U.S. patent number RE35,408 [Application Number 08/623,608] was granted by the patent office on 1996-12-24 for nasal devices.
This patent grant is currently assigned to Patent Development & Investment S.A.. Invention is credited to Bjorn Petruson.
United States Patent |
RE35,408 |
Petruson |
December 24, 1996 |
**Please see images for:
( Certificate of Correction ) ** |
Nasal devices
Abstract
Devices for improving nasal breathing and to nasal drug delivery
devices having two end portions of a resilient material in the form
of relatively thin tabs, preferably having a gentle curvature,
interconnected by a resilient member. Upon bending of the
connecting member, the two end tabs can be positioned in respective
nostrils where they will be biased outwardly against the nasal side
walls, the outward biasing force being sufficient to locate the
device in the nose and to dilate the anterior part of each nasal
cavity by an amount to improve nasal breathing. No part of the
device is grippingly engaged with the septum and a substantial free
passage for air flow remains between the septum wall and the nasal
side wall-contacting face of each end tab.
Inventors: |
Petruson; Bjorn (Goteborg,
SE) |
Assignee: |
Patent Development & Investment
S.A. (Luxembourg, LU)
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Family
ID: |
27426664 |
Appl.
No.: |
08/623,608 |
Filed: |
March 28, 1996 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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391010 |
May 17, 1989 |
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Reissue of: |
701621 |
May 14, 1991 |
05479944 |
Jan 2, 1996 |
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Foreign Application Priority Data
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May 17, 1989 [GB] |
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8627600 |
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Current U.S.
Class: |
128/858; 606/196;
606/199 |
Current CPC
Class: |
A61F
5/08 (20130101); A61F 5/56 (20130101); A61M
15/08 (20130101); A61M 15/085 (20140204); A61M
11/04 (20130101) |
Current International
Class: |
A61F
5/01 (20060101); A61F 5/08 (20060101); A61F
5/56 (20060101); A61M 15/08 (20060101); A61M
11/04 (20060101); A61M 11/00 (20060101); A61F
011/00 () |
Field of
Search: |
;128/857,858,200.24,204.45,207.18 ;606/199,204.45 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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242553 |
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394505 |
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630889 |
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FR |
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1001434 |
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May 1946 |
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FR |
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1046299 |
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Dec 1951 |
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FR |
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1182602 |
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Sep 1957 |
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FR |
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1351537 |
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Dec 1962 |
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FR |
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381127 |
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Sep 1923 |
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DE |
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0453006 |
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Mar 1928 |
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DE |
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882601 |
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Jul 1953 |
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DE |
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1244146 |
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Jun 1970 |
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ES |
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354998 |
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Apr 1931 |
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GB |
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520491 |
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Apr 1940 |
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GB |
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786488 |
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Apr 1955 |
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GB |
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0748326 |
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Apr 1956 |
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GB |
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0768488 |
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Feb 1957 |
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GB |
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2126101 |
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Mar 1984 |
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GB |
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Primary Examiner: Brown; Michael A.
Attorney, Agent or Firm: Merchant, Gould, Smith, Edell,
Weller & Schmidt
Parent Case Text
.[.This.]. .Iadd.This application is Reissue of Ser. No. 07/701,621
filed May 14, 1991, which .Iaddend.is a continuation of 07/391,010,
filed May 17, 1989, now abandoned.
Claims
I claim:
1. A one-piece device for positioning in the nose comprising:
(i) a pair of tabs for positioning in respective nostrils; and
(ii) an elongate connecting member resiliently interconnecting the
tabs;
wherein:
(a) each tab is resilient and has a surface for engaging the outer
side wall of the respective nostril, is relatively thin .[.se.].
.Iadd.so .Iaddend.to project a relatively small distance from the
outer side wall into the passage of the respective nostril and is
formed from a resilient, relatively soft material whereby said
surface may conform to the contours of said respective side
wall;
(b) the connecting member is of a length sufficient to follow a
path from one tab to the other over the septum of the nose;
(c) said connecting member is resiliently bendable from an
inoperative configuration into an operative configuration in which
the tabs are positioned within the nostrils, the connecting member
follows said path over the septum, and there is a restoring force
tending to return said connecting member to the inoperative
configuration; and
(d) the restoring force is sufficient to maintain the device in the
nose of a user by means of engagement of the tabs with their
respective nostril by means of the tabs urging the respective side
walls outwardly.
2. The device of claim 1, wherein said connecting member is
generally straight in the inoperative condition of the device and
is bent resiliently to follow a curved path in the operative
configuration of the device.
3. The device of claim 2, wherein said connecting member comprises
a main relatively thick portion joined to said tabs by relatively
thin hinge portions.
4. The device of claim 3, wherein the hinge portions taper in
thickness from the main portion to the tabs.
5. The device of claim 3, wherein said main portion tapers in
thickness from its center to said respective hinge portions.
6. The device of claim 3, wherein in the inoperative condition the
tabs are displaced by the hinge portions away from the axis of the
main portion of the connecting member.
7. The device of claim 1, wherein the surface of each tab which
engages the nostril side wall is convex.
8. The device of claim 1, wherein each tab is curved in both a
longitudinal and a lateral direction.
9. The device of claim 1, wherein each tab has a tapering lower
portion.
10. The device of claim 9, wherein the tapering lower portion has a
hollow protrusion on the side remote from the nostril side wall,
said protrusion having an opening to permit the dispensing of a
medication from within the protrusion.
11. The device of claim 10, wherein said protrusion is
semispherical.
12. The device of claim 1, wherein each tab is elongated, extends
transversely to said connecting member and has a first relatively
short portion extending on one side of said connecting member to
enable contact with the floor of the nasal cavity, and a second
relatively long portion extending on the other side of said
connecting member.
13. The device of claim 1, wherein the surface of each tab which
engages the nostril side wall is provided with gripping means.
14. The device of claim 13, wherein said gripping means comprises a
plurality of protuberances.
15. The device of claim 1, wherein the surface of each tab which
engages the nostril side wall is provided with a cavity having an
opening to permit the dispensing of a medication from within the
cavity.
16. The device of claim 15, wherein said cavity is defined by a
raised wall extending from said surface.
17. A one-piece device for positioning in the nose comprising:
(i) a pair of tabs for positioning in respective nostrils; and
(ii) a resilient elongated connecting member interconnecting the
tabs;
wherein:
(a) each tab is resilient and has a surface for engaging the outer
side wall of the respective nostril, is relatively thin so as to
project a relatively small distance from the outer side wall into
the passage of the respective nostril;
(b) the connecting member is of a length sufficient to follow a
path from one tab to the other over the septum of the nose, and
comprises a relatively thick main portion connected at its end to
said tabs by thinner hinge portions;
(c) said connecting member is resiliently bendable from an
inoperative configuration into an operative configuration in which
the tabs are positioned within the nostrils, the connecting member
follows said path over the septum, and there is a restoring force
tending to return said connecting member to the inoperative
configuration;
(d) the arrangement of said relatively thick main portion and the
said thinner hinge portions of said connecting member being such
that in said operative condition, bending of the said main portion
is minimized and most of the bending movement is taken by said
hinge portions; and
(e) the restoring force is sufficient to maintain the device in the
nose of a user by means of engagement of the tabs with their
respective nostril outer side wall, and to dilate the nostrils by
means of the tabs urging the respective side walls outwardly.
18. A one-piece device for positioning in the nose comprising:
(i) a pair of tabs for positioning in respective nostrils; and
(ii) a resilient elongated connecting member interconnecting the
tabs;
wherein:
(a) each tab is resilient and has a surface for engaging, the outer
side wall of the respective nostril, and is relatively thin so as
to project a relatively small distance from the outer side wall
into the passage of the respective nostril;
(b) the connecting member is of a length sufficient to follow a
path from one tab to the other over the septum of the nose, and
comprises a main portion connected at its ends to said tabs by
hinge portions;
(c) said connecting member is resiliently bendable from an
inoperative configuration in which said main portion is generally
straight, into an operative configuration in which the tabs are
positioned within the nostrils and in which said main portion is
bowed, the connecting member follows said path over the septum, and
there is a restoring force tending to return said connecting member
to the inoperative configuration; and
(d) the restoring force is sufficient to maintain the device in the
nose of a user by means of engagement of the tabs with their
respective nostril outer side walls, and to dilate the nostrils by
means of the tabs urging the respective side walls outwardly.
19. A one-piece device for positioning in the nose comprising:
(i) a pair of tabs for positioning in respective nostrils; and
(ii) a resilient elongated connecting member interconnecting the
tabs;
wherein:
(a) each tab is elongated, resilient and has a surface for engaging
the outer side wall of the respective nostril, is relatively thin
so as to project a relatively small distance from the outer side
wall into the passage of the respective nostril, extends
transversely to the axis of the connecting member and is formed
from a relatively soft material whereby said surface may conform to
the contours of the respective outer side wall;
(b) the connecting member is of a length sufficient to follow a
path from one tab to the other over the septum of the nose, and
comprises a relatively thick main portion connected at its ends to
said tabs by relatively thin hinge portions;
(c) said connecting member is resiliently bendable from an
inoperative configuration in which said main portion is generally
straight, into an operative configuration in which the tabs are
positioned within the nostrils and in which said main portion is
bowed, the connecting member follows said path over the septum, and
there is a restoring force tending to return said connecting member
to the inoperative configuration;
(d) the arrangement of said relatively thick main portion and the
said thinner hinge portions of said connecting member being such
that in said operative condition, bending of the said main portion
is minimized and most of the bending movement is taken by said
hinge regions and such that said tabs are offset from the axis of
said main portion by said hinge portions; and
(e) the restoring force is sufficient to maintain the device in the
nose of a user by means of engagement of the tabs with their
respective nostril outer side walls, and to dilate the nostrils by
means of the tabs urging the respective side walls outwardly.
20. A device for positioning in the nose to administer medication
comprising:
(i) a pair of tabs for positioning in respective nostrils; and
(ii) an elongated connecting member resiliently interconnecting the
tabs;
wherein:
(a) each tab is resilient and has a surface for engaging the outer
side wall of the respective nostril, is relatively thin so as to
project a relatively small distance from the outer side wall into
the passage of the respective nostril and is formed from a
resilient, relatively soft material whereby said surface may
conform to the contours of said respective side wall;
(b) the connecting member is of a length sufficient to follow a
path from one tab to the other over the septum of the nose;
(c) said connecting member is resiliently bendable from an
inoperative configuration into an operative configuration in which
the tabs are positioned within the nostrils, the connecting member
follows said path over the septum, and there is a restoring force
tending to return said connecting member to the inoperative
configuration; and
(d) the restoring force is sufficient to maintain the device in the
nose of a user by means of engagement of the tabs with their
respective nostril outer side walls, and to dilate the nostrils by
means of the tabs urging the respective side walls outwardly;
and
(e) said tabs are provided with means for retaining a medication to
be administered.
21. The device of claim 20 wherein the surface of each tab which
engages the nostril side wall is provided with a cavity having an
opening to permit the dispensing of medication from within the
cavity.
22. The device of claim 21 wherein the surface of each tab which is
remote from the nostril side wall is provided with a cavity having
an opening to permit the dispensing of medication from within the
cavity.
23. A method for improving nasal breathing comprising the step of
positioning in the nose a device comprising:
(i) a pair of tabs for positioning in respective nostrils; and
(ii) an elongated connecting member resiliently interconnecting the
tabs;
wherein:
(a) each tab is resilient and has a surface for engaging the outer
side wall of the respective nostril, is relatively thin so as to
project a relatively small distance from the outer side wall into
the passage of the respective nostril and is formed from a
resilient, relatively soft material whereby said surface may
conform to the contours of said respective side wall;
(b) the connecting member is of a length sufficient to follow a
path from one tab to the other over the septum of the nose;
(c) said connecting member is resiliently bendable from an
inoperative configuration into an operative configuration in which
the tabs are positioned within the nostrils, the connecting member
follows said path over the septum, and there is a restoring force
tending to return said connecting member to the inoperative
configuration; and
(d) the restoring force is sufficient to maintain the device in the
nose of a user by means of engagement of the tabs with their
respective nostril outer side walls, and to dilate the nostrils by
means of the tabs urging the respective side walls outwardly.
24. A method for improving nasal breathing comprising the step of
positioning in the nose a device comprising:
(i) a pair of tabs for positioning in respective nostrils; and
(ii) a resilient elongated connecting member interconnecting the
tabs;
wherein:
(a) each tab is elongated, resilient and has a surface for engaging
the outer side wall of the respective nostril, is relatively thin
so as to project a relatively small distance from the outer side
wall into the passage of the respective nostril, extends
transversely to the axis of the connecting member and is formed
from a relatively soft material whereby said surface may conform to
the contours of the respective side wall;
(b) the connecting member is of a length sufficient to follow a
path from one tab to the other over the septum of the nose, and
comprises a relatively thick main portion connected at its ends to
said tabs by relatively thin hinge portions;
(c) said connecting member is resiliently bendable from an
inoperative configuration in which said main portion is generally
straight, into an operative configuration in which tabs are
positioned within the nostrils and in which said main portion is
bowed, the connecting member follows said path over the septum, and
there is a restoring force tending to return said connecting member
to the inoperative configuration;
(d) the arrangement of said relatively thick main portion and the
said thinner hinge portions of said connecting member being such
that in said operative condition, bending of the said main portion
is minimized and most of the bending movement is taken by said
hinge regions and such that said tabs are offset from the axis of
said main portion by said hinge portions; and
(e) the restoring force is sufficient to maintain the device in the
nose of a user by means of engagement of the tabs with their
respective nostril outer side walls, and to dilate the nostrils by
means of the tabs urging the respective side walls outwardly.
25. A method of reducing or preventing snoring comprising the step
of positioning in the nose a device comprising:
(i) a pair of tabs for positioning in respective nostrils; and
(ii) an elongated connecting member resiliently interconnecting the
tabs;
wherein:
(a) each tab is resilient and has a surface for engaging the outer
side wall of the respective nostril, is relatively thin so as to
project a relatively small distance from the outer side wall into
the passage of the respective nostril and is formed from a
resilient, relatively soft material whereby said surface may
conform to the contours of said respective side wall;
(b) the connecting member is of a length sufficient to follow a
path from one tab to the other over the septum of the nose;
(c) said connecting member is resiliently bendable from an
inoperative configuration into an operative configuration in which
the tabs are positioned within the nostrils, the connecting member
follows said path over the septum, and there is a restoring force
tending to return said connecting member to the inoperative
configuration; and
(d) the restoring force is sufficient to maintain the device in the
nose of a user by means of engagement of the tabs with their
respective nostril outer side walls, and to dilate the nostrils by
means of the tabs urging the respective side walls outwardly.
26. A method of administering a medication nasally comprising the
step of positioning in the nose a device comprising:
(i) a pair of tabs for positioning in respective nostrils; and
(ii) an elongated connecting member resiliently interconnecting the
tabs; wherein:
(a) each tab is resilient and has a surface for engaging the outer
side wall of the respective nostril, is relatively thin so as to
project a relatively small distance from the outer side wall into
the passage of the respective nostril and is formed from a
resilient, relatively soft material whereby said surface may
conform to the contours of said respective side wall;
(b) the connecting member is of a length sufficient to follow a
path from one tab to the other over the septum of the nose;
(c) said connecting member is resiliently bendable from an
inoperative configuration into an operative configuration in which
the tabs are positioned within the nostrils, the connecting member
follows said path over the septum, and there is a restoring force
tending to return said connecting member to the inoperative
configuration;
(d) the restoring force is sufficient to maintain the device in the
nose of a user by means of engagement of the tabs with their
respective nostril outer side walls, and to dilate the nostrils by
means of the tabs urging the respective side walls outwardly;
and
(3) said tabs are provided with means retaining a medication to be
administered.
27. The method of claim 26 wherein said medication is retained in a
cavity provided on the surface of the tab which engages the nasal
wide wall.
28. The method of claim 26 wherein said medication is retained in a
cavity provided on the surface of the tab remote from the nostril
side wall. .Iadd.
29. A nasal dilator capable of introducing separating stresses in
nasal outer wall tissues, comprising:
a unitary plastic body with a resilient member secured therein, the
body being of non-uniform thickness and having a first thickness
and a portion of greater thickness, the body being substantially
planar absent external forces applied thereto, the body having a
pair of spaced apart end surfaces which, if forced toward one
another from their initial positions within the plane of said body
to substantially reduce direct spacing therebetween by a spacing
reduction force external to said body results in restoring forces
in said body tending to restore said direct spacing between said
end surfaces; and
engagement means with said end surfaces capable of engaging
surfaces of nasal outer wall tissues sufficiently to remain so
engaged against said restoring forces, such that the restoring
forces in said body tend to restore the body to the substantially
planar state and dilate the nose by urging the outer wall tissues
outwardly with the end surfaces of said resilient member, and also
on release of the end surfaces from engagement with the outer wall
tissue the restoring forces further urging the body to return to
the substantially planar state. .Iaddend..Iadd.
30. The nasal dilator of claim 29 wherein said nasal dilator is
configured to restrain nasal outer wall tissues adjacent nasal
passages therein from being drawn in during breathing, said body
having sufficient restoring forces to substantially maintain during
inhalation that spacing occurring between said end surfaces prior
to inhalation. .Iaddend..Iadd.31. The nasal dilator of claim 29
wherein said body includes deformable material between exposed
surfaces of any nasal outer wall tissues engaged by said engagement
means and said resilient member. .Iaddend..Iadd.32. The nasal
dilator of claim 29 wherein said body and said engagement means are
capable of being manually released from surfaces of any nasal outer
wall tissues engaged by said engagement means. .Iaddend..Iadd.33.
The nasal dilator claim 29 wherein said resilient member and said
engagement means together are formed as a strip body having a
length substantially greater than either of its width and
thickness, and a width substantially greater
than its thickness everywhere along said length. .Iaddend..Iadd.34.
The nasal dilator of claim 29 wherein said body is of substantially
constant thickness. .Iaddend..Iadd.35. The nasal dilator of claim
29 wherein said end surfaces are limited in separation therebetween
so that, when said end surfaces are engaging nasal outer wall
tissues adjacent nasal passages therein, a surface of said body can
be in contact with said nose for substantially all of that extent
thereof between said end surfaces. .Iaddend..Iadd.36. The nasal
dilator of claim 29 wherein said spaced-apart end surfaces of said
body are terminated by end edges at opposite ends of said body, and
wherein said resilient member provides said restoring forces in
said body tending to restore said spacing between end surfaces
thereof. .Iaddend..Iadd.37. A nasal dilator capable of introducing
separating stresses in nasal outer wall tissues, comprising:
a resilient unitary plastic body, the body being of non-uniform
thickness and having a first thickness and a portion of greater
thickness, the body being substantially planar absent external
forces applied thereto having a pair of spaced apart end surfaces
which, if forced toward one another from their initial positions
within the plane of said body to substantially reduce direct
spacing therebetween by a spacing reduction force external to said
body, results in restoring forces in said body tending to restore
said direct spacing between said end surfaces; and
said end surfaces comprising engagement means capable of engaging
surfaces of nasal outer wall tissues sufficiently to remain so
engaged against said restoring forces, such that the restoring
forces in said body tend to restore the body to the substantially
planar state and dilate the nose by urging the outer wall tissues
outwardly with the end surfaces of said resilient member, and also
on release of the end surfaces from engagement with the outer wall
tissue the restoring forces further urging the body to
return to the substantially planar state. .Iaddend..Iadd.38. A
nasal dilator comprising:
a unitary plastic member, the member being of non-uniform thickness
and having a first thickness and a portion of greater thickness,
the member being substantially planar absent external forces
applied thereto, the unitary member including:
a first end region adapted to engage the outer wall tissue of a
first nasal passage;
a second end region adapted to engage the outer wall tissue of a
second nasal passage;
an intermediate segment configured to traverse a portion of a nose
located between the first and second nasal passages, the inherent
tendency of the member to return to its normally substantially
planar state when flexed acting to stabilize the outer wall tissue
and thereby act to substantially prevent the outer wall tissue of
the first and second nasal passages from drawing in during
breathing;
a resilient member being at least a portion of the first and second
end regions and the intermediate segment, the resilient member
being capable, at least in part, of deformation that allows the
member to conform to the outer wall tissue of the nasal passages of
a nose, and
the inherent tendency of the member to return to its substantially
planar state acting to dilate the nose by urging the outer wall
tissues outwardly with the end regions of said resilient member,
and also on release of the end regions from engagement with the
outer wall tissue the inherent tendency of the member to return
acting to urge the body to return further
to the substantially planar state. .Iaddend..Iadd.39. The nasal
dilator of claim 38 wherein the member is configured to extend
about a nose such that the intermediate segment traverses an
exterior region of the nose, the first end region engaging a
surface of the outer wall tissue of the first nasal passage and the
second end region engaging a surface of the
outer wall tissue of the second nasal passage. .Iaddend..Iadd.40.
The nasal dilator of claim 38 wherein the resilient member
includes:
at least one resilient band oriented substantially parallel to a
longitudinal length of the truss, the resiliency of the at least
one resilient band acting to prevent the outer wall tissue of the
first and second nasal passages from drawing in during breathing.
.Iaddend..Iadd.41. The nasal dilator of claim 38 wherein the
resilient member stabilizes the outer wall tissue by dilating the
first and second nasal passages to thereby prevent the outer wall
tissue of the first and second nasal
passages from drawing in during breathing. .Iaddend..Iadd.42. A
nasal dilator comprising:
a resilient unitary plastic member, the member being of non-uniform
thickness and having a first thickness and a portion of greater
thickness, the member being substantially planar absent external
forces applied thereto, the unitary member including;
a first end region adapted to engage the outer wall tissue of a
first nasal passage;
a second end region adapted to engage the outer wall tissue of a
second nasal passage;
an intermediate segment configured to traverse a portion of a nose
located between the first and second nasal passages, the inherent
tendency of the member to return to its normally planar state when
flexed acting to bias the outer wall tissue of the first and second
nasal passages outwardly during breathing, and
the inherent tendency of the member to return to its planar state
acting to dilate the nose by urging the outer wall tissues
outwardly with the end regions of said resilient member, and also
on release of the end regions from engagement with the outer wall
tissue the inherent tendency of the body to return acting to urge
the body to return further to the substantially planar state.
.Iaddend..Iadd.43. A nasal dilator comprising:
a resilient unitary plastic member, the member being of non-uniform
thickness and having a first thickness and a portion of greater
thickness, the member being substantially planar absent external
forces applied thereto, the unitary member including:
a first end region adapted to engage the outer wall tissue of a
first nasal passage;
a second end region adapted to engage the outer wall tissue of a
second nasal passage;
an intermediate segment configured to traverse a portion of a nose
located between the first and second nasal passages, the inherent
tendency of the member to return to its normally planar state when
flexed acting to bias the outer wall tissue of the first and second
nasal passages outwardly during breathing,
the resilient member being capable, at least in part, of
deformation that allows the member to conform to the outer wall
tissue of the nasal passages of a nose, and
the inherent tendency of the member to return to its planar state
acting to dilate the nose by urging the outer wall tissues
outwardly with the end regions of said resilient member, and also
on release of the end regions from engagement with the outer wall
tissue the inherent tendency of the member to return acting to urge
the body to return further to the
substantially planar state. .Iaddend..Iadd.44. A nasal dilator
comprising:
a resilient, flexible plastic member, the member being of
non-uniform thickness and having a first thickness and a portion of
greater thickness, the member being substantially planar absent
external forces applied thereto, including:
a first end region adapted to engage the outer wall tissue of a
first nasal passage;
a second end region adapted to engage the outer wall tissue of a
second nasal passage;
an intermediate segment, the member being unitary from the first
end region to the second end region with the intermediate segment
being configured to traverse an exterior region of the nose located
between the first and second nasal passages, the inherent tendency
of the member to return to its normally planar state when flexed
acting to stabilize the outer wall tissue and thereby act to
substantially prevent the outer wall tissue of the first and second
nasal passages from collapsing when inhaling;
a deformable means in at least a portion of the first and second
end regions and the intermediate segment for enhancing the
flexibility of the member in a direction substantially
perpendicular to a longitudinal extent of the member, and
the inherent tendency of the member to return to its planar state
acting to dilate the nose by urging the outer wall tissues
outwardly with the end regions of said resilient member, and also
on release of the end regions from engagement with the outer wall
tissue the inherent tendency of the member to return acting to urge
the body to return further to the substantially planar state.
.Iaddend..Iadd.45. A nasal dilator comprising:
a unitary plastic member, the member being of non-uniform thickness
and having a first thickness and a portion of greater thickness,
the member being substantially planar absent external forces
applied thereto, the unitary member including:
first end region engaging an exterior surface of the outer wall
tissue of a first nasal passage;
a second end region engaging an exterior surface of the outer wall
tissue of a second nasal passage;
an intermediate segment configured to traverse a portion of a nose
located between the first and second nasal passages by extending
about an exterior region, the inherent tendency of the member to
return to its normally planar state when flexed acting to stabilize
the outer wall tissue and thereby act to substantially prevent the
outer wall tissue of the first and second nasal passages from
drawing in during breathing;
a deformable means for allowing the member to conform to the outer
wall tissue of the nasal passages of a nose through the deformable
means capability of being deformable, the deformable means defining
at least a portion of the first and second end regions and the
intermediate segment, and the inherent tendency of the member to
return to its planar state acting to dilate the nose by urging the
outer wall tissues outwardly with the end regions of said member,
and also on release of the end regions from engagement with the
outer wall tissue the inherent tendency of the member to return
acting to urge the body to return further to the
substantially planar state. .Iaddend..Iadd.46. A one-piece device
for engaging the nose comprising:
a pair of tabs positioned with respective nostrils; and
an elongated connecting member resiliently interconnecting the
tabs, wherein:
each tab is resilient and has a surface for engaging the outer side
wall of the respective nostril, is relatively thin and is formed
from a resilient material whererby said surface may conform to the
contours of said respective side wall;
the connecting member is of a length sufficient to follow a path
from one tab to the other over the nose;
said connecting member, the member being of non-uniform thickness
and having a first thickness and a portion of greater thickness,
the member being resiliently bendable from an inoperative
configuration into an operative configuration in which the tabs are
positioned relative with the nostrils, the connecting member
follows said path and there is a restoring force tending to return
said connecting member to the inoperative configuration; and
the restoring force is sufficient to urge the respective side walls
outwardly by means of gripping engagement of the tabs with their
respective nostril by means of the tabs urging the respective side
walls outwardly, such that the restoring forces tend to restore the
member to a substantially planar state and dilate the nose, and
also on release of the end surfaces from engagement with the outer
wall the restoring forces urge the member to return further to the
substantially planar state.
.Iaddend..Iadd.47. The device of claim 46 wherein said connecting
member is generally straight in the inoperative condition of the
device and is bent resiliently to follow a curved path in the
operative configuration of
the device. .Iaddend..Iadd.48. A nasal dilator capable of
introducing separating stresses in nasal outer wall tissues,
comprising:
a unitary plastic body with a resilient member secured therein, the
member being of non-uniform thickness and having a first thickness
and a portion of greater thickness, the member being substantially
planar absent external forces applied thereto, having a pair of
spaced apart end surfaces which, if forced toward one another from
initial positions to substantially reduce direct spacing
therebetween by a spacing reduction force external to said body,
results in restoring forces in said body tending to restore said
direct spacing between said end surfaces; and
engagement means with said end surfaces capable of grippingly
engaging surfaces of nasal outer wall tissues sufficiently to
remain so engaged against said restoring forces, such that the
restoring forces tend to restore the body to the substantially
planar state and dilate the nose, and also on release of the end
surfaces from engagement with the outer wall tissues the restoring
forces further urge the body to return to the
substantially planar state. .Iaddend..Iadd.49. A nasal dilator
capable of introducing separating stresses in nasal outer wall
tissues, comprising:
a resilient unitary plastic body, the body being of non-uniform
thickness and having a first thickness and a portion of greater
thickness, the body being substantially planar absent external
forces applied thereto having a pair of spaced apart end surfaces
which, if forced toward one another from initial positions to
substantially reduce direct spacing therebetween by a spacing
reduction force external to said body, results in restoring forces
in said body tending to restore said direct spacing between said
end surfaces; and
said end surfaces comprising engagement means capable of grippingly
engaging surfaces of nasal outer wall tissues sufficiently to
remain so engaged against said restoring forces, such that the
restoring forces tend to restore the body to the substantially
planar state and dilate the nose, and also on release of the end
surfaces from engagement with the outer wall tissues the restoring
forces further urge the body to return to the
substantially planar state. .Iaddend..Iadd.50. A nasal dilator
comprising:
a unitary plastic member, the member being of non-uniform thickness
and having a first thickness and a portion of greater thickness,
the member being substantially planar absent external forces
applied thereto, the unitary member including:
a first end region adapted to attach to the outer wall tissue of a
first nasal passage;
a second end region adapted to attach to the outer wall tissue of a
second nasal passage;
an intermediate segment configured to traverse a portion of a nose
located between the first and second nasal passages, the inherent
tendency of the member to return to its normally planar state when
flexed acting to stabilize the outer wall tissue and thereby act to
substantially prevent the outer wall tissue of the first and second
nasal passages from drawing in during breathing;
resilient member being at least a portion of the first and second
end regions and the intermediate segment, the resilient member
being capable, at least in part, of deformation that allows the
member to conform to the outer wall tissue of the nasal passages of
a nose, and
the inherent tendency of the member to return to its planar state
also acting on release of the end regions from engagement with the
outer tissue to return the body further to the substantially planar
state.
.Iaddend..Iadd.51. A nasal dilator comprising:
a resilient unitary plastic member, the member being of non-uniform
thickness and having a first thickness and a portion of greater
thickness, the member being substantially planar absent external
forces applied thereto, the unitary member including:
a first end region adapted to attach to the outer wall tissue of a
first nasal passage;
a second end region adapted to attach to the outer wall tissue of a
second nasal passage;
an intermediate segment configured to traverse a portion of a nose
located between the first and second nasal passages, the inherent
tendency of the member to return to its normally planar state when
flexed acting to bias the outer wall tissue of the first and second
nasal passages outwardly during breathing, and also on release of
the end regions from engagement with the outer wall tissue the
inherent tendency of the member acts to urge the body to return
further to the substantially planar state.
.Iaddend..Iadd.52. A nasal dilator comprising:
a resilient unitary plastic member, the member being of non-uniform
thickness and having a first thickness and a portion of greater
thickness, the member being substantially planar absent external
forces; the unitary member including:
a first end region adapted to attach to the outer wall tissue of a
first nasal passage;
a second end region adapted to attach to the outer wall tissue of a
second nasal passage;
an intermediate segment configured to traverse a portion of a nose
located between the first and second nasal passages, the inherent
tendency of the member to return to its normally planar state when
flexed acting to bias the outer wall tissue of the first and second
nasal passages outwardly during breathing, and
the resilient member being capable, at least in part, of
deformation that allows the member to conform to the outer wall
tissue of the nasal passages of a nose, and also on release of the
end regions from engagement with the outer wall tissue the inherent
tendency of the member acts to urge the body to return further to
the substantially planar state.
.Iaddend..Iadd.53. A nasal dilator comprising:
a resilient, flexible plastic member, the member being of
non-uniform thickness and having a first thickness and a portion of
greater thickness, the member being substantially planar absent
external forces applied thereto, including:
a first end region adapted to attach to the outer wall tissue of a
first nasal passage;
a second end region adapted to attach to the outer wall tissue of a
second nasal passage;
an intermediate segment, the member being unitary from the first
end region to the second end region with the intermediate segment
being configured to traverse an exterior region of the nose located
between the first and second nasal passages, the inherent tendency
of the member to return to its normally planar state when flexed
acting to stabilize the outer wall tissue and thereby prevent the
outer wall tissue of the first and second nasal passages from
collapsing when inhaling, and also on release of the end regions
from engagement with the outer wall tissue the inherent tendency of
the member acts to urge the body to return further to the
substantially planar state, and
a deformable means in at least a portion of the first and second
end regions and the intermediate segment for enhancing the
flexibility of the member in a direction substantially
perpendicular to a longitudinal extent
of the member. .Iaddend..Iadd.54. A nasal dilator comprising:
unitary plastic member, the member being of non-uniform thickness
and having a first thickness and a portion of greater thickness,
the member being substantially planar absent external forces
applied thereto, the unitary member including:
a first end region attaching to an outer surface of the outer wall
tissue of a first nasal passage;
a second end region attaching to an outer surface of the outer wall
tissue of a second nasal passage;
an intermediate segment configured to traverse a portion of a nose
located between the first and second nasal passages by extending
about an exterior region, the inherent tendency of the member to
return to its normally planar state when flexed acting to stabilize
the outer wall tissue and thereby act to substantially prevent the
outer wall tissue of the first and second nasal passages from
drawing in during breathing, and also on release of the end regions
from engagement with the outer wall tissue the inherent tendency of
the member acts to urge the body to return further to the
substantially planar state; and
a deformable means for allowing the member to conform to the outer
wall tissue of the nasal passages of a nose through the deformable
means capability of being deformable, the deformable means defining
at least a portion of the first and second end regions and the
intermediate segment.
.Iaddend..Iadd.55. A method for improving nasal breathing
comprising the step of engaging with the nose a device
comprising:
a pair of tabs for positioning with respective nostrils; and
an elongated connecting member resiliently interconnecting the
tabs, wherein:
each tab is resilient and has a surface for engaging the outer side
wall of the respective nostril, is relatively thin and is formed
from a resilient material whereby said surface may conform to the
contours of said respective side wall;
the connecting member is of a length sufficient to follow a path
from one tab to the other over the nose;
said connecting member is resiliently bendable from an inoperative
configuration into an operative configuration in which the tabs are
positioned relative with the nostrils, the connecting member
follows said path and there is a restoring force tending to return
said connecting member to the inoperative configuration; and
the restoring force is sufficient to urge the respective side walls
outwardly by means of engagement of the tabs with their respective
nostril and to dilate the nostrils by means of the tabs urging the
respective side
walls outwardly. .Iaddend..Iadd.56. A method of reducing or
preventing snoring comprising the step of positioning relative with
the nose a device comprising:
a pair of tabs for positioning with respective nostrils; and
an elongated connecting member resiliently interconnecting the
tabs, wherein:
each tab is resilient and has a surface for engaging the outer side
wall of the respective nostril, is relatively thin and is formed
from a resilient material whereby said surface may conform to the
contours of said respective side wall;
the connecting member is of a length sufficient to follow a path
from one tab to the other over the nose;
said connecting member is resiliently bendable from an inoperative
configuration into an operative configuration in which the tabs are
positioned relative with the nostrils, the connecting member
follows said path and there is a restoring force tending to return
said connecting member to the inoperative configuration; and
the restoring force is sufficient to urge the respective side walls
outwardly by means of engagement of the tabs with their respective
nostril and to dilate the nostrils by means of the tabs urging the
respective side
walls outwardly. .Iaddend..Iadd.57. A nasal dilator capable of
introducing separating stresses in nasal outer wall tissues,
comprising:
a resilient unitary plastic body, the body being of non-uniform
thickness and having a first thickness and a portion of greater
thickness, the body being substantially planar absent external
forces applied thereto having a pair of spaced apart end surfaces
which, if forced toward one another from their initial positions
within the plane of said body to substantially reduce direct
spacing therebetween by a spacing reduction force external to said
body, results in restoring forces in said body tending to restore
said direct spacing between said end surfaces; and
said end surfaces comprising engagement means capable of engaging
exposed surfaces of nasal outer wall tissues sufficiently to remain
so engaged against said restoring forces, such that the restoring
forces in said body tend to restore the body to the substantially
planar state and dilate the nose by urging the outer wall tissues
outwardly with the end surfaces of said resilient member, and also
on release of the end surfaces from engagement with the outer wall
tissue the restoring forces urge the body
to return further to the substantially planar state.
.Iaddend..Iadd.58. A one-piece device for engaging the nose
comprising:
a pair of tabs positioned with respective nostrils; and an
elongated connecting member resiliently interconnecting the tabs,
wherein:
each tab has a surface for engaging the outer side wall of the
respective nostril and is relatively thin whereby said surface may
conform to the contours said respective side wall;
the connecting member is of a length sufficient to follow a path
from one tab to the other over the nose;
said connecting member, the member being of non-uniform thickness
and having a first thickness and a portion of greater thickness,
the member being resiliently bendable from an inoperative
configuration into an operative configuration in which the tabs are
positioned relative with the nostrils, the connecting member
follows said path and there is a restoring force tending to return
said connecting member to the inoperative configuration; and
the restoring force sufficient to urge the respective side walls
outwardly by means of engagement of the tabs with their respective
nostril by means of the tabs urging the respective side walls
outwardly, such that the restoring force in said body tends to
restore the body to substantially planar state and dilate the nose
by urging the outer wall tissues outwardly with the end surfaces of
said resilient member, and also on release of the end surfaces from
engagement with the outer wall tissue the restoring force urge the
body to return further to the substantially planar state.
.Iaddend..Iadd.59. The device of claim 58 wherein said connecting
member is generally straight in the inoperative condition of the
device and is bent resiliently to follow a curved path in the
operative configuration of the device. .Iaddend.
Description
The present specification relates to nasal devices. In particular,
it relates to devices for improving nasal breathing capacity and to
nasal drug-delivery devices.
The nose is divided into two cavities by a thin wall or septurn in
the mid-line. The side walls are irregular due to three baffles
important for the air condition function and all the walls are
covered by mucous membranes which have a large ability to warm and
humidify the inspired air. If breathing through the nose is
impaired so that breathing through the mouth becomes necessary,
"conditioning" of the inspired air occurs less efficiently and
hence drying of the mucosa in the throat and bronchi may result. In
many patients with asthma, the bronchial mucosa is highly
susceptible to inhalation of cold air and it is thus particularly
desirable for such individuals to breathe only through the nose. If
the anterior part of each nasal cavity is dilated, the ability to
breathe through the nose increases significantly.
A further undesirable effect related to airway obstruction in the
nose is snoring. A snoring sound is generated during inspiration
when there is an airway obstruction in the nose or throat which is
overcome by deep breathing resulting in vibration of the soft
tissues in the palate and throat and is a very common phenomenon in
sleeping individuals. About 20% of normal adults snore habitually,
the phenomenon being more common in men than women and in people
aged over 40. Despite this, no device for preventing snoring has as
yet found widespread acceptance. The most commonly used method for
stopping an individual snoring remains to disturb them so that
their breathing pattern is modified. However, when the person falls
fully asleep again snoring is liable to recur.
An alternative means of preventing snoring is to dilate the
anterior part of each nasal cavity so that nasal breathing capacity
is improved. While devices for insertion in the nose to improve
nasal breathing capacity have previously been disclosed none of
these, however, are suitable for long term every day use either by
individuals with a snoring problem or asthma sufferers in view of
liability to cause unacceptable discomfort and/or the increase in
size of the nasal cavities being off-set to a large degree by the
size of the portions of the device inserted therein. Moreover, some
of these devices are unacceptable from an aesthetic point of view
for general daytime use by asthma sufferers.
GB-A-1244146, for example, discloses a device for facilitating
nasal breathing comprising two spherical or ellipsoidal frames for
insertion into the nostrils, the frames being formed of a plurality
of interconnected rings of a non-oxidisable metal or rigid plastic
material and being connected by a loose linkage of further such
rings. When fitted into a nose, each spherical or ellipsoidal frame
of a device of this type fills much of the lower part of the nasal
cavity into which it is inserted and contacts both the septum and
the interior surface of the side wall. The frames are liable to
cause irritation, particularly if they contact the sensitive nasal
mucosa, and may give rise to nose bleeds and ulcers. These same
problems are shared by devices more recently disclosed in
GB-A-2126101 for assisting nasal breathing, wherein the end pieces
inserted into the nasal cavities are helical coils formed, for
example, from lightly tempered stainless steel and joined by a
simple loop of the same material which fits around the septum. The
helical coils, when inserted into the nostrils of an individual,
contact both the nasal side walls and the septum and significantly
disrupt air flow through the anterior part of each nasal cavity.
Such devices cannot be maintained in the nose with a high degree of
comfort for a long period of time and despite their ease of
construction have not been widely used either for alleviation of
snoring or for use in treatment of other conditions where an
increase of nasal breathing is desirable.
Devices are also known for fitment in the nose of an individual
which are intended to have the dual function of improving nasal
breathing capacity and enabling delivery of drugs into the nasal
cavities, but none of these have found widespread favour for use in
medical practice, eg. in the treatment of asthma sufferers. For
example, GB-A-768488 discloses nasal drug delivery devices
consisting of a generally U-shaped resilient step with two arms for
fitment in the nasal cavities of an individual, the two arms having
at the upper end a closed oval loop with claws to hold a
drugimpregnated absorbent material, e.g. gauze or cotton wool. Such
devices undesirably depend for retention in the nose both upon
outward pressure of a portion of each arm against the adjacent
nasal side wall and upon a pincenez formed by a lower region of
each arm which grips the septum. Moreover, when a device of this
type is employed in the drug-loaded form, the protrudance of the
drug-holding portions outwards from the nasal side walls towards
the septum substantially reduces the free passageway for air flow
through the anterior part of each nasal cavity. Nasal drug delivery
devices which depend for retention in the nose upon contact with
both the septum wall and the interior of the nasal side walls are
also disclosed in U.S. Pat. No. 2,243,360. In the case of these
devices, two casings for holding a medicament, which are shaped
respectively to fit the lower internal section of a human right and
left nostril, are engaged with both the septum and nasal side walls
by means of a resilient bridge member interconnecting the two
casings. When such a device is fitted in the nose, as with the
drug-delivery devices of GB-A-768488, increase in nasal air flow
is, however, considerably restricted by partial obstruction of the
nasal cavities.
Nasal drug delivery devices of the pincenez-type which when fitted
in the nose grippingly engage with the interior nasal septum wall
separating the two nasal cavities are additionally disclosed in
CH-A-340190.
Further nasal drug delivery devices are known, which are intended
to provide some improvement of nasal breathing capacity and which
depend for retention in the nose solely or at least principally
upon contact of end portions with the nasal side walls.
Representative of such devices are nasal drug delivery devices
disclosed in FR-A-1001434 and DEPS-381127 consisting of two
drug-holding, perforated capsules connected by a resilient member,
which when bent to insert the end capsules into the nasal cavities
of an individual causes the end capsules to be pressed outwardly
against the nasal size walls. Because, however, of the bulbous
shape of the drug containers the increase in nasal cavity size is
severely negated and such devices are not favorable for retention
in the nose for long periods.
The majority of known nasal drug delivery devices when
appropriately positioned in the nose of an individual in fact
provide little or no increase in nasal breathing capacity by virtue
of dilation of the nasal cavities and some even significantly
reduce nasal breathing capacity as a result of the shape of the
nasally-inserted portions. Such devices are exemplified by the
devices disclosed in GB-A-520491, DE-PS-882601, FR-A-394505,
FR-A-1351537, FR-A-1182602, FR-A-630889, FR-A-1046299, U.S. Pat.
No. 1,950,926, U.S. Pat. No. 2,264,153, U.S. Pat. No. 2,277,390,
U.S. Pat. No. 2,715,904 and GB-A-354998.
There is thus a need for improved devices for facilitating nasal
breathing, with or without the capability for nasal drug delivery,
which combine a high degree of comfort with a high degree of
effectiveness in increasing nasal cavity size and which are
sufficiently unobtrusive for every day use. Such devices provide
the basis for the present specification.
There is thus disclosed a device which represents an improvement
over GB-A-768488, in which there is disclosed a device for
positioning in the nose to improve nasal breathing comprising two
end portions interconnected resiliently so that when positioned in
respective nostrils the end portions are biased outwardly against
the nasal side walls. Having regard to this particular prior art
the device disclosed herein is characterized in that the said end
portions are in the form of relatively thin tabs of a resilient
material, the outward biasing force is sufficient to locate the
device in the nose and to dilate the anterior part of each nasal
cavity by an amount to improve nasal breathing and no part of the
device is grippingly engaged with the septum.
The use of flat tabs means that a substantial free passage for air
flow will remain between the septum wall and the non-nasal side
wall contacting face of each of the said end portions. Furthermore,
by having flat tabs which are resilient, comfort is increased and
the area of engagement with the nasal side wall is increased. This
makes it possible to dispense with other location means, such as
engagement with the septum as in the case of the devices of
GB-A-768488.
In preferred embodiments, the length of extension of the end tabs
into the nasal cavities will be chosen such that the end tabs avoid
contact with the sensitive nasal mucosa. Importantly, by virtue of
the fact that such a device is retained in the nasal cavities
solely or at least principally by substantially even pressure
outwards via the end tabs against the nasal side walls below the
mucosa, it may be fitted in the nose for long periods of time, e.g.
overnight, without significant discomfort and without liability to
cause nose bleeds or ulcers. Moreover, the adaptation of the end
tabs to fit closely up against the nasal side walls when correctly
in the nose greatly facilitates increase of air flow. Devices of
this type will have a high degree of patient acceptability and
their manner of insertion can be readily learnt, even by young
children.
The end tabs are desirably about 1-2 mm in thickness and
interconnected by a narrow resilient member, for example about 4-5
mm in width and preferably thicker at the center than at either
end. The precise shape of each end tab will be chosen having regard
to the effect required and the nose of the user. It is particularly
desirable for the end tabs to have a gentle curvature, preferably
with a maximum depth of curvature of about 1-2 mm, in which case
when the device is correctly into the nose, the convex faces of the
end tabs should contact the nasal side walls.
Generally, the maximum length of extension of the end tabs into the
nasal cavities will be about 15-20 mm and the maximum width of each
end tab about 6-10 mm. In the case of a large male nose, for
example, the maximum length of extension of each end tab into its
respective nasal cavity will typically be about 17-20 mm and the
maximum width of each end tab will be about 10 mm. In the case of a
small child, these dimensions will typically be reduced for example
to about 15-17 mm and about 6-8 mm respectively.
Preferably, at their lower ends the tabs will extend below the
connecting member to form a tapering bottom portion, generally
about 4-7 mm in length and preferably having a convexly-curved
edge, which is intended to contact the floor of the nasal cavity
thus assisting retention of the device in the nose. In order to
assist retention of the device in the nose, gripping means may also
be provided on the nasal side wall-contacting face of each of the
end tabs so as to enhance engagement with the nasal side wall.
Thus, a plurality of small circular protuberances or suction cups,
generally about 1 mm in diameter and about 1 mm in length, may be
provided on the nasal side wall-contacting faces of the end tabs.
Generally, such protuberances or suction cups will be spaced as far
as possible at substantially regular intervals.
The top of each end tab will generally either be convexly-curved or
a substantially straight sloping edge. In the latter case, the top
edge will slope downwards towards the outer side, the difference in
height between the two ends of the top edge being approximately 2-3
mm.
The material of the end tabs should be non-toxic and for comfort
will desirably be a soft, flexible polymeric material, e.g. a
synthetic rubber or plastic. Conveniently, the end portions and the
interconnecting portion may be formed as a single unit from a
suitable non-toxic polymeric material. For example, a particularly
preferred polymeric material for construction of a device of the
present invention is silastic, which is often used in surgery
because it is harmless to tissues. By using materials of varying
flexibility, devices of identical dimensions, but with different
nostril dilating ability may be obtained. The material or materials
of such a device will, however, generally be chosen so that it is
very light, preferably only about 1 gram or less.
There are large variations amongst adults in height and length of
the nose, but the distance between the nasal side walls of adults
is fairly constant. For most noses, a suitable length for the
connecting member between the two end tabs will generally be about
3.5-5.5 cm.
As noted above, preferably this portion will be thinner at each end
than in the central region. Thus, the thickness will generally vary
from about 0.5-1 mm to about 2-4 mm in the central region. Most
preferably, the end tabs will be displaced from each other by a
connecting member having two hinge sections separated by a thicker
central region. Thus, for example, the connecting member may have
at either end a short-curved hinge section, e.g. of about 0.5 cm,
with the concave surface of each hinge region abutting on to the
nasal side wall-contacting face of the adjacent end tab. In this
case, the dimensions of the hinge regions and the central region of
the connecting member will be such that when the device is inserted
into the nose the bending of the central region is minimized and
most of the bending movement is taken by the hinge regions. By
using this form of connecting member, a nasal device is obtained
which will fit with comfort into a range of noses despite small
variations in length between the nasal side walls.
Generally, the connecting member will be substantially uniform in
width. Thus, if the connecting member is formed of a soft polymeric
material such as silastic, it will typically be about 4-5 mm in
width along the entire length. In the case of use of a stiffer
material, e.g. a stiff plastic, this width may be reduced. Thus,
the connecting member may be in the form of a thin thread.
A device of the type of the present invention, suitable for
dilating the anterior part of each nasal cavity of an individual,
may be used whenever it is desired to improve nasal breathing
capacity. Such devices are especially useful, for example, for
asthma sufferers and habitual snorers.
Thus, viewed from another aspect, there is disclosed herein a
method of improving nasal breathing wherein a device of the present
invention capable of dilating the anterior part of each nasal
cavity is positioned in the nose.
According to yet another aspect, there is provided a method of
reducing or preventing snoring wherein such a device is employed in
the same way.
A device of the present invention may also be used as a means for
nasally administering a drug. Thus, the end tabs may bear a drug or
drug formulation. The drug or drug formulation may, for example,
impregnate the end tabs or alternatively may be present in one or
more surface cavities or as a coating. One or more surface drug
holders in the form of surface indentations or raised wall cavities
may, for example, be provided on the nasal side wall-contacting
face of each end tab suitable for administration of a drug via
absorption across the nasal wall surface into the blood. One or
more surface drug holders selected from surface indentations,
raised wall cavities or pockets may additionally or alternatively
be provided on the non-nasal side wall contacting face of each end
tab. Such holders may be employed for administration of drugs, e.g.
volatile drugs, by inhalation.
In the case of nasal drug delivery devices of the present invention
provided with drug containers in the form of surface indentations
or raised wall cavities, these will generally be substantially
circular, e.g. about 2-3 mm in diameter. In the case of provision
of at least one raised wall cavity on the nasal side wall
contacting face of each end tab, these drug containers will
preferably be accompanied by small circular protuberances or
suction cups as hereinbefore described of substantially the same
height, e.g. about 1 mm, and substantially uniformly distributed
over the remainder of the same end tab faces.
It is particularly preferred to provide on end tabs having tapering
section extending below the connecting member a drug container in
the form of a pocket located at the bottom of the non-nasal side
wall contacting face. Such a drug holder will preferably be in the
form of a semispherical protuberance having an upper aperture, e.g.
maximally extending outwards from the non-nasal side wall
contacting face of the end tab by about 2-3 mm. Such end tabs may
preferably additionally have at least one raised wall cavity on the
nasal side wall-contacting face as described above and will most
desirably be of curved form.
For incorporation in surface indentations, raised wall cavities or
pockets of a drug-delivery device of the present invention or
formation of a drug-containing coating on the end tabs of such a
device, a drug will generally be employed in a gradual release
form. For example, a drug for this purpose may be mixed with a
fixing agent which melts slowly at the normal temperature of the
nasal cavities, for example, white chocolate, or it may be in
crystalline form and evaporated by the warmth of the nasal wall and
the expired humid air from the lungs.
Thus, viewed from a still further aspect, there is disclosed herein
a method of nasally administering a drug wherein a device according
to the present invention having end tabs bearing said drug or a
formulation comprising said drug is positioned in the nose.
A nasal drug delivery device of this type, which when in use
enables improved nasal breathing capacity, is particularly
desirable for administration of anti-asthmatic drugs of the
.beta..sub.2 -adrenoceptor agonist or corticosteroid type. These
drugs are commonly administered by oral inhalation. However, this
manner of administration has the drawback that generally only 5-10%
of the drug administered actually reaches the bronchi, since much
of the dose is deposited in the throat. Furthermore, some asthma
suffers are unable to acquire the technique for use of an oral
aerosol spray. Using a nasal drug delivery device of the present
invention, an anti-asthmatic drug of the .beta..sub.2 -adrenoceptor
agonist or corticosteroid type can be administered efficiently and
very conveniently over several minutes or several hours.
Nasal drug delivery devices of the present invention have far wider
applicability than in the treatment of asthma. Such devices may be
used to administer any drug which is absorbed across the
nasal/bronchial mucosa and is effective in low doses, e.g. less
than one milligram or any drug for local treatment in the nasal
cavities. Hormones such as insulin, growth hormone and
anti-diuretic hormone, which cannot be taken orally because of
their susceptibility to attack by proteolytic enzymes of the
digestive tract may, for example, be administered in this way.
Examples of drugs for local treatment in the nasal cavities which
may also be administered by means of a drug-delivery device as
hereinbefore described include nasal decongestants. Using such a
device rather than a nasal spray, a decongestant can be better
distributed in the nasal cavities and, if desired, administered
continually over a long period. Further, some immediate relief may
be obtained upon insertion of the device as a result of dilation of
the anterior part of each nasal cavity.
A particularly important advantage of a drug delivery device of the
present invention is that it can be used to administer a
pre-determined dose of a drug to an individual even while asleep.
This is well illustrated by consideration of the problems of asthma
sufferers. Most asthma sufferers have more trouble with their
breathing during the night than during the day. Before retiring to
bed, an asthma sufferer may reduce his liability to develop asthma
symptoms in his sleep by inserting an anti-asthmatic drug delivery
device of the present invention, desirably a device capable of
releasing an effective amount of an antiasthmatic drug over several
hours. Use of a simpler nasal device as provided by the present
invention to just improve nasal breathing capacity overnight may
also be beneficial, particularly if the asthma sufferer has a cold
and is therefore more liable to breathe orally.
Specific embodiments of nasal devices according to the present
invention incorporating some of the features discussed above will
hereinafter be described by way of example with reference to the
accompanying drawings wherein:
FIG. 1 is a plan view of a device for improving nasal breathing
capacity with the non-nasal side wall-contacting faces of the end
tabs uppermost;
FIG. 2 is a side view of the device of FIG. 1;
FIG. 3 illustrates the device of FIG. 1 in the bent form ready for
insertion into the nasal cavities;
FIG. 4 shows the non-nasal side wall contacting face of an end tab
of a drug-delivery device based on the device as shown in FIGS. 1
to 3;
FIG. 5 shows a perspective view of a preferred nasal drug delivery
device of the present invention suitable for a male adult nose
(scale 100:154);
FIG. 6 is an end view of an end tab of the device of FIG. 5;
FIG. 7 is a side view of the device of FIG. 5;
FIG. 8 shows a plan view of the device of FIG. 5 with the concave,
i.e. non-nasal side wall contacting faces of the end tabs
uppermost;
FIG. 9 shows a plan view of the device of FIG. 5 with the convex,
nasal side wall contacting faces of the end tabs uppermost;
FIG. 10 shows a plan view of a child's version of the device of
FIG: 5 (scale 100:154); and
FIG. 11 illustrates the device of FIG. 5 in the bent form ready for
insertion into the nasal cavities.
Referring firstly to FIGS. 1 to 3, the device is formed as a
single-unit from a non-toxic, soft, flexible polymeric material,
e.g. silastic. The two end portions 2a,2b are in the form of gently
curved tabs, about 1 mm in thickness and about 10 mm wide,
interconnected by a resilient connecting member 1, about 3.5 cm
long, about 4-5 mm wide and varying in thickness from about 1 mm at
either end to about 2 mm in the central region. The top edge of
each end tab slopes downwards towards the outer side, the
difference in height between the two ends of the top edge being
about 2-3 min. As stated above, there are large variations amongst
adults in height and length of the nose, but the distance between
the nasal side walls of adults is fairly constant. The dimensions
of the illustrated device have been chosen so that it will be
suitable for use in a wide range of adult noses, e.g. to alleviate
snoring. When the device is correctly inserted into a normal adult
nose with the connecting member bent so that the concave faces of
the end tabs are towards each other, the end tabs will extend about
15-17 mm into the nasal cavities and will be retained in the nasal
cavities resting on skin below the mucosa with their convex faces
in contact with the nasal side walls. In an equivalent device for a
young child, the length of the connecting member will be shorter
and the end tabs smaller in area. In many habitual snorers
deformities in the nose have been found to be an important factor
accounting for their tendency to snore and for such individuals the
shapes of the end tabs may need to be modified.
Referring to the end portion of the nasal drug-delivery device
illustrated in FIG. 4, this device is identical to the device shown
in FIGS. 1 to 3, except that the concave non-nasal side wall
contacting face of each end tab has a plurality of surface
indentations 3 for holding a drug or drug formulation, e.g. a drug
mixed with a fixing agent which melts slowly at the normal
temperature of the nasal cavities. Depending on the fixing agent
and the number and shape of the indentations, the release time of
the drug may vary from a few minutes to a number of hours (e.g. 10
hours).
The more preferred nasal drug delivery device illustrated by FIGS.
5 to 9 and 11 which is intended for use in nasally administering
drugs to human males, is also formed as a single unit from a
nontoxic, soft, flexible polymeric material with two end portions
2a, 2b in the form of thin curved tabs of about 10 mm in maximum
width and having a thickness and maximum depth of curvature of
about 1-2 min. The length of the end tabs 2a 2b are such that when
correctly positioned in the nasal cavities of a human male nose
with the convex faces against the nasal side walls, each end tab
extends into its respective nasal cavity by about 20 mm so that the
top convexly-curved edge is below the sensitive nasal mucosa and
the bottom tapering section of each end tab, extending below the
interconnecting resilient member 1 by about 7 mm, engages with the
floor of the nasal cavity. Retention of the device in the nostrils
depends principally upon the pressure exerted outwards by the end
tabs 2a,2b against the nasal side walls, but is assisted by the
contact of the bottom of each end tab with the floor of the
respective nasal cavity and also by small protuberances 4 of about
1 mm in height and diameter provided on the nasal side
wall-contacting faces of the end tabs.
Sited at the central region of the convex face of each end tab is a
raised wall cavity 5a,5b, about 2-3 mm in diameter and about 1 mm
in height, suitable for use in administering a drug via absorption
across the nasal side wall surface. Such a device can, however,
additionally be employed for administration of a drug by inhalation
by use of the substantially half-spherical pockets 6a,6b with upper
aperture 7a,7b, which extend maximally outwards at the bottom of
the concave face of each end tab by about 2-3 mm. A drug for
incorporation in either of the types of drug container will
generally be in a gradual release form. Thus, the pockets 6a,6b
may, for example, contain a .beta.-adrenoceptor agonist in
combination with a fixing agent which melts slowly at the normal
temperature of the nasal cavities, while the raised wall cavities
5a,5b may, for example, be employed for administration of a hormone
across the nasal side wall surface into the blood.
A further important feature of the device illustrated in FIGS. 5-9
is that the connecting member 1 consists of a thicker central
region 8 of about 4.5 cm in length and varying in thickness from
about 2 mm to about 4 mm at the mid-point sandwiched between two
curved hinge sections 9a,9b, each of about 0.5 cm and varying in
thickness from about 2 nun to about 0.5-1 mm. The concave surfaces
of these hinge sections abutt on to the convex faces of the end
tabs 2a,2b, i.e. the nasal side wall contacting surfaces. When the
device is fitted into a nose, only the hinge sections 9a,9b of the
connecting member together with the end tabs 2a,2b are
substantially bent inwards and by virtue of the hinge sections
9a,9b, the device is adapted to deal with small variations between
adult male noses in the distance between the nasal side walls.
Thus, the extent of inward bending of the hinge sections when the
device is fitted will depend upon the distance between the nasal
side walls of the patient. Devices of the same form but with a
shorter connecting member 1 and end tabs 2a,2b of smaller area may
be constructed for use in smaller noses. Thus, referring to the
child's device illustrated in FIG. 10, the connecting member 1 is
about 3.5 cm in length with a central region 8 of about 2-4 mm in
thickness sandwiched between two much shorter curved hinge sections
9a,9b. These hinge sections are similar to the hinge sections
9a,9b, of the equivalent male adult device described above. The end
tabs 2a,2b have a maximum width of about 8 mm and when inserted
into an appropriate child's nose with the convex faces towards the
side walls should contact the floor of their respective nasal
cavity by means of the tip of the tapering bottom section,
extending 4 mm below the connecting member 1, and press outwardly
against the nasal side walls below the mucosa. The maximum length
of extension of each end tab into its respective nasal cavity will
generally be about 15 mm.
Identical devices, except for omission of the drug containers and
provision of small protruberances as hereinbefore described at
substantially regular intervals over the whole convex face of each
end tab, are alternatively highly preferred for use in facilitating
nasal breathing when contemporaneous nasal administration of a drug
is not desired.
Modifications to the specific devices described and to any broad
aspects of nasal devices referred to or suggested herein may be
apparent to those skilled in the art and the disclosure hereof is
intended to encompass any such modifications. The devices may
embody a number of inventions for which protection may be sought.
The various broad aspects referred to herein are intended as guides
to some specific areas where inventions are presently considered to
lie.
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