U.S. patent application number 12/405837 was filed with the patent office on 2012-11-15 for nasal devices with noise-reduction and methods of use.
Invention is credited to Rajiv Doshi, Arthur Ferdinand, Shapour Golzar, Toru Mino, Arthur G. Sandoval, Elliot Sather, Jeffrey W. Servaites, Jonathan P. Summers.
Application Number | 20120285470 12/405837 |
Document ID | / |
Family ID | 39939045 |
Filed Date | 2012-11-15 |
United States Patent
Application |
20120285470 |
Kind Code |
A9 |
Sather; Elliot ; et
al. |
November 15, 2012 |
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.
Inventors: |
Sather; Elliot; (San
Francisco, CA) ; Mino; Toru; (Chicago, IL) ;
Ferdinand; Arthur; (San Jose, CA) ; Sandoval; Arthur
G.; (San Francisco, CA) ; Servaites; Jeffrey W.;
(San Francisco, CA) ; Summers; Jonathan P.;
(Redwood City, CA) ; Golzar; Shapour; (Dublin,
CA) ; Doshi; Rajiv; (Los Altos, CA) |
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20090241965 A1 |
October 1, 2009 |
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Family ID: |
39939045 |
Appl. No.: |
12/405837 |
Filed: |
March 17, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11298362 |
Dec 8, 2005 |
7735491 |
|
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12405837 |
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61037180 |
Mar 17, 2008 |
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Current U.S.
Class: |
128/207.18 |
Current CPC
Class: |
A61M 16/106 20140204;
A61M 15/08 20130101; A61M 15/085 20140204; A61M 16/208 20130101;
A61M 16/06 20130101; A61M 16/20 20130101; A61M 16/0688 20140204;
A62B 23/06 20130101; A61M 16/0683 20130101; A61F 5/56 20130101;
A61M 15/002 20140204; A61M 2210/0618 20130101 |
Class at
Publication: |
128/207.18 |
International
Class: |
A61M 16/00 20060101
A61M016/00 |
Claims
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.sub.2O/(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.sub.2O/(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.sub.2O/(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.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional patent
application Ser. No. 61/037,180, titled "NASAL DEVICES WITH
NOISE-REDUCTION AND METHODS OF USE", filed on Mar. 17, 2008. This
application is herein incorporated by reference in its
entirety.
BACKGROUND OF THE INVENTION
[0002] Nasal respiratory devices may be worn to treat many medical
conditions, such as sleep disordered breathing (including snoring,
sleep apnea, etc.), Cheyne Stokes breathing, UARS, COPD,
hypertension, asthma, GERD, heart failure, and other respiratory
and sleep conditions. Devices that provide a greater resistance to
exhalation than to inhalation may be particularly useful, and may
be worn by a subject when the subject is either awake or asleep.
Indeed, many subjects may apply a nasal device before falling to
sleep, so that the device may provide therapeutic benefits during
sleep. However, these devices may produce noise during operation
that some users (or their bedmates) may find annoying. For example,
a nasal device including one or more flap valves may produce a
buzzing, whistling, or other audible noise or vibration. In the
worst case, the noise may disrupt the sleep of the user or others
nearby. Thus, there is a need for noise-reduced (or "quiet") nasal
devices which may be worn by a subject during sleep.
[0003] Examples of nasal respiratory devices have been
well-described in the following US patents and patent applications,
each of which is incorporated herein in its entirety: U.S. patent
application Ser. No. 11/298,640 (titled "NASAL RESPIRATORY
DEVICES") filed Dec. 8, 2005; U.S. patent Ser. No. 11/298,339
(titled "RESPIRATORY DEVICES") filed Dec. 8, 2005; U.S. patent
application Ser. No. 11/298,362 (titled "METHODS OF TREATING
RESPIRATORY DISORDERS") filed Dec. 8, 2005; U.S. patent application
Ser. No. 11/805,496 (titled "NASAL RESPIRATORY DEVICES") filed May
22, 2007; U.S. Pat. No. 7,506,649 (titled "NASAL DEVICES") filed
Jun. 7, 2007; U.S. patent application Ser. No. 11/759,916 (titled
"LAYERED NASAL DEVICES") filed Jun. 7, 2007; U.S. patent
application Ser. No. 11/811,401 (titled "NASAL RESPIRATORY DEVICES
FOR POSITIVE END-EXPIRATORY PRESSURE") filed Jun. 7, 2007; U.S.
patent application Ser. No. 11/941,915 (titled "ADJUSTABLE NASAL
DEVICES") filed Nov. 19, 2007; and U.S. patent application Ser. No.
11/941,913 (titled "NASAL DEVICE APPLICATORS") filed Nov. 16,
2007.
[0004] These nasal respiratory devices are adapted to be removably
secured in communication with a nasal cavity, and may include a
passageway (which may just be an opening) through the device, a
valve (or airflow resistor) in communication with the passageway,
and a holdfast. The holdfast is configured to removably secure the
respiratory device at least partly within (and/or at least partly
over and/or at least partly around) the nasal cavity. The airflow
resistor (which may be a valve) is typically configured to provide
greater resistance during exhalation than during inhalation.
[0005] Examples of these devices are shown in FIGS. 1A-2B, and are
briefly described below. Exemplary nasal devices may include an
airflow resistor (e.g., a flap valve or multiple flap valves)
providing a greater resistance to exhalation than to inhalation, a
holdfast to secure the nasal device in communication with the
subject's nose, and optionally a rim body forming a passageway in
which the airflow resistor is positioned, and an aligner for
aligning the device with respect to one or more of the subject's
nostrils. In general, these nasal respiratory devices may be
configured so that the airflow resistor provides a resistance to
exhalation that is between about 10 cm H.sub.2O*sec/L and about 250
cm H.sub.2O*sec/L (e.g., 0.01 and about 0.25 cm H.sub.2O/(ml/sec))
when measured at 100 ml/sec, and a resistance to inhalation that is
between about 0.1 cm H.sub.2O*sec/L and about 20 cm H.sub.2O*sec/L
(e.g., 0.0001 and about 0.02 cm H.sub.2O/(ml/sec)) when measured at
100 ml/sec. For example, FIGS. 1A and 1B show front and back
perspective views (respectively) of one variation of an adhesive
nasal device.
[0006] The nasal device shown in FIGS. 1A and 1B are two
single-nostril devices that have been joined to form a single
device. In similar variations the two single-nostril devices are
not joined by this bridge region 112, but are kept separate, and
may be applied separately to each nostril. The front view of the
nasal device shown in FIG. 1A illustrates the outward-facing side
of this variation of a nasal device, when it is worn by a
subject.
[0007] FIGS. 1A-2B show examples of nasal devices that may be
adapted to include one or more noise-reducing features as described
herein. The resulting noise-reduced nasal device may address the
problems identified above. Nasal devices configured to include
noise-reduction features to help eliminate or reduce unwanted noise
are described and illustrated below, along with methods of using
and methods of forming such devices.
SUMMARY OF THE INVENTION
[0008] Described herein are noise-reduced nasal respiratory devices
configured to reduce or eliminate unwanted buzzing, whistling or
other noises associated with use of a nasal device. In general,
noise-reduced (or noise-reducing) nasal devices are nasal devices
having flap-valve airflow resistors that also include a
noise-reduction feature such as a noise-reduction element, or a
noise-reduction flap valve, or both. These noise-reduction features
reduce whistling, rushing or turbulent sounds of air flowing
through or around the airflow resistor, and may also reduce the
sound of the flap valve opening/closing. For example, noise-reduced
nasal devices may prevent the free end of the flap valve from
oscillating or vibrating and producing an audible sound during use.
In some variations the flap valve is a noise-reduction flap valve
that prevents the free edge region of the flap face of the flap
valve from orienting in parallel with the direction of airflow
through the flap valve during inhalation. In some variations the
device includes a noise-reduction element that controls or limits
the oscillation of the flap, particularly the free edge region of
the flap face and/or the tip of the flap during inhalation. The
noise-reduction element may prevent a free edge region of a face of
the flap valve from becoming oriented substantially in parallel
with the direction of airflow through the opening during
inhalation. As used herein, the "edge region of the flap face"
typically refers to the region of the flap valve face near the free
edge of the flap valve. As described in greater detail below, a
flap valve is generally a flat structure having two opposing faces
and a minimal thickness.
[0009] A noise-reduced airflow resistor is typically an airflow
resistor having a flap valve that is adapted in some manner to
reduce the noises associated with the operation of the nasal device
during respiration. A noise-reduced airflow resistor may also be
referred to as a noise-reducing or noise-reduction airflow
resistor. A noise-reduced airflow resistor may also be referred to
as simply herein as an "airflow resistor." The noise-reduced
airflow resistors described herein typically increase the
resistance to expiration more than the resistance to exhalation.
For example, any of the noise-reduced airflow resistors described
herein may be configured to provide the nasal device with a
resistance to exhalation that is between about 0.01 and about 0.25
cm H.sub.2O/(ml/sec) when measured at 100 ml/sec, and a resistance
to inhalation that is less than the resistance to exhalation, and
may be between about 0.0001 and about 0.02 cm H.sub.2O/(ml/sec)
when measured at 100 ml/sec. These nasal devices may also have one
or more leak pathways that are configured to remain open during
both inhalation and exhalation. During operation of the nasal
devices described herein, the flap valve(s) of the airflow resistor
are typically at least partially closed during exhalation,
increasing the resistance within the target range, and the flap
valve(s) of the airflow resistor are typically at least partly open
during inhalation.
[0010] Thus, a noise-reduced nasal respiratory device may include 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. The noise-reduced nasal respiratory device
may also include a holdfast configured to secure the noise-reduced
nasal respiratory device in communication with the subject's nasal
cavity. Any appropriate holdfast may be used, including adhesive
holdfasts and compressible holdfasts.
[0011] As mentioned, the noise-reduced airflow resistor typically
includes one or more noise-reduction feature such as a
noise-reduction flap valve or a noise-reduction element that acts
on the flap valve (or both). For example, a nose-reduction flap
valve may be a flap valve that is structurally adapted to prevent
the edge of the flap valve from oscillating (e.g., vibrating) at
flow rates present during inhalation and/or exhalation. In some
variations a noise-reducing flap valve is adapted by having a
thickness and/or durometer that is sufficient to prevent
oscillation while allowing operation of the flap valve over a
desired range of exhalation and/or inhalation resistances. In some
variations the flap valve is configured to have an open
configuration that prevents noise.
[0012] A noise-reducing element may be used with a flap valve
(including but not limited to noise-reducing flap valves) to reduce
or prevent vibration or oscillation of the flap valve (and
particularly the edge of the flap valve). As used herein, the
phrase "oscillation" typically refers to vibration of all or a
portion of the flap valve that may result in an audible sound (such
as a buzzing). Any of the noise-reduced nasal respiratory devices
described herein may include either a noise-reducing element (e.g.,
an element that acts on the flap valve) or a noise-reducing flap
valve, or both.
[0013] For example, described herein are noise-reduced nasal
respiratory devices including a noise reduced airflow resistor
comprising a noise-reduction flap valve that is configured to
inhibit exhalation more than inhalation. A noise-reduction flap
valve may also be referred to as a "noise reduction flap" or a
"noise reduced flap." The noise-reduction flap valve may be
configured so that the edge of the flap does not oscillate during
inhalation under a physiological range of inspiratory flow rates.
As mentioned, these devices may include a holdfast configured to
secure the device in communication with the subject's nasal
cavity.
[0014] During inhalation through the nasal device, the flow rate of
air through the nasal device may be between a range of flow rates
broadly within the range of between about 1 and about 750 ml/sec.
The flow rate during normal inhalation may be within this broad
range, or within a subset of this range. For example, the device
may be configured so that the flow rate through the device during
inhalation is typically less than about 100 ml/sec, less than about
200 ml/sec, less than about 250 ml/sec, less than about 500 ml/sec,
less than about 750 ml/sec, etc., or between about 1 and 500
ml/sec, 20 and 750 ml/sec, or 20 and 500 ml/sec, or any other
subset of this range. In particular, the noise-reduced devices
described herein may be configured so that the oscillation of the
flap valve (and thus some or all of the noise of the nasal device)
is reduced or limited. The device may also be configured so that
the noise due to opening and/or closing of the flap valve is
limited.
[0015] There are many types of flaps that may be used and may be
considered noise-reduction flap valves. One particular variation is
a butterfly-type noise-reduction flap. In this variation, the flap
is cut or otherwise arranged so that airflow from inhalation causes
opposing (and optionally connected) flaps to open, and thereby
limit each other's ability to fully open, or to open in parallel
with the direction of airflow through the device. In the
butterfly-type flap, the opposing pairs of flaps extend outward to
form "wings" that push against each other, preventing an edge
region of the flap face from orienting in parallel with the airflow
direction at reasonable physiological airflows, which might
otherwise lead to oscillation of the flap. For example, a
noise-reduction flap valve may have a plurality of cuts arranged so
that the free edge region of the flap face of the flap valve cannot
orient in parallel with the direction of airflow through the valve
during inhalation within a physiologic range of inspiratory flow
rates.
[0016] In some variations, noise-reduced nasal device include an
airflow resistor with a flap having a dampened edge. For example,
the dampened flap edge may be a thickened edge. The damped edge may
prevent oscillation (vibration) of the free edge of the flap. In
some variations, the edge region is stiffer than other portions of
the flap, preventing or inhibiting oscillation. Thus, the edge may
be thicker, or it may be made of different material (or both).
[0017] In some variations, a noise-reduced nasal device is a nasal
device having a flap with a durometer that is greater than 40 (40
Shore A). For example, a noise-reduced nasal device may have a flap
for the flap valve with a durometer of about 50. In some
variations, the flap valve of the noise-reduced nasal device has a
flap with a durometer of greater than about 40 and a thickness that
is between about 1 mil and about 5 mil. In some variations, the
flap has a durometer of greater than 40 and a thickness that is
between about 2 mil and about 4 mil (e.g., the flap has a durometer
of 50 and a thickness of 2 mil, 3 mil or 4 mil). The flap may be
formed of silicone.
[0018] As mentioned above, the nasal devices described herein may
include one or more leak pathways configured to remain open during
both inhalation and exhalation, even as the airflow resistor opens
and closes. These leak pathways may also be configured to reduce
undesirable noise, including whistling. For example, the leak
pathway may be sized or shaped to reduce whistling. In some
variations the edges of the leak are smoothed to prevent whistling.
Any of the surfaces through which airflow may pass through the
nasal device may be smoothed to prevent or inhibit whistling as air
moves over or across them. In some variations, the surfaces of the
leak pathway (or other airflow pathways) may be treated or coated
with a material to reduce noise. For example, the leak pathway may
be coated with a material forming a surface that creates localized
air turbulence.
[0019] Any of the nasal respiratory devices described herein may be
configured to have a resistance to exhalation and/or inhalation
that is within a desired range. For example, the resistance to
exhalation may be between about 10 cm H.sub.2O*sec/L and about 250
cm H.sub.2O*sec/L (e.g., 0.01 and about 0.25 cm H.sub.2O/(ml/sec))
when measured at 100 ml/sec. The airflow resistor, leak pathway(s),
and also the noise-reduction flap and/or a noise-reduction element
may all be configured to achieve this target resistance to
exhalation and/or inhalation. Examples of devices falling within
this range of inspiratory and expiratory resistances are provided
below.
[0020] Also described herein are noise-reduced nasal respiratory
devices including an 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 the free edge region of the flap face does not
orient substantially in parallel with the direction of airflow
through the flap valve during inhalation. The direction of airflow
through the flap valve during inhalation generally refers to the
average direction of airflow through the airflow resistor if the
flap were completely removed (a hypothetical "completely open"
state of the airflow resistor).
[0021] As previously mentioned, the noise-reduction nasal devices
(including devices with noise-reduction flaps) may be configured to
have a resistance to exhalation that is between about 0.01 and
about 0.25 cm H2O/(ml/sec) and a resistance to inhalation that is
between about 0.0001 and about 0.02 cm H2O/(ml/sec) when resistance
is measured at an air flow of 100 ml/sec.
[0022] Also described herein are noise-reduced nasal respiratory
devices having an opening (or passageway) configured to communicate
with the nasal cavity, an airflow resistor comprising a flap valve
in communication with the opening, wherein the airflow resistor is
configured to increase the resistance to air exhaled through the
opening more than the resistance to air inhaled through the
opening, a noise-reduction element in communication with the flap
valve (wherein the noise-reduction element is configured to limit
oscillation of the flap), and a holdfast configured to secure the
opening in communication with the subject's nasal cavity. In
general, the opening of the nasal device may be an opening or
passageway through the nasal device.
[0023] The noise-reduction (or noise-reducing) element may be any
element that reduces the oscillation of the flap valve during
inhalation but does not substantially increase the resistance to
inhalation. For example, the noise-reduction element may include a
projecting surface at least partially into the opening that
prevents an edge region of the flap face of the flap valve form
orienting roughly in parallel with the direction of airflow during
inhalation. The projecting surface (which may be referred to as a
"projection") may be a rib or ribs extending at least partially
across the opening through the nasal device.
[0024] In some variations, the noise-reduction element comprises a
cone that is configured to prevent the edge region of the flap face
of the flap from opening in parallel or approximately in parallel
with the direction of airflow during inhalation. The height of the
cone may be greater than or equal to the height of the flap when
the flap is fully opened during inhalation, and therefore permit
control of the entire flap, including the free end or tip region.
In some cases, the height of the cone may be less than the height
of the flap when the flap is fully opened during inhalation. The
tip region is generally the portion (or portions) of the flap that
extend farthest from the closed position of the airflow resistor
during inhalation. This may also be referred to as the portion of
the flap that extends most proximally (into the nose) during
inhalation when the device is worn.
[0025] A cone-type noise-reduction element may also include a
plurality of cut-out regions for air passage along the perimeter of
the cone. For example, the noise-reduction element may be a
"castle-topped" cone, in which the cone is crenellated. The air
passages may extend all the way to the top surface of the cone, or
may be along the sides. In some variations, the noise-reduction
element is a cage configured to prevent the edge region of the flap
face from opening approximately in parallel with the direction of
airflow during inhalation. For example, a cage-shaped
noise-reduction element may be a dome formed of mesh or wire that
does not substantially add to the airflow resistance through the
nasal device.
[0026] In some variations a noise-reduction element includes a
spacer configured to prevent the edge region of the flap face of
the flap valve from opening in parallel with the direction of
airflow during inhalation. For example, the projection into the
opening through the nasal device may be a `spacer` that keeps the
tip of the flap from aligning in parallel with the direction of
airflow, and thereby from stalling in the steam of air during
inhalation. Multiple spacers may be used.
[0027] As mentioned, the noise-reduction element typically does not
substantially increase the inspiratory resistance, and the
resistance to exhalation for the nasal device including a
noise-reduction element is generally between about 0.01 and about
0.25 cm H.sub.2O/(ml/sec), and the resistance to inhalation is
generally between about 0.0001 and about 0.02 cm H.sub.2O/(ml/sec)
when resistance is measured at 100 ml/sec. In some embodiments the
noise-reduction element may minimally or negligibly increase the
inspiratory resistance.
[0028] Also described herein are noise-reduced nasal respiratory
devices including an opening (or passageway) configured to
communicate with the nasal cavity, an airflow resistor comprising a
flap valve in communication with the opening, wherein the airflow
resistor is configured to increase the resistance to air exhaled
through the opening more than the resistance to air inhaled through
the opening, a noise-reduction element configured to prevent a free
edge region of the flap face from orienting itself roughly or
substantially parallel with the direction of airflow through the
opening during inhalation, and a holdfast configured to secure the
opening in communication with the subject's nasal cavity. Any of
the noise-reduction elements previously described may be used with
these noise-reduction nasal devices.
[0029] Also described herein are noise-reduced nasal respiratory
devices including an opening (or passageway) through the nasal
device configured to communicate with the nasal cavity, an airflow
resistor comprising a flap valve in communication with the opening,
wherein the airflow resistor is configured to increase the
resistance to air exhaled through the opening more than the
resistance to air inhaled through the opening, a noise-reduction
element projecting into the opening configured to prevent the edge
of the flap valve from oscillating, and a holdfast configured to
secure the device in communication with the subject's nasal cavity.
Any of the noise-reduction elements previously described may be
used with these noise-reduction nasal devices.
[0030] Also described herein are methods of decreasing the noise of
operation of a nasal device having a flap valve airflow resistor.
These methods may include the steps of: placing a nasal device at
least partially into or at least partially over a subject's nasal
cavity, wherein the device includes a flap valve airflow resistor
configured to inhibit exhalation more than inhalation; and
inhibiting the flap valve from oscillating during inhalation
through the nasal device. In some variations, the method includes
inhibiting the flap valve from oscillating by preventing an edge
region of the flap face of the flap valve from orienting itself in
a direction that is roughly or substantially parallel with the
direction of inspiratory airflow through the nasal device.
Alternatively the oscillation of the flap may be inhibited by using
a noise-reduction flap valve, as described herein.
[0031] The flap valve may be inhibited from oscillating by limiting
the motion of the distal tip of the flap valve. The distal tip is
also referred to as the portion of the flap that extends most
proximally (into the nose) during inhalation when the device is
worn.
[0032] These methods may also include the step of adhesively
securing the nasal device at least partly within or at least partly
over the subject's nasal cavity.
[0033] Also described herein are methods of decreasing the noise of
operation of a nasal device that include the steps of: placing a
nasal device at least partially into or at least partially over 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 projecting at least partially into the
opening, 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 the flap valve to the
noise-reduction element during inhalation. For example, the
oscillation may be preventing the edge region of the flap face from
orienting in a direction that is roughly or substantially parallel
with the direction of airflow.
[0034] Also described herein are fluttering or vibrating nasal
devices. Fluttering or vibrating valves that are configured
specifically to oscillate are also described herein. These devices
may be referred to as "fluttering" or "vibrating" passive nasal
devices. Such nasal devices typically promote oscillation during
inhalation and/or exhalation, and may promote oscillation of the
edge region of the flap face and/or tip of the flap during
inhalation and or exhalation. These devices may also utilize any of
the previously described device features which may be used to
prevent oscillation and noise in one direction while promoting
oscillation in another direction of airflow. In some variations,
the devices are configured so that the flap valve oscillates at
certain (desirable) frequencies. For example, it may be desirous
for the flap valve to oscillate in a range of frequencies that does
not produce audible noise, but does produces the sensation
(tactile) of vibration. An oscillating or vibratory flap valve may
be used as part of a method for treatment of disorders which would
benefit from the use of nasal vibration, including the treatment of
cystic fibrosis or other respiratory disorders.
INCORPORATION BY REFERENCE
[0035] All publications and patent applications mentioned in this
specification are herein incorporated by reference in their
entirety, as if each individual publication or patent application
was specifically and individually indicated to be incorporated by
reference in its entirety.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] FIGS. 1A and 1B are bottom and top perspective views,
respectively, of one variation of a nasal device.
[0037] FIGS. 2A and 2B show one variation of a layered nasal device
in a top view and an exploded perspective view, respectively.
[0038] FIGS. 3A to 3C illustrate operation of flap valves having
four, six and eight flaps, respectively, during simulated
inspiratory flow.
[0039] FIGS. 4A to 4C show various dome-shaped noise-reduction
elements.
[0040] FIGS. 5A to 5D show noise-reduction elements configured as
projections.
[0041] FIGS. 6A to 6C show conical noise-reduction elements.
[0042] FIGS. 7A to 7C show perspective, top and side
cross-sectional views, respectively of one variation of a
noise-reduction element configured as a cone.
[0043] FIGS. 8A to 8F show perspective views of variations of
cone-type noise-reduction elements.
[0044] FIG. 9A shows a conical noise-reduction element having a low
height, and FIG. 9B shows a portion of a nasal device including a
conical noise-reduction element having a low height.
[0045] FIG. 10 is another variation of a noise-reduction element
configured as a cone.
[0046] FIG. 11 illustrates variations of flaps which may be used as
flap valves.
[0047] FIG. 12A is a butterfly-type noise-reduction flap. FIG. 12B
illustrates the operation of the noise-reduction flap of FIG. 12A
during a simulated inspiratory flow.
[0048] FIG. 13A is another variation of a noise-reduction flap.
FIG. 13B illustrates the operation of the noise-reduction flap of
FIG. 13A during a simulated inspiratory flow.
[0049] FIG. 14A is another variation of a noise-reduction flap.
FIG. 14B illustrates the operation of the noise-reduction flap of
FIG. 14A during a simulated inspiratory flow.
[0050] FIG. 15A is another variation of a noise-reduction flap.
FIG. 15B illustrates the operation of the noise-reduction flap of
FIG. 15A during a simulated inspiratory flow.
[0051] FIG. 16A shows a noise-reduction element. FIG. 16B shows a
flap valve that may be used with the nose-reduction element shown
in FIG. 16A, and FIG. 16C shows a nasal device including the
noise-reduction element of FIG. 16A and the flap of FIG. 16B.
[0052] FIG. 17 is a cross-section though a noise-reduced nasal
device having both a noise-reduction cone and a noise-reduction
flap.
[0053] FIG. 18 is an exploded view of a noise-reduced nasal device
including a noise-reduction element.
[0054] FIGS. 19A to 19C are three variations of noise-reduction
elements.
[0055] FIG. 20 is an exploded view of a noise-reduced nasal device
including a noise-reduction flap.
DETAILED DESCRIPTION OF THE INVENTION
[0056] Described herein are noise-reduced nasal devices.
Noise-reduced nasal devices typically include a noise-reduced
feature such as a noise-reduction flap for a flap valve, a
noise-reduction element, or both. The noise-reducing features
described are configured as part of the nasal device so that the
resistance to exhalation and inspiration of the nasal devices is
typically between about 0.01 and about 0.25 cm H.sub.2O/(ml/sec)
for exhalation and between about 0.0001 and about 0.02 cm
H.sub.2O/(ml/sec) for inspiration when resistance is measured at
100 ml/sec. Inspiratory resistance or resistance to inhalation,
refers to the resistance to airflow moving though the device in the
direction of inhalation when the device is oriented as it would be
when worn by a user. Likewise, expiratory resistance or resistance
to exhalation refers to the resistance to airflow through the
device in the direction of exhalation when the device is oriented
as it would be when worn by a user.
[0057] As used herein, the term noise-reduced nasal device or
noise-reduction nasal device refers to any nasal device that
includes one or more noise-reduction features, such as a
noise-reduction flap valve as described and exemplified herein, or
a noise-reduction element as described herein. Noise reduction
typically refers to the reduction or elimination of noise such as
buzzing, whistling, hissing or other vibratory or airflow noise
which may be heard or sensed by a subject wearing a nasal device.
These noises typically arise from the undesirable and unnecessary
oscillation of the flap valve forming the airflow resistor in the
nasal device.
[0058] As used herein, the singular forms "a," "an," and "the"
include plural reference unless the context clearly dictates
otherwise.
[0059] The noise-reduction features described herein may be used
with any appropriate nasal devices, particularly those having a
flap valve. Before describing the noise-reduction features,
examples of nasal devices that may be used with these
noise-reduction features are first described.
Nasal Devices
[0060] Any appropriate nasal device may be configured as a
noise-reduction nasal device, including the adhesive nasal devices
described in more detail in FIGS. 1A to 2B, below. The
noise-reduction nasal devices described herein typically include a
passageway configured to communicate with a subject's nasal passage
(or cavity), a flap-valve airflow resistor in communication with
the passageway, and a noise-reduction feature.
[0061] The nasal devices described herein may be secured in
communication with a subject's nose, and specifically with one or
both of the subject's nasal cavities. A typical nasal device
includes an airflow resistor that is configured to resist airflow
in a first direction more than airflow in a second direction, and
may also include a holdfast configured to secure the airflow
resistor at least partially over, in, and/or across the subject's
nose or nostril. The holdfast may include a biocompatible adhesive
and a flexible region configured to conform to at least a portion
of a subject's nose. The nasal devices described herein are
predominantly adhesive nasal devices, however the noise-reducing
features described may be used with nasal devices that are not
adhesive nasal devices, including nasal devices having compressible
or expandable holdfasts. Other embodiments include nasal devices in
which the holdfast is mask that fits over the nose, the mouth or
both the nose and mouth.
[0062] Nasal devices may be worn by a subject to modify the airflow
thorough one or (more typically) both nostrils. Nasal devices may
be secured over both of a subject's nostrils so that airflow
through the nostrils passes primarily or exclusively through the
nasal device(s). Adhesive nasal devices are removably secured over,
partly over, and/or at least partly within the subject's nostrils
by an adhesive. The nasal devices described herein may be
completely flexible, or partially rigid, or completely rigid. For
example, the devices described herein may include an adhesive
holdfast region that is at least partially flexible, and an airflow
resistor. The airflow resistor may be flexible, or rigid. In some
variations, the devices described herein also include one or more
alignment guides for helping a subject to orient the device when
securing it over the subject's nose. The alignment guide may also
include or be configured as a noise-reduction element, as described
in greater detail below. The adhesive nasal devices described
herein may be composed of layers. Nasal devices composed of layers,
which may also be referred to as layered nasal devices, may be
completely or partially flexible, as previously mentioned. For
example, a layered nasal device may include an airflow resistor
configured to resist airflow in a first direction more than airflow
in a second direction and an adhesive holdfast layer. In some
variations, the airflow resistor may be a flap valve layer adjacent
to a flap valve limiting layer, and may include an adhesive
holdfast layer comprising an opening across which the airflow
resistor is operably secured. The airflow resistor may be disposed
substantially in the plane of the adhesive holdfast layer. The
adhesive holdfast layer may be made of a flexible substrate that
includes an additional layer of biocompatible adhesive.
[0063] The nasal devices described herein may be considered as
passive nasal devices, because the flap valve may operate to
passively regulate a subject's respiration. For example, a nasal
device may create positive end expiratory pressure ("PEEP") or
expiratory positive airway pressure ("EPAP") during respiration in
a subject wearing the device. In contrast to active nasal devices,
such as CPAP machines that apply positive pressure to the subject,
the passive devices described herein do not require the addition of
pressurized respiratory gas.
[0064] The noise-reduced nasal devices and methods described herein
may be useful to treat a variety of medical conditions, and may
also be useful for non-therapeutic purposes. For example, a nasal
respiratory device may be used to treat sleep disordered breathing
or snoring. The systems, devices and methods described herein are
not limited to the particular nasal device embodiments described.
Variations of the embodiments described may be made and still fall
within the scope of the disclosure.
[0065] As used herein, a nasal device may be configured to fit
across, partly across, at least partly within, in, over and/or
around a single nostril (e.g., a "single-nostril nasal device"), or
across, in, over, and/or around both nostrils ("whole-nose nasal
device"). Any of the features described for single-nostril nasal
devices may be used with whole-nose nasal devices, and vice-versa.
In some variations, a nasal device is formed from two
single-nostril nasal devices that are connected to form a unitary
adhesive nasal device that can be applied to the subject's nose.
Single-nostril nasal devices may be connected by a bridge (or
bridge region, which may also be referred to as a connector). The
bridge may be movable (e.g., flexible), so that the adhesive nasal
device may be adjusted to fit a variety of physiognomies. The
bridge may be integral to the nasal devices. In some variations,
single-nostril nasal devices are used that are not connected by a
bridge, but each include an adhesive region, so that (when worn by
a user) the adhesive holdfast regions may overlap on the subject's
nose.
[0066] One variation of a nasal device that may include a
noise-reduction feature (e.g., a noise-reduction flap or
noise-reduction element) is a layered nasal device, formed of two
or more layers. For example, a layered nasal device may include an
adhesive holdfast layer and an airflow resistor layer. These layers
may themselves be composed of separate layers, and these layers may
be separated by other layers, or they may be adjacent. For example,
the adhesive holdfast layer may be formed of layers (optionally: a
substrate layer, a protective covering layer, an adhesive layer,
etc), and thus may be referred to as a layered adhesive holdfast.
Similarly, the airflow resistor may be formed of multiple layers
(optionally: a flap valve layer, a valve limiter layer, etc.), and
thus may be referred to as a layered airflow resistor. In some
variations, the layered adhesive holdfast and the layered airflow
resistor share one or more layers. For example, the flap valves
layer and the adhesive substrate layer may be the same layer, in
which the leaflets of the flap valve layer are cut from the
substrate layer material. As used herein, a "layer" may be a
structure having a generally planar geometry (e.g., flat), although
it may have a thickness, which may be uniform or non-uniform in
section. As mentioned briefly above, the support backing may be
formed of one of the layers of a layered nasal device, such as the
adhesive substrate layer.
[0067] In some variations, a nasal device has a body region
including a passageway configured to be placed in communication
with a subject's nasal passage. The body region may be a stiff or
flexible body region, and may secure an airflow resistor therein.
In some variations, the body region is at least partially
surrounded by a holdfast (i.e., a planar adhesive holdfast). The
body region may be modular, meaning that it is formed of two or
more component sections that are joined together. Examples of such
nasal devices can be found in U.S. Pat. No. 7,506,649, filed on
Jun. 7, 2007, and previously incorporated by reference in its
entirety. As described therein, the body region may be configured
so that it does not irritate a subject wearing the nasal device.
For example, the body region may be slightly undersized compared to
the size of the average user's nostrils. Thus the body region may
fit into the subject's nose, and the seal with the subject's nose
is formed by the adhesive holdfast region, rather than the body
region. In some variations the body region does not substantially
contact the inner walls of the subject's nose. Furthermore, the
body region may extend only slightly into the subject's nose.
[0068] In some variations, the adhesive nasal device includes a
support frame. The support frame may provide structural support to
all or a portion of the nasal device, such as the flexible adhesive
portion. For example, the support frame may support the adhesive
holdfast portion of the device and be completely or partially
removable after the device has been applied to the subject. In some
variations, the support frame remains on the nasal device after
application. In some variations, the support frame is a support
frame layer.
[0069] An adhesive nasal device may also include a tab or handle
configured to be grasped by a subject applying the device. In some
variations, this tab or handle is formed of a region of the layered
adhesive holdfast.
[0070] The various components of the device may be made of any
appropriate materials, as described in greater detail below. For
example, some device components (e.g., an alignment guide, a body
region, noise-reduction element) may be made of medical grade
plastic, such as Acrylonitrile Butadiene Styrene (ABS),
polypropylene, polyethylene, polycarbonate, polyurethane or
polyetheretherketone. The airflow resistor may be a flap valve and
the flap may be made of silicone or thermoplastic urethane. The
adhesive holdfast may include an adhesive substrate made of
silicone, polyurethane or polyethylene. Examples of biocompatible
adhesive on the adhesive holdfast may include hydrocolloids or
acrylics. These lists of materials are not exclusive, and other (or
alternative) materials may be used.
[0071] In some versions, the nasal device further comprises an
active agent. In some versions, this active agent is a drug (e.g.,
a medicament). In some versions, this active agent comprises an
odorant, such as a fragrance. In some versions, the active agent
comprises menthol, eucalyptus oil, and/or phenol. In other
versions, the nasal device may be used with other pulmonary or
medical devices that can administer medication or other medical
treatment, including, but not limited to, inhalers and
nebulizers.
[0072] A nasal device may include a filter. This filter may be a
movable filter, such as a filter that filters air flowing through
the passageway in one direction more than another direction (e.g.,
the device may filter during inhalation but not exhalation).
[0073] As mentioned, the adhesive nasal devices described herein
typically include a holdfast region (or layer) and at least one
airflow resistor. As will be apparent from the figures, many of
these nasal devices may be removable and insertable by a user
without special tools. In some variations, a subject may use an
applicator to apply the device (e.g., to help align it). FIGS. 1A
through 2B illustrate different exemplary nasal devices.
[0074] FIGS. 1A and 1B show perspective views of one exemplary
variation of an adhesive nasal device that may be configured as a
noise-reduced nasal device and may include a noise-reducing feature
(not apparent in these figures). FIG. 1A shows a front perspective
view of an adhesive nasal device, looking at the "outer" side of
the device, which is the side facing away from the subject's nose
when the device is worn. The device shown in FIG. 1A includes two
single-nostril rim bodies 101 and a single adhesive holdfast 104. A
nasal device may be configured to communicate with a single nostril
(a single-nostril nasal device), or it may be configured to
communicate with both of a subject's nostrils (a double-nostril
nasal device as shown here).
[0075] The holdfast 104 (which adhesively secures the device to the
subject) is shown as a layered structure including a backing or
adhesive substrate 105. This backing may act as a substrate for an
adhesive material, or it may itself be adhesive. The holdfast 104
may have different regions, including two peri-nasal regions
surrounding the rim bodies 101. Each rim body has at least one
passageway 108 for airflow therethrough. The adhesive holdfast also
includes two tabs or grip regions 110 that may make the device
easier to grasp, apply, and remove. A bridge region 112 is also
shown. In this example, the bridge region is part of the adhesive
holdfast (e.g., is formed by the same substrate of the adhesive
holdfast) and connects the peri-nasal regions. Although the tab and
bridge regions are shown as being formed as part of (integral with)
the holdfast material, these regions may also be formed separately,
and may be made of different materials.
[0076] The rim body regions 101 shown in the exemplary device of
FIG. 1A include outer rim body regions which each encompass a
passageway 108. These first (e.g., outer) rim body regions may mate
with second (e.g., inner) rim body regions to form the rim body
region(s) of the device that each include a passageway 108. This
passageway is interrupted by crossing support members 114 (e.g.,
cross-beams or cross-struts) that may partly support or restrict
movement of the airflow restrictor. In addition, each rim body
region 101 includes two leak pathways 116, through which air may
pass even when the passageway through the device is otherwise
blocked by the airflow resistors. The leak pathways 116 are shown
here as small openings at the narrow ends of the oval-shaped outer
rim body region. The rim body region may also be referred to as
`rim` or `scaffold` regions of the device.
[0077] FIG. 1B shows a back perspective view of the opposite side
of the adhesive nasal device shown in FIG. 1A, the "inner side" of
the device. The inner side of the device faces the subject, and a
portion of this side of the device may contact the subject. This
side of the device, and particularly the adhesive holdfast of the
device, includes an adhesive (which may be covered by a protective
cover 107) forming part of the holdfast 104. In some variations,
the entire skin-facing side of the holdfast 104 includes an
adhesive on the surface, although in some variations, only a
portion of this region includes adhesive. The adhesive may be a
distinct layer of the holdfast (e.g., it may be layered on top of
an adhesive substrate), or it may be an integral part of the
holdfast (e.g., the adhesive substrate may be made of an adhesive
material). In some variations an adhesive may be separately added
to the device (e.g., the holdfast region) before use. The adhesive
material may be covered by a removable protective cover or liner
107, to prevent the adhesive from sticking to surfaces until after
the liner is removed. In FIG. 1B, the protective cover 107 covers
the entire skin-facing surface of the holdfast. The device may be
applied by first removing the liner. For example, the liner may be
peeled off, to expose the adhesive. In some variations, the liner
protecting the adhesive may be partially removed. For example, the
tab region 121 of the device may include a separate (or additional)
liner that remains over the tab region when other liner regions are
removed. This may allow the device to be held by the tab region
without having it adhere to the skin. After removing the cover, or
a part of the cover, the device may be positioned and adhered to
the subject's skin around the nasal cavity, so that the passageways
through the rim body are aligned with the openings of the subject's
nasal cavities. In some variations, an additional adhesive cover
region (e.g., the protective cover region over the tabs 121) can
then be removed to secure the device to the rest of the subject's
nose. The adhesive cover may include a fold (or crimp, crease, lip,
or the like) that helps to remove the protective cover from the
adhesive.
[0078] The second, or inner, rim body region 103 shown in the
exemplary device of FIG. 1B is shaped with an inwardly-tapering
edge, so that it may fit at least slightly within the opening of
the subject's nostril when a subject wears the device. The inner
rim body includes one or more passageways 108 that correspond with
the passageways 108 shown in FIG. 1A. Similarly, the leak pathways
pass completely through the rim body (both inner and outer bodies).
The tapering external walls of the inner rim body region(s) shown
in FIG. 1B are shown as smooth, and may also include an additional
material (e.g., an auxiliary holdfast material) for securing them
in the subject's nostrils, or for cushioning them to prevent injury
or discomfort. These surfaces may also be more or less angled, in
order to facilitate comfort when the adhesive nasal device is worn
in the subject's nose. A cross bar (hinge region 115) may also be
provided as part of the inner rim body. The inner rim body 103 may
extend some distance above the peri-nasal annular region of the
holdfast, as shown in FIG. 1B. This distance may be sufficient to
prevent any portion of the airflow resistor (e.g., a flap portion
of a flap valve) from extending out of the device and into the
nasal cavity where it might contact body tissues. In some
variations, the inner body region includes one or more
noise-reduction elements, such as a projection at least partially
into the passageway that prevents an edge region of the flap face
of the flap valve from orienting in parallel with the direction of
airflow during inhalation.
[0079] All of the nasal devices described herein also include an
airflow resistor, which is located in one or more passageways
formed through the device. In FIGS. 1A and 1B, the airflow resistor
is a flap valve, and includes cross bars that support the flap
valve (and can prevent it from opening during exhalation). In
general, the airflow resistor opens in one direction (during
inhalation) and is closed during exhalation. The flap may be made
of silicone. In the device shown in FIGS. 1A and 1B, the flap can
be secured between the inner and outer rim bodies. The flap valve
may also be configured so that the flap is a noise-reduction flap,
as described in greater detail below.
[0080] FIG. 2A is a top view of another example of a nasal device.
The nasal device shown in FIGS. 2A-2B is a layered nasal device
that includes a holdfast layer 201 and an airflow resistor 203. The
reverse side of the device shown in FIG. 2A includes an adhesive
material (not shown) that may be covered by a protective covering.
The protective covering (which may also be referred to as a
protective liner) can be removed to expose the adhesive before
application of the device. Thus, the holdfast layer of the device
secures it to the subject. This holdfast layer may itself be
layered, and may include an adhesive substrate (e.g., a backing
layer). For example, the adhesive substrate may be a foam backing.
This backing may act as a substrate for an adhesive material. In
some variations, the adhesive substrate is itself adhesive. The
holdfast layer 201 may have different regions, including a
peri-nasal regions surrounding a passageway (though which air may
flow), and a tab 205 or grip region forming a tab that may make the
device easier to grasp, apply and remove. Other regions may include
regions of more aggressive and less aggressive adhesive (e.g., more
or less adhesive material), or regions of hydrogel material
(including adhesive hydrogels) to help prevent irritation from
repeated or extended use. Although the tab is shown as part of
(integral with) the holdfast material, this region may also be
formed separately, and may be made of different materials.
[0081] FIG. 2B shows an exploded view of the device of FIG. 2A.
This exploded perspective view illustrates the layers of the
device, including the adhesive holdfast 201 (which may itself be
layered), two layers forming the airflow resistor, including the
flap valve 207 and flap valve limiter 209, and an adhesive ring 211
that may help attach the flap valve and flap valve limiter to the
adhesive holdfast.
[0082] An adhesive holdfast for a nasal device may comprise any
appropriate material. For example, the adhesive substrate may be a
biocompatible material such as silicone, polyethylene, or
polyethylene foam. Other appropriate biocompatible materials may
include some of the materials previously described, such as
biocompatible polymers and/or elastomers. Suitable biocompatible
polymers may include materials such as: a homopolymer and
copolymers of vinyl acetate (such as ethylene vinyl acetate
copolymer and polyvinylchloride copolymers), a homopolymer and
copolymers of acrylates (such as polypropylene,
polymethylmethacrylate, polyethylmethacrylate, polymethacrylate,
ethylene glycol dimethacrylate, ethylene dimethacrylate and
hydroxymethyl methacrylate, and the like), polyvinylpyrrolidone,
2-pyrrolidone, polyacrylonitrile butadiene, polyamides,
fluoropolymers (such as polytetrafluoroethylene and polyvinyl
fluoride), a homopolymer and copolymers of styrene acrylonitrile,
cellulose acetate, a homopolymer and copolymers of acrylonitrile
butadiene styrene, polymethylpentene, polysulfones polyimides,
polyisobutylene, polymethylstyrene and other similar compounds
known to those skilled in the art. Structurally, the substrate may
be a film, foil, woven, non-woven, foam, or tissue material (e.g.,
poluelofin non-woven materials, polyurethane woven materials,
polyethylene foams, polyurethane foams, polyurethane film,
etc.).
[0083] In variations in which an adhesive is applied to the
substrate, the adhesive may comprise a medical grade adhesive such
as a hydrocolloid or an acrylic. Medical grade adhesives may
include foamed adhesives, acrylic co-polymer adhesives, porous
acrylics, synthetic rubber-based adhesives, silicone adhesive
formulations (e.g., silicone gel adhesive), and absorbent
hydrocolloids and hydrogels.
Noise-Reduced Nasal Devices
[0084] As mentioned above, nasal devices including those
illustrated in FIGS. 1A-2B may produce undesirable noises when
worn, particularly during inhalation, when the rate of airflow
through the device is greatest. An analysis of these devices has
identified oscillation of the flap portion of the valve during
inspiratory airflow as one possible source of noise. In particular,
the edge portion of a flap may vibrate or oscillate during the
inspiratory phase of respiration causing an audible buzzing noise,
particularly at relatively high flow rates during inhalation.
[0085] Any of the noise-reduced nasal respiratory devices described
herein may be configured so that the flap valve does not produce
nose from oscillation during operation of the device in a range of
normal inhalation and/or exhalation flow rates. Typical flow rates
for operation during inhalation may be between about 20 and about
750 ml/sec, or between about 20 and about 500 ml/sec, or between
about 10 and about 800 ml/sec, etc.). The flow rate typically
refers to the flow rate through the device during inhalation (or in
some variations, exhalation).
[0086] For example, FIGS. 3A-3C show different flap valve
variations during a simulated inhalational air flow. These figures
capture the oscillation of the flaps of the flap valves which may
produce an audible buzzing sound. For example, FIG. 3A illustrates
a flap valve comprising four valve leaflets (flaps), formed as a
four-piece pie-shaped valve having a central opening or leak
pathway. During inhalation, the four flaps bend upwards, opening
the valve. As shown in the photograph, the upper (tip) regions of
the valves in this figure are blurred, because they are oscillating
a relatively high frequency in the simulated inspiratory airflow.
The flap on the right side of the figure shows a tracing indicating
the angle formed by the valve as it oscillates. In this example,
the valve was measured to oscillate through an approximately 35
degree angle of arc. The rate at which the valve oscillates may
depend on the airflow, the material properties of the valve
(including the stiffness), and the shape of the valve. The rate of
oscillation may also determine the frequency or pitch of the
resulting noise. In some devices, buzzing was not in the audible
range until one or more flaps was constrained; preventing or
limiting flow through one flap effectively increased the rate of
flow through the other flaps, increasing the rate of
oscillation.
[0087] FIGS. 3B and 3C are similar examples showing six-leaflet
(FIG. 3B) and eight-leaflet (FIG. 3C) valves during a simulated
inspiratory airflow. In all of these examples, the unconstrained
ends or edge of the flaps are oscillating within the inspiratory
airflow. "Buzzing" may result when a flap is allowed to open
vertically aligning with the airflow and vibrate in the passing
airstream.
[0088] In theory, the flap oscillates and produces noise when the
force of air pressure on opposite sides of the flap becomes
dynamically unstable, resulting in the back and forth (oscillatory)
motion of the flap as the unstable forces acting on either side of
the flap push on the flap. This phenomenon may be similar to the
motion that the sail of a sailboat undergoes when the sail "luffs".
Based on an analysis of the flaps of flap valve nasal devices
during simulated inspiratory airflow, it appears that oscillation
occurs when the flap valve luffs when an edge face region of the
flap becomes aligned in parallel with the airflow through the
device. When this occurs, the air pressure on either side of the
flap pushes the flap back and forth, oscillating it. This
oscillation may produce a buzzing noise.
[0089] Constraining the oscillation of the flap may reduce or
eliminate noise. For example, a flap may be constrained by limiting
the ability of the edge (particularly the distal tip region) to
oscillate. Alternatively, or in addition, a flap, and particularly
the edge region of the flap, may be dampened to reduce or eliminate
the oscillation. Finally, the flap may be prevented from
oscillating by preventing an edge region of the flap face of the
flap from aligning with the inspiratory airstream.
[0090] Noise-reduction features therefore include elements for
constraining the oscillation of the edge region of a flap. Buzzing,
apparently a result of the oscillations, may be reduced or
prevented by including a noise-reduction feature that prevents the
flaps forming the flap valve from opening so that an edge region of
the flap face of the flap is essentially parallel with the
direction of airflow through the device. Any appropriate structure
for constraining the oscillation may be used as a noise-reduction
element, including cages, spacers, cones, or tethers. Examples of
these noise-reduction elements are given below.
[0091] Noise-reduction elements may be attached to the nasal device
on the proximal side of the device (e.g., the side facing the
subject, in the direction of inspiratory airflow. For example, a
noise-reduction element may be a cone or cage (e.g., dome) that is
placed over or partially across the passageway of the device so
that it may control the edge or tip of the flap. In some variations
the nose-reducing element may also act as an alignment guide, and
may protect the valve or flap valve from interference. The
noise-reduction element may also prevent the flaps from contacting
a subject's nose, which would interfere with their operation and
could irritate the subject's nose or causing a tickling
sensation.
[0092] In general, noise-reduction elements limit the oscillation
of the flap. FIGS. 4A to 4C illustrate noise-reduction elements
configured as domes or cages that extend over the proximal side of
the passageway and limit the motion of the flap valves to prevent
them from buzzing. For example, FIG. 4A is a wire dome 401 that
surrounds the flaps 405 of the flap valves. The dome has large
openings, but the wires forming the dome prevent the flaps of the
valve from opening completely. In particular, they prevent an edge
region of the flap face from opening in parallel with the direction
of airflow through the valve. The arrow 408 indicates the net
direction of airflow during inhalation. In this example, the walls
forming the dome curve inward slightly, preventing the flap(s) from
opening fully during inhalation. In some variations, the dome or
cage has a height that is less than the full extension of the flaps
if they were to open in parallel with the direction of airflow. An
example of this is shown in FIG. 4B.
[0093] In FIG. 4B the noise-reduction element is configured as a
dome formed of a plastic mesh. In this example, the `wires` forming
the dome are thicker than those shown in FIG. 4A, and the openings
in the noise-reduction element are smaller than those in the
noise-reduction element of FIG. 4A. The resistance through the dome
(during both inspiration and exhalation), may therefore be slightly
higher than the resistance without the dome, or compared to the
device shown in FIG. 4A. The example of a noise-reduction element
shown in FIG. 4C may have an even greater effect on the resistance
to airflow through the nasal device. In this example the dome is
formed of a plastic (e.g., shaped or molded plastic) cut to provide
openings (circular openings in this example). These openings may be
larger and/or more numerous, in order to adjust the effect on the
resistance to inspiration. In this way the resistance to
inspiration (and exhalation) can be adjusted so that it is within a
desired range.
[0094] FIGS. 5A-5D show variations of nasal devices including
noise-reduction elements configured as spacers that are formed as
part of a body region as described above for FIGS. 1A and 1B. For
example, in FIG. 5A the inner body region includes a cross-beam
with two projections or spacers 503, 503' extending into the
passageway to contact the distal tips of the flaps during
inhalation, and prevent them from oscillating. In this example, the
edge region of the flap face is prevented from aligning with the
direction of airflow (perpendicular to the opening in FIG. 5A). As
discussed above, this may prevent the flaps from oscillating. In
FIG. 5A these projections 503, 503' extend downwards toward the
flap valve. Any projection that prevents the edge region of the
flap valve from oscillating (e.g., that prevents the edge region of
the flap face from aligning parallel to the direction of airflow)
may work. The noise-reduced nasal device shown in FIG. 5B is
similar to the device shown in FIG. 5A, except that the
noise-reduction elements (projections 503, 503') are longer, and
therefore extend further in the passageway(s). FIGS. 5C and 5D
illustrate another variation of a nasal device including
noise-reduction elements that are configured as projections.
[0095] For example, in FIG. 5C, the noise-reduction element is a
pair of spaced projections 505,505' and 507, 507' arranged so that
each of the pair of flaps valves (not visible in the figure) will
contact both of them when opening during inspiration. The spacing
between the two projections may also help control the air pressure
on one side of the flap, since the space formed between the two
projections on each side will allow a gap preventing pressure to
build up between a face of the flap and the cross-beam or
projection spanning the passageway. This may help further prevent
oscillation of the flap by maintaining the pressure differential
with respect to the opposite face of the flap. The noise-reduced
nasal device shown in FIG. 5D is similar to that shown in FIG. 5C,
except that the projections are smaller (e.g., don't extend as far
across the passageway(s) formed through the device). The size
and/or number of the projections used to reduce or eliminate noise
may depend on the material properties (such as stiffness) of the
flap valve and the velocity of the expected airflow. For example,
more projections that may be used with larger flap valves.
[0096] Other configurations of noise-reduction projections may
include ribs or arcs that extend at least partially across the
opening or passageway. These projections do not need to be part of
a cone (e.g., an alignment cone or other structure) as illustrated
in FIGS. 5A-5C, but may project from the side of the device near
the flap valve (or from the holdfast region). In some variations a
noise-reduction element is a cone (which may also be an alignment
guide) that controls the edge regions of a flap to prevent it from
oscillating and thereby reduce or eliminate noise such as
buzzing.
[0097] For example, FIGS. 6A-6C illustrate three variations of
noise-reduction elements configured as cones. Other examples of
conical noise-reduction elements are shown in FIGS. 7A-10.
[0098] In FIG. 6A the cone extends up from the valve so that the
top of the cone is as high as, or slightly higher than, the tip of
the flap valves. In this example, the inner walls of the cone are
slightly angled inward, so that the distal edge region of the flap
face (the edge region of the flap face facing away from the subject
when the device is worn) cannot move out of the path of the
inspiratory airflow. Put another way, the distal edge regions of
the flap face cannot become parallel with the net direction of air
flow through the passageway of the device. The cone includes
openings (cutout regions) 605 near each flap that may also prevent
pressure from building up behind the flap as it nears the wall,
potentially introducing instability. The openings may also (or
alternatively) provide another path for airflow, helping to
compensate for the size of the opening at the top of the cone, and
keep inspiratory resistance low. FIGS. 6B and 6C illustrate
different variations of cones that may also be used.
[0099] For example, FIG. 6B shows a simple formed cone that does
not include any cutout regions. FIG. 6C shows a similar cone having
a castle-topped (or crenellated) form in which cutouts have been
made along the sides. In variations including cutouts or
crenellations, the number of side cutouts is generally equal to at
least the number of flaps. For example, in FIG. 6C there are eight
flaps (cut to form a flap valve having eight "pie slices") and
eight cuts forming eight crenellations. As mentioned, the cut out
regions 607 may unexpectedly improve the noise-reducing capability
compared to the simple formed cone of FIG. 6B. When tested at high
flow rates (simulating a high inspiratory flow rate), the
castle-topped variation shown in FIG. 6C produced less noise
compared to the simple cone shown in FIG. 6C.
[0100] FIGS. 7A-7C illustrate another variation of a
noise-reduction element configured as a simple formed cone, showing
exemplary dimensions. For example, FIG. 7A shows a side perspective
view of a conical noise-reduction element similar to that shown in
FIG. 6B. FIG. 7B shows a top view of the same conical
noise-reduction element. FIG. 7C is a side view indicating relative
thicknesses and angles for the same noise-reduction cone. This
basic noise-reduction cone may be cut to create the castle-topped
variation or any other conical noise-reduction element. Examples of
additional variations of conical noise-reduction elements are shown
in FIGS. 8A-8F.
[0101] FIGS. 8A through 8C show cones designed to prevent flap
vibration having one or more projection into the passageway region.
For example, FIG. 8A is configured to be used with a flap valve
having six flaps (cut from a circular flap disk). There are three
corresponding projections 803 that are configured to prevent an
edge region of the flap face from orienting parallel to the
direction of fluid flow. FIG. 8B is a similar conical
noise-reduction element having four projections 805 rather than
three, and may be used with an eight-flap variation. FIG. 8C is
another variation having a ring-shaped projection to prevent flap
buzz. The cone having a ring-shaped projection has the advantage
that it can be used any flap valves regardless of the number of
flaps, and further, the projections do not need to be aligned with
the flaps, as may need to be done with the conical noise-reduction
elements shown in FIGS. 8A and 8B. In the examples shown in FIGS.
8A-8C the walls of the cones may be relatively flat or parallel to
the direction of airflow. Thus, although these are referred to as
"cones" or conical noise-reduction elements, the walls don't angle
substantially into the passageway, although the projections may.
These variations may also include cutouts in the sides of the
device, which may lower the inspiratory resistance, and also help
prevent oscillation of the flap.
[0102] FIGS. 8D to 8F illustrate conical noise-reduction elements
having internal walls that angle inward to prevent the oscillation
of the flap. FIG. 8D is similar to the example of FIG. 6A, having
angled sides and cutouts. FIGS. 8E and 8F are different variations
of castle-topped or crenellated cones having cutout regions that
extend to the upper edge of the device. The method of making these
two similar cones may be quite different. For example, the cone
forming the noise-reduction element in FIG., 8E may be formed by
molding a simple formed cone similar to the formed cone shown in
FIG. 7A. The noise-reduction element of FIG. 8F can be formed by
cutting a disk of material and bending or folding it up so that it
forms the cone structure shown.
[0103] A conical noise-reduction cone should be sufficiently tall
so that the entire flap, including the tip region is controlled.
Preventing the edge region of the flap face, including the tip
region of the flap, from aligning with the direction of inspiratory
airflow should prevent the flap from oscillating. FIGS. 9A and 9B
illustrate one variation of a cone that only minimally inhibits
noise due to buzzing or oscillation of the flaps. For example, FIG.
9A shows a short cone. When connected to a nasal device, this short
cone may not project proximally sufficiently far to prevent an edge
region of the flap face from oscillating, since the tips (the
proximal ends of the movable flaps) may extend beyond the cone, as
shown in the example of FIG. 9B. Thus, the height of the cone or
other noise-reduction element should extend far enough to limit or
prevent oscillation of the tip regions of the flap. FIG. 10
illustrates a taller variation of the cone that may be sufficiently
tall compared to the element shown in FIG. 9A.
[0104] FIG. 16A shows another example of a noise-reducing cone
having a noise-reducing element 1601 that projects into the
passageway and prevents the flap valve 1603, an example of which is
provided in FIG. 16B, from orienting in parallel with the direction
of airflow. The projection 1601 contacts the distal tip region of
the flap valve 1603, constraining it from orienting in parallel
with the direction of airflow. FIG. 16C illustrates a nasal device,
shown as an adhesive nasal device, that may be applied to the
subject's nose.
Noise-Reduction Flap Valves
[0105] Noise-reduction flap valves typically include one or more
flaps whose shapes and/or composition limit or prevent oscillation
of the flap. For example a noise-reduction flap may constrain or
limit an edge region of the flap face from aligning in parallel
with the direction of airflow. Noise-reduction flap designs may
provide flaps whose edges are either tethered, and therefore
prevented from extending in the direction of airflow, or include
one or more cuts which cause the flap to assume a three-dimensional
configuration when the airflow through the valve is within the
normal inspiratory range wherein the edge region of the flap faces
are not able to align with the direction of airflow or otherwise
oscillate.
[0106] FIG. 11 illustrates examples of a number of flap valves,
some of which are noise-reduction flap valves. Although these flaps
are formed from a circular layer, any appropriate flap design may
be used. For example, a flap (including a noise-reduced flap) may
be oval or may be pinned or otherwise attached to the nasal device,
rather than being partially cut out of a substrate. FIGS. 12A-15B
show specific examples of noise-reduced flaps and illustrate
principles that may help design them.
[0107] FIG. 12A is a butterfly noise-reduction flap valve. FIG. 12B
shows the butterfly noise-reduction flap valve (which may also be
referred to as a double-butterfly flap valve) in an open
configuration, when inspiratory airflow is flowing through the flap
valve. As seen in FIG. 12B, the flaps open in two opposing
directions; the outer flaps formed by the two outer cuts 1201, bend
upwards, but are prevented from folding upwards and aligning with
the direction of airflow in the valve by the flaps formed by the
inner H-shaped cut 1203. These flaps also open upward, but push
against the other flaps, preventing them from aligning with the
direction of airflow, as shown. The additional cuts also shorten
the effective bendable length of the flap, making the flap stiffer,
and requiring greater inspiratory force in order to fully align a
face of the flap with the direction of airflow. Thus, this
butterfly flap is one variation of a noise-reduction flap
valve.
[0108] FIG. 13A is another variation of a noise-reduction flap
valve also having outer cuts and inner cuts which form flaps that
may oppose each other and form a three-dimensional shape in the
inspiratory airflow pathway. FIG. 13B shows this flap valve in the
open position in an exemplary inspiratory airflow. In this example,
as in the butterfly-type flap valve, the open flaps are constrained
(at normal inspiratory flow rates) from opening so that one or more
edge face regions are aligned in parallel with the direction of
inspiratory airflow and therefore they are constrained from
oscillating.
[0109] Two other variations of noise-reduction flap valves are
illustrated in FIGS. 14A-15B. For example, in FIG. 14A, the
clover-leaf pattern of internal flaps cut into each of the four
larger flaps results in opposing pairs of flaps (e.g., each inner
flap is opposed by an outer flap) that open in opposite directions,
similar to the butterfly flap valve of FIGS. 12A-12B.
[0110] In all of these flap valve designs shown in FIGS. 12A-15B
the opening of the outer flaps is opposed by the opening of an
inner flap that is typically cut into the outer flap. As a result
of the opposing flap openings, neither inner or outer flaps may
open so that an edge region of the flap face is fully parallel with
the direction of current flow, at least within the range of normal
inspiratory airflows. At extremely high flow rates this may not
hold, particularly at non-physiological flow rates.
[0111] In FIGS. 15A and 15B, a four-flap (a four-pie) valve example
has been modified by including an additional "T" shaped cut along
the center of the valve. As a result, these "T" cut regions will
form adjacent flaps that open slightly to stiffen the larger flap
region (the quarter pie-shaped region), preventing it from aligning
an edge region of the flap face with the direction of airflow. This
is illustrated in FIG. 15B. The noise-reduction performance for
this type of valve may be improved by locating the slit forming the
top of the "T" further than halfway up the flap from the attachment
site of the quarter pie-shaped flap. In general, the further up the
flap this cross-slit is located, the greater the stiffness
preventing the quarter pie-shaped flap from opening so that an end
face is aligned with the direction of airflow.
[0112] In some variations, the noise-reduction flap valve comprises
a flexible flap having a durometer (or a durometer and thickness)
that is high enough to reduce noise during the range of air flow
past the flap that is experienced during inhalation through the
device. The durometer of a material is a measure of the `hardness`
or `stiffness` of the material. In general, higher durometer
materials (e.g., higher than about 40 Shore A, higher than about 45
Shore A, higher than about 50 Shore A, etc.) were believed to
increase the noise of operation of the device, and in particular,
higher durometer (stiffer) materials were expected to make noises
upon closing. Surprisingly, experiments examining the noise
resulting from similarly structured flaps with different
thicknesses and durometer revealed that higher durometer materials
were more noise-reducing than lower durometer materials. In
particular, the combination of thickness and durometer of the
materials was found to contribute to noise-reduction in these
experiments. In general, flaps within the range of 2 mil to 5 mil
having a higher durometer (greater than 40, e.g., 50) were quieter
than flaps having a lower durometer. For example, flaps having a
thickness of greater than about 2 mil (e.g., 2 mil, 3 mil, 4 mil)
and flaps having a durometer of greater than 40 (e.g., greater than
45, greater than 50) were more noise-reducing. In particular, flaps
having a thickness of between about 3 mil to 5 mil and a durometer
of about 50 or higher were surprisingly less noisy than flaps
having a lower durometer. In addition to helping reduce the sound
of closing of the flap valve (which may produce a `clicking` noise
upon switching between inhalation and exhalation), the higher
durometer flaps described herein may also reduce noise due to
oscillation. Thus flaps within the above-described range of
durometers and thicknesses may be considered noise-reduced flap
valves.
[0113] The noise-reduction flap valves described herein may also be
used in conjunction with the noise-reduction elements described
herein. For example, a conical noise-reduction element may be used
with a noise-reduction flap valve, as illustrated in FIG. 17. FIG.
17 shows a cross-section through a noise-reduced device including a
noise-reduction flap valve 1703 that is similar to the butterfly
flap valve illustrated in FIGS. 12A and 12B, above. A
noise-reducing cone 1707 is also included, which can help prevent
the edge of the flap(s) from oscillating. Airflow through the
device is indicated by arrows 1705.
[0114] In addition to the noise-reduction elements and
noise-reducing valves shown and described above, a noise-reducing
feature may also dampen the oscillation of the edge of the flap.
For example, the edge of the flap may be thickened or stiffened
compared to other regions of the flap. An increased stiffness in
the flap, and particularly the edge region, may dampen the
oscillation of the flap without substantially changing the airflow
through the device. For example, a device in which the edge portion
of the flap is thicker than other portions of the flap may dampen
oscillations. In another variation, the edge portion may be lined
with a material having a different stiffness (e.g., a different
modulus of elasticity).
[0115] FIGS. 18 and 20 illustrate proposed methods for assembling
noise-reduced nasal devices. For example, FIG. 18 shows an exploded
view of a noise-reduced nasal device including a noise-reduction
element 1801. In this example, the noise-reduction element may be
any of the elements described herein, including those shown in
FIGS. 19A-19C. FIGS. 19A-19C shows three exemplary noise-reduction
elements, including a cage 1901, a ribbed cone 1905, and a
protrusion that is configured as two ribs 1903. In FIG. 18, the
noise-reduction element 1801 may be attached on the proximal side
of the device (the side to be inserted into the nostril in this
example). The noise-reduction element 1801 may be attached by any
appropriate method. For example, the noise-reduction element 1801
may be attached with an adhesive to a portion of the adhesive
holdfast 1803, 1811 which includes an opening or passageway in
which the airflow resistor is attached. The airflow resistor in
this example is formed from a flap valve 1805 and a flap valve
limiter 1807. An annular attachment ring or substrate 1811 is also
used to attach to (and/or partially form) the adhesive holdfast
which may secure the airflow resistor in place. The airflow
resistor may include a noise-reduction flap valve as the flap valve
1805.
[0116] FIG. 20 shows an exploded view of another variation of a
nose-reduced nasal device including a noise-reduction flap valve
2007. This figure is very similar to FIG. 2B except that the flap
layer 207 of FIG. 2B has been replaced with the noise-reduction
flap valve 2007. As mentioned above with reference to FIG., 17,
additional noise-reduction elements may also be included. The
devices may be assembled in any appropriate order, using
appropriate manufacture techniques, to form the nasal devices. For
example, the devices may be manually or automatically
assembled.
[0117] Noise-reduced nasal devices may be worn to treat any
disorder that would benefit from the use of a nasal device,
including but not limited to respiratory or sleeping disorders,
such as snoring, sleep apnea (obstructive, central, mixed and
complex), COPD, cystic fibrosis and the like. Noise-reduced nasal
device may be particularly beneficial for treatments in which the
subject is encouraged or permitted to sleep while wearing the
device, because they may prevent potentially disrupting noise. The
noise-reducing features of these nasal devices may decrease the
noise of operation of the nasal device by preventing the flap valve
from oscillating during operation of the device (particularly
during inhalation). To use the noise-reduced nasal device, it is
first placed in communication with the subject's nasal cavity so
that airflow from the subject's nose passes through the device as
it is worn. The noise-reducing feature (e.g., a noise-reduction
flap valve and/or a noise-reduction element) may then prevent or
eliminate noise by limiting oscillation of the flap during
inhalation and/or exhalation through the device. The nasal device
may be placed in communication with the nasal passageway by placing
it into or at least partially over or around the subject's nasal
cavity. For example, an adhesive holdfast attached to the nasal
device may be used to secure the device in position.
[0118] In addition to the elimination of buzzing due to oscillation
of the flap, noise-reduced nasal devices may also include features
or elements to help reduce whistling or other noise arising
independently of the oscillation of the flap valve. In some
variations, "whistling" noise may be reduced by minimizing or
limiting the creation of turbulence as air flows through the
device. For example, the surfaces of the device across which air
flows (e.g., the passageway, rim body, etc.) may be smoothed or
buffered to prevent whistling. The surfaces may be oriented to
limit whistling by reducing air turbulence. The sizes of openings
such as the leak pathway(s) and central passageways may also be
configured to prevent whistling through the device. In some
variations, opening of the leak pathway (or other surfaces) is
oriented in parallel with the direction of airflow to reduce
whistling by reducing the turbulent flow of air across the device.
In some variations, edges exposed to airflow are smoothed or
rounded to minimize turbulence. Whistling may also be minimized by
reducing the perimeter length of an opening or openings through
which air must pass. For example, in general, air flowing through a
hole of a given frontal area will make less noise than air flowing
through 10 holes each with 1/10 of the area of the single hole, but
having a cumulative perimeter of over 3 times the circumference of
the larger hole.
[0119] Many other materials and structures may be used to achieve
the noise-reducing features described. This description is not
intended to be limited to the structures and materials mentioned,
but is intended to also encompass many other materials and
structures having similar properties. Appendix A, attached below,
suggests a number of modifications and variations of the devices
and methods already described.
[0120] In contrast to the noise-reduced nasal devices, fluttering
or vibrating nasal devices (which may or may not produce noise) may
also be used. In particular, such devices may be configured to
promote a vibration or fluttering sensation when worn, by promoting
oscillation of the edge region of the flap face and/or tip of the
flap during inhalation and or exhalation. The turbulence created by
nasal devices and the resulting pressure waves may be useful for
those patients requiring pulmonary therapy or rehabilitation. For
example, a nasal device that caused oscillation during exhalation
(and subsequent creation of oscillatory pressure waves that may be
transmitted to the smaller airways) could be helpful in the
treatment of cystic fibrosis or other diseases in which mucous
clearance is important. These devices may also utilize any of the
previously described device features which may be used to prevent
oscillation and noise in one direction of airflow while promoting
oscillation and/or pressure waves in another direction of
airflow.
[0121] For example, a method of treating a disorder (e.g., cystic
fibrosis) may include placing a passive-resistance nasal device in
communication with a subject's nasal cavity, and oscillating the
flap valve to produce vibrations. For example, the device may be
configured so that the flap valve oscillates during inhalation
through the nasal device. The nasal devices described herein may
also be referred to as "passive-resistance" nasal devices because
they do not require the active application of air pressure (e.g.,
blowing or pumping air or suctioning or removing air) from the
subject. In some variations the devices are configured to oscillate
during inhalation by orienting a flap (e.g., the flap valve) in
parallel with the direction of airflow during inhalation. The
devices may be configured to include a vibratable member (e.g., a
membrane) in addition to the flap valve that is oriented so that an
edge region is roughly parallel to the direction of airflow through
the device. In some variations, the devices may be configured to
oscillate or vibrate during exhalation as well as, or instead of,
during inhalation.
[0122] Although the nasal devices described herein are configured
so that (in normal operation) the resistance through the device is
greater during exhalation than during inhalation, other
configurations may also be used with the noise-reduced devices or
features described herein. For example, a nasal device may be
configured with an airflow resistor that inhibits inhalation more
than exhalation, which may be used with a noise-reduction element
or flap valve configured to inhibit oscillation of the flap (or
flaps) during exhalation instead (or in addition to) inhalation. In
general a noise-reduced nasal device may limit the oscillation of
the flap during both inhalation and exhalation. While the methods
and devices have been described in some detail here by way of
illustration and example, such illustration and example is for
purposes of clarity of understanding only. It will be readily
apparent to those of ordinary skill in the art in light of the
teachings herein that certain changes and modifications may be made
thereto without departing from the spirit and scope of the
invention.
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