U.S. patent application number 15/114650 was filed with the patent office on 2016-12-01 for facial interface and headgear system for use with ventilation and positive air pressure systems.
This patent application is currently assigned to Human Design Medical, LLC. The applicant listed for this patent is Human Design Medical, LLC. Invention is credited to Veaceslav Gheorghe Arabagi, Andrew Havens Gosline, Donald Harrison, Aaron Jonah Kapelus.
Application Number | 20160346496 15/114650 |
Document ID | / |
Family ID | 55073687 |
Filed Date | 2016-12-01 |
United States Patent
Application |
20160346496 |
Kind Code |
A1 |
Harrison; Donald ; et
al. |
December 1, 2016 |
FACIAL INTERFACE AND HEADGEAR SYSTEM FOR USE WITH VENTILATION AND
POSITIVE AIR PRESSURE SYSTEMS
Abstract
The present disclosure relates to a mask assembly system that
has an adjustable headgear system with an inflatable cushion
connected to the positive air pressure supply for conforming to a
user's face.
Inventors: |
Harrison; Donald; (Park
City, UT) ; Gosline; Andrew Havens; (Cambridge,
MA) ; Arabagi; Veaceslav Gheorghe; (Cambridge,
MA) ; Kapelus; Aaron Jonah; (Jamaica Plain,
MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Human Design Medical, LLC |
Allston |
MA |
US |
|
|
Assignee: |
Human Design Medical, LLC
Boston
MA
|
Family ID: |
55073687 |
Appl. No.: |
15/114650 |
Filed: |
July 16, 2015 |
PCT Filed: |
July 16, 2015 |
PCT NO: |
PCT/US15/40741 |
371 Date: |
August 1, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62025073 |
Jul 16, 2014 |
|
|
|
62025077 |
Jul 16, 2014 |
|
|
|
62049994 |
Sep 12, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0666 20130101;
A61M 16/0694 20140204; A61M 2205/0216 20130101; A61M 16/22
20130101; A61M 16/0066 20130101; A61M 16/1045 20130101; A61M
2016/0661 20130101; A61M 16/0605 20140204; A61M 16/0622 20140204;
A61M 16/0683 20130101; A61M 16/0875 20130101; A61M 16/0816
20130101 |
International
Class: |
A61M 16/06 20060101
A61M016/06; A61M 16/22 20060101 A61M016/22; A61M 16/08 20060101
A61M016/08 |
Claims
1. (canceled)
2. (canceled)
3. (canceled)
4. A mask and headgear assembly comprising: a mask frame, the mask
frame further comprising: a core having an inlet connector for
receiving a supply of pressurized gas from a delivery tube; a right
arm extending from the core; and a left arm extending from the
core, wherein each of the right and left arms form an associated
air pathway through each respective arm, wherein each arm includes
an first aperture for supplying the supply of pressurized gas to a
patient's airways; a headgear interface located about a distal end
of each arm, the headgear interface being configured to be attached
to a headgear assembly, the headgear interface further comprising a
second aperture for communicating a portion of the supply of
pressurized gas to an interior portion of the headgear assembly;
wherein the headgear assembly includes an inflatable cushion
configured to inflate in response to the supply of pressurized gas
delivered through the second aperture; and wherein the inflatable
cushion includes a plurality of CO.sub.2 washout vents provided on
an exterior wall.
5. The mask and headgear assembly of claim 4, wherein the plurality
of CO.sub.2 washout vents are apertures formed from a knife-coated
silicone layer formed on a flexible material.
6. A mask and headgear assembly comprising: a mask frame, the mask
frame further comprising: a core having an inlet connector for
receiving a supply of pressurized gas from a delivery tube; a right
arm extending from the core; and a left arm extending from the
core, wherein each of the right and left arms form an associated
air pathway through each respective arm, wherein each arm includes
an first aperture for supplying the supply of pressurized gas to a
patient's airways; a headgear interface located about a distal end
of each arm, the headgear interface being configured to be attached
to a headgear assembly, the headgear interface further comprising a
second aperture for communicating a portion of the supply of
pressurized gas to an interior portion of the headgear assembly;
and wherein the mask frame includes a sealing lip configured to
abut against and seal against a corresponding aperture in the
headgear assembly.
7. The mask and headgear assembly of claim 5, wherein the headgear
assembly includes a female receiving portion having a secondary
seal.
8. A mask and headgear assembly comprising: a mask frame, the mask
frame further comprising: a core having an inlet connector for
receiving a supply of pressurized gas from a delivery tube; a right
arm extending from the core; and a left arm extending from the
core, wherein each of the right and left arms form an associated
air pathway through each respective arm, wherein each arm includes
an first aperture for supplying the supply of pressurized gas to a
patient's airways; a headgear interface located about a distal end
of each arm, the headgear interface being configured to be attached
to a headgear assembly, the headgear interface further comprising a
second aperture for communicating a portion of the supply of
pressurized gas to an interior portion of the headgear assembly;
and wherein the headgear assembly includes a female receiving
portion having a secondary seal.
9. (canceled)
10. (canceled)
11. (canceled)
12. (canceled)
13. (canceled)
14. A mask and headgear assembly comprising: a mask frame, the mask
frame further comprising: a core having an inlet connector for
receiving a supply of pressurized gas from a delivery tube; a right
arm extending from the core; and a left arm extending from the
core, wherein each of the right and left arms form an associated
air pathway through each respective arm, wherein each arm includes
an first aperture for supplying the supply of pressurized gas to a
patient's airways; a headgear interface located about a distal end
of each arm, the headgear interface being configured to be attached
to a headgear assembly, the headgear interface further comprising a
second aperture for communicating a portion of the supply of
pressurized gas to an interior portion of the headgear assembly;
and wherein the right and left arms pivot about the core.
15. (canceled)
16. (canceled)
17. (canceled)
18. (canceled)
19. (canceled)
20. (canceled)
21. (canceled)
22. (canceled)
23. (canceled)
24. (canceled)
Description
PRIORITY CLAIM
[0001] Priority is claimed to co-pending U.S. Provisional Patent
Application Ser. No. 62/025,073, filed Jul. 16, 2014, 62/025,077,
filed Jul. 16, 2014, and 62/049,994 filed Sep. 12, 2014 which are
hereby incorporated herein by reference in their entirety.
COPYRIGHT STATEMENT
[0002] A portion of the disclosure of this patent application
document contains material that is subject to copyright protection
including the drawings. The copyright owner has no objection to the
facsimile reproduction by anyone of the patent document or the
patent disclosure as it appears in the Patent and Trademark Office
file or records, but otherwise reserves all copyright rights
whatsoever.
BACKGROUND OF THE INVENTION
[0003] 1. Field of the Invention
[0004] The present invention relates to medical devices, and, more
particularly to mask and headgear portions of air delivery devices
that assist with the delivery of gas to the nasal passages of
users. These mask and headgear systems and devices may be used with
positive airway pressure [PAP] such as continuous positive airway
pressure devices [CPAP], automatic positive airway pressure devices
[APAP], variable positive airway pressure devices [VPAP], and
bi-level positive airway pressure devices [BPAP].
[0005] 2. Description of the Prior Art
[0006] Nasal pillows exist to be partially inserted into a user's
nare and form a seal with the nare(s), which allows for the user to
breathe from the ventilator or PAP device. However, nasal pillows
have been known to not necessarily form the best seals for all
users, put unnecessary pressure on the nare region when held in
place by a mask system, and limited on flexibility. Masks have also
tended to be bulky and shift when wearing them at night. Designs
are being made to make masks lighter and more secure.
[0007] A need therefore exists for a nasal pillow that is
interchangeable with a mask system, which is flexible and adaptable
to a user's nare and facial profile, and reduces pressure applied
on the nare region while in use. A need also exists for an
adjustable mask and headgear system that conforms to a user's head
and facial features while being comfortable and securely attaching
the nasal pillows to a user's nares.
SUMMARY OF THE INVENTION
[0008] Contemplated herein is a facial interface and headgear
system for use with ventilation and positive air pressure systems.
The facial interface can include a system and assembly configured
to provide a portion of continuous airway pressure to a user's
airways.
[0009] In one embodiment a mask and headgear assembly is comprised
of a mask frame, where the mask frame further comprises: a core
having an inlet connector for receiving a supply of pressurized gas
from a delivery tube; a right arm extending from the core; and a
left arm extending from the core, wherein each of the right and
left arms form an associated air pathway through each respective
arm, wherein each arm includes an first aperture for supplying the
supply of pressurized gas to a patient's airways; and a headgear
interface located about a distal end of each arm, the headgear
interface being configured to be attached to a headgear assembly,
the headgear interface further comprising a second aperture for
communicating a portion of the supply of pressurized gas to an
interior portion of the headgear assembly.
[0010] The mask and headgear assembly can further include an
inflatable cushion configured to inflate in response to the supply
of pressurized gas delivered through the second aperture.
[0011] The inflatable cushion can include a deformable core
configured to be selectively deformed and retain a deformed
shape.
[0012] The inflatable cushion can include a plurality of CO.sub.2
washout vents provided on an exterior wall. The plurality of
CO.sub.2 washout vents can be formed from knife-coating a silicone
layer over a flexible material, where the material was previously
gas permeable and the silicone layer formed thereon or partially
embedded therein helps trap in oxygen, but enables CO.sub.2 to
escape through the silicone knife coated material.
[0013] The system can further include a nasal pillow assembly
configured to connect to each of the arms over the respective
apertures. In this manner each nasal pillow assembly can be
configured to communicate the supply of pressurized gas from the
air pathway through each nasal pillow assembly and to a user's
nostrils.
[0014] Optionally, a headgear interface can be provided which is
located about a distal end of each of the right and left arms, the
headgear interface being configured to be attached to a headgear
assembly.
[0015] In some embodiments the right and left arms can be offset
with respect to one another so as to be non-coaxial, or in other
words angled with respect to one another. In yet other embodiments
the nasal pillow assembly includes a nasal pillow rotatable about a
nasal pillow axis.
[0016] In some embodiments the headgear interface provided at each
distal end of the left and right arms can include a deformable
sidepiece configured to attach to its respective arm. This
deformable sidepiece can be configured to attach to the arm at
various angular positions with respect to the axis of its
respective right or left arm. In some embodiments the deformable
sidepiece as a planar member which is configured to be selectively
deformed out of plane so as to conform about the facial contours of
a user, for example, to hold a shape corresponding to the curvature
of the user's cheeks. It will be appreciated that this deformable
sidepiece represents a potentially uncomfortable situation wherein
the deformable sidepiece could be pressed into the user's face. As
such, a malleable cover, such as fabric or neoprene can be provided
and configured to encompass the deformable sidepiece.
[0017] In some embodiments the nasal pillow assembly can further
include an attachment sleeve configured to engage with each of the
right and left arms respectively and encompass the associated
aperture. The attachment sleeve can thus be configured to provide
rotation of each pillow assembly about its respective arm without
obstructing flow through the respective aperture. In some
embodiments the attachment sleeve includes a radial hose connection
for interfacing with its respective nasal pillow. This radial hose
connection can be configured to allow for axial adjustable along
the radial hose.
[0018] In yet other embodiments the attachment sleeve can be
provided with one or more washout vents. Alternatively, washout
vents can be provided at distal ends of the right and left arms, or
about the core, or in any combination of the same.
[0019] In some embodiments the nasal pillows can formed in the
shape of a cone, the cone having an elliptical cross section. In
this manner as the pillows are rotated about a central pillow axis,
or about the axis of the radial hose the relative orientation of
each pillow can be adjusted so as to match the nostrils or nares of
the user.
[0020] In some embodiments the headgear can include a plurality of
adjustable straps so as to be adjustable to provide a desired
retention force or a desired sealing force as well as be
customizable so as to match the specific contours of the user's
head. In some embodiments one strap can be configured to extend
over a crown of the user's head, and in other embodiments a strap
can be configured to extend behind a rear portion of the user's
head, or both.
[0021] The deformable sidepiece of the mask and headgear assembly
can attach to each arm using an interference interconnector
comprising a male connection and a female connection located
selectively about either the deformable sidepiece or the
interference interconnector.
[0022] In some embodiments the inlet connector can include a swivel
connector so as to provide a certain degree of flexibility with
respect to an air supply hose and the mask frame provided about the
user's face, for example if the user shifts while sleeping.
[0023] In some embodiments alternative core or mask frames can be
devoid of an attachment sleeve or have arms that pivot about the
core.
[0024] In some embodiments the core can be provided with a heat
moisture exchange (HME) component 326 located within the central
portion. Alternatively, the HME 326 can be provided within the air
supply hose, or within the right or left arms
[0025] In yet additional embodiments a method of providing a
pressurized stream of air using the device described above is
contemplated. The method can include various steps, in varying
combinations including: providing a supply of pressurized gas to a
delivery tube; receiving the supply of pressurized gas at an inlet
of a core; selecting a pair of properly sized nasal pillows from a
plurality of various nasal pillows, each nasal pillow having a
pillow aperture formed at a top end; affixing the pair of nasal
pillows to the core over the respective apertures of each arm such
that the air pathway extends through the pillow aperture of each
pillow; and positioning the nasal pillows such that the air pathway
extends to a user's respiratory system through the nasal pillows
through the user's nares.
[0026] The method can also include the steps of: affixing a
headgear assembly to distal ends of both the right and left arms;
and rotating the nasal pillows such that the elliptical cross
section coincides with the user's particular nare shape, wherein
each of the nasal pillows has an elliptical axial cross
section.
[0027] These and other embodiments form some of the various
inventive concepts as contained herein. The individual embodiments
as described are not intended to be limiting, but are intended only
as illustrative of the various inventive concepts and are not
intended to be limiting except as claimed below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] The foregoing and other objects, aspects, features, and
advantages of the disclosure will become more apparent and better
understood by referring to the following description taken in
conjunction with the accompanying drawings, in which:
[0029] FIG. 1 illustrates a perspective view of a facial interface
and headgear system for use with ventilation and positive air
pressure systems;
[0030] FIG. 2 illustrates a front exploded view of the facial
interface and headgear system for use with ventilation and positive
air pressure systems of FIG. 1;
[0031] FIG. 3 illustrates a core or mask frame structure for use
with the facial interface and headgear system for use with
ventilation and positive air pressure systems of FIGS. 1-2;
[0032] FIG. 4 illustrates an exploded view of the core or mask
frame structure of FIG. 3 illustrating a swivel adapter and heat
moisture
[0033] FIG. 5 illustrates an exemplary headgear system attached to
the core or mask frame structure of FIG. 3;
[0034] FIGS. 6A-E illustrate various exemplary nasal pillows and
configurations for use with the ventilation and positive air
pressure systems of FIGS. 1-2;
[0035] FIG. 7 illustrates a top view of the ventilation and
positive air pressure systems of FIGS. 1-2;
[0036] FIG. 8 illustrates an exemplary embodiment of a potential
headgear connection interface for use with the ventilation and
positive air pressure systems of FIGS. 1-2;
[0037] FIG. 9 illustrates another exemplary embodiment of a
potential headgear connection interface for use with the
ventilation and positive air pressure systems of FIGS. 1-2;
[0038] FIG. 10 illustrates a fitting for the potential headgear
connection interface of FIG. 9;
[0039] FIG. 11 illustrates another alternative fitting for the
potential headgear connection interface of FIG. 9;
[0040] FIG. 12 illustrates a perspective view of an assembly
procedure using the headgear connection interface of FIG. 9;
[0041] FIG. 13 illustrates a perspective view of an assembly
procedure of yet another exemplary embodiment of a potential
headgear connection interface for use with the ventilation and
positive air pressure systems of FIGS. 1-2;
[0042] FIG. 14 illustrates an alternative perspective view of the
assembly procedure of the embodiment of FIG. 13;
[0043] FIG. 15 illustrates a perspective view of a user wearing yet
another exemplary embodiment of a potential headgear connection
interface for use with the ventilation and positive air pressure
systems of FIGS. 1-2;
[0044] FIG. 16 illustrates a perspective view of the assembled
exemplary embodiment of a potential headgear connection interface
of FIG. 15;
[0045] FIG. 17 illustrates a perspective exploded view of the
exemplary embodiment of a potential headgear connection interface
of FIG. 15;
[0046] FIG. 18 illustrates a perspective view of an assembly
procedure of the exemplary embodiment of a potential headgear
connection interface of FIG. 15;
[0047] FIG. 18 illustrates a perspective view of another portion of
the assembly procedure of the exemplary embodiment of a potential
headgear connection interface of FIG. 15;
[0048] FIG. 20 illustrates a perspective view of a user wearing yet
another exemplary embodiment of a potential headgear connection
interface for use with the ventilation and positive air pressure
systems of FIGS. 1-2;
[0049] FIG. 21 illustrates a perspective exploded view of a yet
another exemplary embodiment of a potential headgear connection
interface for use with the ventilation and positive air pressure
systems of FIGS. 1-2;
[0050] FIG. 22 illustrates a perspective view of yet another
partially assembled exemplary embodiment of a potential headgear
connection interface for use with the ventilation and positive air
pressure systems of FIGS. 1-2;
[0051] FIGS. 23A-C illustrate exploded side and front views,
respectively, of an alternative core or mask frame assembly for use
with the ventilation and positive air pressure systems of FIGS.
1-2;
[0052] FIG. 24 illustrates an alternative embodiment of a mask
frame having adjustable arm portions;
[0053] FIG. 25 illustrates a perspective end view of a frame and a
partial view of an inflatable strap assembly in accordance with yet
another embodiment of a headgear connection interface:
[0054] FIG. 26 illustrates a perspective end view of a frame and a
partial view of an inflatable strap assembly having a deformable
core in accordance with yet another embodiment of a headgear
connection interface;
[0055] FIG. 27 illustrates a perspective end view of a frame and a
partial view of an inflatable strap assembly having a deformable
core in accordance with yet another embodiment of a headgear
connection interface; and
[0056] FIGS. 28A-B illustrate a front view of a user wearing any
one of the embodiments as shown in FIGS. 25-27 illustrating an
uninflated and inflated configuration of an inflatable side
strap.
[0057] Reference will now be made to the exemplary embodiments
illustrated, and specific language will be used herein to describe
the same. It will nevertheless be understood that no limitation of
the scope of the invention is thereby intended though the exemplary
embodiments discussed, but the examples are for purposes of
illustration of the inventive concepts.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0058] To provide an overall understanding of the systems, devices,
and methods described herein, certain illustrative embodiments will
be described. Although the embodiments and features described
herein are frequently described for use in connection with CPAP
apparatuses, systems, and methods, it will be understood that all
the components, mechanisms, systems, methods, and other features
outlined below may be combined with one another in any suitable
manner and may be adapted and applied to other PAP apparatuses,
systems, and methods, including, but not limited to, APAP, VPAP,
and BPAP apparatuses, ventilators, systems, and methods.
[0059] The present application seeks to provide a solution to the
aforementioned problems by creating an adjustable, comfortable,
mask assembly system that has interchangeable components,
light-weight, and adaptable to individual users.
[0060] FIGS. 1-2, and 7 illustrate various views of a positive
airway pressure assembly 10 configured to aid in supplying a stream
of positive pressure air to the airways of a patient wearing the
assembly 10. The assembly includes a mask frame 300 having a pair
of nasal pillow assemblies 100 attached thereto. The mask frame 300
receives a stream of pressurized air from a blower (not shown),
which can be attached to the mask frame 300 by means of a supply
hose 30. The air then travels through the mask frame 300 through
apertures 354 and through the associated pillow assemblies 100 to
provide air into the nostrils or nares of the user wearing the
positive airway pressure assembly 10.
[0061] The positive airway pressure assembly 10 can optionally
include a headgear system 20 configured to provide a sealing force
between the individual pillow assemblies 100 and the nostrils of
the user. In certain cases the headgear system 20 can also provide
a positioning force between the mask frame 300 and the maxilla of
the user or patient, for example on the portion of the face between
the upper lip and below the nose. It will be appreciated that the
headgear assembly 20 can be formed of a resilient material, or be
adjustable through various means so as to conform to the individual
user's contours which, understandably, vary between various users.
Further, the headgear assembly 20 can also be configured to affix
to distal ends of the mask frame 300 and can be configured to
provide a certain degree of rotational adjustment between the mask
frame 300 and the headgear 20.
[0062] As shown in various figures, headgear 20 may be comprised of
multiple straps, such as one configured to go over the top portion
of a user's head, and second strap going generally about the back
portion of a user's head. Either strap can have an adjustment
mechanism, no adjustment mechanism, formed of resilient material,
inflexible or formed in a variety of configurations including
having a cover or sleeve formed over a portion of the straps or no
cover or sleeve.
[0063] FIGS. 3-5 illustrate various aspects of the mask frame 300.
It will be appreciated that air supply travels as shown by pathway
arrows 60 through the tube, through a central portion of the mask
frame 300 and exits apertures 354. The apertures can have a pair of
lips or shoulders 358 upon or about which the pillow assembly 100
from FIGS. 1-2 can rest and seal. The mask frame 300 can have a
central portion 310 and left and right arms extending therefrom,
362 and 364 respectively. Each of the right and left arms can be
provided with a headgear connection interface 400 about their
respective distal ends. The headgear connection interface allows
for variation in the types of connectors used for connecting the
headgear (not shown here).
[0064] In some embodiments, the right and left arms can be provided
as co-axial, i.e. straight with respect to each other, so as to
reduce fabrication complexity and cost. Alternatively, and as shown
herein the right and left arms can be angled with respect to one
another so as to better conform in shape to the front of the user's
face, which understandably typically has a curved profile.
[0065] In addition the mask frame or core 300 can be provided with
an inlet connector 322 about the central portion. The inlet
connector can be configured to swivel coaxially with the air supply
hose 30. In addition the core or mask frame 300 can be provided
with a heat moisture exchange (HME) component within the core about
the inlet connector 322. The HME can also be provided in
alternative locations as well as in multiples, for example a pair
of HME units could be provided within the nasal pillow assemblies
or more proximal the apertures 354.
[0066] In particular, FIG. 5 illustrates how the headgear can be
affixed to the core or mask frame 300 through the use of one
embodiment of a headgear connection interface 400. This particular
embodiment illustrates a swivel connection 322 which allows the
headgear to rotate with respect to the distal ends of the mask
frame 300.
[0067] FIGS. 6A-E illustrate various views of a nasal pillow
assembly 100 for use with the nasal mask frame as shown in FIGS.
3-5. The nasal pillow assembly 100 can include a nasal pillow 110
and attachment sleeves 150. The attachment sleeves 150 in this
embodiment are configured to slide over the mask frame 300 and seal
over apertures 354 by having an inner shoulder 359 which abuts
against and slidingly seals against the shoulders 358 as shown in
FIG. 3. In this manner, the air delivered to the mask frame can be
redirected through the pillow assembly 100 and into the user's
nares. The attachment sleeve 150 can be provided with an attachment
portion 154 for receiving the pillow 110. The attachment portion
154 can be provided with a series of ribs or channels configured to
interface with a plurality of annular ribs 114 and/or channels
provided on an annular tube (or stem) forming an attachment portion
of each pillow 110.
[0068] In particular FIG. 6D illustrates an air conform bladder 162
which can be formed as part of the attachment sleeve 150. The air
conform bladder 162 can be formed of a malleable or flexible
material, and have a hollow cavity defined thereby which receives
pressurized gas from the interior of the attachment sleeve 150 when
attached to the mask frame (not shown here). In this manner, as the
pressure rises or is increased when the system is on, the air
conform bladder becomes partially inflated and acts similar to a
balloon. The air conform bladder 162 can then rest against the
maxilla and provide an air cushioned interface between the mask and
the user's face. In some embodiments, the air conform bladder is
formed directly on the core frame, as part of the nasal pillows
devoid of an attachment sleeve, or a part of the attachment sleeve
itself that can form in part the nasal pillow assembly.
[0069] The meshing or integration of the annular ribs 114 with the
channels or ribs 154 provided in the attachment sleeve allows for
incremental adjustment of the relative height or radial positioning
of the nasal pillow 110 with respect to the attachment sleeve 150,
and thereby the mask frame or core, by changing which ribs are
meshed with which respective channel. In this manner each nasal
pillow can translate axially with respect to a pillow axis thus
providing a first degree of freedom 104A. Additionally, the ribs
and channels can slide with respect to one another when twisted
about the pillow axis providing a second degree of freedom 104B
which is rotational about a central axis of each pillow. Finally,
the interior shoulder 359 can also slide with respect to its
relative exterior shoulder of the mask frame 358 as shown in FIG.
3. so as to allow the sleeve, and the associated pillow to rotate
about the axis of the right or left arm thus providing a third
degree of freedom 104C. This sealing lip 359 allows for the
attachment sleeve 150 to rotate about the mask along the mask frame
axis thus providing a third degree of freedom 104C. Additional
flexibility in the system can come from the nasal pillow itself.
For example, the base portion of the nasal pillow, which functions
like a trampoline or pivoting spring allows for the head or conical
portion of the nasal portion to tilt or pivot about the stem or
annular tube. This is made possible by varying the thickness or
durometer of the base portion with respect to the head or conical
portion and the stem or annular tube.
[0070] FIG. 8 illustrates another embodiment of the headgear
connector 400A which utilizes a contoured barb 404 and a
corresponding barb receiver 408. The barb can have a plurality of
shapes including semi-spherical shapes as shown, or any other
conceivable geometric shape with a correspondingly shaped receiver.
In this embodiment the receiver is configured to be deformable or
resilient so as to expand to initially accept the barb 404 when
press therein. After the barb 404 is pressed into the receiver, an
interference fit is formed and the barb will resist, to a certain
degree, being pulled from the receiver 408.
[0071] FIGS. 9-12 illustrate yet another embodiment of a headgear
connector 400C which utilizes a connector 412 which has two ends,
one for attaching to the distal end of the mask frame or core 300,
and the other for interfacing with the headgear 20. The headgear
interfacing end is provided with an aperture 414 configured to
receive a clip barb 416. The core end of the connector 412 has
another corresponding aperture 416 through which a plug 428 can be
provided so as to affix the connector 412 to the core 300. The two
ends of the connector can be configured to rotate with respect to
one another, as illustrated between FIGS. 10 and 11, so as to
provide additional comfort to the user and allow the strap of the
headgear to rest naturally with respect to the distal ends of the
mask frame.
[0072] FIGS. 13-14 illustrate yet another embodiment of a headgear
connection interface 400E in which a strap of the headgear 20 is
provided with a simple annular washer end 436. A plug 432 can then
be provided the annular washer end 436 and have an interference fit
with a corresponding plug adapter end 434 provided about the distal
ends of the mask frame 300.
[0073] FIGS. 15-19 illustrate various views of yet another
embodiment of a headgear connection interface 400G in which a strap
of the headgear 20 is provided with a deformable side piece 500
provided between the headgear 20 and the mask frame 300. The
deformable sidepiece 500 can attach to each arm using an
interference interconnector comprising a male connection 518 and a
female connector 514 as well as attached to the headgear 20 by
means of a male connector 522 and female aperture 524. It will be
appreciated that the relative male of female connectors or
apertures can be located selectively about either the deformable
sidepiece or the interference interconnector. As shown, the
deformable sidepiece 500 can be configured to attach to the each
respective arm at various angular positions, or in other words
rotate with respect to the mask frame 300. Additionally, the
deformable sidepiece 500 can be provided initially as a planar
member, which can then be selectively deformed out of plane so as
to conform about the facial contours of a user. In this manner the
deformable side piece can be shaped so as to follow the contours of
the user's cheeks without touching them, or alternatively touch the
cheeks but equally distribute any pressure applied thereto.
[0074] It should be understood that of the various connectors
described herein, some versions are configured to have the headgear
connect to the mask frame in a fixed connection (non-rotating),
some allow for free rotation connection (no interference or stops),
and some have interference mechanisms to selectively rotate or be
positioned angularly about the mask frame.
[0075] In one instance the deformable sidepiece is formed of a
shape retaining plastic. This plastic can have a general
deformation characteristic along a single plane while maintaining
some rigidity in a second plane. Other types of deformable plastic
can be deformed along multiple planes. In one embodiment the
cross-section of the deformable sidepiece is rectangular. The
curvature of the deformable sidepiece along a particular plane (see
FIGS. 15 and 17) can be preset or formed to transfer the force of
the head gear system around certain features of the user's face.
Since user's faces have three-dimensional features the deformable
sidepiece can then conform to the remaining features of the user's
face. Thus, allowing a customizable headgear system that maintains
a balance between rigidity and flexibility, while being conformable
to a user's unique facial features.
[0076] It will be further appreciated that the deformable sidepiece
500 might cause a certain degree of discomfort to a user. As such,
a malleable sleeve 510 can be provided which encompasses the
deformable sidepiece 500. The malleable sleeve can be formed of
fabric, silicone, or other comfort increasing material having any
number of desired attributes, such as heat transfer rate,
elasticity, softness, etc.
[0077] FIG. 20 illustrates a deformable sidepiece 500A which has a
silicone shell 560 having a malleable shape retaining core.
[0078] FIG. 21 illustrates yet another headgear connection
interface 400H which includes a keyed post 440 located about a
distal end of the mask frame 300 and keyed opening 442 which slid
through the keys to an inner portion 442 with a smaller diameter
which allows free rotation. The assembly can only be separated when
angularly positioned correctly so as to align the keys. It will be
appreciated that the keys should be provided out of phase from each
other in normal angular positions between the mask frame 300 and
the headgear 20 while being worn. In order to ensure that the keyed
components do not separate unintentionally, a cap 444 can be
provided which prevents unintentional separation.
[0079] FIG. 22 illustrates another keyed embodiment, similar to
that of FIG. 21. having an alternative strap portion 442A, which
covers the hardware, i.e. the keyed post 440 and the associated
connector inside the strap 442A, so as to improve comfort and
reduce the likelihood of catching the mask on something while
shifting during sleep and thus tearing the mask off the user's
face. This embodiment utilizes a similar plug 444A to cover the
connection from the outside of the strap 442A and thus prevent
premature decoupling or catching.
[0080] FIGS. 23A-C illustrate an alternative embodiment of a mask
frame 600. This mask frame is more rigid and instead of interfacing
with the nasal pillow assembly 100 using a rotatable sleeve, the
arms of mask frame 600 are rigid and do not provide rotation of the
pillow assemblies 100 about the respective arm portions. This
embodiment provides increased stability for headgear attachment and
facial placement purposes. In this embodiment the nasal pillows are
still permitted to rotate about the pillow's central axis, wherein
the pillows can have an elliptical cross section.
[0081] In this embodiment a plurality of washout vents 604 can be
provided in a central portion of the mask frame 600. Additionally,
the headgear 20 can be attached to the mask frame 600 using any of
the previously discussed headgear attachment interfaces.
[0082] FIGS. 6E, 21 and 23A all show various placements of CO.sub.2
washout vents. Being at a bottom portion of the pillow assembly
100, on the attachment sleeve 150 as shown by 158 in FIG. 6E, at
the ends of the right or left arms, as shown by 159 in FIG. 21, and
on the mask frame at a central portion as shown by 604 in FIG. 23A.
It will be appreciated that any one of these placements either
alone or in any combination is within the scope of the present
invention. The CO.sub.2 washout vents may be comprised of a
material that has silicone knife coated across it. In other
embodiments the CO.sub.2 vent is a plurality of holes that have
been formed therein.
[0083] It is contemplated that the wall thickness and/or durometer
of the nasal pillow portion can be varied. In one exemplary
embodiment the flat underside portion which connects the bell like
top of the nasal pillow to the tube portion may have either a
thinner wall portion then the flared bell like portion and tube
portion or may have a lower durometer value. This thinner wall or
lower durometer value allows the tube connected to the flat
underside to collapse into the bell like portion when pressure is
exerted on the bell like portion. When the nasal pillows are formed
of the silica material or silken like material the nasal pillow
returns to its original state when no pressures being exerted on
it. Again this allows for the flared bell like portion to pay that
about the tube portion when being inserted into the nasal region.
The collapse ability again helps reduce pressure exerted onto the
nasal region while at the same time helping to find an optimal
position that forms a good seal between the nasal pillow and each
of the nostrils.
[0084] It will be appreciated that in certain embodiments the
headgear can cause a direct tightening of the pillows into the
nostrils of the user, thus having a direct correlation to a sealing
force. In yet other embodiments, for example, when providing an air
conform bladder, as discussed with reference to FIG. 7, the force
applied by the headgear can be partially directed through the air
conform bladder and into the maxilla to provide a primarily a
positioning force, where the sealing force can be adjusted by
changing the relative placement of the mask frame on the face,
which is held by the positioning force. In yet additional
embodiments, the nasal pillows can be caused to enter into, and
hold their relative position by the elastic properties of the
pillows being exerted onto the inner walls of the user's nostrils
or nares without the use of headgear altogether.
[0085] FIG. 24 illustrates another alternative core or mask frame
300A where the right and left arms are arranged to pivot or rotate
about the center of the core. In some versions the right and left
arms can form a 180 degree angle between each other, making the
core look more like "T" shape, each arm can then be repositioned to
form a "Y" shape. The angles between each arm can range from
several degrees to greater than 180 degrees. However, most users
will have the arms angled somewhere less than 180 degrees. This
additional degree of freedom presented by this alternative core
300A can also work with the attachment sleeves, rotatable nasal
pillows as described above for a customizable fit.
[0086] In some versions the rotation of the arms is a constant and
consistent motion, which can be enabled by a pressure sliding fit
between the pivoting arm and the core. In other versions discrete
angled positions are enabled by each arm locking into a groove or
channel or other distinct locking mechanism. Some of the rotation
mechanisms can function similar to the locking and rotation
features of the headgear interface assembly.
[0087] FIGS. 25-28 illustrate yet another alternative embodiment of
a mask frame 300B-D. In these embodiments the mask frame 300B-D can
have one of more apertures 710 and 710A respectively, the apertures
being provided about distal ends of the right and left arms of the
mask frame 300B-D so as to provide fluid communication between the
air supply channel within the mask frame 300B-D and a pair of air
cushion straps 750 provided about the distal ends of their
respective right and left arms. The air cushion straps 750 can have
an annular wall which forms a cavity 740 therein, each air cushion
strap 750 having an aperture 754 which provides an interface
through which the apertures 710 or 710A can provide fluid
communication from the air channel of the mask frame 300B-D into
the cavity 740. The mask frame 300B-D can have a sealing lip 714
which interfaces with an edge of the aperture 754 to create a seal
between the air cushion straps 750 and the mask frame 300B-D such
that positive air pressure provided to an interior portion of the
mask frame is communicated into the cavity 740 causing the air
cushion strap to expand and provide a cushioning effect increasing
the comfort of the strap which may rest against the user's face in
certain configuration.
[0088] In some embodiments the air cushion straps can be provided
with a plurality of CO.sub.2 washout vents 768 along an exterior
wall, such that CO.sub.2 can be vented out of the system through
the air cushion straps. These CO.sub.2 washout vents 768 can be
provided by knife coating or otherwise applying a silicone layer
over a flexible and permeable material, which then allows for the
escape of CO.sub.2 but do not cause a significant drop in pressure
of the system such that the required therapeutic pressure is lost
or that the air cushion straps do not inflate.
[0089] It will be appreciated, and as particularly as shown between
FIGS. 25 and 26 that the air cushion straps 750 can be provided as
completely hollow and as a unitary material as shown in FIG. 25, or
alternatively as shown in FIG. 26, having a deformable shape
retaining core 758, being similar in construction to the deformable
sidepiece as discussed above. The deformable shape retaining core
can be provided in a core portion or otherwise provided within the
air cushion cavity, or within its own cavity, such that deforming
the deformable shape retaining core can provide the entire air
cushion strap with a certain desired contour or shape. It will be
understood that in preferred embodiments the deformable shape
retaining core can be provided along an exterior inner wall such
that the air cushion straps inflate in a direction toward the
user's face thus creating an air cushion there between. It will
thus be further understood that holes can be selectively provided
through the deformable shape retaining core such that they
communicate with the CO.sub.2 vents provided therethrough.
[0090] FIG. 27 illustrate yet another embodiment alternative
embodiment of a mask frame 300D being similar to the embodiment of
FIGS. 25-26. In this embodiment the mask frame 300D can also have
one of more apertures 710A, the apertures being provided about
distal ends of the right and left arms of the mask frame 300D so as
to provide fluid communication between the air supply channel
within the mask frame 300D and a pair of air cushion straps 750A
provided about the distal ends of their respective right and left
arms. The air cushion straps 750A can have an annular wall which
forms a cavity therein, each air cushion strap 750A having an
aperture 754A which provides an interface through which the
apertures 710A can provide fluid communication from the air channel
of the mask frame 300D into the interior cavity of each strap. The
mask frame 300D can have a deeper sealing lip 714A which interfaces
with an edge of the aperture 754A or a female receiving portion as
shown, the female receiving portion having an additional seal 762,
which can be rubber or some other malleable material, which is
provided therein so as to create a seal between the air cushion
straps 750A and the mask frame 300D. In some embodiments a
corresponding seal 762A can be provided about the sealing lip 714A
so as to increase the seals effectiveness. In this manner positive
air pressure provided to an interior portion of the mask frame 300D
is communicated into the cavity 740, thus causing the air cushion
strap 750A to expand or otherwise inflate and provide a cushioning
effect. This inflated cushion increases the comfort of the strap
which may then conform to and rest against the user's face in
certain configuration and equally distribute any pressure. The air
cushion strap 750A can similarly be provided with a plurality of
optional CO.sub.2 washout vents provided therein, which can be
formed from applying silicone over the flexible material forming
the cushion strap and allows the CO.sub.2. In some instances the
silicon is applied using a knife-coating method.
[0091] FIG. 6E. 21, 23A, and 25A all show various placements of
CO.sub.2 washout vents. Being at a bottom portion of the pillow
assembly 100, on the attachment sleeve 150 as shown by 158 in FIG.
6E, at the ends of the right or left arms, as shown by 159 in FIG.
21, on the mask frame at a central portion as shown by 604 in FIG.
23A, or on the side straps as shown by 768 in FIG. 25A. It will be
appreciated that any one of these placements either alone or in any
combination is within the scope of the present invention. The
CO.sub.2 washout vents may be comprised of a material that has
silicone knife coated across it. In other embodiments the CO.sub.2
vent is a plurality of holes that have been formed therein.
[0092] In some alternative embodiments the CO.sub.2 washout vents
can be formed on the sidepiece of the headgear system where the
sidepiece does not inflate. In one version a flexible tube runs
along the sidepiece that has CO2 washout vents formed therein, but
does not expand (or negligibly expands) with the positive air
pressure being supplied to the system. Silicone and other rubber
like materials tend to be more soluble to CO2 and repel oxygen and
other gas molecules.
[0093] While the forgoing examples are illustrative of the
principles of the present invention in one or more particular
applications, it will be apparent to those of ordinary skill in the
art that numerous modifications in form, usage and details of
implementation can be made without the exercise of inventive
faculty, and without departing from the principles and concepts of
the invention. Further, discussion with regard to any of the
specific features is intended to be for illustrative purposes, with
the understanding that any feature discussed herein can be used in
combination with any number of other features in any combination
from any of the various embodiments. Accordingly, it is not
intended that the invention be limited, except as by the claims set
forth below.
* * * * *