TR201906563A2 - An amniotic membrane transplantation system. - Google Patents

An amniotic membrane transplantation system. Download PDF

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Publication number
TR201906563A2
TR201906563A2 TR2019/06563A TR201906563A TR201906563A2 TR 201906563 A2 TR201906563 A2 TR 201906563A2 TR 2019/06563 A TR2019/06563 A TR 2019/06563A TR 201906563 A TR201906563 A TR 201906563A TR 201906563 A2 TR201906563 A2 TR 201906563A2
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amniotic membrane
ring
feature
amniotic
plate
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TR2019/06563A
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Can Ertuğrul
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Ondokuz Mayis Ueniversitesi Rektoerluek
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Priority to TR2019/06563A priority Critical patent/TR201906563A2/en
Priority to PCT/TR2020/050568 priority patent/WO2020236125A2/en
Publication of TR201906563A2 publication Critical patent/TR201906563A2/en

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    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0095Packages or dispensers for prostheses or other implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/145Corneal inlays, onlays, or lenses for refractive correction
    • A61F2/1451Inlays or onlays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/48Reproductive organs
    • A61K35/50Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/15Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
    • 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/16Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Medicinal Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Zoology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Molecular Biology (AREA)
  • Reproductive Health (AREA)
  • Biotechnology (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Ophthalmology & Optometry (AREA)
  • Urology & Nephrology (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

Buluş; oftalmoloji alanında amniyon zarının oküler yüzeye sütürsüz (dikişsiz) olarak uygulanabildiği bir amniyon zarı transplantasyonu sistemi ile ilgilidir. Buluş; her hastaya kolayca uygulanabilen, ucuz ve etkili olup, amniyon zarı transplantasyonunun ameliyathane şartlarına ihtiyaç duyulmaksızın yapılmasını sağlamaktadır.Meet; In the field of ophthalmology, it concerns an amniotic membrane transplantation system in which the amniotic membrane can be applied to the ocular surface without sutures. Meet; It can be easily applied to every patient, is inexpensive and effective, and enables amniotic membrane transplantation to be performed without the need for operating room conditions.

Description

TARIFNAME BIR AMNIYON ZARI TRANSPLANTASYONU SISTEMI Bulusun Ilgili Oldugu Teknik Alan Bulus; oftalmoloji alaninda amniyon zarinin oküler yüzeye sütürsüz (dikissiz) olarak, ameliyathane sartlarina ihtiyaç duyulmaksizin uygulanabilmesine olanak saglayan bir amniyon zari transplantasyonu sistemi ile ilgilidir. DESCRIPTION A SYSTEM OF TRANSPLANTATION OF AN AMNIONARY MEMBRANE Technical Field of the Invention Meet; In the field of ophthalmology, the amniotic membrane is sutured to the ocular surface, It is a system that allows it to be applied without the need for operating room conditions. It is related to the amniotic membrane transplantation system.

Bulusla Ilgili Teknigin Bilinen Durumu (Önceki Teknik) Göz hastaliklari ve görme kusurlarinin tani ve tedavisiyle ilgilenen uzmanlik dali olan oftalmoloji alanindaki karsilasilan hastaliklardan biri de oküler yüzeyde meydana gelen bozukluklardir. Oküler yüzey; kornea, konjoktiva ve skleradan olusmaktadir. Dis faktörlerle temas haline olan oküler yüzeyde; travma, kuru göz, kimyasal/termal yaniklar, enfeksiyonlar, immünolojik veya nörotrofik nedenlere bagli olarak oküler yüzey hasari olusmaktadir. Bu tip hasarlarin tedavisinde, öncelikli olarak medikal tedavi uygulanmakla birlikte; tedaviye yanit alinamadigi durumlarda cerrahi girisimlerde bulunulmaktadir. Bu gibi durumlarda uygulanan cerrahi girisimlerden biri de amniyon zari transplantasyonudur. State of the Art of the Invention (Prior Art) It is a specialty that deals with the diagnosis and treatment of eye diseases and visual defects. One of the diseases encountered in the field of ophthalmology is the diseases that occur on the ocular surface. are disorders. ocular surface; It consists of cornea, conjunctiva and sclera. External on the ocular surface in contact with factors; trauma, dry eye, chemical/thermal burns, ocular surface damage due to infections, immunological or neurotrophic causes is formed. In the treatment of this type of damage, primarily medical treatment should be applied. together; In cases where there is no response to treatment, surgical interventions are made. This One of the surgical interventions applied in such cases is amniotic membrane transplantation.

Amniyon zari transplantasyonu; oftalmolojide 1940 yilindan beri uygulanmakta olup, oküler yüzey hasarlarinin tedavisinde en sik kullanilan yöntemlerden biridir. Amniyon zari; plasentanin en iç katmanidir. Histolojik olarak tek katli kübik epitel, bazal membran ve stroma tabakalarindan olusan bir yapida ve 0,02-0,5 mm kalinligindadir. Mevcut teknikte amniyon zarlari, göz bankalarindan dondurulmus ya da kurutulmus olarak veya dogumdan hemen sonra serolojisi negatif olan hastalardan alinarak taze bir sekilde temin edilebilmektedir. Amniotic membrane transplantation; It has been applied in ophthalmology since 1940, It is one of the most commonly used methods in the treatment of ocular surface injuries. amniotic membrane; It is the innermost layer of the placenta. Histologically, single-layered cuboidal epithelium, basement membrane and It has a structure consisting of stroma layers and is 0.02-0.5 mm thick. in the current art amniotic membranes, frozen or dried from eye banks, or It is obtained freshly from patients with negative serology immediately after birth. can be achieved.

Amniyon zarinin epitelizasyonu hizlandirmasi, damar olusumunu azaltmasi, epitel hücre ölümünü yavaslatmasi, inflamasyonu azaltmasi, gözyasini stabilize etmesi, kornea duyusunu iyilestirmesi ve antimikrobiyal özellikte olmasi gibi birçok faydasi bulunmaktadir. Accelerating epithelialization of the amniotic membrane, reducing vascular formation, epithelial cell slowing death, reducing inflammation, stabilizing tears, corneal It has many benefits such as improving the senses and having antimicrobial properties.

Amniyon zarinin oküler yüzeydeki hasarlarin tedavisindeki bu etkinliklerinin sebepleri; a) Amniyon zarinin bazal membrandaki kollajen tip IV, konjoktivadaki ile ayni olmasi, b) Amniyon zari stromasinda büyüme faktörleri, antianjiyojenik ve antiinflamasyon proteinleri ve çesitli proteazlarin inhibitörlerinin bulunmasi, c) Amniyon zari stromasinda inflamasyon baskilayici mediyatörler bulunmasidir. The reasons for their effectiveness in the treatment of ocular surface damage of the amniotic membrane; a) Collagen type IV in the basement membrane of the amniotic membrane is the same as in the conjunctiva, b) Growth factors, antiangiogenic and antiinflammatory proteins in amniotic membrane stroma and the presence of inhibitors of various proteases, c) Inflammation in the amniotic membrane stroma the presence of suppressive mediators.

Teknigin bilinen durumunda, amniyon zari transplantasyonu, amniyon zarinin sütür kullanilarak konjonktiva veya kornea dokusuna dikilmesi ile gerçeklestirilmektedir. Bu amniyon zari implantasyonu yönteminin; - Lokal veya genel anestezi uygulanmasi; lokal anestezide hasta-cerrah uyumsuzlugunda sürenin uzamasi ve komplikasyon gelisme riskinin olmasi, genel anestezide ise hastanin uygulama sonrasinda hastanin uzun süre anestezi etkisinde kalmasi ve bunun da hasta konforunu azaltmasi, - Sütürün amniyon zarindan erken kopmasi ve amniyon zarinin ayrilmasi, uygulama sirasinda konjoktival hemaroji, sütüre bagli gelisen enfeksiyon, sütürün geçtigi yerde olusan konjoktival skar, kanama gibi komplikasyonlarin gerçeklesmesi ve - Kanama pihtilasma sorunu olan hastalarda sütürlü uygulama yapilamamasi, - Hem hasta hem hekim açisindan zorlu bir ameliyat olmasi, gibi dezavantajlari bulunmaktadir. In the state of the art, amniotic membrane transplantation, amniotic membrane suture It is performed by suturing it to the conjunctiva or cornea tissue using This amniotic membrane implantation method; - Administration of local or general anesthesia; patient-surgeon in local anesthesia prolonged period of non-compliance and the risk of developing complications, general In anesthesia, after the application of the patient, the patient is under anesthesia for a long time. effect, which reduces patient comfort, - Premature rupture of the suture from the amniotic membrane and separation of the amniotic membrane, application conjunctival hemorrhage, suture-related infection, the occurrence of complications such as conjunctival scarring, bleeding, and - Inability to apply sutures in patients with bleeding and coagulation problems, - It is a difficult operation for both the patient and the physician, has such disadvantages.

Yukarida bahsedilen yöntem disinda, amniyon zari transplantasyonu uygulamasi ile ilgili mevcut teknikte; donmus ya da kurutulmus hazir amniyon zarinin önceden tutturuldugu ve sütürsüz olarak kullanilan hazir halkalar kullanilmaktadir. Mevcut halka sisteminin yapisi sert polimetil metakrilat (PMMA) malzemesinden olusmaktadir ve söz konusu halka oldukça kalindir. Bu da transplantasyon uygulanan hastanin gözüne rahatsizlik vermektedir. Ayrica, yuvarlak olan bu halkalar uygulama sonrasi gözden çikabilmekte ve uygulama basarisiz olabilmektedir. Söz konusu halkalara daha önceden islenmis ve kurutulmus ya da dondurulmus amniyon zari hazir olarak tutturulmaktadir ve mevcut halka sistemi oldukça pahalidir. Except for the above-mentioned method, the application of amniotic membrane transplantation in the current technique; where the frozen or dried amniotic membrane is pre-attached and ready-made rings used without suture are used. existing ring system Its structure consists of hard polymethyl methacrylate (PMMA) material and the ring in question it is quite thick. This causes discomfort in the eyes of the transplanted patient. gives. In addition, these round rings can come out of sight after the application and application may fail. The rings in question have already been engraved and the dried or frozen amniotic membrane is readily attached and the existing ring system is quite expensive.

Söz konusu bulus; amniyon zari transplantasyonunda kullanilmak üzere gelistirilen ve amniyon zarinin tutunmasi için en az bir halka ve bir tabladan olusan bir sistem ve bu sistemin amniyon zari transplantasyonunda kullanimi ile ilgilidir. The invention in question; developed for use in amniotic membrane transplantation and a system consisting of at least one ring and a plate for the attachment of the amniotic membrane, and this It is related to the use of the system in amniotic membrane transplantation.

Bulusun Kisa Açiklamasi ve Amaçlari Mevcut bulus; teknigin bilinen durumundaki sorunlari ortadan kaldiran ve oküler yüzeye amniyon zari transplantasyonunun sütürsüz olarak uygulandigi amniyon zari halkasi ve tabladan olusan bir sistem ile ilgilidir. Brief Description and Objectives of the Invention The present invention; to the ocular surface, which eliminates the problems in the state of the art and amniotic membrane ring in which amniotic membrane transplantation is performed without suture, and It relates to a system consisting of a table.

Bulusun bir amaci; taze ya da dondorulmus amniyon zarinin oküler yüzeye etkin bir sekilde uygulanmasini saglamaktadir. An aim of the invention is; effective attachment of fresh or frozen amniotic membrane to the ocular surface. ensures its implementation.

Bulusun bir diger amaci; ameliyathane kosullari gerekmeksizin amniyon zari transplantasyonu uygulanabilmesini saglamaktir. Another purpose of the invention; amniotic membrane without operating room conditions to ensure that transplantation can be performed.

Bulusun bir diger amaci; maliyeti düsük bir amniyon zari transplantasyonu sistemi gelistirmektedir. Another purpose of the invention; an inexpensive amniotic membrane transplantation system is developing.

Bulusun bir diger amaci; amniyon zari trasplantasyonu yapilan hastanin gözüne mevcut teknige göre daha az rahatsizlik vererek hastaya maksimum konfor saglamaktir. Another purpose of the invention; The present in the eye of the patient who underwent amniotic membrane transplantation It is to provide maximum comfort to the patient by giving less discomfort than the technique.

Bu amaçlar kapsaminda gerçeklestirilen bulusa konu amniyon zari halkasi, mevcut teknikte kullanilan malzemeden daha yumusak bir malzemeden ve kalinliktan olusmaktadir. Bu da hastanin gözüne daha az zarar vermekte ve hasta için daha konforlu bir uygulama yapilmasini saglamaktadir. Bulusta taze ya da dondurulmus amniyon zari kullanilmakta olup; hastanelerde dogumdan sonra atilan amniyon zarlarinin enfeksiyon açisindan gerekli testlerin yapilmasi sonrasi elde edilmektedir. Bu da hem taze ya da dondurulmus amniyon zari kullanimindan dolayi oküler yüzey tedavisinin çok daha etkin olmasini saglamakta, ayni zamanda da maliyeti düsürmektedir. Bulus konusu sistemin maliyeti tek nikte mevcut olanlara oranla 1/100'ü kadardir. Ayrica; söz konusu bulusun uygulanmasinda sütür kullanilmamaktadir. The amniotic membrane ring, which is the subject of the invention carried out within the scope of these purposes, of a softer material and thickness than the material used in the art. is formed. This causes less damage to the patient's eyes and is more comfortable for the patient. provides an application. In the invention, fresh or frozen amniotic membrane is being used; infection of the amniotic membranes discarded after birth in hospitals It is obtained after performing the necessary tests in terms of This is either fresh or Ocular surface treatment is much more effective due to the use of frozen amniotic membrane. and at the same time, it reduces the cost. The system of the invention The cost is 1/100th of what is available in single nike. Moreover; find out No sutures are used in its application.

Bulusu Açiklayan Sekillerin Tanimlari Sekil 1: Bulusa konu amniyon zari transplantasyon sistemi. Description of Figures Explaining the Invention Figure 1: The amniotic membrane transplantation system of the invention.

Sekil 2: Amniyon zari halkasinin genel görünüsü. Figure 2: General view of the amniotic membrane ring.

Sekil 3: Amniyon zari halkasinin pütürlü yüzey yapisinin 40X büyütmeli biyomikroskop ile elde edilmis mikroskop görüntüsü. Figure 3: 40X magnification of the rough surface structure of the amniotic membrane ring Microscope image obtained with a biomicroscope.

Sekil 4: Bulusa konu tablanin görünüsü. Figure 4: Appearance of the plate that is the subject of the invention.

Sekil 5: Amniyon zarinin (30) tablanin (20) üzerine yerlestirilmesi ve kenarlardan fazlalik zarin kesilmesi isleminin görünüsü. Figure 5: Placement of the amniotic membrane (30) on the plate (20) and from the sides The appearance of the cutting process of the excess membrane.

Sekil 6: Amniyon zari (30) yerlestirilmis tablanin (20) görünüsü. Figure 6: View of the plate (20) with the amniotic membrane (30) inserted.

Sekil 7: Amniyon zarinin (30) tabla (20) üzerinde en dis kismindan içeri dogru Sekil 8: Amniyon zari stromal yüzeyinin halkanin pütürlü yüzeyini örterek pütürlü yüzeye yapistigi amniyon zari transplantasyon sisteminin bir görünüsü. Figure 7: Inward from the outermost part of the amniotic membrane (30) on the plate (20) Figure 8: The stromal surface of the amniotic membrane is rough, covering the rough surface of the ring. A view of the amniotic membrane transplantation system attached to the surface.

Sekil 9: Sütürsüz amniyon zari halkasinin kullanima uygun olarak hazirlanmis son hali ve tabla görünüsü. Figure 9: The end of the sutureless amniotic membrane ring prepared for use state and table view.

Sekil 10: Bulusun bir uygulamasinda kullanilan köseli halkanin (a) üstten ve yandan (b) görünüsü. Figure 10: Top and side of the angular ring (a) used in an embodiment of the invention (b) appearance.

Sekil 11: Delikli amniyon zari halkasinin (40) görünüsü. Figure 11: View of the perforated amniotic membrane ring (40).

Sekil 12: Iki halkali amniyon zari halkasi sistemi. Figure 12: The bicyclic amniotic ring system.

Sekil 13: Ince amniyon zari halkasi. Figure 13: Thin amniotic ring.

Bulusu Olusturan UnsurlarinlKisimIarin/Parçalarin Tanimlari Bu bulus ile gelistirilen amniyon zari transplantasyon sisteminin daha iyi açiklanabilmesi için sekillerde yer alan parça ve kisimlar numaralandirilmis olup, her bir numaranin karsiligi asagida verilmektedir: .Amniyon zari halkasi 11.K0nkav yüzey 12. Konveks yüzey .Tabla 21.Tepe 22. Oluk .Amnion zari 31 .Amnion zarinin stromal yüzü 32. Amnion zarinin epitelyal yüzü 40. Delikli amniyon zari halkasi 41. Delik 50. Ikili halka sistemi 51.Kalin halka 52. Ince halka Bulusun Ayrintili Açiklamasi Söz konusu bulusta; amniyon zari transplanstasyonunda kullanilmak üzere gelistirilmis, en az bir halka ve bir tabla içeren bir sistem açiklanmaktadir. Definitions of Invention Elements,Parts/Parts To better explain the amniotic membrane transplantation system developed with this invention. The parts and sections in the figures are numbered for each number. is given below: .Amniotic membrane ring 11.Knkav surface 12. Convex surface .Table 21. Hill 22. Groove .Amnion membrane 31. Stromal surface of the amniotic membrane 32. Epithelial surface of the amniotic membrane 40. Perforated amniotic membrane ring 41. Hole 50. Double ring system 51.Thick ring 52. Thin ring Detailed Description of the Invention In the invention in question; Developed for use in amniotic membrane transplantation, A system comprising at least one ring and a plate is described.

Bulusta hastanelerde dogumdan sonra atilan amniyon zarlarinin enfeksiyon açisindan gerekli testlerin yapilmasi sonrasi elde edilen taze amniyon zari (30) kullanilmaktadir. In the invention, the amniotic membranes discarded after birth in hospitals in terms of infection. The fresh amniotic membrane (30) obtained after the necessary tests are used is used.

Amniyon zari transplantasyon sisteminin hazirlanma yöntemi; - Steril ortam üzerine tabla (20) konulmasi, - Amniyon zarinin (30) tablanin (20) üzerine amnion zarinin (30) stromal yüzü (31) yukari bakacak sekilde yerlestirilmesi ve tablanin (20) üzerinde yayilmasi, - Tablanin (20) kenarlarindan sarkan fazlalik amnion zarinin (30) kesilmesi, - Amnion zarinin (30) stromal tarafinin (31) yukari baktigini anlamak için küçük üçgen sünger veya pamuk çubuk ile yapisma testi yapilmasi, - Amniyon zarinin oluk (22 ) içine yerlestirilmesi, - Tabla (20) üzerine yerlestirilen amniyon zari (30) üzerine amniyon zari halkasinin (10) konkav (iç bükey) yüzeyi (11) yukari ve konveks (dis bükey) yüzeyi (12) oluk (22) içine oturacak sekilde yerlestirilmesi, - Amniyon zarinin (30) kenar kismindan ince forsepsler yardimiyla distan içe dogru katlanarak amnion zari stromal yüzeyinin (31) amniyon zari halkasinin (30) pütürlü yüzeyini örtmesi ve pütürlü yüzeye yapismasi ile amniyon zarinin epitelyal yüzeyin (32) halkanin kenarlarini kaplamasi, Böylelikle, bu islem sirasinda tablanin (20) üzerine yerlestirilen amniyon zarina (30) tablanin (20) tepe (21) bölümünün yapmis oldugu çikinti sayesinde islem sonunda amniyon zarinda potansiyel bir rezerv bosluk olusturulmaktadir. Bu potansiyel rezerv bosluk, amniyon zari tutturulmus amniyon zari halkasinin (10) göz yüzeyine yerlestirilmesi esnasinda ve sonrasinda korneanin öne yaptigi ileri dogru itme hareketi için telafi edici bir fayda saglamakta; halkanin öne dogru itilmesini engelleyerek halkanin göz yüzeyinde daha düzenli ve sabit kalmasini saglamaktadir. Preparation method of amniotic membrane transplantation system; - Placing the tray (20) on the sterile environment, - The stromal surface of the amniotic membrane (30) on the plate (20) of the amniotic membrane (30) (31) be placed facing up and spread over the table (20), - Cutting the excess amniotic membrane (30) hanging from the edges of the plate (20), - Small enough to understand that the stromal side (31) of the amniotic membrane (30) is facing upwards. adhesion test with triangular sponge or cotton swab, - Placing the amniotic membrane in the groove (22), - The amniotic membrane ring (30) placed on the plate (20) (10) concave (concave) surface (11) upward and convex (concave) surface (12) groove (22) to be placed in such a way that it will fit inside, - From the margin of the amniotic membrane (30) to the outside inward with the help of fine forceps roughness of the amniotic membrane stromal surface (31) of the amniotic membrane ring (30) by folding the epithelial surface of the amniotic membrane by covering its surface and adhering to the rough surface. (32) covers the edges of the ring, Thus, during this procedure, the amniotic membrane (30) placed on the plate (20) At the end of the process, thanks to the protrusion made by the top (21) part of the table (20) A potential reserve space is created in the amniotic membrane. This potential reserve cavity, placement of the amniotic membrane ring (10) attached to the eye surface compensatory for the forward thrust of the cornea during and after provides a benefit; on the eye surface of the ring by preventing the ring from being pushed forward It keeps it more regular and stable.

Tercih durumuna göre amniyon zari (30), kenar kismindan ince forsepsler yardimiyla distan içe dogru katlanarak amnion zari stromal yüzeyinin (31) halkanin (10 ) daha iç kisminda ve tepe (11) kismini örten amnion zari stromal yüzeyi (31 ) ile yapismasi saglanir. Olusturulan sütürsüz amnion zari halkasi kullanima uygun ve hazir hale gelir Bulus konusu amniyon zari halkasi (10), korneanin ve oküler yüzeyin dis kisimlarina uyacak sekilde egrilige sahip konkav iç yüze ve konveks dis yüze sahip ve pütürlü yapida olup; tercihen poliamid malzemeden mamul edilmektedir. Bulusta kullanilan amniyon zari halkasi (10), pütürlü yapisindan dolayi (Sekil 3) amniyon zarini (30) siki bir sekilde tutabilmekte ve göz hareketleri ile kayma meydana gelmemektedir. Amniyon zari halkasinin (10) pütürlü yüzeyi; her türlü girintili çikintili, pürüzsüz olmayan, yüzey tutunmasini arttiracak yapidadir. Bulusta tercihen pütürlü malzeme özel bir malzeme olan poliamid 11 (PA11) kullanilmakta olup, SLS talaslama teknigi ile üretilmektedir. Bulusa konu amniyon zari halkasinin (10) bu pütürlü yüzeyi sayesinde, amniyon zarinin (30) kendi üzerinde kaymasi engellenerek zarin halka üzerinde yapisik durmasi saglanmaktadir. amniyon zari halkasinin (10) yapimi için kullanilan malzeme poliamid 11 (PA11) haricinde diger poliamid türevleri veya metalden de mamul olabilir. Bulusta metal olarak; tercihen paslanmaz çelik, titanyum, alüminyum, nitinol kullanilabilir. Bulusta poliamid haricinde; polimetilmetakrilat (PMMA), polivinil klorür (PVC), polietilen (PE), düsük yogunluklu polietilen (LDPE), yüksek yogunluklu polietilen (HDPE), politetrafloroetilen (Teflon), polipropilen (PP), polietilen tereftalat (PET, PETE), dogal kauçuk, polibütadien, nitril kauçuk, neopren, silikon veya etilen vinil asetat kullanilabilir. Depending on the preference, the amniotic membrane (30) is removed from the edge with the help of thin forceps. the stromal surface of the amniotic membrane (31) is folded inward from the distal to the inner part of the ring (10). Adhesion of the amniotic membrane covering the apex (11) and the apex (11) with its stromal surface (31). is provided. The formed sutureless amniotic membrane ring becomes suitable and ready for use. The amniotic membrane ring (10), the subject of the invention, is attached to the outer parts of the cornea and ocular surface. It has a concave inner surface and a convex outer surface that is curved to fit and has a rough structure. is; preferably made of polyamide material. The amniotic membrane used in the invention ring (10), due to its rough structure (Fig. 3) and no slippage occurs with eye movements. amniotic membrane the rough surface of the ring (10); any indented, non-smooth, surface It has a structure that will increase its adhesion. In the invention, preferably the rough material is a special material. polyamide 11 (PA11) is used and it is produced by SLS machining technique. find it Thanks to this rough surface of the subject amniotic membrane ring (10), the amniotic membrane (30) The membrane is stuck on the ring by preventing it from slipping on itself. is provided. The material used for the construction of the amniotic membrane ring (10) is polyamide 11 Apart from (PA11), it can also be made of other polyamide derivatives or metal. metal in the invention aspect; preferably stainless steel, titanium, aluminum, nitinol can be used. in the find except polyamide; polymethylmethacrylate (PMMA), polyvinyl chloride (PVC), polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), polytetrafluoroethylene (Teflon), polypropylene (PP), polyethylene terephthalate (PET, PETE), natural rubber, polybutadiene, nitrile rubber, neoprene, silicone or ethylene vinyl acetate can be used.

Bulusun bir uygulamasinda; amniyon zari transplanstasyon sistemi iki ayri amniyon zari halkasi (10) içermektedir. Bu ikili halka sisteminde; biri kalin halka (51) biri ince halka (52) olacak sekilde, ince halka dis çapi ile kalin halka iç çapi birbirlerine siki siki geçecek yapida olup, halkalarin arasina amniyon zari (30) sikistirilarak tutturulmaktadir. In one embodiment of the invention; amniotic membrane transplantation system two separate amniotic membranes ring (10). In this double ring system; one thick ring (51) one thin ring (52) The thin ring outer diameter and the thick ring inner diameter will fit tightly together so that It has a structure and is attached between the rings by compressing the amniotic membrane (30).

Bulusun bir baska uygulamasinda; amniyon zari transplanstasyon sistemi sadece bir ince halka (52) içerip, amnion zarinin en dis kismindan içeri dogru katlanarak amniyon zari stromal yüzeyi (31) halkanin içinde bulunan amnion zarinin stromal yüzeyi (31) ile yapistirilmaktadir. In another embodiment of the invention; amniotic membrane transplant system is just a thin contains the ring (52) and folds inward from the outermost part of the amniotic membrane to form the amniotic membrane. Its stromal surface (31) is combined with the stromal surface (31) of the amniotic membrane inside the ring. is being pasted.

Bulusun bir baska uygulamasinda; amniyon zari halkasi (10) üzerinde delikler (41) içermektedir. Delikler (41) dairesel veye kare seklindedir. Bu uygulamada, amniyon zari (30) delikli amniyon zari halkasina (40) cerrahi sütür ile deliklerden geçirilerek dikilmekte ve zarin dikisli olarak delikli amniyon zari halkasina (40) tutturulmasi saglanmaktadir. In another embodiment of the invention; holes (41) on amniotic membrane ring (10) contains. The holes 41 are circular or square in shape. In this application, amniotic membrane (30) is sutured to the perforated amniotic membrane ring (40) by passing it through the holes with surgical sutures. and it is ensured that the membrane is stitched to the perforated amniotic membrane ring (40).

Bulusa konu tabla (20); tabla (20) ortasinda egimi korneanin arka yüzey egimi ile uyumlu olan bir tepe (21) bölümü ile bu tepeyi çevreleyen ve amniyon zari halkasinin (10) yerlestirildigi oluk (22) bölümü içermektedir. Tabla (20), tepe (21) ve oluk (22); tercihen daire seklinde olup, köseli yapida (dikdörtgen vb.) da olabilir. Tabla (20) için kullanilan malzeme poliamid (PA11) ve bunun haricinde diger poliamid türevleri veya metalden mamul olabilir. Bulusta metal olarak; tercihen paslanmaz çelik, titanyum, alüminyum, nitinol kullanilabilir. Bulusta tabla malzemesi olarak poliamid haricinde; polimetilmetakrilat (PMMA), polivinil klorür (PVC), polietilen (PE), düsük yogunluklu polietilen (LDPE), yüksek yogunluklu polietilen (HDPE), politetrafloroetilen (Teflon), polipropilen (PP), polietilen tereftalat (PET, PETE), dogal kauçuk, polibütadien, nitril kauçuk, neopren, silikon veya etilen vinil asetat kullanilabilir. Bulusun tercih edilen bir uygulamasinda; amnion zarini tutturmak kullanilan tabla, daire veya köseli (dikdörtgen vb) yapidadir. Tablanin köseli yapida olmasi durumunda, tabla göz küresinin egimine uygun olacak sekilde hafif egime sahiptir. The inventive tray (20); in the middle of the table (20), its slope is consistent with the posterior surface of the cornea. with a crest (21) that surrounds this crest and is surrounded by the amniotic membrane ring (10) the groove (22) in which it is placed. The plate (20), the apex (21) and the trough (22); preferably It is in the shape of a circle, and it can also be in a angular structure (rectangular, etc.). used for the table (20) the material is polyamide (PA11) and other polyamide derivatives or metal may be the product. As metal in the invention; preferably stainless steel, titanium, aluminum, nitinol can be used. In the invention, apart from polyamide as a table material; polymethylmethacrylate (PMMA), polyvinyl chloride (PVC), polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), polytetrafluoroethylene (Teflon), polypropylene (PP), polyethylene terephthalate (PET, PETE), natural rubber, polybutadiene, nitrile rubber, neoprene, silicone or ethylene vinyl acetate can be used. In a preferred embodiment of the invention; amniotic membrane The table used for fastening is circular or angular (rectangular, etc.). corner of the table in the case of the structure, the table should be slightly inclined to match the inclination of the eyeball. has.

Bulusa konu amniyon zari transplantasyon sisteminin uygulanma yöntemi; hazirlanan sistemdeki halkanin alinarak hastanin gözünün ön yüzüne yerlestirilmesi islem adimini içermektedir. The method of application of the amniotic membrane transplantation system, which is the subject of the invention; prepared Taking the ring in the system and placing it on the front of the patient's eye completes the process step. contains.

Claims (1)

ISTEMLER . Sütürsüz uygulanabilen amniyon zari transplantasyon sistemi olup özelligi; korneanin ve oküler yüzeyin dis kisimlarina uyacak sekilde egrilige sahip konkav iç yüze ve konveks dis yüze sahip ve pütürlü yapida en az bir amniyon zari halkasi (10) ve ortasinda egimi korneanin arka yüzey egimi ile uyumlu olan bir tepe (21) bölümü ile bu tepeyi çevreleyen ve amniyon zari halkasinin (10) yerlestirildigi oluk (22) bölümünü ihtiva eden bir tabla (20) içermesidir. . istem 1'e göre bir sistem olup özelligi; amniyon zari halkasinin (10) poliamid . istem 2'ye göre bir sistem olup özelligi; amniyon zari halkasinin (10) poliamid 11 (PA11) malzemesinden mamul olmasidir. . istem 1'e göre sistem olup özelligi; amniyon zari halkasinin (10) polimetilmetakrilat (PMMA), polivinil klorür (PVC), polietilen (PE), düsük yogunluklu polietilen (LDPE), yüksek yogunluklu polietilen (HDPE), politetrafloroetilen (Teflon), polipropilen (PP), polietilen tereftalat (PET, PETE), dogal kauçuk, polibütadien, nitril kauçuk, neopren, silikon veya etilen vinil asetat malzemesinden mamul olmasidir. . istem 1'e göre sistem olup özelligi; amniyon zari halkasinin (10) paslanmaz çelik, titanyum, alüminyum, nitinol malzemesinden mamul olmasidir. . istem 'lie göre bir sistem olup özelligi; bir adet ince amniyon zari halkasi (10) içermesidir. . Istem1”e göre bir sistem olup özelligi; biri kalin halka (51) biri ince halka (52) olmak üzere iki adet amniyon zari halkasi (10) içermesidir. . istem T'ye göre bir sistem olup özelligi; amniyon zarininin (30) sikistirilmasi için ince halkanin (52) dis çapi ile kalin halkanin (51) iç çapinin birbirlerine siki siki geçecek yapida olmasidir. . istem 1'e göre bir sistem olup özelligi; tablanin (20), tablanin tepe (21) ve oluk (22) bölümlerinin dairesel veya köseli yapida olmasidir. 10.istem 1'e göre bir sistem olup özelligi; tablanin (20) poliamid 11 (PA11), polimetilmetakrilat (PM MA), polivinil klorür (PVC), polietilen (PE), düsük yogunluklu polietilen (LDPE), yüksek yogunluklu polietilen (HDPE), politetrafloroetilen (Teflon), polipropilen (PP), polietilen tereftalat (PET, PETE), dogal kauçuk, polibütadien, nitril kauçuk, neopren, silikon veya etilen vinil asetat malzemesinden mamul olmasidir. 11.lstem 1'e göre bir sistem olup özelligi; tablanin paslanmaz çelik, titanyum, alüminyum, nitinol malzemesinden mamul olmasidir. 12.Istem 1-11'den herhangi birine göre bir sütürsüz amniyon zari transplantasyon sisteminin amniyon zarinin (30) oküler yüzeye uygulanmasi için kullanimi. 13. Istem 1-11'den herhangi birine göre bir amniyon zari transplantasyon sisteminin hazirlanma yöntemi olup özelligi; Steril ortam üzerine tabla (20) konulmasi, Amniyon zarinin (30) tablanin (20) üzerine amnion zarinin (30) stromal yüzü (31) yukari bakacak sekilde yerlestirilmesi ve tablanin (20) üzerinde yayilmasi, Tablanin (20) kenarlarindan sarkan fazlalik amnion zarinin (30) kesilmesi, Amnion zarinin (30) stromal tarafinin (31) yukari baktigini anlamak için küçük üçgen sünger veya pamuk çubuk ile yapisma testi yapilmasi, Amniyon zarinin oluk (22 ) içine yerlestirilmesi, Tabla (20) üzerine yerlestirilen amniyon zari (30) üzerine amniyon zari halkasinin (10) konkav yüzeyi (1 1)yukari ve konveks yüzeyi (12) oluk (22) içine oturacak sekilde yerlestirilmesi, Amniyon zarinin (30) kenar kismindan ince forsepsler yardimiyla distan içe dogru katlanarak amnion zari stromal yüzeyinin (31) amniyon zari halkasinin (30) pütürlü yüzeyini örtmesi ve pütürlü yüzeye yapismasi ile amniyon zarinin epitelyal yüzeyin (32) halkanin kenarlarini kaplamasi, 14.Istem 13”e göre bir yöntem olup özelligi; kullanilan amniyon zarinin (30) taze veya dondurulmus olmasidir.REQUESTS . It is an amniotic membrane transplantation system that can be applied without suture, and its feature is; It has a concave inner surface and a convex outer surface that is curved to fit the outer parts of the cornea and ocular surface, and has at least one amniotic membrane ring (10) in a rough structure and a apex (21) in the middle whose slope is compatible with the posterior surface of the cornea. and a plate (20) containing the groove (22) in which the amniotic membrane ring (10) is placed. . It is a system according to claim 1 and its feature is; polyamide of the amniotic membrane ring (10). It is a system according to claim 2 and its feature is; the amniotic membrane ring (10) is made of polyamide 11 (PA11) material. . It is a system according to claim 1 and its feature is; amniotic membrane ring (10) polymethylmethacrylate (PMMA), polyvinyl chloride (PVC), polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), polytetrafluoroethylene (Teflon), polypropylene (PP), polyethylene terephthalate (PET) , PETE), natural rubber, polybutadiene, nitrile rubber, neoprene, silicone or ethylene vinyl acetate material. . It is a system according to claim 1 and its feature is; The amniotic membrane ring (10) is made of stainless steel, titanium, aluminum, and nitinol. . It is a system according to the claim and its feature is; one thin amniotic membrane ring (10). . It is a system according to Claim1 and its feature is; It contains two amniotic membrane rings (10), one of which is a thick ring (51) and the other is a thin ring (52). . It is a system according to claim T and its feature is; The outer diameter of the thin ring (52) and the inner diameter of the thick ring (51) must be in a structure to fit tightly to each other in order to compress the amniotic membrane (30). . It is a system according to claim 1 and its feature is; the table (20), the top (21) and the groove (22) sections of the table are circular or angular. 10. It is a system according to claim 1 and its feature is; board (20) polyamide 11 (PA11), polymethylmethacrylate (PM MA), polyvinyl chloride (PVC), polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), polytetrafluoroethylene (Teflon), polypropylene (PP) It is made of polyethylene terephthalate (PET, PETE), natural rubber, polybutadiene, nitrile rubber, neoprene, silicone or ethylene vinyl acetate material. 11. It is a system according to claim 1 and its feature is; the table is made of stainless steel, titanium, aluminum, nitinol material. 12. Use of a sutureless amniotic membrane transplantation system according to any one of claims 1-11 for application of the amniotic membrane (30) to the ocular surface. 13. A method of preparing an amniotic membrane transplantation system according to any one of claims 1-11, characterized in that; Placing the plate (20) on the sterile medium, placing the amniotic membrane (30) on the plate (20) with the stromal side of the amniotic membrane (30) facing upwards and spreading it on the plate (20), removing the excess amniotic membrane hanging from the edges of the plate (20). (30) cutting, performing adhesion test with a small triangular sponge or cotton swab to understand that the stromal side of the amniotic membrane (30) (31) is facing upwards, placing the amniotic membrane into the groove (22), Amniotic membrane placed on the table (20) (30) placing the amniotic membrane ring (10) on it in such a way that the concave surface (1 1) is up and the convex surface (12) fits into the groove (22), The edge of the amniotic membrane (30) is folded from the outside inward with the help of thin forceps, and the amniotic membrane stromal surface (31) 14. It is a method according to claim 13, in which the amniotic membrane ring (30) covers the rough surface and adheres to the rough surface, and the epithelial surface (32) of the amniotic membrane covers the edges of the ring. whether the amniotic membrane (30) used is fresh or frozen.
TR2019/06563A 2019-05-02 2019-05-02 An amniotic membrane transplantation system. TR201906563A2 (en)

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