U.S. patent application number 14/752251 was filed with the patent office on 2015-10-15 for method and structure for nasal dilator.
This patent application is currently assigned to Liberman Distributing and Manufacturing Co., d/b/a Lidco Products ("Lidco"), Liberman Distributing and Manufacturing Co., d/b/a Lidco Products ("Lidco"). The applicant listed for this patent is Liberman Distributing and Manufacturing Co., d/b/a Lidco Products ("Lidco"), Liberman Distributing and Manufacturing Co., d/b/a Lidco Products ("Lidco"). Invention is credited to David Gray, Mark A. Litman.
Application Number | 20150290021 14/752251 |
Document ID | / |
Family ID | 45400274 |
Filed Date | 2015-10-15 |
United States Patent
Application |
20150290021 |
Kind Code |
A1 |
Gray; David ; et
al. |
October 15, 2015 |
Method and Structure for Nasal Dilator
Abstract
A nasal dilator and method of making nasal dilators are
provided. The dilator may have a composite base element of at least
two regions, the base element having an outer surface and an inner
surface, the inner surface of the base element having a
pressure-sensitive adhesive disposed thereon; the base element
further including a spring element which imparts return memory into
the base element so that the base element returns towards a planar
conformation during use. The spring element has elastic memory
effected by differential properties in the at least two
regions.
Inventors: |
Gray; David; (St. Paul,
MN) ; Litman; Mark A.; (Edina, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Liberman Distributing and Manufacturing Co., d/b/a Lidco Products
("Lidco") |
St. Paul |
MN |
US |
|
|
Assignee: |
Liberman Distributing and
Manufacturing Co., d/b/a Lidco Products ("Lidco")
St. Paul
MN
|
Family ID: |
45400274 |
Appl. No.: |
14/752251 |
Filed: |
June 26, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13175024 |
Jul 1, 2011 |
9095422 |
|
|
14752251 |
|
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|
61398949 |
Jul 2, 2010 |
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Current U.S.
Class: |
606/204.45 |
Current CPC
Class: |
A61F 5/08 20130101; B29L
2031/753 20130101; B32B 27/08 20130101; B32B 2535/00 20130101; A61F
5/56 20130101; B29K 2067/003 20130101; B29C 48/21 20190201; B32B
27/36 20130101; B29C 61/02 20130101; B29C 48/08 20190201; A61F
2005/563 20130101 |
International
Class: |
A61F 5/08 20060101
A61F005/08 |
Claims
1. A laminated material having a longitudinal length and a
longitudinal width, the laminated material comprising: a first
material comprising a heat activated polyester shrink film
laminated to a second material comprising a polymeric film, wherein
the first material and second material have differing shrink
properties when exposed to heat such that the first material, upon
heat activation, shrinks at a greater ratio than the second
material; wherein said heat activation occurs above ambient
temperature; wherein the longitudinal length of the laminated
material has a curvature in the shape of an arc about the
longitudinal width, wherein the shape of the arc is induced by
cooperation between the first material and second material upon
heat activation of the first material, and wherein the first
material is on the concave side of the arc and the second material
is on the convex side of the arc.
2. The laminated material of claim 1, wherein the heat activated
polyester shrink film is a heat activated polyethylene
terephthalate shrink film.
3. The laminated material of claim 1, wherein the second material
comprises polyester.
4. The laminated material of claim 3, wherein the polyester is
polyethylene terephthalate.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/175,024 filed Jul. 1, 2011 which claims the
benefit of U.S. Provisional Application No. 61/398,949 filed on
Jul. 2, 2010. The entirety of each of these applications is hereby
incorporated by reference for all purposes.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to the field of nasal patches
or nasal dilators that assist in keeping the exterior nasal
passages open to assist in breathing and/or avoiding snoring. A
process, structure, and composition of elements which assist in
providing necessary or useful properties for the nasal dilator are
provided.
[0004] 2. Background of the Art
[0005] Nasal Dilators
[0006] Nasal dilators for opening nasal passages are known in the
art. These nasal dilators are generally strips fabricated from
multiple and separate components including a structural materials
such as a woven material having an adhesive on one side for
adhering to the nose and surrounding skin, a resilient member, and
a backing. When adhered to the nose, the nasal dilators are
designed to affect the opening of the nasal passages, providing
relief for a wearer who may be experiencing difficulty in breathing
or seeking to increase air flow through the nasal passages.
[0007] To accomplish this effect, prior art nasal dilators
generally rely on the elastic or resilient member's ability to
stabilize the nasal passages and reduce or prohibit nasal passage
collapse or closing during breathing. When the strip is positioned
across the nose, the resilient members operate as flexible,
spring-like bands which desire to return to a more planar position,
resulting in the lifting of the outer wall tissue of the nasal
passage. As a result of this lifting, the collapsing or closing of
the nasal passage openings during breathing is reduced.
[0008] As shown in FIG. 1, a typical prior art nasal dilator 100 is
generally sized to fit across the nose of the wearer so as to
engage the outer wall tissue of the left and right nasal passages.
As shown in FIGS. 2-3, these nasal dilators 100 may include an
elongated base substrate layer 30 having a pair of longitudinal
sides, a pair of transverse ends and top and bottom surfaces
thereon. The bottom surface of the base substrate layer 30
generally contains an adhesive layer 32 for permitting easy
attachment to the wearer's skin. Nasal dilators of the prior art
often utilize a separately manufactured resilient member 60
attached to the base substrate layer 30 during assembly. This
resilient member 60 provides a gentle expanding force to the nasal
wall tissue when the dilator is adhesively attached to the nose.
Typically, the dilator 100 further includes a top or backing layer
40. The top or backing layer 40 and resilient member 60 are
generally bonded to the substrate base layer 30, for example, by
using pressure sensitive adhesive layers 42 and 62 during
assembly.
[0009] In some embodiments, nasal dilators of the prior art further
include, for example, an aromatic substance 50, such as a fragrance
or aromatic stimulant or medication, disposed on a portion of the
dilator so as to be inhaled through the nose of the wearer during
breathing. Additionally, a substance that can be transdermally
provided to the patient to effect a local biochemical result may
also be included. The substance can be added to the bottom surface
of the dilator 100, with, or without an aromatic substance.
[0010] Finally, a release liner or release paper strip 10, such as
polymeric coated (e.g., silicone or fluorinated polymer) or wax
coated kraft paper, is generally added over the pressure sensitive
adhesive layer 32 prior to packaging the dilator 100 for sale.
[0011] Due to this design, a typical prior art nasal dilator
requires using separate multiple components, manufacturing each
component in a separate step, and then assembling the device in a
multiple step process. Furthermore, the separate resilient member
used in the typical nasal dilator tends add bulk to the nasal
dilator.
[0012] U.S. Pat. No. 5,533,503 (Doubek at al.) describes a nasal
dilator composed of a separate base substrate material, multiple
separate resilient members comprised of plastic materials, separate
flexible strips of adhesive materials, and a separate top or
backing material. Accordingly, the manufacture of the nasal dilator
is described as requiring the interface adhesive materials to be
first laminated to the resilient band members, and then the top
material laminated to the base material over the resilient band
member.
[0013] U.S. Pat. No. 5,890,486 (Mitra) describes a multiple
component nasal dilator having a separate base or substrate
material, an intermediate segment, single or multiple resilient
band members, adhesive strips, a thermal element, and a top or
backing material. The resilient band members are described as being
metal and/or plastic, and preferably industrial grade, oriented
bi-axially oriented polyester that is approximately 2 mm to 8 mm
wide and 0.25 mm thick. In alternative embodiments, the metal or
plastic resilient band members are described as being formed within
the base or top material through an extrusion process. The nasal
dilators are described as being manufactured by bonding the base
material to the top material, thereby encapsulating the resilient
members, strips of adhesive materials, and thermal element in a
unified structure.
[0014] U.S. Pat. No. 6,244,265 (Cronk et al.) describes a multiple
component nasal dilator wherein separate substrate materials,
resilient members, and backing materials are adhesively joined
together as they are fed into an overlapping position in a die or
roller. Adhesive layers are used to join the backing layer,
resilient member and elongated substrate together prior to
die-cutting to form the final periphery of the dilator. The
described nasal dilators further include medications and/or
fragrances disposed in or on the backing and/or substrate
material.
[0015] U.S. Pat. No. 6,769,429 (Benetti) discloses a nasal dilation
device that includes a single, integral strip of flexible resilient
material having a central portion for positioning over and in
engagement with the top of an individual nose and opposed end
portions including independently flexible upper and lower finger
elements diverging from one another. The resilient material is
described as a single clear plastic material in a thickness range
of from about 0.2 mm to about 0.6 mm. Separate adhesive tape
elements overlie the end portions for releasably securing the end
portion to opposed sides of the individual's nose.
[0016] U.S. Pat. No. 6,694,970 (Spinelli et al.) describes a
multi-component nasal dilator that includes a base material having
an adhesive on one surface for applying the strip across a human
nose and at least one biasing or resilient member attached or
embedded in the strip, wherein the biasing or resilient member is
fabricated from a material, preferably metal, which exhibits a
shape memory effect upon being heated toward a human body
temperature, preferably by the heat of the nose. The biasing or
resilient member is described as having a shape upon being heated
toward the human body temperature that results in the material
reverting to austenite and then recovering its previous shape,
which biases the nasal passages of the human nose toward an open
position.
[0017] U.S. Pat. No. 7,114,495 (Lockwood) describes a multiple
component, multi-layer nasal dilator capable of introducing
separating stresses in nasal outer wall tissues having a resilient
band member, which is symmetrical with respect to a centerline of
the truss that is perpendicular to the long axis of the truss, with
a spring rate which continuously diminishes from the centerline to
the end surfaces. An adhesive on the end surfaces adhesively
engages exposed surfaces of nasal outer wall tissues sufficiently
to keep the truss attached to the nasal wall surfaces while
subjecting them to the restoring forces. The nasal dilator also
includes a top or backing layer, and a cushion layer designed to
prevent direct contact between the resilient band member and the
skin of the user.
SUMMARY OF THE INVENTION
[0018] The present invention is a nasal dilator made from a
composite material that provides shape memory and resiliency,
wherein the nasal dilator comprises one of the following three
embodiments: 1) a composite base element comprising at least two
distinct regions; 2) a coextruded composite base element comprising
at least two materials; or 3) a laminate composite base element
comprising at least two materials; wherein at least one of the
materials or distinct regions has at least one differing chemical
or physical property from the other, and the interaction of the at
least two materials or distinct regions creates a spring-like
element in the base element which imparts resiliency into the base
element and provides the base element with return memory properties
towards a planar conformation. In a preferred embodiment, the
composite material is the only structural material used in the
nasal dilator, and is not part of a type of multicomponent
structure as described in the prior art in the Background of the
Invention. The use of composite material can allow the device to be
lighter and/or thinner than multicomponent devices, for user
comfort, and ease of use.
[0019] In another embodiment, the composite material is used in
combination with one or more additional materials to provide
desirable properties.
[0020] The term "composite" is used to describe an element
comprising two or more chemically or physically differing materials
or two or more chemically or physically differing regions.
Preferably in a composite, at least one of the different materials
is a polymeric material, and more preferably a polymeric material
having semicrystallinity.
[0021] The term "spring-like element" or "spring element" is used
to describe the tension providing element or elastic memory
providing element in the nasal dilator. The spring element
encompasses any region, area, article, layer, or layers within the
base element, in this case within the composite, that provides
forces within the nasal dilator that causes a lifting tension of
the nasal dilator away from the nasal passages. The elastic memory
of the spring element provides its spring-like nature. The spring
element can be induced or formed by the interaction of two or more
materials or regions having differing characteristics. Because the
resiliency of the base element, in this case the composite,
provides the necessary lift to reduce or prohibit nasal passage
collapse or closing during use, the present invention can
effectively eliminate the need for a separate resilient member in
the dilator, and can reduce the amount and thickness of the
materials used to manufacture the nasal dilator and/or simplify the
manufacturing process by reducing the number of steps required to
manufacture the nasal dilator.
[0022] The term polymer includes the possibility of copolymers
and/or cross-linked polymers or copolymers and polymers having
semicrystalline internal structure.
[0023] The nasal dilator of the present invention includes a
composite base element and an adhesive disposed on one-side thereof
for adhering the nasal dilator to the user's nose, which together
form the nasal dilator. The composite base element can be formed
from a single material having different physical characteristics
across two or more regions, or from two or more materials
preferably co-formed during manufacture. In certain embodiments,
the composite base element has one or more materials having spring
elements physically or chemically induced at particular regions on
the base element, resulting in a base element with different
physical characteristics across two or more regions. In certain
embodiments, the composite base element is co-formed through a
co-extrusion process of two different materials. In certain
embodiments, the composite base element is co-formed by laminating
two different materials in a lamination process.
[0024] The base element has an elasticity built into it that will
lift opposed sides of the nose by a spring or elastic action moving
the base element from a curved shape over the nose towards a more
linear form while the nasal dilator remains adhered to the nose. By
using a composite that acts as both a base substrate and a
resilient member, manufacturing steps and/or materials previously
used in the manufacture of nasal dilators can be eliminated, costs
reduced, manufacture simplified and properties tailored.
[0025] The interaction or separate actions of the materials used to
form the composite base element impart the appropriate strength,
flexibility and spring action required for the material to act as a
nasal dilator. For example, a secure retention of
pressure-sensitive adhesive is needed in the outer surface, while a
relatively strong straightening elastic memory is needed to cause
the essential lifting action in the performance of the nasal
dilator. Many commercial dilators have separate metal or hard
plastic fibers, rods or filament inserts that act as resilient
members that must be carefully constructed and placed within the
layers of the nasal dilators, resulting in a construction that can
be complex, costly, and inefficient. By creating a spring element
at or along the interface of chemically or physically differing
materials, the use of separate metal or hard plastic inserts can be
avoided.
[0026] The present technology allows for simultaneous construction
of all components of the composite nasal dilator and subsequent or
simultaneous application of the pressure-sensitive adhesive layer.
In one aspect of the invention, a continuous process for
manufacturing nasal dilators is provided. One underlying element of
technology described herein includes as a preferred embodiment a
process of forming the composite nasal dilator by co-extrusion of
two or more materials with differing characteristics, including
different synthetic polymeric or composite materials, in
appropriate orientation and layering that provides the ultimate
desirable spring element properties. By differing characteristics,
it can include either differences merely by the fact of using
differing polymers (for example polyester, polyacrylates,
polyolefins such as polypropylene (including high density
polypropylene or polyethylene, copolymers thereof and the like), or
materials of differing characteristics or qualities whether the
same or different polymer or copolymer, such as, but not intended
to be limited to, density, quality, response to external
conditions, chemical composition, crystallinity, molecular weight,
crosslinking, glass transition temperature, thermoplastic vs.
thermoset, morphology, heat shrink, cold shrink, expansion,
flexibility, hardness, elasticity, shape memory, stiffness, and the
like. Some desirable properties (e.g., stiffness and memory) may be
developed, activated or made latent in a single co-extrusion step
by controlling the properties, compositions and additives in the
various coextruded elements. Similarly, the composite base element
can be derived through a lamination of two or more materials with
differing properties in an appropriate layering and orientation to
provide the desirable characteristics. The co-formed composite base
element materials act in concert to allow for sufficient
flexibility in the composite nasal dilator structure to conform to
the curvature over a human nose, and then to provide such
sufficient elastic memory in attempting to return towards a planar
orientation of the nasal dilator so as to lift outer surfaces of
the nose and dilate nasal passages within by the lifting
action.
[0027] In certain embodiments, the composite nasal dilator may
include: [0028] a) a composite base element comprising one or more
materials having an outer surface and an inner surface; [0029] b)
the inner surface having a skin-compatible or hypoallergenic or
non-irritating adhering material, which can be a pressure sensitive
material, thereon; [0030] c) wherein the composite base element has
a spring element that provides tension, elastic memory and/or
stiffness to the base element when the base element is transitioned
from a planar to a non-planar state during use; and wherein the
spring element is formed through the interaction of at least two
materials or two distinct regions in the base element, the spring
element imparting resiliency into the base element and providing
the base element with return memory properties towards a planar
conformation during use.
[0031] In one embodiment, the spring element of the base element is
induced by physically or chemically altering at least one region in
the base element. The chemical or physical alteration creates at
least two distinct regions within the base element, whose
interaction induces a spring element. In one embodiment, the spring
element is formed by physically or chemically treating the base
element to alter its elastic memory. In one embodiment, the spring
element is formed by heating certain regions within the base
element. In one embodiment, the base element is comprised of at
least one shrink material or shrink film.
[0032] In one embodiment, the spring element in the base element
may be formed through the interaction of two or more materials with
different native chemical or physical properties, which elements
are co-formed during an extrusion process or lamination process. In
one embodiment, the spring element is derived by co-forming two or
more materials with different coefficients of expansion. In an
alternative embodiment, the spring element is derived by co-forming
two or more materials with different rates of contraction upon
cooling. The differing co-efficient of expansion or contraction
upon cooling properties act to create a tension or stiffness at the
interface of the differing materials within the base element,
resulting in the base element having an elastic memory when the
base element is placed upon the user's nose. This elastic memory is
not substantially altered (e.g., the tension may preferably not
increase by more than 5%) upon ambient heating, as by body
temperature increasing the base temperature of the device from
20.degree. C. to 37.degree. C. In one embodiment, the spring
element of the composite base element is induced by using at least
two materials with differing shrink properties when exposed to
heat, wherein the material with the greater shrinkage creates
tension along the interface of the two materials. In one
embodiment, at least one of the materials of the composite base
element is a shrink film.
[0033] In one embodiment, the composite base element is formed by
co-extruding two or more materials, wherein the interaction between
the two or more materials at or about their interface in the base
element induces a shape memory effect and/or spring element.
[0034] In certain embodiments, differential changes in the
materials or regions of the base element in response to physical
conditions, such as heating, cooling, the loss of solvent, the
absorption of solvent, the loss of moisture, or the absorption of
moisture may induce a change in shape through a controlled
differential bending along the spring element, which can provide
the nasal dilator with a controlled uplifting spring force when
placed on the user's nose. In certain embodiments the change in
shape may cause controlled differential bending along the spring
element resulting in the inner surface of the base element changing
to a concave shape that will secure itself to the nose of the
wearer by the adhesive, with controlled uplifting spring force. In
certain embodiments, the change in shape may cause the base element
to bend in a direction opposite its position during use, creating
control uplifting spring force on the nostrils during use. In
certain embodiments, the change in shape may result in the
development of a curvature along the longitudinal width of the
nasal dilator, creating uplifting spring force during use.
[0035] In certain embodiments, once applied to the nose, the spring
force of the base element may or may not be adjusted by body
temperature, but may be adjusted by application of more or a
different solvent, cooling, or the loss or absorption of moisture.
In certain embodiments, the differing physical characteristics of
the materials or regions of the base element imparting the spring
element may be present initially after formation of the base
element or may be latent properties that can be activated after
formation of the base element, including either before use of the
nasal dilator or during use of the nasal dilator. In a preferred
embodiment, the spring element is induced in the base element by
exposing the base element to sufficient heat to cause a significant
alteration or inducement of lifting tension away from the nasal
passages, wherein at least one material of the base element, or
alternatively one region of the base element, differentially
shrinks or expands in response to the heat, creating the spring
element. The changes in properties should create a lifting force of
at least 2 grams, preferably at least 5 grams on each side of the
nose. In one embodiment, the base element is exposed to heat prior
to application to the nose of a user in order to create the spring
element. In one embodiment, the base element is exposed to heat
prior to packing in order to create the spring element.
[0036] When the two materials used to create the spring element
have differential shrink properties, differential contraction
properties, or differential expansion properties, the application
of thermal energy (by conductive or convective heating, IR
radiation, and the like) will cause the two materials to shrink,
contract, and/or expand at different rates. Particularly when there
is a persistent or permanent change caused by shrinkage,
contraction, or expansion (e.g., as with a heat shrink material
being one of the components, layers or films), the differential in
dimensions caused by shrinkage, contraction, and/or expansion
causes the combined layers to arc or curl, with the "shorter" or
greater shrinking component being on the concave side of the arc
and the "longer" or less shrinking component being on the convex
side of the arc. The changes in the properties of the two
components may also act by the "longer" component on the exterior
or convex side shrinking (thereby reducing differences and
flattening the composite) or by the "shorter" component on the
interior or concave side expanding (thereby reducing differences
and flattening the composite). The arc can be created along the
longitudinal length or, if desired, width of the nasal dilator, or
both. It is preferred that the thermal treatment create a permanent
memory of the dimensional change as by heat shrinkage, heat
contraction, or heat relaxation of the material, as is known to
occur in the classes of shrink materials discussed and described
herein. The extent or degree of arc or curl can be controlled so
that the appropriate tension, elastic memory and/or stiffness are
imparted to the base element when the base element is transitioned
from a planar to a non-planar state during use.
[0037] There are various methodologies of forming these composite
nasal dilators, which may include steps such as: a) creating a
composite base element having an outer surface and an inner
surface, wherein the composite base material is comprised of at
least two materials or two regions differing in at least one
chemical or physical characteristic; and b) inducing a spring
element in the base element through the interaction of the at least
two materials or two regions. In one embodiment, the induction of
the spring element results in the deformation of the base element
from a linear shape so that the base element also deforms from a
planar shape. In certain embodiments, the change in shape may cause
controlled differential bending along the spring element resulting
in the inner surface of the base element changing to a concave
shape that will secure itself to the nose of the wearer by the
adhesive, with controlled uplifting spring force provided during
use. In certain embodiments, the change in shape may cause the base
element to create tension in a direction opposite its position
during use, creating control uplifting spring force on the nostrils
during use. In certain embodiments, the change in shape may result
in the development of a curvature along the longitudinal width of
the nasal dilator, creating uplifting spring force during use.
[0038] In certain embodiments, the nasal dilator may include a base
element having a spring element derived from at least one
physically or chemically altered region of a base element. In
certain embodiments, the spring element is formed by physically or
chemically treating the base element to alter its elastic memory
prior to application to the nose or after application to the nose.
For example, by heat-scoring lines on one side of the base element,
the scored surface may shrink or expand, as desired, creating
spring elements and causing the curvature of the base element to
form the spring upon use. The heat-scoring may be done and then a
chemical or thermal process performed to take advantage of the
difference in local properties created by the scoring, resulting in
the spring properties to becoming active. In certain embodiments,
after the spring element is formed through a first chemical or
physical process, a second chemical or physical process may be
applied to the base element to cause a change in shape along the
spring element so that the inner surface of the base element is a
concave shape. In certain embodiments, the change in shape may
cause the base element to create tension in a direction opposite
its position during use, creating control uplifting spring force on
the nostrils during use. In certain embodiments, the change in
shape may result in the development of a curvature along the
longitudinal width of the nasal dilator, creating uplifting spring
force during use.
[0039] In certain embodiments, the spring element is formed in the
composite base element by co-extrusion of two materials with
different physical or chemical characteristics that cause, or
enable further treatment to cause, a change in shape. For example,
the different physical characteristics may be different
coefficients of thermal expansion, different coefficients of
shrinkage after co-extrusion, different swelling or shrinkage rates
of the differing materials due to a solvent or more than one
solvent being added to or dried out of the co-extruded materials.
In certain embodiments, at least one material has a
three-dimensional shape with an elastic memory.
[0040] In certain embodiments, the spring element is formed in the
composite base element through a lamination of two materials with
different physical or chemical characteristics that cause, or
enable further treatment to cause, a change in shape. For example,
the different physical characteristics may be different
coefficients of thermal expansion, different coefficients of
shrinkage induced after lamination, different changes in
crystallinity and orientation (causing changes in the physical
length of molecules and polymer chains), different swelling or
shrinkage rates of the differing materials due to a solvent or more
than one solvent being added to or dried out of the laminated
materials. In certain embodiments, at least one of the materials
has a three-dimensional shape with an elastic memory. In one
embodiment, the composite base element is comprised of at least one
shrink material. In one embodiment, at least one of the materials
is a shrink film. In one embodiment, the shrink film is laminated
on a second material, wherein the second material has an adhesive
for adhering to a user's nose, which can be a pressure sensitive
adhesive, disposed on a side opposite the shrink film. In one
embodiment, the composite base material is comprised of a first
material comprising a medical grade cloth material and a second
material comprising a shrink material. In one embodiment, the
shrink material is a polyolefin. In one embodiment, the shrink
material is a polyolefin material such as a polyethylene or a
polypropylene shrink film.
[0041] In one aspect of the invention, a continuous process for
manufacturing nasal dilators is provided comprising providing a
base element, wherein the base element is formed by: (a) extruding
a first material having a first surface and a second surface from a
first extrusion die or co-extrusion die, the first surface and
second surface having differential properties that cause or enable
curling tension to be formed or later created in the base element;
and/or (b) extruding a second material having a first surface and a
second surface from a co-extrusion die, or separated slot coating
position downstream from the first extrusion or coextrusion die,
wherein the first material and second material or the first surface
and second surface co-form the base element, the second material or
second surface having different chemical or physical properties
than the first material or first surface, wherein the interaction
of the first material and second material provides a spring-like
function or element to the base element. Differential properties in
the surfaces of even a chemically homogeneous material may be
formed by differential treatment of the surfaces in or after the
extrusion process (e.g., different cooling temperatures and/or
cooling rates on the surfaces, different heating processes on the
opposed surfaces with IR heaters, or different crystalline state or
degree imposition on the surfaces by thermal or irradiation
treatments such as pulsed excimer laser treatment, or a combination
thereof). In one embodiment, the second material is extruded into
or on only a portion of one surface of the first material. It would
be preferred to have the second material asymmetric within the
combination (e.g., totally on one side of the combined materials or
slightly off-centered within the combined materials) so that the
direction and degree of subsequent curvature and tension in the
elastic memory can be better controlled. In certain embodiments,
the interaction of the first material and the second material
results in the base element having an elastic memory or a latent
elastic memory that can be changed by additional processing such as
heat, irradiation or solvent. In certain embodiments, the second
material has a three-dimensional shape with an elastic memory. In
certain embodiments, the first or second material shrinks or
expands when exposed to heat. In one embodiment, the process
further includes exposing the composite base element to heat in
order to induce shrinkage in the first or second material, thereby
creating tension between the two materials which provides the
spring element of the base element. In certain embodiments, the
process further includes extruding or slot coating a third material
onto a surface of the first material opposite the second material,
wherein the third material comprises a pressure sensitive adhesive.
In certain embodiments, the process can further include laminating
a release paper strip, such as silicone or wax coated kraft paper,
over the adhesive, which can be a pressure sensitive adhesive
layer. In certain embodiments, more than one nasal dilator can be
formed in a continuous process.
[0042] One benefit of forming these structures by extrusion and or
extrusion plus slot-coating of the adhesive on the extruded
substrate is the ability to work on a continuous process on a
single continuous line of manufacturing apparatus. The base and
underlying layers of structure in the device can thus be mass
produced on a single web-handling device, and the sheet converted
into appropriately sized individual nasal dilator elements.
[0043] In one aspect of the invention, a continuous process for
manufacturing nasal dilators is provided comprising providing a
composite base element by: (a) providing a first material having a
first surface and a second surface; (b) laminating a second
material having a first surface and a second surface on to at least
one portion of the first material (the lamination being effected
with adhesive or without adhesive, as by direct fusion of the
layers together), wherein the first material and second material
co-form the base element, the second material having different
chemical or physical properties than the first material, and
wherein the interaction of the first material and second material
creates a spring element to the base element. In one embodiment,
the second material is laminated onto only one portion of one
surface of the first material. In certain embodiments, the
interaction of the first material and the second material results
in the base element having an elastic memory. In certain
embodiments, the second material has a three-dimensional shape with
an elastic memory. In one embodiment, the process further includes
exposing the base element to a physical or chemical treatment,
wherein the differential response to the treatment by the two
materials induces the spring element. In certain embodiments, the
physical or chemical treatment may include exposure to heat,
exposure to cold, exposure to dryness, exposure to moisture,
exposure to a chemical or solvent, exposure to thermal or
irradiation treatment (such as pulsed excimer laser treatment), or
any combination thereof. In certain embodiments, the first or
second material shrinks when exposed to heat. In one embodiment,
the process further includes exposing the composite base element to
heat in order to induce shrinkage in the first or second material,
thereby creating tension between the two materials which provides
the spring element of the base element. In one embodiment, the
composite base element is comprised of at least one shrink
material. In one embodiment, the composite base material is
comprised of a first material comprising a medical grade cloth
material and a second material comprising a shrink material. In one
embodiment, the shrink material is a polyolefin. In one embodiment,
the shrink material is a polyethylene or a polypropylene shrink
film. In certain embodiments, the process further includes
disposing on a surface of the base element a pressure sensitive
adhesive. In one embodiment, the process includes laminating a
release paper strip, such as silicone or wax coated kraft paper,
over the pressure sensitive adhesive layer. In certain embodiments,
more than one nasal dilator can be formed in a continuous
process.
[0044] In one embodiment, the composite base element produced as an
extrudate or laminate is die-cut and formed into a roll.
[0045] These and other methodologies may be used to provide the
spring element.
DESCRIPTION OF THE FIGURES
[0046] FIG. 1 shows a typical nasal dilator attached to a person,
including structures of the prior art.
[0047] FIG. 2 shows the construction of a typical nasal dilator
according to the prior art.
[0048] FIG. 3 shows a cross-sectional view of a standard nasal
dilator according to the prior art.
[0049] FIG. 4 shows a cross-sectional view of an exemplary
composite nasal dilator wherein the spring element is derived
within certain regions of the base element by physically or
chemically altering the base element to create specified spring
elements within the base element. FIG. 4A is a top view of a nasal
dilator.
[0050] FIG. 5 shows a cross-sectional view of an exemplary
composite nasal dilator wherein the spring element is derived in
the base element through the interaction of two materials having
physically or chemically differing characteristics.
[0051] FIG. 6 shows a cross-sectional view of an exemplary
composite nasal dilator wherein the spring element is derived at
certain regions of the base element through the interactions of at
least two materials having physically or chemically differing
characteristics.
[0052] FIG. 7 shows a cross-sectional view of an exemplary
composite nasal dilator wherein one or more spring elements are
derived along the length of the base element through the
interactions of at least two materials having physically or
chemically differing characteristics.
[0053] FIG. 8 shows a frontal cropped view of an unfurled roll of a
resultant composite nasal dilator extrudate or laminate with die
cut perforations in the shape of the nasal dilator.
DETAILED DESCRIPTION OF THE INVENTION
[0054] The current invention is directed to nasal dilators and
methods of manufacturing nasal dilators. In particular, the current
invention is directed to nasal dilators having a composite base
element that provides resiliency to the nasal dilator, allowing the
base element to be flexible and providing the base element with
return memory properties towards a planar conformation.
[0055] In one aspect of the present invention, the nasal dilator
includes: [0056] a) a composite base element having an outer
surface and an inner surface; [0057] b) the inner surface having a
(e.g., skin compatible) pressure-sensitive adhesive thereon; [0058]
c) the composite base element having induced therein a spring
element that provides tension, elastic memory, and/or stiffness to
the base element when the base element is transitioned from a
planar to a non-planar state; and wherein the spring element is
formed through the interaction of at least two materials, opposed
surfaces of the base element or two distinct regions providing the
base element with return memory properties towards a planar
conformation.
[0059] Referring now to FIGS. 4-7, a cross-section of exemplary
composite nasal dilators are illustrated therein, the nasal dilator
being generally referred to by reference numeral 200. The nasal
dilator 200 comprises a base layer 210 comprised of a base element
220 and an adhesive layer 230, the adhesive layer 230 being
disposed on the side of the base element 220 that is to be adhered
to the user's nose. The base element 220 is comprised of a
composite material having two differing materials or regions,
wherein the interaction of the differing materials or regions
imparts at least one spring element 240 that provides the base
element with return memory properties towards a planar
conformation.
[0060] The base element 220 may include one or more thin, flexible
materials suitable for use in nasal dilators. Preferably, the base
element 220 is breathable, allowing airflow and/or moisture flow,
and is selected to maximize comfort. The base element 220 may
include, for example, porous or microporous polymer film, a fabric
materials such as one or more woven or non-woven fabric layers,
such as non-woven, polyester fabric with a strengthening mesh
therein, or a combination thereof. One example is a fabric produced
by DuPont E. I. de Nemours & Co., Inc. under the trademark
Sontara.RTM.. Alternatively, the base element 220 may include, for
example, one or more thermoplastic woven or non-woven fabrics, such
as polyethylene or polypropylene (which can be spun-bonded), or a
combination thereof. In other alternatives, the base element 220
may for example include one or more materials such as paper, cloth,
including medical grade cloth, vinyl, polypropylene, including
oriented polypropylene such a MOPP and BOPP, polyester,
polyethylene, including LDPE, LLDPE, MDPE, HMWPE, and HDPE, more
generally polyolefin, polyethylene terephthalate, glycolised
polyethylene terephthalate (PETG), acrylonitrile butadiene styrene,
polycarbonate, polyvinyl chloride, cellophane, cellulose, cellulose
acetate, block co-polymers such as styrenelisoprene, butadiene or
thylene-butylene/styrene (SIS, SBS, or SEBS), polyurethane,
ethylene copolymers such as ethylene vinyl acetates,
ethylene/propylene copolymer elastomers or ethylene/propylene/diene
terpolymer, nylon, crepe, flat back, a foil, rayon, a polyvinyl
derivative, polyamides, cuproammonium cellulose, wool, silk, jute,
hemp, cotton, linen, sisal, ramie, polystyrene, polyurethane,
polyvinylidene chloride, saponified ethylene-vinyl acetate
copolymer, linoleum, acrylics, natural rubber, reclaimed rubber,
synthetic rubber, thermoplastic resin films, biodegradable resins
such as polylactic acid and polyhydroxyalkanoates, polybutylene
terephthalate, polyethylene naphthalate, polybutylene
terephthalate, polyamide, polyimide, other resins, other
thin-films, or combinations thereof
[0061] In certain embodiments the base element 220 is formed by
using two physically or chemically differing materials, wherein the
interaction of the differing materials in relation to each other
imparts a spring element to the base element 220, providing the
desired resiliency in the nasal dilator 200. In certain
embodiments, the base element 220 will include two or more
materials, wherein the interactions of the two or more materials
impart or induce a spring element 240 within or across the base
element 220. In certain embodiments, the different materials may
have different crystallinity, allowing heat in the layers to cause
changes in shape memory, stiffness, and/or flexibility that
differentially effects one material compared to the other.
Different crystalline properties of the materials may be provided
by at least one of: different temperatures used during extrusion or
lamination or subsequent to extrusion or lamination; different
levels or types of solvents; different radiation exposure during or
after extrusion or lamination such as infrared radiation, pulsed
laser, or ultraviolet radiation; different levels of crosslinking
agents; different levels of flexibilizers; or different levels of
crystallinity promoters. Different levels may also include zero
content in one of the materials.
[0062] In certain embodiments, the spring element 240 can be
induced during the co-extrusion of two materials by using different
shapes and orientations of co-extrusion heads or slots which may
impose greater planarity or greater curvature between the at least
two materials.
[0063] In certain embodiments, the base element 220 is comprised of
at least two materials, wherein at least one of the materials
shrinks or expands disproportionately compared to at least one
other material used in the base element 220. In certain
embodiments, the base element 220 is comprised of at least two
materials, wherein at least one of the materials shrinks,
contracts, or expands disproportionately along its longitudinal
length when compared to at least one other material used in the
base element 220. In one embodiment, the base element 220 is
comprised of two or more materials, wherein at least one of the
materials is a shrink film which shrinks disproportionately when
compared to at least one other material used in the base element
220. In one embodiment, the base element 220 is comprised of two or
more materials, wherein at least one of the materials is a shrink
material which shrinks along its longitudinal length in a
disproportionate ratio compared to at least one other material used
in the base element 220. In certain embodiments, the base element
220 is comprised of at least two materials or one material having
opposed surfaces treated to create a differential in bending torque
and/or elastic memory in the base element, wherein at least one of
the materials or surfaces shrinks, contracts, or expands when
exposed to heat in a disproportionate ratio compared to at least
one other material used in the base element 220. Upon exposure to
heat, the shrinkage, contraction, or expansion of the material
creates tension between it and at least one other material within
or across the base element 220, imparting a resiliency on the base
element 220. In certain embodiments, the at least one material has
a three-dimensional shape with an elastic memory.
[0064] Shrink materials useful for the present invention may
include conventionally known materials prepared from one or more
resins that shrink or contract upon heating. Such materials can
include, for example, polymers and/or semicrystalline polymers such
as one or more of the following: polyolefin (including cyclic
polyolefin), including polypropylene and polyethylene; polyvinyl
chloride; polyesters; polystyrenes; polyvinylidene chlorides;
polyethylene terephthalate; polynorbornene; polyimide; polyamide;
polyurethane; polystyrene; polyvinylidene chloride; polyvinyl
chloride; or a combination or combinations thereof. In certain
embodiments, the shrink material may comprise a shrink film. Shrink
films can include, for example, uniaxially and biaxially stretched
shrink films. Shrink films can include, for example, films,
including monolayer and multilayer laminated films, made from one
or more of the resins identified above. For example, shrink films
can include: polyolefin shrink films, such as polyethylene and
polypropylene shrink films (including oriented polypropylenes such
as BOPP and MOPP); polyurethane shrink films; and polyvinyl
chloride shrink films. Monolayer polyolefin shrink films include
cross-linked and uncross-linked oriented polyethylene, oriented
polypropylene, polyurethane, and oriented ethylene-propylene
copolymers. Monolayer polyvinyl chloride ("PVC") shrink films
involve a variety of PVC formulations. Shrink films useful in the
present invention may include shrink films commercially available
from: Bemis Co. Inc. such as Clysar.RTM. ABL polymer, Clysar.RTM.
polymer AFG, Clysar.RTM. EZ polymer, Clysar.RTM. HPG polymer,
Clysar.RTM. LEG polymer, Clysar.RTM. LLG polymer, Clysar.RTM.
ShrinkBox polymer, and Clysar.RTM. VHG polymer; Toyobo Co., such as
Space Clean S5630 polymer; Intertape Polymer Group, such as
Exlfilm.RTM. polymer; Reynolds Packaging LLC such as Reynolon.RTM.
polymer, Reynolon.RTM. Plus polymer and PVC shrink films; Syfan
USA, Corp. such as Sytec.RTM. shrink films; Mitsubishi Polyester
Film; Gunze Ltd. such as Fancy Wrap.RTM. polymer; Toray Industries
Ltd. such as Toradan.RTM. polymer and Lumirror.RTM. polymer; JSR
Corp. such as Arton.RTM. polymer; Nippon Zeon Co. such as
Zeonore.RTM. polymer; and the like In one embodiment, the shrink
film is a polyolefin shrink film. In one embodiment, the shrink
film is a polypropylene. Upon exposure to heat, a shrink material
will either shrink or, if restrained, create shrink tension within
the base element 220, creating a tension along and elasticity along
the spring element 240. This heat reaction is generally activated
when the shrink material is exposed to heat.
[0065] The nasal dilators of the present invention further include
a pressure sensitive adhesive 230 disposed on the inner surface of
the base element 220. The pressure sensitive adhesive 230 adheres
the nasal dilator 200 to the user's nose. The pressure sensitive
adhesive may include any releasable adhesive or releasable
tenacious components to affect pressure-sensitivity. Pressure
sensitive adhesives suitable for nasal dilators are well known and
include water-based pressure-sensitive adhesives, such as acrylate
adhesives, thermoplastics "hot melt" adhesives, two-sided adhesive
tape, elastomer-based adhesives, and acrylic adhesives. Examples
include polyacrylate adhesive, and polyvinylethyl ether blend
adhesives.
[0066] Additional elements of the nasal dilator contemplated in the
current invention may include a release film or release paper strip
that can be added over the pressure sensitive adhesive layer 230
prior to packaging.
[0067] In certain embodiments, the composite base element 220 is
composed of one or more materials extruded from an extrusion die.
In certain embodiments, the base element 220 is composed of at
least two materials formed during a lamination.
[0068] The base element 220 has at least one spring element 240
induced therein. In one embodiment, the spring element 240 is
derived from physically or chemically altering at least one region
of the base element 220 in order to alter its elastic memory. In
one embodiment, the base element 220 is heated in one or more
locations in order to shrink or expand the base element to cause a
curvature, wherein the induced curvature creates the spring element
240. In one embodiment, heat-scoring lines are provided on one side
of the base element 220, and chemical, radiation (e.g., pulsed
excimer laser) or thermal processing is subsequently performed to
take advantage of the difference in local properties created by the
scoring, imparting a spring element 240 within or across the base
element 220. In certain embodiments, after the composite base
element 220 is formed, a subsequent chemical or physical process
may be applied to the base element 220 to cause a change in shape
of the base element 220, imparting a spring element 240 across the
base element 220 so that the inner surface of the base element 220
is transformed into a concave shape. In certain embodiments, the
change in shape may cause the base element 220 to create tension in
a direction opposite its position during use, creating control
uplifting spring force on the nostrils during use. In certain
embodiments, the change in shape may cause the base element 220 to
develop a curvature along the longitudinal width of the nasal
dilator, creating uplifting spring force during use.
[0069] For example, the elastic memory properties of the spring
element 240 may be induced in or created on the base element 220 by
using at least one material in the base element 220 which reacts to
a physical or chemical condition in a differential manner when
compared to at least one other material used in the base element
220. In this way, the positioning or layering of the different
materials, and the effects of the induced spring element 240 can be
controlled by selectively orienting the materials in the base
element 220 in such a way so as to take advantage of the
differential response to the chemical or physical condition. In one
embodiment, the spring element 240 is induced by co-forming two
materials with different coefficients of expansion. In an
alternative embodiment, the spring element 240 is induced by
co-forming two or more materials with different rates of
contraction upon cooling. In still another embodiment, the spring
element 240 is induced by co-forming two or more materials with
differing resistance to force, wherein the resistance of one
material to force acts to induce a strain or tension on the nasal
dilator in the direction of the planar form when the nasal dilator
is placed across the user's nose. In another embodiment, the spring
element 240 is induced by co-forming two or more materials with
different rates of shrinkage when exposed to heat.
[0070] As shown in FIG. 4, the spring element 240 providing the
nasal dilator 200 with flexibility and return memory properties
towards a planar conformation may be imparted within certain
regions of the base element 220. In one embodiment, the spring
element 240 is induced by chemically or physically treating the
base element 220 as described above, for example by heat scoring,
along particular areas 242 of the base element 220 to impart the
spring elements 240 of the base element 220 wherein an induced
spring element effect is desired.
[0071] Alternatively, as shown in FIG. 5, the spring element
regions 240 along the base element 220 can be formed during an
extrusion process of two or more materials, where a first material
250 is extruded and a at least a second material 260 having a
different physical or chemical property than the first material 250
is coextruded with or injected into the first material 250 at
particular spring element regions 240. For example, a first
material 250 of the composite base element 220 can be extruded from
a co-extrusion die, and then a second material 260 having differing
physical or chemical properties can be co-extruded at certain time
and space intervals during the process creating the spring element
regions 240 within the base element 220. The at least two materials
of the base element 220 are capable of interacting and imparting a
desired spring effect along the spring element 240. In one
embodiment, the at least two materials differ in hardness, creating
a resistance to bending, and, as a result, a memory effect is
created along the spring element regions 240 when the nasal dilator
200 is placed on a user's nose. In another embodiment, the at least
two materials differ in a coefficient of expansion or cooling,
that, when the materials differentially expand or contract, create
a spring element 240 upon bending that imparts a resiliency and
memory effect to the base element 220. In certain embodiments, at
least one of the materials is a shrink material that, upon heating,
shrinks and creates tension within the base element 220, creating a
spring element 240. In one embodiment, the first material 250 is a
heat shrink material. In one embodiment, the first material 250 has
a three-dimensional shape with an elastic memory. In one
embodiment, the second material 260 is a heat shrink material. In
certain embodiments, the second material 260 has a
three-dimensional shape with an elastic memory.
[0072] As shown in FIG. 6, the spring element 240 providing the
nasal dilator 200 with flexibility and return memory properties
towards a planar conformation may be imparted across certain
regions of the base element 220 through the interaction of at least
two materials having differing characteristics co-extruded or
laminated during formation of the base element 220. In certain
embodiments, the base element 220 is formed of at least two
different materials, wherein at least one of the materials has a
different physical or chemical property than one other material
used to co-form the base element 220. In one embodiment, the spring
element regions 240 along the base element 220 can be formed during
an extrusion process, where a first material 250 is extruded and at
least a second material 260 having a different physical or chemical
property than the first material 250 is coextruded with the first
material 250 at particular spring element regions 240. For example,
a first material 250 of the composite base element 220 can be
extruded from a co-extrusion die, and then at least a second
material 260 having differing physical or chemical properties can
be co-extruded at certain time and space intervals during the
process creating the spring element regions 240 within the base
element 220. In an alternative embodiment, the spring element 240
can be induced within or across the base element 220 by laminating
at least a first material 250 and a second material 260 having
different chemical or physical properties, wherein the at least
second material 260 is laminated at a position on a surface of the
first material 250 that a spring element effect 240 is desired. The
interaction between the first material 250 and second material 260
is capable of creating the spring element 240. In one embodiment,
the at least two materials differ in hardness, creating a
resistance to bending, and, as a result, a memory effect, at the
spring element regions 240 when placed on the user's nose. In
another embodiment, the at least two materials differ in a
coefficient of expansion or cooling, resulting in a tension created
at the spring element regions 240 upon bending that imparts a
resiliency and memory effect to the base element 220. In certain
embodiments, the base element 220 includes at least one material
that shrinks or expands disproportionately when compared to at
least one other material used to co-form the base element 220. In
one embodiment, at least one of the materials is a shrink material
and is coextruded with or laminated on another material along the
desired spring element regions 240. In certain embodiments, the
shrink material, upon heating, shrinks and creates tension within
the base element 220, creating a spring element 240. In one
embodiment, the first material 250 is a heat shrink material. In
one embodiment, the first material 250 has a three-dimensional
shape with an elastic memory. In one embodiment, the second
material 260 is a heat shrink material. In certain embodiments, the
second material 260 has a three-dimensional shape with an elastic
memory.
[0073] In certain embodiments, as shown in FIG. 7, a spring
elements 240 may be imparted along the longitudinal length of the
base element 220, providing the base element 220 with flexibility
and return memory properties towards a planar conformation. In
certain embodiments, the base element 220 is co-formed of at least
two materials having differing physical or chemical characteristics
during an extrusion, wherein the interaction of the first material
250 and the second material 260 creates a spring element 240 along
the longitudinal length of the base element 220. For example, the
first material 250 of the base element 220 can be extruded from one
co-extrusion die, while a second material 260 having differing
physical or chemical properties is co-extruded during the process.
The interaction of the first material 250 with the second material
260 is capable of creating a desired spring elements 240 across the
length of the base element 220. In an alternative embodiment, the
spring element 240 can be imparted into the base element 220 by
laminating two materials having differing physical or chemical
properties capable of interacting along their length to create a
spring element 240 across the length of the base element 220. In
one embodiment, the two materials differ in hardness, creating a
resistance to bending, and, as a result, a memory effect, along the
spring element 240 is created when placed on the user's nose. In
another embodiment, the two materials differ in a coefficient of
expansion or cooling, resulting in a tension created along the
spring element 240 upon bending that imparts a resiliency and
memory effect to the base element 220. In certain embodiments, the
base element 220 includes a first material 250 or second material
260 that shrinks or expands disproportionately when compared to the
other material. In one embodiment, a shrink material is coextruded
with or laminated on another material at the desired spring element
regions 240. In certain embodiments, the shrink material, upon
heating, shrinks and creates tension within the base element 220,
creating a spring element 240 upon bending. In one embodiment, the
first material 250 is a heat shrink material. In one embodiment,
the first material 250 has a three-dimensional shape with an
elastic memory. In one embodiment, the second material 260 is a
heat shrink material. In certain embodiments, the second material
260 has a three-dimensional shape with an elastic memory.
[0074] In one aspect of the invention, a method for manufacturing
nasal dilators is provided. There are various methodologies of
forming these nasal dilators, which may include steps such as: a)
creating a composite base element having an outer surface and an
inner surface, wherein the composite base material is comprised of
at least two materials, two surfaces or two regions differing in at
least one chemical or physical characteristic; and b) inducing a
spring element in the base element through the interaction of the
at least two materials, two surfaces or two regions. In certain
embodiments, the spring element is induced along the interface of
the two materials, two surfaces, or two regions within the base
element due to a differential change in the materials, surfaces, or
regions in response to physical conditions resulting in a permanent
deformation of at least one of the materials, surfaces, or regions.
In one embodiment, the differential change is due to differences in
the coefficients of expansion, contractions upon cooling, or shrink
properties of the materials, surfaces, or regions. In one
embodiment, the differential change of is due to the differential
loss of solvent, the differential absorption of solvent, the
differential loss of moisture, or the differential absorption of
moisture within the materials, surfaces, or regions, In certain
embodiments, the spring element is induced through the chemical or
physical treatment of the base element resulting in the permanent
physical deformation of at least one of the materials, surfaces, or
regions within the base element.
[0075] In one embodiment, the induction of the spring element
results in the deformation of the base element from a linear shape
so that the base element also deforms from a planar shape. The
change in shape may cause controlled differential bending of the
spring element resulting in the inner surface of the support film
changing to a concave shape that will secure itself to the nose of
the wearer by the adhesive, with controlled uplifting spring force.
In certain embodiments, the change in shape may cause the base
element to create tension in a direction opposite its position
during use, creating control uplifting spring force on the nostrils
during use. In certain embodiments, the change in shape may result
in the development of a curvature along the longitudinal width of
the nasal dilator, creating uplifting spring force during use. The
impartation of curvature along the longitudinal width of materials
is further described in U.S. Patent Publication No.
2009/0324883.
[0076] In certain embodiment, the nasal dilator is constructed on a
base element and an adhesive layer. The base element has an
elasticity built into it that will lift opposed sides of the nose
by a spring or elastic action resulting in the desire of the base
element to move from a curved shape over the nose during use
towards a more linear form. By using differential properties in
different materials of or regions within the base element,
manufacturing steps previously used in the manufacture of nasal
dilators can be eliminated, costs reduced, manufacture simplified,
and properties tailored.
[0077] The present technology allows for simultaneous construction
of all components of the base element and subsequent or
simultaneous provision of the pressure-sensitive adhesive layer.
One underlying element of technology described herein includes
forming the base element by co-extrusion of two or more materials
with differing characteristics, including different synthetic
polymeric or composite materials, in appropriate orientation and
layering that provides the ultimate desirable properties. Some
essential properties (e.g., stiffness and memory) may be developed,
activated or made latent in a single co-extrusion step by
controlling the properties, compositions and additives in the
various coextruded elements.
[0078] In one aspect of this invention, a nasal dilator can be
manufactured using a co-extrusion system. A particularly useful
co-extrusion system employs two or more extruders or multiple
extrusion slots in the same extrusion head, such as that described
in U.S. Pat. No. 5,725,814, each with a gear pump at its output
connected to a co-extrusion die, allowing different materials to be
extruded by each extruder. Varying the speed of one or both gear
pumps varies the content of the extrudate. The gear pumps permit
precise variation of the relative content of the materials extruded
by the several extruders lengthwise along the extrudate. A display
of a cross sectional dimension of the extrudate along a length of
the extrudate permits observation of the lag that occurs between
alteration of gear pump speed and the resultant change in
dimension, so that a speed correction can be made at the
appropriate time to correct or optimize for differing shrinkage and
stretching characteristics between the several extruded materials
in order to induce the desired characteristics within the
extrudate.
[0079] During manufacture of the nasal dilators, in certain
embodiments, the individual extruders feed to the die the base
element materials, and, optionally, the adhesive layer, resulting
in a single step, multiple material extrudate that forms the nasal
dilator. The multiple extruders feeding the co-extrusion die can
direct the layering and spatial placement of the various materials.
For example, the die can layer the materials as follows: a first
material comprising a non-shrink material is directed to the first
layer of the extrudate. A second material comprising a shrink
material is extruded simultaneously with the first material at
desired spring element regions. The result is a two-layer, linear
extrusion. In additional embodiments, a third material comprising a
pressure sensitive adhesive can be coextruded on a surface of the
first material opposite the surface that the second material
interacts with.
[0080] In one embodiment, a co-extrusion system that employs two or
more extruders, each with a gear pump as its output connected to a
co-extrusion die by the use of gear pumps is used to produce the
base element extrudate. Two or more extruders are employed in
combination with a co-extrusion die and a gear pump is interposed
between each extruder and the die. The amount of each material
being delivered to the die is varied by controlling the speed of
each gear pump. A gear pump is formed from two counter-rotating
gears which are tightly meshed. The gear pump is used on the end of
the extruder and acts as a metering pump to meter out a precisely
measured amount of material. The gear pump can be thought of as a
group of measuring cups on a wheel. The measuring cup--in this case
the pocket between the teeth of the pump--is filled with material
such as plastic melt at the input. It travels around the pump,
getting leveled as it does so, so that the amount carried from
input to output is precisely one tooth-full. At the output the
gears mesh very closely, so the material cannot get back to the
input, and so it exits. This type of pump is a positive
displacement pump. The amount which exits is precisely proportional
to the RPM of the pump to a very close tolerance, and the pump is
relatively insensitive to such factors as viscosity, pressure, etc.
Gear pump speed control will thus accurately control the rate of
delivery of material to the die. By using gear pumps between the
extruders and the die of a co-extrusion system, the amount of each
constituent material at each location along the extrudate can be
precisely controlled. In certain embodiments, three or more
extruders or extrusion slots in a single extruder may be employed
in combination with a co-extrusion die, which may allow the
adhesive, which may include a pressure sensitive adhesive, to also
be co-extruded.
[0081] In certain embodiments, for example, wherein the spring
element is created only along certain portions of the base element,
the base element can be manufactured by changing the speed of the
extrudate of, for example, the second material from stopped to
started at areas along the first material where the spring elements
are desired, while simultaneously, slowing the speed of the
extrudate of the first material.
[0082] In other embodiments, if the base element is to be made of
more than one material, wherein the spring element is formed along
the entire longitudinal length of the base element, the speeds of
the gear pumps can be optimized to control for the potential shrink
differences between the two materials, as different materials may
shrink differently with changes in temperature and consequently the
cross sectional dimensions of an extrusion may change as it changes
from one material to another. Compensation for this can be made by
an incremental change in one of the gear pump speeds.
[0083] Similarly, where stretch between the die and a puller varies
from one material to another, tending to alter a cross sectional
dimension, compensation can be effected in a system employing gear
pumps by changing pump speed slightly, or in the case of a tube or
blown film by correcting not only a pump speed, but air injected at
the die.
[0084] In certain cases, a laser gauge downstream of the die can be
used to detect variations in dimension. A sudden temporary gear
speed change will show up on a monitor that displays cross
sectional dimension. The lag, in terms either of time or length
along the extrudate, is determined and the shrinkage or stretch
compensating correction is made in advance of the extrusion of that
portion of the extrudate requiring the correction. The time or
distance in advance that the correction is made is the time or
distance of the measured lag. Similarly, where air is used to
control outside diameter a "blip" or sudden pulse of air is
introduced and the line lag to the laser gauge is noted, whereupon
a correcting air input can be subsequently made at the correct
location.
[0085] Using a co-extrusion system, the thickness of each of the
layers of the extrudate is proportional to the amount of material
which goes into each of the inputs of the die, and can be
controlled. Furthermore, changes to the composition of the
extrudate can be controlled, allowing differential material to be
used along the extrudate, providing for the switching back and
forth between desired characteristics of the base element along a
longitudinal axis.
[0086] In one aspect of the invention, a continuous process for
manufacturing nasal dilators is provided comprising: (a) extruding
a first material having a first surface and a second surface from a
co-extrusion die; (b) extruding a second material having a first
surface and a second surface from a co-extrusion die, wherein the
first material and the second material comprise a base element, and
wherein the first material and second material have different
chemical or physical properties, wherein the interaction of the
first material and the second material at their interface creates a
spring element to the base element; wherein the second material is
extruded into or on at least one portion of one surface of the
first material. In certain embodiments, the second material is a
shrink material. In certain materials, the second material shrinks
when exposed to heat. In certain embodiments, the process further
includes exposing the extrudate to heat in order to shrink the
second material, creating a spring element along the interface of
the first and second materials. In certain embodiment, the process
further includes extruding a third material onto a surface of the
first material opposite the second material, wherein the third
material comprises an adhesive, such as a pressure sensitive
adhesive. In certain embodiments, the process can further include
laminating or temporarily adhering a release liner or a release
paper strip, such as silicone or wax coated kraft paper, over the
pressure sensitive adhesive layer. This can be done according to
standard manufacturing techniques, wherein after or during
application of the adhesive, the release sheet is placed against
the adhesive layer, usually by unrolling a stored release
sheet.
[0087] Similarly, the base element can be derived through a
lamination of two or more materials with differing properties in an
appropriate orientation to provide the desirable characteristics.
The co-formed base element materials act in concert to allow for
sufficient flexibility in the nasal dilator structure to conform to
the curvature over a human nose, and then to provide such
sufficient elastic memory in attempting to return towards a planar
orientation of the base element so as to lift outer surfaces of the
nose and dilate nasal passages by the lifting action. Preformed
adhesive layers (e.g., thermal adhesive layers, water-activated
adhesive layers and the like) may be laminated to the base element.
Application of these layers may also be provided by extrusion of
the adhesive layer through slots or die heads onto the previously
formed base element.
[0088] In one aspect of the invention, a continuous process for
manufacturing nasal dilators is provided comprising: (a) providing
a first material having a first surface and a second surface; (b)
laminating a second material having a first surface and a second
surface on at least one portion of the first material, the second
material having different chemical or physical properties than the
first material, wherein the interaction along the interface of the
first material and the second material creates a spring element in
the base element. In certain embodiments, the second material has a
three-dimensional shape with an elastic memory. In certain
embodiment, the process further includes disposing a third material
onto a surface of the first material opposite the second material,
wherein the third material comprises a pressure sensitive adhesive.
In certain embodiments, the process can further include laminating
a release paper strip, such as silicone or wax coated kraft paper,
over the pressure sensitive adhesive layer. In certain embodiments,
the spring element is induced along the interface of the first
material and second material within the base element due to
differential changes in the two materials in response to physical
conditions. In one embodiment, the differential change is due to
differences in the coefficients of expansion, contractions upon
cooling, or shrink properties of the first material and second
material. In one embodiment, the differential change of the two
materials is due to the differential loss of solvent, the
differential absorption of solvent, the differential loss of
moisture, or the differential absorption of moisture. In certain
embodiments, the spring element is induced through the chemical or
physical treatment of the base element resulting in the permanent
physical deformation of at least one of the materials. In certain
embodiments, the first, second, or both materials shrink when
exposed to heat. In further embodiments, the process further
includes exposing the laminate to heat in order to shrink the first
or second material. The laminate materials can be provided on
rolls, and adhesively joined together in a webbing operation.
[0089] When the two materials used to create the spring element
have differential shrink properties, differential contraction
properties, or differential expansion properties, the application
of thermal energy (by conductive or convective heating, IR
radiation, and the like) will cause the two layers to shrink and/or
expand at different rates. Particularly when there is a persistence
or permanent change caused by shrinkage, contraction, or expansion
(e.g., as with a heat shrink material being one of the components,
layers or films), the differential in dimensions caused by
shrinkage and/or expansion causes the base element to arc or curl,
with the "shorter" or greater shrinking component being on the
concave side of the arc and the "longer" or less shrinking
component being on the convex side of the arc. It is preferred that
the thermal treatment create a permanent memory of the dimensional
change as by heat shrinkage, heat contraction, or heat relaxation
of the material, as is known to occur in the classes of shrink
materials discussed and described herein.
[0090] Other materials may also be included in the nasal dilator.
For example, an adhesive layer or tie layer for assisting in
bonding the differing materials of the composite base element can
be coextruded between the at least first material and second
material, or in the case of a lamination, disposed on a surface of
one of the materials, if needed so improved adhesion between the
materials occurs. Tie layers, for example, can be single components
or multiple component compounds. Typical compounds for this use
including maleic anhydride modified elastomers, ethyl vinyl
acetates and olefins, polyacrylic imides, butyl acrylates,
peroxides such as peroxypolymers, e.g., peroxyolefins, silanes,
e.g., epoxysilanes, reactive polystyrenes, chlorinated
polyethylene, acrylic acid modified polyolefins and ethyl vinyl
acetates with acetate and anhydride functional groups and the like,
which can also be used in blends or as compatiblizers in one or
more of layers. Tie layers are sometimes useful when the bonding
force between the two materials is low. Adhesives can be, for
example, in the form of a water-based adhesive, solvent-based
adhesive, solvent-less adhesive, 100% solids adhesive, or hot melt
adhesive. Such adhesives, for example, can be acrylic based, rubber
based, or silicone based, and can include, for example,
polyacrylates, thermoplastic acrylic solutions, thermal curing
acrylics, self-curing or ambient temperature acrylics, 100% solid
thermoplastic acrylics, vinyl alkyl ether,
polyurethane-polyethylene adhesives, styrene-diene block
copolymers, two component adhesives, such as polyurethane and
polyethylene based adhesives, an crosslinking type adhesives.
Examples of potential acrylic adhesive components include
homopolymers or copolymers of a (meth)acrylic acid alkyl ester, for
example (meth)acrylic acid C.sub.1-C.sub.20 alkyl ester such as
methyl (meth)acrylate, ethyl (meth)acrylate, butyl (meth)acrylate,
2-ethylhexyl (meth)acrylate, and octyl (meth)acrylate; and
copolymers of the above-described (meth)acrylic acid alkyl ester
and another copolymerizable monomer including a carboxyl
group-containing or acid anhydride group-containing monomer such as
acrylic acid, methacrylic acid, itaconic acid, fumaric acid or
maleic anhydride; a hydroxyl group-containing monomer such as
2-hydroxyethyl (meth)acrylate; an amino group-containing monomer
such as morpholyl (meth)acrylate; an amide group-containing monomer
such as (meth)acrylamide; a cyano group-containing monomer such as
(meth)acrylonitrile; or a (meth)acrylic acid ester having an
alicyclic hydrocarbon group such as isobornyl (meth)acrylate.
[0091] The acrylic adhesive polymer can include a copolymer of one
or more of (meth)acrylic acid C.sub.1-C.sub.12 alkyl esters such as
ethyl acrylate, butyl acrylate or 2-ethylhexyl acrylate, and at
least a copolymerizable monomer selected from hydroxyl
group-containing monomers such as 2-hydroxyethyl actylate and a
carboxyl group-containing or acid anhydride group-containing
monomer such as acrylic acid, or a copolymer of one or more of
(meth)acrylic acid C.sub.1-C.sub.12 alkyl esters, a (meth)acrylic
acid ester having an alicyclic hydrocarbon group, and at least a
copolymerizable monomer selected from hydroxyl group-containing
monomers and carboxyl group-containing or acid anhydride
group-containing monomers.
[0092] The acrylic polymer is, for example, prepared by
photopolymerizing (for example, with an ultraviolet light) the
monomer components described above (and polymerization initiator)
in the absence of solvent, as a liquid prepolymer of a high
viscosity. Furthermore, a crosslinking agent can be added to the
prepolymer. The crosslinking agent may be added at the preparation
of the prepolymer. The crosslinking acrylic adhesive composition
may also be obtained by adding, to an acrylic polymer obtained by
polymerizing the monomer components described above or a solution
thereof, a crosslinking agent and a solvent (not essential in a
case of utilizing the solution of the acrylic polymer).
[0093] The crosslinking agent is not particularly restricted, and,
for example, an isocyanate type crosslinking agent, a melamine type
crosslinking agent, an epoxy type crosslinking agent, an acrylate
type crosslinking agent (polyfunctional acrylate), or a
(meth)acrylic acid ester having an isocyanate group may be used for
this purpose. Examples of the acrylate type crosslinking agent
include hexanediol diacrylate, 1,4-butanediol diacrylate,
trimethylolpropane triacrylate, pentaerythritol tetraacrylate, and
dipentaerythritol hexaactylate. Examples of (meth)acrylic acid
ester having an isocyanate group include 2-isocyanatethyl acrylate
and 2-isocyanatethyl methacrylate. The crosslinking agent is
normally employed in an amount of from 0.01 to 15 parts by weight
with respect to 100 parts by weight of the base polymer.
[0094] The crosslinking acrylic adhesive may contain, in addition
to the base polymer and the crosslinking agent, appropriate
additives such as a crosslinking promoter, a tackifier resin (such
as a rosin derivative resin, a polyterpene resin, a petroleum
resin, or an oil-soluble phenolic resin), a viscosifier, a
plasticizer, a filler, an aging resistor, and an antioxidant.
[0095] One particular advantage of the continuous process to create
a nasal dilator described above is that the resultant extrudate or
laminate can be produced in a single, continuous, linear extrusion
or laminating step. As such, the nasal dilator intended for use can
be die cut from a continuously provided liner sheet or web of
extrudate or laminate.
[0096] In one embodiment, the resultant extrudate or laminate web
or sheet is perforated and formed into a roll. Shown in FIG. 8 is a
cropped view of an unfurled roll of a resultant extrudate or
laminate that has a perforation 290 in the shape of the nasal
dilator 200. The perforation can be imparted by a die-cut. The
perforation facilitates the removal of each nasal dilator 200 from
the roll to permit individual application and use. As such, the
nasal dilator can be dispensed as a continuous roll having die cut
perforations as separations. The user simply removes the nasal
dilator from the roll at the die cut perforations, removing the
liner if provided, and affixes the nasal dilator across the
nose.
[0097] In certain embodiments, the materials used to form the
spring element of the current invention can broadly include, but
are not limited to, any material which is capable of being formed
into thin films and exhibits elastomeric properties at ambient
conditions. Elastomeric means that the material will substantially
resume its original shape after being flexed, stretched, or bent.
In certain embodiments, the materials used to form the spring
element are heat-shrinkable elastics. Such materials are
particularly attractive due to the ability to be fabricated into
the base element. For example, using an unstable stretched
shrink-material at ambient conditions and then later applying heat
to shrink the material results in a tension between the shrink
material and at least one other material used in the base element
along the interface of the shrink material and one other material,
providing for resiliency in the base element, allowing the base
element to be flexible, and providing the base element with return
memory properties towards a planar conformation. In certain
embodiments, the heat shrink materials used preferentially shrink
along the longitudinal axis of the base element, resulting in
tension being applied along the interface of the shrink material,
and when bent, creating lift at the ends of the nasal dilator as
the base element seeks a return to planar conformation upon
application to the user's nose.
[0098] To create a shrink material, the material may be heated
within its orientation temperature range (which varies according to
the material's composition, but is usually and preferably above
room temperature) and below the material's melting temperature.
After being stretched, the material can be rapidly cooled; such
rapid cooling or quenching freezes the shrink material molecules in
their oriented state. Upon sufficient heating, the orientation
stresses are released, and the shrink material will begin to shrink
back to its original un-oriented dimension.
[0099] For example, PVC and polyolefin shrink materials provide a
wide range of performance characteristics, such as shrink force
(the amount of force that a material exerts per unit area of its
cross-section during shrinkage), degree of free shrink (the
reduction in surface area a material undergoes when unrestrained),
tensile strength (the highest force that can be applied to a unit
area of material before it begins to break), sealability, shrink
temperature curve (the relationship of shrink to temperature), tear
initiation and resistance (the force at which a material will begin
to tear and continue to tear), optics (gloss, haze and transparency
of material), and dimensional stability (the ability of the film to
retain its original dimensions under all types of storage
conditions).
[0100] Shrink material characteristics play an important role in
selecting a particular shrink material and may differ for different
desired characteristics or equipment. Consideration must be given
to the amount of tension and elasticity desired to be created, the
non-shrink materials used, and the strength of the pressure
sensitive adhesive used to adhere the nasal dilator on the user's
nose.
[0101] Although specific materials, dimensions, temperatures and
apparatus are described in this document, those specific
disclosures are intended to be merely examples of the generic
concepts described and claimed herein.
* * * * *