U.S. patent application number 13/040084 was filed with the patent office on 2012-03-08 for nasal support device for animals and method.
This patent application is currently assigned to WINEASE LLC. Invention is credited to Edward L. Blach, James R. Chiapetta, Daniel E. Cohen.
Application Number | 20120059406 13/040084 |
Document ID | / |
Family ID | 23497224 |
Filed Date | 2012-03-08 |
United States Patent
Application |
20120059406 |
Kind Code |
A1 |
Blach; Edward L. ; et
al. |
March 8, 2012 |
Nasal Support Device for Animals and Method
Abstract
Devices and methods for facilitating air flow in the nasal
passages of domestic animals are disclosed. The devices include
support devices for supporting unsupported tissues of the nasal
passages which facilitate air flow during rest, physical exertion,
respiratory ailment, etc. Components and methods to facilitate
application of the support device to the nose of an animal are also
disclosed.
Inventors: |
Blach; Edward L.; (Roswell,
NM) ; Chiapetta; James R.; (Delano, MN) ;
Cohen; Daniel E.; (Eden Prairie, MN) |
Assignee: |
WINEASE LLC
EAGAN
MN
|
Family ID: |
23497224 |
Appl. No.: |
13/040084 |
Filed: |
March 3, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11708669 |
Feb 20, 2007 |
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13040084 |
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10087668 |
Mar 1, 2002 |
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11708669 |
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09379425 |
Aug 23, 1999 |
6352548 |
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10087668 |
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Current U.S.
Class: |
606/204.45 |
Current CPC
Class: |
A61F 5/08 20130101; A61D
7/04 20130101; A61D 9/00 20130101 |
Class at
Publication: |
606/204.45 |
International
Class: |
A61D 99/00 20060101
A61D099/00 |
Claims
1. A support device for supporting tissues overlying a first and
second nasal passage, the support device comprising: 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 surface layer; and a carrier layer releasably
mounted to the surface layer.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 11/708,669, filed Feb. 20, 2007, which is a
continuation of U.S. patent application Ser. No. 10/087,668, filed
Mar. 1, 2002, which is a continuation of U.S. patent application
Ser. No. 09/379,425, filed Aug. 23, 1999, now U.S. Pat. No.
6,352,548, which applications are hereby incorporated by reference
in their entireties.
FIELD OF THE INVENTION
[0002] The present invention is directed to facilitating air flow
through the nasal passages of an animal. Specifically, the
invention provides nasal support devices and methods for supporting
soft tissue structures of the nasal passages of an animal.
BACKGROUND OF THE INVENTION
[0003] Portions of the following discussion of the nasal anatomy of
domestic animals are excerpted from R. Nickel et al., The Viscera
of Domestic Mammals, (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.
[0004] The nasal anatomy of animals is considerably different than
that of a human. Unlike the human nose that projects distinctly
from the face, in many animals, the nose is incorporated into the
face and forms the large dorsal and lateral areas rostral to the
eyes. The nostrils at the apex of the nose are the entry to the
respiratory system. Once passing through the nostrils, inspired air
moves through the nasal cavities and continues into the
nasopharynx, larynx, trachea and lungs.
[0005] 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
typically bony, while rostrally the septum consists of cartilage
which becomes progressively more flexible toward the apex.
[0006] 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 bones and cartilages of the nose are associated with
the nasal muscles that regulate the size of the nostrils.
[0007] 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.
[0008] A further difference in the formation of the nasal
cartilages of the horse is the presence of alar cartilages. The
alar cartilages consist of a ventral cornu and a dorsal lamina and
support the nostrils dorsally, medially and ventrally. The lamina
of the alar cartilage and the medial accessory cartilage support
the nasal diverticulum, a blind pouch in the dorsal aspect of the
nostril.
[0009] 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.
[0010] The dorsal lateral area of the rostral nasal cavity that is
caudal to the alar cartilages 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.
[0011] The physiological effects of reduced oxygen transfer at rest
and during physical exertion in horses 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. 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).
[0012] Devices for dilating the outer wall tissue of the nasal
passages in humans are known and described in, for example, U.S.
Pat. Nos. 5,476,091; 5,533,503; 5,546,929; 5,549,103; 5,553,605;
5,611,333; and 5,653,224. Devices for supporting outer tissues of
the nasal passages of animals must address the unique 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 U.S. Pat. No. 5,913,873 and International Patent Publication WO
98/47451. The entire disclosure of the foregoing patent and patent
application are incorporated herein by reference.
SUMMARY OF THE INVENTION
[0013] The present invention provides support devices and methods
for supporting the unsupported nasal tissues of an animal. 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
address 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.
[0014] 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.
[0015] In general, a support device according to the invention
provides support to the right and left lateral vestibular walls of
a domestic animal. The device can also include a surface layer, a
support layer, and an engaging layer. The support devices included
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.
[0016] 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.
[0017] 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.
[0018] 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
effect(s) of respiratory diseases in an adult or young animal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a top plan view of one embodiment of a nasal
support device according to the invention;
[0020] FIG. 2 is a profile view of the bony anatomy of the rostral
nasal cavity of the horse;
[0021] FIG. 3 is a bottom exploded view of the nasal support device
of FIG. 1;
[0022] FIG. 4a is a top view of the nasal support device of FIG. 1
with the support layer illustrated in phantom;
[0023] FIG. 4b is a top view of one embodiment of lift members
according to the invention.
[0024] FIG. 5 is a top plan view of the nasal support device of
FIG. 1 having a carrier layer;
[0025] FIG. 6 is a front view of a horse having the embodiment of a
nasal support device of FIG. 1 secured to its nose;
[0026] FIG. 7 is a top plan view of the nasal support device of
FIG. 1 having an alternative embodiment of a carrier layer;
[0027] FIG. 8 is a top plan view of an alternative embodiment of a
nasal support device according to the invention;
[0028] FIG. 9 is a diagrammatic representation of an alternative
embodiment of a nasal support device according to the invention;
and
[0029] FIG. 10 is a diagrammatic representation of another
alternative embodiment of a nasal support device according to the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0030] The invention is directed to devices and methods for
supporting tissues at the rostral aspect of the nasal cavity of
domestic animals. 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
disclosed devices are particularly advantageous for animal devices,
some of the components and features may also be advantageously used
with nasal dilators for humans.
[0031] In general, a support device of the invention can be used
anytime it is desired to facilitate or enhance nasal air intake. In
addition to facilitating air flow, the support devices can also be
used to treat or prevent respiratory ailments in adult or young
animals. The devices and methods of the invention may be
particularly beneficial in horses for reducing the severity or
effect(s) 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),
etc.
[0032] As used herein, the term "rostral" refers to that aspect of
the nose 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. The "vestibule" refers to the rostral aspect of the nasal
cavity that is defined by the alar 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. The supported regions of the vestibule are
generally supported by bone or cartilage.
[0033] 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.
In some species, the ventral border can include the ventral lateral
nasal cartilage. For purposes herein, the vestibular wall can be
divided into at least two portions, a rostral portion being that
portion nearest the nostrils 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.
[0034] Herein, "soft tissue" has its general meaning including
skin, muscle, fat, connective tissue or associated integumentary
structures.
[0035] Some exemplary embodiments of support devices of the
invention and components are described below. Throughout the
specification guidance may be provided through lists of examples.
In each instance, the recited list serves only as a representative
group. The examples of the groups are not meant to be limiting.
[0036] In a typical embodiment, a support device provides support
to at least a portion of the right and left lateral vestibular
walls of an 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 some or all of 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 overlie the intersection of the left and right nasal
bones and the right and left side pieces overlie the first and
second vestibular walls, respectively.
[0037] The side pieces and the midline region of the support device
each have a rostral end, a caudal end and a rostral-poll dimension.
Due to the size and anatomical configuration 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 a support device is preferably
substantially equal to or greater than the rostral poll dimension
of the side pieces. 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.
[0038] 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 some drawing in of the vestibular free wall
into 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.
[0039] The configuration, arrangement and components of a support
devices disclosed herein takes into account the anatomical and
physiological characteristics of the vestibular free wall, 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.
[0040] The size of a device of the invention can vary. Appropriate
size devices configured for an animal 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 support devices 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 can be
about 3 to 12 cm. However, larger and smaller sizes may be
used.
[0041] The transverse dimension of an NSD can also vary. The
"transverse dimension" is defined as the length of the device from
the lateral edge of a first side of the device to the lateral edge
of the second side of the device. The transverse dimension can be
approximately equal at the rostral and caudal edges. Alternatively,
the transverse dimension can vary in a single device depending if
measured, for example, along the caudal edge, the rostral edge, or
somewhere in between.
[0042] Typically, a support device 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 is
also typically included. 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.
[0043] The support layer of the device provides the majority of the
support for the vestibular free wall of the nasal passage.
Generally, the support layer comprises 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 an open mesh or solid
material. One example of a preferred material for a lift member is
a biaxially oriented polyester such as MYLAR.RTM. available from
DuPont Films, Wilmington Del. Other suitable materials for a lift
member are disclosed in U.S. Pat. No. 5,913,873 and International
Patent Publication WO 98/47451 which are incorporated herein by
reference.
[0044] In some embodiments, the lift members can be a generally
uniform thickness throughout their length and width. The thickness
of the lift members can typically be selected based on the support
needed, and is generally the same throughout. However, the lift
members can also vary in thickness in different regions of the
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
ends of the lift member and narrower near the midline region.
Alternatively, a lift member can be wider near the midline region
and narrower at the ends.
[0045] For an adult large animal such as a horse, a suitable
thickness for a lift member prepared from polyester such as
MYLAR.RTM. is about 0.008 to about 0.020 inches. In one preferred
embodiment, the thickness of a support member for an average size
adult horse is about 0.014 inch.
[0046] 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. 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.
[0047] 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 device to provide the desired support to the
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 animal's vestibular tissues.
In one exemplary embodiment of a support device 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.
[0048] A support device according to the invention also includes an
engaging layer. The engaging layer provides for securing the
support device to the animal's nose, typically, by use of an
adhesive. Preferably, the adhesive is biocompatible and provides
minimal or no contact irritation when applied to the external
tissues of an animal.
[0049] Suitable materials for the adhesive of the engaging layer
are single or double coated medical tapes, 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 animal. As will be described below, 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, Minn. One presently preferred adhesive is
Dermamed DM-2009, available from Dermamed, 381 Geneva Avenue,
Pallmadge, Ohio 44278.
[0050] A support device also includes a surface layer. The surface
layer is visible when the device is applied to the nose of an
animal. Thus, one side of the surface layer faces the soft tissue
of the animal's nose and a second side faces away from the nose.
The side facing the animal's nose can include an adhesive to adhere
the surface layer to the support layer, to the engaging layer that
may be exposed between lift members of the support layer, or to a
pad layer, if used. A suitable surface material can be breathable
or non-breathable. One example of a suitable surface layer is No.
9910 non-woven medical tape available from 3M Co., St. Paul,
Minn.
[0051] 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.
[0052] 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., 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.
[0053] 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.
Pat. Nos. 3,691,140; 4,994,322; 5,266,402; 5,502,109; and
5,719,247. The entire disclosure of each of these patents is
incorporated herein by reference. One preferred adhesive is No.
9425 available from 3M Co., St. Paul, Minn. 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) and 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.
[0054] 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.
[0055] Thus, after removal of some or all of the release liner from
the adhesive of the engaging layer, 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.
[0056] 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
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.
[0057] Examples of support devices and methods of the invention
will now be further described by reference to the following
illustrated embodiments.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0058] Anatomical reference points and embodiments of a nasal
support device according to the invention will be described with
reference to the drawings, using the horse as an exemplary animal,
wherein like reference numerals represent like components and
assemblies throughout the several views. Reference to the drawings
is not intended to limit the scope of the invention to the
illustrated embodiments.
[0059] 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, C.sub.T is the caudal transverse dimension,
R.sub.T 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.
[0060] The NSD 10 includes a first side piece 1a and a second side
piece 1b 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. 1, the midline
rostral-poll dimension M is at least equal to the rostral-poll
dimension S of side pieces 1a and 1b. In preferred embodiments, the
rostral-poll dimension of the NSD at the midline 2 is greater than
the rostral-poll dimension S of the first or second side pieces 1a,
1b. It will also be appreciated that in the illustrated embodiment,
the rostral transverse dimension R.sub.T is less than the caudal
transverse dimension.
[0061] 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. A more
complete discussion of the relevant anatomy is disclosed in U.S.
Pat. No. 5,913,873, the entire disclosure having previously been
incorporated herein by reference. 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).
[0062] 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.
[0063] 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.sub.21, T.sub.22, and
T.sub.23 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, 30b),
rostral/intermediate (31a, 31b), caudal/intermediate (32a, 32b) and
caudal (33a, 33b) lateral engagement extensions. Lateral engagement
extensions 29 are comprised of surface layer 11 and engagement
layer 12 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.
[0064] 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 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 M.sub.L 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 M.sub.L region of the lift
member.
[0065] The effect of notches which traverse an increasing portion
of the width dimension of the lift member from nearest the midline
M.sub.L 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.
[0066] 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.
[0067] 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 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 11 is 9910 black non-woven
medical tape available from 3M Co., St. Paul, Minn., the lift
members 21, 22, 23 are MYLAR.RTM. available from DuPont Films,
Wilmington, Del., the engaging layer 13 is DM-2009, available from
Dermamed, Pallmadge, Ohio 44278 and the release liner is DM-2009
release liner, also available from Dermamed.
[0068] 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 10 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 1b 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.
[0069] 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.
[0070] 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.
Pat. No. 5,913,873 and co-pending applications U.S. Ser. Nos.
09/018,603 and 09/264,464, the entire disclosures of which are
being incorporated herein by reference.
[0071] 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.
[0072] 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.
[0073] 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 200 when applied to the caudal apex region of the
vestibular wall. As illustrated, support device 200 has a dorsal
edge 201 which overlies a portion of nasal bone 5 and a ventral
edge 202 which overlies a portion of incisive bone 6. The amount of
dorsal edge 201 and ventral edge 202 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.
[0074] FIG. 10 illustrates an alternative embodiment for supporting
the caudal apex region of the vestibular wall. In this embodiment,
support device 300 extends caudally beyond the intersection 7 of
nasal bone 5 and incisive bone 6. Preferably, support device 300
extends about 0.5 cm to about 5.0 cm caudal to intersection 7.
Support device 300 also extends dorsally and ventrally over nasal
bone 5 and incisive bone 6, respectively, as described for support
device 200.
[0075] It will be appreciated that although support device 200 is
illustrated as a rectangle and support device 300 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 200 and 300 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.
[0076] 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.
[0077] 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/.mu.l) 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.
[0078] 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.
[0079] 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.
[0080] 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 CO.sub.2
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.
[0081] 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.
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