- 20A-4 illustrate a mouth shield device in accordance with another embodiment of the invention, with FIG. 20A-1 being a top view and FIG. 20A-2 being a perspective view and FIG. 20A-3 being a front view in which the outer perimeter of the top and bottom areas of the mouth shield device have tapered edges, as illustrated in the cross- sectional view in FIG. 20A-4.
  • FIGS. 21A-1- 21-A2 2 provide a perspective view and a front view of the elastomeric feature of the mouth shield device with triangular-type valves, a dental guard mechanism and the centrally located slots or notches, above and below the mouth shield device, in accordance with an embodiment of the invention.
  • FIGS. 22A-1- 22A-3 illustrate a mouth shield device in accordance with another embodiment of the invention with dome-type valves and dental guard features.
  • FIG. 22A-1 is a view of the mouth shield device prior to insertion into the mouth
  • FIG. 22A-2 is a cross-sectional view
  • FIG. 22A-3 is a perspective view of the mouth shield device.
  • FIGS. 23A-1- 23A-2 illustrates a mouth shield device in accordance with another embodiment of the invention with umbrella-type valves and dental guard features.
  • FIGS. 23A-1- 23A-2 illustrates a mouth shield device in accordance with another embodiment of the invention with umbrella-type valves and dental guard features.
  • FIGS. 24A-1- 24A-3 illustrates a mouth shield device in accordance with another embodiment of the invention with butterfly-type valves and dental guard features.
  • FIG. 24A- 1 is a view of the mouth shield device prior to insertion into the mouth
  • FIG. 24A-2 is a cross-sectional view
  • FIG. 24A-3 is a perspective view of the mouth shield device.
  • FIGS. 25 A- 1- 25A-2 illustrate an example of a polymer patch structure for slow release of active agents, in accordance with an embodiment of the invention.
  • FIGS. 26A-1- 26A-2 illustrate a mouth shield device in accordance with another embodiment of the invention with triangular-type valves and polymer patch-containing slow release active agents attached to dental guard features.
  • FIG. 26A-1 is a perspective view
  • FIG. 26A-2 is a top view.
  • FIGS. 27 A- 1- 27A-4 illustrate an exemplary mouth shield device for oral delivery of gases for CPAP therapy by means of a single rectangular-type one-way valve, in accordance with an embodiment of the invention, with FIG. 27 A- 1 being a side view of a CPAP-type mouth shield device with a cross-sectional view of an exemplary triangular-type valve, and FIG. 27A-2 is a top view of a CPAP-type mouth shield device before and after bending the mouth shield in order to insert the device into the mouth between the cheeks and lips.
  • FIG. 27A-3 is a perspective view, while FIG 27A-4 is an exploded view that highlights the triangular-type valve design.
  • FIGS. 28 A- 1- 28A-3 illustrate an in-use application by a patient of a CPAP-type mouth shield device for oral delivery of gases for CPAP therapy, in accordance with an embodiment of the invention, with FIG. 28 A- 1 being a cross-sectional side view of a CPAP- type mouth shield device before insertion into the mouth, and FIG. 28A-2 being a cross- sectional view of the CPAP-type mouth shield device in place in a patient’s mouth in the oral vestibular cavity which consists of the area between the lips, cheeks and teeth and extends laterally around the teeth, between the gums and cheeks.
  • FIG. 28A-3 illustrates an in-use application by an exemplary CPAP-type mouth shield device.
  • FIGS. 29A-1- 29A-3 illustrate an exemplary compact, miniature, light weight and strapless full-face, oronasal mask/mouth shield device module, equipped with a nasal pillow, that may be used for CPAP treatment, in accordance with an embodiment of the invention, with FIG. 29 A- 1 being an exemplary top view of the dual combination oronasal mask/mouth shield device module, and FIG. 29A-2 being a cross-sectional side view of the oronasal mask/mouth shield module, and FIG. 29A-3 is a perspective view of the oronasal mask/mouth shield module.
  • FIGS. 30A-1- 30A-3 illustrate another exemplary compact, miniature, light weight and strapless full-face, oronasal mask/mouth shield device module which is also equipped with a nasal pillow and a tongue depressor tube that may also be used for CPAP treatment, in accordance with an embodiment of the invention with FIG. 30A- 1 being an exemplary top view of the dual combination oronasal mask/mouth shield device module, and FIG. 30A-2 being a cross-sectional side view of the oronasal mask/mouth shield module, and FIG. 30A-3 is a perspective view of the oronasal mask/mouth shield module.
  • FIGS. 31A-1- 31A-2 Illustrate an in-use application by a patient of a miniature oronasal mask/mouth shield device module with a nasal pillow and tongue depressor tube for CPAP treatment, in accordance with an embodiment of the invention, with FIG. 31A-1 being a cross-sectional side view of an exemplary oronasal mask/mouth shield module, in place in a patient’s mouth, in the oral vestibular cavity between the lips, cheeks and teeth and extends laterally around the teeth, between the gums and cheeks, and FIG. 31A-2 is a top view of the oronasal mask/mouth shield device module before insertion into the oral vestibule and FIG. 31A-3 is a top view of the oronasal mask/mouth shield device module equipped with a tongue depressor, after insertion into a patient’s mouth.
  • FIGS. 31B-1- 31B-4 illustrate a face view of an in-use application of a miniature oronasal mask/mouth shield device module that is equipped with a nasal pillow as the nasal interface, in accordance with an embodiment of the invention, with FIG. 31A-1 being the oronasal mask/mouth shield device module in place in a patient’s mouth and with an additional nasal clip attachment feature on the oronasal mask/mouth shield device module, in accordance with an embodiment of the invention.
  • a front view of an exemplary oronasal mask/mouth shield device module with a nasal clip attachment is illustrated in FIG. 31B-2 before insertion into a patient’s mouth
  • FIGS. 31B-3 and 31B-4 illustrate a face view of an in-use application of an oronasal mask/mouth shield module, without a nasal clip, while in-use and before use, in accordance with an embodiment of the invention.
  • FIGS. 32A-1- 32A-3 illustrate a miniature nasal pillow mask/mouth shield device module, in accordance with another embodiment of the invention, with FIG. 32A-1 being a cross-sectional side view of a nasal pillow mask/mouth shield device module while in use in a patient’s mouth and for CPAP treatment through the nasal pillow mask, and FIG. 32A-2 being a cross-sectional side view of the nasal pillow mask/mouth shield device module for CPAP treatment through the oral means, while FIG. 32A-3 illustrate a face view of the nasal pillow mask/mouth shield device module while in use and before placement into a patient’s mouth, in accordance with an embodiment of the invention.
  • FIGS. 32B-1- 32B-4 illustrate a miniature oronasal mask/mouth shield device module and nasal mask/mouth shield device module with a nasal cushion as the nasal interface, in accordance with another embodiment of the invention, with FIG. 32A-1 being a face view of an in-use application of oronasal mask/nasal cushion/mouth shield device module, and FIG. 32B-2 being a face view of the module before placement into a patient’s mouth, and FIG. 32B-3 being a face view of an in-use application of nasal mask/nasal cushion/mouth shield device module, and FIG. 32B-4 being a face view of a nasal mask/nasal cushion/mouth shield device module before placement into a patient’ s mouth, in accordance with an embodiment of the invention.
  • FIGS. 33A-1- 33A-4 illustrate a mouth shield device configured for rescue breathing and for applications such as cardiopulmonary resuscitation (CPR) therapy, in accordance with another embodiment of the invention, with FIG. 33 A- 1 being an exploded view of the CPR mouth shield device module, and FIG. 33A-2 being a perspective view of the CPR mouth shield device, and FIG. 33A-3 being a cross-sectional side view of the CPR mouth shield device, and FIG. 33A-4 being a top view of the CPR mouth shield device, in accordance with an embodiment of the invention.
  • CPR cardiopulmonary resuscitation
  • FIGS. 34A-1- 34A-5 illustrate another embodiment of a mouth shield device configured with a long, curved tube means in cases where the victim is unconscious for applications such as cardiopulmonary resuscitation (CPR) therapy, in accordance with an embodiment of the invention
  • FIG. 34A-1 being a perspective view of one embodiment of the mouth shield device
  • FIG. 34A-2 being another embodiment of a CPR mouth shield device module with a tongue depressor tube attachment
  • FIGS. 34A-3, 34A-4 and 34A-5 are perspective, cross-sectional side view and top views, respectively, of exemplary CPR mouth shield devices configured with a long, curved tube means, in accordance with an embodiment of the invention.
  • FIGS. 35A-1- 35A-3 illustrate a rescuer applying CPR therapy by providing chest compressions and using a squeeze-bulb to provide hands-free rescue air, in accordance with an embodiment of the invention, with FIG. 35 A- 1 being a rescuer applying chest compressions, and FIG. 35A-2 being a cross-sectional side view of an exemplary CPR mouth shield device module while in use, and FIG. 35A-3 being a rescuer applying CPR therapy by using chest compressions and a squeeze-bulb to provide hands-free rescue air, in accordance with an embodiment of the invention.
  • Effective treatment of obstructive sleep apnea, snoring and dry mouth has posed a problem most often due to the invasive nature of the devices and lack of compliance due to discomfort and pain that is often associated with extended use of either oral or nasal-based devices.
  • Effective treatment of OSA requires a basic understanding of the elastic properties and compliance of the upper airways and the effect of aerodynamics at the region of the pharynx at the soft palate, on deformation of the upper airways, with changes in airway pressure and resistance during inspiration and expiration.
  • Airway resistance is not constant and is markedly affected by changes in the diameter of the airways and varies between inspiration and expiration.
  • the diaphragm and muscles attached to the rib cage contract.
  • the upper airway dilator muscle, the genioglossus muscle also contract to further open the gap between the tongue and the posterior pharyngeal wall.
  • This leads to an increased airflow and lung volume expansion which produces a negative increase in plural pressures, from -5 to about -8 cm H2O.
  • This negative pressure generates airflow due to a pressure difference between the atmosphere and alveolus, as air enters through either/or both nose or mouth, into the pharynx and trachea inflating the lung airways. Inhalation is therefore an active process as energy is expended during this event.
  • the present disclosure relates to a mouth shield device and methods for regulation of airflow and airway resistance of exhaled air as a means of providing and maintaining a residual amount of positive air pressure in the upper airways throughout the complete respiratory cycle and for restriction of mouth breathing.
  • the present disclosure also includes a mouth shield device and system and methods which allow oral inhalation, while promoting exhalating through the nasal route of the subject during use.
  • the present disclosure also includes a mouth shield device that is comfortable to wear and capable of delivering a defined air flow during inhalation and exhalation and related methods for controlling positive expiratory pressure during use.
  • Embodiments of the mouth shield device and methods disclosed herein promote nasal breathing during exhalation and maintaining upper airway positive pressure for continued dilation of the upper airways throughout the entire respiratory cycle.
  • the device includes a polymer piece configured for placement between the gums and lips and extend laterally and posteriorly between the gums and cheeks, and at least one one-way valve.
  • the valve system may include a vertically translating and expanding membrane or diaphragm to cover an orifice or channel and configured on the device to create a one-way valve action to prevent backflow.
  • the mouth shield device design and configuration create a barrier and shield between the inside and outside regions of the mouth to prevent air leaks and oral venting during use.
  • the valve system includes a passive membrane valve design that covers one or more openings through the thickness of the mouth shield device, that is normally closed and requires a pneumatic actuation (breath actuation) to raise the membrane to open the valve as the user inhales.
  • This valve design is configured to promote the nasal route for expiration and the oral route for inspiratory airflow, while maintaining upper airway positive pressure, as will be explained in further detail herein.
  • the mouth shield device includes and provides a mouth shield and a valve system designed to effectively control and maintain upper airway patency by providing positive airway pressures, for example, to fall within the range of 0.1 to 500 cm of 13 ⁇ 40, e.g. , between 0.1 and 50 cm of 13 ⁇ 40 or between 0.1 and 30 cm of 13 ⁇ 40.
  • the mouth shield device and valve system may be formed from any suitable material known in the art for such purposes.
  • the mouth shield device and valve elements may be composed of elastomeric biocompatible materials such as polyurethane, polycaprolactone, nylons, polyacrylamide, acrylics or polyacrylates (PMMA), cellulosic, polyesters, co-polyesters, polycarbonate, fluoropolymers, polyvinylchloride, silicones or PDMS, nitriles, polyethylene, polystyrene, polypropylene, natural or synthetic rubbers, copolymers, thermoplastic elastomers, copolymers and combinations thereof that are blended into polymers to enhance physical and chemical properties may be used for mouth shield device and valve designs and fabrication.
  • elastomeric biocompatible materials such as polyurethane, polycaprolactone, nylons, polyacrylamide, acrylics or polyacrylates (PMMA), cellulosic, polyesters, co-polyesters, polycarbonate, fluoropolymers, polyvin
  • the mouth shield device and valve designs may be manufactured and fabricated as a one-piece injection molded part that is composed of biocompatible, elastomeric materials such as nylons, polyacrylamide, polyurethanes, acrylics or polyacrylates, cellulosics, polyesters, co-polyesters, polycarbonate, polycaprolactone, fluoropolymers, silicones or PDMS, nitriles, polyethylene, polystyrene, polypropylene, natural or synthetic rubbers, copolymers and combinations thereof, with durometer Shore A hardness values within the range of 5 to 80, e.g., within the range of 10 to 60 or within the range of 20 to 50, or any combinations thereof.
  • biocompatible, elastomeric materials such as nylons, polyacrylamide, polyurethanes, acrylics or polyacrylates, cellulosics, polyesters, co-polyesters, polycarbonate, polycaprolactone, fluoropolymers, silicones or PDMS, nitriles
  • mouth shield devices of the disclosure may further include elastomeric membrane valve system designs and compositions which may provide the benefits of a pressure-driven, breath actuated mechanism.
  • the pneumatic, breath actuation create an air pressure and airflow when a differential pressure (AP) is reached that is enough to lift the elastomeric valve membrane elements to open the valve and facilitate a high-volume airflow during inhalation, while also allowing optimum sealing of the valve elements and therefore prevent backflow while exhaling.
  • AP differential pressure
  • valve mechanisms using elastomeric membrane valving systems and methods described herein may provide improved performance and valve actuation schemes for controlling the flow and
  • mouth shield devices of the disclosure may also be used to prevent or significantly reduce oral venting to reduce symptoms of nocturnal xerostomia, or dry mouth syndrome.
  • the mouth shield device may also include a dental guard feature, (as will be explained in further detail herein), that is located on the ends and sides of the device to keep molars and premolars of the posterior maxillary and mandibular teeth from contacting and function as a protective barrier for individuals who grind their teeth and for treatment of temporomandibular disorders (TMD), bruxism (grinding of teeth) or clenching.
  • a dental guard feature that is located on the ends and sides of the device to keep molars and premolars of the posterior maxillary and mandibular teeth from contacting and function as a protective barrier for individuals who grind their teeth and for treatment of temporomandibular disorders (TMD), bruxism (grinding of teeth) or clenching.
  • the dental guard feature of the mouth shield device may contain polymer patches containing active agents for slow release and delivery of components such as Xylitol or Sorbitol to stimulate saliva production for treatment of dry mouth syndrome and for treatment or prevention of plaque formation between one’s teeth during sleep.
  • active agents may include ingredients, for example, to mask bad breath or covering the offensive odors which may develop during sleep with a variety of herbal, fruity or candy inspired smells.
  • active agents contained in polymer patches may also include components which may reduce cavity production or provide relief from halitosis (bad breath).
  • breath freshening ingredients may also include, mint, cinnamon peppermint, wintergreen, apple, ginger, tangerine, strawberry, chocolate, etc.
  • polymer patches containing active agents may consist of porous polymeric materials which may be water-soluble, water insoluble, or one or more combinations thereof.
  • specific examples include, but are not limited to, carboxymethyl cellulose (CMC), hydroxy-propyl-methylcellulose (HPMC), hydroxyethyl cellulose, (HEC), hydroxypropyl cellulose (HPC), starch, xanthan gum, acacia gum, guar gum, polyvinyl pyrrolidone (PVP), methyl-methacrylate copolymer (MMA), polyvinyl alcohol, sodium alginate, polyethylene glycol, polyacrylic acid, copolymers and combinations thereof.
  • CMC carboxymethyl cellulose
  • HPMC hydroxy-propyl-methylcellulose
  • HEC hydroxyethyl cellulose
  • HPC hydroxypropyl cellulose
  • PVP polyvinyl pyrrolidone
  • MMA methyl-methacrylate copolymer
  • polyvinyl alcohol sodium alginate,
  • mouth shield devices containing a dental guard feature and valve systems may be formed from any suitable material known in the art for such purposes.
  • the mouth shield device, mouth guard and valve elements may be composed of thermoplastic elastomers such as silicone rubber, EPDM (ethylene propylene diene monomer), polyurethanes, fluoroelastomers, or nitriles, etc., with durometer Shore A hardness values within the range of 5 to 80, e.g., within the range of 10 to 60 and or within the range of 20 to 50.
  • the presence of one-way valves in mouth shield devices may provide positive expiratory airway pressure in the upper airways by preventing oral venting, while promoting the use of the nasal route for exhaling. Since nostril openings are smaller, (10 to 12 mm in diameter) than the oral passageway, (39 to 70 mm in diameter), exhaling through the nose creates a back pressure and backflow of air into the lungs, which may provide an additional benefit of increasing the residency time of air in the lungs and thus allow an increased amount of time for the alveolar system to extract oxygen from the inhaled air.
  • exhaling through the nose may also provide additional benefits by reducing evaporative water loss sustained during oral breathing and therefore minimize or prevent dry mouth syndrome during use.
  • FIGS. 1A-1 - 2A-2 a treatment device including a mouth shield device 100, is illustrated in use by a patient, in accordance with an embodiment of the invention, with FIG. 1A-1 being a front view of the mouth shield device while in use, FIG. 1A-2 being a front view of the mouth shield device before placement into the mouth and FIG. 1A-3 being a front view of the mouth shield device before it is folded for insertion into the mouth.
  • FIG. 2A-1 illustrates a side view of the device 100 while in use by a patient, and FIG. 2A-2 is a side view of the device before use.
  • the mouth shield device 100 includes a polymer piece 102 configured to fit within a mouth of an individual to create a barrier and shield between inside and outside regions of the mouth, i.e., between the oral cavity and the buccal sulcus, to reduce oral breathing.
  • the polymer piece may be planar and preferably has an oblong shape with a perimeter 105 having two long sides 110, 110’ and two short sides 120, 120’.
  • a length / of the polymer piece may range from 60 mm to 180 mm.
  • the polymer piece is long enough to extend laterally and posteriorly to cover the molars and between the gums and cheeks, while being short enough to fit into the mouth.
  • a width Wi of the polymer piece may range from 15 mm to 50 mm.
  • the polymer piece is wide enough to extend vertically to fill the maxillary and mandibular vestibular space, while being narrow enough to fit into the mouth.
  • a thickness t of the polymer piece may be uniform, or may have tapered edges, with the thickness ranging from about 0.1 mm to about 10 mm, e.g., about 0.2 mm to about 5 mm, or 0.5 mm to 3 mm, and combinations thereof.
  • the perimeter 105 may define indents 125, 125’ proximate a center 127 of the mouth shield device at top and bottom portions of the oblong shape.
  • a distance W2 between the two long sides at a center portion of the shape may be shorter than a distance wi between the two long sides at a portion of the shape proximate the center portion of the polymer piece, thereby defining the indents.
  • the mouth shield device 100 may contain one or more one-way valves 130 forming openings or orifices 135 extending through a thickness of the polymer piece.
  • the one-way valves may have a combination of shape and size configured to provide a differential pressure between inside and outside regions of the mouth during oral breathing.
  • the valve openings may be configured to provide pressure gradients between the device and the patient’s airways in the range of 0.1 to 500 cm of H O, and e.g., between 0.1 and 50 cm of 13 ⁇ 40 or between 0.1 and 30 cm of H O, including all values and increments therein.
  • the one or more one-way valves are disposed at a center portion 137 of the oblong shape, an example of which is defined by the dot-dash rectangle in FIG. 1A-3. This placement may minimize or prevent potential blocking of valve openings by the lips while patients inhale.
  • center portion refers to a portion of the mouth shield approximately halfway between the two long sides and removed from, i.e., not abutting, the two short sides.
  • the one-way valves are formed integrally with the polymer piece; a sidewall of each valve may be defined by the polymer piece.
  • This configuration is shown in more detail in, e.g., Figures 4A-1 - 4A-3 and 5A-1 - 5A-2.
  • the one-way valve is a separate element that is inserted into and restricted by the polymer piece.
  • the polymer piece may be made from a biocompatible, elastomeric material, such as polyurethane, polycaprolactone, nylons, polyacrylamide, acrylics, polyacrylates (PMMA), cellulosic compounds, polyesters, co-polyesters, polycarbonate, fluoropolymers, polyvinylchloride, silicones, PDMS, polyethylene, polystyrene, polypropylene, natural rubbers, synthetic rubbers, thermoplastic elastomers, nitriles, copolymers, and combinations thereof.
  • a biocompatible, elastomeric material such as polyurethane, polycaprolactone, nylons, polyacrylamide, acrylics, polyacrylates (PMMA), cellulosic compounds, polyesters, co-polyesters, polycarbonate, fluoropolymers, polyvinylchloride, silicones, PDMS, polyethylene, polystyrene, polypropylene, natural rubbers, synthetic rubbers, thermoplastic elastomers,
  • the biocompatible, elastomeric material may have a hardness of at least one of (i) a durometer Shore A hardness value selected from a range of 5 to 90 or (ii) a durometer Shore 00 hardness selected from a range of 5 to 100.
  • FIGS. 3A-1 - 3A-3 illustrate a top view and front view of the exemplary mouth shield device 100.
  • the mouth shield device configuration is designed to create pressure gradients by blocking oral airflow through or around the device during exhalation in order to achieve sufficiently high intraoral dilation forces required to resist the collapse of the upper airways.
  • FIG. 3A-1 is a top view of the device before insertion into the mouth between the lips and gums by a user.
  • mouth shield devices may be composed of elastomeric, biocompatible materials with a low modulus of elasticity that are sufficiently flexible to change shape to conform to the shape of the mouth as it is inserted between the lips and gums by a user (FIG. 3A-2).
  • the mouth shield device and valve systems may be formed from elastomers with durometer Shore A hardness values within the range of 5 to 80, e.g., within the range of 10 to 60 or within the range of 20 to 50 and corresponding Young’s Modulus values within the range of 0.6 to 3.5 MPa, e.g., within the range of 0.7 to 2.2 MPa, or within the range of 0.8 to 1.7 MPa.
  • the valve system of the mouth shield device may have a plurality of openings or orifices or channels that are generally cylindrical, oval, rectangular, triangular or other geometrical shape.
  • the plurality of openings may range in average diameter from about 1 mm to about 40 mm, about 2 mm to about 30 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, and combinations thereof.
  • valve openings may have the same or different shapes or diameters, e.g., some may have an average diameter in a range of about 1 mm to about 5 mm, and others may have an average diameter of about 10 mm to about 15 mm, etc.
  • elastomeric membrane structures that cover valve openings may have a planar, non-planar, curved or other geometrical shape with a very small thickness (z direction) in comparison to the x-y dimensions, i.e., the width of the membrane covering valve openings. It is known in the art that the pressure required to deflect membranes increases with increased thickness (S. Timoshenko, S. Woinowsky-Krieger, Theory of Plates and Shells, 2nd, McGraw-Hill Book Company, New York, 1959) as well as material composition.
  • elastomer membrane valve covers may range in thickness from about 0.02 mm to about 2 mm, about 0.05 mm to about 2 mm, about 0.1 mm to about 2 mm, and combinations thereof.
  • elastomeric membrane elements of valves and valve covers may have the same or different shapes and have an average thickness in the range from about 0.1 mm to about 2 mm, and others may have an average thickness of about 1 mm to about 2 mm, etc.
  • valves of different shapes, sizes, diameters and designs may be used to generate airflows across the mouth shield device with very low resistance and high-volume during inhalation, while providing increased airway resistance for maintaining increased upper airway expiratory pressures, while exhaling.
  • valve systems may be designed and configured to prevent or significantly reduce oral venting which may reduce symptoms of nocturnal xerostomia, or dry mouth syndrome.
  • FIG. 3A-3 an exemplary device is illustrated with four one-way valves 130.
  • the number of valve openings and valve designs may be selected accordingly.
  • FIGS. 4A-1 -7B-3 illustrate further embodiments of the invention in which mouth shield devices with other exemplary valve systems designs and geometrical cross-sectional shapes are provided.
  • These exemplary designs, as described herein, may be suitable for controlling a range of airway resistance, pressure-drop and airflow rates required to effectively control and maintain upper airway patency throughout the entire respiratory cycle.
  • FIGS. 4A-1 - 4A-3 are face view and cross-section views of the exemplary mouth shield device 100 of FIGS. 1A-1 - 1A-3 with one-way valves 430 having a triangular, cross-section design, in accordance with an embodiment of the disclosure.
  • the triangular-shaped one-way valves contain valve elements 430A that are oriented to open at a given pressure during inhalation and close during exhalation to restrict airflow.
  • the triangular one-way valves 430 are preferably formed integrally with the polymer piece to provide increased safety by improving device integrity, durability, and prevent possible detachment of the valve elements 430A from the polymer piece during washing or while in use.
  • FIG. 4A-2 being a cross-section of an exemplary mouth shield device with valves having a triangular-shaped, one-way valve design
  • FIG. 4A-3 illustrates a normally closed, triangular-shaped one-way valve 430 with valve elements 430A, i.e., sidewalls, that open to allow airflow into the lungs as a patient inhales (arrows), and close to block airflow when the patient exhales.
  • FIG. 5A-1 being a front view of the mouth shield device 100 before insertion into the mouth
  • FIG. 5A-2 being a view of the triangular valve structure as viewed by a patient before insertion into the mouth, in accordance with an embodiment of the invention.
  • FIGS. 6A-1 - 6A-3 another embodiment of the mouth shield device 100 includes one-way dome-shaped valves 630, with FIGS. 6A-1 - 6A-2 being a face view and a perspective view of a mouth shield device 100, respectively.
  • the dome-shaped one way valves 630 are preferably formed integrally with the polymer piece in order to provide increased safety by improving device integrity, durability and avoid possible detachment of the valve from the polymer piece during washing or while in use.
  • the dome shaped one-way valves contain valve elements 630A that are oriented to open at a given pressure during inhalation and close during exhalation to restrict airflow. Referring again to FIG.
  • the cross-sectional view of the mouth shield device 100 illustrates a dome-shaped valve structure 630 that may have one or more elastomer valve elements 630A that are fabricated from biocompatible, elastomeric materials with preferably a low modulus of elasticity of at least one of (i) a durometer Shore A hardness value selected from a range of 5 to 90 or (ii) a durometer Shore 00 hardness selected from a range of 5 to 100.
  • the dome shaped valve design may also provide a pneumatic, breath-actuated, and pressure-driven mechanism that lifts and opens the valve elements 630A, when the valve opening force is achieved, as the user inhales and close during exhalation.
  • these designs and methods also provide an increased resistance to airflow since the elastic valve elements are normally closed and therefore seal and cover valve openings 635 as the user exhales.
  • FIGS. 7A-1 -7B- 3 illustrate a mouth shield device with one-way butterfly-type valves 730, also referred to in the industry as umbrella-type valves.
  • the one way butterfly type valve 730 are inserted into and restricted by the polymer piece, 100, in accordance with another embodiment of the invention.
  • a perspective view of the butterfly- type valve 730 is shown in FIG. 7B-1, while FIG. 7B-2 illustrates a more detailed, cross- sectional view of the one-way butterfly-type valve design with biocompatible, elastomeric valve elements 730A configured to provide a sealing or closure mechanism for valve openings 735 when the user exhales.
  • a valve stem 740 secures the butterfly valve in place, which is formed integrally with the polymer piece to provide increased safety by improving device integrity, durability and avoid possible detachment of the valve from the polymer piece during washing or while in use.
  • the elastomeric membrane elements 730A of the one-way butterfly-type valve 730 flex to lift and open the valve element structure 730A when the valve opening pressure and force is achieved, to create an airflow as the user inhales and close during exhalation.
  • FIG. 7B-3 six valve openings 735 are displayed, however, one or more openings with either circular or other geometrical shapes may be used in accordance with aspects of the invention.
  • valve 8A-1 illustrates the relationship between the valve opening pressure required to open exemplary elastomeric butterfly-type valve elements 730A of the disclosure as a function of airflow, for various valve element thickness (1.4 mm, 1.5 mm, 1.6 mm, and 1.7 mm) and for valves composed of 50 durometer silicone. Without intending to be limited by theory, the forces applied on valve membrane elements are frequently
  • elastomeric membrane structures that cover valve openings may have a generally planar, curved or other geometrical shape with a very small thickness in the planar dimensions (z direction) in comparison to the x-y dimensions i.e., width of the membrane covering valve openings.
  • the pressure required to deflect membranes increases with increased thickness (S. Timoshenko, S. Woinowsky-Krieger, Theory of Plates and Shells, 2nd, McGraw-Hill Book Company, New York, 1959), mechanical properties, and adhesion forces between the membrane and valve opening.
  • optimization of the elastomeric membrane material properties, as defined by their Young’s Modulus, in combination with the valve membrane element thickness allows a manner and method for designing valves that open at a given pressure to provide the desired airway resistance, pressure-drop and airflow rates required to effectively control and maintain upper airway patency throughout the entire respiratory cycle.
  • FIG. 8A-2 the relationship between durometer Shore A hardness and Young’s Modulus is illustrated.
  • valve material properties most suitable for effective control of airway resistance, pressure drop and airflow rates may be chosen from the range in Share A Durometer scale values within the range of 5 to 80, e.g., within the range of 10 to 60 and or within the range of 20 to 50 and corresponding Young’s Modulus values within the range of 0.6 to 3.5 MPa, e.g., within the range of 0.6 to 2.2 MPa, or within the range of 0.8 to 1.7 MPa.
  • any suitable method may be used to manufacture the mouth shield device with one or more openings and associated valve designs, as may be known in the art and as may be suitable for the material of interest.
  • injection molding, compression molding, extrusion molding, etc. may be used.
  • Injection molding, either one-shot or two- shot is an established process for industrial applications and well suited for fabrication of either one-piece or two-piece fabrication of mouth shield and valve designs.
  • embodiments of the invention are not limited to any one manufacturing method, and any suitable method may be used.
  • the mouth shield device and valve designs may be manufactured and fabricated as a one-piece injection molded part that is composed of biocompatible, elastomeric materials such as nylons, polyacrylamide, polyurethanes, acrylics or polyacrylates, cellulosics, polyesters, co-polyesters, polycarbonate, polycaprolactone, fluoropolymers, silicones or PDMS, nitriles, polyethylene, polystyrene, polypropylene, natural or synthetic rubbers, copolymers, and combinations thereof.
  • biocompatible, elastomeric materials such as nylons, polyacrylamide, polyurethanes, acrylics or polyacrylates, cellulosics, polyesters, co-polyesters, polycarbonate, polycaprolactone, fluoropolymers, silicones or PDMS, nitriles, polyethylene, polystyrene, polypropylene, natural or synthetic rubbers, copolymers, and combinations thereof.
  • butterfly- type valve systems 730 may be mounted on mouth shield devices as shown herein.
  • the data provided herein support the selection of designs for valve systems and elastomeric valve elements that open at a given pressure to provide the desired airway resistance, pressure-drop, and airflow rates required to effectively control and maintain upper airway patency throughout the entire respiratory cycle.
  • a mouth shield device in another embodiment of the invention, includes one-way membrane-type valves 930, each having one elastomeric, membrane-type element 930A that covers one opening.
  • the size, number and shapes of valve holes or openings 935 in the mouth shield device, containing elastomeric membrane-type valve elements 930A may also be configured to deliver a desired airway resistance, pressure- drop and airflow rates required to effectively control and maintain upper airway patency throughout the entire respiratory cycle.
  • Membrane-type valves 930 with elastomeric valve covers may provide the benefits of a pressure-driven, breath actuated mechanism that creates an airflow when a force is reached to lift the elastomeric elements of the valve covers from valve openings to facilitate a high- volume airflow during inhalation, while also providing the sealing of valve openings by preventing backflow, while exhaling.
  • the lifting and opening of elastomeric valve elements during inhalation provide a very low resistance and high-volume airflow across the mouth shield device during inhalation, while providing a seal of the valve openings to prevent or minimize exhalation through the mouth and therefore, promote nasal breathing.
  • pressure-driven valve designs and types described herein provide elastomeric valve element designs that are breath actuated and configured to create an airflow and force to lift the elastomeric element from valve openings as the user inhales to deliver a unidirectional airflow, when opened and closed to prevent backflow as the user exhales.
  • Valve designs in accordance with embodiments of the invention may also provide one-way valve structures and designs capable of altering airflow and airway resistance, according to their orientation and the direction of airflow, e.g., as the user inhales or exhales.
  • valve types and methods are not intended to be limiting and may include rectangular-shaped valves, triangular-shaped valves, membrane-type valves, dome-shaped valves, umbrella-type valves, or butterfly-type valves, for example, with either one or multiple openings whose size, number, shape and orientation may provide the desired pressure drop, airway resistance and airflow in the upper airways.
  • FIGS. 10A-1 to 10A-4 illustrate an exemplary one-way valve open and close mechanism for triangular-type one-way valve 430 designs, in accordance with an embodiment of the disclosure.
  • the preferred geometrical shape for an exemplary valve design is a valve with a rectangular or oval-shape opening 435 and with elastomeric valve elements, forming a triangular cross-section.
  • the base of the triangle forms the valve opening (FIG. 10A-3) through which the direction of airflow is defined.
  • the sides of the triangle are free to flex and part to open at the apex of the triangle (FIG. 10A-1).
  • the direction of the one way airflow through the valve (arrows) is defined by the orientation of the triangle base on the mouth shield device.
  • valves When air flows from the base to the apex, the valve opens; when air flows in the reverse direction, from the apex to the base, the valve elements are compressed and forced to close the valve, at the apex, by the air pressure.
  • one-way valves are normally closed and provide a breath-actuated, pressure-driven mechanism that lift and open the valve elements when the valve opening force is achieved, as the user inhales and close during exhalation.
  • the rectangular opening 435 may have a length of, e. g., 10 mm and a width of, e. g., 4 mm.
  • valve diameters that yield the least airway resistance and lowest user effort during inhalation may be preferred. Referring to FIG. 17, guidelines are provided which suggest using valve diameters in mouth shield devices that are greater than 6 mm in diameter in order to minimize airway resistance and maximize user comfort during use.
  • FIG 4A-3 a cross-sectional view of an exemplary triangular one-way valve 430 design is shown before use, while FIGS, 10A-1 to 10A-4 illustrate more detailed views of an exemplary triangular-type elastomeric valving mechanism that is pressure actuated and pressure driven while in use.
  • FIGS. 10A-1 - 10A-2 illustrate cross-section and top-views of a triangular-type one-way valve 430, with an exemplary pressure-driven valve mechanism in an open configuration, as a user inhales and FIGS. 10A-3 - 10A-4 being a closed valve configuration, while the user exhales. Expansion and dilation of the elastomeric valve elements 430A during inhalation (FIGS.
  • the elastomeric, pressure-driven valving mechanism may further reduce or prevent exhalation through the mouth and therefore, promote nasal breathing and reduce or eliminate oral venting and symptoms associated with nocturnal xerostomia, or dry mouth syndrome.
  • FIGS. 11A-1 - 11A-2 The pressure-driven valve opening mechanism of dome-shaped one-way valves, previously described in FIG. 6A-3, is illustrated in more detail in FIGS. 11A-1 - 11A-2.
  • the direction of the one-way airflow through the valve 630 (as indicated by arrows) is defined by the orientation of the dome on the mouth shield device.
  • the highly elastomeric nature and compliance of the dome-shaped valve design illustrated in FIG. 11A-1 facilitate an expansion of the valve elements 630A during inhalation and provide a system and method for allowing high airflow and reduced airway resistance while also providing an increased airway resistance and reduced airflow through the valve opening 635 as the user exhales, FIG. 11A- 2.
  • FIGS. 12A-1 - 12A-5 illustrate another embodiment of the mouth shield device, in which FIG. 12A-1 is a perspective view of one butterfly-type valve 730 including elastomeric butterfly-type valve elements 730A and a valve stem 740 that positions and holds the butterfly-type 730 valve and elastomeric valve elements 730A over the valve openings 745 on the polymer piece.
  • FIG. 12A-2 is a cross-sectional view of the butterfly- type valve 730 and its structural features, elastomeric valve elements 730A, valve stem 740 and valve opening 735 configurations.
  • FIG. 12A-3 illustrates a lay-out of six valve openings 745, corresponding to a single butterfly-type valve 730.
  • FIGS. 12A-1 is a perspective view of one butterfly-type valve 730 including elastomeric butterfly-type valve elements 730A and a valve stem 740 that positions and holds the butterfly-type 730 valve and elastomeric valve elements 730A over the valve openings 745 on
  • FIGS. 12A-4 - 12A-5 illustrate an exemplary one-way valving mechanism of butterfly-type valve 730 designs in which during inhalation (FIG. 12A-4) the elastomeric butterfly-type valve elements 730A are pressure actuated and flex and expand to uncover the valve openings 735 and provide airflow into the lungs as the user inhales and close (FIG. 12A-5) during exhalation.
  • the numerical example provided in FIG. 8, in combination with FIGS. 12A-4 - 12A-5 illustrate the effect of material selection (e.g., silicone with 50 Shore A hardness), and butterfly-type valve element 730A thickness on airflow.
  • material selection e.g., silicone with 50 Shore A hardness
  • valve structures and designs may also be configured as butterfly-type valves. More detailed views of butterfly-type valve structures containing six (FIGS. 12A-1 - 12A-5), four (FIGS. 13A-1 - 13A-5), or two (FIGS. 14A-1 - 14A-5) valve openings 745 or any combination thereof, is provided.
  • valve elements 730A facilitate a pressure actuated and pressure driven expansion of the butterfly-type valve elements 730A during inhalation to provide high volume airflow and reduced airway resistance while allowing an increased airway resistance and reduced airflow through the valve opening 735 as the user exhales.
  • all butterfly- type valves have structural features in common which include, a center portion, i.e., a valve stem, 740 which positions and holds the elastomeric valve elements 730A over the valve openings 745 and secures the butterfly valve, which may be formed integrally with the polymer piece in order to provide increased safety by improving device integrity, durability and avoid possible detachment of the valve from the polymer piece during washing or while in use.
  • valve structures and designs may also be configured as membrane-type valves 930 that include elastomeric valve elements 930A that cover one or more valve openings 935 that are generally cylindrical, oval, rectangular or other geometrical shape.
  • membrane-type valves also have a similar functional feature as other one-way valves described herein, as being pneumatic, breath- actuated, and pressure-driven. When the valve opening force is achieved, the valve elements expand and lift to uncover the valve opening as the user inhales and close during exhalation.
  • FIG. 15A-1 - 15A-2 more detailed views of a membrane-type valve structure 930 is illustrated, with FIG. 15A-1 being a cross-sectional view of the membrane-type, one way valve in the open state, after a user inhales and closed, FIG. 15A-2 during exhalation.
  • Numerical examples may further help in appreciating the effect of valve opening diameter on pressure drop or pressure gradient (DR) and airway resistance across valve openings as a function of valve diameter.
  • the airway resistance (R) or pressure gradient (DR) to airflow through an orifice is directly related to the valve orifice shape, diameter, and length as described by the Hagen-Poiseuille Law.
  • the pressure-drop across a mouth shield device with circular openings and under conditions of laminar flow which is obtained for low volume flows during quiet breathing is given by:
  • a P Pressure difference between the inside of mouth and atmosphere
  • V the volumetric flow rate
  • FIGS. 16 - 17 illustrates the relationship between differential pressure across a polymer piece of a mouth shield device 100 as a function of valve hole diameter, for air flow through circular valves during quiet breathing at 0.3 L/s.
  • FIG. 17 illustrates the relationship between air flow resistance and valve hole diameter for air flow through circular valves during quiet breathing at 0.3 L/s.
  • FIGS. 18A-1 - 24A-3 in accordance with embodiments of the invention, mouth shield device designs with dental guard features 800 and exemplary one way valve designs of the invention are illustrated.
  • Dental guard features are formed integrally with the polymer piece 100 and protrude therefrom.
  • Dental guard features are located on the ends and sides of devices and adapted to prevent teeth grinding and having a thickness sufficient to prevent contact of molars of a user.
  • Dental guard features also function as a protective barrier for individuals who grind their teeth and for treatment of
  • the thickness of the dental guard feature may be selected from a range of 0.05 mm to 12 mm, e.g., between a range of 1 mm and 8 mm and most or within the range of 2 mm to 5 mm.
  • FIGS. 18A-1 - 21A-2 illustrate mouth shield devices and mouth guard features with one configuration and one-way valve design 430 with triangular-type valve mechanism.
  • a mouth shield device 100 includes dental guard features 800, formed integrally with the polymer piece and located on the ends and sides of the device to keep molars and premolars of the posterior maxillary and mandibular teeth from contacting.
  • Dental guard features may also function as a protective barrier for individuals who grind their teeth and for treatment of
  • FIG. 18A-1 illustrate a top view of an exemplary mouth shield device, before insertion into the mouth between the lips, cheeks and gums by a user.
  • the dental guard feature may be increased in length, thickness and extend forward into the mouth to protect, in addition to molars and premolars, canines and incisors, as well as extend in width over the tongue to reduce damage to teeth and prevent or minimize noise associated with bruxing or teeth grinding.
  • mouth shield devices 100 and dental guard features 800 may be made from elastomeric, biocompatible materials with a low modulus of elasticity that are sufficiently flexible to change shape to conform to the shape of the mouth during insertion between the lips and gums by a user (FIG. 18A-2).
  • the polymer piece of the mouth shield device, dental guard features and valving system may each be formed from biocompatible, elastomers having at least one of (i) a durometer Shore A hardness value selected from a range of 5 to 90 or (ii) a durometer Shore 00 hardness value selected from a range of 5 to 100, with durometer Shore A hardness values, e.g., within the range of 10 to 60 or within the range of 20 to 50.
  • the dental guard features may be made from a material stiffer or harder than that of the polymer piece. However, for high throughput manufacturing of the mouth shield, it may be preferred to use the same material for both the polymer piece and the dental guard features.
  • the thickness dependence of polymer flexibility and elastic modulus provides a means of controlling the performance of structural features of the polymer piece since the force required to deflect polymer membranes decreases with decreased thickness.
  • a rearrangement of terms for the three -point flexural test for calculation of flexural stress for a rectangular cross-section may further help in appreciating the effect of polymer film thickness on polymer flexibility and stiffness, as measured by the force required to bend a film.
  • the relationship between film thickness and maximum force required to bend the polymer film is given by:
  • the flexibility of a polymer film increases as the force required to bend the film decreases with film thickness and is directly related to its thickness to the second power.
  • This design parameter may further facilitate tool design for device manufacturing, since a single biocompatible elastomeric material may be chosen for construction of an entire mouth shield device module, which may also facilitate high- volume manufacturing.
  • indents 125, 125’ are illustrated for a mouth shield device, in accordance with an embodiment of the invention.
  • the indents 125, 125’ are notches or slots that are located at the top and bottom of the mouth shield device, proximate the center of the mouth shield device, and provide a mechanism for prevention of excessive saliva buildup in front of the mouth shield device while in use.
  • mouth shield designs produce a tight seal between the mouth shield device 100 and cheeks and lips in order to prevent exhale through the mouth, the presence of indents 125, 125’ also provides a mechanism for pressure release when patients cough.
  • Mouth shield device designs and configurations also create a barrier and shield between the inside and outside regions of the mouth to prevent air leaks around the mouth shield device edges, and to reduce oral venting during use.
  • FIGS. 20A-1 - 20A-4 illustrate a mouth shield device with a perimeter 105 surrounding the central region with tapered, thin edges t, in accordance with another embodiment of the invention.
  • the tapered edge features 850 are designed to prevent air leaks around the edges of the mouth shield device by promoting adhesion to the buccal vestibule by flexing and conforming to the buccal surfaces as the user breathes and moves during use.
  • FIG. 19A-1 is a view of the mouth shield device 100, before insertion into the mouth and FIG. 19A-2 is a cross-sectional view of an exemplary mouth shield device with valves having a triangular-type one-way valve design, in accordance with an embodiment of the invention. Also illustrated in FIG. 19A-3 is a cross-sectional view of a normally closed, triangular-type one-way valve, with valve elements 430A, that are breath actuated and pressure-driven to open to allow airflow into the lungs as a patient inhales (arrows), and close to block airflow when the patient exhales.
  • FIG. 20A-1 is a top view of the mouth shield device 100 before insertion into a user’s mouth and FIG. 20A-2 is a perspective view, and FIGS. 20A-3 and 20A-4 are a front view and cross-section views in which the outer perimeter 105 of the oblong-shaped polymer piece 100 may have a thickness t that may be uniform, or may have tapered edges 850, with an average thickness in the range from about 0.02 mm to about 10 mm, about 0.2 mm to about 5 mm, about 0.5 mm to about 3 mm, and combinations thereof.
  • the illustrated mouth shield device also has dental guard features 800.
  • FIGS. 21A-1 - 24A-3 illustrate and provide examples of the above-mentioned valve types with dental guard features 800, in accordance with an embodiment of the invention with FIG. 21A-1, being a perspective view of a curve-shaped mouth shield device with triangular-type valves before insertion into the mouth and FIG. 21A-2 being a front view of the curved mouth shield device.
  • FIGS. 22A-1 - 22A-3 illustrate another mouth shield device design with a mouth guard feature in accordance with an embodiment of the invention, with still another valve design, which provides a dome-type valve 630 mechanism.
  • FIG. 22A-1 is a view by a user before insertion into the mouth
  • FIG. 22A-2 is a cross-sectional view
  • FIG. 22A-3 is a perspective view of a mouth shield device 100 with mouth guard features 800 and dome shaped valves 630.
  • FIGS. 23A-1 - 23A-2 illustrate still another mouth shield device design with butterfly-type one-way valves 730, and mouth guard features in accordance with an embodiment of the invention, with FIGS. 23A-1 being an exploded view of the device showing the placement of the butterfly-type valves 730 onto the polymer piece 100 and FIG. 23A-2 being a perspective view of the device with the butterfly valves attached to the polymer piece 100.
  • FIGS. 24A-1 - 24A-3 illustrate still another mouth shield device design with a membrane-type valve design 930, and mouth guard features 800 in accordance with an embodiment of the invention, with FIG. 24A-1 being a view of the device by a user before insertion into the mouth, FIG. 22A-2 being a cross-sectional view and FIG. 22A-3 being a perspective view of a mouth shield device with mouth guard features and membrane-type valves.
  • the valve mechanisms and designs may include one or more openings that are generally cylindrical, oval, rectangular or other geometrical shape.
  • polymer patches 900 are provided for attachment to the dental guard features 800 of the mouth shield device.
  • the polymer patches 900 provide a means for oral drug delivery and may contain an active agent such as a breath freshener, a flavor, or a medicament, for example a pharmacological agent with activity such as a decongestant, anti-histamine, anti-inflammatory, anti-bacterial, analgesic etc., for possible treatment of dry mouth and other common upper respiratory tract infections, or for systemic delivery of medication during use.
  • components such as Xylitol or Sorbitol may be delivered slowly to stimulate saliva production for treatment of dry mouth syndrome and for treatment or prevention of plaque formation between one’s teeth during sleep.
  • a polymer patch structure may contain active agents for slow release of ingredients that may mask bad breath or cover the offensive odors that may develop during sleep with a variety of herbal, fruity or candy inspired smells. Active agents contained in patches may also include components that may reduce cavity production or provide relief from halitosis (bad breath).
  • breath freshening ingredients may also include mint, cinnamon, peppermint, wintergreen, apple, ginger, tangerine, strawberry, and/or chocolate, etc.
  • the patches containing active agents may be made of porous polymeric materials that may be water-soluble, water insoluble, or one or more combinations thereof. Specific examples include but are not limited to carboxymethyl cellulose (CMC), hydroxy-propyl-methyl cellulose (HPMC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), starch, xanthan gum, acacia gum, guar gum, polyvinyl pyrrolidone (PVP), methyl-methacrylate copolymer (MMA), polyvinyl alcohol, sodium alginate, polyethylene glycol, polyacrylic acid, copolymers and combinations thereof. These compositions may also serve as adhesives 910 for adhesive bonding and attachment of patches to mouth guard features.
  • CMC carboxymethyl cellulose
  • HPMC hydroxy-propyl-methyl cellulose
  • HEC hydroxyethyl cellulose
  • HPC hydroxypropyl cellulose
  • PVP polyvinyl pyrrolidone
  • MMA methyl
  • FIGS. 26A-1 - 26A-2 illustrate an embodiment of the invention in which patches 900 containing one or more exemplary active agents are disposed on mouth guard features 800 of an exemplary mouth shield device 100.
  • FIGS. 27A-1 - 27A-4 an embodiment of a mouth shield device 1000 design with a single one-way valve 1030 and dental guard features is illustrated.
  • a tube 1040 is centered on the polymer piece proximate to the center portion of the mouth shield device and extends from the front of the mouth shield device 1000 to provide a means for connection of a breathing assist device, such as a mechanical ventilator or a portable Continuous Positive Airway Pressure (CPAP) machine to provide assistance in facilitating oral breathing or for delivery of heated, humidified air.
  • a breathing assist device such as a mechanical ventilator or a portable Continuous Positive Airway Pressure (CPAP) machine to provide assistance in facilitating oral breathing or for delivery of heated, humidified air.
  • the mouth shield device may be removably couplable to the breathing assistance device.
  • a triangular-type one-way valve 1030 provides a means for oral delivery of gases for CPAP therapy while also sealing the mouth to prevent exhale through the mouth.
  • design features such as the oblong-shape of the polymer piece and the soft, elastomeric biocompatible material construction provide a comfortable fit into the buccal vestibule.
  • the elastomeric material construction also provides a polymer piece that conforms to the user’s mouth, extending laterally around the molars and vertically over the maxillary and mandibular teeth and gums.
  • the material selection and mouth shield designs may also lead to a compact structure that is light weight and held in place without the need of straps or other means to hold the mouth shield device in place during CPAP therapy.
  • FIG. 28A-1 - 28A-2 illustrate cross-sectional views of a mouth shield device 1000 inserted, in use, into a patient’s mouth (28A-1).
  • the oblong-shaped mouth shield device, FIG. 28A-2 is formed from a soft, elastomeric biocompatible material which is flexible and conforms to the user’s mouth.
  • the mouth shield device 1000 When the mouth shield device 1000 is placed in the user’s mouth, it conforms to the shape of the mouth, and is placed between the cheeks/lips and gums and extends further, laterally into the buccal vestibule (FIG. 28A-2) around the molars and vertically over the maxillary and mandibular teeth and gums.
  • design features provide a light weight device which is held in place in the user’s mouth by the teeth 1050 and lips 1060, FIG. 28A-3.
  • a compact, miniature, light weight and strapless full-face mask is provided, with the mask being attached to the polymer piece of the mouth shield to form a one-piece mouth shield / mask module configured for attachment to a breathing assistance device such as a mechanical ventilator or a portable CPAP machine.
  • the mouth shield / mask module may be removably couplable to the breathing assistance device to provide further assistance in facilitating nasal breathing or for delivery of heated, humidified air.
  • a mouth shield device 1100 is attached by a tube 1140, which contains a one-way valve 1130, to the oronasal mask 1150, equipped with a nasal pillow 1160 to form a one-piece mouth shield / mask module, i.e., mouth shield /oronasal mask module 1165.
  • the oronasal mask 1150 also contains a slit 1135 that may also include a one-way valve to allow exhale through the device, as well as an aperture at the bottom of the oronasal chamber 1135A to allow removal of condensed moisture which may collect during respiration.
  • the oronasal mask may be in line with a tube 1145 which may connect the miniature oronasal mask/mouth shield device module to a CPAP device.
  • FIGS. 30A-1 - 30A-3 illustrate an embodiment of the invention which provides a tongue depressor 1170 that connects to the oronasal mask/mouth shield module 1165.
  • An example of an application of the oronasal mask/mouth shield module is illustrated in FIGS. 31A-1 - 31A-2, with the device module 1165 in a planar configuration, 31A-2, before insertion into the mouth and 31A-3 being an illustration of the mouth shield/oronasal mask module 1165 after insertion into the buccal vestibule.
  • a mouth shield/oronasal mask module 1165 is attached by a tube 1400A to a CPAP machine 1400,
  • the soft patient contacting portion of the oronasal mask may be composed of any suitable material known in the art for such purposes as described herein, and generally shaped to fit the contour of the nose to fit either on the outside or inside the nares or to form a cushion to cover both nares.
  • Soft polymeric materials may be selected from a Shore 00 hardness of 5 to 30, for example, Shore 00 hardness of 5 to 20 or within a range of 5 to 15, to provide an optimum comfort and air seal.
  • FIGS. 31B-1 - 31B-4 Other embodiments of the disclosure may include a miniature and strapless oronasal, or nasal or oral mask device/mouth shield module with a nasal pillow or nasal cushion or nasal puff, or other nasal mask-nose interface, that may be further stabilized while in place by the placement of a nasal clip 1180 as illustrated in FIGS. 31B-1 - 31B-4.
  • the nasal clip may be constructed from a flexible biocompatible polymeric material with a durometer Shore 00 hardness value selected from a range of 5 to 100, e.g., between a range of 10 to 60, or between a range from 10 to 50.
  • the nasal clip material may include adhesive surface properties, as described herein, to insure a comfortable fit around the nose.
  • FIG. 32A-1 a compact, miniature, light weight and strapless nasal pillow mask/mouth shield module is included, FIG. 32A-1, which may be connected for CPAP therapy or alternatively, to the oral mask port, 1145A, FIG. 32A-2, which may include the nasal attachment to a CPAP device or other suitable life support system suitable for supplying oxygen-rich air or administering any suitable medicament to the lungs via the CPAP/nasal pillow mask/mouth shield device module.
  • the mouth shield / nasal pillow mask module is also removably couplable to the breathing assistance device to facilitate it’s use and improve compliance.
  • FIG. 32A-3 illustrate another view of the miniature nasal pillow mask/mouth shield module, while in use.
  • Other embodiments of the disclosure also provide miniature and strapless oronasal mask/mouth shield module with a nasal cushion as the nasal mask-user interface of the oronasal mask/mouth shield module, FIG. 32B-1- 32B-2 and nasal cushion mask/mouth shield module, FIG. 32B-3- 32B-4, with a nasal cushion as the nasal interface of the user.
  • the nasal mask/mouth shield module configuration may provide the greatest flexibility and user comfort by allowing attachment of the CPAP device from either the oral port 1140A or nasal port 1145A.
  • mouth shield designs may provide a treatment device configured for rescue breathing and for providing a method for
  • a method for providing CPR treatment may include positioning in a mouth of an individual a treatment device comprising a polymer piece to create a barrier and shield between inside and outside regions of the mouth.
  • the polymer piece may have an oblong shape having a central region and a perimeter surrounding the central region.
  • At the center portion of the polymer piece may also include a one-way valve forming an opening through a thickness thereof.
  • the one-way valve having a combination of shape and size and configured to provide a differential pressure between the inside and outside regions of the mouth during oral breathing and disposed in the central portion.
  • a tube may also be attached to the polymer piece, thereby forming a polymer piece/tube module.
  • the tube may be a tongue depressor tube or a long-curved tube and squeeze bulb combination, and the treatment device may be configured for providing CPR therapy.
  • the method also comprising, connecting the treatment device to a CPAP machine and providing air to the individual through the treatment device by the CPAP machine.
  • FIG. 33A-1 provides an exploded view of an exemplary mouth shield device that may be used for CPR therapy.
  • the mouth shield device 1000 contains a tube 1040 that connects the mouth shield to a compressible squeeze-bulb 1240 that is used to pump air into a victim’s mouth without the need for mouth-to- mouth resuscitation.
  • a tongue depressor 1170 which may be configured as an oval tube, is also provided in order to clear the airways from obstruction.
  • the oval tube is attached to the polymer piece 1000, thereby forming a polymer piece/tube/squeeze bulb module 1175, with the tube being a tongue depressor tube 1170, FIG. 33A-2.
  • a more detailed cross-sectional view of the polymer piece/tube/squeeze bulb module 1175 is shown in FIG. 33A-3 while a top view of the polymer piece/tube/squeeze bulb module 1175 is illustrated in FIG. 33A-4.
  • a treatment device configured for providing CPR therapy includes a long-curved tube 1180 and squeeze bulb 1240 combination that forms a polymer piece/long-curved tube/squeeze bulb module 1185, may be used to provide rescue air to the individual by squeezing and releasing the squeeze bulb.
  • Illustrated in FIG. 34A-1 is an exemplary polymer piece 1000 with a single one-way valve 1030, while FIG. 34A-2 provide side by side comparisons of the polymer piece/tube/squeeze bulb module 1175 and FIG. 34A-3 is a polymer piece/long-curved tube/squeeze bulb module 1185.
  • FIG.34A-4 Also included in these modules are two one-way valves, 1030 and 1030A, illustrated in the cross-sectional view in FIG.34A-4, which provide and insure a one-way airflow into the victim’s mouth.
  • a longer, curved tube 1180 may be preferred, as also illustrated as a top view in FIG. 34A-5.
  • FIGS. 35A-1, 35A-2 illustrate a victim undergoing CPR treatment with a nose clip 1250 to prevent pressure from leaking out of the nose, with FIG. 35A-1, showing a rescuer providing chest compressions to a victim with the mouth shield / squeeze bulb module in the victim’s mouth and FIG. 35A-2 is a cross-sectional view to the mouth shield / squeeze bulb module in place, in the victim’s mouth.
  • a method for providing CPR treatment may include positioning in a mouth of an individual, a treatment device including a polymer piece to create a barrier and shield between inside and outside regions of the mouth.
  • the polymer piece may include a one-way valve.
  • the one-way valve having a combination of shape and size and configured to provide a differential pressure between the inside and outside regions of the mouth.
  • a tube may be attached to the polymer piece, thereby forming a polymer piece/tube module.
  • the tube may be a tongue depressor tube or a long-curved tube and squeeze bulb combination, configured for providing CPR treatment to the individual while the treatment device is in the individual’s mouth.
  • FIG. 35A-3 illustrates a rescuer providing chest compressions and hands-free rescue air using a squeeze-bulb 1240 that may be operated, for example, by a rescuer’s knee.
  • mouth shield device designs and configurations provide one-way valve configurations to block and prevent exhaling through the mouth while allowing a maximum airflow into the upper airway during inhalation.
  • one-way valve designs in combination with application of Hagen- Poiseuille Law (FIGS. 17 - 18), provide guidance for choosing valve hole diameters suitable for inspirational airflows required to generate enough force for maintaining dilation of the upper airways, throughout the complete respiratory cycle.
  • mouth shield designs and configurations provide compact, miniature, light weight and strapless full-face mask systems that may be used in connection with a breathing assist device such as a mechanical ventilator or a portable CPAP machine to provide further assistance in facilitating nasal breathing or for delivery of heated, humidified air for treatment of sleep disorders such as sleep apnea.
  • a breathing assist device such as a mechanical ventilator or a portable CPAP machine to provide further assistance in facilitating nasal breathing or for delivery of heated, humidified air for treatment of sleep disorders such as sleep apnea.
  • FIGS. 35A-1, 35A-2, and 35A-3 illustrate a victim undergoing CPR treatment with the CPR-mouth shield device in place and FIG. 35A-3 with a rescuer providing chest compressions and using a squeeze-bulb that may be operated, for example, by a rescuer’s knee to provide hands-free rescue air.

Abstract

Des dispositifs de protection buccale et des procédés pour commander l'écoulement et la mise sous pression de l'air pour maintenir une quantité résiduelle de pression positive expiratoire dans les voies respiratoires supérieures pendant la partie de repos du cycle respiratoire et pour la restriction de la respiration buccale nocturne, et pour le fonctionnement sans sangle de masques bucco-nasaux, nasaux ou buccaux pour un traitement de ventilation spontanée en pression positive continue (CPAP) et pour un traitement de réanimation cardio-respiratoire mains libres. Les dispositifs comprennent une pièce polymère créant une barrière entre des régions intérieure et extérieure de la bouche, et au moins une valve unidirectionnelle. Des éléments de valve élastomères sont actionnés par la respiration et actionnés par pression lorsque l'utilisateur respire. Les éléments de valve élastomères s'ouvrent et se dilatent lorsque l'utilisateur inhale pour générer une faible résistance et un flux d'air à volume élevé pendant l'inhalation, tout en scellant les ouvertures de valve pour réduire l'expiration par la bouche et favoriser par conséquent la respiration nasale. Le dispositif prend en charge une respiration libre pendant le sommeil pour le traitement de la sécheresse de la bouche, du ronflement, du grincement des dents ou de l'apnée obstructive du sommeil.
PCT/US2019/025837 2018-04-06 2019-04-04 Dispositif de protection buccale pour le traitement de la sécheresse de la bouche, du grincement des dents, du ronflement et de l'apnée du sommeil et ses procédés d'utilisation WO2019195579A1 (fr)

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