WO2001005341A1 - Outil de decoupe de la cornee - Google Patents

Outil de decoupe de la cornee Download PDF

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Publication number
WO2001005341A1
WO2001005341A1 PCT/AU2000/000855 AU0000855W WO0105341A1 WO 2001005341 A1 WO2001005341 A1 WO 2001005341A1 AU 0000855 W AU0000855 W AU 0000855W WO 0105341 A1 WO0105341 A1 WO 0105341A1
Authority
WO
WIPO (PCT)
Prior art keywords
cornea
incision
corneal
gas
lenticule
Prior art date
Application number
PCT/AU2000/000855
Other languages
English (en)
Inventor
Paul Phillip Van Saarloos
Original Assignee
The Lions Eye Institute Of Western Australia Incorporated
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 The Lions Eye Institute Of Western Australia Incorporated filed Critical The Lions Eye Institute Of Western Australia Incorporated
Priority to AU57970/00A priority Critical patent/AU5797000A/en
Publication of WO2001005341A1 publication Critical patent/WO2001005341A1/fr

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Classifications

    • 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
    • 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
    • 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
    • A61F9/0133—Knives or scalpels specially adapted therefor

Definitions

  • the method and apparatus of the present invention has an application in corneal surgery where lamellar cuts of the cornea are desirable.
  • This apparatus could be used in a number of corneal surgical applications including keratomileusis operations such as Laser in-situ Keratomileusis (LASIK) or Automated Lamellar Keratoplasty (ALK), to fashion a corneal button in corneal transplant operations or to remove specific layers of diseased corneal tissue.
  • keratomileusis operations such as Laser in-situ Keratomileusis (LASIK) or Automated Lamellar Keratoplasty (ALK)
  • LASIK Laser in-situ Keratomileusis
  • ALK Automated Lamellar Keratoplasty
  • the cornea is stratified into five distinct, easily distinguished layers.
  • the epithelium covers the outermost surface of the cornea and consists of 5 to 7 layers of fast replicating cells, which are replaced approximately every 7 days.
  • Bowman's membrane Directly beneath the 50 micron epithelial layer is Bowman's membrane, a 10 -12 micron thick layer of dense collagenous material.
  • the underlying stroma makes up the main body of the cornea, which is formed by layers of parallel collagen bundles. Descement's membrane and the endothelium form the internal portion of the cornea and have a role in the transport of nutrients.
  • the epithelium and endothelium assist in maintaining the clarity of the cornea (Junqueira, Carneiro & Kelley, 1989 cited below).
  • Refractive surgery operations exist where it is desirable to remove small amounts of corneal tissue to effect a refractive change.
  • operations such as Photorefractive Keratectomy the epithelial layer is manually removed and then Bowman's membrane and part of the stroma are ablated by laser energy.
  • this operation can lead to unwanted side effects, such as corneal haze, and is not suitable for higher refractive errors.
  • a more recently developed refractive operation called LASIK maintains the integrity of the epithelial layer and Bowman's membrane (See US patent 4,903,695).
  • a flap of tissue is displaced from the anterior cornea and a minute amount of tissue in the shape of a lens is removed from the stromal bed or from the underside of the lenticule, by way of laser ablation (or by cutting with a second pass of a microkeratome, as in Automated Lamellar Keratoplasty).
  • the corneal lenticule or "flap" is then replaced to its original position, creating an optical correction. This method of refractive surgery produces fewer side effects and quicker healing, as the epithelium and Bowman's membrane are left intact.
  • the corneal flap is usually created during LASIK or ALK with an instrument known as a microkeratome.
  • a microkeratome Prior art microkeratomes, such as those described in US Patents 5,586,980 & 5,591 ,174, utilise an applicator shoe and a sliding blade mounted to an eye retaining ring. Suction is applied to the ring and the sliding blade is then advanced across the cornea by way of dovetailed guides. A partial thickness corneal incision is made, creating a hinged flap of tissue that can be pulled back to allow laser ablation of the stromal bed.
  • the microkeratome assembly may be removed from the cornea before ablation takes place, or, as in US Patent 5,586,980, the assembly may be left in place on the cornea to fixate the position of the eye.
  • microkeratomes The machinery involved in such microkeratomes is very expensive to purchase and has a high risk of mechanical failure or malfunction.
  • Common microkeratome accidents include the formation of a corneal cap (complete removal of the lenticule), an incomplete flap, uneven flap, perforation of the globe, introduction of infection, and other serious and sight threatening complications.
  • Steel blades also need to be regularly replaced and are relatively expensive.
  • An alternative to blade style microkeratomes for ALK involves water jet technology, explained in US Patents 5,556,406 & 5,833,701. These patents teach the use of templates (adapted to fit varying corneal contours) that are placed on the anterior cornea to deform it to a desired planar configuration. Made of porous metal, suction is achieved with minimal vacuum strength.
  • the template is inserted inside a vacuum-held cutting ring and a small diameter, highly pressurised jet of water is used to cut the cornea (like a blade) and form a hinged flap.
  • a trephine structure with an inner flat ring is used to applanate an annular zone of the cornea below which a diametrally disposed blade is rotated to form a cut to a depth determined by a depth stop.
  • a jet of fluid which may be a liquid or a hydrated gas, is then used to separate a flap along a lamella.
  • the flap is said to be hinged and ablation can be effected either on the exposed corneal tissue or on the flap itself.
  • the object of the present invention is to provide a relatively safer, more reliable and predictable alternative to conventional and other known or proposed microkeratomes, that at least in part alleviates the disadvantages of the prior art.
  • the invention provides apparatus for forming a corneal lenticule, including:
  • the means to apply the body to the anterior surface of a cornea is arranged to do so substantially without applanation of the cornea.
  • the means to apply the body to the anterior surface of a cornea is arranged to do so substantially without any increase of intraocular pressure.
  • the incision forming means is such that the incision is a substantially circular incision.
  • the incision forming means is preferably such that the incision is not quite closed so as to form a hinge about which the lenticule is a hinged flap.
  • the incision forming means preferably includes blade means, eg. an annular or cylindrical cutting implement with a cutting edge at one end, eg. a trephine blade.
  • blade means eg. an annular or cylindrical cutting implement with a cutting edge at one end, eg. a trephine blade.
  • the means to cause tissue separation in the interior of the cornea advantageously includes means to direct a suitable gas under pressure, most preferably air, into said interior, eg. a canula, needle or like device.
  • Means eg a vacuum plate, is preferably provided for applying vacuum suction to the surface of the cornea within the incision.
  • Such means may further serve to support the lenticule and maintain its structure during the tissue separation, and to aid complete separation of the tissue within the circular incision
  • the apparatus further includes stop means associated with the incision forming means for controlling the predetermined depth of the incision.
  • the means to apply the body to the surface of the cornea includes vacuum means, eg. a suction ring.
  • vacuum means eg. a suction ring.
  • the suction ring is fixed outside the optical zone of the cornea.
  • suction created is high enough to facilitate guidance of the cutting implement without movement, but low enough to not permanently deform the cornea.
  • the invention further provides a method of forming a corneal lenticule, including forming a closed or nearly closed incision in the anterior surface of a cornea by cutting, in a direction generally parallel to the axis of the cornea, to a predetermined depth, thereby defining a corneal segment bounded laterally by the incision, and causing tissue separation in the interior of the cornea behind the segment to the incision, whereby to separate the segment as a corneal lenticule.
  • the incision is advantageously formed substantially without applanation of the cornea, and/or substantially without any increase in intraocular pressure.
  • the incision is preferably a substantial circular incision.
  • the incision preferably substantially a circle, is not quite closed so as to form a hinge about which the lenticule is a hinged flap.
  • the incision is preferably formed with blade means.
  • the incision may conveniently be formed by an annular or cylindrical cutting implement with a cutting edge at one end, eg. a trephine blade.
  • the tissue separation in the interior of the cornea is effected by directing a suitable gas under pressure, more preferably air, into the interior, eg. by means of a canula, needle or like device, and optionally also by applying vacuum suction to the surface of the cornea within the incision.
  • a suitable gas under pressure more preferably air
  • Control of the incision to its predetermined depth is preferably effected by stop means associated with a cutting implement by which the incision is formed.
  • the incision forming means may be driven manually or by a motorised device.
  • the predetermined depth of the incision is preferably no more than 200 microns, most preferably a maximum is between 60 and 180 microns.
  • the invention is directed to apparatus for separating a segment of a cornea for forming a corneal lenticule, including:
  • a body means to apply the body to the anterior or posterior surface of the cornea;
  • pressurised gas most preferably air
  • the invention further provides a method of separating a segment of a cornea for forming a corneal lenticule, including introducing pressurised gas, most preferably air, into the interior of the cornea at a preselected location, whereby to cause tissue separation in the interior of the cornea by parting collagen bonds, and to thereby separate a segment of the cornea for forming a corneal lenticule.
  • pressurised gas most preferably air
  • the surface of the cornea is subjected to vacuum suction.
  • the means for introducing pressurised gas into the interior of the cornea is preferably a fine canula, needle or like device.
  • the suction ring is affixed outside the optical zone of the cornea.
  • suction created is high enough to guide the cutting implement without movement, but low enough to not permanently deform the cornea.
  • said pressurised air is sterile, filtered air, delivered at a low pressure and a low velocity, with the highest likely velocity being approximately 0.1 ml/s.
  • the apparatus in either or both of the respective aspects, is a single-use device.
  • Figure 1 is a cross-sectional view of apparatus according to an embodiment of the present invention for forming a corneal lenticule, shown in situ on a cornea while in use for carrying out a method according to the invention;
  • Figure 2 is a diagram illustrating one preferred form of the trephine blade of the apparatus of Figure 1 , for forming the incision in the cornea.
  • the illustrated apparatus includes a body in the form of a suction ring 10, a corneal cutting device in the form of a generally cylindrical trephine blade 20 which is slidable within the cutting ring to form an incision in the cornea, and means in the form of a canula or needle 30 arranged to be inserted into the cornea to a predetermined depth for injecting a pulse of compressed air for causing tissue separation in the interior of the cornea.
  • Suction ring 10 has an annular underside channel 12 to which vacuum may be applied via an aperture 14 and chamber 15, for applying the suction ring to the anterior surface of a cornea outside the optical zone of the cornea, and thereby stabilising and controlling the cornea.
  • Suction ring 10 and trephine blade 20 are so dimensioned so that the blade is a close but freely sliding fit within the ring. Further suction is applied to the cornea within the blade via a generally circular vacuum plate 16 to stabilise and control the resection and lifting of the flap, ie to support the lenticule and maintain its structure during the tissue separation so the compressed air does not escape before the tissue separation is completed.
  • Plate 16 has a concave undersurface with a network of fine grooves 18 to which suction is applied via aperture 19 and an associated duct network, and a vacuum line 17.
  • Canula 30 extends through a fine bore 31 in plate 16 so as to be longitudinally adjustable for variation of the depth of injection of the air.
  • the depth of the circular incision formed by blade 20 is determined by the abutment of locking collar 22, fixed on the exterior surface of the blade, with the outer annular face of suction ring 10. In other embodiments there may be more than one locking collar, and/or the locking collar(s) may be fixed and non- adjustable.
  • the depth of canula 30 is determined by the abutment of an adjustably located locking collar 32 on the canula with a further transversely extending plate 35 disposed within trephine blade 20. This plate 35 may optionally serve as an additional vacuum plate spaced outwardly of plate 16 for applying additional vacuum to the space 38 behind plate 16 through a vacuum line 36, to assist the controlled lifting of the flap and optionally attached vacuum plate 16.
  • suction ring 10 is mounted on the globe of the eye and suction is applied to the cornea via air aperture 14.
  • Blade 20, is inserted within the inner edge of suction ring 10.
  • the cutting edge 21 at the end of blade 20 inscribes a closed or nearly closed circular incision 52 into the cornea by cutting in a direction generally parallel to the axis 8 of the cornea (and of the blade) to a depth controlled by contact of locking collar 22 with ring 10.
  • blade 20 may simply be driven axially, or it may rotate, or a combination of both.
  • This incision which is effectively a cylindrical cut, defines a corneal segment 50 bounded laterally of the corneal axis 8 by the incision.
  • the vacuum pressure of the suction ring should be high enough to guide blade 20 through the cornea without lateral movement, but not so high as to permanently deform the cornea.
  • blade 20 has a notched area 25 where no or incomplete cutting can take place so that a hinge is formed in the corneal tissue.
  • Vacuum plate 16 supports the corneal segment 50.
  • the depth of incision 52 is preferably appropriate for LASIK, being in the range of 60 to 200 microns.
  • Canula 30 is now introduced through aperture 31 in vacuum plate 16 and moved so as to penetrate the corneal segment 50 to a chosen depth, usually the same as or slightly less than the depth of incision 52. Locking collar 32 prevents canula 30 from deeper penetration of the cornea.
  • the canula is attached via conduit (not shown) to a source of sterile, pressurised air. Alternatively a syringe or other appropriate means of introducing air into the needle may be utilised. Instead of air, oxygen or nitrogen may be satisfactory.
  • a corneal lenticule or flap is created by the injection of a low velocity, low pressure, air "bubble" through canula 30.
  • this air bubble acts to separate tissue within the cornea by parting collagen bonds and so gently "pushing" the collagen layers of the stroma apart and separating segment 50 as a corneal lenticule.
  • Suction may also be applied through an aperture 36 which taps into the space between vacuum plates 16 and 35. This is an optional step to provide further suction and ensure that the flap tissue is lifted cleanly from the stromal bed.
  • canula 30 may wholly or partially penetrate the corneal segment 50 during formation of the incision 52, eg it may travel axially with blade 20.
  • the flap can then be "flipped" over to expose the stroma to laser ablation, after which the flap can be repositioned, leaving the epithelium and Bowman's membrane intact and the stability of the cornea undisturbed.
  • the method and apparatus of the present invention can be used for removing the epithelium prior to PRK laser ablation, to remove diseased epithelial cells, or to create a corneal button for transplant operations.
  • Figure 2 shows a suitable form of the cutting implement 20.
  • a cutting blade similar to a commercially available trephine is suitable.
  • the blade should be between 6 and 12 mm in diameter, most preferably around 9.5 mm, so that incision 52 is of similar diameter.
  • the trephine blade is modified with a notched zone 25. This notch creates a hinged area, so that the lenticule is formed as a flap of tissue, can be flipped over and repositioned without displacement from the cornea.
  • This design prevents the occurrence of a full thickness flap, and helps to avoid many of the common accidents that occur with prior art microkeratomes.
  • the illustrated apparatus is a relatively inexpensive, lightweight (and optionally disposable) innovation that substantially alleviates the disadvantages of the prior art.
  • canula 30 may already be in position in aperture 31 , during operation of blade 20, thereby piercing the cornea as the incision is made.
  • the cutting action and the injection of the air pulse may be simultaneous or overlapping, though distinct steps are performed. It is to be understood therefore, that this invention is not limited to the particular embodiments described herein above.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Un appareil destiné à former un lenticule de cornée comprend un corps (10) et un dispositif (12) servant à appliquer le corps sur la surface antérieure d'une cornée. Le dispositif (20) est porté par le corps afin de former une incision (52) fermée ou presque fermée dans la surface de la cornée, incision que l'on réalise en coupant dans un sens généralement parallèle à l'axe de la cornée, à une profondeur déterminée, ce qui permet de définir un segment (50) de cornée limitée latéralement par l'incision. Cette invention a aussi trait à un dispositif (31) servant à provoquer la séparation tissulaire à l'intérieur de la cornée derrière le segment par rapport à l'incision, de manière à séparer le segment comme un lenticule de cornée.
PCT/AU2000/000855 1999-07-15 2000-07-17 Outil de decoupe de la cornee WO2001005341A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU57970/00A AU5797000A (en) 1999-07-15 2000-07-17 Corneal cutting implement

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPQ1673A AUPQ167399A0 (en) 1999-07-15 1999-07-15 Corneal cutting implement
AUPQ1673 1999-07-15

Publications (1)

Publication Number Publication Date
WO2001005341A1 true WO2001005341A1 (fr) 2001-01-25

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PCT/AU2000/000855 WO2001005341A1 (fr) 1999-07-15 2000-07-17 Outil de decoupe de la cornee

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AU (1) AUPQ167399A0 (fr)
WO (1) WO2001005341A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003034958A2 (fr) * 2001-10-25 2003-05-01 Carl Zeiss Meditec Ag Dispositif de coupe
WO2007090414A1 (fr) * 2006-02-07 2007-08-16 Zyrus Beteiligungsgesellschaft Mbh & Co. Patente I Kg Trepan aspirant
WO2014005730A1 (fr) * 2012-07-06 2014-01-09 Centre Hospitalier Universitaire De Rouen Lame de préparation d'une greffe endothéliale, et procédé de préparation associé
CZ304908B6 (cs) * 2013-05-24 2015-01-14 Pavel StodĹŻlka Trepan pro transplantaci rohovky
DE102016000242B3 (de) * 2016-01-12 2017-07-06 Novartis Ag Vorrichtung für die Schneidbearbeitung eines humanen Auges
WO2018232220A1 (fr) * 2017-06-15 2018-12-20 SightLife Surgical Systèmes et méthodes de séparation de tissu dans les procédures de greffe cornéenne
WO2020186079A2 (fr) 2019-03-12 2020-09-17 Eyedea Medical, Inc. Procédé et appareil pour la séparation de tissu

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993022988A1 (fr) * 1992-05-20 1993-11-25 Summit Technology, Inc. Extraction de l'epithelium de l'×il
US5556406A (en) * 1994-09-12 1996-09-17 Medjet Inc. Corneal template and surgical procedure for refractive vision correction
WO1999020186A1 (fr) * 1997-10-22 1999-04-29 Medjet, Inc. Elimination de tissus

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993022988A1 (fr) * 1992-05-20 1993-11-25 Summit Technology, Inc. Extraction de l'epithelium de l'×il
US5556406A (en) * 1994-09-12 1996-09-17 Medjet Inc. Corneal template and surgical procedure for refractive vision correction
WO1999020186A1 (fr) * 1997-10-22 1999-04-29 Medjet, Inc. Elimination de tissus

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003034958A2 (fr) * 2001-10-25 2003-05-01 Carl Zeiss Meditec Ag Dispositif de coupe
DE10152152A1 (de) * 2001-10-25 2003-05-15 Zeiss Carl Meditec Ag Schneidvorrichtung
WO2003034958A3 (fr) * 2001-10-25 2004-02-19 Zeiss Carl Meditec Ag Dispositif de coupe
DE10152152B4 (de) * 2001-10-25 2004-02-26 Carl Zeiss Meditec Ag Schneidvorrichtung
EP1832260A1 (fr) * 2001-10-25 2007-09-12 Carl Zeiss Meditec AG Dispositif de coupage
WO2007090414A1 (fr) * 2006-02-07 2007-08-16 Zyrus Beteiligungsgesellschaft Mbh & Co. Patente I Kg Trepan aspirant
WO2014005730A1 (fr) * 2012-07-06 2014-01-09 Centre Hospitalier Universitaire De Rouen Lame de préparation d'une greffe endothéliale, et procédé de préparation associé
FR2992849A1 (fr) * 2012-07-06 2014-01-10 Ct Hospitalier Universitaire Rouen Lame pour la preparation d'un greffon endothelial et procede de preparation associe
CZ304908B6 (cs) * 2013-05-24 2015-01-14 Pavel StodĹŻlka Trepan pro transplantaci rohovky
DE102016000242B3 (de) * 2016-01-12 2017-07-06 Novartis Ag Vorrichtung für die Schneidbearbeitung eines humanen Auges
WO2018232220A1 (fr) * 2017-06-15 2018-12-20 SightLife Surgical Systèmes et méthodes de séparation de tissu dans les procédures de greffe cornéenne
US10864013B2 (en) 2017-06-15 2020-12-15 Corneagen, Inc. Systems and methods for separating tissue in corneal transplant procedures
US11730508B2 (en) 2017-06-15 2023-08-22 Corneagen Inc. Systems and methods for separating tissue in corneal transplant procedures
WO2020186079A2 (fr) 2019-03-12 2020-09-17 Eyedea Medical, Inc. Procédé et appareil pour la séparation de tissu
EP3937865A4 (fr) * 2019-03-12 2022-12-28 Eyedea Medical, Inc. Procédé et appareil pour la séparation de tissu

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