U.S. patent application number 12/277386 was filed with the patent office on 2014-02-20 for device to detect and treat apneas and hypopnea.
The applicant listed for this patent is Daniel John Barton, David Brian Goldstein. Invention is credited to Daniel John Barton, David Brian Goldstein.
Application Number | 20140051938 12/277386 |
Document ID | / |
Family ID | 50100515 |
Filed Date | 2014-02-20 |
United States Patent
Application |
20140051938 |
Kind Code |
A1 |
Goldstein; David Brian ; et
al. |
February 20, 2014 |
Device to detect and treat Apneas and Hypopnea
Abstract
A method and apparatus for the treatment of Sleep Apnea events
and Hypopnea episodes wherein one embodiment comprises a wearable,
belt like apparatus containing a microphone and a plethysmograph.
The microphone and plethysmograph generate signals that are
representative of physiological aspects of respiration, and the
signals are transferred to an imbedded computer. The embedded
computer extracts the sound of breathing and the sound of the heart
beat by Digital Signal Processing techniques. The embedded computer
has elements for determining when respiration parameters falls out
of defined boundaries for said respiration parameters. This
exemplary method provides real-time detection of the onset of a
Sleep Apnea event or Hypopnea episode and supplies stimulation
signals upon the determination of a Sleep Apnea event or Hypopnea
episode to initiate an inhalation. In one embodiment, the stimulus
is applied to the patient by a cutaneous rumble effects actuator
and/or audio effects broadcasting.
Inventors: |
Goldstein; David Brian;
(Groton, MA) ; Barton; Daniel John; (Groton,
MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Goldstein; David Brian
Barton; Daniel John |
Groton
Groton |
MA
MA |
US
US |
|
|
Family ID: |
50100515 |
Appl. No.: |
12/277386 |
Filed: |
November 25, 2008 |
Current U.S.
Class: |
600/301 |
Current CPC
Class: |
A61B 5/4818 20130101;
A61B 5/6831 20130101; A61B 5/741 20130101; A61B 7/003 20130101;
A61B 5/7455 20130101; A61B 5/7405 20130101; A61B 5/0205 20130101;
A61B 5/6817 20130101; A61B 5/7282 20130101; A61B 5/7264 20130101;
A61B 5/0806 20130101; A61B 5/085 20130101; A61B 5/486 20130101 |
Class at
Publication: |
600/301 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/08 20060101 A61B005/08; A61B 5/085 20060101
A61B005/085; A61B 7/00 20060101 A61B007/00 |
Claims
1. An apparatus comprising: a Microphone disposed proximal to a
patient for sensing and conveying data indicative of respiration
and providing corresponding signals; a Plethysmograph for sensing
and conveying data indicative of respiration and providing
corresponding signals; a computer configured for processing signals
generated by the Microphone and Plethysmograph and generating a
control signal in response thereto; a patient stimulator,
responsive to said computer control signal, comprising at least one
of a mechanical tactile sensory stimulator, an audio effects
broadcaster, a speaker, and a Bluetooth Ear-bud.
2. The apparatus of claim 1, wherein said Plethysmograph is a
resistive Plethysmograph.
3. A method, comprising: detecting patient respiration with a
microphone and generating corresponding signals; detecting patient
respiration with a plethysmograph and generating corresponding
signals; processing said microphone signals and said plethysmograph
signals and including detecting a sleep disorder, wherein a
corresponding control signal is provided when said sleep disorder
is detected; and stimulating said patient with at least one of a
mechanical tactile stimulator, an audio effects broadcaster, a
speaker, and a Bluetooth ear bud.
4. The method of claim 3 wherein said wherein processing includes
storing in memory signals derived from a process of
self-calibration.
5. The method of claim 4 wherein said storing signals of the
processes of self-calibration is storing a collection of
respirations that from a set of reference respirations.
6. The method of claim 5 wherein said step of processing included
calculating the parameters of amplitude, periodicity, and wave
width of respiration for each respiration of the collection of
respirations from the processes of self-calibrations.
7. The method of claim 3 wherein said processing comprises
processing according to a computer program using rules based
processing to determine occurrences of Sleep Apnea events and
Hypopnea episodes.
8. The method of claim 7 wherein said computer program uses rules
based processing to determine the parameters of the stimulation
required to induce inspiration to terminate at least one of a Sleep
Apnea event and Hypopnea episode.
9. The method of claim 8 wherein said computer program uses rules
based processing to determine the least amount of stimulation
required to induce inspiration to terminate a Sleep Apnea event or
Hypopnea episode.
10. The method of claim 9 wherein said processing includes
determining a the stimulus threshold the very first time that the
patient uses the invention and storing the stimulus threshold
values as that patient's stimulus baseline.
11. The method of claim 10 wherein said processing includes using
the stored stimulus threshold values as the initial parametric
settings for the application of stimulus at the next and all
subsequently detected Sleep Apnea events and Hypopnea episode.
12. The method of claim 11 wherein said processing include applying
fuzzy logic rules to constantly adjust the stored stimulus
threshold values relative to which the initiation of an inspiration
for each specific sleep cycle is determined.
13. The apparatus as recited in claim 1, wherein said mechanical
tactile sensory stimulator comprises a cutaneous rumble effects
actuator disposed to engage a peripheral sensory area on the
patient, said rumble effects actuator uses an eccentric
bi-directional motor to generate at least one of pulsing, spinning,
multiple, superimposed vibrations, and oscillating modes to
stimulate the patient to induce inspiration.
14. The apparatus as recited in claim 1, wherein said patient
stimulator provides audio effects, said audio effects are a
generated in response to at least one of a plurality of embedded
sound files embedded in the inventions memory to stimulate the
patient to induce inspiration.
15. The apparatus as recited in claim 14, wherein said audio
effects is broadcast to the patient to the patient by the use of
Bluetooth wireless protocol.
16. The apparatus as recited in claim 1, further including a
housing receiving at least said processor therein, and an
adjustable belt receiving said housing thereon.
17. The apparatus as recited in claim 16, wherein said processor
comprises a rules based processor.
18. The apparatus as recited in claim 1, wherein said processor
provides stored stimulus threshold data corresponding to prior
control signals generated to stimulate said patient.
19. The apparatus as recited in claim 1, wherein said processor
provides said control signal to at least one of said audio effects
broadcaster, said speaker and said Bluetooth ear bud to be received
and understood by said patient as plain, spoken language
instructions as how to adjust the invention to provide desired
monitoring of said patients' respirations during sleep.
20. The apparatus as recited in claim 19 wherein said processor
includes a memory having sound files corresponding to the plain,
spoken language instructions.
Description
TECHNICAL FIELD
[0001] The present invention relates to an apparatus to detect and
end occurrences of Sleep Apnea event and Hypopnea episode, in a
manner that will decrease or eliminate hypoxia, hypercapnia and the
disturbance of pulmonary hemodynamics.
BACKGROUND
[0002] Sleep Apnea and Hypopnea are breathing disorders that occurs
during periods of sleep. It is an intermittent cessation or
reduction of ventilation during sleep that results in a decrease in
blood oxygen levels (hypoxia), increase in CO2 (hypercapnia), and
vasoconstriction. The long term effects of these physiological
changes are associated with the development of cardiac arrhythmias,
congestive heart failure, cardiac ischemia, hypertension, heart
disease, brain damage, and diabetes.
[0003] The causes of the various forms of Sleep Apnea and Hypopnea
are not fully understood. There are three general types of Sleep
Apnea: Obstructive, Central and Mixed. Obstructive Sleep Apnea (the
most common type) is a blockage or occlusion of the oropharyngeal
(upper) airway due to a loss of patency of its muscles. With
Obstructive Sleep Apnea (OSA), respiratory functions continue as
paradoxical movement of the thorax or abdomen. This paradoxical
movement acts as a one way piston: air leaves the lungs but little
or none can enter. The cause or causes of Obstructive Sleep Apneas
is still a matter of much debate and research. The average Apnea
event lasts 20 seconds however events of 2 to 3 minutes are not
unknown. During the event, a number of physiological events occur.
These include a vagal bradycardia, an increase in blood pressure,
an increase in norepinephrine, and paradoxical respiratory efforts
with increased respirator efforts. As an apnea eventprogresses,
there is an increasing effort to breathe, increasing carbon dioxide
(Hypercapnia), decreasing oxygen, and increasing level of
proprioception. The longer the Apnea event, the more extreme these
changes are. At the end of an Apnea event tone (patency) returns to
the upper airway muscles so that the upper airway suddenly
re-opens. This can be associated with a sudden gasp or choking as
air rapidly enters the lungs and surges in Heart Rate and Blood
Pressure.
[0004] Information parsed from various research papers: It has been
believed that an arousal from a deeper stage of sleep to a lighter
stage of sleep was required to terminate an Apnea episode; however
studies have cast doubt on that assertion: "In summary, in the vast
majority of patients, if not in all patients, arousal is required
neither to initiate UA (Upper Airway) opening nor to obtain
adequate flow. UA opening would occur at approximately the same
time regardless of when or whether arousal occurs and the flow
response in most patients would still be timely and adequate.
Arousals are incidental events that occur when the thresholds for
arousal and arousal-independent opening are close to each other, as
they appear to be in patients with OSA. By promoting an
unnecessarily high flow response at UA opening, arousals help
perpetuate cycling and likely exacerbate OSA." (YOUNES, Magdy. Role
of Arousals in the Pathogenesis of Obstructive Sleep Apnea.
American Journal of Respiratory and Critical Care Medicine: Mar. 1,
2004. Role of Arousals in the Pathogenesis of Obstructive Sleep
Apnea. Which is hereby incorporated by reference. Although cortical
activation is the gold standard for definition of arousal, several
studies show there are different levels of central nervous system
activation. At the lower range of arousal responses are those
inducing reflex motor responses, autonomic activation, and
appearance of slow wave EEG activity, i.e., delta bursts (D-bursts)
and K-complex bursts (Kbursts), all defined as "subcortical
arousals." At the upper range are arousal responses implying a
cortical activation represented by MA6 and phases of transitory
activation (PAT).
[0005] These findings might corroborate the hypothesis of the
existence of 2 separate neural systems integrated in the arousal
network and undergoing different modulatory influences."
[0006] Further studies indicate that overall, increasing
ventilatory effort may be the most important stimulus to arousal
from sleep, and the stimulus to arousal from hypoxia and
hypercapnia may be mediated principally through stimulating an
increased ventilatory efforts.
[0007] These considerations raise the question of possible
manipulation of the arousal response to maximize the beneficial
effects related to facilitating resumption of airflow, but minimize
the adverse consequences related to sleep fragmentation and
post-apnea hyperventilation. These latter effects appear to relate
more to cortical than brainstem arousal.
[0008] Furthermore some studies concluded that: "The current
findings suggest that strategies of induced arousal, at an
intensity level stimulating respiration while avoiding recruitment
of the ascending arousal system and its potential effects of sleep
disruption, could have potential application as a therapeutic
modality. Apnea was detected by tracheal breath sounds which were
picked up by microphone . . . stimulation decreased the frequency
of apnea episodes and the longest apnea duration. This resulted in
an increase in arterial oxygen saturation. Moreover stimulation
decreased sleep stages I and II, and increased stages III and IV.
These findings suggest that stimulation using the apnea demand-type
stimulator may be an effective treatment for OSA."
[0009] Other research has determined that: the Psa (Blood Pressure)
and HR (Heart Rate) increased more and the SV (Stroke Volume)
decreased more in the apnea that was terminated by an EEG
(cortical) arousal compared with the apnea without an EEG
(subcortical) arousal.
[0010] Furthermore externally applied stimulus is reported to cause
a "trend among our subjects to shortening of the apnea immediately
after the stimulated apnea; that is, the effect of the tone
appeared to extend to the next apnea. We would hypothesize that the
acoustic stimuli did alter sleep state and thus arousal threshold
such that the immediately succeeding apnea might have been more
susceptible to concurrent respiratory afferent stimuli". This took
place in spite of the trend for Obstructive Sleep Apneas to
increase in both frequency and duration during a nights sleep.
[0011] The kind of stimuli provokes different responses in human
subjects: "Previous studies using single-modality paradigm have
shown that sensory gating systems, which select relevant sensory
information, remain functional during sleep In humans, relevant
stimuli (e.g. sound >65 dB, one's own name, experimental noxious
stimulation) induce arousal response more frequently and results in
more intense response compared with irrelevant stimuli.
Simultaneous multi-modality sensory inputs from body surface and
from other organs (e.g. ear) not only increase the amount of
sensory inputs but also can maximize the relevance of stimuli".
HALA'' sz et al., 2004; Kisley et al., 2001; Velluti, 1997, which
is hereby incorporated by reference.
[0012] Central Sleep Apnea results from the brain failing to signal
the muscles to breathe. The neural drive to the respiratory muscles
discontinues for a brief period of time. These transients may
continue throughout the night for periods from ten seconds to as
long as 2 to 3 minutes. The physiological effects are similar to
those of Obstructive Sleep Apnea.
[0013] Mixed Sleep Apnea is a combination of Obstructive Sleep
Apnea and Central Sleep Apnea. There are several known treatments
for Sleep Apnea. They consist of physical, electrical, and
mechanical methods, surgery, and attempts at pharmacological
treatment. The treatment regimen is tailored to the individual, and
is based on the medical profile of the patient being treated.
[0014] The most common effective treatment for patients with sleep
apnea is nasal continuous positive airway pressure (CPAP). In this
form of treatment, the patient wears a mask over the nose while
sleeping. The mask is connected to a compressor that creates a
positive pressure in the nasal passages. The continuous positive
airway pressure system prevents the airway from closing or becoming
obstructed during sleep. The air pressure from the continuous
positive airway system is constant, and can be adjusted to best
suit the individual's apnea condition. The air pressure in the
continuous positive airway pressure system must be adjusted so that
it maintains an open airway in the patient during all periods of
sleep, but does not provide excessive pressure such that the device
is bothersome to the patient. U.S. Pat. No. 4,655,213 discloses
sleep apnea treatments based on the principles of continuous
positive airway pressure. There have also been recent attempts at
varying the applied pressure to increase the effectiveness of
continuous positive airway pressure treatment. U.S. Pat. Nos.
4,773,411 and 6,539,940 disclose such techniques. The disclosures
of these United States patents are incorporated herein by
reference.
[0015] Another treatment for sleep apnea in certain patients
involves the use of a Dental Appliance to reposition oral
structures such as the tongue and the lower jaw. This form of
treatment is typically performed by a dentist or dental specialist
such as an orthodontist. Surgery has also been performed to treat
sleep apnea. In some surgical treatments, the size of the airway is
increased. These surgical procedures contain elevated levels of
risk in comparison to other treatment methods, and often times are
not entirely effective. The form of surgery to be undertaken is
specific to the patient and the patient's medical profile. The
removal of obstructive tissue in the airway such as adenoids,
tonsils or nasal polyps is a common form of surgical treatment for
sleep apnea. The surgical correction of structural deformities is
also a common form of surgical treatment for sleep apnea.
[0016] Another form of surgical treatment for sleep apnea is
uvalopalatopharyngoplasty. This procedure removes excess tissue
from the back of the throat, such as tonsils, uvula, and part of
the soft palate. Somnoplasty is also being investigated as a
possible treatment for sleep apnea. Somnoplasty uses radio waves to
reduce the size of some airway structures such as the uvula and the
back of the tongue.
[0017] Other forms of surgical intervention for sleep apnea include
maxillo-facial reconstruction. Another form of surgical treatment
for patients with severe and life threatening sleep apnea is
Tracheostomy. This procedure involves making a small hole in the
windpipe that accommodates a tube. The tube is opened only during
sleep, and allows a patient to take air directly into the lungs,
effectively bypassing any upper airway obstructions. Tracheostomy
is an extreme procedure that is very rarely used except for cases
of imminent life threatening sleep apnea.
[0018] Attempts at pharmacological treatment for sleep apnea have
included respiratory stimulants such as theophylline, acetazolamide
and medroxy-progesterone, and adenosine. Drugs that stimulate brain
or central nervous system activity, such as naloxone and doxapram,
have also been used in an attempt to treat sleep apnea. Other drugs
that act on the neurotransmitters involved with respiration have
also been used in an attempt to treat sleep apnea. These drugs
include serotonin, dopamine, tryptophan, fluoxetine, and
others.
[0019] More recently, systems have been developed for the purpose
of clearing upper airway passages during sleep using the electrical
stimulation of nerves or muscles. In some cases, these systems
require surgical implantation of sensors and associated electronics
that detect when breathing has ceased and then stimulate the
breathing process. Some hybrid systems have been developed that
require surgical insertion of one or more sensors plus external
equipment for monitoring the breathing process or moving the
obstruction when breathing ceases.
[0020] An apparatus has been patented a means for detecting the
onset of a sleep related disorder using pulse rate and blood oxygen
content information as measured by the device; U.S. Pat. No.
7,387,608 discloses sleep apnea treatments based on those
principles. The disclosures of these United States patents are
incorporated herein by reference.
[0021] An apparatus has been patented a means for detecting the
onset of a sleep related disorder using a multiplicity of
microphones. The apparatus has the microphones emplaced within a
collar worn around the neck of the patient. The apparatus detects
breathing sounds, and in an embodiment when it detects breathing
that is "substantially different from the recorded at least one
signal pattern that is associated with a normal breathing pattern
of the person; and creating a stimulus to the person's neck muscles
to cause the -person to move the person's neck muscles to move the
person's head backwards to restore normal breathing before
cessation of breathing occurs", as disclosed in U.S. Pat. No.
6,935,335. The disclosures of these United States patents are
incorporated herein by reference.
SUMMARY OF THE INVENTION
[0022] The present invention is directed to a apparatus and method
for detecting and treating Sleep Apnea and Hypopnea by terminating
a Sleep Apnea event or Hypopnea episode within seconds of
detection.
[0023] The invention develops through a Method a Referential set of
Parameters specific to the respiration patterns of the specific
patient (rather than defining and applying Generic Trigger point
Parameter as is the case with other inventions). The multiplicity
of Signal Parameters combined with a Fuzzy Control System is more
adaptable to the changes of Respiration that occurs during the
course of the night. Changes of Respiration which might be
interpreted by other inventions (such as those who use averaging or
weighted moving averaging of invention and determined to be a
reversion to a Respiration pattern that is normal for this specific
patient. Normal for the patient is established by the Processing of
the Referential set of Parameters within the Fuzzy Control System.
The inventions method of using both the root-mean-square deviation
of a parameter and the parameters' mean, as opposed to simply
averaging or weighted moving averaging of the parameter, to
establish a reference point for determination of a parameters' out
of bound condition, is a superior method for detecting Apnea events
or Hypoxia episodes.
[0024] In accordance with the present invention, there is provided
a wearable, belt like, apparatus for the treatment of Sleep Apnea
events and Hypopnea episodes containing a Microphone and a
Plethysmograph. The Microphone and Plethysmograph generate signals
that are representative of physiological aspects of respiration.
The signals are transferred to an imbedded computer. The embedded
computer extracts the sound of breathing and the sound of the heart
beat by the means of Digital Signal Processing techniques. The
embedded computer has means for determining when respiration
parameters falls out of defined boundaries for the respiration
parameters. This method is for the real-time detection of the onset
of a Sleep Apnea event or Hypopnea episode. The embedded computer
supplies stimulation signals upon the determination of a Sleep
Apnea event or Hypopnea episode to initiate an inhalation. The
stimulation is provided in a manner so as to avoid the initiation
of a cortical (EEG} arousal and vagal withdrawal of the
parasympathetic tone to the heart. The stimulus is applied to the
patient by a cutaneous rumble effects actuator and audio effects
broadcasting. The actuator is embedded within the invention. It is
a primary object of the present invention to provide a system and
method for detecting and terminating an Sleep Apnea event and
Hypopnea episode, within seconds of the detection, in a manner that
will decrease or eliminate hypoxia, hypercapnia and the disturbance
of pulmonary hemodynamics respirations) as an Apnea Event or
Hypopnea episode could be Processed by the present invention.
Technical Problem
[0025] Positive Airway Pressure (PAP) systems remain the most
effective treatment for sleep apnea. Many patients, however, cannot
tolerate the Positive Airway Pressure systems and associated
apparatus. Common complaints include discomfort with the applied
pressure, discomfort with the mask and equipment, nasal irritation,
nasal stuffiness and congestion, airway dryness, mask air leaks and
noise, entanglement, claustrophobia, noise of the PAP machine,
headaches, abdominal bloating, sore and irritated eyes, and an
overall discomfort with the machinery. The noise and general
obtrusiveness of the PAP apparatus are often disruptive to another
person sleeping with the user. A significant minority of the people
for whom PAP is prescribed (estimated to be 30% to 50%) refuse to
use it. A study determined that of the patients who use PAP
treatment, it is estimated that 34% use it intermittently (4 nights
per week) and/or remove it for part of the night (for this group
median nightly usage is 3.1 hours). Beyond the initial cost of the
PAP (>U$500.00) there is a continuing cost of replacement masks.
It is recommended that masks be replaced every six months
(=>U$100.00/mask).
[0026] A study determined that Dental Appliances was successful in
treating OSA in an average of 52% of treated patients, with success
defined as no more than 10 apneas or hypopneas per hour of sleep.
Treatment adherence is variable with patients reporting using the
appliance a media of 77% of nights at 1 year. A Dental Appliance
typically has a cost in excess of U$1000.00
[0027] Surgery has inherent risks: its' cost is high, its' success
rates vary and over a period of time its' effectiveness fades.
Pharmacological treatments for sleep apnea have not achieved any
consistent levels of effectiveness, and often contain side effects.
Systems that clear the upper airway passages during sleep using the
electrical stimulation of nerves or muscles. These systems may
produce positive results but they also have associated risks due to
surgery, may need replacement at later times (requiring additional
surgery), and may have higher costs and lower reliability than the
more traditional treatments. In addition, the hybrid systems also
have the accompanying physical restrictions and accompanying
disadvantages associated with connections to the external
equipment.
[0028] An apparatus whose means for detecting the onset of a sleep
related disorder relies on blood oxygen content information cannot
determine the onset of a sleep order in real time. Oxygen
saturation level diminishment always lags the cessation of
breathing because it takes time for the as oxygen in the
bloodstream to used up by bodily processes. Hypoxia and hypercapnia
will occur.
[0029] An apparatus whose sole means for detecting the onset of a
sleep related disorder relies on detecting the sounds of breathing
can be confused by extraneous noises, coughing, wheezing and other
internally generated biologic noises. In addition in order for both
the microphones and stimulus devices to work most effectively they
must be in close contact with the neck and this constriction may
prove to be unacceptably uncomfortable to the patient. Many of
these devices provide a single type of auditory stimulus (a fixed
tone of varying intensity) and/or mechanical stimulus (a vibrator).
For example, U.S. Pat. Nos. 7,387,608 discloses such techniques. It
is Claimed that: "The method of arousing the patient from sleep at
the onset of a sleep apnea event will decrease or eliminate the
occurrence of sleep apnea, arrhythmia, and partial epilepsy over
time"
[0030] These methods of stimulus may prove to be initially
effective in reducing the numbers of Apnea events through a process
of Conditioning. However, with Conditioning there co-exists
Habituation. These are two interacting psychological phenomena with
a number of similarities. In Conditioning, an animal is exposed to
some events, and as a consequence, it learns to associate a certain
behavior with a specific situation. In Habituation too, an event
occurs repeatedly, but in this case, the reaction of the animal
wanes with repeated exposure. The dynamics of Habituation is very
similar to the extinction of a response that has previously been
learned during Conditioning. In both cases, the response becomes
less probable or weaker with each occurrence with the event. There
is one large difference between the two situations, however. In
extinction, a learned response is weakened, but in Habituation the
reaction that dies away is typically an innate orienting reaction.
Conditioning may indeed lead to extinguishment of Sleep Apneas
events or the opposite may occur; Habituation might lead to the
patient ignoring the stimulus. If Habituation occurs then Sleep
Apnea events would continue until they spontaneously terminate.
Solution to Problem(s)
[0031] Therefore, there is a need in the art for an improved system
and method for treating Sleep Apnea events and Hypopnea episodes.
In particular, there is a need in the art for a system and method
that does not create other types of sleep disturbing effects, does
not require surgical implementation, does not involve the use of a
complicated apparatus, does not include the use of pharmaceuticals,
does not require the intervention of health professionals, and does
not have the high costs associated with some of the types of
treatments currently in use. Therefore, there is a need for a
system and method for treating Sleep Apnea event and Hypopnea
episode by terminating a Sleep Apnea event and Hypopnea episode in
real time that minimizes the disturbance to pulmonary hemodynamics.
Therefore, there is a need for a system and method for treating
Sleep Apnea event and Hypopnea episode that is easy to use by the
patient, comfortable, and less expensive than other methods of
treatment.
Advantageous Effects of Invention
[0032] An Advantageous Effect of Invention is the superior method
of detection of Sleep Apnea events and Hypopnea episodes: Using the
standard deviation of a parameter in conjunction with the
parameters' mean and a rules based processing (Fuzzy Logic) as
opposed to using only a parameters' mean as a reference point for
determination of a parameters' out of bound condition (excursion)
leads to the diminishment of the occurrence of the invention
detecting a false Apnea event or Hypoxia episode.
[0033] In the situation where the parameters' mean is the only
reference, a single excursion beyond an established limit leads
declaration of an Apnea event or Hypoxia episode. Conversely, with
this method of the invention, when an excursion is determined, a
further determination is performed to establish if the excursion is
smaller than every member of the set of parameters that were
gathered during the Self-calibrations processes. For while an
excursion might be smaller than the mean of the parameter that was
calculated by the processes the Self-calibrations, it might be
greater than any single parameter that formed the set of parameters
that were determined to be "normal" for this specific patient and
which formed the reference set of parameters. The use of rules
based processing (Fuzzy logic) allows the invention to evaluate the
significance of excursions and make decisions as to whether as
excursion merits initiating Stimulus. The invention analyzes a
multiplicity of parameters derived from redundant apparatus to
detect respirations. The use of rules based processing (Fuzzy
logic) allows the invention to evaluate the significance of
excursions of any single parameter or any combination of parameters
from the redundant apparatus and make decisions as to whether as
excursion merits initiating Stimulus.
[0034] Another Advantageous Effect of the Invention is its' ease of
use. Many of the patients who would use the invention are both
obese and old(er). The invention is simple to don. The invention
uses plain language commands to guide the patient in to properly
position the invention.
[0035] Another Advantageous Effect of the Invention is it is not an
encumbrance. The sleeping patient is not physically constrained.
This is important in light of the fact that many of the patients
have enlarged prostrates which, in many cases, necessitates
frequent urination during the night.
[0036] Another Advantageous Effect of the Invention is that it is
less expensive that most other solutions. From the perspective of
overall costs: It does not require the programming of baseline
parameters. Baseline parameters that have to be entered into an
apparatus would require that there be an evaluation of the results
from the patients' polysomnography and using a method to establish
baseline criteria. The invention self determines the baseline
parameters. There are no replacement components. Other devices
require periodic replacement of key components, at a considerable
expense. The invention is no more expensive that the average price
of the most popular form of treatment for Obstructive Sleep Apnea
(CPAP).
[0037] Another Advantageous Effect of the Invention is that it can
be used in conjunction with the most popular form of treatment for
Obstructive Sleep Apnea (CPAP) or as an alternate, independent form
of treatment. There is a significant minority or patients who use
the CPAP intermittently. Using the invention during those times
that the patient is not using CPAP would continue the benefit to
the patient that is realized by maintaining normal blood oxygen and
carbon dioxide levels.
[0038] Another Advantageous Effect of the Invention is it is
self-adapting; it self-determines referential baselines for the
specific patients' normal respiration patterns. One of the
definitions of Obstructive Sleep Apnea is interruptions in airflow
of at least 10 seconds. The invention may, depending on the normal
respiration pattern of that patient, establish a different baseline
as to what an interruption of airflow in seconds would be. By
immediately applying a Stimulus that has been determined to
initiate an inhalation at the lowest level of stimulation, the
effects on the physiology of the patient of the Apnea event or
Hypoxia episode will be minimized.
[0039] Another Advantageous Effect of the Invention is that there
are devices that ramp up the stimulus (be it the frequency of a
mechanical vibrator and/or audio and/or amplitude) until
respiration is restored. This takes time, in which case the
deleterious effects of declining blood oxygen and increasing blood
carbon dioxide accrue, and if it overshoots (there being a delay
between the time a stimulus is applied and the reaction of the
patient to it) it could lead to a heightened waking than is
required to terminate the Apnea event or Hypoxia episode.
[0040] Another Advantageous Effect of the Invention is that it is
self-adapting; it self-determines referential baselines for the
type of Stimulus that is required to terminate an Apnea event or
Hypoxia episode. Research has shown that the amount of stimulus
required to initiate an inspiration changes in cycles during sleep.
The invention continuously evaluates the Stimulus required to
terminate an Apnea event or Hypoxia episode.
[0041] Another Advantageous Effect of the Invention is that it can
supply a very wide range of Stimulus. It has a multiplicity of
embedded Audio files and Haptic pattern files, each with a distinct
irritation index. The invention will determine which files produce
the Stimulus required to initiate an inhalation at the lowest level
stimulation. Since there are many file combinations that will
produce the Stimulus required to initiate an inhalation at the
lowest level stimulation, the invention can avoid Habituation while
maintaining the benefit of Conditioning.
BRIEF DESCRIPTION OF DRAWINGS
[0042] The invention will be described by reference to the
following drawings, in which like numerals refer to like elements,
and in which:
[0043] FIG. 1 is a top and Bottom External view of the present
invention;
[0044] FIG. 2 is a Cross-section view;
[0045] FIG. 3 is a Block Diagram of the manner in which Microphone
and Plethysmographic sensor data is converted into Signals;
[0046] FIG. 4 is a Block diagram of the Electronic and Electrical
elements of the invention;
[0047] FIG. 5 is a Block Diagram of the Training and Monitoring
Processes;
[0048] FIG. 6 is a Block Diagram of the Fuzzy Control System;
and
[0049] FIG. 7 is a diagram of a Patient wearing the invention.
[0050] FIG. 8 is a Block Diagram of Portrait Development
DESCRIPTION OF EMBODIMENTS
[0051] Accordingly, embodiments of the present invention are
provided that meet at least one or more of the following objects of
the present invention. In one embodiment, a wireless auditory
prompter (Bluetooth Earbud) is mounted in the patient's ear and is
activated by the stimulation signal to emit an acoustic stimulus
which is heard by the patient but is inaudible to others. This
embodiment provides a sound to initiate inhalation without
requiring other intervention. In another embodiment, a wired
auditory prompter is mounted in the patient's ear and is activated
by the stimulation signal to emit an acoustic stimulus which is
heard by the patient but is inaudible to others. This embodiment
provides a sound to initiate inhalation without requiring other
intervention.
In another embodiment, a loud speaker is embedded within the
invention and is activated by the stimulation signal to broadcast
an acoustic stimulus which is heard by the patient. This embodiment
provides a sound to initiate inhalation without requiring other
intervention. In another embodiment, the computer detects the
absence of a heartbeat and activates an audible alarm by the
loud-speaker embedded within the present invention.
[0052] In another embodiment, the computer has means to store the
calculated amplitude, periodicity, and duration of respiration for
each respiration of the collection of known good respirations from
the first self-calibration in imbedded memory. In another
embodiment, the computer has means to store the calculated values
and parameters in imbedded memory.
[0053] In another embodiment, the computer has means to store the
time(s) in which a Sleep Apnea event and Hypopnea episode occurs in
imbedded memory. In another embodiment, the computer has means to
store the time(s) in which a Sleep Apnea event and Hypopnea
episodes are terminated in imbedded memory.
[0054] In another embodiment, the computer has means to export the
calculated values and parameters from imbedded memory to other
devices.
[0055] In another embodiment, the computer has means to export the
time(s) in which a Sleep Apnea event and Hypopnea episode occurs
and from imbedded memory to other devices.
[0056] In another embodiment, the computer has means to export the
time(s) in which a Sleep Apnea event and Hypopnea episode are
terminated from imbedded memory to other devices.
[0057] In another embodiment, the computer has means to import
modifications of the computer programs from other devices.
[0058] In another embodiment, the computer has means to import
modifications of the computer program that comprises the rules
based processing (Fuzzy Logic) from other devices.
[0059] In another embodiment, the plethysmographic sensor can be
implemented using a string potentiometer. In another embodiment,
the plethysmographic sensor can be implemented using strain
gauges.
[0060] In another embodiment, the plethysmographic sensor can be
implemented using accelerometers.
[0061] In another embodiment, the plethysmographic sensor can be
implemented using Hall Effect components.
[0062] In another embodiment, the plethysmographic sensor can be
implemented using LEDS and Photo detectors.
[0063] In another embodiment, the plethysmographic sensor can be
implemented using ultrasonic sensors.
[0064] In another embodiment, there might be a plurality of
microphones.
[0065] In another embodiment, the mechanical tactile sensory
stimulator may be implemented using a Haptic Display.
[0066] In another embodiment, the mechanical tactile sensory
stimulator maybe implemented using a Haptic Display comprising
shape memory springs.
[0067] In another embodiment, the mechanical tactile sensory
stimulator maybe implemented using a Haptic Display using multiple
actuators.
[0068] In another embodiment, the mechanical tactile sensory
stimulator maybe implemented using a Haptic Display comprising
rotating drums.
[0069] In another embodiment, the mechanical tactile sensory
stimulator maybe implemented using a Haptic Display comprising
electroactive polymers.
[0070] In another embodiment, sensory stimulation may be applied
optically by the donning of a device that is worn over the eyes and
in which LEDs shine light through the eyelids into the pupils.
[0071] The foregoing has outlined rather broadly the features and
technical advantages of the present invention so that those skilled
in the art may better understand the detailed description of the
invention that follows. Additional features and advantages of the
invention will be described hereinafter that form the subject of
the claims of the invention. Those skilled in the art should
appreciate that they may readily use the conception and the
specific embodiment disclosed as a basis for modifying or designing
other structures for carrying out the same purposes of the present
invention. Those skilled in the art should also realize that such
equivalent constructions do not depart from the spirit and scope of
the invention in its broadest form.
[0072] Before undertaking the Detailed Description, it may be
advantageous to set forth definitions of certain words and phrases
used throughout this patent document: the terms "include" and
"comprise" and derivatives thereof mean inclusion without
limitation; the term "or," is inclusive, meaning and/or; the
phrases "associated with" and "associated therewith," as well as
derivatives thereof, may mean to include, be included within,
interconnect with, contain, be contained within, connect to or
with, couple to or with, be communicable with, cooperate with,
interleave, juxtapose, be proximate to, be bound to or with, have,
have a property of, or the like; and the term "controller" means
any device, system or part thereof that controls at least one
operation, such a device may be implemented in hardware, firmware,
or software, or some combination of at least two of the same.
Definitions for certain words and phrases are provided throughout
this patent document. Those of ordinary skill in the art should
understand that in many, if not most, instances, such definitions
apply to prior, as well as future uses of such defined words and
phrases.
[0073] "Measurement" by the Computer in this application is defined
as an Analog-to-Digital Conversion. The derivative of
Analog-to-Digital Conversion is a numeric value that is
representative of the Signals Amplitude at the time that the
Measurement is made. Those skilled in the art will understand the
method of using Analog-to-Digital conversion.
[0074] "Processing", "Process", "Monitoring", and "Method" are used
interchangeably in this document and are collectively defined as
the application of software programs that are resident within the
Computer as means or manner of procedure to accomplishing
something. The means and reasons for the Processing will be
addressed in detail within this document.
[0075] Other objects and features of the present invention will
become apparent from the following detailed description considered
in conjunction with the accompanying drawings. It is to be
understood, however, that the drawings are designed solely for
purposes of illustration and not as a definition of the limits of
the invention, for which reference should be made to the appended
claims. For a general understanding of the present invention,
reference is made to the drawings. In the drawings, like reference
numerals have been used throughout to designate identical elements.
In accordance with this present invention, there is provided an
apparatus and method for the diagnosis and treatment of Sleep Apnea
and Hypopnea. In one embodiment of the invention, the respirations
of the patient are monitored during sleep by the apparatus, which
acts as a monitoring system to detect and treat Sleep Apnea events
and Hypopnea episodes in the patient. The monitoring system is
comprised of a integrated plethysmographic, a integrated
microphone, a integrated computer and software program, and methods
for applying stimulus to the patient such as a integrated loud
speaker, wired and wireless audio, and a integrated rumble effects
actuator. The invention is a wearable, belt-like device, the device
is fitted around the Thorax or Abdomen of a patient.
[0076] At the onset of a Sleep Apnea event or Hypopnea episode the
respiratory induced movement (expansion and contraction) of the
Thorax and/or Abdomen are significantly reduced. In addition, the
movement of air into the lungs is significantly reduced. These
decreases are indicators of an onset of a Sleep Apnea event or
Hypopnea episode. During sleep, it is normal for the patients'
respiration parameters for amplitude, periodicity, and duration of
respiration to vary. Discerning between those normal variations in
the parameters (for amplitude, periodicity, and duration of
respiration during sleep) and abnormal variations in parameters
(for amplitude, periodicity, and duration of respiration levels),
is performed using a software program that compares those
parameters gathered by monitoring parameters (for amplitude,
periodicity, and duration of respiration during sleep) to those
parameters (for amplitude, periodicity, and duration of
respiration) gathered before the patient fell asleep. This method
accurately identifies the onset of a Sleep Apnea event or Hypopnea
episode and eliminates false determinations. The embedded
computer's software program uses rules based processing (Fuzzy
Logic) to determine when Stimulation is to be applied in order to
restore airway patency (by inducing inspiration). When the
patient's respiration parameters are determined by the rules based
processing (Fuzzy Logic) as showing the onset of an Sleep Apnea
event or Hypopnea episode Stimulation is provided.
[0077] The present invention may use historical data, software
programs, algorithms or subroutines to assist with the
determination of the rules based processing (Fuzzy Logic) that are
appropriate to the patient. The embedded computer's software
program uses rules based processing (Fuzzy Logic) to determine the
least amount of Stimulation required to induce inspiration.
[0078] The Stimulation is in the form of audio signals and by a
cutaneous rumble effects actuator. Rules based processing (Fuzzy
Logic) determine the least amount of Stimulation required to induce
inspiration. FIGS. 1 through 8, discussed below, and the various
embodiments used to describe the principles of the present
invention in this patent document are by way of illustration only
and should not be construed in any way to limit the scope of the
invention. Those skilled in the art will understand that the
principles of the present invention may be implemented in any
suitably modified system for detecting and terminating an
obstructive sleep apnea event. FIG. 1 illustrates one embodiment of
the present invention showing External views, Top and Bottom.
[0079] The embodiment of the present invention that is illustrated
in FIG. 1 has Microphone 125 capable of detecting sounds within the
airway of patient (not shown). One type of microphone that is
suitable for use in the present invention is the electret
microphone. Microphone 125 is attached to the Housing 145 and
Housing 145 is detachably fastened around the Thorax or Abdomen of
the patient (not shown) with a Belt 165 and Velcro clasp (not shown
in FIG. 1). Housing 145 is fastened around the Thorax or Abdomen of
the patient (not shown) so that Microphone 125 is positioned
adjacent to the lungs and in contact with the patient (not shown on
FIG. 1). LEDs 115 & 120 are Status indicators. The emitted
color that the LEDs display are indicative of operational
conditions of the present invention. Buttons 105 & 110 control
the operations of the present invention.
[0080] The Microphone 125 is capable of generating signals
representative of the sounds of breathing of person 120. When
Microphone 125 detects sounds of breathing, it generates a signal.
The signal generated by the Microphone 125 is transferred via an
individual microphone signal line to signal processing circuitry
200 (shown in FIG. 3) contained within Housing 145.
[0081] FIG. 2 is a cross-section (side view) of the present
invention It illustrates that belt 265 has one end attached to
Housing 245. The other end of belt 265 enters Housing 245 and is
attached to Shuttle 270 and too Spring 290. Shuttle 270 travels
within Guide 275. Shuttle 270 is attached to Wiper 280. Wiper 280
is an attachment of Membrane Potentiometer 285. The expansion of
the Thorax or Abdomen during inspiration causes Belt 265 to pull on
Shuttle 270 moving it from its' rest position. Shuttle 270 moves
within Guide 275 and deforms Spring 290. The movement of Shuttle
270 also moves Wiper 280. Wiper 280 is pressed down on the top
layer of Membrane Potentiometer 285, which in turn touches the
bottom layer of Membrane Potentiometer 285. The touching of the
upper and lower layer of Membrane Potentiometer 285 creates a
voltage divider circuit. The output is voltage. The voltage is a
direct inferential reading of the magnitude of the expansion or
contraction of the Thorax/Abdomen at any time. The Computer
processes the voltage as a Signal. The Signal output of Membrane
Potentiometer 285 varies in direct proportion to the position of
Shuttle 270 within Guide 275. When an exhalation occurs the Thorax
or Abdomen contracts, releasing tension on Shuttle 270. Spring 290
moves Shuttle 270 back towards its rest position within Guide 275.
Those skilled in the art will understand the method of using
Membrane Potentiometers to sense position. The cutaneous rumble
effects actuator 200 is attached to the Housing 245. The collection
of elements of FIG. 2 makeup the Integrated Plethysmographic
Sensor.
[0082] FIG. 3 is a Block Diagram of the manner in which Microphone
and Plethysmographic sensor data is converted into Signals.
Referring now to FIG. 3A the Block Diagram is illustrative of the
Signal that is outputted from the Integrated Plethysmographic
Sensor 301. Buffer 302 conditions the voltage Signal from
Plethysmographic Sensor 301. The voltage Signal from Buffer 302 is
the Thorax/Abdomen Movement Signal 303. The Computer (not shown in
FIG. 3) Processes the Signal 303.
[0083] Referring to FIG. 3B the Block Diagram is illustrative of
the Process that the Signals of Breathing Sounds 313 and Heart Beat
Sound 312 that are extracted. The Microphone 304 detects a
multiplicity of Audio Signals. The multiplicity of Audio Signals
are comprised of the Audio components of biologic processes (Heart
Beats, audio component of the turbulence that occurs in the human
respiratory system during respiration, bowels, snoring, wheezing,
yawning, coughing, etc) and external interference artifacts. The
multiplicity of signals forms a spectrum of Audio frequencies. The
elements of the Block Diagram as represented in FIG. 3B (Buffer
305, Bandpass Filter 306, Envelope Detection 307, Log 308, Sum 309,
Integrator 310, and Output Scaling 311) act in concert to filter
out the extraneous signals so as to export only the Signals of
Respiration 313 and the Signals of the Beating Heart 312. The
Process is further detailed in the technical paper ENDER, Derek et
al. Process for the Detection and Analysis of Respiratory Airflow
and Snoring Sounds During Sleep Using Laryngeal Sound
Discrimination: Engineering in Medicine and Biology Society, 1992.
Vol.14. Proceedings of the Annual International Conference of the
IEEE. Volume 6, Issue , 29 Oct.-1 Nov. 1992 Page(s):2636-263. Which
is hereby incorporated by reference. The Computer (not shown in
FIG. 3) processes the exported Signals. Those skilled in the art
will understand this method to extract specific Audio Signals from
a multiplicity of Audio Signals.
[0084] Referring again to FIG. 3C. The Signals that are derived by
the Plethysmographic Sensor 301 and the Microphone 304 are Measured
by the Computer (not shown in FIG. 3). Each Signal is Measured for
three (3) discrete Parameters. The Measurement quantity is assigned
a numeric value that represents a direct inferential reading of the
specific Signal Parameter. The Parameters that are Measured are
the: Amplitude 313 of the Signal. The Amplitude 313 is
representative of the expansion of the Thorax or Abdomen during an
inspiration. Duration of the Signal 314. The Duration of the Signal
314 is the amount time that it takes for an discrete inspiration
and exhalation to be completed. Periodicity of the Signal 315. The
Periodicity of the Signal 315 is the time between discrete
exhalations.
[0085] FIG. 4 is a Block diagram of the Electronic and Electrical
elements of the invention. The operation of the invention is
illustrated in FIG. 4. It is made up of a number of electronic
component sections:
[0086] PIC Computer 409 is the Computer of the invention. On/Off
Switch 401 activates and deactivates the invention. Control1 Switch
402 activation is the method wherein that patient interacts with
the invention. Status LED2 403 is a multicolor LED. The color that
it presents to the patient indicates the status of the invention.
Status LED1 404 is a multicolor LED. The color that it presents to
the patient indicates the status of the invention. Battery Pack 405
provides electrical power to the invention.
[0087] FLASH RAM 406 contains the Force Portraits 601, the Fuzzy
Control System Rules, and the Processing program instructions. The
Computer 409 and it exchange data over a signal buss. SRAM 407
contains the results of arithmetic computations by the Computer
409. The Computer 409 and it exchange data over a signal buss.
Clock Oscillator 408 is the Inventions clock. BlueTooth 410 is the
section that receives Audio Portrait Signals, Alarm Signals, and
Training Period 1 & 2 spoken commands, converts the signals
into Bluetooth formatted Signals and wirelessly transmits the Audio
Portrait Signals to a Bluetooth wireless Earbud 715 (not shown if
FIG. 4) worn by the patient. Speaker 411 Audio Portrait Signals,
Alarm Signals, and Training Period 1 & 2 spoken commands and
broadcasts them to the patient. USB I/O Port 413 is the means by
which external devices communicate with the Computer 409. Signals
414, 415, and 416 are the busses by which the Signals are received
by the Computer 409 for Processing.
[0088] FIG. 5 is a Block Diagram of the Training and Monitoring
Processes. It is a primary object of the present invention to
provide a apparatus and method for detecting and terminating an
Sleep Apnea event and Hypopnea episode, within seconds of aid
detection. To perform the process I draw your attention to FIG. 5A.
FIG. 5A is a block diagram of the Process of Training. The Signals
that are generated during Training Periods #1 and #2 are used by
the invention to perform Self-checking. This Self-checking
procedure verifies that the invention is operating as intended.
[0089] The Process of Self-Checking commences when the patient dons
the invention and presses button On/Off Switch 401 (not shown in
FIG. 5). The patient is directed to adjust the Belt 165 (not shown
in FIG. 5) and Velcro clasp by plain, spoken commands. These spoken
commands are fetched from FLASH RAM 406 (not shown in FIG. 5) by
the Computer 409 (not shown in FIG. 5) and broadcast to the patient
by Bluetooth wireless 410 (not shown in FIG. 5) to the patients
Bluetooth Earbud 715 (not shown in FIG. 5) and/or the Speaker 411
(not shown in FIG. 5). The directions are supplied to the patient
to insure that the Integrated Plethysmographics' Shuttle 270 (not
shown in FIG. 5) is in its' rest position within Guide 275 (not
shown in FIG. 5) that allows for uninterrupted movement of the
Shuttle 270 (not shown in FIG. 5) during inspiration and
exhalation. Furthermore, the Signals are Measured to become a set
of Referential Parameters (the process that is used to create these
Referential Parameters is addressed in detail later in this
document).
[0090] The Process of Training: During Training Period #1, the
patent is directed to breath in specific patterns by plain, spoken
commands. These spoken commands are fetched from FLASH RAM 406 (not
shown in FIG. 5) by the Computer 409 (not showing FIG. 5) and
broadcast to the patient by Bluetooth wireless 410 (not shown in
FIG. 5) to the patients Bluetooth Earbud 715 (not shown in FIG. 5)
and/or the Speaker 411 (not shown in FIG. 5). This Process of
Training commences when the patient dons the invention and presses
button On/Off Switch 401 (not shown in FIG. 5) The specific
patterns include but not limited to:
[0091] "Natural Breathing"
[0092] "Deep Breathing"
[0093] "Fast Breathing"
[0094] "Slow Breathing"
[0095] "No Breathing"
[0096] "Shallow Breathing"
[0097] "Breath while Supine"
[0098] "Breath on the patients Left Side"
[0099] "Breath on the patients Right Side"
[0100] "Breath while Prone"
[0101] During Training Period #2 the patent is directed to push the
Control1 Switch 402 (not shown in FIG. 5) as they are preparing to
go to sleep. All Signals are Measured by the Computer 409 (not
shown in FIG. 5) to derive Values for the Signals intrinsic
Parameters. All Signals are Measured and Processed in an identical
manner.
[0102] To illustrate how Signals are Measured by the Computer 409
(not shown in FIG. 5) to derive Values for the Signals' intrinsic
Parameters and then Processed we will use the Measurement of a
single Parameter as an example. Review FIG. 5A. For this example,
the Signal Parameter that will be Measured and Processed is
"Amplitude" 316 (not shown in FIG. 5): The "Amplitude" is
representative of the expansion of the Thorax or Abdomen that
occurs during an inspiration:
[0103] 1. Signal Input Storage 501, collects the stream of Signals
303 (not shown in FIG. 5), 312 (not shown in FIGS. 5), and 313 (not
shown in FIG. 5) for 60 seconds.
[0104] 2. Within Block 502 the Signals from within Signal Input
Storage 501 are Measured. Values are Processed so that only the
largest Value for any Inspiration is kept. [0105] a. The method of
this specific Processing follows this format: [0106] i. IF
Value(Now) is GREATER than or EQUAL to Value(Previous) THEN assign
Value(Now) to Value(Previous). [0107] ii. IF Value(Now) is Less
than or Equal to Value(Previous) THEN store Value(Previous) within
Value Storage 503 as it is the largest value for this
Inspiration.
[0108] 3. The stored largest Values within Value
Storage 503 form a set named VS.
[0109] 4. The Values set VS is arithmetically Processed in the
following manner within Block 504-- [0110] a. Calculate the
arithmetic average of the Values in the set VS. [0111] b. Subtract
each Value in the set from the arithmetic average. [0112] c. Square
the deviation of each Value in the set from the arithmetic average.
[0113] d. Calculate the arithmetic average of the Squared
deviations. [0114] e. Calculate the square root of the arithmetic
average of the Squared deviations. [0115] f. The result is the
root-mean-square deviation.
[0116] 5. The arithmetic average of the Values in the set VS is
stored as a Referential Parameter in the Training Period 1 and 2
Referential Parameter Storage 505.
[0117] 6. The root-mean-square deviation of the Values in the set
VS is stored as a Referential Parameter in the Training Period 1
and 2
Referential Parameter Storage 505.
[0118] The Process of Monitoring: It is a primary object of the
present invention to provide an apparatus and method for detecting
and terminating a Sleep Apnea event and Hypopnea episode, within
seconds of the detection. FIG. 5B is a block diagram of the Process
of Monitoring. The Signals Input Flow 506 comprises Signals 303
(not shown in FIG. 5), 312 (not shown in FIGS. 5), and 313 (not
shown in FIG. 5). Signals Input Flow 506 is Measured and Processed
by the Computer by Value Assignment 507. The Processing steps
are--
[0119] 1. Upon the Measurement by the Computer 409 (not shown in
FIG. 5) a Numeric Value is assigned for each Parameter that is
Measured.
[0120] 2. The Numeric Value is stored in Numeric Value Storage
508.
[0121] 3. Subtraction arithmetic operation 509. Parametric Numeric
Value(Now) minus it's arithmetic average Referential Parameter
equals Result1.
[0122] The Numeric value for a Parameter is further Processed by
the Computer (not shown in FIG. 5) by recalling the Referential
Parameters specific to the Parameter that is being Processed at
this time.
[0123] The Processing consists of a series logic operation by the
Computer (not shown in FIG. 5). The format of these series of logic
operation Performed within Evaluation 510:
[0124] 1. If Result1 is equal or Greater than 0 then Do
Nothing.
[0125] 2. If Result1 is Less than 0 then [0126] a. Subtract
Parametric Numeric Value(Now) from each Value contained within the
Value Set of VS. [0127] b. If any result of the previous operation
(step 2a) is a positive integer then: [0128] I. Divide Result1 by
the root-mean square deviation Referential Parameters parameter
equals Result2. [0129] II. If Results2 is Less than 0 then Do
Nothing [0130] III. If Results2 is Greater than 0 then present
Results2 to the Fuzzy Control System for determination as to
whether Stimulation should be applied.
[0131] FIG. 6 is a Block Diagram of the Fuzzy Control System The
Detecting and Terminating Process utilizes Fuzzy logic processes.
The Fuzzy Control System controls two Processes.
[0132] 1. Monitoring
[0133] 2. Stimulation
[0134] Fuzzy logic processing is described, for example, in U.S.
Pat. No. 7,426,435, issued to GAUTHIER , et al. Sep. 16, 2008, The
disclosures of these United States patents are incorporated herein
by reference. Another example is NAZERAN, HOMER et al. A Fuzzy
Inference System for Detection of Obstructive Sleep Apnea:
Proceedings--23rd Annual Conference--IEEE/EMBS Oct. 25-28, 2001,
Istanbul, TURKEY, which is hereby incorporated by reference.
[0135] Referring to FIG. 6, the Fuzzy Control System Process for
Monitoring is as follows: Result2 values are the input variables to
the Fuzzy Control System. The Result2 values are mapped into by
sets of membership functions known as "fuzzy sets". The process of
converting a Result2 values (in the nomenclature of Fuzzy Logic
these Result2 values are referred to as Crisp Input Values) to a
fuzzy value is called "fuzzifi-cation". The fuzzification" occurs
in the Input stage 601 of the Fuzzy Control System. The "fuzzified"
Result2 values are evaluated in the next stage of the Fuzzy Control
System, the Processing stage 602. The Processing stage 602 uses a
collection of logic rules. The Computer then makes decisions for
what action to take based on that collection of logic rules. The
Rules are in the form of IF statements:
[0136] An example of a logic rule would be: [0137] IF amplitude IS
very low AND periodicity IS very long apply stimulation.
[0138] In this example, the two input variables are "very low" and
"very long" that have values defined as fuzzy sets. The output
variable, "stimulation", is also defined by a fuzzy set that can
have values like "long", "louder, "less loud", and so on. The
results of the Processing Stage are combined to give a specific
("Crisp") answer; this "Crisp" answer translates results into
values. This takes place in the Crisp Control Stage 604. If the
"Crisp" answer is to initiate Stimulation then the Process steps
are as described or shown herein.
[0139] FIG. 7 is a diagram of a typical Patient wearing the
invention. Patient 700, has the positioned the Housing 705 on his
Thorax and has fastened Belt 710 to hold it in place. The patient
700 is wearing the Bluetooth Earbud 715.
[0140] FIG. 8 is a Block Diagram of Portrait Development. Before
continuing it may be advantageous to set forth definitions of
certain words and phrases. Stored Portrait Stimulation Parameters
are
[0141] Effective Portraits
[0142] Irritation Index
[0143] Audio Portrait
[0144] Force Portrait
[0145] Effectivity Index
[0146] Effective Portraits:
[0147] Is that combination of an Audio Portrait and a Force
Portrait that have been found through a Process (described below)
to generate an inspiration in a Patient who is having an Sleep
Apnea event or Hypopnea episode.
[0148] Irritation Index:
[0149] The Irritation Index is an arbitrary value assigned to
Portraits Audio and Force) at the time that the Portrait is created
and inputted into the FLASH RAM 406. It is indicative of how
reactive a patient would be to that Portrait, As an example, the
playing of an Audio file of a woman screaming would be assigned a
higher Irritation Index value than that of Audio file of a birds
singing.
[0150] Force Portrait:
[0151] The mechanical tactile sensory stimulator 200 (not shown in
FIG. 6) differ from a simple vibrator in that it is capable of
simulating a wide range of tactile effects. The Haptic effects are
assembled by using software instructions to control the force
amplitude, wave shape, and pulse duration to the stimulation
effectors. These instructions are combined to form Force Portraits.
The Force Portraits are stored in the Haptic effects library area
of the Portrait Storage 801 (not shown in FIG. 6). Different Force
Portraits are felt as different tactile sensations by the patients.
These Force Portraits are assigned an Irritation Index value. The
choice of which Force Portrait to use for the mechanical tactile
sensory stimulator is determined by the Fuzzy Logic System.
[0152] Audio Portrait
[0153] A method of Stimulation is the playing of prerecorded Audio
files. These Audio files are stored in the Portrait Storage 801
(not shown in FIG. 6) as Audio Portraits. The Audio Portrait is
made up the Audio File Name, a Volume value, the File length, and
the Audio File Irritation Index value. There are multiplicities of
stored Audio Portrait. The Audio files are sent to the patient by a
Bluetooth wireless transmitter 410 (not shown in FIG. 6) to a
Bluetooth wireless Earbud 715 (not shown in FIG. 6). Bluetooth is a
wireless protocol utilizing short-range communications technology
facilitating data transmission over short distances from fixed
and/or mobile device. Bluetooth wireless communication is
described, for example, in U.S. Pat. No. 7,225,064, issued to
FUDALI, et al. May 29, 2007. The disclosures of these United States
patents are incorporated herein by reference. The choice of which
Audio Portrait to use for the Audio Stimulus is determined by the
Fuzzy Logic System.
[0154] Effectivity Index:
[0155] The Effectivity Index is the sum of the Irritation Indexes
of an Audio and Force Portraits couple. The larger the numerical
value of the Effectivity Index than the more vigorous the Stimulus
delivered to the patient. The present invention relates to an
apparatus to detect and end an occurrence of a Sleep Apnea event or
Hypopnea episode, in a manner that will decrease or eliminate
hypoxia, hypercapnia and the disturbance of pulmonary
hemodynamics.
[0156] To apply Stimulus in a manner that will decrease or
eliminate hypoxia, hypercapnia and the disturbance of pulmonary
hemodynamics it is necessary to determine what stimuli is both
effective in initiating Inspiration within 2 seconds of the
stimulus application while simultaneously decreasing or eliminating
the disturbance of pulmonary hemodynamics.
[0157] The Method to develop a set of stimuli that is both
effective in initiating Inspiration within 2 seconds of the
Stimulus application while simultaneously decreasing or eliminating
the disturbance of pulmonary hemodynamics is as follows. The sets
of stimuli are called Effective Portraits. When the Fuzzy Control
System Process of FIG. 6 (not shown in FIG. 8) detects the onset of
a Sleep Apnea event or Hypopnea episode, it attempts to select the
of Effective Portrait from within Portrait Storage 801.
[0158] If there is no Effective Portrait (as would happen when the
patient initially dons the invention then the Process of developing
an Effective Portrait commences:
[0159] 1. The Fuzzy Control System of FIG. 6 (not shown in FIG. 8)
inputs a random selection of a Force and Audio Portrait from the
Portrait Library 802 forming a Temporary Couple.
[0160] 2. The Temporary Couple is sent to the Stimulus Effectors
806.
[0161] 3. After a 2 Second Delay 805 the Fuzzy Logic System of FIG.
6 (not shown in FIG. 8) Monitors the patient to determine if there
is aninspiration.
[0162] 4. If Fuzzy Logic System of FIG. 6 (not shown in FIG. 8)
determines that further Stimulation is required then another random
selection of a Force and Audio Portrait is made from the Portrait
Library 802 forming another Temporary Couple.
[0163] 5. This Temporary Couple will have a larger Effectivity
Index than the previous Temporary Couple Effectivity Index.
[0164] 6. This Temporary Couple is sent to the Stimulus Effectors
806.
[0165] 7. After a 2 Second Delay 805 the Fuzzy Logic System of FIG.
6 (not shown in FIG. 8) Monitors the patient to determine if there
is an inspiration.
[0166] 8. Steps 5-7 cycle until the Fuzzy Logic System of FIG. 6
(not shown in FIG. 8) determines that Stimulus is no longer
required. The Temporary Couple is stored in Portrait Storage 801 as
an Effective Portrait.
[0167] Effectivity of the Effective Portrait changes in a cyclic
pattern during sleep as the amount of Stimulus required to initiate
an inhalation waxes and wanes. This is the Method for adapting to
that cyclic process--When the Fuzzy Control System Process of FIG.
6 (not shown in FIG. 8) detects the onset of a Sleep Apnea event or
Hypopnea episode, it attempts to use the Effective Portrait that
has been stored in Portrait Storage 801. If there is an Effective
Portrait in Portrait Storage 801 then the Fuzzy Control System of
FIG. 6 (not shown in FIG. 8) will:
[0168] 1. Send that Effective Portrait to the Stimulus Effectors
806.
[0169] 2. After a 2 Second Delay 805 the Fuzzy Logic System of FIG.
6 (not shown in FIG. 8) Monitors the patient. If the Fuzzy Logic
System of FIG. 6 (not shown in FIG. 8) determines that further
Stimulation is required--. [0170] a Force and Audio Portrait is
chosen from the Portrait Library 802 forming a Temporary Couple
whose Effectivity Index is incrementally greater than the
Effectivity Index of the Effective Portrait stored in Portrait
Storage 801. [0171] b. Sends that Effective Portrait to the
Stimulus Effectors 806. [0172] i. Step 2 cycles until the Fuzzy
Logic System of FIG. 6 (not shown if FIG. 8) determines that there
exists' no need further for Stimulation (an inhalation is
detected). [0173] ii. This Temporary Couple replaces the Effective
Portrait stored within Portrait Storage 801.
[0174] 3. If the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8)
determines that no further Stimulation is required then when the
next Sleep Apnea event or Hypopnea episode is detected--. [0175] a
Force and Audio Portrait is chosen from the Portrait Library 802
forming a Temporary Couple whose Effectivity Index is incrementally
less than the Effectivity Index of the Effective Portrait stored in
Portrait Storage 801. [0176] b. Sends that Temporary Couple to the
Stimulus Effectors 806. [0177] c. After a 2 Second Delay 805 the
Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) Monitors the
patient. [0178] i. If the Fuzzy Logic System of FIG. 6 (not shown
in FIG. 8) determines that no further Stimulation is required then
this Temporary Couple replaces the Effective Portrait stored within
Portrait Storage 801. [0179] ii. If the Fuzzy Logic System of FIG.
6 (not shown in FIG. 8) determines further Stimulation is required
then 1) a Force and Audio Portrait is chosen from the Portrait
Library 802 forming a Temporary Couple whose Effectivity Index is
incrementally greater than the Effectivity Index of the Effective
Portrait stored in Portrait Storage 801.
[0180] 2) Sends that Effective Portrait to the Stimulus Effectors
806.
[0181] 3) After a 2 Second Delay 805 the Fuzzy Logic System of FIG.
6 (not shown in FIG. 8) Monitors the patient.
[0182] 4) Step 3) cycles until the Fuzzy Logic System of FIG. 6
(not shown if FIG. 8) determines that there exists' no need further
for Stimulation (an inhalation is detected.
[0183] 5) This Temporary Couple replaces the Effective Portrait
stored within Portrait Storage 801.
CITATION LIST
Patent Literature
[0184] U.S. Pat. No. 7,387,608 Apparatus and method for the
treatment of sleep related disorders Jun. 1, 2008 Dunlop; David A,
Gunderman, Jr.; Robert Dale
[0185] U.S. Pat. No. 7,371,220 System and method for real-time
apnea/hypopnea detection using an implantable medical system May 1,
2008 Koh; Steve, Park; Euljoon, Benser
[0186] 2005/0085865 Breathing disorder detection and therapy
delivery device and method Apr. 1, 2005 Tehrani, Amir J
[0187] 2006/0097879 SIDS and apnea monitoring system May 1, 2006
Lippincott; Kathy J
[0188] 2005/0101833 Apparatus for the treatment of sleep apnea May
1, 2005 Hsu, William
[0189] U.S. Pat. No. 6,935,335 System and method for treating
obstructive sleep apnea Aug. 1, 2005 Lehrman; Michael L., Halleck;
Michael E
[0190] U.S. Pat. No. 6,666,830 System and method for detecting
theonset of an obstructive sleep apnea event Dec. 1, 2003 Lehrman;
Michael L., Halleck; Michael E. Ferguson; Pete, Kumar; Harpal, Lay;
Graham, Llewellyn; Mike, Place; John D.
[0191] U.S. Pat. No. 6,241,683 Phonospirometry for non-invasive
monitoring of respiration Jun. 1, 2001 Macklem; Peter T., Que;
Cheng-Li, Kelly; Suzanne M., Kolmaga; Krzystof , Durand;
Louis-Gilles
[0192] U.S. Pat. No. 6,290,654 Obstructive sleep apnea detection
apparatus and method using pattern recognition Sep. 1. 2001
Karakasoglu; Ahmet
[0193] U.S. Pat. No. 6,011,477 Respiration and movement monitoring
system Jan. 4, 2000 Teodorescu; Horia-Nicolai, Mlynek; Daniel
J.
[0194] U.S. Pat. No. 5,853,005 Acoustic monitoring system Dec. 1,
1998 Scanlon; Michael V
[0195] U.S. Pat. No. 5,769,084 Method and apparatus for diagnosing
sleep breathing disorders Jun. 1, 1998 Katz; Richard A., Lawee;
Michael S., Newman; A. Kief
[0196] U.S. Pat. No. 5,555,891 Vibrotactile stimulator system for
detecting and interrupting apnea in infants Sep. 1, 1996 Eisenfeld;
Leonard I.
[0197] U.S. Pat. No. 5,540,733 Method and apparatus for detecting
and treating obstructive sleep apnea Jul. 1, 1996 Testerman; Roy
L., Erickson; Donald J., Bierbaum; Ralph W.
[0198] U.S. Pat. No. 5,522,862 Method and apparatus for treating
obstructive sleep apnea Jun. 4, 1996, Testerman; Roy L., Erickson;
Donald J.
[0199] U.S. Pat. No. 5,277,194 Breathing monitor and stimulator,
Jan. 1, 1994. Hosterman; Craig, Smith; Alvin W.
[0200] U.S. Pat. No. 5,107,855 Apena monitor for detection of
aperiodic sinusoidal movement Apr. 1, 1992 Harrington; Reginald,
Crossley; Ralph
[0201] U.S. Pat. No. 5,050,614 Apparatus and method for inspiration
detection Sep. 1, 1991 Logan; Charles H.
[0202] U.S. Pat. No. 4,781,201 Cardiovascular artifact filter Nov.
1, 1988 Wright; John C., Triebel
[0203] U.S. Pat. No. 4,694,839 Auxiliary stimulation apparatus for
apnea distress Sep. 1, 1987 Timme; William F.
[0204] U.S. Pat. No. 4,686,999 Multi-channel ventilation monitor
and method Aug. 1, 1987 Snyder; Leon T., Scarfone; Frank A., Reuss;
James L., Campen; George V., Yates; George H.
[0205] U.S. Pat. No. 4,365,636 Method of monitoring patient
respiration and predicting apnea there from Dec. 1, 1982 Barker;
Kent R.
[0206] U.S. Pat. No. 4,296,757 Respiratory monitor and excessive
intrathoracic or abdominal pressure indicator Oct. 1, 1981 Taylor;
Thomas
[0207] CONTINUATION APPLICATION 2505240 OSA HYPDXIA ONSET DETECTOR
AND INTERRUPTOR Nov. 26, 2007
Non-Patent Literature
[0208] H. SCHNEIDER et al, "Effects of arousal and sleep state on
systemic and pulmonary hemodynamics in obstructive apnea", J. Appl.
Physiol. 88: 1084-1092, 2000.
[0209] D. M. Carlson et al, "Acoustically induced cortical arousal
increases phasic pharyngeal muscle and diaphragmatic EMG in NREM
sleep", Journal of Applied Physiology, Vol 76, Issue 4
1553-1559.
[0210] W. T. McNicholas, "Arousal in the sleep apnea syndrome: a
mixed blessing?", Eur Respir J 1998; 12: 1239-1241.
[0211] Robert C. Basner MD et al, "Respiratory and Arousal
Responses to Acoustic Stimulation", Chest. 1997;112:1567-1571.
[0212] Gang Bao et al., "Acute and chronic blood pressure response
to recurrent acoustic arousal in rats", Am J Hypertens (1999) 12,
504-510.
[0213] R. C. Basner et al, "Effect of induced transient arousal on
obstructive apnea duration", J. App Physiol. 78(4): 1469- 1476,
1995.
[0214] Dina Brooks et al, "Obstructive Sleep Apnea as a Cause of
Systemic Hypertension Evidence from a Canine Model", J. Clin.
Invest. Volume 99, Number 1, January 1997, 106-109.
[0215] MARY J. MORRELL et al, "Sleep Fragmentation, Awake Blood
Pressure, and Sleep-Disordered Breathing in a Population-based
Study", Am. J. Respir. Crit. Care Med., Volume 162, Number 6,
December 2000, 2091-2096.
[0216] Robert C. Basner et al, "Respiratory and Arousal Responses
to Acoustic Stimulation", Chest 1997;112;1567-1571.
[0217] RICHARD S. T. LEUNG et al, "Sleep Apnea and Cardiovascular
Disease", Am. J. Respir. Crit. Care Med., Volume 164, Number 12,
December 2001, 2147-2165.
[0218] Denise M. O'Driscoll et al, "Cardiovascular response to
arousal from sleep under controlled conditions of central and
peripheral chemoreceptor stimulation in humans", J Appl Physiol
96:865-870, 2004.
[0219] Denise M. O'Driscoll et al, "Occlusion of the upper airway
does not augment the cardiovascular response to arousal from sleep
in humans", J Appl Physiol 98:1349-1355, 2005.
[0220] U. Leuenberger et al, "Surges of muscle sympathetic nerve
activity during obstructive apnea are linked to hypoxemia", Am. J.
Respir. Crit. Care Med., Volume 164, Number 12, December 2001,
2147-2165.
[0221] RICHARD S. T. LEUNG et al, "Sleep Apnea and Cardiovascular
Disease", Journal of Applied Physiology, Vol 79, Issue 2
581-588.
[0222] Richard B. Berry MD, "Sleep Apnea Impairs the Arousal
Response to Airway Occlusion", Chest. 1996;109:1490-1496.
[0223] T. KATO et al, "Experimentally induced arousals during
sleep: a cross-modality matching paradigm", J. Sleep Res. (2004)
13, 229-23.
[0224] Christian Guilleminault et al, "The effect of CNS activation
versus EEG arousal during sleep on heart rate response and daytime
tests", Clinical Neurophysiology 117 (2006) 731-739.
[0225] Emilia Sforza, MD et al, "Effects of Sleep Deprivation on
Spontaneous Arousals in Humans", SLEEP, Vol. 27, No. 6, 2004.
[0226] J. F. Masa et al, "Assessment of thoracoabdominal bands to
detect respiratory effort-related arousal", Eur Respir J 2003; 22:
661-667.
[0227] R. C. Basner et al, "Effect of induced transient arousal on
obstructive apnea duration", J Appl Physiol 78: 1469-1476,
1995.
[0228] HIROSHI MIKI et al, "New Treatment for Obstructive Apnea
Syndrome by Electrical Stimulation of Submental Region", Tohoku J.
exp. Med., 1988, 154, 91-92.
[0229] C. Guilleminault et al, "The effect of CNS activation versus
EEG arousal during sleep on heart rate response and daytime tests",
Clinical Neurophysiology , Volume 117 , Issue 4 , Pages
731-739.
[0230] Immersion Corporation, "Next-generation TouchSense Vibration
for Video Game Console Systems", 31 Aug. 2006.
[0231] Sheroz Khan, I. Adam et al, "Rule-Based Fuzzy Logic
Controller with Adaptable Reference", International Journal of
Intelligent Technology Volume 3 Number 1.
[0232] E. Sforza et al, "Nocturnal evolution of respiratory effort
in obstructive sleep apnoea syndrome: influence on arousal
threshold, Eur Respir J 1998; 121257-126 DOI:
10.1183/09031936.98.12061257.
[0233] Homer Nazeran et al, "A Fuzzy Inference System for Detection
of Obstructive Sleep Apnea". Proceedings--23rd Annual
Conference--IEEE/EMBS Oct. 25-28, 2001, Istanbul, TURKEY.
* * * * *