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WO2025181525A1 - Dilatateur nasal - Google Patents

Dilatateur nasal

Info

Publication number
WO2025181525A1
WO2025181525A1 PCT/IB2024/052020 IB2024052020W WO2025181525A1 WO 2025181525 A1 WO2025181525 A1 WO 2025181525A1 IB 2024052020 W IB2024052020 W IB 2024052020W WO 2025181525 A1 WO2025181525 A1 WO 2025181525A1
Authority
WO
WIPO (PCT)
Prior art keywords
section
tubular element
nasal
nasal dilator
dilator according
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.)
Pending
Application number
PCT/IB2024/052020
Other languages
English (en)
Inventor
João Antonino DIAS GOMES
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 WO2025181525A1 publication Critical patent/WO2025181525A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/08—Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
    • 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

Definitions

  • the present invention is enclosed in otolaryngology, particularly in the area of devices for improving nasal air-flow.
  • OSA Obstructive Sleep Apnea
  • nasal dilators are small devices which are placed inside the nostrils into the nasal cavity and maintain the air-flow by preventing the collapse of the nostrils and nasal passages.
  • nasal dilators lead to comparatively higher airflow and better sleep quality, the current nasal dilators that are commercially available still cause a slight discomfort.
  • nasal dilators There are several types of nasal dilators currently in the market.
  • One type of nasal dilator is shaped to be positioned against the nasal septum, which becomes painful.
  • nasal dilators which are purposely oversized so to put continuous pressure inside the nasal cavity for the dilator to stay in place at all times, which also cause constant tension and irritation to the nasal epithelium.
  • Other options consist in nasal dilators consisting in cones made from hard plastic of metal which are too rigid and uncomfortable for daily use.
  • nasal dilators Discomfort from nasal dilators in general is caused by the mismatch between the natural size and shape of the nostrils and nasal cavity with the size and shape of the nasal dilators, which is always a problem, as no nose or nostril is the same size. This discomfort often drives the user to inadvertently scratch the nose and, consequently, to displace the nasal dilator or even to lose the nasal dilator during the sleep cycle. The displacement or loss of the nasal dilator leads to nasal obstruction, mouth breathing and ultimately leads to obstructive sleep apnea.
  • the proposed invention innovatively provides a solution for such problem.
  • a nasal dilator comprising two tubular elements connected to each other by means of a connection band, forming a single body structure, each one tubular element configured to be positioned inside a nostril of a human nose, comprising two openings and three sections, each section having a same longitudinal axis, wherein the second section is located between the first and the third section; said first section being a proximal section, said second section being an intermediate section and said third section being a distal section; characterized by the first opening being located in the first section and the second opening being located in the third section; the diameter of the first opening being larger than the diameter of the second opening; and by the thickness of the second section being larger than the thickness of the first and third sections.
  • Each tubular element is positioned inside a human nostril, allowing an unobstructed air flow through both the first and second opening during the normal respiration cycle of inhalation and exhalation, thus preventing the onset of obstructive sleep apnea (OSA).
  • OSA obstructive sleep apnea
  • the second section of each tubular element has an increased thickness compared to both the proximal first section and distal third section of the tubular element, wherein the increased thickness increases the resistance against the collapse of the tubular element walls, thus maintaining the air flow unobstructed for long periods of time.
  • the nasal dilator is configured to be fitted comfortably inside a human nostril as its dimensions match the overall shape of the nasal cavity, wherein the nasal dilator does not exert excessive pressure to the nasal epithelium in narrower segments of the nasal cavity and also maintains its position in wider segments of said nasal cavity.
  • connection band is attached to the first section of each tubular element so that said connection band is positioned perpendicularly to the longitudinal axis of each tubular element.
  • This preferred configuration allows the connection band to be fitted across the nasal columella, between both nostrils, to prevent the tubular elements from being inserted too deep inside the nasal cavity, and also to facilitate the removal of the nasal dilator by pulling said connection band.
  • each tubular element further comprises at least one protrusion that extend radially from the outer surface of the first section, so that said protrusion can be accommodated against the nasal cavity wall, thus preventing the tubular element to slide outwards from the nasal cavity.
  • the protrusion is positioned perpendicularly to the connection band so that said protrusion can be accommodated inside the nasal cavity, specifically in the spaces existing towards the tip of the nose and/or towards the base of the nose near the anterior nasal spine of maxilla.
  • the nasal cavity at the tip of the nose has a depth of 1 - 6 mm in all humans, therefore it is an appropriate space for the protrusion to be accommodated in.
  • the protrusion comprises a pyramidal shape that declines towards the second section of each tubular element, following the natural shape of the nasal cavity walls, wherein the apex of the pyramidal shaped protrusion is round so that it does not harm the nasal epithelium.
  • the nasal dilator comprises two diametrically opposed protrusions in each tubular element, so that one protrusion is fitted inside the nasal cavity towards the tip of the nose, and the other protrusion is accommodated inside the nasal cavity at the base of the nose near the anterior nasal spine of maxilla.
  • This preferred configuration further prevents the tubular elements of sliding out from the nasal cavity by providing two blocking sites, one at the tip of the nose and another at the base of the nose.
  • FIG. 1 perspective view of the nasal dilator (1).
  • the nasal dilator (1) comprises two tubular elements (2) connected to each other by means of a connection band (3).
  • Each tubular element (2) further comprises two openings and three sections, wherein the first opening is located in the first section (2.1) and the second opening is located in the third section (2.3).
  • the first opening has a larger diameter than the second opening.
  • Each tubular element (2) comprises one protrusion (4) extending radially from the outer surface of the first section (2.1), wherein the protrusion has a pyramidal shape in which one facet of said pyramidal shaped protrusion (4) is leveled in the same horizontal plane that contains the first opening.
  • each protrusion (4) is rounded and the pyramidal shape then declines towards the second section of the tubular element (2) in a longitudinal direction, following the natural shape of the nasal cavity.
  • Each tubular element further comprises a plurality of ribs (5), preferably seven ribs (5) in total, extending circumferentially from the tubular element's outer surface, said ribs (5) having rounded edges, wherein two ribs (5) are positioned on the first section (2.1) below the protrusion (4), three ribs (5) are positioned on the second section (2.2) and two ribs (5) are positioned on the third section (2.3).
  • each tubular element (2) comprises at least two protrusions (4) extending radially from the outer surface of the first section (2.1), being said protrusions (4) diametrically opposed to one another and perpendicularly positioned in relation to the direction of the connection band (3).
  • Figure 3 top view of the preferred embodiment of the nasal dilator (1), wherein the inner channel of each tubular element (2) comprises a larger diameter in the first section (2.1) and a smaller diameter in both second (2.2) and third section (2.3) respectively of said tubular element (2).
  • the two tubular elements (2) of the nasal dilator (1) are connected by the connection band (3), wherein one side of the band is slightly larger so that the connection band (3) can be properly positioned across the nasal columella once the tubular elements (2) are positioned inside the nasal cavity.
  • Figure 4 bottom view of the preferred embodiment of the nasal dilator (1).
  • FIG. 5 schematic presentation of the positioning of the nasal dilator (1) inside a human nasal cavity.
  • the nasal dilator (1) is shown with full tracing, while the human nasal cavity is shown with dashed tracing.
  • Each tubular element (2) is positioned inside the nasal cavity so that the first section (2.1) is positioned at the entrance of the nasal cavity as it is the wider section of the nasal dilator, and the second (2.2) and third section (2.3) are positioned in the progressively narrower parts of the nasal cavity in the opposite direction of the nasal cavity entrance.
  • the connection band (3) sits across the nasal columella, preventing the tubular elements (3) to be inserted too deep inside the nasal cavity.
  • the two diametrically opposed protrusions (4) are positioned inside the nasal cavity, one protrusion (4) facing the inner nasal cavity walls at the tip (T) of the nose, while the other protrusion (4) is facing the base of the nose nearthe anterior nasal spine of maxilla (O), thus providing two distinct blocking sites to prevent the tubular elements (2) from sliding out from the nasal cavity.
  • the ribs (5) that extend circumferentially from the outer surface of each tubular provide additional gripping regions to the inner wall of the nasal cavity and provide means to customize the length of the tubular element (2), as the ribs (5) also determine the positions where the tubular element (2) can be cut to decrease the length of the tubular element (2).
  • the length of the tubular element (2) can be shortened without any cutting procedure by collapsing and folding the space between de ribs (5) by longitudinal compression, which makes the ribs (5) to be closer together and shortens the length of the tubular element (2).
  • the preferred embodiment of the present invention is a nasal dilator (1) wherein each tubular element (2) comprising two diametrically opposed protrusions (4) for blocking involuntary movements of the nasal dilator (1) inside the nasal cavity, including sliding movements that would result in the removal of nasal dilator (1) from the nasal cavity.
  • the height of the protrusions (4) is between 3 and 7 mm so that each protrusion is adapted to fit the space inside the nasal cavity near the tip of the nose (T), which has a depth between 1 and 6 mm in all humans.
  • the height of the protrusion (4) as well as its pyramidal shape which follows the natural shape of the inner walls of the nasal cavity, allows the nasal dilator to be fixed at the tip of the nose and/or at the rear of the nasal cavity near the anterior nasal spine of maxilla (O).
  • the second section (2.2) of each tubular element has an increased thickness compared to the first (2.1) and third sections (2.3) of the same tubular element (2), as the outer radius of the second section (2.2) is the same as the outer radius of the first section (2.1) being larger that the outer radius of the third section (2.3), while the inner radius of the second section (2.2) is the same as the inner radius of the third section (2.3), being smaller that the inner radius of the first section (2.1).
  • the increased thickness of the second section (2.2) significantly increases the central resistance against the collapsing of the tubular element (2) at the center, which is essential to maintain the air flow unobstructed at all times.
  • the increased resistance to the collapse of the intermediate section of the tubular elements (2), along with the blocking effects of the two protrusions (4) and ribs (5), allows the nasal dilator (1) to maintain its position and resist the involuntary external forces done by the user during the sleeping period, such as nose scratching or pinching.
  • each tubular element and connection band is made of soft materials such as thermoplastic silicone or silicone resins. These materials become softer and pliable when heated, allowing the nasal dilator (1) to be easily adjusted inside the nasal cavity by the user. While inserting the pliable nasal dilator (1) inside the nasal cavity, the protrusion (4) will hold the nasal dilator (1) in place until the thermoplastic silicone or silicone resins cooldown and the nasal dilator (1) hardens and reverts to its original shape, thus applying a pressure to the inner wall of the nasal cavity, widening the nasal canal to provide an increased nasal air flow to the user. In addition, the pressure also increases the retention of the nasal dilator (1) inside the nasal cavity together with the ribs (5) and protrusions (4) that prevent the movement of the nasal dilator (1), which is useful during intense physical activities that increase the air flow.
  • soft materials such as thermoplastic silicone or silicone resins.
  • the nasal dilator (1) can be manufactured by injection molding into a mold or it can be 3D printed to the desired shape.
  • a relevant aspect of the present invention is that the materials composing each tubular element and connection band are biocompatible, wherein the materials do not have a toxic or injurious effect in the nasal epithelium. Therefore, the nasal dilator (1) being made from biocompatible materials is in contact with the nasal epithelium without causing deleterious effects in the user, such as inflammation.
  • Another embodiment of the present invention is a nasodilator kit, comprising the nasal dilator (1) and a lubricant substance.
  • lubricants such as ozonated oils, facilitates the insertion of the nasal dilator (1) into the nasal cavity of the user and protects the nasal epithelium when it is dry and more susceptible to damages such as irritation.

Landscapes

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

Abstract

La présente invention s'inscrit dans le domaine de l'otolaryngologie, en particulier dans le domaine des dispositifs destinés à améliorer le flux d'air nasal. L'objet de la présente concerne un dilatateur nasal comprenant deux éléments tubulaires reliés l'un à l'autre au moyen d'une bande de liaison, formant une structure de corps unique, chaque élément tubulaire étant conçu pour être positionné à l'intérieur d'une narine d'un nez humain, et comprenant deux ouvertures et trois sections, chaque section ayant un même axe longitudinal, la seconde section se situant entre la première et la troisième section ; le dilatateur nasal étant caractérisé en ce que la première ouverture se situe dans la première section et la deuxième ouverture se situe dans la troisième section ; le diamètre de la première ouverture est plus grand que le diamètre de la deuxième ouverture ; et l'épaisseur de la deuxième section est supérieure à l'épaisseur des première et troisième sections. Le dilatateur nasal est fabriqué à partir de silicone thermoplastique ou de résines de silicone biocompatibles qui sont des matières souples qui facilitent l'insertion du dilatateur nasal à l'intérieur de la cavité nasale. Cette solution empêche l'affaissement des fosses nasales, augmente le flux d'air, tout en étant confortable et sûre.
PCT/IB2024/052020 2024-02-28 2024-03-01 Dilatateur nasal Pending WO2025181525A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PT119282 2024-02-28
PT11928224 2024-02-28

Publications (1)

Publication Number Publication Date
WO2025181525A1 true WO2025181525A1 (fr) 2025-09-04

Family

ID=90368463

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2024/052020 Pending WO2025181525A1 (fr) 2024-02-28 2024-03-01 Dilatateur nasal

Country Status (1)

Country Link
WO (1) WO2025181525A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2672138A (en) * 1950-09-05 1954-03-16 Carlock Marion Pomeroy Device to promote nasal breathing and prevent snoring
US20130081637A1 (en) * 2011-09-29 2013-04-04 Martin P. Foley Nasal insert and cannula and methods for the use thereof
US8834512B1 (en) * 2007-12-12 2014-09-16 International Patent Development Group, Llc Nasal dilator comprising joined legs with end pads and air passages
US20140326244A1 (en) * 2011-11-28 2014-11-06 Best Breathe Company, S.L. Device for Relieving the Symptoms of Nasal Allergies
US20160120689A1 (en) * 2013-05-13 2016-05-05 Anthonius Fredericus Maria Bende Nasal Dilator
CN108784912A (zh) * 2018-06-29 2018-11-13 天津博众纳德生物科技有限公司 一种磁疗防打鼾装置

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2672138A (en) * 1950-09-05 1954-03-16 Carlock Marion Pomeroy Device to promote nasal breathing and prevent snoring
US8834512B1 (en) * 2007-12-12 2014-09-16 International Patent Development Group, Llc Nasal dilator comprising joined legs with end pads and air passages
US20130081637A1 (en) * 2011-09-29 2013-04-04 Martin P. Foley Nasal insert and cannula and methods for the use thereof
US20140326244A1 (en) * 2011-11-28 2014-11-06 Best Breathe Company, S.L. Device for Relieving the Symptoms of Nasal Allergies
US20160120689A1 (en) * 2013-05-13 2016-05-05 Anthonius Fredericus Maria Bende Nasal Dilator
CN108784912A (zh) * 2018-06-29 2018-11-13 天津博众纳德生物科技有限公司 一种磁疗防打鼾装置

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