GB2489275A - Breathing device - Google Patents

Breathing device Download PDF

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Publication number
GB2489275A
GB2489275A GB1104927.7A GB201104927A GB2489275A GB 2489275 A GB2489275 A GB 2489275A GB 201104927 A GB201104927 A GB 201104927A GB 2489275 A GB2489275 A GB 2489275A
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GB
United Kingdom
Prior art keywords
tube length
airway
nasal
airway tube
management device
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.)
Withdrawn
Application number
GB1104927.7A
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GB201104927D0 (en
Inventor
Christopher Alec Grace
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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
Priority to GB1104927.7A priority Critical patent/GB2489275A/en
Publication of GB201104927D0 publication Critical patent/GB201104927D0/en
Priority to PCT/GB2012/000270 priority patent/WO2012127193A1/en
Publication of GB2489275A publication Critical patent/GB2489275A/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0461Nasoendotracheal tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56Devices for preventing snoring
    • A61F5/566Intra-oral devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0666Nasal cannulas or tubing

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

Abstract

The present invention provides an airway management device suitable for use by sufferers of obstructive sleep apnoea and which comprises a bifurcated airway body having a first nasal airway tube length 1a and a second nasal airway tube length 1b and a bridging portion 1c, the first nasal airway tube length 1a and the second nasal airway tube length 1b being adapted to extend from a proximal end thereof seated externally at the entrance of a respective one of the user's nostrils through the nasal cavity to a distal end thereof opening into the oro-pharyngeal region of the user's mouth, the bridging portion 1c linking together the proximal ends of the first nasal airway tube length 1a and the second nasal airway tube length 1b, which may be flared F for a more secure fit. The device not only has a greater airflow but also is inherently more stable and secure than existing naso-pharyngeal airway devices. Overall the device is not liable to dislodgement when sleeping and does not require use of any special anchoring arrangements at each end.

Description

Breathing Devices
Field of the Invention
The present invention concerns improvements in and relating to breathing devices and in particular airway management devices for use by sufferers of obstructive sleep apnoea (O.S.A.) to prevent the condition or alleviate the symptoms.
Background of the Invention
Obstructive sleep apnoea is a widespread medical condition that affects over a million individuals in the UK alone. In the condition, which is often exacerbated by obesity, a common cause is loss of muscle tone in the throat & oral tissues, particularly the soft palate, whereby the individual's breathing is interrupted and becomes very shallow during sleep. The breathing pauses can typically last between 10 and 20 seconds and can occur hundreds of times during a night. In extreme cases this can be lethal and even in mild cases will tend to cause fatigue and can lead to depression, diabetes, high blood pressure, transient ischemic attacks (TIA's), stroke and heart disease.
The traditional radical solution to address O.S.A entails surgery on the tissues of the airway obstruction to ablate them or improve muscle tone. However, more recently various orthodontic or mandibular devices have become available, designed primarily to alleviate snoring and these are generally adapted to be inserted in the mouth and function by mandibular advancement -pulling the tongue forwards and thereby opening the throat slightly improving ventilation of the superior airway but having no effect on the soft palate or nasal airways. These are not a comfortable or effective solution to O.S.A.
A particularly commonly prescribed modern treatment for O.S.A. entails use of a continuous positive airway pressure (C.P.A.P.) machine to ventilate the user's airways. The treatment involves fitting a mask to a patient's face to supply pressurised air to the nose and! or mouth of the patient from a pump machine at the patient's bedside. The air pressure is regulated to suit the individual user. While the use of C.P.A.P. produces an immediate improvement in sleep quality, the mask and the necessity of its being attached to the machine, is cumbersome & restricts movement during sleep. Due to apparatus cost, size and safety issues the C.P.A.P treatment is unsuited for widespread domestic use.
More recently others have developed devices that are simpler to manufacture and use, lightweight and compact and which are designed to be inserted into the nasal passageway. These are primarily known as naso-pharyngeal airway devices and an example of these is shown in POT W0201 0/113305. However, such devices tend comprise relatively hard plastics or rubber single tubes that tend to be somewhat unstable when fitted and in use unless anchored at one or both ends. In POT W0201 0/113305 it is proposed to have a ring at each end and optionally a balloon at the oro-pharyngeal end, whereas in US2O1O/0300450 the device has an inflatable supra-glottic laryngeal cuff. In such cases the device can only be safely fitted in place by a surgeon or by trained medical personnel, not self-administered.
It is an objective of the present invention to provide an airway management device suitable for use by sufferers of obstructive sleep apnoea (O.S.A.) and which has the simple to manufacture and use, lightweight and compact merits of the current naso-pharyngeal airway devices but which provides enhanced airflow, better stability while being readily self-administered.
Summary of the Invention
According to a first aspect of the present invention there is provided an airway management device suitable for use by sufferers of obstructive sleep apnoea and which comprises a bifurcated airway body having a first nasal airway tube length and a second nasal airway tube length and a bridging portion, the first nasal airway tube length and the second nasal airway tube length being adapted to extend from a proximal end thereof seated externally at a mouth of a respective one of the user's nostrils through the nasal cavity to a distal end thereof opening into the oro-pharyngeal region of the user's mouth, the bridging portion linking together the proximal ends of the first nasal airway tube length and the second nasal airway tube length.
Preferably the bridging portion is thickened so that it is prominent relative to the proximal ends of the airway lengths to pass as a robust bridge over the septum of the nose while the proximal ends of the airway lengths remain approximately flush with the nostrils. The bridging portion is suitably of the order of 3mm thick or greater.
Because the device is bifurcated as described it thereby not only has a greater airflow but also is inherently more stable and secure than existing naso-pharyngeal airway devices. Overall the device is not liable to dislodgement when sleeping and does not require use of any special anchoring arrangements at each end.
Nevertheless, preferably the external ends of first nasal airway tube length and the second nasal airway tube length of the device are not only joined together by the bridging portion but also are each flared. Though the device is efficiently anchored against entry into the nasal passages by the existence of the bridging portion, the additional use of flared proximal ends of the tube lengths has the particular benefit of stopping any substantial airflow from passing around each tube length. This has been found to be particularly useful since we have found that otherwise the peripheral airflow can cause irritation of the nasal tissues and induce streams of mucus.
The first nasal airway tube length and the second nasal airway tube length are preferably both configured with an inherent curvature and which most preferably is in a shallow or flattened arc. The first nasal airway tube length and the second nasal airway tube length are suitably configured to extend substantially parallel to each other throughout their length whereby the device is substantially axi-symmetric and preferably are spaced apart by no more than about 5mm. Also it is preferred that the internal diameter of each of the nasal airway tube lengths is 5mm, or of the order of 4mm to 6mm.
Preferably the tubular wall of each airway tube length is of an elastomeric polymer that is 2mm or less and most preferably of the order of 1 mm thick, whereby the tube remains soft and flexible for comfortable fitting and wearing but retains sufficient rigidity of tubular form that it will not be collapsed by irregular soft tissue formations of the nasal cavity or soft palate or localized vascular dilation and airway muscular constriction but will retain integrity as an airway. Presently preferred elastomeric polymers include silicone rubber and polychloroprene.
Suitably the external diameter of the distal end of each nasal airway tube length is of the order of 7mm where the internal diameter is 5mm. With flaring, external diameter of the proximal end of each nasal airway tube length is suitably of the order of double or more the external diameter of the distal end of each nasal airway tube length. In one preferred embodiment the external diameter of the flared proximal end is of the order of 18mm.
With minimal instruction the device of the present invention may be inserted by the user into his or her nasal cavities to reach through to just below the soft palate.
Unlike naso-tracheal cannulae that are fitted to hospital patients for assisted breathing during anaesthesia et cetera, the present device is relatively short and also relatively soft. it suitably reaches to just below the soft palate but not lower to the laryngeal inlet of the trachea (unlike the many laryngeal cuff terminated devices of the prior art) nor does it extend into the trachea. It does not obstruct the trachea or oro-pharyngeal tract and is also not liable to twist and kink as the patient turns their neck.
The device is relatively soft and does not have the same level of tube reinforcement! tubular rigidity as naso-tracheal cannulae. Indeed it can generally be softer than existing naso-pharyngeal airway devices because it is bifurcated and thereby has greater airflow and is inherently more stable and secure than the existing naso-pharyngeal airway devices.
The softness of the device presents minimal risk of any tissue trauma/abrasion during installation and in use. As a result of these advantageous features the device can be readily self-administered, rather than requiring insertion by a surgeon or by trained medical personnel.
In a practical embodiment, that we have found to be suitable for an average adult male, the length of the device from end to end may be of the order of 160mm. The thickness of the tubular body is preferably of the order of 2mm at most and without need of any wire reinforcement or use of special strengthening polymers. Clear silicone or polychloroprene polymers are currently preferred alternative polymers from which the device may be moulded.
As the tubular lengths of the device pass through to the underside of the soft palate, they restrict vibration or movement of the soft palate. With the device in place, normal breathing through the nose is possible with the airway remaining unobstructed and the subject can move freely during sleep without fear of dislodging the device.
Brief Description of the Drawings
The invention will now be more particularly described, solely by way of example, with reference to the accompanying drawings in which: Figure 1 is a front elevation view of an airway management device of the present invention; Figure 2 is a side elevation view of the device; Figure 3 is a longitudinal sectional view of the device showing the airway passage through the device; and Figure 4 is a schematic sectional view of a user's head showing the device in situ extending through the user's nasal cavity to just beyond the soft palate and thus providing for unimpeded airflow to and from the oro-pharynx.
Description of the Preferred Embodiment
Referring to the Figures, the preferred embodiment of the device is formed as a one piece moulding from an elastomer such as latex or more preferably a synthetic elastomer such as silicone or polychloroprene (a synthetic elastomer with similar attributes to natural rubber but without the associated danger of Type I protein allergies).
Both silicone elastomer and polychloroprene are suitable for injection moulding, the most practical & cost efficient process for the manufacture of this device. Both materials are suitably soft and pliable for this application and can withstand high temperatures (up to 137° C) for the purpose of sterilisation by hot water. Flushing with hot water and rinsing in baby bottle sterilising fluid are recommended after each use. These materials, in clear! transparent form, will make apparent any deposits in the tubes.
The device comprises a bifurcated airway body 1 having a first nasal airway tube length la and a second nasal airway tube length lb and a bridging portion Ic. The first nasal airway tube length Ia and the second nasal airway tube length lb are adapted to extend from a proximal end that seats at the external entrance to a respective one of the user's nostrils through the nasal cavity to a distal end opening into the oro-pharyngeal region of the user's mouth. The bridging portion lc links together the proximal ends of the first nasal airway tube length and the second nasal airway tube length and is thickened so that it is prominent relative to the proximal ends of the airway lengths. It forms a robust bridge over the septum of the user's nose while the proximal ends of the airway lengths remain approximately flush with the nostrils. The bridging portion is of the order of 3mm thick or greater.
The external proximal ends of first nasal airway tube length Ia and the second nasal airway tube length lb of the device 1 are not only joined together by the bridging portion Ic but also are each flared F. The flared proximal ends F provide a snug fit in the nostrils and allow easy unassisted normal breathing without inhaled or exhaled air bypassing the airway tubes of the device, which can create irritation.
The nose is the normal and natural entry point to the respiratory tract and the device of the present invention is designed specifically for the prevention or amelioration of sleep apnoea by fitting into the nostrils and with the airway lengths of the device passing to just beyond the soft palate to thereby provide a direct uninhibited airway to the major respiratory tract. The device can be inserted by the user with minimal instruction, a small amount of lubricating gel is recommended. Coughing and swallowing are not affected by the device which is unobtrusive and allows the user complete freedom of movement during sleep.
For a first fitting of the device the user may have it cut to a tailored size by a professional or may follow provided instructions to do so. In practice it is desirable to take a standard size of the device and tailor it to an individual by cutting off a portion of the airway lengths at the distal end. In some cases the trimming may also apply to the flared proximal ends too in order to render them as flush-fitting as possible. After the first fitting the user will not need any assistance to install the device in place for a good night's sleep.
In summary, the device I comprises a pair of gently curved soft elastomeric tubes I a, lb that are flared at one end and at that end joined lc at the top innermost edges.
The whole device is moulded in one piece. On fitting, the tubes Ib, Ic are inserted into the nostrils and, being curved, naturally follow the path through the nasal passages over the soft palate into the top of the throat to just below the bottom skirt of the soft palate, thus preventing the soft palate moving! blocking the nasal passages on exhalation ( apnoea) or vibrating (snoring). The bridging portion lc holds the whole device securely in place.

Claims (14)

  1. Claims 1. An airway management device suitable for use by sufferers of obstructive sleep apnoea and which comprises a bifurcated airway body having a first nasal airway tube length and a second nasal airway tube length and a bridging portion, the first nasal airway tube length and the second nasal airway tube length being adapted to extend from a proximal end thereof seated externally at the entrance of a respective one of the user's nostrils through the nasal cavity to a distal end thereof opening into the oro-pharyngeal region of the user's mouth, the bridging portion linking together the proximal ends of the first nasal airway tube length and the second nasal airway tube length.
  2. 2. An airway management device according to claim 1, wherein the bridging portion is thickened so that it is prominent relative to the proximal ends of the airway lengths to pass as a robust bridge over the septum of the nose while the proximal ends of the airway lengths remain approximately flush with the nostrils..
  3. 3. An airway management device according to claim I or 2, wherein the external ends of first nasal airway tube length and the second nasal airway tube length of the device are not only joined together by the bridging portion but also are each flared.
  4. 4. An airway management device according to claim 1, 2 or 3, wherein the first nasal airway tube length and the second nasal airway tube length are each configured with an inherent curvature.
  5. 5. An airway management device according to claim 1, 2, 3 or 4, wherein the device is substantially axi-symmetric, the first nasal airway tube length and the second nasal airway tube length extending substantially parallel to each other throughout their length.
  6. 6. An airway management device according to any preceding claim, wherein the first nasal airway tube length and the second nasal airway tube length are spaced apart by no more than about 5mm.
  7. 7. An airway management device according to any preceding claim, wherein the internal diameter of each of the nasal airway tube lengths is of the order of 4mm to 6mm.
  8. 8. An airway management device according to any preceding claim, wherein the tubular wall of each airway tube length is of an elastomeric polymer that is 2mm or less thick.
  9. 9. An airway management device according to any preceding claim, wherein the tubular wall of each airway tube length is of an elastomeric polymer selected from silicone rubber and polychloroprene.
  10. 10. An airway management device according to claim 3, wherein with the flaring, the external diameter of the proximal end of each nasal airway tube length is of the order of double or more the external diameter of the distal end of each nasal airway tube length.
  11. 11 An airway management device according to any preceding claim and in use, wherein the device reaches to just below the soft palate of the user.
  12. 12 An airway management device according to any preceding claim, wherein the length of the device from end to end is of the order of 140mm to 170mm.
  13. 13. An airway management device according to any preceding claim, wherein the device is of a substantially transparent polymer.
  14. 14. An airway management device suitable for use by sufferers of obstructive sleep apnoea substantially as hereinbefore described with reference to the accompanying drawings.
GB1104927.7A 2011-03-24 2011-03-24 Breathing device Withdrawn GB2489275A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
GB1104927.7A GB2489275A (en) 2011-03-24 2011-03-24 Breathing device
PCT/GB2012/000270 WO2012127193A1 (en) 2011-03-24 2012-03-26 Breathing device

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB1104927.7A GB2489275A (en) 2011-03-24 2011-03-24 Breathing device

Publications (2)

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GB201104927D0 GB201104927D0 (en) 2011-05-04
GB2489275A true GB2489275A (en) 2012-09-26

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WO (1) WO2012127193A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3856310A4 (en) * 2018-09-24 2022-06-22 NPA Medical, LLC Nasopharyngeal airway device

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017079885A (en) * 2015-10-23 2017-05-18 信越ポリマー株式会社 Clip for nasal cavity insertion tube and nasal cavity insertion tube having the same
GB2611304B (en) * 2021-09-29 2023-10-04 Clairvo Lesley Sleep apnoea device

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3867946A (en) * 1973-10-29 1975-02-25 Robert A Huddy Binasopharyngeal airway
US20060048775A1 (en) * 2004-09-09 2006-03-09 Dunlap Ivan L Nasopharyngeal airway device and method of use
US20080236591A1 (en) * 2007-04-02 2008-10-02 Georges Boussignac Respiratory probe
US20090248058A1 (en) * 2008-04-01 2009-10-01 Robert Kotler Device and Method for Maintaining Unobstructed Nasal Passageways after Nasal Surgery
WO2010113305A1 (en) * 2009-04-01 2010-10-07 株式会社アイ.エス.テイ Tube for resolving obstructive sleep apnea syndrome

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL119693A0 (en) * 1996-11-26 1997-02-18 Roman Gindis Intranasal snore preventing device
KR20090022709A (en) * 2007-08-31 2009-03-04 신상승 Prosthesis for preventing snoring and the method for preventing snoring
US20100300450A1 (en) 2009-05-28 2010-12-02 The Johns Hopkins University Nasal airway management device with inflatable supraglottic laryngeal cuff

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3867946A (en) * 1973-10-29 1975-02-25 Robert A Huddy Binasopharyngeal airway
US20060048775A1 (en) * 2004-09-09 2006-03-09 Dunlap Ivan L Nasopharyngeal airway device and method of use
US20080236591A1 (en) * 2007-04-02 2008-10-02 Georges Boussignac Respiratory probe
US20090248058A1 (en) * 2008-04-01 2009-10-01 Robert Kotler Device and Method for Maintaining Unobstructed Nasal Passageways after Nasal Surgery
WO2010113305A1 (en) * 2009-04-01 2010-10-07 株式会社アイ.エス.テイ Tube for resolving obstructive sleep apnea syndrome

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3856310A4 (en) * 2018-09-24 2022-06-22 NPA Medical, LLC Nasopharyngeal airway device

Also Published As

Publication number Publication date
GB201104927D0 (en) 2011-05-04
WO2012127193A1 (en) 2012-09-27

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