The present invention relates to a vagus nerve stimulator used for supporting the treatment of some neurologic diseases and provided with antimicrobial characteristic in a manner preventing infection formation in the body after surgical operation.

The present invention relates to providing antimicrobial characteristic to all accessories and components of vagus nerve stimulators used for supporting the treatment of diseases like epilepsy, depression, panic attack, Alzheimer, sleep apnea and for supporting obesity treatment.

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 in 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 use of vagus nerve stimulators particularly in epilepsy diseases decreases or ends the frequency and intensity of epileptic seizures. Therefore, their uses increase day by day. Vagus nerve stimulators are placed to the body of the patient by means of surgical operations and they stay in a permanent manner in the body of the patient. Therefore, in the surgical operations applied in placing of the vagus nerve stimulators to the body, hygienic operation conditions shall be provided and moreover, the stimulator shall also be sterilized. In the opposite case, infection formation risk occurs, which results from vagus nerve stimulator inside the body. In epilepsy disease, the patient shall use big number of drugs and these drugs have many side effects. One of these side effects is the bone marrow suppression and this leads to weakening of the immunity system and makes the body prone to infections. Moreover, the patients where epilepsy is observed are generally child patients and this increases the risk of infection of the patients. The electrodes of vagus nerve stimulators are adapted into the body in a manner encircling the vagus nerve from 3 separate locations. After the surgical operation is completed, granulation process begins and adhesions occur by means of fibrosis. This means incorporation of the electrode to the body. Thus, in case of any infection which occurs after this step, removal of the electrode becomes difficult and permanent damage may occur in the nerve even during the removal of the electrode. In the devices placed to the body, it is not important which device component is infected, and the whole device shall be removed and afterwards, the patient shall be subjected to infection treatment and afterwards, a secondary placement operation is needed. Each surgery realized affects the patients and the patients' relatives in an unfavorable manner in terms of financial and physiologic terms and the recovery durations after surgeries also increase.

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 a vagus nerve stimulator provided with antimicrobial characteristic by means of applying a polymeric layer comprising metal ions, 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 a vagus nerve stimulator where infection formation is eliminated in all components placed into the body.

Another object of the present invention is to provide a vagus nerve stimulator which eliminates the secondary surgical operations realized depending on infection.

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 a vagus nerve stimulator positioned in the region inside the body and which stays in the region it is placed in a permanent manner and having stimulator components which incorporate with the vagus nerve and the peripheral tissues. Accordingly, said vagus nerve stimulator is characterized by comprising an antimicrobial polymeric layer applied by means of covalent bonds, such that no gap remains, through a holding surface to the whole outer casing of the stimulator components which remain inside the body in a manner preventing formation of bio-film by the bacteria in order to prevent infection risk in the regions inside the body. In a preferred embodiment of the present invention, said antimicrobial polymeric layer comprises said antimicrobial nano-particles which provide cell fragmentation and which inactivate bacteria. In another preferred embodiment of the present invention, said antimicrobial nano-particles comprise antimicrobial ions which spread to the body inner region through a diffusion surface of the polymeric layer.

In another preferred embodiment of the present invention, the organic compound provided at the polymeric layer is selected as one of halogenated diphenyl ethers, phenol compounds, halophenoics and bisphenolic compounds, resorcinol and derivatives, benzoic esters, quaternary ammonium compounds.

In another preferred embodiment of the present invention, the anorganic compound provided at the polymeric layer is selected as one of zeolites, NaAI silicate.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is the schematic view of the vagus nerve stimulator component with antimicrobial characteristic.

Figure 2 is the schematic view of the bacteria killing mechanism of the antimicrobial polymeric layer. REFERENCE NUMBERS

10 Stimulator Component

1 1 Outer Casing

20 Antimicrobial Polymeric Layer

21 Holding Surface

22 Diffusion Surface

23 Antimicrobial Nano Particle

231 Antimicrobial Ion

30 Body Inner Region

40 Bacteria DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the subject matter vagus nerve stimulator with antimicrobial characteristic is explained with references to examples without forming any restrictive effect only in order to make the subject more understandable.

Vagus nerve stimulator is an active implant placed to the inner region (30) of the body and comprises pluralities of components. In Figure 1 , a detailed schematic view of a stimulator component (10) is given. Accordingly, the antimicrobial polymeric layer (20) is provided on the stimulator component (10). Said antimicrobial polymeric layer (20) is bonded by means of covalent bonds onto the outer casing (1 1 ) of the stimulator component (10). The antimicrobial polymeric layer (20) comprises a holding surface (21 ) connected to said outer casing (1 1 ) and a diffusion surface (22). There are antimicrobial nano-particles (23) inside the polymeric layer (20). Moreover, there are antimicrobial ions (231 ) on the diffusion surface (22) and on the inner region of the body in a distributed manner.

The antimicrobial polymeric layer (20) is provided in the form of a thin film on the stimulator component (10). This film layer is provided by means of applying the synthesized polymer onto the outer casing (1 1 ) after the polymer is dissolved in a solvent. The polymer layer (10) shall be distributed on the outer casing (1 1 ) in a non-gapped and substantially homogeneous manner. In cases where there are gaps, the bacteria (40) colonies may augment in these gaps and may form bio-film. The polymer layer (20) shall show selective characteristic. In other words, while the polymer layer (20) eliminates bacteria (40) in a rapid and effective manner, it shall give minimum damage to the blood and tissue cells, and even, it shall give no damage to the blood and tissue cells.

The components, forming the antimicrobial polymeric layer (20), comprise metals and organic and anorganic compounds which adhere onto the bacteria (40) and which prevent bio-film formation. Within this scope, as organic compounds, halogenated diphenyl ethers, phenol compounds, halophenoics and bisphenolic compounds, resorcinol and derivatives, benzoic esters, quaternary ammonium compounds can be used. As anorganic compounds, zeolites and NaAI silicate can be used. As metal; silver, zinc or copper is preferred.

The elimination mechanism of the bacteria (40) by the antimicrobial polymeric layers (20) is given in Figure 2 and the operation mechanism operates as follows; while the antimicrobial polymeric layer (20) is + charged, the surfaces of the bacteria (40) forming infection are - charged and this elimination function occurs as a result of interaction of these + and - charges. For providing the interaction, the bacteria shall contact the polymeric layer (20). By means of this contact, the antimicrobial nano particles (23) interact with the bacteria (40). By means of this interaction, the membranes of the bacteria (40) are fragmented as a result of the effect of the phospholipids existing on the surface of the bacteria (40). Nano-particles (23) bind to the cell walls of the bacteria (40) and they form gaps at the cell membrane and they deteriorate the balance of the proton channels and they lead to cell fragmentation. Except contact to the polymeric layer (20), the antimicrobial ions (231 ) spreading to the body inner region (30) from the diffusion surface (22) of the nano-particles (23) contribute to fragmentation of the bacteria (40) by means of a similar mechanism.

Microorganisms can gain resistance against various media. This leads to production of microorganism. Particularly the microorganisms, which are naturally more resistant when compared with other microorganisms, can gain resistance more easily against any antimicrobial disinfectant as a result of long contact durations. When the microorganisms stay for long duration in the disinfectant solution, they may gain resistance as in the antibiotics and they may stay vital and even they may continue to reproduce. If the active substance existing in the disinfectant or in the antiseptic preparation is not at a sufficient amount and if the active substance existing in the disinfectant or in the antiseptic preparation is not at a concentration in a manner preventing living of the microorganism, the resistance of the microorganism increases. Therefore, only disinfectant is not sufficient. The greatest advantage presented by the subject matter vagus nerve stimulator is that the antimicrobial polymeric layer (20) can clean itself automatically and it prevents reproduction and spreading of the bacteria (40). The antimicrobial polymeric layer (20) is resistant against the disinfectant and detergents. Thanks to its brilliant and smooth surface, holding of foreign substances like dust, etc. is prevented.

Vagus nerve stimulators are used as a treatment device which is additional to the treatment of various neurologic diseases, essentially treatment of epilepsy. By means of said invention, since all components of stimulators are coated by antimicrobial polymeric later (20), the infections in the body inner region (30) which result from stimulators are eliminated. Thus, particularly in the process after surgical operation, infection formation risk is eliminated and the secondary surgeries which may occur due to infection are eliminated, and the infection treatments are eliminated. 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.