U.S. patent application number 11/941913 was filed with the patent office on 2008-06-19 for nasal device applicators.
This patent application is currently assigned to VENTUS MEDICAL, INC.. Invention is credited to Rajiv Doshi, Robert Andrew Howard, Sandrine Lebas, Bryan Loomas, Jeff Nugent, Arthur G. Sandoval, Elliot Sather, Jeffrey W. Servaites.
Application Number | 20080142018 11/941913 |
Document ID | / |
Family ID | 39402516 |
Filed Date | 2008-06-19 |
United States Patent
Application |
20080142018 |
Kind Code |
A1 |
Doshi; Rajiv ; et
al. |
June 19, 2008 |
NASAL DEVICE APPLICATORS
Abstract
Described herein are applicator systems and applicators for
nasal devices, and methods of applying nasal devices. In general,
an applicator system includes a nasal device and one or more of: an
inserter from which the nasal device is released, a handle that is
releasably connected to the nasal device, or an applicator liner
that can be removed after positioning the device relative to the
nasal cavity.
Inventors: |
Doshi; Rajiv; (Palo Alto,
CA) ; Loomas; Bryan; (Los Gatos, CA) ; Sather;
Elliot; (San Francisco, CA) ; Sandoval; Arthur
G.; (San Francisco, CA) ; Nugent; Jeff; (New
York, NY) ; Servaites; Jeffrey W.; (San Francisco,
CA) ; Lebas; Sandrine; (San Francisco, CA) ;
Howard; Robert Andrew; (Palo Alto, CA) |
Correspondence
Address: |
SHAY GLENN LLP
2755 CAMPUS DRIVE, SUITE 210
SAN MATEO
CA
94403
US
|
Assignee: |
VENTUS MEDICAL, INC.
BELMONT
CA
|
Family ID: |
39402516 |
Appl. No.: |
11/941913 |
Filed: |
November 16, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60859715 |
Nov 16, 2006 |
|
|
|
Current U.S.
Class: |
128/207.18 |
Current CPC
Class: |
A61F 5/08 20130101 |
Class at
Publication: |
128/207.18 |
International
Class: |
A61M 15/08 20060101
A61M015/08 |
Claims
1. A nasal device applicator system for applying a nasal device in
communication with a subject's nasal passage, the system
comprising: a nasal device comprising: a passageway, an airflow
resistor in communication with the passageway, wherein the airflow
resistor is configured to inhibit expiration through the passageway
more than inspiration through the passageway, and a holdfast region
at least partially surrounding the passageway; and an inserter for
inserting a nasal device, the inserter comprising: a handle having
a grip region configured to be grasped; a nasal device engagement
portion having at least one surface configured to engage a nasal
device thereagainst, wherein the engagement portion comprises a
cavity configured to hold the nasal device.
2. The system of claim 1, wherein the inserter comprises an ejector
configured to eject the nasal device from the nasal device
engagement.
3. The system of claim 1, wherein the inserter further comprises a
trigger operably connected to an ejector for triggering ejection of
the nasal device.
4. A nasal device applicator system for applying a nasal device in
communication with a subject's nasal passage, comprising: a nasal
device comprising: a passageway through a first body, wherein the
passageway is configured to fluidly connect with a subject's nasal
passage, an airflow resistor in communication with the passageway,
and a holdfast configured to removably secure the nasal device in
communication with the subject's nasal passage; and a handle
releasably connected to the first body of the nasal device, wherein
the handle comprises a grip surface for holding the nasal
device.
5. The device of claim 4, wherein the handle is frangibly connected
to the first body of the nasal device.
6. A nasal device applicator system for applying a nasal device in
communication with a subject's nasal passage comprising: a nasal
device comprising: a passageway through a first body, wherein the
passageway is configured to fluidly connect with a subject's nasal
passage, an airflow resistor in communication with the passageway,
and a holdfast configured to removably secure the nasal device in
communication with the subject's nasal passage; and an applicator
liner comprising: a grip region configured to be grasped by the
subject, a flexible adhesive backing region releasably secured to
the nasal device, and a folded bend region connecting the grip
region and the adhesive backing region; wherein the applicator
liner may be removed from the nasal device to at least partially
engage the holdfast.
7. The system of claim 6, wherein the applicator liner further
comprises an aligner configured to align the passageway of the
nasal device with the subject's nasal passage.
8. The system of claim 7, wherein the aligner comprises a pop-up
aligner.
9. The system of claim 7, wherein the aligner comprises a foam
aligner.
10. The system of claim 6, further comprising a second applicator
liner having: a grip region configured to be grasped by the
subject, an adhesive backing region releasably secured to the nasal
device, and a bend region connecting the grip region and the
adhesive backing region.
11. The system of claim 10, wherein the grip regions of the
applicator liners extend in opposite directions from the passageway
of the nasal device.
12. The system of claim 10, wherein the grip regions of the
applicator liners extend in the same direction from the passageway
of the nasal device.
13. The system of claim 6, wherein the applicator liner is a paper
liner.
14. A nasal device applicator system for applying a nasal device in
communication with a subject's nasal passage comprising: a nasal
device having an airflow resistor configured to be placed in
communication with the subject's nasal passageway and inhibit
expiration more than inspiration; and an applicator liner
comprising: a grip region configured to be grasped by the subject,
an adhesive backing region releasably secured to the nasal device,
a folded bend region connecting the grip region and the adhesive
backing region; and an aligner attached to the applicator liner,
wherein the aligner is convertible between a collapsed position and
an extended position, wherein the extended position is configured
to align the passageway of the nasal device with the subject's
nasal passage.
15. The system of claim 14, comprising a second applicator liner
including a grip region, an adhesive backing region and a folded
bend region.
16. The system of claim 15, wherein the aligner is positioned
between the applicator liner and the second applicator liner.
17. The system of claim 14, wherein the aligner is a perforated
paper aligner, a foam aligner, or a folded paper aligner.
18. A method of applying a nasal device in communication with a
nasal passage, the method comprising: placing a nasal device
applicator system adjacent to the nose, wherein the nasal device
applicator system comprises a nasal device having an airflow
resistor, and an applicator liner having a grip region, a flexible
adhesive backing region releasably secured to the nasal device, and
a folded bend region connecting the grip region and the adhesive
backing region; and removing the adhesive backing region from the
nasal device to expose an adhesive holdfast by pulling the grip
region.
19. The method of claim 18, further comprising placing an aligner
attached to the applicator liner at least partially in the
nose.
20. The method of claim 18, wherein the step of removing the
adhesive backing region from the nasal device comprises sliding the
grip region over the adhesive backing region as the grip region is
pulled.
21. The method of claim 18, further comprising removing a second
adhesive backing region from the nasal device by pulling a second
grip region.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application 60/859,715 (titled "Nasal Devices"), filed Nov.
16, 2006. This provisional patent application is herein
incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] The devices, methods, and kits described herein relate
generally to applicators for 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 US patent applications, each of which is incorporated
herein in its entirety: U.S. patent application Ser. No.
11/298,640, titled "NASAL RESPIRATORY DEVICES" (filed Dec. 8,
2005); U.S. patent application Ser. No. 11/298,339, titled
"RESPIRATORY DEVICES" (filed Dec. 8, 2005); U.S. patent application
Ser. No. 11/298,362, titled "METHODS OF TREATING RESPIRATORY
DISORDERS" (filed Dec. 8, 2005); U.S. patent application Ser. No.
11/805,496, titled "NASAL RESPIRATORY DEVICES" (filed May 22,
2007); U.S. patent application Ser. No. 11/811,339, titled "NASAL
DEVICES" (field Jun. 7, 2007); and U.S. patent application Ser. No.
11/759,916 (field Jun. 7, 2007).
[0004] These patent applications describe nasal respiratory
devices, including devices configured to be applied in, over, or
across a subject's nose to treat a variety of medical diseases or
conditions. Examples of medical conditions that may be treated
include but are not limited to snoring, sleep apnea (obstructive,
central and mixed), Cheyne Stokes breathing, UARS, COPD,
hypertension, asthma, GERD, heart failure, and other respiratory
and sleep conditions. Nasal devices of particular interest are
those that inhibit expiration more than inspiration. These devices
may be placed in communication with a subject's nasal passage(s)
without effecting respiration through the subject's mouth. One
variation of these nasal devices are nasal respiratory devices
configured to induce positive end-expiratory pressure ("PEEP") or
expiratory positive airway pressure ("EPAP"), that are adapted to
be removably secured in communication with a nasal cavity.
[0005] Exemplary nasal devices are described herein, and may
include one or more airflow resistors that inhibit expiration more
than inhalation. These devices may include a passageway with an
opening at a proximal end, and an opening at a distal end, where
the airflow resistor is in communication with the passageway. The
devices typically also include a holdfast that is configured to
removably secure the respiratory device within (or over, or around)
the nasal passage or cavity.
[0006] The previously described nasal devices may be applied
manually by the subject (self-application), or they may be applied
by a medical professional. Self-application of the devices
typically requires using a mirror as a guide, and practice may be
necessary to readily orient the device properly. Proper application
may be critical to securing the nasal device in communication with
the subject's nasal passageway and ensuring proper function. Thus,
it is desirable to provide devices and/or methods that allow simple
and accurate application of nasal devices. Described herein are
applicators, systems including applicators for nasal devices, and
methods of applying nasal devices that may address these
issues.
SUMMARY OF THE INVENTION
[0007] Systems, devices and methods for applying nasal devices are
provided. A system for applying nasal devices generally includes a
nasal device and an applicator. In particular, the applicator may
be an inserter from which the nasal device is released, a handle
that is connected (e.g., releasably connected) to the nasal device,
or an applicator liner that can be removed after positioning the
device relative to the nasal cavity. The system for applying nasal
devices may be used to apply the nasal device around or over a
nasal passage (or nasal passages), within a nasal passage or nasal
passages, or some combination of around, over and/or within a
subject's nasal passage or nasal passages, depending on the
configuration of the nasal device and applicator.
[0008] For example, a system for applying a nasal device in
communication with a subject's nasal passage may include a nasal
device and an applicator configured as an inserter for inserting a
nasal device at least partially within the subject's nasal passage,
where the inserter includes a handle having a grip region
configured to be grasped, and a nasal device engagement portion
having at least one surface configured to engage a nasal device
thereagainst, wherein the engagement portion comprises a cavity
configured to hold the nasal device. Any appropriate nasal device
may be used, particularly a nasal device including a passageway, an
airflow resistor in communication with the passageway (wherein the
airflow resistor is configured to inhibit expiration through the
passageway more than inspiration through the passageway, and a
holdfast region at least partially surrounding the passageway.
[0009] The inserter may also include an ejector configured to eject
the nasal device from the nasal device engagement. In addition, the
inserter may include a trigger that is operably connected to an
ejector for triggering ejection of the nasal device. The trigger
may be any control, including a button, plunger, knob, switch,
etc.
[0010] Also described herein are systems for applying a nasal
device in communication with a subject's nasal passage that include
a nasal device and a handle that is releasably connected to the
first body of the nasal device, wherein the handle comprises a grip
surface for holding the nasal device. A handle that is releasably
connected to a nasal device may be frangibly (e.g., breakably)
connected, screwed on, friction fit, snap fit, or the like, Any
appropriate nasal device may be included as part of the system,
such as a nasal device having a passageway through a first body,
wherein the passageway is configured to fluidly connect with a
subject's nasal passage, an airflow resistor in communication with
the passageway, and a holdfast configured to removably secure the
nasal device in communication with the subject's nasal passage.
[0011] The handle may be an elongate member that projects from the
device. For example, the handle may project from the device by
about half an inch or more (e.g., one inch, two inches, etc.),
allowing the handle to be readily grasped. The handle may be stiff.
In some variations the handle includes an engagement surface for
engaging at least a portion of the nasal device. For example, the
handle may include an engagement surface that engages at least a
portion of the passageway of the nasal device, and/or the holdfast
region of the nasal device.
[0012] Also described herein are systems for applying a nasal
device in communication with a subject's nasal passage that include
a nasal device and an applicator liner, wherein the applicator
liner comprises a grip region configured to be grasped by the
subject, a flexible adhesive backing region releasably secured to
the nasal device, and a folded bend region connecting the grip
region and the adhesive backing region. The applicator liner may be
removed from the nasal device to at least partially engage the
holdfast. The nasal device typically includes a passageway through
a first body, wherein the passageway is configured to fluidly
connect with a subject's nasal passage, an airflow resistor in
communication with the passageway, and a holdfast configured to
removably secure the nasal device in communication with the
subject's nasal passage.
[0013] In some variations, the applicator liner further comprises
an aligner configured to align the passageway of the nasal device
with the subject's nasal passage. For example, the applicator liner
may include a pop-up aligner that can be transitioned from a first
configuration (e.g., a `flat` or substantially `flat` collapsed
configuration) into a second configuration that can be inserted
into the nose to align the nasal device (e.g., an expanded
configuration). The aligner may be a foam aligner.
[0014] The system may also include a second applicator liner that
has a grip region configured to be grasped by the subject. The
second aligner may also include an adhesive backing region
releasably secured to the nasal device, and a bend region
connecting the grip region and the adhesive backing region. The
grip regions of these applicator liners (e.g., the first and second
applicator liners) may extend in opposite directions from the
passageway of the nasal device. In some variations, the grip
regions of the applicator liners extend in the same direction from
the passageway of the nasal device.
[0015] The applicator aligner may be any appropriate material or
materials, such as paper, fabric, polymer, or the like. In general,
the grip region, bend region and adhesive backing region of the
applicator aligner may be formed from a flat or planar material
(e.g., a layer, strip, membrane, etc.). In some variations the
three regions are made of the same material. In some variations, at
least some of the regions are made of different materials. For
example, all three regions may be formed of paper. The adhesive
backing region may be coated with an adhesive, or an adhesive
release material. For example, the adhesive backing region may
include a wax coating.
[0016] Also described herein are systems for applying a nasal
device in communication with a subject's nasal passage that include
a nasal device having an airflow resistor configured to be placed
in communication with the subject's nasal passageway and inhibit
expiration more than inspiration, and an applicator liner having a
grip region configured to be grasped by the subject, an adhesive
backing region releasably secured to the nasal device, a folded
bend region connecting the grip region and the adhesive backing
region; and an aligner attached to the applicator liner, wherein
the aligner is convertible between a collapsed position and an
extended position, and wherein the extended position is configured
to align the passageway of the nasal device with the subject's
nasal passage.
[0017] This applicator system may also include a second (or more)
applicator liner that also includes a grip region, an adhesive
backing region and a folded bend region, as mentioned above. The
aligner may be positioned between two or more applicator liners, or
attached to only one applicator liner.
[0018] In some variations, the aligner is a perforated aligner, a
foam aligner, or a folded aligner. For example, an aligner may be a
pop-up aligner as previously mentioned. In general, the aligner is
configured so that is can be removed when the applicator liner is
removed. Thus, the aligner is connected to an applicator liner
(typically on the grip region, though it may be part of any region
of the applicator liner), and may be pulled from the nose while the
nasal device is held closely adjacent to the nose. For example, the
aligner may be compressible or collapsible so that it can slide
between the aligner and the nose to remove it after the aligner
system is positioned against the subject.
[0019] Also described herein are methods of applying a nasal device
in communication with a nasal passage. For example, the method may
include the steps of: placing a nasal device applicator system
adjacent to the nose (wherein the nasal device applicator system
comprises a nasal device having an airflow resistor and an
applicator liner having a grip region, a flexible adhesive backing
region releasably secured to the nasal device, and a folded bend
region connecting the grip region and the adhesive backing region);
and removing the adhesive backing region from the nasal device to
expose an adhesive holdfast by pulling the grip region. The step of
removing the adhesive backing region from the nasal device may
include the step of sliding the grip region over the adhesive
backing region as the grip region is pulled.
[0020] The method may also include the step of placing an aligner
attached to the applicator liner at least partially in the nose. In
some variations, the aligner is part of the applicator liner (or is
connected to the applicator liner). In other variations, the
aligner is part of the nasal device.
[0021] Additionally or optionally, the method may also include the
step of removing a second adhesive backing region from the nasal
device by pulling a second grip region.
INCORPORATION BY REFERENCE
[0022] All publications 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIGS. 1A and 1B show front and exploded views, respectively,
of an exemplary nasal device.
[0024] FIG. 2A is another exemplary nasal device.
[0025] FIGS. 2B-2D illustrate the manual application of the nasal
device of FIG. 2A.
[0026] FIG. 3A is an applicator system for applying a nasal device
including an inserter.
[0027] FIGS. 3B-3E illustrate application of a nasal device using
the applicator system of FIG. 3A.
[0028] FIG. 4A is an applicator system for a nasal device.
[0029] FIGS. 4B-4D illustrates application of a nasal device using
the applicator system of FIG. 4A.
[0030] FIG. 5A is an applicator system for a nasal device including
a handle configured to engage the nasal device.
[0031] FIGS. 5B-5D illustrate application of a nasal device using
the applicator system of FIG. 5A.
[0032] FIG. 6A is another applicator system for a nasal device
including handle.
[0033] FIGS. 6B-6D illustrate application of a nasal device using
the applicator system of FIG. 6A.
[0034] FIG. 7A is another applicator system for a nasal device
including a handle configured to engage the nasal device.
[0035] FIGS. 7B-7E illustrate application of a nasal device using
the applicator system of FIG. 7A.
[0036] FIG. 8A is a side perspective view of an applicator having a
handle for applying a nasal device. FIG. 8B is a side perspective
view of the applicator of FIG. 8A as part of an applicator system
including a nasal device.
[0037] FIGS. 8C-8E illustrate application of a nasal device using
the applicator system of FIG. 8B.
[0038] FIGS. 9A and 9B are side and top views of one variation of
an applicator system for applying a nasal device including an
applicator liner.
[0039] FIG. 9C is a top perspective view of a system for applying
nasal devices similar to the system of FIGS. 9A and 9B.
[0040] FIGS. 10A and 10B are side and top views of one variation of
an applicator system for applying a nasal device including an
applicator liner.
[0041] FIG. 10C is a top perspective view of a system for applying
nasal devices similar to the system of FIGS. 10A and 10B.
[0042] FIGS. 11A and 11B are side and top views of one variation of
an applicator system for applying a nasal device including an
applicator liner.
[0043] FIG. 11C is a top perspective view of a system for applying
nasal devices similar to the system of FIGS. 11A and 11B.
[0044] FIGS. 12A and 12B are side and top views of one variation of
an applicator system for applying a nasal device including an
applicator liner.
[0045] FIG. 12C is a top perspective view of a system for applying
nasal devices similar to the system of FIGS. 12A and 12B.
[0046] FIG. 13 is an exploded view of one variation of an
applicator system including an applicator liner.
[0047] FIG. 14A is an applicator system including an applicator
liner.
[0048] FIG. 14B-14F illustrates application of a nasal device using
the applicator system of FIG. 14A.
[0049] FIG. 15A is an applicator system including an applicator
liner.
[0050] FIG. 15B-15F illustrates application of a nasal device using
the applicator system of FIG. 15A.
[0051] FIG. 16A is an applicator system including an applicator
liner and a removable aligner.
[0052] FIGS. 16B-16C illustrate retraction and extension of the
aligner from the applicator system of FIG. 16A.
[0053] FIGS. 16D-16E illustrate application of a nasal device using
the applicator system of FIG. 16A.
[0054] FIGS. 17A-17D illustrate operation of another variation of
an applicator system including an applicator liner and a removable
aligner.
[0055] FIGS. 18A-8D show variations of applicator systems including
applicator liners and removable aligners.
[0056] FIGS. 19A-19C illustrate operation of another variation of
an applicator system including an applicator liner and a removable
aligner.
[0057] FIGS. 20A-20C illustrate operation of another variation of
an applicator system including an applicator liner and a removable
aligner.
[0058] FIGS. 21A-21C illustrate operation of another variation of
an applicator system including an applicator liner and a removable
aligner.
[0059] FIG. 22A is a top perspective view of an applicator system
including an applicator liner.
[0060] FIGS. 22B-22F are top perspective views of applicator
systems including applicator liners and removable aligners.
[0061] FIGS. 23A and 23B are perspective views of another variation
of an applicator system including an applicator liner having a
removable aligner.
DETAILED DESCRIPTION OF THE INVENTION
[0062] Described herein are applicator systems and applicators for
nasal devices, and methods of applying nasal devices. In general,
an applicator system includes a nasal device and one or more of: an
inserter from which the nasal device is released, a handle that is
frangibly connected to the nasal device, or an applicator liner
that can be removed after positioning the device against the
subject. These variations are described in sections II through IV,
respectively.
[0063] The nasal devices described herein typically refer to nasal
devices having an airflow resistor that is configured to inhibit
expiration through the nose more than it inhibits inspiration
through the nose. Examples of nasal devices that may be used with
the applicators described herein are provided in section I, below.
However, the applicator systems and methods for applying nasal
devices described herein may be used with virtually any nasal
device that is configured to be worn in, on, or over a subjects
nostril(s) (nasal passage(s)) without covering the subject's
mouth.
[0064] The nasal devices referred to herein may be equivalently
called nasal respiratory devices, respiratory devices, or simply
"devices." A nasal device may be configured to fit in, over and/or
around a single nostril (e.g., a "single-nostril nasal device"), or
in, 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 "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.
[0065] The systems, devices and methods for applying nasal devices
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. As used
in this specification, the singular forms "a," "an," and "the"
include plural reference unless the context clearly dictates
otherwise.
I. Nasal Devices
[0066] Any appropriate nasal device may be used with the
applicators and systems described herein, particularly adhesive
nasal devices, including those described in more detail in FIGS. 1A
and 1B, below.
[0067] A typical nasal device as referred to herein includes: one
or more passageways through which air may pass to enter or exit a
respiratory orifice, an airflow resistor in communication with the
passageway, and a holdfast (e.g., an adhesive holdfast or a
compressible holdfast). The holdfast secures devices to the subject
so that the passageway(s) of the device is in communication with a
subject's nasal passage, and may include a contact surface (e.g.,
an adhesive surface) or pressure-exerting surface (e.g., a foam or
elastomeric surface), or both. Nasal devices having flap valve
airflow resistors may be particularly useful.
[0068] In general, a nasal device may be secured in communication
with a subject's nose, and specifically with one or both of the
subject's nasal cavities. As mentioned, a typical nasal device
includes an airflow resistor that is configured to resist airflow
in a first direction more than airflow in a second direction, and a
holdfast configured to secure the airflow resistor at least
partially over, in, and/or across the subject's nose or nostril.
The holdfast may include a biocompatible adhesive and a flexible
region configured to conform to at least a portion of a subject's
nose.
[0069] For example, a nasal device may be worn by a subject to
modify the airflow thorough one or (more typically) both nostrils.
One or more nasal devices may be secured over, across, and/or
within both of the subject's nostrils so that airflow through the
nostrils passes primarily or exclusively through the nasal
device(s). A nasal device, particularly an adhesive nasal device,
may be completely flexible, or partially rigid, or completely
rigid. For example, the devices described herein may include an
adhesive holdfast region that is at least partially flexible, and
an airflow resistor. The airflow resistor may be flexible, or
rigid.
[0070] A nasal device may be composed of layers, and may therefore
be referred to as a layered nasal device. In one example, a layered
nasal device includes an airflow resistor configured to resist
airflow in a first direction more than airflow in a second
direction, and an adhesive holdfast layer. In some variations, the
airflow resistor is a flap valve layer adjacent to a flap valve
limiting layer, and may include an adhesive holdfast layer
comprising an opening across which the airflow resistor is operably
secured. The airflow resistor may be disposed substantially in the
plane of the adhesive holdfast layer. The adhesive holdfast layer
may be made of a flexible substrate that includes a biocompatible
adhesive.
[0071] A layered nasal device may be composed of separate layers,
and these layers may be separated by other layers, or they may be
adjacent. For example, an adhesive holdfast layer may be itself
formed of layers (optionally: a substrate layer, a protective
covering layer, an adhesive layer, etc), and thus may be referred
to as a layered adhesive holdfast. Similarly, the airflow resistor
may be formed of multiple layers (optionally: a flap valve layer, a
valve limiter layer, etc.), and thus may be referred to as a
layered airflow resistor. In some variations, the layered adhesive
holdfast and the layered airflow resistor share one or more layers.
For example, the flap valves layer and the adhesive substrate layer
may be the same layer, in which the leaflets of the flap valve
layer are cut from the substrate layer material. As used herein, a
"layer" may be a structure having a generally planar geometry
(e.g., flat), although it may have a thickness, which may be
uniform or non-uniform in section.
[0072] In some variations, a nasal device (including an adhesive
nasal device) has a body including a passageway configured to be
placed in communication with a subject's nasal passage. The body
region may be a stiff or flexible body region, and may secure an
airflow resistor therein. In some variations, the body region is at
least partially surrounded by a holdfast (i.e., a planar adhesive
holdfast). The body region may be modular, meaning that it is
formed of two or more component sections that are joined
together.
[0073] In some variations, the adhesive nasal device may further
include a support frame. The support frame may provide structural
support to all or a portion of the nasal device, such as the
flexible adhesive portion. For example, the support frame may
support the adhesive holdfast portion of the device and be
completely or partially removable after the device has been applied
to the subject. In some variations, the support frame remains on
the nasal device after application. In some variations, the support
frame is a support frame layer.
[0074] An adhesive nasal device may also include a tab or handle as
part of the holdfast or body (e.g., rim body region) of the nasal
device. In some variations, this tab or handle is formed of a
region of the layered adhesive holdfast. This tab or handle is
different than the applicator liners and applicators described in
greater detail below, and cannot be used to precisely position the
nasal device relative to the nose after aligning the nasal device
with the nose, as described for many of the applicator systems
herein.
[0075] The various components of the nasal devices described herein
may be made of any appropriate materials, as described in greater
detail below. For example, some device components (e.g., a body
region of a nasal device, portions of the airflow resistor, etc.)
may be made of medical grade plastic, such as Acrylonitrile
Butadiene Styrene (ABS), polypropylene, polyethylene,
polycarbonate, polyurethane or polyetheretherketone. The airflow
resistor may be a flap valve and the flap may be made of silicone
or thermoplastic urethane. The holdfast may include an adhesive
substrate made of silicone, polyurethane or polyethylene. Examples
of biocompatible adhesive on the adhesive holdfast may include
hydrocolloids or acrylics.
[0076] FIGS. 1A and 1B show one example of a nasal device
configured as a layered nasal device. FIG. 1A is a top view of a
layered nasal device that includes a holdfast layer 101 and an
airflow resistor 103. The reverse side of the device shown in FIG.
1A includes an adhesive material (not shown) that may be covered by
a protective covering. In some variations, this protective covering
is (or is connected to) an applicator liner that may be removed
once the device has been positioned, as described below. In
general, the protective covering (which may also be referred to as
a protective liner) can be removed to expose the adhesive before
application of the device. The adhesive holdfast layer may include
an adhesive substrate that may be, for example, a foam backing.
This backing may act as a substrate for an adhesive material. In
some variations, the adhesive substrate is itself adhesive. The
holdfast layer 101 may have different regions, including a
peri-nasal regions surrounding an opening (though which air may
flow), and a tab 105 or grip region forming a tab that may make the
device easier to grasp and remove. Other regions may include
regions of more aggressive and less aggressive adhesive (e.g., more
or less adhesive material), regions of hydrogel material (including
adhesive hydrogels) to help prevent irritation from repeated or
extended use, etc.
[0077] FIG. 1B shows an exploded view of the device of FIG. 1A.
This exploded perspective view illustrates the layers of the
device, including the adhesive holdfast 101 (which may itself be
layered), two layers of airflow resistor, including the flap valve
107 and flap valve limiter 109, and an adhesive ring 111 that may
help attach the flap valve and flap valve limiter to the adhesive
holdfast.
[0078] An adhesive holdfast for a nasal device may comprise any
appropriate material. For 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.).
[0079] In variations in which an adhesive is used (e.g., as part of
the holdfast and/or as part of the applicator liner), 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.
II. Inserters
[0080] In some nasal device variations, the nasal device is
inserted completely or partially in one or both of the subject's
nostrils. For example, FIGS. 2A-2D illustrates manual insertion of
one variation of a nasal device into a subject's nose. The outer
surface of this nasal device 201 is substantially surrounded by a
holdfast region. The holdfast is made of a memory material (e.g., a
foam) that may be compressed, and thereafter expand back toward its
original shape. To insert the device, the subject (or a physician
or other assistant) may compress the holdfast region by rolling it
between the fingers to decrease the diameter of the device. The
compressed holdfast region allows the device to more easily fit
into the subject's nostril, so that it can be inserted as shown.
Once inserted into the nostril, the device (e.g., the holdfast
region) expands back outwards until it contacts the walls of the
nostril, so that it is held snugly in position. An airflow resistor
(e.g., a flap valve) resides in a passageway through the body of
the device (not visible).
[0081] Nasal device insertion may be simplified or improved by the
use of an applicator. For example, an inserter may be used, as
illustrated in FIGS. 3A-3E. The applicator shown in FIG. 3A is
configured as an inserter 301. In general, an inserter includes a
nasal device engagement portion that releasably engages with the
nasal device. For example, a nasal device engagement portion may be
a cavity, opening or channel into which the nasal device fits, so
that it can be placed at least partially in the subject's nose. In
general, and inserter may include an ejector that pushes or
otherwise ejects the nasal device from the inserter and into the
subject's nose. The ejector may include an ejector control (e.g., a
switch, button, knob, etc.) for triggering ejection.
[0082] For example, in FIG. 3A, the inserter 301 includes a channel
305 into which at least one nasal device 201 fits. The nasal device
201 may be ejected from the distal end of the inserter and into a
subject's nose, as illustrated in FIG. 3D. An inserter may include
a tubular body having a passage or cavity into which one or more
nasal device may be held (e.g., and compressed before insertion),
as shown in FIG. 3B. In some variations the inserter comes
pre-loaded with the nasal device. Thus, the distal end of the
inserter may be open. In the example shown in FIG. 3A, the proximal
end includes a plunger 310 (the ejector control) that may be pushed
to eject the nasal device from the inserter. The plunger shown is
slideably disposed within the inserter 301 so that it (piston-like)
can push a nasal device out of the cavity or passage holding the
nasal device. The opening into the inserter (e.g. the passageway
the opens distally) may be smaller in diameter than the relaxed
diameter of the nasal device. Thus, the nasal device may be
compressed to fit within the inserter, and the nasal device can
expand to fit a nostril into which it has been inserted.
[0083] The inserter variation 301 shown in FIG. 3A also includes a
grip (configured as two finger grips 309, 309') which allows the
device to be more easily held so that the plunger at the distal end
can be pushed to eject the nasal device into the subject's nose. In
some variations the device may also include a bias for returning
the plunger (or pusher) distally, allowing another nasal device to
be loaded into to the inserter. In some variations, more than one
nasal device can be loaded (or pre-loaded) and ejected from the
device (allowing the separate release of more than one nasal device
from the inserter). An inserter may be part of a system or kit. For
example, an inserter may be provided pre-loaded with one or more
nasal devices, or it may be manually loaded by a subject, as shown
in FIG. 3B.
[0084] FIGS. 4A-4D shows another variation of an inserter 402 with
a nasal device. In FIG. 4A the inserter is pre-loaded with a device
401. The proximal end of the inserter is configured as a grip
(handle 403) that can be held by the subject. The handle 403 in
FIG. 4A is a tapered grip, however any appropriately shaped handle
(fluted, looped, etc.) may be used.
[0085] As mentioned, inserters for inserting a nasal device (either
a whole-nose or single-nostril nasal device) generally include one
or more engagement regions for releasably securing the nasal
device. An engagement region typically has one or more surfaces
that engage a nasal device. Thus, a nasal device may be friction
fit to an inserter. For example, an inserter may include an
engagement region configured as a cavity or channel (as shown in
FIG. 3A) into which a nasal device is placed until it is ejected
for insertion into a subject's nose. In some variations, the
inserter includes an engagement configured as a post; the walls of
the post may engage with an opening or passage on the nasal
device.
[0086] Although the inserters illustrated above are single-nostril
nasal device inserters, an inserter may be configured as a
whole-nose nasal device inserter that may inserts a whole-nose
nasal device into, over, or around both of a subject's nostrils.
For example, an inserter may have multiple channels or chambers for
parallel delivery of two single-nostril nasal devices into both
nostrils.
[0087] FIG. 4A also illustrates a protective cap or cover 405 that
covers at least a portion of the nasal device. In particular, the
cap 405 may cover at least a portion of the device that is to be
inserted into the subject's nose (e.g., the distal end of the nasal
device). In general, the cap may cover any appropriate portion of
the nasal device (e.g., the entire device, including the holdfast
region, or just a portion of the device). In some variations, the
cap prevents contamination of the device prior to use.
[0088] The cap 405 shown in FIG. 4A is initially attached to (or
formed from) the distal end of the inserter 402. Thus, the cap is
removed to reveal the end of the nasal device 401 (this end of the
nasal device will be inserted into the subject's nostril). In some
variations, the cap 405 is removably secured onto the device,
rather than onto (or as part of) an inserter, as shown in FIG. 4A.
In FIG. 4A, a pull-tab 407 is used to removably secure the cap 405
over the distal end of the device 401. Before inserting the device
into the nostril, a subject first removes the cap by pulling the
pull-tab 407, as shown. In some variations, the cap may help keep
the device sterile or otherwise fresh.
III. Handles
[0089] In some variations, the applicator system includes an
applicator configured to include a handle that is releasably (e.g.,
frangibly) connected to the nasal device so that it can be removed
after applying the device. Handle variations may be particularly
useful with devices that are at least partially inserted into a
subject's nostril(s).
[0090] For example, FIGS. 5A-5D illustrates one variation of an
applicator system including a nasal device and an inserter
configured as a removable handle. In FIG. 5A, the nasal device 503
is adapted to be held on the distal end of inserter 500. In the
example shown, the nasal device has an opening (e.g., opening into
the passageway of the device) into which a post on the inserter 500
fits. The inserter includes a grip region 501 that can readily be
grasped by the subject's fingers, allowing the subject to
manipulate the nasal device and position it within the nostril.
Once the device is in position, the inserter can be removed,
leaving the device in position. In some variation, the nasal device
is first compressed (e.g., as shown in FIG. 2B), so that it fits
and then expands into position in the subject's nostril. In some
variations, the inserter is frangibly connected to the device, so
that it can be broken off of the device after being positioned
within the subject's nostril.
[0091] A nasal device may include a handle or positioner that can
be used to help insert or position the device. FIGS. 6A-6D
illustrate a device 601 having a handle frangibly attached at the
proximal end. In FIG. 6A the handle is an elongate projection 603
that is frangibly attached to the proximal end of the device. This
handle can be disconnected (e.g., by breaking it off) once the
device is inserted, for example, by twisting and pulling it, as
shown in FIG. 6C. In some variations, the handle is a stiff member.
The handle may be formed so that it is easy to grasp. For example,
the handle may be curved, flattened, textured, or otherwise shaped
to enhance grasping. In some variations, the handle is made of the
same material as a portion of the nasal device (e.g., the same
material as the walls of the passageway, etc.).
[0092] An applicator configured as a handle may also be used with a
layered nasal device, as illustrated in FIG. 7A-E. In this example,
the applicator is configured as a handle 701 that includes a seat
707 onto which the nasal device (the layered nasal device 703) may
sit and/or attach. The distal end of the applicator is configured
as an aligner 711 that can insert into the subject's nostril. The
aligner passes through the passageway of the nasal device, as show
in FIGS. 7B and 7C. In this variation, the aligner region 711 is
substantially flat, so that it may pass through the central
passageway of the nasal device. The nasal device includes a flap
valve and flap valve support 722. The aligner 711 passes through
the flap valve and flap valve support 722 without substantially
disrupting them, as shown most clearly in FIG. 7C.
[0093] A nasal device 703 may be releasably held on the handle by
any appropriate releasable fashion. For example, the nasal device
may be held onto the applicator by a weak adhesive. In some
variations, the nasal device is held onto the seat 707 region by an
adhesive that secures to the outer face of the nasal device (e.g.,
the back side of the holdfast). In some variations, the nasal
device is held to the seat 707 region by a mechanical retainer such
as a clasp or other fastener. The connection between the seat
region of the applicator and the nasal device may be relatively
weak, particularly in comparison to the adhesive connection between
the nasal device and the subject's nose.
[0094] In some variations, the nasal device is releasably held onto
the handle by the connection between the passageway and the distal
end of the handle. In FIG. 7A-7E, the nasal device is at least
partly held onto the applicator by friction between the aligner 711
at the distal end of the applicator and the central passageway
(including the airflow resistor) in the nasal device. Thus, the
nasal device is friction fit onto the applicator when the aligner
is pushed through the device.
[0095] The seat region 707 of the applicator handle 701 in FIGS.
7A-7E also includes two leafs or wings 715, 715' that may be
retracted (pulling the adhesive holdfast away from the distal end
of the nasal device) or extended (to push the a nasal device seated
thereon against the nose during application). This is shown in FIG.
7D. Before applying the nasal device against the nose, the seat
region of the applicator may be at least partially retracted 707 by
pulling down on the arms connected to the seat region 715, 715',
casing the seat region to partially collapse, and folding the nasal
device (adhesive holdfast region) away from the distal end of the
applicator 711. Retracting moving at least part of the adhesive
portion of the nasal device away from the distal end of the
applicator forming the aligner 711 may make it easier to apply the
device without interfering with the adhesive holdfast until the
subject is ready to position the nasal device in or over the nose
and secure the adhesive holdfast.
[0096] In operation, the nasal device applicator system shown in
FIG. 7A-7E may be used to apply one or more nasal devices to a
subject's nose. For example, this nasal device applicator may be
re-used. For example, a nasal device may be first mounted on an
applicator having a handle, as shown in FIG. 7A. In this example,
the holdfast of the nasal device 703 is releasably attached to the
seat 707, e.g., by a weak adhesive. The adhesive holdfast region
may include a protective liner 709 that can be removed by peeling
it off, as indicated in FIG. 7B. In FIG. 7C the liner has been
removed, exposing the adhesive holdfast 713.
[0097] Once the adhesive layer is exposed, the aligner may be at
least partially inserted into the nostril, as shown in FIG. 7D. The
handle allows the nasal device to be oriented as necessary before
it is secured to the nose. In the applicator variation illustrated
in FIGS. 7A-7E, four hinged arms form the wings of the seat region
715 and also slideably connect to the handle, so that pushing
distally on the hinged arms causes the seat region to expand
distally, helping to secure the device against the subject's nose.
The adhesive holdfast helps secure it against the nose. Finally, as
shown in FIG. 7E, the applicator may be removed by pulling the
handle away from the nose. The releasable connection between the
nasal device and the applicator releases, leaving the nasal device
attached to the subject's nose. The user may then help further seal
the device manually if necessary.
[0098] FIGS. 8A-8E illustrate another variation of an applicator
that may be used with an adhesive (e.g., layered) nasal device.
FIG. 8A shows a perspective view of the applicator 801 without a
nasal device attached. In FIG. 8A, the applicator includes a handle
region 803 that can be grasped. The handle is folded to present a
nasal device seating surface having two parts 805, 805',
corresponding to the two leafs or wings in the variation shown in
FIGS. 7A-7E. An elongate central shaft 807 passes through the
handle region 803, and ends distally in an aligner region 809. FIG.
8B shows the inserter of FIG. 8A with a nasal device attached. The
nasal device is a layered nasal device that is flexible. The
aligner is again inserted through the passageway and airflow
resistor (e.g., flap valve and flap valve limiter), and the nasal
device is also releasably secured to the seat region 805, 805' of
the handle of the inserter. The handle of the inserter may then be
flattened (bending the nasal device), as shown in FIG. 8B, leaving
the aligner 809 projecting distally. The handle region 803 slides
over the central shaft 807. Thus, a system including the applicator
and the nasal device may be packaged together flat, similar to the
system shown in FIG. 8B.
[0099] In some variations, the applicator can be expanded to
flatten the nasal device (and spread the seating surface 805, 805')
by sliding the handle region up against the central shaft, as
illustrated from FIGS. 8C to 8D.
[0100] In operation, a nasal device applicator system including a
nasal device and an applicator 801, such as the device shown in
FIG. 8A, may be used to apply a nasal device by first grasping the
handle region 803, as shown in FIG. 8B, then positioning the nasal
device with respect to the nose, as shown in FIG. 8C. Positioning
may be aided by inserting the aligner region 809 of the inserter
into the nose. Once the device is aligned, the seating surfaces of
the device may be expanded by pushing up on the handle region, as
shown in FIG. 8D. Finally, the applicator may be withdrawn,
releasing the nasal device, as shown in FIG. 8E.
IV. Applicator Liners
[0101] A nasal device applicator may also be configured as an
applicator liner. An applicator liner may be used in conjunction
with an adhesive nasal device as part of a system for applying a
nasal device. This system typically includes a nasal device having
an adhesive layer or surface for securing the device to the
subject's nose, and the applicator liner may protect the adhesive
layer. Thus, the applicator liner may be connected to the adhesive
layer of the nasal device, or it may be connected to another
protective liner coving the adhesive layer. The applicator liner is
removed to attach the nasal device in, over, or around the
subject's nasal passage. An applicator liner may allow the nasal
device to be positioned against the subject before removal of the
protective liner, which could not be done otherwise (for example,
with other protective liners covering the adhesive device, as in
FIG. 7B).
[0102] An applicator liner typically includes an adhesive backing
region, a grip region and a bend or hinge region. The grip region
is connected to the adhesive backing region by the bend or hinge
region. All three regions may be made of the same material, or they
may be made of different material. The three regions typically form
a continuous layer that is folded, bent or configured to be folded
or bent when applied. In particular, the bend or hinge region is
configured to be bent when applied to the subject, so that the
adhesive backing layer is folded over the grip region through a
fold in the bend region, and at least a portion of the grip region
is layered over the adhesive backing region when the adhesive
backing region is covering the adhesive holdfast portion of the a
nasal device.
[0103] In operation, a nasal device may be applied using an
applicator liner by first orienting the nasal device and placing it
against the nose or nostril, so that the applicator liner contacts
the face, and then pulling the grip region of the applicator liner,
causing removal of the adhesive backing layer, exposing the
adhesive holdfast directly against the skin. Thus, the adhesive
backing layer (and any protective backing layer, if present) is
removed while the device is properly positioned, without requiring
further positioning.
[0104] As mentioned, the protective backing region of the
applicator liner may at least partially cover the adhesive layer of
the adhesive holdfast. The protective backing liner may protect the
adhesive surface. In this variation, the adhesive backing layer is
configured to be removed from the adhesive holdfast without
damaging the adhesive. For example, the adhesive backing region may
be made of a material that is readily releasable from the adhesive
used by the adhesive holdfast (e.g., a silicone coating, a wax
coating, or other low-friction/non-stick coating). In some
variations, the adhesive backing region of the applicator liner is
attached to the protective liner. In this variation, the adhesive
backing region is configured to securely adhere to the protective
liner, so that it is removed with the adhesive backing region. The
adhesive backing region is made of a flexible material.
[0105] The grip region is configured to be grasped and pulled, slid
or otherwise manipulated. Thus, the grip region may extend beyond
the profile of the nasal device (and beyond the adhesive backing
region), so that it can be readily grasped. In some variations, the
grip region is larger than the adhesive backing region. The grip
region may also include holes, handles, or textured regions to
facilitate gripping. In some variations the grip region comprises a
stiff, or relatively inflexible material.
[0106] The bend or hinge region between the protective backing
region and the grip is typically pre-bent. The bend region may have
a scored surface, or may be creased. In some variations, the bend
region is a hinge. The bend region may be reinforced (e.g., to
prevent tearing when the grip region is pulled. As the protective
backing region is removed from the nasal device by pulling the grip
region, the hinge region straightens, and the bend propagates
through the adhesive backing region. Thus, the adhesive backing
region bends back upon itself.
[0107] In some variations the applicator liner includes an aligner
configured to fit at least partially in the subject's nose and
thereby align the nasal device with the subject's nostril(s). The
aligner may be referred to as a removable aligner. In particular,
the applicator liner may include a collapsible aligner that can be
converted between an expanded configuration, in which it projects
from the applicator liner and can insert into the subject's
nostril, and a collapsed configuration, in which it can be removed
from the nostril when the adhesive backing is removed by pulling on
the grip region. A collapsible aligner may allow the nasal device
to be packaged flat or substantially flat. The aligner may be
attached to the applicator liner, or it may be formed from the same
layer of material as all or a part of the applicator liner.
Generally, an aligner is a protrusion that projects perpendicular
to planar axis of a layered nasal device and is configured to fit
at least partially into a subject's nostril. The aligner may be
conical, round, cylindrical, pyramidal, flat, or any other shape
that may be dimensioned to fit at least partially into a subject's
nostril. In some variations the aligner has a cross-section (e.g.,
parallel to the planar axis of the nasal device) that permits it to
further orient the device with respect to the non-circular shape of
the nostril opening. For example, the aligner may have an oval
cross-section, a teardrop shaped cross-section or an asymmetric
cross-section.
[0108] An aligner included as part of an applicator aligner is
typically a removable aligner, a property which distinguishes it
from aligners included as part of a nasal device (including layered
nasal devices). Removable aligners may also be referred to as
collapsible aligners or `pop-up` aligners.
[0109] In some variations, the applicator system includes two or
more applicator liners connected to the same nasal device. For
example, one applicator liner may be attached to half of the
adhesive layer of the nasal device, and a second applicator liner
may be attached to the other half. When multiple applicator liners
are used with the same nasal device, the applicator liners may be
identical, or they may be different. For example in some
variations, a first applicator liner includes an aligner, and the
second applicator liner does not. In some variations, an aligner is
secured between two (or more) applicator liners.
[0110] FIGS. 9A-12C illustrate different variations of applicator
systems including applicator liners. For example, FIG. 9A shows a
side view of an applicator system having two applicator liners 901,
901'. The first applicator liner 901 includes an adhesive backing
region 903 covering (and removably secured over) the adhesive
holdfast 922 of a layered nasal device 920. The applicator liner in
this example may be made of a paper, polymer, fabric, etc. The
surface of the adhesive backing region contacting the adhesive
surface of nasal device holdfast may be a non-stick surface (e.g.,
a silicone surface) that is matched to the adhesive used, so that
the adhesive backing region may be unpeeled from the adhesive
without compromising the adhesive. The non-stick surface typically
requires only a small amount of force to separate from the adhesive
backing region. The adhesive backing region 903 is connected to the
grip region 907 through bend region 905. In particular, the grip
region is oriented substantially parallel to the adhesive backing
region, and the two regions are connected through the bend region.
The grip region and the adhesive backing region are further
configured so that the pulling the grip region (e.g., away from the
nasal device) causes the adhesive backing region to unpeel from the
nasal device's adhesive holdfast. The adhesive backing region
unpeels by progressively bending, starting from the bend region
905, so that the adhesive backing region doubles back over itself.
This configuration allows the nasal device to be held in position
(aligned) against the nose before exposing the adhesive, greatly
simplifying the application of the nasal device and reducing
misalignment.
[0111] FIG. 9B is a bottom view of the nasal device applicator
system of FIG. 9A, showing the first and second applicator liners
901, 901' and the outside surface of the nasal device 920 (that
will face away from the nostril when the device is applied). The
adhesive backing region is not visible in FIG. 9B. In general, the
grip region of the applicator liner 907 is larger than the adhesive
backing layer, as is apparent in FIG. 9A. Thus, the grip region of
the applicator liner 907 extends beyond the edges of the adhesive
backing layer and the nasal device, providing better leverage and a
larger area to grasp when pulling on the grip region to apply the
nasal device.
[0112] FIG. 9C is a three-dimensional view of an applicator liner
without a nasal device. Each applicator liner may be fabricated
from a single piece of material (e.g., coated paper) and applied to
a nasal device either before or during fabrication of the nasal
device. The applicator liner may be formed by folding and/or
cutting to shape the grip region, adhesive backing region and bend
region. In FIG. 9C, the grip region of each applicator liner 901,
901' includes a cut-out region 909 that may facilitate gripping and
pulling the grip region.
[0113] FIGS. 10A-10C illustrate another variation of an applicator
system including an applicator liner. In this example, the
applicator system has only a single applicator liner, and also
includes an aligner. In FIG. 10A, the applicator liner includes an
adhesive backing region 1003 connected to the adhesive holdfast
1022 (or connected to a protective liner on the adhesive holdfast),
a bend region 1005 and a grip region 1007. The grip region 1007
passes around and through the nasal device 1020 and forms an
aligner 1111. In this example, the aligner passes through the nasal
device (e.g., through the passageway and through or around the
airflow resistor). In some variations, the aligner is located on
the upper side of the system and does not pass through the
passageway.
[0114] FIG. 10B shows a partially transparent top view of the
applicator system of FIG. 10A. In this case, the top view shows the
side of the applicator system that will be applied against the
subject's nose. The grip region 1007 extends beyond the adhesive
backing region (and the airflow resistor). To apply a nasal device
using a system such as the system shown in FIG. 10A-10C, the system
is first applied against the subject's nose, and the extended
aligner is positioned in the subject's nostrils. The grip region is
then pulled to remove the aligner and the adhesive backing region,
and to expose the adhesive holdfast, allowing it to attach to the
subject. In some variations, the aligner may be removed first
(e.g., by pulling the grip region of the applicator liner from the
region closer to the aligner). FIG. 10C shows a perspective view of
a similar applicator liner without an airflow resistor.
[0115] FIGS. 11A-11C illustrate another variation of an applicator
system having a single applicator liner. As shown in FIG. 11A, this
variation of an applicator liner includes two adhesive backing
regions 1103, 1103', two bend regions 1105, 1105. and two grip
regions 1107, 1107'. The two adhesive backing regions are connected
(across the bottom of the nasal device in FIG. 11A) by a connector
region 1113. An aligner (not shown) may also be connected to both
(or either) of the grip regions 1107, 1107' over the region
spanning the passageway of the nasal device 1120.
[0116] FIG. 11B shows a bottom view of the system of FIG. 11A
(facing outward when the system is applied to a subject's face),
including the outline of the nasal device 1120. FIG. 11C shows a
perspective view of an applicator liner similar to the applicator
liner shown in FIGS. 11A and 11B.
[0117] FIGS. 12A-12C illustrate another variation of an applicator
system having two applicator liners. FIG. 12A shows a side view of
the applicator system. An adhesive backing region 1203 extends
across the device (and may extend over the passageway of the nasal
device or it may pass around it, as indicated by the dashed lines
1204), and is connected to the grip region 1207 through bend region
1205. The grip region of the second applicator liner 1207' is
visible in FIG. 12B, which is positioned parallel to the grip
region of the first applicator liner 1207. In this variation, the
two applicator liners extend in the same direction from the nasal
device. Thus, the nasal device may be applied without switching
hands, by pulling on both grip regions using the same (e.g.,
right/left) hand, in contrast to the variations shown in FIGS.
9A-9C and 11A-11C, which may require switching hands to pull the
two grip regions.
[0118] FIG. 12C shows a perspective view of an applicator liner
similar to that shown in FIGS. 12A-12B.
[0119] FIG. 13 is an exploded view of one variation of a system
including a nasal device and an applicator liner. FIG. 13 also
illustrates one method in which an applicator system may be
fabricated, by combining (e.g., serially) different layers forming
the nasal device and applicator liner. In FIG. 13, the nasal device
is a layered nasal device having an airflow resistor that is
configured as a flap valve 1303 and a flap valve limiter 1305. The
nasal device may be assembled by layering the flap valve 1303
across a passageway formed in a substrate 1302 (shown as cut out
region 1301). The substrate forms the substrate for the adhesive
holdfast. For example, the substrate may be a thin layer of
polyurethane coated with an acrylic adhesive on at least one side
(e.g., the side facing away from the flap valve 1303). The flap
valve 1303 layer may be secured to the substrate by an adhesive
mount (double-sided adhesive ring 1307), and the flap valve limiter
1305 may be secured over the flap valve by securing the edge region
of the limiter between the adhesive mount and a second adhesive
mount (single-sided adhesive ring 1309). The adhesive mounts may
also be formed of polyurethane coated with an acrylic adhesive. Two
applicator liners 1313, 1313' may then be secured to the adhesive
side of the substrate 1302. In this example the applicator liners,
including a grip region 1315, bend region 1317 and adhesive backing
region 1319, are formed from a single folded layer of material
(e.g., coated paper). Other arrangements, including other nasal
devices or other applicator liners, may be substituted, and
additional components (e.g., aligners on either or both the nasal
device and/or the applicator liner) may also be included.
[0120] Prior to assembly of the system, the component parts may be
fabricated and at least partially pre-assembled. For example the
applicator liner may be die-cut and folded into the appropriate
configuration. Subassemblies of the nasal device may also be
pre-assembled. For example, the flap valve 1303, mounts 1307, 1309
and flap valve limiter 1305 may be pre-assembled.
[0121] FIG. 14A is a bottom perspective view of another variation
of an applicator system for a nasal device similar to that shown in
FIG. 9B, above (showing the side of the applicator system that will
face away from the subject when the system is applied to the
subject's nose). In FIG. 14A, the nasal device is a nasal device
having a rim body (similar to those describes in pending U.S.
patent application Ser. No. 11/811,339, titled "Nasal Devices",
herein incorporated by reference in its entirety). Thus, the rim
body of the nasal device may act as an aligner for this system. The
`bottom` of the device (visible in FIG. 14A) faces away from a
subject when the nasal device is worn.
[0122] FIGS. 14B-14F illustrate application of a nasal aligner. In
FIG. 14B, the nasal aligner is first placed near the subject's
face, and aligned with the nasal passage. The nasal device (e.g.,
the bottom side of the nasal device) is held in position with one
hand, while the second hand is used to pull the grip region of one
of the applicator liners, as shown in FIG. 14C. The applicator
liner allows the removal of the protective liner (in this case, the
adhesive backing region of the applicator liner) to be removed
while the device is positioned in the nose by pulling the grip
region in the plane approximately parallel to the subject's face.
In FIG. 14D, the applicator liner has been removed from half of the
nasal device. The other half of the nasal device is applied by
switching hands, holding the nasal device with the second hand and
pulling on the grip region of the second applicator liner with the
first hand, as shown in FIG. 14E. After both applicator liners have
been removed, as shown in FIG. 14F, the adhesive holdfast is
secured to the subject's nose, placing the nasal device in
communication with the nasal passage. A second nasal device may be
applied to the other nasal passage in the same manner.
[0123] FIG. 15A shows another system for applying a nasal device,
and FIGS. 15B-15F illustrate application of a nasal device using
this system. The applicator system shown in FIG. 15A includes two
applicator liners and a removable aligner 1501 (shown as two
prongs). This aligner is attached to only one of the applicator
liners. The aligner is extended by folding the system up along the
axis formed between the two applicator liners, as shown in FIG.
15B. After extending the aligner, the applicator system is placed
near the nose, and the removable aligner is placed in the nostril,
as shown in FIG. 15C. Once the device is positioned relative to the
subject's nostril, one of the applicator liners can be removed with
one hand, while the other hand maintains the position of the device
in the nose, as shown in FIGS. 15D and 15E. Thereafter, the second
applicator liner can be removed by again pulling on the grip region
(in a plane parallel to the plane of the nostril opening), as shown
in FIG. 15F.
[0124] The system for applying nasal devices described herein may
also be applied using one hand. FIGS. 12A-12C, described above,
illustrates one variation of a system for delivering nasal devices
including an applicator liner that may be applied to the subject's
nose without switching hands. Typically, systems including two or
more applicator liners in which the grip regions project from the
device in a single direction (e.g., to the right or to the left of
the nasal device, as shown in FIG. 12A) may be removed using one
hand, usually while the other hand holds the nasal device in
position against the subject's nose. In contrast, systems including
two or more applicator liners that have grip regions project from
the device in different directions (e.g., as shown in FIG. 9A) may
require switching hands to completely apply the nasal device.
[0125] Another variation of a system for applying a nasal device
including an applicator liner is shown in FIG. 16A. In this
variation, two applicator liners are illustrated. One of the
applicator liners (referred to as an adjustable applicator liner
1605) includes an aligner region 1603 that is configured to
collapse or pop-up depending on the position of the grip region of
the aligner. This is illustrated in FIGS. 16B and 16C. Pulling the
applicator liner 1605 to the right (away from the midline of the
nasal device), causes the aligner to first extend, as shown in FIG.
16B, and eventually collapse, as shown in FIG. 16C. In this
variation, the system for applying the nasal device may be packaged
flat, because the aligner may be collapsed flat by either pushing
the adjustable applicator liner 1605 in, or by pulling it out.
FIGS. 16D and 16E illustrate application of the nasal device. In
virtually every other way, the basic steps for applying nasal
device with this applicator system (aligning the applicator system
with the nasal cavity, positioning against the face, pulling on the
applicator liner) are identical to those described above for the
applicator systems shown in FIGS. 14A-15F.
[0126] FIGS. 17A-17D illustrate another nasal device applicator
system having a removable aligner that can be packaged flat, and
expanded before applying the nasal device. As shown in FIG. 17A,
the device can be flattened for packaging, including the removable
aligner. Pulling the grip region of one of the applicator liners
expands the removable aligner, as shown in FIG. 17B. In some
variation, the applicator liners are pre-biased so that they open
to expand the aligner when the system is removed from packaging.
For example, a spring may be used to pre-bias them, or the elastic
properties of the applicator liner may bias the liner. In this
example the removable aligner is connected to both the applicator
liners, as shown in FIG. 17C. However, pulling on one of the
applicator liners during application (simulated in FIG. 17D) will
release the aligner from one of the applicator liners, allowing it
to be removed even when positioned in a nostril.
[0127] Removable aligners may be configured in many different ways.
A removable aligner may be attached to one or more applicator
liners. Generally a removable aligner is configured to switch
between a collapsed and an expanded configuration. In the collapsed
configuration, the aligner may be removed from the subject's nose
without substantially disturbing the alignment. A system including
a removable aligner may also be packaged with the aligner in the
collapsed configuration. FIGS. 18A to 22D illustrate different
variations of systems for applying nasal devices including
applicator liners with removable aligners.
[0128] FIGS. 18A-18D illustrate variations of applicator liners
having pop-up aligners. For example, FIG. 18A shows a nasal device
applicator system having two applicator liners (a first liner and a
second liner) and a removable aligner that is configured as a
pop-up aligner. In this variation, the removable aligner is formed
from the same material as the first applicator liner. A strip of
material spanning the adhesive backing region, the bend region and
a portion of the grip region is cut to form the removable aligner.
The strip is essentially displaced towards the grip region to form
the aligner, and one end of the strip 1801 forms a portion of the
adhesive backing layer that is attached to the adhesive holdfast of
the nasal device. The strip is folded in at least two places 1803,
1805 to form the pop-up, removable aligner.
[0129] The pop-up aligner in FIG. 18A is also configured to be
stored flat. The grip region of the first applicator liner may fold
over the second applicator liner, folding the pop-up aligner
between them. The first applicator liner is folded along the bend
region. During storage (e.g., when packaged), the grip region of
the first applicator liner is folded, and the removable aligner is
substantially flat. Before applying the device to the subject's
nose, the grip region of the first applicator liner is folded
(along the bend axis) back over the adhesive backing layer of the
first applicator liner, expanding (`popping up`) the aligner. The
device may then be applied as described above (e.g., for FIGS.
14A-14F).
[0130] The systems for applying nasal devices shown in FIGS. 18B
and 18C are also configured to be stored flat, by folding one of
the grip regions of the applicator liner along the bend region to
collapse the removable aligners. The system of FIG. 18B is very
similar to FIG. 18A, except that the material forming the removable
aligner is frangibly connected to both the first and the second
applicator liners. Thus, pulling one or the other applicator liners
will tear or break the aligner (or the connection of the aligner to
an applicator liner) as the applicator liner is removed. In FIG.
18C the removable aligner is formed by a strip of material that is
attached to the grip region of the first applicator liner, is bent
1811 to form the distal (inserted) end of the aligner, and passes
through a band cut in the second applicator liner that guides the
strip. Pushing or pulling the strip forming the aligner can expand
the aligner (as shown in FIG. 18C) or collapse it flat.
[0131] FIG. 18D illustrates another variation of a pop-up aligner
that is formed by a separate folded material that is connected to
both the first and second applicator liners. The removable aligner
1813 expands into a pyramidal shape, but can collapse flat between
the grip regions of the first and second applicator liners when one
is folded over the other.
[0132] FIGS. 19A-19C illustrate another variation of a removable
pop-up aligner similar to the aligner in FIG. 18D. A folded strip
of material is attached to the grip regions of both applicator
liners. The aligner is collapsed by folding one of the grip regions
over the other, as shown in FIG. 19A. The aligner can be expanded
by separating the two grip regions, as shown in FIG. 19B. In the
expanded configuration the removable aligner can be inserted into
the nose to align the nasal device. The folded strip forming the
aligner can be separated from one of the applicator liners when an
applicator liner is removed from the system, as illustrated in FIG.
19C.
[0133] FIGS. 20A-20C are similar to 19A-19C, however in this
example the aligner is perforated in its middle (along the fold)
2001. This forms a frangible connection that can be torn when one
of the applicator liners is removed from the nasal device during
application, as illustrated in FIG. 20C. Similarly, FIGS. 21A-21C
illustrate a variation in which the aligner is formed by two pieces
of material that are joined by a weak adhesive, as illustrated in
FIG. 21B. Removing one or both applicator liners separates the two
pieces, allowing the aligner to be removed as the nasal device is
applied.
[0134] FIGS. 22A-22F illustrate other variations of systems for
applying nasal devices including applicator liners. FIG. 22A is a
system that does not include a removable aligner, but does include
an aligner that is part of the nasal device (e.g., the body region
of the nasal device). This aligner remains in the subject's nostril
while the device is worn. FIG. 22B-22F are all variations of
systems for applying nasal devices having removable aligners that
are attached to the applicator liner. For example, the removable
aligner of FIG. 22C is a foam aligner that is compressible; the
aligner is formed of two foam parts, each attached to an applicator
liner. The aligner may be removed when the applicator liners are
removed by compressing and collapsing the foam so that it can fit
between the nasal device and the subject's nose or face. Another
example of a foam aligner is shown in FIGS. 23A and 23B. Other
compressible materials may also be used as the aligner, in addition
to foamed materials. The materials forming the removable aligner
attached to applicator liner do not need to be compressible. For
example, any low-profile aligner may be withdrawn by pulling the
grip region of the applicator liner, so long a it is sufficiently
thin (e.g., low-profile) so that it can be slid between the
subject's face (nostril) and the nasal device when the applicator
system is held against the subject's face over the subject's
nostril.
[0135] Systems for applying nasal devices including removable
aligners may be applied by the methods described above. If the
removable aligner is a pop-up aligner, the aligner may be first
expanded. The aligner may be expanded in some variations by
separating the grip regions of the applicator liners. In other
variations, the aligner may be expanded by pushing or pulling on a
tab or strip connected to the aligner. Once the aligner is
expanded, the assembly forming the applicator system is placed
adjacent to the subject's face. The aligner is then placed at least
partially in the subject's nose, and the nasal device applicator
system is held in position. The one or more applicator liners can
then be removed, removing the aligner. Removing an applicator liner
may collapse the aligner. For example, in some variations, the
aligner is frangible and is torn or otherwise removed from one or
the other applicator liners as an applicator liner is pulled away
from the nasal device.
[0136] As mentioned above, the various components of the applicator
systems described herein (such as the applicator liner, aligner,
and the nasal device), may be made of virtually any appropriate
materials. Although specific exemplary materials have been provided
in some examples, these devices are not limited to these materials
unless the context indicates. For example, all or a portion of the
applicator systems described herein may include a shape memory
element or elements. For example, a holdfast, airflow resistor,
body region forming the passageway, inserter, handle, or applicator
liner or aligner may include a shape memory alloy. Any convenient
shape memory material that provides for flexibility and resumption
of configuration following removal of applied force may be employed
in these embodiments. For example, shape memory alloys may be used.
A variety of shape memory alloys are known, including those
described in U.S. Pat. Nos. 5,876,434; 5,797,920; 5,782,896;
5,763,979; 5,562,641; 5,459,544; 5,415,660; 5,092,781; 4,984,581;
the disclosures of which are herein incorporated by reference in
their entirety. The shape memory alloy that is employed should
generally be a biocompatible alloy. Biocompatible alloys may
include nickel-titanium (NiTi) shape memory alloys sold under the
Nitinol.TM. name by Memry Corporation (Brookfield, Conn.). Also of
interest are spring steel and shape memory polymeric or plastic
materials, such as polypropylene, polyethylene, etc.
[0137] Rubber and polymeric materials may also be used as part (or
all) of the nasal devices and/or applicators described herein.
Injection moldable materials such as polyether block amide (e.g.,
PEBAX.RTM.), and the like may be used. Materials which 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 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).
[0138] Biocompatible materials may be used, particularly for those
portions of the system such as the nasal device holdfast, which may
contact a user. In addition to some of the materials described
above the biocompatible materials may also include 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.
[0139] 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. Further, the drawings and illustrations
provided herein may not be to scale; in particular, certain
features may be exaggerated or minimized.
* * * * *