Note: Descriptions are shown in the official language in which they were submitted.
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Method and System to Control Respiration by
Means of Neuro-Electrical Coded Signals
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. Application No.
10/847,738, filed
May 17, 2004, which claims the benefit of U.S. Provisional Application No.
60/471,104,
filed May 16, 2003.
FIELD OF THE PRESENT INVENTION
[0002] The present invention relates generally to medical methods and systems
for
monitoring and controlling respiration. More particularly, the invention
relates to a
method and system for controlling respiration by means of neuro-electrical
coded signals.
BACKGROUND OF THE INVENTION
[0003] As is well known in the art, the brain modulates (or controls)
respiration via
electrical signals (i.e., action potentials or waveform signals), which are
transmitted
through the nervous system. The nervous system includes two components: the
central
nervous system, which comprises the brain and the spinal cord, and the
peripheral
nervous system, which generally comprises groups of nerve cells (i.e.,
neurons) and
peripheral nerves that lie outside the brain and spinal cord. The two systems
are
anatomically separate, but functionally interconnected.
[0004] As indicated, the peripheral nervous system is constructed of nerve
cells (or
neurons) and glial cells (or glia), which support the neurons. Operative
neuron units that
carry signals from the brain are referred to as "efferent" nerves. "Afferent"
nerves are
those that carry sensor or status information to the brain.
[0005] As is known in the art, a typical neuron includes four morphologically
defined
regions: (i) cell body, (ii) dendrites, (iii) axon and (iv) presynaptic
terminals. The cell
body (soma) is the metabolic center of the cell. The cell body contains the
nucleus,
which stores the genes of the cell, and the rough and smooth endoplasmic
reticulum,
which synthesizes the proteins of the cell.
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[0006] The cell body typically includes two types of outgrowths (or
processes); the
dendrites and the axon. Most neurons have several dendrites; these branch out
in tree-
like fashion and serve as the main apparatus for receiving signals from other
nerve cells.
[0007] The axon is the main conducting unit of the neuron. The axon is capable
of
conveying electrical signals along distances that range from as short as 0.1
mm to as
long as 2 m. Many axons split into several branches, thereby conveying
infonnation to
different targets.
[0008] Near the end of the axon, the axon is divided into fine branches that
make contact
with other neurons. The point of contact is referred to as a synapse. The cell
transmitting a signal is called the presynaptic cell, and the cell receiving
the signal is
referred to as the postsynaptic cell. Specialized swellings on the axon's
branches (i.e.,
presynaptic terminals) serve as the transmitting site in the presynaptic cell.
[0009] Most axons terminate near a postsynaptic neuron's dendrites. However,
communication can also occur at the cell body or, less often, at the initial
segment or
terminal portion of the axon of the postsynaptic cell.
[00010] Many nerves and muscles are involved in efficient respiration or
breathing. The
most important muscle devoted to respiration is the diaphragm. The diaphragm
is a
sheet-shaped muscle, which separates the thoracic cavity from the abdominal
cavity.
[00011] With normal tidal breathing the diaphragm moves about 1 cm. However,
in
forced breathing, the diaphragm can move up to 10 cm. The left and right
phrenic
nerves activate diaphragm movement.
[00012] Diapliragm contraction and relaxation accounts for a 75% volume change
in
the thorax during normal quiet breathing. Contraction of the diaphragm occurs
during
inspiration. Expiration occurs when the diaphragm relaxes and recoils to its
resting
position. All movements of the diaphragm and related muscles and structures
are
controlled by coded electrical signals traveling from the brain.
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[00013] Details of the respiratory system and related muscle structures are
set forth in
Co-Pending Application No. 10/847,738, which is expressly incorporated by
reference
herein in its entirety.
[00014] The main nerves that are involved in respiration are the ninth and
tenth cranial
nerves, the phrenic nerve, and the intercostal nerves. The glossopharyngeal
nerve
(cranial nerve IX) innervates the carotid body and senses CO2 levels in the
blood. The
vagus nerve (cranial nerve X) provides sensory input from the larynx, pharynx,
and
thoracic viscera, including the bronchi. The phrenic nerve arises from spinal
nerves C3,
C4, and C5 and innervates the diaphragm. The intercostal nerves arise from
spinal
nerves T7-1 1 and innervate the intercostal muscles.
[00015] The various afferent sensory neuro-fibers provide information as to
how the
body should be breathing in response to events outside the body proper.
[00016] An important respiratory control is activated by the vagus nerve and
its
preganglionic nerve fibers, which synapse in ganglia. The ganglia are embedded
in the
bronchi that are also innervated with sympathetic and parasympathetic
activity.
[00017] It is well documented that the sympathetic nerve division can have no
effect on
bronchi or it can dilate the lumen (bore) to allow more air to enter during
respiration,
which is helpful to asthma patients, while the parasympathetic process offers
the
opposite effect and can constrict the bronchi and increase secretions, which
can be
harmful to asthma patients.
[00018] The electrical signals transmitted along the axon to control
respiration, referred
to as action potentials, are rapid and transient "all-or-none" nerve impulses.
Action
potentials typically have an amplitude of approximately 100 millivolts (mV)
and a
duration of approximately 1 msec. Action potentials are conducted along the
axon,
without failure or distortion, at rates in the range of approximately 1-100
meters/sec.
The amplitude of the action potential remains constant throughout the axon,
since the
impulse is continually regenerated as it traverses the axon.
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[00019] A "neurosignal" is a composite signal that includes many action
potentials.
The neurosignal also includes an instruction set for proper organ function. A
respiratory
neurosignal would thus include an instruction set for the diaphragm to perform
an
efficient ventilation, including information regarding frequency, initial
muscle tension,
degree (or depth) of muscle movement, etc.
[00020] Neurosignals or "neuro-electrical coded signals" are thus codes that
contain
complete sets of information for complete organ function. As set forth in Co-
Pending
Application No. [Attorney Docket No. SCM-02-009CIP], filed May 9, 2005,
once these neurosignals, which are embodied in the "waveform signals" referred
to
herein, have been isolated, recorded, standardized and transmitted to a
subject (or
patient), a generated nerve-specific waveform instruction (i.e., waveform
signal(s)) can
be employed to control respiration and, hence, treat a multitude of
respiratory system
disorders. The noted disorders include, but are not limited to, sleep apnea,
asthma,
excessive mucus production, acute bronchitis and emphysema.
[00021] As is known in the art, sleep apnea is generally defmed as a temporary
cessation of respiration during sleep. Obstructive sleep apnea is the
recurrent occlusion
of the upper airways of the respiratory system during sleep. Central sleep
apnea occurs
when the brain fails to send the appropriate signals to the breathing muscles
to initiate
respirations during sleep. Those afflicted with sleep apnea experience sleep
fragmentation and complete or nearly complete cessation of respiration (or
ventilation)
during sleep with potentially severe degrees of oxyhemoglobin desaturation.
[00022] Studies of the mechanism of collapse of the airway suggest that during
some
stages of sleep, there is a general relaxation of the muscles that stabilize
the upper
airway segment. This general relaxation of the muscles is believed to be a
factor
contributing to sleep apnea.
[00023] Various apparatus, systems and methods have been developed, which
include
an apparatus for or step of recording action potentials or coded electrical
neurosignals, to
control respiration and treat respiratory disorders, such as sleep apnea. The
signals are,
however, typically subjected to extensive processing and are subsequently
employed to
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regulate a"mechanical" device or system, such as a ventilator. Illustrative
are the
systems disclosed in U.S. Pat. Nos. 6,360,740 and 6,651,652.
[00024] In U.S. Pat. No. 6,360,740, a system and method for providing
respiratory
assistance is disclosed. The noted method includes the step of recording
"breathing
signals", which are generated in the respiratory center of a patient. The
"breathing
signals" are processed and employed to control a muscle stimulation apparatus
or
ventilator.
[00025] In U.S. Pat. No. 6,651,652, a system and method for treating sleep
apnea is
disclosed. The noted system includes respiration sensor that is adapted to
capture neuro-
electrical signals and extract the signal components related to respiration.
The signals
are similarly processed and employed to control a ventilator.
[00026] A major drawback associated with the systems and methods disclosed in
the
noted patents, as well as most known systems, is that the control signals that
are
generated and transmitted are "user determined" and "device determinative".
The noted
"control signals" are thus not related to or representative of the signals
that are generated
in the body and, hence, would not be operative in the control or modulation of
the
respiratory system if transmitted thereto.
[00027] It would thus be desirable to provide a method and system for
controlling
respiration that includes means for recording coded waveform signals (i.e.,
coded
electrical neurosignals) that are generated in the body, means for storing the
collected
waveform signals, and means for providing and transmitting waveform signals to
the
body that substantially correspond to the recorded waveform signals and are
operative in
the control of the respiration system.
[00028] It is therefore an object of the present invention to provide a method
and
system for controlling respiration that overcomes the drawbacks associated
with prior art
methods and systems for controlling respiration.
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[00029] It is another object of the invention to provide a method and system
for
controlling respiration that includes means for recording waveform signals
that are
generated in the body and operative in the control of respiration.
[00030] It is another object of the invention to provide a method and system
for
controlling respiration that includes means for generating respiratory signals
that
substantially correspond to coded waveform signals that are generated in the
body and
are operative in the control of respiration system.
[00031] It is another object of the invention to provide a method and system
for
controlling respiration that includes processing means adapted to generate a
base-line
respiratory signal that is representative of at least one coded waveform
signal generated
in the body from recorded waveform signals.
[00032] It is another object of the invention to provide a method and system
for
controlling respiration that includes processing means adapted to compare
recorded
respiratory waveform signals to baseline respiratory signals and generate a
respiratory
signal as a function of the recorded waveform signal.
[00033] It is another object of the invention to provide a method and system
for
controlling respiration that includes monitoring means for detecting
respiration
abnormalities.
[00034] It is another object of the invention to provide a method and system
for
controlling respiration that includes a sensor to detect whether a subject is
experiencing
an apneic event.
[00035] It is another object of the invention to provide a method and system
for
controlling respiration that includes means for transmitting waveform signals
to the body
that substantially correspond to coded waveform signals that are generated in
the body
and are operative in the control of the respiratory system.
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[00036] It is another object of the present invention to provide a method and
system for
controlling respiration that includes means for transmitting signals directly
to the
nervous system in the body that substantially correspond to coded wavefonn
signals that
are generated in the body and are operative in the control of the respiratory
system.
[00037] It is another object of the invention to provide a method and system
for
controlling respiration that can be readily employed in the treatment of
respiratory
system disorders, including sleep apnea, asthma, excessive mucus production,
acute
bronchitis and emphysema.
SUMMARY OF THE INVENTION
[00038] In accordance with the above objects and those that will be mentioned
and will
become apparent below, the method to control respiration generally comprises
(i)
capturing coded waveform signals that are generated in a subject's body and
are
operative in the control of respiration and (ii) transmitting at least a first
waveform
signal to the body that is recognizable by the respiration system as a
modulation signal.
[00039] In one embodiment of the invention, the first waveform signal includes
at least
a second waveform signal that substantially corresponds to at least one of the
captured
waveform signals and is operative in the control of the respiration system.
[00040] In one embodiment of the invention, the first waveform signal is
transmitted to
the subject's nervous system. In another embodiment, the first waveform signal
is
transmitted proximate to a target zone on the neck, head or thorax.
[00041] In another embodiment of the invention, the method to control
respiration
generally comprises (i) capturing coded waveform signals that are generated in
the body
and are operative in control of respiration and (ii) storing the captured
waveform signals
in a storage medium, the storage medium being adapted to store the components
of the
captured waveform signals according to the function performed by the waveform
signal
components, and (iii) transmitting at least a first waveform signal to the
body that
substantially corresponds to at least one of the captured waveform signals and
is
operative in the control of the respiratory system
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[00042] In another embodiment of the invention, the method to control
respiration
generally comprises (i) capturing a first plurality of waveform signals
generated in a first
subject's body that are operative in the control of respiration, (ii)
generating a base-line
respiration waveform signal from the first plurality of waveform signals,
(iii) capturing a
second waveform signal generated in the first subject's body that is operative
in the
control of respiration, (iv) comparing the base-line waveform signal to the
second
waveform signal, (v) generating a third waveform signal based on the
comparison of the
base-line and second waveform signals, and (vi) transmitting the third
waveform signal
proximate to the subject's body, the third waveform signal being operative in
the control
of respiration.
[00043] In one embodiment of the invention, the first plurality of waveform
signals is
captured from a plurality of subjects.
[00044] Preferably, the third waveform signal is transmitted to said subject's
nervous
system. In an alternative embodiment, the third waveform signal is transmitted
,proximate to a target zone on the neck, head or thorax.
[00045] In accordance with a further embodiment of the invention, the method
for
controlling respiration in a subject generally comprises (i) capturing coded
waveform
signals that are generated in the body and are operative in control of
respiration, (ii)
monitoring the respiration status of the subject and providing at least one
respiratory
system status signal in response to an abnormal function of the respiratory
system, (iii)
storing the captured waveform signals and respiratory system status signals in
a storage
medium, and (iv) transmitting at least a first waveform signal to the body
that is
operative in the control of the respiratory system in response to a
respiration status signal
or component of a captured waveform signal that is indicative of respiratory
distress or a
respiratory abnormality.
[00046] In yet another einbodiment, the method to control respiration
generally
comprises (i) capturing a first plurality of coded waveform signals generated
in a first
subject's body that are operative in the control of respiration, (ii)
capturing at least a first
waveform signal from the subject's body that produces an adverse respiratory
event,
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(iii) generating a confounding signal that is operative to mitigate adverse
respiration
events, and (iv) transmitting the confounding waveform signal to the subject's
body to
mitigate the adverse respiratory event.
[00047] Preferably, the noted waveform signals are transmitted to said
subject's
nervous system. In an alternative embodiment, the waveform signals are
transmitted
proximate to a target zone on the neck, head or thorax.
[00048] The system to control respiration in accordance witli one embodiment
of the
invention generally comprises (i) at least a first signal probe adapted to
capture coded
waveform signals from a subject's body, the waveform signals being
representative of
waveform signals naturally generated in the body and operative in the control
of
respiration, (ii) a processor in communication with the signal probe and
adapted to
receive the waveform signals, the processor being further adapted to generate
at least a
first waveform signal based on the captured waveform signals, the first
waveform signal
being recognizable by the respiration system as a modulation signal and (iii)
at least a
second signal probe adapted to be in communication with the subject's body for
.transmitting the first waveform signal to the body to control respiration.
[00049] Preferably, the processor includes a storage medium adapted to store
the
captured waveform signals.
[00050] In one embodiment, the processor is adapted to extract and store
components of
the captured waveform signals in the storage means according to the function
performed
by the signal components.
BRIEF DESCRIPTION OF THE DR.AWINGS
[00051] Further features and advantages will become apparent from the
following and
more particular description of the preferred embodiments of the invention, as
illustrated in
the accompanying drawings, and in which like referenced characters generally
refer to the
same parts or elements throughout the views, and in which:
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[00052] FIGURES 1A and 1B are illustrations ofwaveform signals captured from
the
body that are operative in the control of the respiratory system;
[00053] FIGURE 2 is a schematic illustration of one embodiment of a
respiratory
control system, according to the invention;
[00054] FIGURE 3 is a schematic illustration of another embodiment of a
respiratory
control system, according to the invention;
[00055] FIGURE 4 is a schematic illustration of yet another embodiment of a
respiratory control system, according to the invention;
[00056] FIGURES 5A and 5B are illustrations of waveform signals that have been
generated by the process means of the invention; and
[00057] FIGURE 6 is a schematic illustration of an embodiment of a respiratory
control
system that can be employed in the treatment of sleep apnea, according to the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[00058] Before describing the present invention in detail, it is to be
understood that this
invention is not limited to particularly exemplified apparatus, systems,
structures or
methods as such may, of course, vary. Thus, although a number of apparatus,
systems
and methods similar or equivalent to those described herein can be used in the
practice
of the present invention, the preferred materials and methods are described
herein.
[00059] It is also to be understood that the terminology used herein is for
the purpose of
describing particular embodiments of the invention only and is not intended to
be
limiting.
[00060] Unless defmed otherwise, all technical and scientific terms used
herein have
the same meaning as commonly understood by one having ordinary skill in the
art to
which the invention pertains.
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[0006,1] Further, all publications, patents and patent applications cited
herein, whether
supra or infra, are hereby incorporated by reference in their entirety.
[00062] Finally, as used in this specification and the appended claims, the
singular
forms "a, "an" and "the" include plural referents unless the content clearly
dictates
otherwise. Thus, for example, reference to "a waveform signal" includes two or
more
such signals; reference to "a respiratory disorder" includes two or more such
disorders
and the like.
Defmitions
[00063] The term "nervous system", as used herein, means and includes the
central
nervous system, including the spinal cord, medulla, pons, cerebellum,
midbrain,
diencephalon and cerebral hemisphere, and the peripheral nervous system,
including the
neurons and glia.
[00064] The terms "waveform" and "waveform signal", as used herein, mean and
include a composite electrical signal that is generated in the body and
carried by neurons
in the body, including neurocodes, neurosignals and components and segments
thereof.
[00065] The term "respiration", as used herein, means the process of
breathing.
[00066] The term "respiratory system", as used herein, means and includes,
without
limitation, the organs subserving the function of respiration, including the
diaphragm,
lungs, nose, throat, larynx, trachea and bronchi, and the nervous system
associated
therewith.
[00067] The term "target zone", as used herein, means and includes, without
limitation,
a region of the body proximal to a portion of the nervous system whereon the
application
of electrical signals can induce the desired neural control without the direct
application
(or conduction) of the signals to a target nerve.
[00068] The terms "patient" and "subject", as used herein, mean and include
humans
and animals.
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[00069] The term "plexus", as used herein, means and includes a branching or
tangle of
nerve fibers outside the central nervous system.
[00070] The term "ganglion", as used herein, means and includes a group or
groups of
nerve cell bodies located outside the central nervous system.
[00071] The term "sleep apnea", as used herein, means and includes the
temporary
cessation of respiration or a reduction in the respiration rate.
[00072] The terms "respiratory system disorder", "respiratory disorder" and
"adverse
respiratory event", as used herein, mean and include any dysfunction of the
respiratory
system that impedes the normal respiration process. Such dysfunction can be
caused by
a multitude of known factors and events, including spinal cord injury and
severance.
[00073] The present invention substantially reduces or eliminates the
disadvantages and
drawbacks associated with prior art methods and systems for controlling
respiration. In
one embodiment of the invention, the system for controlling respiration
generally
comprises means for recording (or capturing) coded neuro-electrical or
waveform
signals that are generated in the body and are operative in the control of
respiration,
means for storing the recorded waveform signals, means for generating at least
one
signal that substantially corresponds to at least one recorded waveform signal
and is
operative in the control of respiration, and means for transmitting the signal
to the
subject's body. In a preferred embodiment of the invention, the signal is
transmitted to
the subject's nervous system.
[00074] As indicated, neuro-electrical signals related to respiration
originate in the
respiratory center of the medulla oblongata. These signals can be captured or
collected
from the respiratory center or along the nerves carrying the signals to the
respiratory
musculature. The phrenic nerve has, however, proved particularly suitable for
capturing
the noted signals.
[00075] Methods and systems for capturing coded signals from the phrenic
nerve(s),
and for storing, processing and transmitting neuro-electrical signals (or
coded waveform
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signals) are set forth in Co-Pending Application Nos. 10/000,005, filed
November 20,
2001, and Application No. [Attorney Docket No. SCM-02-009CIP], filed
May 9, 2005; which are incorporated by reference herein in their entirety.
[00076] Referring first to Figs. lA and 1B, there are shown exemplar waveform
signals
that are operative in the efferent operation of the human (and animal)
diaphragm; Fig.
lA showing three (3) signals 10A, lOB, lOC, having rest periods 12A, 12B
therebetween, and Fig. 1B showing an expanded view of signal lOB. The noted
signals
traverse the phrenic nerve, which runs between the cervical spine and the
diaphragm.
[00077] As will be appreciated by one having ordinary skill in the art,
signals 10A,
l OB, 10C will vary as a function of various factors, such as physical
exertion, reaction to
changes in the environment, etc. As will also be appreciated by one having
skill in the
art, the presence, shape and number of pulses of signal segment 14 can
similarly vary
from muscle (or muscle group) signal-to-signal.
[00078] As stated above, the noted signals include coded information related
to
inspiration, such as frequency, initial muscle tension, degree (or depth) of
muscle
movement, etc.
[00079] In accordance with one embodiment of the invention, neuro-electrical
signals
generated in the body that are operative in the control of respiration, such
as the signals
shown in Figs. lA and lb, are captured and transmitted to a processor or
control module.
[00080] Preferably, the control module includes storage means adapted to store
the
captured signals. In a preferred embodiment, the control module is further
adapted to
store the components of the captured signals (that are extracted by the
processor) in the
storage means according to the function performed by the signal components.
[00081] According to the invention, the stored signals can subsequently be
employed to
establish base-line respiration signals. The module can then be programmed to
compare
"abnormaP" respiration signals (and components thereof) captured from a
subject and, as
discussed below, generate a waveform signal or modified base-line signal for
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transmission to the subject. Such modification can include, for example,
increasing the
amplitude of a respiratory signal, increasing the rate of the signals, etc.
[00082] According to the invention, the captured neuro-electrical signals are
processed
by known means and a waveform signal (i.e., neuro-electrical coded signal)
that is
representative of at least one captured neuro-electrical signal and is
operative in the
control of respiration (i.e., recognized by the brain or respiratory system as
a modulation
signal) is generated by the control module. The noted waveform signal is
similarly
stored in the storage means of the control module.
[00083] To control respiration, the generated waveform signal is accessed from
the
storage means and transmitted to the subject via a transmitter (or probe).
[00084] According to the invention, the applied voltage of the waveform signal
can be
up to 20 volts to allow for voltage loss during the transmission of the
signals.
Preferably, current is maintained to less than 2 amp output.
[00085] Direct conduction into the nerves via electrodes connected directly to
such
nerves preferably have outputs less than 3 volts and current less than one
tenth of an
amp.
[00086] Referring now to Fig. 2, there is shown a schematic illustration of
one
embodiment of a respiratory control system 20A of the invention. As
illustrated in Fig.
2, the control system 20A includes a control module 22, which is adapted to
receive
neuro-electrical coded signals or "waveform signals" from a signal sensor
(shown in
phantom and designated 21) that is in communication with a subject, and at
least one
treatment member 24.
[00087] The treatment member 24 is adapted to communicate with the body and
receives the waveform signal from the control module 22. According to the
invention,
the treatment member 24 can comprise an electrode, antenna, a seismic
transducer, or
any other suitable form of conduction attachment for transmitting respiratory
signals that
regulate or operate breathing function in human or animals. Space needed
between para.
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[00088] The treatment member 24 can be attached to appropriate nerves or
respiratory
organ(s) via a surgical process. Such surgery can, for example, be
accomplished with
"key-hole" entrance in a thoracic-stereo-scope procedure. If necessary, a more
expansive thoracotomy approach can be employed for more proper placement of
the
treatment member 24.
[00089] Further, if necessary, the treatment member 24 can be inserted into a
body
cavity, such as the nose or mouth, and can be positioned to pierce the
mucinous or other
membranes, whereby the member 24 is placed in close proximity to the medulla
oblongata and/or pons. The waveform signals of the invention can then be sent
into
nerves that are in close proximity with the brain stem.
[00090] As illustrated in FIG. 2, the control module 22 and treatment member
24 can
be entirely separate elements, which allow system 20A to be operated remotely.
According to the invention, the control module 22 can be unique, i.e.,
tailored to a
specific operation and/or subject, or can comprise a conventional device.
[00091] Referring now to Fig 3, there is shown a further embodiment of a
control
system 20B of the invention. As illustrated in Fig. 3, the system 20B is
similar to system
20A shown in Fig. 2. However, in this embodiment, the control module 22 and
treatment member 24 are connected.
[00092] Referring now to Fig. 4, there is shown yet another embodiment of a
control
system 20C of the invention. As illustrated in Fig. 4, the control system 20C
similarly
includes a control module 22 and a treatment member 24. The system 20C further
includes at least one signal sensor 21.
[00093] The system 20C also includes a processing module (or computer) 26.
According to the invention, the processing module 26 can be a separate
component or
can be a sub-system of a control module 22', as shown in phantom.
[00094] As indicated above, the processing module (or control module)
preferably
includes storage means adapted to store the captured respiratory signals. In a
preferred
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embodiment, the processing module 26 is further adapted to extract and store
the
components of the captured respiratory signals in the storage means according
to the
function performed by the signal components.
[00095] According to the invention, in one embodiment of the invention, the
method
for controlling respiration in a subject includes the following steps:
capturing coded
waveform signals that are generated in a subject's body and are operative in
the control
of respiration and (ii) transmitting at least a first waveform signal to the
body that is
recognizable by the respiration system as a modulation signal.
[00096] In one embodiment of the invention, the first waveform signal includes
at least
a second waveform signal that substantially corresponds to at least one of the
captured
waveform signals and is operative in the control of the respiration system.
[00097] In one embodiment of the invention, the first waveform signal is
transmitted
to the subject's nervous system. In another embodiment, the first waveform
signal is
transmitted proximate to a target zone on the neck, head or thorax.
[00098] According to the invention, the waveform signals can be adjusted (or
modulated), if necessary, prior to transmission to the subject.
[00099] In another embodiment of the invention, the method to control
respiration
generally comprises (i) capturing coded waveform signals that are generated in
the body
and are operative in control of respiration and (ii) storing the captured
waveform signals
in a storage medium, the storage medium being adapted to store the components
of the
captured waveform signals according to the function performed by the signal
components, and (iii) transmitting at least a first waveform signal to the
body that
substantially corresponds to at least one of the captured waveform signals and
is -
operative in the control of the respiratory system.
[000100] In another embodiment of the invention, the method to control
respiration
generally comprises (i) capturing a first plurality of waveform signals
generated in a first
subject's body that are operative in the control of respiration, (ii)
generating a base-line
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respiration waveform signal from the first plurality of waveform signals,
(iii) capturing a
second waveform signal generated in the first subject's body that is operative
in the
control of respiration, (iv) comparing the base-line waveform signal to the
second
waveform signal, (v) generating a third waveform signal based on the
comparison of the
base-line and second waveform signals, and (vi) transmitting the third
waveform signal
to the body, the third waveform signal being operative in the control of
respiration.
[000101 ] In one embodiment of the invention, the first plurality of waveform
signals is
captured from a plurality of subjects.
[000102] In one embodiment of the invention, the step of transmitting the
waveform
signal to the subject's body is accomplished by direct conduction or
transmission
through unbroken skin at a selected appropriate zone on the neck, head, or
thorax. Such
zone will approximate a position close to the nerve or nerve plexus onto which
the signal
is to be imposed.
[000103] In an alternate embodiment of the invention, the step of transmitting
the
waveform signal to the subject's body is accomplished by direct conduction via
attachment of an electrode to the receiving nerve or nerve plexus. This
requires a
surgical intervention to physically attach the electrode to the selected
target nerve.
[000104] In yet another embodiment of the invention, the step of transmitting
a
waveform signal to the subject's body is accomplished by transposing the
waveform
signal into a seismic form. The seismic signal is then sent into a region of
the head,
neck, or thorax in a manner that allows the appropriate "nerve" to receive and
obey the
coded instructions of the seismic signal.
[000105] Referring now to Figs. 5A and 5B, there are shown respiratory signals
190,
191 that were generated by the apparatus and methods of the invention. The
noted
signals are merely representative of the respiratory signals that can be
generated by the
apparatus and methods of the invention and should not be interpreted as
limiting the
scope of the invention in any way.
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[000106] Referring first to Fig. 5A, there is shown the exemplar phrenic
waveform
signal 190 showing only the positive half of the transmitted signal. The
signal 190
comprises only two segments, the initial segment 192 and the spike segment
193.
[000107] Referring now to Fig. 5B, there is shown the exemplar phrenic
waveform
signal 191 that has been fully modulated at 500 Hz. The signal 191 includes
the same
two segments, the initial segment 194 and the spike segment 195.
[000108] According to the invention, the control of respiration can, in some
instances,
require sending waveform signals into one or more nerves, including up to five
nerves
simultaneously, to control respiration rates and depth of inhalation. For
example, the
correction of asthma or other breathing impairment or disease involves the
rhythmic
operation of the diaphragm and/or the intercostal muscles to inspire and
expire air for the
extraction of oxygen and the dumping of waste gaseous compounds, such as
carbon
dioxide.
[000109] As is known in the art, opening (dilation) the bronchial tubular
network
allows for more air volume to be exchanged and processed for its oxygen
content within
the lungs. The dilation process can be controlled by transmission of the
waveform
signals of the invention. The bronchi can also be closed down to restrict air
volume
passage into the lungs. A balance of controlling nerves for dilation and/or
constriction
can thus be accomplished through the methods and apparatus of the invention.
[000110] Further, mucus production, if excessive, can form mucoid plugs that
restrict
air volume flow throughout the bronchi. As is known in the art, no mucus is
produced
by the lung except in the lumen of the bronchi and also in the trachea.
[000111] The noted mucus production can however be increased or decreased by
transmission of the waveform signals of the invention. The noted transmission
of the
waveform signals can thus balance the quality and quantity of the mucus.
[000112] The present invention thus provides methods and apparatus to
effectively
control respiration rates and strength, along with bronchial tube dilation and
mucinous
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action in the bronchi, by generating and transmitting coded waveform signals
to the
body. Such ability to open bronchi will be useful for emergency room treatment
of acute
bronchitis or smoke inhalation injuries. Chronic airway obstructive disorders,
such as
emphysema, can also be addressed.
[000113] Acute fire or chemical inhalation injury treatment can also be
enhanced
through the methods and apparatus of the invention, while using mechanical
respiration
support. Injury-mediated mucus secretions also lead to obstruction of the
airways and
are refractory to urgent treatment, posing a life-threatening risk. Edema
(swelling)
inside the trachea or bronchial tubes tends to limit bore size and cause
oxygen starvation.
The ability to open bore size is essential or at least desirable during
treatment.
[000114] Further, the effort of breathing in patients with pneumonia may be
eased by
modulated activation of the phrenic nerve through the methods and apparatus of
the
invention. Treatment of numerous other life threatening conditions also
revolves around
a well functioning respiratory system. Therefore, the invention provides the
physician
with a method to open bronchi and fine tune the breathing rate to improve
oxygenation
of patients. This electronic treatment method (in one embodiment) encompasses
the
transmission of activating or suppressing waveform signals onto selected
nerves to
improve respiration. According to the invention, such treatments could be
augmented by
oxygen administration and the use of respiratory medications, which are
presently
available.
[000115] The methods and apparatus of the invention can also be effectively
employed
in the treatment of obstructive sleep apnea (or central sleep apnea) and other
respiratory
ailments. Referring now to Fig. 6, there is shown one embodiment of a
respiratory
control system 30 that can be employed in the treatment of sleep apnea. As
illustrated in
Fig. 6, the system 30 includes at least one respiration sensor 32 that is
adapted to
monitor the respiration status of a subject and transmit at least one signal
indicative of
the respiratory status.
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[000116] According to the invention, the respiration status (and, hence, a
sleep
disorder) can be determined by a multitude of factors, including diaphragm
movement,
respiration rate, levels of 02 and/or CO2 in the blood, muscle tension in the
neck, air
passage (or lack thereof) in the air passages of the throat or lungs, i.e.,
ventilation.
Various sensors can thus be employed within the scope of the invention to
detect the
noted factors and, hence, the onset of a respiratory disorder.
[000117] The system 30 fiuther includes a processor 36, which is adapted to
receive
the respiratory system status signal(s) from the respiratory sensor 32. The
processor 36
is further adapted to receive coded waveform signals recorded by a respiratory
signal
probe (shown in phantom and designated 34).
[000118] In a preferred embodiment of the invention, the processor 36 includes
storage
means for storing the captured, coded waveform signals and respiratory system
status
signals. The processor 36 is fiirdier adapted to extract the components of the
waveform
signals and store the signal components in the storage means.
[000119] In a preferred embodiment, the processor 36 is programmed to detect
respiratory system status signals indicative of respiration abnormalities
and/or waveform
signal components indicative of respiratory system distress and generate at
least one
waveform signal that is operative in the control of respiration.
[000120] Referring to Fig. 6, the waveform signal is routed to a transmitter
38 that is
adapted to be in communication with the subject's body. The transmitter 38 is
adapted
to transmit the waveform signal to the subject's body (in a similar manner as
described
above) to control and, preferably, remedy the detected respiration
abnormality.
[000121] According to the invention, the waveform signal is preferably
transmitted to
the phrenic nerve to contract the diaphragm, to the hypoglossal nerve to
tighten the
throat muscles and/or to the vagus nerve to maintain normal brainwave
patterns. A
single waveform signal or a plurality of signals can be transmitted in
conjunction with
one another.
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[000122] In accordance with a further embodiment of the invention, the method
for
controlling respiration in a subject generally comprises (i) capturing coded
waveform
signals that are generated in the body and are operative in control of
respiration, (ii)
monitoring the respiration status of the subject and providing at least one
respiratory
system status signal in response to an abnormal function of the respiratory
system, (iii)
storing the captured waveform signals and respiratory system status signals in
a storage
medium, and (iv) transmitting at least a first waveform signal to the body
that is
operative in the control of the respiratory system in response to a
respiration status signal
or component of a captured waveform signal that is indicative of respiratory
distress or a
respiratory abnormality.
[000123] In yet another embodiment, the method to control respiration
generally
comprises (i) capturing a first plurality of coded waveform signals generated
in a first
subject's body that are operative in the control of respiration, (ii)
capturing at least a first
waveform signal from the subject's body that produces an adverse respiratory
event,
(iii) generating a confounding signal that is operative to mitigate adverse
respiration
events, and (iv) transmitting the confounding waveform signal to the subject's
body to
mitigate the adverse respiratory event.
[000124] Without departing from the spirit and scope of this invention, one of
ordinary
skill can make various changes and modifications to the invention to adapt it
to various
usages and conditions. As such, these changes and modifications are properly,
equitably, and intended to be, within the full range of equivalence of the
following
claims.
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