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WO2012066464A2 - Ensemble support de sonde oropharyngée - Google Patents

Ensemble support de sonde oropharyngée Download PDF

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Publication number
WO2012066464A2
WO2012066464A2 PCT/IB2011/055070 IB2011055070W WO2012066464A2 WO 2012066464 A2 WO2012066464 A2 WO 2012066464A2 IB 2011055070 W IB2011055070 W IB 2011055070W WO 2012066464 A2 WO2012066464 A2 WO 2012066464A2
Authority
WO
WIPO (PCT)
Prior art keywords
stent
assembly according
previous
patient
airway
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2011/055070
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English (en)
Other versions
WO2012066464A3 (fr
Inventor
Sody Naimer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2012066464A2 publication Critical patent/WO2012066464A2/fr
Publication of WO2012066464A3 publication Critical patent/WO2012066464A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

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

Definitions

  • Embodiments of the disclosure relate to an assembly for maintaining patency of human airway passages.
  • OSA Obstructive sleep apnea
  • OSA is a common sleep disorder in which patients suffer from brief interruptions in breathing during sleep.
  • OSA is estimated to have a prevalence of about 2% in women and about 4% in men.
  • OSA is believed to have a high impact on health and involve an increased risk of cardiac disease, hypertension, stroke and impotence. Additionally, OSA may have a short-term effect on daytime alertness and may lead to hyper- somnolence.
  • OSA causes a repetitive obstruction in the posterior pharynx during sleep, in which the soft palate extends to a region at the base of the tongue and obstructs or completely closes the patients airway passages. As the airway closes, breathing stops and the patient awakens. These breath interruptions are brief but prevent the person from having continuous sleep.
  • the relaxation of the muscles in the pharynx may also be the cause of snoring. Air flowing over the relaxed soft palate causes the vibrate creating the snoring sound.
  • OSA and/or snoring there are several alternative treatments for OSA and/or snoring, one of which is a behavioral positional treatment. Apneas tend to increase when sleeping on the back as gravity makes it more likely for the tongue to fall back over the airway and for the airway muscles and other tissue such as the tonsils to relax and block the airway. Behavioral positional treatment involves training a patient to sleep on his side. However, this treatment is not always successful, and can limit patients' comfort when sleeping.
  • a different approach of treating OSA involves weight loss.
  • additional fat around the neck may make a person's airway passage narrower, making obstructions more likely to occur.
  • For some overweight people, especially those with mild cases of OSA, losing weight can relieve sleep apnea symptoms.
  • CPAP Continuous Positive Airway Pressure
  • OSA can also be treated by surgery, which usually requires general anesthesia. There are several surgical procedures available for treating OSA, which use different techniques to increase size of a patient's airway passage and therefore reduce obstructive occurrences.
  • An aspect of embodiments of the invention relates to a removable airway support assembly for maintaining patency (the state of being open) of the oropharynx.
  • the removable support assembly includes an oropharyngeal airway stent (hereinafter "stent") and a fixation member for securing the stent in place in the oropharynx.
  • the airway support assembly may further include an arm connecting the stent to the fixation member.
  • the airway support assembly can prevent or at least mitigate OSA by maintaining an open airway in the posterior pharynx and enabling steady airflow in multiple postures, including lying on the back, during sleep.
  • the stent maintains an open airway when the patient is breathing and closes under pressure exerted when the patient swallows.
  • the stent maintains patency of the airway using a minimal surface area of the stent in contact with oropharyngal tissue.
  • FIG. 1 schematically shows an airway support assembly in accordance with an embodiment of the invention
  • FIG. 2 schematically shows another airway support assembly in accordance with an embodiment of the invention.
  • FIG. 3 schematically shows an airway support assembly positioned in a human subject in accordance with an embodiment of the invention.
  • FIG. 1 schematically shows a removable airway support assembly 100 in accordance with an embodiment of the invention.
  • Airway support assembly 100 comprises an oropharyngeal airway stent 102 (hereinafter “stent”), an arm 112 and a fixation member 114.
  • stent oropharyngeal airway stent 102
  • Stent 102 may be formed as a substantially cylindrical flexible structure having a certain length and configured to maintain patency of the airway in the oropharynx by providing physical support to the oropharyngeal airway.
  • stent 102 may be shaped as a circular cylinder- shaped or elliptical cylinder-shaped mesh.
  • the length of stent 102 is from between about 15 and about 35 mm.
  • the inner diameter of stent 102 when opened is between about 6 and about 10 mm.
  • stent 102 may be made of a material such as a metallic shape-memory alloy, silicone, polyurethane, rubber or any other elastomer, which allows the stent to maintain elastic characteristics and enables the patient to perform routine swallowing movements. During swallowing, the swallowing mechanism applies sufficient pharyngeal pressure, which temporarily causes stent 102 to close.
  • stent 102 returns to its normal open position and reopens the oropharyngeal airway.
  • the ability of the stent to close when in place in the human pharynx allows for comfortable swallowing, thereby enabling the patient to swallow saliva which accumulates in the mouth before and during sleep.
  • stent 102 is configured to remain open and maintain patency of the oropharyngeal airway under pressure of up to 15 centimeters of water (cmH 2 0).
  • Stent 102 can be configured to close, completely or partially, when pressure of 50-60 cmH 2 0 is applied, which is typically the pressure exerted while swallowing, thereby allowing the patient to comfortably swallow while stent 102 is in place in the oropharynx.
  • the pharynx is a highly sensitive region and can be easily irritable by introduction of a foreign object.
  • the pharyngeal reflex (gag reflex) and resistance to foreign objects are correlated to the foreign object's texture and surface area.
  • stent 102 may be made from a relatively smooth material and may be configured to have a relatively small external surface area to limit contact of the stent with oropharyngal tissue when the stent is in position during sleep.
  • the smoothness of the material and relatively small contact area of a stent and oropharynx tissue in accordance with an embodiment of the invention tends to moderate the gag reflex while still maintaining an opening wide enough to allow adequate air flow through the posterior pharynx.
  • the stent may be configured having an external surface formed having a plurality of empty regions, that is lacunae.
  • a L be an area equal to that of the lacunae.
  • a s be the external surface area of the stent.
  • a figure of merit referred to as a "contact index" "Cf which may be used to measure how effective a stent configuration is in reducing contact of the stent with oropharynx tissue is defined by an expression:
  • a contact index C ⁇ is equal to or less than about 0.8 and greater than 0.01.
  • Stent 102 is made from a mesh like material and has a C ⁇ of less than 1.
  • Other examples of stents having a C ⁇ of less than 1 are stents made of porous material and stents constructed from wire or ribbon-like material.
  • Stent 102 may be formed of non-toxic material or combination of materials, optionally devoid of foul odor or taste.
  • stent 102 may further include a local anesthetic aimed at enhancing tolerance of the tissue of the oropharynx to foreign bodies and suppressing the gag reflex.
  • the anesthetic is selected from the group consisting of: amylocaine, benzocaine, butacaine, butamben, chloroprocaine, dimethocaine, meprylcaine, metabutoxycaine, orthocaine, propoxycaine, procaine, proxymetacaine, risocaine, tetracaine, cyclomethycaine, hexylcaine, piperocaine, articaine, bupivacaine, levobupivacaine, ropivacaine, carticaine, cinchocaine, etidocaine, lidocaine, mepivacaine, prilocaine, and trimecaine.
  • the topical anesthetic is applied to the stent shortly before insertion.
  • the stent is drug-eluting and is manufactured to release topical anesthetic when the stent is in contact with the oropharyngal tissue.
  • the stent is coated with a biodegradable polymer admixed with a topical anesthetic which slowly releases the topical anesthetic when the stent is in place and is in contact with human tissue.
  • biodegradable polymers include polyamides, polyesters, polyanhydrides, polyorthoesters, and polycarbonates. Drug eluting stents are further described in United States Patent Number 6,656,162 and United States Patent Number 5,972,027.
  • Airway support assembly 100 is suited for use when stent 102 is located at the interface between the base of the tongue and the anterior retropharynx. Using airway support assembly 100 when stent 102 is not in its desired position is undesired, especially during sleep, and may lead to irritation or rejection. Therefore, airway support assembly 100 includes a fixation member 114 for securing stent 102 in its intended location.
  • Fixation member 114 may be shaped as a teeth guard, a mouth guard, a posterior teeth fixation plate, a set of straps, a harness, a palate retainer or a similar device.
  • fixation member 114 is shown, merely as an example, having the shape of a teeth guard made of a soft resilient, flexible material curved according to the curvature of the teeth line. As the patient bites on the fixation member and clamps his jaws together, the fixation member is secured in place.
  • a fixation member may be affixed to a tooth or to a plurality of teeth and removable by the patient.
  • Airway support assembly 100 may optionally include an arm 112 configured for connecting stent 102 to fixation member 114.
  • the stent may be directly connected to the fixation member.
  • arm 112 may be designed to least interfere with the natural swallowing and breathing mechanism and may enable personal adjustment of airway support assembly 100 to fit the patient's anatomy.
  • the arm comprises a wire that is 0.5-2mm in diameter.
  • measurements of the patient's mouth and oropharynx are taken before construction of airway support assembly 100.
  • measurements of the patient's mouth may be taken by dental impression and mold formation and/or by measurement of dimensions of mouth and oropharynx.
  • One way to adjust the airway support assembly to patient's anatomy is to adjust arm's 112 length either by trimming at the time of the initial fitting of the assembly, or by allowing the arm 112 to partially fold as necessary into the fixation member itself.
  • arm 112 may be a telescopic arm, including multiple segments collapsible into one another.
  • FIG. 2 schematically shows a removable airway support assembly 200 in accordance with an embodiment of the invention.
  • Airway support assembly 200 includes an oropharyngeal airway stent 202 (hereinafter referred to as "stent"), an arm 212 and a fixation member 214.
  • stent oropharyngeal airway stent 202
  • Stent 202 may be formed as a substantially cylindrical flexible structure having a certain length, for example, between 15 and 35 mm, and configured to maintain an open airway in the posterior pharynx by providing a physical support to the oropharyngeal airway.
  • stent 202 may be shaped as a helical coil.
  • Stent 202 may be made of the same material as stent 102 appearing in Fig 1, which enables the patient to perform routine swallowing in a way, which is similar to the way enabled by stent 102 appearing in Fig 1.
  • Stent 202 has a C ⁇ of less than 1 , thereby minimizing contact surface area with the base of tongue and oropharyngal tissue while still being wide enough to allow adequate air flow through the posterior pharynx.
  • airway support assembly 200 may optionally include an arm 212, which is similar to arm 112 appearing in Fig 1.
  • FIG. 3 schematically shows an airway support assembly 300 positioned in a human subject in accordance with an embodiment of the invention.
  • Airway support assembly 300 includes an oropharyngeal airway stent 302 (hereinafter referred to as "stent"), an arm 312 and a fixation member 314.
  • stent oropharyngeal airway stent 302
  • stent 302 is shaped in a helical shape, substantially as depicted.
  • the stent is formed from a wire having a diameter of 1 mm, the stent has an outer diameter of about 8 mm and an inner diameter of about 6 mm and a length of about 30 mm.
  • the stent has a C ⁇ of about 0.17.
  • Stent 302 is attached to fixation member 314 via arm 312. When in use, fixation member 314 is connected to patient's teeth. When in use, stent 302 is positioned in a patient to prevent contact between tongue base 322 and anterior retropharynx 324, thereby maintaining patency of the oropharyngal airway.
  • airway support system further comprises a sheath (not shown) which surrounds the stent 302 to assist in insertion of the stent into the area between tongue base 322 and anterior retropharynx 324.
  • the sheath can be removed upon insertion of the stent.
  • the sheath holds the stent in a collapsed position and upon removal of the sheath, the stent enlarges to support the area between tongue base 322 and anterior retropharynx 324.
  • the sheath further comprises a biologically compatible lubricant to assist the patient in positioning the stent in place.
  • the sheath comprises a material which adds lubrication upon contact with the oral mucosa.
  • Airway support assembly 100 (Fig. 1) or 200 (Fig.2) may be self inserted, simply by inserting the device at will before bedtime and removing it upon arousal. A medical doctor, nurse or technician is not required for the insertion of the airway support assembly.
  • Airway support assembly 100 (Fig. 1) or 200 (Fig.2) is, advantageously, a compact and portable apparatus providing an easy way to maintain an opening at the interface between the base of the tongue and the anterior retropharynx; therefore, it may be possible for the patient to employ both nose and mouth breathing when the device is in place.
  • the airway support assembly may be easy to use, portable, noninvasive and optionally may be anatomically adjusted to the specific patient.
  • the airway support assembly offers a significantly simpler alternative to common OS A/snoring treatments.
  • the airway support assembly or parts thereof can be used multiple times and can be cleaned and sterilized between uses.
  • the airway support assembly or parts thereof is disposable and is intended for single use.
  • Example 1 Use of removable airway support system in OSA patient.
  • This example illustrates that an airway support assembly according to embodiments of the invention has been shown to be effective in maintaining patency of the oropharyngal airway in a patient suffering from sleep apnea.
  • the assembly provided a solution to the problem of sleep apnea in a patient who was adverse to use of a CPAP device.
  • each of the verbs, "comprise,” “include” and “have,” and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb.
  • Descriptions of embodiments of the invention in the present application are provided by way of example and are not intended to limit the scope of the invention.
  • the described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments utilize only some of the features or possible combinations of the features. Variations of embodiments of the invention that are described, and embodiments of the invention comprising different combinations of features noted in the described embodiments, will occur to persons of the art. The scope of the invention is limited only by the claims.

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

Abstract

Un aspect des modes de réalisation de l'invention porte sur un ensemble support de sonde amovible pour maintenir la perméabilité (l'état d'ouverture) de l'oropharynx. L'ensemble support amovible comprend une endoprothèse de sonde oropharyngée (ci-après « endoprothèse ») et un élément de fixation pour fixer l'endoprothèse en place dans l'oropharynx. L'ensemble support de sonde peut comprendre en outre un bras reliant l'endoprothèse à l'élément de fixation.
PCT/IB2011/055070 2010-11-15 2011-11-14 Ensemble support de sonde oropharyngée Ceased WO2012066464A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41348310P 2010-11-15 2010-11-15
US61/413,483 2010-11-15

Publications (2)

Publication Number Publication Date
WO2012066464A2 true WO2012066464A2 (fr) 2012-05-24
WO2012066464A3 WO2012066464A3 (fr) 2012-07-12

Family

ID=45446105

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2011/055070 Ceased WO2012066464A2 (fr) 2010-11-15 2011-11-14 Ensemble support de sonde oropharyngée

Country Status (1)

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WO (1) WO2012066464A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013138861A1 (fr) * 2012-03-20 2013-09-26 Lewer Brian Dispositifs pour maintenir une canule oropharyngée, procédé permettant de créer une canule oropharyngée et systèmes pour maintenir une canule oropharyngée
WO2018160660A1 (fr) * 2017-02-28 2018-09-07 Case Western Reserve University Appareil d'oropharynx destiné à conserver la perméabilité des voies respiratoires

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0408245B1 (fr) * 1989-07-13 1994-03-02 American Medical Systems, Inc. Dispositif d'introduction d'un dilatateur
DE19501363A1 (de) * 1995-01-18 1995-09-21 Hans D Dipl Ing Weitermann Mechanische Schienung der Atemwege zur Verhinderung des Schnarchens und der Atemstillstände
DE10240725B4 (de) * 2002-09-04 2005-12-08 Mahr, Richard, Dipl.-Landw. Vorrichtung zur Verhinderung des Schnarchens und der Atemstillstände während des Schlafs (Apnoe)
DE102006040301A1 (de) * 2005-12-06 2008-03-06 Düring, Klaus, Dr. Vorrichtung zur Schienung eines Hohlraums, Organwegs und/oder Gefäßes
US8127769B2 (en) * 2007-11-18 2012-03-06 Dreamscape Medical Llc Integrated oral appliance for sleep-disordered breathing
US8413661B2 (en) * 2008-08-14 2013-04-09 Ethicon, Inc. Methods and devices for treatment of obstructive sleep apnea
US9132028B2 (en) * 2008-11-25 2015-09-15 Lumen Devices Llc Devices, systems and methods for the treatment of sleep apnea

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013138861A1 (fr) * 2012-03-20 2013-09-26 Lewer Brian Dispositifs pour maintenir une canule oropharyngée, procédé permettant de créer une canule oropharyngée et systèmes pour maintenir une canule oropharyngée
AU2013234867B2 (en) * 2012-03-20 2018-04-05 Medical Advances Through Engineered-Design (MATE) Pty Ltd Devices for maintaining an oropharyngeal airway, methods of creating an oropharyngeal airway and systems for maintaining an oropharyngeal airway
WO2018160660A1 (fr) * 2017-02-28 2018-09-07 Case Western Reserve University Appareil d'oropharynx destiné à conserver la perméabilité des voies respiratoires
CN110352046A (zh) * 2017-02-28 2019-10-18 凯斯西储大学 维持呼吸道通畅的口咽器具
US20200060866A1 (en) * 2017-02-28 2020-02-27 Case Western Reserve University Oropharynx appliance to maintain airway patency
AU2018227793B2 (en) * 2017-02-28 2020-03-19 Case Western Reserve University Oropharynx appliance to maintain airway patency
JP2020508765A (ja) * 2017-02-28 2020-03-26 ケース ウェスタン リザーブ ユニバーシティＣａｓｅ Ｗｅｓｔｅｒｎ Ｒｅｓｅｒｖｅ Ｕｎｉｖｅｒｓｉｔｙ 気道の開通を維持する中咽頭器具
US20240058163A1 (en) * 2017-02-28 2024-02-22 Case Western Reserve University Oropharynx appliance to maintain airway patency
US12053412B2 (en) 2017-02-28 2024-08-06 Case Western Reserve University Oropharynx appliance to maintain airway patency
JP2025061556A (ja) * 2017-02-28 2025-04-10 ケース ウェスタン リザーブ ユニバーシティ 気道の開通を維持する中咽頭器具

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Publication number Publication date
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