DEVICE AND METHOD OF NASAL SUPPORT FOR DOMESTIC MAMMALS Field of the Invention The present invention is concerned with a method for facilitating the flow of air through the passages or nasal passages of a domestic animal. Specifically, the invention provides a device and method for supporting the soft tissue structures of the nasal passages of a pet.
BACKGROUND OF THE INVENTION Portions of the following discussion of the nasal anatomy of domestic mammalian animals are drawn from R. Nickel et al., The Viscera of Domestic Animáis, (2nd revised edition), Springer-Verlag, New York, Hiedelberg, Berlin ( 1979), pp. 211-221. This is an excellent text regarding the comparative anatomy of the visors 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 from that of a human. Unlike the human nose that is projected differently from the face, in domestic animals the nose is incorporated in the face and forms the large dorsal areas and REF: 31785 lateral rostral to the eyes. Nostrils at the tip of the nose are the entrance to the respiratory system of domestic mammals. Once it passes through the nostrils, the inspired air moves to the nasal cavities and advances through the nasopharynx, larynx, trachea and lungs. At the apical entrance to the nose the nostrils are divided by the nasal septum to divide the nasal cavity into right and left halves. The caudal portion of the septum is bony, while the septum consists of cartilage that becomes progressively more flexible towards the tip. The wall of the nose consists of external skin and a medium support layer of caudal bone and cartilage rostrally. The nasal cavity is lined by a mucous membrane. The rostral bones that make up the wall of the nose include the nasal bones, maxilla and incisors. The free borders of the nasal and incisor bone provide union for the cartilages that support the nostrils. The supporting 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 widening 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 on the flow of the rostral nasal passage to the nostrilo. An additional difference in the formation of the nasal cartilages of the horse is the presence of alar cartilages. The alar cartilages consist of a ventral horn and a dorsal lamina that supports the dorsal nostrils median and ventrally. The blade of the alar cartilage and the accessory accessory cartilage support the nasal di article, a blind sac in the dorsal aspect of nostril. The muscles of the nose and upper lip act to dilate the nostrils. This is particularly noticeable during a forced breath. In the horse, these muscles are well developed and can transform the nostrils normally semilunar to circular. The dorsal lateral area of the rostral nasal cavity that is caudal to the alar cartilages in the horse nostrils includes a region of unsupported soft tissue that can be pulled into the nasal cavity during air inspiration to the nasal passages. The nasal di erticle of the horse is part of the soft tissue structures of the horse that can be pulled into the nasal cavity. When the soft tissue is pulled inward it can narrow the nasal cavity and reduce the area for air intake, thus reducing the movement of air to the nasal passages and finally to the lungs where the oxygen is transferred. in the pulmonary alveoli. The physiological effects of reduced oxygen transfer at rest and during physical exercise are documented. Some experts have the theory that exercise-induced pulmonary hemorrhage (EIPH) in performance horses is triggered by suffocation due to the abnormal resistance of a closed or partially closed upper airway. The passage or upper air passage is defined as the region of the respiratory system that is located or located between the nostrils and the trachea at the level of the first rib. From here, the nasal passages are part of this region. Dr. Robert Cook, "EIPH or AIPE?" Tufts University researcher Suggests that the hemorrhage is not caused by EIPH but by asphyxia. "The Equine Athlete, pp. 22-23 (March / April 1997) Devices to dilate the tissue of the external wall of the teeth have been described. nasal passages in humans for example in the North American patents Nos. 5,533,503; 5,546,929; 5,553,605 and RE 35,408. However these devices do not deal with the unique soft tissue structures and mechanical problems associated with the provision of support for the nasal tissues of non-human mammals, especially high performance mammals such as the horse and the camel.
Thus, there is a need to reduce the detrimental effects of reduced air intake or to improve the physiological benefit of increased air intake during the physical exercise of domestic animals. Specifically, there is a need to increase or decrease the narrowing of the nasal passage that can occur during respiration in domestic mammals, especially performance animals such as the horse, the camel and the dog.
BRIEF DESCRIPTION OF THE INVENTION The present invention provides a device and method for using the device for supporting the unsupported nasal tissues of a pet. The invention is concerned with the provision of support in view of the structural and physiological characteristics unique to the nose of a non-human animal, for example a horse. In some embodiments, a nasal support device (NSD) described herein can reduce the inspiratory airflow impedance by at least about 5-10%. In one embodiment the invention consists of an NSD(nasal support device) to be secured to the nose of a pet. The NSD provides support to the left and right side vestibular walls of a pet. The device includes a support layer and a right and left side piece that when secured to the nose of the animal are positioned to provide structural support to the left and right side vestibular walls. The side pieces of the device can be found in the middle region of the device. When secured to the nose of a pet, the middle region of an NSD of the invention is mounted on both sides of the left and right nasal bones of the animal. The sides and the region of the median line each have a rostral end, a caudal end and a rostral-nape dimension. In one embodiment, the rostral-nape dimension of the midline region is at least as large as the rostral-nape dimensions of the lateral pieces. In an alternative modality, the rostral-nape dimension of the midline region is greater than the rostral-nape dimensions of the lateral pieces. In some embodiments, the rostral end of the NSD may extend rostrally between the nostrils in the form of a "tongue" to provide external support to the soft tissues between the nostrils. An NSD configured according to the invention can be used in many different animals. In one modality, an NSD is sized to fit an element of the Equidae family, in which the domestic horse is included. The device is 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, human, horse, camel, etc. In general, an NSD comprises a support layer, a coupling layer and in some embodiments a top layer and / or a pad or bearing layer. The support layer of an NSD may include one or more lifting elements to support the vestibular wall. The lifting elements can travel the nose and extend to a dorsal point to the ventral border of the vestibular wall or beyond the ventral border of the vestibular wall lateral to the incisor bone. Alternatively, one or more NSD lifting elements can be applied on each vestibular wall and support each vestibular wall independently without joining together through the midline of the nose. The invention further provides a method for supporting a first and second vestibular free wall of a pet by securing a device that supports the first and second vestibular free walls to the nose of the animal. In one embodiment, the method includes the use of an NSD as described herein. The method of the invention facilitates the flow of air through the nasal passages of a pet. The device and method of the invention are particularly advantageous for use on the horse and are beneficial to facilitate athletic performance or to reduce the presence, severity or effect (s) of respiratory diseases in an adult or young animal. A device and method according to the invention can be used on an animal that runs freely in a pasture or that uses saddles, harnesses or other equipment that can be attached to the nose of the animal.
BRIEF DESCRIPTION OF THE DRAWINGS Figure la is a top view of a configuration of an NSD embodiment incorporating the functional aspects of the invention. Figure Ib is a top view of a second configuration of an NSD mode that incorporates the functional effects of the invention. The figure is a top view of a third mode configuration of an NSD incorporating the functional aspects of the invention. The figure Id is a top view of a fourth configuration of a modality of an NSD that incorporates the functional aspects of the invention. The figure is a top view of a fifth configuration of a modality of an NSD that incorporates the functional aspects of the invention.
Figure 1 is a top view of a sixth configuration of an NSD embodiment that incorporates the functional aspects of the invention. Figure lg is a top view of a seventh configuration of a modality of an NSD that incorporates the functional aspects of the invention. Figure 1 is a top view of an eighth configuration of an NSD mode incorporating the functional aspects of the invention. Figure li is a top view of a ninth embodiment of an NSD embodiment incorporating the functional aspects of the invention. Figure 2 is a perspective view of the osseous and cartilaginous anatomy of the nasal cavity of the horse's face. Figure 3 is a profile view of the osseous anatomy of the horse's rostral nasal cavity. Figure 4 is a dorsal or superior view of the osseous anatomy of the rostral nasal cavity of the horse. Figure 5 is a top plan view of an NSD embodiment with the separate surface layer and the exposed support layer. Figure 6 is a top plan view of a second embodiment of an NSD with the separated surface layer and the exposed support layer.
Figure 7 is a top plan view of a third embodiment of an NSD with the separated surface layer and the exposed support layer. Figure 8 is a front view of a horse having a mode of an NSD of Figures 5 or 6 secured to its nose. Figure 9 is a front view of a horse having a mode of an NSD of Figure 7 secured to its nose. Fig. 10 is an exploded perspective view of the components of the mode of an NSD configured as shown in Fig. 5. Fig. 11 is a bottom plan view of a coupling layer of a mode of an NSD that It has a discontinuous adhesive configuration. Figure 12 is a bottom plan view of an NSD embodiment having holes through the thickness of the device. Figure 13 is an exploded perspective view of the NSD shown in Figure 12.
DETAILED DESCRIPTION OF THE INVENTION The invention is concerned with devices and methods for supporting soft tissue in the rostral aspect of the nasal cavity of domestic mammals. Specifically, the devices and methods described herein provide support for the unsupported region of the "vestibule" in the rostral nasal cavity. As used herein, domestic mammals include the majority of non-human production and performance animals that have a nose incorporated into the face instead of projecting therefrom, which can benefit from a device according to the invention . In such mammals dogs, sheep, goats, cattle, camels, llamas, etc. are included. A device according to the invention can be particularly useful for members of the Equidae family in which horses, donkeys, mules, zebras, etc. are included. As used in the present "performance activities" or "work" include activities such as traction, drive, racing (plane, obstacles, barrel, etc.), events, hunting, jumps, rodeos, track trip, endurance trip , etc. In general, the device can be used at any time in which it is desired to improve the nasal air intake. In addition to facilitating air flow, an NSD device according to the invention can also be used to treat or prevent respiratory distress in adult or young animals such as foals and calves. It is contemplated that the devices and methods of the invention may be particularly beneficial in horses to reduce the severity or effect (s) of laryngeal hemiplegia, chronic obstructive pulmonary disease (COPD) or exercise-related pathologies such as myositis, dorsal displacement of the soft palate (DDSP) or pulmonary hemorrhage induced by exercise (EIPH) or "bleeding". As used herein, the term "rostral" refers to that aspect of the nose or anatomical structure closest to the tip of the nose. "Flow" refers to that aspect of the nose closest to the nape or caudal aspect of the head in relation to the tip. "Vestibule" refers to the rostral aspect of the nasal cavity that is defined by the cartilages of the rostrally, the bone ventrally incisor, the nasal bone dorsally, the caudal intersection of the incisor and nasal bones caudally and the nasal septum median. Thus, the supported regions of the vestibule are supported by bones or cartilages. 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 ventral incisor bone and the intersection of the nasal and caudally incisor bones. In the horse, the dorsal border of the unsupported region may include the lateral dorsal nasal cartilage and in some species the ventral border may include the ventral lateral nasal cartilage. In the present, "soft tissue" has its general meaning which includes skin, muscle, fat, connective tissue or associated integumentary structures. In general, the anatomy of soft-horn mammals such as the horse and camel gives rise to unique physical mechanical problems to support vestibular soft tissues. For example, in the horse, the alar cartilages that are attached to the rostral border of the nasal septum support the alar fold that gives rise to the blind cutaneous sac that is referred to as the "false" nostril. The provision of structural support for the horse's vestibule preferably includes the provision of the wing fold support. A suitable support device according to the invention, preferably causes minimal irritation to the skin or other anatomical structures of the animal when in use or after its separation. Other anatomical and physiological characteristics of a soft-horn animal must be overcome to provide an appropriate NSD for these animals. For example, the hair covering the external vestibular tissues may reduce the ability of an NSD to remain attached to the animal's nose under certain conditions.
In addition, the presence of numerous sweat glands in this region with or without the presence of hair can also significantly reduce the ability of an NSD to remain attached to this region when the animal is perspiring. A further unique feature is the significant mode of external soft tissues in the vestibular region of some mammals. For example, the muscular anatomy associated with the vestibular wall and the horse nostrils allow for considerable flexion, extension, torsion and side-to-side movement of the external vestibular tissues. Repeated inward and outward movement of the vestibular tissues during inspiration and expiration also affects the ability of an NSD to maintain a functional position in these animals. Thus, the combination of hair, sweat and movement of the vestibular wall during intense exercise presents unique challenges to the adherence and functioning of an NSD in certain animals such as the horse. Another factor considered in the provision of an NSD for the support of the vestibule of a horse or camel is the equipment in which the saddles or harnesses used by the animal are uded when working. In general "saddles" refers to mordants, bridles, moorings, muzzles, collars, saddles and other equipment used with an animal to assemble. "Harness" refers to equipment used with a traction animal. An appropriate configuration and arrangement of an NSD of the invention does not interfere with the operation of the saddles or harnesses and the saddles or harnesses preferably do not interfere with the operation of an NSD. It should be noted that an NSD according to the invention only needs to be coupled with the free side wall of the vestibule, it does not need to be coupled with the nostrils. After visual inspection it will be appreciated that the horse's nostrilo 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 contemplated that the nostrilo support could be provided in some circumstances. In the horse, for example, the muscles of the nose and upper lip generally provide a significant widening of the nostril during forced breathing. Some exemplary embodiments of a device of the invention and its components are described hereinafter. Throughout the specification, guidance is provided through examples of representative groups, the groups are not intended to be limiting.
The configuration and arrangement of an NSD of the invention are determined by the configuration of the tissue to be supported, the amount of support needed and the unique physiological or anatomical characteristics of the animal. In general, the unique nasal anatomy of domestic animals needs configurations, arrangements or dimensions that are different from those required for a human nose. In addition, as discussed previously, the hair, sweat and mobility of the vestibular wall affect the structural arrangement necessary for the functionality of an NSD. In a typical embodiment, an NSD described herein provides support a. the vestibular walls on the right and left sides of the animal. In general, the device udes a support layer having a right and left side piece which when secured to the nose of the animal are positioned to provide structural support to the left and right side vestibular walls. You can also refer to the "right" and "left" side pieces as "first" and "second" or "second" and "first" side pieces. The NSD is generally symmetrical bilaterally and does not use a narrow intermediate section between the side pieces. The side pieces of the device are at approximately the midline of a region of the midline of the device. When the NSD is secured to the nose of a pet, the intersection of the right and left side pieces in the region of the midline are mounted substantially on both sides of the left and right nasal bones of the animal. Each of the lateral pieces and the region of the midline of an NSD have a rostral end, a caudal end and a rostral-nape dimension. Due to the size and related anatomy of the surface area of the vestibular free wall of for example a horse, to provide sufficient support to benefit the animal, the rostral dimension -nuca in the midline region of an NSD of the invention can be substantially equal or greater than the rostral - nape dimension of the lateral pieces that engage with the vestibular free wall. Hence, in one embodiment, the rostral-nape dimension of the midline region is at least as large as the rostral-nape dimension either of one or the other of the lateral pieces. In an alternative modality, the rostral-nape dimension of the midline dimension is greater than the rostral-nape dimension of the right and left lateral pieces. However, a device having a relatively narrow intermediate region similar to some devices available to humans and modified to include an increased surface area, modified support system and modified adhesive system may provide some benefit to an animal. Furthermore, it is contemplated that although the preferred configuration of an NSD of the invention is particularly advantageous for use in animals such as horses, the unique configurations described herein may provide an advantageous improvement in stents for a human nose. In addition, a device having the general configuration of a preferred embodiment of the invention, but sized for use with a human nose may also advantageously provide a sun block or visor effect for the proximal and / or rostral end of a human nose. Two configurational modes particularly suitable for a human or animal nose are illustrated in Figures 1 and 2. In a preferred embodiment for humans, at least two MYLAR® gauge elements 1400A available from DuPont Films, Wilmington DE are transversely applied as support elements in an NSD configuration such as that illustrated in Figure 1. In some modalities, the rostral end of the NSD at or near the midline region extends to the tip of the nose between the nostrils and is termed "tongue." This modality can provide lifting support for most of the rostral aspect of the soft tissues and cartilaginous nasal septum between the nostrils. The 'configuration and structural arrangement of an NSD may vary in some aspect (s) and still maintain the mechanical functioning of a device according to the invention. Customizing the external design of an NSD may reflect aesthetic, personal tastes, racing colors, etc. The overall appearance of the embodiments illustrated in the present description are not exhaustive of those that are within the scope of the invention. Examples of a few general configurations that impart some or all of the functional aspects of the invention are shown in the top plan views of Figures la-i and 5-13. In general, the lower floor configuration of an NSD is substantially identical to the upper floor configuration shown. The side plan view is substantially devoid of ornamental features. As used herein, the term "support" refers to the reduction of the amount of narrowing of the nasal passage that may occur during inspiration or expiration of domestic animals. Thus, "support" may include some of the inward extraction of the vestibular free wall in the rostral passage during inspiration, but less than that which would be presented 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 in this, "neutral" refers to a state in which the unsupported vestibular tissues are neither extracted nor attracted to the nasal cavity nor protrude externally in relation to a resting position. In some arrangements, "support" also includes maintaining the vestibular free wall in a "distended" position outward relative to the neutral position. The configuration and arrangement of an animal support device takes into account the anatomical and physiological characteristics of the vestibular free wall, as well as the bony structures that define its borders. In addition, in most large domestic animals, the structural support necessary to support the lateral free wall must also take into account the weight of the supported tissue and the appropriate leverage to distribute the supported weight without causing pressure wounds or other irritation to the animals. surrounding tissues. In addition, due to the muscular control of the upper lip of the horse, the support of the vestibular free wall also deals with the active and passive mobility of the structures of the tube. The size of a device of the invention may vary. Devices of appropriate size will commonly correspond to the size of the tube that can vary with the size of the body, breed, age and sex of the animal. It is contemplated that NSD of smaller sizes for young animals, such as foals and calves may be beneficial to treat for example upper respiratory conditions. In some modalities, the dimension of the rostral-nape midline of an NSD for an adult horse of average size is approximately 3 to 16 cm, preferably 6-14 cm and the rostral-nape dimension of the right and left sides is of approximately 3 to 12 cm. However, larger and smaller sizes can be used. 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. The transverse dimension may be approximately equal at the rostral and caudal edge. Alternatively, the transverse dimension may vary in a single device depending on whether it is measured for example along the caudal edge, the rostral edge, the narrowest part or the widest part. In an NSD mode for a horse of average size, the transverse dimension in the narrowest part may be approximately 5-12 cm and approximately 10-17 cm in the widest part. Commonly, an NSD according to the invention includes at least one "support layer" and one "coupling layer". In some embodiments, a "surface layer" may be present to cover the side of the support layer that is remote from the nose of the animal when the device is secured to the nose of the animal. Some embodiments may also include one or more "pad layers" that can help reduce the likelihood of pressure injuries caused by the device. The support layer provides the majority of the support for the vestibular free wall of the nasal passage of an NSD. In general, support is provided on the support layer through the use of one or more "lifting elements". As used herein, a "lift element" can be prepared from any suitable support material that provides the desired support to the vestibular free wall. Examples of suitable materials for a lifting element include thermoplastic resins, thermosetting resins, shape memory metals, alloys, skin, etc. The lifting element can be an open mesh or unitary solid material. Alternatively, the lifting element may consist of two or more individual sections of an open or solid mesh material. A preferred thermoplastic resin for a lifting element is a polyester such as MYLAR® available from DuPont Films, Wilmington, DE.
In some embodiments, the lifting elements are of a thickness generally uniform throughout their length and width. The thickness of the lifting elements will be commonly selected based on the necessary support and is generally the same from start to finish. However, the lifting element can also vary in thickness in different regions of the device. In addition, a lifting element does not need to be of the same width over its entire length. That is, the lifting element can be wider at the lateral ends of the lifting element. Alternatively, a lifting element may be wider in the region that will overlap the region of the midline of the nose and narrower at the ends. Proper thicknesses for a lifting element prepared from a polyester such as MYLAR® for a large adult animal such as a horse is from about 0.020 cm (0.008 inches) to about 0.051 cm (0.020 inches). In a preferred embodiment, the thickness of a support element for an adult horse of average size is approximately 0.036 cm (0.014 inches). The support layer may include one or more lifting elements. In a mode that uses a single survey element, the configuration of the peripheral edge of the survey element can define the external contours of the overall device. In other embodiments, two and preferably three or more lifting elements are used. In such embodiments, a plurality of lifting elements can be arranged parallel along the transverse dimension of the device. Alternatively, a plurality of lifting elements can be oriented perpendicular to each other in such a way that one or more lifting elements are oriented parallel to the transverse dimension of the device and one or more lifting elements are oriented parallel to the rostral-nape dimension of the device. device. In yet another embodiment, two or more lifting elements may be oriented in a substantially transverse array to form an "X" shaped appearance in top plan view. In some embodiments it is advantageous to provide lifting elements in a caudal caudal direction. Lifting elements oriented in a caudal rostral direction can be located on the side pieces to further provide the lifting of the NSD. In addition or alternatively, the lifting elements may be oriented in a caudal rostral direction at or near the intersection of the midline of the first and second side pieces. This arrangement of the lifting elements is particularly advantageous for the NSD modalities that extend rostrally to form a "tongue" for the support of the soft tissues between the nostrils. When multiple solid lifting elements are used, the spacing between the individual lifting elements can affect the overall grip and operation of an NSD. Proper spacing between individual lifting elements achieves that the device conforms adaptively to the changing contours of the vestibular wall of an animal during inspiration, expiration or other movements, without separating from the nose of the animal. The width, length and spacing of one or more survey elements may vary based on the overall dimensions of the particular NSD. Also, the length of the individual lifting elements can vary in a single device to traverse some or all of the dorsal-ventral dimension of the vestibular free wall. Preferably, the transverse length dimension of a lifting element is sufficient to traverse the midline of the animal's nose and extend to the right and left lateral pieces beyond the dorsal lateral nasal cartilages to support the free vestibular free walls. left. In some modalities, the lifting elements can extend beyond the ventral edge of the vestibular free wall to a point lateral to the incisor bone. In general, the lifting elements provide a "lifting" effect on the vestibular free wall to reduce traction of the vestibular free wall to the nasal passage during respiration. However, if the lifting elements extend beyond the ventral edge of the vestibular free wall to the lateral aspect of the incisor bone, the incisor bone may act with the lifting elements to "support" the vestibular free wall and facilitate the reduction of the traction of the vestibular wall to the nasal cavity that is provided by the lifting elements. This can be particularly advantageous in large animals during forced breathing. When two or more lifting elements are used, the width of the lifting elements and the spacing between the lifting elements are selected so that the NSD provides the desired support to the vestibular wall with sufficient flexibility to reduce the likelihood of irritation due to the pressure located in the leverage points on the nose of the animal. In addition, the use of multiple lifting elements provides torsional flexibility of the device which helps to maintain the functioning of the device when it is subjected to the unique mobility of the vestibular tissues of the animal. In one embodiment of an NSD for an adult horse of average size, the length of the lifting elements may be about 4 -18 cm, preferably about 9-12 cm, the width may be 0.2 to 2 cm and the spacing between the lifting elements of approximately 0.2 to 2 cm, preferably 0.3 to 0.7 cm. In one embodiment, the lifting element may be a single element of a solid or open mesh material previously described that is configured to support a single vestibular wall. That is, the external contours of the lifting element are configured to follow the peripheral margins of the vestibular wall. Preferably, the perimetral edge of the lifting element is extended to allow the lifting element to overlap the borders of the vestibular wall by approximately 0.2-2 cm. According to this embodiment, the lifting element may include a coupling layer and optionally a surface layer or pad layer as described hereinafter. Preferably the coupling layer can be extended beyond the perimeter of the lifting element to improve adherence to the nose of the animal. However, instead of joining in the region of the midline of the nose, this modality of an NSD comprises two separate pieces, which act as a support for each vestibular wall. An NSD preferably includes a coupling layer. The coupling layer provides assurance of a NSD to the animal. If no surface layer (described later herein) is present and individual lifting elements are used, the coupling layer can also provide maintenance of the unit of the device. Normally the coupling layer can secure the NSD to the nose by the use of an adhesive. Other invasive ways of attaching to the nose, such as suture, are possible but not desired. Preferably, the adhesive is biocompatible and provides minimal irritation or no contact irritation when applied to the external tissues of an animal. Suitable materials for the adhesive of the coupling layer are medical tape covered with one or both sides, transfer adhesives or liquid adhesives. An internal release coating is preferably applied to the NSD to protect the adhesive surface of the coupling layer until application to an animal. Pressure sensitive adhesives (PSA) can be used. Examples of suitable adhesive systems are 1509 double side medical tape and Hydrocolloid Skin Protective Adhesive No. 9942 from 3M Co., St. Paul, MN. A preferred adhesive system is number 1524 transfer adhesive available from 3M Co., St. Paul, MN. The adhesive can be continuous on the surface of the coupling layer. Alternatively, the adhesive can be in a discontinuous configuration that can be formed in multiple ways. For example, a discontinuous configuration may be applied as a pre-cut double-sided medical tape or transfer adhesive. Alternatively, the adhesive can be applied as a liquid adhesive in a discontinuous configuration or using methods such as etching coating. A variety of configurations can be used, which include circles, oval strips or polygons, such as rectangles, squares, triangles, etc. The hexagonal configuration illustrated in Figure 11 is conveniently applied but is not required. The configuration does not need to be symmetric. In addition, the discontinuous adhesive configuration can be extended to the periphery of the device or a continuous configuration adhesive border can be applied around the perimeter of the coupling layer. In addition, two or more adhesives can be used in combination to optimize adhesion under different conditions. For example, a first adhesive could provide greater adhesion under dry conditions and a second adhesive provide greater adhesion under wet conditions. In an alternative embodiment, the adhesive can be applied in a continuous configuration and subsequently made discontinuous. For example, holes can be formed throughout the thickness of an NSD after a continuous adhesive is applied to the coupling layer, to thereby form a discontinuous adhesive layer. No particular hole configuration is necessary. However, preferably, the configuration of the holes is preferably distributed relatively uniformly over the entire surface area of the device and the locations or locations of the holes are selected to prevent penetration through the lifting elements. As discussed above, the shape of the holes that form the discontinuous configuration can be round, oval, polygons, etc. The proportion of adhesive area: adhesive-free area of a discontinuous adhesive configuration can be from about 90:10 to 10:90, usually from about 30:70 to 70:30 and in some embodiments of about 40: 60-60 : 40 Without being limited by a single theory, it is believed that in addition to allowing the transpiration passage to the outer surface of the device, the configuration of discontinuous adhesive particularly in the form of holes facilitates the malleability of the device to allow the device to conform more easily to the superficial contours of the vestibular free wall without the loss of adherence or reduced support of the device. The NSD may include a surface layer. The surface layer is the layer furthest away from the soft tissues of the animal. The side of the surface layer closest to the soft tissue of the animal may include an adhesive for adhering the surface layer to the support layer, to the upper side of the animal layer. coupling that may be exposed between the lifting elements or the pad layer, if used. The surface layer can provide additional support to the vestibular wall and help maintain the unity of the components of an NSD. An unsuitable surface material may be breathable or non-breathable and commonly includes a biocompatible adhesive. An example of a suitable breathable or breathable material as a surface layer is No. 1533 available from 3M Inc., St.Paul ', MN. A preferred non-breathable or breathable surface material is a non-woven medical tape No. 9906T available from 3M Co., St. Paul, MN. It has been found that this material flexes advantageously with changes in the surface contour of the vestibular wall to reduce the likelihood of the device separating from the nose of the animal., for example during intense exercise. Preferably, because this material is not breathable, holes are created throughout the thickness of the device to allow the passage of moisture and an additional cooperative malleability of the NSD. The support layer can be mounted directly to the coupling layer. However, the NSD may also include a "pad layer" applied between the coupling layer and the support layer. Alternatively, the pad layer can be applied between the surface layer and the support layer. An adhesive can be applied on both sides of the pad layer, only on one side or on no side. That is, the pad layer can be "free floating". In another embodiment, a partial pad layer may be applied. According to this embodiment, the pad layer can be applied between the support layer and the surface layer. The pad layer can be adhered to the layers either on one side or the other of the pad layer or only to the layer on one side. For example, the pad layer can be applied between the support layer and the coupling layer or only adhered to the coupling layer and regions of the surface layer between the individual lifting elements.
The pad layer can be formed of any suitable known material. A preferred material is a polyester material that allows the skin of the vestibular wall beneath the device to breathe or breathe. An example of an appropriate pad layer is the SONTARA® product (styles Nos. 8004, 8005, 8027, etc.) available from E.l. DuPont Nemours & Co., DuPont Nonwoven Division, Old Hickory, TN SONTARA® is a non-woven, breathable, spun polyester fabric. If no pad layer is used, the support layer can be mounted directly to the coupling layer when using a double-sided adhesive. Alternatively, the lifting elements may be adhered to a non-adhesive side of the coupling layer or to a non-adhesive pad layer by using a double-sided adhesive such as 3M 1509, 3M Inc., St. Paul, MN. Other arrangements are also contemplated. For example, the adhesive of the coupling layer can be applied between the support layer and the surface layer. According to this embodiment, the coupling layer adheres to the nose of the animal between the individual lifting elements that are not adhered to the animal. The surface layer may include a color, configuration, ornamental design logo, etc., if desired. Alternatively, an ornamental coating layer can be applied to the exposed surface of a support layer or the support layer. The coupling layer, the surface layer or the pad layer (if used) can closely follow the outer contours defined by the support layer. Alternatively, the periphery of the coupling layers or other layers may extend beyond the contours defined by the support layer. In a preferred embodiment, the extension of the periphery of the coupling layer beyond the contours defined by the support layer can provide an improved coupling of the NSD to the nose of the animal. In one embodiment, a margin region of about 0-5 cm to 5 cm, preferably about 2-3 cm of the coupling layer extends beyond the support provided by the support layer. If present, the surface layer commonly has the same perimeter dimensions as the coupling layer. In general, the overall thickness of the device is uniform. Some variation in thickness may occur due to differences in the thickness of those regions of the device that include the support elements and those regions that have spacing between the support elements. It is also recognized that individual or multiple lifting elements can be used without a tie layer (eg surface layer or coupling layer). According to this embodiment, a coupling layer such as a previously described adhesive can be applied to the lifting element. Then one or more lifting elements can be applied directly to the nose of the animal. While this method can deal with physiological and anatomical aspects of the nose of an animal as described herein, the application and removal of the support elements will be annoying. In addition, the support provided by the surface layer or coupling layer in the regions between the lifting elements will be lost.
DETAILED DESCRIPTION OF THE ILLUSTRATED MODE The anatomical landmarks 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. Similar reference numbers represent parts and assemblies or similar sets in all the various views. The reference to the drawings is not intended to limit the scope of the invention. Each of the figures la-i is a top view of a configuration of a modality of an NSD that incorporates the functional aspects of an NSD as described herein. The embodiments shown are exemplary and are not intended to limit the scope of configurations incorporating the principles of the invention. The figure shows several dimensions that can be used to characterize an NSD according to the invention, where the letters followed by a subscript "T" are the transverse dimensions, which include Ct which is the transverse dimension of the caudal edge, Rt is the transverse dimension of the rostral rim, Nt is the transverse dimension of the part narrower and Wt is the transverse dimension of the widest part. S is the rostral-nape dimension of the lateral piece and M is the dimension of the face - nape of the midline region. The bony anatomical structures surrounding the vestibular free wall in the horse that are supported by a device of the invention are described with reference to Figures 2-4. Figure 2 is a perspective view of the bony and cartilaginous structures of the horse's nasal cavity. Figure 3 is a profile view of the bone anatomy and Figure 4 is a top view of the same anatomy of the face of Figure 3. Figures 3 and 4 do not show the cartilaginous anatomy of the adult horse. The lateral free wall of the vestibule is defined dorsally by the dorsal lateral nasal cartilage 1 which is the most lateral aspect of the nasal bone 2. The ventral border of the vestibular free wall is defined by the dorsal free wall 3 of the incisor bone 4. The appearance caudal of the vestibular free wall is defined by the intersection 5 of the nasal bones 2 and incisors 4. The rostrum aspect of the vestibular free wall is limited by the nostrilo (not shown) that is supported dorsally by lamina 6 and ventral by the horn 7 of the cartilage 8 aluro. The middle accessory cartilage 9 and lamina 6 of the aluro cartilage support the "false" nostrilo of the horse. The nasal septum 10 of cartilaginous rostrum is shown in Figure 2. Figures 5-7 illustrate three different embodiments of an NSD (15, 16, 17) according to the invention. The surface layer is removed in each of these figures to expose the upper side of the support layer 20 and the upper side of the cushion layer 21 covering the coupling layer (not shown). The support layer 20 includes transverse lifting elements 22 in Figures 5-7 and longitudinal lifting elements 33 in Figure 7. The lifting elements 22 of Figure 5 are narrower but larger in number than the lifting elements 22. of figure 6. In the embodiment of figure 2, the transverse dimension of the lifting elements fluctuates from 9 cm to 14 cm, the width of the transverse elements is approximately 0.6 cm, the spacing between the elements is approximately 0.6 cm and the thickness of the lifting elements is approximately 0.356 cm (0.14 inches). In the embodiments of Figures 5-7, the peripheral contours of the pad layer (and coupling layer) extend beyond the lifting elements. As shown in Figures 5-7, an NSD includes a first side piece 24 and a second side piece 25 intersecting the midline 26 of the region 26a of the midline region of the device. In service, the rostral end 27 of the device faces the tip of the nose and the caudal end 28 faces the eyes of the animal. In figure 5, the rostral dimension -nuca in the middle line 26 is at least equal to the rostral-nape dimension S of the side piece of the side pieces 24 and 25. Also as shown in the embodiments of the figures 5-7, preferably in the rostral dimension -nuc of the NSD in the middle line M is greater than the rostral-nape dimensions S of the first or second side pieces 24, 25. In Figure 7, the NSD includes a centerpiece that extends rostrally or "tongue" 29 that can be extended rostrally to engage with the nose between the nostrils. In service, an NSD is secured to the nose of the general oriented animal as shown in Figures 8 and 9. Figure 8 is a front view of a horse 30 having a modality of an NSD 31 having an external configuration as it is shown in figures 5 and 6 (15 and 16, respectively) secured to the nose 32. Figure 9 is a front view of a horse 30 having a mode of an NSD 17 as shown in figure 7 secured to its nose 32. As can be seen in figure 9, the tongue 29 of the NSD 17 extends between the nostrils 33 of the horse 30. Figure 10 is an exploded perspective view of the components of an embodiment of an NSD 15 as shown in Figure 5. According to this embodiment, the coupling layer 40 includes an adhesive surface 41 for securing the NSD 15 to the nose of an animal. A pad layer 42 is adhered to the mating layer 40. The pad layer 42 may have an adhesive layer or be free of adhesive. In the embodiment shown, the coupling layer 40 is a double-sided adhesive, such that the upper side 43 of the coupling layer will adhere to the pad layer 42. The support layer 44 includes lifting elements 45. The lifting elements 45 can be adhered to the pad layer 42 when using for example a double-sided adhesive 46. A surface layer 47 can be applied on the backing layer 44 to provide additional unitary strength or a "tarpaulin" for Apply an ornamental design to the device. Appropriate materials for each of the layers have been previously described. The internal release liner for protecting the desired surface 41 of the coupling layer is not shown. Figure 11 illustrates the coupling layer 110 of another embodiment of an NSD 100 with the separate release inner liner. According to this embodiment, a discontinuous adhesive configuration 101 is applied to the NSD 100 as a pre-cut medical tape or transfer adhesive or applied as a printed liquid adhesive. As described above, a polygon adhesive configuration 104 is one of several configurations of appropriate discontinuous adhesives. While the illustrated embodiment does not include holes, the adhesive-free areas 102 in the adhesive configuration 101 provide or allow perspiration to pass through a breathable (or breathable) or non-breathable surface layer to the surface of the NSD. It is believed that the adhesive-free areas 102 of the adhesive configuration 101 of the coupling layer 110 facilitates the coupling of the NSD 110 to the mobile contours of the vestibular wall of the nose of some animals such as the horse. In addition, it is also contemplated that a configuration similar to that shown in Figure 11 may include two different adhesives. That is, a first adhesive could be applied as the adhesive configuration 104 and the second adhesive applied in the regions 102. The two different adhesives could provide adhesive function under different conditions. For example, the first adhesive can provide greater adherence to the nose when the nose is dry and the second adhesive could provide greater adherence when the nose is wet or wet from perspiration. Furthermore, instead of extending the adhesive configuration to the peripheral edge of the edge 109 of the NSD, the coupling layer 110 may include a continuous adhesive border around the perimeter of the NSD. Such a border can be about 0.5 to 5 cm, commonly about 2-3 cm wide. Figure 12 illustrates a bottom plan view of another embodiment of an NSD 150 having a discontinuous adhesive configuration 101 of the coupling layer 110. The release liner or internal liner has been removed. In this embodiment, the discontinuous adhesive configuration 101 is provided by creating holes 107 through the entire thickness of the device. Note that the holes 107 do not pass preferably through the lifting elements 105. In addition to improving the ability of the device 150 to adapt to the contour changes of the outer surface of the vestibular wall, it is believed that the holes 107 provide the transpiration passage or other moisture from the surface of the nose of the animal to the external surface of the device 150. The ability of the moisture to pass to the exterior of the device further reduces the likelihood of the device 150 separates from the nose. As discussed above, the shape of the holes is not limited to the round shape. Figure 13 is an exploded perspective view of the NSD 150 of Figure 12. This embodiment includes a surface layer 103 having an adhesive 120 on the underside 121 of the surface layer 103 to adhere the surface layer 103 to the upper side 123 of the lifting elements 105. A suitable material for the lifting elements 105 is MYLAR® 1400A (MYLAR® gauge 1400 IE which is approximately 350 microns or 0.3556 mm (14 mils) available from DuPont, Wilmington, DE. Currently preferred surface material 103 is a non-woven medical tape No. 9906T available from 3M Co., St. Paul, MN. Coupling layer 110 can be applied as a liquid adhesive to bottom side 121, 124 of surface layer 103 and the lifting elements 105 respectively, Alternatively, the coupling layer may be applied to the lower side 121, 124 of the surface layer 103 and the lifting elements 105 respectively. omo as a double-sided medical tape or transfer adhesive. In one embodiment, two layers of transfer adhesive No. 1524, available from 3M Co. St. Paul, MN, provide the adhesive for the coupling layer 110. An NSD as described herein provides support for the nasal passages of an animal. The support provides increased air flow at rest and during exercise. The effects that facilitate the air flow of an NSD can be determined by several methods which include measurement of the air flow velocities, impulse pressure for the flow and impedance to the air flow. The airflow velocities can be measured by attaching a pneumotachograph to a face mask used by a practicing horse. The driving pressure for the flow can be measured by passing a catheter via the nostrils to the larynx. From the pressure and flows, the impedance to the air flow can be calculated. The flow volume circuits can demonstrate the reduction of dynamic collapse (or crushing) of the nasal passages. It is believed that some embodiments of an NSD as described herein will provide at least about 5-10% reduction in inspiratory impedance, in some modalities at least about 15-25% and in some embodiments a reduction of more than 25%. %. During preliminary studies, one horse showed more than 40% reduction in inspiratory impedance when using an NSD of the invention. A detailed description of useful methods for measuring the airflow effects of an NSD is described in Lumsden et al., "Use of Flow-Volume Loops to Evaluate Upper Airway Obstruction in Exercising Standardbreds," AJVR, 54 (5): 766 -775 (May 19, 1993). In a performance horse, an NSD can be particularly beneficial in reducing the likelihood of respiratory conditions induced by exercise. For example, the use of an NSD is contemplated to reduce the likelihood of exercise-induced pulmonary hemorrhage(EIPH) or "indentations". The ability to decrease the incidence of this condition without the use of pharmacological agents will provide a greater benefit to the horse industry. In addition, an NSD may also facilitate airflow in afflicted horses with partial or complete recurrent laryngeal nerve dysfunction ("snorers") or dorsal displacement of the soft palate. It has been shown that the device reduces the noise associated with recurrent laryngeal nerve dysfunction in some horses. It will be apparent to one skilled in the art that many changes and modifications can be made to the invention without departing from the spirit or scope of the appended claims.
It is noted that, with regard to this date, the best method known to the applicant to carry out the aforementioned invention is that which is clear from the present description of the invention.