TR201708610A2 - VAGUS NERVE STIMULATOR WITH ANTIMICROBIAL PROPERTIES - Google Patents

VAGUS NERVE STIMULATOR WITH ANTIMICROBIAL PROPERTIES Download PDF

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TR201708610A2
TR201708610A2 TR2017/08610A TR201708610A TR201708610A2 TR 201708610 A2 TR201708610 A2 TR 201708610A2 TR 2017/08610 A TR2017/08610 A TR 2017/08610A TR 201708610 A TR201708610 A TR 201708610A TR 201708610 A2 TR201708610 A2 TR 201708610A2
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vagus nerve
antimicrobial
polymeric layer
stimulator
nerve stimulator
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TR2017/08610A
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Turkish (tr)
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Deni̇z Hayati̇
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Hayati Deniz
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Priority to TR2017/08610A priority Critical patent/TR201708610A2/en
Publication of TR201708610A2 publication Critical patent/TR201708610A2/en
Priority to PCT/TR2018/050246 priority patent/WO2019066752A2/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551Spinal or peripheral nerve electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36053Implantable neurostimulators for stimulating central or peripheral nerve system adapted for vagal stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404Biocides, antimicrobial agents, antiseptic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36064Epilepsy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36078Inducing or controlling sleep or relaxation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Vücut içi bölgede (30) konumlandırılan ve daimî olarak konumlandırıldığı bölgede kalarak vagus siniri ve çevre dokularıyla kaynaşan stimülatör bileşenleri (10) bulunduran bir vagus sinir stimülatörü olup özelliği, vücut içi bölgelerde (30) enfeksiyon riskini engellemek üzere bakterilerin (40) biyofilm oluşturmasını önleyecek şekilde vücut içerisinde kalan stimülatör 10 bileşenlerinin (10) tüm dış muhafazasına (11) hiç boşluk kalmayacak şekilde bir tutunma yüzeyi (21) üzerinden kovalent bağlar ile aplike edilmiş bir antimikrobiyal polimerik katman (20) içermesidir. 15 Şekil 1It is a vagus nerve stimulator that is positioned in the intra-body region (30) and contains stimulator components (10) that fuse with the vagus nerve and surrounding tissues by staying in the area where it is permanently located, and its feature is to prevent bacteria (40) from forming biofilms in order to prevent the risk of infection in the intra-body regions (30). It comprises an antimicrobial polymeric layer (20) applied with covalent bonds over an anchoring surface (21) so that no gap is left to the entire outer casing (11) of the stimulator 10 components (10) remaining in the body. 15 Figure 1

Description

TEKNIK ALAN Bulus, nörolojik bazi rahatsizliklarin tedavisinin desteklenmesi amaciyla kullanilan ve operasyon sonrasi vücut içi enfeksiyon olusumunu önleyecek sekilde antimikrobiyal özellik kazandirilmis bir vagus sinir stimülatörü ile ilgilidir. TECHNICAL FIELD The invention is used to support the treatment of some neurological disorders. and in a way to prevent the formation of intra-body infection after the operation. It relates to an antimicrobial vagus nerve stimulator.

Bulus özellikle; epilepsi, panik atak, alzheimer, uyku apnesi rahatsizliklarinin tedavisine yardimci olmak ve obezite tedavisi için kullanilan vagus sinir stimülatörlerinin tüm aksesuar ve bilesenlerine antimikrobiyal özellik kazandirilmasiyla ilgilidir. ÖNCEKI TEKNIK Nöroloji; beyin, beyin sapi, omurilik ve çevresel sinir sistemiyle kaslarin hastaliklarinin ele alindigi bir bilim dalidir. Nörolojik hastaliklar sinir sisteminin çok çesitli ve farkli yerlerinde etki gösterebilmekte ve bireylerde çok çesitli sikayetlerle ortaya çikabilmektedir. Nörolojik hastaliklarda tedavi, hastaliga ve bireye göre uygulanmaktadir. Epilepsi, depresyon, panik atak, alzheimer, uyku apnesi vb. hastaliklarin tedavisinde tedaviye yardimci olmak amaciyla vagus sinir stimülatörleri kullanilmaktadir. The invention especially; epilepsy, panic attack, alzheimer's, sleep apnea vagus nerve used to help treat obesity and to treat obesity antimicrobial properties to all accessories and components of stimulators it's about gaining. PRIOR ART Neurology; brain, brain stem, spinal cord and peripheral nervous system and muscles It is a branch of science that deals with diseases. Neurological diseases of the nervous system It can have an effect in various and different parts of the body and can be associated with a wide variety of complaints in individuals. may arise. Treatment in neurological diseases according to the disease and the individual. is being implemented. Epilepsy, depression, panic attack, alzheimer's, sleep apnea etc. vagus nerve to assist treatment in the treatment of diseases stimulators are used.

Vagus sinir stimülatörlerinin özellikle epilepsi hastalarinda kullanimi epileptik nöbetlerin sikligini ve siddetini azaltmakta ya da sonlandirmaktadir. Bu sebeple kullanimlari gün geçtikçe artmaktadir. Vagus sinir stimülatörleri hastanin vücuduna cerrahi operasyonlar ile yerlestirilmekte ve hastanin vücudunda daimi^ olarak kalmaktadirlar. Bu sebeple vagus sinir stimülatörlerinin vücuda yerlestirilmesinde uygulanan cerrahi operasyonlarda hijyenik çalisma kosullari saglanmali ve ayrica cihazin da sterile edilmis olmasi gerekmektedir. Aksi durumda vücut içerisindeki vagus sinir stimülatörinden kaynaklanan enfeksiyon olusma riski ortaya çikmaktadir. Epilepsi hastaliginda çok miktarda ilaç kullanimi söz konusudur ve bu ilaçlarin kullaniminin birçok yan etkisi mevcuttur. Bu yan etkilerden birisi de kemik iligi baskilanmasi olup bagisiklik sistemini düsürmekte ve vücudu enfeksiyonlara karsi savunmasiz birakmaktadir. Bunlar yaninda epilepsinin görüldügü hastalar genellikle çocuk yastaki hastalardir bu durum hastalarin enfeksiyona yakalanma olasiliklarini arttirmaktadir. The use of vagus nerve stimulators especially in epileptic patients reduces or terminates the frequency and severity of seizures. Therefore their use is increasing day by day. Vagus nerve stimulators are injected into the patient's body. It is placed by surgical operations and permanently in the patient's body. they stay. For this reason, it is necessary to place vagus nerve stimulators in the body. Hygienic working conditions should be provided in surgical operations performed and also The device must also be sterilized. Otherwise, in the body There is a risk of infection from the vagus nerve stimulator. is coming out. There is a large amount of drug use in epilepsy and this The use of drugs has many side effects. One of these side effects is It suppresses the immune system and reduces the body to infections. leaves it defenseless. Besides these, patients with epilepsy they are usually pediatric patients, this is the case of patients getting infection. increases the possibilities.

Vagus sinir stimülatörlerinin elektrotlari vagus sinirini 3 ayri yerden saracak sekilde vücut içerisinde adapte edilmektedir. Cerrahi operasyonun tamamlanmasinin ardindan granülasyon süreci baslamakta ve fibrozis ile yapismalar meydana gelmektedir. Bu durum elektrodun vücuda kaynasmasi anlamina gelmektedir. Electrodes of vagus nerve stimulators are designed to wrap the vagus nerve in 3 different places. adapted in the body. Completion of the surgical operation then the granulation process begins and fibrosis and adhesions occur. is coming. This means that the electrode is fused to the body.

Dolayisiyla bu asamadan sonra meydana gelecek herhangi bir enfeksiyon durumunda elektrodun çikartilmasi zorlasmakta ve hatta çikarma operasyonu sirasinda sinirde kalici hasar meydana gelebilmektedir. Vücuda yerlestirilen cihazlarda, hangi cihaz bileseninin enfekte oldugu bir önem arz etmemekte, tüm cihazin çikarilmasi ve ardindan hastanin enfeksiyon tedavisine alinmasi ve ardindan ikincil bir yerlestirme operasyonu gerekmektedir. Gerçeklestirilen her operasyon hem hastanin hem de hasta yakinlarinin maddi y'onden ve psikolojik yönden olumsuz etkilenmesine sebep olmakta, operasyonlar sonrasindaki toparlanma sürelerini de uzatmaktadir. Therefore, any infection that will occur after this stage In this case, the removal of the electrode becomes difficult and even the removal operation Permanent nerve damage may occur during placed in the body devices, it does not matter which device component is infected, device removal followed by patient treatment for infection and then a secondary insertion operation is required. Each carried out The operation affects both the patient and the patient's relatives financially and psychologically. causes adverse effects on the It also prolongs recovery times.

Sonuç olarak, yukarida bahsedilen tüm sorunlar, ilgili teknik alanda bir yenilik yapmayi zorunlu hale getirmistir. As a result, all the above-mentioned problems are a novelty in the relevant technical field. does not make it mandatory.

BULUSUN KISA AÇIKLAMASI Mevcut bulus yukarida bahsedilen dezavantajlari ortadan kaldirmak ve ilgili teknik alana yeni avantajlar getirmek üzere, metal iyonlari içeren polimerik bir katman uygulanarak antimikrobiyal `özellik kazandirilmis bir vagus sinir stimülatörü ile Bulusun ana amaci, vücut içerisine yerlestirilen tüm bilesenlerinde, enfeksiyon olusumunu ortadan kaldirdigi bir vagus sinir stimülatorü ortaya koymaktir. BRIEF DESCRIPTION OF THE INVENTION The present invention is designed to eliminate the above mentioned disadvantages and a polymeric layer containing metal ions to bring new advantages to the field. with a vagus nerve stimulator with antimicrobial properties by applying The main aim of the invention is to prevent infection in all its components placed in the body. is to reveal a vagus nerve stimulator that eliminates its formation.

Bulusun bir diger amaci, enfeksiyona bagli olarak gerçeklestirilen ikincil cerrahi operasyonlari ortadan kaldiran bir vagus sinir stimülatörü ortaya koymaktir. Another aim of the invention is secondary surgery performed due to infection. is to introduce a vagus nerve stimulator that eliminates operations.

Yukarida bahsedilen ve asagidaki detayli anlatimdan ortaya çikacak tüm amaçlari gerçeklestirmek üzere mevcut bulus, vücut içi bölgede konumlandirilan ve daimi olarak konumlandirildigi bölgede kalarak vagus siniri ve çevre dokulariyla kaynasan stimülatör bilesenleri bulunduran bir vagus sinir stimülatörüdür. Buna göre sözkonusu vagus sinir stimülatörünün özelligi, vücut içi bölgelerde enfeksiyon riskini engellemek üzere bakterilerin biyofilm olusturmasini önleyecek sekilde vücut içerisinde kalan stimülatör bilesenlerinin tüm dis muhafazasina hiç bosluk kalmayacak sekilde bir tutunma yüzeyi üzerinden kovalent baglar ile aplike edilmis bir antimikrobiyal polimerik katman içermesidir. All the above-mentioned purposes that will emerge from the detailed description below. The present invention, in order to realize It stays in the area where it is positioned and connects with the vagus nerve and surrounding tissues. It is a vagus nerve stimulator with fused stimulator components. This According to this, the peculiarity of the vagus nerve stimulator is infection in the intra-body areas. body in a way that prevents bacteria from forming a biofilm to prevent the risk of No gaps in the entire outer casing of the stimulator components remaining inside Applied with covalent bonds over an attachment surface so that it does not remain It contains an antimicrobial polymeric layer.

Bulusun tercih edilen bir yapilanmasi, bahsedilen antimikrobiyal polimerik katmanin, bakterileri hücre parçalanmasi meydana getirerek etkisiz hale getiren antimikrobiyal nano parçaciklar içermesidir. A preferred embodiment of the invention is said antimicrobial polymeric layer, which neutralizes bacteria by causing cell lysis It contains antimicrobial nanoparticles.

Bulusun tercih edilen bir diger yapilanmasi, bahsedilen antimikrobiyal nano parçaciklarin, polimerik katmanin bir difüzyon yüzeyi üzerinden yayilan antimikrobiyal iyonlar içermesidir. Another preferred embodiment of the invention is said antimicrobial nano particles spread over a diffusion surface of the polymeric layer. It contains antimicrobial ions.

Bulusun tercih edilen bir diger yapilanmasi, polimerik katmanda yer alan organik bilesigin halojenlenmis difenil eterler, fenol bilesikleri, halofenoikler ve bisfenolik bilesikler, rezorsinol ve türevleri, benzoik esterler, kuaterner amonyum bilesiklerinden biri olarak seçiliyor olmasidir. Another preferred embodiment of the invention is the organic matter contained in the polymeric layer. compound halogenated diphenyl ethers, phenol compounds, halophenoics and bisphenolic compounds, resorcinol and its derivatives, benzoic esters, quaternary ammonium It is chosen as one of its compounds.

Bulusun tercih edilen bir diger yapilanmasi, polimerik katmanda yer alan anorganik bilesigin zeolitler, NaAI Slikattan biri olarak seçiliyor olmasidir. Another preferred embodiment of the invention is the inorganic layer contained in the polymeric layer. The zeolites of the compound are selected as one of the NaAI Silicate.

SEKILLERIN KISA AÇIKLAMASI Sekil 1'de antimikrobiyal özellik kazandirilmis vagus sinir stimülatör bilesenine iliskin sematik görünüm verilmistir. BRIEF DESCRIPTION OF THE FIGURES Figure 1 shows the vagus nerve stimulator component with antimicrobial properties. A schematic view is given.

Sekil 2'de antimikrobiyal polimerik katmanin bakteri yok etme mekanizmasina iliskin sematik görünüm verilmistir. Figure 2 shows the bactericidal mechanism of the antimicrobial polymeric layer. A schematic view is given.

SEKILLERDE VERILEN REFERANS NUMARALARI Stimülatör Bileseni 11 Dis Muhafaza Antimikrobiyal Polimerik Katman 21 Tutunma Yüzeyi 22 Difüzyon Yüzeyi 23 Antimikrobiyal Nano Parçacik 231 Antimikrobiyal Iyon Vücut Iç Bölgesi 40 Bakteri BULUSUN DETAYLI AÇIKLAMASI Bu detayli açiklamada bulus konusu antimikrobiyal özellik kazandirilmis vagus sinir stimülatörü sadece konunun daha iyi anlasilmasina yönelik hiçbir sinirlayici etki olusturmayacak örneklerle açiklanmaktadir. REFERENCE NUMBERS IN THE FIGURES Stimulator Component 11 Outer Enclosure Antimicrobial Polymeric Layer 21 Grip Surface 22 Diffusion Surface 23 Antimicrobial Nano Particle 231 Antimicrobial Ions Body Inner Region 40 Bacteria DETAILED DESCRIPTION OF THE INVENTION In this detailed explanation, the subject of the invention is the vagus nerve with antimicrobial properties. the stimulator only has no limiting effect on the subject for better understanding. explained with examples.

Vagus sinir stimülatörü, vücut iç bölgesine (30) yerlestirilen aktif bir implanttir ve birden çok bilesenden meydana gelmektedir. Sekil 1'de de bir stimülatör bileseninin (10) detayli bir sematik görünümü verilmistir. Buna göre stimülatör bileseni (10) üzerinde antimikrobiyal polimerik katman (20) yer almaktadir. Bahsedilen antimikrobiyal polimerik katman (20) stimülatör bileseninin (10) dis muhafazasi (11) üzerine kovalent baglarla baglanmis durumdadir. Antimikrobiyal polimerik katman (20) bahsedilen dis muhafaza (11) ile iliskilendirilen bir tutunma yüzeyi (21) ve bir difüzyon yüzeyi (22) içermektedir. Polimerik katman (20) içerisinde antimikrobiyal nano parçaciklar (23) bulunmaktadir. Ayrica difüzyon yüzeyinin (22) üzerinde ve vücudun iç bölgesinde dagilmis durumda antimikrobiyal iyonlar (231) yer almaktadir. The vagus nerve stimulator is an active implant placed in the body interior (30) and consists of multiple components. Figure 1 also shows that a stimulator component (10) a detailed schematic view is given. Accordingly, the stimulator component (10) There is an antimicrobial polymeric layer (20) on it. Said outer casing (11) of antimicrobial polymeric layer (20) stimulator component (10) attached to it by covalent bonds. Antimicrobial polymeric layer (20) a holding surface (21) associated with said outer casing (11) and a it includes a diffusion surface (22). Antimicrobial within the polymeric layer (20) nanoparticles (23). Also above the diffusion surface (22) and there are antimicrobial ions (231) dispersed in the inner part of the body. takes.

Antimikrobiyal polimerik katman (20), stimülatör bileseni (10) üzerinde ince bir film tabakasi halinde bulunmaktadir. Bu film tabakasi sentezlenen polimerin bir çözücü içerinde çözüldükten sonra dis muhafaza (11) üzerine aplike edilmesiyle saglanmaktadir. Polimer katmaninin (10) dis muhafaza (11) üzerinde bosluksuz ve oldukça homojen bir dagilim saglamasi gerekmektedir. Bosluklarin bulundugu durumlarda bakteri (40) kolonilerinin bu bosluklarda çogalarak biyofilm olusturmasi söz konusu olabilmektedir. Polimer katman (20) seçici özellik göstermelidir. Yani bakterileri (40) hizli ve etkin bir sekilde yok ederken kan ve doku hücrelerine minimum derecede zarar vermeli hatta hiç zarar vermemelidir. The antimicrobial polymeric layer (20) is a thin film on the stimulator component (10). exists as a layer. This film layer is a solvent of the synthesized polymer. After dissolving inside, it is applied on the outer casing (11). is provided. Above the outer casing (11) of the polymer layer (10) is a gapless and It should provide a fairly homogeneous distribution. where there are gaps In some cases, bacteria (40) colonies multiply in these spaces and form a biofilm. may occur. The polymer layer (20) should exhibit selective properties. well to blood and tissue cells while rapidly and effectively destroying bacteria (40) It should cause minimal or even no harm.

Antimikrobiyal polimerik katmani (20) olusturan komponentler, bakterilerin (40) üzerlerine yapisarak biyofilm olusmasini önleyecek özellikteki organik ve anorganik bilesikler ile metallerden meydana gelmektedirler. Bu kapsamda organik bilesik olarak; halojenlenmis difenil eterler, fenol bilesikleri, halofenoikler ve bisfenolik bilesikler, rezorsinol ve türevleri, benzoik esterler, kuaterner amonyum bilesikleri kullanilabilmektedir. Anorganik bilesik olarak; zeolitler ve NaAI Slikat kullanilabilmektedir. Metal olarak da gümüs, çinko ya da bakir tercih edilmektedir. Components forming the antimicrobial polymeric layer (20) Organic and inorganic properties that prevent biofilm formation by adhering to them are composed of metals and compounds. In this context, organic compound aspect; halogenated diphenyl ethers, phenol compounds, halophenoics and bisphenolic compounds, resorcinol and its derivatives, benzoic esters, quaternary ammonium compounds can be used. As an inorganic compound; zeolites and NaAI Silicate can be used. Silver, zinc or copper are preferred as metals.

Antimikrobiyal polimerik katmanlarin (20) bakterileri (40) yok etme mekanizmasi Sekil 2'de verilmistir ve çalisma mekanizmasi su sekilde islemektedir; antimikrobiyal polimerik katman (20) + yüklü iken enfeksiyon olusturan bakterilerin (40) yüzeyleri - yüklüdür ve yok etme islevi bu + ve - yüklerin etkilesmesi sonucu meydana gelmektedir. Etkilesmenin saglanmasi için bakterilerin (40) polimerik katman (20) üzerine temas etmesi gerekmektedir. Bu temas ile antimikrobiyal nano parçaciklar (23) bakterilerle (40) etkilesime girmektedirler. Bu etkilesim ile bakterilerin (40) yüzeyinde yer alan fosfolipidlerin de etkisiyle bakterilerin (40) zarlari parçalanmaktadir. Nano parçaciklar (23) bakterilerin (40) hücre çeperlerine baglanma gerçeklestirerek hücre zarinda bosluklar olusturmakta ve proton kanallarinin dengesini bozarak hücre parçalanmasina sebep olmaktadirlar. Mechanism of antimicrobial polymeric layers (20) to destroy bacteria (40) It is given in Figure 2 and the working mechanism works as follows; antimicrobial polymeric layer (20) + loaded with bacteria causing infection (40) surfaces are - charged and their annihilation function is due to the interaction of these + and - charges. is occurring. In order to ensure interaction, the bacteria (40) must be polymerized. layer (20) must be in contact with it. With this contact, antimicrobial nano particles (23) interact with bacteria (40). With this interaction With the effect of phospholipids on the surface of bacteria (40), bacteria (40) membranes are breaking. The nanoparticles (23) are attached to the cell walls of bacteria (40). by binding, it creates spaces in the cell membrane and protons They cause cell fragmentation by disrupting the balance of the channels.

Polimerik katmana (20) temas disinda da nano parçaciklarin (23) difüzyon yüzeyinden (22) vücut iç bölgesine (30) yayilan antimikrobiyal iyonlar (231) da bakterilerin (40) benzer mekanizma ile parçalanmasina katkida bulunmaktadir. Diffusion of nanoparticles (23) outside of contact with the polymeric layer (20) Antimicrobial ions (231) that spread from the surface (22) to the inner part of the body (30) are also contributes to the breakdown of bacteria (40) with a similar mechanism.

Mikroorganizmalar çesitli ortamlara direnç kazanabilmektedirler. Bu durum, mikroorganizma üretmenin gerçeklesmesine sebep olmaktadir. Ozellikle dogal olarak diger mikroorganizmalara göre daha dirençli olan mikroorganizmalar uzun temas süreleri sonucu herhangi bir antimikrobiyal dezenfektana karsi daha kolay direnç kazanabilmektedir. Mikroorganizmalar dezenfektan solüsyonda uzun süre kaldiklarinda antibiyotiklere karsi oldugu gibi, direnç kazanarak canliliklarini koruyabilmekte ve hatta üremelerini sürdürebilmektedirler. Dezenfektan veya antiseptik preparatta bulunan aktif maddenin yeterli miktarda olmamasi ve mikroorganizmanin yasamasina engel olacak konsantrasyonda bulunmamasi durumu da mikroorganizmanin direncini arttirmaktadir. Bu sebeple sadece dezenfektan yeterli gelememektedir. Bulus konusu vagus sinir stimülatörü ile sunulan en büyük avantaj antimikrobiyal polimerik katmanin (20) kendi kendini temizleme özelligi sunarak bakterilerin (40) çogalip yayilmasini engellemektir. Microorganisms can gain resistance to various environments. This situation, causes the growth of microorganisms. especially natural Microorganisms that are more resistant than other microorganisms easier against any antimicrobial disinfectant as a result of contact times can gain resistance. Microorganisms in disinfectant solution for a long time as well as against antibiotics when they remain, they gain resistance and lose their vitality. They can survive and even reproduce. disinfectant or Insufficient amount of active ingredient in the antiseptic preparation and not in a concentration that will prevent the microorganism from living condition increases the resistance of the microorganism. For this reason only disinfectant is not enough. The subject of the invention is the vagus nerve stimulator. The biggest advantage offered is that the antimicrobial polymeric layer (20) is self-contained. It is to prevent the proliferation and spread of bacteria (40) by providing a cleaning feature.

Antimikrobiyal polimerik katman (20) dezenfektan ve deterjanlara karsi dayaniklidir. The antimicrobial polymeric layer (20) is resistant to disinfectants and detergents.

Parlak ve pürüzsüz yüzeyi ile üzerinde toz vb. yabanci maddelerin tutunmasi engellenmektedir. With its shiny and smooth surface, dust etc. adhesion of foreign matter is blocked.

Epilepsi hastaligin tedavisi basta olmak üzere çesitli nörolojik hastaliklarin tedavisine ek bir tedavi cihazi olarak vagus sinir stimülatörleri kullanilmaktadir. Söz konusu bulus ile stimülatörlerin tüm bilesenlerinin antimikrobiyal polimerik katman (20) ile kaplanmasi sayesinde de vücudun iç bölgesinde (30) stimülatörden kaynaklanan enfeksiyonlarin ortadan kaldirilmasi saglanmaktadir. Böylelikle özellikle operasyon sonrasi süreçte enfeksiyon olusumu riski giderilmekte, enfeksiyona bagli gerçeklestirilecek ikincil operasyonlar ve enfeksiyon tedavilerinin önüne geçilmektedir. Treatment of various neurological diseases, especially epilepsy Vagus nerve stimulators are used as an additional treatment device to the treatment. Promise With the subject invention, antimicrobial polymeric layer of all components of stimulators (20), thanks to its coating, it can be removed from the stimulator (30) in the inner part of the body. infections are eliminated. Thus, especially in the post-operative period, the risk of infection is eliminated, secondary operations and infection treatments to be performed due to infection is prevented.

Bulusun koruma kapsami ekte verilen istemlerde belirtilmis olup kesinlikle bu detayli anlatimda örnekleme amaciyla anlatilanlarla sinirli tutulamaz. Zira teknikte uzman bir kisinin, bulusun ana temasindan ayrilmadan yukarida anlatilanlar isiginda benzer yapilanmalar ortaya koyabilecegi açiktir. The scope of protection of the invention is stated in the appended claims and it is absolutely detailed explanation cannot be limited to what is told for the purpose of illustration. Because in technique what has been described above by a specialist without departing from the main theme of the invention It is clear that similar structuring can occur in the light of this.

Claims (1)

ISTEMLER . Vücut içi bölgede (30) konumlandirilan ve daimî olarak konumlandirildigi bölgede kalarak vagus siniri ve çevre dokulariyla kaynasan stimülatör bilesenleri (10) bulunduran bir vagus sinir stimülatörü olup özelligi, vücut içi bölgelerde (30) enfeksiyon riskini engellemek üzere bakterilerin (40) biyofilm olusturmasini önleyecek sekilde vücut içerisinde kalan stimülatör bilesenlerinin (10) tüm dis muhafazasina (11) hiç bosluk kalmayacak sekilde bir tutunma yüzeyi (21) üzerinden kovalent baglar ile aplike edilmis bir antimikrobiyal polimerik katman (20) içermesidir. . Istem 1'e göre bir vagus sinir stimülatörü olup özelligi, bahsedilen antimikrobiyal polimerik katmanin (20), hücre parçalanmasi olusturarak bakterileri (40) etkisiz hale getiren antimikrobiyal nano parçaciklar (23) içermesidir. . Istem 1 veya 2”ye göre bir vagus sinir stimülatörü olup özelligi, bahsedilen antimikrobiyal nano parçaciklarin (23), polimerik katmanin (20) bir difüzyon yüzeyi (22) üzerinden vücut içi bölgeye (30) yayilan antimikrobiyal iyonlar (231) içermesidir. . Istem 17e göre bir vagus sinir stimülatörü olup özelligi, polimerik katmanda (20) yer alan organik bilesigin halojenlenmis difenil eterler, fenol bilesikleri, halofenoikler ve bisfenolik bilesikler, rezorsinol ve türevleri, benzoik esterler, kuaterner amonyum bilesiklerinden biri olarak seçiliyor olmasidir. . Istem 1'e göre bir vagus sinir stimülatörü olup özelligi, polimerik katmanda (20) yer alan anorganik bilesigin zeolitler, NaAI Slikattan biri olarak seçiliyor olmasidir.REQUESTS . It is a vagus nerve stimulator that contains stimulator components (10) that are positioned in the intrabody (30) and stay in the region where it is permanently positioned, and fuse with the vagus nerve and surrounding tissues. The stimulator components (10) remaining in the body contain an antimicrobial polymeric layer (20) applied with covalent bonds over an attachment surface (21) on the entire outer casing (11) without leaving any gaps. . It is a vagus nerve stimulator according to claim 1, characterized in that said antimicrobial polymeric layer (20) contains antimicrobial nanoparticles (23) that inactivate bacteria (40) by causing cell fragmentation. . It is a vagus nerve stimulator according to claim 1 or 2, characterized in that said antimicrobial nanoparticles (23) contain antimicrobial ions (231) that diffuse into the intrabody region (30) over a diffusion surface (22) of the polymeric layer (20). . It is a vagus nerve stimulator according to claim 17, and its feature is that the organic compound in the polymeric layer (20) is selected as one of the halogenated diphenyl ethers, phenol compounds, halophenoics and bisphenolic compounds, resorcinol and its derivatives, benzoic esters, quaternary ammonium compounds. . It is a vagus nerve stimulator according to claim 1, characterized in that the inorganic compound in the polymeric layer (20) is selected as one of the zeolites, NaAI Silicate.
TR2017/08610A 2017-06-12 2017-06-12 VAGUS NERVE STIMULATOR WITH ANTIMICROBIAL PROPERTIES TR201708610A2 (en)

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US8309117B2 (en) * 2002-12-19 2012-11-13 Novartis, Ag Method for making medical devices having antimicrobial coatings thereon
US20040186528A1 (en) * 2003-03-20 2004-09-23 Medtronic, Inc. Subcutaneous implantable medical devices with anti-microbial agents for chronic release
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