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WO2012041345A1 - Système de microkératome utilisé pour découper un capot dans l'oeil humain - Google Patents

Système de microkératome utilisé pour découper un capot dans l'oeil humain Download PDF

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Publication number
WO2012041345A1
WO2012041345A1 PCT/EP2010/005970 EP2010005970W WO2012041345A1 WO 2012041345 A1 WO2012041345 A1 WO 2012041345A1 EP 2010005970 W EP2010005970 W EP 2010005970W WO 2012041345 A1 WO2012041345 A1 WO 2012041345A1
Authority
WO
WIPO (PCT)
Prior art keywords
components
combination
microkeratome system
characteristic
microkeratome
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2010/005970
Other languages
German (de)
English (en)
Inventor
Tobias Jeglorz
Christof Donitzky
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wavelight GmbH
Original Assignee
Wavelight GmbH
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 Wavelight GmbH filed Critical Wavelight GmbH
Priority to PCT/EP2010/005970 priority Critical patent/WO2012041345A1/fr
Publication of WO2012041345A1 publication Critical patent/WO2012041345A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • 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
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A61B90/96—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text using barcodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
    • A61B2017/00119—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
    • A61B2017/00123—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation and automatic shutdown
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00199—Electrical control of surgical instruments with a console, e.g. a control panel with a display
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides

Definitions

  • Microkeratome system for the production of flasks in the human eye
  • the invention relates to a microkeratome system for the production of flaps in the human eye.
  • LASIK laser in situ keratomileusis
  • a disc commonly referred to in the art as a flap is cut out, which is not completely separated from the remaining corneal tissue, but hangs on a so-called hinge (usually referred to by the English term "hinge") on the remaining corneal tissue.
  • the flap can easily be flipped aside to expose the underlying corneal tissue for ablative laser treatment. After the laser treatment, the flap is folded back again; the preceding corneal material removal then leads to a correspondingly altered form of the conical surface, which at best completely compensates for the ametropia to be corrected.
  • the flap is prepared by means of a mechanical microkeratome.
  • This is a microsurgical planer with a razor-sharp, usually oscillating driven cutting blade.
  • An exemplary microkeratome system is marketed by WaveLight GmbH under the trade name RONDO; a brief description of this marketable system can be found in the article "New Microkeratoms Still Coming to the Market” by Leah D. Farr in the periodical publication CATARACT & REFRACTIVE SURGERY TODAY EUROPE, November / December 2007, pages 66, 67.
  • a variant of the conventional LASIK is the Epi-LASIK. While in the LASIK technique, the flap is created by a cut into the stroma, the epi-LASIK avoids a stromal bed cut for the flap. Instead, an epithelial flap is created by incision along and above the Bowman's membrane.
  • the invention relates to mechanical microkeratome systems which produce a corneal flap with (at least) one cutting blade.
  • microkeratome systems considered here there is no restriction on the applicability of the microkeratome systems considered here to one of the abovementioned mechanical techniques of flap production (LASIK, Epi-LASIK).
  • the microkeratome systems considered in the context of the invention are suitable for both techniques.
  • the flap diameter may be determined by the inner diameter of a suction ring to be placed on the eye.
  • the flap thickness can be determined, for example, by the projection about which a cutting blade protrudes over a leveling surface (applanation surface) of a cutting head carrying it.
  • Different cutting heads can thus differ in their projecting surface by a different projection of the cutting blade.
  • Manufacturers of microkeratome systems therefore provide purchasers with complete sets of suction rings and / or cutting heads and / or other functional components, within each set of which the respective components differ by the value of at least one characteristic feature.
  • a manufacturer suction rings for the nominal flap diameter 8 mm, 9 mm and 10 mm, as well as cutting heads for the nominal Flapdicken 100 may pm, 130 pm and 150 [im an ⁇ offer (these numerical values are obviously purely illustrative and not intended to be limiting) , The surgeon then makes a suitable combination of suction ring, cutting head and optionally other components together to produce a flap with the desired dimensions.
  • the invention provides a microkeratome system for the production of flaps in the human eye, comprising
  • control unit for controlling the operation of the microkeratome system, the control unit having access to stored information representative of at least one predetermined combination of the characteristic features of at least a part number of the components, and
  • control unit for inputting information which is representative of a desired combination of the characteristic features of at least a part number of the components, the control unit thereto
  • the invention enables the surgeon to have a desired combination of components (corresponding to a desired combination of characteristic features of these components) checked by the control unit for suitability, in particular for admissibility, before the start of an operation. For this purpose, he can enter suitable information about the input device, which specify the desired feature combination.
  • the desired combination may relate to all exchange components of the microkeratome system which are available and usable in different variants (ie with different values of their characteristic features). However, it is also conceivable that only a combination of a number of parts of the total existing replacement components is the basis of the aptitude test. If, in fact, a particular combination of features of a partial number of the components is in principle not permitted, then it is unnecessary for the user, also for the other components to make desired specifications.
  • a cutting blade suitable for Epi-LASIK may only be used with a specially adapted cutting head suitable for Epi-LASIK. If, on the other hand, the user inputs a suitable cutting blade for the epi-LASIK in combination with a cutting head which is suitable only for the conventional LASIK, this already constitutes an impermissible combination, regardless of the concrete feature choice of any further components.
  • the characteristic features can take different forms. They can be numerical values, for example a diameter or thickness gauge, but they can also be properties other than a specific dimension, for example a specific structural design, which can be represented by a specific code, for example. If a value of a characteristic feature is mentioned here, this means any realization of the respective feature, regardless of whether the feature relates to a dimension, a constructive embodiment or another unique verifiable property of the assigned component. In the case of a motor drive unit of the microkeratome system, for example, such a peculiarity may relate to the number of motors contained in the drive unit (for example, one motor versus two motors). As mentioned, cutting heads may also differ structurally, e.g. depending on whether they are to be used for LASIK treatment or Epi-LASIK treatment.
  • the components comprise a suction ring to be placed on the eye and fixable there by negative pressure, the suction ring being assigned at least one size measure, in particular at least one diameter measure, as a characteristic feature.
  • Suction rings are conventionally described at least by their inner diameter, often by their outer diameter. The inner diameter and possibly also the outer diameter of the suction ring can then each be used as a characteristic feature.
  • the components may further comprise a cutting blade, wherein preferably the shape of the cutting blade for one of at least two different forms of operation serves as a characteristic feature.
  • the mentioned forms of surgery LASIK and Epi-LASIK are the first for possible forms of operation to call. Instead of an indication of the intended form of operation, the
  • cutting blade can also be defined over certain dimensions, for example over a sharpness of the blade (expressed for example by a radius of curvature of the cutting edge of the blade). This is based on the idea that Epi-LASIK typically uses a comparatively blunt cutting blade (blunt compared to cutting blades for conventional LASIK operations) to prevent inadvertent cutting of Bowman's membrane and cutting into the stream ,
  • the components can comprise a cutting head designed to hold a cutting blade and to be brought into engagement with a suction ring, wherein a flap thickness is assigned to the cutting head as a characteristic feature.
  • a cutting head designed to hold a cutting blade and to be brought into engagement with a suction ring, wherein a flap thickness is assigned to the cutting head as a characteristic feature.
  • the cutting head can be designed differently depending on the mode of operation (for example LASIK and Epi-LASIK), the cutting head can be designed differently. Therefore, the cutting head is preferably assigned its characteristic for one of at least two different forms of operation, in particular LASIK and Epi-LASIK, as a further characteristic feature.
  • the components may comprise a motor drive unit, which is assigned a motor characteristic, in particular an engine number, as a characteristic feature.
  • the control unit can be set up to release or block the operation of the microkeratome system if the desired feature combination matches a stored predetermined feature combination.
  • the control unit checks an input desired feature combination as to whether it is permissible. When finding a stored same feature combination, the control unit then releases the microkeratomsystem for operation. Conversely, it is conceivable that the stored feature combinations illegal or at least risky Represent combinations. In this case, blocking of the microkeratome system may be desirable if, among the stored feature combinations, one corresponding to an entered desired feature combination is found.
  • control unit can be set up to match the desired combination of features with a stored predetermined feature combination
  • Output of an acoustic and / or visual indication to effect may inform the surgeon e.g. warn that the combination of components he proposes poses risks to the patient.
  • the invention represents in a highly simplified, schematic form an embodiment of a Mikrokeratomsystems 10 for generating a corneal flap on a human eye 12.
  • the microkeratome system 10 comprises a replaceable with a cutting blade 14 equipped handpiece 16 and a suction ring unit 18, which consists essentially of a the eye 12 auf strictden suction ring 20 and a preferably integrally formed with the suction ring 20, obliquely extending away from this connecting piece 22 composed.
  • the connecting piece 22 contains in a manner not shown, but known per se one or more evacuation channels, which are connected to a corresponding number in the suction ring 20 formed evacuation chambers (not shown in detail). At least one evacuation chamber of the suction ring 20 serves for the suction of the same to the surface of the eye 12th
  • connection piece 22 a consisting of one or more hose lines hose assembly 24 can be connected, which in turn is connected to a running example of a desktop unit central control console 26 of the microkeratome system 10.
  • the control console 26 includes a Vakuumpumpan ever, not shown, by means of the hose line assembly 24 and the connecting piece 22, a vacuum in each evacuation chamber of the suction ring 20 can be generated.
  • the handpiece 16 has a serving as a holder for the cutting blade 14 cutting head 28 and a releasably coupled to the cutting head 28 motor drive unit 30.
  • the cutting head 28 is not shown by Füh- supported information on the suction ring 20 guided in a linear direction of movement.
  • the guide formations may comprise two spaced-apart toothed tracks formed on the suction ring, in which two pinions arranged on the cutting head 28 and in drive connection with the drive unit 30 intermesh. In this way, a linear reciprocating movement of the cutting head 28 relative to the suction ring 20 and consequently relative to the eye 12 is possible. This reciprocating movement of the cutting head 28 is illustrated in FIG. 1 by a double arrow 32.
  • the cutting blade 14 is in turn received laterally movable in the cutting head 28, wherein laterally a direction perpendicular to the direction of movement 32 of the cutting head 28 means.
  • For lateral oscillation is also the cutting blade 14 in a non-illustrated drive connection with the drive unit 30th
  • the drive unit 30 may include a single drive motor (electric motor) or separate motors.
  • a solution with separate motors is shown, for example, in EP 1 757 253 B1; with regard to a single-motor solution, reference may be made, for example, to EP 0 442 156 A1.
  • An electrical control line 34 connects the control console 26 to the handpiece 16.
  • a microprocessor-based control unit 36 is included, which operates in accordance with a control program contained in a memory 38.
  • the control unit 36 controls the operation of the handpiece 16 (more precisely the operation of the drive unit 30) and preferably also the operation of the mentioned vacuum pumping arrangement.
  • the control console 26 is connected in the illustrated embodiment via a further electrical connection line 40 with a reading device 42, which allows the reading of a manufacturer-mounted identifier 44 (represented for example by a bar code) of at least a portion of the components of the microkeratome system 10.
  • a manufacturer-mounted identifier 44 represented for example by a bar code
  • such an identifier 44 is present on the drive unit 30, on the cutting head 28 and on the suction ring unit 18 (specifically on the suction ring 20).
  • the cutting blade 14 may be provided with such an identifier.
  • the identifier 44 contains information which ensures an unambiguous identification of the component concerned, and not only by component type (eg cutting head, driebsei beauty, cutting blade, suction ring), but also according to specific expression of each type.
  • the characteristic is represented by one or more characteristic features of each component, by which the different characteristics of the same component type clearly differ from one another.
  • the user can choose for the drive unit 16 under at least two variants (characteristics), a variant with a single motor and a variant with two motors.
  • the suction ring unit 18 he can choose between a plurality of variants, which differ in each case by the inner diameter of the suction ring 20 and thus by the flap diameter.
  • the user may choose between two sets of variants, a first group for LASIK operations and a second group for epi-LASIK operations. Each group in turn consists of several variants, which differ by a different value of achievable with this cutting head flap thickness.
  • the user may also choose between different forms, a distinguishing feature being the suitability of the cutting blade 14 for LASIK or Epi-LASIK treatments.
  • the multitude of characteristics of the individual components of the microkeratome system 10 creates an even greater variety of possible combinations.
  • a list of different combinations of components of the microkeratome system 10 is stored in the memory 38, wherein the combinations differ by different values of at least one characteristic feature of at least one of the components.
  • the list can contain all conceivable combinations of components; however, it may contain only those combinations that are permitted, or alternatively those that are not permitted or risky.
  • the components considered in a listed combination comprise according to a preferred embodiment at least the cutting head 28 with the flap thickness as a characteristic feature and the suction ring unit 18 with the inner diameter of the suction ring 20 as a characteristic feature.
  • the drive unit 30 may be taken into account with the number of its motors as a characteristic feature in the listed combinations.
  • the design of the cutting head 28 for LASIK treatments or for epi-LASIK treatments may be considered as another characteristic feature of the cutting head 28 in the listed combinations.
  • the cutting blade 14 as another Component, in particular as regards its suitability for LASIK treatments or Epi-LASIK treatments.
  • the mentioned list of combinations of components can be inscribed in the memory unit 38 by the manufacturer or can be registered by a purchaser of the microkeratome system 10, e.g. be programmed before the first use of the same. In any case, it is preferred if the surgeon in the context of planning a specific intervention has no way to change the stored list. Either the list is permanently permanently stored in the memory 38 or only under certain conditions, for example, only with proof of certain access rights, changeable. Regardless, the control console 26 may allow the user to retrieve the stored list to display on a screen, not shown, so that the operator may be able to ascertain in advance as to which combinations of components are permitted or inadmissible.
  • the components can be identified, for example, by elements of their identifier 44, in particular by those elements which indicate the type and the concrete characteristics of the respective component.
  • the surgeon can also enter a desired combination of components in the control center 26. This can be done for example by reading the identifiers 44 of the desired components with the reader 42.
  • the control console 26 can have a manually operable input unit 46, for example in the form of a touch screen, via which the surgeon can enter his desired combination.
  • the surgeon can, for example, call up the available characteristics of the individual components and select a desired one.
  • the control panel 26 displays on the touch screen 46 or a screen separate therefrom the admissibility or inadmissibility of the selected combination.
  • control unit 36 may block the operation of the microkeratome system 10 and, in particular, the operation of the drive unit 30, unless an allowable component combination is selected by the operator.
  • a desired combination is not fundamentally impermissible, but entails an increased risk of surgery. In such cases, although the operation of the operation can be released to the surgeon, but it can on the Touch Screen 46 or another screen will be given a warning text that alerts him to the dangers of the selected combination.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Robotics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un système de microkératome utilisé pour découper un capot dans l'oeil humain, comprenant plusieurs composants à fonction différente, remplaçables indépendamment (14, 18, 28, 30) qui présentent respectivement une caractéristique spécifique. Ledit système comprend également une unité de commande (36) destinée à commander le fonctionnement du système de microkératome. Cette unité de commande a accès à des informations enregistrées qui représentent une combinaison prédéfinie des caractéristiques spécifiques d'au moins un nombre partiel desdits composants. Le système de microkératome selon l'invention comporte également un dispositif d'entrée (46) servant à entrer des informations qui représentent une combinaison souhaitée des caractéristiques spécifiques d'au moins un nombre partiel des composants. L'unité de commande est conçue pour comparer la combinaison de caractéristiques souhaitée avec la combinaison de caractéristiques prédéfinie et induire une réaction en fonction du résultat de comparaison. L'utilisateur est ainsi rendu attentif aux combinaisons risquées sans devoir se fier uniquement à son expérience pour sélectionner des composants.
PCT/EP2010/005970 2010-09-30 2010-09-30 Système de microkératome utilisé pour découper un capot dans l'oeil humain Ceased WO2012041345A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2010/005970 WO2012041345A1 (fr) 2010-09-30 2010-09-30 Système de microkératome utilisé pour découper un capot dans l'oeil humain

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2010/005970 WO2012041345A1 (fr) 2010-09-30 2010-09-30 Système de microkératome utilisé pour découper un capot dans l'oeil humain

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WO2012041345A1 true WO2012041345A1 (fr) 2012-04-05

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0442156A1 (fr) 1990-02-14 1991-08-21 Luis Antonio Ruiz Racloir automatique pour la cornea
EP1504724A1 (fr) * 2003-08-07 2005-02-09 Olympus Corporation Système chirurgical à ultrasons
EP1642555A1 (fr) * 2004-09-30 2006-04-05 Nidek Co., Ltd. Lame pour la chirurgie cornéale et appareil de chirurgie cornéale équipée de celle-ci
DE102005025406A1 (de) * 2005-06-02 2006-12-07 Wavelight Laser Technologie Ag Mikrokeratomsystem
EP1757253B1 (fr) 2005-08-24 2008-11-19 Wavelight Laser Technologie AG Instrument de coupe de microchirurgie opthalmique
WO2010028666A1 (fr) * 2008-09-10 2010-03-18 Wavelight Ag Dispositif d'examen d'un système ophtalmologique de microkératome

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0442156A1 (fr) 1990-02-14 1991-08-21 Luis Antonio Ruiz Racloir automatique pour la cornea
EP1504724A1 (fr) * 2003-08-07 2005-02-09 Olympus Corporation Système chirurgical à ultrasons
EP1642555A1 (fr) * 2004-09-30 2006-04-05 Nidek Co., Ltd. Lame pour la chirurgie cornéale et appareil de chirurgie cornéale équipée de celle-ci
DE102005025406A1 (de) * 2005-06-02 2006-12-07 Wavelight Laser Technologie Ag Mikrokeratomsystem
EP1757253B1 (fr) 2005-08-24 2008-11-19 Wavelight Laser Technologie AG Instrument de coupe de microchirurgie opthalmique
WO2010028666A1 (fr) * 2008-09-10 2010-03-18 Wavelight Ag Dispositif d'examen d'un système ophtalmologique de microkératome

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
AUFSATZ; VON LEAH D. FARR: "New Microkeratomes Still Coming to the Market", CATARACT & REFRACTIVE SURGERY TODAY EUROPE, pages 66,67

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