Title: Nasal ventilation interface
Abstract: A nasal ventilation interface comprising a hollow body having at least one and preferably two nasal apertures, and at least one and preferably two inhale apertures, and at least one and preferably two nasal insert tubes each associated with one of the nasal apertures and having an annular sleeve that forms a seal with a nostril of the patient. The hollow body has at least one and preferably two exhale apertures and at least one valve assembly associated with the exhale apertures that are capable of preventing air from passing through the exhale aperture upon the patient inhaling and allowing air to pass through the exhale aperture upon exhaling. The hollow body may also have at least one and preferably two filters for retaining heat and moisture from the exhale air and transferring the retained heat and moisture into the inhale air.
Patent Number: 6,863,069 Issued on 03/08/2005 to Wood
| Inventors:
|
Wood; Thomas J. (Waycross, GA)
|
| Assignee:
|
InnoMed Technologies, Inc. (Boca Raton, FL)
|
| Appl. No.:
|
364388 |
| Filed:
|
February 12, 2003 |
| Current U.S. Class: |
128/207.18 |
| Intern'l Class: |
A61M 016//00; 206.18; 204.12; 206.11 |
| Field of Search: |
128/200.24,207.12,207.13,207.18,207.16,205.27,205.29,205.24,206.15,206.16
600/529,538,532
|
References Cited [Referenced By]
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|
Primary Examiner: Bennett; Henry
Assistant Examiner: Mitchell; Teena
Attorney, Agent or Firm: Keady, Olds & Maier, PLLC
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No.
10/044,925, file date Jan. 15, 2002, currently pending, which is a
continuation-in-part of U.S. patent application Ser. No. 09/524,371, file
date Mar. 13, 2002 issued as U.S. Pat. No. 6,478,026, on Nov. 12, 2002,
the disclosures of which are incorporated by reference herein in their
entirety.
Claims
What is claimed is:
1. A ventilation interface to be inserted into a nasal passage of a user to
secure the interface, comprising:
a cannula connectable to a source of ventilation gas at a positive
pressure;
at least one flexible nasal insert adapted to be inserted into the nasal
passage, the at least one nasal insert forming a portion of a first gas
flow passage from the cannula to a distal end of the at least one nasal
insert for supplying the ventilation gas to the user; and
at least one non-tapered seal portion provided adjacent to the distal end
of the at least one nasal insert,
wherein the at least one nasal insert is flexible such that the at least
one non-tapered seal portion is adapted to engage an interior portion the
nasal passage of the user.
2. The ventilation interface according to claim 1, wherein the at least one
nasal insert comprises two nasal inserts, and each of the two nasal
inserts is adapted to be inserted into a corresponding nares of the nasal
passage.
3. The ventilation interface according to claim 2, wherein the at least one
seal portion comprises two seal portions, and each of the two seal
portions corresponds to one of the two nasal inserts and is provided
adjacent to one of the corresponding distal ends.
4. The ventilation interface according to claim 3, wherein each of the two
nasal inserts has a substantially oval cross section at the distal end.
5. The ventilation interface according to claim 4, wherein each of the two
nasal inserts is tapered from a portion adjacent the cannula to the distal
end.
6. The ventilation interface according to claim 5, wherein each of the
portions adjacent the cannula has a circumference that is greater than a
circumference of the corresponding distal end.
7. The ventilation interface according to claim 1, wherein the at least one
seal portion has a maximum circumference greater than a circumference of
the distal end.
8. The ventilation interface according to claim 7, wherein the at least one
seal portion comprises a bead having a substantially arcuate cross
section.
9. The ventilation interface according to claim 8, wherein the at least one
nasal insert comprises two nasal inserts, the at least one seal portion
comprises two seal portions, each of the two seal portions corresponds to
one of the two nasal inserts and is provided adjacent to one of the
corresponding distal ends, and each of the two seal portions has a
circumference greater than a circumference of the corresponding distal
end.
10. The ventilation interface according to claim 1, further comprising:
at least one air output forming a second gas flow passage from the cannula
to an exterior of the interface for channeling gas expired by the user.
11. The ventilation interface according to claim 10, wherein the at least
one air output is substantially aligned with the at least one nasal
insert.
12. The ventilation interface according to claim 11, wherein the at least
one air output comprises an interior wall extending from the cannula into
the first gas flow path.
13. The ventilation interface according to claim 12, wherein the at least
one nasal insert comprises two nasal inserts, the at least one air output
comprises two air outputs, and each of the two air outputs is
substantially aligned with the corresponding nasal insert.
14. The ventilation interface according to claim 13, wherein the two nasal
inserts and the two air outputs are unitary with the cannula.
15. The ventilation interface according to claim 12, wherein the at least
one air output comprises an exterior wall extending from the cannula to
the exterior of the interface.
16. The ventilation interface according to claim 15, wherein the at least
one seal portion comprises two seal portions, and each of the two seal
portions corresponds to one of the two nasal inserts.
17. The ventilation interface according to claim 16, wherein each of the
two nasal inserts has a substantially oval cross section at the distal end
and is tapered from a portion adjacent the cannula to the distal end, and
the portion adjacent the cannula has a circumference that is greater than
a circumference of the corresponding distal end.
18. The ventilation device according to claim 15, wherein the interior wall
extends from the cannula a first distance, the exterior wall extends from
the cannula a second distance, and the first distance is less than the
second distance.
19. The ventilation device according to claim 18, wherein the at least one
nasal insert comprises two nasal inserts, the at least one air output
comprises two air outputs, each of the two air outputs is substantially
aligned with one of the corresponding nasal inserts.
20. The ventilation interface according to claim 19, wherein the at least
one seal comprises two seals, and each of the seals corresponds to one of
the two nasal inserts.
21. The ventilation interface according to claim 20, wherein each of the
two nasal inserts has a substantially oval cross section at the distal end
and is tapered from a portion adjacent the cannula to the distal end, and
the portion adjacent the cannula has a circumference that is greater than
a circumference of the distal end.
22. The ventilation interface according to claim 1, wherein the at least
one nasal insert is sufficiently flexible to be expanded by the positive
pressure of the ventilation gas.
23. A ventilation interface to be inserted into a nasal passage of a user
to secure the interface, comprising:
a cannula connectable to a source of ventilation gas at a positive
pressure;
a nasal insert means for forming a gas flow passage for the ventilation gas
from the cannula to the nasal passage of the user, the nasal insert means
adapted to be inserted into the nasal passage; and
a non-tapered sealing means adapted for engaging an interior portion the
nasal passage of the user by expanding.
24. The ventilation interface according to claim 23, wherein the sealing
means for engaging the nasal passage of the user expands due to the
positive pressure of the ventilation gas.
25. A ventilation interface to be inserted into a nasal passage of a user
to secure the interface, comprising:
a cannula connectable to a source of ventilation gas at a positive
pressure;
at least one flexible nasal insert adapted to be inserted into the nasal
passage, the at least one nasal insert forming a portion of a first gas
flow passage from the cannula to a distal end of the at least one nasal
insert for supplying the ventilation gas to the user;
at least one bead-shaped seal portion provided adjacent to the distal end
of the at least one nasal insert,
wherein the at least one nasal insert is flexible such that the at least
one seal portion is adapted to engage an interior portion the nasal
passage of the user.
Description
FIELD OF THE INVENTION
The present invention relates generally to nasal ventilation systems, and
more particularly, to a valved nasal ventilation interface for supporting
respiration.
BRIEF DESCRIPTION OF THE PRIOR ART
Nasal ventilators generally consist of tubes and other means for delivering
gases adapted for use with the nasal or oral passage of a patient.
Typically, a nasal ventilation system comprises a gas source and a
mechanical ventilator such as a continuous positive airway pressure system
(CPAP), bi-level positive airway pressure system (BIPAP), or intermittent
(non-continuous) positive pressure (IPPB). The gas is often room air or
oxygen-enriched air, but can be a mixture of other gases.
The gas is transported by a thin flexible tube made of an inert material.
The tube terminates in an opening which can be inserted into the patient's
nostrils. Typically, a pair of smaller nasal insert tubes protrudes from
the tube or the tube splits at a Y-junction into two smaller tubes, each
smaller nasal insert tube carrying gas to one nostril, thereby increasing
the fraction of inspired oxygen.
Conventional nasal tube systems do not provide a positive seal between the
nasal insert tubes and the nostrils. Most nasal ventilation systems
therefore include a mask that fits over the nose and is intended to
provide a space of oxygen-enriched air for inhalation into the lungs for
respiration. Such systems frequently suffer from air leaking out around
the mask, creating an inability to assure ventilation in many patients.
For example, conventional nasal ventilation systems use head gear and/or
straps to bind the mask in place, but in order to minimize the leakage of
the air the straps must be sufficiently tight. The mask, headgear, and/or
straps thereby exert more than a minor pressure on the patient's face
and/or head, resulting in such masks and headgear tending to be rather
constraining and uncomfortable.
Additionally, most systems are usually very position dependent, whereby if
the mask is moved slightly with respect to the facial contour or with
respect to the nose, air leakage occurs. With such systems, the mask can
become uncomfortable when not in position, thus requiring the patient to
remain rather still in order to alleviate the discomfort and to maintain
oxygen inspiration. As a result many patients lose interest in using the
nasal mask.
Also, some ventilation systems have exhalation valves for the treatment of
breathing problems. Various valve systems have been devised but they all
function similarly. Typically, the exhalation valve is positioned at the
ventilator or in the tubing at least a foot or more from the patient, and
the air that is exhaled by the user is trapped in this "dead space"
between the patient and the valve. Such ventilation systems with exhale
valves are typically bulky and heavy. The patient thus has to have a tidal
volume (breath) that is a little larger than otherwise needed to
compensate for the deadspace. This larger tidal volume is noticeable by
the patient and can be a nuisance while trying to sleep soundly.
Related types of nasal tube systems include low flow oxygen systems which
merely provide oxygen concentration. These systems typically provide nasal
insert tubes that are loosely inserted into the nasal cavities without a
mask. Such systems are low pressure systems for providing oxygen
enrichment to the ambient air that the patient breathes, are not
ventilators (do not provide positive pressure for forced
ventilation/breathing), and could not function as ventilation systems
because of the lack of a seal between the cannula interface and the
patient, the smaller tubing size, and the low pressure of the system.
Additionally, there are no known portable, wearable devices that completely
filter out the allergens that trigger allergic reactions in asthmatics and
allergy sufferers. There are only aerosol treatments and other medications
that treat the symptoms, that is, the allergic reactions themselves.
Furthermore, when a patient presents to an emergency room with severe
bronchial constriction in response to allergens, a bronchodilator is
typically administered to dilate the tracheal airways and bronchioles so
that gas exchange is maintained in the alveoli of the lungs. However, if
bronchial dilation is successful then allergens are also allowed to be
breathed deeper into the bronchioles. Bronchiole constriction is a bodily
reaction to keep any further allergens from reaching the smaller airways.
Forced dilation and deeper penetration of allergens often results in an
even more violent reaction after the bronchodilator has lost some of its
therapeutic effect. This worsened reaction sometimes becomes
life-threatening and can cause death, in particular, to a patient with
status asthmaticus.
Furthermore, present cloth surgical masks typically worn by doctors,
surgeons, and other medical personnel do not filter out many pathogens.
Also, they are hot to the wearer and can obstruct the wearer's view,
especially when looking down during a surgical procedure. Dentists are
concerned with spray and do not trust the presently available surgical
masks.
Accordingly, what is needed but not found in the prior art is a nasal
interface apparatus that can be used with a positive pressure ventilation
system for supporting respiration, that directs substantially all the air
delivered to the nasal interface into the patient's lungs, that is
comfortable and unconstraining to the patient wearer.
SUMMARY OF THE INVENTION
Generally described, the present invention provides a nasal ventilation
interface comprising a hollow body having at least one and preferably two
nasal apertures, at least one and preferably two inhale apertures, at
least one and preferably two connectors each capable of being removably
attached to at least one of preferably two interface tubes, and at least
one and preferably two nasal insert tubes each associated with one of the
nasal apertures of the body and capable of being inserted into a nostril
of a patient. Each nasal insert tube has an annular sleeve with a contact
surface and a diameter that is greater than a diameter of the nasal insert
tube so that each annular sleeve contact surface is thereby capable of
forming a seal with the nostril. The nasal insert tube may be detachably
coupled to the hollow body. There may also be provided a three-way
junction capable of being removably connected to a feed tube.
The hollow body may have at least one exhale aperture and at least one
valve assembly associated with the exhale aperture that is capable of
preventing air from passing through the exhale aperture upon the patient
inhaling and allowing air to pass through the exhale aperture upon
exhaling. The hollow body may also have at least one filter that retains
heat and/or moisture from air passing therethrough upon inhalation and
that transfers the heat and/or moisture to the exhalation air that
subsequently passes therethrough upon exhalation.
In a first embodiment of the present invention, each valve assembly
comprises a valve member pivotally attached to a first inner wall of the
and a second valve member pivotally attached to a second inner wall of the
body opposite the first inner wall. The first and second valve members
overlap and abut each other so that each valve member may pivot in
response to the other valve pivoting. In a second embodiment of the
present invention, each valve assembly comprises a one-way inhale valve
membrane arranged in the body between the nasal aperture and the exhale
aperture or disposed within the inhale aperture, and a one-way exhale
valve membrane disposed within the exhale aperture. In a third embodiment
of the present invention, the body is provided for use without the gas
supply, mechanical ventilator, or tubing, valving may or may not be
provided, and a filter is provided for screening out dust, allergens,
pollen, bacteria, viruses, pathogens, and other air-borne particle matter,
so that the invention may be used as a portable nasal filtration device.
Accordingly, it is an object of the present invention to provide a positive
pressure closed system providing for full ventilation of a patient with
oxygen enrichment capabilities typically provided by low pressure oxygen
concentrator and cannula tubing systems.
It is another object of the present invention to provide a nasal
ventilation interface having improved patient comfort for use over
extended periods.
It is a further object of the present invention to provide a nasal
ventilation interface having increased gas delivery efficiency and with
minimal or no leakage of gas from the nostrils.
It is still another object of the present invention to provide a nasal
ventilation interface having automatic valving for inhaling and exhaling.
It is yet another object of the present invention to provide a nasal
ventilation interface with a valve assembly that decreases the amount of
deadspace that is rebreathed by the patient.
It is yet a further object of the present invention to provide a nasal
ventilation interface that filters the air that is inhaled and/or exhaled
for heat, moisture, allergens, pollen, bacteria, viruses, pathogens, and
other air-borne particle matter.
These and other objects, features, and advantages of the present invention
are discussed or apparent in the following detailed description of the
invention, in conjunction with the accompanying drawings and the appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
The various features and advantages of the invention will be apparent from
the attached drawings, in which like reference characters designate the
same or similar parts throughout the figures, and in which:
FIG. 1 is a side elevation view of a first preferred embodiment of the
present invention in use by a patient;
FIG. 2 is a plan view of the embodiment of FIG. 1;
FIG. 3 is a side elevation view of the hollow body of the embodiment of
FIG. 1;
FIG. 4 is a top plan view of FIG. 3.;
FIG. 5 is a side elevation view of the nasal insert tube of the embodiment
of FIG. 1;
FIG. 6 is a front elevation view of the nasal insert tube of the embodiment
of FIG. 1;
FIG. 7 is a side elevation view of the embodiment of FIG. 1;
FIG. 8 is a side elevation view of the first valve member of the embodiment
of FIG. 1 in a first position;
FIG. 9 is a side elevation view of an alternative first valve member of the
embodiment of FIG. 1;
FIG. 10 is a side elevation view of the first valve member of the
embodiment of FIG. 1 in a second position;
FIG. 11 is a side elevation view of the first valve member of the
embodiment of FIG. 1 with a filter;
FIG. 12 is a side elevation view of the first valve member of the
embodiment of FIG. 1 with a filter;
FIG. 13 is a side elevation view of a second embodiment of the present
invention during the inspiratory cycle;
FIG. 14 is a side elevation view of the second embodiment of FIG. 13 during
the expiratory cycle;
FIG. 15 is a side elevation view of a third embodiment of the present
invention;
FIG. 16 is a side elevation view of a first alternative third embodiment of
the present invention;
FIG. 17 is a side elevation view of a second alternative third embodiment
of the present invention during the inspiratory cycle; and
FIG. 18 is a side elevation view of the second alternative third embodiment
of FIG. 17 during the expiratory cycle.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to FIG. 1, there is illustrated a first embodiment 10 of the
present nasal interface invention as typically worn by a patient 12. The
interface 10 may be connected by feed tubing 14 and a feed valve 16 to a
mechanical ventilator 18 and a gas supply 20. The feed tubing 14 may be a
thin flexible tube made of an inert material such as polyurethane,
silicone, or another material known in the art. It will be noted that all
components of the interface 10 may be made of medical grade biocompatible
materials.
The mechanical ventilator 18 forces a gas such as air through the tubing
14. The mechanical ventilator 18 may be provided by a continuous positive
airway pressure (CPAP) machine for constant air pressure delivered through
the interface 10 to the patient 12. Alternatively, the mechanical
ventilator 18 may be provided by a bilateral positive airway pressure
(BIPAP) machine for intermittent air pressure delivered through the
interface 10 to the patient 12, whereby the pressure is lower during
exhale than during inhale to facilitate breathing by the patient 12. Other
mechanical ventilators known by those skilled in the art may be suitable,
such as IPPB mechanical ventilators. A power source and controls (not
shown) are provided for operating the mechanical ventilator 18.
The gas supply 20 may be a tank of oxygen or another gas as may be
appropriate in a given situation. The oxygen may be mixed with air to form
oxygen-enriched air, with the oxygen concentration controlled by the valve
16. It will be understood that other gases or mists can be provided as may
be desired in a given application.
Referring now to FIGS. 1 and 2, there may be provided two lengths of
interface tube 22 each having a first end 24 and a second end 26, a
three-way tubing junction 28 with two connectors 30 each capable of being
removably attached to one of the first ends 24 of the tube 22, and a
hollow body 32 with two tubing connectors 34 each capable of being
removably attached to one of the second ends of the tube 22. The three-way
tubing junction 28 may be provided by a "Y" junction, a "T" junction, or
another junction as is known in the art, with the connectors 30 of a type
known in the art for connecting tubing.
The tube 22 may be a thin flexible tube made of an inert material such as
polyurethane, silicone, or another material known in the art. The tubes 22
may be of a smaller size than tube 14 where two tubes 22 carry the same
volume of gas as the one tube 14. The feed tube 22 size is selected to
provide a sufficient air volume flow therethrough for full ventilation of
the patient 12. For example, the size of the feed tube 22 may be selected
to accommodate about 120 liters per minute of air therethrough. On the
other hand, typical low pressure oxygen cannula tubing is sized to
accommodate about 5 liters per minute.
Referring now to FIGS. 3 and 4, the hollow body 32 has at least one and
preferably two nasal apertures 36 defined therein, at least one and
preferably two inhale apertures 38 defined therein, at least one and
preferably two connectors 40 associated with each inhale aperture 38 and
capable of being removably attached to said second ends of said interface
tubing 22, and at least one exhale aperture 42 defined therein. The body
32 may be made of a polycarbonate, plastic, polymer, metal, ceramic,
composite, or other material known in the art. The body 32 may have a
generally cylindrical, rectangular, or other regular or irregular shape.
The connectors 30 are of a type known in the art for connecting tubing.
Referring now to FIGS. 5 and 6, there is provided at least one and
preferably two nasal insert tubes 44 each capable of being inserted into a
nostril of the patient 12. Each nasal insert tube 44 has at least one
annular sleeve 46 with a surface 50 formed thereon for forming a gentle
but firm seal with the inner wall of one of the patient's nostrils. The
annular sleeves 46 may be made of a soft pliable material for patient
comfort such as a silicone elastomer or another material known in the art
for providing a surface for forming the gentle but firm seal between the
sleeve 46 and the patient's skin. The annular sleeves 46 preferably have a
generally oval shape for conforming to the shape of the patient's nostrils
to form the seal as described herein, however, other regular or irregular
shapes may be provided.
In order to secure the interface 10 in place without the need for headgear
and/or straps, a force is generated by the sleeves 46 on the inner walls
of the each nostril. This is accomplished by providing each sleeve 46 with
a diameter that is greater than a diameter of the corresponding nasal
insert tube 44. The contact surface 50 thereby provides a surface area
sufficient to spread the required securement force over sufficiently large
area of the inner walls of the nostrils for improved patient comfort.
Additionally, the lobes of most patients' nostrils are generally angled,
and each annular sleeve 46 may have an angled end 48 conforming thereto
for allowing the annular sleeves 46 to be inserted into the patient's
nostrils no more than is necessary to form the seal.
Each nasal insert tube 44 may be detachably coupled to the hollow body 32
so that the interface may be reused by merely changing out the sleeves 44
for each new use. This may be beneficial in certain applications, for
example, for hospital or other uses. Where the interface is provided with
detachable nasal insert tubes 44, the body may be provided with at least
one and preferably two hollow members 52 extending from the body 32 (see
FIGS. 3 and 4), each hollow member capable of detachably receiving one of
the nasal insert tubes 44. The hollow members 52 may have a shape that is
frusto-conical which provides a smooth transition of airflow from the body
32 into the nasal insert tubes 44. Alternatively, the hollow members may
have a cylindrical or other regular or irregular shape.
Alternatively, the nasal insert tubes 44 may be integrally formed with the
body 32, an arrangement which may be beneficial in home use of the
interface 10 where only one patient uses the interface 10. For such
applications, the nasal insert tubes 44 may extend directly from the body
32 without the need for the hollow members 52.
Referring now to FIGS. 7-10, there is provided at least one and preferably
two exhale apertures 54 defined in the body 32 and at least one valve
assembly 56 associated with and preferably arranged within the body 32.
The valve assembly 56 prevents inhalation air 57 from passing through the
exhale aperture 54 when the patient inhales and allows exhale air 59 to
pass through the exhale aperture 54 when the patient exhales. One of the
exhale apertures 54 is arranged between one of the inhale apertures 38 and
one of the nasal apertures 36, and one of the valve assemblies 56 is
arranged between one of the inhale apertures 38 and one of the nasal
apertures 36.
The valve assembly 56 may comprise a first valve member 58 having a first
end 60 and having a second end 62 pivotally attached to a first inner wall
64 of the body 32 between the nasal aperture 36 and the exhale aperture
54. The valve assembly 56 may further comprise a second valve member 66
having a first end 68 and having a second end 70 pivotally attached to a
second inner wall 72 of the body 32 opposite the first inner wall 64 and
between the exhale aperture 54 and the inhale aperture 38. The first valve
member second end 60 and the second valve member second end 68 are capable
of overlapping and abutting each other so that the valve members 60 and 68
may pivot in response to each other thereby providing for controlling the
airflow through the body 32 as described herein.
The first valve member 58 is made of a material providing for one-way fluid
flow therethrough. As shown in FIGS. 8 and 9, for example, the first valve
member may have at least one perforation 74 defined therein with at least
one biased closure member 76 associated therewith such that the inhale air
57 may pass through the perforation 74 in one direction only. For example,
there may be provided one biased closure member 76 for each perforation 74
(see FIG. 8), two biased closure members 76 for each perforation 74 (see
FIG. 9), or other similar arrangements known in the art. Also, the biased
closure member 76 may have a generally frusto-conical shape whereby air
may pass through the perforation 74 from the larger conical end through
the smaller conical end, but not vice versa. The first valve member 60 may
be made of a plastic, polymer, metal, composite, or other material known
in the art. The second valve member 66 is non-perforated and may be made
of a solid plastic, polymer, metal, composite, or other material known in
the art.
FIG. 7 shows the second valve member 66 pivoted to a first position where
the second valve member 66 substantially covers the exhale aperture 54 in
response to a force thereon from the patient 12 inhaling air 57 through
the inhale aperture 38. In this first position, the exhale aperture 54 is
substantially covered by the second valve member 66 alone, by a
combination of the second valve member 66 and the first valve member 58,
or by a combination of the second valve member 66, the first valve member
58, and a stop that will be described hereinafter. The first valve member
58 pivots to a first position in response to the pivoting of the second
valve member 66 as a result of the second end 68 of the second valve
member 60 contacting and forcibly moving the second end 60 of the first
valve member 58. The first valve member 58 is thereby suitably positioned
to receive a force from the exhale air 59 as will described immediately
hereinafter.
FIG. 10 shows the first valve member 58 pivoted to a second position in
response to a force thereon from the patient 12 exhaling air 59 through
the nasal aperture 36. When the first valve member 58 pivots to the second
position, the first valve member second end 60 contacts the second valve
member second end 68 and forces the second valve member 66 to a second
position. In this second position, the exhale aperture 54 is not covered
so that the exhale air 59 may pass through the exhale aperture 54.
In order to limit the range of pivotal motion of the valve members 58 and
66 and thereby maintain their second ends 60 and 68 in abutting contact,
there may be provided at least one and preferably two stops 74 and 76
arranged within the body 32. The first stop 74 limits the pivoting motion
of the first valve member 58 to the first position and the second stop 76
limits the pivoting motion of the second valve member 66 to the second
position. The stops 74 and 76 may be provided by rods, bars, tabs, arms,
or the like extending across or into the body 32.
Alternatively to or in combination with the stops 74 and 76, the range of
pivotal motion of the valve members 58 and 66 may be accomplished by the
second end 60 of the first valve member 58 having an angled portion and
the second end 68 of the second valve member 66 having a yoke or the like
defined thereon that receives the angled second end 60 when the valve
members 58 and 66 are pivoted to the first positions. In another
alternative, the second end 68 of the second valve member 66 has an angled
portion and the second end 60 of the first valve member 58 has a yoke or
the like defined thereon that receives the angled second end 66 when the
valve members are pivoted to the first positions.
Referring now to FIGS. 11-12, at least one and preferably two filters 78
may be provided within the body 32. The filters 78 retain heat and/or
moisture from the exhale air 57 passing therethrough. When the patient
then draws his or her inhale air 59, heat and/or moisture retained by the
filters 78 is absorbed into the inhale air 59 thereby providing for
increased comfort of the patient 12. The filters 78 may be provided by an
air-permeable filter material such as a fabric, plastic, fiber, composite,
or other material known by those skilled in the art. The filters 78 may be
arranged within the body 32 between the nasal aperture 36 and the exhale
aperture 54, outside the body 32 adjacent the exhale aperture 54, or in
another position as will be understood by those skilled in the art.
Referring now to FIGS. 13-14, there is provided a second embodiment 100 of
the present invention. Similar to the first embodiment 10 described
hereinabove, the second embodiment 100 has a body 102 with at least one
and preferably two inhale apertures 104, at least one and alternatively
two or more exhale apertures 106, at least one and preferably two nasal
apertures 108, and at least one valve assembly 110. Each valve assembly
110 may comprise at least one and preferably two one-way inhale valve
membranes 112 and at least one and alternatively two one-way exhale valve
membranes 114. The inhale valve membranes 112 may be arranged in the body
102 between one of the nasal apertures 108 and one of the exhale apertures
106 or may be disposed within the inhale aperture 104. The exhale valve
membranes 114 may be disposed within the exhale apertures 106. The one-way
inhale and exhale membranes 112 and 114 may be provided of a material
similar to that of the first valve member 58 of the first embodiment 10.
The valve assembly 110 thereby prevents inhalation air 116 from passing
through the exhale aperture 106 when the patient inhales and allows exhale
air 118 to pass through the exhale aperture 106 when the patient exhales.
In the use of the first and second embodiments 10 and 100 of the present
invention, the body 32 is positioned under the nose of the patient 12 with
the nasal insert tubes 44 inserted into the patient's nostrils and with
the sleeves 46 securing and sealing the body 32 in place. The lengths of
interface tubing 22 are positioned over the patient's ears so that the
junction 28 is positioned under the patient's chin or behind the patient's
back. The mechanical ventilator 18 is operated to supply air to the nasal
interface 10 at a positive pressure, thereby forcing air through the feed
tubing 14, the interface tubing 22, the interface 10, and into the
patient's nostrils and respiratory system to fully sustain the patient's
breathing.
When the patient 12 inhales and initiates the inspiratory cycle, he or she
typically generates about a negative 1 to 2 centimeters or so of water
pressure. A demand valve (not shown) of the ventilator 18 may be triggered
by this negative pressure thereby starting a positive flow of air into the
interface 10. The patient 12 is thereby able to draw inhalation air 57
through the first valve member 58 in its first position, but not through
the exhale aperture 54 as it is then covered by the second valve member
66.
Upon the tidal inhalation airflow 57 volume being delivered through the
hollow body 32 and nasal insert tubes 44 and to the patient's lungs, the
positive pressure of the inspiratory cycle flow ends. The patient 12 then
initiates the expiratory portion of the inhale/exhale cycle. There is not
enough back pressure to create static pressure in the body 32, so when the
patient 12 begins to exhale air 59 the first valve member 58 is forcibly
pivoted to its second position, thereby forcibly pivoting the second valve
member 66 to its second position where exhale air 59 may flow through the
exhale aperture 54. The cycle may then repeat itself.
Referring now to FIGS. 15-18, there is provided a third embodiment 200 of
the present invention. Similar to the first embodiment 10 described
hereinabove, the third embodiment 200 has a hollow body 202 with at least
one inhale aperture 204, at least one exhale aperture 206, and at least
one and preferably two nasal apertures 208, and at least one nasal insert
tube 210 removably coupled to or integrally formed with the body 202 and
in fluid communication with each nasal aperture 208. At least one valve
assembly 212 may be disposed within the body 202 as may be desired in a
given application.
The insert tubes 210 have annular sleeves 214 similar to those of the first
embodiment 10 such that each annular sleeve 214 forms a seal with the
inner wall of the nostril and additionally exerts a force thereon
sufficient to support the weight of the third embodiment interface 200 in
place during respiration. In this embodiment, the body 200 is not
connected to interface tubing, a mechanical ventilator, or a gas supply,
so the body 202 need not have tubing connectors. Instead, the interface
200 provided is a small, lightweight, plug that is held securely in place
by the annular sleeves 214. The combined cross-sectional area of the nasal
apertures 208 and the combined cross-sectional area of the exhale
apertures 206 are each therefore sized to provide a larger cross-sectional
area than that of the nostrils so that the patient does not blow the
interface 200 out of his or her nose when exhaling.
In the third embodiment 200, there is provided at least one filter 216
disposed within the body 202. The filter 216 may be made of a material
capable of retaining dust, allergens, pollen, bacteria, pathogens, and
other air-borne particle matter from air passing therethrough. The filters
216 may be provided by an air-permeable filter material such as a thin
layer of a treated fabric, plastic, fiber, composite, or other material.
For example, the filter 216 may be made of a commercially available
material known to be used at the air outlet (where the feed tubing 14 is
connected) of some mechanical ventilators 18. When the patient 12 inhales,
the undesired airborne matter is screened out of the air by the filter 216
before entering the patient's nostrils thereby providing for increased
health and comfort of the patient 12.
The filter or filters 216 may be arranged within the body 202 in various
arrangements several of which will now be described. As shown in FIG. 15,
the at least one inhale aperture 204 may be provided by two apertures, the
at least one exhale aperture 206 may be provided by two apertures, and the
valve assembly 212 may be similar to that of the first embodiment 10. In a
first alternative third embodiment as shown in FIG. 16, the at least one
inhale aperture 204 may be provided by two apertures, the at least one
exhale aperture 206 may be provided by a single aperture, the at least one
filter 216 may be provided by a filter 216 in fluid communication with
each inhale aperture 204 (without a filter at the exhale aperture 206),
and the valve assembly 212 may be similar to that of the second embodiment
100. In a second alternative third embodiment as shown in FIGS. 17-18, the
at least one inhale aperture 204 and the at least one exhale aperture 206
may be provided by a plurality of apertures spaced across a surface 218 of
the body 202, the at least one filter 216 may be provided by one filter
216 in fluid communication with the inhale and exhale apertures 204 and
206 and extending across the surface 218, and the interface 200 may be
provided without a valve assembly. The apertures 204 and 206 in the
surface 218 may be provided along the length of the body 202 and/or around
the perimeter or circumference of the body 202.
In the use of the third embodiment interface 200, the body 202 is inserted
into the patient's nostrils before going to sleep, during particularly
high pollen count days, if the onset of an allergic reaction is suspected,
or at other opportune times as will be understood by those skilled in the
art. The interface 200 is portable and may be carried in a patient's
