U.S. patent application number 10/210570 was filed with the patent office on 2003-01-09 for skin stabilization and nasal dilation system.
Invention is credited to Lockwood, Hanford N..
Application Number | 20030005938 10/210570 |
Document ID | / |
Family ID | 22215757 |
Filed Date | 2003-01-09 |
United States Patent
Application |
20030005938 |
Kind Code |
A1 |
Lockwood, Hanford N. |
January 9, 2003 |
Skin stabilization and nasal dilation system
Abstract
A skin stabilization system is formed from lamination elements
consisting of fabric layers bonded to plastic layers which in turn
are laminated to the outer surface of the user's skin by adhesively
attaching them thereto. The lamination elements resist tension,
compression and bending forces and are used to strengthen or
stabilize the skin to reduce deformation. The lamination elements
can be applied as a single unit or interconnected to other
lamination elements by extending the fabric portions of the
laminate. The skin stabilization system can be used as a nasal
dilator. As a nasal dilator, a lamination element is applied to
each side of the nose between the bridge and the cheek, which in
turn causes the center of the lamination element to lift the soft
outer skin of the nasal passage and prevent any deflection that
restricts breathing through the nasal passages. The fabric portions
of the lamination element can be extended over the bridge of the
nose to interconnect the two nasal dilator lamination elements and
assist the user in properly positioning the elements.
Inventors: |
Lockwood, Hanford N.; (San
Mateo, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Family ID: |
22215757 |
Appl. No.: |
10/210570 |
Filed: |
July 31, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10210570 |
Jul 31, 2002 |
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09329663 |
Jun 10, 1999 |
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60089111 |
Jun 12, 1998 |
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Current U.S.
Class: |
128/848 ;
128/858 |
Current CPC
Class: |
A61F 5/08 20130101 |
Class at
Publication: |
128/848 ;
128/858 |
International
Class: |
A61F 005/56; A61F
009/00 |
Claims
What is claimed is:
1. A structure capable of stabilizing soft skin tissue to prevent
deformation comprising: a lamination structure adapted to
incorporate skin into the structure by attaching the structure to
the skin, the structure including spaced-apart peripheral surfaces
adapted to be attached to the skin in proximity to relatively rigid
supports beneath the skin and a center of the structure between the
peripheral surfaces and adapted to be attached to a portion of the
skin which is relatively soft and movable and disposed between the
rigid supports for stabilizing the soft and movable portion of the
skin, whereby the center of the structure limits deflections of the
skin portion when the structure is applied to the skin.
2. A structure according to claim 1 wherein one of the peripheral
surfaces is adapted for attachment to skin proximate a bridge of a
nose, the other one of the peripheral surfaces is attached to skin
overlying a cheekbone, and the center of the structure is adapted
to be attached to a soft lateral wall external to an associated
nasal passage, whereby the structure acts as a nasal dilator.
3. A structure according to claim 1 including attachment means for
attaching the laminated structure to skin.
4. A nasal dilator as claimed in claim 2 wherein the lamination
structure is configured to fit the contour of the nose by
correspondingly deflecting the structure, and wherein the
structure, when deflected and applied to the nose, causes
compressive forces between the peripheral surfaces and skin
overlying the bridge of the nose and skin overlying the cheekbone,
thereby causing a lifting force on the lateral wall external to the
nasal passage which is equal and opposite to the compressive
forces, thereby causing the dilation of the nasal passage.
5. A method of stabilizing skin tissue comprising the steps of
providing a stabilizer having first and second end portions
separated from each other in a longitudinal direction of the
stabilizer; positioning the stabilizer over a skin tissue;
resiliently deforming the stabilizer so that each of the end
portions applies a first force directed towards the skin tissue and
a section of the stabilizer intermediate the end portions applies a
second force to the skin tissue in a direction away from the skin
tissue; and attaching the resiliently deformed stabilizer to the
skin tissue.
6. A method according to claim 5 wherein the step of deforming
comprises deforming the stabilizer so that a side thereof facing
the skin tissue is convexly shaped.
7. A method according to claim 6 wherein the step of attaching
comprises positioning the center section over skin tissue
comprising a nasal wall.
8. A method according to claim 7 wherein one of the end portions is
attached to skin tissue proximate a cheekbone and another one of
the end portions is attached to skin tissue proximate nasal
cartilage on a side of a nose bridge.
9. A method according to claim 5 including the step of giving the
stabilizer a curvature in the longitudinal direction prior to the
step of positioning to thereby increase the forces generated by the
stabilizer following the step of attaching it to the skin
tissue.
10. A nasal dilator for dilating a first nasal passage extending
along a nasal wall located between nasal cartilage extending from a
bridge of a nose along a side of the nose and a cheekbone, the
dilator comprising a resiliently deformable sheet having a length
so that it extends along the nasal wall from proximate the nasal
cartilage to proximate the cheekbone, and an adhesive layer applied
to a side of the sheet which faces the nasal wall when the dilator
is applied to the nasal wall, whereby the sheet, upon adhesively
attaching the dilator to the nasal wall so that its ends are
proximate the nasal cartilage and the cheekbone, generates first
forces which urge the end portions towards the skin tissue and a
second force generated in a mid-section of the sheet intermediate
the end portions thereof which urges the nasal wall away from the
nasal passage.
11. A nasal dilator according to claim 10 comprising a laminate
formed by the sheet, a top cover overlying and adhesively attached
to a side of the sheet opposite the side thereof which carries the
adhesive layer, and a cushion layer disposed between the sheet and
the adhesive layer and adhesively secured to the other side of the
sheet.
12. A nasal dilator according to claim 11 wherein the top cover and
the cushion layer extend beyond a periphery of the sheet.
13. A nasal dilator according to claim 12 wherein portions of the
top layer and the cushion layer extending beyond the periphery of
the sheet include adhesive securing them to each other.
14. A nasal dilator according to claim 13 wherein the top cover,
the sheet, the cushion layer and the adhesive layer are
translucent.
15. A nasal dilator according to claim 13 wherein the top cover,
the sheet, the cushion layer and the adhesive layer are
transparent.
16. A nasal dilator according to claim 10 for additionally dilating
a second nasal passage in addition to dilating the first nasal
passage, the dilator comprising an additional resiliently
deformable sheet for adhesively attaching it to a nasal wall
proximate the second nasal passage, and including a connector
attaching the sheets to each other.
17. A nasal dilator according to claim 16 wherein the connector is
elongated and formed to extend over the bridge of the nose when the
sheets are adhesively attached to the respective nasal walls.
18. A nasal dilator according to claim 17 wherein the connector is
constructed of a readily deformable material.
19. A nasal dilator according to claim 18 including an adhesive on
a side of the connector facing the nose.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to a new field of devices which can
be derived from lamination elements consisting of fabric materials
bonded to layers of plastic which are resistant to tension,
compression and bending forces. The lamination elements when
properly applied by the user include a layer that integrates the
outer surface of skin into the lamination element. The lamination
element with its ability to resist these forces is used to
strengthen or stabilize the skin in a way that reduces deformation
and can strengthen or reinforce soft skin tissue to prevent
deformation under some conditions.
[0002] One use of such a skin stabilizing lamination element is to
prevent deformation of the soft tissue (as used in this
application, typically referring to soft tissue, including the
overlying skin) external to a nasal passage on the side of the
nose. A lamination element can be applied on one side of the nose
between the bridge of the nose and the cheek, which in turn causes
the center of the lamination to hold the soft outer tissue of the
nasal passage and prevent any deflection that restricts breathing
through the respective nasal passage. A similar but opposite-shaped
lamination element is required on the opposite side of the nose to
stabilize the outer tissue of the second nasal passage.
[0003] Blockage of the nasal passages for reasons such as 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.
[0004] 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.
[0005] 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 tissue 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.
[0006] The external structure of the nose consists of tissue and
skin covering 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 tissue 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.
[0007] As an alternative to surgery, the structure of the nose and
the prior art leave two alternatives for the design of nasal
dilators. One alternative is the type of dilator that consists of a
tube or structure which can be inserted into the nasal passage to
hold it in the open position allowing the free passage of air. The
disadvantage of 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.
[0008] The second alternative is a dilator design where each end
that attaches to the external lateral wall of each of the nasal
passages has a resilient member connecting the ends for generating
an external pulling force on the lateral wall to thereby open the
nasal passage. The advantage of this design over the first
alternative is that the nasal passages are not disturbed by an
internal insert. However, this second alternative permits only
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.
[0009] The present invention differs from prior art systems in that
it is a laminated skin stabilizer that locally stabilizes the
lateral wall of the nasal passage. The lamination element adheres
to the skin at the bridge of the nose at one end and to the skin
adjacent to the cheekbone structure on the other end. It stabilizes
the lateral wall tissue where it adheres to the soft skin external
to the nasal passage. The ability of the lamination element to
resist tension, compression and bending forces prevents deformation
of the soft tissue of the lateral wall and promotes easier
breathing.
[0010] In the prior art, there are items, such as bandages, tapes,
and splints, which have some characteristics of a laminated skin
stabilization system. Bandages and tapes have adhesives which stick
to the skin; however, they cannot resist compression and bending
loads. Splints, on the other hand, do not adhere to the skin, but
have the rigid structure required to resist compression, tension,
and bending loads. Splints are usually attached to the skin using
tape which is independent of the splint structure itself.
[0011] The prior art that comes closest to the present invention
are the nasal dilators disclosed in patents to Muchin, Johnson, and
Deubek et al, which are all limited to placing resilient members
over the bridge of the nose and which function very differently
from the present invention.
[0012] The development of nasal dilators goes back to U.S. Pat. No.
701,538, which was filed Sep. 16, 1901, teaches a dilator that fits
within the nasal passages, and functions like the above-described
first alternative. Many of the devices that fit this alternative
are not only used as nasal dilators, they also teach methods for
filtering air or providing a platform for releasing medication
which is entrained in the air passing through the device located in
the nostril. U.S. Pat. Nos. 1,256,188 to Wilson, 2,055,855 to
Weaver, 2,264,153 to Rowe, 2,277,390 to Crespo, 2,674,245 to
Tanditter, 2,715,904 to Hill, 3,905,335 to Kapp, 3,935,859 to
Doyle, 4,201,217 to Slater, 4,221,217 to Amezcua, 4,267,831 to
Aguilar, 4,327,719 to Childers, 4,414,977 to Rezakhany, and
5,479,944 to Petruson are all examples of devices which either
dilate, medicate or filter by inserting the device inside the
nostril.
[0013] U.S. Pat. No. 5,479,944 to Petruson is of particular
interest in the group, because it has tabs which insert in each
nostril which are connected to a resilient member located between
them which is deformed into a curved shape when the tabs are
inserted in each nostril. The single resilient member curves around
the end of the nose clearing the septum and provides a biasing
force to the tabs forcing them against the outer wall of each
nostril, thereby causing each nostril to be opened further. This
design has disadvantages over the present invention, in that the
tabs in contact with the sensitive surface on the inside of the
nostril can cause discomfort to the user. The tabs cannot be
located far up into the vestibule or even further up to the nasal
valve, so that this type of nasal dilator is of limited
effectiveness. Because of the location of the tabs in the nasal
passages, the Petruson dilator will interfere with any attempt by
the user to clear nasal congestion. Also the biasing force is fixed
by the design and size of the connecting member and is not
adjustable by the user.
[0014] The second alternative is the dilator design which attaches
to the outside surface of the nasal lateral walls and has a
resilient member for generating a pull force on the lateral walls
of the nose. An example of this type of nasal dilator is U.S. Pat.
No. 1,292,083 to Sawyer, which has two pads with metal loops that
are attached to the outside of the nasal passages above the nostril
on each side of the nose with an adhesive. A resilient member is
attached to the pads and exerts a pulling force on them, thereby
causing the nasal passage to be dilated. U.S. Pat. No. 1,950,839 to
Chirila is similar to the Sawyer patent except that Chirila uses
suction cups instead of adhesive pads. In both instances, the
resilient member is a single metal spring and the resilient force
is determined by the size and spring rate of the resilient member.
These designs are difficult to fit and can cause injury to the user
if the resilient member should come loose. This would be a
significant problem for a user who is asleep and moves, causing the
resilient member to become dislodged.
[0015] Patents which are part of the second alternative include
U.S. Pat. No. 5,546,929 to Muchin and Spanish Patent 289,561 issued
to Miguel Angel Aviles Iriarti. Generally speaking, they teach that
a single resilient member, or spring, made from a flat piece of
plastic extends over the bridge of the nose to the lateral wall and
is covered by a pad with adhesive material that extends around the
spring member. The spring is inset centrally in the pad, and the
pad is located over the nose bridge and adheres to the outside of
the nasal passages. This enables the respective ends of the spring
to apply a pulling force on the outside of the soft tissue of the
nose, thus dilating the nasal passages.
[0016] A similar dilator is disclosed in U.S. Pat. No. 5,476,091 to
Johnson, except that in the case of the Johnson patent the single
plastic resilient member is replaced by two parallel but not
connected resilient members that provide the spring force to pull
on the nasal valve external wall. The Johnson patent has a top and
bottom pad to contain the resilient members which also have notches
at each end to reduce delamination forces on the dilator. The
dilator of the Johnson patent forms a truss which has a flexible
strip material that defines the first and second end regions and an
intermediate segment. The first and second resilient bands extend
over the length of the truss and generate a force when the end
regions are attached to the skin which lifts the underlying tissue
upwardly and thereby dilates the nasal passages.
[0017] U.S. Pat. No. 5,533,499 to Johnson is a variation of the
dilator shown in U.S. Pat. No. 5,476,091. It teaches that two
parallel but not connected resilient members are mounted on a
single base pad. Each of the end regions of the nasal dilator are
adhesively fixed to the external walls of the nasal passages, while
the interconnecting truss member passes over the bridge of the
nose. The nasal strip configuration of the '499 Johnson patent
turned out to be difficult to fabricate and subject to delamination
of the resilient members.
[0018] U.S. Pat. No. 5,533,503 to Deubek et al is a further
development of the nasal dilator disclosed in the two Johnson
patents discussed above. Deubek has two parallel but not connected
resilient members that are mounted between top and bottom pads.
This patent discloses a new pad configuration at each end of the
dilator which is designed to improve the ease of manufacture and
prevent delamination of the resilient members. The dilator of
Deubek also has a truss with pads at each end and an intermediate
section that bends over the bridge of the nose. The resilient
members generate a force which pulls on the lateral wall, causing
the nasal passage to open.
[0019] U.S. Pat. No. 5,553,605 to Muchin is related to U.S. Pat.
No. 5,546,929 of the same inventor. The '605 patent describes the
same nasal dilator design shown in 5,546,929, except that the nasal
dilator is transparent. It also has a single resilient member that
crosses over the bridge of the nose and terminates in two pads that
attach to the lateral wall on each side of the nose.
[0020] The Spanish patent, the two Muchin patents, the two Johnson
patents, and the Deubek et al patent all have a single band that
crosses the bridge of the nose which contains the resilient member.
The Spanish patent and the Muchin patents use a single resilient
member, while the Johnson and Deubek et al patents have two
parallel but not interconnected resilient members contained in a
single truss passing over the bridge of the nose. The spring rate
in all these dilators is determined by the design of the resilient
member and is set during the manufacture of the nasal dilator.
[0021] The present invention teaches about lamination elements
resistant to tension, compression and bending forces which can be
used as an improved nasal dilator. The lamination element of the
present invention works in a manner that is opposite to the manner
in which the nasal dilation systems of the Spanish, Muchin,
Johnson, and Deubek et al patents work.
SUMMARY OF THE INVENTION
[0022] This invention relates to a new field of devices which can
utilize lamination elements alone or in combination to stabilize
skin, so it can resist deformation caused by external forces. The
lamination elements are made up of fabric materials permanently
bonded to a thin, resilient layer of plastic which resists tension,
compression and bending forces. The lamination element is
permanently bonded to a cushion layer located beneath the plastic
layer. The lamination element also includes a layer that integrates
the outer surface of skin into the lamination element when properly
applied by the user. The lamination element uses its resistance to
tension, compression and bending to stabilize the skin beneath the
center of the lamination element from deflection due to forces
acting on the tissue.
[0023] The lamination elements are small in size and made up of a
top or fabric layer, a plastic layer, a cushion layer, and the skin
layer. Each layer of the laminate is bonded to its adjacent layer
with a permanent adhesive, with the exception of the bond between
the cushion and the skin, which is a strong, but temporary bond.
Each level or layer of the laminate can either have the same
dimensions or be a different size than the adjacent level. This
allows different levels to accomplish different functions, the
plastic layer being the most important element of the laminate.
[0024] The plastic layer provides the structure that resists
tension, compression and bending forces. The plastic layer can be
from 0.005 inch to 0.030 inch thick and is typically up to 1.5
inches long. In a preferred embodiment, the width of the plastic
layer is between about 0.125 inch to about 0.5 inch, depending on
the application. The plastic layer may be solid, may have some
porosity, or may have a hole pattern to provide for the ventilation
of air and moisture from the skin through the lamination element.
The opposite sides of the plastic layer are generally parallel;
however, in some cases, the sides may not be parallel, and the
plastic layer can have another, e.g. triangular, shape.
[0025] Between the plastic layer and the skin is a cushion layer
which cushions the skin from the plastic layer. The cushion layer
is made from woven polyester or equivalent and provides relief from
the rigidity in the plastic layer.
[0026] The top of the lamination element is preferably made from
woven, stretchable synthetic fabric or the like. The top layer is
bonded to the plastic layer and is used to interconnect multiple
lamination elements, depending on how they are being applied. The
most common interconnection is to connect the lamination elements
end-to-end. The stretchable top cover allows the user to adjust the
distance between adjacent lamination elements to properly position
them on the user's nose.
[0027] In a preferred embodiment, the lamination element is used to
stabilize the soft tissue forming the lateral wall of the nasal
passage to perform the functions of a nasal dilator. In this
application, the lamination element is applied so that one of its
ends adheres to the skin which covers the cartilage on the side of
the bridge of the nose. The other end of the lamination element is
positioned on the skin at the cheekbone where the bone provides
support for the skin. The center section of the lamination element
is pushed against and adheres to the soft tissue of the nasal wall
between bridge cartilage and the cheekbone. This resiliently
deforms the plastic layer and generates a force that stabilizes the
lateral nasal wall, thereby pulling it outwardly and opening the
nasal passage. A second and opposite-shaped lamination element is
installed on the adjacent lateral wall of the other nasal
passage.
[0028] Users of the lamination element for stabilizing the lateral
wall of the nasal passage will normally use one on each side of the
nose. To aid the person in positioning the respective lamination
elements, the external fabric layer is preferably extended to
connect the two lamination elements end-to-end. This fabric layer
is readily deformable, e.g. flexible, acts as a positioner, and can
be stretched to assist in properly locating the two lamination
elements which stabilize the nasal walls.
[0029] The specific elements of the design of the adjustable nasal
dilator are shown in the attached drawings and description of the
preferred embodiment.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] FIG. 1 is an exploded view of a lamination element used as a
nasal dilator;
[0031] FIG. 2 is a view of a lamination element used as a nasal
passage dilator;
[0032] FIG. 3 is a view of two lamination elements linked
end-to-end for use as a nasal passage dilator;
[0033] FIG. 4 is a view of a single lamination element located on
the user's nose;
[0034] FIG. 5 is a sectional view through FIG. 4 showing the
application of the lamination element;
[0035] FIG. 6 is a view of two lamination elements linked
end-to-end located on the user's nose; and
[0036] FIG. 7 is a sectional view through FIG. 6 showing the
application of two lamination elements.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0037] Referring to FIG. 1, a lamination element 10 is made up of a
top cover 15 which is bonded to a thin plastic layer 20 which in
turn is bonded to a bottom cushion layer 25 that is attached to the
user's skin 30 when the skin stabilization system of the present
invention is in place. The lamination element 10 stabilizes or
strengthens skin with its ability to resist tension, compression
and/or bending forces. Top cover 15 of the lamination element 10 is
made from a woven polyester or equal and on its bottom side 18 has
an adhesive 16 which is a 3 mils acrylic hypoallergenic medical
grade pressure sensitive type or equal. The adhesive 16 may or may
not cover the entire surface of the top cover 15, depending on the
shape of the lamination element 10 and its use. The top cover 15
also has a top surface 17 which can be either the natural color of
the fabric material or have a specific color added through dying or
printing processes. The top surface 17 can also have printed
designs or carry promotional symbols printed on or otherwise
applied to it.
[0038] A plastic layer 20 is laminated to the bottom surface 18 of
the top cover 15. The plastic layer is made from a polyester sheet
or equal and will typically vary in thickness from about 0.010 inch
to about 0.050 inch. Plastic layer 20 is generally rectangular in
shape and typically has a length from about 0.5 inch to about 1.50
inches and a width that can vary from about 10% to about 60% of the
length of the plastic layer. The plastic layer has two long edges
21 and 22 which are generally parallel; however, when useful for a
given application, long edges 21 and 22 may be angled in relation
to each other. Plastic layer 20 has two short edges 23 and 24 which
are generally at an angle to each other. When useful, short edges
23 and 24 can be parallel to each other, defining ends which are
parallel. Plastic layer 20 can be designed to allow air and
moisture to pass through it. This is achieved with perforations 40
that pass through the plastic layer 20 or by making the plastic
layer 20 from a plastic material that has a porous structure which
allows air and moisture to pass through it. The plastic layer is
generally smaller than top cover 15 and is normally recessed from
the edge of the top cover. If useful for a given application,
plastic layer 20 can have a long edge 21 or a short edge 23 which
can be located at the respective edge of the top cover 15. The
plastic layer also can be made from transparent plastic for use in
a transparent nasal dilator design.
[0039] Plastic layer 20 and top cover 15 are both laminated to a
cushion layer 25. Since plastic layer 20 is normally smaller than
top cover 15, the excess surface of the top cover 15 is directly
laminated to cushion layer 25. The cushion layer prevents direct
contact between the plastic layer 20 and the skin 30. Cushion layer
25 generally has the same shape as top cover 15. The cushion layer
is made from a woven polyester or equal and has a bottom surface 26
which carries a 3 mils acrylic hypoallergenic medical grade
adhesive 41. Cushion layer 25 has a top surface 27 which has a 1.5
mils acrylic hypoallergenic medical grade adhesive 41 to form a
lamination when in contact with bottom surface 22 of plastic layer
20 and bottom layer 18 of top cover 15. The lamination element 10
is fully functional when the cushion layer 25 is adhesively
attached and thereby laminated to the user skin 30 by the medical
grade adhesive 41 on bottom side 26 of the cushion layer. Depending
on the specific use of the lamination element 10, the adhesives on
the bottom side 26 or top side 27 of the cushion layer 25 may or
may not completely cover the bottom surface 26 or top surface 27,
respectively, of the cushion layer. FIG. 2 shows a single
lamination element 10 on which a release liner 48 protects the
adhesive 41 on bottom side 26 of cushion layer 25 during storage
and shipment.
[0040] The lamination element 10 makes the user's skin 30 part of
the overall lamination to perform its function of stabilizing the
user's skin 30 by resisting tension, compression and/or bending
forces. The lamination element 10 stabilizes the soft tissue
between two or more skin 30 surface areas supported by bone or
cartilage, e.g. the wall of the nasal passages.
[0041] FIG. 3 shows two lamination elements 10 which have been
joined end-to-end by an end-to-end link 35 consisting of an
extension 45 of top cover 15 laminated to an extension 46 of
cushion layer 25. The end-to-end link 35 is used to position one
lamination element 10 in relation to the second lamination element
10 to assist in properly positioning both ends of the nasal dilator
assembly, which is typically made up of more than one, i.e. two,
lamination elements 10. The two lamination elements 10 are attached
to a release liner 48 which protects the adhesive 41 on the bottom
of the cushion layer prior to the application of the lamination
elements 10 to the user's skin 30. The release liner 48 is
discarded by the user prior to the application of the skin
stabilization system.
[0042] FIG. 4 shows a single lamination element 10 in use as a
nasal dilator 60. The nasal dilator 60 consists of a top cover 15
laminated to a plastic layer 20 which is laminated to the cushion
layer 25 and, when installed, is effectively further laminated to
the skin 30 on the side of the nose 65. Top cover 15 and cushion
layer 25 of nasal dilator 60 extend beyond the plastic layer 20. A
first dilator end 61 is laminated, e.g. adhesively attached, to the
user's skin 30, where it is reinforced and supported by cartilage
67 located on the side of a bridge 70 of the user's nose 65. The
other, second end 62 of the dilator is laminated to the user's skin
30, where it is reinforced and supported by cheekbone 69 which
terminates adjacent to nose 65. With the nasal dilator 60 laminated
to portions of the user's skin 30 supported by either bone or
cartilage, a center section 58 of the dilator is adhesively
attached and thereby laminated to a soft lateral wall 71 of a
nostril 66 where the ability of the plastic layer 20 to resist
bending stiffens the lateral wall 71, thereby preventing it from
being drawn in when the user inhales, thus facilitating the
breathing of the user.
[0043] FIG. 5 shows the appearance of nose 65 before the nasal
dilator is applied to lateral wall 71 when the nasal passage 76 at
the left side 75 of the septum 73 is restricted. The nasal dilator
60 is shown as it is positioned before it is laminated to the
lateral wall of the nose. Prior to deflection of the plastic layer
20, there is a gap 91 between center section 58 and the soft
lateral nose wall 71. The size of the gap is shown by arrows 90 in
FIG. 5. The right side 80 of septum 73 shows the nasal dilator
properly laminated to lateral wall 71 of nose 65, thereby
eliminating gap 91 and causing the restricted nasal passage 76
(dashed line) to expand outwardly.
[0044] The nasal dilator 60 becomes deflected from its relaxed,
flat configuration when it is properly applied and positioned to
laminate it to the lateral wall of nasal passage 66. The expansion
of the nasal passage 81 is due to the force from the resiliently
deflected plastic layer 20 of the dilator pulling outwardly on the
soft tissue forming lateral wall 71. Force vector arrows 85 and 86
show the direction of force applied to the nose 65 by the nasal
dilator 60 when it is installed. At the first and second ends 61,
62, force vector arrows 85 push against the skin and subject it to
a compression force. Cartilage 67 and cheekbone 69 support skin 30
against this compression force. In addition, the force urges the
first and second ends of the nasal dilator against the skin,
thereby preventing an accidental separation of the dilator ends
from the skin and maintaining a secure connection. At the same
time, the force vector arrow 86 at the center of the nasal dilator
60 exerts a lifting force on lateral nose wall 71 which causes the
lateral wall to move from the dashed line to its new, dilated
position shown on the right side 80 in FIG. 5.
[0045] FIG. 2 shows a single nasal dilator 60 which can be used on
one nostril 66. FIG. 3 shows a nasal strip or dilator 100 which
dilates both nasal passages. It is made from two lamination
elements 10 that have been joined end-to-end by end-to-end link 35
consisting of an extension 45 of the top cover 15 laminated to an
extension 46 of the cushion layer 25. The end-to-end link 35 passes
over the bridge 70 of the nose 65 to assist the user in positioning
each of the lamination elements 10 that make up dual nasal dilator
100. The end-to-end link 35 made up of the extension 45 of the top
cover 15 and the extension 46 of the cushion layer 25 forms an
elastic, readily deformable connection between the two lamination
elements 10 of dual nasal strip 100. When the dual nasal strip is
to be applied to the nose 65, the user can stretch the end-to-end
link 35 over the bridge 70 of the nose 65 to properly position each
of the lamination elements 10 over their respective lateral walls
71 on each side of the nose 65.
[0046] FIGS. 6 and 7 show how the dual nasal strip 100 is installed
on the user's nose 65. On the side 75 of the septum 73, the dual
nasal strip 100 is shown as it looks prior to being laminated to
the lateral wall 71. The restricted nasal passage 76 shows the
reduced area that inhibits breathing. Right side 80 of the septum
73 shows dual nasal strip 100 properly laminated to lateral wall 71
of the nose 65, causing restricted nasal passage 76 (dashed line)
to expand to the open nasal passage 81 because the resilient force
generated by plastic layer 20 of the nasal strip pulls the soft
tissue lateral wall 71 outwardly. The force vectors show the
direction of force applied to the nose 65 by one of the two
lamination elements 10 which make up the dual nasal strip 100 when
it is installed. At the first and second ends 61, 62, the force
vectors 85 apply a compression force against skin 30 supported by
cartilage 67 and cheekbone 69. At the same time, force vector 86 at
the center section of the lamination element 10 applies a lifting
force on the lateral nose wall 71 which causes it to move from the
dashed line to its dilated position shown on the right side 80 in
FIG. 7.
[0047] Tests have been performed to establish the dilating forces
on the lateral wall 71 of the nose 65. By deflecting the plastic
layer 20 by the depth of the gap 91, the resulting lifting force on
the lateral wall 71 can be established. The lifting force is
represented by the force vector arrow 86 at the center of the
lamination element 10. The lifting force results in equal but
opposite compression forces which are represented by force vector
arrows 85 at the first and second ends 61, 62 of the lamination
element. The tested lamination element had a plastic layer 20 made
of 0.020 inch thick polyester sheet, a width of 0.4 inch and a
chord length (along the centerline of the plastic layer) of 1.050
inches. The results shown are the average results of repeated tests
to establish the force levels:
1 Lamination Element 10 Lifting Force Compression Force Deflection
91 Vector 86 Vector 85 .03125 inch 35.44 grams 17.72 grams .0625
inch 81.31 grams 40.66 grams .09375 inch 131.17 grams 65.59
grams
[0048] The compression forces are half of the lifting forces on the
lateral wall 71 of the nostril 66. This makes the dual nasal strip
100 much more comfortable for the user than nasal strips made
according to the prior art. As the lifting force vector 86 is
applied and lateral wall 71 expands outwardly in response, the
lifting force vector 86 diminishes until an equilibrium is
achieved. The dual nasal strip 100 only applies the lifting force
vector 86 required to stabilize the lateral wall 71, thereby
further contributing to the user comfort.
[0049] The dual nasal strip 100 can be fabricated using a
transparent top cover 15 and a transparent cushion layer 25 which
can be made of a transparent perforated polyethylene or
polyurethane. The top cover 15 has hypoallergenic medical acrylic
pressure sensitive-type adhesive 16 or equal on the bottom side 18.
The cushion layer 25 carries an acrylic hypoallergenic medical
grade adhesive 41 on the top surface 27 and the bottom surface 26.
At the same time, the plastic layer 20 can also be made from
transparent plastic for use in a transparent dual nasal strip 100
design.
[0050] 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.
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