U.S. patent application number 13/117886 was filed with the patent office on 2011-09-15 for nasal dilator with variable spring rate.
Invention is credited to Hanford N. Lockwood, JR..
Application Number | 20110224717 13/117886 |
Document ID | / |
Family ID | 40260004 |
Filed Date | 2011-09-15 |
United States Patent
Application |
20110224717 |
Kind Code |
A1 |
Lockwood, JR.; Hanford N. |
September 15, 2011 |
NASAL DILATOR WITH VARIABLE SPRING RATE
Abstract
A nasal dilator strip and methods, the strip including a first
layer including a cover having adhesive on a surface thereof, the
cover having a first edge with a convex locating feature and a
second edge opposite the first edge, the second edge being an
uninterrupted edge, and a second layer having opposite surfaces,
one opposite surface of the second layer being secured to the first
layer, at least a portion of the other opposite surface of the
second layer having adhesive to hold the two-layer nasal dilator
strip in place on a user's nose, the second layer including a
substantially planar resilient member, the resilient member having
a constant thickness and longitudinal sides which converge from a
center of the resilient member to a pair of spaced apart ends.
Inventors: |
Lockwood, JR.; Hanford N.;
(San Mateo, CA) |
Family ID: |
40260004 |
Appl. No.: |
13/117886 |
Filed: |
May 27, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11880217 |
Jul 19, 2007 |
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13117886 |
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Current U.S.
Class: |
606/204.45 |
Current CPC
Class: |
A61F 5/08 20130101 |
Class at
Publication: |
606/204.45 |
International
Class: |
A61F 5/08 20060101
A61F005/08 |
Claims
1. A two-layer nasal dilator strip comprising: a first layer
including a cover having adhesive on a surface thereof, the cover
having a first edge with a convex locating feature and a second
edge opposite the first edge, the second edge being an
uninterrupted edge; and a second layer having opposite surfaces,
one opposite surface of the second layer being secured to the first
layer, at least a portion of the other opposite surface of the
second layer having adhesive to hold the two-layer nasal dilator
strip in place on a user's nose, the second layer including a
substantially planar resilient member, the resilient member having
a constant thickness and longitudinal sides which converge from a
center of the resilient member to a pair of spaced apart ends
which, if forced together from initial positions to reduce direct
spacing between the ends, results in restoring forces in the
resilient member to restore the direct spacing between the
ends.
2. The two-layer nasal dilator strip of claim 1 wherein the second
layer also includes a cushion member.
3. The two-layer nasal dilator strip of claim 2 wherein the
opposite surface of the cushion member has adhesive.
4. The two-layer nasal dilator strip of claim 2 wherein the
opposite surface of the resilient member does not have
adhesive.
5. The two-layer nasal dilator strip of claim 1 wherein the second
edge of the cover is an uninterrupted linear edge.
6. The two-layer nasal dilator strip of claim 1 wherein the
resilient member is made of plastic.
7. The two-layer nasal dilator strip of claim 6 wherein the
resilient member is made of polyester sheet material.
8. The two-layer nasal dilator strip of claim 1 wherein the
resilient member has a thickness of about 0.010 of an inch to about
0.015 of an inch.
9. The two-layer nasal dilator strip of claim 1 wherein the cover
and the resilient member are fabricated from transparent
materials.
10. The two-layer nasal dilator strip of claim 1 wherein the
resilient member is symmetrical with respect to a lateral
centerline of the resilient member.
11. The two-layer nasal dilator strip of claim 1 wherein the
resilient member is asymmetrical with respect to a longitudinal
centerline of the resilient member.
12. The two-layer nasal dilator strip of claim 1 wherein the
longitudinal sides of the resilient member converge from a lateral
centerline to the ends.
13. The two-layer nasal dilator strip of claim 1 wherein the
resilient member has a spring rate which diminishes from the center
to the ends.
14. The two-layer nasal dilator strip of claim 13 wherein the
resilient member has a constantly varying spring rate which
diminishes from a lateral centerline of the resilient member to the
ends.
15. The two-layer nasal dilator strip of claim 1 wherein the
resilient member generates restorative forces capable of supporting
a load of 25 to 30 grams applied to an end of the resilient
member.
16. A nasal dilator strip comprising: a cover having adhesive on a
surface thereof, the cover having a first edge with a convex
locating feature and a second edge opposite the first edge, the
second edge being an uninterrupted edge; and a substantially planar
resilient member secured to the cover, the resilient member having
a constant thickness and longitudinal sides which converge from a
center of the resilient member to a pair of spaced apart ends
which, if forced together from initial positions to reduce direct
spacing between the ends, results in restoring forces in the
resilient member to restore the direct spacing between the
ends.
17. The nasal dilator strip of claim 16 wherein the nasal dilator
strip is a two-layer nasal dilator strip, a first layer including
the cover and a second layer including the resilient member.
18. The nasal dilator strip of claim 17 wherein at least a portion
of a surface of the second layer opposite the cover has adhesive to
hold the two-layer nasal dilator strip in place on a user's
nose.
19. The nasal dilator strip of claim 18 wherein the second layer
also includes a cushion member, the cushion member having the
adhesive to hold the two-layer nasal dilator strip in place on a
user's nose.
20. The nasal dilator strip of claim 16 wherein the resilient
member is symmetrical with respect to a lateral centerline of the
resilient member.
21. The nasal dilator strip of claim 16 wherein the resilient
member is asymmetrical with respect to a longitudinal centerline of
the resilient member.
22. A two-layer nasal dilator strip comprising: a first layer
including a transparent cover having adhesive on a surface thereof,
the cover having a first edge with a convex locating feature and a
second edge opposite the first edge, the second edge being an
uninterrupted edge; and a second layer having opposite surfaces,
one opposite surface of the second layer being secured to the first
layer, at least a portion of the other opposite surface of the
second layer having adhesive to hold the two-layer nasal dilator
strip in place on a user's nose, the second layer including a
substantially planar transparent resilient member, the resilient
member being made of polyester sheet material, the resilient member
having a constant thickness of about 0.010 of an inch to about
0.015 of an inch, the resilient member having longitudinal sides
which converge from a center of the resilient member to a pair of
spaced apart ends which, if forced together from initial positions
to reduce direct spacing between the ends, results in restoring
forces in the resilient member to restore the direct spacing
between the ends, the resilient member being symmetrical with
respect to a lateral centerline of the resilient member, the
resilient member being asymmetrical with respect to a longitudinal
centerline of the resilient member, the resilient member having a
spring rate which diminishes from the center to the ends.
23. The two-layer nasal dilator strip of claim 22 wherein the
second layer also includes a cushion member.
24. The two-layer nasal dilator strip of claim 23 wherein the
opposite surface of the cushion member has adhesive.
25. The two-layer nasal dilator strip of claim 23 wherein the
opposite surface of the resilient member does not have
adhesive.
26. The two-layer nasal dilator strip of claim 22 wherein the
second edge of the cover is an uninterrupted linear edge.
27. The two-layer nasal dilator strip of claim 22 wherein the
longitudinal sides of the resilient member converge from the
lateral centerline to the ends.
28. The two-layer nasal dilator strip of claim 22 wherein the
resilient member has a constantly varying spring rate which
diminishes from a lateral centerline of the resilient member to the
ends.
29. The two-layer nasal dilator strip of claim 22 wherein the
resilient member generates restorative forces capable of supporting
a load of 25 to 30 grams applied to an end of the resilient
member.
30. A method of manufacturing a two-layer nasal dilator strip, the
method comprising: forming a first layer including a cover having a
first edge with a convex locating feature and a second edge
opposite the first edge, the second edge being an uninterrupted
edge; forming a second layer having opposite surfaces, the second
layer including a substantially planar resilient member, the
resilient member having a constant thickness and longitudinal sides
which converge from a center of the resilient member to a pair of
spaced apart ends which, if forced together from initial positions
to reduce direct spacing between the ends, results in restoring
forces in the resilient member to restore the direct spacing
between the ends; applying adhesive to a surface of the first
layer; securing one opposite surface of the second layer to the
first layer; and applying adhesive to at least a portion of the
other opposite surface of the second layer to hold the two-layer
nasal dilator strip in place on a user's nose.
31. The method of claim 30 further comprising applying a release
liner to the other opposite surface of the second layer to protect
the adhesive.
32. The method of claim 30 wherein securing includes securing the
resilient member substantially centered on the cover.
33. The method of claim 30 wherein forming the second layer
includes forming a second layer including the resilient member and
a cushion member.
34. The method of claim 33 wherein applying adhesive to at least a
portion of the other opposite surface of the second layer includes
applying adhesive to the opposite surface of the cushion
member.
35. The method of claim 33 wherein applying adhesive to at least a
portion of the other opposite surface of the second layer includes
not applying adhesive to the opposite surface of the resilient
member.
36. The method of claim 30 wherein forming the first layer includes
forming a cover with an uninterrupted linear second edge.
37. The method of claim 30 wherein forming the second layer
includes forming the resilient member of plastic.
38. The method of claim 37 wherein forming the resilient member
includes forming the resilient member of polyester sheet
material.
39. The method of claim 30 wherein forming the resilient member
includes forming the resilient member with a thickness of about
0.010 of an inch to about 0.015 of an inch.
40. The method of claim 30 wherein forming the first layer includes
forming the cover of a transparent material, and wherein forming
the second layer includes forming the resilient member of a
transparent material.
41. The method of claim 30 wherein forming the second layer
includes forming the resilient member asymmetrically with respect
to a longitudinal centerline of the resilient member.
42. The method of claim 30 wherein forming the second layer
includes forming the resilient member symmetrically with respect to
a lateral centerline of the resilient member.
43. The method of claim 42 wherein forming the resilient member
includes forming the resilient member with the longitudinal sides
converging from the lateral centerline to the ends.
44. The method of claim 30 wherein forming the second layer
includes forming the resilient member with a spring rate
diminishing from the center to the ends.
45. The method of claim 44 wherein forming the resilient member
includes forming the resilient member with a constantly varying
spring rate diminishing from a lateral centerline of the resilient
member to the ends.
46. The method of claim 30 wherein forming the second layer
includes forming the resilient member to generate restorative
forces capable of supporting a load of 25 to 30 grams applied to an
end of the resilient member.
47. A method of introducing separating stresses in nasal outer wall
tissues of a user's nose, the method comprising: providing a
two-layer nasal dilator strip including a first layer including a
transparent cover, the cover having a first edge with a convex
locating feature and a second edge opposite the first edge, the
second edge being an uninterrupted edge, and a second layer having
opposite surfaces, one opposite surface of the second layer being
secured to the first layer, at least a portion of the other
opposite surface of the second layer having adhesive, the second
layer including a substantially planar transparent resilient
member, the resilient member being made of polyester sheet
material, the resilient member having a constant thickness of about
0.010 of an inch to about 0.015 of an inch, the resilient member
having longitudinal sides which converge from a center of the
resilient member to a pair of spaced apart ends which, if forced
together from initial positions to reduce direct spacing between
the ends, results in restoring forces in the resilient member to
restore the direct spacing between the ends, the resilient member
being symmetrical with respect to a lateral centerline of the
resilient member, the resilient member being asymmetrical with
respect to a longitudinal centerline of the resilient member, the
resilient member having a spring rate which diminishes from the
center to the ends; orienting the two-layer nasal dilator strip on
the user's nose with the other opposite surface of the second layer
facing a surface of the nose, with the first edge having the convex
locating feature pointing toward a tip of the nose and with the
second uninterrupted edge pointing away from the tip of the nose;
bending the two-layer nasal dilator strip over a bridge of the
nose; and attaching the adhesive to the surface of the nose.
48. The method of claim 47 wherein bending includes generating in
the resilient member restoring forces capable of supporting a load
of 25 to 30 grams applied to an end of the resilient member.
49. The method of claim 48 wherein attaching includes resisting the
restoring forces generated in the resilient member.
Description
RELATED APPLICATION
[0001] This application is a continuation application of U.S.
patent application Ser. No. 11/880,217, filed on Jul. 19, 2007, the
entire contents of which are incorporated herein by reference.
BACKGROUND
[0002] This invention relates to an improvement to the
configuration of nasal dilators such as those described in Spanish
Patent No. 289,561 to Iriarti dated 15 Sep. 1986 and in the further
patents discussed below. Generally speaking these dilators employ a
resilient band which has an adhesive on the bottom side and
sufficient length so that the resilient band can be bent over the
bridge of the nose, and each end of the band becomes adhesively
attached to the soft tissue on the lateral wall of the nasal
passage.
[0003] Bending the resilient band from its initial planar state to
its deformed state with its ends in contact with the lateral walls
of the nasal passages and the center of the band overlying the
bridge of the nose results in forces tending to pull out on the
lateral wall tissues which stabilize the walls of the nasal
passages during breathing.
[0004] The present invention improves nasal dilators by providing
them with a resilient member which has a variable spring rate that
decreases from the point where the resilient band crosses the
bridge of the nose to the point where the resilient band terminates
at the lateral wall of the nasal passage.
[0005] The nasal dilator of the present invention has a soft fabric
cushion of the same or a slightly greater thickness than the
resilient member. The soft fabric cushion is located in the same
layer as the resilient member and covers the area of the soft
fabric cover which is not in direct contact with the resilient
member. The soft fabric cushion is in contact with edges of the
resilient member and prevents the edges of the resilient member
from pressing into the skin on the user's nose while using the
nasal dilator.
[0006] The present invention further provides a convex protrusion
on the side of the dilator at the center of the bridge of the nose
facing the tip of the nose to indicate to the user the proper
orientation of the dilator when applying it to the nose.
[0007] Blockage of the nasal passages from swelling due to
allergies, colds and physical deformities can lead to breathing
difficulty and discomfort. The nasal passages have mucus membranes
which condition the air in the nasal passages prior to its arrival
in the lungs. If the nasal passages are constricted due to swelling
or minor deformities then the alternative is to breathe through the
mouth. This means that the air bypasses the mucus membranes, losing
the conditioning effects and causing irritation in the throat and
lungs. At night, restrictions to breathing through the nasal
passages can lead to snoring and/or sleep disturbances. In some
cases, the restricted air supply can cause sleep problems brought
on by a lack of oxygen.
[0008] For people with chronic blockages in the nasal passages, the
alternative to correct the problem has been expensive surgery or
medication. People with minor deformities and breathing problems
brought on by swelling of the walls of the nasal passageways have
been turning to various products fitted in or on the nose which
claim to open the nasal passages.
[0009] The structure of the nose limits the options available for
the design of nasal dilators. The nose terminates at the nostril,
which has a slightly expanded volume immediately above it known as
the vestibule. Above the vestibule, the nasal passage becomes
restricted at a point called the nasal valve. At the nasal valve,
the external wall of the nose consists of soft skin known as the
lateral wall, which will deform with air pressure changes induced
within the nasal passage during the breathing cycles. Above the
nasal valve the nasal passage opens up to a cavity with turbinates
over the top of the palate and turns downward to join the passage
from the mouth to the throat.
[0010] The external structure of the nose consists of a skin
covering over the nasal bones which are part of the skull. This
gives the top of the nose a rigid structure at its base. Beyond the
rigid nose bones, there is thin cartilage under the skin which is
attached to the septum, which in turn contributes to the outside
shape of the nose. The septum forms the wall between the two
nostrils and may, if it is crooked, contribute to breathing
problems.
[0011] As an alternative to surgery, the structure of the nose and
the current art leave two main alternatives for the design of nasal
dilators. One alternative uses a tube or a similar structure which
can be inserted into the nasal passage to hold it in the open
position allowing the free passage of air. The disadvantage to this
design is that the dilator structure covers up the mucus membranes
which condition the air. Also dilators of this design are
uncomfortable and can irritate the walls of the nasal passage.
[0012] Another alternative is a dilator design, taught by the
Iriarti patent for example, where each end that attaches to the
external lateral wall of each of the nasal passages has resilient
means connecting the ends for developing an external pulling force
on the lateral wall causing it to open the nasal passage. This
design has the advantage over the first alternative because the
nasal passages are not disturbed by an internal insert. This design
has limited control over the resilient force on the lateral wall of
each of the nasal passages, and the resilient members crossing over
the bridge of the nose can cause discomfort.
[0013] The present invention is an improvement over earlier nasal
dilator configurations because it redistributes the lifting forces
within the resilient band by modifying the spring rate, so that
they can provide optimum lift on the lateral walls of the nasal
passage. In addition maximum comfort for the user is achieved by
adding the cushion layer at the same level as the resilient member
to prevent the edge of the resilient member from pressing into the
skin on the user's nose.
[0014] There is prior art which permits for adjusting the spring
rate of the resilient band in the nasal dilator. For example, U.S.
Pat. No. 5,476,091 to Johnson employs two parallel resilient bands
of constant width and constant thickness which cross over the
bridge of the nose and terminate at the outer wall of each nasal
passage. The Johnson patent shows a plurality of notches cut into
the top of each end of the resilient band to reduce the spring
rate, which in turn prevents the end of the resilient band from
peeling away from the skin. Each notch is a single point reduction
of the spring rate with the spring rate reduction determined by the
depth of the notch.
[0015] U.S. Pat. No. 5,479,944 to Petruson and U.S. Reissue Pat.
No. Re 35,408 to Petruson provide nasal dilators with a one-piece
molded plastic strip, the ends of which carry tabs for insertion
into the nostrils.
[0016] U.S. Pat. No. 5,611,333 to Johnson shows the same concept of
single point reduction in the spring rate of the resilient band
using the notches shown in U.S. Pat. No. 5,476,091 mentioned above.
In addition, the '333 Johnson patent shows other designs for the
resilient band with either holes or slots which are located at the
ends of the resilient bands and are intended to reduce the spring
rate at a single point to prevent the end of the resilient band
from peeling away from the skin.
[0017] U.S. Pat. No. 6,029,658 to Voss shows a beam-shaped
resilient band which extends from one side of the user's nose
across the bridge of the nose to the other side of the nose. The
resilient band is made of plastic and has a varying thickness and
width over the entire span. The resilient band exhibits a rigidity
increase from the center towards the two respective ends which
attach to the sides of the user's nose, which is the exact opposite
of what is attained with the present invention.
[0018] U.S. Pat. No. 6,453,901 to Ierulli discloses several nasal
strip configurations where the cover member extends beyond the
perimeter of the spring member, including one embodiment in which
the strip has some degree of variation in the spring force over a
portion of the length of the strip.
[0019] Some of the better known nasal dilator patents, such as U.S.
Pat. No. 5,533,499 to Johnson, U.S. Pat. No. 5,533,503 to Doubrek
et al., and U.S. Pat. No. 6,318,362 to Johnson, all teach of nasal
dilators with a cushion layer between the resilient member and the
user's skin. U.S. Pat. No. 6,058,931 to Muchin is similar to the
Spanish Iriarti patent in that the resilient member is in direct
contact with the user's skin and no cushion layer is provided.
These nasal dilators differ from the current invention, which
provides a cushion layer at the same level in the nasal dilator
structure which prevents the edge of the resilient member from
pressing into the user's skin, but at the same time does not
prevent contact of the resilient member from the user's skin.
[0020] Even the most recent nasal dilator patents such as U.S. Pat.
No. 6,694,970 to Spinelli, U.S. Pat. No. 6,769,428 to Cronk et al.,
and U.S. Pat. No. 6,769,429 to Benetti do not have the resilient
member with a constantly varying spring rate which is diminishing
from the centerline to each end of the resilient member in
combination with the cushion layer located at the same level as the
resilient member. U.S. Pat. No. 7,114,495 to Lockwood does have the
resilient member with a constantly varying spring rate which
diminishes from the centerline to each end of the resilient member.
However, it has a cushion layer under the resilient member. In
contrast, the cushion layer of the nasal dilator of the present
invention is at the same level as, and surrounds, the resilient
member.
BRIEF SUMMARY OF THE INVENTION
[0021] An object of this invention is to provide a nasal dilator
which exhibits improved performance relative to the nasal dilator
known from the prior art.
[0022] An important feature of the present invention is to provide
a soft fabric cushion layer which is the same size and shape as the
top soft fabric cover and has adhesives on both sides. The cushion
layer is at the same level as the resilient member and equal to or
slightly thicker than the resilient member. As a result, the
cushion layer and the resilient member are substantially flush
where they meet. Since the resilient member is attached to the
bottom of the top fabric cover by adhesives, the cushion layer
surrounds the edge of the resilient member and covers the remaining
area of the top soft fabric cover not covered by the resilient
member. The adhesive on the bottom of the cushion layer is in
contact with the skin on the user's nose when the dilator is in
use.
[0023] Another improvement feature of the present invention is to
configure the resilient band to reduce the width gradually from the
center of the resilient band towards each end in a way that
gradually reduces the spring rate of the resilient band. The
thickness of the resilient band remains constant over its entire
length, which simplifies the structure while keeping costs low.
[0024] A further improvement of the present invention is that the
new dilator has a relatively greater width at its center with the
shape of the bottom edge provided with a slight convex protrusion
which points to the tip of the nose when the dilator is in use. The
outer shape of the dilator is configured to optimize the location
of the resilient member over the soft tissues on the outer wall of
the nasal passages where the dilating forces are most
effective.
[0025] Other improvements provided by the present invention are the
four slits in the top soft fabric cover and the cushion layer at
the boundary that separates the ends of the dilator from the
intermediate structure which connects the ends of the dilator. The
four slits are close to perpendicular to the longitudinal axis of
the dilator and allow the top soft fabric cover and cushion layer
to conform to the many different shapes of the outer walls of the
nasal passages.
[0026] An additional improvement of the present invention is the
use of transparent materials for the top soft fabric cover, the
resilient member, and the cushion layer. Here too the cushion layer
has a thickness that is equal to or slightly thicker than the
resilient member. The normal color for the top soft fabric cover is
tan; however, for sports applications the cover may be black or
some other dark color.
[0027] The nasal dilator of the present invention is a significant
unobvious improvement over the prior art. Nasal dilators that have
been in the market for more than 10 years have a resilient member
held in place on the user's nose by a top cover that defines the
length and width of the dilator as well as adds additional adhesive
surface to overcome the stresses developed by the resilient member.
Another nasal strip that has been sold in the past has a resilient
member sandwiched between a top surface which defines the length
and width of the dilator and a cushion layer that covers the entire
bottom surface of the top layer. Both of these dilators use current
converting technology in their manufacturing process.
[0028] The improved nasal dilator of the present invention uses a
new converting technology that has not been available until now.
The new converting process requires that the resilient member be
formed and located on the bottom surface of the top cover in a
precise location. At the same time the cushion layer must have an
opening cut and be precisely indexed, so that the edges of the
cushion layer match up to the respective edges of the resilient
member in order to achieve the contiguous bottom surface required
by the improved dilator. This improvement in precision in the
converting process is due to computer-controlled indexing, as well
as a special webbing, which do not form part of the present
application.
[0029] The improvements summarized above enhance the performance of
the dilator and make the dilator more comfortable for the user as
compared to prior art dilators in general and the Iriarti dilator
in particular. In another embodiment the invention provides a
method of {text}.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The unique advantages of the present invention will become
apparent to one skilled in the art upon reading the following
specification and by reference to the following drawings:
[0031] FIG. 1 is a side view of the dilator on the nose;
[0032] FIG. 2 is an exploded perspective top view of the components
making up the dilator;
[0033] FIG. 3 is a top view of the dilator with a single resilient
band;
[0034] FIG. 4 is a sectional view of the dilator in FIG. 3 showing
the layers of the components that make up the dilator;
[0035] FIG. 5 is a top view of the dilator with two resilient
bands;
[0036] FIG. 6 is a sectional view of the dilator in FIG. 5 showing
the layers of the components that make up the dilator; and
[0037] FIG. 7 is a drawing showing the force vectors of the dilator
in this invention compared to the force vectors in other, known
dilators.
DETAILED DESCRIPTION
[0038] The specific improvements provided by this invention over
past nasal dilators described in the prior art are best seen in the
attached drawings.
[0039] Referring to FIGS. 1-4, the new nasal dilator 10 is mounted
on the nose 70 of the user. The nasal dilator 10 has a center 11
that is bent over the bridge 71 of the nose 70, and each end 12 and
13 of the nasal dilator 10 is positioned over the lateral wall 72
of the nose 70.
[0040] The lateral wall 72 of the nasal passage 75 is located in
the soft tissue 73 above the nostril flare 74, which in turn is
adjacent to the entrance of the nasal passage 75. When the nasal
dilator 10 which contains a resilient band 30 is deformed from its
normally planar state by being bent over the bridge 71 of the nose
70, the ends 12 and 13 which are attached to the lateral wall 72 of
the nasal passage 75 tend to pull on the lateral wall 72 in a way
that opens the nasal passage 75 and improves the air flow through
the nasal passages 75 during breathing. This invention shows
improvements to the performance of the nasal dilator 10, makes the
nasal dilator 10 easier to use, and increases the comfort of the
nasal dilator 10 when it is used to dilate the lateral walls 72 of
the nasal passages 75.
[0041] The new nasal dilator of the present invention has a top
cover 20 which establishes the length and width of the nasal
dilator 10, a resilient member 30 which is attached to the bottom
surface 22 of the top cover 20, and a cushion layer 40 which is
equal in thickness to the resilient member 30 and covers all of the
bottom surface 22 of the top cover 20 that is not in contact with
the top surface 38 of the resilient member 30. The dilator is flat
in its natural state with the thickness of the nasal dilator 10
that is constant over the entire surface of the top cover 20
including surfaces in contact with the resilient member 30 and the
cushion layer 40. The cushion layer 40 has an adhesive 43 which is
in contact with the skin on the user's nose 70 when the nasal
dilator 10 is in use. The bottom surface 37 of the resilient member
30 does not have an adhesive which is in contact with the skin on
the user's nose 70. The top cover 20 does not contact the skin on
the user's nose 70 when the nasal dilator 10 is in place, which is
a unique feature of the nasal dilator of the present invention.
[0042] As is best seen in FIG. 2, the nasal dilator 10 is made up
of several layers. The first layer is the top cover 20 which is
made from a non-woven polyester cellulose fabric or equal which is
usually tan in color on the top surface 21. The top surface 21 of
the top cover 20 can be dyed in any color or imprinted with a
brand, logo or other information. The top cover 20 also has a
bottom surface 22 which is coated with a 3 mils acrylic
hypoallergenic medical grade pressure-sensitive type adhesive 25 or
equal. The adhesive 25 covers the entire bottom surface 22 of the
top cover 20.
[0043] The top cover 20 has two sides 23 and 24 which run over the
length of the top cover 20 with the exception of an approximately
0.5-inch wide section at the center 11 of the nasal dilator 10. On
one side 23 of the top cover 20, there is a convex protrusion 26
which is configured to indicate the proper orientation of the nasal
dilator 10 when it is in use. When the nasal dilator 10 is properly
positioned on the user's nose, the convex protrusion 26 at the
center 11 of the nasal dilator 10 is pointed towards the tip of the
user's nose 70.
[0044] The second layer is the resilient member, 30, a plastic
layer, which is made from a polyester sheet which is about 0.010
inch to about 0.015 inch thick, depending on the required strength
of the nasal dilator 10. The thickness selected of the resilient
member 30 is constant over the entire length of the resilient
member 30, and the width of the resilient member 30 is greatest at
the center 31 where the nasal dilator 10 passes over the bridge of
the nose 71. The bottom edge 33 of the resilient member 30 curves
toward the top edge 32 as the distance from the center 31 of the
resilient member 30 is increased. This reduction of the width of
the resilient member 30 causes a reduction of the spring rate in
the resilient member 30 over the span from the center 31 to each of
the ends 34 and 35 of the resilient member 30. The width at the
center 31 of the resilient member 30 is less than half of the width
of the top cover 20, and the width of the resilient member 30 at
each of the ends 34 and 35 is approximately half of the width of
the center 31.
[0045] The bottom edge 33 of the resilient member 30 between the
center 31 and the respective ends 34 and 35 is curved over the
length of the strip and is asymmetrical in relation to the
longitudinal center line 36 (see FIG. 3) of the resilient member
30. Other curves for edges 32 and 33 are possible as long as the
maximum width of the resilient member 30 is at the center 31 and
the spring rate is reduced as the distance from the center 31 is
increased until reaching ends 34 and 35. To attain the desired
force distribution and to prevent the development of torsional
forces, the radius of curvature of the edges 32 and 33 of the
resilient member 30 is greater than 1.5 inches. In addition, the
thickness of the resilient member 30 is 3% or greater than the
width of the resilient member 30 at the longitudinal center line 36
in order to establish a baseline spring rate at the centerline of
the resilient member 30 and allow for the reduction of width of the
resilient member 30 over the span to the ends 34 and 35 in which
the polyester of specified thickness will achieve a lifting force
of 25 to 30 grams. This ratio increases as the distance from the
center 31 is increased, and the width of the resilient band
decreases until reaching ends 34 and 35.
[0046] In the same layer as the resilient member 30, there is a
cushion layer 40 which is equal to or slightly thicker than the
resilient member 30 and surrounds the edges 32 and 33 of the
resilient member 30. In this embodiment the edges 48 and 49 of the
cushion layer 40 that are adjacent to the respective edges 32 and
33 of the resilient member 30 have the same curvature as the
resilient member 30 in order to form a contiguous surface between
the bottom 42 of the cushion layer 40 and the bottom 37 of the
resilient member 30. This will prevent the edge of the resilient
member 30 from pressing into the user's skin while the nasal
dilator 10 is in use.
[0047] The cushion layer 40 is made from non-woven polyester
cellulose fabric which is about 0.010 inch to about 0.015 inch
thick. The cushion layer 40 is attached to the bottom surface 22 of
the top cover 20 which is not covered by the resilient member 30.
As a result, the bottom 37 of the resilient member 30 and the
bottom 42 of the cushion layer 40 are in contact with the skin on
the user's nose 70, while the top cover 20 cannot come in contact
with the user's nose 70 when the nasal dilator 10 is in use. This
also distinguishes this present invention from the prior art
because all known nasal dilators either have a cushion layer 40
that prevents the resilient member 30 from contacting the skin on
the user's nose 70 or have no cushion layer 40 which allows both
the bottom surface 22 of the top cover 20 and the bottom surface 37
of the resilient member 30 to have direct contact with the skin on
the user's nose 70.
[0048] The bottom 42 of the cushion layer 40 is coated with a 3
mils acrylic hypoallergenic medical grade pressure-sensitive type
adhesive 43 or equal that is designed to hold the nasal dilator in
place on the user's nose 70. The adhesive 43 on the bottom 42 of
the cushion layer 40 has sufficient strength when adhering to the
user's nose 70 to overcome the stresses developed by the resilient
member 30 when the resilient member 30 is deformed to conform to
the surface of the skin of the user's nose 70. The cushion layer 40
has two sides 45 and 46 which match the two respective sides 23 and
24 of the top cover 20. The cushion layer 40 also has a convex
protrusion 47 which matches the convex protrusion 26 of the top
cover 20.
[0049] A release liner 50 is provided to protect the adhesive
surface 43 on the bottom side of the cushion layer 40. This release
liner 50 is removed from the nasal dilator 10 prior to applying the
nasal dilator 10 to the skin of the user's nose 70.
[0050] FIGS. 3 and 4 show a top view of the first embodiment of the
nasal dilator 10 and a cross-sectional view (AA) which is
perpendicular to the longitudinal axis 36 of the nasal dilator 10.
The cross-sectional view shows the top cover 20 with adhesive 25 on
the bottom surface 22 which is in direct contact with the top
surface 38 of the resilient member 30 and the top surface 41 of the
cushion layer 40. The edges 32 and 33 of the resilient member 30
are in direct contact with the edges 48 and 49 of the cushion layer
40 forming a contiguous bottom surface 44 which prevents the edges
32 and 33 of the resilient member 30 from pressing into the skin on
the nose 70 of the user when the nasal dilator 10 is in use.
[0051] FIGS. 5 and 6 show a top view of another embodiment of the
nasal dilator 10 and its respective cross-sectional view (BB) which
is perpendicular to the long axis of the nasal dilator 10. The
edges 32 (A&B) and 33 (A&B) of two resilient members 30
(A&B) are shown. The cross-sectional view (BB) shows the top
cover 20 with adhesive 25 on the bottom surface 22 which is in
direct contact with the top surface 38 (A&B) of the resilient
members 30 (A&B) and the top surface 41 of the cushion layer
40. The top cover 20 is made from non-woven polyester cellulose
fabric or equal and the top cover 20 defines the length and width
of the nasal dilator 10.
[0052] The second layer has two or more resilient members 30
(A&B) which are made from a polyester sheet which is about
0.010 inch to about 0.015 inch thick, depending on the required
strength of the nasal dilator 10. The thickness selected of the
resilient members 30 (A&B) is constant over the entire length
of the resilient members 30 (A&B), so the nasal dilator 10 can
be manufactured in a converting process. The width of the resilient
members 30 (A&B) is constantly decreasing from the center 31
(A&B) of the resilient members 30 (A&B) to each end 34
(A&B) and 35 (A&B) in this particular embodiment, and the
thickness of the resilient members 30 (A&B) is 3% or greater
than the width of the resilient member over the length of the nasal
dilator.
[0053] As can be seen in FIG. 6, the resilient members 30 (A&B)
are attached to the bottom surface 22 of the top cover 20 with the
adhesive 25 that is applied to the bottom surface 22 of the top
cover 20. The resilient members 30 (A&B) are parallel to the
longitudinal axis 36 of the top cover 20 with each of the ends 34
(A&B) and 35 (A&B) terminating short of the end edges of
the top cover 20. The resilient members 30 (A&B) have no
adhesive on the bottom surface which is in contact with the user's
skin when the nasal dilator 10 is in use.
[0054] Each of the resilient members 30 (A&B) can be
symmetrical or asymmetrical to the longitudinal axis 39 (A&B)
of the resilient members 30 (A&B). Symmetry is achieved by
using identical curves for sides 32 (A&B) and 33 (A&B)
between the center 31 (A&B) and the ends 34 (A&B) and 35
(A&B) of the resilient members 30 (A&B). The concept of
using a reduction of the width in the resilient members 30
(A&B) that causes a reduction of the spring rate in the
resilient members 30 (A&B) can be used in nasal dilator 10 with
one or more parallel resilient members 30 (A&B) that extend
parallel to the longitudinal axis 36 of the nasal dilator 10.
[0055] In the same layer as the resilient members 30 (A&B),
there is a cushion layer 40 which is equal to or slightly thicker
than the resilient members 30 (A&B) and surrounds the edges 32
(A&B) and 33 (A&B) of the resilient members 30 (A&B).
The cushion layer 40 is designed to form a contiguous surface
between the bottom 42 of the cushion layer 40 and the bottoms 37
(A&B) of the resilient members 30 (A&B) to prevent the
edges 32 (A&B) and 33 (A&B) of the resilient members 30
(A&B) from pressing into the user's skin while the nasal
dilator 10 is in use. The cushion layer 40 is made from non-woven
polyester cellulose fabric which is about 0.010 inch to about 0.015
inch thick including the thickness of the attached adhesive 43. The
cushion layer 40 is attached to the bottom surface 22 of the top
cover 20 which is not covered by the resilient members 30
(A&B), and the edges 48 (A&B) and 49 (A&B) of the
cushion layer 40 are in contact with the respective adjacent edges
32 (A&B) and 33 (A&B) of the resilient members 30
(A&B).
[0056] The bottom 42 of the cushion layer 40 is coated with a 3
mils acrylic hypoallergenic medical grade pressure-sensitive type
adhesive 43 or equal capable of withstanding the stresses caused by
the resilient members 30 (A&B) and holding the nasal dilator 10
in place on the user's nose 70. Depending on the specific
converting process used to manufacture the nasal dilator 10, the
cushion layer 40 may also have the same 3 mils acrylic adhesive on
the top surface 41 to control any stretch in the fabric during
manufacturing.
[0057] To protect the adhesive surface 43 on the bottom surface 42
of the cushion layer 40, a release liner 50 is provided as shown in
FIG. 2. This release liner 50 is pealed away exposing the adhesive
43 on the bottom of the cushion layer 40 when the nasal dilator 10
is ready to be placed on the nose 70.
[0058] The nasal dilator 10 in both embodiments is normally in a
planar state when it is removed from the release liner 50 and has
no stresses. When the nasal dilator 10 is bent over the bridge 71
of the nose 70 and the ends 12 and 13 are engaged with the lateral
wall 72 of the nasal passage, then the stresses introduced in the
resilient member 30 cause the ends 12 and 13 of the nasal dilator
10 to pull outwardly and upwardly on the lateral wall 72 to improve
the breathing of the user.
[0059] The nasal dilator 10 in both embodiments can also be
provided as a clear nasal dilator 10. In this case, the top cover
20 is made from a 3 mil polyethylene with the bottom surface 22
coated with 2 mils acrylic hypoallergenic medical grade adhesive
25. The resilient member 30 in both embodiments is made from the
clear polyester and the cushion layer 40 is made from 8 mil
polyethylene with both the top surface 41 and the bottom surface 42
coated with 2 mils acrylic hypoallergenic medical grade adhesive
43.
[0060] Referring to FIGS. 1, 2, 3 and 5 there are four slits 52 in
the top soft fabric cover 20 and the cushion layer 40 at the
boundary of the ends 12 and 13 of the nasal dilator 10 and the
intermediate structure 29 which connects the two ends 12 and 13.
The four slits 52 are shown to be perpendicular to the longitudinal
axis 36 of the nasal dilator 10, and they allow the top soft fabric
cover 20 and the cushion layer 40 to conform to the many different
shapes of the outer wall tissue 73 of the nasal passages 75. In
some cases the slits 52 may be cut at an angle to the longitudinal
axis 36 of the nasal dilator 10.
[0061] The use of a resilient band 30 with a decreasing spring rate
in a nasal dilator 10 has a positive effect on the nasal dilator 10
performance. FIG. 7 shows a comparison of the performance of a
nasal dilator 10 with a decreasing spring rate 60 on the left side
of the vertical centerline 55 and a nasal dilator with a constant
spring rate 80 on the right side of the vertical centerline 55. The
nasal dilator 10 is shown bent over an elliptical surface 56 which
represents the skin 76 of the user's nose 70.
[0062] The nasal dilator 10 with the decreasing spring rate 60 has
a series of vectors 61 pulling out on the elliptical surface 56.
Vectors 61 which are further away from the vertical centerline 55
increase to vector 63. Then they begin to decrease to vector 64 at
the end 12 of the nasal dilator 10. The vectors 61 on the side with
the decreasing spring rate 60 cause the lateral wall 72 to be
pulled up and out at the center of the nasal passage 75, which
improves the air flow in the nasal passage 75. A reactive vector 65
provides an opposing force to vectors 61.
[0063] The right-hand side of FIG. 7 illustrates the forces
generated by a nasal dilator 10 with a constant spring rate 80. It
generates a series of vectors 81 pulling out on the elliptical
surface 56. As the vectors 81 move away from the vertical
centerline 55, they increase until the last vector 83. This means
that the pull on the lateral wall 72 is outward and that the
maximum vector 83 is pulling out on the lateral wall 72 at the edge
of the nasal passage 75. Although air flow is improved, the nasal
dilator 10 with the decreasing spring rate 60 provides better
performance because it opens the lateral wall 72 adjacent to the
center of the nasal passage 75 where the maximum air volume flows.
Also the reactive vector 85 is greater than the reactive vector 65
for the decreasing spring rate 60 nasal dilator 10, which renders
the constant spring rate 80 nasal dilator 10 less comfortable for
the user.
[0064] The description of the preferred embodiment described herein
is not intended to limit the scope of the invention, which is
properly set out in the claims.
* * * * *