Nasal devices with noise-reduction and methods of use

Abstract

Described herein are nose-reduced nasal devices configured to reduce or eliminate the unwanted noises associated with use of a nasal device. These noise-reduced nasal devices include a flap-valve airflow resistor and a noise-reduction feature that is a noise-reduction element, a noise-reduction flap valve, or both. The noise-reduction feature typically prevents the flap valve from oscillating or vibrating and producing an audible sound during use, particularly during inhalation through the device. The method and devices described herein may prevent the flap, and particularly the edge region of the flap face or tip of the flap, from oscillating during inhalation.

1 . A noise-reduced nasal respiratory device comprising:
 a noise-reduced airflow resistor comprising a flap valve, wherein the noise-reduced airflow resistor is configured to inhibit exhalation more than inhalation and to inhibit oscillation of a free edge of the flap valve during inhalation when the flow rate is between about 20 and 750 ml/sec; and   a holdfast configured to secure the noise-reduced nasal respiratory device in communication with the subject's nasal cavity.   
     
     
         2 . The device of  claim 1 , wherein the noise-reduced airflow resistor comprises a noise-reduction flap valve. 
     
     
         3 . The device of  claim 1 , wherein the noise-reduced airflow resistor comprises a noise-reduction element configured to limit oscillation of the flap valve. 
     
     
         4 . The device of  claim 2 , wherein the noise-reduction flap valve comprises a butterfly-type flap valve. 
     
     
         5 . The device of  claim 2 , wherein the noise-reduction flap valve comprises a plurality of cuts arranged so that the edge of the flap valve does not orient substantially in parallel with the direction of airflow through the valve during inhalation. 
     
     
         6 . The device of  claim 2 , wherein the noise-reduction flap valve comprises a first flap and a second flap wherein the first and second flaps are configured to open during inhalation so that the opening of the second flap inhibits the first flap from opening in parallel with the direction of airflow through the valve during inhalation. 
     
     
         7 . The device of  claim 2 , wherein the noise-reduction flap comprises a dampened edge. 
     
     
         8 . The device of  claim 2 , wherein the flap of the noise-reduction flap valve comprises a material having a durometer that is greater than 40 Shore A. 
     
     
         9 . The device of  claim 2 , wherein the flap of the noise-reduction flap valve comprises a material having a durometer that is greater than 40 Shore A and a thickness between about 2 mil and about 5 mil. 
     
     
         10 . The device of  claim 3 , wherein the noise-reduction element comprises a projecting surface that communicates with the flap valve to prevent an edge of the flap valve form orienting substantially in parallel with the direction of airflow through the nasal device during inhalation. 
     
     
         11 . The device of  claim 10 , wherein the projecting surface comprises a rib extending at least partially across an opening through the nasal device, wherein the noise-reduced airflow resistor communicates with the opening through the nasal device to increase the resistance to air exhaled through the opening more than the resistance to air inhaled through the opening. 
     
     
         12 . The device of  claim 3 , wherein the noise-reduction element comprises a cone configured to prevent an edge region of the flap valve from opening substantially in parallel with the direction of airflow during inhalation. 
     
     
         13 . The device of  claim 3 , wherein the noise-reduction element comprises a cone. 
     
     
         14 . The device of  claim 3 , wherein the noise-reduction element comprises a castle-topped cone. 
     
     
         15 . The device of  claim 3 , wherein the noise-reduction element comprises a cage. 
     
     
         16 . The device of  claim 3 , wherein the noise-reduction element comprises a spacer configured to prevent the edge region of the flap valve from opening in parallel with the direction of airflow during inhalation. 
     
     
         17 . The device of  claim 3 , wherein the noise-reduction element does not substantially increase the inspiratory resistance. 
     
     
         18 . The device of  claim 1  further comprising a leak pathway configured to remain open during both inhalation and exhalation. 
     
     
         19 . The device of  claims 1 , wherein the holdfast comprises a compressible holdfast 
     
     
         20 . The device of  claim 1 , wherein the holdfast comprises an adhesive holdfast. 
     
     
         21 . The device of  claim 1 , wherein the nasal respiratory device has a resistance to exhalation that is between about 0.01 and about 0.25 cm H 2 O/(ml/sec) when measured at 100 mil/s. 
     
     
         22 . A noise-reduced nasal respiratory device comprising:
 a noise-reduced airflow resistor comprising a noise-reduction flap valve that is configured to inhibit exhalation more than inhalation, wherein the noise-reduction flap valve is further configured so that a free edge region of the flap valve does not orient in parallel with the direction of airflow through the flap valve during inhalation; and   a holdfast configured to secure the device in communication with the subject's nasal cavity.   
     
     
         23 . The device of  claim 22 , wherein the noise-reduction flap valve comprises a butterfly-type flap valve. 
     
     
         24 . The device of  claim 22 , wherein the noise-reduction flap valve comprises a plurality of cuts arranged so that the edge region of the flap valve does not orient substantially in parallel with the direction of airflow through the valve during inhalation. 
     
     
         25 . The device of  claim 22 , wherein the noise-reduction flap valve comprises a first flap and an opposing second flap wherein the first and second flaps are configured to open during inhalation so that the opening of the second flap inhibits the first flap from opening in parallel with the direction of airflow through the valve during inhalation. 
     
     
         26 . The device of  claim 22 , wherein the noise-reduction flap comprises a dampened edge. 
     
     
         27 . The device of  claim 22 , wherein the flap of the noise-reduction flap valve comprises a material having a durometer that is greater than 40 Shore A. 
     
     
         28 . The device of  claim 22 , wherein the flap of the noise-reduction flap valve comprises a material having a durometer that is greater than 40 Shore A and a thickness between about 2 mil and about 5 mil. 
     
     
         29 . The device of  claim 22  further comprising a leak pathway configured to remain open during both inhalation and exhalation. 
     
     
         30 . The device of  claims 22 , wherein the holdfast comprises a compressible holdfast 
     
     
         31 . The device of  claim 22 , wherein the holdfast comprises an adhesive holdfast. 
     
     
         32 . The device of  claim 22 , wherein the nasal respiratory device has a resistance to exhalation that is between about 0.01 and about 0.25 cm H 2 O/(ml/sec) when measured at 100 ml/s. 
     
     
         33 . A noise-reduced nasal respiratory device comprising:
 an opening configured to communicate with the nasal cavity;   a noise-reduced airflow resistor comprising a flap valve in communication with the opening and a noise-reduction element configured to limit oscillation of the flap valve, wherein the noise-reduced airflow resistor is configured to increase the resistance to air exhaled through the opening more than the resistance to air inhaled through the opening; and   a holdfast configured to secure the opening in communication with the subject's nasal cavity.   
     
     
         34 . The device of  claim 33 , wherein the noise-reduction element comprises a projecting surface that communicates with the noise-reduced airflow resistor to prevent an edge region of the flap valve form orienting substantially in parallel with the direction of airflow through the nasal device during inhalation. 
     
     
         35 . The device of  claim 34 , wherein the projecting surface comprises a rib extending at least partially across the opening. 
     
     
         36 . The device of  claim 33 , wherein the noise-reduction element comprises a cone. 
     
     
         37 . The device of  claim 33 , wherein the noise-reduction element comprises a cone having at least one cut-out region for air passage along the perimeter. 
     
     
         38 . The device of  claim 33 , wherein the noise-reduction element comprises a castle-topped cone. 
     
     
         39 . The device of  claim 33 , wherein the noise-reduction element comprises a cage configured to prevent an edge region of the flap valve from opening in parallel with the direction of airflow during inhalation. 
     
     
         40 . The device of  claim 33 , wherein the noise-reduction element comprises a spacer configured to prevent the edge region of the flap valve from opening in parallel with the direction of airflow during inhalation. 
     
     
         41 . The device of  claim 33 , wherein the noise-reduction element does not substantially increase the inspiratory resistance. 
     
     
         42 . The device of  claim 33  further comprising a leak pathway configured to remain open during both inhalation and exhalation. 
     
     
         43 . The device of  claims 33 , wherein the holdfast comprises a compressible holdfast 
     
     
         44 . The device of  claim 33 , wherein the holdfast comprises an adhesive holdfast. 
     
     
         45 . The device of  claim 33 , wherein the nasal respiratory device has a resistance to exhalation that is between about 0.01 and about 0.25 cm H 2 O/(ml/sec) when resistance is measured at 100 ml/s. 
     
     
         46 . A noise-reduced nasal respiratory device comprising:
 an opening configured to communicate with the nasal cavity;   a noise-reduced airflow resistor comprising a flap valve in communication with the opening and a noise-reduction element configured to prevent an edge of the flap valve from becoming oriented substantially in parallel with the direction of airflow through the opening during inhalation, wherein the noise-reduced airflow resistor is configured to increase the resistance to air exhaled through the opening more than the resistance to air inhaled through the opening; and   a holdfast configured to secure the opening in communication with the subject's nasal cavity.   
     
     
         47 . A method of decreasing the noise of operation of a nasal device having a flap valve airflow resistor, the method comprising:
 placing a nasal device in communication with a subject's nasal cavity, wherein the device includes a flap valve airflow resistor configured to inhibit exhalation more than inhalation; and   limiting the oscillation of the flap valve during inhalation through the nasal device.   
     
     
         48 . The method of  claim 47 , wherein the step of limiting the oscillation of the flap valve comprises preventing an edge region of the flap valve from orienting substantially in parallel with the direction of inspiratory airflow through the nasal device. 
     
     
         49 . The method of  claim 47 , further comprising preventing the flap valve from oscillating by limiting the motion of a free end of the flap valve. 
     
     
         50 . The method of  claim 47 , further comprising adhesively securing the nasal device at least partly over the subject's nasal cavity. 
     
     
         51 . A method of decreasing the noise of operation of a nasal device, the method comprising:
 placing a nasal device in communication with a subject's nasal cavity, wherein the device includes an opening, a flap valve airflow resistor in communication with the opening, and a noise-reduction element, wherein the flap valve airflow resistor is configured to inhibit exhalation more than inhalation; and   inhibiting the oscillation of the flap valve during inhalation through the nasal device by contacting at least a portion of a free edge of the flap valve to the noise-reduction element during inhalation.   
     
     
         52 . A method of treating a disorder, the method comprising:
 placing a passive resistance nasal device in communication with a subject's nasal cavity, wherein the device includes an opening, a flap valve airflow resistor in communication with the opening, wherein the flap valve airflow resistor is configured to inhibit exhalation more than inhalation; and   vibrating the flap valve during inhalation through the nasal device.   
     
     
         53 . The method of  claim 52 , wherein the disorder is cystic fibrosis.