Note: Descriptions are shown in the official language in which they were submitted.
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NASAL SUPPORT DEVICE FOR
DOMESTIC MAMMALS AND METHOD
Field of the Invention
The present invention is directed to facilitating air flow through the nasal
passages of a domestic animal. Specifically, the invention provides devices
and
methods for supporting the soft tissue structures of the nasal passages of a
domestic
animal.
Background of the Invention
Portions of the following discussion of the nasal anatomy of domestic
mammals are excerpted from R. Nickel et al., The Viscera of Domestic Animals,
(2nd revised ed.), Springer-Verlag, New York, Hiedelberg, Berlin (1979), pp.
211-
221. This is an excellent text on the comparative visceral anatomy of domestic
mammals. As used herein, the terms "mammal" and "animal" are used
synonymously and refer to non-human mammals.
The nasal anatomy of domestic animals is considerably different than that of
a human. Unlike the human nose that projects distinctly from the face, in
domestic
animals, the nose is incorporated into the face and forms the large dorsal and
lateral
areas rostral to the eyes. The nostrils in the apex of the nose are the entry
to the
respiratory system of domestic mammals. Once passing through the nostrils,
inspired air moves into the nasal cavities and continues through the
nasopharynx,
larynx, trachea and lungs.
At the apical entrance to the nose the nostrils are partitioned by the nasal
septum to divide the nasal cavity into right and left halves. The caudal
portion of the
septum is bony, while rostrally the septum consists of cartilage which becomes
progressively more flexible toward the apex.
The wall of the nose consists of skin externally and a middle supporting layer
of bone caudally and cartilage rostrally. The nasal cavity is lined by a
mucous
membrane. The rostral bones forming the wall of the nose include the nasal,
maxillary and incisive bones. The free borders of the nasal and incisive bone
provide attachment for the cartilages which support the nostrils. The
supporting
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bones and cartilages of the nose are associated with the nasal muscles that
regulate
the size of the nostrils.
The dorsal and ventral lateral nasal cartilages are formed by the widening of
the rostral part of the nasal septum along its dorsal and ventral margins. In
the
horse, the ventral lateral nasal cartilage is small and may be absent. In many
domestic animals, there is no lateral support for the soft tissue over the
rostral nasal
passage caudal to the nostril.
A further difference in the formation of the nasal cartilages of the horse is
the
presence of afar cartilages. The afar cartilages consist of a ventral cornu
and a dorsal
lamina and support the nostrils dorsally, medially and ventrally. The lamina
of the
afar cartilage and the medial accessory cartilage support the nasal
diverticulum, a
blind pouch in the dorsal aspect of the nostril.
The muscles of the nose and upper lip act to dilate the nostrils. This is
particularly noticeable during labored breathing. In the horse, these muscles
are well
developed and can transform the normally semilunar nostrils to become
circular.
The dorsal lateral area of the rostral nasal cavity that is caudal to the alar
cartilages in the nostrils of the horse includes a region of unsupported soft
tissue
which can be drawn into the nasal cavity during inspiration of air into the
nasal
passages. The nasal diverticulum of the horse is a part of the soft tissue
structures of
the horse which can be drawn into the nasal cavity. When the soft tissue is
drawn in,
it can narrow the nasal cavity and reduce the area for the intake of air, thus
reducing
the air movement into the nasal passages and ultimately to the lungs where the
oxygen is transferred in the pulmonary aveoli.
The physiological effects of reduced oxygen transfer at rest and during
physical exertion are documented. Some experts have theorized that exercise
induced pulmonary hemorrhage (EIPH) in performance horses is caused by
asphyxia
due to abnormal resistance of a closed or partially closed upper airway. The
upper
airway being defined as the region of the respiratory tract lying between the
nostrils
and the windpipe at the level of the first rib. Hence, the nasal passages are
part of
this region. Dr. Robert Cook, "EIPH or AIPE? A Tufts University Researcher
suggests that bleeding is not caused by EIPH, but by asphyxia", The Equine
Athlete,
p. 22-23 (March /April 1997).
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Devices for dilating the outer wall tissue of the nasal passages in humans
have been described in, for example, U.S. Patent Nos. 5,653,224; 5,611,333;
5,533,503; 5,549,103; 5,546,929; 5,553,605; 5,476,091 and RE 35,408. Devices
for
supporting outer tissues of the nasal passages of animals must address the
unique
S soft tissue and mechanical characteristics of an animal nose, particularly
performance animals such as horses, camels and dogs. Support devices for the
nasal
passages of animals are known and described in, for example, U.S. Patent No.
5,913,873 and International Patent Publication WO 98/47451.
Summary of the Invention
According to the invention there is provided a support device for supporting
tissues
overlying a first and second nasal passage. The support device includes an
engaging layer
including an adhesive for engaging the support device to the tissues, a
surface layer, a support
layer positioned between the engaging layer and the surface layer and a
carrier layer releasably
mounted to the surface layer.
The support device is primarily intended to support the unsupported nasal
tissues of a
domestic animal. The invention addresses providing support in view of the
structural and
physiological characteristics, unique to the nose of a non-human animal, for
example, a horse.
In addition to providing features which enhance the function of a support
device during use, the
invention also provides components to facilitate the ease and accuracy of
positioning a device
on an animal's nose. The invention further provides features which permit
reuse of a nasal
support device after removing from an animal's nose and also addresses some of
the needs
which arise when using a support device during certain competitive events. It
will be
appreciated that some of the components or features of the herein disclosed
devices may also be
applicable for use with human nasal dilators.
Throughout the specification, guidance may be provided through lists of
examples. In
each instance, the recited list serves only as a representative group. It is
not meant, however,
that the list is exclusive.
In one embodiment the invention is a nasal support device ("NSD") for securing
to the
nose of the animal. In a typical embodiment, the NSD provides support to the
right and left
lateral vestibular walls of a domestic animal. The device includes a support
layer and a right
and left side piece which when secured to the nose of the animal are
positioned to provide
structural support to the right and left lateral vestibular walls. The side
pieces of the device can
meet at the midline region
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of the device. In some embodiments, when secured to the nose of a domestic
animal, the midline region of an NSD of the invention straddles the left and
right
nasal bones of the animal.
The sides and the midline region of the NSD each have a rostral end, a
caudal end and a rostral-poll dimension. In some embodiments, the rostral-poll
dimension at the midline region can be equal to or greater than either of the
rostral -
poll of the side pieces. In addition, in some embodiments, the device is
bilaterally
symmetrical across both the longitudinal and transverse axes of the device.
In general, a support device according to the invention typically includes a
surface layer, a support layer, and an engaging layer. The support devices can
also
include a carrier layer to facilitate handling and positioning of the device
on an
animal's nose. In some preferred embodiments, the support device is a dark
color.
In alternative embodiments the invention provides facilitation to air flow in
the nasal passages of an animal by supporting the caudal apex region of the
vestibular walls of the animal. The devices are suitable for adult and young
animals.
In general, the structural aspects of an NSD of the invention can be
configured and
sized to fit the nose of, for example, a dog, cat, human, horse, camel, etc.
The disclosed support devices can be used on an animal that is running free
in a pasture, or wearing saddlery, harnesses or other equipment that may be
attached
to the nose of the animal while performing physical activity.
The devices and methods of the invention are particularly advantageous for
use in horses and are beneficial for use during athletic performance or for
reducing
the occurrence, severity or effects) of respiratory diseases in an adult or
young
animal.
In some embodiments, the NSD can be a reusable device. Methods for
reusing an NSD are also disclosed.
Brief Description of the Drawings
FIG. 1 is a top plan view of one embodiment of a nasal support device
according to the invention;
FIG. 2 is a profile view of the bony anatomy of the rostral nasal cavity of
the
horse;
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FIG. 3 is a bottom exploded view of the nasal support device of FIG. 1;
FIG. 4a is a top view of the nasal support device of FIG. 1 with the support
layer illustrated in phantom;
FIG. 4b is a top view of one embodiment of lift members according to the
invention.
FIG 5 is a top plan view of the nasal support device of FIG. 1 having a
carrier layer;
FIG. 6 is a front view of a horse having the embodiment of a nasal support
device of FIG. 1 secured to its nose;
FIG. 7 is a top plan view of the nasal support device of FIG. 1 having an
alternative embodiment of a carrier layer;
FIG. 8 is a top plan view of an alternative embodiment of a nasal support
device according to the invention;
FIG. 9 is a diagrammatic representation of an alternative embodiment of a
nasal support device according to the invention; and
FIG. 10 is a diagrammatic representation of another alternative embodiment
of a nasal support device according to the invention.
FIG. 11 is a diagrammatic representation of a configurational appearance for
an NSD according to the invention having two axes bilateral symmetry;
FIG. 12 is a top side view of one appearance of an NSD having two axes
bilateral symmetry;
FIG. 13 is bottom side view of the NSD of FIG. 12;
FIG. 14 is an alternative embodiment of a bottom side view of the NSD of
FIG. 13;
FIG. 15 is an alternative embodiment of a bottom side view of the NSD of
FIG. 13;
FIG. 16 is an alternative embodiment of a top side view of an NSD having
two axes bilateral symmetry;
FIG. 17 is bottom side view of the NSD of FIG. 16;
FIG. 18 is an alternative embodiment of a bottom side view of the NSD of
FIG. 16;
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FIG. 19 is an alternative embodiment of a bottom side view of the NSD of
FIG. 16;
FIG. 20 an alternative embodiment of a top side view of an NSD having two
axes bilateral symmetry;
FIG. 21 is bottom side view of the NSD of FIG. 20;
FIG. 22 is an alternative embodiment of a bottom side view of the NSD of
FIG. 20;
FIG. 23 is an alternative embodiment of a bottom side view of the NSD of
FIG. 20;
FIG. 24 an alternative embodiment of a top side view of an NSD having two
axes bilateral symmetry;
FIG. 25 is bottom side view of the NSD of FIG. 24;
FIG. 26 is an alternative embodiment of a bottom side view of the NSD of
FIG. 24;
FIG. 27 is an alternative embodiment of a bottom side view of the NSD of
FIG. 24;
FIG. 28 is an alternative embodiment of a bottom side view of the NSD of
FIG. 24;
FIG. 29 an alternative embodiment of a top side view of an NSD having two
axes bilateral symmetry;
FIG. 30 is bottom side view of the NSD of FIG. 29;
FIG. 31 is an alternative embodiment of a bottom side view of the NSD of
FIG. 29;
FIG. 32 is an alternative embodiment of a bottom side view of the NSD of
FIG 29;
FIG. 33 an alternative embodiment of a top side view of an NSD having two
axes bilateral symmetry;
FIG. 34 is bottom side view of the NSD of FIG. 33;
FIG. 35 is an alternative embodiment of a bottom side view of the NSD of
FIG.33;
FIG. 36 is an alternative embodiment of a bottom side view of the NSD of
FIG. 33;
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FIG. 37 is an alternative embodiment of a bottom side view of the NSD of
FIG. 33;
FIG. 38 is an alternative embodiment of an NSD according to the invention;
FIG. 39 is a rostral end view of the NSD of FIG. 38;
FIG. 40 illustrates an alternative embodiment of an NSD positioned over the
lateral vestibular walls of a horse;
FIG. 41 is an alternative embodiment of an NSD according to the invention;
and
FIG. 42 is a bottom plan view of one embodiment of a therapeutic device
according to the invention.
Detailed Description of the Invention
The invention is directed to devices and methods for supporting the soft
tissue at the rostral aspect of the nasal cavity of domestic mammals.
Specifically,
the devices and methods disclosed provide support for the unsupported region
of the
"vestibule" in the rostral nasal cavity. While the components and features of
the
devices disclosed are particularly advantageous for animal devices, some of
the
components and features may also be advantageously used with human nasal
dilators.
As used herein, domestic mammals include most non-human production and
performance animals having a nose incorporated into the face, rather than
projecting
therefrom, that can benefit from a device according to the invention. Such
mammals
include dogs, cats, sheep, goats, cattle, horses, camels, llamas, etc. A
device
according to the invention can be particularly useful for members of the
Equidae
family including horses, donkeys, mules, zebras etc.
As used herein, "performance activities" or "work" includes activities such
as pulling, driving, racing (flat, steeple, barrel, etc.), eventing, hunting,
jumping,
rodeoing, trail riding, endurance riding, etc. In general, the device can be
used
anytime it is desired to facilitate or enhance nasal air intake. In addition,
to
facilitating air flow, an NSD according to the invention can also be used to
treat or
prevent respiratory ailments in adult or young animals such as foals and
calves. The
devices and methods of the invention may be particularly beneficial in horses
for
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reducing the severity or effects) of respiratory conditions such as laryngeal
hemiplegia, chronic obstructive pulmonary disease (COPD) or exercise related
pathologies such as myositis, dorsal displacement of the soft palate (DDSP),
exercise induced pulmonary hemorrhage (EIPH) or "bleeding," etc.
As used herein, the term "rostral" refers to that aspect of the nose or
anatomical structure closest to the apex of the nose. "Caudal" refers to that
aspect of
the nose closest to the poll or caudal aspect of the head relative to the
apex. The
"vestibule" refers to the rostral aspect of the nasal cavity that is defined
by the afar
cartilages rostrally, the incisive bone ventrally, the nasal bone dorsally,
the caudal
intersection of the incisive and nasal bones caudally, and the nasal septum
medially.
Thus, supported regions of the vestibule are supported by bone or cartilage.
The "unsupported" region of the vestibule is also referred to as the "lateral
(free) wall" of the vestibule or "vestibular wall". The lateral wall of the
vestibule
includes the unsupported soft tissue defined by the nostrils rostrally, the
lateral free
border of the nasal bone dorsally, the dorsal free border of the incisive bone
ventrally, and the intersection of the nasal and incisive bone caudally. In
the horse,
the dorsal border of the unsupported region can include the dorsal lateral
nasal
cartilage and, in some species, the ventral border can include the ventral
lateral nasal
cartilage. Herein, "soft tissue" has its general meaning including skin,
muscle, fat,
connective tissue or associated integumentary structures.
Also, for purposes herein, the vestibular wall can be divided into at least
two
portions, a rostral portion being that portion nearest the nostril and a
caudal portion
being that portion nearest the intersection of the nasal and incisive bone.
The region
including about the caudal one quarter to one third of the vestibular wall is
referred
to as the "caudal apex region" and is more fully described below.
It should be noted that an NSD according to the present invention need only
engage the lateral free wall of the vestibule, it preferably does not engage
the
nostrils. Upon visual inspection it will be appreciated that the nostril of
the horse can
expand to a cross-sectional area that is greater than an unsupported cross-
sectional
area measured in the nasal cavity in the region of the lateral vestibular
wall.
However, it is foreseen that support of the nostril could be provided in some
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circumstances. In the horse, for example, the muscles of the nose and upper
lip
generally provide significant flaring of the nostril during labored breathing.
The configuration and arrangement of an NSD of the invention is determined
by the configuration of the tissue to be supported, the amount of support
needed and
S the unique physiological or anatomical characteristics of the animal.
Generally, the
unique nasal anatomy of domestic animals necessitates configurations,
arrangements
or dimensions which are different than that required for a human nose. In
addition,
hair, sweat and vestibular wall mobility affect the structural arrangement
necessary
for functionality of an NSD for animals.
In a typical embodiment, a herein disclosed NSD provides support to a
portion of the right and left lateral vestibular walls of the animal.
Generally, a
support device includes a right and left side piece, each including a support
layer,
which when secured to the nose of the animal are positioned to provide
structural
support to the right and left lateral vestibular walls. The "right" and "left"
side
pieces can also be referred to as "first" and "second" or "second" and "first"
side
pieces. In some embodiments, the support device is bilaterally symmetrical and
the
side pieces of the device meet at the midline in the midline region of the
device.
According to this embodiment, when the support device is secured to the nose
of an
animal, the intersection of the right and left side pieces at the midline
preferably
overlies or straddles the intersection of the left and right nasal bones and
the right
and left side pieces overlie the first and second vestibular walls,
respectively.
The side pieces and the midline region of an NSD each have a rostral end, a
caudal end and a rostral-poll dimension. Because of the size and related
anatomical
characteristics of the surface area of the vestibular free wall of, for
example a horse,
to provide sufficient support to benefit the animal, the rostral-poll
dimension at the
midline region of an NSD of the invention can be substantially equal to or
greater
than the rostral poll dimension of the side pieces that engage the vestibular
free wall.
Hence, in one embodiment, the rostral-poll dimension of the midline region is
at
least as great as the rostral-poll dimension of either of the side pieces. In
an
alternative embodiment, the rostral- poll dimension of the midline region is
greater
than the rostral-poll dimension of the right or left side piece.
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As used herein, the term "support" refers to reducing the amount of
narrowing of the nasal passage that can occur during inspiration or expiration
of
domestic animals. Accordingly, "support" can include a situation in which
there is
some drawing in of the vestibular free wall at the rostral nasal passage
during
inspiration, but less than that which would occur without a device of the
invention.
"Support" also includes maintaining the position of the external soft tissue
over the
rostral nasal passage in a neutral position. As used herein, "neutral" refers
to a state
where the unsupported vestibular tissues are neither drawn into the nasal
cavity nor
protruding externally relative to a resting position. In some arrangements,
"support"
also includes maintaining the vestibular free wall in a "distended" outward
position
relative to the neutral position.
The configuration, arrangement and components of a support device for
animals as disclosed herein takes into account the anatomical and
physiological
characteristics of the vestibular free wall as well as the bony structures
defining the
borders of the vestibular free wall, unique problems presented in applying the
device
to an animal as well as equipment used on or around an animal wearing a nasal
support device. Moreover, in most large domestic animals, the structural
support
necessary to support the lateral free wall must also take into account the
weight of
the tissue supported and the proper leveraging for distributing the weight
supported
without causing pressure sores or other irritation to surrounding tissues. In
addition,
due to the muscle control of the upper lip of the horse, supporting the
vestibular free
wall must also address the active and passive mobility of the muzzle
structures.
The size of a device of the invention can vary. Appropriate sized devices
will typically correspond with muzzle size which can vary with the body size,
breed,
age, and sex, of the animal. It is foreseen that smaller size NSDs for young
animals,
such as calves and foals can be beneficial in treating, for example, upper or
lower
respiratory ailments. In some embodiments, the rostral-poll midline dimension
of
an NSD for an average sized adult horse is about 3 to 16 cm, preferably 6-14
cm and
the rostral poll dimension of the right and left side is about 3 to 12 cm.
The transverse dimension of an NSD can also vary. The "transverse
dimension" is defined as the length of the device from the peripheral edge of
one
side of the device to the peripheral edge of the second side of the device.
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transverse dimension can be approximately equal at the rostral and caudal
edge.
Alternatively, the transverse dimension can vary in a single device depending
if
measured, for example, along the caudal edge, the rostral edge, the narrowest
part or
the widest part or somewhere in between. In one embodiment of an NSD for an
S average size horse, the transverse dimension at the narrowest part can be
about S-12
cm and about 10-l7cm at the widest part.
Typically, an NSD according to the invention includes at least a "support
layer" and an "engaging layer". A release liner which is peelably attached to
the
engaging layer can be used. In some embodiments a "surface layer" can be
present
to cover the side of the support layer that is away from the nose of the
animal when
the device is secured to the nose of the animal. Some embodiments can also
include
a carrier layer which can be removably attached to the surface layer to
facilitate
handling and proper placement of the support device on an animal's nose. The
exterior color of the surface layer is preferably selected to reduce the
likelihood of
the device causing interference with equipment used for determining results of
a
particular competitive event.
The support layer of the device provides the majority of the support for the
vestibular free wall of the nasal passage of an NSD. Generally, support is
provided
in the support layer through the use of one or more "lift members." As used
herein
a "lift member" can be prepared from any suitable material which provides the
desired support to the vestibular free wall. Examples of suitable materials
for a lift
member include thermoplastic resins, thermoset resins, shape memory metals,
alloys, leather, etc. The lift member can be a unitary open mesh or solid
material.
One example of a preferred material for a lift member is a biaxially oriented
2S polyester such as MYLAR~ available from DuPont Films, Wilmington DE. Other
suitable materials for a lift member are disclosed in U.S. Patent No.
5,913,873 and
International Patent Publication WO 98/47451.
In some embodiments, the lift members are of a generally uniform thickness
throughout their length and width. The thickness of the lift members will
typically
be selected based on the support needed, and is generally the same throughout.
However, the lift members can also vary in thickness in dii~erent regions of
the
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device. In addition, a lift member need not be the same width throughout its
length.
That is, a lift member can be wider at the lateral ends of the lift member and
narrower near the midline region. Alternatively, a lift member can be wider in
the
region that will lie over the midline region of the nose and narrower on the
ends.
Suitable thickness for a lift member prepared from a polyester such as
MYLAR~ for an adult large animal such as a horse is about .008 to about .020
inches. In one preferred embodiment, the thickness of a support member for an
average size adult horse is about .014 inches.
The support layer can include one or more lift members. The lift members
can be positioned parallel to the transverse axis of the device and extend
partially or
completely to the lateral edges of the device. Three to six lift members are
preferred
for some animals such as a horse. When more than one lift member is used, the
width, length and spacing of the lift members can vary based on the overall
dimensions of the particular device. Also, the length of the individual lift
members
can vary in a single device so as to traverse some or all of the dorsal-
ventral
dimension of the vestibular free wall. Preferably, the transverse length
dimension of
a lift member is sufficient to traverse the midline of the animal's nose and
extend to
the right and left side pieces beyond the dorsal lateral nasal cartilages to
support the
right and left vestibular free walls. In some embodiments, the lift members
can
extend beyond the ventral edge of the vestibular free wall to a point lateral
to the
incisive bone. Generally, the lift members provide a "lift" effect on the
vestibular
free wall to reduce drawing of the vestibular free wall into the nasal passage
during
respiration. However, if the lift members extend beyond the ventral edge of
the
vestibular free wall to the lateral aspect of the incisive bone, the incisive
bone can
act with the lift members to "stmt" the vestibular free wall and facilitate
the
reduction of the drawing of the vestibular wall into the nasal cavity that is
provided
by the lift members. This may be particularly advantageous in large animals
during
labored breathing.
When using multiple lift members, the spacing between individual lift
members can affect the adherence and overall functioning of the device. When
two
or more lift members are used, the width of the lift members and the spacing
between lift members are selected for the NSD to provide the desired support
to the
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vestibular wall with sufficient flexibility to reduce the chance of irritation
due to
localized pressure at leveraging points on the animal's nose. Use of multiple
lift
members advantageously provides for torsional flexibility of the device which
facilitates function and reduces the likelihood of disengagement of the device
when
subjected to the unique mobility of an animals vestibular tissues. In one
embodiment of an NSD for an average size adult horse, the length of the lift
members can be about 4-18 cm, preferably about 9-13 cm, the width can be about
0.2 to 2 cm and the spacing between lift members about 0.2 to 2 cm, preferably
about 0.3 to 1.0 cm.
In one embodiment, the lift member can be a single member of a previously
described solid or open mesh material that is shaped to support or stmt a
single
vestibular wall. That is, the outer contours of the lift member are configured
to
follow the peripheral margins of the vestibular wall. Preferably, the
perimeter edge
of the lift member is extended to allow the lift member to overlap the borders
of the
vestibular wall by about 0.2 - 2 cm. According to this embodiment, the lift
member
can include an engaging layer and optionally a surface or pad layer.
Preferably, the
engaging layer extends beyond the perimeter of the lift member to enhance
adherence to an animal's nose. However, rather than connecting at the midline
region of the nose, this embodiment of an NSD comprises two separate pieces,
that
act as a stmt for each vestibular wall.
An NSD preferably includes an engaging layer. The engaging layer provides
for securing an NSD to the animal's nose. If no surface layer (described
below) is
present and individual lift members are used, the engaging layer can also
provide for
maintaining the unity of the device. Typically, the engaging layer can secure
the
NSD to the nose by use of an adhesive. Other invasive forms of engaging to the
nose, such as suturing, are possible but not desired. Preferably, the adhesive
is
biocompatible and provides minimal or no contact irritation when applied to
the
external tissues of an animal.
Suitable materials for the adhesive of the engaging layer are single or double
coated medical tape, transfer adhesives, liquid adhesives, pressure sensitive
adhesives (PSA), etc. A release liner is preferably applied to the adhesive of
the
engaging layer to cover the adhesive surface until the support device is
applied to an
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animal. In some embodiments, the release liner can comprise one or more
sections
which can be selectively removed from the engagement layer to facilitate
positioning
of the support device on the nose. Examples of suitable adhesive systems
include
No. 1509 double sided medical tape, No. 9942 Hydrocolloid Skin Protective
Adhesive and No. 1524 transfer adhesive available from 3M Co., St. Paul, MN.
One
presently preferred adhesive is Dermamed DM-2009, available from Dermamed,
381 Geneva Avenue, Pallmadge, OH 44278.
The NSD can include a surface layer. The surface layer is the layer farthest
from the soft tissues of the animal and is visible when the device is applied
to the
animal's nose. Thus, one side of the surface layer faces the soft tissue on
the
animal's nose and a second side faces away from the nose. The side of the
surface
layer closest to the soft tissue of the animal can include an adhesive to
adhere the
surface layer to the support layer, to the side of the engaging layer that may
be
exposed between lift members, or to a pad layer if used. The surface layer can
provide additional support to the vestibular wall and help maintain unity of
the
components of an NSD. A suitable surface material can be breathable or non-
breathable and typically includes a biocompatible adhesive. An example of a
breathable material suitable as a surface layer is No. 1533 available from 3M
Inc.,
St. Paul, MN. One preferred non-breathable surface material is No. 9906T non-
woven medical tape available from 3M Co., St. Paul, MN. Another example of a
suitable surface layer is No. 9910 non-woven medical tape available from 3M
Co.,
St. Paul, MN.
The surface layer can include an ornamental design color, pattern, logo etc.
if
desired. Alternatively, an ornamental veneer layer can be applied to the
exposed
surface of a surface layer or support layer. The color of the surface layer is
preferably selected so as to reduce glare which can interfere with photographs
taken
to determine the outcome of a performance event such as a finish line
photograph
taken in a horse race. Examples of suitable colors which cause reduced glare
are
dark colors such as black, dark blue, dark green, dark gray, dark brown, etc.
The engaging layer may extend only to the peripheral extent of the lift
members of the support layer. Alternatively, the periphery of the engaging
layer can
extend beyond the peripheral extent of the lift members of the support layer
(i.e.,
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laterally, rostrally and caudally). In some preferred embodiments, the
periphery of
the engaging layer can extend beyond the support layer to provide improved
engagement of the support device to the animal's nose. In one such embodiment
a
region of about 0.5 cm to 4 cm, preferably about 1.0 - 2.0 cm of engaging
layer
extends beyond the lateral extent of the lift members of the support layer and
1.0 -
3.0 cm beyond the rostral-caudal extent of the support layer. The surface
layer
typically extends the same distance beyond the lift members as does the
engaging
layer. If present, the surface layer typically has the same perimeter
dimensions as
the engaging layex.
Generally, the overall thickness of the device is uniform. Some variation in
thickness can occur due to differences in thickness of those regions of the
device
including the support members and those regions having spacing between support
members.
The inventors also recognize that single or multiple lift members without a
unifying layer (e.g., surface layer or engaging layer) can be used. According
to this
embodiment, an engaging layer, such as a previously described adhesive, can be
applied to the lift member. One or more lift members can then be applied
directly to
the animals nose. While this embodiment may address the unique physiological
and
anatomical aspects of an animals nose as disclosed herein, the application and
removal of the support members will be cumbersome. In addition, the support
provided by the surface layer or engaging layer in the regions between the
lift
members will be lost.
A support device according to the invention can also include a "carrier
layer". The carrier layer can be removably adhered to the side of the surface
layer
away from the animal's nose. The carrier layer can be made from any suitable
material including paper, metal foil, plastic, cardboard, etc. The carrier
layer is
preferably adhered to the surface layer using an adhesive system which
provides a
peel resistance which is less than the peel resistance between the adhesive of
the
engaging layer and the animal's nose when the support device is adhered to the
animal's nose. Suitable adhesive systems for adhering the carrier layer to the
surface
layer are known and disclosed in, for example, U.S. Patent Nos. 3,691,140;
4,994,322; 5,266,402; 5,502,109; and 5,719,247.
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One preferred adhesive is No.
9425 available from 3M Co., St. Paul, MN. This adhesive system is a double
side
tape wherein a first side of the tape (applied to the carrier layer) has a
greater peel
resistance than the second side of the tape (applied to the surface layer) aad
the peel
resistance of the second side of the tape is less than the peel resistance of
the
adhesive between the engaging layer and the animal's nose.
The perimeter edge of the carrier layer can follow the perimeter edge of the
surface layer of the support device or the perimeter edge of the carrier layer
can
extend beyond the perimeter edge of the surface layer. Alternatively, portions
of the
carrier layer can extend beyond the perimeter edge of the surface layer and
other
portions follow the perimeter edge or not extend to the perimeter edge of the
surface
layer. Extending the perimeter edge of the carrier layer beyond the perimeter
edge
of the surface layer provides a region of the carrier layer which can be
grasped for
handling or removing the carrier layer from the surface layer without
contacting the
adhesive of the engaging layer. Alternatively, the carrier layer can be slit
to provide
an internal edge to grasp for removing the carrier layer from the surface
layer. In a
preferred embodiment, the perimeter edge of the carrier layer can be
configured to
provide a guide for positioning of the support device on an animal's nose.
Thus, after removal of some or all of the release liner from the adhesive of
the engaging Iayer, the carrier layer can be grasped during application of the
device
without contacting the adhesive of the engaging layer. Once engaged to the
nose,
the carrier layer can be peelably removed from the support device. The carrier
layer
can also be marked with instructions for proper positioning and orientation of
the
support device to assist the person applying the device to the animal.
in another embodiment of the invention, a support device can comprise two
separate pieces, one for supporting a portion of each of the right and left
vestibular
wall For example, only the caudal aspect of each of the vestibular walls may
be
supported by the device. According to one such embodiment, the support device
can
extend from the nasal bone to the incisive bone, across the "caudal apex
region" of
the vestibular wall near the intersection of the nasal and incisive bones. In
an
alternative embodiment, the support device can extend rostrally over the
caudal apex
of the vestibular wall from a location caudal to the intersection of the
incisive and
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nasal bones. In another embodiment, the support device can extend from the
nasal
bone to the incisive bone, across the caudal apex of the vestibular wall, and
extend
caudally over the intersection of the incisive and nasal bones.
Examples of support devices and methods of the invention will now be
further described by reference to the following illustrated embodiments.
Detailed Description of Illustrated Embodiment
Anatomical reference points and embodiments of an NSD according to the
invention will be described in detail with reference to the drawings using the
horse
as an example. Like reference numerals represent like parts and assemblies
throughout the several views. Reference to the drawings is not intended to
limit the
scope of the invention to the illustrated embodiments.
FIG. 1 is a top plan view of the configuration of one embodiment of a nasal
support device (NSD) 10 according to the invention. Dimensions which can be
used
to characterize an NSD are shown wherein letters followed by a subscript "T"
are
transverse dimensions. Thus, CT is the caudal transverse dimension, RT is the
rostral
transverse dimension, S is the rostral-poll dimension of the side piece and M
is the
rostral- poll dimension at the midline of the device. The bottom plan view of
NSD
10 is substantially identical to the top plan view of FIG. 1 except that the
support
layer, shown in FIGs. 3 and 4, may be visible in the bottom plan view.
The NSD 10 includes a first side piece la and a second side piece lb that
intersect at the midline 2 of the midline region 2a and 2b. In use, the
rostral end 3 is
oriented towards the apex of the animal's nose and the caudal end 4 is
oriented
towards the eyes of the animal. In the embodiment of FIG. l, the midline
rostral-
poll dimension M is at least equal to the rostral-poll dimension S of side
pieces la
and lb. In some embodiments, the rostral-poll dimension of the NSD at the
midline
2 can be greater than the rostral-poll dimension S of the first or second side
pieces
la, lb. It will be appreciated that in the illustrated embodiment ,the rostral
transverse dimension RT is less than the caudal transverse dimension.
Bony anatomical structures which surround the vestibular free wall which is
supported by a support device of the invention are described with reference to
FIG. 2
which is a profile view of the bony anatomy of the rostral region of the
horse's head.
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A more complete discussion of the relevant anatomy is disclosed in U.S. Patent
No.
5,913,873. Briefly the lateral
free wall of the vestibule is defined dorsally by the lateral aspect of the
nasal bone 5,
ventrally by the incisive bone 6, and caudally by intersection 7 of the nasal
5 and
incisive 6 bones. The rostral aspect of the vestibular free wall is bordered
by the
nostril (not shown).
The shaded area 8 in FIG. 2 depicts the approximate area underlying the
"caudal apex region" of the vestibular wall. In some embodiments, a support
device
of the invention may be configured to support only the caudal apex region of
the
vestibular wall to facilitate air flow through the nasal passages. The caudal
apex
region is nearest the nasal valve region of the nasal passages which is
particularly
vulnerable to narrowing under certain conditions.
FIG. 3 is a bottom exploded view of NSD 10 illustrating a surface layer 11,
support layer 12, engaging layer 13 and release liner 14. A carrier layer is
not
shown in this view. FIG. 4a is a top plan view of the NSD 10 of FIGs. 1 and 3
showing rostral 21, intermediate 22 and caudal 23 Lift members in phantom
lines.
In this embodiment, the transverse length T=" T~, and TZ3 of lift members 21,
22,
and 23, respectively, increases from the rostral end 3 to the caudal end 4 of
NSD 10.
In addition, lateral engagement extensions 29, comprise rostral (30a, 306),
rostral/intermediate (31a, 316), caudaUintermediate (32a, 32b) and caudal
(33a,
33b) lateral engagement extensions. Lateral engagement extensions 29 are
comprised of surface layer 11 and engaging layer 13 which extend beyond the
transverse length (i.e., lateral extent) of lift members 21, 22, and 23 to
facilitate
engagement of NSD 10 to the nose of the animal. The functional aspects of the
lateral engagement extensions can be embodied in various overall device
appearances.
FIG. 4b is a top view of an alternative embodiment of the lift members of
NSD 10. In this view, only lift members 34, 35, 36 are shown and they are in
the
same relative position as shown in phantom lines in FIG. 4a. At the lateral
extent of
each of lift members 34, 35, 36, there are pairs of notches 37a-d, 38a-c, 39a-
c which
can penetrate through a partial or full thickness of each of the lift members
34, 35,
36. In the illustrated embodiment, four pairs of notches 37a-d are present at
the
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lateral end of rostral lift member 34 and three pairs 38a-c, 39a-c are present
at the
lateral end of intermediate lift member 35 and caudal lift member 36. It will
be
appreciated that in this embodiment, the most lateral notches 37d, 38c, 39c of
each
lift member traverse a greater portion of the width of the lift members i.e.,
smaller
unnotched region between notches of a pair) than do notches nearer to midline
ML of
lift members 34, 35, 36. The number of notch pairs can be varied. Typically,
if
additional notch pairs are added, they are added nearer the midline ML region
of the
lift member.
The effect of notches which traverse an increasing portion of the width
dimension of the lift member from nearest the midline ML to the lateral end is
to
gradually decrease the peel force exerted on the engaging layer between the
support
device and the animal's nose and convert it to a shear force to facilitate
engagement
of the NSD 10 to the animal's nose.
Referring to FIG. 3, release liner 14 can comprise a single section or have a
single or multiple slits to make a multiple section release Liner. Suitable
release
liners for use with an adhesive of the engagement layer are known. In one
preferred
embodiment, illustrated in FIG. 3, release liner 14 comprises three
components, a
first lateral piece 40, a second lateral piece 41 and an intermediate piece
42.
According to this embodiment, when applying NSD 10 to an animal's nose,
intermediate piece 42 can be removed first and NSD 10 positioned over the
nasal
bones 5, and the midline region 44c of adhesive 44 of engagement layer 13
lightly
engaged to the skin over the nasal bones. Some repositioning can be performed
before the lateral aspects 44a and 44b of the adhesive 44 is exposed. Once the
proper final position of the NSD 10 is determined, first lateral piece 40 and
second
lateral piece 41 of release liner 14 can be removed and the lateral aspects
44a and
44b of adhesive 44 secured to the animal's nose.
In the embodiment of FIG. 3, the bottom side 50 of surface layer 11 (i.e., the
side towards the animal's nose when in use) includes an adhesive layer 51 to
adhere
the surface layer 11 to the top side 52 of lift members (21, 22, 23) and to
the top side
54 of engaging layer 13. The bottom side 53 of lift members (21, 22, 23) can
include an adhesive 56 to adhere the lift members (21, 22, 23) to the top side
54 of
the engaging layer. The bottom side 55 of engaging layer 13 includes adhesive
44 to
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adhere the device to the animal's nose. Each of the adhesives of NSD 10 can be
a
coated medical tape, transfer adhesive, liquid adhesive, PSA, etc. In one
preferred
embodiment, the surface layer I1 is 9910 black non-woven medical tape
available
from 3M Co., St. Paul, MN, the lift members 21, 22, 23 are MYLAR~ available
from DuPont Films, Wilinington, DE, the engaging layer 13 is DM-2009,
available
from Dermamed, Pallmadge, OH 44278 and the release liner is DM-2009 release
liner, also available from Dermamed.
In some embodiments, an NSD can include a carrier layer. FIG. 5, is a top
view of an NSD 10 including a carrier layer 60 which is releasably adhered to
the
surface layer 11. In this embodiment, carrier layer 60 follows the perimeter
edge 51
of surface layer 11 except at the rostral end 3 of the NSD 10. At the rostral
end 3,
the carrier layer 60 includes a rostral extension 61. Rostral extension 61
provides a
grasping portion 63, for handling NSD I0 with reduced likelihood of contacting
the
adhesive 44 of engagement layer 13, if the release liner has been removed. In
addition, in the embodiment of a carrier layer 60 of FIG. 5, the rostral
extension 61
is configured to provide an alignment guide for proper positioning of the NSD
10 on
an animal's nose. Specifically, by aligning the rostral edge 65 of carrier
layer 60 at
the apex of a horse's nostrils, the side pieces 1a and lb will be properly
aligned over
the lateral vestibular walls. FIG. 6 is a front view of an NSD 10 secured to
the nose
70 of a horse 71.
FIG. 7 is an NSD 10 having an alternative embodiment of a carrier layer 80
releasably adhered to the surface layer 11. As with carrier layer 60 of FIG.
5, carrier
layer 80 includes a rostral extension 81. In addition, carrier layer 80 also
includes a
caudal extension 82 to facilitate handling and positioning of the device 10.
In other
embodiments, the carrier layer could be configured to provide lateral
extensions or a
perimeter extension around the entire device.
A carrier layer and release liner as disclosed herein can also be used with
human
nasal support dilators as well as with animal nasal support devices as
disclosed in, for
example, U.S. Patent Nos. 5,913,873 and 6,033,422.
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FIG. 8 is a top view of an alternative embodiment of an NSD 100 according
to the invention. Four lift members 101,102, 103 and 104 are illustrated in
phantom
lines. It will be appreciated that in this embodiment, lift member 101 at the
rostral
end 105 of NSD 100 has the longest transverse dimension and lift member 104 at
the
caudal end 106 has the shortest transverse dimension. Lateral engagement
extensions 108a, 108b and 109a, 109b are also present for purposes previously
discussed.
FIGS. 9 and 10, illustrate an alternative embodiment of a support device and
method of the invention. For exemplary purposes, the following description
will be
made with illustrations of a support device applied to the skeletal anatomy of
a horse
to appreciate the relative positions of the anatomy and the support provided.
The embodiments of FIGS. 9 and 10 provide localized support to the caudal
apex region of the vestibular wall. FIG. 9 illustrates the positioning,
relative to
shaded area 8, of a support device 150 when applied to the caudal apex region
of the
vestibular wall. As illustrated, support device 150 has a dorsal edge 151
which
overlies a portion of nasal bone 5 and a ventral edge 152 which overlies a
portion of
incisive bone 6. The amount of dorsal edge 151 and ventral edge 152 which
overlies
nasal bone 5 and incisive bone 6 is preferably at least about 0.5 cm and
typically
about 1.0 to 3.0 cm.
FIG. 10 illustrates an alternative embodiment for supporting the caudal apex
region of the vestibular wall. In this embodiment, support device 160 extends
caudally beyond the intersection 7 of nasal bone 5 and incisive bone 6.
Preferably,
support device 160 extends about 0.5 cm to about 5.0 cm caudal to intersection
7.
Support device 160 also extends dorsally and ventrally over nasal bone 5 and
incisive bone 6, respectively, as described for support device 150.
It will be appreciated that although support device 150 is illustrated as a
rectangle and support device 160 as a triangle, other shapes, including
squares,
circles, ovals, octagons, etc., can be used to provide function according to
this aspect
of the invention. In addition, support devices 150 and 160 can include a
carrier
layer, surface layer, support layer, engaging layer and release liners as
described for
other embodiments of the invention. The support layer can comprise one or more
lift members made of previously described materials.
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In another embodiment, an NSD according to the invention provides a
bilaterally symmetrical NSD across two dimensional axes of the device.
Referring
to FIG. 11, a general configuration for an NSD according to this embodiment is
diagrammatically illustrated. As illustrated, NSD 200 has a transverse axis AT
S through the widest transverse dimension WT. NSD 200 also has a longitudinal
axis
AL through the longest rostral-caudal dimension M. Thus, although other
longitudinal dimensions L and transverse dimensions T are present, the
greatest
dimension in either the longitudinal or transverse direction is at the axes.
According to this embodiment, the NSD is bilaterally symmetrical on
opposing aspects of transverse axis AT. That is, the upper surface 201 of NSD
200
looks substantially identical to the bottom surface 202. In addition, the NSD
is
bilaterally symmetrical on opposite sides of longitudinal axis AL such that
the right
surface 204 is substantially identical to the left surface 205. It will be
appreciated
that each axes AT and AL bisects the device into bilaterally symmetrical
halves in
their respective dimensions.
The general appearance of NSD 200 of FIG. 11 can include any of the
structural features or components of other NSDs disclosed herein, but, in
addition to
other advantages, this configuration provides for ease of application and
reduced
likelihood of malfunction due to improper positioning. Specifically, the
device
provides structural features in a configuration which can be placed on the
nose in the
position illustrated in FIG. 11 or rotated 180° therefrom.
In addition, the two axes bilaterally symmetrical devices can include all
structural aspects, components, or functional features described above for
other NSD
embodiments, but within varying appearances as illustrated in FIGS. 12-37 as
described below.
FIG. 12 illustrates a top side view of one appearance for the configuration of
a two axes bilaterally symmetrical NSD as described above with reference to
FIG.
11. FIG. 13-15 illustrate a bottom side view of the embodiment of FIG. 12 with
varying numbers of support members Z10 as described earlier. An intermittent
adhesive pattern can be used as described. Holes may also be placed through
the
device, preferably not located in or through the lift members.
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FIG. 16 is a top side view and FIGS. 17-19 are bottom side views of an
alternative appearance of an NSD containing the configurational features
described.
FIG. 20 is a top side view and FIGs. 21-23 are bottom side views of an
alternative
appearing embodiment. FIG. 24 is a top side view and FIGS. 25-28 are bottom
side
views of another alternative appearing embodiment. FIG. 29 is a top side view
and
FIGS. 30-32 are bottom side views of yet another alternative appearing
embodiment.
FIG. 33 is a top side view and FIGS. 34-37 are bottom side views of another
alternative appearing embodiment of an NSD according to the invention.
Thus, each of the foregoing embodiments illustrated in FIGS. 12-37 can
include some or all of the structural features or arrangements of other NSDs
disclosed herein but with different ornamental appearances. The side view of
each
of the embodiments is substantially void of any ornamental features. In
addition, the
lift members can be of the same number, size, shape, material, material
thickness,
etc. as previously described. In addition, construction features, component
layers,
1 S adhesive features, holes, intermittent adhesive patterns, etc. can be
used.
In another embodiment, an NSD 300 according to the invention can be
provided in component parts, some of which are reusable. FIG. 38 is a top plan
view of one such embodiment and FIG. 39 is an end-on view of the embodiment of
FIG. 38 looking from the rostral aspect R. According to this embodiment, NSD
300
includes a first side piece 301 for engaging to a first lateral vestibular
wall and a
second side piece 302 for engaging a second lateral vestibular wall. An
engaging
layer 303 including adhesives and adhesive systems as described earlier can be
applied to the bottom surfaces 304 or 305 of side pieces 301 and 302,
respectively,
for adhering the side pieces to the lateral vestibular walls. Bridge piece 306
is
configured to traverse the animal's nose and attach at a first lateral region
307 to the
first top side 308 of first side piece 301 and attach at a second lateral
region 309 to a
second top side 310 of second side piece 302. The bridge 306 can attach to the
side
pieces 301 and 302 using known systems such as velcro, buckles, zippers,
snaps,
hooks, hook and loops, snap-rings, clips or other similar attachment providing
for
reusable attachment of bridge piece 306 to the side pieces. The side pieces
301 and
302 will typically be replaced after each use.
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It will be appreciated that bridge piece 306 includes a surface material 320
which keeps individual lift members 312 in a fixed arrangement relative to one
another. The components of the surface layer and lift members can be as
previously
described. Alternative materials consistent with the functional requirements
for an
NSD of the invention can also be used. One, two, three, four or more lift
members
321 can be used as needed. Holes may also pass through the bridge piece 306
which
preferably do not pass through lift members 321.
Side pieces 301 and 302 may or may not include lift members and also may
or may not include holes. If used, one or more lift members can be used which
are
oriented parallel, perpendicular or oblique to the lift members of bridge
piece 306.
FIG. 40 illustrates another embodiment of an NSD 350 having a first side
piece 351 and a second side piece 352 substantially as described for NSD 300
above.
However, in contrast to bridge piece 306, the bridge piece of embodiment 350
comprises at least two, typically three and optionally more, independent lift
members 353. Each lift member can attach at its lateral region 354, 355 to
side
pieces 351 and 352 as described for NSD 300.
FIG. 41 illustrates another embodiment of an NSD 400 having a first side
piece 401 and a second side piece 402 substantially as described for NSDs 300
and
350. However, bridge piece 403 comprises a single unit piece which traverses
the
nose and attaches at its lateral edges 404 and 405 to first side piece 401 and
second
side piece 402 as described above. Hence, for each of the NSD embodiments 300,
350 and 400, the first and second side pieces can be discarded after use and
bridge
pieces 306, 353 and 403 can be reused. With each use, the operator can apply
the
lateral regions to the first and second side pieces with a selected amount of
tension
for a desired amount of support for the lateral vestibular wall.
The present invention also provides reusable nasal support devices for
animals. The term "reusable" refers to a nasal support device which can be
applied
to an animal, removed and subsequently reapplied to the same or a different
animal.
A single use of a nasal support device is typically considered in use from the
time of
adhesion to an animal's nose until removal of the device from the nose.
In one embodiment, a reusable nasal support device can be prepared by
application of a reuse engaging layer to the spent engaging layer of a
previously
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used nasal support device. As used herein, "spent engaging layer" refers to
the
engaging layer used to adhere a nasal support device to an animal after the
nasal
support device has been removed from the animal. The "reuse engaging layer"
provides an adhesive layer for reattaching the nasal support device to an
animal's
nose after an earlier engaging layer is spent. Nasal support devices which can
be
used according to this embodiment of the invention include, for example, any
of the
nasal support devices for animals disclosed herein or in the above recited
patents and
patent applications. Suitable reuse engaging layers include, for example,
double-
sided tape or transfer adhesives such as No. 1524 transfer adhesive available
from
3M Co., St. Paul, MN.
According to this embodiment, subsequent to application of a nasal support
device to an animal, the nasal support device can be removed from the animal
and a
reuse engaging layer applied to the spent adhesive surface of the engaging
layer
which previously was in contact with the nose of the animal. The reuse
engaging
layer is applied to the previously used nasal support device after removal
from the
animal. However, it will be appreciated that if the engaging layer becomes non-
functional (spent) due to the adhesive surface being spent as a result of
adhesion or
other contact with something other than the nose of an animal, nonetheless,
the reuse
engaging layers and methods disclosed herein can be used for preparing a
reusable
nasal support.
When a double-sided tape is used, the adhesive of each side of the tape may
be the same or different. For example, one side of the double-sided tape can
include
an adhesive which provides a high peel resistance from the engaging layer of
the
previously used nasal support device and the second side of the double-sided
tape
can include an adhesive which provides an appropriate peel resistance from the
animal's nose when applied to the nose. In general, the reuse engaging layer
can be
applied to a used nasal support device immediately after removal of the nasal
support device from an animal. In an alternative embodiment, the nasal support
device can be removed from the animal and a period of time allowed to pass
before
application of the reuse engaging layer applied to the nasal support device.
In one
embodiment, the reuse engaging layer is not applied to the used nasal support
device
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for at least three hours, typically at least 12 hours and in a preferred
embodiment at
least 24 hour after removal of the used nasal support device from an animal.
It is foreseen that a nasal support device can be used multiple times and thus
include a plurality of reuse engaging layers applied to the nasal support
device with
or without a reuse of the nasal support device between application of each
subsequent reuse engaging layer.
It is also foreseen that in an alternative embodiment, rather than using a
transfer adhesive tape or double-sided tape, a single-sided tape can be used.
According to this embodiment, one side of the single-sided tape includes an
adhesive for adhering the used nasal support device to an animal's nose. The
second
side of the single-sided adhesive tape does not include an adhesive. Thus, a
liquid
adhesive can then be applied to the engaging surface of the nasal support
device or
to the non-adhesive side of the single-sided tape, or both, and the single-
sided tape
mounted onto the spent engaging layer of the nasal support device. The
adhesive
side of the single-sided tape faces away from the spent engaging layer.
Preferably, the configuration of a single or double-sided tape or transfer
adhesive is pre-cut to substantially the same shape as that of the nasal
support device
on which the reuse engaging layer will be applied. For example, in a preferred
embodiment of a reuse engaging layer for a device as shown in FIG. 3, the
reuse
engaging layer would be shaped substantially as shown for surface layer 11 or
engaging layer 13. However, the configuration of the reuse engaging layer can
alternatively be packaged in a rectangular, square, circular, oval or other
shape and
cut to the desired shape close to the time of application of the reuse
engaging layer
to the nasal support device.
In an alternative embodiment, a reusable nasal support device for animals
can include one or more components as disclosed in the foregoing patents and
patent
applications with a "reusable engaging layer." According to this embodiment,
the
engaging layer can comprise an adhesive system which permits reapplication of
a
nasal support device to an animal after the nasal support device has
previously been
used on the same or a different animal without addition of a new engaging
layer.
One example of such a reusable adhesive which is suitable for this embodiment
of
the invention is a fibrous pressure-sensitive adhesive layer comprising an
entangled
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web of pressure-sensitive adhesive fibers such as disclosed in U.S. Patent No.
5,957,126.
Thus, a support device as disclosed herein provides support for the nasal
passages of an animal, particularly unsupported soft tissues. The devices can
provide reduced resistance to air flow, including reduced turbulence, at rest
and
during exercise. In addition, the support devices can be used to treat or
prevent
respiratory ailments in adult or young animals.
Support of unsupported nasal tissues is particularly advantageous for animals
such as horses because horses are obligate nose breathers. In preferred
embodiments, a herein disclosed NSD may reduce the amount of bleeding which is
associated with exercise-induced pulmonary hemorrhage (EIPH) in horses.
Methods
are known for determining the amount of pulmonary bleeding which occurs during
EIPH. One such method includes performing pulmonary lavage post exertion and
quantifying the number of red blood cells per microliter (i.e., RBC/~d) in the
lavage
fluid. In some embodiments, when a herein disclosed support device is worn
during
physical exertion by a horse susceptible to EIPH, pulmonary red blood cell
counts
can be reduced by at least 5%, preferably by at least 10-20%, in some
embodiments
by 30-40% and in some embodiments by at least 50-70% as compared to when the
same horse is exercised without the NSD.
Without being limited to a particular theory, the inventors believe that
support of the lateral vestibular wall, or portions thereof, over the nasal
region of an
animal decreases resistance to air flow and increases breathing efficiency.
That is,
when wearing an NSD, less energy is consumed by the animal during inspiration
or
expiration of air into the lungs. Resistance to air inflow/outflow is reduced
by
providing a cross sectional area of the nasal passages which is greater than
the cross
sectional area when the support device is not used. It is believed that a
decrease in
cross sectional area of the nasal passages requires an increase in
intrapleural pressure
(i.e., negative pressure) during inspiration to draw the same amount of air
into the
lungs. Airway resistance (R) is related to the pressure (P) across the nasal
airway
passage and flow (F) of air through the nasal passage by the equation: R =
P/F.
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The inventors believe that a high intrapleural negative pressure across
pulmonary aveoli combined with high pulmonary blood pressure during exercise
can
cause rupture of pulmonary blood vessels which manifests as EIPH.
In some embodiments, when a herein disclosed support device is worn
during exercise by a horse, nasal passage resistance can be reduced by at
least about
5-10%, typically 20-30%, and in some animals, by greater than 40%. In
addition, by
reducing nasal passage resistance, less work is required during breathing
resulting in
reduced oxygen consumption and reduced COZ production for the same amount of
exertion. Heart rate may also be reduced in a horse using an NSD when compared
to
the same horse performing at the same level of exertion without an NSD.
In another embodiment, the invention provides therapeutic devices for
treating conditions amenable to the delivery of magnetic, electromagnetic,
thermal
(hot or cold), ultrasonic or other energy emitting modality. The device could
also
provide for delivery of a pharmaceutical agent. According to this embodiment,
the
surface layer and engaging layer components and constructions herein described
for
an NSD can be used. However, in contrast to previously described devices, in
the
present devices, the support layer is supplanted by, or supplemented with, a
therapeutic layer. In addition, the configurational appearance can vary
depending on
the size or region of the body to which it is desired to deliver the
therapeutic energy.
According to this embodiment, the therapeutic layer can include wafer
shaped magnets, electromagnets, ultrasound transmitters, thermal emitters or
other
known therapeutic modality. For example, in one embodiment, the lift members
can
be supplanted by placement of thin magnets which deliver magnetic energy to a
localized region of the body over which the device is placed. In general,
preferred
components of the therapeutic layer, such as magnets, are flexible to conform
to the
location of the body where the device will be applied, but lack significant
elasticity
or shape memory which would act to conform the shape of the body region to the
engaging surface of the device. The adhesive surface can be continuous or
intermittent on one side of the therapeutic layer. A surface layer may
optionally be
used.
In some embodiments, the device can include a surface layer, a therapeutic
layer and an adhesive layer. The surface layer can be configured to include a
border
which extends sufficiently around the perimeter of the therapeutic layer. The
adhesive layer can then be applied over the therapeutic layer and the
perimeter
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WO 00/53132 PCT/US00/05943
border to provide adhesive engagement of the device to a selected location of
the
patient's body. As described for the support layer above, an adhesive can be
used to
adhere the therapeutic layer to the surface layer. Examples of appearances of
suitable configurations can be understood by reference to FIGS. 3, 12-37
wherein
the lift members would be replaced by the particular therapeutic delivery
apparatus.
For example, FIG. 42 illustrates one embodiment of a bottom plan view of
therapeutic device 500. As described for an NSD, the surface layer 501 can
include
an engaging layer 502 (transparent in this view) on the bottom surface 503 of
surface
layer 501 and therapeutic layer 504. In this embodiment, therapeutic layer 504
can
be a wafer magnet 505 or other apparatus for providing a particular
therapeutic
modality.
Many of the adhesive systems disclosed herein are advantageous for adhering
to the body. In addition, by adjusting the moisture absorbing characteristics
of the
adhesives used, such as by addition of a hydrocolloid, such as
carboxymethylcellulose, polyacrylamide, or similar composition, the ability to
maintain position in the presence of sweat or other fluids will be increased.
In
addition to other adhesives, suitable adhesives include adhesives of a type
used to
maintain EKG patches on a human or animal body. In an alternative embodiment,
the therapeutic deliver apparatus can be inserted into a pouch made from
plastic,
PTFE, fabric or other suitable material having a surface coated with an
engaging
layer as disclosed herein.
Examples of conditions which can be treated by placement of a herein
disclosed therapeutic device at or near the location of the condition include:
acute or
chronic inflammation, non-union fractures, splints, muscle soreness, tendon
injuries,
etc.
Having now described the invention, it will be apparent to one of skill in the
art that changes and modifications can be made to the invention without
departing
from the spirit or scope of the appended claims. All modifications and
equivalents
of the disclosed invention are intended to be included within the scope of the
claims.
29
