# US 2014/0194922 A1 · Nasal Dilator and Methods of Fabricating Medical Devices

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- Number: US 2014/0194922 A1
- Document ID: US20140194922A1
- Status: Published application
- Kind: A1
- Application number: 14/139,619
- Filed: 2013-12-23
- Published: 2014-07-10
- Earliest claimed: 2010-12-10
- Assignees: Corbett Lair Inc.
- Inventors: Joseph Vincent IERULLI
- Web page: https://patentgrep.com/patent/US20140194922A1

## CPC

- A61F 5/08: Devices for correcting deformities of the nose {; Devices for enlarging the nostril, e.g. for breathing improvement}
- A61M 2210/0618: Nose
- Y10T 156/1069: Bonding face to face of laminae cut from single sheet
- Y10T 156/1074: Separate cutting of separate sheets or webs
- Y10T 156/1075: of plural laminae from single stock and assembling to each other or to additional lamina
- Y10T 156/1085: One web only
- Y10T 156/1087: Continuous longitudinal slitting
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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.

## Claims

### Claim 1

A plurality of nasal dilators comprising:
an engagement element and a resilient layer;
the engagement element at least substantially defining a dilator periphery, the dilator periphery defining opposite dilator end regions, the end regions being wider than an intermediate region interposed therebetween;
the dilator periphery further being symmetric on opposite sides of at least a lateral centerline such that the dilator periphery on opposite sides thereof are a mirror image; and
the lateral centerline and a longitudinal centerline dividing the dilator into four quadrants, long edges of each quadrant extending from near the lateral centerline to at least near an end edge of the dilator, the long edges of diagonal quadrants being identical.

### Claim 2 (depends on 1)

The nasal dilator of claim 1 wherein the plurality of dilators are laterally nested along at least portions of long edges thereof, wherein;
upper left and lower right quadrants of each dilator are nested along a common line such that the upper left and the lower right quadrants of the laterally nested dilators are adjacent each other, or;
lower left and upper right quadrants of each dilator are nested along a common line such that the lower left and the upper right quadrants of the laterally nested dilators are adjacent each other.

### Claim 3 (depends on 1)

The nasal dilator of claim 1 wherein the dilator periphery is configured so that a first end region of a first dilator and a second end region of a second dilator are nested along a common long edge with a third dilator laterally adjacent thereto;
wherein the first and second dilator end regions conform to a substantial portion of the long edge extending between opposite end edges of the third dilator, the lateral centerlines of the first and second dilators being positioned near the opposite end edges, respectively, of the third dilator; and
one end edge of the first and second dilators, respectively, thus positioned near the lateral centerline of the third dilator.

### Claim 4 (depends on 1)

The dilator of claim 1 wherein the dilator periphery is symmetric on opposite sides of the lateral and longitudinal centerlines, the dilator periphery on opposite sides of either centerline being a mirror image.

### Claim 5 (depends on 1)

The nasal dilator of claim 1, wherein the resilient layer comprises at least one resilient member extending fully between opposite end edges of the dilator.

### Claim 6 (depends on 1)

The nasal dilator of claim 1 wherein the resilient layer comprises from two to three discreet, substantially rectangular, spaced apart, laterally adjacent, parallel resilient members, at least one resilient member extending fully between opposite end edges of the dilator.

### Claim 7 (depends on 1)

The nasal dilator of claim 1 wherein the resilient layer comprises from four to six discreet, substantially rectangular, spaced apart, laterally adjacent, parallel resilient members, at least one resilient member extending fully between opposite end edges of the dilator.

### Claim 8 (depends on 1)

The nasal dilator of claim 1 wherein first and second rows of successive end to end nasal dilators are nested laterally adjacent each other such that the long edges of upper quadrants of the dilators in the first row are nested along the long edges of the upper quadrants of the dilators in the second row.

### Claim 9 (depends on 1)

The nasal dilator of claim 1 wherein the resilient layer comprises at least one substantially rectangular resilient member extending fully between opposite end edges of the dilator, and at least one additional resilient member laterally adjacent thereto, the at least one additional resilient member having divergent end portions extending away from the at least one substantially rectangular resilient member.

### Claim 10 (depends on 1)

The nasal dilator of claim 1 wherein the resilient layer comprises a plurality of discreet, laterally adjacent, substantially parallel resilient members, at least two resilient members each having substantially rectangular mid sections and opposite divergent end portions, said at least two resilient member forming a resilient member structure substantially centered along the longitudinal centerline, the end portions diverging away from the longitudinal centerline of the dilator.

### Claim 11 (depends on 1)

The nasal dilator of claim 1 wherein the resilient layer comprises a plurality of discreet, spaced apart, laterally adjacent, substantially parallel resilient members having substantially rectangular mid sections and opposite divergent end portions, the end portions diverging in the same direction, said direction being toward one side of the longitudinal centerline of the dilator.

### Claim 12 (depends on 1)

The nasal dilator of claim 1 wherein the resilient layer comprises at least one resilient member having a first length, a first width, and a first thickness; and
at least one additional resilient member has a thickness exceeding said first thickness, a width at least equal to said first width, and a length at least equal to said first length.

### Claim 13 (depends on 1)

The nasal dilator of claim 1 wherein the engagement element comprises a thin, supple plastic film, the resilient layer secured to a flat surface side thereof.

### Claim 14 (depends on 1)

The nasal dilator of claim 1 wherein the engagement element comprises a base layer secured to at least a portion of one flat surface side of the resilient layer, and a cover layer secured to at least a portion of an opposite flat surface side of the resilient layer.

### Claim 15 (depends on 6)

The nasal dilator of claim 6 wherein the base layer has a peripheral surface area equal to or greater than a peripheral surface area of the resilient layer and substantially contained within, and being lesser than, a periphery of the cover layer.

### Claim 16 (depends on 1)

The nasal dilator of claim 1, further comprising a protective release liner having a periphery extending outboard at least a portion of the dilator periphery, the release liner periphery including a lip thereat for grasping by a user preliminary to using the dilator.

### Claim 17

A nasal dilator, comprising:
an engagement element laminated to at least one resilient member, edges of said engagement element substantially defining a periphery of the nasal dilator, said periphery consisting of two enlarged lateral end regions joined by a narrower intermediate region, characterized in that;
a complementary nasal dilator may be placed immediately adjacent the nasal dilator such that center points of each dilator are displaced horizontally by about one-half of a width of the dilators and vertically by about one-half of a height of the dilators; and
substantially half of one long edge of the nasal dilator matches peripheral contours of an adjacent substantially half of another long edge of the complementary nasal dilator.

### Claim 18 (depends on 17)

The nasal dilator of claim 17, wherein:
the complementary nasal dilator is rotated 180 degrees before being placed immediately adjacent the nasal dilator.

### Claim 19 (depends on 17)

The nasal dilator of claim 17, wherein:
the complementary nasal dilator is identical to the nasal dilator.

### Claim 20

A nasal dilator comprising:
a resilient element and an engagement element;
the resilient element comprising a resilient member structure including at least three discreet, laterally adjacent, spaced apart, parallel resilient members, 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; and
the nasal dilator characterized by a tripartite arrangement of first and second enlarged end regions joined by a narrower intermediate region.

### Claim 21 (depends on 20)

The nasal dilator of claim 20 wherein the engagement element comprises a thin, supple plastic film, the resilient layer secured to a flat surface side thereof.

### Claim 22 (depends on 20)

The nasal dilator of claim 20 wherein the engagement element comprises a base layer secured to at least a portion of one flat surface side of the resilient layer, and a cover layer secured to at least a portion of an opposite flat surface side of the resilient layer.

### Claim 23 (depends on 22)

The nasal dilator of claim 22 wherein the base layer has a peripheral surface area equal to or greater than a peripheral surface area of the resilient layer and substantially contained within, and being lesser than, a periphery of the cover layer.

### Claim 24 (depends on 20)

The nasal dilator of claim 20, further comprising a protective release liner having a periphery extending outboard at least a portion of the dilator periphery, the release liner periphery including a lip thereat for grasping by a user preliminary to using the dilator.
