WO2022146380A2 - Marqueur cornéen - Google Patents

Marqueur cornéen Download PDF

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Publication number
WO2022146380A2
WO2022146380A2 PCT/TR2021/051556 TR2021051556W WO2022146380A2 WO 2022146380 A2 WO2022146380 A2 WO 2022146380A2 TR 2021051556 W TR2021051556 W TR 2021051556W WO 2022146380 A2 WO2022146380 A2 WO 2022146380A2
Authority
WO
WIPO (PCT)
Prior art keywords
marking
marker
tips
cornea
alignment
Prior art date
Application number
PCT/TR2021/051556
Other languages
English (en)
Other versions
WO2022146380A3 (fr
Inventor
Ertugrul CAN
Original Assignee
Ondokuz Mayis Universitesi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ondokuz Mayis Universitesi filed Critical Ondokuz Mayis Universitesi
Publication of WO2022146380A2 publication Critical patent/WO2022146380A2/fr
Publication of WO2022146380A3 publication Critical patent/WO2022146380A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/14—Arrangements specially adapted for eye photography
    • A61B3/15—Arrangements specially adapted for eye photography with means for aligning, spacing or blocking spurious reflection ; with means for relaxing
    • A61B3/152—Arrangements specially adapted for eye photography with means for aligning, spacing or blocking spurious reflection ; with means for relaxing for aligning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F9/00—Methods 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
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/013—Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
    • A61F9/0136—Mechanical markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937—Visible markers

Definitions

  • the present invention relates to a corneal marker that allows for marking the astigmatic axis in the cornea prior to cataract surgery in eyes with astigmatism.
  • the cornea is a spherical and transparent avascular layer in the front of the eye that refracts light and protects the eye from external effects.
  • Cataract is an eye disease that occurs with the loss of transparency of the lens in the eye and the clouding of the lens of the eye, and today, cataract surgery takes place on the top of surgical interventions performed by ophthalmologists.
  • the astigmatism principal meridian is required to be aligned precisely in order to correct corneal astigmatism during cataract surgery. Marking precisely said principal meridian is of great importance since misalignment can result in a significant loss in reducing astigmatism. Marks on the astigmatic axis cannot be placed in the correct position by the most of the conventional marking devices and methods that are available. A deviation of 10 degrees in marking results in loss of approximately one-third of the desired astigmatism reduction.
  • Apparatuses that are used to mark the astigmatic axis in the cornea before cataract surgery in eyes with astigmatism are available in the state of the art.
  • Most of the corneal marker apparatuses in the prior art are reusable and must be sterilized prior to each marking. Since said apparatuses are high costly, they are supplied in limited numbers and required to be sterilized by physicians for each use. This process causes loss of time and difficulty in process.
  • Single use corneal markers in the state of the art are insufficient for precise measurement, alignment, and accurate marking.
  • the devices in the prior art mark the eye surface with dye immediately upon contact with the eye and do not allow for repetitive adjustments. Markers in the prior art have a scale for adjusting astigmatism.
  • the patient's astigmatism is 72 degrees or 139 degrees
  • 70 degrees for 72 degrees and 140 degrees for 139 degrees can be adjusted since these adjustments have the lowest sensitivity of 5 degrees. This situation reduces the sensitivity in measurement and marking.
  • patent application numbered TR201313421A2 discloses a corneal astigmatism marker and a marking method using this marker that enables performing the process of "marking the astigmatism axis" on the cornea for intraocular lens placement operations.
  • the astigmatic adjustment sensitivity of the mentioned marker was determined as 5 degrees and the marker works with pushing force.
  • the guide legs located therein are connected to the pivot bar and are fixed to the apparatus, while the marking tips are attached to the body.
  • Moria single use ophthalmic instrument in the prior art is used for corneal marking.
  • This instrument is single use and is used for precise marking of the 0-180° axis, namely, the axis passing through the middle.
  • Instrument has a water gage thereon in order to control the balance.
  • this instrument is insufficient to provide balance and to make measurement and alignment for the physician in a steady manner, and incorrect measurement can be made due to hand shaking during marking with said instrument.
  • EP2688530A1 discloses an eye marker device with a disposable tip and eye marking methods.
  • the tip of said device is disposable, the body is reusable and must be sterilized before each use.
  • Astigmatic adjustment accuracy is determined as 10 degrees in this device, thus the device is insufficient for precise measurement. Additionally, it is difficult for the physician to measure and align in a constant manner since there is no support for alignment and balancing in this device. Also, said device is costly and not accessible to every physician.
  • the present invention relates to a corneal marker that allows for marking the astigmatic axis in the cornea prior to cataract surgery in eyes with astigmatism.
  • the primary object of the invention is to provide a disposable corneal marker that can be used without the need for sterilization.
  • the risk of possible infection in patients is eliminated since all parts of the marker are disposable. Special use is provided for each patient with this disposable marker.
  • Another object of the invention is to provide an easy-to-use and ergonomic corneal marker.
  • the physician can mark more easily, comfortably, and safely by means of the ergonomic structure of the marker, the alignment tips, and the spiral spring mechanism of the marker according to the present invention. Easy marking can be performed with this marker before the operation in the operating room.
  • Another object of the invention is to provide a corneal marker that measures and marks with high precision.
  • the marker is fixed at the desired degree with the help of an external scale, with a precision of 1 degree between 0-180° after being aligned.
  • this desired axis of the patient is adjusted and fixed specifically for each patient.
  • the astigmatic adjustment sensitivity of the marker is reduced to 1 degree, which provides much more precise marking.
  • Another object of the invention is to provide a corneal marker that can perform alignment with high accuracy and that can be positioned easily.
  • the marker according to the present invention prevents incorrect measurement and uncontrolled placement due to hand shaking during marking by means of the support obtained with the help of its alignment tips.
  • the marker is supported and aligned by placing it on the limbus in the cornea with the help of the alignment tips, and this process can be repeated until correct alignment is ensured.
  • the devices in the prior art do not allow repetitive adjustments by marking the eye surface with dye immediately upon contact with the eye
  • alignment can be repeated by means of the support provided by the alignment tips of the present invention, and after making sure of the alignment, marking the targeted axis in the cornea and conjunctiva is performed by pushing the pressure plate with the finger.
  • correct alignment, placement and marking is ensured by the present invention.
  • Another object of the invention is to provide a low cost and easily accessible corneal marker.
  • the present invention is produced from polymer, especially thermoplastic polymer or metal, and the present invention can be produced at low cost with the easy and inexpensive supply of these materials.
  • Figure 1 illustrates the corneal marker in a free position.
  • Figure 2 illustrates the view of the cornea marker with the pressure plate (7) pushed during eye marking.
  • Figure 3 illustrates the detailed view of cornea marker during alignment prior to eye marking.
  • Figure 4 illustrates the frontal detailed view of the cornea marker during eye marking.
  • Figure 5 illustrates the side detailed view of the cornea marker during eye marking.
  • the present invention is a corneal marker that performs the marking of the astigmatic axis in the cornea in eyes with astigmatism in a single step prior to cataract surgery.
  • the corneal marker of the present invention comprises:
  • an alignment apparatus (8) that enables the corneal marker to be supported and aligned by placing it on the limbus in the cornea, that is located at the end of the body (3), that comprises at least two alignment tips (1 ),
  • a pivot bar (5) that is positioned inside the body (2), that provides the connection between the marking tips (2) and the pressure plate (7), • a knob (4) that is positioned at the bottom of the pivot bar (5), that allows for remaining fixed the marking tips (2) on the axis, on which they are pre-adjusted by forming weight with the gravity effect,
  • a personalized corneal marker is produced that marks the axis specific to the patient's astigmatism and cannot be changed.
  • the axis is precisely adjusted on the scale and the marker is fixed after aligned at the desired degree such that a precision of 1 degree between 0-180° .
  • Each cornea marker is custom-made and thus, a precision of astigmatic adjustment is reduced to 1 degree.
  • the marking tip (2) has the same axis as the targeted axis.
  • the targeted axis was fixed during the production of the corneal marker according to the present invention.
  • the cornea marker offers a much more precise marking by means of the astigmatic adjustment precision being down to 1 degree.
  • the present invention not only 0°, 90° or 180°, but any axis between 0° and 180° can be marked, and the marking of the cornea can be performed in a single step.
  • the targeted axis can be produced not as pre-fixed, but also in a way that is suitable for adjusting the desired axis for the patient during marking.
  • a scale with a precision of 1 or 5 degrees showing 0-180° can be added on the device.
  • a disposable marker with personalized production and use and that can be used without the need of sterilization is provided, and the risk of possible infection in patients is eliminated since all parts of the marker are disposable.
  • a speculum is inserted into the patient's eye, or the patient's eyelid is lifted with a thumb of the other hand without using a speculum.
  • the corneal marker is brought closer to the patient's eye such that the knob (4) is released.
  • the physician who will mark with the corneal marker places the alignment tip (1 ) on the cornea (10) limbus (corneal border) as shown in Figure 2, Figure 3, Figure 4, and Figure 5. Meanwhile, the physician takes support from the alignment tip (1 ) so that the cornea marker does not slip and his/her hand does not shake. If proper alignment of the marker on the cornea (10) is not provided, the corneal marker is withdrawn and the alignment tip (1 ) is placed back on the limbus of the cornea (10). Thus, correct alignment and placement is ensured, and vertical errors that may occur during marking are eliminated.
  • the alignment tips (1 ) prevent incorrect measurement and uncontrolled placement due to hand shaking.
  • the marking tips (2) that will come into contact with the eye are dyed. After making sure that the alignment tips (1 ) are placed correctly, it is provided that the targeted axis on the cornea (10) and conjunctiva is marked with the marking tip (2) by means of pushing the pressure plate (7) with the finger. The marking process is completed by removing the finger from the pressure plate (7). When the finger is removed from the pressure plate (7) after the marking is performed by means of the spiral spring (6), the marking tip (2) returns to its original state.
  • An ergonomic corneal marker is provided by means of the alignment tips (1 ) that provides support to the physician, the pressure plate (7) that facilitates pressure, and the coil spring (6) that provides ease of marking, of the present invention.
  • Said corneal marker is disposable and can be made of low-cost and easily accessible polymer, preferably thermoplastic, or metal.
  • polymer preferably thermoplastic, or metal.
  • preferably stainless steel, titanium, aluminum and nitinol are used for metal materials.
  • PVC polyvinyl chloride
  • PE polyethylene
  • LDPE low-density polyethylene
  • HDPE high- density polyethylene
  • Teflon polytetrafluoroethylene
  • PP polypropylene
  • PET PETE
  • natural rubber polybutadiene, nitrile rubber, silicon rubber or ethylene vinyl acetate is used for polymer materials.

Landscapes

  • 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

La présente invention concerne un marqueur cornéen qui permet de marquer l'axe astigmatique dans la cornée avant une chirurgie de la cataracte dans des yeux présentant un astigmatisme. L'invention concerne un marqueur cornéen peu coûteux et facilement accessible qui est jetable et peut être utilisé sans nécessiter de stérilisation, qui a une structure ergonomique, qui peut réaliser un alignement et un marquage avec une précision élevée, qui permet le réajustement/le remplacement.
PCT/TR2021/051556 2020-12-31 2021-12-28 Marqueur cornéen WO2022146380A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2020/22813A TR202022813A1 (tr) 2020-12-31 2020-12-31 Kornea işaretleyici.
TR2020/22813 2020-12-31

Publications (2)

Publication Number Publication Date
WO2022146380A2 true WO2022146380A2 (fr) 2022-07-07
WO2022146380A3 WO2022146380A3 (fr) 2023-05-11

Family

ID=82260996

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2021/051556 WO2022146380A2 (fr) 2020-12-31 2021-12-28 Marqueur cornéen

Country Status (2)

Country Link
TR (1) TR202022813A1 (fr)
WO (1) WO2022146380A2 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8491616B2 (en) * 2008-04-02 2013-07-23 Andrew Davis System and method for corneal astigmatic axis marking
JP2012152361A (ja) * 2011-01-26 2012-08-16 Topcon Corp 乱視軸測定装置、及び眼科装置
US20150150723A1 (en) * 2011-03-23 2015-06-04 Mindskid Labs, Llc Eye Marker Tip
WO2012129405A1 (fr) * 2011-03-23 2012-09-27 Mindskid Labs, Llc Dispositif de marquage oculaire
AU2014257146A1 (en) * 2013-04-23 2015-11-12 Surgilum, Llc Eye marker device with electronic positional detection system and tip associated therewith
CN205108040U (zh) * 2015-09-09 2016-03-30 杨卫华 一种带有水平仪的角膜缘散光精确定位装置
CN211633875U (zh) * 2020-02-19 2020-10-09 刘迁 一种眼科手术中散光轴位标记装置

Also Published As

Publication number Publication date
TR202022813A1 (tr) 2022-07-21
WO2022146380A3 (fr) 2023-05-11

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