JP2008539944A - Method and system for controlling respiration with a neuroelectrically encoded signal - Google Patents

Abstract

  The steps of capturing a waveform signal generated in the body of the subject and effective in controlling respiration, and transmitting at least a first waveform signal recognizable by the respiratory system as an adjustment signal to the body. A method for recording, storing and transmitting waveform signals to control respiration.

Description

This application is related to US patent application Ser. No. 10 / 847,738 filed May 17, 2004, based on US Provisional Application No. 60 / 471,104 filed May 16, 2003. Is a continuation-in-part application.

  The present invention relates generally to medical methods and systems for monitoring and controlling respiration. More particularly, the present invention relates to a method and system for controlling respiration with a neuroelectrically encoded signal.

  As is well known in the art, the brain regulates (or controls) respiration with electrical signals (ie, action potentials or waveform signals) that are transmitted throughout the nervous system. The nervous system has two components: the central nervous system that consists of the brain and spinal cord, and the peripheral nervous system that consists of nerve cells (ie, neurons) and peripheral nerves that are generally outside the brain and spinal cord. . The two nervous systems are anatomically separate but functionally interconnected.

  As shown, the peripheral nervous system is composed of nerve cells (ie, neurons) and glial cells (ie, glia) that support the neurons. Active neuronal units that carry signals from the brain are called “efferent” nerves. It is the “afferent” nerve that conveys sensor or status information to the brain.

  As is known in the art, a typical neuron has four morphological definitions: (i) cell body, (ii) dendrites, (iii) axons, and (iv) presynaptic terminals. Including the specified region. The cell body (soma) is the center of cell metabolism. The cell body includes a nucleus that stores cellular genes and rough and smooth endoplasmic reticulum that synthesize cellular proteins.

  The cell body generally has two types of derivatives (or protrusions), dendrites and axons. Most neurons have a number of dendrites, which branch off into a dendrite and serve as the main mechanism for receiving signals from other neurons.

  Axons are the main conduction units of neurons. Axons can carry electrical signals along a length from about 0.1 mm for short ones to about 2 m for long ones. Many axons break into several branches, which convey information to various targets.

  Near the end of the axon, the axon breaks into thin branches that make contact with other neurons. Contact points are called synapses. Cells that transmit signals are called presynaptic cells, and cells that receive signals are called postsynaptic cells. Special protrusions on axon branches (ie, presynaptic terminals) serve as transmission sites within presynaptic cells.

  Most axons terminate near the postsynaptic neuron's dendrites. However, communication may occur in the cell body or, less frequently, in the first or last part of the axon of the postsynaptic cell.

  Efficient respiration and breathing involves many nerves and muscles. The most important muscle exclusively involved in breathing is the diaphragm. The diaphragm is a sheet-like muscle that separates the thoracic cavity from the abdominal cavity.

  For normal periodic breathing, the diaphragm moves about 1 cm. However, in forced breathing, the diaphragm can move up to 10 cm. The left and right phrenic nerves activate diaphragm movement.

  Diaphragm contraction and relaxation changes the volume in the thoracic cavity by 75% during normal resting breathing. Diaphragm contraction occurs during inspiration. Expiration occurs when the diaphragm relaxes and returns to its rest position. All movements of the diaphragm and associated muscles and structures are controlled by encoded electrical signals that exit the brain.

  Details of the respiratory system and associated muscle structure are described in co-pending application Ser. No. 10 / 847,738, which is expressly incorporated herein by reference in its entirety.

The major nerves involved in respiration are the ninth and tenth cranial nerves, the phrenic nerve and the intercostal nerve. The glossopharyngeal nerve (ninth cranial nerve) stimulates the carotid body and detects CO ₂ levels in the blood. The vagus nerve (tenth cranial nerve) provides sensory input from intrathoracic organs, including the larynx, pharynx, and bronchi. The phrenic nerve exits the spinal nerves C3, C4 and C5 and stimulates the diaphragm. The intercostal nerves exit the spinal nerves T7-11 and stimulate the intercostal muscles.

  Various afferent sensory nerve fibers provide information on how the body should breathe in response to unique events outside the body.

  Important respiratory control is activated by the vagus nerve and the nerve fibers of the pre-nervous nerve that form synapses within the ganglia. Ganglia are implanted in the bronchi, which are also stimulated by sympathetic and parasympathetic activity.

  Sympathetic nerve division does not affect the bronchus or allows the air to expand into the lumen (lumen) during breathing (effective for asthmatic patients), while parasympathetic processes It has been described in many literatures that it has the opposite effect and may constrict the bronchi and increase secretion (which can be harmful to asthmatic patients).

  The electrical signal (called action potential) transmitted along the axon to control respiration is a rapid and transient “all or nothing” nerve impulse. The action potential is typically on the order of about 100 millivolts (mV) and has a duration of about 1 millisecond. The action potential travels along the axon at a speed in the range of about 1-100 meters / second without interruption or distortion. Since this impulse is continuously regenerated as it passes through the axon, the magnitude of the action potential remains constant throughout the axon.

  A “neurosignal” is a composite signal that includes many action potentials. The neural signal also includes an instruction set for proper organ function. Thus, the respiratory nerve signal includes an instruction set that includes information regarding the frequency of muscle movement, initial muscle tension, degree (or depth), etc., for the diaphragm to provide efficient ventilation.

  Thus, a neural signal or “neuroelectrically encoded signal” is a code that includes a complete information set of complete organ function. Nerve implemented with “waveform signal” referred to herein, as described in co-pending application No. _______ (Attorney Docket No. SCM-02-009CIP) filed on May 9, 2005 After the signals are separated, recorded, standardized and transmitted to the subject (ie patient), the generated nerve specific waveform commands (ie waveform signals) are used to control respiration, Can treat more respiratory diseases. Such diseases 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 obstruction of the upper respiratory tract during sleep. Central sleep apnea occurs when the brain does not send appropriate signals to the respiratory muscles to breathe during sleep. People with sleep apnea experience sleep disruption and complete or nearly complete cessation of breathing (or ventilation) during sleep, possibly due to severe oxyhemoglobin desaturation.

  Studies of the mechanism of airway collapse have shown that there is general relaxation of the muscle that stabilizes the upper airway segment at several stages of sleep. This general relaxation of the muscle is thought to be a factor causing sleep apnea.

Various devices, systems and methods have been developed that include devices or steps for recording action potentials or encoded electrical nerve signals to control breathing and treat respiratory diseases such as sleep apnea. It was. However, the signal is typically used to adjust a “mechanical” device or system, such as a ventilator, after being subjected to various processes. Examples are the systems disclosed in US Pat. No. 6,360,740 and US Pat. No. 6,651,652 (US Pat. No. 6,360,740).
US Pat. No. 6,360,740 US Pat. No. 6,651,652

  US Pat. No. 6,360,740 discloses a system and method for providing respiratory assistance. The foregoing method includes recording a “breathing signal” generated at the patient's respiratory center. The “breathing signal” is processed and used to control the muscle stimulator or ventilator.

  US Pat. No. 6,651,652 discloses a system and method for treating sleep apnea. The aforementioned system includes a respiration sensor adapted to capture a neuroelectric signal and extract a component of the signal related to respiration. These signals are similarly processed and used to control the ventilator.

  A significant drawback associated with the systems and methods disclosed in the aforementioned patents, as well as most known systems, is that the control signals generated and transmitted are “determined by the user” and “determined by the device”. That is. Thus, the aforementioned “control signals” do not relate to or represent signals generated within the body and are therefore ineffective in controlling or regulating the respiratory system when transmitted.

  Accordingly, means for recording an encoded waveform signal (ie, an encoded electrical nerve signal) generated within the body, means for storing the collected waveform signal, and substantially corresponding to the recorded waveform signal and the respiratory system It is desirable to provide a method and system for controlling respiration that includes means for providing a waveform signal effective for controlling and transmitting to the body.

  Accordingly, it is an object of the present invention to provide a method and system for controlling respiration that overcomes the drawbacks associated with prior art methods and systems for controlling respiration.

  Another object of the present invention is to provide a method and system for controlling respiration having means for recording waveform signals generated within the body and effective for controlling respiration.

  Another object of the present invention is a method and system for controlling respiration having means for generating a respiration signal substantially corresponding to an encoded waveform signal generated within the body and useful for controlling the respiration system. Is to provide.

  Another object of the present invention is to control respiration with processing means adapted to generate a reference respiration signal representing at least one encoded waveform signal generated in the body from the recorded waveform signal. A method and system is provided.

  Another object of the present invention is to control respiration having processing means adapted to compare a recorded respiration waveform signal with a reference respiration signal and to generate a respiration signal as a function of the recorded waveform signal. A method and system is provided.

  Another object of the present invention is to provide a method and system for controlling respiration having monitoring means for detecting respiratory abnormalities.

  Another object of the present invention is to provide a method and system for controlling respiration having a sensor that detects whether a subject is experiencing an apneic event.

  Another object of the present invention is to control respiration having means for transmitting to the body a waveform signal substantially corresponding to an encoded waveform signal generated within the body and useful for respiratory control. It is to provide a method and system.

  Another object of the present invention is to provide breathing, comprising means for directly transmitting a signal to the nervous system in the body that substantially corresponds to an encoded waveform signal generated in the body and useful for respiratory control. It is to provide a method and system for controlling.

  Another object of the present invention is to provide a method and system for controlling respiration that is amenable to the treatment of respiratory diseases including sleep apnea, asthma, excessive mucus production, acute bronchitis and emphysema. is there.

  In accordance with the above objectives and the objectives mentioned and elucidated below, methods of controlling respiration generally capture (i) an encoded waveform signal that is generated within the body of the subject and is effective in controlling respiration. And (ii) transmitting to the body at least a first waveform signal recognizable as a regulatory signal by the respiratory system.

  In one embodiment of the present invention, the first waveform signal has at least a second waveform signal substantially corresponding to at least one of the acquired waveform signals and effective for controlling the respiratory system.

  In one embodiment of the invention, the first waveform signal is transmitted to the subject's nervous system. In another embodiment, the first waveform signal is transmitted near a target zone on the neck, head, or chest.

  In another embodiment of the present invention, a method for controlling respiration generally comprises (i) capturing an encoded waveform signal generated within the body and effective for controlling respiration; and (ii) captured Storing the waveform signal in a storage medium adapted to store a component of the captured waveform signal according to a function performed by the waveform signal component; and (iii) substantially corresponding to at least one of the captured waveform signal And transmitting at least a first waveform signal effective for respiratory system control to the body.

  In another embodiment of the present invention, a method for controlling respiration generally captures a first plurality of waveform signals that are (i) effective in controlling respiration and generated within the body of a first subject. (Ii) generating a reference respiratory waveform signal from the first plurality of waveform signals; (iii) a second effective in controlling respiration and generated in the body of the first patient. And (iv) comparing the reference waveform signal with the second waveform signal, and (v) generating a third waveform signal based on the comparison between the reference signal and the second waveform signal. And (vi) transmitting a third waveform signal effective for controlling respiration to the vicinity of the subject's body.

  In one embodiment of the invention, the first plurality of waveform signals are captured from a plurality of subjects.

  The third waveform signal is preferably transmitted to the nervous system of the subject. In an alternative embodiment, the third waveform signal is transmitted near the target zone on the neck, head or chest.

  According to yet another embodiment of the present invention, a method for controlling respiration of a subject generally includes (i) capturing an encoded waveform signal generated within the body and useful for controlling respiration. And (ii) monitoring the respiratory state of the subject and providing at least one respiratory system state signal in response to an abnormal function of the respiratory system; (iii) the captured waveform signal and the respiratory system state Storing the signal in a storage medium; and (iv) at least a first waveform signal effective for controlling the respiratory system in response to a respiratory state signal or component of the captured waveform signal indicative of dyspnea or abnormal breathing. Communicating.

  In yet another embodiment, a method for controlling respiration generally captures a first plurality of encoded waveform signals that are (i) effective in controlling respiration and generated within the body of a first subject. (Ii) capturing at least a first waveform signal that generates a reverse breathing event from the body of the subject; and (iii) generating a confounding signal effective to mitigate the reverse breathing event. And (iv) transmitting a confounding waveform signal to the body of the subject to alleviate the reverse breathing event.

  The aforementioned waveform signal is preferably transmitted to the nervous system of the subject. In other embodiments, the waveform signal is transmitted near a target zone on the neck, head or chest.

  A system for controlling respiration according to an embodiment of the present invention generally provides (i) a coded waveform signal that represents a naturally generated waveform signal in the body and is effective in controlling respiration. At least a first signal probe adapted to be captured from the body; and (ii) communicable with the signal probe and adapted to receive the waveform signal; A processor adapted to generate at least a first waveform signal recognizable as (iii) communicable with the body of the subject to transmit the first waveform signal to the body to control respiration And at least a second signal probe adapted to be

  The processor preferably has a storage medium adapted to store the captured waveform signal.

  In one embodiment, the processor is adapted to extract the captured waveform signal component according to the function performed by the signal component and store it in the storage means.

  Still other features and advantages will be apparent from the following detailed description of preferred embodiments of the invention as illustrated in the accompanying drawings, in which like reference characters generally refer to the same parts or elements throughout the figures. Point to.

  Before describing the present invention in detail, it should be understood that the present invention is not limited to the specifically illustrated apparatus, system, structure, or method, and, of course, can have various variations. Thus, while practicing the invention, several devices, systems and methods similar or equivalent to those described herein can be used, but the preferred materials and methods are described herein.

  It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only and is not intended to be limiting.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention relates.

  In addition, all publications, patents, and patent applications mentioned above or below in this specification are hereby incorporated by reference in their entirety.

  Finally, as used in this specification and the appended claims, the singular forms include the plural unless specifically stated otherwise. Thus, for example, reference to “a waveform signal” includes two or more such signals, and reference to “a respiratory disorder” includes two or more. Of such diseases.

Definitions The term `` nervous system '' as used herein means the central nervous system including the spinal cord, medulla, pons, cerebellum, midbrain, diencephalon and cerebral hemisphere, and the peripheral nervous system including neurons and glia. To do.

  The terms “waveform” and “waveform signal” as used herein refer to synthetic electricity generated within the body and transmitted by neurons within the body, including neurocodes, neural signals and their components and segments. Means signal.

  The term “breathing” as used herein means a breathing process.

  The term “respiratory system” as used herein means, without limitation, organs useful for respiratory function, including the diaphragm, lungs, nose, throat, larynx, trachea and bronchi and associated nervous system. .

  The term “target zone”, as used herein, is the part of the nervous system that allows the desired neural control to be achieved by the application of an electrical signal without directly applying (or transmitting) the signal to the target nerve A body region close to is meant without limitation.

  The terms “patient” and “subject” as used herein refer to humans and animals.

  The term “nervous plexus” as used herein means a branch or tangle of nerve fibers that are outside the central nervous system.

  The term “neural center” as used herein means a group of transcellular bodies that are outside the central nervous system.

  The term “sleep apnea” as used herein means a temporary cessation of breathing or a decrease in respiratory rate.

  The terms “respiratory disease”, “respiratory disease” and “adverse respiratory event”, as used herein, also mean respiratory system dysfunction that interferes with the normal respiratory process. . Such dysfunction can be caused by a number of known factors and events such as spinal cord injury and disruption.

  The present invention substantially reduces or eliminates the disadvantages and drawbacks associated with prior art methods and systems for controlling respiration. In one embodiment of the present invention, a system for controlling respiration is generally recorded with means for recording (or capturing) encoded neuralelectric or waveform signals generated within the body and useful for controlling respiration. Means for storing the measured waveform signal, means for generating at least one signal substantially corresponding to the at least one recorded waveform signal and effective in controlling respiration, and transmitting the signal to the body of the subject Means. In a preferred embodiment of the invention, the signal is transmitted to the subject's nervous system.

  As shown, respiration-related neuroelectric signals originate from the respiratory center of the medulla. These signals can be captured or collected along the nerves that carry signals from the respiratory center or to respiratory muscle tissue. However, it has been found that the phrenic nerve is particularly suitable for capturing the aforementioned signals.

  A method and system for capturing encoded signals from the phrenic nerve and storing, processing, and transmitting neuroelectric signals (or encoded waveform signals) was filed on November 20, 2001. Co-pending application number 10 / 000,005 and application number ______ filed on May 9, 2005 (attorney docket number: SCM-02-009CIP), these applications are for reference The entirety of which is incorporated herein.

  Referring first to FIGS. 1A and 1B, a typical waveform signal useful for the centrifugal action of a human (and animal) diaphragm is shown, with FIG. 1A intervening with rest periods 12A, 12B 3 Two signals 10A, 10B, 10C are shown, and FIG. 1B is an enlarged view of the signal 10B. Such signals traverse the phrenic nerve that extends between the cervical spine and the diaphragm.

  One skilled in the art will appreciate that the signals 10A, 10B, 10C change as a function of various factors such as physical motion and response to environmental changes. Those skilled in the art will also appreciate that the presence, shape, and number of pulses in the signal section 14 may also vary depending on the muscle (or muscle group) signal.

  As described above, the aforementioned signal includes encoded information related to inspiration, such as frequency, initial muscle tension, and the degree (or depth) of muscle exercise.

  According to one embodiment of the present invention, a neuro-electrical signal generated in the body that is effective in controlling respiration, such as the signals shown in FIGS. 1A and 1b, is captured and transmitted to a processor or control module. .

  The control module preferably has storage means adapted to store the captured signal. In a preferred embodiment, the control module is further adapted to store the captured signal component (extracted by the processor) in the storage means according to the function performed by the signal component.

  According to the present invention, the stored signal can then be used to set a base-line respiration signal. The module then compares the “abnormal” respiratory signals (and components) captured from the patient and generates a waveform signal or modified reference signal for transmission to the patient, as described below. Can be programmed. For this correction, for example, the amplitude of the respiratory signal may be increased or the signal frequency may be increased.

  In accordance with the present invention, the captured neuroelectric signal is processed by known means to represent at least one captured neuroelectric signal and effective in controlling respiration (ie, recognized as a regulatory signal by the brain or respiratory system). A waveform signal (ie, a neuro-electrically encoded signal) is generated by the control module. Similarly, the aforementioned waveform signal is stored in the storage means of the control module.

  The generated waveform signal is accessed from the storage means and transmitted to the subject via a transmitter (or probe) to control respiration.

  According to the present invention, the applied voltage of the waveform signal may be within a maximum of 20 volts in order to take into account voltage loss when transmitting the signal. The current is preferably maintained at an output of less than 2 amps.

  It is preferred that an output of less than 3 volts and an electric current of less than 0.1 ampere flow directly into the nerve via an electrode directly connected to the nerve.

  Referring now to FIG. 2, a schematic diagram of one embodiment of the respiratory control system 20A of the present invention is shown. As shown in FIG. 2, the control system 20A was adapted to receive a neuroelectrically encoded signal or “waveform signal” from a signal sensor (indicated by a dotted line and labeled 21) that can communicate with the subject. It has a control module 22 and at least one treatment element 24.

  The treatment element 24 is adapted to communicate with the body and receives a waveform signal from the control module 22. In accordance with the present invention, the treatment element 24 is an electrode, antenna, seismic transducer, or other suitable form of conduction for transmitting respiratory signals that regulate or manipulate the respiratory function of a human or animal. Ancillary equipment can be included. Space required between para.

  The treatment element 24 can be attached to a suitable nerve or respiratory organ by a surgical process. Such an operation can be accomplished, for example, at the entrance of a “keyhole” in a thoracoscopic procedure. If necessary, a more expandable thoracotomy procedure can be employed to better position the treatment element 24.

  Further, if desired, the treatment element 24 can be inserted into a body cavity such as the nose or mouth and positioned to pierce the mucin or other membrane so that the element 24 can be medullary and / or Located in the immediate vicinity of pons. The waveform signal of the present invention can then be transmitted to a nerve in the immediate vicinity of the brainstem.

  As shown in FIG. 2, the control module 22 and the treatment element 24 may be entirely separate elements that allow remote operation of the system 20A. According to the present invention, the control module 22 may be unique, i.e. adapted to a specific operation and / or subject and may include conventional devices.

  Referring now to FIG. 3, yet another embodiment of the control system 20B of the present invention is shown. As shown in FIG. 3, system 20B is similar to system 20A shown in FIG. However, in this embodiment, the control module 22 and the treatment element 24 are connected.

  Referring now to FIG. 4, yet another embodiment of the control system 20C of the present invention is shown. As shown in FIG. 4, the control system 20 </ b> C similarly includes a control module 22 and a treatment element 24. The system 20C further includes at least one signal sensor 21.

  The system 20C also includes a processing module (or computer) 26. In accordance with the present invention, the processing module 26 may be a separate component or a subsystem of the control module 22 'as indicated by the dotted line.

  As indicated above, the processing module (or control module) preferably includes storage means adapted to store the captured respiratory signal. In a preferred embodiment, the processing module 26 is further adapted to extract the captured respiratory signal component and store it in the storage means according to the function performed by the signal component.

  According to the present invention, in one embodiment of the present invention, a method for controlling the breathing of a patient includes a step of acquiring a coded waveform signal generated within the body of the patient and effective for controlling the breathing. And (ii) transmitting to the body at least a first waveform signal that is recognizable as a regulatory signal by the respiratory system.

  In one embodiment of the present invention, the first waveform signal substantially corresponds to at least one of the captured waveform signals and includes at least a second waveform signal useful for controlling the respiratory system.

  In one embodiment of the invention, the first waveform signal is transmitted to the subject's nervous system. In another embodiment, the first waveform signal is transmitted near a target zone on the neck, head, or chest.

  According to the present invention, the waveform signal can be adjusted (or adjusted) as necessary before being transmitted to the subject.

  In another embodiment of the present invention, a method for controlling respiration generally comprises (i) capturing an encoded waveform signal generated within the body and effective for controlling respiration; and (ii) a captured waveform signal. And (iii) substantially corresponding to at least one of the captured waveform signals and (iii) storing in a storage medium adapted to store the components of the captured waveform signal according to a function performed by the signal components; Transmitting at least a first waveform signal effective for respiratory control.

  In another embodiment of the present invention, a method for controlling respiration generally captures a first plurality of waveform signals that are (i) effective in controlling respiration and generated within the body of a first subject. (Ii) generating a reference respiratory waveform signal from the first plurality of waveform signals; (iii) a second effective in controlling respiration and generated in the body of the first patient. And (iv) comparing the reference waveform signal with the second waveform signal, and (v) generating a third waveform signal based on the comparison between the reference signal and the second waveform signal. And (vi) transmitting a third waveform signal effective to control respiration to the body.

  In one embodiment of the invention, the first plurality of waveform signals are captured from a plurality of subjects.

  In one embodiment of the present invention, the step of transmitting the waveform signal to the subject's body is by direct conduction or transmission through intact skin in a selected appropriate zone of the neck, head or chest. Achieved. Such a zone is close to the location of the nerve or plexus to which the signal is applied.

  In another embodiment of the invention, the step of transmitting the waveform signal to the subject's body is accomplished by direct conduction by attaching electrodes to the receiving nerve or plexus. This requires surgical intervention to physically attach electrodes to selected target nerves.

  In yet another embodiment of the invention, the step of transmitting the waveform signal to the subject's body is accomplished by converting the waveform signal to a vibration form. The vibration signal is then transmitted to the head, neck or chest region to allow the appropriate “nerve” to receive and follow the encoded instructions of the vibration signal.

  5A and 5B, respiratory signals 190, 191 generated by the apparatus and method of the present invention are shown. The foregoing signals are merely representative of respiratory signals that can be generated by the apparatus and method of the present invention and should not be construed to limit the scope of the present invention in any way.

  Referring initially to FIG. 5A, a typical diaphragm waveform signal 190 is shown that shows only the positive half of the transmitted signal. The signal 190 consists of only two parts, an initial part 192 and a spike part 193.

  Referring now to FIG. 5B, a typical diaphragm waveform signal 191 fully modulated at 500 Hz is shown. Signal 191 includes the same two segments, initial segment 194 and spike segment 195.

  In accordance with the present invention, respiration control, in some cases, must simultaneously transmit waveform signals within one or more nerves, including up to five nerves, to control respiration rate and inhalation depth. It may be necessary. For example, correction of asthma and other respiratory disorders or diseases requires periodic movement of the diaphragm and / or intercostal muscles to inhale and exhale air to extract oxygen and dispose of unwanted gas compounds such as carbon dioxide. To do.

  As is known in the art, opening (expanding) the bronchial tubular network allows more air to be exchanged in the lungs to process its oxygen content. The expansion process can be controlled by the transmission of the waveform signal of the present invention. Also, the amount of air that passes through the lungs by closing the bronchi can be limited. Thus, the method and apparatus of the present invention can provide a balance for controlling nerve dilation and / or stenosis.

  Furthermore, if mucus production is excessive, there may be a mucous plug that restricts the flow of air through the bronchi. As is known in the art, mucus is not formed in the lung, but in the bronchial lumen and trachea.

  However, the aforementioned mucus production can be increased or decreased by transmitting the waveform signal of the present invention. Accordingly, the aforementioned transmission of the waveform signal can maintain a balance between the quality and amount of mucus.

  Accordingly, the present invention provides a method and apparatus for effectively controlling respiration rate and respiration intensity, as well as bronchodilation and intramucosal mucus action, by generating and transmitting encoded waveform signals to the body. Such ability to open the bronchi is useful for emergency treatment of acute bronchitis or smoke inhalation damage. It can also address chronic airway obstructive diseases such as emphysema.

  Treatment of acute burns and chemical inhalation disorders can also be facilitated by the method and apparatus of the present invention using mechanical breathing assistance. In addition, mucus secretion due to injury causes the airway to be blocked, does not accept first aid, and makes life dangerous. Edema (swelling) in the trachea or bronchus tends to limit the lumen diameter and cause hypoxia. When treating, the ability to open the lumen diameter is essential or at least desirable.

  Furthermore, by adjusting the activity of the phrenic nerve by the method and apparatus of the present invention, the respiratory effort of pneumonia patients can be reduced. Also, the treatment of many other life-threatening symptoms concentrates on a properly functioning respiratory system. Accordingly, the present invention provides a physician with a method of opening the bronchi and fine-tuning the respiratory rate to improve patient oxygenation. This electronic treatment method (in one embodiment) involves the transmission of an activity waveform signal or a suppression waveform signal to a specific nerve to improve respiration. According to the present invention, such treatment can be enhanced by currently available oxygen delivery and respiratory drugs.

  The methods and devices of the present invention can also be used to treat obstructive sleep apnea (or central sleep apnea) and other respiratory diseases. Referring now to FIG. 6, one embodiment of a respiratory control system 30 that can be used to treat sleep apnea is shown. As shown in FIG. 6, the system 30 includes at least one respiratory sensor 32 adapted to monitor the respiratory condition of the subject and to transmit at least one signal indicative of the respiratory condition.

According to the present invention, the respiratory condition (and thus sleep disturbance) is related to diaphragm movement, respiratory rate, blood O ₂ and / or CO ₂ levels, neck muscle tension, air in the throat or lung airways. It can be determined by a number of factors including passage (or lack) (ie, ventilation). Thus, within the scope of the present invention, various sensors can be used to detect the aforementioned factors and thus the onset of respiratory disease.

  The system 30 further includes a processor 36 adapted to receive a respiratory system status signal from the respiratory sensor 32. The processor 36 is further adapted to receive the encoded waveform signal recorded by the respiratory signal probe (shown in dotted lines and labeled 34).

  In a preferred embodiment of the present invention, the processor 36 has storage means for storing the captured encoded waveform signal and the respiratory status signal. The processor 36 is further adapted to extract the component of the waveform signal and store the signal component in the storage means.

  In a preferred embodiment, processor 36 detects a respiratory condition signal indicative of respiratory abnormalities and / or a waveform signal component indicative of respiratory pain, and generates at least one waveform signal useful for breathing control. To be programmed.

  Referring to FIG. 6, the waveform signal is transmitted to a transmitter 38 adapted to be able to communicate with the body of the subject. The transmitter 38 is adapted to transmit a waveform signal to the subject's body (in a manner similar to that described above) to control and preferably improve detected respiratory abnormalities.

  In accordance with the present invention, the waveform signal is transmitted to the phrenic nerve to contract the diaphragm, transmitted to the hypoglossal nerve to tighten the pharyngeal muscle, and / or the vagus nerve to maintain a normal electroencephalogram pattern. It is preferable to be transmitted to. A single waveform signal or a plurality of signals can be transmitted in combination with each other.

  According to yet another embodiment of the present invention, a method for controlling respiration of a subject generally includes (i) capturing an encoded waveform signal generated within the body and useful for controlling respiration. And (ii) monitoring the respiratory state of the subject and providing at least one respiratory system state signal in response to an abnormal function of the respiratory system; (iii) the captured waveform signal and the respiratory system state Storing the signal in a storage medium; and (iv) providing at least a first waveform signal effective for controlling the respiratory system according to a component of the respiratory state signal or captured waveform signal indicating dyspnea or abnormal breathing to the body. Communicating.

  In yet another embodiment, a method for controlling respiration generally captures (i) a first plurality of encoded waveform signals generated in a first subject's body that is effective in controlling respiration. (Ii) capturing at least a first waveform signal that generates a reverse breathing event from the body of the subject; and (iii) a confounding signal that serves to mitigate the reverse breathing event. And (iv) transmitting a confounding waveform signal to the body of the subject to alleviate the reverse breathing event.

  Without departing from the spirit and scope of this invention, one of ordinary skill can make various changes and modifications to the invention to adapt it to various uses and situations. Accordingly, such changes and modifications are intended to be reasonable and fair and further within the scope of the appended claims.

It is a figure of the waveform signal effective for control of the respiratory system captured from the body. It is a figure of the waveform signal effective for control of the respiratory system captured from the body. 1 is a schematic diagram of one embodiment of a respiratory control system according to the present invention. FIG. FIG. 6 is a schematic diagram of another embodiment of a respiratory control system according to the present invention. FIG. 6 is a schematic diagram of yet another embodiment of a respiratory control system according to the present invention. FIG. 3 is a diagram of a waveform signal generated by the process means of the present invention. FIG. 3 is a diagram of a waveform signal generated by the process means of the present invention. 1 is a schematic diagram of one embodiment of a respiratory control system that can be used to treat sleep apnea according to the present invention. FIG.

Explanation of symbols

21 Signal sensor 22 Control module 24 Treatment element

Claims (51)

A method for controlling the breathing of a subject,
Capturing a plurality of waveform signals generated within the body of the subject and effective in controlling respiration;
Transmitting at least a first waveform signal recognizable as a control signal by the respiratory system of the patient to the body of the patient;
Including methods.   The method of claim 1, wherein the first waveform signal is transmitted to a subject's nervous system.   The method of claim 1, wherein the subject includes a human.   The method of claim 1, wherein the subject comprises an animal. A method for controlling breathing,
Capturing a plurality of waveform signals generated within the body of the subject and effective in controlling respiration;
Transmitting at least a first waveform signal to the body of the patient;
Including
The method wherein the first waveform signal includes at least a second waveform signal substantially corresponding to at least one of the acquired waveform signals and effective for adjustment of the respiratory system of the subject.   6. The method of claim 5, wherein the first waveform signal is transmitted to the subject's nervous system.   The method of claim 5, wherein the subject includes a human.   The method of claim 5, wherein the subject comprises an animal. A method for controlling breathing,
Capturing a plurality of waveform signals generated within the body of the subject and effective in controlling adjustment;
Extracting the components of the captured waveform signal; and
Storing the captured waveform signal and the signal component in a storage medium;
Generating a first waveform signal based on the captured waveform signal;
Transmitting the first waveform signal to the body of the patient;
Including
The method wherein the first waveform signal includes a second waveform signal substantially corresponding to at least one of the captured waveform signals and effective for controlling respiration.   The method of claim 9, wherein the first waveform signal is transmitted to the nervous system of the subject. A method for controlling breathing,
Capturing a first plurality of waveform signals including a first waveform signal generated within the body of a first subject and effective for controlling respiration;
Generating a reference respiratory waveform signal from the first waveform signal;
Capturing a second plurality of waveform signals generated within the body of the first subject and including at least a second waveform signal effective for breathing control;
Comparing the reference respiratory waveform signal with the second waveform signal;
Generating a third waveform signal based on the comparison of the reference respiratory signal and a second waveform signal;
Transmitting the third waveform signal effective for breathing control to the body of the patient;
Including methods.   12. The method of claim 11, wherein the step of capturing the waveform signal comprises capturing the first plurality of waveform signals from a plurality of subjects.   The method of claim 11, wherein the third waveform substantially corresponds to the second waveform signal.   The method of claim 11, wherein the third waveform substantially corresponds to the reference respiratory waveform signal.   The method of claim 11, wherein the third waveform signal is transmitted to the subject's nervous system.   The method of claim 11, wherein the subject includes a human.   The method of claim 11, wherein the subject comprises an animal. A method for controlling breathing,
Capturing a first plurality of waveform signals including a first waveform signal generated within the body of a first subject and effective for controlling respiration;
Storing the first waveform signal in a first location in a storage medium;
Generating a reference respiratory waveform signal from the first waveform signal;
Capturing a second plurality of waveform signals including at least a second waveform signal generated in the body of the first subject and effective for breathing control;
Storing the second waveform signal in a second location in the storage medium;
Comparing the reference respiratory waveform signal with the second waveform signal;
Generating a third waveform signal based on the comparison of the reference respiratory signal and a second waveform signal;
Transmitting the third waveform signal effective for breathing control to the body of the patient;
Including methods.   The method of claim 18, wherein the step of acquiring the waveform signal comprises acquiring the first plurality of waveform signals from a plurality of subjects.   The method of claim 18, wherein the third waveform signal is transmitted to the subject's nervous system.   The method of claim 18, wherein the subject includes a human.   The method of claim 18, wherein the subject comprises an animal. A method for controlling breathing,
Monitoring the respiratory status of the subject and providing at least one respiratory status signal indicative of the respiratory status of the subject;
Capturing a first plurality of waveform signals including a first waveform signal generated within the body of the subject and effective in controlling respiration;
Storing the respiratory system status signal and the first waveform signal in a first location in a storage medium;
Generating a second waveform signal based on the first waveform signal;
Transmitting the second waveform signal effective for respiration control to the subject in response to the respiratory system state signal;
Including methods.   24. The method of claim 23, wherein the second waveform signal is transmitted to the subject's nervous system.   24. The method of claim 23, wherein the second waveform signal is transmitted to the target zone of the subject, and the target zone is selected from the neck, head, and chest.   24. The method of claim 23, wherein the subject includes a human.   24. The method of claim 23, wherein the subject comprises an animal. A method for controlling breathing,
Monitoring the respiratory status of the subject and providing at least one respiratory status signal indicative of the respiratory status of the subject;
Capturing a first plurality of waveform signals including a first waveform signal generated within the body of the subject and effective in controlling respiration;
Extracting a waveform signal component from the first waveform signal;
Storing the respiratory system state signal, the first waveform signal and the waveform signal component in a storage medium;
Generating a second waveform signal based on the first waveform signal;
Transmitting the second waveform signal effective for respiration control to the subject in response to the respiratory system state signal;
Including methods.   30. The method of claim 28, wherein the second waveform signal is communicated to the subject in response to at least one of the waveform signal components.   29. The method of claim 28, wherein the second waveform signal is transmitted to the subject's nervous system.   29. The method of claim 28, wherein the second waveform signal is transmitted to a target zone of the subject, and the target zone is selected from the neck, head, and chest.   30. The method of claim 28, wherein the subject includes a human.   30. The method of claim 28, wherein the subject comprises an animal. A method for controlling breathing,
Monitoring the respiratory status of the subject including a reverse respiratory event and providing at least one respiratory status signal indicative of the status of the respiratory status of the subject;
Capturing a first plurality of waveform signals including a first waveform signal generated within the body of the subject and effective in controlling respiration;
Generating a confounding waveform signal effective to relieve the reverse breathing event in the subject's body;
Transmitting the confounded waveform signal to the subject in response to a respiratory status signal indicative of the reverse respiratory event;
Including methods.   35. The method of claim 34, wherein the confounded waveform signal is transmitted to the subject's nervous system.   35. The method of claim 34, wherein the confounding waveform signal is transmitted to a target zone of the subject, and the target zone is selected from the neck, head, and chest.   35. The method of claim 34, wherein the subject includes a human.   35. The method of claim 34, wherein the subject comprises an animal. A method for controlling breathing,
Monitoring the respiratory status of the subject including a reverse respiratory event and providing at least one respiratory status signal indicative of the status of the respiratory status of the subject;
Providing a confounding waveform signal effective to mitigate the reverse breathing event in the subject's body;
Transmitting the confounded waveform signal to the subject in response to a respiratory status signal indicative of the reverse respiratory event;
Including methods.   40. The method of claim 39, wherein the confounded waveform signal is transmitted to the subject's nervous system.   40. The method of claim 39, wherein the confounding waveform signal is transmitted to a target zone of the subject, and the target zone is selected from the neck, head, and chest. A method for controlling breathing,
Generating a confounding waveform signal effective to alleviate the reverse breathing event in the body of the subject;
Transmitting the confounded waveform signal to the subject in response to the reverse breathing event;
Including methods.   43. The method of claim 42, wherein the confounding waveform signal prevents the reverse breathing event.   43. The method of claim 42, wherein the confounded waveform signal is transmitted to the subject's nervous system.   43. The method of claim 42, wherein the confounding waveform signal is transmitted to a target zone of the subject, and the target zone is selected from a neck, a head, and a chest. A system for controlling breathing,
At least a first signal probe adapted to capture a waveform signal from the body of the subject that is generated naturally in the body and represents a waveform signal that is effective for controlling respiration;
Generating at least a first waveform signal that is communicable with the signal probe and adapted to receive the waveform signal, and further, based on the captured waveform signal, that the respiratory system can recognize as a regulatory signal. An adapted processor;
At least a second signal probe adapted to be communicable with the subject's body, for adjusting and controlling respiration by transmitting the first waveform signal to the subject's body;
Having a system.   The system of claim 46, wherein the processor comprises a storage medium adapted to store the captured waveform signal.   49. The system of claim 46, wherein the second signal probe is adapted to transmit the first waveform signal directly to the subject by transmitting directly to the subject's nervous system. A system for controlling breathing,
A respiratory system sensor adapted to monitor the status of the respiratory system of the subject and transmit at least a first respiratory status signal indicative of the status of the respiratory system of the subject;
At least a first signal probe adapted to capture a waveform signal from the body of the subject representing a waveform signal that is naturally generated in the body and is effective in controlling respiration;
At least a first signal that is communicable with the signal probe and is adapted to receive the respiratory system status signal and the waveform signal, and further, based on the captured waveform signal, is recognized by the respiratory system as a regulatory signal. A processor adapted to generate one waveform signal;
At least a second signal probe adapted to be communicable with the subject and transmitting the first waveform signal to the subject to control respiration;
Having a system.   50. The system of claim 49, wherein the processor comprises a storage medium adapted to store the captured waveform signal.   50. The system of claim 49, wherein the second signal probe is adapted to transmit the first waveform signal directly to the subject by transmitting directly to the subject's nervous system.

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