TR201723325A2

TR201723325A2 - CATHETER ASSEMBLY PROVIDING PERCUTANEOUS THERAPY IN NATIVE DEGENERATIVE AORTIC DOLUTION

Info

Publication number: TR201723325A2
Application number: TR2017/23325A
Authority: TR
Inventors: Tezcan Erdem; Olcay Ayhan
Original assignee: T C Istanbul Aydin Ueniversitesi
Priority date: 2017-12-30
Filing date: 2017-12-30
Publication date: 2018-03-21

Abstract

Buluş özellikle, dejeneratif ve kalsifik aort kapak (4) hastalıklarında aort kapakta (4) biriken kalsifikasyonlar sebebiyle kapak yapısının bozularak daralmasını tedavi etmek amacıyla kullanılan nativ dejeneratif aort darlığında perkütan tedavi sağlayan kateter tertibatı (A) ile ilgilidir. (Şekil 1)In particular, the invention relates to catheter assembly (A) providing percutaneous treatment of native degenerative aortic stenosis used to treat deterioration and narrowing of the valve structure due to calcifications accumulated in the aortic valve (4) in degenerative and calcific aortic valve (4) diseases. (Figure 1)

Description

TARIFNAME NATIV DEJENERATIF AORT DARLIGINDA PERKÜTAN TEDAVI SAGLAYAN KATETER TERTIBATI Teknik Alan Bulus, kalsifik aort darligi olan hastada TAVI öncesi kalsifikasyonu azaltmak veya nativ kapagi sadece dekalsifye etmek için kullanilan kateter tertibati ile ilgilidir. DESCRIPTION PROVIDING PERCUTANEOUS THERAPY IN NATIV DEGENERATIVE AORTIC STRENGTH CATHETER ASSEMBLY Technical Area The invention is aimed at reducing calcification before TAVI in a patient with calcific aortic stenosis or for native treatment. pertains to the catheter assembly used to decalcify the cap only.

Bulus özellikle, dejeneratif ve kalsifik aort kapak hastaliklarinda aort kapakta biriken kalsifikasyonlar sebebiyle kapak yapisinin bozularak daralmasini tedavi etmek amaciyla kullanilan nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati ile ilgilidir. The invention is particularly useful in degenerative and calcific aortic valve diseases that accumulate in the aortic valve. to treat the narrowing of the valve structure due to calcifications Catheter providing percutaneous treatment in native degenerative aortic stenosis used for the purpose of relates to the device.

Bulusun Altyapisi Dejeneratif ve kalsifik aort kapak hastaliginda aort kapakta kalsifikasyonlar birikir ve kapak yapisi bozularak daralma ve kaçaklara neden olur. Aort darligi denen bu durumda hastalarda nefes darligi, anginal yakinmalar, kalp yetersizligi, bayilmalar ve ileri asamada ölüm görülür. Aort darligi genellikle ileri yaslarda, kronik böbrek yetersizligi hastalarinda görülür fakat biküspit aort kapak hastaligi gibi dogustan gelen hastaliklarda, kronik böbrek yetersizligi ve romatizmal kalp kapak hastaliginda daha erken yaslarda gözlenebilir. Invention Background In degenerative and calcific aortic valve disease, calcifications accumulate in the aortic valve and The valve structure deteriorates, causing shrinkage and leaks. This is called aortic stenosis. in patients with shortness of breath, angina, heart failure, fainting and death occurs in the advanced stage. Aortic stenosis is usually in advanced age, chronic kidney insufficiency patients, but congenital diseases such as bicuspid aortic valve disease diseases, chronic kidney failure and rheumatic heart valve disease. can be observed at an early age.

Aort darliginin tanisi hastanin muayenesinde kalpte duyulan üfürüm, ekokardiyografi veya anjiyografide dogrudan transvalvüler basinç gradyentleri ölçülerek konabilir. Su anda aortik dejenerasyonu önleyecek ve geriletecek etkili bir tedavi yoktur ve darlik ilerlediginde aortik kapagin açik cerrahi ile degistirilmesi, perkütan olarak anjiyografik yöntemle yeni kapak takilmasi (Transarterial aortic valve replacement-TAVI) veya aortik valvüloplasti islemi gerekmektedir. Prostetik kapaklarin gelismesinden sonra kapak replasmani standart tedavi haline geldi. Protez kapaklar etkili bir tedavi yöntemi olmakla birlikte uzun dönem antikoagülasyon ihtiyaci, yüksek transvalvüler gradyentler, endokardit riski, ani ve katastrofik olarak mekanik arizalanma gibi riskleri de beraberinde getirmektedir. Diagnosis of aortic stenosis, murmur heard in the heart on examination of the patient, echocardiography or by measuring transvalvular pressure gradients directly on angiography. This Currently, there is no effective treatment to prevent and regress aortic degeneration and stenosis. When it progresses, replacement of the aortic valve with open surgery, percutaneous angiographic new valve replacement (Transarterial aortic valve replacement-TAVI) or aortic valvuloplasty is required. After the development of prosthetic valves valve replacement has become the standard of care. Prosthetic valves are an effective treatment method However, the need for long-term anticoagulation, high transvalvular gradients, risk of endocarditis, sudden and catastrophic mechanical failure. brings with it.

Aortik valvüloplastide balon ile aort kapak genisletilip hastada geçici bir rahatlama saglanabilmektedir. Aortik valvüloplasti sonrasi 6-12 ay içerisinde kapakta tekrar daralma gözlenmektedir. Bu nedenle valvüloplasti aort kapak cerrahisi veya TAVI islemi için uygun olmayan hastalarda geçici bir tedavi yöntemidir. In aortic valvuloplasty, the aortic valve is widened with a balloon and the patient is temporarily relieved. can be provided. Re-valve within 6-12 months after aortic valvuloplasty contraction is observed. Therefore, valvuloplasty aortic valve surgery or TAVI It is a temporary treatment method in patients who are not suitable for the procedure.

Kalp disi cerrahi gerektiren hastalarda, aortik kapak replasmanina köprüleme olarak da aortik valvüloplasti yapilip geçici bir iyilesme saglanabilir. Son dönemde TAVI ile nitinol frame üzerine konmus kendinden genisleyen veya kobalt krom üzerine konmus balonla genisletilebilen aort kapaklar ile kapak replasmani yapilmaya baslanmistir. As a bridging to aortic valve replacement in patients requiring non-cardiac surgery In addition, aortic valvuloplasty can be performed and a temporary improvement can be achieved. Recently, with TAVI self-expanding mounted on nitinol frame or mounted on cobalt chrome Valve replacement with balloon-expandable aortic valves has begun.

TAVI kapak replasmani sirasinda da yogun kalsifikasyon kapakta kaçaga neden olabilmektedir. Bu nedenle kapaktaki kalsiyum miktarini azaltmak önem kazanmaktadir. During TAVI valve replacement, dense calcification can also cause valve leakage. can happen. Therefore, it is important to reduce the amount of calcium in the lid. is winning.

SJ Worley ve A Hartmann kalsifik aortlardan alinan küspislerdeki kalsifikasyonlari ve hastada da cerrahi sirasinda aort kapaktaki kalsifikasyonlari mobil Iitotriptör ile temizlemislerdir. Bu çalismalarda elektromanyetik olarak indüklenmis sok dalgalari kullanilmistir. Aort kapak darliginda ciddi darlik ve kalsifikasyonu tedavi etmek için bir çekirdek ve etrafinda sivi ile sisirilen balon tarif edilmistir. Sok dalgalari sivi ile dolu balon üzerinden aort kapakçiklarina iletilip kalsifikasyonlari kirmakta ve ortadan kaldirmaktadir. SJ Worley and A Hartmann calcifications and calcifications in cusps from calcific aortas. In the patient, calcifications in the aortic valve were detected with a mobile Iitotripter during surgery. they cleaned. In these studies, electromagnetically induced shock waves used. To treat severe stenosis and calcification in aortic valve stenosis A core and a liquid-inflated balloon around it are described. Shock waves filled with liquid It is transmitted to the aortic valves over the balloon, breaking the calcifications and eliminating them. removes.

Kapaklarin ultrasonik olarak dekalsifikasyonu ilk olarak 1972 yilinda Brown ve Davies tarafindan yapilmistir. Ikili, ultrasonu iki hastanin aort darligini tedavi etmede alti hastada ise protez kapak yerlestirmek için aortik annulustan kalsiyumu temizlemekte kullanmislardir. Özellikle küçük aortik annuluslu veya ileri yastaki hastalarda nativ aortik kapagi koruyup cerrahi olarak ultrasonik probla (Cavitron Ultrasonic surgical aspirator (CUSA) veya Dissectron Penstyle) kalsifikasyonu debride etme denenmis fakat takipte artan aort yetersizligi ve reoperasyon riski nedeni ile bu tedavi gözden düsmüstür. Ultrasonic decalcification of lids was first described by Brown and Davies in 1972. made by Duo, ultrasound helped six patients to treat aortic stenosis. In the patient, he is removing calcium from the aortic annulus to place a prosthetic valve. they used. Native aortic valve, especially in patients with small aortic annulus or advanced age and surgically with an ultrasonic probe (Cavitron Ultrasonic surgical aspirator (CUSA) or Dissectron Penstyle) was attempted to debride the calcification but increased on follow-up This treatment was discredited because of aortic regurgitation and the risk of reoperation.

Birkaç seride etkileyici erken sonuçlar elde edilmis fakat 1 yil içinde gelisen ciddi aort yetersizligi nedeni ile birçok hastada reoperasyon gerekmistir. Reoperasyon sirasindaki tipik bulgu inflamasyona bagli ciddi fibröz, aortik küspislerde çekilme ve santral aort yetersizligidir. Impressive early results have been achieved in several series, but severe aortic disease developing within 1 year Many patients required reoperation due to insufficiency. reoperation The typical finding is severe fibrosis due to inflammation, retraction of the aortic cusps and central aortic insufficiency.

CUSA kalsiyumu temizlemekte çok etkili oldugu için cerrahlar cihazi uzun süre ve kapagin birçok noktasinda kullanarak kapaga ileri derecede hasar vermektedirler. Because CUSA is very effective in removing calcium, surgeons do not use the device for a long time and They cause severe damage to the cover by using it at many points of the cover.

Aort kapak replasmani antikoagülasyon, açik cerrahi gerektirmekte ve infektif Bahsedilen TAVI isleminde yeni bir kapak konmaktadir. Bu tedavinin maliyeti yüksektir ve yaklasik %10 hastada kalici kalp pili gerekmektedir. Ayrica aortu kalsifik hastalarda paravalvüler kaçak olusmaktadir. Aortic valve replacement requires anticoagulation, open surgery and is infective. In the mentioned TAVI process, a new cover is placed. The cost of this treatment is high and approximately 10% of patients require a permanent pacemaker. Also in patients with calcified aortic paravalvular leak occurs.

Basit aortik valvüloplastide restenoz oranlari yüksektir. Açik kalp cerrahisinde aortik dekalsifikasyonun uzun dönem sonuçlari etkili degildir. Orta derece aort darligi hastasi koroner bypass operasyonu gerektirmesi durumunda aort kapak replasmani olmaktadir. 19 mm gibi küçük annuluslu hastalarda protez kapak ve TAVI isleminde gradyentler yüksek olmakta bu nedenle öncesinde dekalsifikasyon yöntemine ihtiyaç Cerrahi olarak ultrasonik dekalsifikasyonda inflamasyon nedeniyle fibrozis olusumu ve santral aort kapakçiklarinin kisalmasina bagli santral aort yetersizligi görülmektedir. Restenosis rates are high in simple aortic valvuloplasty. Aortic surgery in open heart surgery The long-term results of decalcification are not effective. moderate aortic stenosis patient aortic valve replacement if coronary bypass operation is required is happening. In the prosthetic valve and TAVI procedure in patients with annulus as small as 19 mm gradients are high, so decalcification method is needed beforehand. Fibrosis formation due to inflammation in ultrasonic decalcification surgically and Central aortic insufficiency is seen due to the shortening of the central aortic valves.

Alkalin peroksit (NaOH + H202) çözeltilerinin çok tahris edici olmasi dolayisiyla kan dolasimina verilecek olan medikal uygulamalarda kullanimi çok kisitlidir. Bu çözeltilerin dogru dozunun ayarlanmasi çok önemlidir. Yaptigimiz ön çalismalarda, sitotoksik etkisinin yani muhtemel doku hasarinin minimum oldugunu gözlemledik. Alkaline peroxide (NaOH + H2O2) solutions are very irritating and therefore blood Its use in medical applications that will be given to the circulation is very limited. This It is very important to set the correct dose of the solutions. In our preliminary studies, We observed that the cytotoxic effect, that is, the possible tissue damage, was minimal.

Fakat minimum da olsa bir inflamasyon oldugu için ortama 10-100mg/L derisimde steroid ilaç eklenince bu inflasyon önlenmektedir. Daha düsük dozlarda alkalin peroksit ve steroid takviyesi etkisiz kalirken, dozlar yükselince ya tahris artmakta ya da maliyet çok artmaktadir. However, since there is minimal inflammation, I average 10-100mg/L on my skin. This inflation is prevented when steroid medication is added. Lower doses of alkaline peroxide and while steroid supplementation is ineffective, increasing doses increase either the irritation or the cost. is increasing a lot.

Literatürde US5295958A numarali ABD patent basvurusunda konu ile ilgili olarak “Bir aort kapagindan kireç haline getirilmis tortulari in vivo olarak çikarmak için bir yöntem ve Cihaz. Aparat, aort kapagi boyunca sabitlenebilen bir çapa balonu kateterini, çökeltileri çikarmak için bir aleti ve aleti baglanti balonu ve aortik vana ile ilgili olarak sabitlemek için tutturma vasitasini içermektedir. Yöntem, bir ankraj balonu kateterinin aort üzerinden ilerletilmesini ve aort kapaginin üzerinden konumlandirilmasini, aort ve aort kapagina göre sabitlestirilmesi için ankraj balonunun sisirilmesini ve daha sonra, aort ve aort kapagina sabitlenerek bir baglama balonuna sabitlenmis bir çökeltme çikarma aletinin çalistirilmasini içerir." ifadelerine yer verilmektedir. In the US patent application numbered US5295958A in the literature, "A A method for removing calcified deposits from the aortic valve in vivo and Device. The apparatus consists of an anchor balloon catheter that can be fixed through the aortic valve, an instrument to remove the precipitates and the instrument associated with the connecting balloon and the aortic valve Includes fastening means for fixing. The method consists of an anchor balloon catheter. advanced over the aorta and positioned over the aortic valve, inflating the anchor balloon to fix it relative to the aortic valve and then, a precipitate fixed to a ligature balloon by fixation to the aorta and aortic valve includes operating the extraction tool."

Bahsedilen basvuruda aort kapagindan kireç haline getirilmis tortulari çikarmak için bir balon ve etrafinda zimpara gibi bir dekalsifikasyon seridi kullanilmaktadir. olarak “Tibbi uygulamalar için bir balon kateteri, yapisal bir dis yüzeye sahip olan hastaya bakan uç bölgesinde bir balona sahiptir. Yapisal dis yüzey, birbirine bagli olmayan dalga oluklari ve dalgali tepelerden olusur. Bir balonun yapilandirilmis dis yüzeyi bitisik yüzeylere yapisabilir. Balon kateteri, uç bölgesinde sol ventrikül kardiyotomi yardimiyla sokulur ve aorta dogru eklenir. Balon, aortun tikanmasini engeller. Balon, kardiyopleji uygulanmasina izin verir ve emme-sizma yoluyla kalbi rahatlatir. Balon kateteri için özel uygulamalar, aortun kireçlenmesiyle, LIMA / RIMA anastomozlarini gerçeklestirmek için ve venovenostomileri gerçeklestirirken uygulanmasini içerir.” ifadelerine yer verilmektedir. In the aforementioned application, a tool is used to remove calcified deposits from the aortic valve. a decalcification strip such as sandpaper is used around the balloon. “A balloon catheter for medical applications is a structured outer surface has a balloon in the patient-facing end region. Structural outer surface, interconnected It consists of non-wave troughs and wavy crests. Structured outer part of a balloon surface can stick to adjacent surfaces. Balloon catheter, tip site left ventricle It is inserted with the aid of a cardiotomy and inserted towards the aorta. Balloon, blockage of the aorta obstacles. The balloon allows cardioplegia to be applied and the heart by suction-leakage. it relaxes. Special applications for balloon catheter, with calcification of the aorta, LIMA / RIMA to perform anastomoses and when performing venovenostomies includes its implementation.” statements are included.

Bahsedilen uygulamada ise açik kalp cerrahisinde sol ventrikülotomi ile girilerek aortu tikamayi ve bypasslarin yapilmasini saglayan bir tertibat ifsa edilmektedir. valvüloplasti sistemi, bir valfin yapraklarina bitisik olarak yerlestirilecek sekilde uyarlanmis bir balonu içermektedir. Balon sivi ile sisirilebilir. Sistem ayrica sok dalgalari üreten bir balon içinde bir sok dalgasi üreteci içerir. Sok dalgalari sivi boyunca yayilir ve valfin kireç çözülmesi ve açilmasi için valf üzerine çarpar.” ifadeleri yer almaktadir. In the aforementioned application, in open heart surgery, the aorta is entered by left ventriculotomy. A device for occlusion and bypasses is disclosed. valvuloplasty system to be placed adjacent to the leaves of a valve Includes an adapted balloon. The balloon can be inflated with liquid. System also insert contains a shock wave generator in a bubble that produces waves. Shock waves through the liquid spreads and hits the valve to descale and open the valve.” place expressions takes.

Bahsedilen uygulamada ise Shockwave ile birlikte bir balon sistemi ifsa edilmektedir. sistemi ve yöntemi. Tersine genlesebilen tikanma araçlarini içeren geçici bir aort kapagi merkezi bir kateter mekanizmasini çevreler. Geçici valf, yükselen aortun içine, koroner ostianin hemen üstünde ve altinda yer alir. Oklüzyon araci, aort duvarina karsi tamamen genisletildiginde, kalp çevrimi sirasinda sürekli koroner perfüzyonu destekleyen bosluklar birakilacak sekilde yapilandirilmistir. Geçici valf, yerine konmasi sirasinda dogal aort kapaginin islevini yerine koyar. Dogal aort kapagi bir kez daha dilate edilir ve daha sonra düsük profilli, uzatilmis, ardisik olarak gönderilen stentlerin yerlestirilmesi ile ablasyon yapilir. Stent (ler), dogal dokularin yerini alir ve PAV'yi tutmak için bir yapi almasi ve saglamlastirmasi için aort anülüsü içinde kalir. PAV, aort anulusundaki stent (ler) içerisinde hassas ve kolaylikla yerlestirilir, yerlestirilir ve dagitilir.” ifadelerine yer verilmektedir. In the mentioned application, a balloon system is disclosed together with Shockwave. system and method. A temporary aorta containing reversible occlusion devices its cap surrounds a central catheter mechanism. Temporary valve into the ascending aorta, The coronary is located just above and below the ostia. Occlusion device against the aortic wall when fully expanded, continuous coronary perfusion during the cardiac cycle It is structured to leave supporting spaces. Temporary valve, replacement It replaces the function of the natural aortic valve during The natural aortic valve once again dilated, and then low-profile, elongated, sequentially delivered stents Ablation is performed by insertion. Stent(s) replace natural tissues and reduce PAV It stays within the aortic annulus to take up a structure to hold it and secure it. PAV, aorta It is precisely and easily deployed, deployed, and delivered within the stent(s) in the annulus. dispersed.” statements are included.

Bahsedilen basvuruda ise asendan aortayi tikayan 3'Iü bir balon ve merkezinden aort kapagin replasmanini saglayan bir sistem ifsa edilmektedir. In the aforementioned application, a triple balloon occludes the ascending aorta and the aorta from its center. A system that provides valve replacement is disclosed.

Yukarida bahsedilen dezavantajlardan dolayi nativ dejeneratif aort darliginda perkütan tedavi saglayan yeni bir kateter tertibati ortaya koyma gereksinimi duyulmustur. Because of the disadvantages mentioned above, percutaneous treatment in native degenerative aortic stenosis There was a need to introduce a new catheter device that provides treatment.

Bulusun Açiklanmasi Teknigin bu konumundan yola çikilarak bulusun amaci, mevcut dezavantajlari ortadan kaldiran nativ dejeneratif aort darliginda perkütan tedavi saglayan yeni bir kateter tertibati ortaya koymaktir. Disclosure of the Invention Starting from this position of the technique, the aim of the invention is to eliminate the existing disadvantages. A new catheter providing percutaneous treatment in native degenerative aortic stenosis to reveal the device.

Bulusun bir diger amaci, açik cerrahi yerine anjiyografik yöntem ile nativ aort kapagi tedavi eden bir yapi ortaya koymaktir. Another aim of the invention is to use the angiographic method instead of open surgery to cover the native aortic valve. is to present a therapeutic structure.

Bulusun bir diger amaci, anjiyografi yöntemi ve bir kateter ile dejeneratif aort kapak ultrasonik veya sok dalgalari ile kalbi durdurup açik cerrahi gerektirmeden dekalsifye eden bir yapi ortaya koymaktir. Another object of the invention is the angiography method and the degenerative aortic valve with a catheter. Decalcification without the need for open surgery by stopping the heart with ultrasonic or shock waves is to present a structure that does.

Bulusun bir diger amaci, sok dalga kullanimi azaltilarak kapaktaki uzun dönemdeki fibrotik degisiklikler ve kaçak olusumu azaltilan bir yapi ortaya koymaktir. Another aim of the invention is to reduce the use of shock waves in the long term in the valve. to reveal a structure with reduced fibrotic changes and leakage formation.

Bulusun bir diger amaci, koroner, serebral ve periferik emboliyi engelleyen bir yapi ortaya koymaktir. Another object of the invention is a structure that prevents coronary, cerebral and peripheral embolism. is to reveal.

Bulusun bir diger amaci, kapak replasmanina gerek kalmadigi için nativ kapagi koruyan ve antikoagülasyon ihtiyaci ortadan kalkip protez kapagin sakincalarindan kaçinmayi mümkün kilan bir yapi ortaya koymaktir. Another object of the invention is the native valve, as valve replacement is not needed. It eliminates the need for anticoagulation and eliminates the problems of the prosthetic valve. is to put forward a structure that makes avoidance possible.

Bulusun bir diger amaci, orta derece aort darligi hastasi koroner bypass operasyonu gerektirmesi durumunda aort kapak replasmani yerine aortik dekalsifikasyon yapilip darlik seviyesi azaltilarak bypass sirasinda aort kapak replasmani ihtiyacini ortadan kaldiran bir yapi ortaya koymaktir. Another aim of the invention is coronary bypass operation in patients with moderate aortic stenosis. If necessary, aortic decalcification can be performed instead of aortic valve replacement. By reducing the level of stenosis, it eliminates the need for aortic valve replacement during bypass. is to present a structure that lifts.

Bulusun bir diger amaci, kateter ile dekalsifikasyon cerrahideki açik yöntemin getirdigi inflamasyonda artis ve travmayi azaltan bir yapi ortaya koymaktir. Another aim of the invention is to introduce the open method in catheter-based decalcification surgery. to reveal a structure that increases inflammation and reduces trauma.

Bulusun bir diger amaci, dekalsifikasyon sonrasi antienflamatuar solüsyon ile kapakta inflamasyonu azaltan ve fibrozis olusumu engelleyen bir yapi ortaya koymaktir. Another object of the invention is to cover the lid with an anti-inflammatory solution after decalcification. to reveal a structure that reduces inflammation and prevents fibrosis formation.

Bulusun bir diger amaci, kimyasal çesit ve oranlari hassas olarak ayarlanan solüsyon sayesinde, kalp gibi hayati organimiz ve çevresindeki dokularda hasar, tahris ve inflamasyona neden olmadan dekalsifikasyonun yapilmasini saglayan bir yapi ortaya koym akti r. Another object of the invention is the solution of finely tuned chemical type and ratio. damage, irritation and damage to our vital organs such as the heart and surrounding tissues. A structure that allows decalcification to occur without causing inflammation. put act r.

Sekillerin Açiklanmasi Sekil - 1 Bulusa konu olan nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibatinin aorta içine yerlestirilmis temsili bir görünümü Sekil- 2 Bulusa konu olan nativ dejeneratif aort darliginda 7.5-18 kV arasi sok dalgasi üreterek perkütan tedavi saglayan kateter tertibatinin temsili bir görünümü Sekil- 3 Bulusa konu olan nativ dejeneratif aort darliginda 23-30 kHz araliginda sürekli ultrason dalgalari ses dalgasi üreterek perkütan tedavi saglayan kateter tertibatinin temsili bir diger görünümü Sekil - 4 Aort kapak ve sinüslere uyumlu üç yaprakli distal filtre ucunun detay görünümü Referans Numaralari Nativ Dejeneratif Aort Darliginda Perkütan Tedavi Saglayan Kateter Tertibati Sol Ventrikül Koroner Arter Aort Kapak Atravmatik Domuz Kuyruk Kateter Ucu Kateter Solüsyon Delikleri Kalsifikasyon çözücü ultrason çekirdek Koroner Arter ve Beyni Koruyan Filtre Filtre Kilifinin Opak Ucu . Filtre Kilifi 11.Kalsifikasyon Çözücü Sok Dalgalari Üreten Çekirdek 12. Filtre Distal Marker 13. Filtre Proksimal Marker 14. Filtre Kilifi Mekanizmasi . Kilavuz Tel Deligi 16. Solüsyon Portu 17. Sok Dalga Konsolu 18. Sok Dalga Konsol Baglantisi 19. Ultrason Çekirdek Baglantisi . Ultrason Konsolu 21.Üç Yaprakli Distal Filtre Ucu 22. Sag Koroner Sinüs 23. Sol Koroner Sinüs 24. Non Koroner Sinüs Bulusun Detayli Anlatimi Bu detayli açiklamada, bulus konusu yenilik sadece konunun daha iyi anlasilmasina yönelik hiçbir sinirlayici etki olusturmayacak örneklerle açiklanmaktadir. Explanation of Figures Figure - 1 Percutaneous treatment in native degenerative aortic stenosis, which is the subject of the invention. A representative view of the catheter assembly inserted into the aorta Figure-2 Shock wave between 7.5-18 kV in native degenerative aortic stenosis, which is the subject of the invention A representative view of the catheter assembly providing percutaneous therapy by producing Figure-3 Continuous degenerative aortic stenosis in the range of 23-30 kHz, which is the subject of the invention. ultrasound waves, which produce sound waves and provide percutaneous treatment of the catheter assembly. another representative view Figure - 4 Detail of a three-leaf distal filter tip compatible with the aortic valve and sinuses view Reference Numbers Catheter Assembly Providing Percutaneous Treatment in Native Degenerative Aortic Stenosis Left Ventricle Coronary Artery Aortic Valve Atraumatic Pig Tail Catheter Tip Catheter Solution Holes Calcification solver ultrasound core Filter Protecting Coronary Artery and Brain Opaque End of Filter Cover . Filter Cover 11. Calcification Solvent Core Generating Shock Waves 12. Filter Distal Marker 13. Filter Proximal Marker 14. Filter Cover Mechanism . Guide Wire Hole 16. Solution Port 17. Sock Wave Console 18. Shock Wave Console Connection 19. Ultrasound Core Connection . Ultrasound Console 21. Three Leaf Distal Filter Tip 22. Right Coronary Sinus 23. Left Coronary Sinus 24. Non Coronary Sinus Detailed Description of the Invention In this detailed description, the innovation subject of the invention is only intended for a better understanding of the subject. It is explained with examples that will not have any limiting effect on the subject.

Bulus, dejeneratif ve kalsifik aort kapak (4) hastaliklarinda aort kapakta (4) biriken kalsifikasyonlar sebebiyle kapak yapisinin bozularak daralmasini tedavi etmek amaciyla kullanilan nativ dejeneratif aort darliginda sürekli ses dalgalari veya soklar seklinde ses dalgalari veren perkütan tedavi saglayan iki farkli kateter tertibati (A) olup özelligi; islem sirasinda sol ventriküle (2) hasari önleyerek ve perforasyona engel olma islevini yerine getiren bahsedilen nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) uç kisminda konumlu atravmatik domuz kuyruk kateter ucu (5), aort kapagin (4) dekalsifikasyonu için gerekli olan kalsiyum çözücü ve antienflamatuar solüsyonun verilmesini saglayan, bahsedilen nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) üzerinde konumlu kateter solüsyon delikleri (6), 23-30 kHz araliginda sürekli olan ultrason dalgalari veya sok seklinde ses dalgalari vererek aort kapak (4) Ieafletlerinin dekalsifikasyonunu saglayan, bahsedilen nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) orta kisminda konumlu kalsifikasyon çözücü ultrasonik çekirdek (7), dekalsifikasyon sirasinda koroner arterler (3), beyin damarlari ve diger periferik damarlara emboli atmasini engelleyen, bahsedilen nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) etrafinda konumlu koroner arter ve beyni koruyan filtre (8) ve koroner arter ve beyni koruyan filtrenin (8) sag ve sol koroner sinüslere (22,23) tam oturmasini ve koroner arterlerin (3) emboliden tam korunmasini saglayan üç yaprakli distal filtre ucu (21) içermesiyle karakterize edilmesidir. Invention, degenerative and calcific aortic valve (4) diseases that accumulate in the aortic valve (4) to treat the narrowing of the valve structure due to calcifications Continuous sound waves or shocks in native degenerative aortic stenosis used for There are two different catheter devices (A) that provide percutaneous treatment that give sound waves in the form of feature; by preventing damage to the left ventricle (2) during the procedure and preventing perforation Percutaneous treatment in the mentioned native degenerative aortic stenosis that fulfills its function atraumatic porcine tail catheter located at the tip of the catheter assembly (A) that provides end (5), calcium solvent required for decalcification of the aortic valve (4) and said native degenerative aorta, which provides the administration of anti-inflammatory solution Catheter positioned on the catheter assembly (A) providing percutaneous treatment in stenosis solution holes (6), continuous ultrasound waves in the range of 23-30 kHz or shock Decalcification of aortic valve (4) Ieaflets by giving sound waves in the form of catheter that provides percutaneous treatment in the mentioned native degenerative aortic stenosis Calcification solvent ultrasonic core (7) located in the middle of the assembly (A), coronary arteries (3), cerebral vessels and other peripheral in said native degenerative aortic stenosis, which prevents embolism to the vessels The coronary artery and brain located around the catheter assembly (A) providing percutaneous treatment filter (8) that protects the coronary artery and brain (8) sinuses (22.23) and full protection of coronary arteries (3) from embolism. It is characterized by the fact that it contains a three-leaf distal filter tip (21).

Sekil- 1'de bulusa konu olan nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibatinin (A) aorta (1) içine yerlestirilmis temsili bir görünümü resmedilmektedir. Figure-1, which provides percutaneous treatment in native degenerative aortic stenosis, which is the subject of the invention. a representative view of the catheter assembly (A) inserted into the aorta (1) is pictured.

Sekil - 2'de bulusa konu olan nativ dejeneratif aort darliginda sok dalgasi üreterek perkütan tedavi saglayan kateter tertibatinin (A) temsili bir görünümü resmedilmektedir. By producing shock wave in native degenerative aortic stenosis, which is the subject of the invention in Figure - 2 A representative view of the catheter assembly (A) providing percutaneous therapy is pictured.

Sekil - 3'de bulusa konu olan nativ dejeneratif aort darliginda sürekli ses dalgalari vererek perkütan tedavi saglayan kateter tertibatinin (A) temsili bir diger görünümü resmedilmektedir. Continuous sound waves in native degenerative aortic stenosis, which is the subject of the invention in Figure - 3 Another representative view of the catheter assembly (A) providing percutaneous treatment by is pictured.

Sekil - 4”de aort kapak (4) ve sinüslere (22,23,24) uyumlu üç yaprakli distal filtre ucunun (21) detay görünümü resmedilmektedir. Figure - 4” three-leaf distal filter compatible with the aortic valve (4) and sinuses (22,23,24) The detail view of the tip (21) is illustrated.

Aorta (1), sol ventrikül (2), koroner arter (3), aort kapak (4), sag koroner sinüs (22), sol koroner sinüs (23) ve non koroner sinüs (24) içeren insan vücuduna, bulusa konu olan nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) uygulama seklinde, islem sirasinda sol ventriküle (2) hasari önleyerek ve perforasyona engel olma islevini yerine getiren bahsedilen nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) uç kisminda konumlu atravmatik domuz kuyruk kateter ucu (5), aort kapagin (4) dekalsifikasyonu için gerekli olan kalsiyum çözücü ve antienflamatuar solüsyonun verilmesini saglayan, bahsedilen nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) üzerinde konumlu kateter solüsyon delikleri (6), 23-30 kHz araliginda sürekli ultrason dalgalari veya sok seklinde ses dalgalari vererek aort kapak (4) leafletlerinin dekalsifikasyonunu saglayan, bahsedilen nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) orta kisminda konumlu kalsifikasyon çözücü ultrasonik çekirdek (7) veya 75-18 kV arasi sok seklinde ses dalgalari veren kalsifikasyon çözücü sok dalgalari üreten çekirdek (11) dekalsifikasyon sirasinda koroner arterler (3), beyin damarlari ve diger periferik damarlara emboli atmasini engelleyen, bahsedilen nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) etrafinda konumlu koroner arter ve beyni koruyan filtre (8), bahsedilen koroner arter ve beyni koruyan filtre (8) uçunda konumlandirilmis filtre kilifinin opak ucu (9), bahsedilen koroner arter ve beyni koruyan filtreyi (8) açip kapama islevini yerine getiren filtre kilifi (10), aralikli olarak 7.5- 18 W arasi sok dalgalari vererek dekalsifikasyonu saglayan kalsifikasyon çözücü 7.5- 18 W arasi sok dalgalari üreten kalsifikasyon çözücü sok dalgalari üreten çekirdek (11) veya kalsifikasyon çözücü ultrasonik çekirdek (7), tedavi sonlandirilip nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibatinin (A) geri çekilmesi esnasinda filtre kilifi (10) ilerletme ve geri çekme islemini yerine getiren filtre kilifi mekanizmasi (14), bahsedilen geri çekme esnasinda ne kadar geri çekilecegini ölçme islemini yerine getiren filtre distal marker (12) ve filtre proksimal marker (13), kilavuz tele yataklik eden kilavuz tel deligi (15), aort kapagin (4) dekalsifikasyonu için gerekli olan solüsyonun kateter solüsyon deliklerine (6) ulasmasini saglayan solüsyon portu (16), kalsifikasyon çözücü 7.5-18 kV arasi sok dalgalari üreten kalsifikasyon çözücü sok dalgalari üreten çekirdek (11) sok dalga kaynagi olarak konumlandirilan sok dalga konsolu (17), bahsedilen kalsifikasyon çözücü sok dalgalari üreten çekirdek (11) ile sok dalga konsolu (17) arasindaki baglantiyi saglayan sok dalga konsol baglantisi (18), bahsedilen 23-30 kHz araliginda sürekli ultrason dalgalari üreten kalsifikasyon çözücü ultrasonik çekirdeginin (7) ultrason dalga kaynagi olarak konumlandirilan ultrason konsolu (20), bahsedilen ultrasonik çekirdek (7) ile ultrason konsolu (20) arasindaki baglantiyi saglayan ultrason çekirdek baglantisi (19), koroner arter ve beyni koruyan filtrenin (8) sag ve sol koroner sinüslere (22,23) tam oturmasini ve koroner arterlerin (3) emboliden tam korunmasini saglayan üç yaprakli distal filtre ucu (21) ana parçalari kullanilmaktadir. Aorta (1), left ventricle (2), coronary artery (3), aortic valve (4), right coronary sinus (22), left the human body containing the coronary sinus (23) and the non-coronary sinus (24) Catheter device (A) application providing percutaneous treatment in native degenerative aortic stenosis form, by preventing damage to the left ventricle (2) during the procedure and preventing perforation. percutaneous treatment in the mentioned native degenerative aortic stenosis, which fulfills the function of being atraumatic porcine tail catheter located at the tip of the catheter assembly (A) that provides end (5), calcium solvent required for decalcification of the aortic valve (4) and said native degenerative aorta, which provides the administration of anti-inflammatory solution Catheter positioned on the catheter assembly (A) providing percutaneous treatment in stenosis solution holes (6), in the form of continuous ultrasound waves in the range of 23-30 kHz or in the form of shock providing decalcification of aortic valve (4) leaflets by giving sound waves, catheter device providing percutaneous treatment in said native degenerative aortic stenosis (A) calcification solvent ultrasonic core located in the middle (7) or 75-18 kV calcification solver producing shock waves that give sound waves in the form of core (11) during decalcification coronary arteries (3), cerebral vessels and other said native degenerative aorta, which prevents it from embolizing peripheral vessels Coronary artery located around the catheter assembly (A) providing percutaneous treatment in stenosis the filter (8) protecting the artery and the brain, the filter (8) protecting the said coronary artery and the brain The opaque end (9) of the filter cover positioned at the end of the said coronary artery and brain The filter cover (10), which performs the function of opening and closing the filter (8) that protects Calcification solvent that provides decalcification by giving shock waves between 18 W 7.5- Core producing calcification-resolving shock waves producing shock waves between 18 W (11) or the calcification-resolving ultrasonic core (7), the treatment is terminated and the native Back of the catheter assembly (A) providing percutaneous treatment in degenerative aortic stenosis The filter cover (10) that performs the advancing and retracting operation of the filter cover during pulling the sheath mechanism (14) determines how much to retract during said retraction. filter distal marker (12) and filter proximal marker (13), which perform the measurement process, Guide wire hole (15), which accompanies the guide wire, for decalcification of the aortic valve (4) the solution that allows the necessary solution to reach the catheter solution holes (6) port (16), calcification solvent Calcification producing shock waves between 7.5-18 kV The core (11), which generates the solvent shock waves, is positioned as the shock wave source. shock wave console (17), the core producing said calcification solvent shock waves The shock wave console providing the connection between (11) and the shock wave console (17) Its connection (18) produces continuous ultrasound waves in the said 23-30 kHz range. as ultrasound wave source of calcification solvent ultrasonic core (7) positioned ultrasound console (20), ultrasound with said ultrasonic core (7) ultrasound core connection (19), which provides the connection between the ensure that the filter (8) that protects the artery and brain is fully seated in the right and left coronary sinuses (22.23). and three-leaf distal filter providing complete protection of the coronary arteries (3) from embolism The main parts of the tip (21) are used.

Bahsedilen nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A), ciddi kalsifik aort darligi olan hastada TAVI öncesi kalsifikasyonu azaltmak veya nativ kapagi sadece dekalsifye etmek için kullanilmaktadir. Femoral artere bir kilif yerlestirilmekte ve AL1 anjiyografi kateteri destegi ile 0.035 inç destek kilavuz teli aort kapaktan (4) geçirilerek sol ventriküle (2) yerlestirilmektedir. Catheter device providing percutaneous treatment in the aforementioned native degenerative aortic stenosis (A), to reduce calcification before TAVI in the patient with severe calcific aortic stenosis or The native cap is used for decalcification only. A sheath to the femoral artery A 0.035 inch support guide wire is inserted into the aorta with an AL1 angiography catheter support. It is placed in the left ventricle (2) by passing it through the valve (4).

Kilavuz tel üzerinden nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) sol ventriküle (2) ilerletilmektedir. Operatörün tercihine göre sekil 2lde gösterilen veya sekil 3'te gösterilen 23-30 kHz araliginda sürekli ultrason dalgalari üreten ultrasonik ses dalgasi veren tertibatlar kullanilmaktadir. Catheter providing percutaneous treatment in native degenerative aortic stenosis over the guide wire device (A) is advanced to the left ventricle (2). Figure 2l according to the operator's preference continuous ultrasound waves in the range of 23-30 kHz shown in figure 3 Devices that produce ultrasonic sound waves are used.

Nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) aort kapaktan (4) geçirilmekte, filtre kilifinin opak ucu (9) aort kapagin (4) hemen üzerine gelecek sekilde yerlestirilmektedir. Filtre kilifi mekanizmasi (14) ile koroner arter ve beyni koruyan filtre (8) kismen açilarak üç yaprakli distal filtre ucunun (21) sag, sol ve non koroner sinüslere (22,23,24) yerlestirilmesi saglanmakta, böylece koroner arter (3) ve diger periferik arterlere emboli gitmesine engel olunmaktadir. Catheter device providing percutaneous treatment in native degenerative aortic stenosis (A) aortic is passed through the valve (4), the opaque end of the filter sheath (9) just above the aortic valve (4). is placed in the next section. With the filter cover mechanism (14), coronary artery and The filter (8) protecting the brain is partially opened and the three-leaf distal filter tip (21) is placed on the right, left and It is provided to be placed in non-coronary sinuses (22,23,24), thus coronary artery (3) and embolism to other peripheral arteries is prevented.

Nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibatinda (A) operatörün tercihine bagli olarak kateter solüsyon deliklerinden (6) kalsifikasyon çözücü solüsyon, 23-30 kHz araliginda sürekli ultrason dalgalari üreten kalsifikasyon çözücü ultrasonik çekirdek (7) veya kalsifikasyon çözücü 7.5-18 kV arasi sok dalgasi üreten çekirdek (11) aktive edilmesinden önce sonra veya farkli aralik ve sürelerde solüsyon portundan (16) verilmektedir. In the catheter assembly providing percutaneous treatment in native degenerative aortic stenosis (A) calcification from catheter solution holes (6) at operator preference solvent solution, calcification producing continuous ultrasound waves in the range of 23-30 kHz solvent ultrasonic core (7) or calcification solvent shock wave between 7.5-18 kV before or after activation of the producing nucleus (11) or at different intervals and times. the solution is given from the port (16).

Bahsedilen 23-30 kHz araliginda sürekli ultrason dalgalari üreten kalsifikasyon çözücü ultrasonik çekirdek (7) aktive oldugu sürece kalsifikasyon ve inflamasyon engelleyici solüsyon veya izotonik serum çözeltisi sogutulmus olarak verilerek kapak dokulari ve ileti sisteminin isinmasi ve skar olusumu engellenmektedir. Calcification solver that produces continuous ultrasound waves in the aforementioned 23-30 kHz range calcification and inflammation inhibitor as long as the ultrasonic core (7) is activated solution or isotonic serum solution is given chilled and cover tissues and Heating of the message system and scar formation are prevented.

Dekalsifikasyon için farkli süre ve tekrarlarda Sekil 2'deki gibi sok dalga konsolu (17) aktive edilerek 7.5-18 kV arasi sok dalgalari uygulanmaktadir. Dekalsifikasyon için sekil 3'teki 23-30 kHz araliginda sürekli ultrason dalgalari üreten kalsifikasyon çözücü ultrasonik çekirdekli (7) kateter kullaniliyor ise ultrason konsolu (20) araciligi ile kapak dekalsifiye edilir. Shock wave console as in Figure 2 at different times and repetitions for decalcification (17) It is activated and shock waves between 7.5-18 kV are applied. for decalcification Calcification solver that produces continuous ultrasound waves in the range of 23-30 kHz in figure 3 If a catheter with an ultrasonic core (7) is used, cover the valve via the ultrasound console (20). is decalcified.

Dekalsifikasyon sonrasi islemi bitirmeden gerekli durumlarda antienflamatuar bir kateter solüsyon deliklerinden (6) verilerek fibrozis olusumu daha iyi baskilanabilmektedir. Before finishing the process after decalcification, an anti-inflammatory Fibrosis formation is better by giving the catheter solution through the holes (6). can be suppressed.

Gerekli solüsyon ve sok dalgasi/ultrason uygulamasi sonrasi tedavi sonlandirilip kateterin geri çekilmesi için filtre kilifi mekanizmasi (14) ile koroner arter ve beyni koruyan filtre (8) geri toplanip filtre distal markerinin (12) filtre kilifi opak ucu (9) ile üst üste geldigi görülür. Nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) femoral arterden kilavuz tel üzerinden geri çekilerek islem sonlandirilir. After the necessary solution and shock wave/ultrasound application, the treatment is terminated. the coronary artery and brain with the filter-sheath mechanism (14) for retraction of the catheter. The filter (8) that protects appears to be on top. Catheter providing percutaneous treatment in native degenerative aortic stenosis The procedure is terminated by withdrawing the assembly (A) from the femoral artery over the guide wire.

Ultrasonik ve elektromanyetik sok dalgalari ile cerrahideki kadar hasar vermemek için bu tedavilerden herhangi birine ek olarak, plagin yapisi ve sekli gibi unsurlara bagli olarak ayarlanacak olan kimyasal çözelti farkli sürelerde (10dk-30 dk) nativ dejeneratif aort darliginda perkütan tedavi saglayan kateter tertibati (A) içerisinde uygulanarak aort kapaktaki (4) plaklarin dekalsifikasyonu saglanmaktadir. 100mg/L steroid ilaç seklinde olacak olup, tam derisimler vakaya göre ayarlanabilmektedir. “Metilprednisolon 40mg ampül” formundaki steroid ilaçtan 2 ampül 1L kimyasal çözeltiye eklendigi sekilde bir örnek uygulama tavsiye edilen kullanim sekli ve dozudur. Fakat kullanilacak steroid ilaç sadece metilprednisolon ile sinirli degildir. Solüsyon içerisinde NaOH ve H202 kimyasallari dekalsifikasyon ajani olarak görev yapmaktadir. Steroid ilaç ise dekalsifikasyon sonucu olusacak inflamasyonu engellemektedir. In order not to damage as much as in surgery with ultrasonic and electromagnetic shock waves In addition to any of these treatments, depending on factors such as the structure and shape of the plaque. The chemical solution, which will be adjusted as It is applied in the catheter assembly (A) that provides percutaneous treatment in aortic stenosis. decalcification of plaques in the aortic valve (4) is provided. It will be in the form of 100mg/L steroid medicine, and the exact concentrations are based on the case. can be adjusted. 2 of the steroid drugs in the form of “methylprednisolone 40mg ampoule” A sample application is recommended as the ampoule is added to 1L chemical solution. its usage and dosage. However, the steroid drug to be used is only with methylprednisolone. not angry. NaOH and H2O2 chemicals in solution as decalcifying agent works as. If it is a steroid drug, it will be formed as a result of decalcification. inhibits inflammation.

Kimyasal formülasyonun (yikama çözeltisi) içerisine sitrik asit ve EDTA (etilen diamin tetra asetik asit)'nin sodyum ve kalsiyum tuzlari, fosfat tamponu, asetat tamponu, sitrat tamponu kimyasallarindan en az bir tanesi 0,01-O,2M derisiminde eklenebilmektedir. Citric acid and EDTA (ethylene diamine) are added to the chemical formulation (washing solution). sodium and calcium salts of tetra acetic acid), phosphate buffer, acetate buffer, citrate At least one of the buffer chemicals can be added at a concentration of 0.01-0.2M.

Yikama çözeltisinin pH degerinin 6-10 arasi, tercihen 7-9 arasi olmasi istenmektedir. The pH value of the washing solution is desired to be between 6-10, preferably between 7-9.

NaOH eklenerek 7-9 araligina getirildigi bir uygulama ortaya konulmaktadir. An application is presented in which NaOH is added to bring it to the range of 7-9.

Claims

CLIENTS The invention is based on two different catheter systems that provide percutaneous treatment that gives continuous sound waves or sound waves in the form of shocks in native degenerative aortic stenosis, which is used to treat the narrowing of the valve structure due to calcifications accumulated in the aortic valve (4) in degenerative and calcific aortic valve diseases (A ) is the feature; The atraumatic pig tail catheter tip (5) located at the end of the catheter assembly (A), which provides percutaneous treatment in the mentioned native degenerative aortic stenosis, which prevents damage to the left ventricle (2) during the procedure and prevents perforation, is the necessary for decalcification of the aortic valve (4). Catheter solution holes (6) located on the catheter device (A), which provides the administration of calcium solvent and anti-inflammatory solution and provides percutaneous treatment in the said native degenerative aortic stenosis, aortic valve (4) by giving continuous ultrasound waves in the range of 23-30 kHz or sound waves in the form of shocks. Calcification-solving ultrasonic core (7) located in the middle of the catheter assembly (A), which provides decalcification of the cuffs and provides percutaneous treatment in the said native degenerative aortic stenosis, said native degenerative aorta, which prevents embolism to coronary arteries (3), brain vessels and other peripheral vessels during decalcification. percus It is ensured that the catheter device (A) that provides diagnostic treatment (A), the filter that protects the coronary artery and the brain (8) and the filter that protects the coronary artery and the brain (8) are fully seated in the right and left coronary sinuses (22.23) and that the coronary arteries (3) are fully protected from embolism. It is characterized by the fact that it contains a three-leaf distal filter tip (21).

A catheter device (A) that provides percutaneous treatment in a native degenerative aortic stenosis according to claim 1, and its feature is; it contains the opaque end (9) of the filter cover positioned at the end of the filter (8) that protects the coronary artery and the brain.

A catheter device (A) that provides percutaneous treatment in a native degenerative aortic stenosis according to any of the above claims, and its feature is; the filter cover (10) that performs the function of opening and closing the filter (8) that protects the coronary artery and the brain, the core (11) that produces shock waves that provide decalcification by intermittently giving shock waves between 75-18 kV or continuous ultrasound in the range of 23-30 kHz. It contains calcification solvent ultrasonic core (7) that produces waves. .

A catheter device (A) that provides percutaneous treatment in a native degenerative aortic stenosis according to any of the above claims, and its feature is; The filter jacket (10) includes a filter sleeve mechanism (14) that performs the advancing and retracting processes during the withdrawal of the catheter assembly (A) that provides percutaneous treatment in native degenerative aortic stenosis after the treatment is terminated. .

A catheter device (A) that provides percutaneous treatment in a native degenerative aortic stenosis according to any of the above claims, and its feature is; it contains filter distal marker (12) and filter proximal marker (13), which performs the process of measuring how much to be withdrawn during said retraction. .

A catheter device (A) that provides percutaneous treatment in a native degenerative aortic stenosis according to any of the above claims, and its feature is; It contains a solution port (16) that allows the solution required for the decalcification of the aortic valve (4) to reach the catheter solution holes (6). .

A catheter device (A) that provides percutaneous treatment in a native degenerative aortic stenosis according to any of the above claims, and its feature is; The core (11), which produces calcification-solving shock waves, contains the shock wave console (17) positioned as the shock wave source. .

A catheter device (A) that provides percutaneous treatment in a native degenerative aortic stenosis according to any of the above claims, and its feature is; it contains a shock wave console connection (18) that provides the connection between the said calcification solver 7. and the shock wave console (17). .

A catheter device (A) that provides percutaneous treatment in a native degenerative aortic stenosis according to any of the above claims, and its feature is; said calcification solver ultrasonic core (7), which produces continuous ultrasound waves in the range of 23-30 kHz, includes ultrasound console (20) positioned as ultrasound wave source.

10. A catheter device (A) that provides percutaneous treatment in a native degenerative aortic stenosis according to any of the above claims, and its feature is; it contains an ultrasound core connection (19) that provides the connection between the calcification-solving ultrasonic core (7), which produces continuous ultrasound waves in the range of 23-30 kHz, and the ultrasound console (20).

11. Catheter device (A) providing percutaneous treatment in a native degenerative aortic stenosis according to any of the above claims, and its feature is; said

12. A catheter device (A) that provides percutaneous treatment in native degenerative aortic stenosis according to one of the above claims, calcium solvent and anti-inflammatory solution, and its feature is; It contains at least one of the chemicals of citric acid and EDTA (ethylene diamine tetra acetic acid) sodium and calcium salts, phosphate buffer, acetate buffer, citrate buffer at a concentration of 0.01-0,2M in said calcium solvent and anti-inflammatory solution.

13. A catheter device (A) that provides percutaneous treatment in native degenerative aortic stenosis according to one of the above claims, calcium solvent and anti-inflammatory solution, and its feature is; the pH value of said washing solution is between 6-10, preferably between 7-9.

14. It includes an application in which the pH value of the washing solution containing percutaneous treatment in native degenerative aortic stenosis is brought to the range of 7-9 by adding NaOH to any of the above claims, calcium solvent and anti-inflammatory solution.