U.S. patent application number 13/164684 was filed with the patent office on 2011-10-06 for nasal devices.
Invention is credited to Rajiv Doshi, Matthew Durack, Sandrine Lebas, Bryan Loomas, Ryan Kendall Pierce, Arthur G. Sandoval, Elliot Sather, Jeffrey W. Servaites.
Application Number | 20110240038 13/164684 |
Document ID | / |
Family ID | 38832411 |
Filed Date | 2011-10-06 |
United States Patent
Application |
20110240038 |
Kind Code |
A1 |
Doshi; Rajiv ; et
al. |
October 6, 2011 |
NASAL DEVICES
Abstract
Described herein are adhesive nasal devices. In particular, the
adhesive nasal respiratory devices described herein are configured
to be worn in communication with a subject's nasal cavity and may
include a rim body having a passageway therethrough, an airflow
resistor in communication with the passageway of the rim body, and
a flexible, adhesive holdfast layer extending outward from the
periphery of the rim body. The rim body region may be formed from
multiple parts (e.g., a first and a second rim body region), and
the airflow resistor may be secured between the parts forming the
rim body. Methods of manufacturing and assembling these adhesive
nasal devices are also described.
Inventors: |
Doshi; Rajiv; (Los Altos,
CA) ; Loomas; Bryan; (Los Gatos, CA) ; Pierce;
Ryan Kendall; (San Francisco, CA) ; Sather;
Elliot; (San Francisco, CA) ; Sandoval; Arthur
G.; (San Francisco, CA) ; Servaites; Jeffrey W.;
(San Francisco, CA) ; Lebas; Sandrine; (San
Francisco, CA) ; Durack; Matthew; (San Francisco,
CA) |
Family ID: |
38832411 |
Appl. No.: |
13/164684 |
Filed: |
June 20, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12369681 |
Feb 11, 2009 |
7987852 |
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13164684 |
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11811339 |
Jun 7, 2007 |
7506649 |
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12369681 |
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60905850 |
Mar 7, 2007 |
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60859715 |
Nov 16, 2006 |
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60811814 |
Jun 7, 2006 |
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Current U.S.
Class: |
128/848 |
Current CPC
Class: |
A61M 16/106 20140204;
A61M 16/208 20130101; A61F 5/08 20130101; A62B 23/06 20130101; A61M
16/0616 20140204; A61M 15/085 20140204; A61M 15/08 20130101; A61M
16/0866 20140204; A61F 5/56 20130101; A61M 16/0688 20140204 |
Class at
Publication: |
128/848 |
International
Class: |
A61F 5/56 20060101
A61F005/56 |
Claims
1. A nasal device adapted to be secured in communication with a
subject's nasal cavity, the device comprising: an airflow resistor
configured to inhibit airflow during expiration more than airflow
during inspiration; and a flexible, adhesive holdfast and wherein
the airflow resistor is configured to have a resistance to
expiration between about 5 cm H.sub.2O/(L/sec) and about 250 cm
H.sub.2O/(L/sec) when resistance is measured at a flow rate of 100
ml/sec.
2. The device of claim 1, wherein the flexible, adhesive holdfast
extends outward from the airflow resistor.
3. The device of claim 1, wherein the flexible, adhesive holdfast
is configured to seal the nasal device around the subject's
nostril.
4. The device of claim 1, further comprising an
internally-projecting region at least partially surrounding the
airflow resistor configured to project into the subject's
nostril.
5. The device of claim 1, wherein the flexible, adhesive holdfast
is adapted to be secured in communication with both of a subject's
nostrils.
6. The device of claim 1, further comprising a leak pathway through
the nasal device configured to be open during both expiration and
inspiration.
7. The device of claim 1, wherein the airflow resistor comprises a
flap valve.
8. A nasal device adapted to be secured in communication with a
subject's nasal cavity, the device comprising: an airflow resistor,
wherein the airflow resistor is configured to inhibit airflow
during expiration more than airflow during inspiration; and a
flexible, adhesive holdfast configured to seal the nasal device
around the subject's nostril.
9. The device of claim 8, wherein the flexible, adhesive holdfast
extends outward from the airflow resistor.
10. The device of claim 8, further comprising an
internally-projecting region at least partially surrounding the
airflow resistor configured to project into the subject's
nostril.
11. The device of claim 8, wherein the flexible, adhesive holdfast
is adapted to be secured in communication with both of a subject's
nostrils.
12. The device of claim 8, further comprising a leak pathway
through the nasal device configured to be open during both
expiration and inspiration.
13. The device of claim 8, wherein the airflow resistor comprises a
flap valve.
14. A nasal device adapted to be secured in communication with a
subject's nasal cavity, the device comprising: an airflow resistor
configured to inhibit airflow during expiration more than airflow
during inspiration; and a flexible, adhesive holdfast and further
comprising a protective cover configured to be removed from the
adhesive holdfast to expose at least a portion of the biocompatible
adhesive.
15. The device of claim 14, wherein the flexible, adhesive holdfast
extends outward from the airflow resistor.
16. The device of claim 14, wherein the flexible, adhesive holdfast
is configured to seal the nasal device around the subject's
nostril.
17. The device of claim 14, further comprising an
internally-projecting region at least partially surrounding the
airflow resistor configured to project into the subject's
nostril.
18. The device of claim 14, wherein the flexible, adhesive holdfast
is adapted to be secured in communication with both of a subject's
nostrils.
19. The device of claim 14, further comprising a leak pathway
through the nasal device configured to be open during both
expiration and inspiration.
20. The device of claim 14, wherein the airflow resistor comprises
a flap valve.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 12/369,681 filed Feb. 11, 2009, titled "NASAL
DEVICES", which is a continuation of U.S. patent application Ser.
No. 11/811,339 filed June, 2007, titled "NASAL DEVICES", which
claims priority to U.S. Provisional Patent Applications: Ser. No.
60/905,850 filed Mar. 7, 2007, titled "NASAL DEVICES"; 60/859,715,
filed Nov. 16, 2006, titled "NASAL DEVICES; and 60/811,814, filed
Jun. 7, 2006, titled "RESPIRATORY DEVICES". Each of these
provisional patent applications is incorporated herein by reference
in its entirety.
BACKGROUND OF THE INVENTION
[0002] The devices, methods, and kits described herein relate
generally to nasal devices. These nasal devices may be
therapeutically used to treat medical disorders, particularly in
the fields of cardiovascular medicine, sleep medicine, pulmonology,
gastroenterology, and internal medicine.
[0003] Nasal respiratory devices have been well-described in the
following U.S. patent applications, each of which is incorporated
herein in its entirety: U.S. patent application Ser. No. 11/298,640
filed Dec. 8, 2005, titled "NASAL RESPIRATORY DEVICES"; U.S. patent
application Ser. No. 11/298,339 filed Dec. 8, 2005, titled
"RESPIRATORY DEVICES"; and U.S. patent application Ser. No.
11/298,362 filed Dec. 8, 2005, titled "METHODS OF TREATING
RESPIRATORY DISORDERS". These patent applications generally
describe nasal respiratory devices and methods for treating a
variety of medical diseases through the use of such devices.
Although these patent applications generally describe variations of
nasal respiratory devices, certain specific variations of nasal
respiratory devices have not previously been described and may
provide additional properties in both use and manufacture.
Described below are new nasal devices, accessories for nasal
devices, methods of using and method of manufacturing nasal
devices, and kits including nasal devices.
SUMMARY OF THE INVENTION
[0004] Described herein are specific variations of adhesive nasal
devices, accessories for adhesive nasal devices, methods of
manufacturing adhesive nasal devices, methods of using adhesive
nasal devices, and kits including adhesive nasal devices. Adhesive
nasal devices may be worn by a subject to modify the airflow
thorough one or (more typically) both nostrils. As described in
more detail below, an adhesive nasal device may be secured at least
partly over or at least partly within the subject's nostril (or
nostrils) so that airflow through the nostrils passes primarily (or
exclusively) through the nasal device. Generally, the adhesive
nasal device is removably secured over the subject's nostrils by an
adhesive.
[0005] As used herein the term "adhesive nasal device" may refer to
a device for covering one or both of a subject's nostrils. Thus,
the description herein may generally apply to nasal respiratory
devices adapted to fit over both of a subject's nostrils.
[0006] The adhesive nasal devices described herein may include a
rim body region having one or more passageways formed therethrough.
An airflow resistor (e.g., valve) may be secured in communication
with a passageway through the rim body of the adhesive nasal
device. The airflow resistor may regulate flow of air into and out
of the nostril, and through the device. In particular, the airflow
resistor may inhibit expiration more than inspiration. In some
variations, the adhesive nasal device includes two airflow
resistors, configured so that one airflow resistor is in fluid
communication with each nostril. In some variations, an adhesive
nasal device is worn in communication with each nostril (thus, a
subject may wear two such devices). In addition, an adhesive nasal
device includes an adhesive holdfast (or holdfast region)
configured to secure the adhesive nasal device in communication
with the subject's nasal passageway(s).
[0007] Described herein are adhesive nasal devices adapted to be
secured (e.g., removably secured) in communication with a subject's
nasal cavity. The device may include a rim body having a passageway
therethrough, an airflow resistor in communication with the
passageway of the rim body, a thin, flexible, adhesive holdfast
layer extending outward from the periphery of the rim body, the
adhesive holdfast layer comprising an adhesive substrate and a
biocompatible adhesive, and a protective cover configured to be
removed from the adhesive holdfast to expose at least a portion of
the biocompatible adhesive. The airflow resistor may be configured
to inhibit airflow during expiration more than airflow during
inspiration.
[0008] The rim body may be a stiff or rigid rim body or in some
cases may be flexible or less rigid. In some variations, the
adhesive holdfast layer is a thin layer that has a substantially
flat surface on two sides, and a relatively thin edge between the
two sides. One of these two sides may be configured as a
skin-contacting (adhesive) side. In some variations, the stiff rim
body includes an outer rim body secured to an inner rim body. As
described herein, the term "outer rim body" may refer to the
portion of the rim body that extends furthest from the subject when
the device is worn by the subject, and the term "inner rim body"
may refer to the portion of the rim body that is closest to the
subject when the device is worn by the subject. In some variations,
the rim body is formed by a first and a second rim body region that
correspond to an outer and an inner rim body region. In other
variations, the first and second rim body regions correspond to a
lateral and medial body region (e.g., lateral and medial
side-by-side body regions).
[0009] The airflow resistor may be secured in communication with
the passageway at any region, including within the stiff rim body.
For example, the airflow resistor may be secured between the first
and the second rim body regions.
[0010] In some variations, the adhesive nasal devices include a
second rim body having a second airflow passage therethrough and a
second airflow resistor secured in communication with the second
airflow passage. Thus, the adhesive nasal device may have two
passageways, and each passageway may be configured to communicate
with one of the subject's nasal passageways or nostrils. The
adhesive holdfast may include a bridge connecting the first and
second rim bodies. The adhesive nasal device may also include a tab
or handle configured to be grasped by a subject applying or
removing the device. For example, the holdfast region may include a
tab or handle.
[0011] The airflow resistor may be any appropriate airflow
resistor. For example, the airflow resistor may include a flap
valve. The different regions and components of the device may be
made of any appropriate material, but especially biocompatible
materials, since the device is to be worn by the subject. For
example, the rim body may be made of medical grade plastic,
including a medical grade plastic selected from the group
consisting of: Acrylonitrile Butadiene Styrene (ABS),
polypropylene, polyethylene, polyurethane, polycarbonate, and
polyetheretherketone.
[0012] Also described herein are adhesive nasal device adapted to
be secured in communication with a subject's nasal cavity. These
devices may include a first rim body, a second rim body (wherein
the first rim body is attached to the second rim body and the
combined first and second rim bodies include an airflow passage
therethrough), an airflow resistor in communication with the
airflow passage, and an adhesive holdfast secured to the combined
first and second rim bodies, wherein the adhesive holdfast
comprises a biocompatible adhesive configured to secure the nasal
device in alignment with the subject's nasal orifice.
[0013] As described, the airflow resistor may be configured to
inhibit airflow during expiration more than airflow during
inspiration. For example, the airflow resistor may be secured
between the first and second rim bodies, and may be configured as a
flap valve. The first rim body may be attached to the second rim
body by any securement means. For example, the first and second rim
body regions may be attached to each other by a snap or press fit,
by a weld (e.g., an ultrasonic weld), by a glue or epoxy, or the
like. These devices may include a third rim body that is attached
to a fourth rim body, wherein the combined third and fourth rim
bodies include a second airflow passage therethrough and a second
airflow resistor secured in communication with the second airflow
passage, and the adhesive holdfast may include a bridge between the
combined first and second rim bodies and the combined third and
fourth rim bodies.
[0014] The first rim body (and the third rim body, if present) may
include a flanged rim. The adhesive holdfast may comprise a
flexible adhesive substrate. The adhesive holdfast may include a
protective cover configured to be removed by removing the cover off
of an adhesive region of the adhesive substrate. Thus, the
protective cover protects the adhesive until this region of the
holdfast is adhesively secured to the subject. The adhesive
holdfast may include an opening within the annular region through
which the combined first and second rim body regions extend. Thus,
in some variations, the adhesive holdfast extends along the outer
periphery of the assembled rim body.
[0015] As mentioned, the adhesive holdfast region may include a tab
configured to be grasped by a subject applying or removing the
device. Further, the rim body (e.g., the first and second rim
bodies) may be made of medical grade plastic such as Acrylonitrile
Butadiene Styrene (ABS), polypropylene, polyethylene,
polycarbonate, polyurethane and polyetheretherketone. The airflow
resistor may be a flap valve and the flap may be made of silicone
or thermoplastic urethane. The adhesive holdfast may include an
adhesive substrate made of silicone, polyurethane or polyethylene.
The biocompatible adhesive may be a hydrocolloid or an acrylic
material.
[0016] Also described herein are adhesive nasal device adapted to
be secured (e.g., removably secured) in communication with one or
both of a subject's nasal cavities that include an inner rim body
having at least one airflow passage therethrough, an outer rim body
having at least on airflow passage therethrough (wherein the outer
rim body is attached to the inner rim body so that the airflow
passage of the inner rim body is continuous with the airflow
passage of the outer rim body), an airflow resistor secured between
the inner and outer rim regions within the airflow passage, and an
adhesive holdfast secured between the outer and inner rim body.
[0017] Also described herein are methods of treating a subject that
include the steps of removing a protective cover from an adhesive
holdfast region of an adhesive nasal device (wherein the adhesive
nasal device comprises a rim body having a passageway therethrough,
an airflow resistor in communication with the passageway of the rim
body, and a flexible, adhesive holdfast layer extending outward
from the periphery of the rim body), and applying the adhesive
nasal device to a subject's nasal cavity (or both nasal cavities).
In any of the variations described herein, the adhesive holdfast
may comprise a layer of adhesive substrate including a
biocompatible adhesive. This adhesive holdfast may extend so that
the skin-contacting surface of the adhesive holdfast is
substantially perpendicular from the axis of the passageway through
the rim body. In some variations, the skin-contacting surface
(e.g., the surface configured to adhesively secure the device to
the user) is off axis of an airflow passageway through the rim
body.
[0018] Also described are methods of making an adhesive nasal
device comprising, the method including the steps of placing an
airflow resistor between a first rim body and a second rim body,
placing an adhesive holdfast between the first rim body and the
second rim body, and securing the first rim body to the second rim
body to secure the airflow resistor and the adhesive holdfast
therebetween.
[0019] Also described are methods of making an adhesive nasal
device, the method including the steps of forming a rim body having
a passageway therethrough by securing a first and second rim body
region to each other, and securing an airflow resistor within the
airflow passageway, and securing an adhesive holdfast to the rim
body.
INCORPORATION BY REFERENCE
[0020] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference in their
entirety to the same extent as if each individual publication or
patent application was specifically and individually indicated to
be incorporated by reference in its entirety.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] A better understanding of the features and advantages of the
present invention will be obtained by reference to the following
detailed description that sets forth illustrative embodiments, in
which the principles of the invention are utilized, and the
accompanying drawings.
[0022] FIGS. 1A and 1B are a bottom and top perspective views,
respectively, of one variation of an adhesive nasal device as
described herein.
[0023] FIG. 2 is an exploded view of the adhesive nasal device of
FIG. 1.
[0024] FIG. 3 is a cross-section through another variation of an
adhesive nasal device.
[0025] FIGS. 4A and 4B are cross-sectional views of one variation
of a rim body as described herein.
[0026] FIGS. 5A and 5B are top and bottom perspective views of an
inner rim body region similar to the variation shown in FIG. 4.
[0027] FIGS. 6A and 6B are top and bottom perspective views of one
variation of an outer rim body, as described herein.
[0028] FIGS. 7A-7C are variations of adhesive nasal devices.
[0029] FIGS. 8A-8F are perspective views of a various flaps for
flap valve devices as described herein.
[0030] FIG. 9 is a flap valve secured to one portion of an adhesive
nasal device, as described herein.
[0031] FIGS. 10A-10C show an adhesive holdfast region of an
adhesive nasal device.
[0032] FIGS. 11A-11E are variations of the general shape of an
adhesive holdfast region.
[0033] FIGS. 12A-12C illustrate additional variations of adhesive
holdfasts.
[0034] FIGS. 13A-13C illustrate additional adhesive holdfast
regions.
[0035] FIGS. 14A and 14B show variations of adhesive holdfasts.
[0036] FIG. 15 is another variation of an adhesive holdfast.
[0037] FIGS. 16A-16C are different alternative variations of the
adhesive holdfast region.
[0038] FIGS. 17A-17E are different alternative variations of the
adhesive holdfast region.
[0039] FIGS. 18A-18C are variations of the adhesive holdfast region
of an adhesive nasal device.
[0040] FIG. 19A is one variation of an adhesive nasal device.
[0041] FIG. 19B shows the device of FIG. 19A applied to a subject's
nasal cavity.
[0042] FIG. 20 illustrates a bottom view of an adhesive nasal
device applied to a subject's nasal cavity.
[0043] FIG. 21 illustrates assembly of one variation of an adhesive
nasal device.
[0044] FIG. 22A is another example of the assembly of an adhesive
nasal device.
[0045] FIG. 22B illustrates the connection between two regions of
an adhesive nasal device.
[0046] FIG. 23A illustrates one method of securing a holdfast to a
nasal device, and FIG. 23B shows a top view of a device as shown in
FIG. 23A.
[0047] FIG. 24A illustrates another example of the assembly of an
adhesive nasal device.
[0048] FIG. 24B illustrates how one variation of an adhesive nasal
device may be inserted into a subject's nostril and secured in
place.
[0049] FIGS. 25A-25E show different design variations of rim body
regions and adhesive holdfast regions forming adhesive nasal
devices.
[0050] FIGS. 26A-26C show cross-sections though assembled adhesive
nasal devices.
[0051] FIGS. 27A and 27C show different configurations of adhesive
holdfast regions, and FIGS. 27B and 27D show the variations of
FIGS. 27A and 27C (respectively) when worn by a subject.
[0052] FIGS. 28A and 28B illustrate a fitting adapter.
[0053] FIGS. 29A and 29B show bottom views of two variations of an
adhesive nasal device compatible with a nasal cannula adapter.
[0054] FIGS. 30A, 30B and 30C show a cannula adapter.
[0055] FIG. 31 illustrates a cross-section of a cannula adapter
engaged to an adhesive nasal device.
[0056] FIGS. 32A and 32B show another variation of cannula
adapter.
[0057] FIG. 33 illustrates the connection of a nasal cannula to a
pair of cannula adapters.
[0058] FIG. 34 shows another variation of an adhesive nasal
device.
[0059] FIG. 35 shows another variation of an adhesive nasal
device.
[0060] FIG. 36A shows one variation of a rim body region;
[0061] FIGS. 36B and 36C show side perspective and end views of
another variation of a rim body region.
[0062] FIGS. 37A and 37B show side perspective views of a first and
second rim body region, respectively.
[0063] FIGS. 38A and 38B show two variations of flap valves that
may be used with any of the devices described herein.
[0064] FIGS. 39A and 39C show side perspective views of one
variation of a portion of an adhesive nasal device, and FIGS. 39B
and 39D show sections through the devices of FIGS. 39A and 39C
respectively.
[0065] FIGS. 40A and 40B are perspective views of one variation of
an outer rim body and an inner rim body, respectively.
[0066] FIG. 41A is a perspective view of one variation of a rim
body for an adhesive nasal device.
[0067] FIG. 41B-41D are perspective views of the rim body shown in
FIG. 41A, including exemplary dimensions (in inches).
[0068] FIGS. 42A and 42B illustrate one method of using an adhesive
nasal device as described herein.
DETAILED DESCRIPTION OF THE INVENTION
[0069] An adhesive nasal respiratory device is one variation of a
general nasal respiratory device in which an adhesive holdfast
region is used to secure the device in fluid communication with one
or both of a subject's nostrils. A nasal respiratory device,
including an adhesive respiratory device, may be used for creating
positive end expiratory pressure ("PEEP") or expiratory positive
airway pressure ("EPAP") during respiration in a subject wearing
the device. The adhesive respiratory devices and methods described
herein may be useful to treat a variety of medical disease states,
and may also be useful for non-therapeutic purposes. The devices
and methods described herein are not limited to the particular
embodiments described. Variations of the particular embodiments
described may be made and still fall within the scope of the
disclosure. It is also to be understood that the examples and
particular embodiments described are not intended to be
limiting.
[0070] As used herein, an adhesive nasal device may be configured
to fit in, at least partly in, over, at least partly over and/or
around a single nostril (e.g., a "single-nostril nasal device"), or
in, at least partly in, over, at least partly over and/or around
both nostrils ("whole-nose nasal device"). Both single-nostril
nasal devices and whole-nose nasal devices may be referred to
herein as "adhesive nasal devices," and unless the context
indicates otherwise, any of the features described for
single-nostril nasal devices may be used with whole-nose nasal
devices, and vice-versa. In some variations, an adhesive nasal
device is formed from two single nostril nasal devices that are
connected to form a unitary adhesive nasal device that can be
applied to the subject's nasal cavity. Single-nostril nasal devices
may be connected by a bridge (or bridge region, which may also be
referred to as a connector). The bridge may be movable (e.g.,
flexible), so that the adhesive nasal device may be adjusted to tit
a variety of physiognomies. The bridge may be integral to the nasal
devices. Examples of the bridge region are described in more detail
below. In some variations, single-nostril nasal devices are used
that are not connected by a bridge, but each include an adhesive
region, so that (when worn by a user) the adhesive holdfast regions
may overlap on the subject's nose, thus forming a bridge which may
facilitate removal.
[0071] As used in this specification, the singular forms "a," "an,"
and "the" include plural reference unless the context clearly
dictates otherwise. The following descriptions including various
design parameters or goals, and methods and devices which fit the
design parameters or goals. It should be understood that the
devices and methods described herein (and recited by any claims)
are not limited to any particular theory of operation.
[0072] In general, an adhesive nasal device includes a rim body
having one or more passageways through which air may pass to enter
or exit a nostril; an adhesive holdfast for securing the device to,
over, and/or within a subject's nostril; and an airflow resistor
(e.g., a valve or valves) for regulating the passage of air through
the passageway(s). As will be apparent from the figures, many of
these devices may be removable and insertable by user without
special tools.
[0073] In operation, an adhesive nasal device is placed in
communication with one or both of a subject's nostrils to modify
the flow of air through the subject's nasal cavity or cavities.
Thus, the respiratory devices described herein include one or more
airflow resistors for modifying the flow of air through the nose in
at least one direction. In most variations of the devices described
herein, the airflow resistor is configured to occlude airflow
through a passageway in one direction more than it occludes airflow
in the opposite direction. For example, an airflow resistor may
occlude airflow during exhalation more than inhalation. Examples of
airflow resistors are described below, but may include valves
airflow resistors (e.g., flap valves, hinge-less valves, balloon
valves, stepper valves, ball valves, etc.) or the like.
[0074] To use many of the adhesive nasal devices described herein,
a subject first applies an adhesive respiratory device over his
nasal cavity (or nasal cavities) by removing a protective cover
material from an external adhesive region of the device (the
holdfast) and applying gentle pressure to cause the device to
adhere around the nostrils. In this way, the device may be seated
around the nasal orifice (and may intrude at least partly into the
nostrils) and form at least a partial seal between the nostrils and
the device so that the majority of flow into and out of the
nostrils passes through the passageways of the nasal device. Once
the device is applied to the subject's nose, respiration through
the nostrils may be regulated. In some variations, the adhesive
nasal device is configured so that there is only nominal resistance
through the nasal device during inhalation, but increased
resistance to airflow during exhalation. During inhalation in a
subject wearing such a device, the subject may breathe through the
nose (and thus through the nasal device). During exhalation, the
adhesive nasal device provides greater resistance to airflow
through the device. Thus, the subject may still breathe
predominantly though the nose (and the nasal device) during
exhalation, but may also breathe at least partly through the
mouth.
[0075] It may also be beneficial for a subject to wear a nasal
respiratory device over an extended period of time (e.g., during a
period of sleep). Described below are variations of adhesive nasal
devices that are comfortable to wear, and secure in or over the
subject's nose or nasal passages. In some variations, a grip (e.g.,
a tab, handle, strap, or other additional interface region) may be
included to help secure the device to the subject's nostril, nose
or face, and may additionally or alternatively be helpful in
positioning or manipulating (e.g., gripping) the device,
particularly when it is being applied. This additional interface
region may be formed of the same material as the adhesive holdfast
region, or it may be a separate region, as described in more detail
below.
[0076] In some versions of the device, the adhesive holdfast in
combination with a rim body (with or without an additional adaptor
to connect with standard PAP tubing) may be used with a positive
airway pressure machine (CPAP, VPAP, bi-level PAP for example) and
related tubing that is well known to those skilled in the art.
Headgear and/or straps may still be required to help affix the
tubing to a subject's head or face.
[0077] FIGS. 1A and 1B show perspective view of one exemplary
variation of an adhesive nasal device as described herein, FIG. 2
shows an exploded view of the same variation, and FIG. 3 shows a
cross-section through this variation. FIG. 1A shows a perspective
view of an adhesive nasal device, looking at the "outer" side of
the device, which is configured to be the side facing away from the
subject's nose when worn. The device shown in FIG. 1A includes two
single-nostril rim bodies 101 and a single adhesive holdfast 104.
The holdfast 104 (which, in this variation, secures to the subject)
is shown as a layered structure including a backing or adhesive
substrate 105. This backing may act as a substrate for an adhesive
material, or it may itself be adhesive. The holdfast 104 may have
different regions, including two peri-nasal regions surrounding the
rim bodies 101. Each rim body has at least one passageway 108 for
airflow therethrough. The adhesive holdfast also includes two tabs
or grip regions 110 that may make the device easier to grasp,
apply, and remove. A bridge region 112 is also shown. In this
example, the bridge region is part of the adhesive holdfast (e.g.,
is formed by the same substrate of the adhesive holdfast) and
connects the peri-nasal regions. Although the tab and bridge
regions are shown as being formed as part of (integral with) the
holdfast material, these regions may also be formed separately, and
may be made of different materials.
[0078] The rim body regions 101 shown in the exemplary device of
FIG. 1A correspond to outer rim body regions which each encompass a
passageway 108. As described below, these first (e.g., outer) rim
body regions may mate with a second (e.g., inner) rim body regions
to form the rim body region(s) of the device that includes the
passageway 108. These passageways in this example are interrupted
by crossing support members 114 (e.g., cross-beams or cross-struts)
that may partly support or restrict movement of the airflow
restrictor. In addition, each rim body region 101 includes two leak
pathways 116, through which air may pass even when the passageway
through the device is otherwise blocked by the airflow resistors.
The leak pathways 116 are shown here as small openings at the
narrow ends of the oval-shaped outer rim body region. The rim body
region may also be referred to as `rim` or `scaffold` regions of
the device.
[0079] FIG. 1B shows a perspective view of the opposite side of the
adhesive nasal device shown in FIG. 1A, the "inner side" of the
device. The inner side of the device faces the subject, and a
portion of this side of the device may contact the subject. This
side of the device, and particularly adhesive holdfast of the
device, includes an adhesive (which may be covered by a protective
cover 107) forming part of the holdfast 104. In some variations,
the entire skin-facing side of the holdfast 104 includes an
adhesive on the surface, although in some variations, only a
portion of this region includes adhesive. The adhesive may be a
distinct layer of the holdfast (e.g., it may be layered on top of
an adhesive substrate), or it may be an integral part of the
holdfast (e.g., the adhesive substrate may be made of an adhesive
material). In some variations, adhesive may be separately added to
the device (e.g., the holdfast region) before use. The adhesive
material may be covered by a removable protective cover or liner
107 to prevent the adhesive from sticking to surfaces until after
the liner is removed. In FIG. 1B, the protective cover 107 covers
the entire skin-facing surface of the holdfast. The device may be
applied by first removing the liner. For example, the liner may be
peeled off, to expose the adhesive. In some variations, the liner
protecting the adhesive may be partially removed. For example, the
tab region 121 of the device may include a separate (or additional)
liner that remains over the tab region when other liner regions are
removed. This may allow the device to be held by the tab region
without having it adhere to the skin. After removing the cover, or
a part of the cover, the device may be positioned and adhered to
the subject's skin around the nasal cavity, so that the passageways
through the rim body are aligned with the openings of the subject's
nasal cavities. In some variations, an additional adhesive cover
region (e.g., the protective cover region over the tabs 121) can
then be removed to secure the device to the rest of the subject's
nose. The adhesive cover may include a fold (or crimp, crease, lip,
or the like) that helps to remove the protective cover from the
adhesive.
[0080] The second, or inner, rim body region 103 shown in the
exemplary device of FIG. 1B is shaped with an inwardly-tapering
edge, so that it may fit at least slightly within the opening of
the subject's nostril when a subject wears the device. The inner
rim body includes one or more passageways 108 that correspond with
the passageways 108 shown in FIG. 1A. Similarly, the leak pathways
pass completely through the rim body (both inner and outer bodies).
The tapering external walls of the inner rim body region(s) shown
in FIG. 1B are shown as smooth, and may also include an additional
material (e.g., an auxiliary holdfast material) for securing them
in the subject's nostrils, or for cushioning them to prevent injury
or discomfort. These surfaces may also be more or less angled, in
order to facilitate comfort when the adhesive nasal device is worn
in the subject's nose. A cross bar (hinge region 115) may also be
provided as part of the inner rim body. The inner rim body 103 may
extend some distance above the peri-nasal annular region of the
holdfast, as shown in FIG. 1B. This distance may be sufficient to
prevent any portion of the airflow resistor (e.g., a flap portion
of a flap valve) from extending out of the device and into the
nasal cavity where is might contact body tissues.
[0081] FIG. 2 shows an exploded view the adhesive nasal device
shown in FIGS. 1A and 1B, from the perspective of the inner side of
the device (similar to the perspective shown in FIG. 1B). This
exploded view shows five components of the device: a first 103 and
third 103' (e.g., inner) rim body regions, a second 101 and fourth
101' (e.g., outer) rim body regions, an airflow resistor (in this
example, flap valve 201), an adhesive substrate (with adhesive) 105
and a protective cover 107 that fits over the adhesive layer. As
shown in the exploded view, the first 103 and second 101 rim body
regions can be clamped together to secure the layered holdfast
(including the adhesive substrate 105 and adhesive) and the airflow
resistor 201 between the two rim body pieces 101, 103. The
protective cover 107 in this example is not clamped between the
inner and outer rim body regions. This is shown in detail in the
cross-sectional view shown in FIG. 3.
[0082] FIG. 3 shows a cross-section though one of the two regions
shown in FIGS. 1A, 1B and 2. The cross-section is taken through the
middle of one of the two rim bodies (through the short axis of the
oval-shaped rim body), directly through the hinge region 115 (refer
to FIG. 113). The airflow resistor in this exemplary device is a
flap valve type airflow resistor, having a flexible flap valve 201
that is secured between the inner rim body region 103 and the outer
rim body region 101, as shown in FIG. 3. The flap valve 201 is
secured both by the compression of the first 103 and second 101 rim
body regions and by the two posts 301 that pass through openings in
the flap valve 201. In FIG. 3, the posts 301 project upwards from
the outer rim body region 101. The outer 101 and inner 103 rim body
regions may be secured together by a friction fitting (e.g., a
press fit such as a snap-fit), indicated by the arrow labeled 309.
Thus, the inner and outer rim body regions may mate together to
form the rim body.
[0083] In FIG. 3 the holdfast region (including the adhesive and
adhesive substrate 105) is secured between the first (inner) 103
and second (outer) 101 rim body regions and is held in place
between the two, as shown. In this example, the inner rim body
region includes an edge or annular region 305 that presses down
into the holdfast (e.g., adhesive substrate 105) and secures the
holdfast against the upper rim body region 103. In some variations,
the rim body regions may include posts, grips, or mating regions
that secure the holdfast between the inner and outer rim body
regions. The protective cover 107 covers the adhesive side of the
substrate 105 to protect the adhesive until the cover is removed
and the device is applied to a subject.
[0084] In this example, the adhesive holdfast is a layered
structure that includes a substrate layer, an adhesive coating, and
a protective cover for protecting the adhesive coating. Thus, the
adhesive holdfast is a relatively flat structure that surrounds and
projects from the rim body approximately perpendicularly from the
passageway(s) for airflow through the rim body.
[0085] The adhesive nasal device illustrated in FIGS. 1A through 3
may be worn over a subject's nose by securing the adhesive surface
of the holdfast against the subject's nose (e.g., to the skin
around and/or just within the opening of the nasal orifice) so that
the rim body regions cover the nostrils. The device may effectively
form a complete or partial seal around the subject's nasal openings
so that airflow into and out of the nose passes through the
adhesive nasal device. In particular, airflow through the device
passes through the passageways of the nasal device, including the
airflow passageways that are regulated by airflow resistors, and
any leak passageways (e.g., which are not regulated by an airflow
resistor).
[0086] FIGS. 1A-3 show one embodiment of the invention. Additional
embodiments are described below with reference to the different
components that may be included as part of an adhesive nasal
device. The description below is broken into sections that are
intended only to help organize the description, and do not
necessarily indicate organization of an adhesive nasal device. It
should be understood that an adhesive nasal respiratory device
within the scope of the invention described herein may include
additional features, or may not include some of the features, or
may include alternative embodiments of some or all of the
features.
Rim Body
[0087] The rim body region of the adhesive nasal respiratory
devices typically includes an airflow passageway, and a region of
attachment to a holdfast. The rim body may be formed of a
relatively rigid or more flexible material that provides support
for the passageway or passageways there through. The rim body may
be formed of two or more interlocking parts, however in some
variations the rim body region may be made of a single component.
For example, the rim body may be formed by joining a first rim body
and a second rim body, as illustrated above. The shape of the rim
body region may be adapted both to support a passageway and to fit
a subject's nose comfortably. Furthermore, the rim body region may
be configured to hold or secure other components of the device such
as the holdfast and/or airflow resistor and/or a bridge or other
means that connects one respiratory device to another.
[0088] The rim body may also be referred to as a modular rim body,
referring to rim bodies that are formed of two or more parts or
sections. In some variations, modular rim bodies are formed of rim
body regions that engage with each other (either directly or
indirectly) to form the assembled modular rim body. For example, a
first rim body region may engage with a second rim body region to
secure a holdfast and/or an airflow resistor between the first rim
body region and the second rim body region. Thus, additional
components of the nasal device may be secured to the modular rim
body region (including components that do not form part of the rim
body or internal passageway(s)).
[0089] An adhesive nasal respiratory device may have a single rim
body (though it may be formed of different parts) configured as a
single-nostril device, or it may have two rim body regions that are
each configured to be used over or at least partially within one of
a user's nostrils. In some variations, a single rim body region is
configured to span both nostrils, or to be connected in
communication with both nostrils.
[0090] The rim body (or rim body region) of the adhesive nasal
device is generally configured to fit over, within or partially
within or be positioned in close proximity to a subject's nasal
cavity. For example, the rim body may be small enough to
comfortably fit within a broad range of nasal cavity sizes. The rim
body may have a central axis that aligns with the direction of
airflow into or out of the nasal cavity. The outer perimeter of the
rim body perpendicular to this central axis may be generally
circular, oval, or lobular in partial cross-section, at various
points along the central axis.
[0091] As mentioned above, the rim body may be formed from two or
more parts that combine to form the entire rim body. For example,
the rim body may comprise an inner and an outer rim body region
that interlock or mate with each other to form the rim body. FIG. 4
shows a cross-sectional view of one variation of a rim body that
has two interlocking subparts, and an inner 401 (or first) rim body
region and an outer (or second) rim body region 402. The inner rim
body region 401 (or first rim body region) may be configured to fit
at least partially within the subject's nostril. For example, the
outer perimeter of the inner rim body region may be smooth, and may
be shaped to fit within the nasal passageway with only minimal (if
any) contact with the sides of the subject's nostril passageway. In
some variations, the curvature of the outer perimeter at least
partially conforms to the curvature of a subject's inner nostril
passageway. For example, one side of the inner rim body region may
be less curved than the other side (e.g., the side facing the
subject's septum when the device is worn). In this instance, "side"
refers to the external surface of the inner rim body region
substantially perpendicular to the central axis. Although this
first rim body region is referred to as an `inner` rim body region,
it should be clear that some variations of the rim body are not
configured to project into a nasal passage, but may be completely
outside of the nose, or may not project substantially into the
nasal passage when worn by the user.
[0092] FIGS. 5A and 5B show top and bottom perspective views of an
inner rim body region similar to the variation shown in FIG. 4. The
inner rim body region includes a passage 510 that is divided by a
crossbar 520. As described in more detail below, this crossbar may
support or secure the airflow resistor (e.g., flap valve) within
the passageway. In addition, the crossbar may provide additional
structural support for the rim body. For example, the cross bar may
act as a flap valve limiter to prevent the flap valve from opening
in an undesirable direction (e.g., during expiration). In general,
a separate or additional flap valve limiter (e.g., mesh, bar, etc.)
may be used as part of the airflow resistor in devices including a
flap valve.
[0093] The bottom perspective view of the inner rim body shown in
FIG. 5B illustrates the annular edge of the inner rim body 507 that
is configured to mate with the annular edge of the outer rim body
(shown in FIGS. 6A and 6B). This annular edge region includes six
protrusions 505 that may mate with recessed regions in the outer
rim body, and may also help secure the holdfast region between the
inner body rim and outer body rim. Thus, these protrusions may be
sharp or dull, and may pierce or simply compress the holdfast.
[0094] An outer 402 rim body region may be configured to fit
substantially outside of a subject's nostril. In some variations,
the outer rim body region may be configured to fit within the
subject's nostril. In FIG. 4, the outer rim body region has a
flanged outer edge (having a larger diameter than the inner rim
body region). This flanged edge forms a tip or rim which may both
help prevent the device from entering the nasal passage, in and/or
may provide a surface on which the holdfast may be supported.
[0095] FIGS. 6A and 6B show top and bottom perspective views of one
variation of an outer rim body 601 that is configured to mate with
an inner rim body similar to that shown in FIGS. 5A and 5B. The
outer rim body includes a passageway 610 that is divided into four
sections by the support beams 605, 607 that may be used to support
a portion of the airflow resistor (e.g., a flap valve). In this
variation, the outer rim body also includes two posts 612 that may
also be used to secure and position the flap region of a flap
valve, as described in greater detail below. Recessed regions 614
on the annulus of the outer rim body may mate with protrusions in
the inner rim body, as described above. FIG. 6B also illustrates
leak pathways 651, 652. An adhesive nasal device may be configured
to include leak paths that allow a basal level of airflow through
them even when the airflow resistor otherwise inhibits the passage
of air. For example, the a flap valve may be shaped so that when it
is secured between the inner and outer body rims, and allowed to
close, the flap valve does not cover the two teak paths 601, 602.
In some variations, the flap may partially or completely cover the
leak paths. In some variations, no leak path is included. In some
variations, a leak path is included through the airflow resistor
(e.g., as one or more holes through a flap valve).
[0096] The outer 402 (or second) rim body region may connect with
the first rim body region to form the entire rim body region, as
shown in FIG. 4. The outer and inner rim body regions may connect
by friction fitting, interlocking, bonding (e.g., welding), gluing
or the like, including combinations. For example, in FIG. 4, the
inner rim body 401 press-fits to the outer rim body 402. In this
variation, the inner rim body 401 includes an annular recessed
region 404 and an annular protruding region that can mate with an
annular protruding region 406 and an annular recessed region on the
outer rim body. In some variations, the inner and outer rim body
regions may be secured together by an adhesive, or by welding or
otherwise bonding to two regions in a junction region of the inner
and outer rim body regions, in some variations the outer and inner
rim body regions may include engagement regions such as posts or
snaps.
[0097] The rim body may be made of any appropriate material,
including, but not limited to metals, plastics, rubbers, ceramics,
wood, chrome, or combinations thereof. Other materials may include
acrylics, latex, polyethylene, polypropylene, polystyrene,
polyvinyl chloride, polyvinylidene chloride, polyvinyl acetate,
polyacrylate, styrene-butadiene copolymer, chlorinated
polyethylene, polyvinylidene fluoride, ethylene-vinyl acetate
copolymer, ethylene-vinyl acetate-vinyl chloride-acrylate
copolymer, ethylene-vinyl acetate-acrylate copolymer,
ethylene-vinyl acetate-vinyl chloride copolymer, nylon,
acrylonitrile-butadiene copolymer, polyacrylonitrile, polyvinyl
chloride, polychloroprene, polybutadiene, thermoplastic polyimide,
polyacetal, polyphenylene sulfide, polycarbonate, thermoplastic
polyurethane, thermoplastic resins, thermosetting resins, natural
rubbers, synthetic rubbers (such as a chloroprene rubber, styrene
butadiene rubber, nitrile-butadiene rubber, and
ethylene-propylene-diene terpolymer copolymer, silicone rubbers,
fluoride rubbers, and acrylic rubbers), elastomers (such as a soft
urethane, water-blown polyurethane), and thermosetting resins (such
as a hard urethane, phenolic resins, and a melamine resins).
[0098] Biocompatible materials may be used, particularly for those
portions of the device which may contact a user, including the rim
body. In addition to some of the materials described above, the
biocompatible materials may also include a biocompatible polymer
and/or elastomer. Suitable biocompatible polymers may include
materials such as: a homopolymer and copolymers of vinyl acetate
(such as ethylene vinyl acetate copolymer and polyvinylchloride
copolymers), a homopolymer and copolymers of acrylates (such as
polypropylene, polymethylmethacrylate, polyethylmethacrylate,
polymethacrylate, ethylene glycol dimethacrylate, ethylene
dimethacrylate and hydroxymethyl methacrylate, and the like),
polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene,
polyamides, fluoropolymers (such as polytetrafluoroethylene and
polyvinyl fluoride), a homopolymer and copolymers of styrene
acrylonitrile, cellulose acetate, a homopolymer and copolymers of
acrylonitrile butadiene styrene, polymethylpentene, polysulfones
polyimides, polyisobutylene, polymethylstyrene and other similar
compounds known to those skilled in the art. Teflon, Mylar, PFA,
LDPE, Hytrel, HDPE and polyester may also find use in any
components of the devices.
[0099] Materials that are relatively stiff may be particularly
useful. In addition, materials that are biocompatible and/or
sterilizable may also be preferred, for example, medical grade
plastics such as Acrylonitrile Butadiene Styrene (ABS), latex,
polypropylene, polycarbonate, and polyetheretherketone. The
forgoing materials are intended as illustrations only.
[0100] As mentioned above, the adhesive nasal devices (particularly
the rim body region) may be configured to be comfortably worn by a
user. For example, the devices may be configured so that the rim
bodies do not apply significant pressure to the septal region (or
other regions) of a subject's nose when worn. FIG. 7B shows one
variation of an adhesive nasal device in which the nasal device
impinges on the septal region of a subject's nose. FIG. 7A shows a
cross-section through the subject's nose and one variation of an
adhesive nasal device 701. The nasal device includes two rim bodies
704, 704'. In this variation of the nasal device 701, the rim
bodies are attached to an adhesive holdfast 705 so that they bodies
extend substantially into the nasal passages. The device is applied
to the nose such that the holdfast region secures the device across
the nasal passages, and seals around the edges of the nostrils.
When this device 701 is worn, the distal portion of the rim bodies
may contact the septum 710, as shown. In practice, this contact may
be irritating, particularly if the rim body 704, 704' is made of a
stiff material or is sharp. FIG. 7C illustrates another variation
of an adhesive nasal device in which the rim bodies 704, 704' do
not project as far into the nasal passages, and are therefore less
likely to contact the septum. For example, the rim body may be made
of a first (inner) rim body and a second (outer) rim body, where
the inner rim body is relatively short (and therefore does not
project far into the nose) or is shaped so as to avoid the septum,
as shown in FIG. 7A, 722.
[0101] FIG. 7A shows another possible variation, in which the rim
body is configured so that it is less likely to contact the septal
region of the nose. FIG. 7A shows an overlay of two cross-sectional
profiles through adhesive nasal devices. The first device 720 has a
profile in which the rim body regions are relatively symmetric
about a central axis. The cross-section of the second device 722
has a cross-sectional profile in which the portion of the adhesive
nasal device nearest the septal region (i.e. the central region of
the device) is angled so that when the device is worn, it is less
likely to contact the septal region of the nose.
[0102] As described above, the rim body may form one or more
passages through which air may flow. These passages may be of any
appropriate size. For example, in some variations, a passage
through the device has sufficient cross-sectional area (or the sum
cross-sectional areas of all of the passages through the device) so
that a comparable amount of air may flow through the passageway
during at least part of the respiratory cycle (e.g., during
inhalation) compared to the rate and/or amount of air that flows
through a nostril without the device present. Thus, in some
variations, the passageway through the device may have a
cross-sectional area that is greater than approximately half of the
cross-sectional area of the unobstructed nasal passage.
[0103] In addition to rim bodies formed from an inner rim body and
an outer rim body, the devices described herein may be formed of
two or more pieces oriented along the axis of the passageway, as
illustrated in FIGS. 37A and 37B. FIG. 37A shows a first (e.g.,
lateral) and a second (e.g., medial) rim body region that may be
combined to form a complete rim body. The airflow resistor and
holdfast may also be affixed to the rim body, as described. In this
example, the airflow resistor may be secured within the passageway
formed by the first and second rim body before the first and second
rim body regions are secured together.
[0104] The rim bodies described herein may also include an
attachment site (or sites) for one or more airflow resistors,
Airflow Resistors
[0105] An airflow resistor is typically positioned in communication
with at least one airflow passageway of the adhesive respiratory
device, so that at least some of the air flowing through the
passageway passes the airflow resistor. Thus, an airflow resistor
modulates, alters, varies, or keeps constant the amount of
resistance, the degree of airflow, or the pressure differential
across the device or through a passageway in the device. Any
appropriate airflow resistor may be used as part of the adhesive
nasal devices described herein. In general, the airflow resistors
described herein occlude airflow through a passageway in one
direction more than they occlude airflow in the opposite direction.
For example, an airflow resistor may occlude airflow during
exhalation more than inhalation. Examples of airflow resistors are
described below. In addition, examples of airflow resistors may be
found in published U.S. patent application Ser. No. 11/298,640,
titled "NASAL RESPIRATORY DEVICES" (filed Dec. 8, 2005), previously
incorporated by reference in its entirety.
[0106] In some embodiments, the pressures created by the airflow
resistor during exhalation may be between 0.01 and 100 cm of
H.sub.20 measured at a flow rate of 100 ml/sec, and more preferably
in between 0.5 and 25 cm of H.sub.20 measured at flow rate of 100
ml/sec.
[0107] Valve-type airflow resistors are particularly suitable.
Examples of valves which may be used as airflow resistors include:
flap valves (having one or more flaps); hingeless valves;
stopper-type valves; membrane-type valves; ball valves;
balloon-type valves; and the like. This list is not intended to be
exhaustive, and other types of selective airflow resistors may be
used. Moreover, multiple airflow resistors may also be used, which
may include combinations of different types of airflow resistors.
Flap valves are of particular interest. An airflow resistor
configured as a flap valve typically includes a hinged or flexible
flap (or flaps) that is movably secured so that the flap may open
when air flows in one direction, and close when air flows in the
opposite direction, or when air is not flowing. The opening and
closing of the flap may allow air to flow across the valve, and
thereby regulate airflow within a passageway in which the flap
valve is positioned. In operation, the flap portion of the flap
valve can thus selectively occlude airflow in one direction more
than in other directions.
[0108] Valves configured for PEEP (positive end expiratory
pressure) may also be used with any of the devices described
herein. For example, a valve may be configured to have a non-zero
threshold pressure for opening during expiration so that the valve
is closed during expiration when the pressure across the valve is
below the threshold pressure for opening during expiration, but the
valve opens during expiration when the valve exceeds the threshold
pressure for opening during expiration.
[0109] In some variations, a flap valve for use in an adhesive
respiratory device includes a flap, one or more valve aligners
(e.g., posts) that help secure the orientation of the valve and may
help secure it in position, one or more valve supports (e.g.,
cross-bars) or valve limiters that prevent the valve from
collapsing or opening when air flows in one direction through the
passageway, and a valve seal region (e.g., a rim or ridge) against
which the flap may be seated or abut when the valve is closed.
[0110] As mentioned above, one or more leak pathways may be
included as part of an adhesive respiratory device. A leak pathway
typically allows air to flow through the passageway even when the
airflow resistor is closed. Thus a minimum basal level of airflow
may be permitted through the passageway regardless of the state of
the airflow resistor. In some variations, the leak pathway is a
hole or unoccluded passage. A leak pathway may be a part of any
region of the nasal respiratory device. For example a leak pathway
may be part of the airflow resistor, part of the rim, part of the
holdfast region, or part of the body of the nasal respiratory
device (or some combination thereof). In some embodiments, the leak
pathway may be present due to the intentional lack of perfect
sealing or abutment of various components of the device (e.g.,
between the holdfast and the valve bodies or between the flap valve
and the valve aligners, etc). A nasal respiratory device may be
configured to have multiple leak pathways.
[0111] In some variations, the airflow resistor includes a flap
valve. The flap of a flap valve may be made of a flexible material,
or a hinged stiff material. In some variations, the flap comprises
thin sheet of flexible material that is shaped to fit within the
passageway and at least partially occlude airflow through the
passageway when the flap is seated against the valve seal region.
The flap may also be shaped so that it does not occlude airflow
through one or more leak pathways. FIGS. 8A-8F show different
variations of flap valves. All of the flap valves shown in FIGS.
8A-8F are similarly shaped, and include two access regions 801,
801' through which two valve aligners (e.g., posts) can project to
align the valves.
[0112] FIG. 8A shows a perspective view of a flap for a flap valve.
The flap 800 is roughly oval shaped, as is better seen in the top
view shown in FIG. 8B. The top and bottom regions of the flap shown
in FIG. 8B are flattened or cut away. As will be apparent from some
of the other figures, in which a similar flap valve is used, this
cut away region may be positioned so that a leak pathway is not
occluded by the flap when the flap is seated against the valve seal
region (e.g., during expiration). The oval shape of the flap
generally corresponds to an oval-shaped passageway through the
nasal respiratory device. In some variations, teak pathways (e.g.,
holes, slits, etc.) may be present in the flap of the flap
valve.
[0113] The access regions 801, 801' in FIGS. 8A and 8B are circular
cut-outs through which the posts may pass to align and help secure
the flap in position, as is apparent in other figures (e.g., FIGS.
2 and 3). In some variations it may be advantageous to use shapes
other than holes for the access region. For example, cuts (such as
L-shaped, I-shaped, C-shaped, and X-shaped) cuts may be used.
Access regions formed of cuts may be advantageous over holes formed
through the flap, because they do not produce `clads` of material
that must be removed from the airflow resistor. Such chads are
potentially problematic because they may not fully separate from
the flap during manufacture. FIGS. 8C and 8D show examples of flaps
in which the access regions 803, 803' are formed by cutting an
X-shape through the valve where the posts may be inserted.
Similarly, FIGS. 8E and 8F show flaps in which the access regions
are cut in different shapes so that the posts may pass through the
access regions by pushing aside a portion of the flap, as shown in
FIG. 8E.
[0114] FIGS. 38A and 38B show two variations of flaps each having
two access regions 3801, 3801', 3803, 3803' in which one of the
access regions is larger than the other (and larger than the
diameter of the posts to secure the flap. These variations may
allow for enhanced size tolerance in manufacturing or assembling
the flaps as part of a nasal respiratory device.
[0115] In many of the examples of airflow resistors shown as part
of the adhesive nasal devices described herein (e.g., in FIGS.
1-4), the flap is secured between the first and second body
regions, and aligned by two posts 301, as shown in FIG. 3. In this
variation, the flap may flex inwards during inhalation, permitting
airflow through the passageway, and the flap may be seated against
the valve seal region (including the valve supports) 605 in the
outer region during exhalation. In some variations, the flap may be
secured within the passageway by staking, pinning, gluing or the
like. For example, in FIG. 9, a heat stake is used to secure the
flap to the base within the passageway of the nasal airflow
resistor.
[0116] The flap may comprise any appropriate material, including
those previously mentioned. For example, the flap may comprise
polymeric materials, rubber (natural and synthetic), paper, fabric,
or the like. For example, materials that may be used include:
latex, polyethylene, polypropylene, polystyrene, polyvinyl
chloride, polyvinylidene chloride, polyvinyl acetate, polyacrylate,
styrene-butadiene copolymer, chlorinated polyethylene,
polyvinylidene fluoride, ethylene-vinyl acetate copolymer,
ethylene-vinyl acetate-vinyl chloride-acrylate copolymer,
ethylene-vinyl acetate-acrylate copolymer, ethylene-vinyl
acetate-vinyl chloride copolymer, nylon, acrylonitrile-butadiene
copolymer, polyacrylonitrile, polyvinyl chloride, polychloroprene,
polybutadiene, thermoplastic polyimide, polyacetal, polyphenylene
sulfide, polycarbonate, thermoplastic polyurethane, thermoplastic
resins, thermosetting resins, natural rubbers, synthetic rubbers
(such as a chloroprene rubber, styrene butadiene rubber,
nitrile-butadiene rubber, and ethylene-propylene-diene ter
copolymer, silicone rubbers, fluoride rubbers, and acrylic
rubbers), elastomers (such as a soft urethane, water-blown
polyurethane), and thermosetting resins (such as a hard urethane,
phenolic resins, and a melamine resins), and injection moldable
materials such as polyether block amide (e.g., PEBAX.RTM.), and the
like.
[0117] In some variations, the flap is made out of silicone or
thermoplastic urethane. For example, the flap may be a thin and
flexible piece of silicone. This flap may be any appropriate
thickness that allow it to be flexible (e.g., to move from the open
and closed positions). For example, the flap may comprise silicone
that is between 0.0001 and 0.1 inches thick. In some embodiments,
the silicone is approximately 0.002 inches thick.
[0118] In some variations, the flap is formed from a layer of
material (e.g., a thin film such as a polyurethane film, etc.), and
this same layer forms the adhesive substrate of the adhesive
holdfast. Thus the same layer may be cut to form the flap valve
leaflets. This layer of material may be secured between two or more
regions forming a rim body so that the outer region of the layer
extends from the valve body, and is coated with an adhesive,
forming the adhesive holdfast.
Adhesive Holdfast
[0119] The adhesive nasal devices described herein may further
comprise an adhesive holdfast for releasably securing the device in
communication with a nasal cavity. The adhesive holdfast may
include one or more adhesive surfaces that are suitable for use
against a subject's body (e.g., skin and/or nasal cavity). Thus,
the adhesive holdfast may include a biocompatible adhesive. The
adhesive holdfast may facilitate the positioning and securing of
the device in a desired location with respect to the subject's
nose, such as over, partially over, partially within, or within
(e.g., substantially within) a nostril. An adhesive holdfast may be
configured to secure the device to any appropriate region of the
subject's nose or nasal passage, including the nostrils, nares or
nasal chambers, limen, vestibule, greater alar cartilage, alar
fibrofatty tissue, lateral nasal cartilage, agger nasi, floor of
the nasal cavity, turbinates, sinuses (frontal, ethmoid, sphenoid,
and maxillary), and nasal septum. The term "nasal cavity" may refer
to any sub-region of the Nasal Fossa (e.g., a single nostril, nare,
or nasal chamber).
[0120] In general, the adhesive holdfast is configured to be
applied predominantly to the outside of the nose (e.g., the skin
surrounding the nasal opening). In some versions, the holdfast may
also secure a seal between the respiratory device and the nose, so
that at least some of the air exchanged between the outside of the
patient and the nostril must pass through the respiratory device,
in some versions, the holdfast seals the device in communication
with the nose completely, so that all air through the nostril (or
nostrils) must be exchanged through the device. In some versions,
the holdfast seal is incomplete, so that only some of the air
exchanged between the patient and the external environment passes
through the device. As used herein, "air" may be air from
environment external to the patient, or it may be any respiratory
gas (e.g., pure or mixed oxygen, CO.sub.2, heliox, or other gas
mixtures provided to the user).
[0121] The adhesive holdfast may be a flexible so that it conforms
to the surface of the subject's skin, which may be relatively
irregularly shaped, and may include hair and the like. In some
variations, the adhesive holdfast is made of a porous material that
permits the passage of water vapor, liquid water, sweat and/or oil,
which may enhance comfort. The adhesive holdfast may also include a
texture or patterned relief surface to enhance bonding to the
subject's nose region.
[0122] The adhesive holdfast may be made of layers. For example,
the adhesive holdfast may include a substrate layer to which a
biocompatible adhesive is applied. The substrate is typically a
flat (predominantly 2-sided) material that is flexible. An adhesive
may be present on at least one surface of the substrate, allowing
it to adhere to the subject's nasal region. In some variations, the
substrate layer is itself adhesive without needing an additional
adhesive. An additional protective cover may also be removably
attached to the adhesive of the adhesive layer. The protective
cover may allow the device (and particularly the adhesive holdfast)
to be manipulated without inadvertently sticking the device to the
fingers or other parts of the body and it may also prevent
contamination of the adhesive. The protective cover may be a
removable paper or other film that can be peeled off or otherwise
removed to expose the adhesive. In some variations, the adhesive of
the adhesive holdfast is activatable. For example, the adhesive
becomes `sticky` only after exposure to an activator (e.g., water,
air, light, etc.).
[0123] FIG. 10A illustrates a schematic of a cross-section through
an adhesive holdfast having layers. In FIG. 10A, the adhesive
holdfast includes a flexible substrate layer 1010, to which an
adhesive 1020 is applied. A removable protective cover layer 1040
is placed on top of the adhesive 1020 to protect the adhesive. As
shown in this cross-section, a separate piece of protective cover
layer 1030 is placed at the right and left edges no that the larger
section of removable liner overlaps with these edge pieces 1040. As
seen in FIG. 10B, these edge pieces may help removal of the
protective cover and may also help grasping the device after the
larger piece of liner 1030 is removed, so that the adhesive does
not stick to the finger. Once the device is positioned, these
smaller tabs of protective cover 1040 can be peeled off as well.
Thus, they may be folded or otherwise provided with a convenient
way of grasping and removing them.
[0124] In some variations, a protective cover is not used. As
already mentioned, in some variations, the substrate and adhesive
are a single layer, so that the substrate comprises an adhesive
material, or a material that can be activated to become
adhesive.
[0125] The adhesive holdfast may comprise any appropriate material.
Fore example, the adhesive substrate may be a biocompatible
material such as silicone, polyethylene, or polyethylene foam.
Other appropriate biocompatible materials may include some of the
materials previously described, such as biocompatible polymers
and/or elastomers. Suitable biocompatible polymers may include
materials such as: a homopolymer and copolymers of vinyl acetate
(such as ethylene vinyl acetate copolymer and polyvinylchloride
copolymers), a homopolymer and copolymers of acrylates (such as
polypropylene, polymethylmethacrylate, polyethylmethacrylate,
polymethacrylate, ethylene glycol dimethacrylate, ethylene
dimethacrylate and hydroxymethyl methacrylate, and the like),
polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene,
polyamides, fluoropolymers (such as polytetrafluoroethylene and
polyvinyl fluoride), a homopolymer and copolymers of styrene
acrylonitrile, cellulose acetate, a homopolymer and copolymers of
acrylonitrile butadiene styrene, polymethylpentene, polysulfones
polyimides, polyisobutylene, polymethylstyrene and other similar
compounds known to those skilled in the art. Structurally, the
substrate may be a film, foil, woven, non-woven, foam, or tissue
material (e.g., poluelofin non-woven materials, polyurethane woven
materials, polyethylene foams, polyurethane foams, polyurethane
film, etc.).
[0126] In variations in which an adhesive is applied to the
substrate, the adhesive may comprise a medical grade adhesive such
as a hydrocolloid or an acrylic. Medical grade adhesives may
include foamed adhesives, acrylic co-polymer adhesives, porous
acrylics, synthetic rubber-based adhesives, silicone adhesive
formulations (e.g., silicone gel adhesive), and absorbent
hydrocolloids and hydrogels.
[0127] The removable protective cover layer may be made of any
appropriate matter that may be released from the adhesive. For
example, the protective cover material may comprise craft paper. In
some variations, the protective cover includes a material having a
wax or hydrophobic coating on one or both sides (particularly the
side contacting the adhesive). For example, the protective cover
material may comprise a polyethylene film, or polyethylene coated
paper (e.g. Kraft paper). The protective cover may be any of the
other materials described herein. Any of the materials commonly
used in the manufacture of bandages (particularly disposable
bandages such as Band-Aids.TM.), ostomy kits, and wound care
products may be used in any or all components of devices described
herein.
[0128] In general, the adhesive holdfast may comprise any
appropriate shape that allows the airflow passageway and airflow
resistor to be positioned with respect to one or both nasal
passages so that some (or most) of the airflow through the nasal
passages must pass through the adhesive nasal device. In some
variations, the adhesive holdfast attaches to the nose (or nasal
passage) and forms a partial or complete seal therewith, thereby
channeling airflow into or out of the nasal passageway through the
device, and also securing the device in position. Thus, there are
many designs that would achieve these criterions, many of which are
described below.
[0129] For example, FIG. 10B shows one variation of the adhesive
holdfast region of an adhesive nasal device. This variation is
intended for use with a device having two rim body regions, each
configured to operate with one of a subject's nasal passageways. As
described above, an inner and outer rim body region (including a
passageway and airflow resistor) may be secured to the openings
1050, 1050' shown in the adhesive holdfast region. These openings
1050, 1050' are configured so that they approximately align with a
subject's nasal passageways. Thus, the adhesive holdfast region
1001 in this variation comprises two annular regions joined by
bridge region 1080 that can adhere around the openings of the
subject's nares. In addition, the holdfast 1001 shown in FIGS. 10A
and 10B includes two additional tabs 1090, 1090' that may act as
handles or grips. These regions may also adhere to the subject's
nose and may wrap around the nares region and over to the side of
the nose. This may also further secure the device in position.
[0130] As mentioned above, openings 1050, 1050' are configured so
that they approximately align with a subject's nasal passageways.
In practice, the arrangement of nostril openings may be highly
variable between individuals. FIG. 10C reflects two parameters of
variation that may be addressed by the configuration of the
adhesive holdfast. In FIG. 10C, arrows illustrate both the
separation of the nostril openings 1018 and the tilt or angle of
each nostril opening with respect to an imaginary line through the
long axes of each nostril opening 1095. The adhesive holdfast may
be configured to allow for variation of either or both of these
parameters by allowing modification of the bridge region 1080. For
example, in FIGS. 10B and 10C, the bridge region 1080 has been
reduced in diameters by forming slits 1082, 1082' at either end.
The narrowing of the bridge region 1080 may allow it to flex or
bend (changing the angle of the nostril opening 1095).
[0131] Other variations of the general shape of the adhesive
holdfast region are shown in FIGS. 11A-11E. These variations also
include tab or grip regions. In FIGS. 11A and 11B, the bridge
regions 1180 of the adhesive holdfasts have different widths and
lengths in the region between the two holdfast annular regions
configured to surround the subject's nostrils. The thinner bridge
1180 region shown in FIG. 11A may be more easily bent than the
wider bridge region 1180 of the variation in FIG. 11B. In addition,
the location of the bridge region between the two annular regions
may also be varied to achieve a sufficiently adjustable device. For
example, the bridge region 1180 in FIG. 11C is located somewhat
centrally between the annular regions, whereas the bridge region
1180 in FIG. 11E is located closer to the "top" (e.g., towards the
front of the nose when a device including this adhesive holdfast is
worn by a subject). This positioning may allow the device further
separate the annular regions as they bend apart from each other. In
all of these variations, the adhesive holdfast is composed of a
flexible or pliable material, which may allow it to more readily
conform to the outer surface of the nose. FIGS. 11C to 11E, also
include cuts or notches 1110 at a peripheral region of the
holdfast. These notches may enhance the ability of the adhesive
holdfast to conform to the shape of a subject's face (e.g., nose
and/or lip region), particularly when the holdfast must adhere to
regions of the subject's nose and face that are at different angles
with respect to each other. For examples, the notches shown in
FIGS. 11C to 11E may help the holdfast region attach both to the
outer rim of the nose as well as the adjacent upper lip region, and
outer curvature of the nostril.
[0132] FIGS. 12A-12C illustrate other variations of adhesive
holdfasts for devices having two rim bodies, in which the lower
(e.g., inward facing when worn) and/or upper (e.g., outward facing
when worn) areas of the holdfast annular region are notched. In
addition, FIG. 12C illustrates a variation in which the bridge
region 1280 includes a hole 1285, thereby reducing the material
forming the bridge while retaining a substantial amount of
structural strength (effectively creating two parallel bridges).
This may allow the two halves of the adhesive holdfast region to
more readily bend than a larger, unbroken bridge region would.
[0133] FIGS. 13A-13C illustrate an adhesive holdfast region in
which have a bridge region that can expand as well as bend. For
example, the adhesive substrate can comprise a flexible or
stretchable material. In some variations, this material is elastic;
however it may be preferable for the bridge material to comprise a
relatively inelastic material, so that it does not apply force to
return to the unstreched shape after begin applied to the subject's
nose. FIG. 13A shows one variation of an adhesive holdfast in a
first (unstreched) position. The openings through which the rim
body regions are secured is separated by a distance x. In FIG. 13B,
the same adhesive holdfast has been stretched so that the bridge
region is extended, and the openings for the rim body regions of
the device are now separated by a distance y, where y>x.
Similarly, the adhesive holdfast shown in FIG. 13C comprises a
bridge region 1380 that is serpentine, or shaped so that it can
accordion open, allowing it to more readily adjust to different
nose sizes.
[0134] The adhesive holdfast regions illustrated above show
adhesive nasal devices configured to have two rim bodies and to
communicate with both of a subject's nostrils. Thus, the adhesive
holdfast includes two annular holdfast regions (one surrounding
each rim body) are connected by a bridge region. However, adhesive
nasal respiratory devices may be configured to communicate with a
single nostril. Thus two unconnected nasal respiratory device (each
device including a single annular adhesive holdfast region) may be
connect to each nostril. FIGS. 14A and 14B show variations of an
adhesive holdfast for such a device. Compared to the previously
described adhesive holdfasts, the holdfast in FIG. 14A has a
slightly expanded annular region, particularly in the region of the
device worn near the subject's inner nostril area 1401. In
operation, this portion of the holdfast may overlap (and be adhered
to an overlapping portion) with another adhesive holdfast from an
adhesive nasal device worn in/around the other nostril. In some
embodiments, the shape of the holdfast is completely symmetrical as
shown in FIG. 14B. Thus, the same device may be used in either the
right or left nostril. In some variations the devices may be
configured as "left nostril" and a "right nostril" devices that may
be worn together.
[0135] It is not necessary that the entire adhesive holdfast region
include adhesive, although many of the substantially flat holdfast
regions described in the preceding figures may have a biocompatible
adhesive over much of the skin-contacting surface which may be
covered by a protective layer that can be at least partially
removed later. In some variations, only a subset of the holdfast
region (including the outer layer) includes an adhesive. For
example the region adjacent to the rim body may not include an
adhesive, or the region beneath the tabs or grips may not include
an adhesive.
[0136] Some variations of the adhesive holdfast include one or more
additional components for helping to secure the device to the
subject's nose. For example, the tab or grip region described above
may also help secure the device to the subject's nose (or help its
removal from the nose). In some variations, the adhesive nasal
device also includes an over-the-nose bridge, as illustrated in
FIG. 15. The over-the-nose portion 1501 may include a region of the
adhesive holdfast that fits over the bridge region of the subject's
nose, and helps to secure the device in place on the subject's
nose. In particular, over-nose-portion 1501 may help create a seal
between the device and the nose/nostrils by exerting a force in an
upward direction. In addition to the bridge region, one or more
tabs (or pairs of tabs) may also be used. Other examples of an
adhesive holdfast region showing over-the-nose bridge portion 1501
can be seen in FIGS. 16A, 16B and 17B-17D. FIGS. 17A-17E illustrate
different alternative variations of an adhesive holdfast region.
For example, FIG. 17A shows a device having only a very narrow
adhesive holdfast region (e.g., annular region), but including
tabs. FIGS. 17B and 17C show devices with over-the-nose bridge
regions 1706 and tabs or grips 1704, where the grips are oriented
in different directions. In the variation shown in FIG. 16B, two
pairs of tabs or grips 1601, 1603 are included.
[0137] In some variations, the adhesive nasal devices described
herein are adapted to fit different users having a diversity of
sizes and shapes, particularly the shapes and sizes of their noses.
As already described, the devices, including particularly the
adhesive holdfast region, may be configured to that it is adaptable
to different nose shapes. FIGS. 27A and 27C exemplify different
configurations of adhesive holdfast regions. FIG. 27B illustrates
how a device having a holdfast design as shown in FIG. 27A could be
worn by a user. In this example, the slit or cut region 2701, 2701'
separates to better conform to the subject's nose, as seen in FIG.
278. FIG. 27C shows another variation, in which silts are not
included. FIG. 27D shows a subject wearing this device.
[0138] In some variations, the holdfast region may extend into the
nostril, rather than just adhering around the outer surface of the
nasal passages. For example, the adhesive holdfast may include a
region adjacent to the rim body (or bodies) that projects into the
nostril, and can be secured against the walls of the nostril, as
illustrated in FIGS. 18A-18C. In FIG. 18A, the adhesive holdfast
includes both a layered (e.g., substantially flat) region that can
adhere to the outer rim of the subject's nostrils, and twin
internally-projecting regions 1801, 1801' that fit into the
subject's nose. In some variations these internally-projecting
regions do not have an adhesive outer surface or include adhesive
on only a restricted portion of their outer surface (e.g., near the
flat portion of the holdfast). In some variations, the
internally-projecting regions may comprise a compressible material
(e.g., a foam or the like) so that they may be secured within the
nasal passages, and/or may cushion the inner rim base region (or
any other portion of the adhesive nasal device) that projects into
the subject's nostrils. Thus, in some variations, the
inwardly-projecting portion of the holdfast is smaller than the
nasal opening, and does not necessarily contact the sides of the
subject's nasal passage. Conical or tubular projections into the
nostril or in close proximity to the nostril openings may find
use.
[0139] FIG. 18B illustrates another variation of the
inwardly-projecting holdfast region, similar to that described
above, except the inwardly projecting holdfast region has a tapered
or curved outer edge 1810. In FIG. 18B the outer edge is nearly
concave, a shape that may be useful to prevent irritation to the
subject by cushioning the inner rim body, but minimizes the chance
that the inwardly-projecting region contacts the nasal passageway.
FIG. 18C shows another variation having a slightly less curved
outer wall (e.g., the wall cross-section is not convex, but may
have a constant slope, or be slightly concave). Convex interfaces
with the inside or outside of the nostril may also find use.
[0140] In some variations the inwardly-projecting region is
configured as a plug which inserts into the nasal opening and is
held against the nasal opening by the flexible adhesive holdfast.
Thus, the plug may form a seal with the nasal opening. In some
variations, the holdfast (though generally made of a flexible
material) includes one or more rigid or semi-rigid regions that may
be used to add support. For example, FIG. 19A shows one variation
of an adhesive nasal device 1900 having a holdfast region including
plugs 1903 that insert at least partly into the subject's nasal
openings, a rigid support backing 1905 to support the plugs, and a
flexible adhesive region (including two sets of tabs) for securing
the device to the outer region of the subject's nose, as shown in
FIG. 19B. In this example, the outer surface of the plug region of
the holdfast 1903 include a hydrogel material 1907 that may enhance
the ability to form a seal, and may also increase comfort when the
device is worn.
[0141] As will be clear from the exemplary holdfast regions
(previously discussed, the holdfast region may help position the
rim body (and thus the passageway and airflow resistor) with
respect to the subject's nasal passageway. In variations in which
the rim body is secured through openings in the holdfast, the
openings may determine where the rim body resides with respect to
the nasal passageway when worn on a subject's nose. In some
variations, the rim body 2001 is biased to one particular side of
the nasal passageway, as shown in FIG. 20. In other variations, the
rim body may be positioned in approximately the center of the nasal
passageway.
Manufacture of Adhesive Nasal Devices
[0142] The adhesive nasal devices described herein are typically
assembled to provide a device of sufficient durability that it can
be worn without risk of malfunction or breaking when worn over a
subject's respiratory orifice. The modular (e.g., formed of two or
more parts) rim body described above, including an first and second
rim body portions, may be used to secure the other component parts
of the device including the holdfast region and the airflow
resistor by securing these regions between the inner and outer rim
bodies and securing the rim body portions together.
[0143] FIG. 21 illustrates the assembly of one variation of an
adhesive nasal device. In FIG. 21, the adhesive holdfast 2105
includes a central cut-out region 2103 into which a portion of the
outer rim body 2110 fits. The rim body surrounds airflow
passageways, including leak pathways and the passageway regulated
by the airflow resistor, as described above. The airflow resistor
in FIG. 21 is configured as a flap valve, and the flap 2109 fits
onto posts projecting from the outer rim body 2110 (although they
may also project from the inner rim body). The inner rim body 2101
can then mate with the outer rim body 2110, and secure the flap
2109 and the adhesive holdfast 2105 therebetween, and the outer
2110 and inner 2101 rim body regions can then be secured together.
For example, the outer 2110 and inner 2101 rim body regions can be
secured together by welding (e.g., ultrasonic welding) or by press
fit.
[0144] In FIG. 21, the holdfast region is held between the inner
and outer rim body regions by the shape of the rim body regions as
well as the compression between them. In addition, the adhesive
layer of the adhesive holdfast may also be used to help secure the
holdfast region to the rim body. This adhesive may also help form a
seal between the adhesive holdfast and the rim body, further
helping direct airflow through the airflow passageway of the device
when worn by a subject. Thus, in FIG. 21, the adhesive holdfast
2105 has a central annular region 2107 in which the adhesive has
been exposed (e.g., by removal of the protective cover in this
region). FIG. 22A shows another example of the assembly of an
adhesive nasal device, similar to that shown in FIG. 21.
[0145] In FIG. 22A, the inner rim body 2201 includes posts that
align and secure the flap 2209 within the passageway formed through
the rim body. This example also includes two teak pathways 2215
which are not covered by the flap valve 2209 of the airflow
resistor. FIG. 22B illustrates a cross-section through the
assembled device shown in FIG. 22A. In FIG. 22B, the inner 2201 and
outer 2210 rim body regions may be welded together where they mate
with each other 2223 and 2223' securing the flap valve and the
adhesive holdfast layer between the first and second rim body
regions.
[0146] As mentioned above, the adhesive holdfast may be secured
between the first and second rim bodies by pressure (and/or by
adhesive). For example, a portion of the first rim body may press
the adhesive holdfast against the second rim body (or vice versa).
In some variations, an annular edge of the first rim body
compresses the holdfast against the second rim body. In some
variations, either the first or second rim body regions may include
one or more mating regions that help hold the adhesive holdfast
between the first and second body regions. FIG. 23A shows one
variation in which an edge of the first body rim includes a pointed
or sharp portion 2301 that pins the adhesive holdfast against the
opposite second body rim. In some variations, such posts or
projections may help secure the adhesive holdfast between the first
and second body rims. FIG. 23B shows a top view of a device having
four such projections arranged around the periphery of the inner
rim body 2302.
[0147] As mentioned previously, in some variations, the rim body is
not assembled by closing the holdfast region in order to secure the
two components together. For example, in some variations the
holdfast region is formed around the rim body. FIG. 24A illustrates
another example in which the holdfast region is pulled over the
pre-formed rim body region. In FIG. 24A, two rim bodies 2402, 2402'
are aligned (e.g., using a guide 2405, as shown to hold them in
position) and an adhesive holdfast 2409 is pulled over the rim
bodies. In this example, the adhesive holdfast 2409 is flexible
(and may even be somewhat elastic) so that the openings 2411, 2411'
may expand as the holdfast is drawn over the larger diameter
portion of the rim body (corresponding to the inner rim body
region). The rim body includes a lip or channel 2415 into which the
edge of the openings 2411, 2411' may sit after being pulled over
the rim bodies. The lip or channel may also be configured as a
barb, to prevent the adhesive holdfast from sliding off of the rim
body. Variations in which the adhesive holdfast is pulled over the
assembled rim body may be particularly useful for reusable (or
partially reusable) devices. For example, the rim bodies may be
reused with a new adhesive holdfast region by pulling the rim
bodies off of the old adhesive holdfast. In general, the adhesive
nasal device described herein may be disposable, or configured for
single use. FIG. 24B is a cross-section illustrating how an
embodiment similar to that shown FIG. 24A may be inserted into a
subject's nostril and secured in place. In this variation, the rim
body includes a soft outer portion 2435, and a stiffer inner
portion 2437, including the airflow resistor and passageway (and
any leak paths). The adhesive holdfast includes an adhesive layer
2439 that is attached to the rim body.
[0148] FIGS. 25A-25E illustrate a number of different design
variations showing the relationships between the rim body and the
adhesive holdfast region 2525. For example, in FIG. 25A, the inner
rim body 2505 includes a pointed (or sharp) edge region that
pinches (or even punctures) the holdfast region and secures it
against the outer rim body 2507, similar to the design described
above for FIGS. 23A and 23B. FIG. 25B shows another variation in
which the adhesive holdfast 2525 is not secured to the rim body by
closing it between an inner and an outer rim body portions.
Instead, the adhesive holdfast 2525 is slid over the rim body 2501,
and it may be held against the rim body by other means (e.g.,
adhesive, welding, tacking, etc.). In this example an inner rim
body 2515 may still fit into the outer rim body 2517 (e.g., to
secure the airflow resistor therein).
[0149] FIGS. 25C and 25D reflect different variations of the rim
body having an inner 2505 and outer 2507 rim body regions that
close to secure the adhesive holdfast in position. FIG. 25E shows a
partial exploded perspective view of the device shown in FIG. 25D,
in which the inner rim body 2505 includes interlocking sections
that fit into holes or receptacles in the outer rim body 2507. In
this variation, the adhesive holdfast 2525 includes holes through
which these interlocking tabs fit. In other variations, the
adhesive holdfast is simply compressed between the inner and outer
rim bodies.
[0150] In variations in which two or more rim body portions are
joined to form the rim body, the individual rim body portions may
be joined in any appropriate way. For example, a snap-fitting may
be used to engage the inner and outer rim body portions, as shown
in FIG. 26B. FIG. 26A shows a cross-section though an assembled
device including a rim body and an adhesive holdfast. The circled
region 2600 indicates the region of the partial cross-section of
the assembled rim body shown as different alternatives in FIGS. 26B
and 26C. In FIG. 26B, the inner rim body 2605 has interlocked with
the outer rim body 2607, so that the two are `snap-fit` together. A
portion of the adhesive holdfast 2617 is also shown attached to the
inner body rim 2605 (in part due to the adhesive on the adhesive
holdfast). In FIG. 26C, the inner 2605 and outer 2607 rim bodies
are welded (e.g., ultrasonically welded) together in the region
indicated 2620.
[0151] In operation, the user secures the devices to his or her
nose by applying the adhesive holdfast region against the nose to
form a seal, so that the majority of airflow through the nose
passes through an airflow resistor, thereby regulating respiration
through the nose. For example, the airflow resistor may be
configured so that resistance to exhalation is greater than
resistance to inhalation.
[0152] In addition to the components described above, the adhesive
nasal devices may be used with additional components, including
fitting adapters and cannula adapters (or nasal cannula
connectors). A fitting adapter may be an additional (e.g.,
separate) piece that attaches in, around, or to the subject's nose
to act as an additional substrate for attachment of the adhesive
nasal device. For example in subject's whose noses are too small
for a standard-sized adhesive nasal device to comfortably fit (and
seal), a fitting adapter may be used to better secure the adhesive
nasal device.
[0153] A fitting adapter (which may be made from the same basic
material as the adhesive holdfast of the device) is first applied
to the subject's nose, and the adhesive nasal device may then be
applied over the fitting adapter and onto the nose. For example, a
fitting adapter may be applied to the external septal region of the
nose (e.g., the tissue between the two nostril openings), and
provide a regular and possibly larger surface against which the
adhesive nasal device may fit. FIGS. 28A and 28B illustrate a
fitting adapter 2805 applied to the outer septal region of a
subject. In FIG. 28B, an adhesive nasal adapter has been applied
overtop of the fitting adapter. Although the fitting adapter shown
is an external septal fitting adapter, a fitting adapter may be
provided to any region of the nose, including the entire nose, or a
sub-portion thereof.
[0154] Any of the devices described herein may also be used with a
cannula adapter so that they may be used with a cannula. Thus, a
cannula may be secured in proximity to the subject's nasal orifice
by the adhesive nasal device. For example, a cannula may be used to
take measurements of airflow (or pressure) through the nasal
passageway. In some variations, a cannula is attached directly to
an adhesive nasal device without requiring a separate (or
removable) adapter. In general, the cannula opening is aligned with
an opening through the adhesive nasal device, such as a leak
pathway. In some variations, the cannula (or an additional cannula)
opening may be aligned with the passageway opening that is
regulated by the airflow resistor. FIG. 29A shows a bottom view of
a portion of an adhesive nasal device 2900 having four leak
pathways 2903 through the airflow resistor (flap valve 2906). In
order to measure flow within the nasal passage when an adhesive
nasal device is worn, the cannula opening 2910 should be aligned
with the leak pathway 2903, as indicated. FIG. 29B shows a similar
illustration of an adhesive nasal device 2900' having leak pathway
openings 2903' encircling the valved airflow pathway 2906'.
[0155] A cannula adapter may be configured to securably attach to
the bottom (e.g., the outer rim body) of the adhesive nasal device
so that the cannula opening is aligned with a leak pathway. FIG.
30A shows a cannula adapter 3010 attached to an adhesive nasal
device. In this example the cannula adapter 3010 is attached to the
rim body so that the cannula 3020 opening is positioned opposite a
leak pathway through the flap (similar to the arrangement discussed
above for FIG. 29A). The cannula adapter includes a
cannula-securing lumen (into which a cannula 3020 is mounted) and a
support frame 3015 that attaches to the rim body of the adhesive
nasal device. The cannula adapter may be attached by any
appropriate method, including an adhesive by using a glue) or by a
mechanical engagement, or some combination. In some variations, the
cannula adapter is removably attached to the adhesive nasal device.
In other variations, the cannula adapter is permanently attached to
the adhesive nasal device. FIG. 31 illustrates cross-section of a
cannula adapter engaged to an adhesive nasal device.
[0156] The cannula adapter shown in FIG. 31 is connected to the
outer rim base 3107 so that the cannula opening is substantially
continuous with the opening of a teak pathway 3111 on the adhesive
nasal device. This arrangement may allow a determination of the
back pressure in the nasal passage when wearing the device, even
when the airflow resistor (flap 3109) changes from opened to
closed. In some variations, a cannula or tube may extend beyond the
level of the airflow resistor (further inside the nasal cavity) in
order to capture intra-nasal pressures during portions or the
entirety of the respiratory cycle. In some variations, a cannula
adapter may be configured to read from both nasal passages. For
example, FIGS. 32A and 32B show a variation of cannula adapter that
is configured to attach to both rim bodies in an adhesive nasal
device configured to fit over both nostrils. This adapter includes
a hinged bridge region 3202 that is shown here as a living hinge
allowing the adapter to fit subject's having different nostril
spacings. The cannula adapter includes an opening that aligns with
the leak pathway of adhesive nasal device, and also includes a male
lure fitting 3205 to which the cannula tubing may be attached. FIG.
32B illustrates a side view of this variation of the cannula
adapter.
[0157] A cannula adapter for an adhesive nasal respiratory device
may be used with a commonly (or commercially available) nasal
cannula, including two-prong cannulas. FIG. 33 illustrates the
connection of a typical nasal cannula 3301 to a pair of cannula
adapters 3305. The cannula adapters 3305 shown in FIG. 33 are
configured to attach to the rim base regions 3307 of an adhesive
nasal device 3300 by snap-fits 3310 that snap onto the rim
base.
[0158] FIGS. 34 and 35 show two additional variations of adhesive
nasal devices. In FIG. 34, the adhesive nasal device includes a
self expanding rim body. Thus, the rim body has a first (inner)
portion that is slideable within the second (outer) portion. Moving
one portion with respect to the other portion causes the outer
portion to expand or contract. In FIG. 34 this is caused by the
action of the wedge-shaped (or angled) inner portion pushing apart
the walls of the outer portion as the inner portion is moved in one
direction. Such self-expanding nasal devices may be used to secure
the device within a subject's nostril without the need for
additional adhesive, although it could be used with adhesive. In
some variations, the device includes locking regions (e.g., `ribs`)
that prevent the inner portion from easily backing out once it has
been expanded by moving the inner portion inwards.
[0159] FIG. 35 illustrates an adhesive nasal device in which a
single airflow resistor is used to cover both nostrils. In this
variation, the adhesive holdfast secures a horizontally elongated
portion opposite from both nostrils so that both nostrils empty
into a common chamber or lumen. This common space is continuous
with a passageway having an airflow resistor (and possible also
leak pathways) therein.
[0160] FIG. 36A to 36C shows different variations of rim body
regions of an adhesive nasal device as described. In FIG. 36A, the
rim body region having an upper edge (e.g., along the top of the
first rim body region) that is substantially flat. In contrast,
FIG. 36B shows a perspective view of a rim body region that has an
arced or curved profile. This curved profile may help protect a
moving flap region, and may also make fabrication easier. FIG. 36C
shows an end view of the rim body shown in FIG. 36B.
[0161] In some variations of the adhesive nasal devices described
herein, one or more components of the device are impregnated with,
contain or are coated with one or more compounds that may be
inhaled during use. The presence of airflow, heat or other
conditions may facilitate the release of the compound into the
inhaled air or surrounding tissues. The compound may be herbal
(such as menthol or lavender), chemical or pharmaceutical (such as
an antihistamine or anti asthma drug) in nature. Depending on the
compound, the user might experience a pleasant aroma (which may
soothe or promote sleep or activity) or medical benefits, such as
nasal decongestion or asthma relief. The compound may be inhaled
during all or at least a portion of the time the user is wearing
the device. The compounds may be used as part of a sleep apnea,
snoring or a respiratory device, or may find use in other
embodiments for other medical conditions.
[0162] Any of the nasal respiratory devices described herein may be
embodied used to treat sleep apnea (including obstructive sleep
apnea, or OSA), snoring, or any other disorder, including those
listed herein.
[0163] The adhesive nasal devices may include a filter that removes
particulate matter from external air upon inhalation. Particulate
matter that would be removed may include dust and allergens. The
filter may be made of a material that can act as a filter for
allergens, pollen, dander, smog, etc. By providing a filter within
the device, sinusitis, sleep apnea, snoring, hay fever, allergic
rhinitis, and other allergic respiratory conditions may be reduced
or prevented. This filter may in fact be part of the airflow
resistor or may be a separate component of the device. Any suitable
filtering material known to those skilled in the art may be used
with the respiratory devices described herein. Such materials
include, but are not limited to, activated carbon charcoal filters,
hollow-fiber filters, and the like. A filter may not appreciably
alter resistance to airflow in either direction, or it may alter
airflow to substantially the same degree in both directions
(inhalation and exhalation). In some versions, the filter comprises
a material having a large pore size so that airflow is not
significantly inhibited.
[0164] In some versions, the device is used with an active agent.
In some versions, the active agent comprises a drug. An active
agent (e.g., a medicament) or other compound can be placed in or on
the device to deliver the active agent into the mouth, tongue, hard
and soft palates, sinuses, nose, nasal cavity, pharynx, vocal
cords, larynx, airways, lungs, trachea, bronchi, bronchioles,
alveoli, air sacs, or any tissues that are exposed to inspiratory
or expiratory airflow. In some cases, the active agent may be
embedded or impregnated in the device or components of the device.
In some cases the active agent is a coating. An active agent may
comprise any compound that is in some way useful or desirable for
the patient. For example, the active agent may be any odorant,
including: menthol, phenol, eucalyptus, or any agent that provides
a fragrance in the inspired air. Alternatively, an active agent may
comprise a drug with beneficial effects, such as beneficial
vasculature effects. For example, an active agent may comprise a
drug that effects the blood vessels (oxymetazoline or any other
vasoactive compound), nasopharynx, airways or lungs (albuterol,
steroids, or other bronchoconstriction or bronchodilation
compounds). An active agent may comprise, for example, an
antibiotic or a steroid. The above list of active agents is not
meant to be limiting.
[0165] An active agent may be placed in or on any portion of the
device. Furthermore, the location of the active agent within the
respiratory device may specifically guide the delivery of the
active agent. For example, in versions of the respiratory device
configured to be placed at least partially inside a respiratory
cavity, when the holdfast includes an active agent (e.g., coated,
embedded or otherwise part of the holdfast), the drug may be
delivered through the mucus membranes of the respiratory cavity. In
another example, an active agent may be included as a powder or
releasable coating that may be aerosolized and delivered within the
respiratory system. Thus, an active agent may be on a surface of
the device (e.g., the passageway, holdfast or airflow resistor) or
embedded within any surface of the device. A separate
drug-containing region may also be included in the device. The
addition of an active agent may be of particular interest in
treating allergies and sinusitis. Respiratory devices (with or
without airflow resistors) may therefore comprise active agents
such as menthol or other fragrant compounds.
EXAMPLES
[0166] FIGS. 42A and 42B illustrates how an adhesive single-nostril
nasal device may be applied to and worn by a user. In FIG. 42A, a
user first peels off all (or a part of) the protective cover,
exposing the adhesive holdfast region. The user may then place the
device over one of the nostrils, so that the passageway through the
device is aligned with the nasal openings. The rim body (e.g.,
inner rim body) may help the user to align the nasal opening and
the central passageway of the device. The adhesive device may be
applied against the nostril to secure it into position. The user
may first wash the area to which the adhesive device will be
applied to remove material (e.g., dirt, oils, etc.) that could
prevent adhesion (and/or a seat) between the adhesive device and
the nostril and/or nose.
[0167] Once a single-nostril device has been applied over one
nostril (as shown in FIG. 42B), a second device may be applied to
the other nostril. The adhesive holdfast regions of the two devices
may overlap. To remove the devices, the user may simply peel off
the adhesive devices. In some cases, as one device is removed, it
will facilitate removal of the second device since the two
once-independent devices may be adhered together.
[0168] FIGS. 39A to 41D illustrate another variation of an adhesive
nasal device. FIG. 39A shows a side perspective view of a rim body
portion of an adhesive nasal device. FIG. 39B is a cross-section
through this rim body, taken through line B-B' (shown in FIG. 39A).
In this variation, the rim body includes an inner (or upper) rim
body 3907 and an outer (or lower) rim body 3905 that fits together
to form the firm body region. In this variation, the inner rim body
mates with the outer rim body at a sealing surface 3909 between the
inner and outer rim body regions. This sealing surface may be
sufficiently snug so that an additional teak pathway is not formed
between the inner and outer rim bodies.
[0169] In the example shown in FIGS. 39A-39D, the inner and outer
rim bodies are jointed together by two snaps (or snap-fits) 3911,
3911' which are visible in FIG. 39D. FIG. 39D shows a cross-section
through FIG. 39C taken through line D-D'. The snaps 3911, 3911' are
located at the inner portion of the ends of the long axis of the
rim body, as indicated by 3913, 3913' on FIG. 39A. These snaps
3911, 3911' may allow the inner and outer rim bodies to be secured
to one another. Although the adhesive holdfast is not shown in
FIGS. 39A-39D, a channel region 3915 is included within the rim
body (formed between the interface of the inner and outer rim
bodies making up the rim body). The adhesive holdfast may be
secured in this channel 3915. The channel 3915 in this exemplary
device is configured differently than the channel described
previously for securing the holdfast to the rim body (e.g., FIG.
3). For example, the channel 3915 extends downward into a concavity
formed in the outer rim body, as seen in FIGS. 39B and 39D. This
configuration may allow the device to have a more compact profile
than configurations in which this channel projects horizontally
between the inner and outer rim bodies, or upwards towards the
inner rim body.
[0170] The two snap fit regions 3911, 3911' are shown more clearly
in FIGS. 40A and 40B. FIGS. 40A and 40B are perspective views of
the outer and inner rim body components, respectively. In this
example, the outer rim body includes two projecting snaps 3911,
3911' that may mate with openings in the inner rim body 4011 (one
of which is shown in FIG. 40B) to secure the two components
together. As described previously, in some variations, the entire
circumference around the main airflow passageway of the inner and
outer rim bodies may interlock, or snap together, rather than just
the two snap fittings shown in this embodiment. However, it may be
advantageous to include snap fittings in only one or more regions
(e.g., preferably two or more opposing regions) of the rim body.
For example, the rim body (both inner and outer rim bodies) may be
fabricated by injection molding. Fabrication of an undercut snap
fitting portion may be simplified by including a pass core in the
design. A pass core is a region near an undercut portion of the
mold form that includes a passageway for a core element to fit, and
thereby help form the undercut region. Two pass core regions 4015,
4015' can be seen in FIG. 40A.
[0171] As mentioned previously, the adhesive nasal devices
described herein may have any appropriate dimensions or shapes.
FIGS. 41A to 41D illustrate one variation of a rim body in which
exemplary dimensions (in inches) are indicated. For the sake of
simplicity, the adhesive holdfast region of the device is not
included in these figures, but would be included as part of the
actual device. FIG. 41A shows a perspective view of a rim body
region. FIG. 41B shows a side view (along the long axis of the
device) of the rim body example shown in FIG. 41A. The maximum
diameter of this inner rim body is 0.56 inches (shown as the length
of the major axis of the inner rim body), while the maximum
diameter of the outer rim body is approximately 0.66 inches (shown
in FIG. 41D as the length of the major axis of the outer rim body).
The height of this rim body is 0.24 inches, and the maximum
diameter of the inner rim body is 0.37 inches, as shown in FIG.
41C. The maximum diameter of the outer rim body of this example is
0.47 inches.
[0172] The dimensions given above are approximate, and may be
varied. In general, the rim body may be of any appropriate size so
that the adhesive nasal device may be comfortably worn by a
subject. For example, the rim body may be larger or smaller, and
the generally elliptical opening of the rim body may be narrower or
wider. In some variations, the size and dimensions may be adjusted
so that the devices may be worn by subject having any size nasal
opening.
[0173] Placement of the adhesive nasal devices may be done in front
of a mirror or can occur without looking at a mirror. Alter
placement of the adhesive nasal devices, the user may test whether
an adequate seal has been created or has been maintained between
the adhesive holdfast and the region in, on, over or around the
nostrils through a variety of methods. In some cases, the user may
place his finger or thumb on the outer rim body in an attempt to
create a seal between the outer rim body and his finger/thumb. On
exhalation for example, it will be clear to the user whether a good
seal has been created between the device and his nasal cavity
because exhalation will be more difficult. In some embodiments of
the device, a sticker or similar adhesive means may be stuck to the
outer rim body, which will serve to obstruct flow of air through
the passageway defined by the outer rim body. During exhalation,
the user will therefore be able to determine whether an adequate
seal exists between the adhesive holdfast and the region in, on,
over or around the nostrils. If a seal does not exist, then the
user can make adjustments to ensure adequate sealing. Once the seal
has been verified, then the user can remove the sticker or other
adhesive means from the outer rim body and commence the use of the
device.
[0174] While the methods and devices have been described in some
detail here by way of illustration and example, such illustration
and example is for purposes of clarity of understanding only. It
will be readily apparent to those of ordinary skill in the art in
light of the teachings herein that certain changes and
modifications may be made thereto without departing from the spirit
and scope of the invention.
* * * * *