U.S. patent application number 12/583588 was filed with the patent office on 2010-02-25 for diagnostic indicator and psg interface for a closed loop neuromodulator.
This patent application is currently assigned to Dymedix Corporation. Invention is credited to Reinhold Henke, Peter Stasz.
Application Number | 20100049264 12/583588 |
Document ID | / |
Family ID | 41319888 |
Filed Date | 2010-02-25 |
United States Patent
Application |
20100049264 |
Kind Code |
A1 |
Henke; Reinhold ; et
al. |
February 25, 2010 |
Diagnostic indicator and PSG interface for a closed loop
neuromodulator
Abstract
This document discusses, among other things, a system and method
for providing diagnostic information from a closed loop
neuromodulator, configured to provide sleep therapy for a patient,
to a user or a polysomnograph (PSG). A first portion of the
diagnostic information can be received at a diagnostic indicator
register of the closed loop neuromodulator and an LED driver can be
switched using the first portion of the diagnostic information. A
second portion of the diagnostic information can be received at a
PSG interface of the closed loop neuromodulator and provided to the
PSG for display.
Inventors: |
Henke; Reinhold; (Plymouth,
MN) ; Stasz; Peter; (Mounds View, MN) |
Correspondence
Address: |
SCHWEGMAN, LUNDBERG & WOESSNER, P.A.
P.O. BOX 2938
MINNEAPOLIS
MN
55402
US
|
Assignee: |
Dymedix Corporation
Shoreview
MN
|
Family ID: |
41319888 |
Appl. No.: |
12/583588 |
Filed: |
August 21, 2009 |
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Current U.S.
Class: |
607/3 ;
600/529 |
Current CPC
Class: |
A61M 2016/0033 20130101;
A61M 2021/0066 20130101; A61B 5/4058 20130101; A61M 21/02 20130101;
A61M 2230/40 20130101; A61M 2021/0027 20130101; A61M 2021/0044
20130101; A61B 5/02055 20130101; A61B 5/4818 20130101; Y02A 90/26
20180101; H03H 11/126 20130101; A61M 2021/0072 20130101; A61M
2205/3553 20130101; H03H 11/1252 20130101; H03H 1/0007 20130101;
Y02A 90/24 20180101; A61M 2021/0022 20130101; A61M 2205/52
20130101; Y02A 90/10 20180101; A61M 2021/0011 20130101; A61N 1/3601
20130101 |
Class at
Publication: |
607/3 ;
600/529 |
International
Class: |
A61N 1/00 20060101
A61N001/00; A61B 5/08 20060101 A61B005/08 |
Claims
1. A closed loop neuromodulator interface for providing diagnostic
information from a closed loop neuromodulator, configured to
provide sleep therapy for a patient, to a user or a polysomnograph
(PSG), the interface comprising: a diagnostic indicator register
coupled to a data bus of the closed loop neuromodulator, the
diagnostic indicator register configured to receive a first portion
of the diagnostic information and to switch an LED driver of a
plurality of LED drivers in response to the first portion of the
diagnostic information; and a PSG interface configured to receive a
second portion of the diagnostic information and to provide the
second portion of the diagnostic information to the PSG.
2. The interface of claim 1, including a digital airflow buffer
coupled to an inhalation LED driver of the plurality of LED
drivers, the digital airflow buffer configured to receive a digital
airflow signal indicative of a respiration state of the patient
from a hardened sensor interface of the closed loop neuromodulator;
and wherein the inhalation LED driver is configured to illuminate
an inhalation LED when the digital airflow signal is indicative of
an inhalation respiration state of the patient.
3. The interface of claim 2, wherein the closed loop neuromodulator
is configured to detect a sleep related disorder using the digital
airflow signal and to provide a first stimulus to the patient in
response to the detected sleep disorder event, the first stimulus
configured to not interrupt the detected sleep disorder event; and
wherein the closed loop neuromodulator is configured to provide,
following the first stimulus, a second stimulus to the patient in
response to the detected sleep disorder event, the second stimulus
having more energy than the first stimulus and configured to
interrupt the detected sleep disorder event.
4. The interface of claim 1, including a stimulus signal buffer
coupled to the PSG interface, the stimulus signal buffer configured
to receive a stimulus signal, indicative of the sleep therapy, from
a stimulus generator of the closed loop neuromodulator and to
provide the stimulus signal to the PSG interface.
5. The interface of claim 1, including a driver signal buffer
coupled to the PSG interface, the driver signal buffer configured
to receive a driver signal from a stimulus escalator of the closed
loop neuromodulator and to provide the driver signal to the PSG
interface.
6. The interface of claim 1, including an analog airflow signal
buffer coupled to the PSG interface, the analog airflow signal
interface configured to receive an analog airflow signal indicative
of respiration effort of the patient from a hardened sensor
interface of the closed loop neuromodulator and to provide the
analog airflow signal to the PSG interface.
7. The interface of claim 1, including digital airflow signal
buffer coupled to an exhalation LED driver of the plurality of LED
drivers, the digital airflow signal buffer configured to receive a
digital airflow signal indicative of a respiration state of the
patient from a hardened sensor interface of the closed loop
neuromodulator, wherein the exhalation LED driver is configured to
illuminate an exhalation LED when the digital airflow signal is
indicative of an exhalation respiration state of the patient.
8. The interface of claim 1, including an activity signal buffer
coupled to a sleep disorder LED driver of the plurality of LED
drivers, the activity signal buffer configured to receive an
activity signal indicative of abnormal respiration activity from an
activity detector of the closed loop neuromodulator, wherein the
sleep disorder LED driver is configured to illuminate a sleep
disorder LED when the activity signal is indicative of abnormal
respiration activity.
9. The interface of claim 1, including an activity signal buffer
coupled to an apnea LED driver of the plurality of LED drivers, the
activity signal buffer configured to receive an activity signal
indicative of abnormal respiration activity from an activity
detector of the closed loop neuromodulator, wherein the apnea LED
driver is configured to illuminate an apnea LED when the activity
signal is indicative of apnea.
10. A system for providing diagnostic information from a closed
loop neuromodulator, configured to provide sleep therapy for a
patient, to a user or a polysomnograph (PSG), the system
comprising: a sensor configured to detect information indicative of
respiration from a patient; the closed loop neuromodulator
configured to optimize sleep therapy for the patient, the closed
loop neuromodulator including: a closed loop neuromodulator
interface for monitoring operation of a closed loop neuromodulator
configured to provide sleep therapy to a patient, the interface
including: a diagnostic indicator register coupled to a data bus of
the closed loop neuromodulator, the diagnostic indicator register
configured to receive a first portion of the diagnostic information
and to switch an LED driver of a plurality of LED drivers in
response to the first portion of the diagnostic information; a PSG
interface configured to receive a second portion of the diagnostic
information and to provide the second portion of the diagnostic
information to the PSG for display to a user; a stimulus signal
buffer coupled to the PSG interface, the stimulus signal buffer
configured to receive a stimulus signal, indicative of the sleep
therapy, from a stimulus generator of the closed loop
neuromodulator and to provide the stimulus signal to the PSG
interface; a driver signal buffer coupled to the PSG interface, the
driver signal buffer configured to receive a driver signal from a
stimulus escalator of the closed loop neuromodulator and to provide
the driver signal to the PSG interface; an analog airflow signal
buffer coupled to the PSG interface, the analog airflow signal
interface configured to receive an analog airflow signal indicative
of respiration effort of the patient from a hardened sensor
interface of the closed loop neuromodulator and to provide the
analog airflow signal to the PSG interface; a digital airflow
signal buffer coupled to an inhalation LED driver of the plurality
of LED drivers and a exhalation LED driver of the plurality of LED
drivers, the digital airflow signal buffer configured to receive a
digital airflow signal indicative of a respiration state of the
patient from a hardened sensor interface of the closed loop
neuromodulator; an activity signal buffer coupled to a sleep
disorder LED driver of the plurality of LED drivers, the activity
signal buffer configured to receive an activity signal indicative
of abnormal respiration activity from an activity detector of the
closed loop neural modulator; wherein the inhalation LED driver is
configured to illuminate an inhalation LED when the digital airflow
signal is indicative of an inhalation respiration state of the
patient; wherein the exhalation LED driver is configured to
illuminate an exhalation LED when the digital airflow signal is
indicative of an exhalation respiration state of the patient; and
wherein the sleep disorder LED driver is configured to illuminate a
sleep disorder LED when the activity signal is indicative of
abnormal respiration activity; wherein the closed loop
neuromodulator is configured to receive respiration information
from the sensor, to detect a sleep disorder event using respiration
information, and to provide a first stimulus to a transducer in
response to the detected sleep disorder event, the first stimulus
configured to not interrupt the detected sleep disorder event;
wherein the closed loop neuromodulator is configured to provide,
following the first stimulus, a second stimulus to the transducer
in response to the detected sleep disorder event, the second
stimulus having more energy than the first stimulus and configured
to interrupt the detected sleep disorder event; and wherein the
transducer is configured to deliver the first and second stimuli to
the patient.
11. The system of claim 10, wherein the sensor includes at least
one of a thermocouple, a thermistor, an air pressure transducer, an
electrode, a respiratory effort belt, or a pyro/piezoelectric
sensor.
12. The system of claim 10, wherein the transducer includes at
least one of an acoustic transducer, a tactile mechanical agitator,
an ocular stimulator, an electrical stimulator, a thermal
stimulator, or an ultrasonic stimulator configured to modulate an
audible signal onto an ultrasonic sound carrier.
13. A method for providing diagnostic information from a closed
loop neuromodulator, configured to provide sleep therapy for a
patient, to a user or a polysomnograph (PSG), the method
comprising: receiving a first portion of the diagnostic information
at a diagnostic indicator register of the closed loop
neuromodulator; switching an LED driver of a plurality of LED
drivers using the first portion of the diagnostic information;
receiving a second portion of the diagnostic information at a PSG
interface of the closed loop neuromodulator; and providing the
second portion of the diagnostic information to the PSG for
display.
14. The method of claim 13, including receiving a stimulus signal
indicative of the sleep therapy from a stimulus generator of the
closed loop neuromodulator at a stimulus signal buffer; and
providing the stimulus signal to the PSG using the PSG
interface.
15. The method of claim 13, including receiving a driver signal
from a stimulus escalator of the closed loop neuromodulator at a
driver signal buffer; and providing the driver signal to the PSG
interface using the PSG interface.
16. The method of claim 13, including receiving an analog airflow
signal indicative of respiration effort of the patient from a
hardened sensor interface of the closed loop neuromodulator; and
providing the analog airflow signal to the PSG using the PSG
interface.
17. The method of claim 13, including receiving a digital airflow
signal indicative of a respiration state of the patient from a
hardened sensor interface of the closed loop neuromodulator at a
digital airflow signal buffer; and illuminating an inhalation LED
when the digital airflow signal is indicative of an inhalation
respiration state of the patient.
18. The method of claim 17, including: detecting a sleep disorder
event using the digital airflow signal; and providing sleep therapy
to the patient in response to the detected sleep disorder
signal.
19. The method of claim 18, wherein the providing sleep therapy
includes: providing a first stimulus to the patient in response to
the detected sleep disorder event, the first stimulus configured to
not interrupt the first sleep disorder event; and providing,
following the first stimulus, a second stimulus to the patient in
response to the detected sleep disorder event, the second stimulus
having more energy than the first stimulus and configured to
interrupt the detected sleep disorder event.
20. The method of claim 12, including receiving an activity signal
indicative of abnormal respiration activity from an activity
detector of the closed loop neural modulator, and illuminating a
sleep disorder LED when the activity signal is indicative of
abnormal respiration activity.
Description
PRIORITY AND RELATED APPLICATIONS
[0001] This application claims the benefit under 35 U.S.C 119(e) of
the following United States Provisional Patent Applications, the
contents of which are incorporated herein by reference in their
entirety: U.S. Provisional Patent Application Ser. No. 61/090,966
filed Aug. 22, 2008, U.S. Provisional Patent Application Ser. No.
61/090,968 filed Aug. 22, 2008, U.S. Provisional Patent Application
Ser. No. 61/091,118 filed Aug. 22, 2008, U.S. Provisional Patent
Application Ser. No. 61/091,112 filed Aug. 22, 2008, U.S.
Provisional Patent Application Ser. No. 61/091,105 filed Aug. 22,
2008, U.S. Provisional Patent Application Ser. No. 61/091,101 filed
Aug. 22, 2008, U.S. Provisional Patent Application Ser. No.
61/091,099 filed Aug. 22, 2008, U.S. Provisional Patent Application
Ser. No. 61/091,094 filed Aug. 22, 2008, U.S. Provisional Patent
Application Ser. No. 61/091,087 filed Aug. 22, 2008, U.S.
Provisional Patent Application Ser. No. 61/091,082 filed Aug. 22,
2008, U.S. Provisional Patent Application Ser. No. 61/091,078 filed
Aug. 22, 2008, and U.S. Provisional Patent Application Ser. No.
61/091,074 filed Aug. 22, 2008.
TECHNICAL FIELD
[0002] The present subject matter relates generally to sleep
therapy and more specifically to a diagnostic indicator and PSG
interface for a closed loop neuromodulator.
BACKGROUND
[0003] Sleep disorders have recently become the focus of a growing
number of physicians. Sleep disorders include obstructive sleep
apnea, central sleep apnea, complex sleep apnea, snoring, restless
leg syndrome (RLS), periodic limb movement (PLM), sudden infant
death syndrome (SIDS), and related neurological and physiological
events or conditions occurring during sleep. Many hospitals and
clinics have established sleep laboratories (sleep labs) to
diagnose and treat sleep disorders. In the sleep laboratories,
practitioners use instrumentation to monitor and record a patient's
sleep states, stages and behaviors during sleep. Practitioners rely
on these recordings to diagnose patients and prescribe proper
therapies.
[0004] A goal of addressing sleep disorders is to help a person
sleep better. Another goal of addressing sleep disorders is to help
a person live longer. It is well known that various undesirable
behaviors often occur during sleep such as snoring, apneas,
abnormal breathing, Bruxism (teeth clenching and grinding) and the
like. It is further known that these disorders and other
undesirable behaviors can not only lead to insufficient amounts of
sleep or fatigue but are also linked to co-morbidities such as
obesity, diabetes, hypertension, cardiac diseases, stroke and SIDS,
all of which can lead to a pre-mature death. Serious efforts are
being made to reduce or eliminate these undesirable disorders and
behaviors in part because of these co-morbidity concerns.
[0005] Various stimulation controllers/systems are available in the
art for altering undesirable behavior during sleep. These
controllers/systems may be used to control a stimulation device.
U.S. Pat. No. 5,540,733 to Testerman et al. discloses "[a] method
for treating obstructive sleep apnea in a patient by electrical
stimulation of muscles in the upper airway." In U.S. Pat. No.
7,115,097 to Johnson, "[a] notification system monitors changes in
air flow channeled between a positive air pressure generator and a
CPAP mask supplying positive airway pressure to a patient during
treatment of sleep apnea." In U.S. Pat. No. 6,544,199 to Morris,
"[a] system is provided for monitoring an undesired behavioral
disorder such as Bruxism, jaw clenching, or snoring." In another
example, U.S. Patent Publication No. US2006/0145878 to Lehrman et
al. discloses "[a] System and method for treating obstructive sleep
apnea by terminating an obstructive sleep apnea event before the
cessation of breathing occurs."
[0006] It is well known that several states of sleep exist and
involve varying levels of consciousness. It is further well known
that the beneficial effects of sleep improve when it is
uninterrupted. To the extent that the above controllers/systems and
associated stimulation devices alter a patient's sleep state or in
a worst-case scenario actually awaken a patient, the devices have
gone too far. While they may have stopped the undesirable behavior,
they have neither helped a person sleep better nor have they helped
a person to live longer.
SUMMARY
[0007] There is a need to provide an apparatus and method that
controls the stimulation of the central nervous system sufficiently
to interrupt an undesirable neurological and/or sleep behavior by a
means universally sensed by most patients where the device avoids
significantly changing sleep states and certainly avoids waking a
patient.
[0008] With the present subject matter, sleep therapy devices may
be used in the absence of sleep lab personnel and practitioners who
often make the adjustments to the devices on an ongoing basis.
These adjustments include the initial patient setup, the intensity
of stimulation, and the type of stimulation. Additional adjustment
is necessary when the type of stimulation is varied to assure that
the controlling device is correctly configured. Certain
optimization adjustments are also made by practitioners. Thus,
there is a need for an apparatus and method that automatically and
autonomously optimizes its operation, as discussed in more detail
below, so that there is no need for periodic patient or physician
intervention.
[0009] The initial setup of the patient involves configuring the
device based on an assessment of the patient with regard to the
neurological and physiological condition of the patient. This
process is somewhat of a big picture accuracy adjustment that makes
sure the device is configured to properly address the correct sleep
disorder taking into consideration the physical attributes and
condition of the patient. In the absence of a practitioner, there
is a need for a device with automatic and autonomous setup
capabilities so the device can be correctly configured at the
outset of treatment and begin to properly treat the patient.
[0010] A better understanding of the present subject matter may be
gained from the following discussion regarding the adjustments
relating to the intensity and type of stimulation. If the types of
stimuli are applied with the same intensity, timing and duration on
a repeated basis, there is a natural tendency to become habituated
to them and then there is no reasonable assurance that the next
stimulus is going to be effective to cause the patient to start
resuming normal respiration. In a similar fashion, if the same type
of stimulus is repeatedly applied, there is also a tendency to
become habituated. In light of the precision needed in treating
patients to avoid cortical arousal, there is a need to
periodically, frequently or constantly vary the stimuli intensity
and type in order for the stimuli to be noticed by the patient's
central nervous system. In the absence of a practitioner, there is
a need for the device to provide auto-adjusting, auto-optimizing
and auto-dosing.
[0011] As different types of stimuli are used in sleep labs and in
patient's homes, practitioners may use different controllers for
different stimuli. Where a single controller is used, adjustments
assure proper signals are sent to the stimulating device. As
discussed above, in the absence of a practitioner, there is a need
for auto-optimizing and thus a need for a device to be able to vary
the stimuli provided. As such, there is also a need for a
controller that is auto-adjusting so that the controller
automatically adjusts for the different types and sensitivities of
sensors and transducers that are being connected to a closed loop
neuromodulator.
[0012] As also mentioned, practitioners often make certain
optimizing adjustments to a controller to optimize the treatment
being provided. In the absence of a practitioner, there is also a
need for an apparatus and method that is auto-optimizing so that
the controller automatically and immediately optimizes the
application of therapy when physiological patient conditions change
from day-to-day or between applications of individual therapies
during each night sleep or session.
[0013] As sleep therapy devices continue to be used in the homes of
patients, issues of "electronic smog" and electrostatic shock
become a concern as patients handle and wear the devices,
especially in dry climates and during the winter. Additionally,
there is an increasing use of wireless technology such as wireless
telephone transmissions, wireless routers, cordless phone systems,
remote control burglar alarm devices, remote control toys, etc that
could interfere with a sleep therapy device. Thus, there is also a
need to provide an apparatus that is electronically hardened
against the electronically harsh and hostile environments often
encountered in modern life, modern homes and modern sleeping
environments.
[0014] Additionally, patients' homes and sleeping environments are
non-controlled environments. In a sleep lab or clinic, the same
stimulus may be applied. In a home environment the sleeping patient
may be subjected to external stimulus, passing trains, noisy bugs
and kids, TV running while sleeping, snoring bed partner, noisy
neighbors, honking cars, conversations by non sleeping people, high
speed trains, car traffic, etc. the possibilities for sleeping
patient arousal are countless. In certain predictable environments,
the patents' central nervous system (CNS) has already gotten used
to certain stimulus and has learned over time to tune them out
consciously and subconsciously. However, other stimulus, both
intermittent and chronic stimulus, are difficult to overcome
including changes in individual patients based on physiology,
mental state (mood etc), sensitivity to air pressure and other
atmospheric parameters, sickness, disease, room decorations and
bedding (sound dampening measures make the room quieter thus one
can hear the stimulus better), time of day, season (people with
allergies and hay fever will have different sensitivities to the
stimulus dosages depending on their level of allergies or hay
fever), noisy bed partners . . . etc.
[0015] A robust dosage optimization system works reliably and
repeatedly on different patients, with different patient
conditions, different moods, sickness, disease, different
environments, time of day, locations (on average, the city of New
York is louder than the city of Bismarck, N. Dak. and the device
and the invention has to work equally well in either city), and
over many years of use, preferably the entire lifespan of a human
being once they start treatment using this apparatus and
method.
[0016] Subjects that have an influence on patient's needs to,
current and immediate dosing requirements:
[0017] Environmental (sound, noise, etc)
[0018] Health (disease, sickness, disability, etc)
[0019] Physical condition (earwax in the ear canal, stress,
etc)
[0020] Physiological (hearing loss, etc)
[0021] Neurological (tinnitus, fibromyalgia, etc)
[0022] Seasonal (allergies, seasonal noise, etc)
[0023] Atmospheric (pressure, heat, humidity, etc)
[0024] Thus, there is a need for an apparatus and method that is
capable of periodically, constantly and prescriptively changing
(varying) an applied stimulus to interrupt a sleep disorder event.
For example changing a stimulus type, stimulus level, stimulus
rate, stimulus duration, stimulus sequence, level escalation, rate
escalation duration escalation, or combination thereof.
[0025] There is a need to provide an apparatus and method to
further ensure patient compliance with physicians prescribed
treatments.
[0026] There is a need to provide an apparatus and method that
controls the stimulation of the central nervous system sufficiently
to interrupt an undesirable neurological and/or sleep behavior by a
means universally sensed by most patients where the device avoids
significantly changing sleep states and certainly avoids waking a
patient. There is a need in the art to provide precise dosing of
patients.
[0027] There is a need to provide an apparatus and method that
controls the stimulation of the central nervous system sufficiently
to interrupt an undesirable neurological and/or sleep behavior by a
means universally sensed by most patients where the device avoids
significantly changing sleep states and certainly avoids waking a
patient.
[0028] There is a need to provide an apparatus that is capable of
being used with a wide range of transducers. Additionally, there is
a need for this device to be protected against electronically
hostile environments involving EMI and ESD commonly found in
homes.
[0029] There is a need to provide an apparatus and method that
controls the stimulation of the central nervous system sufficiently
to interrupt an undesirable neurological and/or sleep behavior by a
means universally sensed by most patients where the device avoids
significantly changing sleep states and certainly avoids waking a
patient.
[0030] Also, as sleep therapy becomes more common, the devices used
to treat it are beginning to extend beyond use in sleep labs and
are often used right in a patient's own home. The sleep therapy
devices are thus used in the absence of sleep lab personnel and
practitioners who can read and interpret the device. Thus, there is
a need for a device that indicates the input it is receiving, the
functions it is performing, and the output it is transmitting.
Moreover, devices that are used in homes may need to be initially
set to function properly for given patient parameters. In these
situations, a practitioner may need to use a sleep device in
conjunction with a more sophisticated polysomnograph machine (PSG)
in order to ensure that it is properly set. Thus, there is a need
for the device to be compatible with a polysomnograph machine.
[0031] There is a need to provide an apparatus and method that
controls the stimulation of the central nervous system sufficiently
to interrupt an undesirable neurological and/or sleep behavior by a
means universally sensed by most patients where the device avoids
significantly changing sleep states and certainly avoids waking a
patient.
[0032] Also, as sleep therapy becomes more common, the devices used
to treat it are beginning to extend beyond use in sleep labs and
are often used right in a patient's own home. The sleep therapy
devices are thus used in the absence of sleep lab personnel and
practitioners who often make the adjustments to the devices on an
ongoing basis. Thus, there is a need in the art for a device that
can properly operate and control a closed loop neuromodulator.
[0033] Finally, there is a need to provide an apparatus that is
comfortable to wear, easy to set-up, and simple to use to further
its ability to avoid alteration of sleep states.
[0034] Certain embodiments of the present subject matter provide a
closed loop neuromodulator that by means of detecting the presence
or absence of certain biological sensor signals provides
dynamically and precisely dosed stimulation of the central nervous
system in general and to the human central nervous system in
specific by means of immediate biological feedback and appropriate
stimulation of one or more of the five human senses.
[0035] In one embodiment, a closed loop neuromodulator includes an
EMI/ESD hardened sensor interface, an activity detector, a stimulus
timer, a stimulus escalator a stimulus generator, a stimulus
sequencer, and an EMI/ESD hardened transducer driver.
[0036] In one embodiment, a method for dosage optimization in a
closed loop neuromodulator includes monitoring a patient for an
activity indicating a sleep disorder, applying a first stimulus
based on a stored stimulus parameter to a patient once a sleep
disorder is detected, rechecking the patient for continued activity
indicating a sleep disorder, determining if the stimulus was an
over stimulation or an under stimulation, and decreasing,
increasing, or maintaining the stimulus parameter.
[0037] In another embodiment, determining whether the stimulus was
an over stimulation or an under stimulation includes querying
whether the patient has continued activity and if not, whether the
stimulus was a first stimulus. In another embodiment, the method
includes decreasing the stimulus parameter when the stimulus was an
over stimulus and recording and storing a new stimulus parameter.
In yet another embodiment, the method includes increasing the
stimulus parameter when the stimulus was an under stimulus and
recording and storing a new stimulus parameter. In still another
embodiment, the method includes bypassing the increasing or
decreasing of the stimulus parameter when the stimulus was an
optimal stimulus.
[0038] In another embodiment, a diagnostic method of use of a
stimulation controller includes connecting a closed loop
neuromodulator to a patient, connecting a PSG machine to the
stimulation controller, connecting a remote terminal to the
stimulation controller, receiving information regarding the patient
and the controller from a diagnostic interface and a PSG machine,
and adjusting the parameters of the closed loop neuromodulator to
optimize the controller for stimulating a patient or range of
patients.
[0039] In another embodiment, a therapeutic method of use of a
stimulation controller includes connecting a closed loop
neuromodulator to a patient wherein the controller auto-adjusts and
proceeds to optimize dosage based on a limited range of available
parameters provided by a sleep professional.
[0040] In one embodiment, a virtual device development system like
National Instruments CompactRIO running code that has been
developed using National Instruments LabVIEW virtual development
system including the wire terminations for the sensor and for the
transducer is provided.
[0041] In another embodiment, a field programmable gate array
(FPGA) with an internal processor, read-only memory (ROM), random
access memory (RAM), reset management, an oscillator, an
analog-to-digital converter, a digital-to-analog converter,
configuration string, and wire terminals for the sensor and for the
transducer is provided.
[0042] In another embodiment, a mixed signal micro controller like
one of the ColdFire product line available from Freescale
Semiconductors is executing code, command and algorithms developed
with an appropriate software compiler is provided.
[0043] In another embodiment, a discrete circuit assembly
consisting of a printed circuit board (PCB) populated with
electronic components including the wire terminations for the
sensor and for the transducer is provided.
[0044] In another embodiment, software residing inside a personal
computer (PC) is executing code, command and algorithms developed
with an appropriate software development system like C, C+ or C++,
with an attached data acquisition system including the wire
terminations for the sensor and for the transducer are
provided.
[0045] In another embodiment, a custom integrated circuit like the
one that is available from semiconductor houses is executing code,
commands and algorithms developed on a silicon computer aided
design (CAD) platform including the wire terminations for the
sensor and for the transducer is provided.
[0046] In Example 1, a closed loop neuromodulator interface for
providing diagnostic information from a closed loop neuromodulator,
configured to provide sleep therapy for a patient, to a user or a
polysomnograph (PSG) can include a diagnostic indicator register
coupled to a data bus of the closed loop neuromodulator, the
diagnostic indicator register configured to receive a first portion
of the diagnostic information and to switch an LED driver of a
plurality of LED drivers in response to the first portion of the
diagnostic information, and a PSG interface configured to receive a
second portion of the diagnostic information and to provide the
second portion of the diagnostic information to the PSG.
[0047] In Example 2, the interface of Example I optionally includes
a digital airflow buffer coupled to an inhalation LED driver of the
plurality of LED drivers, the digital airflow buffer configured to
receive a digital airflow signal indicative of a respiration state
of the patient from a hardened sensor interface of the closed loop
neuromodulator, and the inhalation LED driver of Example I is
optionally configured to illuminate an inhalation LED when the
digital airflow signal is indicative of an inhalation respiration
state of the patient.
[0048] In Example 3, the closed loop neuromodulator of any one or
more of Examples 1-2 is optionally configured to detect a sleep
related disorder using the digital airflow signal and to provide a
first stimulus to the patient in response to the detected sleep
disorder event, the first stimulus configured to not interrupt the
detected sleep disorder event, and the closed loop neuromodulator
is optionally configured to provide, following the first stimulus,
a second stimulus to the patient in response to the detected sleep
disorder event, the second stimulus having more energy than the
first stimulus and configured to interrupt the detected sleep
disorder event.
[0049] In Example 4, the interface of any one or more of Examples
1-3 optionally includes a stimulus signal buffer coupled to the PSG
interface, the stimulus signal buffer configured to receive a
stimulus signal, indicative of the sleep therapy, from a stimulus
generator of the closed loop neuromodulator and to provide the
stimulus signal to the PSG interface.
[0050] In Example 5, the interface of any one or more of Examples
1-4 optionally includes a driver signal buffer coupled to the PSG
interface, the driver signal buffer configured to receive a driver
signal from a stimulus escalator of the closed loop neuromodulator
and to provide the driver signal to the PSG interface.
[0051] In Example 6, the interface of any one or more of Examples
1-5 optionally includes an analog airflow signal buffer coupled to
the PSG interface, the analog airflow signal interface configured
to receive an analog airflow signal indicative of respiration
effort of the patient from a hardened sensor interface of the
closed loop neuromodulator and to provide the analog airflow signal
to the PSG interface.
[0052] In Example 7, the interface of any one or more of Examples
1-6 optionally includes a digital airflow signal buffer coupled to
an exhalation LED driver of the plurality of LED drivers, the
digital airflow signal buffer configured to receive a digital
airflow signal indicative of a respiration state of the patient
from a hardened sensor interface of the closed loop neuromodulator,
wherein the exhalation LED driver is configured to illuminate an
exhalation LED when the digital airflow signal is indicative of an
exhalation respiration state of the patient.
[0053] In Example 8, the interface of any one or more of Examples
1-7 optionally includes an activity signal buffer coupled to a
sleep disorder LED driver of the plurality of LED drivers, the
activity signal buffer configured to receive an activity signal
indicative of abnormal respiration activity from an activity
detector of the closed loop neuromodulator, wherein the sleep
disorder LED driver is configured to illuminate a sleep disorder
LED when the activity signal is indicative of abnormal respiration
activity.
[0054] In Example 9, the interface of any one or more of Examples
1-8 optionally includes an activity signal buffer coupled to an
apnea LED driver of the plurality of LED drivers, the activity
signal buffer configured to receive an activity signal indicative
of abnormal respiration activity from an activity detector of the
closed loop neuromodulator, wherein the apnea LED driver is
configured to illuminate an apnea LED when the activity signal is
indicative of apnea.
[0055] In Example 10, a system, for providing diagnostic
information from a closed loop neuromodulator, configured to
provide sleep therapy for a patient, to a user or a polysomnograph
(PSG), of any one or more of Examples 1-9 optionally includes a
sensor configured to detect information indicative of respiration
from a patient, the closed loop neuromodulator configured to
optimize sleep therapy for the patient, the closed loop
neuromodulator including a closed loop neuromodulator interface for
monitoring operation of a closed loop neuromodulator configured to
provide sleep therapy to a patient, the interface including a
diagnostic indicator register coupled to a data bus of the closed
loop neuromodulator, the diagnostic indicator register configured
to receive a first portion of the diagnostic information and to
switch an LED driver of a plurality of LED drivers in response to
the first portion of the diagnostic information, a PSG interface
configured to receive a second portion of the diagnostic
information and to provide the second portion of the diagnostic
information to the PSG for display to a user, a stimulus signal
buffer coupled to the PSG interface, the stimulus signal buffer
configured to receive a stimulus signal, indicative of the sleep
therapy, from a stimulus generator of the closed loop
neuromodulator and to provide the stimulus signal to the PSG
interface, a driver signal buffer coupled to the PSG interface, the
driver signal buffer configured to receive a driver signal from a
stimulus escalator of the closed loop neuromodulator and to provide
the driver signal to the PSG interface, an analog airflow signal
buffer coupled to the PSG interface, the analog airflow signal
interface configured to receive an analog airflow signal indicative
of respiration effort of the patient from a hardened sensor
interface of the closed loop neuromodulator and to provide the
analog airflow signal to the PSG interface, a digital airflow
signal buffer coupled to an inhalation LED driver of the plurality
of LED drivers and a exhalation LED driver of the plurality of LED
drivers, the digital airflow signal buffer configured to receive a
digital airflow signal indicative of a respiration state of the
patient from a hardened sensor interface of the closed loop
neuromodulator, an activity signal buffer coupled to a sleep
disorder LED driver of the plurality of LED drivers, the activity
signal buffer configured to receive an activity signal indicative
of abnormal respiration activity from an activity detector of the
closed loop neural modulator, wherein the inhalation LED driver is
configured to illuminate an inhalation LED when the digital airflow
signal is indicative of an inhalation respiration state of the
patient, wherein the exhalation LED driver is configured to
illuminate an exhalation LED when the digital airflow signal is
indicative of an exhalation respiration state of the patient, and
wherein the sleep disorder LED driver is configured to illuminate a
sleep disorder LED when the activity signal is indicative of
abnormal respiration activity, wherein the closed loop
neuromodulator is configured to receive respiration information
from the sensor, to detect a sleep disorder event using respiration
information, and to provide a first stimulus to a transducer in
response to the detected sleep disorder event, the first stimulus
configured to not interrupt the detected sleep disorder event,
wherein the closed loop neuromodulator is configured to provide,
following the first stimulus, a second stimulus to the transducer
in response to the detected sleep disorder event, the second
stimulus having more energy than the first stimulus and configured
to interrupt the detected sleep disorder event, and wherein the
transducer is configured to deliver the first and second stimuli to
the patient.
[0056] In Example 11, the sensor of any one or more of Examples
1-10 optionally includes at least one of a thermocouple, a
thermistor, an air pressure transducer, an, electrode, a
respiratory effort belt, or a pyro/piezoelectric sensor.
[0057] In Example 12, the transducer of any one or more of Examples
1-11 optionally includes at least one of an acoustic transducer, a
tactile mechanical agitator, an ocular stimulator, an electrical
stimulator, a thermal stimulator, or an ultrasonic stimulator
configured to modulate an audible signal onto an ultrasonic sound
carrier.
[0058] In Example 13, a method for providing diagnostic information
from a closed loop neuromodulator, configured to provide sleep
therapy for a patient, to a user or a polysomnograph (PSG), of any
one or more of Examples 1-12 optionally includes receiving a first
portion of the diagnostic information at a diagnostic indicator
register of the closed loop neuromodulator, switching an LED driver
of a plurality of LED drivers using the first portion of the
diagnostic information, receiving a second portion of the
diagnostic information at a PSG interface of the closed loop
neuromodulator, and providing the second portion of the diagnostic
information to the PSG for display.
[0059] In Example 14, the method of any one or more of Examples
1-13 optionally includes receiving a stimulus signal indicative of
the sleep therapy from a stimulus generator of the closed loop
neuromodulator at a stimulus signal buffer, and providing the
stimulus signal to the PSG using the PSG interface.
[0060] In Example 15, the method of any one or more of Examples
1-14 optionally includes receiving a driver signal from a stimulus
escalator of the closed loop neuromodulator at a driver signal
buffer, and providing the driver signal to the PSG interface using
the PSG interface.
[0061] In Example 16, the method of any one or more of Examples
1-15 optionally includes receiving an analog airflow signal
indicative of respiration effort of the patient from a hardened
sensor interface of the closed loop neuromodulator, and providing
the analog airflow signal to the PSG using the PSG interface.
[0062] In Example 17, the method of any one or more of Examples
1-16 optionally includes receiving a digital airflow signal
indicative of a respiration state of the patient from a hardened
sensor interface of the closed loop neuromodulator at a digital
airflow signal buffer and illuminating an inhalation LED when the
digital airflow signal is indicative of an inhalation respiration
state of the patient.
[0063] In Example 18, the method of any one or more of Examples
1-17 optionally includes detecting a sleep disorder event using the
digital airflow signal and providing sleep therapy to the patient
in response to the detected sleep disorder signal.
[0064] In Example 19, the providing sleep therapy of any one or
more of Examples 1-2 optionally includes:providing a first stimulus
to the patient in response to the detected sleep disorder event,
the first stimulus configured to not interrupt the first sleep
disorder event and providing, following the first stimulus, a
second stimulus to the patient in response to the detected sleep
disorder event, the second stimulus having more energy than the
first stimulus and configured to interrupt the detected sleep
disorder event.
[0065] In Example 20, the method of any one or more of Examples
1-19 optionally includes receiving an activity signal indicative of
abnormal respiration activity from an activity detector of the
closed loop neural modulator and illuminating a sleep disorder LED
when the activity signal is indicative of abnormal respiration
activity.
[0066] Auto adjusting is the method by which the apparatus
automatically and autonomously adjusts itself to the patient and to
different sensor and transducer sensitivities.
[0067] Auto optimizing is the method by which the apparatus
automatically and constantly optimizes its operation constantly
during operation to the immediate and sometimes different patient
conditions.
[0068] Auto dosing is the method by which the apparatus
automatically and autonomously doses the right amount of
therapeutic stimuli according to the needs of the individual
patient for optimal comfort and performance.
[0069] The apparatus issues specific doses and types of stimuli to
the patient until the resumption of breathing has been
detected.
[0070] A neuromodulator includes a controller that applies stimuli
and where a patient's central nervous system forms a feedback loop
to assist in the modulation or adjustment of the stimuli.
[0071] While the present disclosure is directed toward treatment of
sleep disorders, further areas of applicability will become
apparent from the description provided herein. It should be
understood that the description and specific examples are intended
for purposes of illustration only and are not intended to limit the
scope of the present disclosure.
BREIF DESCRIPTION OF THE DRAWINGS
[0072] The forgoing features, objects and advantages of the
invention will become apparent to those skilled in the art from the
following detailed description, especially when considered in
conjunction with the accompanying drawings in which like the
numerals in the several views refer to the corresponding parts:
[0073] FIG. 1A is a configuration diagram of a sleep diagnostic
closed loop neuromodulator in place on a sleep patient according to
one example of the present subject matter.
[0074] FIG. 1B is a configuration diagram of a sleep therapy closed
loop neuromodulator in place on a sleep patient according to one
example of the present subject matter.
[0075] FIG. 2A illustrates generally an electrical block diagram of
a sleep diagnostic closed loop neuromodulator.
[0076] FIG. 2B is an electrical block diagram of the sleep therapy
closed loop neuromodulator according to one example of the present
subject matter.
[0077] FIG. 3A illustrates generally an electrical block diagram of
an EMI/ESD Hardened Sensor Interface.
[0078] FIG. 3B is a detailed electrical block diagram of an EMI/ESD
Hardened Sensor Interface according to one example of the present
subject matter.
[0079] FIG. 3C is an electrical schematic diagram of an EMI/ESD
Hardened Sensor Interface according to one example of the present
subject matter.
[0080] FIG. 3D is an electrical timing diagram of an analog to
digital conversion of an airflow sensor signal by an EMI/ESD
Hardened Sensor Interface.
[0081] FIG. 4A illustrates generally an electrical block diagram of
an Activity Detector.
[0082] FIG. 4B is a detailed electrical block diagram of an
Activity Detector according to one example of the present subject
matter.
[0083] FIG. 4C is a timing diagram of an apnea detection of an
Activity Detector according to one example of the present subject
matter.
[0084] FIG. 5A illustrates generally an electrical block diagram of
a Stimulus Timer.
[0085] FIG. 5B is a detailed electrical block diagram of a Stimulus
Timer according to one example of the present subject matter.
[0086] FIG. 6A illustrates generally an electrical block diagram of
a Stimulus Sequencer.
[0087] FIG. 6B is a detailed electrical block diagram of a Stimulus
Sequencer according to one example of the present subject
matter.
[0088] FIG. 6C is timing diagram of various Stimulus generator
sequences of a Stimulus Sequencer according to one example of the
present subject matter.
[0089] FIG. 7A illustrates generally an electrical block diagram of
a Stimulus Generator.
[0090] FIG. 7B is a detailed electrical block diagram of a Stimulus
Generator according to one example of the present subject
matter.
[0091] FIG. 8A illustrates generally an electrical block diagram of
a Stimulus Escalator.
[0092] FIG. 8B is a detailed electrical block diagram of a Stimulus
Escalator according to one example of the present subject
matter.
[0093] FIG. 9A illustrates generally an electrical block diagram of
an EMI/ESD Hardened Transducer Driver.
[0094] FIG. 9B is a detailed electrical block diagram of an EMI/ESD
Hardened Transducer Driver according to one example of the present
subject matter.
[0095] FIG. 9C is an electrical schematic diagram of an EMI/ESD
Hardened Transducer Driver.
[0096] FIG. 10A illustrates generally an electrical block diagram
of a Diagnostic Indicators and PSG Interface.
[0097] FIG. 10B is an detailed electrical block diagram of a
Diagnostic Indicators and PSG Interface according to one example of
the present subject matter.
[0098] FIG. 11A illustrates generally an electrical block diagram
of a Device Controller & Data Logger.
[0099] FIG. 11B is detailed electrical block diagram of a Device
Controller & Data Logger according to one example of the
present subject matter.
[0100] FIG. 12A illustrates generally an electrical block diagram
for implementation in a virtual product development platform of a
sleep diagnostic closed loop neuromodulator according to one
example of the present subject matter.
[0101] FIG. 12B illustrates generally an electrical block diagram
for implementation in a Field Programmable Gate Array (FPGA) of a
sleep diagnostic closed loop neuromodulator according to one
example of the present subject matter.
[0102] FIG. 12C illustrates generally an electrical block diagram
for implementation in a Mixed Signal Micro Controller of a sleep
diagnostic closed loop neuromodulator according to one example of
the present subject matter.
[0103] FIG. 12D illustrates generally an electrical block diagram
for implementation in a Custom Integrated Circuit (IC) of a sleep
diagnostic closed loop neuromodulator according to one example of
the present subject matter.
[0104] FIG. 12E illustrates generally an electrical block diagram
for implementation in a Discrete Component Printed Circuit Board
Assembly (PCB) of a sleep diagnostic closed loop neuromodulator
according to one example of the present subject matter.
[0105] FIG. 12F illustrates generally an electrical block diagram
for software based implementation in a Personal Computer of a sleep
diagnostic closed loop neuromodulator according to one example of
the present subject matter.
[0106] FIG. 12G illustrates generally an electrical block diagram
for implementation in a virtual product development platform of a
sleep therapy closed loop neuromodulator according to one example
of the present subject matter.
[0107] FIG. 12H illustrates generally an electrical block diagram
for implementation in a Field Programmable Gate Array (FPGA) of a
sleep therapy closed loop neuromodulator according to one example
of the present subject matter.
[0108] FIG. 12I illustrates generally an electrical block diagram
for implementation in a Mixed Signal Micro Controller of a sleep
therapy closed loop neuromodulator according to one example of the
present subject matter.
[0109] FIG. 12J illustrates generally an electrical block diagram
for implementation in a Custom Integrated Circuit (IC) of a sleep
therapy closed loop neuromodulator according to one example of the
present subject matter.
[0110] FIG. 12K illustrates generally an electrical block diagram
for implementation in a Discrete Component Printed Circuit Board
Assembly (PCB) of a sleep therapy closed loop neuromodulator
according to one example of the present subject matter.
[0111] FIG. 12L illustrates generally an electrical block diagram
for software based implementation in a Personal Computer (PC) of a
sleep therapy closed loop neuromodulator according to one example
of the present subject matter.
[0112] FIG. 13A illustrates generally a diagram depicting the
stimulus parameters of a closed loop neuromodulator.
[0113] FIG. 13B illustrates generally a timing diagram depicting
stimulation timing.
[0114] FIG. 14A illustrates generally a timing diagram depicting
over stimulation.
[0115] FIG. 14B illustrates generally a timing diagram depicting
optimal stimulation.
[0116] FIG. 14C illustrates generally a timing diagram depicting
under stimulation.
[0117] FIG. 15A illustrates generally a timing diagram depicting
stimulus escalation without repeats of the previous stimulus.
[0118] FIG. 15B illustrates generally a timing diagram depicting
stimulus escalation with repeats of the previous stimulus.
[0119] FIG. 16A illustrates generally a diagram depicting stimulus
level optimization.
[0120] FIG. 16B illustrates generally a diagram depicting stimulus
duration optimization.
[0121] FIG. 16C illustrates generally a timing diagram depicting
stimulus rate optimization.
[0122] FIG. 17 is a detailed flow-chart for the Stimulus Dosage
Optimization of the closed loop neuromodulator according to one
example of the present subject matter.
[0123] FIG. 18A is a detailed electrical schematic diagram of the
analog section of a simplified discrete component embodiment of a
closed loop neuromodulator according to one example of the present
subject matter.
[0124] FIG. 18B is a detailed electrical schematic diagram of the
digital section of a simplified discrete component embodiment of a
closed loop neuromodulator according to one example of the present
subject matter.
[0125] FIG. 18C is a detailed electrical schematic diagram of the
level escalation section of a simplified discrete embodiment of a
closed loop neuromodulator according to one example of the present
subject matter.
[0126] FIG. 18D is a detailed electrical schematic diagram of the
power supply section of a simplified discrete component embodiment
of a closed loop neuromodulator according to one example of the
present subject matter.
[0127] FIG. 19 illustrates generally a diagram depicting a
Stimulation Bio-Feedback Loop of a closed loop neuromodulator.
DETAILED DESCRIPTION
[0128] The following detailed description relates to a closed loop
neuromodulator directed toward treating patients with sleep
disorders. The closed loop neuromodulator is more particularly
directed at stimulating a patient to interrupt and terminate an
undesired sleep behavior or condition such as snoring, obstructive
sleep apnea, central sleep apnea, complex sleep apnea, snoring,
restless leg syndrome (RLS), periodic limb movement (PLM), Bruxism
(teeth grinding and clenching), sudden infant death syndrome (SIDS)
and other neurological disorders not necessarily related to sleep.
The closed loop neuromodulator may be used in conjunction with a
sensor and a transducer affixed to a patient. The sensor transmits
respiratory information to the closed loop neuromodulator that
analyzes the information, adjusts to the patient during a first
use, applies a proper and precise stimulation type and dosage, and
optimizes its operation and transducer output dosing depending on
the past and present sensor information received. The dosage may be
adjusted based on at least the following parameters: 1. Stimulus
Type, 2. Stimulus Rate, 3. Stimulus Duration, 4. Stimulus Level, 5.
Stimulus Escalation, 6. Stimulus Sequence.
[0129] The controller counts the amount of applied pulses and
measures the time observed to cause the resumption of breathing in
a sleeping person. The number of pulses and amount of time elapsed
until the resumption of breathing is a direct measure for the
effectiveness of the applied pulse stimuli. The number of pulses,
intensity of stimulation and time observed to cause the resumption
of breathing must be at a minimum in order to obtain optimal
results. When the number of stimuli pulses exceeds a limit, then
the signal level of the new stimuli for the next breathing
cessation event increases automatically. When the number of stimuli
pulses falls below a lower limit, then the signal level of the new
stimuli for the next breathing cessation event reduces
automatically.
[0130] The following detailed description includes discussion of
sensors and transducers affixed to patients. Additionally, elements
of a closed loop neuromodulator are discussed including an
electromagnetic interference/electrostatic discharge (EMI/ESD)
hardened sensor Interface, an Activity Detector, a stimulus timer,
a stimulus escalator; a stimulus generator, a stimulus sequencer,
and an EMI/ESD hardened transducer driver. Information regarding
the waveforms and timing signals received and generated are also
included.
[0131] The present invention can be readily understood from FIGS. 1
through 19.
[0132] FIG. 1A shows an overall use and configuration of a sleep
diagnostic closed loop neuromodulator according to one example of
the present subject matter. A typical sleep diagnostic patient 1
suffering from a sleep disorder has been outfitted with a sensor 2
to measure respiratory effort. A pair of sensor output wire leads 3
connects the sensor to the input of the controller device 4. The
output of the controller 4 connects via a pair of wire leads 5 to
the transducer 6. Another output of the controller 4 connects via a
set of wire leads 7 to a sleep lab PSG machine 8. A remote
diagnostic input/output port of the controller 4 connects via a set
of wire leads 9 to a remote diagnostic terminal 14.
[0133] Preferably, the sensor 2 of FIG. 1A is a piezoelectric
sensor constructed in accordance with the teachings of U.S. Pat.
Nos. 5,311,875 and 6,254,545 to Stasz, the teachings of which are
hereby incorporated by reference as if fully set forth herein.
Those skilled in the art will understand and appreciate that
various sensors are known including, but not limited to
thermocouples, thermistors, air pressure transducers, electrodes
and respiratory plethysmography inductance (RIP) belts and that
these sensors are within the scope of the invention.
[0134] The transducer shown in FIG. 1A is preferably an aural
ear-bud type transducer, a tactile mechanical agitator, an ocular
stimulator, or an ultrasonic stimulator based on modulating an
audible signal onto an ultrasonic sound carrier. For example, the
transducer may be an agitator as described in the U.S. Provisional
Patent Application titled Agitator to Stimulate the Central Nervous
System, filed on May 2, 2008 with Ser. No. 61/049,802, the contents
of which are hereby incorporated by reference herein. Those skilled
in the art will understand and appreciate that various transducers
exist for stimulating central nervous systems and are thus within
the scope of the present invention.
[0135] FIG. 1B shows an overall use and configuration of a sleep
therapy closed loop neuromodulator according to one example of the
present subject matter. A sleep therapy patient 1 suffering from a
sleep disorder has been outfitted with a sensor 2 to measure
respiratory effort. A pair of sensor output wire leads 3 connects
the sensor to the input of the controller device 4. The output of
the controller 4 connects via a pair of wire leads 5 to the
transducer 6.
[0136] Preferably, the sensor 2 of FIG. 1B is a piezoelectric
sensor constructed in accordance with the teachings of U.S. Pat.
Nos. 5,311,875 and 6,254,545 to Stasz, the teachings of which are
hereby incorporated by reference as if fully set forth herein.
Those skilled in the art will understand and appreciate that
various sensors are known including, but not limited to
thermocouples, thermistors, air pressure transducers, electrodes
and respiratory effort belts, pyro/piezoelectric sensors and that
these sensors are within the scope of the invention.
[0137] The transducer shown in FIG. 1B is preferably an aural
ear-bud type transducer, a tactile mechanical agitator, an ocular
stimulator, or an ultrasonic stimulator based on modulating an
audible signal onto an ultrasonic sound carrier. For example, the
transducer may be an agitator as described in the U.S. Provisional
Patent Application titled Agitator to Stimulate the Central Nervous
System, filed on May 2, 2008 with Ser. No. 61/049,802, the contents
of which are hereby incorporated by reference herein. Those skilled
in the art will understand and appreciate that various transducers
exist for stimulating central nervous systems and are thus within
the scope of the present invention.
[0138] Referring to FIG. 2A, there is indicated generally by
numeral 4 a block diagram of the sleep diagnostic closed loop
neuromodulator along with a sensor 2 and a transducer 6. Attached
to the sensor and sleep diagnostic closed loop neuromodulator is a
pair of wire terminations 3 via which the sleep diagnostic closed
loop neuromodulator receives the sensor output. Attached to the
transducer and sleep diagnostic closed loop neuromodulator is a
pair of wire terminations 5 via which the sleep diagnostic closed
loop neuromodulator transmits the transducer input. A sleep lab PSG
machine 8 connects to the controller 4 connects via a set of wire
leads 7. A remote diagnostic terminal 14 connects to the controller
4 via a set of wire leads 9. Furthermore the sleep diagnostic
closed loop neuromodulator indicated generally by numeral 4
contains an EMI/ESD hardened sensor Interface 10, an activity
detector 20, a stimulus timer 30, a stimulus sequencer 40, a
stimulus generator 50, a stimulus escalator 60, an EMI/ESD hardened
transducer driver 70, a diagnostic indicator and PSG interface 80,
and a device controller and data logger 90.
[0139] Referring to FIG. 2B, there is indicated generally by
numeral 4 a block diagram of the sleep therapy closed loop
neuromodulator along with a sensor 2 and a transducer 6. Attached
to the sensor and sleep therapy closed loop neuromodulator is a
pair of wire terminations 3 via which the sleep therapy closed loop
neuromodulator receives the sensor output. Attached to the
transducer and sleep therapy closed loop neuromodulator is a pair
of wire terminations 5 via which the sleep therapy closed loop
neuromodulator transmits the transducer input. Furthermore the
sleep therapy closed loop neuromodulator indicated generally by
numeral 4 contains an EMI/ESD hardened sensor Interface 10, an
activity detector 20, a stimulus timer 30, a stimulus sequencer 40,
a stimulus generator 50, a stimulus escalator 60, an EMI/ESD
hardened transducer driver 70, a diagnostic indicator and PSG
interface 80, and a device controller and data logger 90.
EMI/ESD Hardened Sensor Interface
[0140] Even though most countries have legal requirements that
mandate EMC compliance, electronic devices must still work
correctly when subjected to certain amounts of electromagnetic
interference (EMI), and should not emit EMI, which could interfere
with other equipment. This issue is known in the industry as
self-compatibility and this fact is crucial to the operation of the
invention because of the very low analog biomedical signals
involved.
[0141] A robust sleep therapy system works reliably in a modern
harsh and hostile environment in close proximity to cell phone
transmissions, wireless internet transmitters, wireless phone
system transmitters, etc. Modern environments, even home
environments have high concentration of EMI and RFI especially in
the 60 Hz/120 Hz due to home power wiring and fluorescent, compact
fluorescent lighting and switch mode power supplies operating in
home appliances. Additionally, wireless technology such as wireless
telephone transmissions, wireless routers, cordless phone systems,
remote control burglar alarm devices, remote control toys, and the
like may emit EMI. Issues of self-compatibility are also a concern
and involve minimizing the emission of EMI that could interfere
with other portions of the device or other equipment. Thus, EMI
that could interfere with a sleep device is a concern, but the EMI
emitted by the device is also a concern. ESD hardening protects
sensitive electronics due to common and regular handling of the
product containing the sensitive electronics in a standard home
environment where static discharges are common, especially during
the winter seasons in colder climate zones and during the dry
seasons in warmer climate zones.
[0142] EMI/ESD hardening against the aforementioned offenders not
only satisfies domestic and international requirements on emissions
and susceptibility but also results in robust operation, cleaner
internal signals, improved signal to noise ratio (SNR) and greater
dynamic range.
[0143] In one embodiment, an EMI/ESD hardened sensor interface
includes a sensor input connector, at least one EMI/RFI filter, a
grounded metal shield, an ESD protection device, a supply filtered
balanced signal amplifier, a supply filtered signal filter, and a
supply filtered analog to digital converter.
[0144] In another embodiment, the EMI/ESD hardened sensor interface
the EMI/RFI filter includes an external EMI/RFI filter and an
internal EMI/RFI filter. In another embodiment, the external
EMI/RFI filter is situated along the signal path outside the
grounded metal shield. In yet another embodiment, the internal
EMI/RFI filter is situated along the signal path inside the
grounded metal shield. In yet another embodiment, each of the
elements of the interface are arranged series and the grounded
metal shield encloses the internal EMI/RFI filter, the ESD
protection device, the balanced signal amplifier, the signal
filter, and the analog to digital converter.
[0145] In another embodiment, a method is provided including
sensing a behavior of a patient and filtering, amplifying, and
converting the signal from an analog to a digital signal is also
provided. In this embodiment, the signal may also be output to a
diagnostic indicator and PSG interface.
[0146] Referring to FIG. 3A, there is indicated more specifically
by numeral 10 an EMI/ESD hardened Sensor Interface. The EMI/ESD
hardened sensor Interface 10 is designed to interface with a
multitude of different types of respiratory sensors 2. For example,
but not limited to, polyvinylidene fluoride film (PVDF) sensors,
thermocouples, thermistors, air pressure transducers, electrodes
and respiratory effort belts, and pyro/piezoelectric sensors all
could be used and connected via the pair of sensor wire
terminations 3 to the EMI/ESD hardened sensor Interface 10 in order
to detect respiratory flow. The term, the causes and the subject of
EMI/ESD are well known to someone skilled in the art. The EMI/ESD
hardened sensor Interface 10 comprises a multitude of EMI/ESD
countermeasures in order to ensure that the sensor signal 3 will be
detected, processed and decoded correctly by this invention without
suffering from the adverse affects of EMI and ESD. The EMI/ESD
hardened sensor Interface 10 connects via the digital airflow
signal 12 to the activity detector. Furthermore, the EMI/ESD
hardened sensor Interface 10 connects via the analog airflow signal
130 to the Diagnostic Indicator and PSG Interface. A detailed
description of the EMI/ESD hardened sensor Interface 10 is provided
below and in a separately filed U.S. Provisional Patent Application
titled EMI/ESD Hardened Sensor Interface for a closed loop
neuromodulator, filed on Aug. 22, 2008, the contents of which are
hereby incorporated by reference herein.
[0147] The relationship between the analog airflow signal and
digital airflow signal is shown near the bottom of FIG. 3A, where
the positive sloping portion of the analog signal is converted to
inhalation in the digital signal and the negative sloping portion
of the analog signal is converted to exhalation in the digital
signal. As discussed above, an analog airflow activity signal
indicating the inhalation and exhalation duration and waveforms may
allow a sleep lab practitioner to process the signal further with a
PSG in order to make a more detailed diagnosis. A digital airflow
activity signal indicating the inhalation and exhalation duration
may allow a sleep lab practitioner to see directly on the machine,
via LED's or other indicators, the patient's respiratory activity
and possibly at which point of the respiration cycle the patient
has stopped breathing.
[0148] An analog airflow activity signal is provided indicating the
inhalation duration and exhalation waveforms so that the sleep lab
practitioner can process the signal further with a PSG in order to
make a more detailed diagnosis.
[0149] A digital airflow activity indicator is provided indicating
the inhalation duration and exhalation duration so that the sleep
lab practitioner can see directly on the machine the patient's
respiratory activity and possibly at which point of the respiration
cycle the patient has stopped breathing.
[0150] Referring to FIG. 3B, there is indicated more specifically
by numeral 10 a detailed block diagram of an EMI/ESD hardened
sensor interface according to certain embodiments. The sensor
interface includes a sensor input connector 101, external and
internal EMI/RFI filters 102, 108, ESD protection 110, a supply
filtered balanced signal amplifier 112, a supply filtered signal
filter 114, and a supply filtered analog to digital converter 116.
Also included is a metal shield 106.
[0151] The sensor input connector 101 provides an input termination
for a pair of wire leads 3 extending from an external sensor 2. The
sensor input connector may consist of an outlet for plugging in the
wire leads 3. The sensor input connector 101 may be connected to an
external EMI/RFI Filter via its signal wire pairs 120.
[0152] The external EMI/RFI filter 102 provides an initial level of
EMI/RFI protection by filtering out high frequency EMI and RFI.
This may include, but is not limited to, EMI and RFI from
electronic devices such as pagers, wireless internet connections,
cordless phones, cellular phones, and the like. The external
EMI/RFI may be configured to filter out interference ranging from
approximately 100 MHz to 10 GHz. The external EMI/RFI filter may be
connected to an internal EMI/RFI filter via wire pairs 122.
[0153] The wire pairs 122 extending from the external EMI/RFI
filter may penetrate the wall of a metal shield 106 and further
extend to the internal EMI/RFI filter. The circuit covering metal
shield 106 may surround several elements of the device including
the internal EMI/RFI filter 108, the ESD protection 110, the supply
filtered balanced signal amplifier 112, supply filtered signal
filter 114, and supply filtered analog to digital converter 116.
The metal shield 106 may provide an internal environment shielded
against interference. The metal shield 106 is connected to a
multitude of 1/4'' spaced ground connections 104 for providing a
good and solid ground connection even at extremely high
frequencies.
[0154] The wire pairs 122 extending from the external EMI/RFI
filter may penetrate the wall of the metal box 106 and may further
extend to the internal EMI/RFI filter. As such, the wire pairs 122
may act as a conduit for interference to enter the protective metal
box 106. Thus, the internal EMI/RFI filter 108 may act as a second
level of protection against interference and may be directed at
filtering conducted emissions and common mode emissions. This
filter 108 may be configured to filter out interference ranging
from about 2 KHZ to 500 MHz. The internal EMI/RFI filter 108 may be
connected to the ESD protection 110 via wire pairs 124.
[0155] The ESD protection 110 may provide a barrier to
electrostatic shock. By dissipating high levels of energy entering
the device, the ESD protection 110 may protect the device from
damage due to such surges of energy. The ESD protection 110 may be
connected to a supply filtered balanced signal amplifier 112 with
wire pair 126.
[0156] The supply filtered balanced signal amplifier 112 may be
configured to filter out any internal interference emitted by
internal elements of the device. In fact, each of the remaining
elements of the EMI/ESD Hardened sensor interface including the
balanced signal amplifier 112, signal filter 114, and analog to
digital conversion may all be configured to filter out this
internal interference further adding to the self-compatibility of
the device.
[0157] The supply filtered balanced signal amplifier 112 may be
further configured to amplify the incoming signal. The biological
signals received from a patient are commonly low energy signals.
Having filtered out most of the interference, the signal may be
amplified without also amplifying associated noise. As such, the
signal may be made more identifiable and more appropriate for
analysis. The supply filtered balanced signal amplifier 112 may be
connected to the supply filtered signal filter 114 via single wire
128.
[0158] It is noted here that wire pairs 3, 120, 122, 124, and 126
may be configured, as is well known in the art, to rely on each
other to cancel out certain amounts of interference. The current
connection 128 may be a single wire connection because of the
internal environment provided by metal shield 106 and the upstream
filters.
[0159] The supply filtered signal filter 114 may receive the
amplified signal from the supply filtered balanced signal amplifier
112 via the connection 128. As mentioned above, the supply filtered
signal filter 114 may also be configured to filter out internal
interference. In addition, the supply filtered signal filter is
configured to filter out artifacts of the biological signal. These
artifacts may include signals picked up by the sensor 2 and
included in the signal transmitted to the stimulation controller.
These artifacts may be an associated heart rate of a patient, other
noises or movements in a room, or other signals picked up by the
sensor in addition to the signal intended. With knowledge of the
range of frequencies expected to be received from a particular
sensor, based on the condition being monitored, the supply filtered
signal filter 114 may filter out those frequencies not pertinent to
the analysis. For example, if breathing is being monitored, a range
of the expected frequency of breathing can be used to eliminate
signals outside that range. The supply filtered signal filter may
be connected to a supply filtered analog to digital converter via
wire 130.
[0160] The supply filtered analog to digital converter 116 may be
configured, like the balanced signal amplifier 112 and the signal
filter 114, to filter out internal interference. In addition, the
analog to digital converter 116 may convert the signal from an
analog signal to a digital signal by converting positive sloping
portions of a breathing curve to a digital inhalation signal and by
converting negative sloping portions of a breathing curve to a
digital exhalation signal.
[0161] It is noted here that connection 130, extending from the
signal filter 114 to the analog to digital converter 116, may be
split so as to provide an output of the fully filtered analog
signal to a diagnostic indicator and PSG interface prior to
converting the signal to a digital signal. The digital signal then,
may be output via connection 112 to the diagnostic indicator and
PSG interface and also to additional elements of a stimulation
controller.
[0162] Referring to FIG. 3C there is indicated more specifically by
numeral 10 a detailed schematic diagram of the EMI/ESD hardened
sensor Interface. The sensor input connector 101 comprises of
connector J1 with the two-signal wire pair leads designated as pin
1 and pin 2 respectively. The external EMI/RFI 102 filter comprises
of a pair of ferrite beads FB1 and FB2 acting as the filter series
element, and of a pair of metal shield penetrating feed-through
capacitors C1 and C2 as the parallel element to ground for common
mode filtering. The metal shield 106 covers the sensitive signal
carrying analog signal circuit and is connected to a multitude of
1/4'' spaced ground connections 104 for providing a very low
impedance connection to circuit ground even at extremely high
frequencies. The metal shield 106 in connection with the printed
circuit ground plane on the opposite side of the PCB and with an RF
tight picket fence constructed of interleaved vias that connect the
ground plane to the ground flooded top component copper layer forms
a continuous electrostatic shield around the entire volume of the
EMI/ESD hardened sensor Interface 10. The internal EMI/RFI filter
108 comprises a differential mode filtering capacitor C3 connected
to C1 and C2. Also connected to C1 and C2 is the input wire pair of
a high frequency common mode choke L1. The output wire pair of the
high frequency common mode choke L1 is connected to the input of
the two ESD energy absorbing series resistors R1 and R2 and to a
second filter capacitor C4. The output wire pair of the energy
absorbing resistors R1 and R2 is connected to another set of EMI
suppressing filter capacitors C5, C6 and C7. The ESD protection 110
comprises primarily of diodes D1, D2, D3 and D4. The cathode of D1
is connected to the positive supply terminal. The anode of D1 is
connected to the non-inverting input terminal 3 of opamp U1. The
anode of D2 is connected to the negative supply terminal. The
cathode of D2 is connected to the non-inverting input terminal 3 of
opamp U1. The cathode of D4 is connected to the positive supply
terminal. The anode of D4 is connected to the non-inverting input
terminal 3 of opamp U2. The anode of D3 is connected to the
negative supply terminal. The cathode of D3 is connected to the
non-inverting input terminal 3 of opamp U2. D1 through D4 present
the parallel clamping element of the ESD protected opamp input
terminal. Resistors R1 and R2 in connection with the Diodes D1, D2,
D3 and D4 form an ESD suppression circuit. Resistors R1 and R2 form
the series ESD power absorbing elements. It is clearly shown that
the input terminal 3 node of the operational amplifier U1 and U2 of
the supply filtered balanced signal amplifier 112 are thus EMI and
ESD protected. The supply filtered balanced signal amplifiers 112
comprise of operational amplifiers (opamps) U1 and U2. Both opamps
U1 and U2 are connected in a two-amplifier instrumentation
amplifier configuration. The four gain setting resistors RP1:A,
RP1:B, RP1:C and RP1:D are closely matched (typically to 0.1%)
within the same single resistor package so to provide the maximum
amount of common mode rejection. Resistor R4 by means of connection
to signal ground provides the input signal load for the J1.1
signal. Resistor R8 by means of connection to signal ground
provides the input signal load for the J1.2 signal. Negative supply
filtering of the operational amplifier U1 comprises of a conducted
RF power absorbing inductor L2 and a conducted RF power suppressing
cascaded capacitor bank consisting of C8 and C10 in parallel to
ground. The conducted RF power absorbing inductor L2 is connected
in series with the negative supply power terminal V- and the
negative power supply terminal 2 of the operational amplifier U1.
Positive supply filtering of the operational amplifier U1 comprises
of a conducted RF power absorbing inductor L3 and a conducted RF
power suppressing cascaded capacitor bank consisting of C9 and C12
in parallel to ground. The conducted RF power absorbing inductor L3
is connected in series with the positive supply power terminal V+
and the positive power supply terminal 5 of the operational
amplifier U1. Furthermore, conducted emissions bypassing capacitor
C11 is connected across the U1 operational amplifier power pin 2
and pin 5. Negative supply filtering of the operational amplifier
U2 comprises of a conducted RF power absorbing inductor L4 and a
conducted RF power suppressing cascaded capacitor bank consisting
of C13 and C15 in parallel to ground. The conducted RF power
absorbing inductor L4 is connected in series with the negative
supply power terminal V- and the negative power supply terminal 2
of the operational amplifier U2. Positive supply filtering of the
operational amplifier U2 comprises of a conducted RF power
absorbing inductor L5 and a conducted RF power suppressing cascaded
capacitor bank consisting of C14 and C17 in parallel to ground. The
conducted RF power absorbing inductor L5 is connected in series
with the positive supply power terminal V+ and the positive power
supply terminal 5 of the operational amplifier U2. Furthermore,
conducted emissions bypassing capacitor C16 is connected across the
U2 operational amplifier power pin 2 and pin 5. The single ended
output of the supply filtered balanced signal amplifier 112 is
available at the pin 1 of operational amplifier U2. The output of
the supply filtered balanced signal amplifier 112 connects to the
input of the supply filtered signal filter 114. The supply filtered
signal filter 114 is configured as a 3.sup.rd order Butterworth low
pass filter by means of filter series element resistors R10, R11
and R12 and by means of filter parallel elements C18, C19 and C20.
Negative supply filtering of the operational amplifier U3 comprises
of a conducted RF power absorbing inductor L6 and a conducted RF
power suppressing cascaded capacitor bank consisting of C21 and C23
in parallel to ground. The conducted RF power absorbing inductor L6
is connected in series with the negative supply power terminal V-
and the negative power supply terminal 2 of the operational
amplifier U3. Positive supply filtering of the operational
amplifier U3 comprises of a conducted RF power absorbing inductor
L7 and a conducted RF power suppressing cascaded capacitor bank
consisting of C22 and C25 in parallel to ground. The conducted RF
power absorbing inductor L7 is connected in series with the
positive supply power terminal V+ and the positive power supply
terminal 5 of the operational amplifier U3. Furthermore, conducted
emissions bypassing capacitor C24 is connected across the U3
operational amplifier power pin 2 and pin 5. The single ended
output of the supply filtered signal filter 114 is available at the
pin 1 of operational amplifier U3. The output of the supply
filtered signal filter 114 connects to the input of the supply
filtered analog to digital converter 116. The supply filtered
analog to digital converter 116 is configured as a self-referencing
phase detector by means of phase shifting series element resistors
R13 and by means of phase shifting parallel element C26 feeding
into the inverting and non-inverting inputs of opamp U4. The signal
detection threshold of the self-referencing phase detector is set
by the ratio of resistor R15 to R14. A ratio of 0.01 has been found
to be working optimally in this application. Negative supply
filtering of the operational amplifier U4 comprises of a conducted
RF power absorbing inductor L8 and a conducted RF power suppressing
cascaded capacitor bank consisting of C27 and C29 in parallel to
ground. The conducted RF power absorbing inductor L8 is connected
in series with the negative supply power terminal V- and the
negative power supply terminal 2 of the operational amplifier U4.
Positive supply filtering of the operational amplifier U4 comprises
of a conducted RF power absorbing inductor L9 and a conducted RF
power suppressing cascaded capacitor bank consisting of C28 and C31
in parallel to ground. The conducted RF power absorbing inductor L9
is connected in series with the positive supply power terminal V+
and the positive power supply terminal 5 of the operational
amplifier U4. Furthermore, conducted emissions bypassing capacitor
C30 is connected across the U4 operational amplifier power pin 2
and pin 5. The single ended output of the supply filtered analog to
digital converter 116 is available at the pin 1 of operational
amplifier U4. The single ended output 12 of the supply-filtered
analog to digital converter 116 connects to the input of the
Activity Detector 20.
[0163] Referring to FIG. 3D, there is indicated a timing diagram of
the analog to digital conversion function of the EMI/ESD hardened
Sensor Interface 10. The top graph indicated by roman numeral I.
depicts the analog waveform representation of the respiratory
signal coming from the airflow sensor. The bottom graph indicated
by Roman numeral II. Depicts the digital representation of the
respiratory signal to the Activity Detector. A positive slope of
the analog waveform represents inhaling. A negative slope of the
analog waveform represents exhaling. The output of the supply
filtered analog to digital converter 116 of FIG. 25 changes its
output to a low level as soon as the analog waveform of graph I.
changes its slope from positive to negative indicating exhaling.
The output waveform of the supply filtered analog to digital
converter 116 in graph II. changes its output to a high level as
soon as the analog waveform of graph I. changes its slope from
negative to positive indicating inhaling.
[0164] Due to the nature of the device application, through its
typical long sensor and transducer wires, exposure of the output to
ESD may potentially destroy the transducer driver circuitry. Thus,
special ESD countermeasures have to be put in place in order to
prevent damage or total destruction of the sensitive, low power
circuitry.
[0165] The EMI/ESD hardened sensor interface 10 may comprise a
multitude of EMI/ESD countermeasures in order to ensure that the
sensor signal 3 will be detected, processed and decoded correctly
by this invention without suffering from the adverse affects of EMI
and ESD. The following is a list of EMC component level
countermeasures for the EMI/ESD hardened sensor interface:
[0166] The following is a list of EMC component level
countermeasures for the EMI/ESD hardened sensor Interface:
[0167] 1. Feed-through capacitors
[0168] 2. Instrumentation amplifier
[0169] 3. Matched gain setting resistor network to maintaining high
CMRR
[0170] 4. Ferrite beads, series EMI suppression element
[0171] 5. Filter capacitors, parallel EMI suppression element
[0172] 6. Common mode RF filter, parallel EMI suppression
element
[0173] 7. Common mode RF choke, series EMI suppression element
[0174] 8. Power supply rail filtering
[0175] 9. Signal decoupling, parallel EMI suppression element
[0176] 10. Signal lead filtering, series EMI suppression
element
[0177] 11. Component location
[0178] 12. PCB routing
[0179] 13. Close proximity
[0180] 14. Short and wide traces are better than long and skinny
ones
[0181] 15. Schottky diodes, EMI suppression parallel element
[0182] 16. Resistors, series EMI suppression element
[0183] 17. Inductors, series EMI suppression element
[0184] 18. Cascaded capacitor banks, 0.01 uf and 10 uF
[0185] 19. Inductors in V+ and V- feeds before capacitor cascade,
power feed output
[0186] For the purpose of EMI/RFI shielding of the EMI/ESD hardened
sensor Interface 10, a metal case is mounted on to of the picket
fenced PCB circuit boundary with ground pane and ground flooded
signal layers.
[0187] The use of the following PCB based EMC countermeasures:
[0188] 1. Power and ground planes
[0189] 2. Layer flooding
[0190] 3. Picket fencing
[0191] 4. Short and narrow signal traces
[0192] 5. Short and wide power traces
[0193] The following operational parameters are adjustable
[0194] 1. Filter response (Butterworth, Bessel, Chebyshev,
Elliptic, etc.)
[0195] 2. High pass cut-off frequency (0.01 Hz to 100.00 Hz)
[0196] 3. Low pass cut-off frequency (0.01 Hz to 100.00 Hz)
[0197] 4. Signal Amplifier gain (-70 dB to +40 dB)
[0198] 5. Signal detection threshold (0.01% to 10%)
[0199] EMI/ESD hardening against the aforementioned offenders not
only satisfies domestic and international requirements on emissions
and susceptibility but also results in robust operation, cleaner
internal signals, improved signal to noise ratio (SNR) and greater
dynamic range. The sensor interface 10 described herein allows for
a stimulation controller to be used with various sensors including
those to be developed in the future. Moreover, the sensor interface
described allows for a practitioner to view an analog and digital
version of a patient signal and further allows for additional
analysis and processing of each signal.
[0200] A method of using the sensor interface may involve
positioning a sensor on a patient and connecting the sensor to the
sensor interface. The method may further involve receiving a signal
from the sensor positioned on the patient and filtering the signal
to remove EMI/RFI interference, further treating the signal to
prevent transmission of ESD, filtering out internal interference,
amplifying the signal, further filtering the signal to remove
signal artifacts resulting from the sensor sensitivity, converting
the signal from an analog to a digital signal and outputting either
an analog signal, a digital signal, or both.
Activity Detector
[0201] An activity detector may receive a previously converted
digital signal from a sensor interface as shown in FIGS. 2A and 2B.
The received signal may, for example, indicate when a person is
inhaling and when they are exhaling. The activity detector may
interpret that signal based on certain stored information. For
example, the activity detector may be calibrated based on a
patient's status as an adult and may define an upper limit of one
inhalation/exhalation cycle as being 6 seconds long. By monitoring
the incoming digital inhalation/exhalation signal the activity
detector may determine if a cycle is abnormal. The activity
detector may then notify other elements of a stimulation
controller.
[0202] There is a need for a device that can monitor a patient for
basic indications of a sleep disorder to allow other portions of an
apparatus to standby on less than full power unless and until they
are needed.
[0203] Referring to FIG. 4A, there is indicated more specifically
by numeral 20 an Activity Detector. AN ACTIVITY IS NOT LIMITED TO
APNEA IT MAY ANY EVENT SUCH AS SNORING, LEG MOVEMENT, LIMB
MOVEMENT, JAW MOVEMENT, POTENTIAL SIDS EVENT (BABY NOT BREATHING),
ETC. The Activity Detector 20 receives its input via the digital
signal 12 from the output of the EMI/ESD hardened sensor Interface
10. The Activity Detector 20 connects via the activity signal 22 to
the Stimulus Timer 30. For the purpose of inter-device
communication, command and control, the Activity Detector 20
connects to the Device Controller Bus 92. A detailed description of
the Activity Detector 20 is provided below and in a separately
filed U.S. Provisional Patent Application titled Activity Detector
for a closed loop neuromodulator, filed on Aug. 22, 2008, the
contents of which are hereby incorporated by reference herein.
[0204] The decision of whether a patient is experiencing an apnea
or is breathing normally is made in the Activity Detector.
[0205] An activity detector 20 is shown receiving a digital airflow
signal 12 from an EMI/ESD hardened sensor interface 10. The
Activity Detector 20 may transmit an activity signal 22 to a
stimulus timer or other elements of a stimulation controller.
Additionally, for purposes of inter-device communication, command,
and control, the activity detector 20 may also be connected to a
device controller bus 92. Also shown in FIG. 4A is a diagram of
inhalation and exhalation as it relates to normal and abnormal
breathing. It is noted here, that an activity can be any activity
relevant to a neurological condition. In many cases, as in the case
of sleep apnea, the relevant activity will be breathing activity.
For purposes of discussion, a majority of following relates to
inhalation and exhalation as it relates to sleep apnea, but those
skilled in the art will understand and appreciate that the activity
could also be snoring, leg movement, limb movement, jaw movement,
or any other activity relevant to a neurological condition or sleep
disorder.
[0206] The Activity Detector 20 may convert the digital airflow
signal 12, or other relevant signal, into a digital activity signal
22. As shown in FIG. 4A, the digital airflow signal 12 is high when
the patient is inhaling and is low when the patient is exhaling. In
contrast, the digital activity signal 22 is high when the patient
is breathing normally and is low when the patient is breathing
abnormally. The activity detector 22 may determine the difference
between normal and abnormal based on previously set or calibrated
standards. For example, the typical breathing range for a sleep
patient may be between 10 to 20 breaths per minute reflecting a 3
to 6 second breathing cycle. Thus, the activity detector may be
calibrated to indicate abnormal breathing when the patient fails to
breath for more than 6 seconds. The available range, however, can
be set to any range relevant to the activity being monitored and
may even be calibrated to detect continuity of activity rather than
absence of activity. For example, leg movement disorders may
involve setting the activity detector to trigger the remaining
elements of the stimulation controller when the activity continues
for a given amount of time.
[0207] The Activity Detector 20 converts the digital airflow signal
12 into a digital activity signal 22. The digital airflow signal 12
is high when the patient is inhaling and is low when the patient is
exhaling. The digital activity signal 22 is high when the patient
is breathing normally and is low when the patient is breathing not
normally. The typical breathing range for a sleep patient is
between 10 to 20 breaths per minute. The invention goes well above
and below this rate to accommodate other events in other CNS
disorders.
[0208] A purpose of the Activity Detector 20 is to detect
obstructive sleep apnea, central sleep apnea, complex sleep apnea,
but also snore, snore and apneas, leg movement, limb movement, jaw
movement etc.
[0209] Referring to FIG. 4B, there is indicated more specifically
by numeral 20 a detailed block diagram of the Activity Detector.
The activity detector may include several inhalation and exhalation
devices including: gates 204, 206, counters 220, 224, registers
216, 228, magnitude comparators 246, 238, and count threshold
registers 230, 240. The activity detector may also include a
respiration sampling clock and a respiration sampling clock
register as well as an activity gate 244.
[0210] The inhalation and exhalation gates 204, 206 may continually
receive the incoming digital airflow signal 12 and send timed
signals to their respective counters 220, 224. For example, when
the incoming digital airflow signal 12 is high, reflecting
inhalation, the inhalation gate 204 may send a signal to the
inhalation counter 220 every millisecond or any other regular time
interval. This regular time interval may be referred to as the
clock sampling rate and the gates 220, 224 may rely on the
respiration sampling clock 202 to trigger them based on this
sampling rate. Thus, based on the information the gates 204, 206
receive from the incoming digital airflow signal 12 and the
respiration sampling clock 202, the gates 204, 206 may "open" and
thus send a triggering signal to their respective counters 220,
224. In turn, each time the inhalation and exhalation counters 220,
224 receive a signal from their respective gate 204, 206, the
counters 220, 224 may advance their count.
[0211] Signal 12 actually gates the sampling clock and allows a
specific amount of clock pulses to reach the counter in order to
give a signal count that is relative to the inhalation or
exhalation duration. If that count is higher than the threshold
then abnormal breathing has been detected.
[0212] The respiration-sampling clock 202, responsible for
triggering the inhalation and exhalation gates 204, 206 based on
the clock sampling rate, may receive this clock sampling rate
through an 8-bit parallel load port connection to a respiration
sampling clock register 208. The respiration sampling clock
register 208 may be interfaced with an internal control bus 92. The
register is readable and writable and the clock sampling rate can
be stored in the respiration clock register 208 via the control bus
92 and may be adjusted as required for a given condition. The
respiration sampling clock 202, may then receive this clock
sampling rate from the register 208 and trigger the gates
accordingly.
[0213] Referring again to the inhalation and exhalation counters
220, 224, a primary 8-bit parallel output 234, 236 of the counters
may be connected to the 8-bit input of their respective magnitude
comparators 246, 238. The magnitude comparators 246, 238 may
constantly compare the actual inhalation or exhalation count to a
threshold count. As soon as the actual inhalation or exhalation
count of the respective counter is equal to or greater than a
respective threshold count, the magnitude comparator may issue a
single bit magnitude signal 242, 248 to the activity gate 244.
[0214] Similar to the respiration sampling clock, the magnitude
comparators 246, 238 rely on a count threshold register 230, 240
interfaced with a control bus 92. The count threshold registers
230, 240 are readable and writable and the threshold value may be
stored in the registers via the control bus 92. This value may then
be uploaded to the magnitude comparators 246, 238 via the 8-bit
parallel connection 234, 236, for comparison with the actual count.
For example, if a 6 second breathing cycle is considered normal and
anything over 6 is abnormal, the inhalation threshold and
exhalation threshold may each be set to approximately 3 seconds in
the count threshold registers 230, 240. This value can then be
uploaded by the magnitude comparators 246, 238 and compared with
the actual count of a patient.
[0215] The actual inhalation/exhalation count established by the
counters 220, 224 may also be available via a byte wide secondary
count parallel output 218, 226 extending to an 8-bit count register
216, 228. As with the respiration sampling clock register, the
inhalation and exhalation count registers may be interfaced with an
internal control bus 92. As such, the actual 8-bit inhalation or
exhalation count may be read via the count registers 216, 228
through the 8-bit internal control bus 92.
[0216] Referring back to the activity gate 244, it may provide an
activity signal 22 to additional elements of a stimulation
controller. The activity signal 22 may be high during normal
breathing and low during abnormal breathing. When either the
inhalation magnitude comparator 246 or the exhalation magnitude
comparator 238 provides a low signal, due to an inhalation or
exhalation counter overrun, the activity signal 22 may also provide
a low signal, indicating abnormal breathing. It is noted that the
activity signal 22 may not reflect an Apnea event because in order
for the detected non-breathing event to be qualified as a sleep
apnea, the breathing has to secede for a medically established
amount of time. Further analysis may be provided within a stimulus
timer to determine whether an apnea event has been detected.
[0217] A method of providing a normal or abnormal activity signal
includes receiving a digital inhalation and exhalation signal,
counting the time for each of inhalation and exhalation and
comparing the count to a threshold value. The method further
includes providing a normal activity signal when the threshold
value is not exceeded and providing an abnormal activity signal
when the threshold value is exceeded.
[0218] Respiration sampling clock range: 0 to 255 ms, 1 ms
resolution
[0219] Inhalation count register range: 0 to 255 s, 1 s
resolution
[0220] Exhalation count register range: 0 to 255 s, 1 s
resolution
[0221] Inhalation count threshold range: 0 to 255 s, 1 s
resolution
[0222] Exhalation count threshold range: 0 to 255 s, 1 s
resolution
[0223] An advantage of the present subject matter is that the
information it provides allows for the device to make further
decisions on how much of the device needs to be activated. For
instance, if breathing is continually normal, the device may
temporarily shut down other elements to conserve energy. (E.g. shut
down generators, timers and gain block when breathing is detected.
Activate generators, timers and gain block when no breathing is
detected.)
[0224] Referring to FIG. 4B, there is indicated more specifically
by numeral 20 a detailed block diagram of the Activity Detector.
Input connection to the output of the EMI/ESD Hardened Sensor
Interface is provided by the digital signal 12. The digital input
12 connects to the first input of the inhalation gate 204 and to
the first input of the exhalation gate 206. The
respiration-sampling clock 202 connects to the second input of the
inhalation gate 204 via connection 212. The respiration-sampling
clock 202 also connects to the second input of the exhalation gate
via connection 212. The clock-sampling rate of the
respiration-sampling clock 202 is being set by the loading of the
respiration-sampling clock 202 via its 8-bit parallel load port 210
via the respiration sampling clock register 208. The respiration
sampling clock register can be written and read-back via the
inhalation count register 216 through the 8-bit internal control
bus 92. The output of the inhalation gate 204 provides a
gated/timed inhalation clock signal via its output 222 to the input
of the inhalation counter 220. The inhalation counter 220 advances
its count each time a gated inhalation clock signal triggers it.
The actual inhalation count is available via the byte wide
secondary inhalation count parallel output 218. An 8-bit inhalation
count register 216 is connected to the inhalation count output 218.
The actual 8-bit inhalation count can be read via the inhalation
count register 216 through the 8-bit internal control bus 92. The
primary 8-bit parallel output 234 of the inhalation counter 220 is
connected to the 8-bit input of the inhalation magnitude comparator
246. The 8-bit inhalation magnitude comparator 246 constantly
compares the actual inhalation count via the 8-bit parallel
connection 234 from the inhalation counter 220 with the inhalation
threshold count port 232 whose value has been loaded into the
inhalation count threshold register 230 via the internal control
bus 92. As soon as the actual inhalation count of inhalation
counter is equal or greater than the inhalation threshold count
that has been loaded into the inhalation count threshold register
230, a single bit magnitude signal 242 is being issued and passed
to the two input OR gate 244. The output of the exhalation gate 206
provides a gated/timed exhalation clock signal via its output 214
to the input of the exhalation counter 224. The exhalation counter
224 advances its count each time a gated exhalation clock signal
triggers it. The actual exhalation count is available via the
byte-wide secondary exhalation count parallel output 226. An 8-bit
exhalation count register 228 is connected to the exhalation count
output 226. The actual 8-bit exhalation count can be read via the
exhalation count register 228 through the 8-bit internal control
bus 92. The primary 8-bit parallel output 226 of the exhalation
counter 224 is connected to the 8-bit input of the exhalation
magnitude comparator 238. The 8-bit exhalation magnitude comparator
238 constantly compares the actual exhalation count via the 8-bit
parallel connection 236 from the exhalation counter 224 with the
exhalation threshold count port 250 whose value has been loaded
into the exhalation count threshold register 240 via the internal
control bus 92. As soon as the actual inhalation count of the
exhalation counter 224 is equal or greater than the exhalation
threshold count that has been loaded into the exhalation count
threshold register 240, a single bit magnitude signal 246 is being
issued and passed to the two input OR gate 244. The output of the
Two Input OR gate 244 is high during normal breathing. As soon as
either the inhalation magnitude comparator or the exhalation
comparator goes low due to an inhalation or exhalation counter
overrun do to a non breathing event, the Activity Signal output 22
of the two input OR gate 244 goes low, indicating abnormal
breathing. The activity signal 22 is not an Apnea signal because in
order for the detected non-breathing event to be qualified as a
sleep apnea, the breathing has to secede for at least a few
seconds. The decision whether an apnea event has been detected is
made within the Stimulus Timer 30.
[0225] FIG. 4C is a timing diagram of an apnea detection of an
Activity Detector according to one example of the present subject
matter.
[0226] In one embodiment, an activity detector is provided
including a respiration sampling clock, at least one gate, at least
one counter, at least one magnitude comparator, and an activity
gate. In this embodiment, the respiration sampling clock is
configured to provide a clock sampling rate to the at least one
gate. The at least one gate is configured to receive a digital
inhalation and exhalation signal and trigger the at least one
counter based on the clock sampling rate. The at least one
magnitude comparator is configured to compare a count provided by
the at least one counter to a threshold count and signal the
activity gate, when the threshold count is exceeded. In this
embodiment, the activity gate is configured to provide an activity
signal indicating normal or abnormal breathing.
[0227] In another embodiment, the at least one gate includes an
inhalation gate and an exhalation gate. In another embodiment, the
at least one counter includes an inhalation counter and an
exhalation counter. In another embodiment, the at least one
magnitude comparator includes an inhalation magnitude comparator
and an exhalation magnitude comparator. In yet another embodiment,
each of the respiration sampling clock, the at least one gate, the
at least one counter, and the at least one magnitude comparator
each have an associated register for communication with a control
bus.
[0228] In another embodiment, a method of providing a normal or
abnormal activity signal includes receiving a digital inhalation
and exhalation signal, counting the time for each of inhalation and
exhalation and comparing each count to a separate threshold value.
The method further includes providing a normal activity signal when
the threshold value is not exceeded and providing an abnormal
activity signal when the threshold value is exceeded.
Stimulus Timer
[0229] A stimulus timer may receive a previously converted digital
signal from an activity detector as shown in FIGS. 2A and 2B. As
shown in FIG. 3, the received signal may, for example, indicate
when a person is breathing abnormally. The stimulus timer may
further analyze the signal to determine if any abnormal activity
constitutes a manifestation of a sleep disorder. For example, the
stimulus timer may be set to trigger additional elements of a
closed loop neuromodulator when a person fails to breath for more
than 20 seconds. Thus, by monitoring the incoming digital activity
signal the stimulus timer may determine if the abnormal breathing
constitutes sleep apnea and may notify other elements of a
stimulation controller accordingly. The stimulus timer may provide
a stimulus start signal, a stimulus rate signal, and a stimulus
duration signal.
[0230] Referring to FIG. 5A, a stimulus timer 30 is shown receiving
an incoming activity signal 22 from an activity detector 20. The
stimulus timer 30 may transmit a stimulus start signal 32, a
stimulus rate signal 34, and stimulus duration signal 36 to a
stimulus sequencer 40 or other elements of a stimulation
controller. Additionally, for purposes of inter-device
communication, command, and control, the stimulus timer 30 may also
be connected to a device controller bus 92.
[0231] Referring to FIG. 5A, there is indicated more specifically
by numeral 30 a stimulus timer. The stimulus timer 30 receives its
input via the activity signal 22 from the Activity Detector 20. The
stimulus timer 30 connects via the stimuli start signal 32, stimuli
rate signal 34 and the stimuli duration signal 36 to the stimulus
sequencer 40. For the purpose of inter-device communication command
and control, the Stimulus Timer 30 connects to the common Device
Controller Bus 92. A detailed description of the stimulus timer 30
is provided below and in a separately filed U.S. Provisional Patent
Application titled Stimulus Timer for a closed loop neuromodulator,
filed on Aug. 22, 2008, the contents of which are hereby
incorporated by reference herein.
[0232] The Stimulus Timer is responsible for diagnostic and therapy
related closed loop neuromodulator functions.
[0233] A purpose of the Stimulus Timer 30 is to process the
activity signal 22 from the Activity Detector 20 and derive
specific timing information from it that is crucial to the
operation of the closed loop neuromodulator such as therapy delay,
apnea detection, apnea duration measurement, apnea counts, stimulus
delay, stimulus rate and stimulus duration timing.
[0234] In addition, the Stimulus Timer 30 enables, a low power
design, which is crucial for battery operation. A genera power down
signal that will be issued to all functional but non essential
elements can be issued by the device controller by polling the
apnea duration register. The general power down signal will keep
other functional modules and functional blocks of the design
inactive until their function and operation are needed,
milliseconds after an apnea has been detected. Low power operation
shuts down functional blocks when not needed for immediate
operation. E.g. shut down generators, timers and gain block when
breathing is detected. Activate generators, timers and gain block
when no apnea has been detected.
[0235] The timing of issuing stimuli and sending them to the
patient continues until the resumption of breathing has been
detected.
[0236] Referring to FIG. 5B, a detailed block diagram of the
stimulus timer 30 is provided. The stimulus timer 30 may include
several therapy delay elements including a gate 310, timer 306, and
register 302. The stimulus timer 30 may also include several apnea
threshold elements including a gate 322, timer 318, and register
314. Additional apnea related devices include an apnea duration
timer 330 and an apnea duration register 326 as well as an apnea
counter 338 and an apnea count register 334. It is noted here, that
the neurological condition or sleep disorder is not limited to
sleep apnea, but that reference is made to sleep apnea for purposes
of description. Those skilled in the art will understand and
appreciate that the sleep disorder could also be snoring, bruxism,
or any other neurological condition or sleep disorder. Several
stimuli related elements may also be included. A stimulus delay
gate 348, timer 344, and register 340 may be provided as well as a
stimulus rate generator 354 and register 350. Additional stimulus
related elements may include a stimulus duration timer 362 and
register 358 as well as a stimulus counter 366 and stimulus count
register 312.
[0237] As previously discussed, the stimulus timer 30 may receive
an activity signal 22 from an activity detector 20. The activity
signal 22 may be directed into a first input of a therapy delay
gate 310. Together with the therapy delay timer 306 and therapy
delay register 302, the therapy delay gate 310 may allow a
stimulation controller to be set not to provide any stimulus for a
given period of time. For example, if it is desired to allow a
patient to achieve a certain sleep state or simply get into a
reasonably deep sleep prior to stimulating them, the therapy delay
system can be set to block stimulation until a certain time has
passed. As such, the therapy delay register 302, which is both
writable and readable through the 8-bit internal control bus 92,
allows for a delay to be stored in the therapy delay register 302.
The therapy delay timer 306 receives its therapy delay time value
through the 8-bit parallel connection 304 to the Therapy delay
register 302 and, in turn, may signal the therapy delay gate 310 to
open once the time has elapsed.
[0238] Once the therapy delay time has elapsed, the therapy delay
gate 310 allows the activity signal to pass through to the apnea
threshold gate 322 via connection 324. The apnea threshold gate 322
in conjunction with the apnea threshold timer 318 and apnea
threshold register 314 qualifies whether the patient experiences an
apnea or not. That is, the length of time defining sleep apnea
(e.g. 20 seconds), or any other condition, can be stored in the
apnea threshold register 314, which can be written to and read-back
through the 8-bit internal control bus 92. The apnea threshold
timer 318 receives its apnea threshold value through the 8-bit
parallel connection 316 to the apnea threshold register 314 and, in
turn, may signal the apnea threshold gate 322 to open once the
apnea threshold has been exceeded. That is, when the activity
signal has remained low for longer than the apnea threshold, the
apnea threshold gate 322 will open.
[0239] The apnea threshold gate 322 connects to the stimulus delay
gate 348 via connection 324. Along its path to the stimulus delay
gate 348, the connection 324 also connects to the apnea duration
timer 330 and the apnea counter 338. The apnea duration timer 330
may measure the apnea duration indicated by a low level of Therapy
delay [[apnea threshold]] gate output 324 [[332]]. The apnea
counter may count individual apneas as indicated by the output of
the apnea threshold gate 322. These elements are intended for
collecting data for export via the internal control bus 92. Thus,
these elements are further connected via 8-bit parallel connections
to associated registers 326 and 334. The apnea duration register
326 and apnea count register 334 are, in turn, connected via an
8-bit connection to the internal control bus 92. As with other
registers disclosed herein, these registers 326, 324 are readable
and writable so as to be able to store the values associated with
the apnea duration timer and apnea counter for later reading by
another device.
[0240] Beyond the apnea duration timer 330 and the apnea counter
338, the connection 324 proceeds to the stimulus delay gate 348.
The stimulus delay gate 348 delays the start of any CNS stimulus
until the set Stimulus Delay Time has expired. This stimulus delay
may allow for an additional level of control over the timing of the
stimulus. That is, the stimulus may be delayed due to the therapy
delay. It may also be delayed beyond a determination of abnormal
breathing to wait for a determination of whether an apnea has
occurred. While the stimulus delay may be set to zero, it may also
be set to some positive value providing some level of control over
the timing of the stimulus relative to a determination of apnea.
Thus, the stimulus may not be delivered immediately once an apnea
has been determined. Similar to the previously discussed register,
timer, and gate combinations, a stimulus delay register 340 may be
provided to store the stimulus delay time. The stimulus delay
register 340 may be both readable and writable via an 8 bit
internal control bus 92. The stimulus delay timer may receive the
stimulus delay time through the 8-bit parallel connection 342 from
the stimulus delay register 340. The stimulus delay timer 344
connects to the stimulus delay gate 348 and may allow the stimulus
delay gate 348 to open once the stimulus delay time has
elapsed.
[0241] The stimulus delay gate 348 connects to the stimulus rate
generator 354 via connection 32. Connection 32 represents the
stimulus start signal. If the therapy delay time has elapsed and
the apnea threshold time has been exceeded and the stimulus delay
time has elapsed, a stimulus start signal may be released from the
stimulus delay gate 348 through connection 32.
[0242] This stimulus start signal may be directed out of the
stimulus timer, but also is directed to the stimulus rate generator
354 for further processing. The stimulus rate generator 354
generates the stimulation rate at which the CNS stimuli are sent to
the transducer/patient. That is, where successive stimuli are being
used to treat a patient, the stimulus rate generator 354 defines
the time from the start of one stimulus to the start of the next
stimulus. The stimulus rate generator 354 may receive its input
directly from the stimulus rate register 350 through the 8-bit
parallel connection 352. As with other registers, the stimulus rate
register 350 is responsible for storing the stimulus rate. The
stimulus rate register 350 may be both writable and readable
through the 8-bit internal control bus 92.
[0243] The stimulus rate generator 354 connects to the stimulus
duration timer 362 via connection 34. Connection 34 represents the
stimulus rate signal. This stimulus rate signal may be directed out
of the stimulus timer 30, but may also be directed to a stimulus
duration timer 362 for further processing. The stimulus duration
timer 362 may define the time over which the CNS stimuli are sent
to the transducer/patient. That is, where single or multiple
stimuli are being used to treat a patient, the stimulus duration
timer defines the continuous length of each individual pulse. Like
the stimulus rate generator/register combination, the stimulus
duration timer 362 receives its duration time value through the
8-bit parallel connection 360 to the stimulus duration register
358. The stimulus duration register 358 can be written to and
read-back through the 8-bit internal control bus 92. The output of
the stimulus duration timer 362 is the stimulus duration signal
36.
[0244] The timing of issuing stimuli and sending them to the
patient may be continued until the resumption of breathing has been
detected. As this process continues, the stimulus counter 366 may
keep track of the number of stimuli being issued. The stimulus
counter 366, may in turn store this value in the readable and
writable stimulus count register 312, making this value available
to the rest of the system through 8-bit internal control bus
92.
[0245] A method may be performed involving receiving an activity
signal from an activity detector, intercepting the activity signal
with a therapy delay gate until the therapy delay has lapsed after
which the signal passes to a apnea threshold gate. The apnea
threshold gate intercepts the activity signal until an apnea
threshold has been exceeded after which the signal passes to the
stimulus delay gate. The stimulus delay gate intercepts the signal
until a stimulus delay has lapsed after which the signal is issued
from the stimulus timer as a stimulus start signal. A stimulus rate
generator may issue a stimulus rate signal and a stimulus duration
timer may issue a stimulus duration signal.
[0246] Therapy delay range: 0 to 255 min, 1 min resolution
[0247] Apnea threshold range: 0 to 255 s, 1 s resolution
[0248] Apnea duration range: 0 to 255 s, 1 s resolution
[0249] Apnea counter range: 0 to 255 apneas
[0250] Stimulus delay range: 0 to 25.5 s, 100 ms resolution
[0251] Stimuli rate generator range: 0 to 25.5 seconds, 100 ms
resolution
[0252] Stimuli duration timer range: 0 to 2.55 seconds, 10 ms
resolution
[0253] Referring to FIG. 5B, there is indicated more specifically
by numeral 30 a detailed block diagram of the stimulus timer. The
input of the Stimulus Timer 30 connects to the output of the
Activity Detector 20 via the activity signal 22. The activity
signal 22 connects to the first input of the therapy delay gate
310. The Therapy Delay Gate 310 delays any stimulation activity
until the set Therapy Delay Time has been expired. The Therapy
Delay Gate 310 connects to the Apnea Threshold Gate 324 via
connection 324. The therapy delay timer 306 connects to the second
input of the therapy delay gate 310 via the connection 308. The
therapy delay timer 306 receives its therapy delay time value from
through the 8-bit parallel connection 304 from the Therapy delay
register 302. The therapy delay register 302 can be written and
read-back through the 8-bit internal control bus 92. The Apnea
Threshold Gate 322 in conjunction with the Apnea Threshold Timer
318 qualifies whether the patient experiences an Apnea or not. The
apnea threshold gate 322 connects to the Stimulus Delay Gate 348
via connection 324. The Apnea threshold timer 318 connects to the
second input of the Apnea Threshold Gate 322 via the connection
320. The Apnea threshold timer 318 receives its apnea threshold
value through the 8-bit parallel connection 316 from the apnea
Threshold Register 314. The apnea threshold Register 314 can be
written and read-back through the 8-bit internal control bus 92.
The Apnea duration timer 330 measures the apnea duration indicated
by a low level of Therapy delay gate output 324. The Apnea duration
timer 330 connects to the output 332 of the apnea threshold Gate
322. The value of the Apnea duration timer 330 can be read through
the 8-bit parallel connection 328 from the apnea duration Register
326. The apnea duration Register 326 can be read through the 8-bit
internal control bus 92. The Apnea counter 338 counts individual
apneas as indicated by the output of the apnea threshold gate 322.
The value of the Apnea counter 338 can be read through the 8-bit
parallel connection 336 from the apnea count Register 334. The
apnea count register 334 can be read through the 8-bit internal
control bus 92. The stimulus delay gate 348 delays the start of any
stimulus until the set Stimulus Delay Time has been expired. The
stimulus delay Gate 348 connects to the clock input of the stimulus
rate generator 354 via connection 32. The stimulus delay timer 344
connects to the second input of the stimulus delay gate 348 via the
connection 346. The stimulus delay timer 344 receives its stimulus
delay time value through the 8-bit parallel connection 342 from the
stimulus delay register 340. The stimulus delay register 340 can be
written and read-back through the 8-bit internal control bus 92.
The stimulus delay gate 348 connects to the stimulus rate generator
354 via connection 32. Connection 32 represents the stimulus start
signal. The stimulus rate generator 354 generates the stimulation
rate at which the stimuli are sent to the transducer/patient. The
stimulus rate generator 354 connects to the clock input of the
stimulus rate generator 354 via connection 32. The stimulus rate
generator 354 receives its stimulus rate value through the 8-bit
parallel connection 352 from the stimulus rate register 350. The
stimulus rate register 350 can be written and read-back through the
8-bit internal control bus 92. The stimulus rate generator 354
connects to the stimulus duration timer 362 via connection 34.
Connection 34 represents the stimulus rate signal. The stimulus
duration timer 362 times the stimulation duration at which the
stimuli are sent to the transducer/patient. The input of the
stimulus duration timer 362 connects to the output of the stimulus
rate generator 354 via connection 34. The stimulus duration timer
362 receives its duration time value through the 8-bit parallel
connection 360 from the stimulus duration register 358. The
stimulus duration register 358 can be written and read-back through
the 8-bit internal control bus 92. The output of the stimulus
duration timer 362 is the stimulus duration signal 36. Stimulus
duration 36 represents the duration at which the patient/transducer
is subjected to the current single stimulus.
[0254] The single stimulus energy is contained under the area of
the individual stimuli pulse shape over time. In order to increase
the stimulus energy either the level of the stimulus must be
increased or the duration of the stimulus must be increased. The
energy provided by any given pulse of stimulation may be determined
by defining the area of the individual stimuli pulse shape over
time. That is, energy equals power times time (E=P*t) where P
represents the power of a stimulus pulse and t represents the
duration of stimulus pulse. In order to increase the stimulus
energy either the level of the stimulus can be increased or the
duration of the stimulus can be increased. Where sleep
practitioners are attempting to stifle a sleep disorder and yet
avoid arousing a patient, the ability to adjust each of these is
advantageous. The stimulus timer disclosed herein allows for
adjustment for the duration of element of this energy approach.
[0255] The stimulus timer disclosed herein is advantageous because
it allows for precise dosing of patients. First, once an apnea or
other neurological condition is detected, the initial dose can be
introduced at a specific predetermined time. Second, a series of
pulses of stimulation may be provided and the stimulus timer allows
those pulses to be adjusted relative to one another in time. Third,
the stimulus timer further allows for each pulse to be shortened or
lengthened.
[0256] Additionally, the Stimulus Timer 30 enables, a low power
design, which may be beneficial under battery operation. When used
in a closed loop neuromodulator such as that shown in FIG. 2A or
2B, a general power down signal may be issued to all functional but
non essential elements by the device controller, which may poll the
apnea duration register to determine if an apnea is occurring. The
general power down signal may keep other functional modules and
functional blocks of the device inactive until their function and
operation are needed, milliseconds after an apnea has been
detected. Low power operation may allow for shutting down
functional blocks when not needed for immediate operation. E.g.
shutting down generators, timers and gain blocks when breathing is
detected. Activate generators, timers and gain block when an apnea
has been detected.
[0257] In one embodiment, a stimulus timer for a closed loop
neuromodulator includes a therapy delay gate, an apnea threshold
gate, a stimulus delay gate, a stimulus rate generator, and a
stimulus duration timer, wherein the stimulus delay gate issues a
stimulus start signal, the stimulus rate generator issues a
stimulus rate signal, and the stimulus duration timer issues a
stimulus duration signal.
[0258] In another embodiment, the stimulus timer also includes an
apnea duration timer. In another embodiment, an apnea counter is
also included. In yet another embodiment, the therapy delay gate,
apnea threshold gate, and stimulus delay gate each have an
associated timer and register, where the associated registers are
in communication with an internal control bus. In still another
embodiment, a stimulus counter is also included.
[0259] A method may be performed involving receiving an activity
signal from an activity detector, intercepting the activity signal
with a therapy delay gate until the therapy delay has lapsed after
which the signal passes to a apnea threshold gate. The apnea
threshold gate intercepts the activity signal until an apnea
threshold has been exceeded after which the signal passes to the
stimulus delay gate. The stimulus delay gate intercepts the signal
until a stimulus delay has lapsed after which the signal is issued
from the stimulus timer as a stimulus start signal. A stimulus rate
generator may issue a stimulus rate signal and a stimulus duration
timer may issue a stimulus duration signal.
Stimulus Sequencer
[0260] A stimulus sequencer may receive a stimulus start signal, a
stimulus rate signal, and a stimulus duration signal from a
stimulus timer as shown in FIGS. 2A and 2B. The stimulus sequencer
may then determine which stimulus wave shapes to be applied and in
what order. For example, the stimulus sequencer may select a
combination of stimuli including a tone, a click, and a pop may
then provide the order in which these stimuli are used to stimulate
a patient. The stimulus sequencer may then transmit a generator
select signal to a stimulus generator or other components of a
stimulation controller.
[0261] Referring to FIG. 6A, there is indicated more specifically
by numeral 40 a stimulus sequencer. The stimulus sequencer 40
receives its inputs via the stimuli start signal 32, stimuli rate
signal 34 and stimuli duration signal 36 from the stimulus timer
30. The stimulus sequencer 40 connects via the generator select
signal 42 to the stimulus generator. For the purpose of
inter-device communication command and control, the Stimulus
Sequencer 40 connects to the common Device Controller Bus 92. A
detailed description of the stimulus sequencer 40 is provided below
and in a separately filed U.S. Provisional Patent Application
titled Stimulus Sequencer for a closed loop neuromodulator, filed
on Aug. 22, 2008, the contents of which are hereby incorporated by
reference herein.
[0262] A function of the stimulus sequencer is to provide
anti-habituation therapy to avoid habituation to stimuli types in
patients. In order to avoid habituation to certain stimuli types a
multitude of different stimuli types have to be generated and
activated as needed in very specific and deliberate sequences. The
sequencer activates a very specific stimulus generator as needed
and as prescribed. The sleep practitioner can input the stimulation
sequence into the device for diagnosis and therapy.
[0263] There is a need for fixed operation/manual mode so that the
sleep lab practitioner can operate the unit in manual mode for the
purpose of experimenting, diagnosing and prescribing the optimum
range for specific sleep patient's stimuli type regimen.
[0264] Referring to FIG. 6B, the stimulus sequencer may include a
sequence address generator 406, a sequence memory array 418, and a
stimulus generator selector 430. The stimulus address generator 406
may be in communication with an internal control bus 92, through a
stimulus address generator register 402. The stimulus memory array
418, may be in communication with an internal control bus 92
through a sequence load control register 408, a sequence load
address register 414, and a sequence load data register 420. The
stimulus generator selector 430 may be in communication with an
internal control bus 92 through a stimulus generator selector
register 426.
[0265] The stimulus sequencer decides on which stimulus wave shape
is to be applied and in what order. The orders can be but are not
limited to:
[0266] 1. Fixed
[0267] 2. Sequential
[0268] 3. Circular
[0269] 4. Random
[0270] 5. Periodic
[0271] 6. Custom
[0272] 7. Patterned
[0273] 8. Continuous
[0274] Fixed means that the same stimulus types are repeatedly
applied every time a stimulus is being issued
[0275] Sequential means that the stimulus types may be changed from
stimulus to stimulus during the same apnea, but that the same
stimulus sequence starts over the next time an Apnea is
detected.
[0276] Circular means that the stimulus types may change from
stimulus to stimulus during the same apnea, but when a new apnea
occurs and the next stimulus is being issued, it will be the next
stimulus in the circular sequence. The stimulus types are lined up
in a circle. The circle has no specific start or end points.
[0277] Random means that the stimulus types are issued in an
arbitrary sequence. The stimulus sequence can be generated by a
quasi random signal source (QRSS) and subsequently recorded and
loaded into the sequence memory array.
[0278] Periodic means that the stimulus types are issued in a
sequence that is like going up a ladder and then coming down, then
going back up and so forth.
[0279] Custom means that the stimulus types are issued in a long
pre-defined sequence as prescribed by the sleep practitioner.
[0280] Patterned means that the stimulus types are issued in short
defined sequences as prescribed by the sleep practitioner.
[0281] Continuous means that the stimulus type is continuously
issued to the transducer/patient with the defined stimulus rate and
stimulus duration whether an apnea is present or not. This test
mode allows the sleep practitioner to listen, experience and
measure the selected stimulus at will.
[0282] An element of the stimulus sequencer is its sequence memory
array which is loaded with the sequence as selected and described
above either on start-up or during operation by the device
controller who manages and keeps track of the stimulus
sequencing.
[0283] The sequence memory array is of a 256.times.8-bit <00Hex
to <FFHex> read writable random access memory (RAM) type. The
sequence memory array can be any size memory and is not limited to
256.times.8-bit.
[0284] The sleep practitioner may load the stimuli sequences as
needed via remote terminal instructions into the sequence memory
array.
[0285] All load, control, address and data values are being
communicated from the device controller through the internal
control bus via the individual registers.
[0286] The device controller communicates the sequence information
of which is the current generator being selected, which is the next
generator a sequence and which was the last generator selected in a
sequence.
[0287] Sequence address generator range: 0 to 255 addresses
[0288] Sequence load control range: 8-bit (clear, set, reset,
clock)
[0289] Sequence load address range: 8-bit (A0 . . . A7)
[0290] Sequence date load range: 8-bit (DB0 . . . DB7)
[0291] Device controller keeps track of the following: sequence
start points and sequence end points.
[0292] Upon receipt of the stimulus start signal, the 8-bit or
N-bit programmable sequence generator/counter selects the next
stimulus sequence upon receipt of the stimulus rate signal for
generating the sequence of the appropriate stimulus generator. With
each new stimulus duration signal clocked into the sequence address
generator, a new address is being generated and input into the
sequence memory array for selection of the particular stimulus type
for that specific stimulus.
[0293] Referring to FIG. 6B, there is indicated more specifically
by numeral 40 a detailed block diagram of the stimulus sequencer.
The input of the stimulus sequencers 40 are the stimulus start
signal 32, stimulus rate signal 34 and the stimulus duration signal
36. The stimulus start signal 32 connects to sequence address
generator 406 internally gated enable port. The stimulus rate
signal 34 connects to the sequence address generator 406 clock
input port. The stimulus duration signal 36 connects to the
stimulus generator selector gated enable port. The sequence address
generator 406 connects to the sequence memory array 418 via the
address selection bus 412. The sequence address generator 406
receives its programmable count parameters through the 8-bit
parallel connection 404 from the sequence address generator 402.
The sequence address generator register 402 can be written and
read-back through the 8-bit internal control bus 92. The sequence
memory array 418 connects to the stimulus generator selector 430
via the stimulus sequence data bus 424. The sequence memory array
418 receives its sequence load control commands through the 8-bit
parallel connection 410 from the sequence load control register
408. The sequence load control register 408 can be written and
read-back through the 8-bit internal control bus 92. The sequence
memory array 418 receives its sequence address load commands
through the 8-bit parallel connection 416 from the sequence load
address register 414. The sequence load address register 414 can be
written and read-back through the 8-bit internal control bus 92.
The sequence memory array 418 receives its sequence data load
commands through the 8-bit parallel connection 422 from the
sequence load data register 420. The sequence load data register
420 can be written and read-back through the 8-bit internal control
bus 92. The stimulus generator selector 430 receives its stimulus
generator commands through the 8-bit parallel connection 428 from
the stimulus generator selector register 426. The stimulus
generator selector register 426 can be written and read-back
through the 8-bit internal control bus 92. The stimulus generator
selector 430 connects to the stimulus generator via the 8-bit
stimulus generator data bus 42.
[0294] Referring to FIG. 6C, there is indicated more specifically
by numeral 4002 a detailed stimulus sequence timing diagram for the
various types of aforementioned stimulus.
[0295] The stimulus sequencer disclosed herein may help to avoid
habituation to stimuli types in patients. In order to avoid
habituation to certain stimuli types a multitude of different
stimuli types may be generated and activated as needed in very
specific and deliberate sequences. The sequencer activates a very
specific stimulus generator as needed and as prescribed. The sleep
practitioner can input the stimulation sequence into the device for
diagnosis and therapy.
[0296] The sequencer may be capable of a fixed operation/manual
mode so that the sleep lab practitioner can operate the unit in
manual mode for the purpose of experimenting, diagnosing and
prescribing the optimum range for specific sleep patient's stimuli
type regimen.
Stimulus Generator
[0297] A stimulus generator may receive a generator select signal
from a stimulus sequencer as shown in FIGS. 2A and 2B. The
generator select signal may contain a sequence of stimulus types in
a specific order and may also define the duration of each stimulus.
The stimulus generator may include individual generators for each
stimulus type available such as one generator for generating a hiss
signal, another generator for generating a click signal, and
additional types as discussed below. The stimulus generator
processes the generator select signal by signaling the individual
generators defined by the generator select signal to generate a
stimulus signal for the duration also defined by the generator
select signal. The stimulus generator may then emit a stimulus
signal to a stimulus escalator or other portions of a stimulation
controller.
[0298] Referring to FIG. 7A, there is indicated more specifically
by numeral 50 a stimulus generator. The stimulus generator 50
receives its inputs via the stimuli select signal 42, from the
stimulus sequencer 40. The stimulus generator 50 connects via the
stimuli signal 52 to the stimulus escalator 60. For the purpose of
inter-device communication command and control, the Stimulus
Generator 50 connects to the common Device Controller Bus 92. A
detailed description of the stimulus generator 50 is provided below
and in a separately filed U.S. Provisional Patent Application
titled Stimulus Generator for a closed loop neuromodulator, filed
on Aug. 22, 2008, the contents of which are hereby incorporated by
reference herein.
[0299] A function of the stimulus generator is to provide different
types of stimuli in order to avoid habituation to stimuli signal in
patients. In order to avoid habituation to certain stimuli types a
multitude of different stimuli types have to be generated and
activated as needed. The sleep practitioner can input the
stimulation sequence into the device for diagnosis and therapy.
[0300] There is a need for fixed operation/manual mode so that the
sleep lab practitioner can operate the unit in manual mode for the
purpose of experimenting, diagnosing and prescribing the optimum
range for specific sleep patient's stimuli regimen.
[0301] The stimulus generator delivers the stimulus type according
either what the sleep practitioner has prescribed or what the
auto-adjusting routine has determined to be the optimal stimulus
type for the particular patient. The stimulus types can be but
either single or a combination thereof, but is not limited to:
[0302] 1. Tone
[0303] 2. Click
[0304] 3. Pop
[0305] 4. Noise
[0306] 5. Hiss
[0307] 6. Modulated
[0308] 7. Siren
[0309] 8. Warble
[0310] 9. Custom
[0311] Tone means that the stimulus type is harmonic in nature such
as sinusoidal, square, trapezoidal, triangular, saw tooth, etc type
signal waveforms. A tone may sound similar to a tone played on an
instrument.
[0312] Click means that the stimulus type is a single, abrupt and
sharp waveform transition generating a wide frequency spectrum. A
click may sound similar to a single sharp hand clap or door
slamming shut.
[0313] Pop means that the stimulus type is a single but less sharp
waveform transition generating a narrow frequency spectrum. A pop
may sound similar to a bottle of Champaign being opened or a
thunderclap from a single but distant lightning strike.
[0314] Noise means that the stimulus type is constant and consists
of all frequency components in the relevant frequency band of
interest. White noise for example has a very evenly distributed
frequency spectrum and its power distribution is constant over a
wide frequency range. Pink noise for example has a constant power
density in a given octave frequency ratio of F2/F1=2, were F2 is
the higher frequency and F1 is the lower frequency. White noise
sounds rather sharp whereas pink noise sounds rather mellow. A
noise signal may sound similar to a TV or Radio with the
transmitter turned off or similar to the sound of a high speed
train passing by.
[0315] Hiss means that the stimulus type is constant and consists
of all frequency components however experiencing natural signal
growth and signal decay. A hiss may sound like steam escaping from
a vent or an angry cat or an agitated snake.
[0316] Modulated means that the stimulus type is being modulated by
another signal similar to an amplitude modulation (AM) or frequency
modulation (FM). A modulated sound does not sound remind of
anything from this world. Most modulated sounds find applications
in science fiction movies.
[0317] Siren means that the stimulus type is being modulated by
high frequency ascending and descending waveform. A siren will
sound like a police care trying to get the drivers attention.
[0318] Warble means that the stimulus type is being modulated by
low frequency ascending and descending waveform. A warble may sound
like a piece of machinery working normally or working under
stress.
[0319] A custom stimulus generator provides a custom stimulus
signal type, for example, but not limited to, a recording of a
person's voice, such as that of crying baby to subliminally
stimulate a mother's central nervous system.
[0320] The sleep practitioner may load the stimulus generator
combinations as needed via remote terminal instructions into the
sequence memory array.
[0321] The sleep practitioner may also load the stimulus generator
frequencies, intensities and combinations as needed via remote
terminal instructions into the appropriate stimulus generator
registers.
[0322] All load, control, address and data values are being
communicated from the device controller through the internal
control bus via the individual registers.
[0323] The device controller communicates the information of which
is the current generator or combination is being selected.
[0324] Tone stimulus generator range: 0 to 255 variations
[0325] Click stimulus generator range: 0 to 255 variations
[0326] Pop stimulus generator range: 0 to 255 variations
[0327] Noise stimulus generator range: 0 to 255 variations
[0328] Hiss stimulus generator range: 0 to 255 variations
[0329] Modulated stimulus generator range: 0 to 255 variations
[0330] Siren stimulus generator range: 0 to 255 variations
[0331] Warble stimulus generator range: 0 to 255 variations
[0332] Referring to FIG. 7B, there is indicated more specifically
by numeral 50 a detailed block diagram of the stimulus generator.
The input of the stimulus generator 50 is the stimulus generator
select signal 42. The generator select signal 42 connects to the
bank of stimulus tone generators 506, 516, 526, 536, 546, 556, 566,
and 576. The stimulus generator select signal 42 connects to the
sequence address generator 406 input select port. The generator
signal 42 connects to the tone stimulus generator 506 Gen A enable
port. The tone stimulus generator 506 connects to the stimulus
generator-summing amplifier 580 via connection 508. The tone
stimulus generator 506 receives its programmable parameters through
the 8-bit parallel connection 504 from the tone stimulus generator
register 502. The tone stimulus generator register 502 can be
written and read-back through the 8-bit internal control bus 92.
The generator signal 42 connects to the click stimulus generator
516 Gen B enable port. The click stimulus generator 516 connects to
the stimulus generator-summing amplifier 580 via connection 518.
The click stimulus generator 516 receives its programmable
parameters through the 8-bit parallel connection 514 from the click
stimulus generator register 512. The click stimulus generator
register 512 can be written and read-back through the 8-bit
internal control bus 92. The generator signal 42 connects to the
pop stimulus generator 526 Gen C enable port. The pop stimulus
generator 526 connects to the stimulus generator-summing amplifier
580 via connection 528. The pop stimulus generator 526 receives its
programmable parameters through the 8-bit parallel connection 524
from the pop stimulus generator register 522. The pop stimulus
generator register 522 can be written and read-back through the
8-bit internal control bus 92. The generator signal 42 connects to
the noise stimulus generator 536 Gen D enable port. The noise
stimulus generator 536 connects to the stimulus generator-summing
amplifier 580 via connection 538. The noise stimulus generator 536
receives its programmable parameters through the 8-bit parallel
connection 534 from the noise stimulus generator register 532. The
noise stimulus generator register 532 can be written and read-back
through the 8-bit internal control bus 92. The generator signal 42
connects to the hiss stimulus generator 546 Gen E enable port. The
hiss stimulus generator 546 connects to the stimulus
generator-summing amplifier 580 via connection 548. The hiss
stimulus generator 546 receives its programmable parameters through
the 8-bit parallel connection 544 from the hiss stimulus generator
register 542. The hiss stimulus generator register 542 can be
written and read-back through the 8-bit internal control bus 92.
The generator signal 42 connects to the modulated stimulus
generator 556 Gen F enable port. The modulated stimulus generator
556 connects to the stimulus generator-summing amplifier 580 via
connection 558. The modulated stimulus generator 556 receives its
programmable parameters through the 8-bit parallel connection 554
from the modulated stimulus generator register 552. The modulated
stimulus generator register 552 can be written and read-back
through the 8-bit internal control bus 92. The generator signal 42
connects to the siren stimulus generator 566 Gen G enable port. The
siren stimulus generator 566 connects to the stimulus
generator-summing amplifier 580 via connection 568. The siren
stimulus generator 566 receives its programmable parameters through
the 8-bit parallel connection 564 from the siren stimulus generator
register 562. The siren stimulus generator register 562 can be
written and read-back through the 8-bit internal control bus 92.
The generator signal 42 connects to the warble stimulus generator
576 Gen H enable port. The warble stimulus generator 576 connects
to the stimulus generator-summing amplifier 580 via connection 578.
The warble stimulus generator 576 receives its programmable
parameters through the 8-bit parallel connection 574 from the
warble stimulus generator register 572. The warble stimulus
generator register 572 can be written and read-back through the
8-bit internal control bus 92. The stimulus generator-summing
amplifier 580 connects to the stimulus escalator via the stimulus
signal 52.
[0333] A single selected stimulus generator issues one pulse of its
specific signal type for the length of the incoming stimulus
duration.
[0334] The stimulus generator described herein may provide
anti-habituating sleep therapy using different types of stimuli in
order to avoid patient habituation to the stimuli signal. In order
to avoid habituation to certain stimuli types, a multitude of
different stimuli types may be generated and activated as needed.
The sleep practitioner can input the stimulation sequence into the
device for diagnosis and therapy.
[0335] The device may also provide for a fixed operation/manual
mode so that the sleep lab practitioner can operate the unit in
manual mode for the purpose of experimenting, diagnosing and
prescribing the optimum range for specific sleep patient's stimuli
regimen.
[0336] In one embodiment, a stimulus generator for a closed loop
neuromodulator includes a plurality of stimulus generators,
corresponding plurality of stimulus generator registers, and a
stimulus generator summing amplifier. The plurality of stimulus
generators may include eight stimulus generators each directed at
different generating different stimuli. The eight stimulus
generators may include a tone generator, a click generator, a pop
generator, a noise generator, a hiss generator, a modulated
generator, a siren generator, and a warble generator.
Stimulus Escalator
[0337] A stimulus escalator may receive a stimulus signal 52, a
stimulus start signal 32, and a stimulus rate signal 34 from a
stimulus generator as shown in FIGS. 2A and 2B. In an effort to
avoid overly stimulating a sleep patient it is often effective to
start with a relatively low level stimulus and increase the
stimulus level until the appropriate level is reached. The stimulus
escalator implements this rationale, by receiving the input signals
listed above and emitting a corresponding driver signal with a
given level signal. The stimulus escalator may determine how to
increase each signal (e.g. linearly, exponentially, etc.)
[0338] Referring to FIG. 8A, there is indicated more specifically
by numeral 60 a stimulus escalator. The stimulus escalator 60
receives its inputs via the stimulus signal 52 from the stimulus
generator 50 and stimulus start signal 32 and stimuli rate signal
34 from the stimulus timer 30. The stimulus escalator 60 connects
via the driver signal 62 to the EMI/ESD hardened transducer driver
70. For the purpose of inter-device communication command and
control, the Stimulus Escalator 60 connects to the common Device
Controller Bus 92. A detailed description of the stimulus escalator
60 is provided below and in a separately filed U.S. Provisional
Patent Application titled Stimulus Escalator for a closed loop
neuromodulator, filed on Aug. 22, 2008, the contents of which are
hereby incorporated by reference herein.
[0339] A function of the stimulus escalator is to provide
anti-habituating sleep therapy to avoid habituation to stimuli
levels in patients. In order to avoid habituation to certain
stimuli levels a multitude of different stimuli levels have to be
generated and activated as needed in very specific and deliberate
level escalation. The escalator activates a very specific stimulus
level as needed and as prescribed. The sleep practitioner can input
the stimulation escalation gain and escalation envelope function
via an escalation table into the device for diagnosis and
therapy.
[0340] There is a need for fixed operation/manual mode so that the
sleep lab practitioner can operate the unit in manual mode for the
purpose of experimenting, diagnosing and prescribing the optimum
range for specific sleep patient's stimuli level regimen.
[0341] The stimulus escalator decides on which stimulus level is to
be applied and with what escalation envelope function. The envelope
functions can be but are not limited to:
[0342] 1. Constant
[0343] 2. Linear
[0344] 3. Polynomial
[0345] 4. Exponential
[0346] 5. Logarithmic
[0347] Constant means that the same stimulus level escalation
envelope function is constant that the same stimulus level is
repeatedly applied every time a stimulus is being issued.
[0348] Linear means that the same stimulus level escalation
envelope function is linear and in the form Y=Ax+B so that the next
applied stimulus obeys the aforementioned mathematical relationship
with the previously issued stimulus.
[0349] Polynomial means that the same stimulus level escalation
envelope function is polynomial and in the form Y=A*x.sup.2+B*x+C
so that the next applied stimulus obeys the aforementioned
mathematical relationship with the previously issued stimulus.
[0350] Exponential means that the same stimulus level escalation
envelope function is polynomial and in the general form
Y=A*e.sup.-(x/B), so that the next applied stimulus obeys the
aforementioned mathematical relationship with the previously issued
stimulus.
[0351] Logarithmic means that the same stimulus level escalation
envelope function is polynomial and in the general form
Y=A*Log.sub.n(B*x), so that the next applied stimulus obeys the
aforementioned mathematical relationship with the previously issued
stimulus.
[0352] An element of the stimulus escalator is its escalation
memory array which is loaded with the escalation level envelope
values as selected and described above either on start-up or during
operation by the device controller who manages and keeps track of
the stimulus sequencing.
[0353] The escalation memory array is of a 256.times.8-bit
<00Hex to <FFHex> read writable random access memory (RAM)
type. The escalation memory array can be any size memory and is not
limited to 256.times.8-bit.
[0354] The sleep practitioner may load the escalation values as
needed via remote terminal instructions into the escalation memory
array.
[0355] All load, control, address and data values are being
communicated from the device controller through the internal
control bus via the individual registers.
[0356] The device controller communicates the escalation
information of which is the current stimulus level, which is the
next stimulus level and which was the last stimulus level
issued.
[0357] Escalation address generator range: 0 to 255 addresses
[0358] Escalation load control range: 8-bit (clear, set, reset,
clock)
[0359] Escalation load address range: 8-bit (A0 . . . A7)
[0360] Escalation date load range: 8-bit (DB0 . . . DB7)
[0361] The device controller keeps track of the following:
escalation start levels and escalation end levels.
[0362] Upon receipt of the stimulus start signal, the 8-bit or
N-bit programmable escalation generator/counter selects the next
escalation level upon receipt of the stimulus rate signal for
generating the escalation level of the appropriate stimulus
generator. With each new stimulus duration signal clocked into the
escalation address generator, a new address is being generated and
input into the escalation memory array for selection of the
particular stimulus level for that specific stimulus.
[0363] Referring to FIG. 8B, there is indicated more specifically
by numeral 60 a detailed block diagram of the stimulus escalator.
The inputs of the stimulus escalator 60 are the stimulus start
signal 32, the stimulus rate signal 34 and the stimulus signal 52.
The stimulus start signal 32 connects to the escalation address
generator 606 internally gated enable port. The stimulus rate
signal 34 connects to the escalation address generator 606 clock
input port. The escalation address generator 606 connects to the
escalation memory array 618 via the address selection bus 612. The
escalation address generator 606 receives its programmable count
parameters through the 8-bit parallel connection 604 from the
escalation address generator 602. The escalation address generator
register 602 can be written to and read-back from the 8-bit
internal control bus 92. The escalation memory array 618 connects
to the programmable gain amplifier 630 via the escalation data bus
624. The escalation memory array 618 receives its escalation load
control commands through the 8-bit parallel connection 610 from the
escalation load control register 608. The escalation load control
register 608 can be written to and read-back from the 8-bit
internal control bus 92. The escalation memory array 618 receives
its escalation address load commands through the 8-bit parallel
connection 616 from the escalation load address register 614. The
escalation load address register 614 can be written and read-back
through the 8-bit internal control bus 92. The escalation memory
array 618 receives its escalation data load commands through the
8-bit parallel connection 622 from the escalation load data
register 620. The escalation load data register 620 can be written
to and read-back from the 8-bit internal control bus 92. The
programmable gain amplifier 630 receives its gain setting data
through the 8-bit parallel connection 628 from the programmable
gain amplifier register 626. The programmable gain amplifier
register 626 can be written to and read-back from the 8-bit
internal control bus 92. The programmable gain amplifier 430
connects to the EMI/ESD hardened transducer driver via the driver
signal 62.
[0364] The programmable gain amplifier 430 can be programmed in 0.3
dB gain steps per bit. In a gain block the gain is expressed in
decibel (dB). Loss or gain is expressed in dB. The loss/gain range
of the programmable gain amplifier is about 76.5 dB but more or
less possible.
[0365] In one embodiment, a stimulus escalator for a closed loop
neuromodulator includes an escalation address generator, an
escalation register array, and a programmable gain amplifier. In
another embodiment, the stimulus escalator further includes an
escalation address generator register, where the escalation address
generator is configured to receive escalation addresses from the
escalation address generator register. In another embodiment, the
stimulus escalator further includes an escalation load control
register, an escalation load address register, and an escalation
load data register. In yet another embodiment, the stimulus
escalator further includes a programmable gain amplifier
register.
EMI/ESD Hardened Transducer Driver
[0366] A transducer driver may receive input from a stimulus
escalator and may then transmit this signal to a transducer, as
shown in FIGS. 2A and 2B. Moreover, as also depicted in FIGS. 2A
and 2B, this sensor interface may be the final output or exit
location for a stimulation controller and may therefore be a
potential inlet for EMI and ESD. Thus, the transducer driver may be
equipped with EMI and ESD protection to prevent interference with
and/or damage to the transducer driver or the overall
controller.
[0367] Referring to FIG. 9A, there is indicated more specifically
by numeral 70 an EMI/ESD hardened transducer driver. The EMI/ESD
hardened transducer driver 70 receives its input via the driver
signal 62 from the output of the stimulus escalator 60. The EMI/ESD
hardened transducer driver 70 connects via the pair of wire
terminals 5 to the transducer 6. A detailed description of the
EMI/ESD hardened transducer driver 70 is provided below and in a
separately filed U.S. Provisional Patent Application titled EMI/ESD
Hardened Transducer Driver for a closed loop neuromodulator, filed
on Aug. 22, 2008, the contents of which are hereby incorporated by
reference herein.
[0368] Even though most countries have legal requirements that
mandate EMC compliance, electronic devices must still work
correctly when subjected to certain amounts of electromagnetic
interference (EMI), and should not emit EMI, which could interfere
with other equipment. This issue is known in the industry as
self-compatibility and this fact is crucial to the operation of the
invention because of the very low analog biomedical signals
involved.
[0369] A robust sleep therapy system works reliably in a modern
harsh and hostile environment in close proximity to cell phone
transmissions, wireless internet transmitters, wireless phone
system transmitters, etc. Modern environments, even home
environments have high concentration of EMI and RFI especially in
the 60 Hz/120 Hz due to home power wiring and fluorescent, compact
fluorescent lighting and switch mode power supplies operating in
home appliances. Additionally, wireless technology such as wireless
telephone transmissions, wireless routers, cordless phone systems,
remote control burglar alarm devices, remote control toys, and the
like may emit EMI. Issues of self-compatibility are also a concern
and involve minimizing the emission of EMI that could interfere
with other portions of the device or other equipment. Thus, EMI
that could interfere with a sleep device is a concern, but the EMI
emitted by the device is also a concern.
[0370] ESD hardening protects sensitive electronic due to common
and regular handling of the product containing the sensitive
electronics in a standard home environment were static discharges
are common especially during the winter seasons in colder climate
zones and during the dry seasons in warmer climate zones.
[0371] EMI/ESD hardening against the aforementioned offenders not
only satisfies domestic and international requirements on emissions
and susceptibility but also results in robust operation, cleaner
internal signals, improved signal-to-noise-ratio (SNR) and greater
dynamic range.
[0372] Due to the nature of the device application, through its
typical long sensor and transducer wires, exposure of the output to
ESD may potentially destroy the transducer driver circuitry. Thus,
special ESD countermeasures have to be put in place in order to
prevent damage or total destruction of the sensitive, low power
circuitry.
[0373] The following is a list of EMC component level
countermeasures for the EMI/ESD hardened transducer driver:
[0374] 1. Feed-through capacitors
[0375] 2. Balanced drive amplifier
[0376] 3. Matched gain setting resistor network to maintaining high
CMRR
[0377] 4. Ferrite beads, series EMI suppression element
[0378] 5. Filter capacitors, parallel EMI suppression element
[0379] 6. Common mode RF filter, parallel EMI suppression
element
[0380] 7. Common mode RF choke, series EMI suppression element
[0381] 8. Capacitor as signal decoupling, parallel EMI suppression
element
[0382] 9. Inductor as signal lead filtering, series EMI suppression
element
[0383] 10. Capacitor as power feed filtering, parallel EMI
suppression element
[0384] 11. Inductor as power feed filtering, series EMI suppression
element
[0385] 12. Schottky diodes, EMI suppression parallel element
[0386] 13. Resistors, series EMI suppression element
[0387] 14. Inductors, series EMI suppression element
[0388] 15. Cascaded capacitor banks, 0.01 uf and 10 uF
[0389] 16. Inductors in V+ and V-feeds before capacitor cascade,
power feed output
[0390] For the purpose of EMI/RFI shielding of the EMI/ESD hardened
transducer driver 70, a metal case is mounted on to of the PCB
picket fenced circuit boundary. The picket fence is connected to
the ground pane and ground flooded signal layer.
[0391] The following is a list of PCB based EMC countermeasures for
the EMI/ESD hardened transducer driver:
[0392] 1. Power and ground planes
[0393] 2. Layer flooding
[0394] 3. Picket fencing
[0395] 4. Short and narrow signal traces
[0396] 5. Short and wide power traces
[0397] 6. Components must be placed in close proximity to each
other
[0398] 7. PCB routing must be as short as possible
[0399] 8. Short and wide traces are better than long and skinny
ones
[0400] The following operational parameters that are adjustable
within the EMI/ESD hardened sensor Interface:
[0401] 1. Amplifier gain (-20 dB to +20 dB)
[0402] Referring to FIG. 9B there is indicated more specifically by
numeral 70 a detailed block diagram of the EMI/ESD hardened
transducer driver. The input signal 42 for the EMI/ESD hardened
transducer driver 70 is being generated by the output of the
stimulus escalator. The supply filtered balanced drive amplifier
704 amplifies the input signal 42 to match the appropriate drive
level of the externally connected transducer 6. The balanced output
wire pair 720 of the supply filtered balanced drive amplifier
connects to the ESD protection circuit 706. The balanced output
wire pair 722 of the ESD protection circuit 706 connects to the
internal EMI/RFI filter 708. The balanced output wire pair 724 of
the internal EMI/RFI filter 708 penetrates the metal casing 701 and
connects to the external EMI/RFI filter. The balanced output wire
pair 726 of the external EMIRFI filter connects to the transducer
output connector 712. The metal shield 701 covers as the sensitive
signal carrying analog signal circuit as indicated and is connected
to a multitude of 1/4'' spaced ground connections 701 for providing
a very low impedance connection to circuit ground even at extremely
high frequencies. The metal shield 701 in connection with the
printed circuit ground plane on the opposite side of the PCB and
with an RF tight picket fence constructed of interleaved vias that
connect the ground plane to the ground flooded top component copper
layer forms a continuous electrostatic shield around the entire
volume of the EMI/ESD hardened transducer driver 70.
[0403] Referring to FIG. 9C, there is indicated a schematic diagram
specifically by numeral 70 an EMI/ESD hardened transducer
driver.
[0404] The input signal 42 for the EMI/ESD hardened transducer
driver 50 is being generated by the output of the stimulus
escalator. The supply filtered balanced drive amplifiers 704
comprise of operational amplifiers (opamps) U1 and U2. Both opamps
U1 and U2 are connected in a two-amplifier balanced drive amplifier
configuration. The balanced amplifier gain is set by the ratio of
the resistors R2/R1 and R4/R3. Resistor R2 by means of connection
to signal ground provides drift compensation for opamp U1. Resistor
R5 by means of connection to signal ground provides drift
compensation for opamp U2. Negative supply filtering of the
operational amplifier U1 comprises of a conducted RF power
absorbing inductor L1 and a conducted RF power suppressing cascaded
capacitor bank consisting of C1 and C3 in parallel to ground. The
conducted RF power absorbing inductor L1 is connected in series
with the negative supply power terminal V- and the negative power
supply terminal 2 of the operational amplifier U1. Positive supply
filtering of the operational amplifier U1 comprises of a conducted
RF power absorbing inductor L2 and a conducted RF power suppressing
cascaded capacitor bank consisting of C2 and C5 in parallel to
ground. The conducted RF power absorbing inductor L2 is connected
in series with the positive supply power terminal V+ and the
positive power supply terminal 5 of the operational amplifier U1.
Furthermore, conducted emissions bypassing capacitor C4 is
connected across the U1 operational amplifier power pin 2 and pin
5. Negative supply filtering of the operational amplifier U2
comprises of a conducted RF power absorbing inductor L3 and a
conducted RF power suppressing cascaded capacitor bank consisting
of C6 and C8 in parallel to ground. The conducted RF power
absorbing inductor L3 is connected in series with the negative
supply power terminal V- and the negative power supply terminal 2
of the operational amplifier U2. Positive supply filtering of the
operational amplifier U2 comprises of a conducted RF power
absorbing inductor L4 and a conducted RF power suppressing cascaded
capacitor bank consisting of C7 and C10 in parallel to ground. The
conducted RF power absorbing inductor L4 is connected in series
with the positive supply power terminal V+ and the positive power
supply terminal 5 of the operational amplifier U2. Furthermore,
conducted emissions bypassing capacitor C9 is connected across the
U2 operational amplifier power pin 2 and pin 5. The balanced ended
output of the supply filtered balanced drive amplifier 704 connects
to the output ESD protection 706. The ESD protection 706 comprises
primarily of diodes D1, D2, D3 and D4. The cathode of D1 is
connected to the positive supply terminal. The anode of D1 is
connected to the output terminal 1 of opamp U1. The anode of D2 is
connected to the negative supply terminal. The cathode of D2 is
connected to the output terminal 1 of opamp U1. The cathode of D4
is connected to the positive supply terminal. The anode of D4 is
connected to the non-inverting input terminal 3 of opamp U2. The
anode of D3 is connected to the negative supply terminal. The
cathode of D3 is connected to the non-inverting input terminal 3 of
opamp U2. D1 through D4 present the parallel clamping element of
the ESD protected opamp input terminal. Resistors R7 and R8 in
connection with the Diodes D1, D2, D3 and D4 form an ESD
suppression circuit. Resistors R7 and R8 form the series ESD power
absorbing elements. It is clearly shown that the output terminal 1
of the operational amplifiers U1 and U2 of the supply filtered
balanced drive amplifier 704 are EMI and ESD protected. The
internal EMI/RFI filter 708 comprises a differential mode filtering
capacitor C15 connected to C16 and C17. Also connected to C16 and
C17 is the input wire pair of a high frequency common mode choke
L5. The output wire pair of the high frequency common mode choke L5
is connected to the input of the two ESD energy absorbing series
resistors R7 and R8 and to a second filter capacitor C14. The
output wire pair of the energy absorbing resistors R7 and R8 is
connected to another set of EMI suppressing filter capacitors C11
C12 and C13. The sensor output connector 712 comprises of connector
J2 with the two-signal wire pair leads designated as pin 1 and pin
2 respectively. The external EMI/RFI 710 filter comprises of a pair
of ferrite beads FB1 and FB2 acting as the filter series element,
and of a pair of metal shield penetrating feed-through capacitors
C16 and C17 as the parallel element to ground for common mode
filtering. The EMI/ESD hardened transducer driver 70 is designed to
drive various transducer types.
[0405] The following is a list of possible transducers that may be
connected to the EMI/ESD hardened transducer driver 70.
[0406] Acoustic transducers by which a sound is introduced into the
ear canal or the room to disrupt the undesired behavior and
pattern.
[0407] Ultrasonic transducers by which an audio tone is used to
modulate an ultrasonic beam directed at the patient. The brain
demodulates the signal and the detected audio signal is perceived
as such. The ultrasonic beam is very narrow thus; only the patient
is subjected to it, the rest of the space remains quiet and
unaffected. Therefore, no aural ear bud phones would be needed.
[0408] Tactile transducers by which a mechanical device such as the
mechanical agitator applies a gentle touch to the patient's
skin.
[0409] Visual transducers by which a flash of light is applied to
the eyes. An eye cover with red LED which would turn on for a short
amount of time during stimulation.
[0410] Puff-of-Air transducers by which an air puff is applied to
the patient's skin.
[0411] Electrical transducers (biomedical electrodes) by which a
gentle electrical stimulation is applied to the patient's skin.
[0412] Alternatively, a signal duplexer can be used in order to
utilize the same PVDF sensor that is detecting airflow with
pyroelectric and piezoelectric properties as the stimuli delivering
transducer. The pyroelectric and piezoelectric properties of the
PVDF film are reciprocal. This is because the piezoelectric
capability of the film included either converting mechanical
vibrations to electrical signals and/or converting electrical
signals to mechanical, including audio or ultrasound
vibrations.
[0413] In one embodiment, an EMI/ESD hardened transducer driver for
a closed loop neuromodulator includes a supply filtered balanced
drive amplifier, an ESD protection device, at least one EMI/RFI
filter, a grounded metal shield, and a transducer output connector.
In another embodiment, both an internal and an external EMI/RFI
filter are provided. In another embodiment, the external EMI/RFI
filter is situated along a signal path outside the grounded metal
shield. In yet another embodiment, the internal EMI/RFI filter is
situated along a signal path inside the grounded metal shield. In
another embodiment, each of the elements are arranged in
series.
Diagnostic Indicator and PSG Interface
[0414] In sleep medicine, a stimulation controller may be used to
receive input from a sensor on a patient, analyze the input, and
further may be used to activate a transducer to stimulate the
patient. FIGS. 1A and 1B show at least two embodiments of a
stimulation controller in position on a patient. The following
description relates to a diagnostic indicator and PSG interface
included in a stimulation controller.
[0415] As shown in FIGS. 2A and 2B, the diagnostic indicator and
PSG interface may receive input from various devices in a
stimulation controller. The purpose of the diagnostic indicator is
to provide an indication to the user or the sleep practitioner of
what information the stimulation controller is receiving, what
functions it is performing, and what information it is
transmitting. The diagnostic indicator may include a series of
LED's indicating such information. Additionally, the diagnostic
indicator and PSG interface may be compatible with a PSG machine
and thereby provide a sleep practitioner with more sophisticated
output beyond LED output.
[0416] A detailed description of the Diagnostic Indicator and PSG
Interface 80 is provided below and in a separately filed U.S.
Provisional Patent Application titled Diagnostic Indicator and PSG
Interface for a closed loop neuromodulator, filed on Aug. 22, 2008,
the contents of which are hereby incorporated by reference
herein.
[0417] Referring to FIG. 10A, there is indicated more specifically
by numeral 80 a Diagnostic Indicator and PSG Interface. The
Diagnostic Indicator and PSG Interface 80 receives multiple inputs
from the other elements of the closed loop neuromodulator. The
following signals are inputs to the Diagnostic Indicator and PSG
Interface 80: The Analog airflow signal 130 and the digital airflow
signal 12 from the EMI/ESD Hardened Sensor Interface, the activity
signal 22, from the Activity detector, the stimuli signal 52 from
the Stimulus Generator and the driver signal 62 from the Stimulus
Escalator. A push button switch 38 also connects to the Diagnostic
Indicator and PSG Interface 80 via the push button input connection
39 for the purpose of activating the sleep therapy delay timer. The
following signals are outputs from the Diagnostic Indicator and PSG
Interface 80: The therapy delay indicator 81, the inhalation
indicator 82, the power indicator 83, the therapy mode indicator
84, the apnea indicator 85, the apneas detected indicator 86, the
diagnostic mode indicator 87, the exhalation indicator 88, and the
stimulus indicator 89. The Diagnostic Indicator and PSG interface
80 connects via the PSG connection 7 to the PSG machine 8. A
detailed description of the stimulus escalator 40 is provided
below.
[0418] The diagnostic indicator and PSG interface provide a simple
human-machine interface for indicating internal device operation
and connection to external diagnostic instrumentation such as a PSG
for further analysis of patient data gathered by the closed loop
neuromodulator.
[0419] Pushing the therapy delay button when the unit is in therapy
delay mode, de-activates the therapy delay mode, turns the therapy
delay indicator off and resets the count down timer.
[0420] The therapy delay indicator 81 notifies the sleep
practitioner or patient that the therapy delay timer is active and
that the device will not provide any therapy until that indicator
turns off.
[0421] The inhalation indicator 82 notifies the sleep practitioner
or the patient that the patient respiration cycle is currently in
the inhalation phase.
[0422] The power indicator 83 notifies the sleep practitioner or
the patient that the power to the closed loop neuromodulator is
turned on and that the device has passed its self-test routing.
[0423] The therapy mode indicator 84 notifies the sleep
practitioner or the patient that the closed loop neuromodulator is
currently in therapy mode.
[0424] The apnea indicator 85 notifies the sleep practitioner that
the patient is currently experiencing a sleep apnea episode or any
other CNS disorder that the modulator is configured for.
[0425] The apneas detected indicator 86 notifies the sleep
practitioner or the patient that the patient has experienced sleep
apneas during the current therapy or diagnostic cycle.
[0426] The diagnostic mode indicator 87 notifies the sleep
practitioner or the patient that the closed loop neuromodulator is
currently in therapy mode.
[0427] The exhalation indicator 88 notifies the sleep practitioner
or the patient that the patient respiration cycle is currently in
the exhalation phase.
[0428] The stimulus indicator 89 notifies the sleep practitioner
that the patient is currently experiencing a sleep apnea episode
and that a stimulus is currently being applied.
[0429] Referring to FIG. 10B, there is indicated more specifically
by numeral 80 a detailed block diagram of the diagnostic indicator
and PSG interface. The Diagnostic Indicator and PSG Interface 80
receives multiple inputs from the other elements of the closed loop
neuromodulator. The Analog airflow signal 130 connects to the
airflow signal buffer 828. The Airflow signal buffer output 830
connects to the input of the Analog airflow output 832. The analog
airflow output port 834 is bundled together with the PSG connection
port 7. The stimuli signal 52 connects to the stimulus signal
buffer 812. The stimuli signal buffer output 814 connects to the
input of the stimulus marker output 816. The stimulus marker output
port 818 is bundled together with the PSG connection port 7. The
driver signal 62 connects to the driver signal buffer 820. The
driver signal buffer output 820 connects to the input of the
stimulus sound monitor output 824. The stimulus sound monitor
output 826 is bundled together with the PSG connection port 7. The
digital airflow signal 12 connects to the digital airflow signal
buffer 802. The Digital airflow signal buffer 802 separates the
inhalation phase of the digital airflow signal 12 from the
exhalation phase of the digital airflow signal 12. The exhalation
output port 804 of the digital airflow signal buffer 802 drives the
Exhalation LED driver 854. The output of the exhalation LED driver
854 drives the exhalation indicator 88. The inhalation output port
806 of the digital airflow signal buffer 802 drives the inhalation
LED driver 852. The output of the inhalation LED driver 852 drives
the inhalation indicator 82. The activity signal 22 connects to the
activity signal buffer 810. The activity signal buffer output port
808 of the activity signal buffer 810 drives the input of the apnea
LED driver 850. The output of the apnea LED driver 850 drives the
apnea indicator 85. The push button switch connection 39 connects
to the push button latch 868. The push button latch output 870
connects to a single bit read port of the diagnostic indicator
register 836. After the diagnostic indicator, register 836 has
accessed and read the status of the push button latch 868, the push
button latch 868 clears and is ready to accept another push button
activation. The diagnostic indicator register 836 can be written to
and read-back from the 8-bit internal control bus 92. Writing to
the diagnostic indicator register 836 sets or resets the LED driver
driving output bits. The output port 838 of the diagnostic
indicator register 836 drives the Apneas detected LED driver 856.
The output of the Apneas detected LED driver 856 drives the apneas
detected indicator 86. The output port 840 of the diagnostic
indicator register 836 drives the power-on LED driver 858. The
output of the power-on LED driver 858 drives the power-on indicator
83. The output port 842 of the diagnostic indicator register 836
drives the therapy delay LED driver 860. The output of the therapy
delay LED driver 860 drives the therapy delay indicator 81. The
output port 844 of the diagnostic indicator register 836 drives the
diagnostic mode LED driver 862. The output of the diagnostic mode
LED driver 862 drives the diagnostic mode indicator 87. The output
port 846 of the diagnostic indicator register 836 drives the
therapy mode LED driver 864. The output of the therapy mode LED
driver 864 drives the therapy mode indicator 84. The output port
848 of the diagnostic indicator register 836 drives the stimulus
LED driver 866. The output of the stimulus LED driver 866 drives
the stimulus indicator 89.
[0430] In one embodiment, a diagnostic indicator for a closed loop
neuromodulator includes a plurality of incoming signal buffers, a
diagnostic indicator register, and a plurality of LED drivers. In
another embodiment, a stimulus marker output is also included. In
another embodiment, the diagnostic indicator includes a stimulus
sound monitor output. In yet another embodiment, an analog airflow
output is included. In still another embodiment, a push button
latch is included.
[0431] In another embodiment, a method of using a PSG machine in
conjunction with a stimulation controller is provided.
Device Controller and Data Logger
[0432] In sleep medicine, a stimulation controller may be used to
receive input from a sensor on a patient, analyze the input, and
further may be used to activate a transducer to stimulate the
patient. FIGS. 1A and 1B show at least two embodiments of a
stimulation controller in position on a patient. The following
description relates to a device controller and data logger included
in a stimulation controller for interfacing with a wide range of
sensors.
[0433] The device controller and data logger, as shown in FIGS. 2A
and 2B, may be placed in communication with various elements of a
closed loop neuromodulator via an internal control bus. Each
element of the closed loop neuromodulator may contain a register or
series of registers that the device controller and data logger is
in communication with. The device controller and data logger can
write to and read from the several registers throughout the closed
loop neuromodulator and log information as well as interpret and
react to the information. The device controller and data logger can
then write new information to the several registers throughout the
closed loop neuromodulator. Parameters relating to stimulus type,
stimulus rate, stimulus duration, stimulus level, stimulus
escalation, and stimulus sequence are all adjustable for purposes
of precisely dosing sleep patients.
[0434] The above functions can be completed without the support of
sleep practitioner supervision. However, the device controller and
data logger may be placed in communication with a remote diagnostic
terminal which allows a sleep practitioner to modify various
settings within the closed loop neuromodulator to allow for more
precise dosing of patients.
[0435] A detailed description of the Device Controller and Data
Logger 90 is provided below and in a separately filed U.S.
Provisional Patent Application titled Device Controller and Data
Logger for a closed loop neuromodulator, filed on Aug. 22, 2008,
the contents of which are hereby incorporated by reference
herein.
[0436] Referring to FIG. 11A, there is indicated more specifically
by numeral 90 a device controller and data logger. The common
device controller and data logger 90 is connected on the external
side to the remote diagnostic terminal 14 and on the internal side
to the device controller bus 92. A detailed description of the
device controller and data logger 90 is provided below.
[0437] A purpose of the device controller and data logger provides
an inter-device communication command and control for the closed
loop neuromodulator. Furthermore, the device controller and data
logger provides an external communication interfaced to the remote
terminal for the closed loop neuromodulator. In addition, the state
controller within the device controller executes the state-by-state
instructions of the auto-adjusting routing, the auto-optimizing
routine and the auto-dosing routine. Those routines are described
in detail below.
[0438] Referring to FIG. 11B, there is indicated more specifically
by numeral 90 a detailed block diagram of the device controller and
data logger.
[0439] The external communication interface 9 includes a USB
interface and an Ethernet interface. The external communication
interface 9 connects via connection 902 to the Ethernet port 904.
The Ethernet 904 port connects to the Ethernet controller 908 via
connection 906. The external communication interface 9 connects via
connection 922 to the USB port 914. The USB port 914 connects to
the USB controller 918 via connection 916. The communication
controller 922 connects to the Ethernet controller 908 via
connection 910 and to the USB controller via connection 920. The
state machine 930 connects to the communication controller 922 via
connection 924. The state machine 930 connects to the power-on
reset generator 934 via connection 932. The state machine 930
connects to the internal data bus interface 946 via the multi-bit
control bus 936, via the multi-bit address bus 938 and via the
multi-bit data bus 940. The state machine 930 connects to the
stimulation escalation array loader 928 via the multi-bit control
bus 936, via the multi-bit address bus 938 and via the multi-bit
data bus 940. The state machine 930 connects to the real-time-clock
926 via the multi-bit control bus 936, via the multi-bit address
bus 938 and via the multi-bit data bus 940. The state machine 930
connects to the device register memory 942 via the multi-bit
control bus 936, via the multi-bit address bus 938 and via the
multi-bit data bus 940. The state machine 930 connects to the
stimulation sequence array loader 944 via the multi-bit control bus
936, via the multi-bit address bus 938 and via the multi-bit data
bus 940. The internal data bus interface 946 communicates to all
other bus-interfacing registers of the closed loop neuromodulator
through the 8-bit parallel control bus 92.
[0440] In one embodiment, a device controller and data logger for a
closed loop neuromodulator includes a communication controller, a
state machine, an internal data bus interface, a real time clock,
an escalation register array loader, a sequence register array
loader, and a device register memory. In another embodiment, the
communication controller is adapted to connect to a remote terminal
via a USB or Ethernet connection. In another embodiment, the device
controller further includes a power-on reset generator. In still
another embodiment, the device controller is in communication with
a closed loop neuromodulator via an internal control bus connected
to the internal data bus interface.
Auto-Adjusting, Optimization and Dosing
[0441] Start with lowest possible stimuli and increase towards
optimum and not starting with highest possible stimuli and decrease
towards optimum because highest possible stimuli will generate an
arousal of the CNS.
[0442] Ideally, the ratio of stimuli generated to airflow-detected
occurrences is above 2 to 1. The rationale for this is that the
first stimuli signal should not generate any arousal so that it is
established that the signal level is low enough as neither to
change the sleeping patients sleep state nor to awake him. Then
with that base stimuli level established, the next stimuli level
generated should be high enough to cause and arousal in order to
cause resumption of breathing. Since the first level was not high
enough to cause any cortical arousal and the second level was just
slightly above the first level, one can safely assume that the
second level was not strong enough to neither change the sleeping
patients sleep state nor wake him up completely. This device
automatically figures out both levels.
[0443] Patient setup during a first use includes measuring and
setting an actual and optimal level of stimulation for each
individual patient automatically during first use, then storing the
associated parameters in a setup register.
[0444] Making sure that the individual patient responds to the
applied stimuli within the predetermined time.
[0445] Self Optimizing includes constantly measuring the ratio
between applied stimuli and non-breathing events to make sure that
the patient changes neither sleep state nor wakes up due to over
stimulation. Furthermore making sure that the patient does not
remain in an apnea state due to under stimulation
[0446] Latch in third to the last stimuli gain setting before the
resumption of breathing and start there, as the next first stimuli
level for the next no breathing episode.
[0447] Escalation steps change from soft to mild to moderate to
strong then harsh.
[0448] Record in memory the last gain setting that caused the
resumption of breathing.
[0449] Typically, stimuli type optimization is performed in a
clinic on a diagnostic level. The method of stimuli type selection
in the apparatus is for the benefit of the sleep practitioner and
clinical researcher so that the optimum stimuli or sequence of
stimuli for the desired response can be selected.
[0450] CNS respiration resumption delay is the time difference
between stimuli detection to resumption of breathing.
[0451] CNS stimulus detection delay is the time difference between
stimuli started to arousal.
[0452] A detailed description of the Method for Dosage Optimization
is provided below and in a separately filed U.S. Provisional Patent
Application titled Method for Dosage Optimization in a closed loop
neuromodulator, filed on Aug. 22, 2008, the contents of which are
hereby incorporated by reference herein.
[0453] Stimulus dosage optimization is about constantly monitoring
the effect that the presently applied stimulus has on the sleeping
patient's CNS and subsequently appropriately adjusting the next
stimulus in order to achieve the optimal transfer of energy into
the CNS for the sleeping patient at the time when the patient
requires apnea therapy without waking the patient or significantly
changing the sleep state of the patient.
[0454] Patient setup is about learning what the initial stimulus
parameters are that result in an optimal transfer of energy into
the sleeping patient's CNS.
[0455] For the nonprofessionals, the escalation steps change from
soft to mild to moderate to strong then harsh.
[0456] The method may be used in conjunction with a central nervous
system stimulation controller such as that described herein.
[0457] Additionally, the method may be applied while using a
transducer such as that described in the U.S. Provisional Patent
Application titled Agitator to Stimulate the Central Nervous System
filed on May 2, 2008, with Ser. No. 61/049,802, the contents of
which are hereby incorporated by reference herein.
[0458] Additional U.S. patents hereby incorporated by reference
herein include:
TABLE-US-00001 Dymedix Patents Granted U.S. Pat. No. Inventor(s)
Breath Sensing Apparatus 5,311,875 Stasz et al. Electronic
Temperature/Pressure D410.584 Stasz et al. Transducer Electronic
Temperature/Pressure D417.161 Stasz et al. Transducer Pyro/Piezo
Sensor 6,254,545 Stasz et al. Pyro/Piezo Sensor with Enhanced
6,485,432 Stasz et al. Sound Response Pyro/Piezo Sensor 6,491,642
Stasz Snore Sensor 6,551,256 Stasz et al. Signal Processing Circuit
for Pyro/Piezo 6,702,755 Stasz et al. Transducer Nasal Vibration
Transducer 6,894,427 Alfini
[0459] A patient setup is performed during a first application of
stimuli. During the first time use, a closed loop neuromodulator
performs a patient setup for patient assessment.
[0460] During a first application of stimuli during a first use of
the closed loop neuromodulator, the controller starts with the
stimulus parameter default settings as stored in the closed loop
neuromodulator memory and defined by an attending sleep
practitioner and related to the outcome of clinical studies on the
patient.
[0461] During patient setup, the modulator starts with the lowest
energy stimulus and moves towards an optimum selection and setting
of stimulus parameters.
[0462] During patient setup, the closed loop neuromodulator
detects, and records the actual stimulation for each individual
patient automatically during first use.
[0463] During stimulus level patient setup, the closed loop
neuromodulator records and stores the stimulus level value that
caused the resumption of normal breathing as a marker. During the
next apnea episode, the closed loop neuromodulator uses the stored
stimulus level marker and starts the first stimulus level either
one or more stimulus levels below the first stimulus level marker
value.
[0464] During stimulus duration patient setup, the closed loop
neuromodulator records and stores the stimulus duration value that
caused the resumption of normal breathing as a marker. During the
next apnea episode, the closed loop neuromodulator uses the stored
stimulus duration marker and starts the first stimulus level either
one or more stimulus levels below the first stimulus duration
marker value.
[0465] During stimulus rate patient setup, the closed loop
neuromodulator records and stores the stimulus rate value that
caused the resumption of normal breathing as a marker. During the
next apnea episode, the closed loop neuromodulator uses the stored
stimulus rate marker and starts the first stimulus level either one
or more stimulus levels below the first stimulus rate marker
value.
[0466] During stimulus type patient setup, the closed loop
neuromodulator records and stores the stimulus type value that
caused the resumption of normal breathing as a marker. During the
next apnea episode, the closed loop neuromodulator uses the stored
stimulus type marker and starts the first stimulus level either one
or more stimulus levels below the first stimulus type marker
value.
Stimulus Dosage Optimization
[0467] Ideally, the ratio of stimulus generated to sleep disorder
events, including apnea events, is above 2 to 1. The rationale for
this is that the first stimulus signal should not generate any
arousal so that it is established that the signal level is low
enough as neither to change the sleeping patients sleep state nor
to awake him. Then with that base stimulus level established, the
next stimulus level generated should be high enough to cause and
arousal in order to cause resumption of breathing. Since the first
level was not high enough to cause any cortical arousal and the
second level was just slightly above the first level, one can
safely assume that the second level was not strong enough to
neither change the sleeping patients sleep state nor wake him up
completely. This device automatically figures out both levels.
[0468] Stimulus dosage Optimizing, constantly measures the ratio
between applied stimulus and non-breathing events to monitor that
the patient changes neither sleep state nor wakes up due to over
stimulation. Furthermore making sure that the patient does not
remain in an apnea state due to under stimulation.
[0469] During the first stimulus dosage optimization, closed loop
neuromodulator continues with the stimulus parameter settings as
recorded and stored during the patient setup.
[0470] During stimulus dosage optimization, the closed loop
neuromodulator detects, and records the actual stimulation for each
individual patient automatically during each apnea episode.
[0471] During stimulus dosage level optimization, the closed loop
neuromodulator recalls the last recorded stimulus level value that
caused the resumption of normal breathing as a new marker. During
the next apnea episode, the closed loop neuromodulator uses the new
stored stimulus level marker and starts the first stimulus level
either one or more stimulus levels below the new stimulus level
marker value.
[0472] During stimulus dosage duration optimization, the closed
loop neuromodulator recalls the last recorded stimulus duration
value that caused the resumption of normal breathing as a new
marker. During the next apnea episode, the closed loop
neuromodulator uses the new stored stimulus duration marker and
starts the first stimulus level either one or more stimulus levels
below the new stimulus duration marker value.
[0473] During stimulus dosage rate optimization, the closed loop
neuromodulator recalls the last recorded stimulus rate value that
caused the resumption of normal breathing as a new marker. During
the next apnea episode, the closed loop neuromodulator uses the new
stored stimulus rate marker and starts the first stimulus level
either one or more stimulus levels below the new stimulus rate
marker value.
[0474] During stimulus dosage type optimization, the closed loop
neuromodulator recalls the last recorded stimulus type value that
caused the resumption of normal breathing as a new marker. During
the next apnea episode, the closed loop neuromodulator uses the new
stored stimulus type marker and starts the first stimulus level
either one or more stimulus levels below the new stimulus type
marker value.
[0475] Referring to FIG. 19, there is indicated more specifically
by numeral 1 a sleeping patient. The sleeping patient 1 comprises
the following elements, a human Central Nervous System (CNS) 1901,
a human respiratory CNS pathway 1902 connecting the human CNS 1901
to a respiratory system 1903. The respiratory system 1903 provided
a pathway 1904, in this case, human respiration providing airflow
to the patient's nose or mouth 1905. The patient's respiratory
airflow 1906 is blown across an airflow sensor 2 (for example, but
not limited to the one taught in the STASZ U.S. Pat. No. 6,254,545
etc). The airflow sensor 2 connects to the closed loop
neuromodulator 4 via a sensor wire pair 3. The closed loop
neuromodulator 4 comprises the following elements, an activity to
voltage conversion 1907, which connects via connection 1908 to the
input of the closed loop neuromodulator process 1909, closed loop
neuromodulator process 1909 connects via connection 1910 to the
input of the voltage to stimulus conversion 1911. The output of the
voltage to stimulus conversion 1911 connects via wire connection 5
to the stimulus transducer 6. Stimulus transducer 6 delivers the
closed loop neuromodulator generated stimulus via the biological
connection 1912, to one or more of the patient's five senses
(taste, smell, touch, sight and/or sound) in this case a sound
transducer connected to the patient's outer ear 1913. The patient's
outer ear 1913 connects via the patient's inner ear 1914 to the
human peripheral nervous system (PNS) 1915. The human peripheral
nervous system 1915 connects via the auditory nerve 1916 to the
human central nervous system 1901.
[0476] Referring to FIG. 13A, there is indicated more specifically
by numeral 2000 the stimulus parameters. First, the stimulus
sequence 2002 is selected then optimized. Second, the stimulus type
2004 is selected then optimized. Third, the stimulus type 2004 is
selected then optimized. Fourth, the stimulus duration 2008 is
selected then optimized. Fifth, the stimulus rate 2010 is selected
then optimized. Sixth, the stimulus escalation 2012 is selected
then optimized. The cycle completes and continues. This figure
points out that this invention makes use of those elements and that
this invention is referring to them in the descriptions below.
Additionally, as sleep therapy is delivered to a patient and
modulated to treat sleep disorder events, in various examples, the
closed loop neural modulator changes the stimulus to avoid
habituation of the patient to a particular form of stimuli.
Anti-habituating sleep therapy, in such embodiments, modulates
anti-habituating sleep therapy elements 2013 including stimulus
sequence, stimulus type, or combinations thereof, to prevent
patient habituation. In one example, anti-habituating sleep therapy
monitors average energy levels of delivered therapy stimuli and
modulates the therapy to avoid habituation if the average energy
exceeds a threshold. In some examples, therapy is modulated after a
predetermined time interval to avoid habituation. It is understood
that other anti-habituating sleep therapy methods are possible
without departing from the scope of the present subject matter.
[0477] Referring to FIG. 13B, there is indicated more specifically
by numeral 2020 a diagram of general stimulation timing. There is
indicated by roman numeral I. an activity signal of a closed loop
neuromodulator. The activity signal is represented by a logic level
signal. The logic levels may take on either a logic high state
("1") or a logic low state ("0"). The high state indicates "normal
breathing" which means that the patient is not currently
experiencing a breathing disorder. The low state indicates "Apnea"
which means that the patient is currently experiencing a breathing
disorder. There is indicated by Roman numeral II. a driver signal
of a closed loop neuromodulator. The driver signal is represented
by an analog level signal. The analog levels may take on any level
value between a lowest level and a highest level. The lowest and
the highest level are determined by the specific embodiment of the
apparatus. The absence of a signal indicates "no stimulation". No
stimulation means that the patient is currently not subjected to a
CNS stimulus signal. The presence of a signal indicates
"stimulation". Stimulation means that the patient is currently
subjected to a CNS stimulus signal. Letter A indicates the falling
edge of the activity signal indicating a change from the patient
normal breathing level to the apnea level. In response to the
activity signal going low, the apparatus inserts a stimulation
delay lasting from letter A to letter B to allow for internal
processing delays and internal device set-up times. Letter B
indicates the start of the actual stimulus driver signal as it is
being sent to the patient. Letter C indicates the point where the
patient's central nervous system detects the presence of the
stimulus signal. At this time the stimulus could stop, however, the
apparatus has no knowledge or information that the patient just
detected the stimulus signal, thus the stimulus signal continues
for another duration that is indicated as the excess stimulation.
It is also a goal of this invention to minimize the excess
stimulation duration in order to minimize over stimulation through
excess stimulus duration. Letter D indicates the end of the
stimulus signal as it is being sent to the patient. The time
between C and E is the time it takes the patient's CNS to detect,
realize and act upon the received stimulus. In this case, the
detection of the stimulus at point C is triggering the resumption
of breathing at point E. The time between A and B is the apparatus
internal stimulation delay. The time between B and D is the
apparatus controlled stimulation duration. The time between D and E
is the time between the end of stimulation till the time of
respiration resumption. The time between B and C is patient
dependent and represents the CNS stimulus detection delay. The time
between C and E is patient dependent and represent the CNS
respiration resumption delay.
[0478] Referring to FIG. 14A, there is indicated more specifically
by numeral 2030 a diagram of a stimulation optimization, more
specifically the situation of patient CNS overstimulation. There is
indicated by Roman numeral I. an activity signal of a closed loop
neuromodulator. The activity signal is represented by a logic level
signal. The logic levels may take on either a logic high state
("1") or a logic low state ("0"). The high state indicates "normal
breathing" which means that the patient is not currently
experiencing a breathing disorder. The low state indicates "Apnea"
which means that the patient is currently experiencing a breathing
disorder. There is indicated by Roman numeral II. a driver signal
of a closed loop neuromodulator. The driver signal is represented
by an analog level signal #1. The analog levels may take on any
level value between a lowest level and a highest level. The lowest
and the highest level are determined by the specific embodiment of
the apparatus. The absence of a signal indicates "no stimulation".
No stimulation means that the patient is currently not subjected to
a CNS stimulus signal. The presence of a signal indicates
"stimulation". Stimulation means that the patient is currently
subjected to a CNS stimulus signal.
[0479] Shortly after the activity signal changes from the normal
breathing state to the apnea state, the driver signal issues a
stimulus signal #1. Shortly after the apparatus has issued the
stimulus signal #1, the apparatus has issued the activity signal
changes state from apnea to normal breathing, meaning that the
patient has started to resume normal respiration shortly after the
first stimulus signal. This is not quite a desirable situation
because it is safe to assume that this stimulus signal was simply
too strong and it aroused the CNS more dramatically than desired
and cause the patient most likely to wake up and in a lesser case,
change sleep states and resume breathing. The key point of this
invention is to neither wake the patient nor make him or her change
sleep states significantly. When the second stimulus after the
detection of an apnea caused this effect than according to this
invention, the patient has been optimally stimulated.
[0480] Referring to FIG. 14B, there is indicated more specifically
by numeral 2040 a diagram of a stimulation optimization, more
specifically the situation of patient optimal CNS stimulation.
There is indicated by Roman numeral I. an activity signal of a
closed loop neuromodulator. The activity signal is represented by a
logic level signal. The logic levels may take on either a logic
high state ("1") or a logic low state ("0"). The high state
indicates "normal breathing" which means that the patient is not
currently experiencing a breathing disorder. The low state
indicates "Apnea" which means that the patient is currently
experiencing a breathing disorder. There is indicated by Roman
numeral II. a driver signal of a closed loop neuromodulator. The
driver signal is represented by an analog level signal #1. The
analog levels may take on any level value between a lowest level
and a highest level. The lowest and the highest level are
determined by the specific embodiment of the apparatus. The absence
of a signal indicates "no stimulation". No stimulation means that
the patient is currently not subjected to a CNS stimulus signal.
The presence of a signal indicates "stimulation". Stimulation means
that the patient is currently subjected to a CNS stimulus
signal.
[0481] Shortly after the activity signal changes from the normal
breathing state to the apnea state, the driver signal issues a
stimulus signal #1. Since after a short while stimulus signal #1
has not caused the resumption of breathing, a second stimulus
signal #2 issues. Since the first stimulus signal has not caused
the respiration to resume, one can safely assume that the patient
neither woke up nor did patient change sleep states, nor did the
first stimulus cause a significant CNS arousal. Shortly after the
second stimulus signal #2 issues, the activity signal changes state
from apnea to normal breathing, indicating that the patient has
started to resume normal respiration shortly after the second
stimulus signal has been issued by the apparatus. This is a
desirable situation because it is safe to assume that the second
stimulus was of adequate strength to cause the patient to breathe
again. Is also safe to assume since the first stimulus signal was
not strong enough to cause the resumption of breathing and neither
woke the patient nor caused the patient to change sleep state, that
the second stimulus, which was just slightly stronger, did also not
wake nor significantly changed the patients sleep states. The
second stimulus #2 was dosed optimally in order to cause the
patient to resume breathing after the first stimulus showed no
effect. The key point of this invention is to neither wake nor make
the patient change sleep states significantly. When the second
stimulus after the detection of an apnea caused this effect than
according to this invention, the patient has been optimally
stimulated.
[0482] Referring to FIG. 14C, there is indicated more specifically
by numeral 2050 a diagram of a CNS stimulation optimization, more
specifically the situation of patient CNS under stimulation. There
is indicated by Roman numeral I. an activity signal of a closed
loop neuromodulator. The activity signal is represented by a logic
level signal. The logic levels may take on either a logic high
state ("1") or a logic low state ("0"). The high state indicates
"normal breathing" which means that the patient is not currently
experiencing a breathing disorder. The low state indicates "Apnea"
which means that the patient is currently experiencing a breathing
disorder. There is indicated by Roman numeral II. a driver signal
of a closed loop neuromodulator. The driver signal is represented
by an analog level signal #1. The analog levels may take on any
level value between a lowest level and a highest level. The lowest
and the highest level are determined by the specific embodiment of
the apparatus. The absence of a signal indicates "no stimulation".
No stimulation means that the patient is currently not subjected to
a CNS stimulus signal. The presence of a signal indicates
"stimulation". Stimulation means that the patient is currently
subjected to a CNS stimulus signal.
[0483] Shortly after the activity signal changes from the normal
breathing state to the apnea state, the driver signal issues a
stimulus signal #1. Since after a short while stimulus signal #1
has not caused the resumption of breathing, a second stimulus
signal #2 issues. Since the first stimulus signal has not caused
the respiration to resume, one can safely assume that the patient
neither woke up nor did patient change sleep states, nor did the
first stimulus cause a significant CNS arousal.
[0484] Shortly after the second stimulus signal #2 issues, the
activity signal still does not change state from apnea to normal
breathing, indicating that the patient has not yet started to
resume normal respiration shortly after the second stimulus signal
has been issued by the apparatus. This is also not a desirable
situation because it has not caused the patient to resume
breathing. It is safe to assume that the second stimulus was also
not of adequate strength to cause the patient to breathe again. It
is also safe to assume since the first stimulus signal was not
strong enough to cause the resumption of breathing and neither woke
the patient nor caused the patient to change sleep state, that the
second stimulus, which was just slightly stronger, did also not
wake nor significantly changed the patients sleep states.
[0485] The third stimulus #3 was dosed properly but not optimally,
even though it caused the patient to resume. The key point of this
invention is to neither wake nor make the patient change sleep
states significantly but cause the speedy safe resumption of
breathing soon after an apnea event has been detected. When the
third stimulus after the detection of an apnea caused the patient
to breathe than according to this invention, the patient has been
under stimulated.
[0486] A goal of this invention to attempt to maintain an optimal
stimulus dosage, which neither wakes the patient nor causes the
patient to change sleep states and to optimally dose the individual
stimulus accordingly. The method employed to obtain this goal is to
constantly monitor and keep track of the effectiveness of patient
stimulation. If the patient resumes breathing after the first
stimulus then the next time the patient experiences an apnea, the
first stimulus will be issued with significantly less strength.
Strength is defined as the amount of energy contained within the
applied stimulus. A first stimulus with significantly reduced
strength should not cause the patient to resume breathing because
this would indicate that the stimulus was strong enough to cause so
much CNS stimulation that the patient either woke up or the patient
experienced a significant change in sleep state. This method is
being repeated until the first stimulus issued after the detection
of an apnea does not cause the resumption of breathing in a
patient. It can thus be safely assumed that if the second stimulus
is just slightly higher and causes the resumption of breathing that
the second stimulus was dosed optimally. Furthermore, that if the
second stimulus does neither cause resumption of breathing and that
the third stimulus which is also slightly stronger than the third
causes the resumption of breathing, that the first stimulus issued
shortly after the next detection of an apnea is less in strength
than the third stimulus that was applied in the previous apnea.
[0487] Referring to FIG. 15A, there is indicated more specifically
by numeral 2060 a diagram of a CNS stimulation application.
[0488] There is indicated by Roman numeral I. an activity signal of
a closed loop neuromodulator. The activity signal is represented by
a logic level signal. The logic levels may take on either a logic
high state ("1") or a logic low state ("0"). The high state
indicates "normal breathing" which means that the patient is not
currently experiencing a breathing disorder. The low state
indicates "Apnea" which means that the patient is currently
experiencing a breathing disorder.
[0489] There is indicated by Roman numeral II. a stimulus rate
signal of a closed loop neuromodulator. The stimulus rate signal is
represented by a logic level signal. The logic levels may take on
either a logic high state ("1") or a logic low state ("0"). The
stimulation signal rate may be adjusted either manually by the
sleep professional or automatically by the apparatus (e.g. as
instructed or required by the CNS stimulation optimization method).
Shortly after the activity signal changes from the normal breathing
state to the apnea state, the stimulus rate signal changes state
from a logic low to a logic high after the stimulus delay period,
which may also be adjusted either manually by the sleep
professional or automatically by the apparatus (e.g. as instructed
or required by the CNS stimulation optimization method). The change
of signal state from low to high of the stimulus rate signal
indicates the start of a stimulus signal. The stimulus rate signal
remains active and keeps on changing states indicating the need for
continuously issuing CNS stimulus to the patient until normal
breathing has resumed.
[0490] There is indicated by Roman numeral III. a stimulus duration
signal of a closed loop neuromodulator. The stimulus duration
signal is represented by a logic level signal. The logic levels may
take on either a logic high state ("1") or a logic low state ("0").
The stimulus duration may be adjusted by either manually by the
sleep professional or automatically by the apparatus (e.g. as
instructed or required by the CNS stimulation optimization method).
As soon as the stimulus rate signal II. changes state from low to
high, the stimulus duration signal goes high (active) for the
specific duration of the presently applied CNS stimulus. The
stimulus duration signal remains active and keeps on changing
states indicating the need for continuously issuing CNS stimulus to
the patient until normal breathing has resumed.
[0491] There is indicated by Roman numeral IV. a driver signal of a
closed loop neuromodulator. The driver signal is represented by an
analog level signal #1. The analog levels may take on any level
value between a lowest level and a highest level. The CNS
stimulation level may be adjusted either manually by the sleep
professional or automatically by the apparatus (e.g. as instructed
or required by the CNS stimulation optimization method). The
absence of a signal indicates "no stimulation". No stimulation
means that the patient is currently not subjected to a CNS stimulus
signal. The presence of a signal indicates "stimulation".
Stimulation means that the patient is currently subjected to a CNS
stimulus signal. The first CNS stimulus issued by the driver signal
IV. after the activity signal transitions from high to low
indicating an apnea is indicated by numeral #1A. The numeral
indicates that this is the first (I) stimulus (#) of this apnea of
stimulus level A (A). The selection of which stimulus level is to
be issued shortly after an apnea has been detected may be may be
controlled either manually by the sleep professional or
automatically by the apparatus (e.g. as instructed or required by
the CNS stimulation optimization method). In this case, the
stimulus selected is of the lowest level (aka; strength, volume,
loudness). After the first stimulus dosage has been issued to the
patient's CNS, the apparatus waits for a certain CNS stimulation
dwell time that is dependent on the stimulus rate and stimulus
duration. After the stimulation dwell time has expired, a new
stimulus will be issued unless the activity signal transitions from
low to high indicating that normal breathing has resumed and that
no more stimulus are required.
[0492] If normal breathing has not resumed after issuing first
stimulus #1A then the apparatus may issue second stimulus #2B of
stimulus level B. According to this invention, this stimulus may be
of a different type, may be of a different level, may be of a
different rate, or may be of a different duration. In this example,
only a different level is indicated. A higher stimulus level
delivers more energy into the CNS and it is assumed that a higher
stimulus level causes a stronger response from the CNS. It is hoped
in this case that following the arousal of the patient's CNS by the
detection of the presently applied stimulus will cause the
resumption of breathing.
[0493] If normal breathing has not resumed after issuing second
stimulus #2B then a third the apparatus may issue stimulus #3C of
stimulus level C. The apparatus will again monitor for the
resumption of the desired patient activity or the cessation of the
undesired patient activity.
[0494] If normal breathing has not resumed after issuing third
stimulus #3C then a fourth stimulus #4D of stimulus level the
apparatus may issue D. The apparatus constantly monitors for the
resumption of the desired patient activity or the cessation of the
undesired patient activity.
[0495] In this case, CNS stimulus #4D was successful in causing the
resumption of the patient's desired activity (breathing) indicated
by the low to high transition of the activity signal.
[0496] After the patient has resumed the desired activity/normal,
breathing the apparatus will issue no further CNS stimulus until
the activity signal transitions from high to low again indicating a
detection of a sleep apnea or any other undesired behavior that can
be controlled by controlled stimulation of the CNS.
[0497] Referring to FIG. 15B, there is indicated more specifically
by numeral 2070 a diagram of a CNS stimulus escalation method.
[0498] There is indicated by Roman numeral I. an activity signal of
a closed loop neuromodulator. The activity signal is represented by
a logic level signal. The logic levels may take on either a logic
high state ("1") or a logic low state ("0"). The high state
indicates "normal breathing" which means that the patient is not
currently experiencing a breathing disorder. The low state
indicates "Apnea" which means that the patient is currently
experiencing a breathing disorder.
[0499] There is indicated by Roman numeral II. a driver signal of a
closed loop neuromodulator. The driver signal is represented by an
analog level signal. The analog levels may take on any level value
if instructed to do so between a lowest level and a highest level.
In this case, the first stimulus being issued after a short delay
in response to apnea detection is #1A. Stimulus #1A may be of any
type, level, duration or rate. If stimulus #1A does not cause the
resumption of normal breathing then after a certain amount of time
that is dependent on the specific stimulus rate, second stimulus
#2B is being issued. Since the first stimulus #1A did not produce
the desire result, the level for stimulus #2B has been increased by
a specific amount, which depends on the type of level escalation
envelope function. In this case, the level escalation envelope
function is linear. This means the each next stimulus level
increases with the same factor as the one before. Other level
stimulus escalation envelope functions are possible as discussed in
the Stimulus Escalator section included herein. If stimulus #2B
does not cause the resumption of normal breathing then after a
certain amount of time that is dependent on the specific stimulus
rate, a third stimulus #3C is being issued. Since the second
stimulus #2B did not produce the desire result, the level for
stimulus #3C has been increased by a specific amount, which depends
on the type of level escalation envelope function. If stimulus #3C
does not cause the resumption of normal breathing then after a
certain amount of time that is dependent on the specific stimulus
rate, a fourth stimulus #4D is being issued. Since the third
stimulus #3C did not produce the desire result, the level for
stimulus #4D has been increased by a specific amount which depends
on the type of level escalation envelope function. This pattern of
issuing ever changing and increasing stimulus types, levels,
durations and rates continues until normal breathing has been
detected.
[0500] There is indicated by Roman numeral III. a driver signal of
a closed loop neuromodulator. The driver signal is represented by
an analog level signal. The analog levels may take on any level
value if instructed to do so between a lowest level and a highest
level. In this case, the first stimulus being issued after a short
delay in response to apnea detection is #1A'. Stimulus #1A' may be
of any type, level, duration or rate and stimulus #1A' does not
have to be the same as stimulus #1A. If stimulus #1A' does not
cause the resumption of normal breathing then after a certain
amount of time that is dependent on the specific stimulus rate, a
second stimulus #2A'' is being issued. Since the first stimulus
#1A' did not produce the desire result, the type, duration or rate
for stimulus #2A'' has been changed by a specific amount which
depends on the type of level escalation envelope function, however,
the level has not been increased this time. Either in this case the
escalation envelope function is defined as a type, duration or rate
change and the envelope function may be linear or take on any other
mathematical function including a randomization. This means the
each next stimulus is different from the one before. Other stimulus
escalation envelope functions are possible as discussed in the
Stimulus Escalator section and the Stimulus Sequencer section
included herein. If stimulus #2A'' does not cause the resumption of
normal breathing then after a certain amount of time that is
dependent on the specific stimulus rate, a third stimulus #3B' is
being issued. Since the second stimulus #2A'' did not produce the
desire result, the type, duration or rate for stimulus #3B' has
been changed by a specific amount which depends on the type of
escalation envelope function. If stimulus #3B' does not cause the
resumption of normal breathing then after a certain amount of time
that is dependent on the specific stimulus rate, a fourth stimulus
#4B'' is being issued. Since the third stimulus #3B' did not
produce the desired result, the level for stimulus #4B'' has been
increased by a specific amount which depends on the type of
escalation envelope function. This pattern of issuing ever changing
and increasing stimulus types, levels, durations and rates
continues until normal breathing has been detected. It shall be
noted that the same level has been repeated twice in this sequence
of stimulus delivery.
[0501] There is indicated by Roman numeral IV. a driver signal of a
closed loop neuromodulator. The driver signal is represented by an
analog level signal. The analog levels may take on any level value
if instructed to do so between a lowest level and a highest level.
In this case, the first stimulus being issued after a short delay
in response to an apnea detection is #1A'''. Stimulus #1A''' may be
of any type, level, duration or rate. If stimulus #1A''' does not
cause the resumption of normal breathing then after a certain
amount of time that is dependent on the specific stimulus rate, a
second stimulus #2A'''' is being issued. Since the first stimulus
#1A''' did not produce the desire result, the type, duration or
rate for stimulus #2A'''' has been changed by a specific amount
which depends on the type of level escalation envelope function,
however, the level has not been increased this time. Either in this
case the escalation envelope function is defined as a type,
duration or rate change and the envelope function may be linear or
take on any other mathematical function including a randomization.
This means the each next stimulus is different from the one before.
Other stimulus escalation envelope functions are possible as
discussed in the Stimulus Escalator section included herein. If
stimulus #2A'''' does not cause the resumption of normal breathing
then after a certain amount of time that is dependent on the
specific stimulus rate, a third stimulus #3A''''' is being issued.
Since the second stimulus #2A'''' did not produce the desire
result, the type, duration or rate for stimulus #3A''''' has been
changed by a specific amount, which depends on the type of
escalation envelope function. If stimulus #3A''''' does not cause
the resumption of normal breathing then after a certain amount of
time that is dependent on the specific stimulus rate, a fourth
stimulus #4B''' is being issued. Since the third stimulus #3A'''''
did not produce the desired result, the level for stimulus #4B'''
has been increased by a specific amount which depends on the type
of escalation envelope function. This pattern of issuing ever
changing and increasing stimulus types, levels, durations and rates
continues until normal breathing has been detected. It shall be
noted that the same level has been repeated three times in this
sequence of stimulus delivery.
[0502] Referring to FIG. 16A, there is indicated more specifically
by numeral 2080 a diagram of a CNS stimulus level optimization
method.
[0503] There is indicated by Roman numeral I. an activity signal of
a closed loop neuromodulator depicting non-optimized apnea duration
at time interval T. The activity signal is represented by a logic
level signal. The logic levels may take on either a logic high
state ("1") or a logic low state ("0"). The high state indicates
"normal breathing" which means that the patient is not currently
experiencing a breathing disorder. The low state indicates "Apnea"
which means that the patient is currently experiencing a breathing
disorder.
[0504] There is indicated by Roman numeral II. A driver signal of a
closed loop neuromodulator. The driver signal is represented by an
analog level signal. The analog levels may take on any level value
if instructed to do so between a lowest level and a highest level.
In this case, the first stimulus being issued after a short delay
in response to apnea detection is the lowest stimulus level
possible #1A. Stimulus #1A may be of any type, duration or rate. If
stimulus #1A does not cause the resumption of normal breathing then
after a certain amount of time that is dependent on the specific
stimulus rate, second stimulus #2B is being issued. Since the first
stimulus #1A did not produce the desired result, the level for
stimulus #2B has been increased by a specific amount, which depends
on the type of level escalation envelope function. In this case,
for sake of simplicity, the level escalation envelope function has
been chosen to be linear. This means the next stimulus level
increases with the same factor as the one before. Other level
stimulus escalation envelope functions are possible as discussed in
the Stimulus Escalator section included herein. If stimulus #2B
does not cause the resumption of normal breathing then after a
certain amount of time that is dependent on the specific stimulus
rate, a third stimulus #3C is being issued. Since the second
stimulus #2B did not produce the desire result, the level for
stimulus #3C has been increased by a specific amount, which depends
on the type of level escalation envelope function.
[0505] If stimulus #3C does not cause the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, a fourth stimulus #4D is being issued.
Since the third stimulus #3C did not produce the desire result, the
level for stimulus #4D has been increased by a specific amount
which depends on the type of level escalation envelope
function.
[0506] If stimulus #4D does not cause the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, a fifth stimulus #5E is being issued.
Since the fourth stimulus #4D did not produce the desire result,
the level for stimulus #5E has been increased by a specific amount,
which depends on the type of level escalation envelope
function.
[0507] If stimulus #5E does not cause the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, a sixth stimulus #6F is being issued.
Since the fifth stimulus #5E did not produce the desire result, the
level for stimulus #6F has been increased by a specific amount,
which depends on the type of level escalation envelope
function.
[0508] If stimulus #6F does not cause the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, a seventh stimulus #7G is being issued.
Since the sixth stimulus #6F did not produce the desire result, the
level for stimulus #7G has been increased by a specific amount
which depends on the type of level escalation envelope
function.
[0509] It shall be noted that the seventh stimulus in this case #7G
has caused the resumption of normal breathing in the sleeping
patient. At this point, the method instructs the apparatus to store
the value of the level that caused the resumption of breathing in
memory. This value shall be used as a marker so that the first
stimulus level the closed loop neuromodulator selects and issues
after detection of the next apnea episode is at least one or more
escalation levels below the level that caused the resumption of
breathing during the previous apnea episode experienced by the
patient. In this special case stimulus level #G was the one that
caused the resumption of normal breathing, thus the first level
that shall be issued when the next apnea episode occurs is stimulus
level #E.
[0510] There is indicated by Roman numeral III. an activity signal
of a closed loop neuromodulator depicting an optimized apnea
duration at time interval T+1 indicating the next apnea episode
following the apnea episode duration at the time interval T. The
activity signal is represented by a logic level signal. The logic
levels may take on either a logic high state ("1") or a logic low
state ("0"). The high state indicates "normal breathing" which
means that the patient is not currently experiencing a breathing
disorder. The low state indicates "Apnea" which means that the
patient is currently experiencing a breathing disorder.
[0511] There is indicated by Roman numeral VI. A driver signal of a
closed loop neuromodulator. The driver signal is represented by an
analog level signal. The analog levels may take on any level value
if instructed to do so between a lowest level and a highest level.
In this case, the first stimulus being issued after a short delay
in response to the next apnea detection is the third level down
from the level during the previous apnea that caused the resumption
of normal breathing in the sleeping patient stimulus level #1E.
Stimulus #1E is preferably of the same type, duration or rate but
may be of any type, duration or rate. If stimulus #1E does not
cause the resumption of normal breathing then after a certain
amount of time that is dependent on the specific stimulus rate, a
second stimulus #2F is being issued. Since the first stimulus #1E
did not produce the desired result, the level for stimulus #2F has
been increased by a specific amount, which depends on the type of
level escalation envelope function. In this case, for sake of
simplicity, the level escalation envelope function has been chosen
to be linear. This means the next stimulus level increases with the
same factor as the one before. Other level stimulus escalation
envelope functions are possible as discussed in the Stimulus
Escalator section included herein. If stimulus #2F does not cause
the resumption of normal breathing then after a certain amount of
time that is dependent on the specific stimulus rate, a third
stimulus #3G is being issued. Since the second stimulus #2F did not
produce the desire result, the level for stimulus #3G has been
increased by a specific amount which depends on the type of level
escalation envelope function.
[0512] It shall be noted that the third stimulus this time #3G has
caused the resumption of normal breathing in the sleeping patient.
At this point, again, the method instructs the apparatus to store
the value of the level that caused the resumption of breathing in
memory. This value shall be used as a marker so that the first
stimulus level the closed loop neuromodulator selects and issues
after detection of the next apnea episode is at least one or more
escalation levels below the level that caused the resumption of
breathing during the previous apnea episode experienced by the
patient. In this special case stimulus level #G was the one that
caused the resumption of normal breathing, thus the first level
that shall be issued when the next apnea episode occurs is stimulus
level #E.
[0513] The method changing stimuli and patterns of issuing more
energy containing stimulus types, levels, durations and rates
continues until normal breathing has been detected.
[0514] Referring to FIG. 16B, there is indicated more specifically
by numeral 2090 a diagram of a CNS stimulus duration optimization
method.
[0515] There is indicated by Roman numeral I. an activity signal of
a closed loop neuromodulator depicting non-optimized apnea duration
at time interval T. The activity signal is represented by a logic
level signal. The logic levels may take on either a logic high
state ("1") or a logic low state ("0"). The high state indicates
"normal breathing" which means that the patient is not currently
experiencing a breathing disorder. The low state indicates "Apnea"
which means that the patient is currently experiencing a breathing
disorder.
[0516] There is indicated by Roman numeral II. a driver signal of a
closed loop neuromodulator. The driver signal is represented by an
analog level signal. The analog levels may take on any level value
if instructed to do so between a lowest level and a highest level.
In this case, the first stimulus being issued after a short delay
in response to apnea detection is the shortest stimulus duration
possible #1A. Stimulus #1A may be of any type, level or rate. If
stimulus #1A does not cause the resumption of normal breathing,
then after a certain amount of time that is dependent on the
specific stimulus rate, second stimulus #2B is being issued. Since
the first stimulus #1A did not produce the desired result, the
duration (more duration equals more energy) for stimulus #2B has
been increased by a specific amount which depends on the type of
duration escalation envelope function. In this case, for sake of
simplicity, the duration escalation envelope function has been
chosen to be linear. This means the next stimulus duration
increases with the same factor as the one before. Other duration
stimulus escalation envelope functions are possible as discussed in
the Stimulus Escalator section included herein. If stimulus #2B
does not cause the resumption of normal breathing then after a
certain amount of time that is dependent on the specific stimulus
rate, a third stimulus #3C is being issued. Since the second
stimulus #2B did not produce the desired result, the duration for
stimulus #3C has been increased by a specific amount, which depends
on the type of duration escalation envelope function.
[0517] If stimulus #3C does not caused the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, a fourth stimulus #4D is being issued.
Since the third stimulus #3C did not produce the desired result,
the duration for stimulus #4D has been increased by a specific
amount, which depends on the type of duration escalation envelope
function.
[0518] If stimulus #4D does not cause the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, a fifth stimulus #5E is being issued.
Since the fourth stimulus #4D did not produce the desire result,
the duration for stimulus #5E has been increased by a specific
amount, which depends on the type of duration escalation envelope
function.
[0519] It shall be noted that the fifth stimulus in this case #5E
has caused the resumption of normal breathing in the sleeping
patient. At this point, the method instructs the apparatus to store
the value of the duration that caused the resumption of breathing
in memory. This value shall be used as a marker so that the first
stimulus duration the closed loop neuromodulator selects and issues
after detection of the next apnea episode is at least one or more
escalation durations below the duration that caused the resumption
of breathing during the previous apnea episode experienced by the
patient. In this special case duration level #E was the one that
caused the resumption of normal breathing, thus the first stimulus
duration that shall be issued when the next apnea episode occurs is
stimulus level #D.
[0520] There is indicated by Roman numeral III. an activity signal
of a closed loop neuromodulator depicting an optimized apnea
duration at time interval T+1 indicating the next apnea episode
following the apnea episode duration at the time interval T. The
activity signal is represented by a logic level signal. The logic
levels may take on either a logic high state ("1") or a logic low
state ("0"). The high state indicates "normal breathing" which
means that the patient is not currently experiencing a breathing
disorder. The low state indicates "Apnea" which means that the
patient is currently experiencing a breathing disorder.
[0521] There is indicated by Roman numeral VI. a driver signal of a
closed loop neuromodulator. The driver signal is represented by an
analog level signal. The analog durations may take on any duration
value if instructed to do so between a lowest duration and a
highest duration. In this case, the first stimulus being issued
after a short delay in response to the next apnea detection is the
third duration down from the duration during the previous apnea
that caused the resumption of normal breathing in the sleeping
patient stimulus duration #1D. Stimulus #1D is preferably of the
same type, level and/or rate but may be of any type, level and/or
rate. If stimulus #1D does not cause the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, second stimulus #2E is being issued.
Since the first stimulus #1D did not produce the desired result,
the duration for stimulus #2E has been increased by a specific
amount, which depends on the type of duration escalation envelope
function. In this case, for sake of simplicity, the duration
escalation envelope function has been chosen to be linear. This
means the next stimulus duration increases with the same factor as
the one before. Other duration stimulus escalation envelope
functions are possible as discussed in the Stimulus Escalator
section included herein.
[0522] It shall be noted that the second stimulus this time #2E has
caused the resumption of normal breathing in the sleeping patient.
At this point, again, the method instructs the apparatus to store
the value of the stimulus duration that caused the resumption of
breathing in memory. This value shall be used as a marker so that
the first stimulus duration the closed loop neuromodulator selects
and issues after detection of the next apnea episode is at least
one or more escalation durations below the duration that caused the
resumption of breathing during the previous apnea episode
experienced by the patient. In this special case stimulus duration
#E was the one that caused the resumption of normal breathing, thus
the first duration that shall be issued when the next apnea episode
occurs is stimulus duration #D, because the escalation resumption
point has been set to one level down in this case.
[0523] The method changing stimuli and patterns of issuing more
energy containing stimulus types, levels, durations and rates
continues until normal breathing has been detected.
[0524] Referring to FIG. 16C, there is indicated more specifically
by numeral 2100 a diagram of a CNS stimulus rate optimization
method.
[0525] There is indicated by Roman numeral I. an activity signal of
a closed loop neuromodulator depicting non-optimized apnea duration
at time interval T. The activity signal is represented by a logic
level signal. The logic levels may take on either a logic high
state ("1") or a logic low state ("0"). The high state indicates
"normal breathing" which means that the patient is not currently
experiencing a breathing disorder. The low state indicates "Apnea"
which means that the patient is currently experiencing a breathing
disorder.
[0526] There is indicated by Roman numeral II. A driver signal of a
closed loop neuromodulator. The driver signal is represented by an
analog level signal. The analog levels may take on any level value
if instructed to do so between a lowest level and a highest level.
In this case, the first stimulus being issued after a short delay
in response to an apnea detection is the lowest stimulus rate
possible (as defined in the default settings) #1A. Stimulus #1A may
be of any type, duration or level. If stimulus #1A does not cause
the resumption of normal breathing then after a certain amount of
time that is dependent on the specific stimulus rate, second
stimulus #2B is being issued. Since the first stimulus #1A did not
produce the desired result, the rate for stimulus #2B has been
increased (sped up) by a specific amount, which depends on the type
of rate escalation envelope function. In this case, for sake of
simplicity, the rate escalation envelope function has been chosen
to be linear. This means the next stimulus level increases with the
same factor as the one before. Other rate stimulus escalation
envelope functions are possible as discussed in the Stimulus
Escalator section included herein. If stimulus #2B does not cause
the resumption of normal breathing then after a certain amount of
time that is dependent on the specific stimulus rate, a third
stimulus #3C is being issued. Since the second stimulus #2B did not
produce the desire result, the rate for stimulus #3C has been
increased by a specific amount, which depends on the type of rate
escalation envelope function.
[0527] If stimulus #3C does not cause the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, a fourth stimulus #4D is being issued.
Since the third stimulus, #3C did not produce the desire result,
the rate for stimulus #4D has been increased by a specific amount
which depends on the type of rate escalation envelope function.
[0528] If stimulus #4D does not cause the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, a fifth stimulus #5E is being issued.
Since the fourth stimulus #4D did not produce the desire result,
the rate for stimulus #5E has been increased by a specific amount
which depends on the type of rate escalation envelope function.
[0529] If stimulus #5E does not cause the resumption of normal
breathing then after a certain amount of time that is dependent on
the specific stimulus rate, a sixth stimulus #6F is being issued.
Since the fifth stimulus #5E did not produce the desire result, the
rate for stimulus #6F has been increased by a specific amount which
depends on the type of rate escalation envelope function.
[0530] It shall be noted that the seventh stimulus in this case #6F
has caused the resumption of normal breathing in the sleeping
patient. At this point, the method instructs the apparatus to store
the value of the rate that caused the resumption of breathing in
memory. This value shall be used as a marker so that the first
stimulus rate the closed loop neuromodulator selects and issues
after detection of the next apnea episode is at least one or more
escalation rates below the rate that caused the resumption of
breathing during the previous apnea episode experienced by the
patient. In this special case stimulus rate #F was the one that
caused the resumption of normal breathing, thus the first rate that
shall be issued when the next apnea episode occurs is stimulus rate
#D.
[0531] There is indicated by Roman numeral III. an activity signal
of a closed loop neuromodulator depicting an optimized apnea
duration at time interval T+1 indicating the next apnea episode
following the apnea episode duration at the time interval T. The
activity signal is represented by a logic level signal. The logic
levels may take on either a logic high state ("1") or a logic low
state ("0"). The high state indicates "normal breathing" which
means that the patient is not currently experiencing a breathing
disorder. The low state indicates "Apnea" which means that the
patient is currently experiencing a breathing disorder.
[0532] There is indicated by Roman numeral VI. a driver signal of a
closed loop neuromodulator. The driver signal is represented by an
analog level signal. The analog levels may take on any level value
if instructed to do so between a lowest level and a highest level.
In this case, the first stimulus being issued after a short delay
in response to the next apnea detection is the third rate down from
the rate during the previous apnea that caused the resumption of
normal breathing in the sleeping patient stimulus rate #1D.
Stimulus #1D is preferably of the same type, duration and/or level
but may be of any type, duration or level. If stimulus #1D does not
cause the resumption of normal breathing then after a certain
amount of time that is dependent on the specific stimulus rate,
second stimulus #2E is being issued. Since the first stimulus #1D
did not produce the desired result, the rate for stimulus #2E has
been increased by a specific amount, which depends on the type of
rate escalation envelope function. In this case, for sake of
simplicity, the rate escalation envelope function has been chosen
to be linear. This means the next stimulus rate increases with the
same factor as the one before. Other rate stimulus escalation
envelope functions are possible as discussed in the Stimulus
Escalator section included herein. If stimulus #2E does not cause
the resumption of normal breathing then after a certain amount of
time that is dependent on the specific stimulus rate, a third
stimulus #3F is being issued. Since the second stimulus #2E did not
produce the desire result, the rate for stimulus #3F has been
increased by a specific amount, which depends on the type of rate
escalation envelope function.
[0533] It shall be noted that the third stimulus this time #3F has
caused the resumption of normal breathing in the sleeping patient.
At this point, again, the method instructs the apparatus to store
the value of the rate that caused the resumption of breathing in
memory. This value shall be used as a marker so that the first
stimulus rate the closed loop neuromodulator selects and issues
after detection of the next apnea episode is at least one or more
escalation rates below the rate that caused the resumption of
breathing during the previous apnea episode experienced by the
patient. In this special case stimulus rate #F was the one that
caused the resumption of normal breathing, thus the first rate that
shall be issued when the next apnea episode occurs is stimulus rate
#D.
[0534] The method changing stimuli and patterns of issuing more
energy containing stimulus types, levels, durations and rates
continues until normal breathing has been detected.
[0535] Referring to FIG. 17, there is indicated more specifically
by numeral 2110 a flowchart of stimulus dosage optimization routine
for a closed loop neuromodulator. The stimulus dosage optimization
routine begins with the Stimulus Dosage Optimization start command
2112. The next step after the start command 2112 is the instruction
to load the stored stimulus parameters 2114, which at first may be
the default values as defined by the outcome of clinical trials or
as defined by a sleep practitioner. The next process after loading
the stored stimulus parameters is to monitor for Apnea 2116. The
next step after monitoring for an apnea is the decision point which
asks for the Next Apnea? 2118. If the answer to the decision point
question is NO then the routine will continue to monitor for Apnea.
If the answer to the decision point question is YES then the next
process in the routine is to Apply Stimulus to Patient 2120. During
and after the stimulus has been applied to the patient another
decision point asks if the patient is still in Apnea? 2122. If the
answer to the decision point question is NO then the routine
encounters another decision point, which asks if this was the first
Stimulus? 2130 in this apnea episode. If the answer to this
decision point question is YES, then the routine indicates "Over
Stimulation" 2132, which may be subsequently logged, and time
stamped for further use and reference. The next step after "Over
Stimulation" 2132 which also means that the first stimulus issued
to the patient caused the resumption of breathing is to decrease
the stimulus parameter 2134 followed by a Record & Store New
Stimulus Parameter 2136 instruction. Since the patient is not
experiencing an Apnea at this state, the next step is to monitor
for Apnea 2116. If the patient experiences another apnea then the
answer to the Next Apnea 2118 decision point question is YES then
the next process in the routine is to Apply Stimulus to Patient
2120. During and after the stimulus has been applied to the patient
another decision point asks if the patient is still in Apnea? 2122.
If the answer to the decision point question is YES then the
routine indicates "Under Stimulation" 2124, which may be
subsequently logged, and time stamped for further use and
reference. The next step after "Under Stimulation" 2124 which also
means that the stimulus issued to the patient did not cause the
resumption of breathing is to increase the stimulus parameter 2126
followed by a Record & Store New Stimulus Parameter 2128
instruction. Since the patient is experiencing an Apnea at this
state, the next step is to Apply Stimulus to the Patient 2120.
During and after the stimulus has been applied to the patient a
decision point asks if the patient is still in Apnea <?>
2122. If the answer to the decision point question is NO then the
routine encounters another decision point which asks if this was
the first Stimulus <?> 2130 in this apnea episode. If the
answer to this decision point question is NO, then the routine
indicates "Optimal Stimulation" 2138, which may be subsequently
logged, and time stamped for further use and reference. The
stimulus dosage optimization routine may at this point be
terminated, re-routed to another routine or start all over
again.
Diagnostic and Therapy Modes
[0536] There is a need for automatic/autonomous mode, so that the
sleep patient can operate the unit at home without any manual
interaction or intervention. In diagnostic mode the sleep lab
practitioner can find the optimum range of stimulus escalation for
the individual patient. In various examples, diagnostic mode is
used in a sleep lab to setup a closed loop neuromodulator and then
the patient is sent home where the closed loop neuromodulator is
used in therapy mode to provide sleep therapy. In some examples, a
sleep lab only uses diagnostic mode of the neuromodulator.
[0537] In therapy mode, the unit executes its operation based on
the ranges defined and set by the sleep practitioner.
[0538] In therapy mode, the unit is the controller part of a
respiratory biofeedback loop.
[0539] Delay, rate, duration, period, frequency, range etc. are all
variable and manually adjustable by sleep lab practitioner when
this invention is used in diagnostic mode or automatically
adjustable when used in therapy mode.
[0540] Especially ranges or all adjustable parameters are settable
by the sleep practitioner in diagnostic mode.
[0541] Therapy mode is automatic and is an autonomous
operation.
[0542] All timing is variable, adjustable, controllable, either
manual or automatic.
[0543] In therapy mode, the unit can operate under minimum power
requirements and highest efficiency, thus, saving battery life and
extending time of operation. The use of a digital output drive
amplifier like a class D-audio amplifiers that are available from
semiconductor manufacturers will allow for efficient use of battery
power during the application of therapy stimuli.
[0544] A set of subroutines in the diagnostic remote terminal can
make calculations based on the registers and values provided by the
device. A few examples of such calculations that will give the
medical practitioner a better patient picture are listed below:
[0545] 1. Average Breaths per Minute (or any other time
reference)
[0546] 2. Average Inhale duration over Exhale duration ratio
[0547] 3. Average Apneas per hour (or any other time reference)
[0548] 4. Average Stimuli per hour
[0549] 5. Average Stimuli per Apnea
[0550] 6. Histograms of inhalation count and durations
[0551] 7. Histograms of exhalation counts and durations
[0552] 8. Histograms of inhalations over exhalations ratios
[0553] 9. Histogram of total Apnea episodes
[0554] 10. Histogram of total stimuli applied
[0555] 11. Histogram of Apneas per hour
[0556] 12. Histogram of Stimuli per hour
[0557] 13. Histogram of Stimuli per Apnea
[0558] 14. Standard Deviations for all calculated statistics
[0559] 15. Detailed time stamped event logs for each apnea
episode
Closed Loop Neuromodulator
[0560] Each of the closed loop neuromodulator's 4 internal building
block output signals are made available via individual signal
output ports for connection to a PSG for further analysis: These
building blocks include the digital signal 12 generated by the
EMI/ESD hardened sensor Interface 10, activity signal 22 generated
by the Activity Detector 20, power-down signal 24 generated by the
Activity Detector 20, reset signal 26 generated by the Activity
Detector, start signal 32 generated by the stimulus timer, trigger
signal 34 generated by the stimulus timer, driver signal 42
generated by the stimulus escalator, transducer output 5 generated
by the EMI/ESD hardened transducer driver, stimuli select signal 62
generated by the stimulus sequencer, stimuli signal 66 generated by
the stimulus sequencer, and stimuli output signal 72 generated by
the stimulus generator.
[0561] FIG. 3 is an electrical block diagram of one specific
embodiment of the closed loop neuromodulator 4 depicted in FIG. 2
and FIG. 1. There is indicated generally by numeral 4 a block
diagram of the closed loop neuromodulator along with a sensor 2 and
a transducer 6. Attached to the sensor and closed loop
neuromodulator is a pair of wire terminations 3 via which the
closed loop neuromodulator receives the sensor output. Attached to
the transducer and closed loop neuromodulator is a pair of wire
terminations 5 via which the closed loop neuromodulator transmits
the transducer input. Furthermore the closed loop neuromodulator
indicated generally by numeral 4 contains a mixed signal micro
controller (such as a Freescale FireWire processor) or an FPGA
based processor (such as a National Instrument, LabVIEW based RIO
virtual device development system) with internal processor,
read-only memory (ROM), random access memory (RAM), reset manager,
power pump, oscillator, analog-to-digital converter (ADC),
digital-to-analog converter (DAC) and embedded code.
[0562] The present invention is advantageous because it is directed
toward precise dosing of specific stimuli, which makes the device
universally effective for most sleep patients. This is in contrast
to the continuous positive air pressure (CPAP), Bi-level positive
air pressure (BPAP), and any other CNS Stimulation controller that
arouses or wakes the patient of the prior art.
[0563] An additional advantage of the present invention is the
precision with which stimulating doses can be given to a person
suffering from various kinds of neurological or sleeps
disorders.
[0564] Another advantage of the present invention relates to the
various types of stimuli it can apply in order to avoid patient
habituation.
[0565] An additional advantage is the device's ability to be used
in a clinical, research or laboratory setting in order to diagnose
patients and figure out which type of stimuli works optimally for a
specific patient, a group of patients or any other setting.
[0566] An additional advantage is that upon detection of a no
breathing signal, the device sends single stimuli of a certain
level, frequency, modulation, and shape for certain duration to the
patient. If breathing does not resume after a preset amount of
time, then another yet stronger stimuli signal will be issued to
the patient.
[0567] Another advantage is that the sequence of issuing stimuli
and sending them to the patient continues until the resumption of
breathing has been detected.
[0568] Another advantage is that during low power operation
functional blocks may be shut down when not needed for immediate
operation. E.g. shut down generators, timers and gain block when
breathing is detected. Activate generators, timers and gain block
when no breathing is detected.
[0569] This further supports the device's ability to interrupt an
undesirable behavior while avoiding alteration of a sleep
state.
[0570] This invention has been described herein in considerable
detail in order to comply with the patent statutes and to provide
those skilled in the art with the information needed to apply the
novel principles and to construct and use such specialized
components as are required. However, it is to be understood that
the invention can be carried out by specifically different
equipment and devices, and that various modifications, both as to
the equipment and operating procedures, can be accomplished without
departing from the scope of the invention itself.
[0571] The description of the various embodiments is merely
exemplary in nature and, thus, variations that do not depart from
the gist of the examples and detailed description herein are
intended to be within the scope of the present disclosure. Such
variations are not to be regarded as a departure from the spirit
and scope of the present disclosure.
[0572] FIGS. 18A through 18C depict an embodiment of a sleep
therapy device, which formed the basis of a feasibility study and
is a device that was used during clinical tests.
[0573] Below is a Bill-of-Materials of components for the
components depicted in FIGS. 18A through 18C.
TABLE-US-00002 Reference Designator Value B1 9 V C1 10 uF/Tant C10
0.01 uF C11 0.039 uF C12 10 uF/Tant C13 0.39 uF C14 1 uF C15 0.1 uF
C16 100 pF C17 1 uF C19 0.039 uF C2 10 uF/Tant C20 0.1 uF C21 1 uF
C3 10 uF/Tant C4 0.1 uF C5 0.1 uF C7 0.39 uF C8 0.056 uF C9 10
uF/Tant D1 Green D2 5.6 V D3 RED D4 1N4148 D5 1N4148 J1 Header,
3-pin, F J2 Header, 3-pin, M J3 Header, 2-pin, M J4 Header, 6-pin,
M J5 Header, 6-pin, M R1 1 M R10 560k R11 560k R12 560k R13 1k R14
1.5k R15 1k R16 100 R17 10 M R18 5.6 M R19 2.7 M R2 100 R20 100k
R21 1.35 M R22 560k R23 1k R24 270k R25 1 M R28 1 M R29 10k R3 560k
R30 1 M R31 220k R32 20k R33 1 M R34 1k R35 1 M R36 2.2 M R4 220k
R40 10k R41 2.2k R43 10k R45 22k R47 22k R48 10 R49 10k R5 56k R50
100k R51 100k R52 10k R53 100k R54 330k R55 220k R56 150k R57 82k
R58 47k R6 5.6k R7 27k R8 100k S1 ON/OFF S2 6 pos Rotary Switch S3
6 pos Rotary Switch S4 6 pos Rotary Switch U1 TLE2426 U10: A CD4001
U10: B CD4001 U10: C CD4001 U10: D CD4001 U11: A CD4001 U11: B
CD4001 U11: C CD4001 U11: D CD4001 U12: A CD4066 U12: B CD4066 U12:
C CD4066 U12: D CD4066 U2: A LMC6482 U2: B LMC6482 U3: A CD4098 U3:
B CD4098 U4: A LMC6482 U4: B LMC6482 U5: A CD4001 U5: B CD4001 U5:
C CD4001 U5: D CD4001 U6 CD4060 U7: A LMC6482 U7: B LMC6482 U8
CD4017 U9 CD4017
Additional Notes
[0574] The above detailed description includes references to the
accompanying drawings, which form a part of the detailed
description. The drawings show, by way of illustration, specific
embodiments in which the invention can be practiced. These
embodiments are also referred to herein as "examples." Such
examples can include elements in addition to those shown and
described. However, the present inventor also contemplates examples
in which only those elements shown and described are provided.
[0575] All publications, patents, and patent documents referred to
in this document are incorporated by reference herein in their
entirety, as though individually incorporated by reference. In the
event of inconsistent usages between this document and those
documents so incorporated by reference, the usage in the
incorporated reference(s) should be considered supplementary to
that of this document; for irreconcilable inconsistencies, the
usage in this document controls.
[0576] In this document, the terms "a" or "an" are used, as is
common in patent documents, to include one or more than one,
independent of any other instances or usages of "at least one" or
"one or more." In this document, the term "or" is used to refer to
a nonexclusive or, such that "A or B" includes "A but not B," "B
but not A," and "A and B," unless otherwise indicated. In the
appended claims, the terms "including" and "in which" are used as
the plain-English equivalents of the respective terms "comprising"
and "wherein." Also, in the following claims, the terms "including"
and "comprising" are open-ended, that is, a system, device,
article, or process that includes elements in addition to those
listed after such a term in a claim are still deemed to fall within
the scope of that claim. Moreover, in the following claims, the
terms "first," "second," and "third," etc. are used merely as
labels, and are not intended to impose numerical requirements on
their objects.
[0577] The above description is intended to be, and not
restrictive. For example, the above-described examples (or one or
more aspects thereof) may be used in combination with each other.
Other embodiments can be used, such as by one of ordinary skill in
the art upon reviewing the above description. The Abstract is
provided to comply with 37 C.F.R. .sctn.1.72(b), to allow the
reader to quickly ascertain the nature of the technical disclosure.
It is submitted with the understanding that it will not be used to
interpret or limit the scope or meaning of the claims. Also, in the
above Detailed Description, various features may be grouped
together to streamline the disclosure. This should not be
interpreted as intending that an unclaimed disclosed feature is
essential to any claim. Rather, inventive subject matter may lie in
less than all features of a particular disclosed embodiment. Thus,
the following claims are hereby incorporated into the Detailed
Description, with each claim standing on its own as a separate
embodiment. The scope of the invention should be determined with
reference to the appended claims, along with the full scope of
equivalents to which such claims are entitled.
* * * * *