WO2019070211A2 - An electrode embodiment for vagus nerve stimulator - Google Patents

Abstract

The present invention is an electrode (10) comprising clamps embodied side by side on a body (23) comprising an adjustable grabbing arm (234) and a fixed grabbing arm (232) defining a nerve channel (237) where the nerve passes, and conductor components placed in a manner facing the nerve channel (237) in said clamps; characterized by comprising an adjustment gap (233) embodied at the end of the fixed grabbing arm (232) and through which the adjustable grabbing arm (234) passes in a manner changing the length of the section forming the nerve channel (237) of said adjustable grabbing arm (234) in order to provide adjustment of the dimension of the nerve channel (237) depending on the changing diameter of the nerve, and adjustment barriers (235) embodied on the adjustable grabbing arm (234) and based on said adjustment gap (233) in order to provide fixing of the adjustable grabbing arm (234) at the desired position.

Description

AN ELECTRODE EMBODIMENT FOR VAGUS NERVE STIMULATOR TECHNICAL FIELD

The present invention relates to an electrode embodiment developed for a vagus nerve stimulator and completely implanted into the body in order to be used particularly in the treatment of neurologic diseases.

PRIOR ART

Neurology is the science branch where brain, brain stem, vertebra and peripheral nerve system and muscle diseases are worked on. Neurologic diseases may show effect on very different and various locations of the nerve system and they may occur with various complaints in the patients. Treatment of neurologic diseases is applied depending on the disease and the patient. Vagus nerve stimulators are used for supporting the treatment of diseases like epilepsy, depression, panic attack, Alzheimer, sleep apnea, etc. The greatest characteristic expected from vagus nerve stimulators used in epilepsy disease is to minimize the frequency and intensity of epileptic seizures. Epileptic seizures break the instantaneous immune resistance of the patient and moreover, they lead to development of complications in the patient depending on the intensity of the seizure.

By means of vagus nerve stimulators, the nerves, which lost their functions, are stimulated and they are made functional again by means of nerve stimulating components placed into the body. In order to realize these functions, an electrode is used which is placed to the neck region in connection with a signal generator. Electrical signals used in the stimulators are completely compliant to the natural activity of the human neuro-physiology. By means of the electrodes, these electrical signals are transmitted to the nerves.

The electrodes used in vagus nerve stimulators are helical electrodes. During operation, positioning of electrodes in the wrong position necessitates changing of the position thereof. In the opposite case, the efficiency of signal stimulation decreases. Moreover, the electrodes may have to be removed and renewed. In cases of position changes, renewing, etc, the removal of helical electrodes from the nerve is a substantially difficult procedure and damage occurrence risk in the nerve is substantially high. In order to prevent damage occurrence, the electrodes are cut and left in the patient. Besides, adaptation of the electrodes necessitates an application area depending on the training process and personal experience of the surgeon. Thus, there is a need for adaptation of the electrodes by surgeons who are expert in their fields. Because of these disadvantages, clamp electrodes are used instead of helical electrodes. The electrode embodiment described in the application with number US2014188202 can be shown as example to clamp electrodes. In said application, an embodiment is disclosed which encircles the nerve from one end and which is formed by being encircled around itself from the other end. The adaptation of the electrode to the nerve can be realized by means of a relatively simpler operation and removal of the electrode prevents damage occurrence in the nerve when compared with the helical electrodes. A similar application has been given in the application with number US2010298920. In this application, an elastic electrode is encircled onto the nerve. These electrode embodiments have an important disadvantage despite its advantages. The diameters of the nerves change depending on the age of the patient. Therefore, electrodes which are compliant with different nerve diameters shall be used. In said inventions, since the electrode is wrapped onto itself, the diameter obtained finally can be reduced to a specific diameter and the usage for smaller diameters is not possible. As a result, because of all of the abovementioned problems, an improvement is required in the related technical field.

BRIEF DESCRIPTION OF THE INVENTION The present invention relates to vagus nerve stimulator electrode developed for efficient and safe stimulation in suitable nerve regions, for eliminating the above mentioned disadvantages and for bringing new advantages to the related technical field.

The main object of the present invention is to provide an electrode embodiment which can be removed and fixed without giving damage to the nerve.

Another object of the present invention is to provide an electrode embodiment which is suitable to be used for different nerve diameters. Another object of the present invention is to provide an electrode embodiment where the usage of said electrode embodiment does not need a training prior to surgical operation and which can be applied by means of a standard operation step. In order to realize all of the abovementioned objects and the objects which are to be deducted from the detailed description below, the present invention is an electrode comprising clamps embodied side by side on a body comprising an adjustable grabbing arm and a fixed grabbing arm defining a nerve channel where the nerve passes, and conductor components placed in a manner facing the nerve channel in said clamps. Accordingly, said electrode is characterized by comprising an adjustment gap embodied at the end of the fixed grabbing arm and through which the adjustable grabbing arm passes in a manner changing the length of the section forming the nerve channel of said adjustable grabbing arm in order to provide adjustment of the dimension of the nerve channel depending on the changing diameter of the nerve, and adjustment barriers embodied on the adjustable grabbing arm and based on said adjustment gap in order to provide fixing of the adjustable grabbing arm at the desired position.

In a preferred embodiment of the present invention, a safety barrier is embodied after the adjustment barriers on said adjustable grabbing arm.

In another preferred embodiment of the present invention, at least one negative clamp is embodied in a manner extending downwardly from said body and a negative conductor component is positioned at the grabbing arms in said negative clamp.

In another preferred embodiment of the present invention, at least one positive clamp is embodied in a manner extending downwardly from said body and a positive conductor component is positioned at the grabbing arms in said positive clamp. In another preferred embodiment of the present invention, a negative conductor cable, which transmits signal to said negative conductor component, extends inside the body.

In another preferred embodiment of the present invention, a positive conductor cable, which transmits signal to said positive conductor component, extends inside the body.

In another preferred embodiment of the present invention, at least one of said clamps is a fixing clamp.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is the general view of the vagus nerve stimulator. Figure 2 is the general view of the electrode embodiment. Figure 3 is another general view of the electrode. Figure 4 is the lateral perspective view of the electrode. Figure 5 is the detailed view of the electrode. REFERENCE NUMBERS

10 Vagus Nerve Stimulator

1 1 Signal Generator

1 1 1 Cover

1 12 Cable Housing

1 13 Upper Seaming Bore

1 14 Lateral Seaming Bore

20 Electrode

21 Connector

22 Cable Tube

221 Negative Conductor Cable

222 Positive Conductor Cable

23 Body

231 Channel

232 Fixed Grabbing Arm

233 Adjustment Gap

234 Adjustable Grabbing Arm

235 Adjustment Barrier

236 Safety Barrier

237 Nerve Channel

24 Fixing Clamp

25 Negative Clamp

251 Negative Conductor Component 26 Positive Clamp

261 Positive Conductor Component DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the subject matter electrode (20) is explained with references to examples without forming any restrictive effect only in order to make the subject more understandable.

With reference to Figure 1 , the vagus nerve stimulator (10), where the general view of the section implanted into the body is given, comprises an electrode (20) adapted to the vagus nerve and a signal generator (1 1 ) which transmits signal to said electrode (20) and adapted by being seamed to the tissues inside the body. The signal generator (1 1 ) is connected to an external charging device outside the body and to a magnetic wrist-strap. A cover (1 1 1 ) is provided on the signal generator (1 1 ) and there is a cable housing (1 12) at one end of said cover (1 1 1 ). Through said cable housing (1 12), the signal generator (1 1 ) is connected to the electrode (20). The adaptation of the signal generator (1 1 ) onto the tissues is realized through an upper seaming bore (1 13) and a lateral seaming bore (1 14) embodied on the signal generator (1 1 ).

The electrode (20) comprises a connector (21 ) placed to the cable housing (1 12), a cable tube (22) placed at the continuation of said connector (21 ) and a body (23) embodied at the continuation of said cable tube (22). On said body (23), there are three clamps embodied side by side such that there is a fixing clamp (24), a negative clamp (25) and a positive clamp (26). The distance between the negative clamp (25) and the positive clamp (26) is 5-6 mm. A negative conductor cable (221 ) and a positive conductor cable (222), coming through the signal generator (1 1 ), extend inside the cable tube (22). Said negative conductor cable (221 ) extends to the negative clamp (25) and it is connected to a negative conductor component (251 ) provided in the negative clamp (25). Said positive conductor cable (222) extends to the positive clamp (26) and it is connected to a positive conductor component (261 ) provided in the positive clamp (26). All body (23) components forming the electrode (10) embodiment are made of silicon and they do not comprise any conductor material. The body (23) is a single-piece embodiment which does not comprise connection elements and said clamps are embodied in a manner extending downwardly from the body. The body (23) comprises a channel (231 ) and a fixed grabbing arm (232) forming the clamps which are the same of each other and embodied in a manner extending downwardly of said channel (231 ) and an adjustable grabbing arm (234) embodied at the opposite of said fixed grabbing arm (232). There is an adjustment gap (233) embodied at the end of said fixed grabbing arm (232) and said adjustable grabbing arm (234) is passed through said adjustment gap (233). Two adjustment barriers (235) are provided side by side on the adjustable grabbing arm (234) and a safety barrier (236) is embodied at the continuation of said adjustment barriers (235). Fixation of the adjustable grabbing arm (234) in the position where it is placed in the adjustment gap (233) is realized by means of delimiting the adjustable grabbing arm (234) by said adjustment barriers (235). Thanks to passing of the adjustable grabbing arm (234) through the adjustment gap (233) and thanks to connecting said adjustable grabbing arm (234) to the fixed grabbing arm (232), a nerve channel (237) is defined between the fixed grabbing arm (232) and the adjustable grabbing arm (234). The dimension of said nerve channel (237) can be changed through the adjustment barriers (235) where the adjustment gap (233) is connected.

After adaptation of the signal generator (1 1 ) into the body through said upper seaming bore (1 13) and the lateral seaming bore (1 14), the electrode (20) is adapted to the nerve. In this direction, first of all, the nerve is grabbed by the fixing clamp (24). Afterwards, the negative clamp (25) and the positive clamp (26) grab the nerve. While the fixing clamp (24) provides fixing of the electrode (10) embodiment to the nerve, the negative clamp (25) and the positive clamp (26) provide signal transmission to the nerve. Holding of the vagus nerve is provided by means of extending of clamps, provided side by side, inside said nerve channels (237). Grabbing of the nerve by the clamps is provided by means of passing of the fixed grabbing arm (232) through the adjustment gap (233) such that the adjustable grabbing arm (234) encircles the nerve. By means of the adjustment barriers (235) selected according to the diameter of the nerve, the adjustable grabbing arm (234) is fixed onto the fixed grabbing arm (232). During or after the surgical operation, said safety barriers (236) prevent opening of the adjustable grabbing arm (234) against a possible sliding problem which may occur in the electrode (20) and said safety barriers (236) prevent damage occurrence in the nerve. Afterwards, the nerve, grabbed by the clamps, transmits signal from the signal generator (1 1 ) onto the negative conductor component (251 ) through negative conductor cable (221 ) and transmits signal from the signal generator (1 1 ) onto the positive conductor component (261 ) through the positive conductor cable (222). The negative conductor component (251 ) and the positive conductor component (261 ) extend on the inner surfaces of the fixed grabbing arm (232) and the adjustable grabbing arm (234) and they provide obtaining of a signal on the region where the nerve is encircled. Thus, as the signal, coming from the signal generator (1 1 ), is transmitted to the nerve, nerve stimulation is realized. The electrode (10) can be applied in an independent manner from the nerve dimension (diameter) thanks to the structure of clamps. Thus, the electrode (10) can easily provide holding to the nerve in patients with any age. Moreover, while the negative conductor component (251 ) and the positive conductor component (261 ) contact vagus nerve by means of its curved structure, it encircles the nerve at the same time. Thus, signal transmission can be provided to the nerves in a more efficient manner. This encircling effect provided in the electrode (20) also prevents nerve damages which may occur during implantation. Moreover, thanks to the flexible structures of fixed grabbing arm (232) and the adjustable grabbing arm (233), adaptation onto the nerve and removal from the nerve can be realized easily by every surgeon.

The protection scope of the present invention is set forth in the annexed Claims and cannot be restricted to the illustrative disclosures given above, under the detailed description. It is because a person skilled in the relevant art can obviously produce similar embodiments under the light of the foregoing disclosures, without departing from the main principles of the present invention.

Claims

An electrode (10) comprising clamps embodied side by side on a body (23) comprising an adjustable grabbing arm (234) and a fixed grabbing arm (232) defining a nerve channel (237) where the nerve passes, and conductor components placed in a manner facing the nerve channel (237) in said clamps; characterized by comprising an adjustment gap (233) embodied at the end of the fixed grabbing arm (232) and through which the adjustable grabbing arm (234) passes in a manner changing the length of the section forming the nerve channel (237) of said adjustable grabbing arm (234) in order to provide adjustment of the dimension of the nerve channel (237) depending on the changing diameter of the nerve, and adjustment barriers (235) embodied on the adjustable grabbing arm (234) and based on said adjustment gap (233) in order to provide fixing of the adjustable grabbing arm (234) at the desired position.

An electrode (10) according to claim 1 , wherein a safety barrier (236) is embodied after the adjustment barriers (235) on said adjustable grabbing arm (234).

An electrode (10) according to claim 1 , wherein at least one negative clamp (25) is embodied in a manner extending downwardly from said body (23) and a negative conductor component (251 ) is positioned at the grabbing arms in said negative clamp

(25) .

An electrode (10) according to claim 1 , wherein at least one positive clamp (26) is embodied in a manner extending downwardly from said body and a positive conductor component (261 ) is positioned at the grabbing arms in said positive clamp

(26) .

An electrode (10) according to claim 1 or 3, wherein a negative conductor cable (221 ), which transmits signal to said negative conductor component (251 ), extends inside the body (23).

6. An electrode (10) according to claim 1 or 4, wherein a positive conductor cable (222), which transmits signal to said positive conductor component (261 ), extends inside the body (23).

7. An electrode (10) according to claim 1 , wherein at least one of said clamps is a fixing clamp (24).