Patent Publication Number: US-9901480-B2

Title: Nasal dilator with means to direct resilient properties

Description:
RELATED APPLICATIONS 
     This application is a CONTINUATION of Nonprovisional patent application Ser. No. 13/866,008 filed 18 Apr. 2013, now U.S. Pat. No. 9,364,368 which was a CONTINUATION of Nonprovisional patent application Ser. No. 13/206,462 filed 9 Aug. 2011, now U.S. Pat. No. 8,444,670, which is a CONTINUATION of Nonprovisional patent application Ser. No. 12/106,289 filed 19 Apr. 2008, now U.S. Pat. No. 8,062,329, which claims priority benefit of Provisional Patent Application No. 60/913,271 filed 21 Apr. 2007. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to apparatus and methods of dilating external tissue. As disclosed and taught in the preferred embodiments, the tissue dilator devices are particularly suitable for use as external nasal dilators for supporting, stabilizing, and dilating nasal tissues adjacent and overlying nasal airway passages, including the nasal valve and/or the vestibule areas thereof. 
     BACKGROUND OF THE INVENTION 
     A portion of the human population has some malformation of the nasal passages which interferes with breathing, including deviated septa and swelling due to allergic reactions. A portion of the interior nasal passage wall may draw in during inhalation to substantially block the flow of air through the nasal passage. Blockage of the nasal passages as a result of malformation, symptoms of the common cold or seasonal allergies are particularly uncomfortable at night, and can lead to sleep disturbances, irregularities and general discomfort. 
     Spring-based devices for dilating outer wall tissues of the human nose adjacent the nasal passages have a history spanning over one hundred years. The spring-based concept uses resilient means which flex across the bridge of the nose together with means to engage the nasal passage outer walls from either the interior mucosa or exterior epidermis sides thereof and thus stabilize or urge outwardly the nasal outer wall tissue. Some examples of present external nasal dilators are disclosed in U.S. Pat. No. 6,453,901; D379,513; D429,332; D430,295; D432,652; D434,146; D437,64; and Japanese patent Reg. No. 1037944; the entire disclosures of which are incorporated herein by reference. The commercial success of at least one of these inventions, together with that of other modern external nasal dilators, collectively and commonly referred to as nasal strips, has led to the creation and establishment of a nasal dilator product category in the present consumer retail marketplace. Commercial success of prior art nasal dilator devices disclosed before 1990, in particular that of U.S. Pat. No. 1,292,083 (circa 1919), is presumed to be commensurate with the nature of consumer product retail environments at the time of those inventions. 
     Throughout the history of those medical devices which engage external bodily tissue (i.e., tissue dilators, nasal splints, ostomy devices, surgical drapes, etc.), a long-standing practice in the construction and use thereof has been to interpose a buffer material between the device and the user&#39;s skin to facilitate engagement of the device to the skin and to aid user comfort. Said material, such as a spunlaced polyester nonwoven fabric, typically has properties which permit limited, primarily plastic and somewhat elastic deformation within the thickness thereof. These properties can spread out peeling, separating or delaminating forces such as may be caused by gravity acting on the weight of the device; the device&#39;s own spring biasing force or rigidity (such as that of a tissue dilator or nasal splint); biasing force that may be present in bodily tissue engaged by the device; surface configuration differences between the device and the skin of the device wearer; displacement of the device relative to the skin or external tissue as a result of shear, tensile, cleavage and/or peel forces imparted thereat via wearer movement (e.g., facial gestures) and/or contact with an object (e.g., clothing, pillow, bedding, etc.); and so on, that may cause partial or premature detachment of the device from the wearer. By spreading out these delaminating forces, said interface material acts as a buffering agent to prevent the transfer of said forces to its adhesive substance, if any, and thereby to the skin. Preventing the transfer of focused delaminating forces substantially eliminates any itching sensation (caused by the separation of the adhesive substance or device from the skin) that a wearer may experience if these delaminating forces were otherwise imparted directly to the skin. 
     There has been a continuing need in the art to develop nasal dilators which address and improve upon the dynamics and design parameters associated with limited skin surface area adjacent the nasal passages, adhesive attachment, delaminating spring biasing forces, device comfort, and durational longevity. 
     Firstly, tissues associated with and adjacent the nasal passages have limited skin surface areas to which dilation may be applied. Said surfaces extend upward from the nostril opening to the cartilage just above the nasal valve, and extend outward from the bridge of the nose to each approximate line where the sides of the nose meet each cheek. 
     Secondly, nasal dilators are, of necessity, releasably secured to said skin surfaces by use of pressure sensitive adhesives. Skin surfaces transmit moisture vapor to the surrounding atmosphere. Said adhesives break down in the presence of skin oils, moisture and the transmission of moisture vapor, often within hours. 
     Thirdly, the functional element of present and historic spring-based nasal dilator devices designed to engage and stabilize and/or expand nasal outer wall tissue is a semi-rigid resilient member which extends beyond each side of the bridge of the nose adjacent the nostrils. External nasal dilator devices of the present modern era feature a flat, substantially rectangular or slightly arcuate resilient member made of plastic. When engaged to a nose, the resilient member exerts a spring biasing force which tends to substantially return or restore the device to an original, generally planar, state thus dilating the local tissue. Said spring biasing force creates primarily peel and some tensile forces generated at the end regions of the device where engaged to the nose of a wearer. Said forces work to delaminate the end regions of the dilator device from skin surfaces so engaged. 
     Constructing a device with less than 10 grams of spring biasing force in order to mitigate delaminating peel forces may not provide suitable stabilization to, or dilation of, nasal outer wall tissues. Over-engineering the dilator by using a more aggressive adhesive, a greater amount of adhesive, or greater adhesive surface area in order to withstand greater spring biasing force increases the likelihood of user discomfort during use and damage to the tissue upon removal of the device. Additionally, a dilating spring biasing force of 40 grams or more could, in and of itself, be uncomfortable for most users. 
     Presently known spring-based nasal dilator devices which are suitable or adaptable for mass commercialization in the present consumer retail market typically fall within a range of dimensions of 5.0 to 7.5 cm (2.0″ to 3.0″) in length and 1.2 to 2.5 cm (0.5″ to 1.0″) in width. Resilient members are typically from about 4.2 to 5.8 cm (1.7″ to 2.3″) long, approximately 0.048 to 0.12 cm (0.12″ to 0.30″) wide and typically 0.010″ thick. A resilient member thickness of more or less than 0.010″ is not common in the art, but may be incorporated with proportionate adjustments to width and length. Examples include devices disclosed in U.S. Pat. No. D379,513; 5,533,503; 5,546,929; RE35408; 6,453,901; 7,114,495; and Spanish Utility Model 289-561 for Orthopaedic Adhesive. These devices provide sufficient dilation of nasal passage outer wall tissues and thus provide the claimed benefit to the vast majority of users. In addition, the &#39;503 and &#39;901 disclosures teach means for shifting, transforming and redistributing delaminating peel and tensile forces into primarily shear forces. Said shifting or transforming is desirable since the pressure sensitive adhesive disposed on nasal dilator devices for engaging skin surfaces adjacent the nasal passages withstand shear forces generally better, longer and more reliably than peel forces. 
     The &#39;503 device features a complicated structure at the device lateral end edges whereby to shift, transform or redistribute said delaminating peel and tensile forces. Said structure includes first and second parallel, spaced apart, resilient spring bands with identical scalloped end edges forming upper and lower protrusions separated by a valley. The extent of said protrusions are defined by the respective ends of the resilient bands. Outboard and adjacent said upper and lower protrusions are respective upper and lower extensions separated from said protrusions by upper and lower back cuts. Said extensions extend past said protrusions. The &#39;503 specification teaches that the constituent features of this end edge structure combine to effectively minimizes significant inadvertent peeling of the device end regions from the outer wall tissue of the nasal passages as a result of the discontinuity of shape of the materials at the intersection of said protrusions and said extensions, as defined by said back cuts, and redistributes and transforms peeling and tensile delaminating forces into primarily shear forces which are imparted to said upper and lower extensions extending beyond said back cuts. 
     The &#39;901 disclosure teaches a simpler end region structure which includes relief cuts placed adjacent each terminal end of a single resilient spring band, extending around its terminal ends and slightly along the upper and lower longitudinal edges thereof, corresponding to the general outline of the terminal ends of the resilient band without contact thereto. When in use on the nose of a wearer, this structure shifts peel and tensile delaminating forces into primarily shear forces which are imparted to the material extending between said relief cuts and the lateral end edges of the device. 
     U.S. Pat. No. 5,611,333 discloses a dilator device which features various openings, slits, notches and cuts formed within the peripheral edges of a resilient member whereby to selectively reduce spring biasing forces locally so that the resilient member may be used as a stand alone dilator device without the use of additional materials for maintaining the dilator device engaged to the nose of a wearer. 
     The present invention builds upon the prior art by providing means to direct the resilient properties of a nasal dilator whereby to overcome the aforementioned dynamics and design parameters associated with external dilation of nasal outer wall tissues. 
     SUMMARY OF THE INVENTION 
     The present invention teaches, depicts, enables, illustrates, describes and claims new, useful and non-obvious apparatus and methods of providing dilation to external tissue. In particular, the present invention provides a wide variety of tissue dilators adapted to engage an exterior tissue region of a nose to dilate the nasal passages thereof including the vestibule and/or nasal valve areas. It is the principal objective of the present invention to provide nasal dilator devices which improve and build upon the prior art and address unmet needs in the art. 
     In the specification and claims herein, the term vertical refers to a direction parallel to the thickness of the dilator or truss. The term horizontal refers to a direction parallel to the length, or longitudinal extent, or long axis of the dilator or truss. The term lateral refers to the width or opposing end edges of the dilator or truss, or a direction perpendicular to the length, longitudinal extent, or long axis of the dilator or truss. The term longitudinal centerline refers to a line parallel to the longitudinal extent of the dilator or truss, bisecting the width of the dilator or truss midway between its upper and lower long edges. The term lateral centerline refers to a line perpendicular to the length, longitudinal extent, or long axis of the dilator or truss, bisecting the long axis, or upper and lower long edges, midway along the length thereof. 
     The external nasal dilator of the present invention comprises a laminate of vertical layers. The laminated layers form a unitary, or single body, truss with each layer consisting of one or more members and/or components. The layers preferably include a base layer, resilient layer, and cover layer. Any single layer, or a combination of two or more layers may define the peripheral shape or edges of the dilator. The dilator is die cut from a continuous laminate of material layers, and dilator members or components may be die cut, in whole or part, from one or more continuous material layers before or during assembly of the continuous laminate. The truss features horizontal regions including first and second end regions adapted to engage outer wall tissues of first and second nasal passages, respectively, and an intermediate region adapted to traverse a portion of a nose located between the first and second nasal passages and joining the end regions. In use the dilator acts to stabilize and/or expand the nasal outer wall tissues and prevent said tissues from drawing inward during breathing. 
     Embodiments of the nasal dilator of the present invention include, without limitation, new and non-obvious means to direct the resilient properties thereof. Said means include one or more material separations, or discontinuity of shape of material, formed within the peripheral edges of the truss (an interior material separation), and may include one or more material separations or discontinuity of shape of material extending inward from a peripheral edge of the truss (an exterior material separation). Said material separations may be formed before, during or after the peripheral shape of the dilator is die cut from the aforementioned continuous laminate of materials. An interior material separation may also include forming, modifying or configuring at least a portion of the resilient layer before assembling the constituent layers of the dilator into the vertical laminate. Said formation, modification or configuration may include forming the peripheral shape of the resilient member, such as gradiently tapering its width, or may include forming component extensions such as spring fingers, or may include interior or exterior material separations, such as a cut, opening or notch, as described above with respect to the truss, but made to the resilient member alone. 
     An interior material separation may form a flap capable of separating or vertically protruding, in part, from the truss when the dilator is flexed across the nose of a wearer. Similarly, an exterior material separation may form a horizontal protrusion, also capable of separating, in part, from the truss when the dilator is flexed across the nose of a wearer. In either case, said separation or vertical protrusion changes the angle of focused spring biasing forces, at least in part, and thus shifts or transforms at least some of said forces from primarily peel and tensile forces to primarily shear forces. Said change in angle further redistributes or imparts said transformed forces to tissue engaging surface areas extending beyond the material separation. Thus, spring biasing forces may be distributed to the potentially larger surface area of the dilator end regions, as opposed to a greater delaminating tendency, such as that from peel forces, being imparted to a smaller surface area. Said potential larger surface area is as a result of the configuration of the end regions of the truss and/or the configuration of the respective layers of the dilator. The effect of material separations can lessen overall delaminating forces without reducing the spring biasing force of the dilator, in that shear forces are more easily withstood by the tissue engaging adhesives typically disposed on the tissue engaging surfaces of the dilator. Accordingly, a lesser amount of adhesive and/or less aggressive adhesive (and thus less costly) disposed on the tissue engaging surfaces of the dilator would, in addition, be more comfortable to the user and more easily removed from the tissue so engaged. An opposing pair of said material separation may be spaced apart along the longitudinal centerline of the truss. 
     An interior material separation extending vertically through the dilator, including the resilient layer, may also form a flap capable of separating or vertically protruding, in part, from the resilient layer. Said separation or vertical protrusion may also change, at least in part, the angle of spring biasing forces thereof, while allowing spring biasing forces to continue along a further extent of the resilient member or component. Said interior material separation may be confined within the peripheral edges of the resilient layer material or, alternatively, may sever the resilient member from one long edge thereof and extend across a portion of its width. 
     Means to direct resilient properties thus also include a dynamic relationship between the effects of interior and exterior material separations, including the degree of horizontal spacing between an opposing pair thereof, and any other modification to, or configuration of, the resilient layer, such as its peripheral shape or the inclusion of additional material separations made thereto. 
     The preferred embodiments of the present invention further include a truss with means for horizontally aligning the dilator to the nose of a wearer comprising a positioning aid located at the intermediate region forming a separation, projection or other index marker; means to spread the spring biasing force of resilient layer to a greater, primarily lateral, surface area of dilator, and means to prevent one or more material separations from separating in part from the truss. This latter means may also be used to extend or increase the tissue engaging surface area of the truss. 
     The skilled man in the art will appreciate the applicability of the continually developing art of medical device converting; specifically, continuous rotary laminating and die cutting, and flatbed and class A tool die cutting and punching. 
     The present invention is not limited to the illustrated or described embodiments as these are intended to assist the reader in understanding the subject matter of the invention. The preferred embodiments are examples of forms of the invention comprehended by the devices taught, enabled, described, illustrated and claimed herein. All structures and methods which embody similar functionality are intended to be covered hereby. In certain instances, the devices depicted, taught, enabled and disclosed herein represent families of new, useful and non-obvious tissue dilators having a variety of alternate embodiments. The skilled man will appreciate that features, devices, elements, members or components thereof, methods, processes or techniques may be applied, interchanged, eliminated in whole or part, or combined from one embodiment to another. Dilator members or components thereof, materials, layers or regions may be of differing size, area, thickness, length or shape than that illustrated or described while still remaining within the purview and scope of the present invention. The preferred embodiments include, without limitation, the following numbered, discrete forms of the invention, as more fully described below. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
       In the drawings which accompany this disclosure, like elements are referred to with common reference numerals. Drawings are not rendered to scale. 
         FIG. 1  is an exploded perspective view of a nasal dilator in accordance with the present invention. 
         FIG. 2  is a perspective view of the nasal dilator of  FIG. 1 . 
         FIG. 3  is a plan view of the nasal dilator of  FIG. 1 . 
         FIG. 4  is a fragmentary plan view, on an enlarged scale, illustrating one end region of the nasal dilator of  FIG. 3 . 
         FIG. 5  is a perspective view of a portion of a face with the nasal dilator of  FIG. 1 . secured to the nose. 
         FIG. 6  is a front elevation view of the nasal dilator of  FIG. 5  secured to the nose, seen as a portion of a face, of a wearer. 
         FIG. 7  is a is a fragmentary perspective view, on an enlarged scale, of the dilator of  FIG. 5  secured to the nose of a wearer. 
         FIG. 8  is a plan view of a variation of the nasal dilator of  FIG. 1 . 
         FIG. 9  is a fragmentary plan view, on an enlarged scale, illustrating one end region of the nasal dilator of  FIG. 8 . 
         FIG. 10  is a fragmentary plan view, on an enlarged scale, illustrating an alternative end region structure to that of the nasal dilator of  FIG. 9 . 
         FIG. 11  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 12  is a fragmentary plan view, on an enlarged scale, illustrating one end region of the nasal dilator of  FIG. 11 . 
         FIG. 13  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 14  is a fragmentary plan view, on an enlarged scale, illustrating one end region of the nasal dilator of  FIG. 13 . 
         FIG. 15  is a fragmentary plan view, on an enlarged scale, illustrating an alternative end region structure to that of the nasal dilator of  FIG. 14 . 
         FIG. 16  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 17  is a fragmentary plan view, on an enlarged scale, illustrating one end region of the nasal dilator of  FIG. 16 . 
         FIG. 18  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 19  is a fragmentary plan view, on an enlarged scale, illustrating a portion of one end region of the nasal dilator of  FIG. 18 . 
         FIG. 20  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 21  is a fragmentary plan view, on an enlarged scale, illustrating a portion of one end region of the nasal dilator of  FIG. 20 . 
         FIG. 22  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 23  is a fragmentary plan view, on an enlarged scale, illustrating one end region of the nasal dilator of  FIG. 22 . 
         FIG. 24  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 25  is a fragmentary plan view, on an enlarged scale, illustrating a portion of one end region of the nasal dilator of  FIG. 24 . 
         FIG. 26  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 27  is a fragmentary plan view, on an enlarged scale, illustrating a portion of one end region of the nasal dilator of  FIG. 26 . 
         FIG. 28  is an exploded perspective view of the nasal dilator of  FIG. 26 . 
         FIG. 29  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 30  is a fragmentary plan view, on an enlarged scale, illustrating a portion of one end region of the nasal dilator of  FIG. 29 . 
         FIG. 31  is a front elevation view of the nasal dilator of  FIG. 29  secured to a nose, seen as a portion of a face, of a wearer. 
         FIG. 32  is an exploded perspective view of the nasal dilator of  FIG. 29  including additional end region components. 
         FIG. 33  is a plan view of an alternative form of nasal dilator embodying features of the present invention. 
         FIG. 34  is a fragmentary plan view, on an enlarged scale, illustrating a portion of one end region of the nasal dilator of  FIG. 33 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     An embodiment of a nasal dilator,  10 , in accordance with the present invention is illustrated in  FIG. 1 . Dilator  10  comprises a vertical laminate of material layers including: a base layer composed of at least one base member,  14 , including components thereof; a resilient layer comprised of at least one resilient member,  22 , including components thereof and a cover layer composed of at least one cover member,  18 , including components thereof. A protective layer of release paper liner,  15 , removably covers any exposed adhesive from any layer preliminary to use of dilator  10  on the nose of a wearer. The periphery of release liner  15  may correspond to the periphery of dilator  10  or a periphery exceeding one or more dilators  10 . The components or layers of dilator  10  are preferably aligned along their longitudinal centerlines. 
     The preferred material for the base and cover layers is from a group of widely available flexible nonwoven synthetic fabrics that allow the skin on user nose  11  to exchange gases with the atmosphere and to maximize comfort of dilator  10  thereon. Alternatively, any suitable fabric or plastic film may be used. A continuous pressure sensitive adhesive substance, biocompatible with external human tissue, is disposed on at least one flat surface side of said material which is the adhesive side, opposite the non-adhesive side. The non-adhesive side is typically opposite the skin engaging side. A protective layer of continuous release paper liner covers said adhesive. Said materials are typically available in continuous rolls wound in a machine direction (MD) or warp, which is perpendicular to the cross direction (XD) or fill, of the fabric. The base and cover layers of dilator  10  may be fabricated parallel to either the warp or the fill of said fabrics. The preferred material for the resilient layer is a biaxially oriented polyester resin (PET). PET has suitable spring biasing properties both MD and XD, and is widely available under trade names such as Mylar® and Melinex® in a variety of standard thickness including 0.005″, 0.007″, and 0.010″. 
     The width, length and peripheral outline or edges of dilator  10  may be defined by the base layer, cover layer, or a combination of any two or more layers or portions thereof. The base and cover layers of dilator  10  may have like or dissimilar dimensions or peripheral edges, in whole or in part, compared to each other. Their respective peripheral shapes may be uniform or non-uniform, and may also be of like or dissimilar size or scale. Portions of any layer may define a horizontal region of the dilator or a portion thereof. Furthermore, the base and cover layers of dilator  10  may be interchanged, or either the base layer or cover layer may be optionally eliminated in whole or in part. The base and resilient layers may have identical peripheral edges, and thus may be formed as a single unit. Portions of one or both flat surfaces of any layer, member or component thereof, may overlap portions of any flat surface of another layer. Preferably, however, the base layer acts as a buffer in engaging the user&#39;s skin, as described hereinbefore with respect to medical devices, and portions of one or more dilator layers may engage nasal outer wall tissues simultaneously. When engaged on the nose of a wearer, preferably no portion of a layer extends substantially over a skin surface area beyond those surface areas associated with the nasal passages as described hereinbefore. 
     As illustrated in  FIG. 2 , the laminated layers of dilator  10  form a unitary, or single body, truss,  30 , having horizontal regions as indicated by bracketed broken lines. Truss  30  includes a first end region,  32 , a second end region,  34 , and an intermediate region,  36 , interconnecting first end region  32  to second end region  34 . The layers, members or components of dilator  10  may overlap or extend from their originating region to an adjacent region. End regions  32  and  34  are adapted to engage outer wall tissues of first and second nasal passages, respectively. The width of each end region is preferably greater than the width of respective portions or components of resilient member  22  extending horizontally therein. End regions  32  and  34  include lateral end edges,  33   a  and  33   b , respectively, which define the outer, lateral ends of truss  30  and thus dilator  10 . End edges  33   a  and  33   b  may be angled inward in a straight line between upper and lower corners of the long edges of dilator  10 , said angle corresponding approximately to the line where the nose meets the cheek. The width of intermediate region  36  is preferably narrower than the width of end regions  32  and  34 , preferably without resilient member  22  being formed narrower at its mid section that at its outer ends as a result. 
     Finished dilators  10  are typically die cut from a continuous laminate of material layers. However, dilator layers, members or components thereof, material separations or horizontal regions of truss  30  may be formed or die cut, in whole or part, from one or more of continuous materials before, or during, assembly of the material laminate from which finished dilators  10  are die cut. In fabricating dilators  10 , end regions  32  and  34  are preferably formed as mirror images of each other. However, asymmetric or non-identical end region configurations have the advantage of providing disparate dilating forces and tissue engaging surface areas to opposing nasal outer wall tissues, and thus more accurate or customized dilation or stabilization to the respective nasal passages. It will thus be obvious to the skilled man that virtually any two end region structures of the preferred embodiments herein may be intentionally combined in a given dilator device. For the sake of clarity and simplicity, however, the preferred embodiments illustrate end regions  32  and  34  as mirror images of each other. Additionally, certain of the enlarged fragmentary plan views refer to features of end region  34 , but are equally applicable to end region  32 . 
     When engaged to and flexed across a nose  11 , dilator  10 , through its resilient means as a result of its constituent members and layers combined to form single body truss  30 , acts to stabilize and/or expand the nasal outer wall tissues and prevent said tissues from drawing inward during breathing. 
     Dilator  10  includes resilient means having resilient properties provided through its resilient layer and configured to provide suitable spring return biasing force as described hereinbefore. Overall spring biasing force is generally determined by the width, length, and thickness of at least one resilient member  22  or the resilient layer as a whole from its constituent member(s) and/or components. Resilient member  22  preferably has an adhesive substance disposed on at least a portion of at least one of two opposite flat surface sides for engaging or laminating it to other layers, members or components of dilator  10  or for engaging the skin surface of the nose. Resilient member  22  has opposite terminal ends,  23   a  and  23   b , respectively, that may conform to at least portions of the lateral end edges  33   a  and  33   b  of dilator  10 . Terminal ends  23   a  and  23   b  may extend to one or both of said lateral end edges of dilator  10 , or may extend short of one or both end edges. 
     Dilator  10  includes means to direct its resilient properties. Said means may comprise configuration of or modification to, the resilient layer or the material from which the resilient layer is formed. Said configuration or modification may be made either in the course of forming resilient member  22 , or may be made to the resilient layer material separately, or at the time said material is assembled into the continuous material laminate from which dilator  10  is die cut (i.e., at the time the vertical laminate of dilator  10  is formed). Said configuration or modification may include cuts, notches, openings, or the like formed in the resilient layer material; or by varying the finished dimensions of the resilient member or a component thereof, such as by forming a gradiently tapered width; or by peripheral shape of the resilient member, such as by extensions or divergent spring finger components extending outward from its longitudinal extent; or by more than one resilient member, each member contributing a portion of the total spring biasing force. Having divergent spring fingers or multiple resilient members may increase the effective surface area subject to resilient layer spring biasing forces by spreading those forces to a greater, primarily lateral, surface area of dilator  10 . 
     Said means to direct the resilient properties of dilator  10  further comprises at least one separation or discontinuity of shape of material of one or more regions or layers of truss  30 . Said material separation or discontinuity of shape comprises a relief cut or back cut, slit, opening, notch, or the like, having a lateral and/or longitudinal extent, formed within the peripheral edges of dilator  10  (an interior material separation), or extending inward from a peripheral edge thereof (an exterior material separation). Said material separation extends vertically through at least one layer of dilator  10  and may optionally extend through release liner  15 . An interior material separation extending across the width of the resilient member  22  redefines its functional length (said function being the creation of spring biasing forces when flexed), and thus changes the dimensional relationship between its length and width/thickness. This also changes the spatial, dimensional relationship between the functional portion of the resilient layer and the other members or layers of dilator  10 . Said interior material separation thus further creates and defines at least one additional, substantially nonfunctional, component of the resilient layer. 
     One or more opposing pairs of interior or exterior material separations may be placed within or near respective end regions  32  and  34  of truss  30 . An opposing pair is preferably positioned in a spaced apart relationship along or near the dilator&#39;s longitudinal centerline. The spacing apart of a pair of material separations is dynamic, and determines, at least in part, some degree of direction of resilient properties, as well as the longitudinal extent of dilator  10  affected thereby. Said means to direct resilient properties thus further comprises a dynamic relationship between the effect of an opposing pair of material separations and any other modification to, or configuration of the resilient layer, including additional material separations or pairs thereof. For the sake of clarity and simplicity, interior and exterior material separations are shown uniform or as mirror images of each other in the preferred embodiments illustrated herein. As previously noted, however, asymmetric or non-identical elemental configurations have the advantage of providing disparate dilating forces and tissue engaging surface areas to opposing nasal outer wall tissues, and thus more accurate or customized dilation or stabilization to the respective nasal passages. Accordingly, it will be obvious to the skilled man that disparate material separations may be intentionally combined in a given dilator device, or identical or opposing material separations may be of dissimilar size or scale. Additionally, certain of the enlarged fragmentary plan views illustrate material separations positioned at end region  34 , but are equally applicable to end region  32 . 
     As detailed hereinbefore, an interior material separation extending vertically through dilator  10  including the resilient layer, may be contained entirely within the peripheral edges of resilient member  22  (or a component thereof) or extend inward from a peripheral edge thereof. Said material separation may allow formation of a flap capable of separating or vertically protruding, in part, from the resilient layer. Said separation or vertical protrusion may also change, at least in part, the angle of spring biasing forces of resilient member  22 , while also allowing spring biasing forces to continue along a further extent of the resilient member or component. By virtue of extending vertically through the resilient member without severing its entire width, said interior material separation reduces the total spring biasing force of resilient member  22 , primarily from the point of said separation to the adjacent terminal end thereof. In this manner, an opposing pair of interior material separations may be spaced apart along the horizontal extent of resilient member  22  so as to redirect a greater portion of total spring biasing force between the spaced apart pair and a corresponding lesser portion extending from each separation to corresponding terminal ends  23   a  and  23   b.    
     Accordingly, the type, number, and location of one or more interior and/or material separations or pairs thereof, the configuration of resilient member  22  and its corresponding resiliency, the relative size and shape of end regions  32  and  34 , and the dynamic relationships between these various elements, all contribute to directing the resilient properties of dilator  10 . Various examples thereof are given in the preferred embodiments and discussed in more detail herein below. 
     As seen in  FIGS. 1-15 , an interior material separation comprises a relief cut,  24 , located within each end region of truss  30 . Relief cut  24  preferably extends vertically through the cover, resilient and base layers of dilator  10 .  FIG. 4  more particularly identifies relief cut  24  having an outside edge,  26 , which defines its width, and upper and lower long edges,  27   a  and  27   b  which define at least portions of its length. Outside edge  26  preferably corresponds to at least a portion of the nearest end edge  33   a  or  33   b , respectively, of end regions  32  and  34 . As discussed hereinbefore, each end region is shown as a mirror image of the other, so only one end region will be described with particularity.). Outside edge  26  severs the entire width of resilient member  22  laterally, preferably extending slightly past the upper and lower long edges thereof, before turning to upper and lower edges  27   a  and  27   b . Upper and lower edges  27   a  and  27   b  extend inward preferably about 0.125″ in a direction parallel to upper and lower long edges of resilient member  22 . Relief cuts  24  redefine the functional length of resilient member  22 , as described hereinbefore, creating additional, substantially nonfunctional, resilient layer components. 
       FIGS. 5-7  show dilator  10  adhered to and flexed across the bridge of a nose,  11 , seen as a portion of a human face,  12 . Relief cut  24  allows formation of a flap,  25 , at the redefined terminal ends of resilient member  22 , said flap capable of separating or vertically protruding, in part, from respective end regions  32  and  34  of truss  30 , and leaving a corresponding opening or gap,  28 , from where it separates from the truss when dilator  10  is engaged to nose  11 . The length of upper and lower edges  27   a  and  27   b  and the width of outside edge  26  of relief cut  24  define the shape and dimensions of flap  25 ; its length being parallel to the longitudinal extent of resilient member  22 . Said length determines in part the degree of said separation or vertical protrusion and the corresponding change in angle, and thus transfer, of focused spring biasing forces from primarily peel forces and tensile forces into primarily shear forces, as discussed hereinbefore. Said transformed spring biasing forces are redistributed or imparted to tissue engaging surfaces of dilator  10  extending in an area between gap  28  and the surrounding peripheral edges of end region  32 , as generally illustrated by directional arrows in  FIG. 7 . Relief cuts  24  are preferably spaced apart along the longitudinal extent of dilator  10 , placed closer to respective end edges  33   a  and  33   b  than to intermediate region  36 , so as to direct resilient properties along a greater, rather than lesser, longitudinal extent of dilator  10 . 
       FIGS. 8-9  illustrate a variation of the nasal dilator of  FIG. 1  in which relief cut  24  has a scalloped edge.  FIG. 9  shows outside edge  26  extending from respective upper and lower edges  27   a  and  27   b , intersecting upper and lower long edges of resilient member  22  at substantially right angles thereto, before curving arcuately inward to form two scalloped portions of identical length and width. The respective lengths of said scalloped portions may be defined by the respective lengths of upper and lower edges  27   a  and  27   b  and by the horizontal location of the intersection between each scalloped portion. As more particularly illustrated in  FIG. 9 , portions of end edge  33   b  curve arcuately between upper and lower long edges of end region  34 . The apex of said arcuate curve preferably corresponds to the longitudinal axis of dilator  10 . Terminal end  23   b  of resilient member  22  terminates along said apex. End edge  33   b  may optionally correspond to the scalloped contour of outside edge  26 . 
       FIG. 10  shows an alternative structure of relief cut  24  illustrated in  FIG. 9  in which outside edge  26  forms scalloped portions of dissimilar shape.  FIG. 10  indicates by bracketed broken lines the total length of relief cut  24  being defined by the respective lengths of upper and lower edges  27   a  and  27   b  and the contour of outside edge  26 . The respective widths of scalloped portions thereof may be either identical or dissimilar, and are defined by the location of the intersection therebetween. The length and width of the scalloped portions of outside edge  26  of relief cut  24  may result in slightly greater spring biasing forces imparted along the upper long edge of resilient member  22 . In addition, the longer of the two scalloped portions tend to cause greater separation of flap  25  from gap  28 , thus having a corresponding effect on spring biasing properties of dilator  10  as discussed hereinbefore. 
       FIGS. 11-12  illustrates another alternative structure of relief cut  24  in which outside edge  26  forms a scalloped edge identical to a portion of corresponding end edge  33   b  or  33   b . As more particularly illustrated in  FIG. 12 , outside edge  26  of relief cut  24  extends from upper and lower edges  27   a  and  27   b , preferably intersecting upper and lower long edges of resilient member  22  at right angles thereto before forming a single scalloped edge. Said scalloped edge conforms to a corresponding center portion of end edge  33   b  of end region  34 . The total length of relief cut  24 , denoted by bracketed broken lines, is defined by the length of upper and lower edges  27   a  and  27   b , plus the horizontal extent of the scalloped portion of outside edge  26  extending toward end edge  33   b.    
       FIG. 12  further illustrates end edge  33   b  having three portions situated along a common lateral plane, represented by broken lines. Said lateral plane may be optionally set at an oblique angle to the long axis of dilator  10 , corresponding approximately to the line where nose  11  meets the cheek of a face  12 . The upper and lower of said three portions curve arcuately inward from the outside corners of upper and lower long edges of end region  34 , forming an exterior material separation comprising a valley,  38 , at the intersections of respective upper and lower corners of terminal end  23   b  of resilient member  22 . From the intersections formed by valleys  38 , end edge  33   b  curves outwardly again to form said scalloped center portion. The apex of said center portion corresponds to the longitudinal axis of resilient member  22 , with terminal end  23   b  thereof terminating along said scalloped center portion. 
       FIGS. 13-14  illustrate a combination of interior and exterior material separations in accordance with the present invention.  FIG. 13  shows end edges  33   a  and  33   b  having scalloped portions which correspond substantially to terminal ends  23   a  and  23   b  of a pair of parallel, spaced apart, resilient members  22 . Said terminal ends define the longitudinal extent of dilator  10 . A pair of interior material separations comprising relief cuts  24  are placed in a spaced apart relationship in opposing end regions of truss  30 , each relief cut forming a scalloped edge across the width of at least one of said pair of resilient members  22 .  FIG. 14  more particularly shows outside edge  26  of relief cut  24  intersecting upper and lower long edges  27   a  and  27   b , respectively, at oblique angles thereto. The shape of outside edge  26  preferably corresponds to a corresponding portion of scalloped end edge  33   b.    
       FIG. 14  further illustrates a pair of exterior material separations comprising upper and lower back cuts,  37   a  and  37   b , extending vertically through at least the cover layer of dilator  10  and inward from end edge  33   b . Each back cut is positioned at the intersection of a corresponding valley  38 , adjacent and parallel to the upper and lower long edges of at least one resilient member  22 . This arrangement defines a horizontal protrusion at the end portions of said one resilient member. Lower back cut  37   b  forms a separation between said horizontal protrusion and a corresponding lower extension,  35   b . Extension  35   b  may optionally extend horizontally beyond terminal end  23   b , and thus may further define the longitudinal extent of dilator  10 . 
     The interior material separation positioned in end region  34  may allow formation of a flap  25  at the redefined terminal ends of upper resilient member  22 , capable of separating or vertically protruding, in part, from truss  30  when dilator  10  is flexed across the nose. Similarly, the horizontal protrusion defined by upper and lower back cuts  37   a  and  37   b  is also capable of separating or protruding vertically, in part, from the truss when the dilator is flexed across the nose of a wearer. In each case the material separation changes the angle, in part, of focused spring biasing forces, transforming said forces as described hereinbefore. With respect to the interior material separation, said transformed forces are imparted to the end region in general. With respect to said exterior material separations, said transformed forces are imparted, at least in part, to extension  35   b.    
     The parallel spaced apart resilient members  22  may be of like or dissimilar width. A dynamic relationship exists not only between the respective spring biasing properties of multiple resilient members of dissimilar widths, but also between the location of relief cuts  24 , the length(s) of relief cut(s)  24 , back cuts  37   a  and  37   b , and the combined spring biasing forces generated by said pair of resilient members  22 . Though all of these elements are shown as symmetric pairs, it will be obvious to the skilled man that said elements may be resized, recombined or omitted. 
       FIG. 15  illustrates an alternative end region structure to that shown in the embodiment of  FIG. 14 , in which relief cut  24  extends across said pair of resilient members  22 . Respective scalloped portions of outside edge  26  extend across the width of each resilient member. End edge  33   b  has three portions situated along a common lateral plane. Said plane is shown perpendicular to the long axis of dilator  10 , but may be optionally situated at an oblique angle thereto, corresponding approximately to the line where the nose meets the cheek. The upper and lower of said three portions curve arcuately inward from the outside corners of upper and lower long edges of end region  34 , forming valley  38  at intersections adjacent above and below respective upper and lower corners of terminal ends  23   b  of said pair of resilient members  22 . From said intersections end edge  33   b  curves outwardly again to form said scalloped center portion. The apex of said center portion corresponds to the longitudinal axis of the pair of resilient members  22 , with terminal ends  23   b  thereof terminating along said scalloped center portion. 
       FIGS. 16-17  illustrate another combination of interior and exterior material separations in accordance with the present invention. End edges  33   a  and  33   b  form a scalloped portion corresponding to respective terminal ends  23   a  and  23   b  of resilient member  22 . The distance between said terminal ends represents the longitudinal extent of dilator  10 . Exterior material separations comprising upper and lower notches,  39   a  and  39   b , are positioned parallel to and adjacent upper and lower long edges of resilient member  22 . Notches  39   a  and  39   b  extend vertically through the base and cover layers of dilator  10 , and inward from end edges  33   a  and  33   b , respectively. Notches  39   a  and  39   b  define intersections between said scalloped portion of end edges  33   a  and  33   b  and upper and lower tab extensions  35   a  and  35   b , respectively, of end regions  32  and  34 . Tab extensions  35   a  and  35   b  may optionally extend to, or beyond, said scalloped portions, the latter thus further defining the longitudinal extent of dilator  10 . As more particularly illustrated in  FIG. 17 , said scalloped mid portion of end edge  33   b  and notches  39   a  and  39   b  define a horizontal protrusion, also capable of separating in part from the end region  34 , as discussed hereinbefore. Said separation changes the angle, at least in part, of spring biasing forces, and shifts and transforms said forces, similarly as described with respect to  FIG. 13 , imparting said transformed forces to both upper and lower tab extensions  35   a  and  35   b  of end region  34 . 
     The dilator of  FIGS. 16-17  further includes an opposing pair of interior material separations each comprising an elongated opening,  29 , extending vertically through at least resilient member  22  and contained within the width thereof. Opening  29  may be optionally formed before assembly of the vertical laminate of dilator  10 , or (as shown) formed as dilator  10  is die cut from a continuous material laminate. Opening  29  has a gradient increase in width along its length, extending horizontally from inward to outward, which defines corresponding adjacent upper and lower portions of resilient member  22  having a gradient reduction in width. Opening  29  may be of any size or shape contained within the width of resilient member  22 . Each of the opposing pair thereof is preferably positioned horizontally between the lateral centerline of truss  30  and respective end edges  33   a  and  33   b.    
     The relative width of opening  29  compared to the width of resilient member  22  thereat, together with the distance between said opposing pair of openings  29  defines a dynamic relationship, which determines spring biasing forces generated between said openings and extending beyond each opening to corresponding terminal ends  23   a  and  23   b , respectively, of resilient member  22 . Another dynamic relationship exists between the configuration of interior material separations, openings  29 , and the exterior material separations at respective end edges  33   a  and  33   b.    
       FIGS. 18-19  illustrate an embodiment of dilator  10  in accordance with the present invention in which the end regions of truss  30  include upper and lower bifurcated end region portions. In addition, resilient member  22  includes a plurality of component spring fingers,  21 , diverging and extending outward from a common center. Said common center is preferably aligned with the lateral and longitudinal centerlines of intermediate region  36 . Spring biasing forces generated by the resilient layer of dilator  10  are gradiently reduced, at least in part, in the course of being directed to spring fingers  21 . Upper and lower fingers  21  having uniform gradient widths, but may optionally curve, be asymmetric, and may be equidistant or of varying distance from said common center. As noted hereinbefore, divergent or asymmetric dilator features can provide disparate spring biasing forces. Fingers  21  may be further defined by a slit,  31 , extending inward from the point where upper fingers diverge from lower fingers. 
     Fingers  21  extend into corresponding bifurcated portions of end regions  32  and  34 . Terminal ends  23   a  and  23   b  of upper fingers  21  extend to, and conform with, portions of end edges  33   a  and  33   b  thereat. Terminal ends  23   a  and  23   b  of lower fingers  21  extend short of end edges  33   a  and  33   b . Spring fingers  21  and slits  31  of resilient member  22  are configurations preferably made prior to assembling the vertical laminate of dilator  10 . The divergent extent of spring fingers  21  determines the lateral spread of spring biasing forces at end regions  32  and  34 . The gradient width and the length of each spring finger  21 , defined in part by the length of slit  31 , determines the gradient reduction in spring biasing forces along the longitudinal and lateral extents of resilient member  22 . In addition, the divergent end region structure of dilator  10  provides additional lateral, torsional, flexibility primarily at the end regions, allowing dilator  10  to simultaneously effect dilation of nasal outer wall tissues adjacent both the nasal valve and nasal vestibule. 
     As more particularly illustrated in  FIG. 19 , end edge  33   b  has one of two exterior material separations comprising a valley,  38 ′, forming the intersection between said upper and lower bifurcated end region portions. A second exterior material separation comprising a slit,  31 ′, extends inward from the terminus of valley  38 ′ preferably along the longitudinal axis of truss  30 , corresponding to slit  31  in resilient member  22 . Slit  31 ′ preferably extends short of resilient member  22 . 
     As further illustrated in  FIG. 19 , upper bifurcated end region portions include relief cut  24  extending across the width of upper spring finger  21 . Another relief cut  24  is positioned outboard and adjacent terminal end  23   b  of lower spring finger  21 , corresponding to the shape of said terminal end. Relief cuts  24  have upper and lower edges  27   a  and  27   b , respectively, defining their length and extending parallel to the long edges of spring finger  21 . Outside edge  26  preferably extends beyond upper and lower long edges of spring finger  21 , substantially following the contour of the corresponding end edge  33   b . Relief cuts  24  allow formation of a flap, as described hereinbefore, capable of separating or vertically protruding, in part, when dilator  10  is flexed across the nose; said separations or vertical protrusions changing the angle, in part, of spring biasing forces, as described hereinbefore, transforming said forces and imparting them, at least in part, to tissue engaging surface areas extending outward to corresponding peripheral edges of said bifurcated end region portions of truss  30 . 
       FIGS. 20-21  illustrate an embodiment in accordance with the present invention where enlarged end portions,  20 , of resilient member  22 , formed as a modification prior to assembling the vertical laminate of dilator  10 , correspond generally to the shape of end regions  32  and  34  of truss  30 . Resilient member end edges  23   a  and  23   b  extend to, and conform with, portions of end region end edges  33   a  and  33   b , respectively. As more particularly illustrated in  FIG. 21 , valley  38 ′ extends inward from said end edge, simultaneously bifurcating end regions  32  and  34 , as well as enlarged end portions,  20 , of resilient member  22 . Said bifurcation forms spring fingers,  21 ′, in resilient member  22  and upper/lower bifurcated end region portions having common inside long edges therewith. Valley  38 ′ may be configured to gradiently reduce the width of at least one spring finger  21 ′. Depending upon the dimensional relationship between the width of enlarged end portions  20  and the length and width of valley  38 ′, said bifurcation may laterally spread, and/or reduce, or gradiently reduce the spring biasing forces of dilator  10  primarily at end regions  32  and  34 . This divergent end region structure provides additional lateral torsional flexibility primarily at the end regions of truss  30 , allowing dilator  10  to simultaneously effect dilation of nasal outer wall tissues adjacent both the nasal valve and nasal vestibule. 
       FIGS. 22-23  illustrate an embodiment of dilator  10  in accordance with the present invention in which enlarged end portions  20  of resilient member  22  correspond substantially to the peripheral shape of the respective end regions of truss  30  and are positioned substantially at the lateral and longitudinal axes thereof. Resilient member terminal ends  23   a  and  23   b  thus extend short of, but conform with, end region end edges  33   a  and  33   b , respectively, of said end regions. Said end edges form upper and lower horizontal protrusions extending to a common lateral plane, represented by broken lines, perpendicular to the long axis of dilator  10 . Said horizontal protrusions define the longitudinal extent of dilator  10 . 
     As more particularly illustrated in  FIG. 23 , relief cut  24  is positioned adjacent terminal end  23   b  of resilient member  22 , preferably as closely as practicable thereto. Its upper and lower edges  27   a  and  27   b  extend parallel to, and at least partway along, upper and lower long edges of enlarged end portions  20 . Outside edge  26  corresponds generally to the contour of terminal end  23   b  of resilient member  22 . The width of enlarged end portion  20  spreads spring biasing forces generated by resilient member  22 , at least in part, laterally across end region  34 . Relief cut  24  may cause the terminal end of resilient member  22  to separate or vertically protrude from the truss when dilator  10  is flexed across the nose, with the corresponding effect thereat as described hereinbefore, transforming said forces and imparting them, at least in part, to tissue engaging surface areas extending outward and beyond relief cut  24  to corresponding peripheral edges of end region  34 . 
       FIGS. 24-34  illustrate variations of an embodiment of dilator  10  in accordance with the present invention in which resilient member  22  has a gradiently reduced width which provides reduced spring biasing force extending horizontally from the lateral centerline of truss  30  to respective terminal ends  23   a  and  23   b . The mid portion of resilient member  22  preferably has a constant width representing its widest portion. In the embodiment of  FIGS. 24 and 25 , terminal ends  23   a  and  23   b  extend short of respective lateral end edges  33   a  and  33   b  of truss  30 . In the embodiment of  FIGS. 26-34 , said terminal ends extend to, and conform with, portions of said respective lateral end edges. 
     The embodiment of dilator  10  shown in  FIGS. 24-25  shows relief cut  24  placed outboard and adjacent terminal ends  23   a  and  23   b  of resilient member  22 . Relief cut  24  extends around and corresponds to the periphery of each said terminal end, substantially as described with respect to the embodiment of  FIGS. 22 and 23 . As described hereinbefore, relief cut  24  may cause the terminal end of resilient member  22  to separate or vertically protrude from the truss when dilator  10  is flexed across the nose, with the corresponding effect thereat as described hereinbefore, transforming said forces and imparting them, at least in part, to tissue engaging surface areas extending outward and beyond relief cut  24  to corresponding peripheral edges of end region  34 . 
     As further illustrated in  FIG. 24 , dilator  10  includes two elongated openings  29  extending vertically through at least the resilient layer, similar to that described with respect to openings  29  in the embodiment of  FIGS. 16 and 17 . Opening  29  is horizontally positioned at the approximate intersection of intermediate region  36  and respective end regions  32  and  34  of truss  30 . In this instance, opening  29  has its widest end placed to the inside, with upper and lower long edges parallel to the upper and lower long edges of resilient member  22 . Opening  29  thus defines upper and lower portions of resilient member  22  adjacent thereto having a constant width. The closed end of opening  29  may optionally include a slit extending to corresponding terminal end  23   a  or  23   b  of resilient member  22 . 
       FIGS. 26-28  illustrate an alternative structure in which the resilient and base layers of dilator  10  converge toward common upper and lower long edges at intermediate region  36 . Two opposing relief cuts  24  extend vertically through the truss, including the resilient layer thereof, severing a portion of the width of resilient member  22 . Cover member  18  comprises two components each corresponding substantially to respective end regions  32  and  34  of truss  30 , thus leaving portions of the resilient and base layers uncovered. A single interior material separation comprising elongated opening  29  is positioned at the lateral and longitudinal centerlines of the truss, extending vertically at least through resilient member  22 . Opening  29  also serves as an aid for aligning dilator  10  to the bridge of nose  11 . The peripheral shape of resilient member  22  and opening  29  may be formed prior to assembling the constituent layers of dilator  10 . 
     Opening  29  effectively reduces the spring biasing strength of resilient from that which would otherwise be generated at its widest portion. Accordingly, there is a dynamic relationship between the size of opening  29  and the dimensions of resilient member  22 , said dynamic relationship contributing to the direction of spring biasing properties of dilator  10 . Opening  29  and relief cuts  24  direct spring biasing properties extending outward horizontally from intermediate region  36  when dilator  10  is in use on nose  11 . Relief cut  24  includes a scalloped outside edge  26  which allows formation of a partial flap capable of separating or vertically protruding, in part, from resilient member  22  when the dilator is flexed across the nose of a wearer. The degree of vertical protrusion thereat is limited, however, the dynamic relationship between the size, shape and position of opposing relief cuts  24 , relative to the dimensions of resilient member  22 , determine the distribution of focused spring biasing forces therebetween, as well as those forces extending beyond each relief cut  24  toward respective terminal ends  23   a  and  23   b  when dilator  10  is in use on nose  11 . Said terminal ends extend to, and conform with, a scalloped mid portion of end edges  33   a  and  33   b  of truss  30 . 
     As more particularly illustrated in  FIG. 27 , upper edge  27   a  of relief cut  24  extends parallel to upper long edge of resilient member  22 . Outside edge  26  intersects the upper long edge of resilient member  22  at a right angle thereto before curving arcuately outward to form scalloped edge  26 . The mid portion of end edge  33   b  is defined by upper and lower back cuts  37   a  and  37   b , positioned adjacent upper and lower long edges of resilient member  22 . Back cuts  37   a  and  37   b  extend vertically through the base and cover layers and inward from corresponding valley  38  at end edge  33   b , similarly as described with respect to the embodiments of  FIGS. 13-14 and 16-17 . Together with back cuts  37   a  and  37   b , said scalloped mid portion of end edge  33   b  defines a horizontal protrusion, also capable of separating in part from end region  34 . Said separation changes the angle, at least in part, of spring biasing forces extending beyond relief cuts  24 , and shifts and transforms said forces, as described hereinbefore, redistributing said transformed forces, at least in part, to upper and lower tab extensions  35   a  and  35   b.    
       FIGS. 29-32  illustrate another alternative structure of dilator  10  in which opposing pairs of interior and exterior material separations, together with the configuration of the resilient layer, direct the resilient properties of dilator  10 .  FIG. 29  shows interior material separations comprising opposing relief cuts  24  extending vertically through dilator  10 . Relief cuts  24  are positioned at opposite ends of the intermediate region of truss  30  substantially at the intersections between intermediate region  36  and respective end regions  32  and  34  thereof. Relief cuts  24  each form a flap capable of separating or vertically protruding, in part, from the resilient layer when the dilator is flexed across the nose, and may be any size contained within the peripheral edges of resilient member  22 , with the corresponding effect thereat as described hereinbefore. The relative sizes of opposing relief cuts  24  together with the gradiently reduced width of resilient member  22  contribute to the overall gradient reduction of spring biasing properties of the resilient layer extending horizontally from intermediate region  36  to respective end regions  32  and  34 . Depending upon the lateral extend of outside edge  26  and the length of upper and lower long edges  27   a  and  27   b , opposing relief cuts  24  may also dynamically direct a greater amount of total spring biasing force to the horizontal extent therebetween and a lesser amount extending beyond each relief cut  24  to respective end edges of truss  30 . 
       FIG. 30  more particularly illustrates said exterior material separations comprising upper and lower back cuts  37   a  and  37   b , extending inward from a corresponding valley  38  at end edge  33   b  adjacent upper and lower long edges of resilient member  22 , as described hereinbefore. Together with back cuts  37   a  and  37   b , the scalloped mid portion of end edge  33   b  defines a horizontal protrusion, also capable of separating in part from the end region  34  when dilator  10  is flexed across a nose  11 , redistributing transformed spring biasing forces to tab extensions  35   a  and  35   b  of end region  34  as described hereinbefore.  FIG. 31  more clearly illustrates separation flaps  25  formed by said interior and exterior material separations, separating or vertically protruding, in part, from end regions  32  and  34  of truss  30 , directing resilient properties thereof as described hereinbefore. 
     As illustrated in  FIG. 32 , dilator  10  includes means to prevent one or more material separations from separating or vertically protruding from the truss. An additional cover layer component,  19 , may be optionally applied by a user over one or more of said interior or exterior material separations, effectively hindering or preventing at least a portion of its separation or vertical protrusion from truss  30 . End region component  19  preferably corresponds in shape to at least a portion of either end region of truss  30 , and may, for example, be peeled by hand from a sheet containing a plurality thereof (i.e., in the same manner one would peel a self-adhesive label from a continuous sheet thereof) and placed on top of a corresponding portion of cover member  18 , preferably centered over one or more said material separation(s). Component  19  may also be configured such that its peripheral edges extend beyond the peripheral edges of said horizontal portion of cover member  18 , as shown, effectively allowing the user to extend or increase the tissue engaging surface area of dilator  10 . It will be obvious to the skilled man in the art that end region component  19  may be added to virtually any of the preferred embodiments illustrated herein. 
       FIGS. 33-34  illustrate an embodiment of dilator  10  in accordance with the present invention in which an opening and relief cuts are combined into a single element. Opening  29  extends vertically through and laterally across the upper and lower long edges of resilient member  22 . The outside edge of opening  29  preferably conforms to corresponding end edge  33   a  or  33   b  of truss  30  which, in the present example, is angled inward in a straight line between upper and lower corners of the long edges of dilator  10 , said angle corresponding approximately to the line where the nose meets the cheek. Opening  29  includes upper and lower relief cuts,  27   a ′ and  27   b ′, extending inward from the respective upper and lower inside corners thereof, adjacent and parallel to the upper and lower long edges of resilient member  22 . Relief cuts  27   a ′ and  27   b ′ allow formation of a flap at the redefined terminal ends of resilient member  22 , said flap capable of separating or vertically protruding, in part, from the truss when dilator  10  is flexed across the nose, with the corresponding effect thereat as described hereinbefore. 
     With respect to  FIGS. 24-34 , and as described hereinbefore, a dynamic relationship exists between the configuration of resilient member  22  (in these particular embodiments, the gradient tapering of its upper and lower long edges), and a combination of interior and exterior material separations, plus additional, optionally user-applied components, each and all contributing to the direction of resilient properties of dilator  10 . 
     The dilator of  FIGS. 33-34  further includes a material formation,  41   a  and  41   b , located along the upper and lower long edges of intermediate region  36  midway between end edges  33   a  and  33   b . Formation  41   a  comprises an upper protrusion and a corresponding lower indentation  41   b . Material formation  21  may be of any suitable size or shape, and may be symmetric, asymmetric, straight, curved or gradient. Formation  41  forms a positioning aid for aligning dilator  10  to a nose  11 . When dilator  10  is applied to the nose, one or more formations  41  are meant to be aligned with the vertical center line of the bridge of the nose by the user, thus aiding precise horizontal placement of dilator  10  to nose  11 . Alternatively, one or more material formation  41  may be made within the periphery of truss  30 , and need not extend through all layers thereof so long as they are visible, and allow the user to align the lateral center of dilator  10  with the vertical center line of the bridge of nose  11 . 
     The foregoing descriptions and illustrations are intended to reveal the scope and spirit of the present invention and should not be interpreted as limiting, but rather as illustrative of the inventive concepts and techniques thereof. Skilled men in the art to which the present invention is directed will appreciate that insubstantial changes, modifications and alterations of the present disclosure may be made and each such insubstantial change, modification and alteration are intended to be fully covered hereby.