JPH07501233A - Treatment of anxiety disorders with nerve stimulation - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Treatment of anxiety disorders with nerve stimulation Background of the invention The present invention applies modulated electrical signals to predetermined nerves or nerve bundles of a patient to treat mental disorders and neurological disorders. It relates to methods and devices for the treatment and control of harmful or pathological disorders, and in particular: An implantable neurostimulator is used to apply modulated electrical signals to the vagus nerve to treat anxiety disorders (a relating to a method of treating patients with be.

The present invention particularly aims to improve vagus nerve activity. Those who treat pathological symptoms such as anxiety and panic attacks by selectively modulating Relates to laws and devices.

Anxiety disorders are one of the most common mental illnesses. When it worsens, the patient becomes incapacitated. In addition to subjective feelings such as anxiety, panic, and tingling, heart tachycardia, palpitations, and sweating may occur. , tremors, etc. have also been reported.

Patients with anxiety disorders commonly have insomnia as a side effect, and patients have difficulty falling asleep. The patient complains that the patient has difficulty waking up frequently. Anxiety disorders are often treated with sedatives Withdrawal symptoms occur when administration of the drug is stopped. This withdrawal symptom is caused by stimulants such as amphetamines. It may also occur when you stop using it. George and others are Arch .

Gen, Psycho, 46.1989.153-156, of lactate Subjective signs of anxiety with injection and hyperventilation vagal nerve sensitivity decreases (therefore, parasympathetic nerve sensitivity decreases). It has been reported that the transactivation activity decreases.

Decreased vagus nerve activity is clearly associated with panic attacks and is also associated with excessive anxiety. It is also thought to be related to Therefore, the inventors discovered that the vagus nerve (10th It is believed that anxiety disorders can be effectively treated by stimulating the cranial nerves. I got it.

Human nerves are made up of several thousand C fibers (generally designated as groups A, B, and C) of different sizes. It will be done. Each fiber transmits signals from the brain to other parts of the body and vice versa. example The vagus nerve has approximately 100,000 fibers (axons) of three different types; each transmits a signal. Under normal conditions, each nerve axon transmits information in only one direction. . The A and B fibers are miniphosphorylated (i.e., have a miniphosphorus sheath (m yelin 5heath), and the fibers of C are miniphosphorylated. Not yet.

Miniphosphorylated fibers are generally larger than non-miniphosphorylated fibers and have less electrical conductivity. conduction is fast and has a low threshold for electrical stimulation. required to stimulate miniphosphorylated fibers. Stimulation pulses that require relatively little electrical energy and have a constant width and amplitude A specific intensity one-time curve is shown for .

A and B fibers have relatively narrow pulse widths, e.g. 50-200 microseconds (μS). is stimulated by A fibers have slightly faster electrical conduction than B fibers, and the dark value of electrical stimulation is also lower. Slightly lower. C fibers are relatively small, transmit electrical signals very slowly, and have a low stimulation threshold. activation requires wide pulse width (e.g. 300-1000 μs) and high amplitude is necessary. A and B fibers are selectively stimulated without stimulating C fibers. C The pulse size and width required to stimulate the fibers will also activate the A and B fibers. let

Electrical stimulation of nerve fibers usually activates nerve signals in both directions (two directions). , selectively stimulate in one direction by using a specific nerve electrode and stimulation waveform You can also do that. As already mentioned, each axon normally transmits signals in only one direction. .

Woodba! J-(WoodBury) is a rat that was experimentally induced to have seizures. Report on the vagus nerve stimulating effect of Bpilepsia J, 199 0, No. 31 (supp 2), 87-S9), the vagus nerve is connected to body cavities and internal organs. Cardiac fibers (convey pulses inward to the brain or nerve centers such as the spinal cord) nerve fibers) and efferent fibers (transmit pulses to the effector to stimulate and activate them) It states that the nerve fibers are composed of nerve fibers that transmit signals to the outside. Hesitation Most of the nerve fibers are C fibers, and most of them are located in the body of the neck, that is, in the ganglia. A visceral cardiac fiber with certain cells whose central process connects the fibers to various areas of the brain ( (e.g., hypothalamus, thalamus, and amygdala) △, ending in the nucleus of a single tract that sends It continues to the medullary tract, cerebellum, nucleus fasciculata, and the intermediate reticular formation of other regions.

Woodbury further detected by stimulating cardiac fibers of the vagus nerve in animals Possible EEG changes occur in all regions, and the type and degree of EEG changes depend on the stimulus. It states that it depends on the parameters. Chase is lost Influencing EEG activity in certain parts of the brain by activating the taxis (Exp Neural (1966) 16: 36-49). The applicant has discovered that weak stimulation at high frequencies (>7011z) can cause miniphosphorus formation. When only the nerve fibers (A and B) that have been activated are activated, EEG synchronization occurs, Stimulation intensity is increased to a level that activates non-miniphosphorylated (C) nerve fibers. I thought that EEG desynchronization would occur when this occurred. Woodbury is even more lost It has the effect of broadly suppressing seizures and certain involuntary movements by stimulating the We have discovered that it is possible to generate

Physiologically, electrically stimulating the vagus nerve from the outside is effective in stimulating the vagus nerve and various involuntary movements. It has already been proposed in the treatment of disorders. In particular, on October 27, 1997, Zabala (J , Zabara) U.S. Patent No. 4.702.254 (hereinafter referred to as Patent '254) to reduce or prevent seizures, which are characterized by abnormal neural discharge patterns in the brain. A method and an implant are described. Embedding as described in Patent '254 Neurocybernetic prosthetic device (Neurocybcrnetic) prosthesis (NCP) is an external electrical current from the NCP generator that connects the nerves of the brain. Neurocybernet that adapts to the electrochemical characteristics of specific inhibitory nerve groups that act on the web The system uses a vector identification method. Inhibitory nerves are embedded eastward to other nerves. directly or indirectly and selectively activates NCP to a state of high cranial nerve discharge. Also controls spasticity or seizures. This patent's spectral discrimination analysis method uses active Depending on the electrochemical properties of the nerve you want to Select electrical parameters. The patent also states that A suitable NCP generator output application location is generally a cranial nerve, particularly the vagus nerve. It states that.

The NCP described in the '254 patent can be activated manually or automatically to provide treatment during an attack. Continue treatment. In the manual case, it is activated when the patient feels the atmosphere at the beginning of the attack. make it move. In addition, if automatic, certain state parameters may be set just before or at the beginning of a seizure. Detects instantaneous changes in data and starts operation. In addition, the NCP is activated periodically. used as a prophylactic or prevention method to reduce the occurrence and/or severity of attacks. You can also The patented °254 NCP stimulator is implanted in the patient's chest and An electrode placed at the location where the signal is applied, i.e. a location close to the brain along the vagus nerve. with a negative electrode placed far from the brain and a positive electrode connected to a neural site.

The main objective of the invention is to implant only a portion of an implantable neurostimulation device or circuit into the body. or an extracorporeal neurostimulator in which the nerve electrodes and their leads are implanted subcutaneously. By selectively modulating the electrical activity of the vagus nerve, excessive anxiety and The goal is to treat anxiety disorders, including anxiety and panic attacks.

Summary of the invention The present invention significantly increases vagus nerve sensitivity and vagus nerve activity by selectively stimulating the vagus nerve. and, when appropriate, increase the patient's EEG synchronization to treat and control anxiety disorders. METHODS AND APPARATUS. The nerve stimulation device (embedded) used in the device of the present invention (preferably, but not necessarily, the type that can be treated) may be overused with selective therapy. Treat and control high-degree anxiety and panic attacks. This treatment method addresses the root cause of the disorder. Although it is not necessarily effective in alleviating the cause of the disorder, it is possible to modulate the patient's vagus nerve to prevent the disorder. Symptoms can be treated and alleviated. A nerve stimulator is applied to the patient's vagus nerve. The stimulation provides the desired therapeutic modality (morlity) when programmed by the attending physician to generate output pulses with electrical parameters It will be done. Depending on the stimulation parameters, vagus nerve stimulation and EEG can be synchronized and increased. It is possible to effectively treat disorders in which β-wave activity is present.

Various vagus nerve modulation methods can be selected from a large number of 7 actors for the treatment of anxiety disorders. . These factors include (1) consideration of which nerve fibers should be stimulated; ii) modalities to perform EEG synchronization; (■1) physiological signals are impaired; whether such a signal is generated indicating the beginning of the Detected or easy to use for triggering the key and/or after (V) modulation Although there is a “carryover” or non-responsive period during which the benefits of modulation are retained, Please, etc. These are when choosing a stimulation plan to treat a particular disorder. This is not all of the factors that should be considered, and I have not necessarily pointed them out according to their importance. There is no such thing, but it is only applied in special cases.

The treatment of the present invention uses Inarai's signal parameters and threshold curves to stimulate the patient's vagus nerve. It activates various fibers and selectively modulates their electrical activity. Nerves in the vagus nerve of electric sounds Appropriately setting the pulse width and amplitude of the electrical signal applied by the stimulator nerve fibers are selectively stimulated. For example, A fibers rather than B and C fibers. However, it is possible to stimulate only A and B fibers instead of C fibers, or stimulate A, B, and C fibers at the same time. Ru. However, the selection process must consider a variety of relevant factors.

For example, C fibers transmit signals very slowly, so they respond poorly to fast stimulation methods. The response rate is not very high. These fibers become unresponsive after a relatively short period of stimulation. , increasing EEG synchronous activity by stimulating C fibers with 901Iz. In treatments requiring L, it is prudent to use short trains of pulses for stimulation. Dew. These fibers become unresponsive to stimulation within a relatively short period of time, so longer pulses It is impossible to trace the line of Rus. Impress another short pulse train after an appropriate recovery time. In addition, treatment can also be carried out. The exact pattern you should use, e.g. on and The length of off time is determined and adjusted based on each patient and the type of anxiety disorder being treated. be done.

Treatment can be improved by appropriately specifying the amplitude and frequency range of the applied signal. Fibers can be tuned to EEG synchronization for control. EEG synchronization is Usually performed by stimulation at a frequency of 75 tlz or higher with a signal level of less than 3 V . The actual voltage required will depend on the electrode type, geometry and electrode-tissue interface. determined by the impedance of the interface.

The basic stimulation method of the present invention consists of pre-programmed nerve stimulation from a stimulation generator. The electrical activity of the vagus nerve is increased by applying electrical pulses to increase the sensitivity and activity of the vagus nerve. It is to modulate it.

As already mentioned, in some patients EEG synchronization occurs when the signal is applied to the vagus nerve. It is desirable to program the waveform to increase the For automatic stimulation application The preferred detection method is standard cardiac monitoring, which detects tachycardia in the absence of physical exertion. Use of code detection circuits and/or impedance measurements to detect hyperventilation It is the use of circuits. These are typical signs of abnormal fear, anxiety or panic attacks. It is used to detect symptoms or things related to them. Although not common, patients Detectors that detect loss of consciousness in patients are also useful, as syncope may occur. Ma or by the patient when the patient feels such fear, anxiety or panic. allow the neurostimulator to be activated manually (or by the on-site physician) is preferable. In this case, of course, there is no need to surgically implant the detector.

The subject of the invention is preferably an implant for treating and controlling anxiety disorders by neural stimulation. There is a device using an implantable neurostimulator and F1. applied to the vagus nerve The modulating signal can stimulate or suppress other neural signals, resulting in stimulation or inhibitory neuronal signals. A transmitter (Neurotransmitter) is emitted. Specification Both states are expressed using the term ``stimulate''. Apply modulation signal The preferred nerve for vagus nerves is the vagus nerve, but one or more other nerves, especially the brain It should be emphasized that effective treatment can also be achieved by applying stimulation to the nerves. However, these treatments are also included within the scope of the present invention.

Accordingly, a particular subject of the invention is electrical stimulation of the vagus nerve or other cranial nerves of a patient. Activate a specific group from all selected nerve fiber groups by applying a stimulus to selectively increase the sensitivity and activity of the vagus nerve and/or increase the patient's E The present invention provides a method and device for treating and controlling anxiety disorders by synchronizing EG.

Another object of the present invention is to prevent the vagus nerve of a patient from detecting symptoms or signs of the disorder. Automatically or manually modulate vagus nerve activity by applying selected stimuli There are methods for treating and controlling anxiety disorders that suppress the disorder.

Brief description of the drawing The above and other objects, features and advantages of the present invention will be understood with reference to the accompanying drawings. It will become clear from the description of the preferred embodiment below.

Figure 1 shows the method used in the treatment of anxiety disorders according to the present invention (parameters are within appropriate ranges). Implantable neurostimulator electronic package (stimulation generator) for This is a simplified block diagram of Figure 2 shows the stimulation generator and lead of a neurostimulator implanted in a patient's body. 1 is a diagram illustrating a preferred embodiment of a electrode/electrode system and a detection device combined therewith; FIG. , Figure 3 shows a device implanted into the vagus nerve in a patient's neck to modulate vagus nerve activity. Figure 4 is a detailed view of a portion of the neural electrode that is Stimulus generators useful for elucidating parameters related to signals applied to FIG. 3 is a diagram showing an idealized electrical output signal waveform of the controller.

Description of the preferred embodiment Figure 1 shows the basic components of the stimulus generator of a neurostimulator and their interrelationships. This is a block diagram showing the position and combination when this is made into an implant. Details of the lead/electrode system used are shown in FIGS. 2 and 3. Used in the device of the present invention The general form of a neurostimulator suitable for Rikio (Anthony J, Varricbio) November 10, 1989 Pending U.S. Patent Application No. 07/434.985 (hereinafter filed '985) application). The entire specification of this '985 application is hereby incorporated by reference. some of which are summarized in this application for the convenience of the reader.

This neurostimulator consists of a typical microprocessor and other standard electrical and electronic components. and, in the case of implantable devices, a non-identical device to control and display the device status. A programmable device located outside the patient's body and/or Communicate with the monitor. Passwords, /% and passwords are required to ensure data consistency. Use king and parity checks. Neurostimulators hold energy (any battery operated device, especially a device implanted for the medical treatment of a disease) and various safety features such as means to prevent the device from being reset accidentally. Further means are provided.

The stimulus generator 10 (FIG. 1) is inserted into the patient's body by the surgeon as shown in FIG. Preferably, it can be implanted in a pocket formed just under the skin of the chest by However, primarily external neurostimulation devices can also be used. Mako, this nerve stimulation The device includes a lead device for applying the stimulation generator's output signal to the patient's vagus nerve. An implantable stimulation electrode (described in detail below) having a position 22 is included. patient The external components of the system remotely transmit parameter changes to a stimulus generator. A programmable wand (optical) that monitors the signal from the stimulus generator. character reader), computer, adjust each parameter, and generate a stimulus generator. software to control communication between the computer, programmable wand, and computer. Includes software. These components external to the device are not shown.

The stimulus generator IO or other embedded or external circuitry described above may In addition to logic and control circuits based on microprocessors, it also detects events that indicate abnormalities. A detection circuit may be provided to automatically trigger the stimulation signal generator. for example , implanting a known cardiac lead and associated electrodes on the right side of the patient's heart. or by implanting known impedance-measuring electrodes in the patient's chest or detecting signs of anxiety disorders. to detect cardiac tachycardia, hyperpnea, or syncope in a patient, or to detect collapse in a patient. A known activity sensor is modified and used as described above. For these devices and methods This will be explained with reference to FIG. The use of these detection devices requires complex and precise Surgical implantation is required, and detection signal analysis and recognition circuits are used. If the patient's condition allows, the patient is aware that a seizure has begun, as is necessary. Manual activation of the stimulus generator is sometimes preferred.

The stimulus generator 10 shown in FIG. 1 has a battery (or battery group) 12. . The battery 12 is used for implantable medical electronic devices (such as implantable cardiac pacemakers or implantable cardiac pacemakers). Reliable, long-lasting, commonly used to drive defibrillators, etc. It can be made into a type of battery. In a preferred embodiment of the stimulus generator, the battery is a single battery. This is a thium thionyl chloride cell. The terminal of the battery 12 is connected to the voltage regulator 13 connected to the input side of the The voltage regulator 13 smoothes the battery output to prevent disturbances. It provides a constant output voltage and can be used to step up or divide the voltage if required for special applications. look at

Voltage regulator 13 provides power to logic and control section 15 . This logic/control unit 15 A microprocessor is provided to control the programmable functions of the device. Professional Functions that can be programmed include output current, output signal frequency, output signal pulse width, and output Continuously or periodically modulates signal on time, output signal off time, and vagus nerve activity. daily processing time, output signal start delay time, etc.

These are programmable so that the output signal can be transferred to the stimulation electrode set 25 (second (Fig. 3), thereby treating and controlling the disorder. Vagus nerve activity can be arbitrarily modulated for. Stimulus generator logic - Timing signals for the control functions are generated by a crystal oscillator 16. stimulus generator manually (placed at the electronic package or in close proximity to the implant location) (with an external magnet not shown). A magnetically actuated reed switch 14 is provided.

Embedded stimulus generator and external electronics (programming signals, monitoring equipment) Communication between the devices (including both the Programming signals for data changes can be received from the programmable wang (approximately The transfer of information (to and from) can be done remotely. Some of the above systems are Once programmed, the clinician can use an external computer and programmable wang to ) The device will operate continuously at the programmed settings until reprogrammed.

The power down circuit 18 is electrically connected to the reed switch 14 and the logic/control circuit 15. , and the crystal oscillator 16. This power down circuit 18 is a crystal oscillator. The timing is taken from the clock pulse from 16, and the microprocessor of the logic/control section 15 power to the processor and/or oscillator until the device is effectively asleep and still alive. It is lowered to the point where it can be activated quickly when the command comes. In a preferred embodiment, the within a few hours after the device is activated and produces the programmed stimulation output signal. The power-down circuit automatically enters power-down mode (i.e. It is preferable to go into a sleep state). To control most anxiety or panic attacks 5 to IO hours appears to be sufficient time, but this time will vary depending on the needs of each patient. You can make it longer or shorter depending on your needs. After that, power down next time. When the microprocessor and/or oscillator is disabled, the microprocessor and/or oscillator are e.g. by holding a magnet very close to the reed switch) or automatically (for example, by holding a magnet very close to the reed switch) or automatically (at the onset of a seizure) The device remains in a low power state until it is activated (detection of physiological signs indicative of the condition).

The power-down circuit can be made with a CMO3 semiconductor circuit, which is well known in the field of integrated circuits. , it is easy for those skilled in the art to incorporate it into a neurostimulation device.

Reducing the power required by the device between episodes of an anxiety disorder and allows you to use the battery power for a long enough time, significantly longer than otherwise. Treatment is possible over a period of time. As a result, equipment life is significantly longer and equipment The time between surgical implants is longer and the device does not have power-down characteristics. The dimensions of the device are significantly smaller in comparison.

The logic controller 15 of the stimulus generator 10 was programmed for the treatment of disorders. It controls an output section 19 that generates a signal level. Output section 19 and its programmed The electrical contacts 20 of the stimulation generator on the housing 21 and the stimulation voltage It is connected to the lead assembly 22 which is connected to the pole (FIG. 2, '!53).

cardiac GIJ-domain, impedance electrodes or If the collapse detector is implanted in the patient's body, the detection signal analysis circuit 23 is provided inside the housing 21 of the stimulus generator, and is connected to the master of the logic and control section 15. It is connected to the microprocessor and the detection electrode 60.

The housing 21 containing the stimulus generator 10 is sealed and free from patient body fluids and It is made of materials such as titanium that are biologically compatible with tissue. Diseases described herein Further detailed structure and operation of neurostimulators other than those suitable for the treatment of It is stated in the application and can be referred to.

Figure 2 shows a patient's chest implanted in a pocket created by the surgeon just under the skin. Stimulus generator 10 (located inside case 21 with connector 20) FIG. This stimulus generator IO is a pacemaker The pulse generator is implanted in a manner similar to that of a pulse generator. Stimulating nerve electrode set 25 (third ) is connected to the distal end of an insulated conductive lead assembly 22.

The proximal end of this lead assembly 22 is connected to the connector 20.

Electrode set 25 is disclosed in U.S. Pat. No. 40, Mar. 1986 to Bullara. Preference is given to bipolar stimulation electrodes of the type described in 4.573.481.

This electrode assembly is surgically implanted into the vagus nerve 27 in the patient's neck. two electric Poles 25-1 and 25-2 are wrapped around the vagus nerve and are assigned to the applicant. 990], 2J-125th TeIJ-Junior (Recse S, Tcrry Electrodes with a spiral retention button as described in U.S. Pat. No. 4,979,511 by J. Preferably, the assembly is secured to the nerve. Lead 22 had chest and neck exercises It is fixed by a suture connection 3o to nearby tissue in a state where it can be bent at times.

As detailed in the Bullara patent cited above, the electrode assembly Since the solid body 25 has an automatically determined size and a flexible spiral structure, The risk of physical damage to the nerves is minimized and mutual exchange of nerves and body fluids is allowed.

Shaping the electrode assembly to match the shape of the nerve increases the stimulation contact area. , the stimulation threshold is lowered. Structurally, the electrode assembly consists of two platinum plates that make up the electrode. The first two helical loops of the three looped helical assemblies are connected to each electrode. 25-1 and 25-2, and each conductive ribbon electrode has two leads. The wires are welded. The remaining part of each loop is made of silicone rubber, and the third The loop serves as a tether 28 for the electrode assembly. spiral bipo The typical inner diameter of the spiral electrode assembly is about 2 mm and the length of each helix is about 7 mm. (measured along the axis of the nerve).

3 conventional cardiac bipolar lead/electrode pairs in the right atrium or chamber of the patient's heart. 3 is embedded and connected to the detection circuit of the signal analysis circuit 23 via the lead 37 to prevent excessive Cardiac tachycardia manifested by anxiety, fear, or panic (i.e., not sinus tachycardia) Detect.

Suitable equipment and circuitry are well known in the field of cardiac base manufacturers. or, A known device 42 for measuring changes in a patient's breathing rate and changes in electrical impedance is used. Implanted in the patient's chest in the form of a circuit combined with electrodes caused by anxiety or panic Hyperventilation may also be detected. In this case, the impedance measurement device 7 and the stimulus generator 1o (electrically connected to the g analysis circuit 23 and tested) If the output impedance exceeds a predetermined threshold, the generator will program output pulses are generated.

Another form of detection device suitable for triggering the application of a pulse waveform to the vagus nerve is A motion detector 45 detects sudden movements indicating patient collapse, such as syncope, sudden weakness, etc. This is a method of embedding. For example, the signal analysis circuit 23 (or RF detector) A steep high level such as a spike (broken part in a chevron shape) that causes the device to operate Recognize the signal. In another embodiment, the adhesive may be applied directly to the skin of the patient's chest. Excessive humidity combined with anxiety or panic attacks can be detected using a fixed external moisture detector. It is possible to detect and stop sweating.

If the patient being treated is not completely disabled by the anxiety disorder, neurological The stimulator is automatically activated by a device implanted in the patient or worn by the patient. Instead of (or in addition to) allowing the patient to manually activate the is desirable and preferable. Patients generally recognize the symptoms and signs of anxiety disorders easily. , for example, by placing a magnet directly above the implanted device. A switch can be activated to activate the stimulator at the onset of a seizure. Either a continuous stimulus signal (which may include periods in which the signal alternates on and off) is added to modulate vagus nerve activity.

For example, the copyright of the above-mentioned stimulus Jay and Rater has been registered by the applicant. r of Copyrights, Library of Congress ) type of programming software or other software based on the description herein. An IBM compatible personal computer (not shown) using appropriate software. It can be programmed using a programmed song (not shown). stimulation Once the generator has been implanted, the song and software will create a stimulus generator. Able to communicate non-invasively with the controller. The song is powered by an internal battery and has enough power for communication. Preferably, a "power on" light is provided to indicate power. Also, song Another table showing that data transfer is taking place between the stimulus generator and the stimulus generator. Preferably, an indicator light is provided.

The operation of the stimulus generator lO for controlling and treating anxiety disorders is shown in Figure 4. This will be explained with reference to the signal waveform. This figure 4 shows the output section for the electrode array 25. 19 is an idealized diagram of the output signal generated by No. 19. FIG. This diagram mainly shows the output signal on. time, output signal off time, output signal frequency, output signal pulse width, and output signal current. This is shown to clarify the terms including each parameter.

Appropriate range of stimulation parameters and parameters of stimulation output signal for anxiety disorder treatment Table 1 shows typical values of the data.

Anxiety disorders are characterized by activation in the patient's biological rhythm or other periodic manner. The problem is that even with programming, treatment cannot be easily performed.

It is desirable to incorporate various features into neurostimulation devices to maintain patient safety and comfort. . For example, the output stimulus is ramped up during the first 2 seconds of the stimulus rather than being applied suddenly. Comfort is increased by broccramming it so that it stretches. Also, the vagus nerve Embedded clamp circuit to limit the maximum voltage applied to the It can also be equipped with a stimulus generator. Its maximum limit is the patient's vagus nerve Set to prevent scratches or damage.

Programmable functions of neurostimulator and stimulation generator after implantation of the device Monitor activation and function by designing non-intrusive communication with becomes easier. The programming software provides linear menus in addition to the main functions of the device. Provides manual drive operation, HELP function, prompts and messages to A simple and easy-to-use design that fully informs the user of everything happening at each stage of configured to facilitate quick programming. programming is exciting Change the adjustable parameters of the generator and its output signals and test the equipment diagnostics. preferably have the ability to store and retrieve telemetered data. Buried When checking the installed device, the current status of the adjustable parameter can be monitored on an external PC. the programmer can select any or all of these parameters. It is desirable to be able to easily change the data at the same time. Specific nog parameter is selected to vary, displays all allowable values for that parameter. The programmer selects the appropriate desired values to input into the neurostimulator by be able to.

Diagnostic tests verify proper operation of the equipment and verify communications, battery or lead/electrode impedance. -Used to indicate the existence of a problem such as dancing. For example, the battery turned on Sometimes the end of a battery's life is imminent, indicating that a new device needs to be implanted. vinegar. It can also show that neural electrodes are clearly not being used in diagnostic tests. Wear.

As described above, preferred embodiments of the treatment and control of anxiety disorders by vagus nerve modulation according to the present invention However, those skilled in the art can easily understand the above embodiment from the above description without departing from the spirit of the present invention. It is clear that changes and improvements can be made. For example, fully embedded A neurostimulator that can be used with electronic energization is preferred, but if desired an electronic energized package can be used. Most of it can also be expelled from the body. RF to provide the energy level needed for stimulation It can also be provided by a power device.

Embedded components can be limited to lead/electrode devices, coils, and DC rectifiers. can. Combine pulses programmed with desired parameters with RF carrier to the vagus nerve, and then adjust the signal to apply stimulation to the vagus nerve. It is also possible to modulate vagus nerve activity by regenerating a pulsed signal that Ru. This substantially eliminates battery replacement. Disadvantages of that method The main drawback is that the patient must carry an external transmitter, which requires more power for activation. The main point is that the stability of the output current to the nerves decreases.

The external stimulation generator is connected to a subcutaneously extending lip toward the set of implantable neural electrodes. It can also be used with a code. The big problem here is the possibility of infection. , perform short-term tests to determine whether treatment of a particular patient's disorder will be successful. Such a temporary arrangement is also effective for application. As a result, definitive or If it is promising, you can make it a more permanent implant.

The invention is limited only by the scope of the claims appended hereto.

Claims (20)

[Claims] 1. Detects signs of damage and imprints predetermined electrical signals into the patient's vagus nerve in response. In addition, it is specially designed to reduce the symptoms of the disorder being treated by stimulating the vagus nerve. A method of treating patients with anxiety disorders characterized by symptoms. 2. The predetermined electrical signals described above are programmed to increase vagus nerve activity in the patient. 2. The method of claim 1, wherein the pulse waveform has signal parameters determined. 3. 3. The device according to claim 2, wherein a predetermined electrical signal is automatically applied upon detecting a symptom of a fault. Method. 4. Claim to detect signs of disorder by detecting fast heart rate in patients who do not have sinus tachycardia The method described in Section 3. 5. 4. The method according to claim 3, wherein the detection of symptoms of the disorder is performed by sensing hyperventilation of the patient. 6. 4. The method of claim 3, wherein the detection of symptoms of the disorder is performed by sensing excessive palpitations of the patient. . 7. 4. The method of claim 3, wherein the detection of signs of impairment is by sensing collapse of the patient. 8. Detection of signs of impairment by patient recognition of signs and manual activation of signals 3. The method according to claim 2, wherein the method is applied to the vagus nerve. 9. The above signals are programmed to increase synchronization of the patient's EEG and 2. The method of claim 1, wherein the method is applied to a nerve. 10. of electrical signals including pulse width, output current, frequency, on-time and off-time 2. The method of claim 1, wherein the parameter value is selectively programmable. 11. a neurostimulation generator for generating electrical output signals and the patient's vagus nerve; is electrically connected to a neurostimulation generator for outputting the above electrical output signal to an implantable lead/electrode means; Selectively stimulate the vagus nerve to increase electrical activity in the vagus nerve to alleviate the disorder. selectable parameter values of the electrical output signal of the neurostimulation generator to for treating an anxiety disorder in a patient characterized in that the method comprises: nerve stimulator. 12. The electrical output signal has a pulse waveform, and the selection means selects the signal parameters of this pulse waveform. 12. The meter according to claim 11, comprising programmable means for programming the meter. Device. 13. Programmable signal parameters for pulse waveforms include pulse width, output current, frequency 13. The apparatus of claim 12, including wave number, on time or off time. 14. Apparatus according to claim 11, comprising detection means for detecting symptoms of an anxiety disorder. . 15. The neurostimulation generator detects the patient's wandering in response to the detection of symptoms by the sensing means. 15. The device of claim 14, including control means for applying electrical signals to the nerve. 16. the detection means comprises means for detecting cardiac tachycardia in the absence of physical movement of the patient; 16. The apparatus according to claim 15. 17. 16. The method according to claim 15, comprising detection means or means for detecting hyperventilation of the patient. equipment. 18. 16. The apparatus of claim 15, wherein the detection means comprises means for detecting collapse of the patient. Place. 19. Manually actuate the neural stimulation generator means to transmit its electrical output signal to the patient. 12. The device of claim 11, including means for applying to the vagus nerve. 20. a stimulus that, when activated, produces a programmable electrical output signal in response means and This stimulation means is electrically connected to the patient's vagus nerve so that the vagus nerve is programmed. implantable lead/electrode means for outputting an electrical output signal; detection means for detecting the onset of the anxiety disorder to be treated and activating the stimulation means; Implants for treating patients with anxiety disorders characterized by consisting of Possible neurostimulator.