Nasal Dilator and Methods of Fabricating Medical Devices

Abstract

Methods are disclosed for converting on a mass scale elongated material webs into finished parts or devices. Slits form strands in a web, the strands comprising interconnected objects which correspond to parts of finished devices. Strands are combined with additional webs to form a material laminate from which finished devices are die cut. The methods are suitable for a range of converting applications including medical devices, particularly the external nasal dilator. Complex dilator devices produced from the methods are formed as a single body truss having horizontal regions adapted to engage outer wall tissues of first and second nasal passages of a nose. When in use the dilator stabilizes or expands nasal outer wall tissues and prevents the outer wall tissues from drawing inward during breathing. Methods of manufacture comprise separate steps for fabricating and assembling the elements and layers of finished dilator devices and for packaging finished devices individually or in groups. Waste material is incorporated into subsequent fabrication processes to produce the same or complementary devices.

I claim: 
     
         1 . A nasal dilator comprising:
 an engagement element comprising at least one of a base member or a cover member;   a functional element comprising at least two discrete, adjacent, spaced apart, substantially parallel resilient members, the resilient members having mid-sections substantially parallel to a longitudinal centerline of the nasal dilator, wherein   at least one of the at least two substantially parallel resilient members includes lateral end portions that diverge obliquely away from the longitudinal centerline of the nasal dilator and toward a nearest long edge of the nasal dilator.   
     
     
         2 . The dilator of  claim 1  wherein a first resilient member of the at least two resilient members extends from end to end in a straight line, a second resilient member of the at least two resilient members has opposite end portions that diverge obliquely away from the longitudinal centerline toward a nearest long edge of the nasal dilator; and
 wherein a plan view periphery of the nasal dilator is symmetric about a lateral centerline of the nasal dilator and asymmetric about the longitudinal centerline thereof. 
 
     
     
         3 . The dilator of  claim 1  wherein at least a different one of the at least two substantially parallel resilient members includes lateral end portions that diverge obliquely away from the longitudinal centerline of the nasal dilator and toward a different nearest long edge of the nasal dilator, the dilator further comprising:
 a third resilient member extending from end to end in a straight line, said third resilient member positioned between the at least two substantially parallel resilient members and parallel to the longitudinal centerline. 
 
     
     
         4 . The dilator of  claim 1  wherein:
 the engagement element comprises a base member having a first peripheral shape and a cover member having a second peripheral shape; 
 the functional element comprising at least two substantially parallel resilient members forms a third peripheral shape; and 
 wherein each of the peripheral shapes are different from each other, such that the cover member has a greatest surface area, the base member has a lesser surface area than the cover member, and a total surface area of all of the at least two substantially parallel resilient members is less than or equal to the lesser surface area of the base member. 
 
     
     
         5 . The dilator of  claim 1  wherein all of the resilient members have opposite end portions that diverge obliquely in a common direction toward a same long edge of the nasal dilator; and
 wherein a plan view periphery of the nasal dilator is symmetric about a lateral centerline of the nasal dilator and asymmetric about the longitudinal centerline thereof. 
 
     
     
         6 . The dilator of  claim 1  wherein the lateral end portions of the second resilient member are longer than a mid portion thereof. 
     
     
         7 . The dilator of  claim 1  wherein at least one resilient member has a first length, a first width, and a first thickness, and at least one other resilient member has a thickness exceeding the first thickness, a width at least equal to the first width, and a length at least equal to the first length. 
     
     
         8 . The dilator of  claim 1  wherein the engagement element comprises a thin, supple plastic film, and
 the at least two resilient members of the functional element are secured to a flat surface side thereof. 
 
     
     
         9 . The nasal dilator of  claim 1 , further comprising a protective release liner having a periphery extending outboard at least a portion of the nasal dilator periphery, the release liner periphery including a lip thereat for grasping by a user preliminary to using the dilator. 
     
     
         10 . A nasal dilator comprising a laminate of vertically stacked material layers, including:
 a base layer comprising a base member having a first peripheral shape;   a resilient layer comprising at least one resilient member having a second peripheral shape;   a cover layer comprising a cover member having a third peripheral shape; and   wherein each of the peripheral shapes are different from each other, such that the cover member has a greatest surface area, the base member has a lesser surface area than the cover member, and the at least one resilient member has a lesser surface area than the base member.   
     
     
         11 . The nasal dilator of  claim 10 , wherein the resilient layer comprises from one to six discrete, laterally adjacent, spaced apart, substantially parallel resilient members. 
     
     
         12 . A nasal dilator comprising:
 an engagement layer comprising at least one of a base member or a cover member; and   at least one oblong resilient member having roughly parallel long edges and a longitudinal resilient member centerline therebetween, wherein   the longitudinal resilient member centerline includes curves bending both left and right.   
     
     
         13 . The nasal dilator of  claim 12 , wherein the at least one oblong resilient member whose longitudinal resilient member centerline has curves bending both left and right, forms a shape that is symmetric about a lateral centerline of the dilator, such that a shape of the oblong resilient member on one side of the lateral centerline is a mirror image of a shape of the oblong resilient member on another side of the lateral centerline.