KR20090014252A - Direct current stimulator system for brain stimulation - Google Patents

Abstract

A galvanism stimulator system of an implantable type in the body for a brain stimulus is provided to improve a symptom of nervous system disease to cure the disease. A galvanism stimulator system(1) of an implantable type in the body for a brain stimulus includes a storage battery(12), a circuit member(13), an electrode member(14), a terminal member(15), a conducting wire fixing member and two fixing members. The circuit member controls polarity and intensity of the DC power supply, the stimulus time and a cycle with an external remote controller.

Description

DIRECT CURRENT STIMULATOR SYSTEM FOR BRAIN STIMULATION}

The present invention relates to a human body insert type direct current electric stimulator system for supplying direct current electric stimulation to various cortical stimulation electrodes for supplying direct electric stimulation to the brain cortex. Local anesthesia of the scalp and scalp incision of about 2cm can be installed on the upper part of the skull for insertion of small human body. It is. The human implantable large-capacity DC stimulator is designed to allow long-term electrical stimulation by inserting it under the chest subcutaneous when the efficacy of DC electrical stimulation is demonstrated through the small-capacity DC stimulator. In addition, it is designed to control the polarity and intensity of the stimulus, stimulation time and period from the outside through an external controller.

Various neurological functions of the human body are regulated or influenced by neurological activity of the brain. Neural activity of the brain has inhibitory or excitatory functions, which can maintain the adequacy of nerve function due to the proper combination of these two functions. However, if the coordination of these functions is destroyed by trauma, disease, or disease of the brain, pathological neurological abnormalities may be caused. For example, strokes caused by occlusion or rupture of cerebrovascular vessels may significantly decrease excitability of brain nerve function, resulting in motor weakness, paresthesia, speech impairment, and perceptual impairment. This excessive increase causes abnormal excess neuronal activity resulting in seizures. Parkinson's disease is also known to be caused by excess activity of the extraventricular nucleus in the brain's sagittal region.

Traditionally, electrical stimulation to the brain has used alternating current electrical stimulation to control brain neuronal function. Parkinson's disease symptoms were ameliorated by feeding high-frequency alternating electrical stimulation to the brain's core. Recently, based on the effect of symptomatic improvement of stroke patients by transcranial self-stimulation study, the improvement of symptoms by AC type electric stimulation has been reported in stroke patients, and in the epilepsy patients, various types of AC type electric stimulation are delivered to the brain. There is a reported decrease in seizures. In recent years, the transcranial DC electric stimulation method has been tried in various neurological diseases, and the positive effect has been demonstrated. In particular, cathodic DC stimulation significantly inhibits neuronal activity and can be applied to diseases in which neuronal activity is abnormally increased, such as epilepsy and Parkinson's disease. The same inhibition of neuronal activity can be applied in distinct diseases. In the same concept, it can be used in many neurological diseases such as dementia, depression, overactive concentration disorder, Lou Gehrig's disease, and multiple sclerosis due to neurological abnormalities.

The current method of transcranial DC electrostimulation is a method of delivering DC stimulation to the brain by mounting a 5cm × 5㎝ electrode plate on the frontal and temporal or larynx, which has the disadvantage of overcoming the electrical resistance of the scalp and skull. There is a problem that the brain stimulation of the unnecessary wide area is made, rather than a local stimulation suitable for a specific target site. In addition, the intensive rehabilitation treatment that is accompanied with brain stimulation is not smooth, there is always an error or deviation in mounting the stimulation electrode on a certain area, and the medical staff must be assisted to install and operate the stimulator. There is a difficulty in limiting life by having to visit. In addition, even when a long period of electrical stimulation or cyclic electrical stimulation is required, the electric stimulator is not available at home, so it is difficult to be hospitalized.

DC stimulation on the human body has been used for the purpose of promoting bone fusion in fractures or spinal fusion, or for controlling obesity by reducing the motility of the gastrointestinal tract, but designed to improve neurological symptoms. An implantable DC electrostimulator has not yet been developed.

In addition, the existing electric stimulator is a short period of time to use the electrical stimulation within a few months, depending on the patient may be used for many years, but all of them are complex anesthesia and the procedure of drilling through a long tunnel under the skin as shown in Figure 6 In addition, the procedure of repeating the incision of the scalp and skull under the general anesthesia should be repeated even after removal after use, resulting in an inconvenience of the patient and an increase in medical expenses.

Therefore, in the present invention, a case where a short-term electric stimulation is required according to a period in which a direct current electrical stimulation is required for the brain stimulation, and a patient who needs to determine the effect of the direct current electrical stimulation in a short time, the human body-type small-capacity direct current type electrical stimulation for the brain stimulation A stimulator system was invented to allow removal and treatment with local anesthesia and small scalp incisions.

It is an object of the present invention to regulate the excitability and suppression of brain neuronal function to provide a controlled DC electric stimulation to the local cerebral cortex for the treatment and improvement of symptoms of neurological diseases. To provide a system.

In addition, another object of the present invention is to supply a local direct current electrical stimulation to a specific part of the brain, and at the same time can be accompanied by intensive rehabilitation treatment, the human implantable small dose that can reduce the medical cost and user convenience To provide a direct current type electric stimulator system.

In addition, another object of the present invention to provide a human implantable small-capacity DC electric stimulator system that can adjust the electric stimulation according to the characteristics of the disease by controlling the polarity and intensity of the electric stimulation through the electric stimulation controller from the outside.

In addition, another object of the present invention is to install the electrical stimulator on the skull only by local anesthesia and small scalp incision, it is easy to remove the economical human implantable small-sized DC electric stimulator that can reduce the cost and time of surgery To provide a system.

 In addition, another object of the present invention is to provide a human body implantable large-capacity type DC electric stimulator system for patients requiring long-term direct current electric stimulation.

As described above, the human body implantable DC electric stimulator system for brain stimulation according to the present invention supplies electrical stimulation to the cerebral cortex to suppress or excite the activity of nerves in the brain, thereby causing cranial nerves due to neurological trauma, disease, and disorder. There is an excellent effect to recover the degradation of the function.

In addition, the human body implantable DC electric stimulator system for brain stimulation according to the present invention supplies a local direct current DC electric stimulation to a specific part of the brain, at the same time can be accompanied by intensive rehabilitation treatment, reducing medical costs and user convenience Can be planned.

In addition, the human body insertion type DC electric stimulator system for brain stimulation according to the present invention can adjust the electrical stimulation according to the characteristics of the disease by controlling the polarity and intensity of the electrical stimulation through the electrical stimulation controller from the outside.

In addition, the human body insertion type DC electric stimulator system for brain stimulation according to the present invention can be installed on the skull with local anesthesia and only a small scalp incision, it can be easily removed to reduce the cost and time of surgery.

In addition, the small-capacity type and the large-capacity type DC stimulator are divided into small-capacity type and large-capacity type to verify the efficacy of DC electrical stimulation. The flexibility of the application and the adequacy of the selection were achieved.

The above-described objects of the present invention are inserted under a scalp and a connecting terminal portion capable of connecting a power supply battery and a circuit portion for generating a DC stimulation current, a ground electrode portion grounded to the skull or subcutaneous tissue, and an epidural or subdural electrode with a stimulator. Two fixing parts fixed with a male screw to the skull to prevent movement when the wires are moved, and the polarity and strength of the DC wire stimulator which acts as a protection and guide and fixation when the wires of the electrode pass through the solid skull. It is achieved by providing a human body implantable direct current electric stimulator system for brain stimulation composed of an external stimulator capable of adjusting the stimulation time, and the like.

According to a preferred feature of the present invention, the above-described ground electrode member serves as a ground electrode to form an electric field in contact with the skull or scalp subcutaneously with an exposed metal part not coated on the underside of the electric stimulator.

According to a more preferable feature of the present invention, the above-described conductive wire fixing member is a tubular member of a plastic material bent in a 'b' type to pass the conductive wire of the electrode and to fix the position with a silk suture or screw.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings, which are intended to describe in detail enough to be easily carried out by those skilled in the art to which the present invention pertains. This does not mean that the technical spirit and scope of the present invention is limited.

1 is a cross-sectional view of a human body insertion-type small-capacity DC stimulator for brain stimulation according to an embodiment of the present invention, Figure 2 is a human body insertion-type small-capacity DC electric stimulator for brain stimulation according to an embodiment of the present invention A side view showing a state in which an electrode lead is connected together with the wire fixing member of FIG. 3A and 3B illustrate a human body-type small-capacity DC electric stimulator and a cortical stimulation electrode for brain stimulation according to an embodiment of the present invention. Figure 4 is a state diagram showing the installation process, Figure 4 is a human state insertion type small-capacity DC stimulator for brain stimulation according to an embodiment of the present invention and the connection state diagram of the various dural or subdural electrodes are shown, Figure 5 Figure 2 is a cross-sectional view of the human implantable large-capacity DC stimulator for brain stimulation according to an embodiment of the present invention, Figure 6 is a brain stimulation according to an embodiment of the present invention Figure 7 shows a state of use of the human body insertion type large-capacity DC electric stimulator system, the external regulator of the DC electric stimulator for brain stimulation according to an embodiment of the present invention, Figure 8 is a view of the present invention According to an embodiment of the present invention is shown a state of use of the external regulator of the human body insertion type small-capacity DC electric stimulator system for brain stimulation, Figure 9 is a human body insertion-type large-capacity DC electricity for brain stimulation according to an embodiment of the present invention A state diagram of the use of the stimulator and the external controller is shown, and FIG. 10 is a schematic diagram of an algorithm for inserting a human body DC electric stimulator system for brain stimulation according to an embodiment of the present invention.

The human body insertion-type small-capacity DC electric stimulator 1 for brain stimulation according to an embodiment of the present invention includes a terminal part connected to the cranial fixing part 11 and the cortical stimulation electrode 40 for fixing the skull and the electric stimulator ( 15) and an internal battery part 12, a circuit part 13 for generating a DC electric stimulation wave, and a ground electrode part 14 for grounding by contact with a skull or scalp subcutaneous, and a conductor wire for connecting and fixing the lead of the brain electrode. The fixing member 20 is included. The wire fixing member has a connection terminal of 1-4 channels, and is formed of a solid silicon type (type) (51). The human implantable small-capacity direct current electric stimulator (1) for brain stimulation is packaged in a titanium case, which contains the battery 12 and the electric circuit (13) in the case, and the silicon type (51) Should be firmly connected by laser welding. The outside of the titanium case of the electric stimulator is insulated with a silicon film, and the ground electrode portion 14 serves as a ground electrode with the exposed titanium metal surface.

The circuit unit 13 generates a DC electric stimulation wave, and the polarity, intensity, stimulation time, and period of the DC electric current enable radio wave communication to be linked with an external regulator.

In addition, the wire fixing member 20 is a plastic conduit made of polypropylene has a 'b' shape and functions to fix the position with a suture at the two perforations and to prevent the bending and damage of the wire.

Hereinafter, a description will be given of a procedure using the human body insertion-type small-capacity DC stimulator 1 for brain stimulation according to an embodiment of the present invention described above.

First, the operator cuts the scalp 130 into which the cerebral cortex stimulation electrode 40 is to be inserted into 2 cm and punctures the skull 100, and when the cerebral cortex stimulation electrode 40 is completely inserted, it is exposed to the outside. The human implantable small-capacity DC electric stimulator 1 for brain stimulation is connected to the end of the conductive wire 30, and locally supplies electricity of a selected pattern according to the treatment site. The supplied electricity is introduced into the cortical stimulation electrode 40 through the conductive wire 30 to apply a direct current electrical stimulation to the cerebral cortex 120.

Hereinafter, a description will be given of a procedure using the human body insertion type DC electric stimulator 1 for brain stimulation according to an embodiment of the present invention described above.

First, the operator cuts the scalp 130 into which the cerebral cortical stimulation electrode 40 is to be inserted into 2 cm and punctures the skull 100, and when the cortical stimulation electrode 40 is fully inserted into the subcutaneous layer below the collarbone. Insert the incision, and then drill the tunnel to the scalp incision through the electrode lead 30, connects the electrode lead 30 to the end of the lead 30 exposed to the terminal outside, the brain at the incision below the clavicle By inserting the human body large-capacity type DC electric stimulator 50 for stimulation is to supply electricity of the selected pattern according to the treatment site.

Hereinafter, an algorithm (FIG. 10) for the operation of the human body implantable DC electric stimulator system for brain stimulation according to the present invention will be described.

Based on clinical, neuroimaging, and neurophysiological data in patients with neurological diseases, patients with the DC electrostimulation method are selected, and the parameters of DC electrostimulation are set according to neurological symptoms and disorders. The electrode insertion position is determined in the selected patients and the electrode is inserted at the correct position. The human implantable small-capacity DC electric stimulator is inserted under the scalp and connected to the electrode for brain cortex stimulation. After inputting the set parameter to external controller, it operates by transmitting the same parameter to DC electric stimulator through radio wave communication. Observe and evaluate the effects of electrical stimulation over a period of time, and if the effects of electrical stimulation are insufficient, readjust the parameters of the electrical stimulation through an external stimulator. Once the effects of electrical stimulation have been fully demonstrated, patients who require long-term electrical stimulation therapy should be replaced with an implantable high-capacity DC electrostimulator.

1 is a cross-sectional view of the human body insertion type small-capacity DC electric stimulator for brain stimulation according to an embodiment of the present invention.

Figure 2 is a side view showing the electrode lead connected with the wire fixing member of the human body insertion type small-capacity DC electric stimulator for brain stimulation according to an embodiment of the present invention.

Figure 3a to 3b is a state diagram showing the installation process of the human body insertion type small-capacity DC electric stimulator and the brain cortical stimulation electrode for brain stimulation according to an embodiment of the present invention.

Figure 4 is a state of use of the human body insertion-type small-capacity DC electric stimulator and various cortical stimulation electrodes for brain stimulation according to an embodiment of the present invention.

Figure 5 is a cross-sectional view of the human body insertion type DC electric stimulator for brain stimulation according to an embodiment of the present invention

Figure 6 is a state of use of the human body insertion-type large-capacity DC electric stimulator for brain stimulation according to an embodiment of the present invention.

Figure 7 is a perspective view of an external regulator of the direct current electric stimulator for brain stimulation according to an embodiment of the present invention.

8 is a state of use of the external regulator of the human body insertion type small-capacity DC electric stimulator system for brain stimulation according to an embodiment of the present invention.

Figure 9 is a state of use of the human body insertion-type large-capacity DC electric stimulator and external regulator for brain stimulation according to an embodiment of the present invention.

10 is an algorithmic schematic diagram of a human body implantable DC armature system for brain stimulation according to an embodiment of the present invention.

* Description of the symbols for the main parts of the drawings *

1: Small-capacity DC electric stimulator of human body type for brain stimulation

11: two old government

12: storage battery

13: circuit part

14: grounding electrode

15: connecting terminal part

20: conductor fixing member

30: electrode lead

40: cortical stimulation electrode

50: Human body insertion type DC electric stimulator for brain stimulation

51: silicon mold

60: stimulation regulator

61: connecting cable

62: operation switch

63: Status LED

100: skull

10: dura mater

120: cerebral cortex

130: scalp

140: computer (laptop)

150: computer (PDA)

Claims (3)

In the human body implantable DC electrostimulator system for brain stimulation, A storage battery for supplying power; A circuit member capable of adjusting the polarity and the intensity of the DC power supply, the stimulation time and the period in conjunction with an external remote controller; A ground electrode member grounded under the skull or scalp; A terminal member electrically connected to the epidural or subdural brain electrode; A wire fixing member for fixing and protecting the epidural electrode at the cranial perforation site; Cranium fixing member for fixing the stimulator to the skull; And It is suitable for short-term use and can be easily operated by local anesthesia and small scalp incision. In the human body implantable DC electrostimulator system for brain stimulation, A storage battery for supplying power; A circuit member capable of adjusting the polarity and the intensity of the DC power supply, the stimulation time and the period in conjunction with an external remote controller; A grounding electrode member grounded to the subclavian thoracic subcutaneous region; A terminal member electrically connected to the epidural or subdural brain electrode; A wire fixing member for fixing and protecting the epidural electrode at the cranial perforation site; And Human implantable large-capacity DC electric stimulator for brain stimulation suitable for long-term use. In the human body implantable DC electrostimulator system for brain stimulation, A program for setting the polarity, intensity, stimulation time and period of the direct current electric stimulation; An interface system capable of connecting a computer program and an external stimulus controller; And an external regulator comprising a circuit and an antenna for radio wave communication with the electrical stimulator.

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