U.S. patent application number 15/383514 was filed with the patent office on 2017-11-09 for sleep apnea and anti-snoring monitor.
The applicant listed for this patent is Real 3D Polymers Group LLC. Invention is credited to Shail Chokhavatia, Dinesh Shah, Nidhi Shah, Sureshkumar Shah.
Application Number | 20170319129 15/383514 |
Document ID | / |
Family ID | 59057693 |
Filed Date | 2017-11-09 |
United States Patent
Application |
20170319129 |
Kind Code |
A1 |
Shah; Nidhi ; et
al. |
November 9, 2017 |
SLEEP APNEA AND ANTI-SNORING MONITOR
Abstract
A Home Sleep Testing (HST) device for the diagnosis of
obstructive sleep apnea (OSA) and snoring. The Device has an orally
mounted microprocessor and sensor set configured to measure a
user's movement, sleep pattern and snoring.
Inventors: |
Shah; Nidhi; (Chicago,
IL) ; Shah; Sureshkumar; (Troy, MI) ; Shah;
Dinesh; (Troy, MI) ; Chokhavatia; Shail;
(Paramus, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Real 3D Polymers Group LLC |
Troy |
MI |
US |
|
|
Family ID: |
59057693 |
Appl. No.: |
15/383514 |
Filed: |
December 19, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62269331 |
Dec 18, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/566 20130101;
A61M 2016/0036 20130101; A61M 2205/332 20130101; A61M 2230/50
20130101; A61B 5/01 20130101; A61M 16/024 20170801; A61B 5/087
20130101; A61M 2205/3584 20130101; A61M 16/0069 20140204; A61B
5/4818 20130101; A61M 2205/3592 20130101; A61M 2016/0027 20130101;
A61B 5/038 20130101; A61M 16/049 20140204; A61B 5/4836 20130101;
A61M 16/0493 20140204; A61B 2562/12 20130101; A61N 1/0548 20130101;
A61M 2205/3375 20130101; A61B 5/682 20130101; A61B 5/14552
20130101; A61M 2207/00 20130101; A61M 2230/205 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/01 20060101 A61B005/01; A61B 5/03 20060101
A61B005/03; A61B 5/087 20060101 A61B005/087; A61B 5/1455 20060101
A61B005/1455; A61M 21/00 20060101 A61M021/00; A61M 16/06 20060101
A61M016/06; A61M 16/00 20060101 A61M016/00; A61M 16/04 20060101
A61M016/04; A61B 5/00 20060101 A61B005/00; A61F 5/56 20060101
A61F005/56; A61B 5/00 20060101 A61B005/00 |
Claims
1. An oral sleep apnea and anti-snoring treatment device
selectively engagable with a patient's lips and teeth, said oral
sleep apnea treatment device comprising: a front hollow housing
defining a first through passage, said front hollow housing having
an exterior surface configured to engage the patients lips; a
mouthpiece having an exterior surface defining a tooth engaging
surface and defining second and third through passages, each
defining an aperture disposed adjacent to the adjacent to the
retromolar pad members when engaged with the patient's teeth; and
one of a pressure generating device and an air flow generating
device disposed within the first through passage, the generating
device configured to create an airflow through the second and third
passage and adjacent the retromolar pad members.
2. The device of claim 1, wherein the device comprises a battery
disposed within the front hollow housing, said battery being
electrically coupled to the generating device.
3. The device of claim 1, wherein the device comprises a controller
configured to regulate electrical power supplied to the generating
device.
4. The device of claim 3, wherein the front hollow housing is
selectively engageable to the mouthpiece.
5. The device of claim 4, wherein the mouthpiece is formed using
one of additive manufacturing, injection molding, thermoforming and
blow molding.
6. The device of claim 5 wherein the mouthpiece is injection
over-molding with an elastically deformable, low durometer
material.
7. The device of claim 1, wherein the mouthpiece defines an
aperture configured to project moving air onto an oropharynx area
of the patient.
8. The device of claim 1, further comprising first and second
members having member defining a u-shape, said first and second
members defining the defining second and third through passages,
and a plurality of flanges disposed between the first and second
members and said plurality of flanges engaging a tongue.
9. The device of claim 1, the mouth piece comprises first and
second u shaped components, the first and second u-shaped members
defining the second and third through passages.
10. The device of claim 1, further comprising a control module in
the front hollow housing, wherein the control module is coupled to
a plurality of sensors, the control module configured to provide a
signal to control operation of the generating device.
11. The device of claim 9, wherein the plurality of sensors
comprise at least one of a pressure sensor, an airflow sensor,
temperature sensors, sound sensor, an accelerometer, and a pulse
oximeter.
12. The device of claim 9, wherein the control module comprises one
of a closed loop control system and a wireless communication
module.
13. The device of claim 1 further comprising a mandibular
advancement device.
14. The device of claim 1 further comprising a nostril tubes in
connection to the front hollow housing to a nasal passage.
15. An oral sleep apnea treatment device selectively engagable with
a patient's lips and teeth, said oral sleep apnea treatment device
comprising: a front hollow housing defining a first through
passage, said front hollow housing having an exterior surface
configured to engage the patients lips; a mouthpiece having an
exterior surface defining a tooth engaging surface and defining
second and third through passages, each defining a plurality of
apertures disposed adjacent to soft tissues within the patient's
mouth when engaged with the patient's teeth; and a blower disposed
within the first through passage, the blower configured to create
an airflow through the second and third passage and onto the
patients soft tissue.
16. The device of claim 15 further comprising electrodes configured
to engage the soft palates and tongue.
17. The device of claim 15 further comprising a tilt sensor
configured and a feedback mechanism, the feedback mechanism
configured to wake the patient when the patient is not sleeping on
a patient's side.
18. The device of claim 15 wherein the mouthpiece a boil and bite
material.
19. The device of claim 15 wherein the plurality of apertures
disposed adjacent to soft tissues within the patient's mouth are
configured to blow air at very low flow rate, the micro-holes
positioned adjacent a patients lingual area.
20. The device of claim 15 comprising a controller and a plurality
of sensors disposed within in the front hollow housing, the
controller being configured to calculate an AHI index.
21. The device of claim 20, wherein the plurality of sensors
comprise one of a pressure sensor, an airflow sensor and one or
more temperature sensors, sound sensor, tilt sensor, and a pulse
oximeter.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 62/269,331, filed on Dec. 18, 2015. The entire
disclosure of the above application is incorporated herein by
reference.
FIELD
[0002] The teachings are directed towards sleep apnea/anti-snoring
devices and more particularly to a cordless and tubeless hybrid
sleep apnea/anti-snoring devices for reducing and measuring sleep
apnea and snoring.
BACKGROUND
[0003] Obstructive sleep apnea (OSA) is a Sleep disorder with
partial or complete cessation of breathing during one's sleep. This
sleep disorder is currently treated by methods such as a surgery,
oral appliance therapy, negative pressure to pull soft palate and
tongue forward, implantable devices that keep the airway open
during sleep by stimulating the hypoglossal nerve, strips for nose
for expiratory positive airway pressure, Positive Air Pressure
(PAP) therapy or a combination involving several methods. PAP
therapies are also employed to treat other medical and respiratory
disorders, such as Cheynes-Stokes respiration, congestive heart
failure, and stroke. A common PAP device comprises a flow generator
(e.g., a blower) that delivers gas via delivery conduit (hollow
tube) to an individual interface. It is also known to deliver the
PAP as a continuous positive airway pressure (CPAP), a variable
airway pressure, such as bi-level pressure (Bi-PAP) that varies
with the individual's respiratory cycle or an auto-titrating
pressure (APAP) that varies with the monitored condition of the
individual. Nasal, oral-nasal and full face masks are common
interfaces utilized for delivering PAP to the individual's
airway.
[0004] These masks can be uncomfortable due to improper fit, tight
straps to hold mask in place, skin irritation at points of contact,
dryness of throat cause claustrophobia, excessive PAP pressure and
are a major factor in individual therapy non-compliance. Also the
PAP machines can be noisy. Studies show individual non-compliance
for PAP therapy from 29 to over 83%.
[0005] Obstructive sleep apnea (OSA) is a Sleep disorder with
partial cessation (hypopnea) or complete cessation (apnea) of
breathing during one's sleep. This sleep disorder is diagnosed and
analyzed by a technician monitored overnight sleep study in a sleep
laboratory setting (Polysomnography or PSG) with multiple
physiological parameters and more recently by Home Sleep Testing
devices with limited parameters.
[0006] The federal Center for Medicare and Medicaid Services (CMS)
has provided guidance for various types of sleep studies based on
number of parameters and whether study is attended by Sleep
technician or is unattended. A brief summary of the classification
system for sleep studies based on these guidelines is provided
below.
[0007] Most of the current Home Sleep Testing (HST) devices are
worn on chest while current device of invention is only device
which is worn in mouth. It is very comfortable, convenient, small
in size and provide for more information due to proximity of
several sensors to nose and mouth where actual sleep disturbances
events should be measured.
[0008] Type I HST devices using in attended sleep studies performed
in a sleep lab and monitored by a sleep technician with full sleep
staging (i.e. monitoring the transition through the various sleep
stages). Typically, Type I devices include the following channels
(parameters):EEG (electroencephalogram), EMG (electromyogram--chin
and Limb), EOG (electrooculogram), respiratory airflow (with
oronasal flow monitors), respiratory effort (Thorax and Abdomen),
oxygen saturation (oximetry), ECG (electrocardiography), snoring
sounds, and body position--additional channels for CPAP/BiPAP
levels, CO2, pH, pressure etc.
[0009] Type II Home sleep test (HST) devices use a portable
monitor, performed without any sleep technician monitoring the
study, with at least 7 channels or parameters. Type II devices
typically include at the very least the following Parameters: EEG,
EOG, ECG/heart rate, EMG, Airflow, Respiratory effort, Oxygen
saturation. Type III Home sleep tests (HST) use a portable monitor
unattended with a minimum of 4 channels. Type III devices usually
include the following parameters: 2 respiratory movement/airflow, 1
ECG/heart rate, 1 oxygen saturation. Type IV Home sleep test (HST)
with Type IV portable monitor, unattended with a minimum of 3
channels. Type IV devices must allow parameters that allow direct
calculation of an AHI (Apnea Hypopnea Index) or RDI (Respiratory
Disturbance Index) as the result of measuring airflow or
thoracoabdominal movement. The RDI is defined as the average number
of respiratory disturbances.
[0010] Alternately devices that record other information to derive
AHI or RDI must be approved by CMS through the review of published
peer reviewed medical literature. It is very expensive to perform
the traditional attended PSG sleep studies in sleep labs (Type I)
to diagnose for OSA. Patients have difficulty getting to sleep in a
unfamiliar surrounding with various wires connected to their limbs
and head and being continuously watched and monitored. This created
a need for a simpler and cheaper way to diagnose for OSA and led to
the development of portable sleep monitors--Home Sleep Testing
machine (HST) complying with the CMS guidelines and offering
results comparable to that of PSG in a home setting.
SUMMARY
[0011] The teachings relates to oral or nasal or a combination of
oral and nasal device for treatment and diagnosis of obstructive
sleep apnea and snoring; having microprocessors and sensors, can
include the following configurations and all devices are with or
without mandibular advancement (MAD): Oral Device having
micro-blowers and control module--positive airflow (PAP) device;
Oral Device having micro-blowers and control module--auto control
positive airflow (Auto PAP) device and proprietary algorithm for
auto adjustment of pressure and/or flow rate; Oral/Nasal Device
having micro-blowers with positive airflow (PAP or APAP) utilizing
nasal passage for air delivery; Oral Device without micro blower
and with or without microprocessor, sensors and data acquisition
system; and the above oral devices with capability for testing
sleep apnea known as HST or OOCST (out of center sleep testing)
diagnostic PAP device and capability to treat OSA.
[0012] All above configurations according to the teachings within
this application can be without mandibular advancement (MAD) and
can be provided with upper mouth piece only (i.e. without the lower
mouth piece) or with lower mouth piece only (i.e. without the upper
mouth piece). All above devices can be customized or non-customized
by using casting, 3d printing or boil and bite techniques.
[0013] According to the present teachings, an oral sleep apnea
treatment device selectively engagable with a patient's lips and
teeth is presented. The oral sleep apnea treatment device includes
a front hollow housing defining a first through passage, said front
hollow housing having an exterior surface configured to engage the
patient's lips. A mouthpiece is provided having an exterior surface
defining a tooth engaging surface and defining second and third
through passages, each defining an aperture disposed adjacent to
the adjacent to the retromolar pad members when engaged with the
patient's teeth. A pressure and/or air flow generating device in
the form of a blower is disposed within the first through passage.
The pressure and/or air flow generating device configured to create
an airflow through the second and third passage and adjacent the
retromolar pad members.
[0014] According to another teaching, the device has a battery
disposed within the front hollow housing, said battery being
electrically coupled to the pressure and/or air flow generating
device.
[0015] According to another teaching, the afore mentioned device
has a controller configured to regulate electrical power supplied
to the pressure and/or air flow generating device.
[0016] According to another teaching, in the afore mentioned device
the front hollow housing is selectively engageable to the
mouthpiece.
[0017] According to another teaching, the afore mentioned device is
formed using one of additive manufacturing, injection molding, and
blow molding.
[0018] According to another teaching, the afore mentioned device
the mouthpiece is injection over-molding with an elastically
deformable, low durometer material.
[0019] According to another teaching, the afore mentioned device
further has first and second members having member defining a
u-shape said first and second members defining the defining second
and third through passages, and a plurality of flanges disposed
between the first and second members and said plurality of flanges
engaging a tongue.
[0020] According to another teaching, the afore mentioned the mouth
piece has first and second u shaped components, the first and
second u-shaped members defining the second and third through
passages.
[0021] According to another teaching, the afore mentioned device
further has a control module in the front hollow housing, wherein
the control module is coupled to a plurality of sensors, the
control module configured to provide a signal to control operation
of the pressure and/or air flow generating device.
[0022] According to another teaching, the afore mentioned device
includes a plurality of sensors which can be one of a pressure
sensor, an airflow sensor, temperature sensors, sound sensor, an
accelerometer, and a pulse oximeter According to another teaching,
the afore mentioned device wherein the control module has a closed
loop control system and a wireless communication module.
[0023] According to another teaching, the afore mentioned devices
further having a mandibular advancement device.
[0024] According to another teaching, the afore mentioned device
further including a nostril tubes in connection to the front hollow
housing to a nasal passage.
[0025] According to the present teachings, a home sleep test device
is provided which is selectively engagable with a patient's lips
and teeth. The home sleep test device includes a front hollow
housing defining a first through passage, the front hollow housing
having an exterior surface configured to engage the patient's lips.
A mouthpiece is provided having an exterior surface defining a
tooth engaging surface and defining second and third through
passages, each defining an aperture disposed adjacent to the
adjacent to the retromolar pad members when engaged with the
patient's teeth. A data acquisition system within the first through
passage. The data acquisition system is configured to measure an
airflow through the second and third passage and adjacent the
retomolar pad members.
[0026] According to another teaching, the device has a battery
disposed within the front hollow housing, said battery being
electrically coupled to the controller.
[0027] According to another teaching, in the afore mentioned device
the front hollow housing is selectively engageable to the
mouthpiece.
[0028] According to another teaching, the afore mentioned device is
formed using one of additive manufacturing, injection molding, and
blow molding.
[0029] According to another teaching, the afore mentioned device
the mouthpiece is injection over-molding with an elastically
deformable, low durometer material.
[0030] According to another teaching, the afore mentioned device
further has first and second members having member defining a
u-shape, said first and second members defining the defining second
and third through passages, and a plurality of flanges disposed
between the first and second members and said plurality of flanges
engaging a tongue.
[0031] According to another teaching, the afore mentioned the mouth
piece has first and second u shaped components, the first and
second u-shaped members defining the second and third through
passages.
[0032] According to another teaching, the afore mentioned device
further has a control module in the front hollow housing, wherein
the control module is coupled to a plurality of sensors, the
control module configured to provide a signal to control operation
of the pressure and/or air flow generating device.
[0033] According to another teaching, the afore mentioned device
includes a plurality of sensors which can be one of a pressure
sensor, an airflow sensor, temperature sensors, sound sensor, an
accelerometer, and a pulse oximeter.
[0034] According to another teaching, the afore mentioned device
wherein the control module has a closed loop control system and a
wireless communication module.
[0035] According to another teaching, the afore mentioned devices
further having a selectively adjustable mandibular advancement
device.
[0036] The teachings additionally relate to device designs and
functioning of device manufacturing methods, and materials for
single piece, micro, tubeless, cordless, anti-snoring (AS)/sleep
apnea treatment (SA) devices where airflow from the front of the
mouth is directed from the device to the back of the mouth,
bypassing the soft tissues, palates, tongue etc. This flow can be
directly to the oropharynx or laryngopharynx area, with or without
use of micro-blowers (and with or without microprocessor/sensors in
both cases). The device can be attached to the upper arch (teeth)
or the lower arch (teeth) or to both arches. The design of the
device allows for simultaneous nose and mouth breathing.
[0037] The device can be non-customized or customized for the
individual. Air-flow is directed to the oropharynx area (throat
area) from the mouth opening (lips area) using a front hollow
housing and hollow tubes or other hollow shapes passageways
attached to inner mouthguard bypassing soft tissues. In case of
standard CPAP configuration, air flow at a predetermined air flow
rate and pressure is supplied. In case of an Auto PAP device, the
pressure and airflow is continuously adjusted as per need using
micro fan(s), sensors and microprocessor with firmware (algorithm).
In addition to an auto continuous positive air pressure (Auto CPAP)
or non-auto continuous positive air pressure (CPAP) controlled
mechanism, the oral device can also bring lower jaw forward
(mandibular advancement device--MAD), increasing air passage,
further mitigating OSA and snoring.
[0038] This hybrid device is referred to herein as a single piece
Oral CPAP with MAD device. In all above concepts, the device has
the capability to record data within the system using a micro-SD
card or to transfer data wirelessly to mobile devices or to cloud
using Bluetooth to permit live monitoring of the medical condition
of the individual and treatment compliance. The device can record
data (air flow rate, respiratory efforts, oxygen saturation,
pressure, temperature, snoring pattern, and position during sleep)
which can be used to determine sleep parameters such as AHI
(Apnea/Hypopnea) index, SpO2, snoring level, breathing variation
etc., using proprietary algorithm.
[0039] The afore mentioned devices according to the present
teachings can be controlled by preprogrammed algorithms or by
wirelessly updating with mobile device of parameters such as
pressure, flow rate, mode of operation etc.
[0040] The afore mentioned devices according to the present
teachings can also utilize active noise cancellation techniques and
passive methods such as specific sound insulating/absorbing
materials to reduce the noise from the operation of the device.
[0041] The afore mentioned devices according to the present
teachings can also incorporate features for tongue movement control
such as preventing it from falling to the back of mouth and
creating obstruction to the air way passage.
[0042] The afore mentioned devices according to the present
teachings can be without micro blowers (or may be also without
hollow tubes) can also be used as diagnostic sleep apnea device
such as Home Sleep Study (HST) device. The sensors to measure air
flow directly or differential pressure to measure the airflow while
breathing (air flow limitation to calculate AHI index); a pulse
oximeter to measure SpO2, heart rate and temperature; a position
sensor (tilt sensor) to indicate position of body while at sleep,
Sound sensor to measure breathing variation and snoring; miniature
video camera mounted on the mouthguard to take pictures of inside
of mouth during sleep and a processing unit to capture and analyze
these parameters to provide a comprehensive sleep study report for
a type 3 and other types HST device. These parameters are captured
on a memory card built into the unit or wirelessly transferred
using Bluetooth, wifi, cloud or other similar technologies.
[0043] The afore mentioned devices according to the present
teachings can be formed of two pieces: a front hollow housing (in
which micro fan(s), sensors, microprocessors etc. are inserted
after manufacturing) and an inner mouth piece with hollow air
passage way. These pieces have snap fit and easy unsnap fit
features.
[0044] The afore mentioned devices according to the present
teachings can be formed of a plurality of processes. For example,
the front hollow housing with is made by injection molding, while
hollow passage way for inner mouthpiece can be achieved by.
Multi-step process: separately injection mold partial hollow tube
followed by bonding these two pieces to create hollow passage way
in inner mouth piece; one step injection molding process with multi
cavities and rotating tool; water or gas injection molding to
achieve hollow air passage way; and lost core foam injection
molding.
[0045] The afore mentioned devices according to the present
teachings can be both non-customized and customized devices are
manufactured by similar processes as described above except for
customizations (to fit the teeth perfectly) is achieved by
processes such as 3D printing (hard or hard/soft materials), "boil
and bite" concept and micro-cellular foaming injection molding
processes.
[0046] The afore mentioned devices according to the present
teachings can bring airflow from the front of the mouth to back of
the throat (pharynx area) and can be combined with mandibular
advancement (bringing the lower jaw forward) to further assist in
eliminating or reducing snoring and sleep apnea, referred to herein
as PAP-MAD without micro-blower (with or without microprocessor and
sensors) or PAP-MAD with micro-blower(s) and microprocessor and
sensors or Auto-CPAP/MAD with micro-blower(s) having
sensors/microprocessor and closed loop control system and algorithm
to have comfortable pressure/air flow change during sleep.
[0047] According to another teaching, the afore mentioned
structures can be used for oral or nasal or a combination of oral
and nasal device as Home Sleep Testing (HST) device for the
diagnosis of obstructive sleep apnea (OSA) and snoring. The HST can
include having microprocessors and sensors.
[0048] The HST unit for standard OSA testing without mandibular
advancement (MAD) can be provided with upper mouth piece only (i.e.
without the lower mouth piece) or with lower mouth piece only (i.e.
without the upper mouth piece).
[0049] According to an alternate teaching, the HST unit can include
mandibular advancement (MAD) to validate specific mandibular
advancement setting and treatment of sleep apnea with or without
innovative oral CPAP sleep apnea device or current CPAP device.
[0050] According to an alternate teaching, the HST unit can be used
in conjunction with CPAP for determining the efficacy of a pressure
setting.
[0051] According to an alternate teaching, the HST unit can device
as sleep apnea diagnostic as well as treatment device: In addition
to device performing as diagnostic tool (as Home Sleep Testing
(HST) or Out of center Sleep Testing (OOCST) for detecting OSA, the
same device can also be used as sleep apnea treatment and/or
anti-snoring device.
[0052] According to an alternate teaching, the HST unit can be
fitted with a mix of sensors to measure air flow; SpO2 (oxygen
saturation in blood), heart rate (beats/min) and respiratory
effort. These parameters would be sufficient to perform a sleep
study conforming to the guidelines by CMS or AASM for a Type III or
Type iV study. Additional sensors can be included to measure
temperature; body positions while at sleep, Sound (breathing)
variation and snoring, Single channel ECG (heart), EEG for brain
activity etc.
[0053] Actual sleep time is not measured by current HST devices
while in one embodiment the device can have built-in sensors or
wirelessly communicating sensors like heart rate, breathing
monitoring, position sensor for body movement during sleep,
temperature along with proprietary algorithm helps in measuring
actual (true) sleep time which is very important for accurate
(true) AHI number, a measure of severity of sleep apnea.
[0054] In one embodiment, the device would be fitted with a
differential pressure sensor to measure airflow and pressure (or
alternately with a PVDF calibrated strip), a novel pulse ox sensor
from lips for oxygen saturation and heart rate (alternately could
be a standard pulse oximeter with Bluetooth capability), and a
photophlethysmographic (PPG) sensor to measure respiratory effort
(alternately could be a standard RIP belt to acquire the same
parameter). All these parameters would be continuously acquired and
stored on a memory SD card built into the unit (device) or
wirelessly transferred using Bluetooth, wi-fi, cloud or other
similar technologies to a mobile device or to cloud based server.
This data can then be analyzed by automated computer algorithms for
episodes of breathing irregularities while sleeping--such as
apneaic or hypopneaic events and summarized to provide AHI/RDI
information. The RDI is defined as the average number of
respiratory disturbances. The device can be controlled wirelessly
using mobile devices.
[0055] In another embodiment, the device can be enhanced by
addition of sound sensor to measure breathing patterns and snoring
variation, thermistor for temperature of air flow and breathing
pattern, miniature video camera mounted on the mouthguard to take
pictures of inside of mouth during sleep and a processing unit to
capture and analyze these parameters to provide a far more
comprehensive sleep study report compared to the Type III or Type
IV HST devices.
[0056] Both of above embodiments can be adapted to validate
Mandibular Adjustment (MAD) setting by providing oral component
with mandibular adjustments (lower jaw advancement) in specific
fine increments.
[0057] Also the device of present invention can be concurrently
used with CPAP and validate efficacy of pressure setting for the
CPAP treatment.
DRAWINGS
[0058] FIGS. 1A to 1I depict various embodiments of a sleep apnea
treatment or anti-snoring device attached to upper arch with hollow
front housing and hollow side tubes (with or without
microprocessor/sensors attached to front hollow housing) to bring
air at the end of the throat (pharynx) area according to the
present teachings;
[0059] FIG. 1J depicts different cross sections of device--from
front of the housing to end of inner piece (oropharynx area)
according to the present teachings;
[0060] FIG. 1K shows further cross section at the center of device
as per FIG. 1I cross section;
[0061] FIG. 1L shows further cross section at the center of device
as per FIG. 1I cross section FIG. 1M shows the device with cross
section areas to be taken for further figures and FIG. 1N depict
one cross section of device as per FIG. 1M;
[0062] FIG. 1O shows the next cross section as per FIG. 1M;
[0063] FIG. 1P depicts the next cross section as per Figure;
[0064] FIGS. 1S-1Y represent various views of the device shown in
1O.
[0065] FIGS. 1Q and 1R further depict the cross sections to the
present teachings;
[0066] FIG. 2A to 2C depict a sleep apnea or anti-snoring device
with both upper and lower arches, where the upper arch comprises a
curved center hollow passageway designs from front of mouth other
than hollow tube to keep the tongue down while delivering airflow
directly to the oropharynx/throat area according to the present
teachings;
[0067] FIG. 2D shows hollow tube or hollow passageway design
according to FIG. 2 having a lower portion rotated with respect to
an upper portion.
[0068] FIG. 2E shows an end view of the hollow tube or hollow
passage way design shown in FIG. 2D;
[0069] FIGS. 3A and 3B depict a sleep apnea or anti-snoring device
with different designs of strips with two sided adhesive buttons or
tapes to keep the individual's tongue forward while still allowing
tongue side to side movement according to the present
teachings;
[0070] FIGS. 4A-4E depict conventional CPAP single piece oral sleep
apnea treatment device with micro-blower(s) for continuous positive
airflow with microprocessors and sensors according to the present
teachings;
[0071] FIGS. 5A-5D depict a variety of suitable micro-blowers for
use with the teachings;
[0072] FIGS. 6A and 6B depict an Auto CPAP (APAP) device with a
miniature control module inserted in hollow housing having
micro-blower(s) and sensors and microprocessor (micro-chip)
etc.;
[0073] FIGS. 6C and 6D depict micro fan(s) is mounted vertical,
blowing the air straight into housing and hollow tubes. FIG. 6D
Show that micro fan(s) can be mounted horizontal and control module
can be mounted vertically to each according to the present
teachings;
[0074] FIG. 7A depict an CPAP or Auto-CPAP (APAP) control module
comprising various items inserted in the housing of the device;
[0075] FIG. 7B depicts a schematic of the data flow and control
module according to one embodiment of the teachings;
[0076] FIG. 8A depicts current mandibular advancement device (MAD)
and FIG. 8B depicts a combination micro, tubeless, maskless, single
piece Oral CPAP device with mandibular advancement capability
(Hybrid PAP-MA Oral Device or Hybrid APAP-MA Oral Device);
[0077] FIG. 9 depicts one embodiment of a nasal/oral device with or
without the MAD CPAP Device;
[0078] FIG. 10 depicts thin plastic membrane which depresses the
upper arch of mouthguard (at the end, throat area) which expands
and stays expanded during air flow from micro blower, stopping soft
palates to collapse, allowing more open airway passage;
[0079] FIG. 11 depicts exploded view of separate pieces of device
to be manufactured;
[0080] FIG. 12 depicts various flows schemes for manufacturing
methods for a Customized, single piece, micro oral PAP or APAP
device;
[0081] FIGS. 13A-13D depict a customized, single piece, micro oral
PAP device made by a "Boil and Bite" manufacturing process;
[0082] FIGS. 14A-14D depict a customized, single piece, micro oral
PAP device manufactured by "Bite only" micro-cellular foaming
injection molding;
[0083] FIG. 15 depicts a single step manufacturing method for
hollow device by injecting material in two cavities, cavities
rotation, followed by injecting plastic at intersection of two
halves, creating hollow part;
[0084] FIG. 16 depicts micro-holes in the hollow tube (or hollow
passage way), blowing air at very low flow rate, but stimulating
the tongue to stay forward original position (does not allow to
fall back) during sleep. These micro-holes can be near the tongue
(lingual area) and/or at the end of throat area (oropharynx area);
and
[0085] FIG. 17 depicts special microchip embedded into mouthguard
for nerve stimulation hand a plurality of metal stimulators. It's
designed to be in close proximity to the nerves of the tongue
muscle. This reduces the tongue falling back during sleep, allowing
more open airway passage.
DETAILED DESCRIPTION
[0086] The teachings relates to device designs, working function of
device, and manufacturing methods for single piece, micro,
tubeless, cordless, anti-snoring (AS)/sleep apnea treatment (SA)
devices where airflow from the front of the mouth is directed from
the device to the back of the mouth, bypassing the soft tissues,
palates, tongue etc., directly to the oropharynx or laryngopharynx
area, with or without use of micro-blowers. If micro-blowers are
not used, the device can have micro-sensors and microprocessors
attached to front hollow housing. The sensors can be insert molded
in the inner piece of the device. The device can be attached to the
upper arch (teeth) or the lower arch (teeth) or to both arches. The
design of the device allows for simultaneous nose breathing. The
device can be Non-customized or customized for the individual.
Air-flow is directed to the oropharynx area (throat area) from the
mouth opening (lips area) using a front hollow housing and hollow
tubes (or different hollow passage ways designs) bypassing soft
tissues. In case of an Auto PAP device, the desired pressure and
airflow is achieved (automatically adjusted continuously during
sleep) using micro fan(s), sensors and microprocessor having closed
loop feedback control system and proprietary algorithm using a
compact control module inserted inside the front hollow housing of
the oral or oral/nasal device. Sensors with low energy battery can
also be attached to mouthguard during injection molding process for
compliance and few data acquisition purposes. The device has the
capability to record data within the system using a micro-SD card
or to transfer data wirelessly using Bluetooth or cloud to permit
live monitoring of the medical condition of the individual and
treatment compliance.
[0087] In addition to an auto continuous positive air pressure
(Auto CPAP) or non-auto continuous positive air pressure
(conventional CPAP) controlled mechanism, the oral device can also
bring lower jaw forward (mandibular advancement device--MAD)
reducing further occurrence of the sleep apnea and snoring
significantly, referred to herein as: A. PAP-MAD without
micro-blower but with micro sensors and microprocessor or B.
CPAP-MAD with micro-blower(s) more micro-sensors and microprocessor
or C. Auto-CPAP/MAD with micro-blower(s) having sensors and closed
loop control system and proprietary algorithm to have comfortable
(auto-adjustable) pressure/air flow during sleep
[0088] The device can also be modified to use as a diagnostic sleep
apnea device with additional sensors. The device can be controlled
wirelessly to set parameters such as pressure, flow rate etc., by
any wired or wireless device such as a smart phone, smart notebook
etc., using Bluetooth type or other wireless technologies.
[0089] The teachings relates to oral or nasal or a combination of
oral and nasal device for treatment and diagnosis of obstructive
sleep apnea and snoring; having microprocessors and sensors,
comprising of following configurations and all devices are with or
without mandibular advancement (MAD): [0090] 1. Oral Device having
micro-blowers and control module--positive airflow (PAP) device
[0091] 2. Oral Device having micro-blowers and control module--auto
control positive airflow (APAP) device and proprietary algorithm
for auto adjustment of pressure and/or flow rate [0092] 3.
Oral/Nasal Device having micro-blowers with positive airflow (PAP
or APAP) utilizing nasal passage for air delivery [0093] 4. Oral
Device without micro blower and with or without microprocessor,
sensors and data acquisition system [0094] 5. Above oral devices
with capability for testing sleep apnea known as HST or OOCST (out
of center sleep testing) diagnostic PAP device and capability to
treat OSA
[0095] All above configurations without mandibular advancement
(MAD) can be provided with upper mouth piece only (i.e. without the
lower mouth piece) or with lower mouth piece only (i.e. without the
upper mouth piece). The Non-customized device or customized devices
(to fit individual's teeth) are supplied in different sizes such as
small, medium and large. Both non-customized and customized devices
consist of two pieces A and B as shown below: A. front hollow
housing (in which micro fan(s), sensors, microprocessors etc. are
inserted after manufacturing) and B. inner mouth piece with hollow
air passage way.
[0096] Front housing has snap/un-snap fit concept where front
hollow housing section is easily snap-fitted with inner mouth piece
and also can be easily un-snapped (removed from inner mouth piece).
Below are manufacturing methods: A. Front hollow housing with is
made by injection molding. To prevent air leakage between hollow
housing and inner mouth piece, an elastomeric ring is mounted on
front housing or elastomeric ring is molded in one step process as
two shot injection molding. B. For inner mouthpiece, the following
manufacturing methods are used to achieve predetermined hollow
passage ways. The inner mouth piece is divided into two portion: 1.
Partial hollow tube and 2. Mouthguard (upper or lower arch) 1.
Multi-step process: 1. Separately injection mold partial hollow
tube and mouthguard (or two shot molding of mouthguard where it can
be soft/hard material or "boil bite" soft material with hard
material) followed by bonding of partial hollow tube and mouthguard
to create hollow passage way in inner mouth piece. The bonding can
be mechanical, vibration welding, laser welding or adhesively
bonding; 2. One step injection molding process where partial walls
of tube and mouthguard are molded in two cavities of a single mold,
followed by rotating cavities where two halves are aligned and
second material is injected at intersection, bonding these two
pieces and creating hollow structure. Here, the second material is
soft material or "Boil and Bite" material, creating customized oral
device in a single step process; 3. Water or gas injection molding
to achieve hollow air passage way; and 4. Lost core foam injection
molding
[0097] Both non-customized and customized devices are manufactured
to fit the individual's teeth (upper arch, lower arch or both). The
customized device provides better fit and more comfort. The
customized device is also supplied in 3 different sizes such as
small, medium and large based on internal teeth arch sizes of
different individuals.
[0098] There are different manufacturing methods for customized
devices such as: 3D Printing of Device--This is accomplished by
scanning of the teeth or creating an impression of teeth, creating
a CAD file of teeth for 3D printing of the device, followed by 3D
printing of hard or hard/soft device in a single step. Here, hollow
sections such as tubes and hollow housings are manufactured in a
single step, due to design freedom of 3D printing process. "Boil
and Bite" concepts such as: a) Over-molding of "Boil and Bite"
material on 3D printed part (also known as insert molding): This is
accomplished by injection molding of soft "Boil and Bite" on hard
3D printed hollow device (part) as an "insert" in injection molding
tool. b) Over-Molding of "Boil and Bite" material on previously
hollow Injection molded device (part): Injection molding of soft
"Boil and Bite" material on previously injection molded hollow
device as "an Inert" (here, hollow structure for housing and
tubes/hollow air passage way can be manufactured by several methods
described above. c) micro-cellular foaming injection molding
process where micro-cellular foam material is injected on top of
mouthguard.
[0099] The device can be single piece construction, if the device
does not contain any sensors/microprocessor or
sensors/microprocessor and battery are completely sealed, then no
need to have snap-fit feature. This single piece construction can
be achieved by bonding of two separate injection molded halves at
pre-determined line (or separately injection molding hosing with
partial tube and mouthguard) followed by bonding these two pieces
to create hollow structure or by water injection molding or by lost
core foam injection molding.
[0100] In all cases, it is recommended to replace mouth piece from
front housing or replace "boil and bite" portion of mouth piece
once it wears out in order to protect the teeth, keeping correct
teeth alignment and not creating TMJ. The front hollow housing with
or without microprocessor and sensors can be reused.
[0101] For both Non-customized and customized devices, they can be
used without micro-blower where air flow is directed from the front
to oropharynx area due to hollow tubes or hollow passage ways.
Here, the device can have microprocessor and key sensors to provide
feedback on sleep quality and AHI index as well as compliance.
[0102] For both Non-customized and customized devices a
micro-blower or multiple micro-blowers can be inserted into the
front hollow housing of the device. The micro-blower continuously
blows air into hollow internal airflow passages attached to the
mouth guard, thus working as a conventional CPAP machine, but
without any external tubes or wires or cords attached.
[0103] For device described above, the device can also be fitted
with a control module having microprocessor and sensors for
pressure, airflow rate, temperature, pulse rate and oxygen
saturation, snoring pattern, position during sleep, respiratory
efforts etc. with a closed loop control system (hardware). This
embodiment allows for the automatic control of airflow pressure
and/or air volumetric flow rate as in Auto CPAP or Bi-CPAP type
machines without the need for external tube, wires, cords, fittings
using proprietary algorithms built into the device unit command
module.
[0104] The device brings airflow from the front of the mouth to
back of the throat (pharynx area) and can be combined with
mandibular advancement (bringing the lower jaw forward) to further
assist in mitigating snoring and sleep apnea, referred to herein as
PAP-MAD without micro-blower or CPAP-MAD with micro-blower or
Auto-CPAP/MAD with closed loop control system.
[0105] The device may comprise the capability to record data by
micro-SD card or wirelessly transfer data for real time monitoring
and treatment compliance. The device can be controlled wirelessly
using mobile devices.
[0106] One embodiment of the teachings comprises tongue depression
design of hollow tube (or any hollow passage design). This serves
two purpose: bring the air from outside to back of throat and same
time keeping the tongue down, keeping more air passage open at the
oropharynx area.
[0107] One embodiment of the device comprises of utilizing PVDF
sensor technology with airflow and apnea/hypopnea detection already
calibrated off the shelf strips (from Dymedix) or standard PVDF
film strips that can be mounted in our device with proprietary
algorithm to enable CPAP/APAP type operation for all the above PAP
devices identified above.
[0108] One embodiment provides special design at back of the upper
or lower arch of mouthguard which attracts the tongue to stay
forward position during, keeping more air passage way open. One
embodiment provides curve vertical semi-rigid plastics strip (fish
tail shape) attached to hollow side tubes on both side, which
pushes upper lip mouth area outward, keeping nasal air way passage
open, helping further air coming from nose during sleep, reducing
snoring and sleep apnea.
[0109] One embodiment of the teachings comprises providing
micro-holes in the hollow tube (or hollow passage way), blowing air
at very low flow rate, but stimulating the tongue to stay forward
original position (does not allow to fall back) during sleep. These
micro-holes can be near the tongue (lingual area) and/or at the end
of throat area in a hollow tube (left and right) connecting the end
of the two sides of hollow tubes of upper or lower ach, directly
blowing air to tongue and to soft palates of throat region. Slight
disturbance of tongue and soft palate by air from these holes may
be sufficient, not allowing soft tissues to relax, keeping air
passage way open during breathing during sleep without waking up an
individual.
[0110] Other embodiments envisage using nasal or oral-nasal
delivery of air flow from device with or without auto control
module and micro-blowers. One embodiment of the teachings comprises
that the light source and pulse oximeter probe can be mounted
outside the lip on vertical plastic strip which is part of hollow
housing while the light detector is mounted on the mouthguard.
Other concept of wired pulse oximeter can be mounted on ear lobe.
Wireless pulse oximeter can be mounted on finger or any other
location as done by conventional pulse oximeter. The information
can be transferred to Bluetooth of the teachings device or
Bluetooth of the smart phone or any such device.
[0111] One of the benefit of the device compared to current PAP
machine is that there is no need to vent the air during exhalation
since device allows to exhale thro' nose even when the micro blower
is continuously blowing air during exhalation.
[0112] One embodiment of the teachings comprises special microchip
embedded into mouthguard for nerve stimulation. The ultra-small
neurostimulator, is mounted on the mouthguard (bonded to mouthguard
or insert molded this tiny chip in plastic during injection molding
of mouthguard). It's designed to be in close proximity to the
nerves of the tongue muscle for stimulation. This reduces the
tongue falling back during sleep, allowing more open airway
passage.
[0113] Other embodiments envisage using nasal or oral-nasal
delivery of air flow from device with or without auto control
module and micro-blower(s). One embodiment of the teachings
comprises an impact sport guard with additional airflow during the
sports activity and protection of teeth. This embodiment is
referred to herein as a positive airway pressure impact sports
guard with or without micro-blower(s). This is accomplished by
front housing having impact absorbing material or a 3-D printed
lattice structure to absorb and distribute energy away from the
teeth.
[0114] One embodiment of the teachings comprises that the light
source and pulse oximeter probe can be mounted outside the lip on
plastic which is part of hollow housing while the light detector is
mounted on the mouthguard. Other concept of wired pulse oximeter
can be mounted on ear lobe. Wireless pulse oximeter can be mounted
on finger or any other location as done by conventional pulse
oximeter. The information can be transferred to Bluetooth of the
teachings device or Bluetooth of the smart phone or any such
device.
[0115] The device can also be configured as a sleep apnea
diagnostic device to detect OSA. For this use, the device has
various sensors located in the hollow housing and/or the maxillary
or mandibular arches which would be capable of measuring and
recording oxygen saturation in blood and pulse rate (pulse
oximeter), air flow rate, respiratory effort by Bluetooth/wifi
enabled effort belts (RIP belts); temperature, position (tilt),
Single lead ECG sensor packages with wireless connectivity can be
used to monitor and record heart rhythm; also EEG sensors packages
can be incorporated to monitor and record brain activity. Also
inside mouth camera can be used to monitor changes in air passage.
Proprietary algorithms can be applied to this data to determine AHI
which could be correlated to standard Sleep diagnostic tests such
as PSG or PG.
[0116] The device can be modified to serve as a sleep apnea
diagnostic device. For this use, the device has more sensors
located in the front outside housing and/or maxillary or mandibular
arches such as differential pressure to measure air flow; pulse
sensor to measure oxygen saturation in blood, pulse rate,
temperature; a position sensor (tilt sensor) to indicate position
of body while at sleep, Sound sensor to measure breathing variation
and snoring; miniature video camera on the mouthguard to take
pictures of inside of mouth during sleep; PVDF based sensor for air
flow and temperature measurement; respiratory effort sensor (RIP
belt). These data along with heart rate can provide information on
AHI (Apnea Hypopnea Index) number for the individual (level of
sleep apnea) as well as ability to discriminate between OSA and
central apneas. EKG probes can be used for monitoring heart rhythm
which can communicate with the device with wireless technology.
Also additionally EEG sensors can be incorporated to measure brain
activity and provide data on actual sleep time. The device can
perform as diagnostic tool (as Home Sleep Testing (HST) or Out of
center Sleep Testing (OOCST) for detecting OSA.
[0117] The device can also be used to titrate oral appliances such
as mandibular advancement (MAD devices) and help select appropriate
treatment without extensive sleep lab or home sleep testing. HST
can be conducted with different mandibular advancement positions
and the Diagnostic results from each overnight sleep study (HST)
with different positions compared to select the best position for
optimal treatment.
[0118] The device can also be configured with PVDF sensors applied
to the patients' area above the lips and below the nostrils with a
Dymedix sensor (previously calibrated) or with a PVDF film
installed in the hollow housing and/or the maxillary or mandibular
arches, with airflow and apnea/hypopnea detection capability to
provide HST capability. PVDF film has a property that allows it to
produce an electrical signal when variation in force, sound,
acceleration, pressure, or heat is applied such as by airflow with
varying temperatures (breathing in and exhaling), snoring sound,
moving while asleep, etc. This signal can be captured and magnified
by proper filters and amplifiers to produce waveforms as utilized
by PSG/HST diagnostic devices and can be monitored and stored to
provide and record indications of snoring, apnea/hypopnea and so
on. The PVDF sensor would replace or enhance the sensors already
indicated above.
[0119] In one embodiment the device can deliver compounds and or
excite or stimulate appropriate nerves in the mouth to open air way
passages. According to the present teachings, each device within
the specification can be used with or without microblowers. Turning
to the figures, FIG. 1A depicts an individual with no sleep apnea
treatment device inserted in the mouth. Oropharynx area (upper
airway) 15 is almost closed during sleep causing sleep apnea or
snoring. In FIG. 1B, the same individual shown in FIG. 1A is
depicted having a sleep apnea treatment device 13 according to the
teachings inserted into the mouth, and oropharynx area 15 (airway
passage) is less obstructed as air comes from the front of hollow
housing of device and is delivered to the oropharynx area,
completely bypassing air flow restriction areas such as soft
palates, and tongue during sleep, reducing sleep apnea or snoring.
Direct continuous air delivery during inhalation reduces sleep
apnea occurrence as the airway passage is less obstructed.
[0120] FIG. 1C depicts a CAD drawing for the device 13. FIGS. 1D
and 1E shows different designs of device. All FIGS. 1C,1D and FIG.
1E having an upper arch can be customized using several mentioned
methods. FIGS. 1D and 1E have sensors and/or microprocessor 127
mounted in the outer housing next to hollow airway passage opening.
This sensor helps doctor to determine the patient compliance, sleep
information and other parameters real time and/or over long period
of time. FIG. 1C depicts a front top perspective view and FIG. 1E
depicts a rear perspective view of one embodiment of the device of
the teachings. As shown in FIG. 1C and FIG. 1E, device 13 comprises
three main components: hollow front housing 110 with front opening
126 for air entrance and 127 space for microprocessor and sensors
(for FIGS. 1D and 1E), hollow side tubes 115 which bring air from
hollow opening 126 in hollow front housing 110 to oropharynx area
15 as seen in FIG. 1B and upper arch 100 which can be
Non-customized or customized. Upper arch 100 can be made of single
material or can comprise soft material 121 touching the teeth and
semi-rigid material 122 on outside, facing lower teeth as shown in
FIG. 1F. FIG. 1G shows the device 13 with strips to keep tongue
down. Figure H shows micro-processor and sensors attached to front
housing.
[0121] Hollow side tubes 115 can be manufactured using the same
materials as rest of device 13 or they can be manufactured from
material 122 that is slightly more rigid than upper arch 100
material 121 as shown in FIG. 1F so they do not collapse,
restricting the airflow. The rigidity of material also allows
withstanding teeth grinding forces during sleep. By using a high
modulus material, the wall thickness of hollow side tubes 115 and
hollow front housing 110 can be in the range of 0.3 mm to 2 mm, the
overall size of device 13 can be reduced, making device 13 more
comfortable and increasing internal hollow space for airflow.
Hollow side tubes 115 can be coated in their interior surfaces to
reduce friction. Hollow side tubes 115 can be made of plastic
material having low coefficient of friction, to minimize the air
pressure drop from front air entrance area to exit at the back of
throat area. Another primary cause of reduced air flow is
turbulence, caused by the flow of the air when traveling in an
indirect pathway. Where the air flow transitions, there should be a
smooth transition curve which will result in less turbulence
(smooth transition), so airflow will not be effected (laminar flow
rather than turbulent flow). This will reduce the incoming air
pressure drop, requiring less pressure need. Less air turbulence
will also reduce air flow noise.
[0122] Hollow side tubes 115 can also have outer surfaces made of
soft material for the comfort of the individual. The inside
diameter (cross-section based on design) of hollow side tubes 115
can be constant or the inside diameter can be reduced slowly from
front hollow housing connection towards the oropharynx/throat area
to increase the air velocity, further aiding reduction of
obstruction in the upper air passage. This also helps in increase
response time when an Auto CPAP concept is used. As cross-sectional
area decreases, air velocity increases inside hollow side tubes
115. The law of conservation of mass means that the size of hollow
side tube 115 can be calculated to provide a desired air velocity
using the following equation:
V.sub.2=(V.sub.1*A.sub.1)/A.sub.2 [0123] V is velocity and A is
Area
[0124] Device 13 can be designed (figure not shown) to be used with
a lower arch (lower teeth) only rather than an upper arch 100 as
shown in FIGS. 1C and 1E. In this embodiment, the front hollow
housing 110 (for air flow) and hollow side tubes 115 are attached
to the lower arch of the mouth guard, eliminating the need for the
upper arch mouth guard.
[0125] FIG. 1J shows few cross sections of device from front of the
housing to oropharynx area (towards throat area) as per FIG. 1I.
The cross section of hollow tubes or hollow air passage ways is
determined by AHI index of an individual and required air flow rate
and pressure.
[0126] FIG. 1K shows different designs of hollow tubes and hollow
passage ways. The hollow passage ways can be in the form of
tubes--round, oval, rectangular or any other size and dimension
based on required airflow and pressure determined by hand
calculation or by computational fluid dynamics (CFD). The hollow
passage ways can be buccal side, lingual side or at occlusal area
(between the upper and lower teeth). The hollow passage ways can be
reduced in dimension from front to back. The length of hollow air
passage way can be varied.
[0127] The hollow passage way can have micro holes at predetermined
area from front to back just to excite tongue to stop it falling
back, keeping air passage way open., The hollow passage way from
two side tubes can be connected at the throat area having other
hollow tube, creating "C" hollow section and there are holes only
in tube at throat area to provide controlled air flow and pressure
to reduce sleep apnea. FIG. 1L, FIG. 1M and FIG. 1N depict cross
sections of one embodiment of a sleep apnea treatment or
anti-snoring device 14 without micro-blowers having both upper and
lower arches 100, 101 where hollow side tubes 115 are connected
with upper arch 100. FIG. 1L and FIG. 1N depict a CAD drawing while
FIG. 1M depicts the CAD drawing of an alternative design having
micro holes which apply air to the tongue or soft pallet or throat
area. Upper arch (maxillary) 100 and lower arch (mandibular) 101 of
the device 14 have dimensions fitting upper and lower teeth of the
wearer such that the device 14 does not move the lower jaw forward
as would a MAD (mandibular advancement device).
[0128] Buttons or any snap fit design or matching tabs design on
arches can be used to keep upper arch 100 and lower arch 101 of the
device 14 together during sleep. Hollow front housing 110 comprises
an opening 126 in the front of the device 14 where air enters and
exits during breathing (inspiration and expiration). Hollow front
housing 110 can be of any shape (rectangular, oval, square, round
etc.) and is not limited to the shape depicted in FIGS. 1B to 1L.
The size of hollow front housing 110 depends on the person's mouth
opening size. For Non-customized devices, the size of hollow front
housing 110 is designed in such a way that it will cover majority
of the population having different facial dimensions, and can be
manufactured in small, medium and large sizes. For customized
devices, the device substantially fits the individual's teeth, but
it is not necessary to cover all teeth as long as device does not
come out during sleep.
[0129] FIG. 1O-1R show the sections of the device (fitting upper
and lower arches/teeth) with front hollow housing opening having
micro-sensors and microprocessor. FIG. 1N depicts an individual
with full sleep apnea device while 1P depicts the device with a
front portion removed, thus allowing for disinfection of only the
moth portion., unsnapping the front hollow housing after the use of
device.
[0130] The non-customized or customized device can be a single
piece construction made out of semi-solid material, elastomeric
material or hard/soft (soft in contact with teeth) materials. The
device can be made by injection molding or/and two shot
over-injection molding or insert injection molding processes or
thermoforming processes, followed by bonding technologies as
described earlier. Single piece design or two piece snap fit design
with tubes (hollow air passage way), compact construction, fit,
finish and comfort are the key factors used in the design,
selection of materials and manufacture of the device.
[0131] FIG. 10 depict air entrance opening 126 in hollow front
housing 110 and air exit opening 130 from upper arch hollow side
tubes 115 during inspiration. FIG. 1R depicts a cross section of
device 14. FIG. 1O depicts device 14 with hollow front housing 110
and hollow side tubes 115 attached to upper arch 100. Hollow front
housing 110 can be completely detached and easily attachable at
intersection 135, snap fit connection. FIGS. 1S-1Y represent
various views of the device shown in 1O.
[0132] Further the top of housing part 110 can be split into 2 snap
fit components if needed, permitting easy assembly and access for
the electronics including micro-blower that will be mounted inside
the hollow front housing 110.
[0133] The snap fit design (connect and disconnect of hollow
housing from inner mouth piece) is essential to clean the device
after every night and also to replace the inner mouthguard after
few months as it wears out due to teeth grinding forces. Patient
has to order only inner mouth piece and connect with original front
housing to function like new device, reducing cost. For the
customized "Boil and Bite" soft portion can be changed after
certain usage if "boil and bite" is mechanical attached to rigid
arch, further reducing the cost to patient and also frequent change
reduces the bruxism or jaw deformation.
[0134] FIGS. 2A-2C depict one embodiment of a device 24 having air
entrance opening 226 comprising a curved hollow air tube 230
connected from hollow front housing 210 directly to the center of
upper arch 200, bringing air directly from the outside of the mouth
to the back of the mouth. FIG. 2A, FIG. 2B and FIG. 2C and FIG. 2D
and FIG. 2E are CAD drawings showing different views of the device
24. In this embodiment, the mouth has to be kept open slightly to
permit the hollow air tube 230 to pass the teeth area and this is
accomplished by putting tabs or spacer on bottom of upper arch and
top of bottom arch or using the tube 230 to create this separation
to allow pass-through. Here, spacer between upper and lower arch is
built in (molded) to allow the center hollow tube pass through when
device is inserted in the mouth, without touching the teeth. FIG.
2C depicts hollow tube without spacer can be used to separate upper
and lower arch to direct the air flow from front of mouth to throat
area. It works as spacer as well as hollow air passage way.
[0135] Curved hollow air tube 230 can be curved slightly downward
so that it can apply pressure downward on the tongue such that the
tongue does not fall backward during sleep, helping to keep the
upper air way passage open (oropharynx area of mouth) and reducing
the sleep apnea. Further the tube 230 will be flexible in the
lateral domain to permit small sideways movement of the tongue for
comfort. Curved hollow air tube 230 can be of any shape, round,
square, rectangular. Curved hollow air tube 230 can be made of
single material or multi-material where outside material is softer
than internal material for individual's comfort. This concept can
be used with or without mandibular advancement and with or without
CPAP or Auto-CPAP having micro blower(s). The center hollow air
passage way can be hollow spoon shape so that it can apply pressure
on downward on the tongue, larger surface area than just the above
mentioned hollow tube, further preventing the tongue to fall
backward, helping even more air way passage open, and further
reducing sleep apnea.
[0136] In one embodiment, curved hollow air tube 230 can be used
along with hollow side tubes 215. FIGS. 3A and 3B depict one
embodiment of device 34 to keep the tongue forward (not allowing
the tongue fall back). If the device 34 is made to fit only the
upper arch teeth or lower arch teeth, then multiple strips 340 can
be joined accordingly as shown from left to right of the mouth
guard arches 300, 301 (not shown in figure). Strips 340 can be
straight, concave or convex. Strips 340 can be made of polymeric
elastomer material. To stop the tongue from falling back, two sided
pressure sensitive or moisture sensitive or any other chemistry
type adhesive tape 350 in the form of small buttons or other shapes
like rectangular tape can be used to cover the strip in whole or in
part. Before placing the sleep apnea device 34 in the mouth, the
adhesive buttons or tape 350 can be placed on one or more strips
340 by removing release paper on one side of the adhesive tape or
buttons 350. Then, the other side of the adhesive buttons or tape
350 is exposed by removing release paper and the device 34 is
inserted in the mouth. The adhesive of the adhesive buttons or tape
350 bonds to the tongue. The elasticity of adhesive and design of
the adhesive buttons or tape 350 will allow some movement of the
tongue from left to right or right to left, but will keep the
tongue in a forward position, stopping the tongue from falling
backward and keeping the airway passage open. Directional
elasticity of the adhesive can allow significantly more movement of
tongue from left to right or right to left compared to inward
movement towards throat, not falling back. This will increase
comfort level during sleep as some movement of tongue is allowed.
It is also possible to hold the tongue in a forward position by
putting the adhesive buttons or tape 350 at the back wall 315 of
hollow front housing 310/arch 300, 301.
[0137] FIGS. 4A-4E depict a device 44 having micro-blower(s) 445
with continuous positive airflow (oral CPAP device) concept without
automatic feedback control of pressure, flow rate, temperature, but
with built-in microprocessor and sensors in device for compliance
and monitoring purpose. FIG. 4A depicts a cross section of device
44 having Nanofan(s) or micro blower(s) 445 with
sensors/microprocessors etc. 455 is the direction of flow in the
interior 414 of hollow front housing 410. Here, micro blower(s) is
attached horizontally to front housing, bringing the air flow from
bottom of the hollow housing. While FIGS. 4B and 4C shows device
where micro-blower(s) is mounted vertically, bringing the airflow
directly from front housing to hollow tubes or hollow air passage
way. This is most preferable way of mounting the micro blower(s)
since this attachment provides less resistance to air flow and less
flow turbulence. This design also provides ease of device
manufacturing. But, in few types of micro-blowers, vertical mount
may not be feasible. Sensors, microprocessors, USB drive, batteries
etc. are inserted in open chamber 460 of the front housing next to
micro blower opening in FIGS. 4B and 4C. Device 44 is depicted in
FIGS. 4A, 4B and 4C having micro blower(s) 445 in the interior 414
of hollow front housing 410 having sensors, microprocessor,
batteries and USB card, Blue tooth port etc. The mounting of these
sensors and other items are discussed in FIG. 7. The dimensions of
the walls of the hollow front housing 410 depend on the type of
material and manufacturing process. The dimensions of opening 426
of hollow front housing 410 vary depending on the type and number
of micro blowers 445 that are used. When micro-blowers 445 are
inserted when opening 426 is in the front of hollow front housing
410, micro-blowers 445 have a tight fit with the inner wall of
hollow front housing 410. Elastomeric/rubber gasket can be used to
prevent or minimize air leakage. As shown in FIG. 4A, micro-blowers
445 rest on bottom walls on both sides of hollow front housing 410
having bottom opening 455 for air entrance. Gasket material can be
used to seal the front opening 426 of the hollow front housing 410
around the wall of micro-blower 445.
[0138] The front or bottom opening 455 of hollow front housing 410
allows for air flow for micro-blowers 445. This way, during
inhalation, as micro-blowers 445 turn on, air comes in from the
bottom opening 455 of hollow front housing 410, exits hollow front
opening 410, moves other side of micro-blower(s) and then moves
into hollow side tubes 415, directing air directly at the
oropharynx area. It is possible to increase the pressure or
velocity of incoming air by reducing the size of the hollow side
tubes 415 from the entrance at the hollow front housing 410 to the
exit in the oropharynx area. It is also possible to change the
pressure and flow rate of incoming air by changing the voltage
supply to the micro-blower(s). The arrows in FIGS. 4A, 4B, 4C, 4D
and 4E show the airflow directions from opening of the hollow front
housing 410 through micro blowers 445 to the hollow side tubes 415
to oropharynx area (throat area) and can have a 3 to 5 times the
tidal volume. Only difference is that micro-blower(s) are mounted
vertically, directing the air flow straight into the hollow tubes
or hollow passage way in case of FIG. 4B and FIG. 4C. FIG. 4B shows
embodiment with micro-blower mounted vertically and allowing for
straight air flow to back of mouth. FIG. 4D depicts a person
wearing this kind of oral CPAP device.
[0139] The design of device 13 envisages placement of the
micro-blower at center FIG. 4A and FIG. 4C or on the side of front
hollow housing as shown in FIG. 4B When the blower is placed on the
side as opposed to the center, the dimensions on both tubes or
either hollow passage on device inside the mouth will be adjusted
to get even flow rates from both hollow passage discharges of air
at back of mouth (oropharynx area).
[0140] This continuous positive airway pressure oral device (PAP or
CPAP), provides unobstructed breathing by delivering a constant
flow of air through the side tube(s) or center tube(s) or any other
hollow air passage designs connected to the front hollow housing,
directly to upper air passage way. The oral device with housing is
designed such a way that when individual wears it, it is secured to
the lips so that little or no air escapes from the front. Also, the
micro-blower(s) are constantly running, so exhalation will mostly
occur through nose. Due to this constant level of airflow during
inspiration, air pressure, air flow and air velocity increases in
the oropharynx (throat area) so the upper airway does not collapse
during inhalations while sleeping. Air flow from the micro-blower
can be adjusted by control module as required.
[0141] Although this is not an Auto-CPAP type device but only a
CPAP type device, the device can adjust the micro-blower output to
match inspiration and expiration cycles based on temperature
sensors, if needed but constant running of micro-blower(s) is
preferred.
[0142] A variety of suitable micro-blowers are shown in FIGS.
5A-5D. Depending on the individual's requirement (based on sleep
study), a specific micro-blower type and size can be selected to
have fixed volumetric air flow rate up to 30 liters per minute
and/or air pressure of up to 30 cm H20 (3000 pascal). It is
possible to change (set) the pressure and volumetric flow rate of
the same micro-blower manually. A CFD (computation flow analysis)
will be used to determine and demonstrate the efficacy of the
device under various design parameters and biological
physiologies.
[0143] Micro-blowers with different mechanisms can be used
including but not limited to the following: The micro-blowers can
be based on concepts such as Piezo-nanofan 570 shown in FIG. 5A.
The Piezo nanofan consists of blades made of stainless steel, brass
or even Mylar. Attached to the blades is a patch of piezoelectric
ceramic material. Piezoelectric material deforms in the presence of
a voltage field. Positive and negative electrical voltage affect
the material differently. As a positive voltage is applied, the
ceramic can expand, causing the blade to move in one direction. A
negative electrical voltage can cause the ceramic material to
contract and move the blade back in the opposite direction. The
fan's speed can be adjusted by changing the frequency of the
current. The nanofan or micro blower can be based on axial air gap
technology 571 as shown in FIG. 5B with almost no power loss. One
can use roots blower 572 as shown in FIG. 5C, a more positive
displacement pump. One can use a micro-blower concept using-Air
Multiplier 573 as shown in FIG. 5D (powerful airflow, no blade).
The Air Multiplier is a blower with an unusual characteristic in
that it does not have any visible blades. It appears to be a
circular tube mounted on a pedestal. The shallow tube is only a few
inches deep.
[0144] One can use centrifugal fans, of which there are 3 major
classes--forwardly curved, backwardly curved or straight-bladed.
They generally move less air but at a higher pressure. Some fans
are called compressors if they turn at sufficient speed to
materially compress the air they are moving. Centrifugal fans are
usually mounted in a housing that looks like a snail shell. The
inlet is in the center and the discharge is the opening of the
shell at the outer edge of the scroll. When the blower is
integrated with a housing and a motor, it then becomes a
blower.
[0145] One can use a plurality, such as hundreds, of Nano blowers
instead of micro-blowers inserted into the hollow housing of the
device. In case of an SAT (sleep apnea treatment) or AS
(Anti-snoring) device with several nano-blowers, it is possible to
generate the full range of treatment pressures up to and in excess
of a treatment number of 20 cm pf H.sub.2O, because of the strength
of the electrostatic force that drives the nano-blower plates, like
bellows, open and closed, together and apart. Each nano-blower can
push a small amount of air at significant pressure, and hundreds of
nano-blowers work in parallel to achieve the required volume to
effectively treat the particular individual's sleep apnea. Due to
significantly less air leakage and pressure drop, the individual
may not need to have this high treatment number of pressure 20 to
30 cm of H2O (current CPAP machine--30 cm of H2O or up to 3000
pascal), but can be achieved in case if it is needed. To reduce
cost, these micro or nano-blowers can be manufactured by "roll to
roll" (R2R) or similar low cost, high volume manufacturing
processes. Since, oral CPAP innovation directs air directly from
front of the housing to oropharynx area, bypassing the tongue and
soft pallets, the pressure required is significantly low compared
to current CPAP devices. CFD data shows that 2 cm of H2O can be
sufficient, not 20 to 30 cm of H2O required for traditional current
CPAP machines. This is a great advantage since it will
significantly reduce the numbers of Nano blowers compared to nose
mounted CPAP device, or less powerful or less number of other
micro-blowers described above.
[0146] The dimension (sizes and shapes) of the hollow front housing
of the device depends on the type and size of micro-blower(s) and
also for a specific individual and face size or there can be three
sizes offered (small, medium and large). For example, a
micro-blower is shown having dimension of 17 mm.times.17 mm.times.8
mm fan, having volumetric airflow of 30 liters per min (500 ml per
second). Tidal volume (air volume displaced during inspiration or
expiration) without extra effort is 500 ml during inspiration (for
breathing). A typical respiratory rate for an adult at rest is 12
to 20 breath per minute, meaning each breath (in and out) is 3 to 5
seconds. For example, given 2.5 seconds inspiration time (breath),
tidal volume is 500 ml. For inspiration time of 2.5 seconds, air
volume taken in is 500 ml (200 ml per second).
[0147] If this micro-blower is used (having capacity of 1 CFM=30
liter per min=500 ml per sec), air volume can be 1250 ml (500
ml.times.2.5 sec) per inhalation, increasing the airflow rate by
2.5 times then required in normal case. For patient suffering for
sleep apnea, this will open the air passage in the oral cavity
significantly and prevent the collapse of soft tissues in
oropharynx and larynx, preventing mild to moderate sleep apnea and
snoring. By using hollow tubes taking air directly to pharynx area,
air is brought in faster where needed, even further reducing sleep
apnea and snoring event of patient. If one micro-blower does not
perform as needed, more than one micro-blower in series can be used
to get more airflow and pressure.
[0148] FIGS. 6A and 6B depict an Auto CPAP (APAP--Automatic
positive air pressure) device 64 with Miniature Auto Control Module
605 inserted in hollow front housing 610 along with micro-blower(s)
645 and sensors 646. 605 can be mounted horizontally or vertically
depending on the type of micro-blower(s) used. FIG. 6C depict
micro-blower(s) 645 and automotive control module are mounted
vertically in front housing. Control module 605 is data-capable and
records all information on events and compliance. Control module
605 having a microprocessor with several sensors 646 and
micro-blower(s) 645 is placed directly in hollow front housing 610
of a single piece and may provide variable flow depending on the
response measures and calculated by the controller., Micro, oral
device 64 having very small space in comparison to current Auto
CPAP devices where the control module 605 along with blower/motor
645 is located remotely from the individual and airflow is brought
through a hose or tube to the nose or mouth or both. Vertical mount
of micro blower may allow to reduce overall size of the device.
[0149] The microprocessor or micro-chip in control module 605 is in
communication with airflow (differential pressure), temperature,
tilt, sound sensors and pulse oximeter 646 to provide continuous
feedback of changes in any parameters to microprocessor. Sensors
646 not only can be attached to control module 605 but also to the
mouth guard (inside arch 600), further increasing the capability of
device 64 for sleep apnea and also other purposes such as
diagnostic device as well as compliance information. Based on the
history and AHI index, the microprocessor automatically adjusts air
flow rate/pressure to improve the comfort level of the patient. To
reduce further discomfort and also keep air passage way open for
longer time, micro blower(s) may not be supplying air flow
continuously. This is achieved by using a thermistor sensor in 646
which monitors the individual's breathing and send an output that
reduces the flow of the device 64 internal blower when the
individual starts to exhale. The exhalation temperature is higher
than inhalation temperature. The resulting lowered resistance
prevents the individual from feeling as though he is "fighting"
against the machine when breathing, reducing discomfort. The
control module can be mounted inside the front hollow as shown in
FIGS. 6A and 6B or also can be mounted on the top portion or bottom
or side portion of the housing. Also it can be split into multiple
PCB's with varying configuration. Pressure sensors can be used
monitor the pressure delivered to the individual in all type of PAP
machine types.
[0150] Analog Temperature Sensor (breathing timing sensor) is a
small package thermistor which can be used for a fast response.
This sensor can be placed in a location where it can be contacted
with exhaled air. Analog temperature sensors provide a signal to
the microprocessor indicating the start of the exhalation and
inhalation cycle. The exhalation temperature is higher than room
temperature, indicating start of exhalation, giving feedback to
microprocessor to control micro-blowers. Start of inhalation is
sensed by temperature or/and air pressure sensor.
[0151] A customized or Non-customized oral Auto CPAP type
(automatic positive airway pressure) device continuously monitors
the sensor parameters and utilizing proprietary algorithms
automatically varies the air flow or pressure as per individuals
need. APAP adjusts the air flow (pressure) to improve upper airway
passage opening to a comfortable level, not too much pressure or
airflow then required.
[0152] Through the use of firmware (proprietary algorithm) on the
control module, the device automatically controls the air pressure
and airflow rate by continuously changing air micro-blower's speed
using closed loop control system. It is not necessary that
individual has to have all teeth, so long as the device can be held
in the individual's mouth by a few teeth. The device has a
fast-response micro-blower(s), pressure transducer and
microprocessor. The device control module discerns stoppage or
blockage of breathing from data being collected from the various
sensors and will accordingly adjust the air flow (pressure) from
the micro-blower to varying preset values as per the proprietary
algorithm. As discussed in connection with devices without
micro-blowers, the Auto-CPAP device with micro-blower can be
attached to upper arch or lower arch, or attached to both arches
with or without moving lower jaw forward (like a MAD device). There
is also an air filter (washable or disposable) that can be attached
in front of the micro-blower to filter dirt. Hypoallergenic
disposable filters are made of non-woven acrylic and polypropylene
fibers with a polypropylene carrier. The combination of materials
helps block very fine particles, and some filters claim to have
anti-microbial agents. The hollow housing can be made of plastics
having anti-microbial agents (with or without controlled
release).
[0153] The micro blower and microprocessors etc. can be powered by
coin type or other types of micro-battery or rechargeable (electric
or USB type) coin cell or other types of micro-battery such as a
polymeric micro-battery. Data storage and transfer can be achieved
by a variety of technologies, thus eliminating need for any cord or
wires. Two such technologies include Bluetooth.RTM. and micro-SD
card. The device may incorporate Bluetooth.RTM. technology such
that the device is continuously synced (or synced whenever desired)
with any other Bluetooth.RTM. enabled mobile device such as smart
cell phone, tablet, computer etc. The mobile device can then up
link through the Internet to send the data from the device to an
Internet server. The device can then provide sleep apnea related
data to a device having an appropriate app, which data can then be
analyzed and stored on the device and/or can be communicated/shared
with doctors or other medical professionals or other third parties
via email or via cloud. Using a smart phone or similar devices, it
is also possible to send input to control module of the device to
set up initial required air flow (pressure) etc. for individual as
needed.
[0154] Micro-SD card: The micro-SD card can store all sleep apnea
data during sleep and can be downloaded to a device such as a smart
phone or computer at a later time. Other configurations of the
device can include Wi-Fi capable. Additionally, the control module
may have the capability to manual control if needed and OLED to
show the state of the system. The control module may use an
algorithm that learns from individual's breathing pattern and
reduces device pressure on exhalation (expiration). Sound output
from the device will be between 12 to 18 dBA during normal
operation. By CPAP industry standards that are considered to be
exceptionally quiet. Auto-off function puts the display backlight
to sleep Functions offered on current CPAP devices can also be
incorporated into this oral CPAP device or on mobile app to a
connected mobile device with display for power status, pressure and
ramp time. It also gives audio visual feedback when programming
ramp and pressure settings.
[0155] FIG. 7A depicts the cross section of an Auto-CPAP (APAP)
front hollow housing with micro blower 760 and control module 735
consisting of various elements inserted in the hollow front housing
of a device that is in communication with mobile devices 770 to
download (sync) the data. Elements include but are not limited to:
LCD and touch screen control 700 and on/off switch 701
Bluetooth.RTM. sensor 705 and micro-SD card 710, pressure sensor
715, airflow sensor 720, temperature sensor 725, sound sensor 730,
and tilt (position) sensor 732, microprocessor with firmware 740,
rechargeable battery with USB port 745, material or fabric with
high water absorption capability during exhalation and desorption
during inhalation 755, micro-blowers 760 and air filter 765. The
sensors may be positioned differently than shown inside the mouth
in the mouthguard or alternate locations as required. 770 depicts a
mobile device in communication with Bluetooth.RTM. or other
wireless communication link 775 mounted with a sleep apnea device
comprising a control module. 785 depicts the respiratory belt (RIP)
belt. 780 depicts pulse oximeter that will also communicate with
the control module via Bluetooth or other wireless methods. A
material 755 is incorporated after the microblower to absorb
moisture of exhalation.
[0156] FIG. 7B depicts a schematic of the control module of a
device to treat sleep apnea and snoring. The device has proprietary
firmware/algorithm to operate in different modes such as CPAP, Auto
CPAP, Bi-CPAP etc. Method of operation of a single piece tubeless
Auto CPAP oral device: The control module is programmed with
firmware/algorithm to perform the following operations as shown in
FIG. 7B. The individual puts the oral device in his/her mouth,
fitting it well, and then turns the on/off switch 701. The device
can also be turned on using a connected device such as a smart
phone 770 via Bluetooth.RTM. 705. The start of inhalation can be
detected by setting a pre-determined value for temperature sensor
725 (less than body temperature) or air pressure sensor 715
(atmospheric pressure). Air enters when the micro-blower 760 starts
during inspiration via a signal given by the microprocessor 740,
based on input from temperature sensor 725 and/or pressure sensor
715. The air is filtered by filter 765 before entering in the
hollow front housing 610. A material 755 incorporated into the
control module area 605 has high water absorption capability from
the surroundings. If needed, this material 755 can be soaked in
water and incorporated in the hollow front housing 610 before sleep
to achieve a level of humidity.
[0157] This material 755 does not affect the air flow due to its
location in the hollow front housing 610, but at the same time it
picks up moisture during exhalation. Moisture is then released in
air during inspiration, the amount of moisture depending on air
flow rate and temperature. The humidity level does not alter the
pressure level or change the therapeutic value of CPAP device, it
just improves the comfort. Due to the relatively tight seal of the
device at the lips, there is little or no leakage and the
individual can also breathe through the nose. Also, since the micro
blower(s) are continuously running, air is always entering thro'
mouth during inhalation and exhalation. As air always enters thro'
mouth via micro blower, person more likely to exhale through nose,
thus there is no need for tight seal of oral device at mouth.
[0158] The RIP Belt 785 and Pulse Ox 780 will continuously send
data about respiratory effort and oxygen saturation as well as
Pulse rate via wireless methods to the control module and which can
then be recorded on the storage device. Sensors read pressure and
flow rate values and once they deviate from predetermined set
values, they provide input to the microprocessor 740 of the control
module 605 which in turn changes the micro-blower 760 speed up or
down (changing the power supply level). The control module 605 is
operable to determine the occurrence of an apnea from a reduction
in respiratory airflow below a threshold, and if an apnea has
occurred, to determine the duration of the apnea and to cause the
flow generator (micro-blowers 760) to increase the treatment
pressure/flow rate by an amount which is an increasing function of
the duration of the apnea, and a decreasing function of the
treatment pressure/flow rate immediately before the apnea.
[0159] The start of expiration can be detected by temperature
sensor 725 or air flow sensor 720 or sound sensor 730. During
expiration, the speed of micro-blower 760 can be reduced to
decrease resistance to airflow during expiration, for increasing
comfort. Data-recording devices such a micro SD card can be used to
record multiple variables from the sensors described in FIG. 7 or
can be wirelessly uploaded to servers. This will help to determine
optimum pressure, but the most common measurement is individual's
"Apnea/Hypopnea Index" or "AHI", where the goal is to get AHI to
5.0 or lower.
[0160] The same Auto CPAP device can also be used as BiPAP/VPAP by
changing the algorithm of the firmware on the control module to
have different modes of operation during sleep as described below.
Bilevel-PAP (Bilevel Positive Airway Pressure) provides two levels
of pressure: IPAP (Inspiratory Positive Airway Pressure) and a
lower EPAP (Expiratory Positive Airway Pressure). Bilevel or
variable level machines (BiPAP/VPAP) blows air in two levels, one
for inhalation (IPAP) and one for exhalation (EPAP). This method is
used in situations where marked difficulty breathing is
present.
[0161] These devices can be available a) either in a range of air
flow/pressure values so that individual will be able to obtain the
device with the treatment number appropriate for him/her, much like
contact lenses or b) device will be made adaptive so that they will
self-adjust (like some current high-end APAP machines) to provide
the exact pressure for effective treatment
[0162] FIGS. 8A-8B depict the same concepts for the devices as
above in FIGS. 6A-6D and 7A-7B but the single piece micro oral
tubeless device 84 has capability of bringing the lower jaw forward
(mandibular advancement) in the same manner as MAD devices 80 as
seen in FIG. 8A currently in the market by opening of the mouth
upper airway passage area (oropharynx area). As seen in FIG. 8A,
current MAD devices 80 lack a hollow front housing, microblowers or
hollow side tubes in the mouth guard upper and lower arches 800,
801. Oral MAD CPAP device 84 shown in FIG. 8B and FIG. 8B consists
of CPAP module 805 (same as 605 in FIG. 6A) incorporated in hollow
front housing 810, with hollow side tubes 815 (same as 115 in FIG.
1D) to deliver air directly to oropharynx area and design mechanism
880 as an example to bring the lower jaw forward.
[0163] The lower jaw, mandibular, can be moved forward by other
mechanisms available in the market. The single piece micro oral
MAD/CPAP device design mechanism 880 allows the mandible to be
advanced in increments of 1 mm or less with a protrusive adjustment
range of at least 5 mm. In addition, reversal of the advancement is
possible. The protrusive setting is verifiable. It maintains a
stable retentive relationship to the teeth, implants or edentulous
ridge and retains the prescribed setting during use. This concept
of mandibular advancement (MAD) can be used for customized or
Non-customized device and also for CPAP, Auto-CPAP, Bi-PAP devices
etc., along with other features/concepts described for other
embodiments of the teachings as described herein. The current MAD
devices on market, essentially only bring the lower jaw forward by
methods such as Herbst, TAP, EMA (strap) etc.
[0164] These current devices do not have any capability of
measuring any parameters of air flow during sleep or providing any
titration data or functioning as a CPAP or APAP. Teachings Device
shown in 8B has all the capabilities (including the electronic
package of command module and sensors) of all embodiments described
earlier plus the capability of mandibular advancement using various
methods as shown in FIG. 8A including variations to those indicated
above (Herbst, TAP and EMA) to achieve this.
[0165] This oral device can have electrical stimulation capability
for providing mild shocks to the soft palates and tongue. When the
electronic sensors detect blockage of air passage (by soft palates
relaxing or when the tongue falls back and blocks the airway
passage), the device can provide a mild electrical stimulation, and
alleviate the blockage of airway passage from persisting further
due to above events.
[0166] It has been proven that side sleeping position reduces the
sleep apnea events by more than 20%. When individual moves from
side position to subprime position, the tilt sensor records it and
the built-in proprietary algorithm (software) sends a signal to
thin plastic sheet (or a patch on face) attached to the device and
touching to lip(s) to vibrate. This reminds individual to sleep on
side. The individual slowly adjusts to this and over few nights
adjusts to sleep on side without waking up. One of the appliance
designs is very simple that it will be just upper mouthguard with
outside housing having tilt sensor to remind the individual to
sleep on side.
[0167] This device can be used as impact sport guard with
additional airflow during play and protection of teeth. It is
referred to as a positive airway pressure impact sports guard
without micro-blower(s). Such impact sport guards have a hollow
housing in the front with two hollow side tubes attached to upper
arch of the device. They can also be used for people in contact and
non-contact sports acting as a protection mouth guard as well as a
device to increase air intake, just like breathing deeply without
the thought and effort. The impact blow abruption and dissipation
characteristics are achieved by making device using additive
manufacturing (3D printing) technologies with lattice
structure.
[0168] FIG. 9 depicts a nasal/oral device 94 with CPAP/MAD or Auto
CPAP Device/MAD. This nasal/oral device 94 can also be used without
mandibular advancement (without MAD). Internal hollow tubes inside
the mouth (on upper or arches) can be blocked or eliminated in the
oral device (no air flow going through the mouth), but two hollow
flexible conduits 916 are connected to two nostrils from the top of
the hollow front housing 910 of oral device in which micro-blowers
945 are attached; or the airflow can be from both nose and mouth if
the internal mouth tubes are left open. This can be achieved by
nasal elastomeric housing 990 (Like nasal pillows used in CPAP
machines) snug fitting the nose where conduit 916 are coming out
from the oral PAP device 94. The end of each of the two tubes 916
has an expandable elastomeric attachment or nasal cannula 995 or
nose pillows for each nostril, snug fitting inside the nostrils
which holds the two tubes 916 and nose housing 990 in place during
sleep.
[0169] The nasal cannula can also be kept in place by using strip
around the ears. The oral device 94 has two functions: 1. the
hollow front housing 910 with micro-blower 945 delivers air flow to
nose by itself or along with the airflow through the mouth during
inspiration instead of inside mouth 2. The oral device 94 holds the
nose housing 995 with control module, micro-blowers 945 and sensors
and tubes 916, the whole air delivery system, in place as device is
attached to teeth (upper or lower or both upper and lower aches).
This oral device 94 can have a mechanism to bring lower jaw forward
(MAD device), further opening the air passage way in mouth.
[0170] This device 94 allows reduction of sleep apnea by providing
natural air flow through nose (natural breathing) in combination
with lower jaw movement (nose CPAP or APAP with MAD Device). The
elastomeric housing 990 snug fitting the nose have micro holes
allow and controls the airflow during the expiration. Airflow from
the hollow front housing 910 can also be controlled during the
expiration by reducing the speed of micro-blowers 945 if expiration
should be slowed down. Note for Nasal airflow the technique to
increase humidity is described earlier in FIG. 7 while inhaling
will be used.
[0171] Micro-Nasal PAP device: In a specific embodiment of the
device, it can be attached directly to nose with microprocessors
and sensors. This nasal micro PAP device has external housing, snug
fitting with nose with two hollow tubes going into nostril. The
external housing has micro blowers or nano-blowers with similar
concepts of control module with pressure and flow rate sensors as
described previously for the oral PAP devices (FIGS. 4A-4D or FIG.
6B). It is a stand-alone single unit like oral device but attached
to the nose instead of mouth. The device has no external tubes or
cords.
[0172] A fabric or film with directional nano pores structure can
be disposed in front of the oral or nasal device to slow
expiration. The device can have breathable anti-microbial fabric or
film with directional nano pores structure with or without
micro-blower SA or AS device. This fabric can be placed in front of
the hollow box where air enters into the mouth or nose during
inhalation. This fabric can be adhesively bonded, or can be
permanent or preferably removed every day to wash or insert same
one or new one (every moth) before using device. As the individual
breathes in, the fabric or film's nano structure design opens the
pores, allowing the individual to breathe in normally. Then, as the
individual breathes out, expiration is slowed as the nano structure
pores closes slightly to create a gentle pressure that naturally
opens the airway and relieves snoring or mild to moderate sleep
apnea.
[0173] The data acquisition capability of the oral devices of the
various configurations described above (FIG. 7A and FIG. 7B allows
it to be used as a diagnostic device for sleep apnea for diagnosis
of Sleep Breathing Disorder--specifically obstructive sleep apnea
and allows to set parameters for current CPAP machines or device of
current invention. This oral HST device can essentially function as
a stand-alone HST (Home Sleep Testing) or OOCST (Out of Center
Sleep Testing) device such as Resmed's Apnea link or Itamar's
Medibyte and so on. In the present system, it can be used to set
parameter of oral sleep apnea device of current teachings.
[0174] The device is a multi-channel screening tool, that can
measure all or selected parameters such as airflow through mouth or
nose, snoring, oxygen saturation, pulse, temperature, body
position, respiratory effort during sleep, EKG, EEG by various
sensors that are built into the device or linked via wired or
wireless technologies such as Bluetooth or Wi-Fi.
[0175] The acquired data from this device can be used to calculate
apnea-hypopnea index (AHI) based on the sleep time recorded based
on proprietary algorithm which can generate a comprehensive sleep
study report with a custom app or software. This AHI determination
with other parameters recorded would permit prescribing/specifying
appropriate CPAP/APAP/BiPAP treatment option (setting appropriate
pressure (and/or air flow rate) for PAP or pressure range (and/or
air flow rate) for APAP devices as well as MAD (Mandibular
Advancement Device) treatment option (setting the position of the
lower jaw advancement). The device can also have a miniature/nano
IR or thermal imaging video camera which can help detect changes in
the airway passage during sleep.
[0176] In one embodiment of the device, it can be used to validate
the mandibular advancement device (MAD) setting used for treatment
of OSA and snoring (OS/SA). In this version, the device would have
all sensors mentioned above or limited sensors and built in
capability on the control module to discriminate the efficacy of
the MAD treatment and validate the lower jaw advancement setting
selected. If used limited sensors, it would have 3 indicators that
would indicate if the efficacy of the MAD treatment made a positive
difference (i.e. reduce the OSA/AHI or reduced snoring) or made no
difference or made a negative difference and made the symptoms
worse. The indicator can be a color coded system (such as
green/yellow/red) or light up different labelled lights to depict
the 3 outcomes. The efficacy of MAD device can be also be shown as
actual AHI index number.
[0177] The devices can be of any constructions/concepts as
described previously but not limited to: 1. only upper arch or
lower arch device or device with both arches 2. Both upper and
lower teeth arch without bringing lower jaw forward 3. Both upper
and lower teeth arch where lower arch is adjustable to bring lower
jaw forward, 4. Center hollow tubes/hollow passage ways or strips
or any other design to keep tongue down.
[0178] The various embodiment of the device described above also
work as night guard to prevent bruxism, teeth grinding and also
treat TMJ in addition to reduce snoring and sleep apnea.
[0179] FIG. 10 depicts thin plastic bag attached to upper arch of
mouthguard (at the end, throat area) which expands and stays
expanded during air flow from micro blower, stopping soft palates
to collapse, allowing more open airway passage. If device has no
micro blower, during normal breathing this bag will expand during
inhalation and collapse during exhalation but stays in place due to
specific bag design and support design with upper arch. It is also
possible to have dome same semi-rigid plastic bonded with upper
arch which will not allow the soft palate to relax, keep in place
during sleep.
[0180] The Non-customized device or customized devices (to fit
individual's teeth) are supplied in different sizes such as small,
medium and large. The device can be made by snap-fitting injection
molded hollow front housing with rest of the part--hollow side
tubes and upper and lower arches (mouthguard). This way hollow
front housing can be easily detached from rest of the device after
sleep to clean the mouthguard or when required such as repairing or
replacement.
[0181] FIG. 11 depicts an exploded view of device as separate
pieces which are snap fitted together after manufactured. 1110 is
front housing and 1120 is inner mouth piece. 1111 is partial hollow
tube and 1112 is base of mouthguard. While 1113 is "boil and Bite"
piece on top of base piece of mouthguard 1112 for
customization.
[0182] FIG. 12 depicts several manufacturing methods for device.
Both non-customized and customized devices consist of two pieces A
and B as shown below: front hollow housing 1210 (in which micro
fan(s), sensors, microprocessors etc. are inserted after
manufacturing); and an inner mouth piece with hollow air passage
way. The front housing has snap/un-snap fit concept where front
hollow housing section is easily snap-fitted with inner mouth piece
and also can be easily un-snapped (removed from inner piece).
[0183] The systems can be formed using the following methods. The
front hollow housing 1210 is made by injection molding. To prevent
air leakage between hollow housing and inner mouth piece, an
elastomeric ring is mounted on front housing or elastomeric ring is
molded in one step process as two shot injection molding. For the
inner mouthpiece 1220, the following manufacturing methods are used
to achieve predetermined hollow passage ways. The inner mouth piece
is divided into two portions: 1. Partial hollow tube 1211 and 2.
Base piece of Mouthguard 1212 (upper or lower arch) A multi-step
process can be used which includes separately injection mold
partial hollow tube 1211 and base piece of Mouthguard 1212 followed
by bonding these two pieces to create hollow passage way in inner
mouth piece 1220.
[0184] One can also make partial hollow tube 1211 and base piece of
Mouthguard 1212 by thermoforming process followed by bonding these
two pieces to create hollow passage way in inner mouth piece 1220.
Thermoforming process allows for customization. Bonding of these
two pieces can be done by ultrasonic welding, laser welding or
mechanical bonding or combinations of these technologies or
adhesive bonding or other bonding technologies, creating the thin
device with hollow side tubes. The wall thickness can be as low as
0.5 mm in several areas. One step injection molding process where
partial walls of tube 1211 and base mouthguard 1212 are molded in
two cavities of a single mold, followed by rotating cavities where
two halves are aligned and second material 1213 is injected at
intersection, bonding these two pieces and creating hollow
structure. Here, the second material 1213 is soft material or same
as "Boil and Bite" material 1213, creating customized oral device
in a single step process. (see FIG. 15). Water or gas injection
molding to achieve hollow air passage way. Lastly, lost core foam
injection molding can be used to for the passages.
[0185] Both non-customized and customized devices are manufactured
by similar processes as described above except for customizations
(to fit the teeth perfectly) is achieved by processes such as 3D
printing (hard or hard/soft materials), "boil and bite" concept and
micro-cellular foaming injection molding processes and
thermoforming of a plastic sheet on a tooth model. The device can
be single piece construction, if it device does not contain any
sensors/microprocessor or sensors/microprocessor and battery are
completely sealed, then no need to have snap-fit feature. This
single piece construction can be achieved by bonding of two
separate injection molded halves at pre-determined line (or
separately injection molding hosing with partial tube and
mouthguard) followed by bonding these two pieces to create hollow
structure or by water injection molding or by lost core foam
injection molding. 3d printing or additive manufacturing can be
used to form the components or single piece device.
[0186] FIGS. 13A-13D depict a customized cross sections of the
device using "Boil or Bite" concept to fit individual teeth. FIG.
13A and FIG. 13B depict portions of a device 134A, having both
upper and lower arches 1300, 1301 with hollow front housing 1310
and hollow side tubes 1315 attached to upper arch 1300. FIG. 13C
and FIG. 13D depict a device 134B having upper arch 1300 only with
hollow front housing 1310 and hollow side tubes 1315. Upper and
lower arch portions touching the teeth are made of material which
will soften on boiling in water, due to glass transition
temperature of lower than 100 C and will form to the shape of teeth
upon biting in the mouth. The arch portions may be made of single
soft material or soft and hard material. Soft material is used for
"Boil and Bite" and hard material provides the support during bite.
The hollow front housing 1310 and hollow side tubes 1315 (and
bottom of upper and lower arch portions) are made of high
temperature plastics which do not soften at all at 100 C (boiling
point of water) due to their glass transition temperature greater
than 100 C. This way, after "Boiling and Biting" the device 134A,
134B, the individual can customize the device to fit his/her teeth
and still air flow will not be affected as rest of the dimensions
of device will not be changed during boiling and biting (hollow
tubes and the hollow housing dimensions).
[0187] The "Boil and Bite" devices can be manufactured by two
methods. 1. First, "Boil and Bite" soft portions of the upper and
lower arches are injection molded (or two-shot injection molded
from soft/hard material) and this portion is inserted in a second
tool where it is over-molded with high temperature plastics
material forming rest of the part having hollow side tubes and
hollow front housing or 2. "Boil and bite" portions of upper and
lower arches and rest of the device (hollow side tubes and hollow
front housing and bottom arch) are injection molded separately as
shown in FIG. 13A or 13C, then mechanically snap-fitted to make a
single device shown in FIG. 13B or 13D. Later concept 2 may be
better approach for individual since "Boil and Bite" portion
requires to be replaced every six months to preserve the bite. For
individual, the second concept eliminates to buy whole unit, they
must only buy a "boil and bite" portion, when needed, saving
money.
[0188] FIGS. 14A-14D show a customized, single piece, micro oral
PAP device 144 manufactured by micro-cellular foaming injection
molding. Device 144 illustrates a concept for temporarily
customizing device 144 during sleep, allowing good grip by teeth
and increasing comfort level. As shown in FIG. 14A, a soft material
121 is used for the portion of the device 144 touching the teeth
which is made out of microcellular foam 1400. The microcellular
foam 1404 can be open cell structure with regular elastomeric
polymer or closed cell structure with highly elastomeric material.
Soft material 121 may alternatively comprise polymeric gel
material.
[0189] As shown in FIG. 14B, the individual inserts the device 144
in the mouth, and upon biting on the device, the applied pressure
deforms the elastomeric structure of microcellular foam 1404,
allowing the impression of teeth on the inside 1423 of the soft
microcellular foam 1404. This way, device 144 stays in place during
sleep. To take device 144 out from mouth upon waking up, the
individual has to apply vertical downward force on device 144. Once
device 144 is removed from the individual's mouth, the
microcellular foam 1404 returns to its original shape and is ready
for the next night to again form a customized device. FIG. 14C
shows device 144 with microcellular foam 1404, while FIG. 14D
depicts cross section A-A of a portion of upper arch 1400 showing
the microcellular foam 1404 taking the shape of the individual's
teeth after bite.
[0190] FIG. 15 depict a single step manufacturing method for hollow
device by injecting material in two cavities, cavities rotation,
followed by injecting plastic at intersection of two halves,
creating hollow part.
[0191] FIG. 16 depicts micro-holes in the hollow tube (or hollow
passage way), blowing air at very low flow rate, but stimulating
the tongue to stay forward original position (does not allow to
fall back) during sleep. These micro-holes can be near the tongue
(lingual area) FIG. 16 A and/or at the end of throat area
(oropharynx area) as shown in FIG. 16B.
[0192] FIG. 16B depicts micro holes in the hollow tube at end
connected to two side tubes of an arch, directing the air flow at
the end of oropharynx (directly at throat region). This can
significantly help in keeping airway open compared to providing
airflow by just two sides tubes.
[0193] FIG. 17 depicts special microchip embedded into mouthguard
for nerve stimulation. FIG. 18 depicts device as an impact sport
guard with additional airflow during play and protection of teeth.
Energy absorbing and dissipation away from the teeth is achieved by
selecting right plastic material and internal design of the part
wall like honeycomb or lattice like structure. This embodiment is
referred to herein as a positive airway pressure impact sports
guard with or without micro-blower(s).
[0194] FIG. 19 depicts the device as a sleep apnea diagnostic
device to detect OSA., having various sensors located in the hollow
housing and/or the maxillary or mandibular arches which would be
capable of measuring and recording key data and proprietary
algorithms providing AHI index which could be correlated to
standard Sleep diagnostic tests such as PSG or PG.
[0195] Rigid or semi-rigid plastic examples suitable for use in
manufacturing the devices include, but are not limited to:
Commodity thermoplastics such as polyvinyl chloride, polyolefin and
polystyrene: polyvinyl chloride having properties such as but not
limited to: density of 1.2 to 1.4 g/cc, tensile strength in range
of 40 to 55 Mpa, tensile elongation in range of 20 to 100%,
flexural modulus in range of 2.0 to 5 GPa; polyolefin such as
polyethylene and polypropylene materials having properties such as
but not limited to: density in range of 0.86 to 0.98 g/cc, tensile
strength in range of 20 to 60 Mpa, tensile elongation in range of
50 to 150%, flexural modulus in range of 1.5 to 2.0 GPa, notched
impact strength in range of 50 to 200 J/m; polycarbonate having
properties such as but not limited to: density of 1.2 g/cc+/-0.1,
tensile strength in range of 50 to 85 Mpa, tensile elongation in
range of 40 to 140%, flexural modulus in range of 2.0 to 2.6 GPa,
impact strength in range of 300 to 1000 J/m; acrylics such as
polymethyl methacrylate (PMMA), acrylic copolymers and acrylic
multipolymer blends having properties such as but not limited to:
density in range of 1.1 to 1.2 g/cc, tensile strength in range of
30 to 75 Mpa, tensile elongation in range of 4 to 30%, flexural
modulus in range of 1.5 to 4.0 GPa, notched impact strength in
range of 100 to 300 J/m; Rigid thermoplastics polyurethanes (TPU)
can be polyester, polycarbonate or polyether based TPU having
properties such as but not limited to: density with the range of
1.05 g/cc to 1.20, shore D hardness of 35 D to 85D, tensile
strength @ break 35 to 70 MPa, tensile elongation in range of 50 to
300%, flexural modulus in range of 0.5 to 2.5 GPa; Polyesters
including PBT or PET having properties such as but not limited to:
density in range of 1.2 to 1.4 g/cc, tensile strength @ break in
range of 40 to 70 Mpa, tensile elongation in range of 40 to 100%,
flexural modulus in range of 2.0 to 3.5 GPa, notched impact
strength in range of 35 to 70 J/m; ABS having properties such as
but not limited to: density in range of 1.00 to 1.05 g/cc, tensile
strength @ break in range of 30 to 50 Mpa, tensile elongation in
range of 5 to 30%, flexural modulus in range of 2.0 to 3.0 GPa,
notched impact strength in range of 250 to 350 J/m; Nylons or
polyamides such as PA 6, PA 66, PA 11, PA 12, PA 46, PA 610, having
properties such as but not limited to: density in range of 1.00 to
1.2 g/cc, tensile strength @ break in range of 45 to 85 Mpa,
tensile elongation in range of 30 to 200%, flexural modulus in
range of 1.0 to 3.0 GPa, notched impact strength in range of 25 to
120 J/m; Polyether ether ketone (PEEK) having properties such as
but not limited to: density in range of 1.30 to 1.35 g/cc, tensile
strength @ break in range of 90 to 150 Mpa, tensile elongation in
range of 10 to 40%, flexural modulus in range of 4.0 to 4.5 GPa,
notched impact strength in range of 55 to 65 J/m; Composites of
above plastics with glass fiber, carbon fiber and other fillers
polymeric alloys comprising blends of polymers such as
polycarbonate alloys with polybutylene terephthalate (PBT), and
polyethylene terephthalate (PET) for improved chemical resistance,
PC/ABS copolymer alloys for ease of processability, PC/TPU, PC/ABS,
PC/SMA, PBT/PET/ASA alloys, PA/TPU and several combinations of all
the plastics described above; thermosets comprising photopolymers
made out of methacrylated oligomers, monomers, acrylated monomers,
low molecular weight polymers or elastomers to reduced brittleness
having properties such as but not limited to: density in range of
1.10 to 1.20 g/cc, tensile strength @ break in range of 40 to 65
Mpa, tensile elongation in range of 10 to 40%, flexural modulus in
range of 2.0 to 4.0 GPa, notched impact strength in range of 10 to
40 J/m and shore D hardness of 50 to 80D; Soft and elastomeric
plastics include, but are not limited to: soft polyurethanes, EVA
(ethylene vinyl acetate), TPE such as SEBS, elastomeric nylons,
silicones elastomers, biopolymers (PLA--polylactic acid),
thermoplastics or thermoset elastomers.
[0196] The devices can be formed of copolyester produced when more
than one diacid or diol is used in the polyester polymerization
process, such as PETG (polyethylene terephthalate glycol), PCTG
(Polycyclohexylene dimethylene terephthalate glycol) with
properties such as but not limited to: density in range of 1.2 to
1.7 g/cc, tensile strength @ break in range of 25 to 30 Mpa,
Tensile elongation in range of 110 to 300%, flexural modulus in
range of 1.8 to 2.2 GPa, notched impact strength in range of 100
J/m to no break; soft polyurethanes (TPU elastomers) having
properties such as but not limited to: density with the range of
1.05 g/cc to 1.30, shore D hardness of 30 D to 75D, tensile
strength @ break 15 to 50 MPa, tensile elongation in range of 300
to 800%, flexural modulus in range of 0.03 to 0.15 GPa. compression
set 10 to 45%, tear strength 80 to 180 N/mm; EVA (ethylene vinyl
acetate) having properties such as but not limited to: density with
the range of 0.93 g/cc to 0.96 g/cc, shore D hardness of 30 D to
50D, tensile strength @ break 3 to 35 MPa, tensile elongation in
range of 300 to 800%, elastic modulus in range of 0.015 to 0.08
GPa; and silicones elastomers having properties such as but not
limited to: density with the range of 1.12 g/cc to 1.2 g/cc, shore
A hardness of 30A to 70A, tensile strength @ break 8 to 15 MPa,
tensile elongation in range of 300 to 800%, compression set 10 to
20%, tear strength 30 to 40 N/mm.
[0197] Additionally, the material can be formed of TPE such as SEBS
having properties such as but not limited to: density with the
range of 1.15 g/cc to 1.25 g/cc, shore D hardness of 35D to 75D,
tensile strength @ break 10 to 45 MPa, tensile elongation in range
of 200 to 375%, compression set 5 to 30%, tear strength 80 to 100
N/mm. Polymeric materials can also be blended with fillers such as
carbon fibers, carbon nanotubes, glass microsphere, silica, etc.,
to obtain the desired properties of a mouth guard.
[0198] The invention relates to oral or nasal or a combination of
oral and nasal sleep apnea diagnostic device as Home Sleep Testing
(HST) device for the diagnosis of obstructive sleep apnea (OSA) and
snoring; having microprocessors and sensors, comprising of
following configurations: 1) Basic HST unit for standard OSA
testing. This configuration without mandibular advancement (MAD)
can be provided with upper mouth piece only (i.e. without the lower
mouth piece) or with lower mouth piece only (i.e. without the upper
mouth piece); 2) HST unit with mandibular advancement (MAD)--this
is to validate specific mandibular advancement setting and
treatment of sleep apnea with or without innovative oral CPAP sleep
apnea device or current CPAP device; 3) HST unit to be used in
conjunction with current CPAP for determining the efficacy of a
pressure setting; 4) HST device as sleep apnea diagnostic as well
as treatment device: In addition to device performing as diagnostic
tool (as Home Sleep Testing (HST) or Out of center Sleep Testing
(OOCST) for detecting OSA, the same device can also be used as
sleep apnea treatment and/or anti-snoring device.
[0199] The device can be fitted with a mix of sensors to measure
air flow; SpO2 (oxygen saturation in blood), heart rate (beats/min)
and respiratory effort. These parameters would be sufficient to
perform a sleep study conforming to the guidelines by CMS or AASM
for a Type III or Type iV study. Additional sensors can be included
to measure temperature; body positions while at sleep, Sound
(breathing) variation and snoring, Single channel ECG (heart), EEG
for brain activity etc. Actual sleep time is not measured by
current HST devices while in one embodiment the device can have
built-in sensors or wirelessly communicating sensors like heart
rate, breathing monitoring, position sensor for body movement
during sleep, temperature along with proprietary algorithm helps in
measuring actual (true) sleep time which is very important for
accurate (true) AHI number, a measure of severity of sleep
apnea.
[0200] In one embodiment, the device would be fitted with a
differential pressure sensor to measure airflow and pressure (or
alternately with a PVDF calibrated strip), a novel pulse ox sensor
from lips for oxygen saturation and heart rate (alternately could
be a standard pulse oximeter with Bluetooth capability), and a
photophlethysmographic (PPG) sensor to measure respiratory effort
(alternately could be a standard RIP belt to acquire the same
parameter).
[0201] All these parameters can be continuously acquired and stored
on a memory SD card built into the unit (device) or wirelessly
transferred using Bluetooth, wifi, cloud or other similar
technologies to a mobile device or to cloud based server. This data
can then be analyzed by automated computer algorithms for episodes
of breathing irregularities while sleeping--such as apneaic or
hypopneaic events and summarized to provide AHI/RDI information.
The RDI is defined as the average number of respiratory
disturbances. The device can be controlled wirelessly using mobile
devices.
[0202] In another embodiment, the device can be enhanced by
addition of sound sensor to measure breathing patterns and snoring
variation, thermistor for temperature of air flow and breathing
pattern, miniature video camera mounted on the mouthguard to take
pictures of inside of mouth during sleep and a processing unit to
capture and analyze these parameters to provide a far more
comprehensive sleep study report compared to a Type III or Type IV
HST device. Additional data can be received from a Repertory
Inductance plethysmography belt or photophlethysmographic
sensor.
[0203] Both of above embodiments can be adapted to validate
Mandibular Adjustment (MAD) setting by providing oral component
with mandibular adjustments (lower jaw advancement) in specific
fine increments. Also the device of present invention can be
concurrently used with CPAP and validate efficacy of pressure
setting for the CPAP treatment.
[0204] The foregoing description is merely illustrative in nature
and is in no way intended to limit the disclosure, its application,
or uses. The broad teachings of the disclosure can be implemented
in a variety of forms. Therefore, while this disclosure includes
particular examples, the true scope of the disclosure should not be
so limited since other modifications will become apparent upon a
study of the drawings, the specification, and the following claims.
It should be understood that one or more steps within a method may
be executed in different order (or concurrently) without altering
the principles of the present disclosure. Further, although each of
the embodiments is described above as having certain features, any
one or more of those features described with respect to any
embodiment of the disclosure can be implemented in and/or combined
with features of any of the other embodiments, even if that
combination is not explicitly described. In other words, the
described embodiments are not mutually exclusive, and permutations
of one or more embodiments with one another remain within the scope
of this disclosure.
[0205] Spatial and functional relationships between elements (for
example, between modules) are described using various terms,
including "connected," "engaged," "interfaced," and "coupled."
Unless explicitly described as being "direct," when a relationship
between first and second elements is described in the above
disclosure, that relationship encompasses a direct relationship
where no other intervening elements are present between the first
and second elements, and also an indirect relationship where one or
more intervening elements are present (either spatially or
functionally) between the first and second elements. As used
herein, the phrase at least one of A, B, and C should be construed
to mean a logical (A OR B OR C), using a non-exclusive logical OR,
and should not be construed to mean "at least one of A, at least
one of B, and at least one of C."
[0206] In the figures, the direction of an arrow, as indicated by
the arrowhead, generally demonstrates the flow of information (such
as data or instructions) that is of interest to the illustration.
For example, when element A and element B exchange a variety of
information but information transmitted from element A to element B
is relevant to the illustration, the arrow may point from element A
to element B. This unidirectional arrow does not imply that no
other information is transmitted from element B to element A.
Further, for information sent from element A to element B, element
B may send requests for, or receipt acknowledgements of, the
information to element A.
[0207] In this application, including the definitions below, the
term `module` or the term `controller` may be replaced with the
term `circuit.` The term `module` may refer to, be part of, or
include processor hardware (shared, dedicated, or group) that
executes code and memory hardware (shared, dedicated, or group)
that stores code executed by the processor hardware.
[0208] The module may include one or more interface circuits. In
some examples, the interface circuits may include wired or wireless
interfaces that are connected to a local area network (LAN), the
Internet, a wide area network (WAN), or combinations thereof. The
functionality of any given module of the present disclosure may be
distributed among multiple modules that are connected via interface
circuits. For example, multiple modules may allow load balancing.
In a further example, a server (also known as remote, or cloud)
module may accomplish some functionality on behalf of a client
module.
[0209] The term code, as used above, may include software,
firmware, and/or microcode, and may refer to programs, routines,
functions, classes, data structures, and/or objects. Shared
processor hardware encompasses a single microprocessor that
executes some or all code from multiple modules. Group processor
hardware encompasses a microprocessor that, in combination with
additional microprocessors, executes some or all code from one or
more modules. References to multiple microprocessors encompass
multiple microprocessors on discrete dies, multiple microprocessors
on a single die, multiple cores of a single microprocessor,
multiple threads of a single microprocessor, or a combination of
the above.
[0210] Shared memory hardware encompasses a single memory device
that stores some or all code from multiple modules. Group memory
hardware encompasses a memory device that, in combination with
other memory devices, stores some or all code from one or more
modules.
[0211] The term memory hardware is a subset of the term
computer-readable medium. The term computer-readable medium, as
used herein, does not encompass transitory electrical or
electromagnetic signals propagating through a medium (such as on a
carrier wave); the term computer-readable medium is therefore
considered tangible and non-transitory. Non-limiting examples of a
non-transitory computer-readable medium are nonvolatile memory
devices (such as a flash memory device, an erasable programmable
read-only memory device, or a mask read-only memory device),
volatile memory devices (such as a static random access memory
device or a dynamic random access memory device), magnetic storage
media (such as an analog or digital magnetic tape or a hard disk
drive), and optical storage media (such as a CD, a DVD, or a
Blu-ray Disc).
[0212] The apparatuses and methods described in this application
may be partially or fully implemented by a special purpose computer
created by configuring a general purpose computer to execute one or
more particular functions embodied in computer programs. The
functional blocks and flowchart elements described above serve as
software specifications, which can be translated into the computer
programs by the routine work of a skilled technician or
programmer.
[0213] The computer programs include processor-executable
instructions that are stored on at least one non-transitory
computer-readable medium. The computer programs may also include or
rely on stored data. The computer programs may encompass a basic
input/output system (BIOS) that interacts with hardware of the
special purpose computer, device drivers that interact with
particular devices of the special purpose computer, one or more
operating systems, user applications, background services,
background applications, etc.
[0214] The computer programs may include: (i) descriptive text to
be parsed, such as HTML (hypertext markup language), XML
(extensible markup language), or JSON (JavaScript Object Notation)
(ii) assembly code, (iii) object code generated from source code by
a compiler, (iv) source code for execution by an interpreter, (v)
source code for compilation and execution by a just-in-time
compiler, etc. As examples only, source code may be written using
syntax from languages including C, C++, C#, Objective-C, Swift,
Haskell, Go, SQL, R, Lisp, Java.RTM., Fortran, Perl, Pascal, Curl,
OCaml, Javascript.RTM., HTML5 (Hypertext Markup Language 5th
revision), Ada, ASP (Active Server Pages), PHP (PHP: Hypertext
Preprocessor), Scala, Eiffel, Smalltalk, Erlang, Ruby, Flash.RTM.,
Visual Basic.RTM., Lua, MATLAB, SIMULINK, and Python.RTM..
[0215] None of the elements recited in the claims are intended to
be a means-plus-function element within the meaning of 35 U.S.C.
.sctn.112(f) unless an element is expressly recited using the
phrase "means for" or, in the case of a method claim, using the
phrases "operation for" or "step for."
[0216] Example embodiments are provided so that this disclosure
will be thorough, and will fully convey the scope to those who are
skilled in the art. Numerous specific details are set forth such as
examples of specific components, devices, and methods, to provide a
thorough understanding of embodiments of the present disclosure. It
will be apparent to those skilled in the art that specific details
need not be employed, that example embodiments may be embodied in
many different forms and that neither should be construed to limit
the scope of the disclosure. In some example embodiments,
well-known processes, well-known device structures, and well-known
technologies are not described in detail.
[0217] The terminology used herein is for the purpose of describing
particular example embodiments only and is not intended to be
limiting. As used herein, the singular forms "a," "an," and "the"
may be intended to include the plural forms as well, unless the
context clearly indicates otherwise. The terms "comprises,"
"comprising," "including," and "having," are inclusive and
therefore specify the presence of stated features, integers, steps,
operations, elements, and/or components, but do not preclude the
presence or addition of one or more other features, integers,
steps, operations, elements, components, and/or groups thereof. The
method steps, processes, and operations described herein are not to
be construed as necessarily requiring their performance in the
particular order discussed or illustrated, unless specifically
identified as an order of performance. It is also to be understood
that additional or alternative steps may be employed.
[0218] When an element or layer is referred to as being "on,"
"engaged to," "connected to," or "coupled to" another element or
layer, it may be directly on, engaged, connected or coupled to the
other element or layer, or intervening elements or layers may be
present. In contrast, when an element is referred to as being
"directly on," "directly engaged to," "directly connected to," or
"directly coupled to" another element or layer, there may be no
intervening elements or layers present. Other words used to
describe the relationship between elements should be interpreted in
a like fashion (e.g., "between" versus "directly between,"
"adjacent" versus "directly adjacent," etc.). As used herein, the
term "and/or" includes any and all combinations of one or more of
the associated listed items.
[0219] Although the terms first, second, third, etc. may be used
herein to describe various elements, components, regions, layers
and/or sections, these elements, components, regions, layers and/or
sections should not be limited by these terms. These terms may be
only used to distinguish one element, component, region, layer or
section from another region, layer or section. Terms such as
"first," "second," and other numerical terms when used herein do
not imply a sequence or order unless clearly indicated by the
context. Thus, a first element, component, region, layer or section
discussed below could be termed a second element, component,
region, layer or section without departing from the teachings of
the example embodiments.
[0220] Spatially relative terms, such as "inner," "outer,"
"beneath," "below," "lower," "above," "upper," and the like, may be
used herein for ease of description to describe one element or
feature's relationship to another element(s) or feature(s) as
illustrated in the figures. Spatially relative terms may be
intended to encompass different orientations of the device in use
or operation in addition to the orientation depicted in the
figures. For example, if the device in the figures is turned over,
elements described as "below" or "beneath" other elements or
features would then be oriented "above" the other elements or
features. Thus, the example term "below" can encompass both an
orientation of above and below. The device may be otherwise
oriented (rotated 90 degrees or at other orientations) and the
spatially relative descriptors used herein interpreted
accordingly.
[0221] In the foregoing description, the teachings have been
described with reference to specific exemplary embodiments thereof.
It will be apparent to those skilled in the art that a person
understanding these teachings may conceive of changes or other
embodiments or variations, which utilize the principles of this
teachings without departing from the broader spirit and scope of
the teachings. The specification and drawings are, therefore, to be
regarded in an illustrative rather than a restrictive sense.
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