External nasal dilator

Abstract

An external nasal dilator includes a flexible substrate having a top edge, a bottom edge, a left edge, and a right edge that collectively define an outer perimeter of the external nasal dilator. The left recess is along the left edge and the right recess is along the right edge. The left concave part and the right concave part divide the flexible substrate into two transversely opposite upper leaf-shaped parts and two transversely opposite lower leaf-shaped parts. Comprising the two laterally opposed upper lobes carries an upper resilient member that applies a first expansion force to the inner nasal valve. Comprising the two laterally opposed lower lobes carries a lower elastic member that is different from the upper elastic member and applies a second expansive force to the outer nasal valve. The intermediate section longitudinally separates the upper resilient member from the lower resilient member.

Description

[0001] Cross-references to related applications

[0002] This disclosure claims priority to U.S. Application No. 63 / 536,791, filed September 6, 2024, which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to the field of nasal expanders, and more specifically to external nasal expanders. Background Technology

[0004] External nasal dilators facilitate breathing through the nose. They gently widen the nasal passage by applying an outward dilating force that supports the passage and prevents it from collapsing inward during inhalation. Such dilators consist of one or more strips of elastic material attached to an adhesive substrate. When the dilator adheres to the skin of the nose, the elastic material acts like a spring, applying an outward force to the nose during inhalation. Summary of the Invention

[0005] The problem with conventional commercially available external nasal dilators is that they act only on the internal nasal flap and essentially ignore the external nasal flap. An improved external nasal dilator is needed that applies dilating force to both the internal and external nasal flaps. It would also be advantageous to separate the dilating force applied to the internal nasal flap from the dilating force applied to the external nasal flap and to provide additional adhesive surface area on the portion of the external nasal dilator that acts on the external nasal flap. The novel external nasal dilator described herein addresses one or more of these problems.

[0006] A first example of this external nasal dilator is configured to dilate laterally opposed internal and external nasal flaps of a human nose. The external nasal dilator includes a flexible substrate having an adhesive post-surface for adhering the external nasal dilator to the human nose. The flexible substrate has a top edge, a bottom edge, a left edge, and a right edge that collectively define the outer periphery of the external nasal dilator. The left and right edges converge inward toward each other to form a left recess along the left edge and a right recess along the right edge. The left and right recesses divide the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions. The upper segment of the flexible substrate includes the two laterally opposed upper leaf-shaped portions and carries an upper elastic member extending laterally from one upper leaf-shaped portion to the other. When the external nasal dilator is adhered to the nose, the upper elastic member applies a first dilation force to the internal nasal flap. The lower section of the flexible substrate includes two laterally opposing lower leaf-shaped portions and carries a lower elastic member that differs from the upper elastic member and extends laterally from one lower leaf-shaped portion to the other. The lower elastic member and the lower section are laterally elongated relative to the upper elastic member and the upper section, respectively. When the external nasal expander is adhered to the nose, the lower elastic member applies a second expansion force to the external nasal flap. The middle section of the flexible substrate extends laterally between the upper and lower elastic members and longitudinally separates them. A left recess and a right recess are located within the middle section.

[0007] External nasal dilators may also include one or more of the additional features discussed below.

[0008] The middle section, the right concave portion, and the left concave portion can separate the first expansion force at the upper leaf-shaped portion from the second expansion force at the lower leaf-shaped portion.

[0009] After bonding, the surface area on the lower section can be greater than the surface area on the upper section.

[0010] The second expansion force can be greater than the first expansion force.

[0011] The left convergence point defining the innermost edge of the left concave portion and the right convergence point defining the innermost edge of the right concave portion can be closer to the upper elastic member rather than closer to the lower elastic member.

[0012] Multiple discrete slits can pass through the middle section, the discrete slits being laterally spaced and longitudinally elongated.

[0013] A pair of opposing cuts may extend longitudinally through the flexible substrate at their respective laterally opposite ends of the lower elastic member. The opposing cuts define a pair of opposing flaps of the lower elastic member that guide a second expansion force. The upper elastic member has a lateral length from its left end to its right end, and the distance between the opposing cuts is less than the lateral length.

[0014] A second example of this external nasal dilator is configured to dilate laterally opposed internal and external nasal flaps of a human nose. The external nasal dilator includes a flexible substrate having an adhesive post-surface for adhering the external nasal dilator to the human nose. The flexible substrate has a top edge, a bottom edge, a left edge, and a right edge that collectively define the outer periphery of the external nasal dilator. An upper segment of the flexible substrate carries an upper elastic member extending laterally across the upper segment. When the external nasal dilator is adhered to the nose, the upper elastic member applies a first dilution force to the internal nasal flap. A lower segment of the flexible substrate carries a lower elastic member, distinct from and extending laterally across the lower segment. When the external nasal dilator is adhered to the nose, the lower elastic member applies a second dilution force to the external nasal flap. A middle segment of the flexible substrate extends laterally between the upper and lower elastic members and longitudinally separates them. A plurality of discrete slits passing through the middle segment are laterally spaced and longitudinally elongated.

[0015] External nasal dilators may also include one or more of the additional features discussed below.

[0016] The left and right edges converge inward toward each other to form a left recess along the left edge and a right recess along the right edge. The left and right recesses divide the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions. The upper segment includes the two laterally opposed upper leaf-shaped portions, and an upper elastic member extends laterally from one upper leaf-shaped portion to the other. The lower segment includes the two laterally opposed lower leaf-shaped portions. A lower elastic member extends laterally from one lower leaf-shaped portion to the other. The lower elastic member and the lower segment are laterally elongated relative to the upper elastic member and the upper segment, respectively. The left and right recesses are located in the middle segment.

[0017] The slit can extend longitudinally toward the longitudinal midline of the external nasal dilator.

[0018] The slit can extend longitudinally toward the longitudinal midline of the external nasal dilator at an angle of 15° to 75° relative to the lateral direction.

[0019] The left and right edges may converge inward toward each other to form a left recess along the left edge and a right recess along the right edge. The left and right recesses divide the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions. The upper segment includes the two laterally opposed upper leaf-shaped portions. An upper elastic member extends laterally from one upper leaf-shaped portion to the other. The lower segment includes the two laterally opposed lower leaf-shaped portions. A lower elastic member extends laterally from one lower leaf-shaped portion to the other. The left and right recesses are located in the middle segment. The middle segment, the right recess, and the left recess separate the first expansion force at the upper leaf-shaped portions from the second expansion force at the lower leaf-shaped portions.

[0020] After bonding, the surface area on the lower section can be greater than the surface area on the upper section.

[0021] The lower elastic member and the lower section can extend laterally relative to the upper elastic member and the upper section.

[0022] After bonding, the surface area of ​​the lower section can be greater than that of the upper section. The lower elastic member and the lower section are laterally elongated relative to the upper elastic member and the upper section. The second expansion force is greater than the first expansion force.

[0023] The left and right edges may converge inward toward each other to form a left recess along the left edge and a right recess along the right edge, dividing the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions. The upper segment includes the two laterally opposed upper leaf-shaped portions. An upper elastic member extends laterally from one upper leaf-shaped portion to the other. The lower segment includes the two laterally opposed lower leaf-shaped portions. A lower elastic member extends laterally from one lower leaf-shaped portion to the other. The left and right recesses are located in the middle segment. The left convergence point defining the innermost edge of the left recess and the right convergence point defining the innermost edge of the right recess are closer to the upper elastic member than to the lower elastic member.

[0024] A pair of opposing slits can extend longitudinally through the flexible substrate at their respective laterally opposite ends of the lower elastic member. The opposing slits define a pair of opposing flaps of the lower elastic member that guide the second expansion force. The upper elastic member has a lateral length from its left end to its right end. The distance between the opposing slits is less than the lateral length.

[0025] A pair of opposing cuts may extend longitudinally through the flexible substrate at their respective laterally opposite ends of the lower elastic member. The opposing cuts define a pair of opposing flaps of the lower elastic member, which guide the second expansion force. The upper elastic member has a lateral length from its left end to its right end, and the distance between the opposing cuts is less than the lateral length.

[0026] A third example of this external nasal dilator is configured to dilate laterally opposed internal and external nasal flaps of a human nose. The external nasal dilator includes a flexible substrate having an adhesive post-surface for adhering the external nasal dilator to the human nose. The flexible substrate has a top edge, a bottom edge, a left edge, and a right edge that collectively define the outer periphery of the external nasal dilator. The left and right edges converge inward toward each other to form a left recess along the left edge and a right recess along the right edge. The left and right recesses divide the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions. The upper segment of the flexible substrate includes the two laterally opposed upper leaf-shaped portions and carries an upper elastic member extending laterally from one upper leaf-shaped portion to the other. When the external nasal dilator is adhered to the nose, the upper elastic member applies a first dilation force to the internal nasal flap. The lower segment of the flexible substrate includes two laterally opposing lower leaf-shaped portions and carries a lower elastic member that differs from the upper elastic member and extends laterally from one lower leaf-shaped portion to the other. When the external nasal expander is adhered to the nose, the lower elastic member applies a second expansion force to the external nasal flap. The middle segment of the flexible substrate extends laterally between the upper and lower elastic members and longitudinally separates them. A left and right recess are located in the middle segment. The left convergence point defines the innermost edge of the left recess, and the right convergence point defines the innermost edge of the right recess. The left and right convergence points are closer to the upper elastic member than to the lower elastic member.

[0027] External nasal dilators may also include one or more of the additional features discussed below.

[0028] The middle section, the right concave portion, and the left concave portion can separate the first expansion force at the upper leaf-shaped portion from the second expansion force at the lower leaf-shaped portion.

[0029] After bonding, the surface area on the lower section can be greater than the surface area on the upper section.

[0030] The second expansion force can be greater than the first expansion force.

[0031] Multiple discrete slits can pass through the middle section, the discrete slits being laterally spaced and longitudinally elongated.

[0032] A pair of opposing cuts may extend longitudinally through the flexible substrate at their respective laterally opposite ends of the lower elastic member. The opposing cuts define a pair of opposing flaps of the lower elastic member, which guide the second expansion force. The upper elastic member has a lateral length from its left end to its right end, and the distance between the opposing cuts is less than the lateral length.

[0033] Each of these examples of external nasal expanders may also include any features of the other examples. Attached Figure Description

[0034] Figure 1 This is a partial cross-sectional view of the left side of a human nose.

[0035] Figure 2 yes Figure 1 The bottom view.

[0036] Figure 3 This is a front view of the first example of an external nasal expander.

[0037] Figure 4 yes Figure 1 Rear view of the external nasal dilator.

[0038] Figure 5 yes Figure 1 A three-dimensional view of the left front of the external nasal dilator.

[0039] Figure 6 yes Figure 1 Rear view of an external nasal dilator, which includes a release liner.

[0040] Figure 7 yes Figure 1 A frontal stereoscopic exploded view of the external nasal expander.

[0041] Figure 8 yes Figure 1 A top view of the external nasal expander.

[0042] Figure 9 yes Figure 1 Bottom view of the external nasal dilator.

[0043] Figure 10 yes Figure 1 Left side view of the external nasal dilator.

[0044] Figure 11 yes Figure 1 Right side view of the external nasal dilator.

[0045] Figure 12 It adheres to the human nose. Figure 1 Left stereoscopic view of the external nasal dilator.

[0046] Figure 13 It adheres to the human nose. Figure 1 A left-side stereoscopic view of the external nasal dilator, showing the external and internal nasal flaps.

[0047] Figure 14 yes Figure 13 The bottom view.

[0048] Figure 15 This is a front view of a second example of an external nasal expander.

[0049] Figure 16 yes Figure 15 Rear view of the external nasal dilator.

[0050] Figure 17 yes Figure 15 A magnified view.

[0051] Figure 18 yes Figure 3 Front view of the nasal dilator (above) and Figure 15 A front view of the nasal dilator (below), where letters and arrows indicate measurements between different points on each dilator. Detailed Implementation

[0052] This disclosure describes some examples of external nasal dilators and related methods, but not all possible examples. When a particular feature is disclosed in the context of a particular example, that feature may also be used in combination with other examples and / or in the context of other examples, to the extent practicable. External nasal dilators and related methods can be implemented in many different forms and should not be construed as being limited to the features and examples described herein.

[0053] Since the following description will cover different parts of the human nose, please refer to [reference needed]. Figure 1 and Figure 2 This paper discusses various aspects of the human nose. Figure 1 and Figure 2 In the diagram, the portion of the nose beneath the skin is shown with fine and dashed lines. The external part of the nose 100 includes the nasal root 102, the bridge of the nose 104, the tip of the nose 106, the outer wall 108, the nasal alae 110, and the nostrils 112. The nostrils 112 define openings leading to the nasal cavity 114 or the airway.

[0054] Each nostril 112 further defines an external nasal flap 116, which is defined by the alar 110, alar margin 118, nasal septum 120, medial crura 122, and nasal sill 124. The external nasal flap 116 is shown in short dashed lines.

[0055] Further inward of each nasal cavity 114 is an internal nasal flap 126, which is defined by the nasal septum 120, the anterior end of the inferior turbinate, and the superior lateral cartilage 128. The internal nasal flap 126 is shown as a long dashed line. Physiological conditions that narrow the external nasal flap 116 or the internal nasal flap 126 restrict airflow through the nasal cavity 114.

[0056] When correctly positioned above the bridge 104 of the nose 100, the external nasal dilator applies a rebound or expansion force to the outer wall 108 above the nasal cavity 114. The expansion force increases the cross-sectional area of ​​the nasal cavity 114 at the level of the inner nasal flap 126 and the outer nasal flap 116.

[0057] refer to Figures 3 to 5 A first example of an external nasal dilator 200 includes an anterior surface 204, a posterior surface 206 opposite to the anterior surface 204, a top edge 208, a bottom edge 210 opposite to the top edge 208, a left end 212, and a right end 214 opposite to the left end 212. The external nasal dilator 200 extends from the left end 212 to the right end 214 in the transverse direction and from the top edge 208 to the bottom edge 210 in the longitudinal direction. The external nasal dilator 200 is substantially symmetrical about an imaginary longitudinal midline M.

[0058] The top edge 208 defines the top periphery of the external nasal dilator 200 and extends from the left end 212 to the right end 214. The central region of the top edge 208 includes a nasal placement member 216 that forms symmetrical protrusions along the top edge 208 to help the wearer see where the external nasal dilator 200 is positioned on the nose. In use, the wearer places the nasal placement member 216 evenly around the midline M on the bridge of the nose 104. When worn correctly, the midline M is substantially coaxial with the anatomical midline of the nose 100. The nasal placement member 216 facilitates proper placement on the nose so that the external nasal dilator 200 can expand both the internal and external nasal flaps.

[0059] The top edge 208 has a concave curvature between the center line M and the left end 212 and between the center line M and the right end 214, such that the top edge 208 bends downward from the respective left end 212 and right end 214 and then bends upward toward the center line M.

[0060] The bottom edge 210 defines the bottom periphery of the external nasal expander 200 and extends from the left end 212 to the right end 214. The left end 212 defines the left edge 218, and the right end 214 defines the right edge 220. Between the left end 212 and the right end 214, the bottom edge 210 has a concave curvature such that the bottom edge 210 curves upward toward the midline M from the left end 212 and the right end 214, respectively. This concave curvature is advantageous because it allows the lower segment 228 to extend downward toward the external nasal flap 116 when worn, which provides a larger adhesive surface area near the external nasal flap 116 and a smaller adhesive surface area near the bridge of the nose 104.

[0061] The left edge 218 defines the left periphery of the external nasal expander 200. The right edge 220 defines the right periphery of the external nasal expander 200. The left edge 218 and the right edge 220 are connected to the top edge 208 and the bottom edge 210 to jointly define the outer periphery of the external nasal expander 200.

[0062] The left edge 218 and the right edge 220 converge inward toward each other to form a left recess 221 along the left edge 218 and a right recess 223 along the right edge 220. The left recess 221 and the right recess 223 divide the external nasal dilator 200 into two laterally opposed upper leaf-shaped portions 225a and 225b and two laterally opposed lower leaf-shaped portions 227a and 227b.

[0063] In the left recess 221 and the right recess 223, the left edge 218 and the right edge 220 converge inward toward the center line M to the left convergence point 222 and the right convergence point 224, respectively.

[0064] The area above the left convergence point 222 and the right convergence point 224 to the top edge 208 is the upper segment 226 of the external nasal dilator 200. The area below the left convergence point 222 and the right convergence point 224 to the bottom edge 210 is the lower segment 228 of the external nasal dilator 200.

[0065] The upper segment 226 includes two laterally opposed upper leaf-shaped portions 225a and 225b, and carries an upper elastic member 230 extending laterally from one upper leaf-shaped portion 225a to the other upper leaf-shaped portion 225b. When the external nasal dilator 200 is adhered to the nose, the upper elastic member 230 applies a first dilation force to the internal nasal flap.

[0066] The upper elastic member 230 is positioned on the external nasal dilator 200 such that the upper elastic member 230 extends laterally across the upper segment 226 from the left edge 218 to the right edge 220, and applies a first dilation force to the laterally opposite internal nasal flap 126 when the external nasal dilator 200 is attached to a person's nose.

[0067] The lower segment 228 includes two laterally opposed lower leaf-shaped portions 227a and 227b and carries a lower elastic member 232, which differs from the upper elastic member 230 and extends laterally from one lower leaf-shaped portion 227a to the other lower leaf-shaped portion 227b. The lower elastic member 232 and the lower segment 228 are laterally elongated relative to the upper elastic member 230 and the upper segment 226, respectively. When the external nasal dilator 200 is adhered to the nose, the lower elastic member 232 applies a second dilution force to the external nasal flap.

[0068] The lower elastic member 232 is positioned on the external nasal dilator 200 such that it extends laterally across the lower segment 228 from the left edge 218 to the right edge 220, and applies a second dilating force to the laterally opposed external nasal flap 116 when the external nasal dilator 200 is attached to the person's nose. The lower elastic member 232 is different from and separate from the upper elastic member 230.

[0069] In this first example, the longitudinal width of the lower elastic member 232 is greater than the longitudinal width of the upper elastic member 230. This is not always necessary, but may be advantageous in allowing the lower elastic member 232 to apply a second expansion force at a location close to the outer nasal flap 116, which is typically farther away than the inner nasal flap 126.

[0070] The intermediate segment 238 extends longitudinally between the bottom edge 234 of the upper elastic member 230 and the top edge 236 of the lower elastic member 232, and extends laterally between the left edge 218 and the right edge 220. The left recess 221, the right recess 223, and the convergence points 222 and 224 are located in the intermediate segment 238.

[0071] For details, please refer to the following: Figure 4 The rear surface 206 forms a nasal contact surface that contacts the skin of the nose 100, and the external nasal expander 200 is adhered to the skin of the nose using a skin contact adhesive 240. In some examples, the skin contact adhesive 240 substantially covers the entire rear surface 206. In other examples, the skin contact adhesive 240 covers only a portion of the rear surface 206.

[0072] Skin contact adhesive 240 is an adhesive suitable for skin contact. Skin contact adhesives can adhere to the skin but can be removed with minimal damage to the skin. Examples of skin contact adhesives include, but are not limited to, acrylic adhesives, silicone adhesives, hydrogels, hydrocolloids, silicones, etc. Adhesive materials may also include skin-beneficial additives such as vitamins, vitamin E, and / or zinc oxide.

[0073] In the example shown, most of the surface area of ​​the rear surface 206 is located in the lower segment 228, which means that most of the adhesive surface area where the skin-contact adhesive 240 is located is on the lower segment 228. This can be advantageous because at least a portion of the lower segment 228 is designed to adhere to the nasal wing 110, and in some examples, the lower elastic member 232 exerts a greater expansion force than the upper elastic member 230, which may require additional adhesive surface to mitigate detachment.

[0074] refer to Figure 6 The rear surface 206 may be covered by a release liner 242, which forms part of the packaging of the external nasal dilator 200 and is designed to cover the skin contact adhesive 240 before use. Before the wearer applies the external nasal dilator 200 to the nose, the wearer removes the release liner 242 to expose the adhesive 240, and then adheres the external nasal dilator 200 to the nose.

[0075] The release liner 242 can have a one-piece construction covering the adhesive 240, or a two-piece construction as shown with a seam 244 near the center line M of the external nasal dilator 200.

[0076] Release liner 242 is typically a paper or plastic film used to prevent premature adhesion of adhesive 240. Release liner 242 may consist of a base material coated on one or both sides with a release agent that facilitates easy removal from adhesive 240. For example, release liner 242 may be made of any conventional nasal dilator release liner material, such as polymer-coated paper.

[0077] The external nasal expander 200 is composed of a flexible substrate supporting an upper elastic member 230 and a lower elastic member 232. (Reference) Figure 7-11 The flexible substrate may include multiple layers, including a base layer 246, an elastic layer 248 and a cover layer 250 laminated together.

[0078] The base layer 246 and the cover layer 250 can be composed of a comfortable, thin, flexible material. Such materials can include, for example, woven or nonwoven fabrics, such as polyester, polyethylene, polypropylene, polyurethane, etc. Alternatively, the material can include woven or nonwoven plastic materials, such as polyethylene, polypropylene, polyurethane, etc. In other examples, the material can be foam, silicone, etc.

[0079] The base layer 246 includes a rear surface 206 having a skin contact adhesive 240 for adhering the external nasal expander 200 to the nose.

[0080] The substrate 246 includes an elastic layer bonding side 252 that bonds to the elastic layer 248, such that the elastic layer 248 and the substrate 246 cooperate with each other. The elastic layer bonding side 252 may include an adhesive or the like capable of attaching the elastic layer 248 to the substrate 246.

[0081] In some specific examples, the substrate 246 has a thickness of about 0.5 μm to about 500 μm. The substrate 246 can be oxygen and / or moisture permeable or impermeable, depending on the material chosen.

[0082] The elastic layer 248 includes an upper elastic member 230 and a lower elastic member 232. The upper elastic member 230 and the lower elastic member 232 may extend fully to the left edge 218 and the right edge 220, or they may terminate at a position close to but not reaching the left edge 218 and the right edge 220.

[0083] In other examples, the elastic layer 248 may include a single elastic member or more than two elastic members. In the illustrated example, the upper elastic member 230 and the lower elastic member 232 extend substantially parallel to the lateral direction of the external nasal dilator 200. The upper elastic member 230 and the lower elastic member 232 each include a first end 254 and a second end 256.

[0084] The upper elastic member 230 and the lower elastic member 232 can be made of any suitable material having the required flexibility and elasticity to produce the desired magnitude of expansion force, such as metal, plastic, etc. The expansion force is a spring-biased force generated by the elasticity of the elastic members 230, 232. The elastic members 230, 232 are typically flat, semi-rigid, and elastic to generate an expansion force when bending across the nose, which is the force that lifts the outer wall tissue of the nostrils. This expansion force is typically between about 5 grams and 35 grams, between 15 grams and 35 grams, or sometimes about 25 grams. In a specific example, the elastic members 230, 232 are made of biaxially oriented polyester with a thickness of 0.1 mm to 0.3 mm and a longitudinal width of 3 mm to 6 mm. The longitudinal width and / or front-to-back thickness of the elastic members 230, 232 can be selected to obtain an external nasal dilator 200 with the desired magnitude of expansion force. Other specific examples of materials that can be used to make the elastic members 230, 232 include polyethylene, polypropylene, etc.

[0085] The tensile strength of an elastic member can be measured using conventional techniques. U.S. Patent No. 11,344,444 provides an example in which the elastic member is compressed into a U-shape while the force is measured using a measuring instrument.

[0086] The elastic members 230 and 232 can be fixed to the elastic layer bonding side 252 of the base layer 246 by an adhesive material on the elastic layer bonding side. The adhesive material can cover the elastic layer bonding side 252, or can have substantially the same size and shape as the elastic members 230 and 232.

[0087] The number and design of the elastic members 230 and 232 can depend on the required magnitude of the force to be applied to the nose, the direction of the force to be applied to the nose, and aesthetic considerations.

[0088] The upper elastic member 230 and the lower elastic member 232 are positioned between the base layer 246 and the cover layer 250 and are held in place by an adhesive that also prevents the base layer 246 and the cover layer 250 from separating when the external nasal dilator 200 is worn or removed.

[0089] The cover layer 250 is primarily made of a thin, flexible material. The cover layer 250 may be made of the same material as the base layer 246, or of a different material. The cover layer 250 and the base layer 246 may be laminated together using an adhesive, which may include a heat-fusible film. The cover layer 250 may have a thickness of about 1 μm to about 500 μm and may be oxygen- and moisture-permeable or impermeable. The cover layer 250 may also comprise woven and / or nonwoven fabrics. For example, the cover layer may also be colored to match different skin tones or have decorative colors, such as purple. The cover layer 250 may also include decorative features and / or markings, such as text printed thereon or attached thereto, logos, etc.

[0090] In some examples of the external nasal expander 200, the covering layer 250 is optional.

[0091] exist Figures 3 to 11 In the example shown, the external nasal expander 200 includes a pair of opposing incisions 258 that extend fully through the covering layer 250, the elastic layer 248, and the basal layer 246. Figure 7 As shown, cut 258 divides the lower elastic member 232 in two. Cut 258 creates a separation in both the transverse and longitudinal directions by penetrating the material constituting each layer. Cut 258 is located at the transversely opposite ends of the lower elastic member 232. Figure 6 As shown, the cut 258 can also extend through the release liner 242.

[0092] In other examples, the cut 258 does not extend completely through the cover layer 250, the elastic layer 248, and the base layer 246. In some examples, the cut extends through the upper elastic member 230 and / or the lower elastic member 232, but does not extend through at least one of the cover layer 250 or the base layer 246.

[0093] The cut 258 includes an outer edge 260, an upper cutting edge 262, and a lower cutting edge 264. The outer edge 260 defines the longitudinal width of the cut 258. The upper cutting edge 262 and the lower cutting edge 264 extend laterally from the outer edge 260 toward the centerline M. The curvature of the outer edge 260 can simulate the laterally adjacent portions of the left edge 218 or the right edge 220 to the cut 258.

[0094] The outer edge 260 divides the longitudinal width of the lower elastic member 232 and extends beyond the top edge 236 and bottom edge 266 of the lower elastic member 232. The upper cutting edge 262 and the lower cutting edge 264 extend inward toward the centerline M, substantially parallel to the top edge 236 and bottom edge 266 of the lower elastic member 232.

[0095] refer to Figures 12 to 14An external nasal dilator 200 is shown attached to the outer wall of the human nose. When attached to the nose, the external nasal dilator 200 applies a dilating force to the outer wall, which lifts the outer wall tissue of the nostrils and dilates the nasal cavity. Dilatating the nasal cavity reduces airflow resistance and increases airflow through the nasal cavity during breathing. The right side of the nose is... Figure 12 The mirror image.

[0096] exist Figure 13 In this configuration, the external nasal dilator 200 is positioned relative to the internal nasal flap 126 and the external nasal flap 116 at their intended locations on the nose. The upper elastic member 230 is positioned near and / or directly above the internal nasal flap 126, such that a first dilating force F1 is primarily concentrated on the internal nasal flap 126. The lower elastic member 232 is positioned at least partially directly above the external nasal flap 116 on the nasal ala 110, such that a second dilating force F2 is concentrated on the external nasal flap 116. The space in the intermediate section 238 between the upper elastic member 230 and the lower elastic member 232 is sufficient to adequately separate the first dilating force F1 and the second dilating force F2, thereby concentrating these dilating forces at the desired location on the nose.

[0097] In addition, such as Figure 13 As shown, the lower segment 228 is positioned on and / or slightly above the nasal ala 110. This positioning places a large portion of the adhesive surface area on the posterior surface 206 of the external nasal dilator 200 on or slightly above the nasal ala 110, facilitating the application of the second expansion force F2 to the nasal ala 110 close to the external nasal flap 116. The concave curvature of the bottom edge 210 allows it to extend downwards directly above the external nasal flap 116, which also allows a significant amount of adhesive surface area to be close to the external nasal flap 116 and below the lower elastic member 232. In this way, a large portion of the adhesive surface area on the posterior surface 206 of the external nasal dilator 200 is closer to the left edge 218 and right edge 220 than the midline M.

[0098] When the material adheres to and is positioned across the bridge of the nose, the separation caused by the cut 258 forms opposing protruding flaps 268, leaving a gap 270 caused by the separation. The length of the flaps 268 determines the degree of separation. The flaps 268 are reoriented at an angle to the expansion force F2 applied by the lower elastic member 232, changing it from a primary peeling and tensile force to a primary shear force. This reoriented expansion force is applied to the outer wall of the nose.

[0099] In other examples, the type, number, and location of the incisions 258 can vary. In one particular example, there is also a pair of opposing incisions 258 that pass through the upper segment 226. In another example, there is a pair of opposing incisions 258 that pass through the upper segment 226 but not the lower segment 228. In yet another example, the external nasal dilator 200 does not include any incisions 258.

[0100] The upper elastic member 230 and the lower elastic member 232 each have an effective length responsible for generating the expansion force. In the first example, the effective length of the upper elastic member 230 is a lateral length from its first end 254 to its second end 256. The effective length of the lower elastic member 232 is less than that of the upper elastic member 230 because the cutout 258 defines the effective length of the lower elastic member 232. The effective length of the lower elastic member 232 extends laterally between opposite outer edges 260.

[0101] The cut 258 reduces the lateral length of the lower elastic member 232 that generates the expansion force. This, in turn, allows the lower elastic member 232 to generate a greater expansion force than it would otherwise be able to generate.

[0102] The lateral length of the upper elastic member 230 is greater than the effective length of the lower elastic member 232. Because the upper elastic member is positioned at a narrower part of the nose, it can extend laterally beyond the nose. This can further help relieve nasal congestion.

[0103] Now refer to Figures 15 to 17 Another example of an external nasal dilator 300 is described. The same reference numerals indicate features common to the first example described above in the second example. This second example of the external nasal dilator 300 has the same overall construction as the first example of the external nasal dilator 200, but three features are different.

[0104] The external nasal dilator 300 is made of a substantially transparent material, making the cover layer 250, elastic layer 248, and base layer 246 substantially transparent. To make the cover layer 250 and base layer 246 substantially transparent, they can be made of, for example, a transparent plastic film. Multiple slits 302 passing through the cover layer 250 and base layer 246 allow moisture to pass through the material of the cover layer 250 and base layer 246.

[0105] Slit 302 is formed through an intermediate section 238 of the external nasal dilator 300, extending between the upper elastic member 230 and the lower elastic member 232. Slit 302 extends longitudinally and is laterally spaced along the intermediate section 238. In the example shown, slit 302 extends longitudinally relative to the lateral direction at an angle A toward the longitudinal centerline M of the nasal attachment member 304.

[0106] In some examples, angle A is 15 to 75 degrees, 18 to 72 degrees, 25 to 65 degrees, or about 65 degrees.

[0107] In some examples, the longitudinal length of slit 302 is 2 mm to 4 mm, 2.5 mm to 3.5 mm, 2.8 mm, or about 3 mm.

[0108] In some examples, the lateral spacing between slits 302 on the same side of the centerline M is 5 mm to 10 mm, 6 mm to 8 mm, 6.5 mm to 7.5 mm, 6.8 mm, or about 7 mm.

[0109] In some examples, the lateral spacing between adjacent slits 302 on either side of the centerline M may be the same as or different from that described above. In one particular example, this lateral spacing is 5 mm to 10 mm, 6 mm to 8 mm, 6 mm to 7 mm, or approximately 6.5 mm.

[0110] Anglesing the slit 302 toward the longitudinal midline M has at least two advantages. First, the angled slit 302 helps the wearer align the nasal attachment on the nose. Second, as described above, angles the slit 302 reduce the risk of tearing the external nasal dilator 200 when removing it from the nose.

[0111] In other examples, slit 302 may be combined with or replaced by intermediate segment 238 positioned on other parts of external nasal dilator 200.

[0112] In the second example, the longitudinal width of the lower elastic member 232 is substantially equal to or very close to the longitudinal width of the upper elastic member 230. Using a lower elastic member 232 with a smaller longitudinal width may be ideal for some people because such a lower elastic member 232 applies a smaller second expansion force F2 compared to the lower elastic member 232 in the first example.

[0113] It should be understood that other examples of external nasal dilators may include resilient members with longitudinal widths and / or transverse lengths that are relatively different from those shown in the figures.

[0114] It should be understood that slit 302 can be used with, except for Figures 15 to 17 Other examples of nasal dilators besides the one shown are combined, including the first example of an external nasal dilator 200.

[0115] Return to reference Figure 1 , Figure 2 , Figure 12 , Figure 13 and Figure 14When the external nasal dilator 200 is attached to the outer wall 108 of the nose 100, the upper elastic member 230 is positioned on the nose 100 such that the upper elastic member 230 extends laterally across the bridge 104 of the nose 100 and applies a first expansion force F1 to the laterally opposite inner nasal flap 126. When the external nasal dilator 200 is attached to the nose 100, the lower elastic member 232 is positioned on the nose 100 such that the lower elastic member 232 extends laterally across the bridge 104 of the nose 100 and applies a second expansion force F2 to the laterally opposite outer nasal flap 116.

[0116] In some examples, the second expansion force F2 can be greater than the first expansion force F1. This feature is sometimes advantageous because, due to the rigidity and thickness of the nasal alar 100, a greater force may be required to open the external nasal flap 116 compared to the internal nasal flap 126. In such cases, the second expansion force F2 can be, for example, 1.2 times, 1.5 times, 1.8 times, 2 times, 2.2 times, 2.4 times, 2.6 times, 2.8 times, or 3 times greater than the first expansion force F1.

[0117] Differentiating the upper elastic member 230 and the lower elastic member 232 from each other provides greater independence between the first expansion force F1 and the second expansion force F2. The upper leaf-shaped portions 225a, 225b and the lower leaf-shaped portions 227a, 227b near the convergence points 222, 224 at the left end 212 and the right end 214 provide additional independence between the first expansion force F1 and the second expansion force F2. These features collectively allow the four corners of the external nasal dilator 200 to apply expansion forces F1 and F2 in four directions.

[0118] Convergence points 222 and 224 are closer to the upper elastic member 230 than to the lower elastic member 232. This feature is advantageous because it provides a larger surface area for the lower segment 228 to adhere to the lower portion of the nose 100 and the larger nasal ala 110. This, in turn, can help the lower segment 228 remain adhered to the nose, even if the second expansion force F2 is greater than the first expansion force F1. A larger surface area for adhesion to the nasal ala 110 can also help open the external nasal flap 116.

[0119] The aforementioned external nasal dilators 200 and 300 can be used in a method of applying dilation force to a person's nose. This method includes attaching the external nasal dilators 200 and 300 to the outer wall of the nose such that the nasal placement member 216 is symmetrically positioned about the bridge of the nose 104, the upper elastic member 230 is positioned on the outer wall 108 near the inner nasal flap 126, and the lower elastic member 232 is positioned on the outer wall 108 near the outer nasal flap 116.

[0120] External nasal dilators 200 and 300 can be used in any situation where the wearer wishes to stabilize and / or dilate the nasal cavity 114, such as when ill, during exercise, while sleeping, and for many other purposes. Examples of methods for manufacturing external nasal dilators, which can be modified, are described in U.S. Patent Nos. 8,062,329, 8,858,587, and 8,641,852.

[0121] From Figure 7 The external nose expanders 200, 300 are manufactured by die-cutting from a continuous laminate of material layers. In another example, individual components can be die-cut separately from one or more continuous material layers before or during the assembly of the complete laminate.

[0122] refer to Figure 18 The measurements between certain points on the two examples of the nasal dilators shown in the accompanying drawings are labeled with capital letters. Double-headed arrows indicate the points corresponding to the measurements. In Table 1, d1 represents an actual approximate measurement of the first example of the external nasal dilator 200, and d2 represents an actual approximate measurement of the second example of the external nasal dilator 300. The range of each of these measurements is also provided merely as an example.

[0123] Table 1

[0124] exist Figure 18 In the diagram, the dashed line connects the end of the upper elastic member 230 to the cutout 258. This illustrates the difference in effective length between the upper elastic member 230 and the lower elastic member 232, showing that the effective length of the lower elastic member 232 is shorter than that of the upper elastic member 230.

[0125] The measurements in Table 1 correspond to the relative dimensions of different portions of the external nasal dilators 200 and 300. Dividing one measurement by the other yields the ratio of the two measurements. These ratios form part of this disclosure.

[0126] Multiple external nasal expanders can be packaged for sale by placing each expander in a separate package and then placing the packaged expanders in boxes, bags, etc., for consumers to purchase. The package of multiple expanders may include expanders with the same expansion force or expanders with different rebound forces. In some examples, the package may form an array of expanders with different expansion forces. In other examples, the package and / or the expanders themselves may include color or other markings indicating the relative expansion force of the external nasal expanders.

[0127] The external nasal dilator and related methods are not limited to the details and features described in conjunction with the exemplary embodiments. Various changes and modifications can be made to the nasal dilator and methods without departing from the scope of the claims.

Claims

1. An external nasal dilator configured to dilate laterally opposed internal and external nasal flaps of a human nose, said external nasal dilator comprising: A flexible substrate having an adhesive surface for adhering the external nasal expander to a human nose, the flexible substrate having a top edge, a bottom edge, a left edge, and a right edge that together define the outer periphery of the external nasal expander, the left edge and the right edge converging inward toward each other to form a left recess along the left edge and a right recess along the right edge, the left recess and the right recess dividing the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions; The upper section of the flexible substrate includes the two laterally opposed upper leaf-shaped portions and carries an upper elastic member extending laterally from one upper leaf-shaped portion to the other upper leaf-shaped portion; wherein, when the external nasal expander is adhered to the nose, the upper elastic member applies a first expansion force to the internal nasal flap; The lower segment of the flexible substrate includes the two laterally opposed lower leaf-shaped portions and carries a lower elastic member that is different from the upper elastic member and extends laterally from one lower leaf-shaped portion to the other. The lower elastic member and the lower segment are respectively laterally elongated relative to the upper elastic member and the upper segment. When the external nasal expander is adhered to the nose, the lower elastic member applies a second expansion force to the external nasal flap. The middle section of the flexible substrate extends laterally between the upper elastic member and the lower elastic member and longitudinally separates the upper elastic member and the lower elastic member, with the left recess and the right recess located in the middle section.

2. The external nasal dilator according to claim 1, wherein, The middle section, the right concave portion, and the left concave portion separate the first expansion force at the upper leaf-shaped portion from the second expansion force at the lower leaf-shaped portion.

3. The external nasal dilator according to claim 1, wherein, The surface area of ​​the bonded surface on the lower section is greater than the surface area on the upper section.

4. The external nasal dilator according to claim 1, wherein, The second expansion force is greater than the first expansion force.

5. The external nasal dilator according to claim 1, wherein, The left convergence point defining the innermost edge of the left recess and the right convergence point defining the innermost edge of the right recess are closer to the upper elastic member than to the lower elastic member.

6. The external nasal dilator of claim 1 further comprises a plurality of discrete slits passing through the intermediate section, the discrete slits being laterally spaced and longitudinally elongated.

7. The external nasal dilator according to claim 1, further comprising: A pair of opposing cuts, each extending longitudinally through the flexible substrate at a laterally opposite end of the lower elastic member, define a pair of opposing flaps of the lower elastic member that guide the second expansion force; and The upper elastic member has a lateral length from its left end to its right end, and the distance between the opposite cuts is less than the lateral length.

8. An external nasal dilator configured to dilate laterally opposed internal and external nasal flaps of a human nose, said external nasal dilator comprising: A flexible substrate having an adhesive post-adhesion surface for adhering the external nasal expander to a human nose, the flexible substrate having a top edge, a bottom edge, a left edge and a right edge that collectively define the outer periphery of the external nasal expander; The upper section of the flexible substrate carries an upper elastic member that extends laterally across the upper section; wherein, when the external nasal expander is adhered to the nose, the upper elastic member applies a first expansion force to the internal nasal flap; The lower section of the flexible substrate carries a lower elastic member, which is different from the upper elastic member and extends laterally across the lower section; wherein, when the external nasal expander is adhered to the nose, the lower elastic member applies a second expansion force to the external nasal flap; The middle section of the flexible substrate extends laterally between the upper elastic member and the lower elastic member, and longitudinally separates the upper elastic member and the lower elastic member; and Multiple discrete slits pass through the middle section, the discrete slits being laterally spaced and longitudinally elongated.

9. The external nasal dilator according to claim 8, wherein: The left edge and the right edge converge inward toward each other to form a left recess along the left edge and a right recess along the right edge, the left recess and the right recess dividing the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions. The upper section includes the two laterally opposed upper leaf-shaped portions, and the upper elastic member extends laterally from one upper leaf-shaped portion to the other upper leaf-shaped portion; The lower section includes the two laterally opposed lower leaf-shaped portions, and the lower elastic member extends laterally from one lower leaf-shaped portion to the other lower leaf-shaped portion; The lower elastic member and the lower segment extend laterally relative to the upper elastic member and the upper segment, respectively; and The left and right recesses are located in the middle section.

10. The external nasal dilator according to claim 8, wherein, The slit extends longitudinally toward the longitudinal midline of the external nasal dilator.

11. The external nasal dilator according to claim 8, wherein, The slit extends longitudinally toward the longitudinal midline of the external nasal dilator at an angle of 15° to 75° relative to the lateral direction.

12. The external nasal dilator according to claim 8, wherein: The left edge and the right edge converge inward toward each other to form a left recess along the left edge and a right recess along the right edge, the left recess and the right recess dividing the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions. The upper section includes the two laterally opposed upper leaf-shaped portions, and the upper elastic member extends laterally from one upper leaf-shaped portion to the other upper leaf-shaped portion; The lower section includes the two laterally opposed lower leaf-shaped portions, and the lower elastic member extends laterally from one lower leaf-shaped portion to the other lower leaf-shaped portion; The left recess and the right recess are located in the middle section; and The middle section, the right concave portion, and the left concave portion separate the first expansion force at the upper leaf-shaped portion from the second expansion force at the lower leaf-shaped portion.

13. The external nasal dilator according to claim 8, wherein, The surface area of ​​the bonded surface on the lower section is greater than the surface area on the upper section.

14. The external nasal dilator according to claim 8, wherein, The lower elastic member and the lower segment extend laterally relative to the upper elastic member and the upper segment.

15. The external nasal dilator according to claim 8, wherein: The surface area of ​​the bonded surface on the lower section is greater than the surface area on the upper section; The lower elastic member and the lower segment extend laterally relative to the upper elastic member and the upper segment; and The second expansion force is greater than the first expansion force.

16. The external nasal dilator according to claim 8, wherein: The left edge and the right edge converge inward toward each other to form a left recess along the left edge and a right recess along the right edge, the left recess and the right recess dividing the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions. The upper section includes the two laterally opposed upper leaf-shaped portions, and the upper elastic member extends laterally from one upper leaf-shaped portion to the other upper leaf-shaped portion; The lower section includes the two laterally opposed lower leaf-shaped portions, and the lower elastic member extends laterally from one lower leaf-shaped portion to the other lower leaf-shaped portion; The left recess and the right recess are located in the middle section; and The left convergence point defining the innermost edge of the left recess and the right convergence point defining the innermost edge of the right recess are closer to the upper elastic member than to the lower elastic member.

17. The external nasal dilator according to claim 8, further comprising: A pair of opposing cuts, the opposing cuts extending longitudinally through the flexible substrate at corresponding laterally opposite ends of the lower elastic member, the opposing cuts defining a pair of opposing flaps of the lower elastic member, the flaps guiding the second expansion force; as well as The upper elastic member has a lateral length from its left end to its right end, and the distance between the opposite cuts is less than the lateral length.

18. The external nasal dilator according to claim 8, further comprising: A pair of opposing cuts, each extending longitudinally through the flexible substrate at a laterally opposite end of the lower elastic member, the opposing cuts defining a pair of opposing flaps of the lower elastic member, the flaps guiding the second expansion force; and The upper elastic member has a lateral length from its left end to its right end, and the distance between the opposite cuts is less than the lateral length.

19. An external nasal dilator configured to dilate laterally opposed internal and external nasal flaps of a human nose, said external nasal dilator comprising: A flexible substrate having an adhesive surface for adhering the external nasal expander to a human nose, the flexible substrate having a top edge, a bottom edge, a left edge, and a right edge that together define the outer periphery of the external nasal expander, the left edge and the right edge converging inward toward each other to form a left recess along the left edge and a right recess along the right edge, the left recess and the right recess dividing the flexible substrate into two laterally opposed upper leaf-shaped portions and two laterally opposed lower leaf-shaped portions; The upper section of the flexible substrate includes the two laterally opposed upper leaf-shaped portions and carries an upper elastic member extending laterally from one upper leaf-shaped portion to the other upper leaf-shaped portion; wherein, when the external nasal expander is adhered to the nose, the upper elastic member applies a first expansion force to the internal nasal flap; The lower section of the flexible substrate includes the two laterally opposed lower leaf-shaped portions and carries a lower elastic member. The lower elastic member is different from the upper elastic member and extends laterally from one lower leaf-shaped portion to the other lower leaf-shaped portion. When the external nasal expander is adhered to the nose, the lower elastic member applies a second expansion force to the external nasal flap. The middle section of the flexible substrate extends laterally between the upper elastic member and the lower elastic member and longitudinally separates the upper elastic member and the lower elastic member; the left recess and the right recess are located in the middle section; and The left convergence point defines the innermost edge of the left recess and the right convergence point defines the innermost edge of the right recess, the left convergence point and the right convergence point being closer to the upper elastic member than to the lower elastic member.

20. The external nasal dilator of claim 19, wherein, The middle section, the right concave portion, and the left concave portion separate the first expansion force at the upper leaf-shaped portion from the second expansion force at the lower leaf-shaped portion.

21. The external nasal dilator according to claim 19, wherein, The surface area of ​​the bonded surface on the lower section is greater than the surface area on the upper section.

22. The external nasal dilator according to claim 19, wherein, The second expansion force is greater than the first expansion force.

23. The external nasal dilator of claim 19 further comprises a plurality of discrete slits passing through the intermediate section, the discrete slits being laterally spaced and longitudinally elongated.

24. The external nasal dilator of claim 19, further comprising: A pair of opposing cuts, each extending longitudinally through the flexible substrate at a laterally opposite end of the lower elastic member, the opposing cuts defining a pair of opposing flaps of the lower elastic member, the flaps guiding the second expansion force; as well as The upper elastic member has a lateral length from its left end to its right end, and the distance between the opposite cuts is less than the lateral length.

25. An external nasal dilator comprising any combination of the features described in claims 1-24.

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