WO2021260356A1

WO2021260356A1 - Nasal air flow control device

Info

Publication number: WO2021260356A1
Application number: PCT/GB2021/051568
Authority: WO
Inventors: Sanjiv Kumar KANWAR
Original assignee: Converse Healthcare Limited
Priority date: 2020-06-23
Filing date: 2021-06-21
Publication date: 2021-12-30
Also published as: GB2596309A; GB202009584D0; GB2596309B

Abstract

A nasal air flow control device is provided, the device comprising one or more nasal inserts, each nasal insert comprising an insert body having a wall, a proximal end and a distal end, the insert body comprising a cavity extending between the proximal end and the distal, the insert body having at least one proximal opening in the wall at the proximal end of the insert body and a distal opening in the wall at the distal end of the insert body; and a valve member disposed in the cavity and moveable therein between a first position and a second position; wherein the portion of the wall at the distal end of the insert body defining the distal opening comprises an inlet portion defining an inlet, a valve seat portion spaced apart from the inlet portion and defining a valve seat, and a throat portion disposed between the inlet portion and the valve seat portion defining a throat; wherein when the valve member is in the first position, it contacts the valve seat portion and closes the distal opening, preventing air flowing through the cavity in the insert body; and wherein when the valve member is in the second position, it is displaced from the valve seat portion and both the proximal and distal openings are open, allowing air to flow through the cavity in the insert body.

Description

NASAL AIR FLOW CONTROL DEVICE

The present invention relates to a device for the control of air flow during speech. The device finds use in the control of the air flow into and out of the nose of a subject wearing the device and can provide assistance to the subject forming words and speaking in a clear manner.

Devices for use in assisting, modifying or controlling the breathing of a subject have been known in the art for some time. For example, US 2,532,282 discloses an inhaler for use in dispensing medicinally charged vapours or fumes into the nostrils of a subject.

An expiratory breathing exercise device is described and shown in US 4,403,616. The device comprises an elongate, enclosed air flow column having an air inlet into which the user exhales. Exhalation into the device causes an air floatation element to be lifted within the column.

A nose filter is disclosed in IL 181884. The nose filter comprises a body having a passageway therethrough for the passage of air. The nose filter further comprises a filter assembly. A number of different embodiments of the nose filter are described and shown. In all embodiments, the arrangement is such that air is forced to flow through the filter assembly when the subject inhales, but air bypasses the filter assembly when the subject exhales.

Devices for insertion into the nostrils of a subject to control, improve or otherwise modify the breathing of the subject are known in the art.

WO 2006/063339 describes and shows a range of devices to mimic the effects of pursed-lip breathing and provide the benefits of non-invasive ventilation. The devices comprise a passageway, an airflow resistor in communication with the passageway, and a holdfast for removably securing the respiratory device in communication with a respiratory cavity of the subject. The device may be held in the mouth of the subject or inserted into the nose of the subject. WO 2006/063339 describes a range of conditions for which the devices provide a benefit, including COPD, heart failure, pulmonary oedema, sleep apnea, cystic fibrosis, asthma, cardiac valve disease, arrhythmias, anxiety and snoring. A valved nasal cannula is disclosed in WO 2007/134458. The cannula is insertable into the nose of a subject and functions to restrict the flow of air therethrough on a selective basis. The cannula comprises a body having a passageway therethrough, a valve for restricting the flow of air through the passageway, and a protective grid extending across the cannula passageway. The cannula is described as assisting with breathing disorders during sleep, including snoring and sleep apnea.

EP 2 184036 discloses a nose implant for insertion into the respiratory channel of the nose of a subject. The implant comprises a channel body having a breathing channel extending therethrough. A sealing element, such as a ball, acting as a check valve is disposed within the channel. The implant is intended to reduce foreign matter contacting the nasal mucous membrane, without creating a perceptible impairment to the normal breathing pattern of the subject.

A nose device is disclosed in US 2010/0331777. The device has a conical portion for insertion into the nose of a subject. A screw winding is arranged on the outer surface of the conical portion. In use, the device keeps the nose channel of the subject open. A filter may be provided in the device for filtering inhaled air.

US 2013/0081637 discloses a nasal insert and cannula. The nasal insert comprises a housing having an interior passage therethrough. A longitudinal gap is provided along a length of the housing. An outer, peripheral dimension of the housing is adjustable by varying the size of the gap. A valve is provided to limit the flow of air through the interior passage in at least one direction. The nasal insert is described as providing benefits in subjects suffering from a range of diseases and physiological disorders associated with breathing.

US 2017/0100275 discloses a nasal congestion and obstruction relief and breathing assist device. The device comprises one or two open-ended tubular elements. A liner-shaped filter may be provided within the or each tubular element. The device is indicated to increase the flow of air through the nose of the subject, for example to ventilate the sinuses of the subject and prevent or alleviate sinusitis.

US 2018/0236201 discloses a device for assisting subjects suffering from sleep apnea. The device comprises a pair of tubular housings. A ball is moveable within each housing to control the flow of air through the housings as the subject breathes. US 2009/0194100 discloses a nostril plug for improving articulatory disorder by controlling the flow of air when the subject exhales.

A nasal prosthesis for closing the nasal cavity upon exhalation is disclosed in KR 102080433 B.

A number of speech disorders can be addressed using devices to control the flow of air through the nose of the subject. One particular such disorder is velopharyngeal dysfunction (VPD). VPD arises in subjects as a result of conditions that affect the function of the soft palate, for example a cleft palate, congenital paralysis of the soft palate or cerebrovascular disease. In summary, VPD arises in subject where the soft palate does not fully close against the back of the throat during speech, allowing air to escape through the nasal cavity and out of the nose. As a result, the subject experiences an involuntary leakage of air from the nasal cavities. This results in a speech impediment characterised by the speech having a muffled, nasal quality. In the case of a cleft palate, while the cleft palate can be repaired by surgery, VPD can still remain a condition of many subjects.

VPD may be treated by surgery in some cases, for example where there is a clear structural basis, for example where the palate is too short or does not move properly. In cases where surgery is not appropriate, treatment may be provided by way of a palatal prosthetic.

Suwaki, M, et al. ‘Nasal speaking valve: a device for managing velopharyngeal incompetence’, Journal of Oral Rehabilitation, 2008, 35, pages 73 to 78, disclose a nasal speaking valve for managing VPD and improve speech. The nasal speaking valve comprises a hollow, tapered body for insertion into each nostril of the subject. Each hollow body is provided with a one way valve at one end. The one way valve is shown as comprising a flexible valve member that is bent under the action of the subject inhaling, displacing the valve member from a valve seat and allowing air to pass through the body. An attempt to exhale through the device forces each valve member against its respective valve seat and preventing air escaping from the nasal cavity and out of the nose. Suwaki, M, et al. describe that the nasal speaking valve is able to replace known palatal lift prostheses (PLP), without the attendant problems of wearing a PLP, such as difficulty swallowing and a vomiting reflex. Perhaps most recently, GB 2569145 discloses a nasal breathing control apparatus. The apparatus comprises one or more axially extending, generally cylindrical bodies having an inner chamber. The body is provided with an opening in each end of the chamber, to allow the passage of air therethrough. A float is disposed within the inner chamber and is moveable between a first position, in which the float closes one opening in the body, and a second position, in which the float partially blocks the second opening in the body. The inner chamber within the body is provided with a seat at its distal end, to allow the float to seal the opening at the distal end of the body when the float is in the first position. The seat is connected to an inlet at the distal end of the body, through which air may be drawn into the chamber when the user inhales. The apparatus is described as controlling the breathing of a subject, in particular to restrict or eliminate the ability of the subject to exhale air through their nose.

While the apparatus of GB 2569145 addresses a number of the issues arising with the management of VPD, there is a need for an improved device, which allows for an improved management of the breathing pattern of the subject and overcome the speech impediments arising from VPD.

According to the present invention, there is provided a nasal air flow control device, the device comprising one or more nasal inserts, each nasal insert comprising: an insert body having a wall, a proximal end and a distal end, the insert body comprising a cavity extending between the proximal end and the distal, the insert body having at least one proximal opening in the wall at the proximal end of the insert body and a distal opening in the wall at the distal end of the insert body; and a valve member disposed in the cavity and moveable therein between a first position and a second position; wherein the portion of the wall at the distal end of the insert body defining the distal opening comprises an inlet portion defining an inlet, a valve seat portion spaced apart from the inlet portion and defining a valve seat, and a throat portion disposed between the inlet portion and the valve seat portion defining a throat; wherein when the valve member is in the first position, it contacts the valve seat portion and closes the distal opening, preventing air flowing through the cavity in the insert body; and wherein when the valve member is in the second position, it is displaced from the valve seat portion and both the proximal and distal openings are open, allowing air to flow through the cavity in the insert body.

The device of the present invention provides control of the flow of air into and out of the nasal passages of the user. In particular, the device controls the flow of air during speech, such that the user is prevented from experiencing an involuntary leakage of air from the nasal cavity, thus allowing a desirable flow of air via the oral route, thereby improving speech, in particular allowing the speech to be more cogent and audible. This is of particularly help with users suffering from VPD and greatly improves the ability of the user to form the sounds associated with speech.

In addition, the device is advantageously suitable for manufacture, in particular on a large scale. More particularly, device may be readily formed from resilient materials, such as mouldable soft plastic or silicone rubber, or such like materials. The form of the distal end of the body allows for the valve member to be readily inserted into the cavity through the distal opening during manufacture, while also retaining strength in the distal end of the body and improving the overall strength and integrity of the device.

The device comprises one or more nasal inserts. The or each nasal insert is inserted into a nostril of the user. The nasal insert comprises an insert body having a wall. The insert body comprises a proximal end and a distal end.

The terms ‘proximal’ and ‘distal’ as used herein refer to the orientation of the insert body when inserted into a nostril of the user during normal use. In particular, the term ‘proximal’ is a reference to the end or portion of the insert body that is innermost, that is disposed furthest within the nostril of the user during normal use. Conversely, the term ‘distal’ is a reference to the end or portion of the insert body that is outermost, that is disposed closest to the outer end of the nostril.

The wall of the insert body may be formed from any suitable material that may be safely accommodated within the nostrils of the user. Preferably, the wall of the insert body is formed from a resilient material. The material of the insert body is pliable, allowing the insert body to be a comfortable fit within the nostril of the user and create an air-tight seal, without discomfort to the user or causing irritation of the nasal passage. Resilient materials prevent the insert body being permanently deformed by the user, for example during insertion or removal of the insert body into or from the nostril.

The wall of the insert body is preferably formed from a material that allows the insert body to be moulded. Suitable techniques for moulding the insert body are known in the art and include injection moulding.

In a preferred embodiment, the wall of the insert body is formed from a polymer, more preferably a resilient polymer. Suitable resilient polymers include elastomers, including synthetic rubbers. Suitable resilient polymers, in particular medical grade polymers, are known in the art and are commercially available. A preferred group of polymers available in medical grades are the silicone rubbers. A particularly preferred silicone rubber is a liquid silicone rubber. Liquid silicone rubbers are generally provided in the form of a two-component system, with the two components being combined and mixed immediately prior to use, for example injection moulding. Suitable commercially available liquid silicone rubber materials for forming the insert body include NuSil MED- 4930, available commercially from Avantor Inc., or similar commercially available products.

The material used to form the wall of the insert body may have any suitable hardness. The hardness of the material should be selected to allow the insert body to be inserted and accommodated within the nostrils of the user without undue discomfort. The hardness of the material may also be selected to allow the insert body to be formed, in particular by moulding. Preferably, the wall of the insert body is formed from a material having a Shore A hardness of from 15 to 45, more preferably from 20 to 40, more preferably still from 25 to 35, still more preferably about 30.

The insert body may have any suitable shape that allows it to be inserted into and accommodated in a nostril of the user without significant or undue discomfort. In particular, the insert body may have any suitable cross-sectional shape. In a particularly preferred embodiment, the insert body is circular in cross-section.

The insert body may have a constant cross-sectional area along its length. Preferably, the insert body is tapered, more preferably, with the diameter of the insert body at the distal end being greater than the diameter of the insert body at the proximal end. Preferably, the taper of the insert body is from 5 to 17°, more preferably from 7 to 15°, still more preferably from 9 to 13°, especially from 10 to 12°.

The dimensions of the insert body may be selected to allow the insert body to be inserted into and accommodated within the nostril of a user. In particular, the insert body is of a size that allows the insert body to be inserted into the nostril with only a minor amount of force, but is still retained within the nostril and is not prone to falling out under the action of gravity and/or the action of the user exhaling.

The distal end of the insert body may have a diameter in the range of from 5 to 20mm, more preferably from 7 to 18mm, more preferably from 10 to 15mm. In one preferred embodiment, the distal end of the insert body has a diameter of from 11 to 13mm, especially about 12mm. However, it is to be understood that the device may be provided with insert bodies in a range of different sizes, to be better suit the user, and other dimensions may be employed accordingly.

The proximal end of the insert body may have a diameter in the range of from 4 to 12mm, more preferably from 5 to 11mm, more preferably from 6 to 10mm. In preferred embodiment, the proximal end of the insert body has a diameter of from 7 to 9mm, especially about 8mm. In embodiments in which the proximal end of the insert body is rounded, the aforementioned dimensions are of the largest diameter of the rounded portion at the proximal end of the insert body.

In one preferred embodiment, the proximal end of the insert body is rounded.

In one preferred embodiment, the distal end of the insert body is substantially flat.

The inset body can be considered to have a central longitudinal axis extending from its distal end to its proximal end. In one preferred embodiment, the insert body is symmetrical about the central longitudinal axis along its length.

The insert body comprises a cavity extending between the proximal end and the distal end of the insert body. The cavity may have any suitable shape. In one preferred embodiment, the cavity has a circular cross-section. A particularly preferred form for the cavity is generally cylindrical. The cavity is preferably symmetrical about the central longitudinal axis of the insert body. When the device is in use, air passes through the cavity from the distal end of the insert body to the proximal end of the insert body when the user inhales.

The cavity may have any suitable size, to allow air to pass therethrough as the user inhales. Preferably, the cavity has a diameter of from 2 to 6mm, more preferably from 2.5 to 5mm, still more preferably from 3 to 5mm, more preferably still from 3.5 to 4.5mm. In one preferred embodiment the cavity has a diameter of from 3.75 to 4.25mm, preferably from 4 to 4.2mm.

In preferred embodiment, the length of the cavity is preferably from 3 to 7mm, more preferably from 3.5 to 6.5mm, still more preferably from 4 to 6mm, more preferably still from 4.5 to 5.5, for example from 4.75 to 5.25mm, especially about 5mm.

However, it is to be understood that the device may be provided with insert bodies, and hence the cavity, in a range of different sizes, to be better suit the user, and other dimensions may be employed accordingly.

The insert body comprises at least one opening in the wall at the proximal end of the insert body. The proximal opening extends through the wall of the insert body from the cavity to the outer surface of the insert body. In use, air passes from the cavity through the at least one proximal opening in the wall at the proximal end when the user inhales.

The insert body may comprise a single opening in the wall at its proximal end. Preferably, the insert body is provided with a plurality of openings in the wall at its proximal end, for example two, three, four or more openings. In a preferred embodiment, the wall of the proximal end of the insert is provided with from two to four openings, more preferably three openings.

The or each opening in the wall at the proximal end of the insert body may have any suitable form. Preferably, the or each opening is circular in cross-section.

The or each opening in the wall at the proximal end of the insert body may have any suitable diameter. The diameter of the or each proximal opening is selected to allow sufficient air to pass therethrough as the user inhales. The or each proximal opening may have a diameter of from 0.5 to 2mm, preferably from 0.6 to 1 75mm. In one embodiment, the insert body comprises three proximal openings, each opening having a diameter of about 1.5mm. The diameter of the or each proximal opening may be selected according to the number of openings being employed and the size of the insert body.

The total cross-sectional area of the one or more openings in the wall at the proximal end of the insert body may be from 3 to 7mm², preferably from 4 to 6mm², more preferably from 4.5 to 5.5mm², more preferably still from 5 to 5.5mm². The cross- sectional area of the one or more openings may be larger or smaller, depending upon the size of the insert body, as discussed above.

Preferably, the one or more openings in the wall at the proximal end of the insert body are arranged symmetrically about the central longitudinal axis of the insert body.

One preferred embodiment of the device comprises a plurality of openings in the wall at the proximal end of the insert body, with all of the openings being arranged around, but not on, the central longitudinal axis of the insert body.

The insert body comprises an opening in the wall at its distal end. The distal opening extends through the wall of the insert body from the cavity to the outer surface of the insert body. In use, air passes from the cavity through the opening in the wall at the distal end when the user inhales.

The distal opening is defined by the wall at the distal end of the insert body and comprises three portions.

First, the distal opening comprises an inlet defined by an inlet portion of the wall. The inlet is at the distal end of the insert body and is open at the distal end. In use, air enters the cavity in the insert body through the inlet as the user inhales.

The inlet may have any suitable form. Preferably, the inlet has a circular cross- section.

The inlet is preferably defined by a single continuous surface extending between the distal end of the inlet and the proximal end of the inlet, where the inlet is connected to the distal end of the throat, described in more detail below.

The inlet may have a uniform diameter along its length. Preferably, the distal end of the inlet has a larger diameter than the proximal end of the inlet. More preferably, the inlet is tapered, more preferably a single continuous taper. Preferably, the taper is such that the distal end of the inlet is larger in diameter than the proximal end of the inlet. By providing the inlet with a taper of this form, the insertion of the valve member into the cavity through the distal opening is facilitated, as described in more detail below.

The inlet may have a taper of from 30 to 90°, preferably from 40 to 80°, still more preferably from 50 to 70°, more preferably still from 55 to 65°, especially about 60°.

The diameter of the inlet at its distal end is preferably from 2 to 6mm, more preferably from 2.5 to 5mm, still more preferably from 3 to 5mm, more preferably still from 3.5 to 4.5mm. In one preferred embodiment the distal end of the inlet has a diameter of from 3.75 to 4.25mm, preferably from 4 to 4.2mm.

In one preferred embodiment, the diameter of the distal end of the inlet is the same as the diameter of the cavity in the insert body.

The diameter of the proximal end of the inlet is preferably from 0.5 to 4mm, more preferably from 0.5 to 3mm, still more preferably from 0.75 to 2.5mm, more preferably still from 1 to 2mm. In one preferred embodiment the proximal end of the inlet has a diameter of from 1.25 to 1.75mm, preferably 1.5mm.

The inlet may have any suitable length, that is the distance from the distal end to the proximal end of the inlet in a direction parallel to the central longitudinal axis of the insert body. Preferably, the inlet has a length of from 1 to 4mm, more preferably from 1.5 to 3mm, still more preferably from 1.75 to 2.5mm, especially about 2mm.

However, it is to be understood that the device may be provided with insert bodies in a range of different sizes, with appropriate inlet dimensions, to be better suit the user, and other dimensions may be employed accordingly.

The inlet is preferably arranged to by symmetrical about the central longitudinal axis of the insert body.

Further, the distal opening comprises a valve seat defined by a valve seat portion of the wall defining the distal opening. The valve seat is spaced apart from the inlet.

More particularly, the valve seat is disposed proximally of and spaced apart from the inlet. In use, the valve seat receives the valve member, as described hereinafter, to seal the distal opening of the insert body and to prevent the flow of air through the insert body, in particular when the user exhales.

The valve seat may have any suitable form. Preferably, the valve seat has a circular cross-section.

The valve seat is preferably defined by a single continuous surface extending between the proximal end of the valve seat and the distal end of the valve seat, where the valve seat is connected to the proximal end of the throat, described in more detail below.

The valve seat may have a uniform diameter along its length. Preferably, the distal end of the valve seat has a smaller diameter than the proximal end of the valve seat. More preferably, the valve seat is tapered, more preferably a single continuous taper. Preferably, the taper is such that the distal end of the inlet is smaller in diameter than the proximal end of the valve seat. By providing the valve seat with a taper of this form, the sealing of the valve member against the valve seat to prevent the flow of air is more effective.

The valve seat may have a taper of from 60 to 120°, preferably from 70 to 110°, still more preferably from 80 to 100°, more preferably still from 85 to 95°, especially about 90°.

The diameter of the distal end of the valve seat is preferably from 0.5 to 4mm, more preferably from 0.5 to 3mm, still more preferably from 0.75 to 2.5mm, more preferably still from 1 to 2mm. In one preferred embodiment the distal end of the valve seat has a diameter of from 1.25 to 1.75mm, preferably 1.5mm.

The diameter of the valve seat at its proximal end is preferably from 2 to 6mm, more preferably from 2.5 to 5mm, still more preferably from 3 to 5mm, more preferably still from 3.5 to 4.5mm. In one preferred embodiment the proximal end of the valve seat has a diameter of from 3.75 to 4.25mm, preferably from 4 to 4.2mm.

The valve seat may have any suitable length, that is the distance from the distal end to the proximal end of the valve seat in a direction parallel to the central longitudinal axis of the insert body. Preferably, the valve seat has a length of from 0.5 to 3mm, more preferably from 0.75 to 2.5mm, still more preferably from 1 to 2mm, for example from 1 to 1.5mm, especially about 1.35mm. However, it is to be understood that the device may be provided with insert bodies in a range of different sizes, with appropriate valve seat dimensions, to be better suit the user, and other dimensions may be employed accordingly.

The valve seat is preferably arranged to by symmetrical about the central longitudinal axis of the insert body.

In one preferred embodiment, the diameter of the proximal end of the valve seat is the same as the diameter of the distal end of the inlet.

The proximal end of the valve seat opens into the cavity in the insert body. Preferably, the diameter of the proximal end of the valve seat is the same as the diameter of the distal end of the cavity.

Still further, the distal opening comprises a throat defined by a throat portion of the wall defining the distal opening. The throat is disposed between the inlet and the valve seat. Most preferably, the distal end of the throat is connected to the proximal end of the inlet. Similarly, it is most preferred that the proximal end of the throat is connected to the valve seat. In use, air flows from the inlet through the throat past the valve seat into the cavity within the insert body, in particular when the user inhales.

The throat may have any suitable form. Preferably, the throat has a circular cross- section.

The diameter of the throat may vary along its length. For example, the throat may be tapered. In one embodiment, the throat is tapered such that the distal end of the throat has a larger diameter than the proximal end of the throat.

The throat is preferably defined by a single continuous surface extending between the proximal end of the throat and the distal end of the throat, most preferably between the proximal end of the inlet and the distal end of the valve seat.

The throat preferably has a uniform diameter along its length. A preferred form for the throat is generally cylindrical.

The diameter of the throat is selected to allow the valve member, described hereinafter, to be inserted into the cavity in the insert body through the distal opening. In a preferred embodiment, the diameter of the distal end of the throat is the same as the diameter of the proximal end of the inlet.

In a preferred embodiment, the diameter of the proximal end of the throat is the same as the diameter of the distal end of the valve seat. In a preferred embodiment, the diameter of the throat at its distal end is the same as the diameter at its proximal end.

The diameter of the throat is preferably from 0.5 to 4mm, more preferably from 0.5 to 3mm, still more preferably from 0.75 to 2.5mm, more preferably still from 1 to 2mm. In one preferred embodiment the distal end of the valve seat has a diameter of from 1.25 to 1.75mm, preferably 1.5mm.

The throat may have any suitable length, that is the distance from the distal end to the proximal end of the throat in a direction parallel to the central longitudinal axis of the insert body. Preferably, the throat has a length of from 0.5 to 4mm, more preferably from 0.75 to 3mm, still more preferably from 1 to 2.5mm, for example from 1 to 2mm, especially about 1 5mm.

However, it is to be understood that the device may be provided with insert bodies in a range of different sizes, with appropriate throat dimensions, to be better suit the user, and other dimensions may be employed accordingly.

The throat is preferably arranged to by symmetrical about the central longitudinal axis of the insert body.

The ratio of the length of the throat to the diameter of the throat may be from 2:1 to 1:2, preferably from 1.5:1 to 1:1.5, still more preferably from 1.25:1 to 1:1.25. A ratio of about 1 is preferred, that is the diameter of the throat is the same as the length of the throat. The length of the inlet may be equal to or greater than the length of the throat.

The ratio of the length of the inlet to the length of the throat may be from 2: 1 to 1 : 1 , preferably from 1.75:1 to 1:1, more preferably from 1.5:1 to 1:1, especially about 1.3:1.

The length of the valve seat may be equal to or greater than the length of the throat. The ratio of the length of the valve seat to the length of the throat may be from 2:1 to 1:1, preferably from 1.75:1 to 1:1, more preferably from 1.5:1 to 1:1, still more preferably from 1.25:1 to 1:1, more preferably still from 1.1:1 to 1:1, especially about 1.03:1.

The length of the distal opening is the combined lengths of the inlet, the throat and the valve seat. Preferably, the length of the distal opening is from 3 to 7mm, more preferably from 3.5 to 6mm, still more preferably from 4 to 5.5mm, more preferably still from 4.5 to 5mm. In one preferred embodiment, the length of the distal opening is about 4.85mm.

The length of the distal opening may be from 20 to 75% of the length of the nasal insert, preferably from 25 to 60%, more preferably from 30 to 50%, still more preferably from 35 to 45%, especially about 40%.

The length of the distal opening may be from 20 to 75% of the length of the total length of the distal opening and the cavity, preferably from 25 to 70%, more preferably from 30 to 65%, still more preferably from 35 to 55%, especially about 50%.

The length of the cavity may be from 20 to 75% of the length of the nasal insert, preferably from 25 to 65%, more preferably from 30 to 55%, still more preferably from 35 to 50%, especially about 45%.

The arrangement of the distal opening in the insert body, in particular comprising the inlet, the throat and the valve seat, provides significant strength to the distal end of the insert body and to the insert body as a whole, while at the same time allowing the device to be constructed, in particular allowing the valve member, described hereinbelow, to be inserted through the distal opening into the cavity during manufacture. The increased strength of the distal end of the insert body improves the seal formed between the valve seat and the valve member. In particular, the valve seat is not liable to be deformed by the valve member under the action of the user attempting to exhale through the device in use. In addition, the increased strength provides an improved seal between the outer surface of the insert body and the inner surface of the nostril of the user during use. This in turn prevents the involuntary leakage of air past the device, which is an aspect of VPD, as discussed above.

As noted above, the device of the present invention further comprises a valve member. The valve member is disposed in the cavity within the insert body. During manufacture of the device, the valve member is inserted into the cavity through the distal opening in the distal end of the insert body. During use, the valve member is moveable within the cavity, under the action of the user inhaling and exhaling, as described below.

The valve member may have any suitable shape. The distal end of the valve member should have a form that can cooperate with the valve seat, so as to form an air tight seal to prevent the flow of air when the user exhales. Preferably, the distal end of the valve member has a curved surface, more preferably a dome, especially a spherical dome.

The proximal end of the valve member should have a form such that the valve member does not block the one or more openings in the proximal end of the insert body and prevent the flow of air from the cavity out of the openings, when the valve member is disposed at the proximal end of the cavity. In particular, with the valve member in this position, sufficient cross-sectional area of the one or more openings should remain open for sufficient air to flow through the openings and allow the user to inhale. Preferably, the proximal end of the valve member has a curved surface, more preferably a dome, especially a spherical dome.

Preferably, at least one of the distal end and the proximal end of the valve member is hemispherical. In one preferred embodiment, the valve member is spherical.

The valve member may be formed from any suitable material. The valve member is preferably formed from a material having a density of at least 5 g/cm³, more preferably at least 6 g/cm³, still more preferably at least 7 g/cm³. A density of at least 7.5 g/cm³ is preferred, especially from 7.5 g/cm³ to 8 g/cm³.

The valve member is preferably formed from metal, with steel, especially stainless steel being preferred.

In use, the valve member is moveable within the cavity between a first position and a second position. In the first position, the valve member is in contact with the valve seat and acts to close the distal opening and prevent the flow of air through the distal opening. The valve member will occupy the first position when the user exhales. As noted above, the arrangement of the wall at the distal end of the insert body and the distal opening provides sufficient strength to prevent the action of the valve member deforming the valve seat. In the second position, the valve member is displaced from the valve seat. In this position, air is free to flow through the insert body, in particular through the distal opening, into the cavity and out through the one or more proximal openings as the user inhales. Should the user inhale sharply, the valve member may contact the wall at the proximal end of the cavity. However, as noted above, the valve member does not close or seal the one or more proximal openings and air is still passed through the insert body during inhalation.

To be moveable within the cavity as described above, the diameter of the valve member is smaller than the diameter of the cavity. The space between the valve member and the wall of cavity should allow sufficient air to flow through the cavity when the valve member is in the second position and allow the user to inhale normally, with little or no resistance.

The diameter of the valve member may be from 1.5 to 5.5mm, more preferably from 2 to 5mm, still more preferably from 2.5 to 4.5mm, more preferably still from 3 to 4mm. In one preferred embodiment the cavity has a diameter of from 3.25 to 3.75mm, preferably from 3.4 to 3.6mm.

The diameter of the valve member is preferably from 60 to 95% of the diameter of the cavity within the insert body, more preferably from 70 to 90%, still more preferably from 75 to 90%, more preferably from 80 to 90%. In one preferred embodiment, the valve member has a diameter that is from 82 to 87% of the diameter of the cavity, more preferably from 83 to 86%.

However, it is to be understood that the device may be provided with insert bodies in a range of different sizes, with appropriate valve member dimensions, to be better suit the user, and other dimensions may be employed accordingly.

The device of the present invention may comprise a single nasal insert, as hereinbefore described. In such embodiments, the nasal inserts are used in pairs, with one nasal insert being inserted into each nostril of the user.

In one preferred embodiment, the device comprises two nasal inserts, each as described above. The two inserts are preferably connected by a bridge, in use the bridge extending outside of the nostrils between the two nasal inserts. Preferably, the device comprises a first nasal insert and a second nasal insert, and a bridge connected at a first end to a distal end portion of the insert body of the first nasal insert and at a second end to a distal end portion of the insert body of the second nasal insert.

In this embodiment, the bridge and the two nasal inserts may be formed separately and then connected. More preferably, the insert bodies of the two nasal inserts and the bridge are formed together as a single component, for example by moulding, such as injection moulding.

The bridge can facilitate the insertion and removal of the device from the nostrils of the user. In use, it is advantageous if the bridge lies against the end of the septum of the nose of the subject. In this way, the bridge can also act to keep each nasal insert in position within the respective nostril, in particular preventing the nasal inserts from being positioned too far in the nostril.

The bridge is preferably flexible. In one preferred embodiment, the bridge is generally U-shaped.

The bridge may be used to remove the insert bodies from the nostrils of the user simply by the user pulling the bridge. Therefore, the bridge should be strong enough to perform this function, without breaking and without permanently distorting the shape of the insert body, to ensure the safe removal of the device from the nose of the user.

In one preferred embodiment, the bridge has a rectangular or square cross- section. However, other shapes may be employed.

The dimensions of the bridge will depend on such factors as the material used to form the device. The diameter of the bridge may be in the range of from 1 to 3mm, preferably from 1.5 to 2.5mm, for example about 1 75mm.

As noted above, the device of the present invention may be provided in a single size or, alternatively, may be provided in a range of different sizes. As discussed above, the dimensions of the features of the device, such as those of the cavity, the inlet opening and its component parts, and the valve member may differ from one size to another. Alternatively, the dimensions of the aforementioned features may be the same for different sizes, with the change in size being provided by varying the outer dimensions of the insert body. This alternative provides advantages, in particular facilitating the manufacture of the device in a range of different sizes. In a further aspect, the present invention provides the use of a nasal insert as hereinbefore described to control the flow of air through the nasal passages of a subject during speech. In one embodiment, the subject is suffering from velopharyngeal dysfunction (VPD).

In a still further aspect, the present invention provides a method for controlling the flow of air when the subject is speaking, the method comprising inserting into each nostril of the subject a nasal insert as hereinbefore described. In one embodiment, the subject is suffering from velopharyngeal dysfunction (VPD).

Embodiments of the present invention will now be described, by way of example only, having reference to the accompanying figures, in which:

Figure 1 is a view of the head of a subject with a device according to one embodiment of the present invention in place in their nostrils;

Figure 2 is a perspective view of a device according to one embodiment of the present invention;

Figure 3 is a cross-sectional view of a device according to one embodiment of the present invention with the valve member in a first position;

Figure 4 is a cross-sectional view of the device of Figure 3 with the valve member in a second position; and

Figure 5 is an enlarged view of the distal opening of the device of Figures 3 and 4.

Turning to Figure 1, there is shown the head of a subject, generally indicated as 2. The subject has a nose 4 having left and right nostrils 6 and 8. One embodiment of the device of the present invention, generally indicated as 102, is being worn by the subject. The device 102 is shown in perspective view in Figure 2. Referring to Figure 2, the device 102 comprises a first nasal insert 104 and a second nasal insert 106. In use, each nasal insert 104, 106 is inserted into a respective nostril within the nose of the subject, as shown in Figure 1.

The first nasal inset 104 has a proximal end 104a and a distal end 104b. Similarly, the second nasal insert 106 has a proximal end 106a and a distal end 106b. In use, the proximal ends 104a, 106a are disposed within the respective nostril, while the distal ends 104b, 106b are disposed at or adjacent the opening of the nostril.

An elongate, generally U-shaped bridge 108 is connected at each end to the distal end 104b, 106b of the nasal inserts 104, 106. The bridge 108 connects the two nasal inserts 104, 106 and facilitates the insertion and removal of the device. By bearing on the end of the septum of the nose of the subject, the bridge 108 also acts to retain the two nasal inserts 104, 106 in position within their respective nostrils. In addition, the bridge 108 may be used to pull both nasal inserts 104, 106 out of the nostrils.

Turning to Figure 3, there is shown a cross-sectional view of a device according to one embodiment of the present invention. The device, generally indicated as 202, comprises a nasal insert, generally indicated as 204, having an insert body 206 with a end 206a and a distal end 206b. The insert body 206 is generally in the form of a right frustrum of a cone, with the diameter of the proximal end 206a smaller than the diameter of the distal end 206b. The proximal end 206a is domed. The distal end 206b is generally flat. The insert body 206 has a central longitudinal axis, indicated by the line A -A.

The device 202 shown in Figure 3 may be used as one of a pair for devices, with each device being inserted into a respective nostril of the user, as shown in Figure 1. Alternatively, the device 202 may be formed together with a second device and the two devices connected by a bridge, as shown in Figure 2.

The insert body comprises a wall 208. The wall 208 defines a generally cylindrical cavity 210 within the insert body 206.

The insert body 206 has a plurality of distal openings 212 in the wall 208 at the proximal end 206a of the insert body. In the embodiment shown in in Figure 3, the insert body has three openings 212, of which two are visible in the cross-section of Figure 3. The openings 212 are arranged symmetrically around the longitudinal axis A - A. The insert body 206 further comprises a proximal opening, generally indicated as 220, in the wall 208 at the distal end 206b of the insert body. Details of the proximal opening are shown in Figure 5 and described in more detail below.

The device 202 further comprises a valve member, in the form of a ball 222. The ball 22 is moveable within the cavity 210. The diameter of the ball 222 is less than the diameter of the cavity 210 so as to define a space between the ball and the wall 208. In use, air passes through the space between the ball and the wall.

Referring to Figure 5, there is shown an enlarged cross-sectional view of the distal opening 220 of the device of Figures 3 and 4. The distal opening 220 is defined by the wall 208 and comprises an inlet 230, a throat 240 and a seat 250.

The inlet 230 is defined by an inlet portion 232 of the wall 208. The inlet 230 is open at the proximal end 206b of the insert body 206 and tapers inwards in the proximal direction to provide the inlet 230 with a frustoconical form. The included angle of the taper of the inlet 230 is about 60°.

The throat 240 is defined by a throat portion 242 of the wall 208. The throat 230 opens at its proximal end into the inlet 230. The throat 240 is cylindrical.

The seat 250 is defined by a seat portion 252 of the wall 208. The seat 250 opens at its proximal end into the throat 240. The seat 250 tapers outwards in the proximal direction to provide the seat 250 with an inverted frustoconical form, as viewed in Figure 5. The included angle of the taper of the seat 250 is about 90°.

In use, the device 202 is inserted into a nostril of the user, with the proximal end 206a of the insert body 206 innermost and the distal end 206b at or closest to the opening of the nostril. The insert body 206 forms a seal against the inner wall of the nostril and prevents air flowing past the device and requiring that all air entering the nostril passes through the device.

The ball 222 is moveable within the cavity 210, as noted above, between a first position and a second position. In the first position, shown in Figure 3, the ball is in contact with and forms a seal with the seat 250, closing the passage from the distal opening 220 through the cavity 210 to the proximal openings 212. In the second position, shown in Figure 4, the ball is displaced from the seat 250 and the passage from the distal opening 220 through the cavity 210 to the proximal openings 212 is open for the flow of air, indicated by the arrows in Figure 4.

With the device inserted into their nostril, inhalation by the user causes the ball 222 to move to a second position, displaced from the seat 250, as shown in Figure 4. In this position, the user can inhale normally, with air flowing through the distal opening 220, through the cavity 210 past the ball 222 and through the proximal openings 212 into the nostril and the nasal passage of the user. When the user exhales, the ball 222 is forced into the first position against the seat 250 and forms a seal. This prevents air passing out of the nostril through the device. As a result, the user is required to exhale through their mouth. As discussed above, this significantly improves the quality of the speech of the user, in particular a user suffering from VPD.

The insert bodies and the bridge, if present, of the devices shown in Figures 1 to 5 may be formed by moulding, in particular injection moulding. A preferred material for forming the insert bodies is liquid silicone rubber, for example NuSil MED-4930. The ball 222 is inserted into the cavity within the insert body through the distal opening. The material of the wall of the insert body is sufficiently resilient so as to resume its form and retain the valve member within the cavity in the nasal insert. The ball is preferably formed from 420 grade stainless steel.

The form of the wall 208 and the distal opening 220 allow the insert body to be formed from a sufficiently soft material to provide comfort for the user, in particular during prolonged use of the device, and to allow the valve member to be inserted readily into the cavity through the distal opening during manufacture, while at the same time providing the distal end portion of the insert body with strength and rigidity, in particular to allow the valve member to form an effective air-tight seal with the seat, and preventing the seat deforming or collapsing during use.

Claims

1. A nasal air flow control device, the device comprising one or more nasal inserts, each nasal insert comprising: an insert body having a wall, a proximal end and a distal end, the insert body comprising a cavity extending between the proximal end and the distal, the insert body having at least one proximal opening in the wall at the proximal end of the insert body and a distal opening in the wall at the distal end of the insert body; and a valve member disposed in the cavity and moveable therein between a first position and a second position; wherein the portion of the wall at the distal end of the insert body defining the distal opening comprises an inlet portion defining an inlet, a valve seat portion spaced apart from the inlet portion and defining a valve seat, and a throat portion disposed between the inlet portion and the valve seat portion defining a throat; wherein when the valve member is in the first position, it contacts the valve seat portion and closes the distal opening, preventing air flowing through the cavity in the insert body; and wherein when the valve member is in the second position, it is displaced from the valve seat portion and both the proximal and distal openings are open, allowing air to flow through the cavity in the insert body.

2. The nasal air flow control device according to claim 1 , wherein the wall of the insert body is formed from a resilient material, preferably wherein the wall of the insert body is formed from liquid silicone rubber.

3. The nasal air flow control device according to either of claims 1 or 2, wherein the material of the wall of the insert body has a Shore A hardness of from 25 to 35.

4. The nasal air flow control device according to any preceding claim, wherein the insert body is tapered.

5. The nasal air flow control device according to any preceding claim, wherein the proximal end of the insert body is rounded and/or wherein the distal end of the insert body is substantially flat.

6. The nasal air flow control device according to any preceding claim, wherein the cavity is circular in cross-section, preferably wherein the cavity is generally cylindrical.

7. The nasal air flow control device according to any preceding claim, wherein the insert body comprises a plurality of proximal openings at the proximal end.

8. The nasal air flow control device according to any preceding claim, wherein the inlet is circular in cross-section.

9. The nasal air flow control device according to any preceding claim, wherein the inlet is tapered, wherein the distal end of the inlet is larger in diameter than the proximal end of the inlet.

10. The nasal air flow control device according to any preceding claim, wherein the valve seat is circular in cross-section.

11. The nasal air flow control device according to any preceding claim, wherein the valve seat is tapered, wherein the distal end of the valve seat is smaller in diameter than the proximal end of the valve seat.

12. The nasal air flow control device according to any preceding claim, wherein the diameter of the proximal end of the valve seat is the same as the diameter of the distal end of the inlet.

13. The nasal air flow control device according to any preceding claim, wherein the throat has a circular cross-section.

14. The nasal air flow control device according to any preceding claim, wherein the throat has a uniform diameter along its length.

15. The nasal air flow control device according to any preceding claim, wherein the diameter of the proximal end of the throat is the same as the diameter of the distal end of the valve seat.

16. The nasal air flow control device according to any preceding claim, wherein the diameter of the distal end of the throat is the same as the diameter of the proximal end of the inlet.

17. The nasal air flow control device according to any preceding claim, wherein the ratio of the length of the throat is the same as the diameter of the throat.

18. The nasal air flow control device according to any preceding claim, wherein the ratio of the length of the inlet to the length of the throat is from 2:1 to 1:1.

19. The nasal air flow control device according to any preceding claim, wherein the ratio of the length of the valve seat to the length of the throat is from 2:1 to 1:1.

20. The nasal air flow control device according to any preceding claim, wherein the valve member is spherical.

21. The nasal air flow control device according to any preceding claim, wherein the valve member has a density of at least 6 g/cm³.

22. The nasal air flow control device according to any preceding claim, wherein the diameter of the valve member is from 70 to 90% of the diameter of the cavity.

23. The nasal air flow control device according to any preceding claim, wherein the device comprises a first nasal insert and a second nasal insert, and a bridge connected at a first end to a distal end portion of the insert body of the first nasal insert and at a second end to a distal end portion of the insert body of the second nasal insert.

24. The use of a nasal air flow control device according to any preceding claim to control the air flow through the nasal passage of a subject during speech.

25. A method for controlling the flow of air during speech of a subject, the method comprising inserting into each nostril of the subject a nasal insert according to any of claims 1 to 23.