U.S. patent application number 13/624501 was filed with the patent office on 2013-01-24 for ventilation interface for sleep apnea therapy.
This patent application is currently assigned to INNOMED TECHNOLOGIES INC.. The applicant listed for this patent is Angelo Caruso, Louis Javier COLLAZO, Shara Hernandez, Bruce Sher, Thomas Wood. Invention is credited to Angelo Caruso, Louis Javier COLLAZO, Shara Hernandez, Bruce Sher, Thomas Wood.
Application Number | 20130019870 13/624501 |
Document ID | / |
Family ID | 38171999 |
Filed Date | 2013-01-24 |
United States Patent
Application |
20130019870 |
Kind Code |
A1 |
COLLAZO; Louis Javier ; et
al. |
January 24, 2013 |
VENTILATION INTERFACE FOR SLEEP APNEA THERAPY
Abstract
The ventilation interface for sleep apnea therapy interfaces a
ventilation device to the patient's airways. The ventilation
interface includes a pair of nasal inserts made from flexible,
resilient silicone which are oval shaped in cross-section and
slightly tapered from a base proximal the ventilation supply to the
distal tip end. A bead flange is disposed about the exterior of
each insert at the distal end of the insert. A bleed port for
release of exhaled air is defined through a conical vent projecting
normally to the path of the incoming air flow, and continues
through a nipple extending to the exterior of the air conduit. In
one embodiment, a pair of nasal inserts are integral with a nasal
cannula body, with bleed ports axially aligned with each insert. In
another embodiment, each insert is independently connected to a
separate, thin-walled, flexible supply line.
Inventors: |
COLLAZO; Louis Javier;
(Pompano Beach, FL) ; Caruso; Angelo; (Boca Raton,
FL) ; Hernandez; Shara; (Davie, FL) ; Sher;
Bruce; (North Palm Beach, FL) ; Wood; Thomas;
(Waycross, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
COLLAZO; Louis Javier
Caruso; Angelo
Hernandez; Shara
Sher; Bruce
Wood; Thomas |
Pompano Beach
Boca Raton
Davie
North Palm Beach
Waycross |
FL
FL
FL
FL
GA |
US
US
US
US
US |
|
|
Assignee: |
INNOMED TECHNOLOGIES INC.
Coconut Creek
FL
|
Family ID: |
38171999 |
Appl. No.: |
13/624501 |
Filed: |
September 21, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11702229 |
Feb 5, 2007 |
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13624501 |
|
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|
10940989 |
Sep 15, 2004 |
7188624 |
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11702229 |
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|
09524371 |
Mar 13, 2000 |
6478026 |
|
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10940989 |
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60124323 |
Mar 13, 1999 |
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Current U.S.
Class: |
128/205.24 ;
128/205.25 |
Current CPC
Class: |
A61M 16/0616 20140204;
A61M 16/0833 20140204; A61M 16/20 20130101; A61M 16/201 20140204;
A61M 16/0816 20130101; A61M 2206/20 20130101; A61M 16/06 20130101;
A61M 16/0694 20140204; A61M 16/0666 20130101 |
Class at
Publication: |
128/205.24 ;
128/205.25 |
International
Class: |
A61M 15/08 20060101
A61M015/08; A61M 16/20 20060101 A61M016/20; A61M 16/06 20060101
A61M016/06 |
Claims
1. A respiratory interface comprising: at least one nasal insert
comprising; a hollow body; at least one inlet aperture for allowing
gas to enter the hollow body; and at least one nasal aperture for
allowing gas to exit towards a patient.
2. The respiratory interface of claim 1, wherein the at least one
nasal insert is oval shaped.
3. The respiratory interface of claim 1 further comprising: at
least one of an indentation, aperture, slot, perforation, or
opening defined in the nasal insert.
4. The respiratory interface of claim 1, further comprising: a
plurality of indentations, apertures, slots, perforations, or
openings defined in the nasal insert.
5. The respiratory interface of claim 1, further comprising: a
connection area on the nasal insert that may connect the nasal
insert to one of a headgear and chin strap.
6. The respiratory interface of claim 1, further comprising: at
least one second nasal insert.
7. The respiratory interface of claim 6, further comprising: a
connecting member that joins the at least one nasal insert and the
at least one second nasal insert.
8. The respiratory interface of claim 7, wherein the connecting
member is detachable from the at least one nasal insert and the at
least one second nasal insert.
9. The respiratory interface of claim 6, wherein the at least one
nasal insert and the at least one second insert are variable in
size.
10. A respiratory interface, comprising: at least one nasal insert
comprising; a hollow body; at least one inlet aperture for allowing
gas to enter the hollow body; at least one nasal aperture for
allowing gas to exit towards a patient; and a valve operatively
associated with the nasal insert.
11. The respiratory interface of claim 10, wherein the valve is
located proximate the at least one nasal aperture of the at least
one nasal insert.
12. The respiratory interface of claim 10, wherein the valve
located proximate the at least one inlet aperture of the at least
one nasal insert.
13. The respiratory interface of claim 10, wherein the valve is
integral to the at least one nasal insert.
14. The respiratory interface of claim 10, wherein the valve is
assembled between the at least one nasal insert and a second
component.
15. The respiratory interface of claim 14, wherein the second
component is at least one of a flange or an inlet aperture
cover.
16. The respiratory interface of claim 10, further comprising: at
least one bleed port for expelling or exhausting gas.
17. The respiratory interface of claim 10, wherein the bleed port
is located at the valve or between the valve and the nasal
aperture.
18. The respiratory interface of claim 10, wherein the valve is a
one direction valve.
19. The respiratory interface of claim 10 wherein the valve is at
least one of a flapper valve, a check valve, a biased valve, a
pucker valve, a duckbill valve, a dome valve, a spring-loaded
valve, a propeller valve, a shuttle valve, a plunger valve or a
piston valve.
20. The respiratory interface of claim 10, wherein the valve opens
when a pressure threshold is exceeded.
21. The respiratory interface of claim 10, wherein the valve is
electronically adjustable.
22. A respiratory interface comprising: a first nasal insert; a
second nasal insert; and a chamber coupled to the first nasal
insert and the second nasal insert.
23. The respiratory interface of claim 22, wherein the chamber is
hollow.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 11/702,229, filed Feb. 5, 2007, which is a
continuation of U.S. patent application Ser. No. 10/940,989, filed
Sep. 15, 2004, which is now U.S. Pat. No. 7,188,624, which is a
continuation-in-part of U.S. patent application Ser. No.
09/524,371, filed Mar. 13, 2000, which is now U.S. Pat. No.
6,478,026, which claims priority to U.S. Provisional Patent
Application No. 60/124,323, filed Mar. 13, 1999, the disclosures of
which are incorporated by reference herein in their entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to ventilation devices, and
particularly to a ventilation device having a nasal inserts which
are inserted into the nostrils and seal against the nostrils
without the aid of harnesses, head straps, adhesive tape or other
external devices, and having exhalation ports designed to eliminate
whistling noises, the ventilation interface having particular
utility in various modes of therapy for obstructive sleep
apnea.
[0004] 2. Description of the Related Art
[0005] Sleep apnea is a potentially lethal affliction in which
breathing stops recurrently during sleep. Sleep apnea may be of the
obstructive type (sometimes known as the pickwickian syndrome) in
which the upper airway is blocked in spite of airflow drive; the
central type with decreased respiratory drive; or a mixed type.
Breathing may cease for periods long enough to cause or to
exacerbate cardiac conditions, and may be accompanied by swallowing
of the tongue. Sleep apnea frequently results in-fitful periods of
both day and night sleeping with drowsiness and exhaustion, leaving
the patient physically and mentally debilitated.
[0006] In recent years it has been found that various forms of
positive airway pressure during sleep can be an effective form of
therapy for the apnea sufferer. Ventilation can be applied in the
form of Continuous Positive Airway Pressure (CPAP) in which a
positive pressure is maintained in the airway throughout the
respiratory cycle, Bilevel Positive Airway Pressure (BiPAP) in
which positive pressure is maintained during inspiration but
reduced during expiration, and Intermittent Mechanical Positive
Pressure Ventilation in which pressure is applied when an episode
of apnea is sensed. Positive airway pressure devices have
traditionally employed either a face mask which only covers the
patient's nose, or nasal pillows as the interface between the
ventilation device and the patient's airway. However, there are
problems with both of these interfaces.
[0007] The face mask requires a harness, headband, or other
headgear to keep the mask in position, which many patient's find
uncomfortable, particularly when sleeping. The face mask must seal
the mask against the patient's face, and may cause irritation and
facial sores, particularly if the patient moves his head while
sleeping, causing the mask to rub against the skin. Face masks are
also position dependent, and may leak if the mask changes position
with movement of the patient's head. The face mask applies pressure
to the sinus area of the face adjacent to the nose, causing the
airways to narrow, thereby increasing the velocity of flow through
the airway, but decreasing the pressure against the nasal mucosal
walls. This strips moisture from the mucosal wall during
inspiration, thereby causing drying and a burning sensation. These
factors will often result in the patient's removal of the mask and
discontinuance of positive airway pressure therapy.
[0008] Nasal pillows are pillowed style nasal seals which are
pressed against the inferior portion of the nares to close the
nostril openings. Nasal pillows require a headband or harness to
maintain the pressure, resulting in the same patient discomfort
noted with face masks. Nasal pillows have about a 0.25'' internal
diameter at the nasal entry port where the seal is made. Therefore,
pressurized air must pass through a constricted port, increasing
the velocity of airflow, with resultant drying and burning of the
nasal airways. The narrowed interface diameter of the nasal pillows
causes a pressure drop, which is directly proportional to the drop
in the number of available air molecules within the closed system.
It is the volume of air molecules at the area in the patient's
throat where the apneic events appear that is needed to correct
apnea. The narrower the airways or the internal diameter of the
nasal interface, the lower the volume of air molecules that will be
available and the greater the driving pressure that is required to
meet the volume demand. An increase in driving pressure does not
fully compensate for the loss in the number of air molecules
available.
[0009] A further problem with existing ventilation devices is that
the carbon dioxide bleed ports for venting exhaled gases are noisy
on both nasal face masks and nasal pillows. The whistling noise
that occurs while utilizing such devices can prove quite annoying
to the patient, awakening the patient and causing the patient to
discontinue use of the ventilation device.
[0010] A number of devices have been proposed which include a
ventilation interface for supplying gases to be inhaled, for
collecting exhaled gases, or for mounting sensors for measuring or
monitoring respiratory function.
[0011] U.S. Pat. Nos. 5,335,654 and 5,535,739, issued on Aug. 9,
1994 to Rapoport and Jul. 16, 1996 is to Rapoport et al.,
respectively, describe a CPAP system using a conventional nasal
mask, the innovation comprising a flow sensor in the input line
connected to a signal processor to determine the waveform of
airflow, which is connected to a flow controller to adjust the
pressure of airflow as required. U.S. Des. Pat. No. 333,015, issued
Feb. 2, 1993 to Farmer et al. shows an ornamental design for a
nasal mask. U.S. Des. No. 262,322, issued Dec. 15, 1981 to Mizerak,
shows an ornamental design for a nasal cannula with a mouth
mask.
[0012] U.S. Pat. No. 4,782,832, issued Nov. 8, 1988 to Trimble et
al., discloses nasal pillows held in the patient's nose by a
harness arrangement, the device having a plenum with two accordion
or bellows shaped nipples for fitting against the nostril openings.
U.S. Pat. No. 4,774,946, issued Oct. 4, 1988 to Ackerman et al.,
teaches a nasal and endotracheal tube apparatus for administering
CPAP to infants, the nose tubes having a bulbous portion for
seating in the pares of an infant and a headband with a Velcro.RTM.
closure for supporting the cannula and supply tubes.
[0013] U.S. Pat. No. 5,269,296, issued to Landis on Dec. 14, 1993,
and U.S. Pat. Nos. 5,477,852 and 5,687,715, issued to Landis et al.
on Dec. 26, 1995, and Nov. 18, 1997, respectively, describe CPAP
devices for the treatment of sleep apnea with relatively stiff or
rigid nasal cannulae or prongs surrounded by inflatable cuffs to
retain the cannulae in the pares, but which also may be
supplemented by an inflatable head harness to position the cannulae
and hold them in place, the two cannulae being joined by a conduit
having vent holes to vent exhaled air. U.S. Pat. No. 5,533,506,
issued Jul. 9, 1996 to the present inventor, discloses a nasal
tube: assembly in which the tubes are tapered, frustro-conical
assemblies with a soft membrane over the distal tip and a washer at
the base of the nasal tube to prevent the tubes from falling
through a support bar connected to a harness, the nasal tubes
forming a positive seal with the inside of the nostrils to prevent
the escape of gases.
[0014] U.S. Pat. No. 5,682,881, issued Nov. 4, 1997 to Winthrop et
al., shows a nasal cannula for CPAP therapy with cone shaped nasal
prongs in which the cannula is secured to the patient's upper lip
by adhesive tape strips. U.S. Pat. No. 4,915,105, issued Apr. 10,
1990 to Lee, teaches a miniature respiratory breather apparatus in
which relatively stiff or rigid nasal tubes have elastomeric
packings for sealing the tubes in the nares.
[0015] Several patents describe improvements to nasal cannulae, but
without sealing the nose tubes against the nostrils to prevent
leakage of gas, including: U.S. Pat. No. 3,513,844, issued May 26,
1970 to Smith (metal strip in cannula cross-tube to retain
configuration matching patient's lip); U.S. Pat. No. 4,106,505,
issued Aug. 15, 1978 to Salter et al. (cannula body with ends
extending upward and rearward); U.S. Pat. No. 4,915,104, issued
Apr. 10, 1990 to Marcy (clasp with lanyard supporting supply tubes
to ease pressure on ears); U.S. Pat. No. 5,025,805, issued Jun. 25,
1991 to Nutter (cylindrical soft sponge cuff around supply tubes to
ease pressure and prevent skin injuries); U.S. Pat. No. 5,046,491,
issued Sep. 10, 1991 to Derrick (device for collecting gases
exhaled from both nose and mouth); U.S. Pat. No. 5,335,659, issued
Aug. 9, 1994 to Pologe (device for mounting optical sensor on nasal
septum); U.S. Pat. No. 5,509,409, issued Apr. 23, 1996 to
Weatherholt (nasal cannula with face guards); U.S. Pat. No.
5,572,994, issued Nov. 12, 1996 to Smith (rotatable coupling in
supply tubing); U.S. Pat. No. 5,636,630, issued Jun. 10, 1997 to
Miller et al. (support for supply tubes); U.S. Pat. No. 5,704,916,
issued Jan. 6, 1998 to Byrd (novel head strap for nasal cannula);
and U.S. Pat. No. 5,704,799, issued Apr. 21, 1998 to Nielsen
(device with one-way flow through cannula and flow restrictor to
equalize flow into two nose members).
[0016] None of the above inventions and patents, taken either
singly or in combination, is seen to describe the instant invention
as claimed. Thus a ventilation interface for sleep apnea therapy
solving the aforementioned problems is desired.
SUMMARY OF THE INVENTION
[0017] The ventilation interface for sleep apnea therapy interfaces
a ventilation device which provides positive airway pressure
(either continuous, bilevel, or intermittent) with the patient's
airways. The ventilation interface includes a pair of nasal inserts
made from flexible, resilient silicone which are oval shaped in
cross-section and slightly tapered from a base proximal the
ventilation supply to the distal tip end. A bead flange is disposed
about the exterior of each insert at the distal end of the insert.
A bleed port for release of exhaled air is defined through a
conical vent projecting normally to the path of the incoming air
flow, and continues through a nipple extending to the exterior of
the air conduit. In one embodiment, a pair of nasal inserts are
integral with a nasal cannula body, with bleed ports axially
aligned with each insert. In another embodiment, each insert is
independently connected to a separate, thin-walled, flexible supply
line.
[0018] Advantageously, the construction of the nasal inserts
permits the ventilation interface to be retained in the patient's
nares without requiring a harness, head strap, or other-retaining
device. The nasal inserts do not merely-seal the base of the
nostrils, but are inserted into the nostrils farther than nasal
pillows, as far as the nasal mucosal membrane, and are retained by
resilient expansion of the inserts, the flanges engaging notches in
the nares, together with the pressure of incoming air, which forms
a positive seal to prevent the leakage of air past the inserts. The
nasal inserts are constructed according to specifications which
permit the inserts to be relatively thin-walled, and are oval
shaped in cross-section to conform to the shape of the nostrils.
This construction permits the nasal inserts to have a large
internal diameter in order to pass a greater volume of air than
nasal pillows or prongs, without significant narrowing of the air
passages, thereby maintaining lateral pressure, and avoiding drying
and burning of the patient's nasal passages, as well as supplying a
sufficient number of air molecules at the desired pressure to keep
the patient's airways patent. Consequently, the ventilation device
is more comfortable for the patient to wear while sleeping than
conventional positive airway pressure devices, but at the same time
is more effective in treating the patient's apnea.
[0019] The bleed ports are specially designed to avoid the
whistling noises commonly experienced with conventional nasal masks
and nasal pillows. By projecting the vent structure into the air
passage normal to the direction of the air flow from the supply
tubes, incoming air must turn ninety degrees and exit through a
long, restricted diameter bleed port to vent to the atmosphere,
eliminating whistling noises to increase patient comfort. In the
embodiment having a nasal cannula body, the bleed ports are axially
aligned with the nasal inserts, providing CO.sub.2 with a direct
path to exit the cannula body. When the nasal inserts are attached
to independent supply tubes, the bleed ports are at the base of the
nostrils, providing essentially normal exhalation.
[0020] When the nasal inserts are directly connected to the supply
tubes, the nasal inserts may be even more thin-walled than when
attached to a cannula body, resulting in an even greater volume of
air supplied through the cannula body, up to a 20% increase in
volume. In this case the supply tubes may be similar to heat-shrink
tubing, being made from a very thin-walled thermoplastic is
material that is lightweight and flexible so that the supply tubing
may collapse when not in use, but will expand to a predetermined
diameter under pressure applied by a ventilator.
[0021] Accordingly, it is an object of the invention to provide a
ventilation interface for sleep apnea therapy having nasal inserts
which seal against the nares and do not require a harness, head
strap, or other external devices to maintain pressure for retaining
the inserts in or against the patient's nostrils.
[0022] It is another object of the invention to provide a
ventilation device having nasal inserts made of flexible, resilient
plastic with a bead flange for retaining the inserts in the nares,
wherein the walls of the insert are thin-walled and maintain
lateral pressure in the nares in order to provide a greater
internal diameter for the delivery of a greater volume of air
molecules at a constant delivery pressure and without forcing
ventilation gases through restricted ports or passageways so that
drying and burning of the patient's nasal airways is avoided while
delivering a therapeutic volume of air to maintain the apneic
patient's airways in a patent condition.
[0023] It is a further object ventilation interface for sleep ports
to avoid whistling noises at the interface a vent passage for
expired air.
[0024] Still another object of the invention is to provide a
ventilation interface which is lightweight and comfortable so that
the apnea patient is not tempted to discard the ventilation device
is while sleeping.
[0025] It is an object of the invention to provide improved
elements and arrangements thereof for the purposes described which
is inexpensive, dependable and fully effective in accomplishing its
intended purposes.
[0026] These and other objects of the present invention will become
readily apparent upon further review of the following specification
and drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0027] Advantages of embodiments of the present invention will be
apparent from the following detailed description of the exemplary
embodiments. The following detailed description should be
considered in conjunction with the accompanying figures in
which:
[0028] FIG. 1 is a front environmental view of a ventilation
interface for sleep apnea therapy according to the present
invention.
[0029] FIG. 2A is an exploded elevational of a ventilation
interface according to the present invention.
[0030] FIG. 2B is a perspective view of a ventilation interface
embodied in a nasal cannula body according to the present
invention.
[0031] FIG. 3 is a section view along the lines 3-3 of FIG. 2A.
[0032] FIG. 4 is a section view along the lines 4-4 of FIG. 2A.
[0033] FIG. 5 is a section view along the lines 5-5 of FIG. 2A.
[0034] FIG. 6 is a perspective view of an embodiment of the
ventilation interface with the nasal inserts incorporated into
independent supply tubes.
[0035] FIGS. 7A-7B illustrate an exemplary embodiment of a nasal
insert for a respiratory interface.
[0036] FIGS. 8A-8E illustrate another exemplary embodiment of a
respiratory interface and nasal inserts for a respiratory
interface.
[0037] FIGS. 9A-9B illustrate another exemplary embodiment of a
respiratory interface.
[0038] FIGS. 10A-10C illustrate additional exemplary embodiments of
a nasal insert for a respiratory interface.
[0039] Similar reference characters denote corresponding features
consistently throughout the attached drawings.
DETAILED DESCRIPTION
[0040] Aspects of the invention are disclosed in the following
description and related drawings directed to specific embodiments
of the invention. Alternate embodiments may be devised without
departing from the spirit or the scope of the invention.
Additionally, well-known elements of exemplary embodiments of the
invention will not be described in detail or will be omitted so as
not to obscure the relevant details of the invention. Further, to
facilitate an understanding of the description discussion of
several terms used herein follows.
[0041] As used herein, the word "exemplary" means "serving as an
example, instance or illustration." The embodiments described
herein are not limiting, but rather are exemplary only. It should
be understood that the described embodiment are not necessarily to
be construed as preferred or advantageous over other embodiments.
Moreover, the terms "embodiments of the invention", "embodiments"
or "invention" do not require that all embodiments of the invention
include the discussed feature, advantage or mode of operation.
[0042] The present invention is a ventilation interface for sleep
apnea therapy, designated generally as 10 in the drawings. The
ventilation interface 10 provides an interface for connecting a
ventilation device which provides positive airway pressure (either
continuous, bilevel, or intermittent) with the patient's airways.
As shown in FIGS. 1 and 2A, the ventilation interface 10 includes a
conventional adapter or Y-connector 12 having a first end adapted
to receive a supply hose 14 from a mechanical ventilator (not
shown) and a second end having a pair of ports 16 with barbed
connectors for attachment to two supply tubes 18. Supply tubes 18
may be, e.g., 0.3125'' ID (inside diameter) flexchem tubing, made
of polyvinyl chloride or other conventional gas supply tubing. For
sleep apnea therapy, the mechanical ventilator will usually supply
room air at a pressure of between five and fifteen centimeters of
water. The room air may be supplemented with oxygen if desired by
splicing an oxygen supply line into supply hose 14 or using a
triple port connector in lieu of Y-connector 12. It is normally
unnecessary to humidify or add moisture to the air supplied by the
mechanical ventilator in using the ventilation interface 10 of the
present invention, as the interface 10 is designed to avoid
stripping moisture from the nares, so that moisture does not have
to be added to relieve patient discomfort from drying or burning
sensation in the nasal airways.
[0043] In the embodiment shown in FIGS. 1 and 2A, the ends of the
supply tubes distal from the Y-connector 12 are attached to
opposite ends of a nasal cannula body 22 by barbed connectors 20.
Barbed connectors 20 preferably have an inside diameter
substantially equal to the inside diameter of supply tubes 18 in
order to prevent any constriction or narrowing of the air passage
which may cause increased velocity in air flow. Nasal cannula body
22, described more fully below, has a pair of nasal inserts 30
which are inserted into the nares of the patient P). The supply
tubes may be looped over the patient's ears and joined to the Y
connector 12, which may be suspended at about the patient's chest
level when the patient is standing, as shown in FIG. 1. For
Bi-level Positive Airway Pressure (BiPAP) or Intermittent
Mechanical Positive Pressure Ventilation therapy, a suitable valve
may be connected between the supply tubes 18 and the cannula body
22. An exemplary valve is described in the Applicant's prior
application, Ser. No. 09/524,371, filed Mar. 13, 2000, which is
hereby incorporated by reference in its entirety.
[0044] The nasal cannula body 22 is shown in greater detail in FIG.
2B. The cannula body 22 is an arcuate, hollow, body having
substantially flat top wall 22a and flat sidewalk 22b merging with
a semi-cylindrical bottom wall 22c defining an air chamber 22d
(seen more clearly in FIG. 3) for the passage of air and other
gases, and having cylindrical tubes 24 at opposite ends which
receive one end of the barbed connectors 20. A notch 26 is defined
transversely across the top wall 22a of the cannula body 22,
defining a pair of mounting pads 28. A pair of nasal inserts 30 are
formed integral with the mounting pads 28. The nasal inserts 30 are
hollow and form a continuous flow path or conduit for the passage
of inhaled and exhaled gases between the patient's nasal air
passages and the air chamber 22d.
[0045] The nasal inserts are shown in greater detail in FIGS. 3, 4,
and 5. The nasal inserts 30 are substantially oval in
cross-section, with the major axis substantially parallel with the
notch and the minor axis normal to the notch. The nasal inserts 30
taper slightly from a wide base 32 proximal the cannula body 22 to
the open distal tip ends 34. The nasal inserts 30 have a flange 36
about the distal tip ends 34 on the exterior surface of the inserts
30, which may be formed as a semi-cylindrical bead.
[0046] The cannula body 22, including the nasal inserts 30, are
preferably made from silicone elastomer. The cannula body 22 or air
chamber 22d has an internal diameter of at least 0.3125 inches
throughout its length. The walls of the nasal inserts 30 may be
thinner than the top wall 22a. The thickness of the walls of the
nasal inserts 30 are preferably between about 1/32 and 1/20 inches.
The thickness of the walls at the flange 36 may be about 1/16
inches. The hardness of the walls of the nasal insert 30, as tested
on a type A Shore durometer, may range between about 15 and 40,
preferably about 30. If the walls of the nasal inserts 30 are made
any thinner, they will fail to have sufficient integrity, and if
made any thicker, they will have insufficient flexibility to form a
seal against the nares. The thinness and softness of the nasal
inserts 30 make them virtually unnoticeable while in the nostrils.
For an adult patient, the nasal inserts may have a height of
between about 0.25 and 0.75 inches. The internal diameter of the
nasal inserts 30 may measure about 0.75'' on the major axis and 0.5
on the minor axis, allowing for generous laminar air flow and
delivering pressure more by volume of air molecules than velocity
of air flow, and deliver about double the volume of nasal pillows,
which have a round internal diameter of, for example, about 0.25
inches. Nasal pillows cannot be made with such large internal
diameters, because it becomes difficult to create a seal under the
bottom of the nose, as the pillows would have an internal diameter
larger than the internal diameter of the nares, and the pillows are
not as flexible as the nasal inserts 30 of the present
invention.
[0047] In use, the nasal inserts 30 are inserted up the patient's
nostrils until the flanges 36 lodge against the mucous membranes.
As such, the nasal inserts 30 are considered an invasive device.
Testing has confirmed that the nasal inserts 30 are biocompatible
and meet regulatory requirements. The nasal inserts are retained in
the patient's nares by the flanges 36, by the flexibility and
resiliency of the silicone elastomer, and by lateral pressure of
the room air, which is maintained at between five and fifteen
centimeters of water. The oval cross-section of the nasal inserts
30 is shaped to conform to the normally oval shape of the nares.
The relative large internal diameter of the nasal inserts 30
permits air to be supplied to the patient's airways in sufficient
volume at the driving pressure without accelerating the rate of
airflow that the patient has sufficient positive airway pressure to
be of therapeutic value in maintaining the patient's airways patent
during an episode of obstructive apnea without drying the nasal
passages. The notch 26 in the top wall 22a of the cannula body 22
lends additional flexibility to the cannula body 22, so that the
nasal cannula 22 can be adjusted for deviated septums, thick
septum, and other anatomical variations in the configuration of the
nostrils.
[0048] The cannula body 22 has a pair of bleeder ports 38 disposed
in the bottom wall 22c directly below and axially aligned with the
nasal inserts 30. The bleeder ports are formed by an upper
conically shaped nipple 40 extending upward into the air chamber
22d, and a lower conically shaped nipple 42 extending below the
bottom wall 22c. The bleeder port has an internal diameter of about
three millimeters and extends for a length of about 0.25 inches.
The upper nipple 40 extends about 0.125 inches into the air chamber
22d. The internal diameter of the bleeder port 38 is ample to
permit venting of carbon dioxide exhaled by the patient while not
being so large as to cause a significant pressure drop in the
cannula body 22, and axial alignment of the bleeder port 38 with
the nasal inserts 22 creates a direct path for venting of the
expired gases. At the same time, laminar flow of air supplied by
the supply tubes is normal to the bleeder ports 38, so that air
supplied by the ventilator must bend ninety degrees to exit through
the elongated bleeder port 38. The effect of this construction is
that the bleeder port 38 is virtually silent in operation,
eliminating the whistle associated with bleeder holes in
conventional ventilation interfaces.
[0049] FIG. 6 is a generally diagrammatic view of an alternative
embodiment of the ventilation interface, designated 50 in the
drawing. In this embodiment, each nasal insert 52 is connected to a
separate supply tube 54, the supply tubes 54 being connected to the
mechanical ventilator supply hose 56 by a suitable Y-connector 58
or adapter, the cannula body 22 and common air chamber 22d being
omitted. The nasal inserts 52 have substantially the same
construction as nasal inserts 30, being oval in cross-section and
having a similar height and an annular flange 60 about the distal
tip for lodging the nasal insert 52 in a naris. The nasal insert 52
is also made from silicone elastomer, and has the same softness,
thickness, flexibility and resilience as the nasal insert 30. In
this configuration, since the inserts are not connected to the
cannula body 22, the angle at which the inserts 52 enter the
nostrils is not restricted by the cannula body 22, and therefore
the nares can accept a greater displacement, and may accommodate a
20% greater volume of air molecules through the insert 52 than the
insert 30.
[0050] In this embodiment, the supply tubes 54 may be made from a
flexible, lightweight, but relatively inelastic thermoplastic
material, similar to heat shrink tubing, so that the supply tubes
54 may be at least partially collapsed in the absence of pressure
from the mechanical ventilator, but expand to their maximum
diameter under a pressure of between five to fifteen centimeters of
water. The lightweight of the supply tubes 54 decreases any
pressure on the patient's ears resulting from the weight of the
supply tubes, increasing patient comfort. The bleeder ports 62 have
a similar construction to the bleeder ports 38, having an internal
nipple 65 normal to the axis of the nasal insert 52 and an external
nipple 64, the bleeder ports 62 being just above the base of the
inserts 52 and normal to the flow of supply air through the inserts
52.
[0051] It will be understood by those skilled in the art that the
dimensions of the nasal inserts 30 and 52, and of the bleeder ports
38 and 62, are representative dimensions for a ventilation
interface 10 or 50 designed for adults, and that the ventilation
interface 10 or 50 may be made with correspondingly reduced
dimensions for teenage children, preteens, and infants. It will
also be understood that the nasal inserts 30 and 52 may be made
from thermoplastic elastomers other than silicone, providing that
the material has similar softness, resilience, flexibility, and
biocompatibility. It will also be understood by those skilled in
the art that the nasal inserts 30 and 52, although illustrated in
conjunction with ventilation devices for the treatment of sleep
apnea, may be used in any other application where it is desirable
to have an interface forming a seal between at person's nasal
airways and a ventilation or gas collection device, including, but
not limited to, rescue breathing apparatus used by firefighters and
other emergency personnel, scuba diving tanks, etc.
[0052] FIGS. 7A-7B illustrate an exemplary embodiment of a nasal
insert 700 for a respiratory interface. The nasal insert may
include a hollow body 702, an inlet aperture 704 for allowing gas
to enter hollow body 702, and a nasal aperture 706 for allowing gas
to exit hollow body 702 toward the patient. The nasal insert 700
may have a generally oval shape to facilitate conforming to the
shape of the patient's nostril; however, other regular or irregular
shapes may be provided. In some exemplary embodiments, a nasal
interface can have a single nasal insert 700, as shown in FIGS.
7A-7B. In other exemplary embodiments, a nasal interface can have
two nasal inserts 700 as described further below. In some exemplary
embodiments, the two nasal inserts 700 may be provided separately.
In other exemplary embodiments, the two nasal inserts 700 may be
connected, as described further below.
[0053] Nasal insert 700 can have at least one weight-reducing
structure 708. The weight reducing structures 708 can include
indentations or apertures, such as slots, perforations, and like
openings that may function to reduce the weight or structure of the
nasal insert. The weight reducing structures 708 may be provided in
any number, orientation, or combination. In use, nasal insert can
function to open the nasal passage to improve airflow and reduce
resistance.
[0054] Nasal insert 700 can be inserted into the patient's nostril
and may form a seal therewith. The fit between nasal insert 700 and
the nostril may be sufficient to retain a portion of the nasal
insert within a portion of the nostril. In some exemplary
embodiments, nasal insert 700 can act as a stent and can compensate
for or correct a deviated septum.
[0055] In some exemplary embodiments, the nasal insert may have a
connection area 710. Connection area 710 may be utilized to connect
a headgear (e.g. a strap or the like) to the nasal insert to
facilitate supporting the nasal insert 710 as well as creating
and/or assisting the seal. In other exemplary embodiments, a
headgear could be formed integrally with the respiratory interface
having at least one nasal insert 710. Connection area 710 may also
be utilized to connect a chin strap to support the interface or
limit a patient's ability to open the mouth. In other exemplary
embodiments, a chinstrap could be formed integrally with the
respiratory interface having at least one nasal insert 710.
Furthermore, in some exemplary embodiments, a chin strap or chin
flap may be attached to any of the invention embodiments to
facilitate keeping the mouth of the patient closed.
[0056] FIG. 8A illustrates an exemplary embodiment of a respiratory
interface 800 having a pair of nasal inserts 802 that may be joined
by a connecting member 804. Connecting member 804 can be provided
as a separate component or could be formed integrally with nasal
inserts 802. Connecting member 804 can have a rectangular
cross-section, a circular cross-section, or any other
cross-section. Each nasal insert 802 may have a flange 806 on the
end having a nasal aperture 808. An exemplary nasal insert with a
flange is described in U.S. patent application Ser. No. 10/044,925,
filed Jan. 15, 2002, which is hereby incorporated by reference in
its entirety.
[0057] During use, nasal insert 802 may be retained by flange 806,
by the flexibility and resiliency of nasal insert 802 and/or flange
806, or by a combination thereof. In some exemplary embodiments,
flange 806 may be in the form of a bead or a thin wiping detail and
may facilitate sealing within the nostril. In some exemplary
embodiments, flange 806 may be detachably coupled to the nasal
insert.
[0058] In some exemplary embodiments, nasal insert 802 may further
include a valve 810. FIGS. 8B-8C show an exemplary embodiment of a
valve 810 located near the nasal aperture 808 of the nasal insert.
In this location, the distance between the valve and the nasal
aperture may be minimized, thereby facilitating the creation of a
smaller deadspace volume. The air that is exhaled by the patient
can be trapped in this deadspace. Valve 810 may formed integrally
with the nasal insert or may be assembled to the nasal insert.
[0059] FIGS. 8D-8E show an exemplary embodiment of a valve 812
located near the inlet aperture 814 of the nasal insert. Valve 812
may formed integrally with the nasal insert or may be assembled to
the nasal insert. Valves 810 and 812 may be assembled between the
nasal insert 802 and a second component, such as, for example, a
flange 806 or an inlet aperture cover 816 respectively. In some
exemplary embodiments, valve 812 may be attached to an inlet
aperture cover 816 by any desired coupling, such as, for example,
by assembly or by overmolding. The inlet aperture cover 816 may
then be coupled to the nasal insert 802, for example at a valve
receptacle 818.
[0060] FIGS. 9A-9B illustrate another exemplary embodiment of a
respiratory interface 900. Respiratory interface 900 can include a
pair of nasal inserts 902 coupled to and in communication with a
chamber 904. Chamber 904 may be hollow and may be adapted to reduce
deadspace, for example by constructing chamber 904 to be
substantially small. In some exemplary embodiments, chamber 904 may
have one valve 906 for both nasal inserts 902. In other exemplary
embodiments (not shown), chamber 904 may have one valve
corresponding to each insert 902. Chamber 904 may have a thinner
top wall 908 disposed between the nasal inserts 902 to facilitate
increasing the flexibility of chamber 904 so as to better conform
to a patient's nostril configuration. In some exemplary
embodiments, each nasal insert 902 may further have a flange 910 on
the nasal aperture end 912 thereof.
[0061] In some exemplary embodiments, multiple sizes of nasal
inserts and/or flanges can be provided so as to allow for fitting
different sizes of nostrils. The taper, shape, length, thickness,
material, durometer, and other characteristics of a nasal insert
and/or flange may be varied in design and construction as needed.
FIG. 10A shows an exemplary embodiment of a nasal insert 1000,
where a second flange 1002 may be coupled to nasal insert 1000 over
a first flange 1004 so as to offer two different size
configurations. FIG. 10B shows another exemplary embodiment of a
nasal insert 1000 having an outer nasal insert sleeve 1006 coupled
to nasal insert 1000 so as to offer two different size
configurations. A second flange 1002 or an outer nasal insert
sleeve 1006 may be coupled to nasal insert 1000 through any means
known to one skilled in the art. FIG. 10C shows another exemplary
embodiment of a nasal insert 1008 having multiple flanges 1010.
[0062] It should be understood that a valve may be incorporated
into any of the embodiments described herein. An exemplary valve is
described in the U.S. patent application Ser. No. 09/524,371, filed
Mar. 13, 2000, which is hereby incorporated by reference in its
entirety. The valve may allow air to pass through the nasal insert
during inhalation, but may also work to prevent air from passing
through the nasal insert during exhalation. The valve may serve to
resist flow (i.e. increase resistance) in one direction. Increased
resistance during exhalation may create a back pressure inside the
patient's airway. In some exemplary embodiments, the valve may be
replaceable. Features in the respiratory interface, such as ribs or
walls, or separate components, such as the inlet aperture cover,
may serve to limit or control the movement range of the valve.
[0063] Various valve types configured to allow gas passage in one
direction can be utilized, e.g., a flapper valve, a check valve, a
biased valve, a pucker valve, a duckbill valve, a dome valve,
spring-loaded valve, propeller valve, shuttle valve, plunger valve,
piston valve, or any other valve known in the art that enables the
nasal interface to function as described herein. Valves that open
when a certain pressure is reached (i.e. "cracking pressure") can
also be utilized. Also, valves that have electronic adjustment can
be utilized.
[0064] The embodiments disclosed herein may have at least one bleed
port for expelling or exhausting gas. The bleed port may be of
sufficient size and dimension to allow the patient's exhalation to
exhaust from the interface. The bleed port can be located on any
portion of the respiratory interface. For example, the bleeder port
may be located at or proximate the valve or between the valve and
the nasal aperture.
[0065] Various materials may be used to construct the respiratory
interface. Exemplary materials for any of the components of the
interface may include silicone, plastic, composite, or any material
known to those of ordinary skill in the art. Some materials such as
foams and gels may facilitate a design that could fit a wider range
of nostrils. In some exemplary embodiments, the contact surface of
the flange may have a silicone exterior and may be filled with gel
or foam. In some exemplary embodiments, fabric may be used for at
least a portion of the respiratory interface, for example for the
chamber. In some exemplary embodiments, a portion of the
respiratory interface could be inflatable or air-filled, for
example the nasal insert.
[0066] Securing the respiratory interface may be accomplished in
various ways. Securing the respiratory interface via the nasal
insert shape, the materials, a flange, and/or headgear, have
previously been described. Other ways of securing the respiratory
interface, such as an over-nose strap, over-nose clip or spring,
adhesive, septum clip or spring, or intra-nasal clip or spring,
could alternatively be utilized.
[0067] While the embodiments described herein have been in the form
of a nasal insert, it is envisioned that any style of interface
could be combined with a valve. This can include, but isn't limited
to, full-face masks, nasal masks, nasal prong interfaces, oral
masks, and hybrid masks (i.e., combined masks such as an oral mask
with nasal prongs or a nasal mask with nasal prongs). Exemplary
masks are described in U.S. Patent Applications 2002/0059935,
2006/0124131, 2006/0174887, 2007/0221226, 2007/0272249,
2008/0011305, and 2009/0107506, the disclosures of which are
incorporated by reference herein in their entireties. As previously
mentioned, the valve in larger interfaces may be improved if the
valve is located substantially close to the patient's nose and/or
mouth to minimize deadspace.
[0068] While embodiments described herein may be connected with a
gas supply, mechanical ventilator, or PAP machine, the respiratory
interface may function without being connected. The valve can
allows the patient to generate the positive airway pressure needed
for the treatment as previously described.
[0069] It is to be understood that the present invention is not
limited to the embodiments described above, but encompasses any and
all embodiments within the scope of the following claims.
* * * * *