Nasal Dilator and Methods of Fabricating Medical Devices

• US 20110093004A1
• Filed: 12/10/2010
• Published: 04/21/2011
• Est. Priority Date: 02/06/2007
• Status: Active Grant

• Current Assignee: Horizon IP Tech LLC
• Original Assignee: Corbett Lair Inc.
• Inventors: Ierulli, Joseph V.
• Granted Patent: US 8,641,852 B2
• Time in Patent Office: Days
• US Class Current: 606/204.45
• CPC Class Codes: A61F 5/08 Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: Y10T 156/1069 Bonding face to face of laminae cut from single sheet
• CPC Class Codes: Y10T 156/1074 Separate cutting of separate sheets or webs
• CPC Class Codes: Y10T 156/1075 of plural laminae from single stock and assembling to each other or to additional lamina
• CPC Class Codes: Y10T 156/1085 One web only
• CPC Class Codes: Y10T 156/1087 Continuous longitudinal slitting

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

1. A method of converting elongated material webs into an elongated material laminate, comprising the steps of:

a) forming a plurality of continuous slits in a first elongated web, the slits positioned laterally across the width thereof and extending vertically through at least a portion of the web and longitudinally along the machine direction thereof without intersecting the outside long edges or an adjacent slit, to form a plurality of elongated strands;

b) separating at least one predetermined elongated strand from said plurality, and

c) combining said at least one predetermined elongated strand with at least one additional elongated web to form the material laminate.

2. The method of claim 1 and further including forming one or more continuous slits in the elongated material laminate, the slits positioned laterally across the width thereof and extending vertically through at least a portion of the laminate and longitudinally along the machine direction thereof without intersecting the outside long edges or an adjacent slit, thereby dividing the material laminate, at least in part, into a plurality of elongated laminate strands.

3. The method of claim 2 and further including forming cross slits between the long edges of at least one laminate strand so as to bisect the laminate strand into a plurality of finished devices.

4. The method of claim 2 and further including:

a) cutting vertically through at least a portion of at least one laminate strand along prescribed lines, and

b) removing material from around said prescribed lines so as to separate the elongated laminate strand into a plurality of finished devices and waste material.

5. The method of claim 1 and further including:

a) cutting vertically through at least a portion of the material laminate along prescribed lines, and

b) removing at least a portion of the material laminate from around said prescribed lines whereby so as to render a plurality of finished devices and waste material.

6. The method of claim 5 wherein:

a) said cutting vertically through at least a portion of said material laminate along prescribed lines extends to a paper liner, and

b) said removing at least a portion of the material laminate from around said prescribed lines renders said plurality of finished devices releasably secured on said paper liner.

7. The method of claim 6 and further including means for segmenting said plurality of finished devices.

8. The method of claim 1 wherein:

a) a second elongated web from said at least one additional elongated web includes a plurality of continuous slits positioned laterally across the width thereof, the slits extending vertically through at least a portion of the web and longitudinally along the machine direction thereof without intersecting the outside long edges or an adjacent slit, the slits forming a plurality of elongated strands;

b) wherein said combining one or more predetermined elongated strands with at least one additional elongated web includes predetermined elongated strands from said first elongated web and from said second elongated web, and

c) wherein the material laminate further comprises a third elongated web from said at least one additional elongated web, layered on top of the combined predetermined elongated strands.

9. The method of claim 8 wherein:

a) said continuous slits form the widths of said plurality of elongated strands in said first and second elongated webs such that;

b) the collective width of a repeating number of laterally contiguous elongated strands from said first elongated web corresponds to the collective width of a repeating number of laterally contiguous elongated strands from said second elongated web such that;

c) said predetermined elongated strands from said first elongated web align with said predetermined elongated strands from said second elongated web.

10. The method of claim 1:

a) wherein a second elongated web from said at least one additional elongated web includes a plurality of continuous slits positioned laterally across the width thereof, the slits extending vertically through at least a portion of the web and longitudinally along the machine direction thereof without intersecting the outside long edges or an adjacent slit, the slits forming a plurality of elongated strands;

b) wherein said combining one or more predetermined elongated strands with at least one additional elongated web includes predetermined elongated strands from said first elongated web and from said second elongated web;

c) the material laminate further including a third elongated web layered on top of said predetermined elongated strands;

d) cutting vertically through at least a portion of the material laminate at intervals along prescribed lines, including forming one or more continuous slits in the material laminate, the continuous slits positioned laterally across the width thereof and extending vertically through at least a portion thereof, the continuous slits further extending along the machine direction of the material laminate without intersecting the outside long edges or an adjacent slit, the slits and prescribed lines forming a plurality of elongated laminate strands;

e) separating one or more predetermined elongated laminate strands from the laminate;

f) layering said predetermined elongated laminate strands onto a separate elongated paper liner so as to form one or more of a subsequent material laminate;

g) cutting vertically through at least a portion of said one or more of the subsequent material laminate along prescribed lines so as form at least a portion of the peripheries of a plurality of finished devices, and

h) removing at least a portion of the material laminate from around said prescribed lines so as to render a plurality of finished devices and waste material.

11. The method of claim 10 wherein the outside long edges of said elongated laminate strands define, at least in part, at least a portion of the long edges of said finished devices.

12. The method of claim 10 wherein said cutting vertically through at least a portion of one or more of the subsequent material laminate along prescribed lines simultaneously forms at least a portion of the peripheral edges of said finished devices and at least a portion of the peripheral edges of a paper liner corresponding to each finished device, the paper liner having a periphery which extends outside at least a portion of the device periphery.

13. The method of claim 1 and further including a plurality of said first elongated web positioned in a spatial relationship such that said predetermined elongated strands are separated from each elongated web so as to be in a predetermined laterally spaced apart relationship across the width of said at least one additional elongated web.

14. The method of claim 13 in which at least one of the plurality of said first elongated web is of a different thickness than at least one other elongated web from said plurality.

15. The method of claim 1 wherein:

a) said plurality of elongated strands comprises at least two groups, at least some of the strands in each group being identical, and

b) the individual strands in at least one group being laterally spaced, said spacing determined, at least in part, by the configuration of the strands in at least one other group.

16. The method of claim 15 wherein the configuration of elongated strands in at least one group is distinct from the configuration of elongated strands in at least one other group.

17. The method of claim 15 wherein a subsequent plurality of elongated strands from a second group thereof are aligned with the spaces occupied by the elongated strands from a first group.

18. The method of claim 1 and further including a plurality of said first elongated web, wherein:

a) at least one of the plurality of said first elongated web is of a different thickness than at least one other elongated web from said plurality;

b) said plurality of elongated strands have at least a first thickness and a subsequent plurality of elongated strands have at least a second thickness, and

c) some of said predetermined elongated strands have at least a first thickness and some of said predetermined elongated strands have at least a second thickness.

19. A method of converting elongated material webs into a plurality of a finished medical device, comprising:

a) means for dividing at least a first elongated material web longitudinally into a plurality of elongated strands, the respective widths of at least some of the strands corresponding, at least in part, to design attributes specific to the finished device;

b) the elongated strands comprising a plurality of interconnected members corresponding, at least in part, to at least a portion of a layer, element, member or component of the finished device;

c) means for separating predetermined elongated strands and combining said strands with at least a second elongated material web so as to have lateral spacing between the predetermined strands, said combining forming, at least in part, a material laminate;

d) means for cutting through at least a portion of the material laminate along prescribed lines, including bisecting said elongated strands into the plurality of members or components, the lines further forming at least a portion of a layer or element of the finished device and defining at least a portion of the peripheral edges of the finished device, and

e) means for separating waste material from the laminate so as to render said plurality of finished devices.

20. The method of claim 19 wherein said prescribed lines are formed, at least in part, along one or more common lines corresponding to at least portions of the peripheral edges of said plurality of finished devices.

21. A nasal dilator comprising:

a) a plurality of vertically stacked layers forming a unitary, single body truss, the truss having a longitudinal extent including first and second end regions for engaging outer wall tissues of first and second nasal passages, respectively, an intermediate region joining the first and second end regions and configured to traverse the bridge of the nose located between the first and second nasal passages, the truss having spring biasing properties and an inherent tendency to return to a normally planar state when flexed, acting to stabilize nasal outer wall tissue and thereby prevent said tissue from drawing in during breathing, and further being capable, at least in part, of resilient deformation allowing the truss to conform, at least in part, to the outer wall tissues,

b) means for an engagement element, a functional element, and a directional element, and

c) at least a portion of at least one of said vertically stacked layers defining at least a portion of each of the functional, engagement, and directional elements.

22. The dilator of claim 21 wherein at least a portion of at least one of said vertically stacked layers diverges laterally from a direction parallel to the longitudinal extent of the truss.

23. The dilator of claim 21 wherein the functional element comprises at least two resilient members, a portion of at least one long edge of at least one resilient member diverging from a direction parallel to the longitudinal extent of the truss.

24. The dilator of claim 21 wherein each of said vertically stacked layers is a different peripheral shape.

25. The dilator of claim 21 wherein the functional element comprises a resilient layer having four or more resilient members.

26. The dilator of claim 21 wherein the functional element comprises a resilient layer having a non uniform thickness.

27. The dilator of claim 21 wherein at least a portion of at least one of said vertically stacked layers conforms, at least in part, to an arcuate shape.