TR202022813A1 - Corneal marker. - Google Patents

Corneal marker.

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Publication number
TR202022813A1
TR202022813A1 TR2020/22813A TR202022813A TR202022813A1 TR 202022813 A1 TR202022813 A1 TR 202022813A1 TR 2020/22813 A TR2020/22813 A TR 2020/22813A TR 202022813 A TR202022813 A TR 202022813A TR 202022813 A1 TR202022813 A1 TR 202022813A1
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Turkey
Prior art keywords
marking
alignment
marker
corneal
cornea
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TR2020/22813A
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Turkish (tr)
Inventor
Can Ertuğrul
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Ondokuz Mayis Ueniversitesi
Ondokuz Mayis Üni̇versi̇tesi̇
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Application filed by Ondokuz Mayis Ueniversitesi, Ondokuz Mayis Üni̇versi̇tesi̇ filed Critical Ondokuz Mayis Ueniversitesi
Priority to TR2020/22813A priority Critical patent/TR202022813A1/en
Priority to PCT/TR2021/051556 priority patent/WO2022146380A2/en
Publication of TR202022813A1 publication Critical patent/TR202022813A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/14Arrangements specially adapted for eye photography
    • A61B3/15Arrangements specially adapted for eye photography with means for aligning, spacing or blocking spurious reflection ; with means for relaxing
    • A61B3/152Arrangements specially adapted for eye photography with means for aligning, spacing or blocking spurious reflection ; with means for relaxing for aligning
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • 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
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/013Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
    • A61F9/0136Mechanical markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937Visible markers

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Ophthalmology & Optometry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Eye Examination Apparatus (AREA)
  • Prostheses (AREA)

Abstract

Buluş, astigmatizması olan gözlerde katarakt ameliyatı öncesinde korneadaki astigmatik ekseni işaretlemeyi sağlayan bir kornea işaretleyici ile ilgilidir. Buluşa konu kornea işaretleyici ile tek kullanımlık ve sterilizasyona gerek duyulmadan kullanılabilen, ergonomik yapıda, yüksek hassasiyet ile hizalama ve işaretleme yapabilen, tekrar ayarlama/yerleştirme yapılmasına izin veren, düşük maliyetli ve kolay ulaşılabilir bir kornea işaretleyici sağlanmaktadır.The invention relates to a corneal marker that enables marking the astigmatic axis in the cornea before cataract surgery in eyes with astigmatism. With the corneal marker, which is the subject of the invention, a low cost and easily accessible corneal marker is provided, which can be used without the need for sterilization, has an ergonomic structure, can align and mark with high precision, and allows re-adjustment/placement.

Description

TARIFNAME KORNEA ISARETLEYICI Bulusun Ilgili Oldugu Teknik Alan Bulus, astigmatizmasi olan gözlerde katarakt ameliyati öncesinde korneadaki astigmatik ekseni isaretlemeyi saglayan bir kornea isaretleyici ile ilgilidir. Teknigin Bilinen Durumu Kornea, gözün en ön kisminda bulunan, isigi kiran ve gözü dis etkilerden koruyan, küresel ve saydam yapida olan damarsiz tabakadir. Katarakt ise göz içerisinde yer alan mercegin seffafligini yitirerek, göz merceginin matlasmasi ile ortaya çikan göz hastaligi olup, katarakt cerrahisi günümüzde göz hekimleri tarafindan uygulanan cerrahi girisimlerin ilk siralarinda yer almaktadir. Katarakt ameliyati sirasinda korneal astigmatizmanin düzeltilmesi için astigmatizm dik meridyeninin hassas bir sekilde hizalanmasi gerekmektedir. Söz konusu dik meridyeninin kesin olarak isaretlenmesi çok önemlidir çünkü yanlis hizalama astigmatin azaltilmasinda önemli bir kayipla sonuçlanabilir. Mevcut geleneksel isaretleme cihazlarinin ve yöntemlerinin çogu ile astigmatik eksendeki isaretler dogru konuma yerlestirilememektedir. Isaretlemede 10 derecelik bir sapma, yaklasik olarak istenen astigmat azalmasinin üçte birinin kaybedilmesiyle sonuçlanmaktadir. Astigmatizmasi olan gözlerde katarakt ameliyati öncesinde korneadaki astigmatik ekseni isaretlemek için kullanilan aparatlar teknigin bilinen durumunda mevcuttur. Önceki teknikte yer alan kornea isaretleyici aparatlarin çogu tekrar kullanilabilir özelliktedir ve her isaretleme öncesinde steril edilmeleri gerekir. Söz konusu aparatlarin maliyeti yüksek oldugu için sinirli sayida temin edilmektedir ve hekimler tarafindan her kullanimda steril edilmesi gerekmektedir. Bu islem zaman kaybi ve islem zorluguna neden olmaktadir. Mevcut teknikte yer alan tek kullanimlik kornea isaretleyiciler ise hassas ölçüm, hizalama ve dogru isaretleme konusunda yetersiz kalmaktadir. Ayni zamanda, önceki teknikte yer alan cihazlar göze dokunur dokunmaz boya ile göz yüzeyini isaretlemekte ve tekrar eden ayarlamalara müsaade etmemektedir. Önceki teknikte yer alan isaretleyicilerde astigmati ayarlamaya yarayan bir skala yer almaktadir. Örnegin hastanin astigmati 72 derece veya 139 derece ise, mevcut isaretleyicilerde skala üzerinde ayarlama yaparak 72 dereceyi veya 139 dereceyi ayarlayabilmek mümkün olsa da bu ayarlamalar en düsük 5 derecelik hassasiyette Bu durum ölçüm ve isaretlemede hassasiyeti düsürmektedir. yerlestirme operasyonlari için kornea üzerinde "astigmat ekseninin isaretlenmesi" isleminin yapilabilmesini saglayan bir kornea astigmatizma isaretleyicisi ve bu isaretleyicinin kullanildigi bir isaretleme yöntemi açiklanmaktadir. Söz konusu isaretleyicide astigmatik ayarlama hassasiyeti 5 derece olarak belirlenmistir ve isaretleyici itme hareketi ile çalismaktadir. Burada yer alan kilavuz ayaklari pivot çubuga baglidir ve aparata sabit yapidadir, isaretleme uçlari ise gövdeye baglidir. Önceki teknikte yer alan Moria tek kullanimlik oftalmik alet ise korneal isaretleme için kullanilmaktadir. Bu alet tek kullanimlik olup, 0-180° ekseninin yani ortadan geçen eksenin hassas isaretlenmesi için kullanilmaktadir. Alet üzerinde dengenin kontrol edilmesi için su terazisi yer almaktadir. Ancak bu alet denge saglanmasi ve hekimin sabit bir sekilde ölçüm ve hizalama yapabilmesi için yetersiz kalmaktadir ve söz konusu alet ile isaretleme sirasinda el titremesine bagli olarak hatali ölçüm yapilabilmektedir. Teknigin bilinen durumunda yer alan EP2688530A1 patent basvurusunda ise uç kismi kullan-at özellikte olan bir göz isaretleme cihazi ve göz isaretleme yöntemleri açiklanmaktadir. Söz konusu cihazin uç kismi kullan-at özellikte olsa da gövde kismi tekrar kullanilabilir yapidadir ve her kullanim öncesi steril edilmesi gerekmektedir. Bu cihazda astigmatik ayarlama hassasiyeti 10 derece olarak belirlenmistir; bu sebeple cihaz hassas ölçüm için yetersiz kalmaktadir. Ek olarak, bu cihazda hizalama ve dengeleme için bir destek bulunmadigindan, hekimin sabit bir sekilde ölçüm ve hizalama yapabilmesi zorlasmaktadir. Ayni zamanda söz konusu cihaz yüksek maliyetli olup her hekim tarafindan ulasilabilir degildir. Mevcut teknikteki kornea isaretleyicilerin tekrar tekrar kullanilmasi dolayisiyla sterilizasyon isleminin zaman kaybina sebep olmasi, islem zorlugu, tekrar ayarlama/yerlestirme yapilmasina izin vermemesi ve bu aparatlar ile yeterince hassas isaretleme yapilamamasi gibi sebepler dolayisiyla; tek kullanimlik ve sterilizasyona gerek duyulmadan kullanilabilen, ergonomik yapida, yüksek hassasiyet ile hizalama ve isaretleme yapabilen, tekrar ayarlama/yerlestirme yapilmasina izin veren, düsük maliyetli ve kolay ulasilabilir kornea isaretleyicilerin gelistirilmesi ihtiyaci bulunmaktadir. Bulusun Kisa Açiklamasi ve Amaçlari Bulus, astigmatizmasi olan gözlerde katarakt ameliyati öncesinde korneadaki astigmatik ekseni isaretlemeyi saglayan bir kornea isaretleyici ile ilgilidir. Bulusun ilk amaci, tek kullanimlik olan ve bu sayede sterilizasyona gerek duyulmadan kullanilabilen bir kornea isaretleyici saglanmasidir. isaretleyicinin tüm parçalarinin tek kullanimlik olmasi ile hastalarda olasi enfeksiyon bulasma riski ortadan kaldirilmaktadir. Kullan-at niteligindeki bu isaretleyici ile her hastaya özel kullanim saglanmaktadir. Bulusun bir diger amaci, kullanimi kolay ve ergonomik yapida bir kornea isaretleyici saglanmasidir. Bulusa konu isaretleyicinin ergonomik yapisi, içerdigi hizalama uçlari ve helezon yayli mekanizmasi sayesinde hekim daha kolay, rahat ve güvenli isaretleme yapabilmektedir. Bu isaretleyici ile ameliyathanede operasyon öncesi kolayca isaretleme yapilabilmektedir. Bulusun bir diger amaci, yüksek hassasiyette ölçüm ve isaretleme yapan bir kornea isaretleyici saglanmasidir. Üretim asamasinda, harici bir skala yardimiyla isaretleyici istenilen derecede, 0-180° arasi 1"er derecelik hassasiyet olacak sekilde, hizalandiktan sonra sabitlenmektedir. Üretim asamasinda her bir hastaya özel olarak, hastanin bu istenilen ekseni (aksi) ayarlanip sabitlenmis olur. Böylece, önceki teknigin aksine isaretleyicinin astigmatik ayarlama hassasiyeti 1 dereceye kadar inmektedir ve bu da çok daha hassas isaretleme yapma imkâni sunmaktadir. Bulus ile sadece 0°, 90° veya 180° degil, 0" ile 180° arasi herhangi bir eksen isaretlenebilmektedir ve korneanin isaretlenmesi islemi tek bir adimda yapilabilmektedir. Bulusun diger bir amaci, yüksek dogrulukta hizalama yapan ve kolay yerlestirilen bir kornea isaretleyici saglanmasidir. Bulusa konu isaretleyici, sahip oldugu hizalama uçlari yardimiyla elde edilen destek sayesinde, isaretleme esnasinda el titremesine bagli olarak hatali ölçüm yapilmasini ve kontrolsüz yerlestirme yapilmasini engellemektedir. Hizalama uçlari yardimiyla isaretleyicinin korneada limbus üzerine yerlestirilerek desteklenmesi ve hizalanmasi saglanmaktadir, dogru hizalamanin saglandigindan emin olunana kadar bu islem tekrarlanabilmektedir. Önceki teknikte yer alan cihazlar göze dokunur dokunmaz boya ile göz yüzeyini isaretleyip, tekrar eden ayarlamalara izin vermezken; bulusun hizalama uçlari ile sagladigi destek sayesinde hizalama tekrar edilebilmekte ve hizalamadan emin olunduktan sonra basi levhasi parmak ile itilerek kornea ve konjonktivada hedeflenen aksin isaretlemesi yapilmaktadir. Böylece bulus ile dogru hizalama, yerlestirme ve isaretleme saglanmaktadir. Bulusun bir diger amaci, düsük maliyetli ve kolay ulasilabilir bir kornea isaretleyici saglanmasidir. Bulus polimer, özellikle termoplastik polimer veya metalden üretilmektedir ve bu malzemelerin kolay ve ucuz bir sekilde temin edilebilmesiyle bulus da düsük maliyetli olarak üretilebilmektedir. Bulus ile tek kullanimlik ve sterilizasyona gerek duyulmadan kullanilabilen, ergonomik yapida, yüksek hassasiyet ile hizalama ve isaretleme yapabilen, tekrar ayarlama/yerlestirme yapilmasina izin veren, düsük maliyetli ve kolay ulasilabilir bir kornea isaretleyici saglanmaktadir. Sekillerin Açiklamasi Sekil 1: Kornea isaretleyicinin serbest konumdaki görseli. Sekil 2: Kornea isaretleyicinin gözü isaretleme esnasinda basi levhasi (7) itilmis haldeki görseli. Sekil 3: Kornea isaretleyicinin gözü isaretleme öncesinde hizalama esnasindaki detay görseli. Sekil 4: Kornea isaretleyicinin gözü isaretleme esnasindaki karsidan detay görseli. Sekil 5: Kornea isaretleyicinin gözü isaretleme esnasindaki yandan detay görseli. Bulusu Olusturan Unsurlarin/Parçalarin Tanimlari Bulus ile gelistirilen kornea isaretleyioinin daha iyi açiklanabilmesi için sekillerde yer alan parça ve kisimlar numaralandirilmis olup, her bir numaranin karsiligi asagida verilmektedir: Hizalama ucu isaretleme ucu Pivot çubuk Helezon yay Basi Levhasi Hizalama aparati . Kornea Bulusun Ayrintili Açiklamasi Bulus, astigmatizmasi olan gözlerde katarakt ameliyati öncesinde korneadaki astigmatik ekseni isaretleme islemini tek bir adimda gerçeklestiren bir kornea isaretleyicidir. Bulusa konu kornea isaretleyici, Sekil 1'de görüldügü üzere: - iç kisminda pivot çubuk (5) ve uç kisminda en az iki hizalama ucuna (1) sahip hizalama aparati (8) bulunan gövde (3), - kornea isaretleyicinin korneada Iimbus üzerine yerlestirilerek desteklenmesini ve hizalanmasi saglayan, gövdenin (3) üç kisminda konumlanmis, en az iki adet hizalama ucu (1) içeren hizalama aparati (8), o kornea ve konjonktivaya aks ile uyumlu isaretin koyulmasini saglayan, pivot çubuga (5) bagli en az iki adet isaretleme ucu (2), o isaretleme uçlari (2) ile basi levhasi (7) arasindaki baglantiyi saglayan, gövdenin (2) iç kisminda konumlanmis pivot çubuk (5), 0 yer çekimi etkisi ile agirlik olusturarak isaretleme uçlarinin (2) önceden ayarlandigi aksta sabit kalmasini saglayan, pivot çubugun (5) alt kisminda konumlanmis topuz (4), o üzerine baski uygulanarak isaretleme yapmak için kullanilan, pivot çubuga (5) bagli konumlanmis basi levhasi (7), - isaretleme uçlarinin (2) ileri itilmesini ve geri eski konumuna dönmesini saglayan, gövde (3) ve basi levhasi (7) arasinda konumlanmis helezon yay (6) içermektedir. Bulusa konu kornea isaretleyicide herhangi bir astigmati ayarlamaya yarayan bir skala yer almamaktadir. Yapim asamasinda hastanin astigmatizmasina özel aksi isaretleyen ve degistirilemeyen bir kisiye özel kornea isaretleyici üretimi söz konusudur. isaretleyicinin yapim asamasinda skala üzerinde hassas olarak eksen ayarlanip isaretleyici istenilen derecede, 0-180° arasi 1'er derecelik hassasiyet olacak sekilde, hizalandiktan sonra sabitlenmektedir. Her kornea isaretleyici kisiye özel olarak üretilmekte ve bu sayede astigmatik ayarlama hassasiyeti 1 dereceye kadar düsürülen bir hassasiyet saglanmaktadir. isaretleme ucu (2) hedeflenen eksen (aks) ile ayni eksene sahiptir. Hedeflenen eksen bulusa konu kornea isaretleyicinin yapim asamasinda sabitlenmistir. Kornea isaretleyici, astigmatik ayarlama hassasiyetinin 1 dereceye kadar inmesi ile çok daha hassas isaretleme yapma imkâni sunmaktadir. isaretlenebilmekte ve korneanin isaretlenmesi islemi tek bir adimda yapilabilmektedir. Istege bagli olarak, hedeflenen eksen önceden sabitlenmis olarak degil, isaretleme esnasinda hasta basinda istenilen ekseni ayarlamaya uygun olacak sekilde de üretilebilir. Bu durumda cihazin üzerine 0-180°'yi gösteren 1'er veya 5'er derecelik hassasiyetli skala eklenebilir. Kisiye özel üretim ve kullanim ile kullan-at özellikte, sterilizasyona gerek duyulmadan kullanilabilen bir isaretleyici saglanmakta ve isaretleyicinin tüm parçalarinin tek kullanimlik olmasi ile hastalarda olasi enfeksiyon bulasma riski ortadan kaldirilmaktadir. Islem sirasinda hastanin gözüne spekulum takilmakta veya spekulum kullanmadan diger elin basparmagi ile hastanin göz kapagi kaldirilmaktadir. Topuz (4) serbest kalacak sekilde kornea isaretleyici hastanin gözüne yaklastirilmaktadir. Kornea isaretleyici ile isaretleme yapacak olan hekim, hizalama ucunu (1) Sekil 2, Sekil 3, Sekil 4 ve Sekil 5'te gösterildigi üzere kornea (10) limbusuna (korneanin siniri) yerlestirmektedir. Bu esnada hekim, kornea isaretleyicinin kaymamasi ve elinin titrememesi için hizalama ucundan (1) destek almaktadir. Isaretleyicinin kornea (10) üzerinde düzgün hizalanmasi saglanamadiysa, kornea isaretleyici geri çekilerek hizalama ucu (1) tekrar korneada (10) Iimbusa yerlestirilir. Böylece dogru hizalama ve yerlestirme saglanarak isaretleme esnasinda ortaya çikacak vertikal hata ortadan kaldirilmis olur. Hizalama uçlari (1) el titremesine bagli olarak hatali ölçüm ve kontrolsüz yerlestirme yapilmasinin önüne geçmektedir. Islem öncesinde göze temas edecek olan isaretleme uçlari (2) boyanmaktadir. Hizalama uçlarinin (1) dogru yerlestiginden emin olunduktan sonra basi levhasi (7) parmak ile itilerek, isaretleme ucu (2) ile kornea (10) ve konjonktivada hedeflenen aksin isaretlenmesi saglanir. Basi levhasindan (7) parmak çekilerek isaretleme islemi tamamlanmis olur. Helezon yay (6) sayesinde isaretleme yapildiktan sonra parmak basi levhasindan (7) çekildiginde isaretleme ucu (2) tekrar eski haline döner. Bulusun hekime destek saglayan hizalama uçlari (1), basiyi kolaylastiran basi levhasi (7) ve isaretleme kolayligi sunan helezon yay (6) sayesinde ergonomik bir kornea isaretleyici saglanmaktadir. Söz konusu kornea isaretleyici tek kullanimlik olup, düsük maliyetli ve kolay ulasilabilir olan polimer, tercihen termoplastik veya metalden mamul edilebilir. Bulusta metal olarak tercihen paslanmaz çelik, titanyum, alüminyum veya nitinol kullanilmaktadir. Polimer olarak tercihen termoplastik, 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 kauçuk veya etilen vinil asetat kullanilmaktadir. TR TR TR TR TR TR DESCRIPTION CORNEA MARKER Technical Field to which the Invention Relates The invention relates to a corneal marker that allows marking the astigmatic axis in the cornea before cataract surgery in eyes with astigmatism. State of the Art The cornea is the avascular layer with a spherical and transparent structure located at the front of the eye, refracting light and protecting the eye from external influences. Cataract is an eye disease that occurs when the lens inside the eye loses its transparency and becomes dull, and cataract surgery is among the top surgical interventions performed by ophthalmologists today. In order to correct corneal astigmatism during cataract surgery, the perpendicular meridian of astigmatism must be precisely aligned. It is very important that the perpendicular meridian in question is precisely marked because misalignment can result in a significant loss of astigmatism reduction. With most of the existing traditional marking devices and methods, the marks on the astigmatic axis cannot be placed in the correct position. A 10-degree deviation in pointing results in the loss of approximately one-third of the desired astigmatism reduction. The devices used to mark the astigmatic axis of the cornea before cataract surgery in eyes with astigmatism are available in the state of the art. Most of the corneal marking devices in the prior art are reusable and must be sterilized before each marking. Since the cost of the devices in question is high, they are supplied in limited numbers and must be sterilized by physicians every time they are used. This process causes loss of time and processing difficulties. Disposable corneal markers in the current technique are inadequate in terms of precise measurement, alignment and accurate marking. At the same time, prior art devices mark the eye surface with paint as soon as it touches the eye and do not allow repeated adjustments. The markers in the prior art include a scale to adjust astigmatism. For example, if the patient's astigmatism is 72 degrees or 139 degrees, although it is possible to adjust 72 degrees or 139 degrees by making adjustments on the scale in the existing markers, these adjustments are at the lowest sensitivity of 5 degrees. This reduces the precision in measurement and marking. A corneal astigmatism marker that allows "marking the astigmatism axis" on the cornea for placement operations and a marking method using this marker are described. The astigmatic adjustment sensitivity of the marker in question is determined as 5 degrees and the marker works with a pushing movement. The guide legs here are connected to the pivot rod and are fixed to the apparatus, while the marking tips are connected to the body. The Moria disposable ophthalmic instrument in the previous technique is used for corneal marking. This tool is disposable and is used for precise marking of the 0-180° axis, that is, the axis passing through the middle. There is a spirit level on the device to check the balance. However, this device is insufficient to ensure balance and for the physician to make stable measurements and alignment, and inaccurate measurements may be made due to hand tremors during marking with the device in question. In the patent application EP2688530A1, which is in the state of the art, an eye pointing device with a disposable tip and eye pointing methods are described. Although the tip of the device in question is disposable, the body part is reusable and must be sterilized before each use. The astigmatic adjustment sensitivity of this device is determined as 10 degrees; For this reason, the device is insufficient for precise measurement. Additionally, this device does not have a support for alignment and balancing, making it difficult for the physician to measure and align stably. At the same time, the device in question is high-cost and not accessible to every physician. Due to reasons such as the repeated use of corneal markers in the current technique, causing the sterilization process to waste time, the difficulty of the process, not allowing re-adjustment/placement, and not being able to make precise enough marking with these devices; There is a need to develop low-cost and easily accessible corneal markers that are disposable and can be used without the need for sterilization, have an ergonomic structure, can align and mark with high precision, and allow readjustment/positioning. Brief Description and Purposes of the Invention The invention relates to a corneal marker that allows marking the astigmatic axis in the cornea before cataract surgery in eyes with astigmatism. The first purpose of the invention is to provide a corneal marker that is disposable and thus can be used without the need for sterilization. Since all parts of the marker are disposable, the risk of possible infection in patients is eliminated. This disposable marker allows specific use for each patient. Another aim of the invention is to provide an easy-to-use and ergonomic corneal marker. Thanks to the ergonomic structure of the marker subject to the invention, the alignment tips it contains and the coil spring mechanism, the physician can make markings more easily, comfortably and safely. With this marker, marking can be made easily before the operation in the operating room. Another aim of the invention is to provide a corneal marker that measures and marks with high precision. During the production phase, with the help of an external scale, the marker is fixed at the desired degree, after being aligned, with a precision of 1 degree between 0-180°. During the production phase, the desired axis (axis) of the patient is adjusted and fixed specifically for each patient. Thus, the previous Unlike the technique, the astigmatic adjustment sensitivity of the marker decreases to 1 degree, which provides the opportunity for much more precise marking. With the invention, not only 0°, 90° or 180°, but any axis between 0" and 180° can be marked, and the process of marking the cornea is a single process. It can be done in steps. Another aim of the invention is to provide a corneal marker that aligns with high accuracy and is easy to place. The marker subject to the invention prevents inaccurate measurements and uncontrolled placement due to hand tremors during marking, thanks to the support obtained with the help of its alignment tips. With the help of alignment tips, the marker is placed on the limbus in the cornea to ensure its support and alignment. This process can be repeated until it is ensured that the correct alignment is achieved. While devices in the previous technique mark the eye surface with paint as soon as it touches the eye and do not allow repeated adjustments; Thanks to the support provided by the alignment tips of the invention, the alignment can be repeated and after ensuring the alignment, the head plate is pushed with the finger and the targeted axis in the cornea and conjunctiva is marked. Thus, correct alignment, placement and marking are achieved with the invention. Another aim of the invention is to provide a low-cost and easily accessible corneal marker. The invention is produced from polymer, especially thermoplastic polymer or metal, and since these materials can be obtained easily and cheaply, the invention can also be produced at low cost. The invention provides a low-cost and easily accessible corneal marker that is disposable and can be used without the need for sterilization, has an ergonomic structure, can align and mark with high precision, and allows re-adjustment/positioning. Explanation of Figures Figure 1: Image of the corneal marker in a free position. Figure 2: Visual of the corneal marker with the head plate (7) pushed while marking the eye. Figure 3: Detail image of the corneal marker during alignment before marking the eye. Figure 4: Detail image from the front of the corneal marker while marking the eye. Figure 5: Side detail image of the corneal marker while marking the eye. Definitions of the Elements/Parts Composing the Invention In order to better explain the corneal marking device developed with the invention, the parts and parts in the figures are numbered and the equivalent of each number is given below: Alignment tip marking tip Pivot rod Helical spring Head Plate Alignment apparatus. Cornea Detailed Description of the Invention The invention is a corneal marker that performs the process of marking the astigmatic axis on the cornea in a single step before cataract surgery in eyes with astigmatism. The corneal marker subject to the invention, as seen in Figure 1: - body (3) with a pivot rod (5) on the inside and an alignment apparatus (8) with at least two alignment tips (1) at the tip, - by placing the corneal marker on the Imbus in the cornea. Alignment apparatus (8) containing at least two alignment tips (1) positioned on three parts of the body (3) and providing support and alignment, at least two pieces connected to the pivot rod (5) that ensures that a mark compatible with the axis is placed on the cornea and conjunctiva. The marking tip (2), the pivot rod (5) positioned on the inside of the body (2), which provides the connection between the marking tips (2) and the head plate (7), creates weight with the effect of 0 gravity, on the axis where the marking tips (2) are pre-adjusted. The knob (4) positioned at the bottom of the pivot rod (5) which ensures its stability, the head plate (7) positioned connected to the pivot rod (5) which is used to mark by applying pressure on it, - the marking ends (2) to be pushed forward and back to the previous position. It contains a coil spring (6) positioned between the body (3) and the head plate (7), allowing it to return to its position. The corneal marker subject to the invention does not include a scale to adjust any astigmatism. During the construction phase, a personalized corneal marker is produced that marks the patient's astigmatism and cannot be changed. During the construction of the marker, the axis is precisely adjusted on the scale and the marker is fixed at the desired degree after being aligned with 1 degree precision between 0-180°. Each corneal marker is produced specifically for the individual, thus providing a sensitivity that reduces astigmatic adjustment sensitivity by up to 1 degree. The marking tip (2) has the same axis as the targeted axis. The targeted axis is fixed during the construction phase of the corneal marker subject to the invention. The corneal marker offers the opportunity to make much more precise markings by reducing the astigmatic adjustment sensitivity to 1 degree. It can be marked and the marking of the cornea can be done in a single step. Optionally, the targeted axis can be produced not only as pre-fixed but also as suitable for adjusting the desired axis at the bedside during marking. In this case, a 1 or 5 degree precision scale showing 0-180° can be added to the device. With personalized production and use, a disposable marker that can be used without the need for sterilization is provided, and since all parts of the marker are disposable, the risk of possible infection in patients is eliminated. During the procedure, a speculum is placed on the patient's eye or the patient's eyelid is lifted with the thumb of the other hand without using a speculum. The corneal marker is brought closer to the patient's eye so that the knob (4) is released. The physician who will mark with the cornea marker places the alignment tip (1) on the limbus (corneal border) of the cornea (10) as shown in Figure 2, Figure 3, Figure 4 and Figure 5. Meanwhile, the physician receives support from the alignment tip (1) to prevent the corneal marker from slipping and his hand from shaking. If proper alignment of the marker on the cornea (10) is not achieved, the corneal marker is withdrawn and the alignment tip (1) is placed again in the cornea (10). Thus, correct alignment and placement is ensured and vertical errors that may occur during marking are eliminated. Alignment tips (1) prevent incorrect measurement and uncontrolled placement due to hand tremor. Before the process, the marking tips (2) that will come into contact with the eyes are painted. After ensuring that the alignment tips (1) are positioned correctly, the head plate (7) is pushed with the finger and the targeted axis in the cornea (10) and conjunctiva is marked with the marking tip (2). The marking process is completed by removing the finger from the head plate (7). After marking, thanks to the coil spring (6), the marking tip (2) returns to its previous state when it is pulled from the fingertip plate (7). An ergonomic corneal marker is provided thanks to the invention's alignment tips (1) that provide support to the physician, the head plate (7) that facilitates pressure, and the coil spring (6) that provides ease of marking. The corneal marker in question is disposable and can be made of low-cost and easily accessible polymer, preferably thermoplastic or metal. In the invention, stainless steel, titanium, aluminum or nitinol is preferably used as metal. The polymer is preferably thermoplastic, 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 rubber or ethylene vinyl acetate are used. TR TR TR TR TR TR

Claims (1)

ISTEMLER 1. Korneadaki astigmatik ekseni isaretlemek için kullanilmak üzere tek kullanimlik kornea isaretleyici olup özelligi, iç kisminda pivot çubuk (5) ve uç kisminda en az iki hizalama ucuna (1) sahip hizalama aparati (8) bulunan gövde (3), kornea isaretleyicinin korneada limbus üzerine yerlestirilerek desteklenmesini ve hizalanmasi saglayan, gövdenin (3) uç kisminda konumlanmis, en az iki adet hizalama ucu (1) içeren hizalama aparati kornea ve konjonktivaya aks ile uyumlu isaretin koyulmasini saglayan, pivot çubuga (5) bagli en az iki adet isaretleme ucu (2), isaretleme uçlari (2) ile basi levhasi (7) arasindaki baglantiyi saglayan, gövdenin (3) iç kisminda konumlanmis pivot çubuk (5), yer çekimi etkisi ile agirlik olusturarak isaretleme uçlarinin (2) önceden ayarlandigi aksta sabit kalmasini saglayan, pivot çubugun (5) alt kisminda konumlanmis topuz (4), üzerine baski uygulanarak isaretleme yapmak için kullanilan, pivot çubuga (5) bagli konumlanmis basi levhasi (7), isaretleme uçlarinin (2) ileri itilmesini ve geri eski konumuna dönmesini saglayan, gövde (3) ve basi levhasi (7) arasinda konumlanmis helezon içermesidir. Istem 1,e göre kornea isaretleyici olup özelligi, termoplastik, 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 kauçuk ve etilen vinil asetat içeren gruptan seçilen bir polimer veya paslanmaz çelik, titanyum, alüminyum ve nitinol içeren gruptan seçilen bir metalden mamul olmasidir. Istem 1”e göre kornea isaretleyici olup özelligi, astigmatik ayarlama hassasiyetinin 1 derece olmasidir.1. It is a disposable corneal marker to be used to mark the astigmatic axis on the cornea, and its feature is the body (3) with a pivot rod (5) on the inside and an alignment apparatus (8) with at least two alignment tips (1) on the tip, and the corneal marker is located at the limbus in the cornea. The alignment apparatus contains at least two alignment tips (1), located at the end of the body (3), which provides support and alignment by placing it on the cornea and conjunctiva. 2), the pivot rod (5) positioned on the inside of the body (3), which provides the connection between the marking tips (2) and the head plate (7), the pivot, which creates weight with the effect of gravity and ensures that the marking tips (2) remain fixed on the axis where they are pre-adjusted. The knob (4) positioned at the bottom of the rod (5), the head plate (7) connected to the pivot rod (5) which is used for marking by applying pressure on it, the body (3) which allows the marking ends (2) to be pushed forward and returned to its previous position. ) and the head plate (7). It is a corneal marker according to claim 1 and its feature is thermoplastic, 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 rubber and ethylene vinyl acetate, or a metal selected from the group including stainless steel, titanium, aluminum and nitinol. It is a corneal marker according to claim 1 and its feature is that its astigmatic adjustment sensitivity is 1 degree.
TR2020/22813A 2020-12-31 2020-12-31 Corneal marker. TR202022813A1 (en)

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US8491616B2 (en) * 2008-04-02 2013-07-23 Andrew Davis System and method for corneal astigmatic axis marking
JP2012152361A (en) * 2011-01-26 2012-08-16 Topcon Corp Astigmatic axis measurement instrument and ophthalmic apparatus
US9283117B2 (en) * 2011-03-23 2016-03-15 Mindskid Labs, Llc Eye marker device
US20150150723A1 (en) * 2011-03-23 2015-06-04 Mindskid Labs, Llc Eye Marker Tip
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