NASAL INSPIRATORY RESISTANCE TRAINER

Abstract

Herein we describe a nasal inspiratory resistance trainer (“NIRT”) that increases the difficulty of nasal breathing. The device is specially designed to limit the cross-sectional area of the nostril, which decreases the volume of air a person can easily intake per unit time, typically achieved by reducing tidal volume per breath, reducing respiratory rate, or a combination thereof. Specific implementations are described.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of co-pending U.S. patent application Ser. No. 12/371,154, filed on Feb. 13, 2009, which claimed the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/028,953, filed Feb. 15, 2008, and further claimed the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/040,169, filed Mar. 28, 2008, all of which are herein incorporated by reference. This patent application also claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/613,533, filed Mar. 21, 2012, and further claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/666,190, filed Jun. 29, 2012, all of which are herein incorporated by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

Not applicable.

FIELD OF INVENTION

The present invention relates to devices useful in promoting slower, breathing, with reduced volume of air intake per unit time, by limiting nasal respiration. The present invention relates to methods useful for the treatment, prevention, and/or management of many medical conditions, including asthma, allergy, respiratory disorders, high blood pressure, panic disorder, and other complications that can be negatively impacted by overbreathing.

BACKGROUND OF THE INVENTION

Over the years, a variety of nasal dilators, nose braces, nasal strips, bandages, breathing equipment, jaw retainers, orthodontic inserts, tongue retainers, mechanisms, instruments and other devices have been suggested to improve breathing quality and have met with varying degrees of success. Devices that require insertion into the nostrils have been tried, with the intent of opening the nostrils and allow more air to enter the nose. Various nasal strips have also been suggested. In one version of the Breathe Right® nasal strip manufactured by CNS, Inc. of Minneapolis, Minn., adhesive strips are lined with two parallel plastic rods. When placed across the bridge of the nose, an adhesive nasal strip adheres to the soft area above the flare of each nostril and provides an excessive pulling force to lift and open the nasal passages. In another version of the Breathe Right® nasal strip, a flexible metal strip is attached to an adhesive band that is placed on the inside of the nose. The spring action of the metal strip pulls the sides of the nose outward. Many other devices have been proposed with the intent of increasing air flow through the nose.

Another approach, analogous to resistance weight training, or high-altitude training, is to practice breathing through artificially high resistance, thereby potentially increasing the strength of various muscles involved in breathing. In other words, rather than making breathing easier by increasing air flow through the nose, this approach makes breathing more difficult during training sessions, hopefully making breathing easier during normal conditions. There are numerous inspiratory resistance trainers that are currently marketed, but these devices require oral inhalation by users. Such devices may indeed increase the strength of various muscles involved in breathing, as advertised, but oral inhalation is generally disfavored by the medical community, and these devices may train users to revert to oral breathing when breathing is difficult, which can be deleterious for users.

Nasal breathing, particularly nasal inhalation, is widely believed to be preferred to oral breathing, particularly for asthmatics, as nasal inhalation humidifies, warms, and filters incoming air. Bishop et al. (Physiotherapy 93 (2007) 129-136) have recently demonstrated that forced nasal breathing, via mouth taping, has the effect of increasing end-tidal carbon dioxide levels.

Scientific evidence has shown that paced breathing can lower blood pressure significantly by relaxing the muscles surrounding constricted blood vessels. The problem for many people, however, is that proper paced breathing does not come naturally or easily. A tonal-based biofeedback system has been incorporated into a portable electronic device (RESPeRATE®, produced by InterCure, Inc.) to lower blood pressure naturally by using biofeedback tones to direct breathing and reduce breathing rate. This FDA-approved device has been clinically demonstrated to reduce blood pressure. However, it is expensive and requires the user to wear a chest strap that monitors breathing.

Numerous medical conditions, including asthma, allergy, respiratory disorders, high blood pressure, panic disorder, and other complications, can be negatively impacted by overbreathing, which can be defined as breathing a greater volume of air per unit time than is desirable for the individual. Average adults at rest typically breathe about 10-15 times per minute, with an average tidal volume of about 500 mL, corresponding to a typical tidal volume of about 6 L/minute. For example, an adult at rest breathing a tidal volume exceeding 15 L/minute is likely overbreathing. People who chronically overbreathe have chronic hyperventilation syndrome. Herein we describe methods and devices suitable to help treat or prevent these problems.

BRIEF SUMMARY OF THE INVENTION

Herein, a nasal inspiratory resistance trainer (“NIRT”) is described that increases the difficulty of nasal breathing. The device is specially designed to limit the cross-sectional area of the nostril, which decreases the volume of air a person can easily intake per unit time, typically achieved by reducing tidal volume per breath, reducing respiratory rate, or a combination thereof. The associated method comprises uses for the device. A subject utilizing the devices and methods of the invention may experience the following results: increased tolerance for carbon dioxide in the body, reduced respiration rate, reduced breathing volume, enhanced nasal to oral breathing ratio, strengthened breathing muscles, and reduced blood pressure.

NIRT devices of the present invention include devices useful for restricting air flow through the nose. In some embodiments of the invention, the devices can restrict air flow into the nose with minimal physical contact with the nose. The device of the present invention attaches to the exterior surface of the nose and exerts a compressive pressure that pushes the nostrils towards a closed position, thereby decreasing the cross-sectional area through which inhaled air and exhaled air can travel. In some embodiments the device of the present invention compresses a portion of the nostril. In some embodiments, the device of the present invention compresses over the length of the nostril. In some embodiments, multiple zones of compression with varying forces are incorporated.

Unlike prior art nose clips useful for swimming and diving, NIRT devices of the present invention are not intended to prevent nasal breathing. The prior art nose clips pinch the nostrils with excessive compressive force, causing the wearer to resort to oral breathing. The NIRT device exerts far less force on the nostril, merely decreasing the cross-sectional area of the nostril. It has been shown that the force necessary to compress the nostril is 235+/−127 mN. (see Fuller et al., (1995), Measurement of the EMG-Force Relationship in a Human Upper Airway Muscle, 79 Journal of Applied Physiology, pp. 270-78). The compression force exerted by the NIRT device of the present invention can be set to utilize a force less than this maximum of 362 mN, or 108 mN, irrespective of the distance between the contact points on the nostrils. The NIRT devices encourage the practice (by systematic training) of nasal breathing in spite of resistance. In all embodiments of the present invention, the compressive force of the NIRT device is generated by rotating a screw which causes compression of the nostril.

In one embodiment, the NIRT comprises two strips connected by a screw mechanism. The NIRT device fits over the bulbous tip of the nose and the strips contact the lateral portion of the nostril. Accordingly, under normal use conditions, the human subject rotates the screw mechanism causing the two strips to move toward each other, thereby compressing the nostril. The human subject continues to rotate the screw until the cross-sectional area of the nostril is decreased. In another similar embodiment, the NIRT comprises two strips connected by a turnbuckle.

In another embodiment, the NIRT device comprises two screws with symmetric tips connected by a bridge. The NIRT device fits over the bulbous tip of the nose and symmetric tips contact the lateral portion of the nostril. Accordingly, under normal use conditions, the human subject rotates the screws causing the two tips to move away from the bridge, thereby compressing the nostril. The human subject continues to rotate the screw until the cross-sectional area of the nostril is decreased. In another similar embodiment, the NIRT comprises non-symmetric tips.

An asthmatic subject utilizing a NIRT device according to the methods of the invention is exposed to conditions of impaired air flow somewhat analogous to asthma attacks, and therefore can hone techniques useful in dealing with real asthma attacks, including: avoiding panic, reducing respiratory volume, and breathing through the nose in spite of increased air resistance. Furthermore, the methods of the invention help to prevent asthma attacks by decreasing habitual hyperventilation and increasing the proportion of inhalations through the nose relative to inhalations through the mouth.

The present invention is useful for the treatment, management, and prevention of symptoms relating to asthma and rhinitis. For example, the methods and devices of the present invention can be used on subjects with allergies to allergens such as ragweed or tree pollen, ideally training subjects to avoid hyperventilating when airflow is impaired by allergy-induced congestion.

The present invention is also useful for reducing blood pressure. Individuals using a NIRT device of the present invention typically breathe more slowly when using the device than they do when not wearing the device. In most cases, this reduced breathing rate is not the result of a conscious decision to breathe more slowly, but instead is a natural result of the increased inhalation and exhalation times required to process a normal volume of air. The NIRT-induced reduction in breathing rate can induce a relaxation of constricted blood vessels, prompting a reduction in blood pressure.

The present invention is also useful for treating panic disorder. After training with the NIRT device, an individual afflicted with panic disorder can have improved responses to panic attacks, or to conditions that may lead to panic attacks, thereby potentially reducing the number and severity of panic attacks, and reducing the associated symptoms of panic disorder.

The present invention is also useful for treating hyperventilation syndrome, also referred to as chronic hyperventilation syndrome, which can cause or exacerbate medical conditions including but not limited to asthma, allergies, and high blood pressure, and which is estimated to afflict between 1% and 10% of the population.

BRIEF DESCRIPTION OF THE DRAWINGS

The summary above, and the following detailed description, will be better understood in view of the drawings which depict details of preferred embodiments.

FIG. 1 shows a schematic cross-sectional view of one embodiment of a NIRT device with a bridge.

FIG. 2 shows a side view of the device shown in FIG. 1.

FIG. 3 shows a schematic cross sectional view of a NIRT device with side walls.

FIG. 4 shows a side view of the device shown in FIG. 3.

FIG. 5 shows a schematic cross sectional view of a NIRT device with a turnbuckle.

FIG. 6 shows a schematic cross sectional view of another embodiment of a NIRT device utilizing multiple screws and symmetric tips.

FIG. 7 shows a top view of the device shown in FIG. 6.

FIG. 8 shows a schematic cross sectional view of a NIRT device utilizing multiple screws and non-symmetric tips.

FIG. 9 shows a top view of the device shown in FIG. 8.

FIG. 10 shows a schematic view of a screw.

FIG. 11 shows a prior art nose clip in a deflected position.

FIG. 12 shows a side view of the devices in FIG. 1 in a deflected position.

FIG. 13 shows a side view of the devices in FIG. 1 in a deflected position, which exerts the same force as the device in FIG. 12.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to a nasal inspiratory resistance trainer (“NIRT”). The present invention is also directed to useful methods for the treatment, prevention, and/or management of respiratory disorders and associated complications.

A nasal inspiratory resistance trainer (NIRT) 10 in accordance with the present invention is illustrated generally in FIG. 1. The NIRT device has a first strip 1 and a second strip 2. The first strip 1 and the second strip 2 are oriented substantially parallel to each other. As shown, the first strip 1 and the second strip 2 are generally rectangular. As shown in FIG. 1, the first strip 1 and the second strip 2 have a consistent longitudinal width. Other shapes are contemplated such as spoon-shaped, teardrop or oval.

The first strip 1 contains a threaded hole capable of accepting a screw 3. This unitary structure may be easier to manufacture. Alternatively, the first strip 1 contains a non-threaded hole. A nut is aligned with the non-threaded hole and attached to the first strip 1. The screw 3 would pass through both the nut and the non-threaded hole. The material of first strip 1 and the second strip 2 is selected to maximize comfort for the human subject while minimizing skin irritations. The first strip 1 and the second strip 2 are formed of a biocompatible material. Suitable materials for first strip 1 and the second strip 2 include but are not limited to plastics and metals. Suitable materials combine the strength and rigidity required, at a relatively inexpensive cost.

Screw 3 is a commercially-available screw in a standard size. Suitable materials for screw 3 include but are not limited to plastics (e.g., nylon) and metals. Suitable materials combine the light-weightiness required, at a relatively inexpensive cost. To aid in the operation of the device, screw 3 may be striped as shown in FIG. 10. This is a visual cue to the human subject as to how far to rotate the screw.

Spring 7 encircles screw 3. Spring 7 presses against the first strip 1 and second strip 2 in the uncompressed state. As the screw is rotated, spring 7 compresses. The spring 7 facilitates the smooth traverse of the first strip 1 toward the second strip 2. The spring 7 also prevents the second strip 2 from sliding toward the first strip 1.

The NIRT device may comprise a means for preventing rotation. As shown in FIGS. 1-2, bridge 4 constrains the first strip 1 to the second strip 2. Bridge 4 prevents the first strip 1 from rotating when the screw 3 is rotated. With the bridge 4, when screw 3 is rotated, the first strip 1 traverses the gap between the first strip 1 and the second strip 2, rather than rotating in place. Alternatively, as shown in FIGS. 3-4, sidewalls 5 constrain the first strip 1 to the second strip 2. The sidewalls are attached to the second strip 2. The sidewalls 5 are not attached to the first strip 1; rather, the first strip 1 slides along the sidewalls 5. When screw 3 is rotated, the first strip 1 traverses the gap between the first strip 1 and the second strip 2, rather than rotating in place. While the second strip 2 and the sidewalls 5 are shown as separate components, an integral structure could be formed.

As shown in FIGS. 1-4, the head of the screw 3 is located near second strip 2. However, due to the symmetry of the design, the head of the screw 3 could be located near first strip 1. To aid in rotation, a knob (not shown) is affixed to screw. Suitable materials include rubber, plastic, metal, nylon, or ceramics. The knob allows for the screw 3 to be easily turned. In order to aid in turning, a washer (not shown) may be inserted between the knob and the second strip 2. Suitable materials for the washer include metal, plastic or nylon.

The use of screw 3 allows the device to have a greater degree of precision. Small increments of force can be adjusted with the slight turn of screw 3. The device 10 can be adjusted to fit a wide variety of noses, since the gap between the first strip 1 and the second strip 2 can be increased or decreased in an infinite number of incremental steps.

In operation, the devices shown in FIGS. 1-4 function similarly. The NIRT device 10 is placed over the bulbous tip of the nose of a human subject. The first strip 1 contacts one nostril and the second strip 2 contacts the other nostril. Accordingly, under normal use conditions, the human subject rotates the screw 3 causing the first strip 1 to move toward the second strip 2, thereby compressing the nostrils. The human subject continues to rotate the screw until the cross-sectional areas of the nostrils are decreased.

In another embodiment shown in FIG. 5, the NIRT device has a first strip 1 substantially similar to the first strip 1 in FIGS. 1-4. The first strip 1 contains a threaded hole capable of accepting a turnbuckle 6. This unitary structure may be easier to manufacture. Alternatively, the first strip 1 contains a non-threaded hole. A nut is aligned with the non-threaded hole and attached to the first strip 1. The turnbuckle would pass through both the nut and the non-threaded hole. The NIRT device has another strip 1′. The strip 1′ contains a threaded hole capable of accepting a turnbuckle 6. Alternatively, the strip 1′ contains a non-threaded hole. A nut is aligned with the non-threaded hole and attached to the strip 1′. The turnbuckle would pass through both the nut and the non-threaded hole.

In order for the device to function, the threaded hole on strip 1′ must have the opposite threading from the threaded hole on strip 1. For instance, if the threaded hole on the first strip 1 has right handed threads, then the threaded hole on strip 1′ must have left handed threads. Alternatively, if nuts are utilized, the nut attached to strip 1 must have opposite threading as the nut attached to strip 1′

The first strip 1 and strip 1′ are formed of a biocompatible material. Suitable materials for first strip 1 and strip 1′ include but are not limited to plastics and metals. Suitable materials combine the strength and rigidity required, at a relatively inexpensive cost.

Turnbuckle 6 is a commercially-available turnbuckle in a standard size. Suitable materials for turnbuckle include but are not limited to plastics and metals. Suitable materials provide the requisite low weightat a relatively inexpensive cost. To aid in the operation of the device, the turnbuckle may be striped (not shown), similar to the screw shown in FIG. 10. This is a visual cue to the human subject as to how far to rotate the turnbuckle.

As turnbuckle 6 is rotated, the first strip 1 and the strip 1′ move toward each other. To aid in rotation, a knob (not shown) could be affixed to the middle of the turnbuckle 6. Suitable materials include rubber, plastic, metal, or ceramics. The knob allows for the turnbuckle 6 to be easily turned.

The NIRT device may comprise a means for preventing rotation. Bridge 4 (not shown) constrains the first strip 1 to strip 1′. Bridge 4 prevents the first strip 1 and strip 1′ from rotating when the turnbuckle 6 is rotated. With the bridge, when turnbuckle 6 is rotated, the first strip 1 and strip 1′ move toward each other, rather than rotating in place. Alternatively, sidewalls 5 (not shown) constrain the first strip 1 to strip 1′. The sidewalls are attached to strip 1′. The sidewalls 5 are not attached to the first strip 1. Rather the first strip 1 slides along the sidewalls 5. When turnbuckle 6 is rotated, the first strip 1 and strip 1′ move toward each other, rather than rotating in place

In operation, the devices shown in FIGS. 1-5 function similarly. The NIRT device 10 is placed over the bulbous tip of the nose of a human subject. The first strip 1 contacts one nostril and the strip 1′ contacts the other nostril. Accordingly, under normal use conditions, the human subject rotates the turnbuckle 6 causing the first strip 1 and the strip 1′ to move toward each other, thereby compressing the nostrils. The human subject continues to rotate the turnbuckle until the cross-sectional areas of the nostrils are decreased.

The devices in FIGS. 1-5 have a unique feature not found in prior art devices. Prior art nose clips have a single neutral position. The neutral position is defined as the position where stresses or strains on the device are lowest. With a single neutral position, prior art devices return to one pre-determined distance. FIG. 11 demonstrates this concept. FIG. 11 shows as typical, prior art nose clip 20. The prior art nose clip 20 has a single neutral position where the prior art nose clip 20 has zero deflection. In the neutral position, the legs of the prior art nose clip 20 are a distance 21 apart. The distance 21 is based on the manufactured shape of the prior art nose clip 21. When stretched to a distance beyond 21 as shown in FIG. 11, the prior art nose clip 20 applies a force directly proportional to the deflection, according to the formula:

P=3 δ_maxEI/L³

where δ_max is the maximum deflection, E is the modulus of elasticity, I is the moment of inertia, and L is the length of the beam.

As such, prior art nose clip 20 has to deflect a greater distance for larger noses and therefore applies a greater force. For any distance the prior art device is spread apart, the force is a known value and can not be altered. In other words, the device is not capable of applying a set force, such as 375 mN, to noses of different shapes. Typically, the prior art nose clips cannot apply a specified force over a range of different force values because they are intended to prevent nasal breathing. Prior art nose clips apply excess force in order to completely block the flow of air through the nose. The design of prior art nose clips is a product of this intended use.

The devices shown in FIGS. 1-5 function in a completely different manner. A NIRT device has an infinite number of neutral positions. The neutral position is defined as the position where stresses or strains on the device are lowest. A neutral position is determined based on rotation of the screw 3 or turnbuckle 6 which shortens or lengthens the distance between the first strip 1 and either the second strip 2 or strip 1′. In other words, a NIRT device has an infinite number neutral position where first strip 1 and either the second strip 2 or strip 1′ both have zero deflection. In the neutral position, the distance between first strip 1 and either the second strip 2 or strip 1′ is not determined by the manufactured shape of the device like distance 21 shown in FIG. 11.

As shown in FIG. 12, the screw 3 of the NIRT device has been rotated so that strip 1 and second strip 2 are separated by a distance 11. In this neutral position, the first strip 1 and second strip 2 have zero deflection. When stretched to a distance beyond 11 as shown in FIG. 12, the NIRT devices applies a force directly proportional to the deflection, according to the formula:

P=3 δ_maxEI/L³

where δ_max is the maximum deflection, E is the modulus of elasticity, I is the moment of inertia, and L is the length of the beam.

However, as shown in FIG. 13, the screw of the NIRT device has been rotated so that strip 1 and strip 2 are separated by a distance 110. In this neutral position, the first strip 1 and second strip 2 have zero deflection. When stretched to a distance beyond 110 shown in FIG. 12, the NIRT devices applies a force directly proportional to the deflection. If the deflection is the same for FIG. 12 and FIG. 13, then the force applied by the NIRT device is the same. In other words, the device is capable of applying a set force regardless of the distance separating the first strip and the second strip. As such, the device is capable of applying a force, such as 375 mN, to noses of different shapes. The purpose of the NIRT devices is to reduce the cross-sectional area of the nostril. The design of the device is critical to achieving this intended use.

A NIRT device 10 in accordance with the present invention is illustrated generally in FIG. 6. In the embodiment shown, the NIRT device has two screws 3 and two nuts 8. Alternatively, nuts 8 could be replaced with a solid block of material with a threaded hole. In one embodiment, the screws 3 are oriented substantially parallel to each other. The nuts 8 are attached to a bridge 4. Alternatively, nuts 8 and bridge 4 could be a unitary structure. Bridge 4 is a means for preventing rotation.

As shown in FIG. 6, screws 3 are attached to tips 9. In one embodiment, tip 9 rotates when screw 3 rotates. This structure is easier to manufacture. In another embodiment, tip 9 does not rotate when screw 3 rotates. This structure may be more comfortable for the human subject 100, since the tip will not rub against the nose during rotation. Tip 9 can be attached to the screw through any means typical in the art. As shown in FIG. 7, each tip 9 is symmetrical with respect to the axis of screw 3. In other words, each tip 9 has a consistent width with respect to the axis of screw 3. To aid in the operation of the device, the screws 3 may be striped as shown in FIG. 10. This is a visual cue to the human subject as to how far to rotate the screw.

The NIRT device 10 is placed over the bulbous tip of the nose of a human subject. The first tip 9 contacts one nostril and the second tip 9 contacts the other nostril. Accordingly, under normal use conditions, the human subject then rotates each screw 3 causing the tip 9 to move away from the bridge 4, thereby compressing the nostril. The human subject continues to rotate the screw until the cross-sectional area of the nostril is decreased. The human subject rotates the other screw 3 in a similar manner causing the other tip 9 to move away from the bridge 4.

Alternatively, screws 3 are attached to tips 9′. Each tip 9′ rotates when the attached screw 3 rotates. Unlike the tips 9 shown in FIG. 6, the tips 9′ are not symmetric with respect to the axis of screw 3. As shown in FIG. 8, each tip 9′ has an extension that slants away from the screw 3. To aid in the operation of the device, the screws 3 may be striped as shown in FIG. 10. This is a visual cue to the human subject as to how far to rotate the screw.

In operation, the human subject rotates the screws 3 to a desired length. At this point in time, the device is positioned similar to the positioning shown in FIG. 9. In other words, each tip has an extension that is positioned to slant away from the screw 3. Then, the NIRT device 10 is placed over the bulbous tip of the nose of a human subject and the tips 9′ rest against the nostril. The human subject grasps both screws 3 and rotates the screws. When the screws 3 are rotated between 90 and 180 degrees, the cross-sectional area of the nostril is decreased.

The NIRT device is far more comfortable to wear than prior art nose clips because the NIRT applies a smaller compressive force. The NIRT device aims at reducing the cross-sectional area of the nostrils rather than closing them completely. As such, the design of the NIRT device is a product of this intended use. In some embodiments, the extent of available cross-sectional area in the nasal passage through which air can flow is controlled by moderating the compressive pressure of the device. In some embodiments, said cross-sectional area is controlled by the placement of the device.

The present invention is useful for the treatment, management, and prevention of symptoms relating to respiratory disorders such as asthma and rhinitis. The methods of the present invention are useful for the treatment of both allergic asthma and non-atopic asthma, and are useful for the treatment of allergic rhinitis and non-allergic rhinitis. For example, the methods and devices of the present invention are useful in training a child suffering from seasonal allergic rhinitis (e.g., “hay fever”) to avoid overbreathing and to better cope with nasal congestion. There is a tendency in many individuals with asthma or rhinitis to inhale more air than is needed, which can decrease carbon dioxide levels in the blood, which can lead to increased mucus production, thereby exacerbating congestion and often increasing the tendency to hyperventilate. The methods and devices of the present invention assist in disrupting this cycle.

There has been considerable interest in the Buteyko breathing technique, which was developed in Russia by Konstantin Buteyko. The Buteyko Breathing Centre claims over 90% of asthmatics who completed the Buteyko course in Russia no longer need medication. Further, these results have been replicated in Australia. Butevko Trials and Results, Buteyko Breathing Centre, http://www.buteyko.co.uk/buteyko-trials.htm. The Buteyko technique is based on the hypothesis that asthma is caused by hyperventilation. The technique teaches the ability to reduce the frequency and depth of breathing. In a recent randomized control trial, asthmatics were taught the Buteyko technique. Cooper et al., Effect of Two Breathing Exercises (Buteyko and Pranayama) in Asthma: A Randomized Trial, 58 Thorax 674-79 (2006). Training was given in small groups to learn the exercises. Participants were asked to use the technique twice daily. Additionally, participants were asked to use the technique to relieve asthma symptoms and only to use their bronchodilator if that failed. The results show that the Buteyko technique reduced asthma symptoms and bronchodilator use compared with other groups who did not use the technique.

However, during an attack, an asthmatic's breathing is closer to hyperventilation, where the body is in a state of faster and deeper breathing. The device of the present invention assists asthmatics in reducing the frequency and depth of breathing by training with a device that reducing the cross-sectional area of the nasal passage. The device of the present invention is a passive constraint that allows asthmatics to practice constrained breathing in a non-emergency setting. By honing in on personal tempos and patterns to correct hyperventilation, asthmatics may be able to better handle future attacks. It has also been shown that asthmatics over-perceive nasal resistance, and switch from nasal to oral breathing at lower resistive loads. Hallani et al., Asthmatics Have Increased Sensitivity to Nasal Loads and Tend to Breathe Oro-nasally, American Thoracic Society Annual Scientific Meeting. 163 Am. J. Respir. Crit. Care Med. A60 (2001). This suggests that any reduction in compression is preferably incremental to accommodate the differing sensitivities of asthmatics. The device of the present invention achieves this goal by incorporation a screw mechanism. The screw in all embodiments allows for incremental adjustments to the compression of the nostril. Fine-tune adjustments allow asthmatics to hone techniques for nasal breathing under different levels of pressure, without resorting to oral breathing. Additionally, only one NIRT is necessary for both beginners and advanced users, since the pressure can be varied from nearly 0 mN to full compression of the nostril at approximately 362 mN.

Nasal breathing, in general, is preferred to mouth breathing for asthmatics. Mouth breathing allows airborne allergens to reach the lower airways, and dries the bronchial mucous membrane. One study suggests that a mere 60 minutes of forced mouth breathing results in a significant decrease in lung function as measured by FEV₁. Hallani et al., Enforced Mouth Breathing Decreases Lung Function in Mild Asthmatics, 13 Respirology 553 (2008). Additional research has favored nasal breathing. One recent study (Bishop et al., The use of mouth taping in people with asthma: a pilot study examining the effects on end-tidal carbon dioxide, (2007), 93 Physiotherapy p. 129) demonstrated that forced nasal breathing, via mouth taping, has the effect of increasing end-tidal carbon dioxide levels.

The device of the present invention can be used to promote nasal breathing. By overcoming the perceived increase in resistance, users, including individuals with allergies or asthma, can train themselves to maintain nasal breathing in compromising situations. Nasal breathing through the duration of an attack forces air through the conditioning process of the nasal mucosa and prevents the decrease in lung function associated with mouth breathing.

The methods and devices of the present invention may be useful for reducing blood pressure. This outcome is particularly relevant for individuals having hypertension or prehypertension, and may be most effective when used by individuals who typically have high respiration rates. That said, the methods and devices of the invention may also be useful for individuals not afflicted with hypertension or prehypertension, particularly when used on a preventative basis. Individuals with prehypertension have a systolic pressure (top number) ranging from 120 to 139 millimeters of mercury (mm Hg) or a diastolic pressure (bottom number) ranging from 80 to 89 mm Hg. Individuals with hypertension have a systolic pressure greater than 140 mm Hg or a diastolic pressure greater than 90 mm Hg.

In one embodiment of the invention, subjects having hypertension or prehypertension train with the NIRT device three or more times per week, for at least ten minutes per session. Subjects training with the device may experience reduced blood pressure relative to what the blood pressure would otherwise be in the absence of training with the device. To date, such training has only been performed on individuals having normal blood pressure, and clinical trials are planned to investigate the extent of blood pressure reduction that can be achieved by training with NIRT devices.

The methods and devices of the present invention are compatible with other methods for reducing blood pressure, including exercise, use of other medical devices to reduce blood pressure, and pharmacotherapy such as administration of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers, and calcium channel blockers.

The methods and devices of the present invention may be useful for treating panic disorder. Recent evidence suggests that rather than taking deep breaths during a panic attack, a more effective strategy during or preceding panic attacks may be to reduce breathing volume, for example by breathing slower and more shallow, thereby boosting carbon dioxide levels. Patients trained to breathe slower and shallower showed significant improvement in panic disorder symptoms. (Meuret et al., “Feedback of End-tidal pCO2 as a Therapeutic Approach for Panic Disorder”, Journal of Psychiatric Research, 42 (2008), 560-8).

In one embodiment of the invention, subjects having panic disorder train with the NIRT device three or more times per week, for at least ten minutes per session. Subjects training with the device can improve their ability to handle a panic attack, or even to ward off a panic attack by breathing less and retaining carbon dioxide.

In preferred embodiments of the invention, the amount of use is prescribed based upon the patient's needs. For example, an adolescent patient suffering from asthma can use the NIRT device multiple times per day for months or years. The duration and frequency of training sessions using the NIRT devices of the present invention can vary according to the methods of the invention. For example, the NIRT can be applied daily, or can be used sporadically. It can be applied for a short time, or can be utilized for multiple hours. In preferred embodiments, the NIRT is applied to the nose and utilized for at least five minutes at least one time per week.

Incorporation by Reference

All publications, patents, and patent applications cited herein are hereby expressly incorporated by reference in their entirety and for all purposes to the same extent as if each was so individually denoted.

Equivalents

While specific embodiments of the subject invention have been discussed, the above specification is illustrative and not restrictive. Many variations of the invention will become apparent to those skilled in the art upon review of this specification. The full scope of the invention should be determined by reference to the claims, along with their full scope of equivalents, and the specification, along with such variations.

The articles “a” and “an” are used herein to refer to one or to more than one (i.e. to at least one) of the grammatical object of the article. By way of example, “a spring” means one spring or more than one spring.

Any ranges cited herein are inclusive.

Claims

1. A method of limiting nasal respiration in a human subject, comprising:

placing a first contact point of a nasal inspiratory resistance trainer in contact with the external surface of the right nostril of said human subject;

placing a second contact point of said nasal inspiratory resistance trainer in contact with the external surface of the left nostril of said human subject;

adjusting a screw mechanism;

wherein said nasal inspiratory resistance trainer is capable of exerting a specified amount force regardless of the distance between said first contact point and said second contact point.

2. The method of claim 1, wherein said nasal inspiratory resistance trainer has an infinite number of neutral positions.

3. The method of claim 2, wherein said neutral position is the position where stresses or strains on the device are lowest.

4. The method of claim 2, wherein the step of adjusting the screw mechanism comprises adjusting the screw mechanism from a neutral position to a position of greater stresses or strains.

5. The method of claim 2, wherein said nasal inspiratory resistance trainer is capable of deflecting a specified distance regardless of the size of the nose of said human subject.

6. The method of claim 1, wherein said nasal inspiratory resistance trainer is capable of exerting a specified amount force regardless of the size of the nose of said human subject.

7. The method of claim 1, wherein said specified amount force is less than 362 mN.

8. The method of claim 7, wherein said specified amount force is between 108 mN and 362 mN.

9. The method of claim 1, wherein said specified amount of force partially decreases the cross-sectional area of the nostril.

10. The method of claim 9, wherein the cross-sectional area of the nostril is reduced by 25% to 75%.

11. The method of claim 1, wherein the total volume of air inhaled per unit time by said human subject using said nasal inspiratory resistance trainer is decreased relative to the total volume of air inhaled per unit time by said human subject when not using said nasal inspiratory resistance trainer.

12. The method of claim 1, wherein the method is useful for the treatment, prevention, and/or management of medical conditions that are exacerbated by overbreathing.

13. The method of claim 12, wherein said medical condition is selected from the group consisting of: high blood pressure, panic disorder, allergies, and asthma.

14. The method of claim 1, wherein said human subject is asthmatic.

15. The method of claim 14, wherein said human subject hones one or more techniques useful in dealing with real asthma attacks selected from the group consisting of avoiding panic, reducing respiratory volume, and breathing through the nose in spite of increased air resistance.

16. The method of claim 14, wherein said human subject decreases habitual hyperventilation and increases the proportion of inhalations through the nose relative to inhalations through the mouth.

17. The method of claim 12, wherein said overbreathing occurs on a chronic basis, and wherein said human subject has chronic hyperventilation syndrome.

18. The method of claim 1, wherein said nasal inspiratory resistance trainer enhances respiration quality in said human subject.