MX2007013995A - Method and system to control respiration by means of simulated neuro-electrical coded signals - Google Patents

Abstract

A method to control respiration generally comprising generating and transmitting at least a first simulated neuro-electrical coded signal to the body that is recognizable by the respiratory system as a modulation signal.

Description

METHOD AND SYSTEM FOR CONTROLLING BREATHING BY MEANS OF SIMULATED NEURO-ELECTRIC CODIFIED SIGNALS CROSS REFERENCE TO RELATED REQUESTS This application is a continuation-in-part of the Application of E.U. No. 11 / 129,264, filed May 13, 2005, which is a continuation in part of the US Application. No. 10 / 847,738, now US Patent. No. 6,937,903, which claims the benefit of the Provisional Application of E.U. No. 60 / 471,104, filed May 16, 2003. FIELD OF THE PRESENT INVENTION The present invention relates in general 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 simulated neuro-electrical coded signals. BACKGROUND OF THE INVENTION As is well known in the art, the brain modulates (or controls) respiration by 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 spinal cord and the peripheral nervous system, which generally comprises groups of nerve cells (i.e., neurons) and nerves peripherals that are located outside the brain and spinal cord. The two systems are anatomically separated, but functionally interconnected.; As indicated, the peripheral nervous system is constructed of nerve cells (or neurons) and glial cells (or glia), which supports neurons. The operating neuronal units that carry signals from the brain are referred to as "efferent" nerves. The "afferent" nerves are those that transport sensory or status information to the brain. As is known in the art, a typical neuron includes four morphologically defined regions: (i) the cell body, (ii) dendrites (iii) axon and (iv) presynaptic terminals. The body of the cell (soma) is the metabolic center of the cell. The body of the cell contains the nucleus, which stores the genes of the cell and the rough and smooth endoplasmic reticulum, which synthesizes the proteins of the cell. : The cell body typically includes two types; of excrescences (or processes); the dendrites and the axon. Most neurons have several dendrites; they branch outward like a tree and serve as the main apparatus for the reception of signals from other nerve cells.; The axon is the main driving unit of the neuron. The axon is capable of transporting electrical signals over distances ranging from as short as 0.1 mm to as long as 2 m. Many axons are divided into numerous branches, thus transporting the information to different objectives. Near the final part of the axon, the axon divides into thin branches that come into contact with other neurons. The point of contact is referred to as a synap $ is. The transmitting cell of a signal is called the presynaptic cell, and the receptor cell of the signal is referred to as the postsaptic cell. Specialized protuberances on the branches of the axon (i.e., presynaptic terminals) serve as the transmitting site in the presynaptic cell. The majority of axons end near the dendrites of the postsynaptic neuron. However, communication can also occur in the cell body or, less frequently, in the initial segment or terminal portion of the axon of the postsynaptic cell. Many nerves and muscles are involved in breathing or efficient breathing. The most important muscle dedicated to breathing is the diaphragm. The diaphragm is a leaf-shaped muscle that separates the thoracic cavity from the abdominal cavity. With normal tidal breathing, the diaphragm moves approximately 1 cm. However, in a forced breath, the diaphragm can move up to 10 cm. The left and right phrenic nerves activate the movement of the diaphragm. Contraction and relaxation of the diaphragm account for approximately 75% volume change in the chest during normal and silent 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 that travel from the brain. 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. The main nerves that are involved in breathing are the ninth and tenth cranial nerves, the phrenic nerve and the intercostal nerves. The glossopharyngeal nerve (cranial nerve IX) innervates the body of the catotid and detects the levels of C02 in the blood. The vagus nerve (cranial nerve X) provides a sensory input from the larynx, pharynx and thoracic viscera, including the bronchi. The phrenic nerve originates from the vertebral nerves C3, C4 and C5 and innervates the diaphragm.

The intercostal nerves originate from the vertebral nerves T7-11 and innervate the intercostal muscles. The various afferent sensory neuro-fibers provide information on how the body should be breathing in response to events external to the body itself. An important respiratory control is activated by the vagus nerve and its preganglionic nerve fibers, which synapse in ganglia. These ganglia are incorporated into the bronchi that are also innervated with sympathetic and parasympathetic activity. It is well documented that the sympathetic nervous division may have no effect on the bronchi or may dilate the lumen (inner diameter) to allow more air to enter during respiration, which is useful with asthma patients, although the The parasympathetic process offers the opposite effect and can constrict the bronchi and increase secretions, which can be harmful for asthma patients. The electrical signals transmitted along the axon to control respiration, referred to as action potentials, are fast and transient nerve impulses "all-or-none". The action potentials typically have approximately 100 millivolts (mV) and a duration of approximately 1 msec. The potentials of action 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 potentials remains constant throughout the axon, since the impulse regenerates continuously as it passes through the axon. A "neuroseñal" is a composite signal that includes many action potentials. The neuroseñal also includes an established instruction for a correct function of the organ. A respiratory neuroseñal would therefore include an established instruction for the diaphragm to perform efficient ventilation, including information concerning 1 frequency, initial muscular tension, degree (or depth) of muscular movement, etc. Neuro-signals or "neuro-electrical coded signals" are therefore codes that contain complete sets of information for the full function of the organ. As previously stated in Co-pending Application No. 11 / 125,480, filed May 9, 2005, once you are <neuroseñales, which are incorporated in the "simulated neuroelectric encoded signals" referred to herein, have been isolated, registered, standardized and transmitted to a subject (or patient), a generated nerve-specific instruction can be employed (ie, signal can be employed (ie ) to control breathing and, of this way, treat a multitude of disorders of the respiratory system. The disorders noted include, but are not limited to, sleep apnea, asthma, excessive mucus production, acute bronchitis and emphysema. As is known in the art, sleep apnea is generally defined as a temporary cessation of breathing during sleep. Obstructive sleep apnea is a 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 respiratory muscles to start breathing during sleep. Those affected by sleep apnea experience a fragmentation of sleep and a complete or almost complete cessation of breathing (or ventilation) during sleep with potentially severe degrees of oxyhemoglobin desaturation. Studies on the mechanism of collapse of the airways suggest that during some stages of sleep, there is a general relaxation of the muscles that stabilize the segment of the upper airways. It is believed that this general relaxation of the muscles is a contributing factor to sleep apnea. Several apparatuses, systems and methods have been developed, including an apparatus or stage for recording action potentials or electrical coded electrical signals, to control breathing and treat other respiratory disorders, such as sleep apnea. However, the signals are typically subject to an extensive process and are subsequently used to regulate a "mechanical" device or system, such as a fan. The systems described in the U.S. Patent. Nos. 6,360,740 and 6,651,652 are illustrative. In U.S. Patent No. 6,360,740 a system and method for providing respiratory assistance are described. The method noted includes the step of recording "respiratory signals", which are generated in the respiratory center of the patient. "Respiratory signals" are processed and used to control a muscle stimulation device or ventilator. In U.S. Patent No. 6,651,652 a system and method for treating sleep apnea is described. The annotated method includes a respiration detector that is adapted to capture neuroelectric signals and extract signal components related to respiration. The signals are processed and used in a similar way to control a fan. A major disadvantage associated with the systems and methods described in the annotated patents, as well as with the major: art of the known systems, is that the control signals that are generated and transmitted are "user-determined" and "determined by the user". device". The signs "Controlled annotations are not related or are representative of the signals that are generated in the body and, therefore, would not be operative in the control or modulation of the respiratory system if they are transmitted to it. A method and system for controlling respiration that includes a means for generating and transmitting simulated neuro-electrical signals encoded to the body that are operative in the control of the respiratory system It is therefore an object of the present invention to provide a method and system for controlling respiration that overcomes the disadvantages associated with methods and systems for controlling respiration of the prior art It is another object of the present invention to provide a method and system for controlling respiration that includes a means for generating and transmitting neuro-electrical signals. encoded simulated to the body that are operative in the control of the system respiratory theme. It is another object of the present invention to provide a method and system for controlling respiration that includes a means for transmitting simulated coded neuro-electrical signals directly to the nervous system of the body. It is another object of the invention to provide a method and system for controlling respiration that includes a means to record waveform signals that are generated in the body and are operative in the control of respiration. It is another object of the invention to provide a method and system for controlling respiration that includes a means: a processor adapted to generate a basal cell respiratory signal that is representative of at least one coded wave signal generated in the body from registered waveform signals. It is another object of the invention to provide a method and system for controlling respiration that includes a means: adapted processor for comparing respiratory waveform signals recorded with baseline respiratory signals, and generating respiratory signals as a function of the! registered waveform signal. It is another object of the invention to provide a method and system for controlling respiration that includes a means of monitoring for detecting abnormalities of respiration. It is another object of the invention to provide a method and system for controlling respiration that includes a detector to detect if a subject is experiencing an apneic event. : It is another object of the invention to provide a method and system for controlling respiration that can be easily employed in the treatment of respiratory system disorders, including sleep apnea, asthma, excessive production of mucus, acute bronchitis and emphysema. SUMMARY OF THE INVENTION In accordance with the above objectives and those which will be mentioned and will become apparent below, the method for controlling respiration generally comprises (i) generating at least a first simulated coded neuro-electrical signal that is recognizable by the respiratory system as a modulation signal; and (ii) transmit the first simulated neuro-electrical signal to the body to control the respiratory system. In a preferred embodiment of the invention, the simulated encoded neuro-electrical signal comprises a frequency modulated signal. Preferably, the simulated encoded neuro-electrical signal is modulated within a predetermined signal envelope. In one embodiment, the signal envelope includes a positive voltage region that transits from an initial voltage equal to approximately zero (0) to a region of maximum voltage in a first period of time at a decreased voltage equal to approximately zero (0) in a second period of time and a region of negative voltage that substantially corresponds to the positive voltage region.

Preferably, the simulated encoded neuro-electrical signal is frequency modulated within the signal envelope at a frequency in the range of about 50-1000 Hz. Preferably, the peak voltage or peak amplitude of the modulated encoded neuro-electrical signal is it is in the range of about 100 mV to 20 V. In one embodiment of the invention, the time at the peak voltage or amplitude is in the range of about 50 msec to 2.0 sec. In one embodiment of the invention, the modulated encoded neuro-electrical signal is transmitted to the subject's nervous system. In another embodiment, the modulated encoded neuro-electrical signal is transmitted to a point near the target area on the neck, head or thorax. According to a further embodiment of the invention, the method for controlling respiration in a subject generally comprises (i) generating at least a first simulated encoded neuro-electrical signal that is recognizable by the respiratory system as a modulation signal, (ii) ) monitor the status of the subject's breathing and provide at least one status signal from the respiratory system in response to abnormal function of the respiratory system, (iii) transmit the first simulated coded neuro-electrical signal to the body in response to the respiratory status signal that is indicative of respiratory distress or respiratory abnormality. BRIEF DESCRIPTION OF THE DRAWINGS The additional features and advantages will be apparent from the following and more particular description of the preferred embodiments of the invention, as illustrated in the accompanying drawings, and in which the same referenced characters generally refer to the same parts or elements through all views and in which: Figures 1? and IB are illustrations of waveform signals captured from the body that are operative in the control of the respiratory system; Figure 2 is a schematic illustration of one embodiment of a respiratory control system, according to the invention; Figure 3 is a schematic illustration of another embodiment of a respiratory control system, according to the invention; Figure 4 is a schematic illustration of yet another embodiment of a respiratory control system, according to the invention; Figures 5A and 5B are illustrations of simulated waveform signals that have been generated by means of the process of the invention; Figure 6 is a schematic illustration of one embodiment of a respiratory control system that can be employed in the treatment of sleep apnea, according to the invention; Figure 7 is an illustration of a waveform signal captured from a phrenic nerve that is operative in the control of the respiratory system and a signal envelope associated therewith, according to the invention; Figure 8 is an illustration of one embodiment of a signal envelope of the invention; and Figure 9 is an illustration of a mode of a simulated coded neuro-electrical signal of the invention. DETAILED DESCRIPTION OF THE INVENTION Before describing in detail the present invention, it should be understood that this invention is not limited to particularly exemplified apparatuses, systems, structures or methods, as such they can, of course, vary. Although a number of apparatuses, systems and methods similar or equivalent to those described herein may be used, in the practice of the present invention, preferred materials and methods are described herein. It should also be understood that the terminology used herein is solely for the purpose of describe particular embodiments of the invention and are not conceived as limiting. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one having ordinary experience in the art to which the invention pertains. further, all publications, patents and patent applications cited herein, either supra or xnfra are incorporated in their entirety by reference. 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, the reference to "a waveform signal" includes two or more such signals; the reference to "a respiratory disorder" includes two or more such disorders and the like. Definitions The term "nervous system", as used herein, means and includes the central nervous system, including the spinal cord, marrow, pons, cerebellum, mesocephalic, diencephalon and cerebral hemisphere and peripheral nervous system, including neurons and glia.

The terms "waveform" and "waveform signal", as used herein, mean and include a composite electrical signal that is generated in the body and transported by neurons in. the body, including the neurocodes, neuroseñales and components and segments thereof. The term "simulated waveform signal", as used herein, means an electrical signal that substantially corresponds to "waveform signal". The term "signal envelope", as used herein, means the envelope or area defined by a "waveform signal" or portion thereof (i.e., signal segment). The term "simulated encoded neuro-electrical signal", as used herein, means an electrical signal1 that is modulated within a "signal envelope". The term "signal train", as used herein, means a composite signal having a plurality of signals, such as the "simulated encoded neuro-electrical signal" and "simulated waveform" signals defined above. Unless stated otherwise herein, the simulated encoded neuroelectric signals that are generated by the process means of the invention are they designate and adapt to be transmitted continuously or at intervals established for a subject. The term "breathing", as used in the present, means the process of breathing. The term "respiratory system," as used herein, means and includes, without limitation, organs that subserve the function of respiration, including the diaphragm, lungs, nose, throat, larynx, trachea and bronchi and the system nervous associated with them. The term "target zone", as used herein, means and includes, without limitation, a region of the body proximate to a portion of the nervous system upon which the application of electrical signals may induce the desired neural control without direct application (or driving) signals to a target nerve. The terms "patient" and "subject", as used herein, mean and include humans and animals. The term "plexus", as used herein, means and includes a branch or tangle of nerve fibers outside the central nervous system. The term "ganglion," as used herein, means and includes a group or groups of nerve cell bodies located outside the nervous system. central. The term "sleep apnea," as used herein, means and includes the temporary cessation of breathing or a reduction in the rate of respiration. 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 breathing process. Such dysfunction can be caused by a multitude of known factors and events, including injury and rupture of the spinal cord. The present invention substantially reduces or eliminates the disadvantages and drawbacks associated with methods and systems for controlling respiration of the prior art. In one embodiment of the invention, the method for controlling respiration in a subject generally comprises generating at least one simulated encoded neuro-electrical signal that is recognizable by the subject's respiratory system as a modulation signal and traversing the coded neuro-electrical signal. simulated to the body of the subject. In a preferred embodiment of the invention, the modified encoded neuro-electrical signal is transmitted to the subject's nervous system. As indicated, the neuro-electrical signals related to breathing originate in the center respiratory of the medulla oblongata. These signals can be captured or collected from the respiratory center or along the signaling nerves of the signals to the respiratory musculature. Nevertheless, the phrenic nerve has proven to be particularly suitable for capturing the annotated signals. Methods and systems for capturing coded signals from the phrenic nerve / s and for storing, processing and transmitting neuro-electrical signals (or coded waveform signals) are set forth in Co-pending Applications Nos. 10 / 000,005, filed on November 20, 2001, and Application No. 11 / 125,480, filed May 9, 2005; which are incorporated by reference herein in its entirety. Referring first to Figures 1A and IB, these show exemplary waveform signals that are operative in the efferent operation of the human (and animal) diaphragm; Figure 1A showing three (3) signals 10A, 10B, 10C, jue jue have rest periods 12A, 12B between them and Figure IB showing an expanded view of the signal 10B. The annotated signals pass through the phrenic nerve, which runs between the cervical spine and the diaphragm. As will be appreciated by a person of ordinary skill in the art, signals 10A, 10B, 10C will vary as a function of several factors, such as effort physical, reaction to changes in the environment, etc. As will also be appreciated by one skilled in the art, the presence, shape and number of pulses of signal segment 14 may similarly vary signal-to-signal of the muscle (or muscle group 1). As stated above, the annotated signals include coded information related to inspiration, such as frequency, initial muscle tension, degree (or depth) of muscle movement, etc. According to one embodiment of the invention, the neuro-electrical signals generated in the body that are operative in the control of respiration, such as the signals shown in Figures 1A and IB, are captured and transmitted to a processor or module. of control. 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 (which are extracted by the processor) in the storage means according to the function performed by the signal components. According to the invention, the stored signals can subsequently be used to establish baseline signals of respiration. The module can then be programmed to compare breathing signals "abnormal" (and components thereof) captured from a subject and, as discussed below, generate a simulated or simulated coded neuro-electrical waveform signal (discussed below) or a modified baseline signal for the transmission to the subject. Such modification may include, for example, increasing the amplitude of a respiratory signal, increasing the rate of the signals, etc. According to the invention, the captured neuro-electrical signals are processed by known means and a simulated waveform signal (or simulated encoded neuro-electrical signal) is generated that is representative of at least 1 captured neuro-electrical signal and is operative in the control of respiration (ie, recognized by the brain or if, respiratory system as a signal of modulation), by means of the control module. The simulated signal is stored in a similar manner in the storage medium of the control module. In one embodiment of the invention, to control respiration, the simulated waveform signal (or simulated coded neuro-electrical signal) is accessed from the storage medium and transmitted to the subject by a transmitter (or probe). . According to the invention, the applied voltage of the simulated waveform signal can be up to 20 volts to allow the loss of voltage during the transmission of the signals. Preferably, the current is maintained at an output of less than 2 amp. Direct conduction to the nerves through electrodes directly connected to such nerves preferably has outputs less than 3 volts and current less than one-tenth of an amp. Referring now to Figure 2, a schematic illustration of one embodiment of a respiratory control system 20A of the invention is shown. As illustrated in Fitjura 2, the control system 20A includes a control module 22, which is adapted to receive coded neuro-electrical signals or "waveform signals" from a signal detector (shown in dotted lines and designated 21) that is in communication with a subject and at least one treatment unit 24. The treatment member 24 is adapted to communicate with the body and receives the simulated waveform signal or simulated coded neuro-electrical signal from the module. 22. In accordance with the invention, the treatment member 24 may comprise an electrode, antenna, a seismic transducer or any other suitable form of conduction connection for transmitting respiratory signals that regulate or operate the respiration function in Hurjians or animals. .

I The treatment member 24 can be attached to appropriate nerves or respiratory organ (s) by a surgical procedure. Such surgery can be performed, for example, with a "lock" entry in a thoracic stereoscopic procedure. If necessary, a more expansive thoracotomy procedure may be employed for more appropriate placement of the treatment member 24. In addition, if necessary, the treatment member 24 may be inserted into a body cavity, such as the nose or mouth, and may positioned to perforate the mucous membranes or other membranes, by means of which the limb 24 is placed in close proximity to the medulla oblongata and / or variola bridges. The simulated signals of the invention can then be sent to the nerves that are in close proximity to the cerebellum. As illustrated in Figure 2, the control module 22 and the treatment member 24 can be completely separate elements, which allows the system 20A to be operated remotely. According to the invention, the control module 22 may be unique, i.e., designed for a specific operation and / or subject or may comprise a conventional device. Referring now to Figure 3, a further embodiment of a control system 20B of the invention is shown. As illustrated in Figure 3, system 20B is. similar to the system 20A shown in Figure 2. However, in this embodiment, the control module 22 and the treatment member 24 are connected. Referring now to Figure 4, this shows yet another additional embodiment of a control system 20C of the invention. As illustrated in Figure 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 detector 21. The system 20C also includes a module processing (or computer) 26. In accordance with the invention, the processing module 26 may be a separate component or may be a subsystem of a control module 22 ', as shown in dotted lines. As indicated above, the processing module (or control module) preferably includes a storage medium adapted to store the captured respiratory signals. In a preferred embodiment, the processing module 26 is further adapted to extract and store the components of the respiratory signals captured in the storage medium according to the function performed by the signal components. According to the invention, in one embodiment of the invention, the method for controlling respiration in a subject includes (i) generating a first simulated waveform signal that is recognizable by the respiratory system as a modulation signal and (ii) transmitting the first simulated waveform signal to the body to control the respiratory system. In another embodiment of the invention, the method for controlling respiration comprises (i) capturing coded waveform signals that are generated in a body of a subject and that are operative in the control of respiration, (ii) (generating a first simulated waveform signal that is recognizable by the respiratory system as a modulation signal and (iii) transmitting the first simulated waveform signal to the body In one embodiment of the invention, the first simulated waveform signal includes at least one second waveform signal that substantially corresponds to at least one of the captured waveform signals and is operative in the control of the respiratory system In one embodiment of the invention, the first simulated waveform signal it is transmitted to the nervous system of the subject.In another modality, the first simulated waveform signal is transmitted close to the target area on the neck, head and thorax. With the invention simulated waveform signals can be adjusted (or modulated), if necessary, before transmission to the subject. In another embodiment of the invention, the method for controlling respiration generally comprises (i) capturing the coded waveform signals that are generated in the body and that are operative in the control of respiration and (ii) storing the signals of waveform captured on a storage medium, the storage means being adapted to store the components of the captured waveform signals according to the function performed by the signal components, (iii) generating a first signal in the form of simulated wave that substantially corresponds to at least one of the waveform signals captured, and (iv) transmitting the first simulated waveform signal to the body for the control of the respiratory system. In another embodiment of the invention, the method for controlling respiration generally comprises (i) capturing a first plurality of waveform signals generated in a first subject body that are operative in the control of respiration, (ii) generating a Respiratory baseline waveform signal from the first plurality of waveform signals, (iii) capturing a second waveform signal generated in the first subject body that is operative in breath control, (iv) comparing the basal waveform signal with the second waveform signal, (v) generating a third signal Waveform based on the comparison enters the basal and second waveform signals, and (vi) transmits the third waveform signal to the body, being the third waveform signal, operational in the control of the breath. In one embodiment of the invention, the first plurality of waveform signals is captured from a plurality of subjects. In one embodiment of the invention, the step of transmitting the waveform signals to the body of the subject is performed by conduction or direct transmission through the skin without injury in an appropriate selected area on the neck, head or thorax. Such a zone will approach a position close to the nervous nerve or plexus on which the signal must be imposed. In an alternate embodiment of the invention, the step of transmitting the waveform signals to the body of the subject is performed by direct conduction by means of the attachment of an electrode to the receptor nerve or nerve plexus. This requires a surgical intervention to physically attach the electrode to the selected target nerve. In still another embodiment of the invention, the step of transmitting a signal to the body of the subject is carried out by transposing the signal in a seismic form. The signal is then sent to a region of the head, neck or thorax in a manner that allows the appropriate "river" to receive and obey the codified instructions of the seismic signal. Referring now to Figures 5? and bE these show the simulated waveform signals 190, 1 1 that were generated by the apparatus and methods of the invention. The annotated signals are only representative of the simulated waveform signals that can be generated by the apparatus and methods of the invention and should not in any way be construed as limiting the scope of the invention. Referring first to Figure 5 ?, this shows the exemplary simulated phrenic waveform signal 190 which shows only the positive half of the transmitted signal. Signal 190 comprises only two segments, the initial segment 192 and the peak segment 193. Referring now to Figure 5B, this shows the exemplary simulated phrenic waveform signal 191 which has been fully modulated at 500 Hz. The signal 191 includes the same two segments, the initial segment 194 and the peak segment 195. As indicated above, the simulated coded neural signals of the invention comprise frequency modulated signals that are modulated within a predetermined signal envelope. According to the invention, the signal envelope is defined and therefore, derived from a waveform signal (or segment of a waveform signal) that is generated in the body. Referring now to Figure 7, this shows the waveform signal 16 that was captured from the phrenic nerve that is operative in the control of the respiratory system. As illustrated in Figure 7, the signal 16 defines a signal envelope 220, which in one embodiment is disposed proximate to the signal amplitude transition points 17 (i.e., external shape defined by the signal). According to the invention, the signal envelope 220 can be represented approximately 100% of the shape defined by the signal 16, as shown in Figure 8 or a percentage thereof. For example, in a predicted embodiment, the signal envelope represents approximately 80% of the envelope (or shape) defined by the base signal. As illustrated in Figure 8, the signal envelope 220 includes a positive voltage region 222 that preferably transits from an initial voltage equal to about 0 V (at t0) to a maximum voltage region 226 in a first time period ( ti), ie, t0-? ti to approximately 0V in a second period of time (t2), ie, t0- > t2. The signal envelope 220 also includes a negative voltage region 224 that preferably substantially corresponds to the voltage region positive 222. Preferably, t] is in the range of approximately 50 msec-1 sec, more preferably, in the range of approximately 100 msec-900 msec, depending on the subject's normal respiration rate. Preferably, t2 is in the range of approximately 100 msec-1 sec. In one embodiment of the invention, the maximum voltage within the region 226 is in the range of approximately 100 mV-20 V, more preferably, in the range of approximately 150 mV-2 V. Preferably, the maximum voltage region 226 it has a period of time associated with it (designated "t3") in the range of approximately 0.0001-25 msec. According to the invention, the signal envelope 220 and, therefore, the signal modulated therein can also be modified to increase or decrease the transition time from OV to a maximum voltage (or amplitude), ie, to a , the maximum voltage and / or time t3 within the maximum voltage region and / or maximum voltage transition OV (a t2).; Referring now to Figure 9, this shows a mode of a simulated coded neuro-electrical signal 230, which has been modulated at 500 Hz within the signal envelope 220. As indicated, according to the invention, the neurological signals simulated coded electrical Modulate within the signal envelope to a multitude of frequencies. Preferably, the simulated coded neuroelectric signals of the invention are frequency modulated within a signal envelope at a frequency in the range of about 50-1000 Hz for a period of time, ie, t0-t2, in the range of approximately 400 msec at 2.0 sec. As will be appreciated by a person of ordinary skill in the art, the time noted will depend on the subject's normal breathing rate. In a preferred embodiment of the invention, the simulated encoded neuro-electrical signal is frequency modulated within a signal envelope at a frequency in the range of about 50-300 Hz for a period of time in the range of about 0.5-1.0. sec. According to the invention, the simulated encoded neuro-electrical signals of the invention can be used to construct "signal streams", comprising a plurality of simulated encoded neuro-electrical signals. The signal train may comprise a continuous stream of simulated encoded neuro-electrical signals or may include interposed signals or periods of rest, i.e., zero voltages and current, between one or more simulated encoded neuro-electrical signals. The signal train can also include signals simulated substantially similar encoded neuro-electric, different simulated encoded neuro-electrical signals, e.g., modulated within different signal envelopes or a combination thereof. According to a further embodiment of the invention, the method for controlling respiration in a subject thus includes (i) generating at least a first simulated encoded neuro-electrical signal that is recognizable by the respiratory system as a modulation signal and (ii) ) transmit the first simulated coded neuro-electrical signal to the body to control the respiratory system. In one embodiment of the invention, the first simulated encoded neuro-electrical signal is transmitted to the subject's nervous system. In another embodiment, the first simulated coded neuro-electrical signal is transmitted close to the target area on the head, neck or thorax. According to a further embodiment of the invention, the method for controlling respiration in a subject includes generating a first signal train, said signal train including a plurality of simulated encoded neuro-electrical signals that are recognizable by the respiratory system as modulation signals; and (ii) transmit the first signal train to the body to control the respiratory system. According to the invention, the control of the breathing can, in some cases, require sending one or more simulated coded neuro-electrical signals to one or more nerves, including up to eight nerves simultaneously to control inhalation breathing and depth rates. For example, correction of asthma or other abnormalities or diseases of respiration involves the rhythmic operation of the diaphragm and / or the intercostal muscles to inspire and expire air for oxygen extraction and discharge of waste gaseous compounds, such as carbon dioxide. As is known in the art, the opening (dilation) of the bronchial tubular network allows more volume of air to be exchanged and processed by its oxygen content within the lungs. The dilation process can be controlled by the transmission of the signals of the invention. The bronchi can be closed to restrict the passage of air volume to the lungs. A balance can thus be achieved to control the nerves for dilation and / or constriction through the methods and apparatuses of the invention. In addition, the production of mucus, if excessive, can form mucoid plugs that restrict the flow of air volume through the bronchi. As is known in the art, mucus is not produced by the lung except in the lumen of the bronchi and also in the trachea.

; The production of annotated mucus can, however, be increased or decreased by transmitting the signals of the invention. The transmission of the above mentioned signals of the invention can thus balance the quality and quantity of mucus. The present invention thus provides methods and apparatus for effectively controlling the rate and force of respiration, together with the dilation of the bronchial tube and mucinous action in the bronchi, generating and transmitting simulated neuro-electrical signals coded to the body. Such capacity to open the bronchi will be useful, in emergency room, for the treatment of acute bronchitis or lesion by inhalation of smoke. They can also address chronic obstructive airway disorders, such; like emphysema. The treatment of injury by an acute inhalation of fire or chemicals can also be improved, through the methods and apparatus of the invention, although using a mechanical breathing support. Mediated mucus secretions due to injury also lead to airway obstruction and are reluctant to emergency treatment, representing a life-threatening risk. An edema (swelling) within the trachea or bronchial tubes tends to limit the size of the cavity and causes oxygen starvation. The ability to open the size of the cavity is essential or at least desirable during the treatment. In addition, the effort to breathe in patients with pneumonia can be facilitated by the modulated activation of the phrenic nerve through the methods and apparatus of the invention. The 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 the bronchial tubes and fine-tune the respiration rate to improve the oxygenation of the patients. This method of electronic treatment (in one modality) encompasses the transmission of simulated encoded or suppressive neuro-electrical signals on the selected nerves to improve breathing. According to the invention, such treatments could be increased by the administration of oxygen and the use of respiratory drugs, which are currently available. The methods and apparatus of the invention can also be used effectively in the treatment of obstructive sleep apnea (or central sleep apnea) and other respiratory conditions. Referring now to Figure 6, this shows a modality of the respiratory control system 30 that can be employed in the treatment of sleep apnea. As illustrated in Figure 6, the system 30 includes at least one breath detector 32 that is adaptp to monitor the status of a subject's breathing and transmit at least a signal indicative of respiratory status. According to the invention, the status of respiration (and, thus, a sleep disorder) can be determined by a multitude of factors, including diaphragm movement, respiration rate, O2 and / or CO2 levels in the blood, stress muscle of the neck, air passage (or lack thereof) in the air passages of the throat or lungs, eg, ventilation. Several detectors can thus be used within the scope of the invention to detect the factors noted and, therefore, the onset of a respiratory disorder. The system 30 further includes a processor 36, which is adapted to receive the status signal (s) of the respiratory system from the respiratory detector 32. The processor 36 is further adapted to receive registered coded waveform signals. by a respiratory signal probe (shown in dotted lines and designated 34). In a preferred embodiment of the invention, the processor 36 includes a storage means for storing the encoded, captured waveform signals and status signals of the respiratory system. The processor 36 is further adapted to extract the components of the waveform signals and store the components signal in the storage medium. 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 stress and generate at least one coded neuro-electrical signal simulated that is operative in the control of breathing. Referring to Figure 6, the simulated encoded neuro-electrical signal is directed to a transmitter 38 that is adapted to be in communication with the body of the subject. Transmitter 38 is adapted to transmit the simulated coded neuroelectric signal to the body of the subject (in a manner similar to that described above) to control and, preferably, remedy the detected breathing abnormality. According to the invention, the simulated encoded neuro-electrical signal is preferably transmitted to the phrenic nerve to contract the diaphragm, to the hypoglyceous nerve to compress the muscles of the throat and / or the vagus nerve to maintain normal brain wave patterns. A single signal or a plurality of signals can be transmitted in conjunction with each other. Therefore, according to an additional embodiment of the invention, the method for controlling the Breathing in a subject generally comprises (i) generating at least a first simulated coded neuro-electrical signal that is recognizable by the respiratory system as a modulation signal, (ii) monitoring the subject's breathing status and providing at least one signal of status of the respiratory system in response to abnormal function of the respiratory system, (iii) transmitting the simulated coded neuro-electrical signal to the body to control the breathing system in response to a signal of status of respiration that is indicative of an effort respiratory or respiratory abnormality. EXAMPLES The following examples are provided to enable those skilled in the art to understand and practice the present invention more clearly. These should not be considered as limiting the scope of the invention, but only illustrated as representative of them. EXAMPLE 1 Three pigs were subjected to several simulated, coded, frequency modulated neuro-electrical signals. Four signals were used that had four different periods of modulation; 400 msec, 800 msec, 1.2 sec and 2.0 sec. The voltage levels for each signal were as follows; +/- 200 mV, +/- 230 mV and +/- 250 mV. Each signal 'was modulated within a signal envelope substantially similar to the envelope) shown on the iyur * 8, at a frequency of at least 500 Hz. During the application of each signal, 3e monitored the following physiological parameters: input tidal volume, output tidal volume , oxygen saturation and C02.

The results of a representative study are shown in Tables II-V, below.

Table II Tidal Volume of Entry Table III Output Tidal Volume Table IV Table V It can be seen from Tables II-V that the tidal volumes, oxygen saturation and end-tidal C02 levels, vary depending on the period of time of the transmitted signal and the voltage at which the signal is transmitted. In this study, the maximum tidal volume was achieved with a signal of 800 msec and a voltage of +/- 250 mV. The maximum oxygen levels were achieved with a signal of 1.2 sec and a voltage of +/- 230 mV. The minimum levels of C02 were achieved with a signal of 400 msec and a voltage of +/- 200 mV. It will thus be apparent to a person of ordinary skill in the art that the simulated encoded neuro-electrical signals of the invention can be modified to achieve the desired results, either to increase or decrease the tidal volume, to maximize the oxygen levels or to minimize the levels of carbon dioxide or some combination thereof. Without departing from the spirit and scope of this invention, a person with ordinary experience can make various changes and modifications to the invention to adapt it to various uses and conditions. As such, these changes and modifications are properly comparable and are proposed to be within the full range of equivalences of the following claims.

Claims (23)

1. CLAIMS 1. The use of a plurality of captured waveform signals, which are generated in the body of a subject to generate a frequency modulated signal that is frequency modulated within a signal envelope; wherein said frequency modulated signal is recognizable by the subject's respiratory system as a modulation signal. The use of claim 1, wherein said signal envelope includes a positive voltage region that transits from an initial voltage equal to approximately 0 V to a maximum voltage region in a first time period at approximately 0 V in a second period of time. 3. The use of claim 2, wherein said signal envelope includes a negative voltage region that substantially corresponds to said positive voltage region. 4. The use of claim 2, wherein said first time period is in the range of approximately 50 msec - 1 sec. 5. The use of claim 2, wherein said second period of time is in the range of approximately 100 msec - 1 sec. The method of claim 2, wherein the maximum voltage within said maximum voltage region is in the range of approximately 100 mV - 20 V. 7. The use of claim 1, wherein said simulated encoded neuro-electrical signal is frequency modulated within said signal envelope at a frequency in the range of about 50-1000 Hz. The use of claim 1, wherein said simulated coded neuro-electrical signal is frequency modulated for a second period of time in the range of about 400 msec to 2.0 sec. 9. The use of a frequency modulated signal that is frequency modulated within a signal envelope at a frequency in the range of approximately 50-1000 Hz to generate a first simulated coded neuro-electrical signal used to control respiration in a subject with need thereof, wherein said first simulated coded neuro-electrical signal is recognizable by the subject's respiratory system as a signal of modulation; and wherein said at least said first simulated coded neuro-electrical signal is transmitted to the body of the subject, whereby the control of the subject's respiratory system is effected. 10. A system for controlling respiration in a subject, comprising: means for generating a first simulated coded neuro-electrical signal that is recognizable by the the subject's respiratory system as a modulation signal, said simulated encoded neuro-electrical signal comprising a frequency-modulated signal that is frequency modulated within a signal envelope at a frequency in the range of about 50-1000 Hz; and means for transmitting at least said first coded neuro-electrical signal simulated to the subject's body, by means of which control of the subject's respiratory system is effected. The system of claim 10, wherein said signal envelope includes a positive voltage region that transits from an initial voltage equal to about 0 V to a maximum voltage region in a first time period to approximately 0 V in a second period of time. The system of claim 11, wherein said signal envelope includes a negative voltage region that substantially corresponds to said positive voltage region. The system of claim 11, wherein said first time period is in the range of approximately 50 msec - 1 sec. The system of claim 11, wherein said second time period is in the range of about 100 msec - 1 sec. 15. The indication system 11, wherein the maximum voltage within said maximum voltage region is in the range of about 100 mV - 20 V. 16. The system of claim 10, wherein said simulated encoded neuro-electrical signal is frequency modulated during a second period of time in the range of approximately 400 msec to 2.0 sec. 17. A neuro-electrical signal for controlling respiration in a subject, said neuro-electrical signal comprising a frequency modulated signal that is frequency modulated within a signal envelope at a frequency in the range of about 50-1000 Hz. The signal of claim 17, wherein said signal envelope includes a positive voltage region that transits from an initial voltage equal to about 0 V to a maximum voltage region in a first time period at about 0 V in a second period of time. 19. The signal of claim 17, wherein said signal envelope includes a negative voltage region that substantially corresponds to said positive voltage region. 20. The signal of claim 18, wherein said first time period is in the range of approximately 50 msec - 1 sec. 21. The signal of claim 18, wherein said second period of time is in the range of approximately 100 msec - 1 sec. The system of claim 18, wherein the maximum voltage within said maximum voltage region is in the range of about 100 mV - 20 V. The system of claim 17, wherein said neuro-electrical signal Simulated encoding is modulated in frequency during a second period of time in the range of approximately 400 msec to 2.0 sec.