U.S. patent application number 13/959819 was filed with the patent office on 2013-12-05 for patient interface assembly and system using same.
This patent application is currently assigned to RIC INVESTMENTS, LLC. The applicant listed for this patent is RIC INVESTMENTS, LLC. Invention is credited to DERRICK BLAKE ANDREWS, LANCE RANARD BUSCH, PETER CHI FAI HO, RICHARD J. LORDO, JEROME MATULA, JR., LUKE STONIS, CHRISTOPHER VON DOHLEN.
Application Number | 20130319422 13/959819 |
Document ID | / |
Family ID | 34221390 |
Filed Date | 2013-12-05 |
United States Patent
Application |
20130319422 |
Kind Code |
A1 |
HO; PETER CHI FAI ; et
al. |
December 5, 2013 |
PATIENT INTERFACE ASSEMBLY AND SYSTEM USING SAME
Abstract
A patient interface assembly that includes a patient interface
device, a headgear, and pivoting coupling member joining the
interface device to a headgear assembly. In one embodiment, the
patient interface device is a nasal cushion that includes a
formable support mounted to the nasal cushion for providing support
and adjustment of the nasal cushion to improve fit and comfort. In
a further embodiment, a pair of rigid connecting members couple the
patient interface device to the headgear.
Inventors: |
HO; PETER CHI FAI;
(PITTSBURGH, PA) ; MATULA, JR.; JEROME; (APOLLO,
PA) ; LORDO; RICHARD J.; (BUTLER, PA) ; BUSCH;
LANCE RANARD; (TRAFFORD, PA) ; ANDREWS; DERRICK
BLAKE; (MARKLETON, PA) ; STONIS; LUKE;
(COLUMBUS, OH) ; VON DOHLEN; CHRISTOPHER; (ST.
LOUIS PARK, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
RIC INVESTMENTS, LLC |
WILMINGTON |
DE |
US |
|
|
Assignee: |
RIC INVESTMENTS, LLC
WILMINGTON
DE
|
Family ID: |
34221390 |
Appl. No.: |
13/959819 |
Filed: |
August 6, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13363769 |
Feb 1, 2012 |
8517025 |
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13959819 |
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12102463 |
Apr 14, 2008 |
8127765 |
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13363769 |
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10918832 |
Aug 13, 2004 |
7357136 |
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12102463 |
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60496059 |
Aug 18, 2003 |
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Current U.S.
Class: |
128/206.21 |
Current CPC
Class: |
A61M 2205/0216 20130101;
A61M 2205/0266 20130101; A61M 16/0825 20140204; A61M 16/06
20130101; Y02E 60/50 20130101; C10L 1/328 20130101; H01M 8/0618
20130101; A61M 16/0666 20130101; A61M 16/0605 20140204; H01M 8/0625
20130101; A61M 16/0622 20140204; H01M 8/04164 20130101; A61M
16/0683 20130101; A61M 2210/0618 20130101; A61M 16/0633
20140204 |
Class at
Publication: |
128/206.21 |
International
Class: |
A61M 16/06 20060101
A61M016/06 |
Claims
1. A patient interface assembly for use in the delivery of a
breathing gas to a patient, comprising: a patient interface device
having a first side and a second side, wherein the first side is
proximate to a right side of a patient's face and the second side
is proximate to the left side of such a patient's face responsive
to the patient interface device being donned by such a patient; a
headgear having a first side and a second side, wherein the first
side is proximate to a right side of a patient's head and the
second side is proximate to the left side of such a patient's head
responsive to the headgear being donned by such a patient, the
first side having a first post and the second side having a second
post; a rigid coupling member adapted to couple the patient
interface device to the headgear, wherein the rigid coupling member
includes a first arm connected between the first side of the
patient interface device and a first side of the headgear such that
the first arm extends over a right cheek region of such a patient's
face, and a second arm connected between the second side of the
patient interface device and the second side of the headgear such
that the second arm extends over a left cheek region of such a
patient's face, wherein the first and the second arm are rigid, the
first arm having a first slot and the second arm having a second
slot, wherein the first post is received within the first slot in a
manner that allows a position of the first post in the first slot
to be moved to enable an effective length of the first arm to be
adjusted and the second post is received within the second slot in
a manner that allows a position of the second post in the second
slot to be moved to enable an effective length of the second arm to
be adjusted.
2. The patient interface assembly of claim 1, wherein the first
post is part of a first friction lock having a first lock nut
coupled to the first post and the second post is part of a second
friction lock having a second lock nut coupled to the second post,
the first friction lock being structured to allow the position of
the first post in the first slot to be fixed and the second
friction lock being structured to allow the position of the second
post in the second slot to be fixed.
3. The patient interface assembly of claim 1, wherein the first arm
and the second arm each have a shape that generally matches a
contour of a human face underlying the first arm and the second arm
responsive to the patient interface assembly being worn by a
patient.
4. A patient interface assembly for use in the delivery of a
breathing gas to a patient, comprising: (a) a patient interface
device; (b) a headgear adapted to be worn by a patient, wherein the
headgear comprises: (1) an adjustable length cross strap adapted to
extend over the top of a patient's head, the cross strap having a
first terminal end structured to be positioned on a first side of
the patient's head responsive to the patient interface assembly
being donned by the patient, (2) an adjustable length rear strap
adapted to extend about the rear portion of the patient's head, the
rear strap having a second terminal end structured to be positioned
on the first side of the patient's head adjacent to the first
terminal end responsive to the patient interface assembly being
donned by the patient, a length of the cross strap and a length of
the rear strap being adjustable independent of one another, and (3)
an adjustment assembly structured to be positioned on the first
side of the patient's head responsive to the patient interface
assembly being donned by the patient, the adjustment assembly
including a connecting element having a first end attached to the
first terminal end of the cross strap and a second end attached to
the second terminal end of the rear strap, wherein the adjustment
assembly is configured such that a single actuation of the
adjustment assembly on the first side of the patient's head changes
the length of both the cross strap and the rear strap
simultaneously.
5. The headgear of claim 4, wherein the connecting element
comprises a cord linking the cross strap and the rear strap, and
wherein the adjustment assembly further includes a locking element
through which the cord is threaded in a manner wherein the cord
forms a loop, and wherein the length of both the cross strap and
the rear strap are adjusted simultaneously by adjusting a size of
the loop through the locking element.
6. The headgear of claim 4, wherein the headgear further comprises
a forehead strap defined by a semi-rigid material operatively
coupled to the rear strap.
7. A patient interface assembly for use in the delivery of a
breathing gas to a patient, comprising: a patient interface device
having a first side and a second side, wherein the first side is
proximate to a right side of a patient's face and the second side
is proximate to the left side of such a patient's face responsive
to the patient interface device being donned by such a patient; a
headgear having a first side and a second side, wherein the first
side is proximate to a right side of a patient's head and the
second side is proximate to the left side of such a patient's head
responsive to the headgear being donned by such a patient; a rigid
coupling member adapted to couple the patient interface device to
the headgear, wherein the rigid coupling member includes a first
arm connected between the first side of the patient interface
device and a first side of the headgear such that the first arm
extends over a right cheek region of such a patient's face, and a
second arm connected between the second side of the patient
interface device and the second side of the headgear such that the
second arm extends over a left cheek region of such a patient's
face, wherein the first and the second arm are rigid.
8. The patient interface assembly of claim 7, wherein the first arm
is adjustably coupled to the first side of the headgear so as to
change an effective length of the first arm, and the second arm is
adjustably coupled to the second side of the headgear so as to
change an effective length of the second arm.
9. The patient interface assembly of claim 7, wherein the first arm
and the second arm each have a shape that generally matches a
contour of a human face underlying the first arm and the second arm
responsive to the patient interface assembly being worn by a
patient.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation under 35 U.S.C. .sctn.120
of U.S. patent application Ser. No. 13/363,769, filed Feb. 1, 2012,
which is a Divisional under 35 U.S.C. .sctn.120 of U.S. patent
application Ser. No. 12/102,463, filed Apr. 14, 2008, now U.S. Pat.
No. 8,127,765, granted Mar. 6, 2012, which is a Continuation under
35 U.S.C. .sctn.120 of U.S. patent application Ser. No. 10/918,832,
filed Aug. 13, 2004, now U.S. Pat. No. 7,357,136, which claims
priority under 35 U.S.C. .sctn.119(e) from provisional U.S. patent
application No. 60/496,059, filed Aug. 18, 2003, the contents of
which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention pertains to a patient interface
assembly, a system for supplying a flow of gas to a patient that
incorporates such an assembly, and to a patient interface device
and a headgear for use in such an assembly.
[0004] 2. Description of the Related Art
[0005] There are numerous situations where it is necessary or
desirable to deliver a flow of breathing gas, non-invasively, to
the airway of a patient, i.e., without intubating the patient or
surgically inserting a tracheostomy tube in their trachea. For
example, it is known to ventilate a patient using a technique known
as non-invasive ventilation. It is also known to deliver continuous
positive airway pressure (CPAP) or variable airway pressure, which
varies with the patient's respiratory cycle or a monitored
condition of the patient, to treat a medical disorder, such as
sleep apnea syndrome, in particular, obstructive sleep apnea (OSA),
congestive heart failure, stroke, Cheynes-Stokes respiration, etc.
Non-invasive ventilation and pressure support therapies involve the
placement of a patient interface device, which is typically a nasal
or nasal/oral mask, on the face of patient to interface the
ventilator or pressure support device with the airway of the
patient, so that a flow of breathing gas can be delivered from the
pressure/flow generating device to the airway of the patient.
[0006] Because such patient interface devices are typically worn
for an extended period of time, a variety of concerns must be taken
into consideration. For example, in providing CPAP or other
positive pressure therapy to treat OSA, the patient normally wears
the patient interface device all night long while he or she sleeps.
One concern in such a situation is that the patient interface
device is as comfortable as possible, otherwise the patient may
avoid wearing the interface device, defeating the purpose of the
prescribed pressure support therapy.
[0007] Typically patient interface devices include a mask shell
having a cushion attached to the shell that contacts the surface of
the patient. The mask shell and cushion are held in place by a
headgear that wraps around the head of the patent. The mask and
headgear form the patient interface assembly. A typical headgear
includes flexible, adjustable straps that extend from the mask to
attach the mask to the patient. Other techniques for attaching a
patient interface device use a vice-like device that anchors at the
front and back of the patient's head to support the mask on the
user. See, e.g., U.S. Pat. No. 6,516,802. While such conventional
interface devices are generally well accepted, there remains a
class of patients that do not find these devices to be sufficiently
comfortable, too bulky, or otherwise inadequate. Thus, alternative
techniques for interfacing a pressure support system to the airway
of a patient are desired.
SUMMARY OF THE INVENTION
[0008] Accordingly, the present invention provides a patient
interface assembly that addresses the above-identified concerns and
that overcomes shortcomings of conventional patient interface
assemblies. The patient interface assembly of the present invention
provides the patient with improved patient interface stability and
overall comfort. The present invention further provides a system
for delivering a flow of gas to a patient that addresses the above
identified concerns and that does not suffer from the shortcomings
of conventional techniques. This is achieved by providing a system
for delivering a flow of gas to a patient that includes a gas flow
generating device capable of producing a flow of gas and a conduit
having a first end portion operatively coupled to the gas flow
generating device and a second end portion. The conduit carries the
flow of gas from the gas flow generating device. The system
includes a patient interface assembly comprising a patient
interface device operatively coupled to the second end portion of
the conduit and a headgear.
[0009] The patient interface device, in one embodiment of the
present invention, is a nasal interface device having a nasal
cushion and a pair of laterally spaced nares elements for insertion
into the nostrils of the patient. A formable support is preferably
mounted to the nasal cushion for providing support for the nasal
cushion while allowing for adjustments to provide increased fit and
comfort of the nasal cushion. The nasal cushion is coupled to a
coupling elbow or cradle having exhaust diffusion plates.
[0010] The headgear assembly of the present invention includes a
substantially rigid, minimal contact harness assembly. The headgear
of an exemplary embodiment includes an adjustment assembly that
allows for a simultaneous adjustment of multiple straps.
[0011] A length adjustment assembly in one embodiment adjusts the
distance between an adjustment assembly and the nasal interface
device to accommodate patients having different facial sizes. The
adjustment assembly is a position adjustment mechanism which
provides a force adjustment by an integrated spring. The adjustment
assembly allows a cantilevered support to support the patient
interface device without a set of headgear straps located at the
patient interface device.
[0012] In a further embodiment, the coupling member couples the
patient interface device to the headgear and a spring, associated
with the coupling member, biases the patient interface device
against such a patient's face when the patient interface assembly
being donned by such a patient. This ensures that the patient
interface device is properly seated on the user.
[0013] In yet another embodiment, a rigid coupling member couples
the patient interface device to the headgear. The rigid coupling
member includes a first rigid arm connected between a first side of
the patient interface device and a first side of the headgear and a
second rigid arm connected between a second side of the patient
interface device and a second side of the headgear. Preferably the
length of the first and second arms is adjustable to properly fit
the patient interface assembly on the patient.
[0014] These and other features and characteristics of the present
invention, as well as the methods of operation and functions of the
related elements of structure and the combination of parts and
economies of manufacture, will become more apparent upon
consideration of the following description and the appended claims
with reference to the accompanying drawings, all of which form a
part of this specification, wherein like reference numerals
designate corresponding parts in the various figures. It is to be
expressly understood, however, that the drawings are for the
purpose of illustration and description only and are not intended
as a definition of the limits of the invention. As used in the
specification and in the claims, the singular form of "a", "an",
and "the" include plural referents unless the context clearly
dictates otherwise.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a side perspective view of a patient interface
assembly according to the principles of the present invention;
[0016] FIG. 2 is a front view of the patient interface assembly of
FIG. 1;
[0017] FIG. 3 is an exploded view of a nasal interface device and
cradle in the patient interface assembly of FIG. 1;
[0018] FIG. 4 is a side view of the nasal interface device and
cradle of FIG. 3;
[0019] FIG. 5 is an exploded view of the nasal interface device and
formable support in the patient interface assembly of FIG. 1;
[0020] FIG. 6 is an exploded view of the cradle and an exhaust
diffusion plate adapted to be disposed on the cradle in the patient
interface assembly of FIG. 1;
[0021] FIG. 7 is a perspective view of the exhaust diffusion plate
of FIG. 6;
[0022] FIG. 8 is a cross-sectional view of the exhaust diffusion
plate of FIG. 7;
[0023] FIG. 9 is an exploded view of a length adjustment assembly
and an angle adjustment assembly provided in the patient interface
assembly of FIG. 1;
[0024] FIG. 10 is a side view of the length adjustment assembly and
the angle adjustment assembly of FIG. 9;
[0025] FIG. 11 is a rear perspective view of the length adjustment
assembly and the angle adjustment assembly of FIG. 9;
[0026] FIG. 12 is a cross-sectional view of the length adjustment
assembly and the angle adjustment assembly of FIG. 9;
[0027] FIG. 13 is a side view of specific components of the angle
adjustment assembly;
[0028] FIGS. 14-16 are perspective, front (partially in section),
and top views, respectively, of the headgear and a mounting
assembly in the patient interface assembly of FIG. 1;
[0029] FIGS. 17A and 17B are cross-sectional views and FIG. 17C is
a top view of a nasal interface device according to a further
embodiment of the present invention;
[0030] FIG. 18 is a perspective view of a nasal interface device
and an alternate embodiment for the formable support;
[0031] FIG. 19A shows an exploded view of a nasal interface device
and cradle according to another alternate embodiment, and FIG. 19B
shows a perspective view of a nasal cushion and support according
to the embodiment of FIG. 19A;
[0032] FIG. 20 is a cross-sectional side view of an alternate
embodiment having a ball and socket connection;
[0033] FIG. 21A is a perspective view of an alternate embodiment
for the length adjustment assembly and the angle adjustment
assembly, FIG. 21B is a side view of the length adjustment assembly
and the angle adjustment assembly of FIG. 21A, FIG. 21C is a
cross-sectional side view of the length adjustment assembly and the
angle adjustment assembly of FIG. 21A, FIG. 21D is a perspective
view of the interior of the press and release buttons of the length
adjustment assembly and the angle adjustment assembly of FIG.
21A;
[0034] FIGS. 22A and 22B are side and perspective views,
respectively, of an alternate embodiment of the patient interface
assembly of the present invention shown being worn by a patient,
and FIG. 22C is a detailed view of the angle adjustment assembly of
FIG. 22A;
[0035] FIG. 23 is a side view of an alternate embodiment of the
headgear assembly according to the principles of the present
invention;
[0036] FIG. 24 shows another alternate embodiment of the angle
adjustment assembly;
[0037] FIG. 25 shows another alternate embodiment of the headgear
adjustment assembly for adjusting the fit of the headgear;
[0038] FIG. 26 is a perspective view of a still further embodiment
of a patient interface assembly according to the principles of the
present invention; and
[0039] FIG. 27 is a perspective view of the patient interface
assembly of FIG. 26 shown being worn by a patient.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0040] FIGS. 1-16 illustrate an exemplary embodiment of a patient
interface assembly 10 according to the principles of the present
invention. The patient interface assembly 10 supports a patient
interface device 12 on a patient's head. Patient interface device
12 communicates a flow of breathing gas between the patient's
airway and a pressure generating device 14, such as a ventilator,
CPAP device, or variable pressure device, e.g., a BiPAP.RTM. device
manufactured and distributed by Respironics, Inc. of Pittsburgh,
Pa., or an auto-titration pressure support system. A BiPAP.RTM.
device is a bi-level device in which the pressure provided to the
patient varies with the patient's respiratory cycle, so that a
higher pressure is delivered during inspiration than during
expiration. An auto-titration pressure support system is a system
in which the pressure varies with the condition of the patient,
such as whether the patient is snoring or experiencing an apnea or
hypopnea. For present purposes, pressure generating device 14 is
also referred to as a gas flow generating device, because flow
results when a pressure gradient is generated.
[0041] Communicating a flow of breathing gas between the patient's
airway and a pressure generating device 14 includes delivering a
flow of breathing gas to the patient from the pressure generating
device and exhausting a flow of gas from the patient to ambient
atmosphere.
[0042] The system for delivering a breathing gas to a patient
according to the present invention comprises a pressure or gas flow
generating device 14 that produces a flow of gas, a conduit 16,
which is also referred to as a patient circuit, having a first end
portion 18 operatively coupled to the gas flow generating device
and a second end portion 20. Conduit 16 carries the flow of gas
from pressure generating device 14 during operation of the system
to patient interface device 12 coupled to second end portion 20 of
conduit 16. A headgear 22 according to the principles of the
present invention, includes a mounting assembly 24 that couples
patient interface device 12 to conduit 16, and an adjustable
harness assembly 26.
[0043] In the illustrated embodiment the patient interface device
12 is a nasal interface device. However, the present invention also
contemplates that other devices for communicating a flow of gas to
an airway of a patient, such as a nasal mask, oral mask, or
mouthpiece, or combination nasal/oral masks, are suitable for use
as patient interface device 12.
[0044] Patient interface device 12 is generally a nasal interface
having a nasal cushion 28 and a pair of laterally spaced nares
elements 30 at its distal end for insertion into the nostrils of
the patient. See FIGS. 3-4. The body of nasal cushion 28 includes a
hollow chamber and extends from an oval shaped opening 32 to
laterally spaced outlet legs 34. Each outlet leg 34 is provided
with one of nares element 30. The body of nasal cushion 28 curves
about an axis substantially perpendicular to a plane separating the
two nares elements. Each nares element 30 has an opening 36 to
communicate with the nasal passages of the patient. Each of nares
elements 30 is substantially dome-shaped having an elliptical base
proportional to anthropometrical data of a nostril opening. Nasal
cushion 28 is preferably formed from a soft cushiony material, such
as silicone, appropriately soft thermoplastic elastomers, closed
cell foam, or thin materials.
[0045] The curved surface of nasal cushion 28 includes an inner
curved surface 38 and an outer curved surface 40 substantially
concentric to inner curved surface 38. See FIG. 4. A formable
support 42 is preferably mounted to outer curved surface 40.
Formable support 42 provides support to nasal cushion 28 while
allowing for adjustments to provide increased fit and comfort of
the nasal cushion. In the illustrated embodiment, formable support
42 is substantially T-shaped having a stem portion 44 and a cross
portion 46. See FIG. 5. Cross portion 46 extends from one end of
stem portion 44 at a cross portion midpoint 48. Ends 50 of cross
portion 46 curve from midpoint 48.
[0046] In the illustrated embodiment, outer curved surface 40 of
nasal cushion 28 includes mounting tabs 52 to mount to ends 50 of
cross portion 46 of support 42. Ends 50 of the cross portion 46
have through-holes 54 to mount to the corresponding mounting tabs
52. See FIG. 5.
[0047] Formable support 42 is preferably formed from a formable
metal, such as aluminum. Support 42 can be conformed by pressing on
the support with the patient's or caregiver's fingers. By
manipulating the support, the angle of the nasal cushion with
respect to the facial-frontal plane, and/or the angle of nare
contact of the nares elements can be changed.
[0048] Alternatively, formable support 42 could be formed from
Nitinol (Nickel Titanium Naval Ordinance Laboratory), which is
known as shape memory metal, or a plastic with a low softening
point temperature, such as EVA (Ethylene Vinyl Acetate) could be
used. EVA is commonly used in boil and bite mouthpieces that
athletes use. The EVA support in this case could be warmed in hot
water and then formed.
[0049] While the illustrated formable support 42 is T-shaped,
alternatively, the support could be Y-shaped. T or Y-shaped
supports 42 can be hollow or solid. While the illustrated
embodiments show externally mounted supports, the supports could
also be molded within the nasal cushion itself. Alternatively,
formable support 42 could be bonded to the cushion in discreet
locations. An alternate shaped formable support 56 is illustrated
in FIG. 19A. In the embodiment of FIG. 18, support 56 is formed
from a formable wire generally following the outline of outer
curved surface 40 of nasal cushion 28. By having formable support
56 connected to nasal cushion 28 at discreet locations, there is
some relative movement between nasal cushion 28 and support 56
during adjustment of the support.
[0050] In FIGS. 19A and 19B, which illustrate further exemplary
embodiments for the formable support, the support is mounted to
outer curved surface 40 of nasal cushion 28 using three pockets 59
provided on outer curved surface 40. Each pocket receives an end
portion of the formable support. The configurations for attaching
the formable support to the nasal cushion shown in FIGS. 3, 4, 18,
and 19A-19B provide an advantage in that the formable support can
be readily attached and detached from the nasal cushion. This
allows formable supports of different stiffness to be used in the
same nasal cushion and allows for easy replacement of the nasal
cushion or the formable support.
[0051] The present invention contemplates varying a property of the
walls forming nasal cushion 28, outlet legs 34, and nares elements
30, such as the thickness and/or elasticity, to provide performance
improvements in the patient interface, such as increased comfort,
better mask/patient seal, and/or greater customization capability.
For example, FIGS. 17A-17C illustrates a nasal cushion wall 55 that
is relatively thick. A base portion 57 of a nares element wall 61
is also relatively thick, but tapers as the distance from base
portion 57 increases. Between the relatively thick walled based
portion 57 of nares element wall 61 and nasal cushion wall 55 is a
relatively thin wall portion 63. Providing thin wall portion 63
between these two thick walls allows nares element 30 to articulate
relative to nasal cushion 28 so that the nares element better fits
the nostrils of the user. In addition, the formability of the nasal
cushion is increased by providing a relatively deep spacing between
outlet legs 34. It is to be understood that a similar function,
whereby the nares elements are moveable relative the nasal cushion,
can be achieved without varying the thickness of the walls. For
example, a material having a relatively high degree of elasticity
(stretchable) can be provided at location 63, while walls 55 and 61
are formed from a material of lower elasticity. Of course, a
combination of varying wall thickness and elasticity are also
contemplated by the present invention.
[0052] In the illustrated embodiments, with the possible exception
of that shown in FIGS. 19A and 19B, stem portion 44 of T-shaped
formable support 42 is receivable in a corresponding notched
portion 68 provided in oval shaped opening 60 of cradle 58.
Alternatively, formable support 42 can be mounted to nasal cushion
28 by corresponding pockets on outer curved surface 40 of nasal
cushion 28, as shown in FIGS. 19A and 19B.
[0053] In the present invention, oval shaped opening 32 of nasal
cushion 28 is coupled to a coupling elbow or cradle 58. Cradle 58
is substantially curved having an oval shaped opening 60 that
connects to oval shaped opening 32 of nasal cushion 28. In the
illustrated exemplary embodiment, cradle 58 has a double wall
construction 62 and forming a hollow chamber 64. An opposite end 66
of the cradle is substantially circular. See FIGS. 3-4. It is to be
understood, however, that the present invention contemplates
joining nasal cushion 28 and cradle 58 using other configurations
for the cooperating parts. For example, a groove (double wall) can
be provided in the end of nasal cushion 28 so that the end of
cradle 58 fits into the groove formed in the cushion.
[0054] In the illustrated embodiment, tabs 67 are provided on
opposing sides of nasal cushion 28 at end 66. Corresponding tab
receiving slots 69 are provided on cradle 58 for receiving tabs
when the nasal cushion is properly coupled to the cradle. Tabs 67
and slots 69 assist in aligning the cushion with the receiving end
of the cradle. To help retain cradle 58 and cushion 28 in an
engaged relation, tabs 67 and slots 69 are configured and arranged
so that the tab cannot be easily pulled apart. For example, in the
illustrated embodiment, slot 69 has an "arrow" shape and tab 67 is
a similar shape. This "arrow" shape allows the tab to be readily
inserted into the slot due to the wedge-shaped tip of the arrow,
but prevents disengagement due to the flat back end of the tab
abutting the flat back ends of the arrow-shaped slot. Of course,
other configurations for tab 67 and slot 69 are provided for
accomplishing these functions. In addition, the tab can be provided
on the cradle and the slot provided in the cushion.
[0055] As shown in FIGS. 4 and 6-8, an outer curved surface 70 of
cradle 58 includes an exhaust diffusion plate 72 having diffusion
holes 74 for exhausting exhaled gas from the pressurized system to
the atmosphere. Preferably, exhaust diffusion plate 72 includes
diffusion holes 74 having a tapered diameter and arranged in a fan
pattern. In the illustrated embodiment, exhaust diffusion plates 72
provide a substantially 180 degree radial diffusion. It is to be
understood that the present invention contemplates forming the
diffusion plate at other locations on the cradle and forming the
holes in the diffusion plate in any desired configuration to
achieve an almost infinite number of different diffusion patterns.
For example, multiple diffusion plates can be provided so that
diffusion plates are provided at various locations on the cradle.
In addition, the holes, which are otherwise provided in the
diffusion plate, can be formed directly in the wall of the cradle.
In which case, the diffusion plate(s) can be eliminated. Of course,
a combination of exhaust ports defined directly in the wall of the
patient interface device and a diffusion plate(s) can also be used.
Diffusion plate 74 is preferably formed from a rigid material.
However, the present invention also contemplates that the diffusion
plate can be formed from a material that is deformable.
[0056] End 66 of cradle 58 is connected to a length adjustment
assembly 76, which adjusts the distance between an angle adjustment
assembly 78 and nasal interface device 12, to accommodate patients
having different facial sizes. As shown in FIGS. 1-2 and 9-13,
length adjustment assembly 76 includes a tubular section 80 and an
adjustment nut 82. Tubular section 80 is received within adjustment
nut 82. A lower end 84 of tubular section 80 is connected to
circular end 66 of cradle 58 using any conventional technique, such
as a friction fitting. Threading 86 is provided on the exterior of
tubular section 80 and on an interior of adjustment nut 82. Length
adjustment is accomplished by rotating adjustment nut 82 so that
the threading on adjustment nut 82 engage the threading on tubular
section 80. Rotating adjustment nut 82 causes tubular section 80 to
move up or down inside a pivot tube 88 coupled to adjustment nut
82. Pivot tube 88 is part of angle adjustment assembly 78, which is
described in greater detail below.
[0057] Angle adjustment assembly 78, which is best shown in FIGS.
9-13, is a position adjustment mechanism with pre-fixed angular
locating positions to control the position or angle of the rigid
gas flow conduit relative to the patient's face over a relatively
large range of angles, e.g., a 45.degree. range. In addition to
this relatively large adjustment capability, angle adjustment
assembly provides a force adjustment by means of an integrated
spring on a secondary pivoting member over in a narrower range of
angles, e.g., 5.degree. range. The angle adjustment assembly allows
a cantilevered support to support the patient interface device
without a set of headgear straps located at the patient interface
device.
[0058] Angle adjustment assembly 78 includes an adjustment
mechanism that itself includes a mounting bracket 90, an angular
pivot housing 92, and a pivot tube 88. Mounting bracket 90 is
attached to harness assembly 26 of headgear 22 and comprises a pair
of substantially parallel mounting bracket arms 94 extending from a
harness assembly attaching portion 96. Each mounting bracket arm 94
is substantially L-shaped and extends outward from harness assembly
attaching portion 96 of mounting bracket 90 to a bend portion 98
before extending upwardly to a distal portion 100. Each distal
portion 100 includes a plurality of spaced locking/adjustment key
holes 102. In the illustrated embodiment, nine key holes 102 are
provided on each distal portion 100 corresponding to nine preset
positions, which are about 5 degrees apart covering a total angular
range of 45 degrees.
[0059] Bend portion 98 of each mounting bracket arm 94 includes a
pivot hole 104. A pivot axis 106 extends between pivot holes 104 in
mounting bracket arms 94. Both angular pivot housing 92 and pivot
tube 88 pivot relative to mounting bracket 90 independently about
axis 106. Angular pivot housing 92 is mounted between the mounting
bracket arms 94 and includes a substantially circular bracket 108
having an interior annular opening 110 and a pair of substantially
parallel extension arms 112 extending from opposite sides of
circular bracket 108. Circular bracket 108 has a pair of slots 114
having pivot holes 116 corresponding to mounting bracket pivot
holes 104. A distal end 118 of each extension arm 112 includes a
rigid oval portion (FIG. 13) or a flat rectangular portion, as
shown in FIGS. 11-12, functioning as a thumb rest.
[0060] On the exterior portion of each extension arm 112,
intermediate circular bracket 108 and distal end 118, there is
provided an extension key 120 adapted for locking/adjustment
engagement with the plurality of locking/adjustment key holes 102
of corresponding mounting bracket arm 94. The angular position of
angular pivot housing 92 relative to mounting bracket 90 is locked
by two extension keys 120 on extension arms 112 of angular pivot
housing 92. In the illustrated embodiment, the locking is dual
directional, but could also be a one-directional ratchet type. The
angular position of angular pivot housing 92 relative to mounting
bracket 90, and thus, the angular position of patient interface
device 12 relative to the forehead of the patient, can be released
and adjusted by squeezing and moving the two thumb rests at distal
ends 118 of extension arms 112 to move extension keys 120 from one
angular position to the next and then releasing the thumb rests so
locking/adjustment keys 120 are engaged within the desired
locking/adjustment key holes 102. This angular positioning of the
angular pivot housing is illustrated by arrow 107 in FIG. 13.
[0061] Pivot tube 88 is a rigid tubular member mounted within
interior annular opening 110 of circular bracket 108. A pair of
pivot projections 122 extend from opposite sides of the exterior of
pivot member 88. When assembled, each pivot projection 122 extends
through a corresponding circular bracket pivot hole 116 and then
through a corresponding mounting bracket arm pivot hole 104. Pivot
tube 88 pivots relative to mounting bracket 90, but its motion is
restricted by angular pivot housing 92. Pivot tube 88 provides a
second range of movement of about 5 degrees.
[0062] As shown in FIGS. 11 and 13, pivot tube 88 is biased by an
integrated lever spring 124 provided on circular bracket 108
intermediate extension arms 112. The bias provided by the lever
spring is illustrated by arrow 115 in FIG. 13. Pivot tube 88 is
pushed inwardly (deflected toward the user when in use) to the most
inner position with respect to the angular pivot housing 92 by
spring 124. Pivoting of pivot tube 88 against the bias force is
limited by contact with the integrated lever spring 124.
[0063] In an alternate embodiment shown in FIG. 24, a thumbscrew
126 is mounted on the front of the pivot tube below the centerline
of the pivot. By rotating the screw, the tube is pushed toward the
user when donned by the user. Alternatively, the screw could be
mounted above the pivot so that rotating the screw causes the tube
above the pivot to be pushed out, which, in turn, push the tube
below the pivot toward the user. Additionally, a torsion spring
could be mounted on the pivots to provide a spring force biasing
the position of the patient interface toward the user. Of course,
other spring type arrangements can be provided on angle adjustment
assembly 78 to bias the patient interface device at end 84 of tube
80 toward the user.
[0064] An alternate embodiment of angle adjustment assembly 78' is
shown in FIGS. 21A-21D. In this embodiment, angle adjustment
assembly 78' includes a pair of press-and-release buttons 128 with
a built-in spring 130 action. Press-and-release buttons 128 are
operated by pressing the buttons to disengage a locking mechanism,
thereby allowing tube 80 to rotate relative to mounting bracket 90'
to the desired position.
[0065] In a further alternate embodiment, the coupling between the
patient interface device and the coupling elbow or cradle is
adjustable. An example of this is shown in FIG. 20. More specially,
FIG. 20 illustrates a coupling between cradle 58' and a nasal mask
131. This illustrated coupling is a ball 132 and socket 134 type
joint, where the ball is allowed to rotate within the socket. More
specifically, cradle 58' includes a ball end 132, which is
receivable in a socket portion 134 of the patient interface device,
thereby allowing the tubing portion to be angled or rotated with
respect to the patient interface device. Friction between the ball
and socket maintain the position between these two elements once
they are moved to the desired position. Although a ball-and-socket
type of configuration is shown, it is to be understood that other
adjustable type joints could be used for coupling the patient
interface device to the elbow/cradle. In addition, the
ball-and-socket arrangement can be reversed, with the ball being
provided on the patient interface and the socket on the
elbow/cradle.
[0066] As shown in FIGS. 1, 2, and 14-16, harness assembly 26 of
headgear 22 is adapted to be worn on the head of a patient and
includes a cross strap 136 extending over the top of the patient's
head and a forehead strap 138 extending over the forehead and
temples of the patient. Forehead strap 138 and cross strap 136 are
formed from a semi-rigid plastic and preferably have a cushioning
element on the patient contacting side. Each end 140 of forehead
strap 138 includes an angled connecting port 142 for adjustable
connection to cross strap 136. In the illustrated embodiment, each
angled connecting portion 142 includes five adjusting holes 144,
while each end of the cross strap 136 includes two corresponding
projections 146 enabling the corresponding connecting portion 142
of forehead strap 138 and the ends of cross strap 136 to be
selectively interconnected to adjustable lengths depending on the
head parameters of the patient to provide a secure fit. It can be
appreciated that each side of cross strap 136 can be adjusted
independently of the other side. In addition, the hole and
projections can be reversed, and more or less holes and projections
can be provided.
[0067] Harness assembly attaching portion 96 of mounting bracket 90
is attached to a center portion of forehead strap 138. In an
exemplary embodiment of the present invention, harness assembly
attaching portion 96 is releaseably attached to a mounting bracket
166 provided on forehead strap 138. See FIGS. 14-16.
[0068] A rear strap 148 is provided having a rigid connecting
element 150 on each end. Each connecting element 150 is receivable
in a key slot opening 152 provided on angled connecting portion 142
below the cross strap adjusting holes 144. Rear strap 146 loops
through connecting elements 150 and is adjusted by hook and loop
fasteners or other appropriate means. Thus, each end of rear strap
146 is selectively attachable to the semi-rigid headgear portions
and the length of the rear strap is adjustable on either end. Those
skilled in the art will appreciate that the connecting element 150
and slot 152 arrangement can be reversed, with the slot or other
female receiving portion provided on the rear strap and the
connecting element and the other cooperating male portion provided
on angled connecting portion 142.
[0069] Alternatively, as shown in FIG. 25, adjustment of harness
assembly 26 is accomplished by means of an adjustment assembly 154,
which simultaneously adjusts both cross strap 136' and rear strap
148'. Specifically, cross strap 136' and rear strap 148' are linked
together on one side of harness assembly 26 via a connecting
element 156, such as a cord. Connecting element 156 is attached to
adjacent ends of cross 136' and rear 148' straps. Connecting
element 156 is threaded through a locking element 158 forming a
loop 160. The effective length of cross strap 136' and rear strap
148' is adjusted by adjusting the size of the connecting element
loop 160 through locking element 158. Thus, the positions of cross
strap 136' and rear strap 148' about the patient's head are
simultaneously adjusted by the single adjustment of the connecting
element 156.
[0070] It should be noted that the present invention contemplates
eliminating loop 160 in favor of allowing cross strap 136' and rear
strap 148' to be adjusted independently. That is, separate
connecting elements can be provided for cross strap 136' and rear
strap 148' so that each can be adjusted by means of locking element
158.
[0071] FIG. 23 illustrates a further embodiment for controlling the
adjustment of the harness assembly. In this embodiment, end
portions 161 and 162 of cross strap 136''' and rear strap 148'',
respectively, are connected to one another via a connecting member
163. In the illustrated embodiment, connecting member 163 is a cord
that is connected to portion 165 of the headgear assembly. More
specifically, connecting member 163 runs through holes 167a, 167b
provided in portion 165. Cross strap 136'', rear strap 148'', or
both, include a strap tightening system 169, which in the
illustrated embodiment is shown as being provided on rear strap
148''.
[0072] Strap tightening system 169 is any conventional system that
is used to increase or decrease the length of the strap, such as a
hook and loop configuration. In the illustrated exemplary
embodiment, hooks 171 are provided on strap 148'' and corresponding
loops 173 are provided on a pad 175. Of course, this configuration
can be reversed. Tightening of strap 148'' is accomplished by
pulling more of the strap across the pad and fastening the strap
back onto the pad.
[0073] Because of the connection between cross strap 136'' and rear
strap 148'' provided by connecting member 163, tightening or
shortening the length of one of these straps has the effect of
simultaneously tightening or shortening the length of the other.
Thus, this embodiment for the headgear provides a single means
(strap tightening system 169) for adjusting the one strap that
automatically adjusts another strap in the headgear.
[0074] Referring again to FIGS. 1, 2, and 14-16, the upper end of
tubular section 80 of length adjustment assembly 76 is connected to
an air hose 164. Cross strap 136 further includes mounting bracket
166 for mounting a crown swivel 168 for attaching air hose 164 to
conduit 16. Crown swivel 168 includes a lower tubular member 170
and an upper tubular member 172 each connected to a swivel joint
174, so that the lower tubular member 170 and the upper tubular
member 172 can freely swivel. The lower tubular member 170 includes
a clip portion 176 for selectively and releasably connecting
mounting bracket 166 to cross strap 136. In an exemplary embodiment
of the present invention, clip portion 176 selectively connects
mounting bracket to strap 136 in the same manner as harness
assembly attaching portion 96 attaches to forehead strap 138
discussed below.
[0075] Referring now to FIGS. 11, 12, and 14-16, the manner in
which harness assembly attaching portion 96 attaches to forehead
strap 138 and lower tubular member 170 attaches to cross strap 136
will now be discussed. It should be noted that the manner in which
assembly attaching portion 96 is attached to forehead strap 138 and
the manner in which an attaching portion 96' disposed on lower
tubular member 170 is attached to cross strap 136 are substantially
similar. Thus, reference is made only to one of these attachment
configurations, namely the attachment of attachment portion 96' on
lower tubular member 170 to cross strap 136, and only this
attachment configuration is shown in FIGS. 14-16.
[0076] Cross strap 136 and forehead strap 138 each includes a
mounting bracket 166 on which the corresponding attaching portion
97, 97' attaches. Please note that only the mounting bracket on the
cross strap is shown. Each attaching portion 96, 96'; includes clip
portions 97, 97' on each side of attaching portion 96, 96'.
Squeezing clip portions 97, 97' toward one another causes them to
deflect from a biased position, where an engaging portion 99, 99'
engages a portion 101 of mounting bracket 166, to a deflected
position, where engaging portion 99, 99' disengages from portion
101, thereby allowing the attaching portion to slide off of the
mounting bracket. See FIGS. 11 and 12.
[0077] Preferably, mounting bracket 166 and attaching portion 96,
96' are configured such that they can only be assembled in one
orientation to ensure that the patient interface assembly is
assembled correctly. The ability to attach and detach mounting
assembly 28 and angle adjustment assembly 78 from the corresponding
portion of the headgear assembly allows the components of the
patient interface assembly to be disassembled for easy cleaning and
allows for easy part replacement.
[0078] A still further alternate embodiment is shown in FIGS.
22A-22C. In this embodiment, there is no length adjustment assembly
76, but there is a biasing assembly, generally indicated at 179,
for the patient interface device, which in this embodiment, is a
nasal mask. The nasal mask is attached to one end of a lever bar
178. The opposite end of the lever bar is connected to a pivot 180
on a mounting bracket 182 located at the central portion of the
forehead strap. An integrated spring 184 is provided on the
mounting bracket to bias the patient interface device toward the
user when the patient interface system is donned by the user, as
indicated by arrow 183. Spring 184 may be fixed or adjustable to
allow an increasing or decreasing sealing force. This adjustment
would typically be made based on the patient's individual
prescription pressure. In the illustrated embodiment, a second
spring 186 is provided on mounting bracket 182 to provide an
additional bias force on lever bar 178. Of course, this second
spring is optional.
[0079] It is also to be understood that the present invention
contemplates that other spring biasing techniques, in place or on
in addition to those shown in the figures, can be used to urge the
patient interface device toward the patient. For example, a spring
can be provided on the patient side of level bar 178 and attached
to mounting bracket 182 or the forehead strap.
[0080] FIGS. 26 and 27 illustrate another embodiment of a patient
interface assembly 200 according to the principles of the present
invention, in which FIG. 27 shows the patient interface assembly as
worn by a patient. Patient interface assembly 200 includes a
patient interface device 202 and a headgear 204 adapted to be worn
by the patient. In the illustrated embodiment, patient interface
device 202 is a nasal mask adapted to cover the area of the face
surrounding the nares. It is be understood that the patient
interface device can correspond to any conventional interface
device or the interface device 12 discussed above. Headgear 204
corresponds to headgear 22 discussed above and can include all of
the features of that headgear.
[0081] One difference between the patient interface assembly of
FIGS. 26 and 27 and that of the previous embodiment is in the
manner in which the patient interface device is biased or held
against the surface of the patient. In the embodiment of FIGS. 26
and 27 a rigid coupling member, generally indicated at 206, couples
patient interface device 202 to headgear 204. The rigid coupling
member includes a first arm 208 connected between a first side of
the patient interface device and a first side of the headgear, and
a second arm 210 connected between a second side of the patient
interface device and a second side of the headgear, wherein the
first and the second arm are rigid. The first and second arms are
preferably formed from a light-weight material, such as plastic. In
addition, the first arm and the second arm are also preferably
sized and shaped that they generally match the contour of a human
face that underlies each arm when the patient interface assembly is
donned by the patient.
[0082] In a preferred exemplary embodiment of the present
invention, the first arm and the second arm are adjustably coupled
to the headgear such that the length of the first and second arms
can be controlled to fit the needs of each patient. In the
illustrated embodiment, this adjustable connection is achieved by
providing a slot 212 in the end of first arm 208 and at the end of
the second arm. Of course, only the first arm is shown in FIGS. 26
and 27. A friction lock 214 is disposed in the slot. The friction
lock includes a post that is disposed in the slot and a lock nut
that is threaded onto the post. Loosening the nut allows the post
to move along the slot, and tightening the nut causes the nut to
hold the friction lock in place. It is to be understood that the
present invention contemplates using any conventional technique for
controlling the positions of the first and second arms relative to
the headgear.
[0083] The first and second arms can be connected to the patient
interface device in a fixed relationship, i.e., such that the arms
do not move relative to the mask shell, or in a non-fixed
relationship. In an exemplary embodiment, the non-fixed
relationship includes coupling the arms to an elbow connector 216
such that the arms swivel or rotate about this connector. For
example, the present invention contemplates that the first and
second arms are defined from an integral piece of material with a
hole defined therein. The elbow coupling is disposed in the hole
such that the arms can rotate around the elbow coupling.
[0084] As in the previous embodiment, a connector tube 218 is
connected to elbow coupling 216 and an air hose 164 is coupled to
tube 218. A connecting element 220 is provided to couple air hose
164 and/or coupling tube 218 to a forehead strap 138. If desired,
another coupling element 222 can be provided at cross strap 136 to
connect the patient circuit to the headgear. Connecting elements
220 and 222 can be any conventional device that secures the tube to
the headgear, such as a simple strap, or they can correspond to the
coupling systems discussed above.
[0085] Although the invention has been described in detail for the
purpose of illustration based on what is currently considered to be
the most practical and preferred embodiments, it is to be
understood that such detail is solely for that purpose and that the
invention is not limited to the disclosed embodiments, but, on the
contrary, is intended to cover modifications and equivalent
arrangements that are within the spirit and scope of the appended
claims.
* * * * *