U.S. patent application number 15/206664 was filed with the patent office on 2016-11-03 for adjustable nasal prong and headgear assembly.
This patent application is currently assigned to Respcare, Inc.. The applicant listed for this patent is Respcare, Inc.. Invention is credited to Louis J. Collazo, Norman Hansen.
Application Number | 20160317776 15/206664 |
Document ID | / |
Family ID | 44654932 |
Filed Date | 2016-11-03 |
United States Patent
Application |
20160317776 |
Kind Code |
A1 |
Collazo; Louis J. ; et
al. |
November 3, 2016 |
ADJUSTABLE NASAL PRONG AND HEADGEAR ASSEMBLY
Abstract
The invention is directed to a ventilation interface, which
includes a cannula having one or more nasal prongs, a ventilation
tube connected to the cannula and headgear. The cannula is secured
onto the patient through one or more arced couplers positioned
between the cannula and headgear. The cannula has a first side
wall, a second side wall and a top wall which form a reservoir. The
top wall includes a first portion, a second portion and a notch
positioned between the first portion and second portion. The
ventilation tube includes one or more bleed ports and provides
breathable gas to a patient. The headgear includes a first strap
and a second strap. The first strap includes a first portion and
second portion that contains two or more slots to connect the
second strap. Each portion of the first strap includes an inner
layer and an outer layer.
Inventors: |
Collazo; Louis J.; (Pompano
Beach, FL) ; Hansen; Norman; (Highland Beach,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Respcare, Inc. |
Coconut Creek |
FL |
US |
|
|
Assignee: |
Respcare, Inc.
Coconut Creek
FL
|
Family ID: |
44654932 |
Appl. No.: |
15/206664 |
Filed: |
July 11, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12731803 |
Mar 25, 2010 |
9387300 |
|
|
15206664 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0816 20130101;
A61M 16/0057 20130101; A61M 16/0666 20130101; A61M 16/06 20130101;
A61M 16/0683 20130101; A61M 16/0875 20130101; A61M 16/0605
20140204; A61M 16/0825 20140204; A61M 16/0611 20140204; A61M
2205/0216 20130101; A61M 2205/42 20130101 |
International
Class: |
A61M 16/08 20060101
A61M016/08; A61M 16/00 20060101 A61M016/00; A61M 16/06 20060101
A61M016/06 |
Claims
1-23. (canceled)
24. A respiratory interface comprising: a cannula having at least
one coupler; at least one nasal prong coupled with the cannula; and
a headgear having at least one connector adapted to be attached to
the at least one coupler of the cannula; and wherein an angle of
the at least one nasal prong relative to the headgear is varied by
a relative position between the connector and the coupler.
25. The respiratory interface of claim 24, wherein the at least one
nasal prong is located on a top wall of the cannula.
26. The respiratory interface of claim 24, wherein the at least one
coupler includes at least one female sleeve.
27. The respiratory interface of claim 24, wherein the at least one
coupler is on a side wall of the cannula.
28. The respiratory interface of claim 24, wherein the at least one
connector of the headgear includes at least one male tine.
29. The respiratory interface of claim 28, wherein the at least one
male tine includes at least one position indicator.
30. The respiratory interface of claim 24, further comprising a
ventilation tube coupled to the cannula.
31. The respiratory interface of claim 30, wherein the ventilation
tube is coupled to the cannula via a ball-and-socket connector.
32. The respiratory interface of claim 24, wherein the respiratory
interface further includes at least one bleed port.
33. The respiratory interface of claim 24, wherein the at least one
nasal prong is removably coupled to the cannula.
34. The respiratory interface of claim 24, wherein the at least one
nasal prong includes at least one sealing portion.
35. The respiratory interface of claim 24, wherein the at least one
nasal prong includes an adjustable upper portion with an opening
located at a distal tip of the nasal prong.
36. A respiratory interface comprising: a cannula having at least
one coupler; at least one nasal prong coupled with the cannula; and
a headgear having at least one connector adapted to be slidably
inserted into the at least one coupler of the cannula; and wherein
a position of the cannula relative to the headgear is accomplished
by varying an insertion depth of the connector into the
coupler.
37. The respiratory interface of claim 36, wherein the at least one
nasal prong is coupled with a top wall of the cannula.
38. The respiratory interface of claim 36, wherein the at least one
coupler of the cannula includes at least one female sleeve.
39. The respiratory interface of claim 36, wherein the at least one
connector of the headgear includes at least one male tine.
40. A respiratory interface comprising: a cannula having at least
one female coupler: at least one nasal prong coupled with the
cannula; and a headgear having at least one male coupler adapted to
be slidably inserted into the at least one female coupler along a
curved path.
41. The respiratory interface of claim 40, wherein the at least one
nasal prong is coupled to a top wall of the cannula.
42. The respiratory interface of claim 40, wherein the at least one
female coupler includes at least one female sleeve.
43. The respiratory interface of claim 40, wherein the at least one
male coupler includes at least one male tine.
Description
FIELD OF THE INVENTION
[0001] This invention is directed to nasal prong and headgear
assemblies for use when delivering breathable gas in treating
various respiratory issues including, but not limited to, sleep
apnea and in other forms of assisted respiration. More
specifically, the invention relates to a headgear capable of
pivotally attaching with the cannula of the nasal prong through one
or more arced couplers.
BACKGROUND OF THE INVENTION
[0002] Ventilation interfaces are used for various applications.
One such application involves current treatments for sleep apnea.
Sleep apnea is a common sleep disorder characterized by sustained
pauses in breathing during sleep. The disorder occurs in both
infants and adults. Each episode, known as an apnea, can last more
than ten seconds and results in blood oxygen desaturation. A
clinical diagnosis of sleep apnea is defined as five or more
episodes per hour. There are three types of sleep apnea: central,
obstructive, and complex.
[0003] Obstructive sleep apnea (OSA) constitutes the most common
form of sleep apnea. OSA is a medical condition that includes
repeated, prolonged episodes of cessation of breathing during
sleep. During a period of wakefulness, the muscles of the upper
part of the throat passage of an individual keep the passage open,
thereby permitting an adequate amount of air (which contains
oxygen) to flow to the lungs. During sleep, the throat passage
narrows due to relaxation of the muscles. In individuals having a
normal sized throat passage, the narrowed throat passage remains
open enough to permit a sufficient level of oxygen to flow into the
lungs. However, in individuals with smaller sized throat passages,
the narrowed throat passage prohibits adequate amounts of oxygen to
flow into the lungs.
[0004] In addition, an obstruction, such as a relatively large
tongue, an occlusion in the upper respiratory track or an
odd-shaped plate can also prohibit a sufficient amount of oxygen to
flow to the lungs--thus also resulting in OSA. OSA can result in a
variety of medical conditions including daytime drowsiness,
headache, weight gain or loss, limited attention span, memory loss,
poor judgment, personality changes, lethargy, inability to maintain
concentration and/or depression.
[0005] Other medical conditions can also prevent individuals,
including adults and infants, from receiving an adequate amount of
oxygen to the lungs. For example, an infant who is born prematurely
can have lungs that are not developed to an extent necessary to
receive adequate amounts of oxygen. Further, prior to, during,
and/or subsequent to certain medical procedures and/or medical
treatments, an individual can be unable to receive an adequate
amount of oxygen. Under these circumstances, it is known to use a
ventilation interface to apply a positive pressure to the throat of
the individual, thereby permitting an adequate amount of oxygen to
flow into the lungs.
[0006] In known ventilation interfaces, oxygen and/or room air
containing oxygen is delivered through the mouth and/or nose of the
individual. The most common form of positive pressure treatment for
OSA is use of a continuous positive airway pressure (CPAP) device.
A CPAP device forces a pressurized breathable gas into the
patient's respiratory track and allows air to pass the
obstruction(s) and/or occlusion(s). Other forms of positive
pressure delivery exist, such as bi-Level positive airway pressure
(BiPAP) in which a relatively higher positive pressure is
maintained during inspiration and a relatively lower positive
pressure is maintained during expiration, and intermittent
mechanical positive pressure ventilation (IPPV) in which a positive
pressure is applied when apnea is sensed (i.e., the positive airway
pressure is applied intermittently or non-continuously). With all
these types of therapy, a positive pressure device (i.e., flow
generator) connects via a ventilation tube to a ventilation
interface. The interface connects to either the patient's nose,
mouth or both orifices.
[0007] Various interfaces have been developed for positive
pressure, and more specifically CPAP therapy. These include various
shaped full-face masks, nasal masks, nasal prong masks, oral masks
and hybrid masks (i.e., those masks that combine masks such as
having an oral cavity with nasal prongs). Nasal prongs offer one
popular form of interface for use with CPAP therapy because they
are relatively small, less bulky and more comfortable for many
patients to wear for long periods of time.
[0008] Nasal prongs can generally be separated into two types:
nasal pillows and nasal inserts. Nasal pillows typically abut
against the openings of a user's nares when in use and may not be
inserted substantially within the nasal passages. Nasal inserts are
typically positioned within the nasal passages of a user and may or
may not abut against the nasal openings. Embodiments and the
principles thereof are contemplated for any nasal prong and the
like, as will be readily recognized by one having ordinary skill in
the art. Nevertheless, for illustrative purposes in a non-limiting
manner, exemplary embodiments are described below in reference to
nasal pillows.
[0009] A seal is maintained between the patient and the ventilation
interface through use of headgear. More specifically, the headgear
of a nasal pillow assembly creates an upward force by compressing
the nasal pillows onto the nasal openings. This compression should
be sufficient to effectuate the seal without creating discomfort to
the patient. These nasal pillow systems, unlike nasal mask and
full-face mask interfaces, help reduce the risk of patients feeling
claustrophobic while being treated for OSA through CPAP therapy.
However, one issue with nasal pillows is that they have to be
calibrated and properly fitted to maintain an effective seal
between the interface and patient, while still being comfortable to
wear for long periods of time.
[0010] Various forms of nasal pillow and headgear assemblies have
been developed which attempt to address these design criteria. Two
initial examples of nasal pillow interfaces found in the prior art
include U.S. Pat. No. 5,724,965 and U.S. Pat. No. 6,431,172. Both
nasal pillow systems require multiple part construction for the
reservoir that includes both a hard plastic first component and a
softer second component. Thus, the gas reservoir requires at least
two parts, which leads to various connecting points that can leak.
Moreover, both these prior art systems require complicated
headgear, which increases the risk of the patient feeling
claustrophobic. Moreover, these designs are complicated, difficult
to calibrate and fail to allow easy adjustment by the patient
during use.
[0011] While more recent commercially available nasal pillow
designs continue to provide alternative headgear and connection
systems to calibrate the reservoir proximate to the patient's face,
these systems still have several drawbacks. Two such examples are
the ResMed.RTM. Swift LT and the Fisher & Paykel.RTM. Opus.TM.
nasal pillows. Both require a two part cannula comprised of: a
rigid frame that connects with the ventilation tube and a second
more pliable silicone base that has the nasal pillows.
[0012] The Swift LT interface includes a ratchet system, which can
rotate and lock at various positions relative to the headgear to
adjust the angle of the nasal pillows to the patient's face. Since
the axis of the ratchet system is well below the nasal pillows, the
nasal pillows move in an arc relative to the axis. Therefore, any
rotational adjustment undesirably impacts how the user wears the
headgear, and consequently forces the user to recalibrate and make
further adjustments to the interface and headgear to achieve a
proper fit. Also, the toothed part of the ratchet system (which
connects to the reservoir) is made of a soft rubber or silicone
elastomer, which invariably will degrade and lead to
stripping--thus inhibiting the ability to angle the pillows
relative to the headgear and effectuate an effective seal between
the nares and the patient. Moreover, the complicated design
requires a significant level of time and attention to adjust.
[0013] The Opus.TM. nasal pillow does not include a means at all to
adjust the angle of the pillows relative to the headgear and
therefore the user's face. There are several other drawbacks to
both the ResMed.RTM. Swift LT and the Fisher & Paykel.RTM.
Opus.TM. nasal pillows. Neither product allows the user to quickly
disconnect the cannula or to disconnect the cannula while
maintaining the headgear in place. Also, both products require
extra parts to provide the adequate pillow sizes required to fit
different patients.
[0014] Accordingly, there is a need in the art of ventilation
interfaces for a nasal prong that allows for more simplified
construction and that includes an effective means for adjusting and
calibrating the interface in relation to the patient to ensure long
term comfort. In addition, there is a need in the art for an
improved headgear that can connect to the interface to allow a
patient to easily assemble, disassemble, adjust and position the
interface to ensure an effective seal with the nares. Finally,
there is a need in the art to simplify the nasal prong offerings
without compromising sealing and comfort. In short, the design
should allow more comfortable long term use, require less assembly
and be easily calibrated.
SUMMARY OF THE INVENTION
[0015] The present invention solves many of the problems with
current ventilation interfaces, including nasal prong and headgear
designs. In one embodiment of the invention, the ventilation
interface may include a single-body constructed cannula made of
silicone elastomer having a first side wall, a corresponding second
side wall in parallel relation to the first side wall, a top wall,
a front wall and a back wall which form a reservoir. The top wall
of the cannula may include a first portion, a second portion and a
notch positioned between both portions. Integrally attached to both
portions is a set of two nasal prongs, the first nasal prong
positioned on the first portion while the second nasal prong is
located on the second portion of the cannula. Connected to the
cannula through a ball-and-socket connector is a ventilation tube
capable of providing pressurized breathable gas to a patient.
Positioned between the ball-and-socket connector and the
ventilation tube is a connector that contains one or more bleed
ports.
[0016] Headgear may be attached to the cannula through two arced
couplers. A first arced coupler includes a curved female sleeve
located on the first side wall of the cannula and a corresponding
first curved male tine attached to the headgear. Similarly, a
second arced coupler includes a curved female sleeve located on the
second side wall of the cannula and a second curved male tine which
is also attached to the headgear.
[0017] The invention is further directed to an improved headgear
that may comprise a first strap and a corresponding second strap.
The first strap includes a first portion and a second portion, the
second portion mirroring the size and orientation of the first
portion. Each portion of the first strap may include a flexible
inner layer and corresponding rigid outer layer. Each inner layer
has a first section, a second section and a corresponding third
section of material. The inner layer may be made of single piece
construction.
[0018] The second section of the flexible inner layer is oriented
at an angle below the first section, while the third section is
oriented at an angle above the second portion. The third section
connects to the cannula through the arced coupler. The outer layer
has one or more slots. Optionally, the shape and configuration of
the outer layer mirrors that of the inner layer. More specifically,
the outer layer includes a first slot and a corresponding second
slot, the second slot having a position and angle different than
the first slot such that both slots are capable of positioning the
second strap at a different angle about a patient's head.
[0019] The second strap of the headgear includes a first end and a
corresponding second end, both ends having a hook-and-loop fastener
sufficient to attach the second strap to one or more slots located
on the outer layer of the first strap. A tube holder is positioned
on the middle portion of the second strap. This tube holder has a
sufficient size and dimension to maintain and secure the
ventilation tube.
[0020] In another embodiment of the invention, the headgear may
attach to the cannula through a male member and female slot
system--instead of a sleeve and tine assembly. More specifically,
the arced coupler may include a male member located on a side wall
of the cannula. The male member has a sufficient size and dimension
to as to fit within and pivotally engage a female slot located on
the headgear. Moreover the unique shape of the arced coupler allows
the user to pivot the cannula about an axis to properly seat the
ventilation interface proximate to the nares to effectuate an
improved seal.
[0021] In yet another embodiment of the invention, the headgear may
engage the cannula through a pin and receptacle configuration. More
specifically, the back wall of the cannula includes a receptacle.
In addition, the headgear may include a rigid pivot pin. The pin
has a sufficient size and dimension to rest within and engage the
receptacle.
[0022] In still yet another embodiment of the invention, the
headgear may attach to the cannula of the ventilation interface
through at least one connecting portion, which includes a center
strap.
[0023] In addition, nasal prongs may also be detachably coupled
with the ventilation interface. Each detachable nasal prong
includes at least two prong portions. The prong portions offer the
patient different sizes or styles of nasal prongs in one component.
In addition (or alternatively), the nasal prongs can have an upper
portion that is located at the distal tip of the nasal prong. The
upper portion is adjustable to different configurations.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] For a fuller understanding of the invention, reference is
made to the following detailed description, taken in connection
with the accompanying drawings illustrating various embodiments of
the present invention, in which:
[0025] FIG. 1 is a perspective view of the cannula and headgear
assembly;
[0026] FIG. 2 is an exploded view of the various components of the
cannula and headgear assembly;
[0027] FIG. 3A is a front perspective view of the cannula;
[0028] FIG. 3B is a back perspective view of the cannula;
[0029] FIG. 3C is a front perspective view of the cannula and the
ventilation tube;
[0030] FIG. 4 is a cross-sectional view of the cannula and the
ventilation tube;
[0031] FIG. 5A is a side view of the cannula and headgear
assembly;
[0032] FIG. 5B is a front view of the cannula and headgear
assembly;
[0033] FIG. 6A is a perspective view showing how the headgear
connects to two arced couplers located on the cannula;
[0034] FIG. 6B is a cross-sectional view showing how the headgear
connects to the cannula;
[0035] FIG. 6C is a cross-sectional view showing the headgear
secured to the cannula;
[0036] FIG. 6D is a perspective view of an alternative embodiment
showing how the headgear connects to the cannula;
[0037] FIG. 6E is a side view of the alternative embodiment showing
how the headgear connects to the cannula;
[0038] FIG. 7A is a perspective view of a detachable nasal
prong;
[0039] FIG. 7B is a cross-sectional view of the nasal prong shown
in FIG. 7A;
[0040] FIG. 8A is a perspective view of another embodiment of a
detachable nasal prong;
[0041] FIG. 8B is a cross-sectional view of the nasal prong shown
in FIG. 8A;
[0042] FIG. 9A is a perspective view of an alternative embodiment
of a nasal prong;
[0043] FIG. 9B is a perspective view of the cannula configured to
interface with detachable nasal prongs;
[0044] FIG. 10A is a cross-sectional view of one configuration of
the alternative nasal prong embodiment shown in FIG. 9A;
[0045] FIG. 10B is a cross-sectional view of a second configuration
of the alternative nasal prong embodiment shown in FIG. 9A.
[0046] FIG. 10C is a cross-sectional view of a third configuration
of the nasal prong embodiment shown in FIG. 9A.
[0047] FIG. 11A is a perspective view of an alternative embodiment
showing how the headgear connects to the cannula.
[0048] FIG. 11B is a cross-sectional view of the alternative
embodiment shown in FIG. 11A.
[0049] FIG. 12 is a perspective view of a handle applied to a
cannula and headgear assembly.
[0050] FIG. 13 is a perspective view of yet another embodiment of
the headgear.
DETAILED DESCRIPTION OF THE INVENTION
[0051] The present invention will now be described more fully
hereinafter with reference to the accompanying drawings, in which
preferred embodiments of the invention are shown. This invention
may, however, be embodied in many different forms and should not be
construed as limited to the embodiments set forth herein. Rather,
these embodiments are provided so that this disclosure will be
thorough and complete, and will fully convey the scope of the
invention to those skilled in the art. Like numbers refer to like
elements throughout. The terms "embodiment of the invention,"
"embodiments", or "invention" do not require that all embodiments
of the invention include the discussed feature, advantage, or mode
of operation.
[0052] The invention described in detail below and in the figures
is designed to cooperate and be used with any form' of ventilation
interface for the administration of breathable gas having a
headgear and some form of facial seal. Such ventilation interfaces
can include any form of facial mask, nasal prong mask, so called
"hybrid" masks or other style and shaped masks having an oral
cavity and some form of nasal prong--which will be readily
understood by those of ordinary skill in the art. Accordingly, the
ventilation interfaces described and disclosed in United States
Patent Application Nos. 2006/10124131 (Chandran et al.),
2006/0174887 (Chandran et al.), 2007/10272249 (Chandran et al.),
and 2008/0011305 (Chandran et al.) are incorporated by reference
herein in their entireties.
[0053] Nasal prongs can generally be separated into two types:
nasal pillows and nasal inserts. Nasal pillows typically abut
against the openings of a user's nares when in use and may not be
inserted substantially within the nasal passages. Nasal inserts are
typically positioned within the nasal passages of a user and may or
may not abut against the nasal openings. Embodiments and the
principles thereof are contemplated for any nasal prong and the
like, as will be readily recognized by one having ordinary skill in
the art. Nevertheless, for illustrative purposes in a non-limiting
manner, exemplary embodiments are described below in reference to
nasal pillows.
The Overall Ventilation Interface
[0054] One embodiment of the invention includes a ventilation
interface 100 illustrated in FIGS. 1 and 2. First turning to FIG.
1, the interface 100 is comprised of three components: a
ventilation tube 200, a cannula 300 and headgear 500. Preferably
made of a polymer or composite, the ventilation tube 200 is soft,
bendable and flexible. The ventilation tube 200 contains a
plurality of circular ridges 210 (in parallel relationship to one
another) which helps ensure the ventilation tube 200 does not kink
or become bent so as to reduce the pressure of supplied breathable
gas. In other embodiments, the ridges 210 could be helically swept
over at least a portion of the length of the ventilation tube
200.
[0055] The ventilation tube 200 includes a first end 230 and a
corresponding second end 240. Located at the first end 230 of the
ventilation tube 200 is a rigid fitting 250, typically made of hard
plastic, which allows connection to the flow generator (not shown).
Rigid fitting 250 preferably is a swivel coupling, comprised of at
least two parts. The second end 240 of the ventilation tube 200
connects with the cannula 300. In embodiments, the ventilation
interface 100 may have more than one ventilation tube 200 and the
rigid fitting may be in the form of a "Y" coupler.
[0056] FIG. 1 further illustrates the salient components of the
headgear 500 (discussed in detail below). As shown, the headgear
500 includes a first strap 510 and a second strap 520. The first
strap 510 includes an inner layer 511 and an outer layer 512. The
outer layer 512 extends throughout at least a portion of the inner
layer 511 of the first strap 510. The inner layer 511 should be
flexible and made of a compressible and bendable material, which
can include, but is not limited to, neoprene. Other similar
material known to those of ordinary skill in the art can also be
used. The outer layer 512 is preferably more rigid than the inner
layer 511, but should still be flexible to allow conformance to the
curvature of the patient's face (not shown). The outer layer 512 of
the first strap 510 is preferably made of a polymer, thin flexible
metal, or composite.
[0057] The first strap 510 of the headgear 500 includes a first
portion 530 and a corresponding second portion 540. The first
portion 530 connects to the second portion 540 through connector
550. The connector 550 allows for adjustment (i.e., loosening and
tightening) of both the first portion 530 and second portion 540
onto the face. The connector 550 is preferably plastic and capable
of maintaining both portions 530 and 540 in a compressed state on
the patient's face.
[0058] FIG. 1 also illustrates the second strap 520 of the headgear
500. The second strap 520, like the inner layer 511 of the first
strap 510, is soft, flexible and preferably includes neoprene. The
second strap 520 has a middle portion 523. Positioned on the middle
portion 523 of the second strap 520 is a tube holder 524. The tube
holder 524 is of sufficient size and dimension so as to hold and
maintain the ventilation tube 200 while the interface 100 is worn
by the patient.
[0059] The tube holder 524 may be constructed of a polymer that
allows the ventilation tube 200 to fit or snap into it. The tube
holder 524 may also be formed of a material that allows it to wrap
around and hold the ventilation tube 200, such as fabric with hook
and loop closure ends. In embodiments, the tube holder 524 may be
located on any portion of the headgear 500 to allow the patient to
route the ventilation tube 200 in different positions.
[0060] As shown in FIGS. 1 and 2, the cannula 300 is connected to
the ventilation tube 200. While there exist a variety of means by
which the ventilation tube 200 can connect to the cannula 300, one
preferred embodiment of the ventilation interface 100 includes a
connector 270 located on the second end 240 of the ventilation tube
200. As shown, one form of connector 270 contemplated by the
invention is a ball-and-socket connector. Such embodiment would
allow connector 270 to have three degrees of freedom with the
cannula 300 to allow a large degree of roll, pitch and yaw. Other
embodiments contemplate having the connector 270 and cannula 300
couple as a swivel to allow 360 degrees of rotation and one degree
of freedom.
[0061] As illustrated in FIG. 1 and FIG. 2, a socket 260 is located
between the cannula 300 and connector 270. Such connector 270 has a
ball 261 on the distal end that engages the socket 260. Such ball
261 and socket 260 are preferably made of hard plastic. The various
degrees of freedom allow the ventilation tube 200 to be positioned
below, along, or above the patient's face.
[0062] While the connector 270 shown in FIG. 2 is "L" shaped akin
to an elbow, other alternative shaped can be used and employed
within the ventilation interface 100. This connector 270 also
includes one or more bleed ports 280 (as further shown in FIG. 3C)
of sufficient size and dimension to allow the patient to exhale the
breathable gas supplied by a flow generator. The bleed ports 280
can be a plurality of holes 281 oriented within the connector 270
to minimize noise while dispersing the expelled air. However, in
other embodiments contemplated by the invention, these bleed ports
280 can be located on other portions of the ventilation interface
100 including, but no way limited to, the cannula 300.
[0063] FIGS. 3A and 3B illustrate one preferred form of the cannula
300. While one of ordinary skill in the art will recognize various
forms of cannulas sufficient to effectuate a seal with the nares of
the patient, the preferred cannula 300 includes a reservoir 310
(best shown in FIG. 4). The reservoir 310 is formed through a first
side wall 315, a corresponding second side wall 320, a top wall
330, a corresponding bottom wall 340, a front wall 350, and a back
wall 360. However, the reservoir 310 can be of various sizes and
shapes--and should not be limited to the orientation herein
described. The first side wall 315 is essentially parallel to the
second side wall 320 and has essentially the same size and
dimension. Positioned on the top wall 330 are one or more nasal
prongs 370. The nasal prongs 370 can take many a form as previously
discussed and described in greater detail below.
[0064] The nasal prongs 370 and various walls 320-360 form one
integral single cannula 300. By having an integral cannula,
assembly and disassembly are simplified for the patient, the
cannula size is reduced and leak between walls and separate cannula
parts is eliminated. Although preferably made of a low durometer
silicone elastomer, the cannula 300 can be made of plastic,
composite or any similar material known to those of ordinary skill
in the art.
[0065] Referring now to FIG. 3A, located on the front wall 350 of
the cannula 300 is an aperture 380. The aperture 380 may be
circular and includes an engagement area 381 for fluidically
connecting with the ventilation tube 200. The connection may be in
the form of a press fit, mating flange, threads, clips, or any
connection method known to those of ordinary skill in the art. The
engagement area 381 is of sufficient size and dimension to connect
and maintain the socket 260 or the connector 270, depending on the
embodiment.
The Cannula and Nasal Prongs
[0066] FIG. 3C offers a more detailed perspective of the preferred
cannula 300. As shown, the top wall 330 of the cannula 300 includes
a first portion 331 and a corresponding second portion 332.
Positioned between the first portion 331 and second portion 332 is
a notch 333. Located on the first portion 330 is a first nasal
prong 371. Likewise, a second nasal prong 372 is located on the
second portion 332 of the top wall 330. Both nasal prongs 371 and
372 have essentially the same size and dimension. The notch 333
allows for clearance of the bottom of the patient's nose. Further,
notch 333 allows the top wall 330 of the cannula 300 to flex
inward. The act of inwardly flexing both the first portion 331 and
second portion 332 helps orient and position both nasal prongs 370
in relation to the opening of the nares of the patient.
[0067] FIG. 3C further shows one general orientation of the nasal
prongs 370. Here, the nasal prongs 370 are illustrated as nasal
pillow style nasal prongs. As shown, each nasal prong 370 includes
a top sealing member 375. The sealing member 375 is essentially
elliptical in cross section. At the distal tip of the top sealing
member 375 is an opening 377. The opening 377 allows breathable gas
to flow from the ventilation tube 200 into the reservoir 310 of the
cannula 300 and ultimately to the patient. As illustrated in FIG.
3C, the sealing members 375 of both nasal prongs 370 inwardly tilt
toward each other.
[0068] In addition, FIG. 3C also shows one orientation for the
bleed ports 280 located on the connector 270. In the preferred
embodiment, the connector 270 includes an essentially flat portion
271 having one or more bleed ports 280. In one contemplated
arrangement, the bleed ports 280 are cloistered and arranged in a
plurality of rows having multiple bleed ports 280. The bleed ports
280 are sufficient to allow breathable gas respired from the
patient to leave the ventilation interface 100.
[0069] FIG. 4 offers a cross-sectional view of the cannula 300, the
ventilation tube 200, the socket 260 and the connector 270. In
addition, FIG. 4 shows how a ball 261 is disposed at one distal end
of the connector 270. The ball 261 engages a socket 260. The ball
261 both pivots and rotates within the socket 260 and helps orient
the ventilation tube 200.
The Headgear
[0070] FIGS. 5A and 5B offer a more detailed view of the preferred
headgear 500. FIG. 5A provides a side view of the headgear 500, as
well as the cannula 300, connector 270 and the ventilation tube
200. As shown (and previously discussed above), the headgear 500
includes a first strap 510 and a corresponding second strap 520.
FIG. 5A illustrates the first portion 530 of the first strap 510,
showing both the inner layer 511 and outer layer 512. It is noted
that the second portion 540 (shown in FIG. 5B) of the first strap
510 is a mirror image of first portion 530, and therefore has all
of the same components and functionality found in the first portion
530.
[0071] The inner layer 511 includes three component sections
513-515, each integrally connected to one another at a different
angle. These include a first section 513, a second section 514, and
a corresponding third section 515. It is preferable that the inner
layer 511 is cut from a single piece of material such that all
three sections 513-515 are a single piece. During use, the first
section 513 is positioned over the back of the head, the second
section 514 is positioned between the ear and the eye, and the
third section 515 extends towards the cannula 300.
[0072] FIG. 5A also shows one preferred structure for the outer
layer 512 of the first portion 530. Like the first portion 511, the
outer layer 512 may include three outer sections: first outer
section 516, second outer section 517, and third outer section 518.
These three outer sections 516-518 mirror the orientation of the
first section 513, second section 514 and corresponding third
section 515 of the first portion 511 described above. Positioned
where the first outer section 516 meets the second outer section
517 is at least one slot 560.
[0073] As further illustrated in FIG. 5A, preferably there are two
slots 560: a first slot 561 and a second slot 562. The first slot
561 is oriented and placed at a different angle in comparison to
the second slot 562. This allows the second strap 520 to be
attached to either slot 560 at a different orientation so to assist
in properly fitting the interface 100 to the patient.
[0074] FIG. 5B provides a front view of the interface 100 and
illustrates one version of the preferred second strap 520 of the
headgear 500. The second strap 520 includes a first end 525 and a
corresponding second end 526. In addition, a tube holder 524 is
positioned on the middle portion 523 of the second strap 520. The
tube holder 524 is capable of maintaining the ventilation tube 200
during use of the interface 100 by the patient.
[0075] Positioned at both ends 525 and 526 of the second strap 520
are fasteners 527, which are preferably a hook-and-loop fastener.
Each fastener 527 engages a slot 560, located on the first strap
510, sufficient to attach the second strap 520 onto the first strap
510 to form the headgear 500. Moreover, each fastener 527 can be
periodically adjusted about either slot 560, including while
wearing the interface 100, such that the cannula 300 is properly
oriented and sealed in relation to the patient.
The Arced Coupler
[0076] FIGS. 6A through 6E provide several embodiments regarding
how the headgear 500 is preferably attached to the cannula 300.
First turning to FIG. 6A, the cannula 300 includes a first side
wall 315 and a corresponding second side wall 320 (best shown and
illustrated in FIG. 3B). Positioned on the first side wall 315 is a
curved female sleeve 390 and positioned on the corresponding second
side wall 320 is a corresponding curved female sleeve 391. It is
noted that the curved female sleeves 390 and 391 have all of the
same features and functionality. It is also understood that a
curved female sleeve could be located on any of the walls of the
cannula 300 or even through cannula 300 itself, as long the
reservoir 310 remains sealed.
[0077] Each curved female sleeve 390 and 391 is capable of
receiving and engaging a curved male tine 395 and 396 respectively.
Both curved male tines 395 and 396 are located on the third outer
sections 518 respectively of the headgear 500. The combination of a
curved female sleeve and a curved male tine forms an arced coupler
398 which attaches the headgear 500 onto the cannula 300.
[0078] FIG. 6B illustrates a cross sectional view through curved
female sleeve 390 prior to assembly of the curved male tine 395.
FIG. 6C illustrates a cross sectional view of an arced coupler 398
(shown in FIG. 6C) (i.e. the curved male tine 395 assembled to the
curved female sleeve 390). As is shown in FIG. 6B, curved female
sleeve 390 contains a cavity 392 of sufficient size and dimension
to engage and secure the curved male tine 395.
[0079] As best shown in FIG. 6C, curved male tine 395 can move in
an arc path within curved female sleeve 390, allowing cannula 300
to rotate relative to headgear 500 and therefore allow the user to
adjust the location of the nasal prongs 370. Also, if the user
desires, cannula 300 can be removed from headgear 500 by simply
moving cannula 300 further away from the face until curved male
tine 395 decouples from curved female sleeve 390.
[0080] As opposed to the prior art, this can be done without the
user removing the interface from the face. Also as opposed to the
prior art, this allows the user to continue to wear the headgear
500 without the cannula 300. Optionally, the distal end of each
curved male tine 395 and 396 can include a catch 394. This catch
394 can engage a ledge 393 on the curved female sleeve 390 at one
specific angle of rotation to further prevent the incidental
removal of the curved male tine 395. If enough force is applied
however by the user, the catch 394 can disengage from the ledge
393.
[0081] FIG. 6D and FIG. 6E offer a second embodiment of the arced
coupler 400. First turning to FIG. 6D, this arced coupler 400
includes a curved female slot 401 located on each of the third
outer sections 518 of the headgear 500. Adjacent the curved female
slot 401 is a squared opening 404 that is sufficiently larger than
the curved female slot 401.
[0082] As further shown in FIG. 6D, in this embodiment of the
ventilation interface 100, both the first side wall 315 and
corresponding second side wall 320 of the cannula 300 include a
male member 410. The male member 410 can include stem 411 and a
larger head 412. The head 412 of the male member 410 is capable of
fitting within the squared opening 404 of the female slot 401
during assembly and disassembly of the headgear 500 from the
cannula 300.
[0083] Once positioned beyond the squared opening 404, the stem 411
can glide within the curved female slot 401 of the headgear 500,
allowing for angular adjustments of the cannula 300 relative to the
headgear 500. While the stem 411 is within the curved female slot
401, the head 412 prevents the male member 410 from disengaging
from the curved female slot 401 in a direction normal to surface
415 of the headgear 500. Combination of the male member 410 with
the curved female slot 401 forms the second embodiment of the arced
coupler 400.
[0084] One additional optional feature contemplated by the
invention is that of an axis for rotational adjustment that passes
through or above each nasal prong 370. In an embodiment where the
axis passes through the nasal prongs 370, the nasal prongs 370 only
rotate and therefore do not change position (i.e., translate and
rotate as would occur if the axis were below the nasal prongs 370)
relative to the headgear 500 during angular adjustment. This way,
an angular adjustment can be made without additional adjustments to
the headgear. The embodiments shown in FIGS. 6A to 6E all have an
axis 305 that passes through the nasal prongs 370. In these
embodiments, the location of the axis 305 is a result of the arced
couplers. The location and curvature of the arced couplers 398 or
400 can be modified in design to move the location of the axis 305
so that it passes through or above the nasal prongs 370.
Detachable Nasal Prongs
[0085] The invention is further directed towards detachable and
adjustable nasal prongs. These alternative nasal prongs are
preferably made of a soft, pliable, compressible and biocompatible
material such as silicone elastomer. However, one of ordinary skill
in the art will recognize other similar materials that can be used.
FIG. 3 illustrates nasal prongs 370 that are integral to cannula
300. In these embodiments, the nasal prongs 370 may be detachably
coupled with the cannula 300, as is described in detail in the
aforementioned referenced patent applications identified above.
Detachable nasal prongs may have a different durometer, such as a
lower durometer, or be made of a different material than other
portions of the cannula.
[0086] FIGS. 7A, 7B, 8A, and 8B illustrate two different
embodiments for a detachable nasal prong. First turning to FIGS. 7A
and 7B, the detachable nasal prong 770 includes a first prong
portion 771 and a second prong portion 772. Here, each prong
portion is illustrated as a nasal pillow style nasal prong in a
non-limiting manner. First prong portion 771 has a first sealing
member 775 and second prong portion 772 has a second sealing
membrane 776. Depending on which prong portion is oriented towards
the patient, one of the first or second sealing members engages the
nares. At the tip of first prong portion 771 is a first opening 777
and at the tip of the second prong portion 772 is a second opening
778. Both the first and second openings are capable of providing
pressurized breathable gas to the patient.
[0087] Located in nasal prong 770 is a ringed member 783, which
includes a first ring 784, a recess 785, and a corresponding second
ring 786. The ringed member 783 is capable of engaging an aperture
387 (shown in FIG. 9B) located within the first portion 331 and
second portion 332 of the cannula 300. Put another way, the ringed
member 783 is of a sufficient size and dimension so as to fit and
seal within the aperture 387 provided on the top wall 330 of the
cannula 300. A connection between the nasal prong 770 and the
aperture 387 may be in the form of a press fit, mating flange,
threads, clips, or any connection method known to those of ordinary
skill in the art.
[0088] FIG. 7B provides a cross sectional view of the detachable
nasal prong 770 illustrated in FIG. 7A. Here, the second sealing
member 776 is larger in size and dimension in comparison to the
first sealing member 775. Likewise, the second opening 778 may be
larger than the first opening 777.
[0089] The nasal prong 770 illustrated in both FIG. 7A and FIG. 7B
further enhances the adjustability of the cannula 300. Should the
patient have small nares, the cannula 300 is fitted with nasal
prongs 770 such that the first sealing member 775 is oriented to
contact the nares, while the second sealing portion 776 is
positioned within the cannula 300. Should the patient have large
nares, then each nasal prong 770 is turned 180 degrees such that
the second sealing member 776 is oriented to contact the nares,
while the first sealing portion 775 is positioned within the
cannula 300. Should the patient have different sized nares, each
nasal prong 770 could be oriented differently to provide the sizing
needed to provide a comfortable seal.
[0090] FIGS. 8A and 8B show another similar embodiment of a
detachable nasal prong. The detachable nasal prong 870 includes a
first prong portion 871, a second prong portion 872, and a third
prong portion 873. This embodiment illustrates that more than two
nasal portions can be located on a detachable nasal prong 870. This
embodiment also illustrates that each nasal prong portion can be of
a different size, or even of a different type of nasal prong. For
example, first prong portion 871 can be a nasal pillow style nasal
prong, the second prong portion 872 can be a nasal pillow style
nasal prong that is smaller than the first prong portion 871, and
the third prong portion 873 can be a nasal insert style nasal
prong. First prong portion 871 has a first sealing surface 875, and
third prong portion 873 has a third sealing surface 877. Second
prong portion 872 may have a seal component 876 that is coupled to
it. Seal component 876 may be a different durometer or material
than second prong portion 872. For example, second prong portion
872 may be silicone and seal component 876 may be constructed of
foam or gel.
[0091] Similar to nasal prong 770, each prong portion of nasal
prong 870 has a ringed member 883, which is capable of engaging an
aperture 387 located within the first portion 331 and second
portion 332 of the cannula 300 (all shown in FIG. 9B). Depending on
which prong portion is positioned towards the patient, one of the
first, second, or third prong portions engages the nares while the
other two remaining prong portions would be within the cannula 300.
Detachable nasal prongs 770 and 870 could also be adapted to couple
with any mask that has nasal prongs, including hybrid masks (i.e.,
those masks that combine masks such as having an oral cavity with
nasal prongs).
[0092] FIGS. 9A, 10A, 10B, and 10C offer additional structure that
can be applied to a nasal prong, such as the integral nasal prong
370 or the detachable nasal prong 770. FIG. 9A illustrates a nasal
prong 970, which is shown to be detachable in a non-limiting way.
The sealing member 975 includes an upper portion 999, which is
located at the distal tip of the nasal prong 970 and which has an
opening 920. The upper portion 999 may be adjustable.
[0093] FIGS. 10A, 10B, and 10C illustrate cross-sections of
different configuration of the nasal prong 970. In FIG. 10A, upper
portion 999 is shown adjusted to be fully extended. In this
configuration, the upper portion 999 extends further into the nose
of the patient during use. In this configuration, the upper portion
999 serves several purposes. First the upper portion 999 minimizes
the opportunity for the nasal prong 970 to inadvertently become
dislodged from the patient's nose. Second, the upper portion 999
helps the flow of the breathable gas become laminar in order to
improve patient comfort.
[0094] Upper portion 999 could also fold or roll inwardly. This
adjustment could shorten the length of the upper portion 999, could
decrease the size of the opening 920, or could change the size or
shape of the sealing member 975. FIG. 10B illustrates one example
of an embodiment where the upper portion 999 has been folded
inwardly. Upper portion 999 could also fold or roll outwardly. This
adjustment could shorten the length of the upper portion 999, could
increase the size of the opening 920, or could change the size or
shape of the sealing member 975. FIG. 10C illustrates one example
of an embodiment where the upper portion 999 has been rolled
outwardly. A rolled or folded upper portion 999 could also serve to
create a sealing bead 990, as shown in FIG. 10C. Further adjustment
of the upper portion 999 would further adjust the size and shape of
the sealing bead 990.
[0095] FIGS. 11A and 11B illustrate another embodiment regarding
how the headgear 500 is attached to the cannula 300. FIG. 11A shows
the cannula 300 disassembled from the headgear 500. In this
embodiment, cannula 300 has back wall 360 that contains a
receptacle 590, and headgear 500 has a pin 580 that is located
between the first portion 530 and the second portion 540. In
embodiments, receptacle 590 could be located on any portion of the
cannula 300 and could be embedded within or protrude from cannula
300. Pin 580 is configured to fit into receptacle 590 and provides
for easy assembly and disassembly of the cannula 300 from the
headgear 500. For example, the user could remove the cannula 300
while still wearing the headgear 500.
[0096] FIG. 11B is a cross-section of the embodiment when
assembled. Pin 580 is configured to allow the user to make angular
adjustments to the cannula 300 with respect to the headgear 500 for
improved fitting and comfort. Pin 580 is preferably made of a
harder material than cannula 300 and could be pushed into the
receptacle 590 during assembly. Pin 580 is preferably circular in
cross-section to allow for rotation with respect to the receptacle
590. The friction fit between the pin 580 and the receptacle 590
would allow the user to place the cannula 300 in an infinite number
of angular positions.
[0097] The pin 580 could have an alternate cross-sectional shape or
have details to allow the cannula to rotate to a predetermined
number of positions. For example, the pin 580 could be egg shaped,
square, hex shaped, or any other shape. The pin 580 could have
divots, slots, bumps, ratchets, cams, or other types of details.
The receptacle 590 may have a corresponding shape or details to
engage the pin 580. The shapes and details described for the pin
580 could be applied to the receptacle 590 instead and the details
of the receptacle 590 could be applied to the pin 580 instead, as
would be recognized by those having ordinary skill in the art. In
embodiments, a secondary part (not shown), such as a bushing, could
be located between the pin 580 and the receptacle 590.
[0098] Preferably, the pin 580 is fixed to the headgear 500 and the
cannula 300 rotates about pin 580. In an alternate configuration,
the pin 580 could be assembled to the headgear 500 in a manner that
allowed it to rotate within the headgear. For example, the pin 580
could fit into holes (not shown) in the headgear 500. Either
configuration ultimately allows the user to rotate the cannula 300
with respect to the headgear 500. In this alternate configuration,
it is understood that the methods and details described above
pertaining to the pin 580, the receptacle 590, and their connection
could be applied to the pin 580, the holes (not shown) in the
headgear, and their connection.
[0099] FIG. 12 illustrates a handle 1250, which could be utilized
on embodiments to assist in rotating the cannula 300. The handle
1250 provides the user with additional leverage and an easier
feature to grasp to facilitate fitting or calibration. The handle
1250 could also function as a key, allowing the cannula 300 to only
move relative to the headgear 500 if the handle 1250 is engaged.
The handle 1250 could be engaged by insertion, twisting, by
pressing or releasing a button, or any other method recognized by
those having ordinary skill in the art. A handle 1250 that is
detachable is preferred so it could be constructed in any manner,
out of any material, or any size that provided the most leverage.
While the handle 1250 could be integral, a detachable handle 1250
could be removed prior to the patient lying down as to not
interfere with the comfort of using the interface.
[0100] FIG. 13 shows yet another embodiment of a headgear for the
ventilation interface. Headgear 1300 has a first strap 1310 and a
second strap 1320. Headgear 1300 also has a center strap 1330 that
connects to the second strap 1320. Center strap 1330 has a nose
portion 1340, which goes over at least a portion of the nose. At
the base of the nose portion 1340 is a connecting portion 1350.
Connecting portion 1350 is configured to couple with the
ventilation interface. Connecting portion 1350 has at least one
aperture 1360 that could engage with the nasal cannula 300 or
directly with the nasal prongs 370. By tightening any of the first
strap 1310, the second strap 1320, or the center strap 1330, the
nasal prongs would engage with nares of the patient to create a
comfortable seal. This tightening would create an upward sealing
force on nares from the nasal prongs.
[0101] The connecting portion 1350 could be configured to couple
with other types of mask seals, such as facial cushions, and allow
for the patient to create a comfortable seal with the face. Similar
to the materials of the headgear 500, the materials of headgear
1300 are preferably soft and flexible, such as the fabrics
discussed previously. Polymers, such as silicone or rubber, could
also be utilized in the headgear 1300. Nose portion 1340 is
preferably made of silicone.
* * * * *