MX2007013975A - Controlling respiration by stimulated action potential signals - Google Patents

Abstract

A method to control respiration generally comprising generating and transmitting at least one simulated action potential signal to the body that is recognizable by the respiratory system as a modulation signal.

Description

METHOD AND SYSTEM FOR CONTROLLING BREATHING THROUGH POTENTIAL SIGNALS OF SIMULATED ACTION CROSS REFERENCE WITH RELATED APPLICATIONS This application is a continuation in part of the E.ü Application. 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 potential signals of simulated action. BACKGROUND OF THE INVENTION As is well known in the art, the brain modulates (or controls) respiration through electrical signals (ie, 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 It generally comprises groups of nerve cells (ie, neurons) and peripheral nerves that are located outside the brain and spinal cord. The two systems will be anatomically blended, but functionally interconnected. As indicated, the peripheral nervous system is constructed of nerve cells (or neurons) and renal cells (or glia), which support neurons. The units of operating neurons that carry signals from the brain are referred to as "efferent" nerves. The "afferent" nerves are those that carry detection or status information to the brain. 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 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 body of the cell typically includes two types of external excretions (or processes); the dendrites and the axon. Most neurons have several dendrites; these branch out in three ways and serve as the main apparatus for receiving 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 large as 2 m. Many axons are divided into several branches, thus transporting the information towards different objectives. Near the end of the axon, the axon divides into thin branches that make contact with other neurons. The point of contact is referred to as a synapse. The cell that transmits a signal is called the presynaptic cell and the cell that receives the signal is referred to as the post-synaptic cell. The specialized lumps in the branches of the axon (ie, presynaptic terminals) serve as the site of transmission in the presynaptic cell. Most axons end near the dendrites of a post-synaptic neuron. However, communication may also occur in the cell body or, less frequently, in the initial segment or terminal portion of the post-synaptic cell axon. 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, which separates the thoracic cavity from the abdominal cavity.

With normal tidal breathing, the diaphragm moves about 1 era. However, in forced breathing, the diaphragm can move up to 10 cm. The phrenic nerves, left and right, activate the movement of the diaphragm. Contraction and relaxation of the diaphragm represent approximately 75% volume change in the chest during normal 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 cranial nerves, ninth and tenth, the phrenic nerve, and the intercostal nerves. The glossopharyngeal nerve (cranial nerve IX) innervates the carotid body and detects the levels of CO2 in the blood. The vagus nerve (cranial nerve X) provides the sensory input of the larynx, pharynx and thoracic viscera, including the bronchi The phrenic nerve originates from the spinal nerves C3, C4 and C5, and innervates the diaphragm. The intercostal nerves originate from the spinal nerves T7-11 and innervate the intercostal muscles. The various afferent sensory neuro-fibers provide information as to how the body should breathe in response to events outside the body itself. An important respiratory control is activated by the vagus nerve and its pre-ganglionic nerve fibers, which synapse with the ganglia. The lymph nodes are embedded in 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 surface) in order to allow more air to enter during respiration, which is useful in asthma patients, while the parasympathetic process It has the opposite effect and can contract the bronchi and increase secretions, which can be harmful in asthma patients. The electrical signals transmitted along the axon to control respiration, referred to as action potentials, are fast and transient impulses "all or nothing". The action potentials typically have an amplitude of approximately 100 millivolts (mV) and a duration of approximately 1 msec. The action potentials are conducted along the axon, without failure or distortion, at speeds in the range of approximately 1-100 meters / sec. The amplitude of the action potential remains constant throughout the axon, since the impulse regenerates continuously as it traverses the axon. A "neuroseñal" is a composite signal that includes many action potentials. The neuroseñal also includes an established instruction for the adequate function of organs. A respiratory neuroseñal would thus include an established instruction for the diaphragm to perform efficient ventilation, including information regarding frequency, initial muscle tension, degree (or depth) of muscular movement, etc. Neuro-signals or "neuro-electrical coded signals" are thus codes that contain complete sets of information for the complete function of the organs. As established in Co-pending Application No. 11 / 125,480, filed on May 9, 2005, once these neuroseñales, which are incorporated in the "simulated action potential signals", referred to herein, have been isolated, registered, standardized and transmitted to a subject (or patient), a specific generated nerve instruction (ie, signal (s)) can be used to control the breathing and in this way treat a multitude of disorders of the breathing system. The disorders observed 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 the recurrent occlusion of the upper airways of the respiratory system during sleep. Central sleep apnea occurs when the brain fails to send adequate signals to the respiratory muscles to start breathing during sleep. Those who suffer from sleep apnea experience fragmentation of sleep and complete or almost complete cessation of breathing (or ventilation) during sleep with potentially severe degrees of oxyhemoglobin desaturation. Studies of 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 respiratory tract. This general relaxation of the muscles is thought to be a contributing factor to sleep apnea. Various devices, systems and methods have been developed, which include an apparatus or registration stage of action potentials or coded electrical neuroseñales, to control breathing and treat respiratory disorders, such as sleep apnea. The signals, however, are typically subjected to extensive processing and are subsequently employed to regulate a "mechanical" device or system, such as a fan. Illustrative are the systems disclosed in Pat. Nos. 6, 360,740 and 6, 651, 652. In the US Patent. No. 6,360,740, a method and system to provide respiratory assistance is discussed. The method noted includes the step of recording "respiratory signals", which are generated in the respiratory center of a patient. "Respiratory signals" are processed and used to control a muscle stimulation device or ventilator. In the U.S. Patent No. 6,651,652, a system and method to treat sleep apnea is discussed. The annotated system includes the breathing sensor that is adapted to capture neuro-electrical signals and extract the 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 set forth in the annotated patents, as well as most of the known systems, is that the Control signals that are generated and transmitted are "determined by the user" and are "device determinants". The "control signals" noted are not related, therefore, nor are they 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. Therefore, it would be desirable to provide a method and system for controlling respiration, including means for generating and transmitting potential signals of simulated action to the body, which are operative in the control of the respiratory system. Accordingly, an object of the present invention is to provide a method and system for controlling respiration, which overcomes the disadvantages associated with methods and systems of the prior art for the control of respiration. Another object of the present invention is to provide a method and system that includes means for generating and transmitting potential signals of simulated action towards the body, which are operative in the control of the respiratory system. Another object of the invention is to provide a method and system for controlling respiration, including means for generating and transmitting respiratory or respiratory signals. waveform, simulated, which substantially correspond to the coded waveform signals that are generated in the body and are operative in the control of the respiratory system. Another object of the invention is to provide a method and system for controlling respiration, including means for recording waveform signals that are generated in the body and are operative in the control of respiration. Another object of the invention is to provide a method and system for controlling respiration, including processing means adapted to generate a baseline respiratory signal that is representative of at least one encoded waveform signal, generated in the body at from recorded waveform signals. Another object of the invention is to provide a method and system for controlling respiration, including processing means adapted to compare waveform, respiratory, recorded signals to respiratory baseline signals, and generate a respiratory signal as a function. of the registered waveform signal. Another object of the invention is to provide a method and system for controlling respiration, including means for detecting abnormalities of respiration.

Another object of the invention is to provide a method and system for controlling respiration, including a sensor in order to detect whether a subject is experiencing an apnea event. Another object of the invention is to provide a method and system for controlling respiration, which can be easily used in the treatment of disorders of the respiratory system, including sleep apnea, asthma, excessive production of mucus, acute bronchitis and emphysema. SUMMARY OF THE INVENTION According to the above objects and those which will be mentioned and will become apparent below, the method for controlling respiration generally comprises (i) generating at least one first simulated action potential signal that is recognizable by the system of respiration as a signal of modulation and (ii) transmit the first signal of simulated action potential towards the body to control the respiratory system. In one embodiment of the invention, the simulated action potential signal has a first region that it has. a first positive voltage in the range of about 100-1500 mV during a first period of time in the range of about 100-400 ^ iseg and a second region having a first negative voltage in the range of about -50mV to -750mV during a second period of time in the range of approximately 200-800 n $ eg. In a preferred embodiment of the invention, the first positive voltage is approximately 800 mV, the first time period is approximately 200 the first negative voltage is approximately -400 mV and the second time period is approximately 400 ^ iseg. In one embodiment of the invention, the simulated action potential signal is transmitted to the subject's nervous system. In another embodiment, the simulated action potential signal is transmitted close to a target area in the neck, head or chest. According to a further embodiment of the invention, the method for controlling respiration in a subject generally comprises (i) generating at least a first signal of simulated action potential that is recognizable by the respiratory system as a modulation signal, (ii) ) monitor the subject's breathing status and provide at least one status signal from the respiratory system in response to an abnormal function of the respiratory system, (iii) transmit the first simulated action potential signal to the body in response to a signal ' of respiratory status that is indicative of respiratory dysfunction or a respiratory abnormality. BRIEF DESCRIPTION OF THE DRAWINGS The additional 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 similar references refer to the same parts or elements through of all views, and in which: FIGURES 1A and IB are illustrations of shape signs; wavelengths captured from the body, which 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 mode of. a respiratory control system, according to the invention; 'FIGURES 5A and 5B are illustrations of simulated waveform signals, which have been generated by 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; Y FIGURE 7 is a schematic illustration of a mode of a simulated action potential signal, which has been generated by the process 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, since such, of course, may vary. Therefore, although a number of apparatuses, 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. It should also be understood that the terminology used herein is for the purpose of describing only particular embodiments of the invention and is not intended to be limiting. Unless defined otherwise, all technical and scientific terms used herein have the same meaning commonly understood by one having ordinary experience in the subject matter to which the invention relates. In addition, all publications, patents and patent applications cited herein, whether above or below, are incorporated herein by reference in their totality Finally, as used in this specification and the appended claims, the singular forms "a, an" and "the," include plural references, 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, midbrain, diencephalon and cerebral hemisphere, and the peripheral nervous system, including neurons and glia. The terms "waveform" and "waveform signal", as used herein, mean and include a composite electrical signal, which is generated in the body and transported by neurons in the body, including neurocodes, neuroseñales and components and segments thereof. The term "simulated waveform signal", as used herein, means an electrical signal or component thereof, which substantially corresponds to a "waveform signal".

The term "simulated action potential signal", as used herein, means and includes a signal that exhibits positive voltage (or current) during a first period of time and negative voltage for a second period of time. The term "simulated action potential signal" thus includes square wave signals, modified square wave signals and frequency modulated signals. The term "signal feature", as used herein, means a composite signal having a plurality of signals, such as the "simulated action potential" and "simulated waveform" signals, as defined above. Unless stated otherwise, the potential simulated action signals of the invention are designed and adapted to be transmitted continuously or at fixed intervals to a subject. The term "respiration", as used herein, means the process of respiration. The term "respiratory system", as used herein, means and includes, without limitation, the organs that sub-serve the respiratory function, including the diaphragm, lungs, nose, throat, larynx, trachea and bronchi , and the nervous system associated with them.

The term "target zone", as used herein, means and includes, without limitation, a req. Of the body proximate a portion of the nervous system, wherein the application of electrical signals may induce the desired neuronal control without direct application (or conduction) of the 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 means and includes a group or groups of nerve cell bodies, located outside the central nervous system. 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 process of respiration. Such dysfunction can be caused by a multitude of known factors and events, including damage and division of the spinal cord. The present invention reduces or substantially eliminates the disadvantages associated with the methods and systems of the prior art in controlling ie breathing. In one embodiment of the invention, the method for controlling respiration in a subject, generally comprises generating at least one simulated action potential signal that is recognizable by the subject's respiratory system as a modulation signal and transmitting the potential signal of the subject. simulated action to the body of the subject. In a preferred embodiment of the invention, the simulated action potential signal is transmitted to the subject's nervous system. As indicated, the neuro-electrical signals related to breathing originate in the respiratory center of the medulla oblongata. These signals can be captured or collected from the respiratory center or along nerves that carry signals to the respiratory musculature. However, the phrenic nerve has proven to be particularly suitable for capturing the annotated signals. Methods and systems for capturing signals encoded from the phrenic nerve (s), and for storing, processing and transmitting neuro-electric signals (or coded waveform signals), are set forth in the Application Co-pending No. 10 / 000,005, presented on 20 November 2001, and Application No. 11 / 125,480, filed May 9, 2005; which are incorporated in the pipeline for reference in their entirety. Referring first to Figs. 1A and IB, exemplary waveform signals are shown which are operative in the efferent operation of the human (and animal) diaphragm; Fig. 1A shows three (3) signals 10A, 10B, 10C, having rest periods 12A, 12B between them, and Fig. IB shows an expanded view of the signal 10B. The annotated signals pass through the phrenic nerve, which passes between the cervical spine and the diaphragm. As will be appreciated by one of ordinary skill in the art, the signals 10A, 10B, 10C will vary as a function of various factors, such as physical exercise, 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 can similarly vary from signal to signal in muscles (or group of muscles). As noted above, the annotated signals include coded information, related to inspiration, such as frequency, initial muscle tension, degree of muscle movement (or depth), etc. According to one embodiment of the invention, the neuro-electrical signals generated in the body, which are operative in the control of respiration, such as the signals shown in Figs. 1A and IB, are captured and transmitted to a processor or control module. 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 carried out by the signal components. According to the invention, the stored signals can be used later to establish baseline breathing signals. The module can then be programmed to compare "abnormal" breath signals (and components thereof) captured from a subject and, as discussed below, generate a simulated waveform signal or modified baseline signal for transmission to the subject. Such modification can; include, for example, increase the amplitude of a respiratory signal, increase the speed of transmission of signals, etc. In accordance with the invention, the captured neuro-electric signals are processed by known means and a simulated waveform signal (ie, simulated neuro-electrical encoded signal) which is representative of at least a neuro-electrical signal captured and operative in breath control (ie, recognized by the brain or the respiratory system as a modulation signal), is generated by the control module. The annotated simulated waveform signal is similarly stored in the storage medium of the control module. In one embodiment of the invention, to control respiration, the simulated waveform signal is accessed from the storage medium and transmitted to the subject through a transmitter (or probe). According to the invention, the applied voltage of the simulated waveform signal can be up to 20 volts to allow voltage loss during signal transmission. Preferably, the current is maintained at less than 2 output amps. The direct conduction to the nerves through electrodes directly connected to such nerves, preferably has emissions of less than 3 volts and current of less than one tenth of an ampere. 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, the which is adapted to receive neuro-electric coded signals or "waveform signals" from a signal sensor (shown in dotted lines and designated 21) that is in communication with a subject, and at least one treatment member 24. The treatment member 24 is adapted to communicate with the body and receives the signal from simulated waveform (or simulated action potential signal, discussed below) from the control module 22. According to the invention, the treatment member 24 may comprise an electrode, antenna, seismic transducer, or any other suitable form driving restraint to transmit respiratory signals that regulate or operate the breathing function in humans or animals. The treatment member 24 can be attached to the appropriate nerves or respiratory organ (s) through a surgical procedure. Such surgery can be carried out, for example, with "key-hole" entry in a thoracic-stereo scope procedure. If necessary, a more expansive thoracotomy approach 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 be placed to pierce the mucinous or other membrane, whereby the member 24 is placed in proximity to the medulla oblongata and / or pons. The simulated signals of the invention can then be sent towards nerves that are close to the brainstem. As illustrated in FIG. 2, the control module 22 and the treatment member 24 can be entirely separate elements, which allows the system 20A to be operated remotely. Ading to the invention, the control module 22 may be unique, ie, anchored to a specific operation and / or subject, or may comprise a conventional device. Referring now to FIG. 3, a further embodiment of a control system 20B of the invention is shown. As illustrated in Fig. 3, the system 20B is similar to the system 20A shown in Fig. 2. However, in this embodiment, the control module 22 and the treatment member 24 are connected. Referring now to FIG. 4, another embodiment of a second control system 20C of the invention is still shown. 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. The system 20C also includes a processing module (or computer) 26. Ading to the invention, the processing module 26 may be a separate component or may be a sub-system of a control module 22 ', as shown in dotted lines.

As indicated above, the processing module (or control module) preferably includes storage means 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, in adance with the function carried out by the signal components. Ading to the invention, in one embodiment of the invention, the method for controlling respiration in a subject includes 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 in order to control the respiratory system. In another embodiment of the invention, the method for controlling respiration comprises capturing encoded waveform signals, which are generated in the body of a subject and are operative in the control of respiration, (ii) generating a first signal of form simulated wave 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 signal simulated waveform that substantially corresponds to at least one of the waveform signals captured and is operative in the control of the respiratory system. In one embodiment of the invention, the first simulated waveform signal is transmitted to the subject's nervous system. In another embodiment, the first simulated waveform signal is transmitted close to a target zone in the neck, head or chest. Ading to the invention, the simulated waveform signals can be adjusted (to be modulated), if necessary, before they are transmitted to the subject. In another embodiment of the invention, the method for controlling respiration generally comprises (i) capturing encoded waveform signals that are generated in the body and are operative in the control of respiration and (ii) storing signals in the form of wave captured in a storage medium, the storage medium being adapted to store the components of the waveform signals captured, ading to the function carried out by the signal components, (iii) generating a first signal in the form of simulated wave corresponding substantially to at least one of the waveform signals captured, and (iv) transmitting the first simulated waveform signal to the body in order to control 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 the body of a first subject, which are operative in the control of respiration, (ii) generating a baseline respiration waveform signal from the first plurality of waveform signals, (iii) capturing a second waveform signal generated in the body of a first subject, which is operative in the breath control, (iv) comparing the baseline waveform signal with the second waveform signal, (v) generating a third waveform signal based on the comparison of the second waveform signal. waveform and baseline; and (vi) transmitting the third waveform signal to the body, with the third waveform signal being operative in the breath control. 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 carried out by conduction or direct transmission through non-fractured skin in a selected suitable area, on the neck, head or thorax. Such an area will approach a position close to the nerve or plexus of the nerve on which the signal is imposed. In an alternate embodiment of the invention, the step of transmitting the waveform signals to the body of the subject is carried out by direct conduction through 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 seismic signal is then sent to a region of the head, neck or thorax in a manner that allows the appropriate "nerve" to receive and obey the encoded instructions of the seismic signal. Referring now to Figs. 5A and 5B, simulated waveform signals 190, 191 are shown, which were generated by the apparatus and methods of the invention. The annotated signals are merely representative of the simulated waveform signals that can be generated by the apparatus and method of the invention and should not be construed as limiting the scope of the invention in any way. Referring first to the FIg. 5A, the simulated, phrenic, exemplary waveform signal 190 is shown, showing only the positive half of the transmitted signal. The signal 190 comprises only two segments, the segment starts L 192 and segment pi or 193. Referring now to Fig. 5B, the simulated, phrenic, exemplary waveform signal 191 is shown, which has been fully modulated at 500 Hz. Signal 191 includes the same two segments , the initial segment 194 and the peak segment 195. Referring now to FIG. 7, a mode of a simulated action potential signal 200 of the invention is shown. As discussed in detail below, the simulated action potential signal 200 has been successfully employed to control respiration. As illustrated in FIG. 7, the simulated action potential signal 200 comprises a substantially square, modified wave signal. According to the invention, the simulated action potential signal 200 includes a positive voltage region 202 having a first positive voltage (Vi) during a first period of time (Ti) and a first negative region 204 having a first voltage negative (V2) during a second period of time (T2). Preferably, the first positive voltage (Vi) is in the range of approximately 100-1500 mV, more preferably in the range of approximately 700-900 mV, even more preferably approximately 800 mV; he first period of time (Ti) is in the range of about 100-400 iseg, even more preferably, about 200 ^ iseg; the first negative voltage (V) is in the range of about -50 mV to -750 mV, more preferably in the range of about -350 mV to -450 mV, even more preferably, about -400 mV; the second period of time (T2) is in the range of approximately 200-800 μsec, more preferably in the range of approximately 300-600sec, even more preferably, approximately 400e iseg. The simulated action potential signal 200 thus comprises a continuous sequence of substantially square positive and negative voltage (or current) waves, or bursts of substantially square voltage waves (or current), positive and negative, which preferably exhibit a CD component signal substantially equal to zero. Preferably, the simulated action potential signal 200 has a repetition rate in the range of about 0.5-4 KHz, more preferably in the range of about 1-2 KHz. Even more preferably, the repetition rate is approximately 1.6 KHz.; In a preferred embodiment of the invention, the maximum amplitude of the simulated action potential signal 200 is approximately 200 mV. As will be appreciated by Someone with ordinary experience in the field, the effective amplitude for the applied voltage is a strong function of several factors, including the electrode used), the placement of the electrode and the preparation of the nerve. According to the invention, the potential simulated action signals of the invention can be used to construct "signal trains", which comprise a plurality of simulated action potential signals. The signal train may comprise a three continuous of simulated action potential signals or it may include interposed signals or periods of rest, ie, zero voltage and current, between one or more potential signals of simulated action. The signal train may also comprise simulated, substantially similar potential action signals, different simulated action potential signals or a combination thereof. According to the invention, the different potential signals of simulated action can have a first positive voltage (V1) and / or first period of time (Ti) and / or first negative voltage (V2) and / or second period of time (T2). ) different According to one embodiment of the invention, the method for controlling respiration in a subject thus includes the generation of a first signal of simulated action potential that is recognizable by the respiratory system as a modulation signal and (ii) the transmission of the first simulated action potential signal to the body to control the respiratory system. In one embodiment of the invention, the first simulated action potential signal is transmitted to the subject's nervous system. In another embodiment, the first simulated action potential signal is transmitted close to a target area in the neck, head 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 first signal train including a plurality of potential signals of simulated action that are recognizable by the respiratory system as signals of modulation and (ii) transmitting the first three signals to the body to control the respiratory system. According to the invention, the control of respiration, in some cases, may require to send potential signals of action and simulated waveform towards one or more nerves, including up to five nerves simultaneously, in order to control the speeds of breathing and depth of inhalation. For example, correction of asthma or other respiratory dysfunction or disease involves the rhythmic operation of the diaphragm and / or the intercostal muscles to inspire and expire air to the extraction of oxygen and discharge of residual gaseous compounds, such as carbon dioxide. As is known in the art, the opening (dilation) of the tubular network of bronchi allows a greater volume of air to be exchanged and its oxygen content to be processed inside the lungs. The dilation process can be controlled by the transmission of the signals of the invention. The bronchi can also be closed to restrict the passage of air volume to the lungs. A balance of the control nerves for dilation and / or constriction can thus be carried out through the methods and apparatuses of the invention. In addition, mucus production, if excessive, can form mucoid obstructions that restrict the flow of air volume through the bronchi. As is known in the art, no mucus is produced by the lung except in the space of the bronchi and also in the trachea. However, the production of annotated mucus can be increased or decreased by the transmission of the signals of the invention. The transmission of the aforementioned signals of the invention can thus balance the quality and quantity of the mucus. The present invention thus provides methods and apparatus for effectively controlling respiration rates and resistance, along with dilatation of the bronchial tube and mucinous action in the bronchi, generating and transmitting potential signals of action and simulated waveform towards the body. Such ability to open the bronchi will be useful for emergency room treatment of acute bronchitis or damage from smoke inhalation. Obstructive, chronic, respiratory tract disorders such as emphysema can also be managed. The treatment of acute damage by inhalation of chemicals or fire can also be improved through the methods and apparatuses of the invention, while using mechanical support of respiration. Mucous secretions mediated by damage also lead to obstruction of the airways and are refractory to urgent treatment, placing life in serious risk. Edema (swelling) inside the trachea or bronchial tubes tends to limit the size of the perforation and causes oxygen depletion. The ability to open the size of the perforation 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 apparatuses of the invention. The treatment of numerous other conditions that risk life also depends on a good functioning of the respiratory system. Accordingly, the invention It provides the doctor with a method to open the bronchial tubes and fine tune the breathing speed in order to improve the oxygenation of the patients. This method of electronic treatment (in one modality) abaica the transmission of activation or suppression of potential signals of simulated action on selected nerves in order 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 apparatuses of the invention can also be effectively employed in the treatment of obstructive sleep apnea (or central sleep apnea) and other respiratory disorders. Referring now to Fig. 6, a modality of a respiratory control system 30 that can be used in the treatment of sleep apnea is shown. As illustrated in FIG. 6, the system 30 includes at least one breathing sensor 32 that is adapted to monitor the breathing status of a subject and transmit at least one signal indicative of respiratory status. According to the invention, the respiratory status (and, therefore, a sleep disorder) can be determined by a multitude of factors, including diaphragm movement, respiration rate, O2 and / or CO2 levels in the blood, tension muscle in the neck, air passage (or lack of it) in the air passages of the throat or lungs, that is, ventilation. The various sensors 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 sensor 32. The processor 36 is further adapted to receive coded waveform signals, recorded by a respiratory signal probe (shown in dotted lines and designated 34). In a preferred embodiment of the invention, the processor 36 includes 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 signal components in the storage medium. In a preferred embodiment, the processor 36 is programmed to detect status signals of the respiratory system indicative of breath abnormalities and / or waveform signal components indicative of respiratory system dysfunction and generates at least one waveform signal simulated or simulated action potential signal that is operative in the control of the breathing . Referring to Fig. 6, the simulated waveform signal or simulated action potential signal is directed to a transmitter 38 that is adapted to be found in communication with the subject's body. The transmitter 38 is adapted to transmit the simulated waveform signal or simulated action potential signal to the body of the subject (in a manner similar to that described above) in order to control and, preferably, remedy the detected breathing abnormality. According to the invention, the simulated waveform signal or simulated action potential signal is preferably transmitted to the phrenic nerve to contract the diaphragm, so that the hypoglossal nerve tenses the muscles of the throat and / or the nerve vague maintain normal brainwave patterns. A single signal or plurality of signals can be transmitted in conjunction with others. Thus, 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 action potential signal that is recognizable by the respiratory system as a signal of modulation, (ii) monitor the subject's breathing status and provide at least one status signal from the respiratory system in response to abnormal function of the respiratory system, (iii) transmitting the simulated action potential signal to the body to control the respiratory system in response to a respiratory status signal that is indicative of respiratory dysfunction or a respiratory abnormality . EXAMPLES The following examples are provided to enable those skilled in the art to understand and practice the present invention more clearly. They should not be considered as limiting the scope of the invention, but merely illustrated as representative of the same. Example 1 Four (4) young pigs, ranging in weight from 40 to 80 pounds, were exposed to nebulized methacholine that dissolved in saline. The parameters of ventilation, arterial oxygen saturation and exhaled carbon dioxide were monitored at various concentrations of methacholine. The vagus nerve of the pig was exposed in the neck.

As reflected in Table I, three signals were used. The signal 1 comprised a sinusoidal signal having 500 Hz to 800 mV. Signal 2 comprised a simulated action potential signal having a positive voltage region of 400 ^ iseg, 800 mV and a negative voltage region of 800 ^ iseg, -400 mV. Signal 3 comprised a simulated action potential signal having a positive voltage region of 200 useg, 800 mV and a negative voltage region of 400 Useg, -400 mV. Table 1 Referring to Table 1, it can be seen that, after the administration of methacholine and the transmission of the annotated signals, there was a marked reduction in respiratory velocity and effort, which were similar to baseline levels without administration of methacholine There was also a marked reduction in oxygen saturation and exhaled C02. It was further found that when a simulated action potential signal having a first voltage of 800 mV for 200 μsec and a first negative voltage of about -400 mV for about 400 μ =? 9, is applied to the pig, a reduction is made in the sensitivity to methacholine of at least a factor of 2 and at most a factor of 8.

The example thus reflects that a modified square wave signal can be applied to the vagus nerve to dramatically reduce the physiological response to drugs, which produce asthma symptoms. As will be appreciated by one having ordinary skill in the art, the potential simulated action signals of the invention can thus be effectively employed to mitigate the normal human response to asthma activators, reduce the severity of asthma attacks and allow the delivery of medication. anti-inflammatory for better control of asthma symptoms during acute attacks. Without departing from the spirit and scope of this invention, one of ordinary experience can make various changes and modifications to the invention to adapt it to various uses and conditions. Therefore, these changes and modifications are suitably, equally, and attempt to be within the full range of equivalences of the following claims.

Claims (39)

1. CLAIMS 1. The use of a first signal of simulated action potential to generate a modulation signal recognizable by the respiratory system of the subject, used to control respiration in said subject in need thereof, wherein said first potential signal of simulated action includes a positive voltage region having a first positive voltage during a first period of time and a first negative region having a first negative voltage for a second period of time; and wherein at least the first simulated action potential signal is transmitted to the subject's body.
2. 2. The use of claim 1, wherein said first positive voltage is in the range of about 100-1500 mV.
3. 3. The use of claim 1, wherein said first positive voltage is in the range of about 700-900 mV.
4. 4. The use of claim 1, wherein said first time period is in the range of about 100-400 μsec.
5. 5. The use of claim 1, wherein said first time period is in the range of about 150-300 μsec.
6. 6. The use of claim 1, wherein said first negative voltage is in the rancid from about -50 mV to -750 mV.
7. The use of claim 1, wherein said first negative voltage is in the range of about -350 mV to -450 mV.
8. The use of claim 1, wherein said second period of time is in the range of about 200-800 ^ tsec.
9. The use of claim 1, wherein said second period of time is in the range of about 300-600 ^ iseg.
10. The use of claim 1, wherein said simulated action potential signal is transmitted to the subject's nervous system.
11. The use of claim 1, wherein the subject comprises a human.
12. 12. The use of claim 1, wherein the subject comprises an animal.
13. The use of claim 1, wherein a plurality of said first simulated action potential signals is transmitted to the subject.
14. 14. The use of a first simulated action potential signal to generate a modulation signal recognized by the respiratory system of the subject, used to control breathing in a subject in need thereof, wherein at least one status signal of the respiratory system is provided, indicative of the status of the subject's respiratory system; wherein said first simulated action potential signal includes a positive voltage region having a first positive voltage for a first period of time and a first negative region having a first negative voltage for a second period of time; and wherein said first simulated action potential signal is transmitted to said subject in response to said status signal of the respiratory system.
15. The use of claim 14, wherein said first simulated action potential signal includes a positive voltage region having a first positive voltage during a first period of time and a first negative region having a first negative voltage during a second period of time.
16. The use of claim 15, wherein said first positive voltage is in the range of about 100-1500 mV.-
17. 17. The use of claim 15, wherein said first positive voltage is in the range of about 700-900 mV.
18. 18. The method of claim 15, wherein said first period of time is in the range of about 100-400 useg.
19. 19. The use of claim 15, wherein said first time period is in the range of about 150-300 ^ iseg.
20. The use of claim 15, wherein said first voltage is in the range of about -50 mV to -750 mV.
21. 21. The use of claim 15, wherein said first negative voltage is in the range of about -350 mV to -450 mV.
22. 22. The use of claim 15, wherein said second period of time is in the range of about 200-800 ^ iseg.
23. 23. The use of claim 15, wherein said second time period is in the range of about 300-600 ^ iseg.
24. 24. The use of claim 14, wherein said first simulated action potential signal is transmitted to said subject's nervous system.
25. 25. The use of claim 14, wherein said first simulated action potential signal is transmitted to a target area in said subject, said target area of the neck, head and thorax being selected.
26. 26. The use of claim 14, wherein said subject comprises a human.
27. 27. The use of claim 14, wherein; said subject comprises an animal.
28. 28. The use of claim 14, wherein a plurality of said first simulated action potential signals is transmitted to said subject.
29. 29. A system for controlling respiration in a subject, comprising: processing means for generating a first simulated action signal that is recognizable by the subject's respiratory system as a modulation signal, including said first action potential signal simulated a positive voltage region having a first positive voltage in the range of about 100-1500 mV during a first period of time in the range of about 100-400 psec and a first negative region having a first negative voltage in the range from about -50 mV to -750 mV for a second period of time in the range of about 200-800 psec; and means for transmitting at least said first simulated action potential signal to the subject's body, whereby the control of the subject's respiratory system is effected.
30. 30. The system of claim 29, wherein said first positive voltage is in the range of approximately 700-900 mV.
31. The system of claim 29, wherein said first time period is in the range of about 150-300 psec.
32. 32. The system of claim 29, wherein said first negative voltage is in the range of about -350 mV to -450 mV.
33. 33. The system of claim 29, wherein said second time period is in the ango of about 300-600 psec.
34. 34. The system of claim 29, wherein said means for transmitting said first simulated action potential signal to the subject's body is adapted to transmit said first simulated action potential signal to the subject's nervous system.
35. 35. A simulated action potential signal for controlling respiration in a subject, said simulated action potential signal including a positive voltage region having a first positive voltage in the range of approximately 100-1500 mV during a first period of time in the range of about 100-400 psec and a first negative region having a first negative voltage in the range of about -50 mV to -750 mV for a second period of time in the range of about 200- 800 p $ ec.
36. 36. The signal of claim 35, wherein said first positive voltage is in the range of about 700-900 mV.
37. 37. The signal of claim 35, wherein said first time period is in the range of about 150-300 psec.
38. 38. The signal of claim 35, wherein said first negative voltage is in the range of about -350 mV to -450 mV.
39. 39. The signal of claim 35, wherein said second time period is in the range of about 300-600 psec. RESU EN A method to control breathing that generally comprises the generation and transmission of al. less a simulated action potential signal towards the body, which is recognizable by the respiratory system as a modulation signal.