WO2011141760A1 - Ophthalmic diagnostic or therapeutic apparatus optionally including an implant insertion device, positioning system and method of handling the apparatus - Google Patents

Ophthalmic diagnostic or therapeutic apparatus optionally including an implant insertion device, positioning system and method of handling the apparatus Download PDF

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Publication number
WO2011141760A1
WO2011141760A1 PCT/IB2010/001096 IB2010001096W WO2011141760A1 WO 2011141760 A1 WO2011141760 A1 WO 2011141760A1 IB 2010001096 W IB2010001096 W IB 2010001096W WO 2011141760 A1 WO2011141760 A1 WO 2011141760A1
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WO
WIPO (PCT)
Prior art keywords
implant
eye
diagnostic
therapeutic
positioning system
Prior art date
Application number
PCT/IB2010/001096
Other languages
French (fr)
Inventor
Steffen Gebauer
Original Assignee
Gebauer Medizintechnik 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 Gebauer Medizintechnik Gmbh filed Critical Gebauer Medizintechnik Gmbh
Priority to PCT/IB2010/001096 priority Critical patent/WO2011141760A1/en
Publication of WO2011141760A1 publication Critical patent/WO2011141760A1/en

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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
    • 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
    • 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
    • A61F2009/0035—Devices for immobilising a patient's head with respect to the instrument
    • A61F2009/0043—Devices for immobilising a patient's head with respect to the instrument by supporting the instrument on the patient's head, e.g. head bands
    • A61F2009/0052—Devices for immobilising a patient's head with respect to the instrument by supporting the instrument on the patient's head, e.g. head bands the instrument being supported on the patient's eye
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia
    • 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
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts

Definitions

  • OPHTHALMIC DIAGNOSTIC OR THERAPEUTIC APPARATUS OPTIONALLY INCLUDING AN IMPLANT INSERTION DEVICE, POSITIONING SYSTEM AND METHOD OF HANDLING THE APPARATUS
  • the present invention relates to an ophthalmic diagnostic or therapeutic apparatus which can be used for the insertion of an ophthalmic implant into an opening of an eye or for applying a diagnostic or therapeutic treatment to an eye of a patient.
  • the invention further relates to a positioning system for use with such a diagnostic or therapeutic apparatus.
  • the invention relates to methods of handling the apparatus for insertion of an ophthalmic implant into a prepared opening in a tissue of an eye or for positioning the diagnostic or therapeutic device at a desired position for applying a diagnostic or therapeutic treatment to an eye of a patient.
  • Ophthalmic diagnostic or therapeutic methods are well known techniques used to make a diagnosis or an external or internal treatment of the eye. Examples of such diagnosis or treatments are surgical methods or non-surgical methods. Examples of non-surgical methods are methods for measuring the curvature of the cornea, the measuring of the osmotic pressure of the eye etc. Usually, these methods are used for diagnosis only, but can also be used to make a map of the eye before a surgical treatment of the eye is carried out. In some of the surgical methods, the eye is partly or fully opened to treat the cornea or the lens of a patient's eye. For example, the curvature of the cornea can be treated or the lens can be replaced by a new one.
  • An example of a surgical treatment method in which corneal rings are typically used is the laser-assisted in situ keratomileusis LASIK treatment for the correction of myopia established since about the beginning of 1990.
  • a thin lamella of corneal tissue is typically cut from the surface of the cornea using a blade which is called mikrokeratome.
  • the corneal lamella usually remains attached by a hinged portion of corneal tissue to form a flap.
  • the flap is then held back and a laser beam is used for the treatment of the inside tissue of the cornea.
  • the curvature of the surface of the cornea can be changed by using a laser beam to adjust the visual acuity.
  • corneal implants have become significant impact in ophthalmology, especially in case the vision abnormalities cannot easily be corrected by the above-mentioned laser-based procedures, e.g. photorefractive keratectomy (PRK) or LASIK.
  • PRK photorefractive keratectomy
  • LASIK LASIK
  • Another common condition in which a corneal implant can be used to improve the patient's comfort is a cataract. If the patient is suffering at a cataract, the natural crystalline lens is clouded such that the passage of light rays through the lens to the retina is obstructed or blocked.
  • the corneal implant can in these treatments be a refractive intraocular lens.
  • the intraocular lens usually is inserted into a patient's eye via a small incision in the cornea.
  • EP 1 491 163 A2 describes, for example, a suitable ophthalmic instrument including a lens insertion assembly and an insertion actuator to inert a foldable intraocular lens into a patient's eye.
  • the insertion assembly and the actuator are manually handled by the operator to enable him the exact positioning of the lens in the eye.
  • the lens is automatically unfolded by elastic strain energy, for example.
  • Some of the lenses are designed such that they are automatically positioned in a central position in the eye by means of some small filaments after they have been inserted into the anterior chamber of the eye.
  • corneal inlays In the last few years, new lenses have been developed which are not inserted into the inner of the eye, but which are implanted into the corneal tissue. They are called corneal inlays or corneal onlays. These corneal implants can be lenses or corneal rings having a diameter of 2-5 mm and a thickness of 10-150 ⁇ . Some different shape forms of such implants are described in WO 96/40005 Al, for example, wherein the shape mainly depends on the function of such an implant.
  • the implants can be used, for example, to correct the typical vision abnormalities such as myopia, hyperopia, astigmatism, or presbyopia.
  • the implantation process typically starts with the opening of the corneal tissue, followed by inserting the corneal implant at the desired depth of the cornea.
  • the opening can be made either by means of cutting the corneal tissue with a blade, such as a mikrokeratom or by using a laser, e.g. a femtosecond laser.
  • the form of the opening can be a linear or circular cut such that the corneal tissue can either be displaced like a flap or the implant can be inserted into a pocket or channel made beforehand in the corneal tissue.
  • WO 96/40005 describes the insertion of several implants in the corneal tissue using a circumferential intrastromal channel as opening. Thereby, each implant needs to be exactly positioned to a predetermined position. The operator handles the insertion device manually to control the exact positioning of the implant.
  • a positioning system for the use with a diagnostic or therapeutic apparatus.
  • the system comprises at least a fixation device mounting means reversibly connecting a fixation device fixing an eye to be diagnosed or treated with the positioning system, a diagnostic or therapeutic device mounting means reversibly connecting a diagnostic and/or therapeutic device with the positioning system, and one or more positioning means adapted to align the diagnostic and/or therapeutic device relative to the fixation device in at least two dimensions.
  • an ophthalmic therapeutic apparatus which can optionally be used with the positioning system of the first aspect.
  • the apparatus comprises at least a fixation device fixing an eye to be treated in an eye -holding means of the fixation device, an implant insertion device holding an ophthalmic implant for inserting it into a purposely prepared opening in a tissue of the eye, and a positioning system aligning the implant insertion device relative to the fixation device.
  • an ophthalmic diagnostic or therapeutic apparatus which can optionally be used with the positioning system of the first aspect is provided.
  • the apparatus of this aspect comprises at least a fixation device fixing an eye to be diagnosed or treated in an eye-holding means of the fixation device, a diagnostic and/or therapeutic device, and a positioning system aligning the diagnostic or therapeutic device relative to the fixation device in at least two dimensions.
  • a method of handling the therapeutic apparatus according to the second aspect is provided.
  • the method can be used for the insertion of an ophthalmic implant into a purposely prepared opening in a tissue of an eye, wherein said method comprising at least the steps of:
  • a method of handling the apparatus according to the third aspect is provided.
  • the method of this aspect can be used for positioning a diagnostic or therapeutic device at a desired position for applying a diagnostic or therapeutic treatment to a patient's eye.
  • the method comprises at least the steps of:
  • Figure 1 shows a positioning system according to an embodiment of the present invention comprising an eye ring (10), a positioning system including positioning means (20) which can be separately moved in two directions and a platform (30) for mounting diagnostic or therapeutic devices.
  • the platform can be moved in x-direction by means of a first screw (40) and in y-direction by means of a second screw (45) of the positioning system.
  • Figure 2 shows an alternative embodiment of a three-dimensional positioning system of the present invention and, more particularly, a cross-sectional view of an eye ring (11) that bears a ring-like support structure (21) on top of it that can be moved on a sphere relative to the position of the eye ring (11).
  • the support structure (21) can be immobilized relative to the eye ring (11) by operating the Bowden cable (51) of the positioning system.
  • the support structure is further equipped with an integrally formed ring-like platform (31) having holes for mounting diagnostic or therapeutic devices.
  • Figure 3 shows an ophthalmic therapeutic apparatus according to an embodiment of the present invention.
  • the drawing shows an eye ring (100) as the fixation device for fixing the eyeball (500) in a fixed position relative to the eye ring.
  • a cylindrical bushing (200) is rigidly connected to the eye ring (100) in order to align an implant insertion device (300) relative to the fixation device and a corneal opening (550) formed in the cornea of the eye.
  • the Figure shows an ophthalmic implant (400) held on the front part of the implant holding means (260).
  • Figure 4 shows an enlarged view of an embodiment of the implant holding means (260) of an implant insertion device (300) used in the ophthalmic therapeutic apparatus shown in Figure 3.
  • the implant holding means (260) is adapted to hold the ophthalmic implant (400) by means of a specific microstructure (340) at its front side.
  • Figure 5 shows an enlarged view of an alternative embodiment of an implant holding means (260) provided at the front part of an implant insertion device which could be mounted at an ophthalmic therapeutic apparatus of the present invention.
  • This embodiment has an upper portion (330) and a lower portion (350) which can be moved against each other by means of the pin (370) to release the implant (400) from the lower portion (350).
  • FIG. 6 shows an enlarged view of a further alternative embodiment of an implant holding means (260) which could be mounted at the front part of an implant insertion device of an ophthalmic therapeutic apparatus of the present invention.
  • the ophthalmic implant (not shown in the drawing) is held in place during the insertion process by means of applying vacuum via the vacuum connector (360) at the front side of the implant insertion device (380) having holes (390) for applying vacuum suction to the implant.
  • Figure 7 shows an enlarged view of a further alternative embodiment of an implant holding means (260) which could be mounted at the front part of an implant insertion device of an ophthalmic therapeutic apparatus of the present invention.
  • the ophthalmic implant (400) is mechanically held at its front tip by means of the first clamping sheet (305) and the second clamping sheet (315).
  • the front tip can be opened and closed by means of moving a wedge (310) between or away from the two clamping sheets using the pin (375).
  • Figure 8 shows an enlarged view of an implant holding means (260) of an implant insertion device to which a blade (600) is additionally mounted underneath the insertion device (320) to create an opening in the eye.
  • the present invention relates to a positioning system for the use with a diagnostic or therapeutic apparatus.
  • the positioning system comprises a fixation device mounting means, a diagnostic or therapeutic device mounting means, one or more positioning means adapted to align the diagnostic and/or therapeutic device relative to the fixation device, and optional further means or devices, if necessary.
  • a diagnostic or therapeutic apparatus is an ophthalmic instrument for the use in diagnosis or therapy of a patient's eye.
  • Diagnosis means herein a process of attempting to determine the identity of a possible disease or disorder of a patient's eye and to the opinion reached by this process. Diagnosis can be made by a clinician, but is not restricted thereto.
  • an optician may also use the diagnostic apparatus according to the present invention to determine specific conditions of the eye.
  • Therapy or therapeutic treatment is in the context of the present invention the attempted remediation of a health problem of a patient's eye, usually following a diagnosis. However, therapeutic treatment may also a supportive therapy that does not treat or improve the underlying condition, but instead increases the patient's comfort.
  • a positioning system is in the context of the present invention a system for controlling and/or steering the site in or at the eye where the diagnosis or treatment should be applied to with high accuracy.
  • the site can, for example, be positioned with accuracy in the range from one or more millimeters to a sub-millimeter range, including the range from about 1 ⁇ to about 5 mm, more particularly from 1 ⁇ to 1 mm, 10 ⁇ to 500 ⁇ , and 20 ⁇ to 100 ⁇ .
  • the fixation device which can be mounted on the positioning system of the present invention can be any device fixing an eye to be diagnosed and/or treated such that the eyeball cannot be moved within the fixation device after its fixation therein.
  • fixation means can be described as vacuum fixation means or friction fixation means such as a corneal suction ring or an eye ring or an eye ring having a frictional surface on the side in contact with the eyeball.
  • Another fixation means can be fixed at the eyeball with an eye holding surface reversibly holding the eye using glue. By means of the glue, the eye ring can be fixed on the eyeball and, after the treatment, removed by washing the glue away.
  • the fixation device mounting means being part of the positioning system of the first aspect can be any means adapted for connecting the positioning system of the invention with such a fixation device.
  • the fixation device mounting means can either reversibly connect the fixation device with the positioning system or can be integrally formed with the fixation device.
  • the diagnostic or therapeutic device mounting means can be any means adapted for reversibly connecting one or more diagnostic and/or therapeutic devices to the positioning system.
  • the diagnostic or therapeutic device mounting means can be a platform or plate having fixing means such as holes or pins for mounting one or more diagnostic or therapeutic devices.
  • the diagnostic or therapeutic devices may be plugged on the platform or fixed with screws to the platform such that they are in a fixed position on the platform.
  • a diagnostic device for being mounted on the platform can be any ophthalmologic diagnosis instrument for making a diagnosis of a patient's eye.
  • a therapeutic device may be any instrument for applying a therapy at a patient's eye, for example a treatment at the surface of the eyeball, the corneal tissue, or the inner tissues or parts of the eye such as the lens or the retina.
  • the positioning means included in the positioning system of the first aspect can, in the context of the present invention, be any means which allows an aligning of the diagnostic and/or therapeutic device relative to the fixation device in at least one direction.
  • the positioning system can also be adjusted to be a two or more dimensional positioning system. In the following the x-direction is used for defining the first dimension and the y-direction is used for defining the second dimension perpendicular to the x-direction. That means that a two-dimensional positioning system can adjust the diagnosis and/or treatment site in a plane, i.e. in x- and y-direction (cf. Figure 1).
  • a three-dimensional system can additionally adjust the diagnosis and/or treatment site in z-direction perpendicular to the x-y-plane.
  • z- direction is in the sense of the following description the direction in which the light falls into the eyeball and the x- and y-directions are perpendicular thereto.
  • the fixation device fixing the patient's eye (not shown) is integrally provided with the fixation device mounting means (10).
  • the fixation device is a corneal suction eye ring.
  • the positioning means (20) including guiding means (22, 24) and screws (40, 45) for moving the platform (30) are provided on the top of the fixation device mounting means (10).
  • At the back of the eye ring there is a vacuum connection (25) standing out vertically from the face of the eye ring.
  • the vacuum connection is used to connect the eye ring to a vacuum pump by means of a vacuum tubing so that the eye ring can be fixed to an eyeball by means of applying vacuum.
  • a system of positioning means that enables a platform (30) which is placed on top of the guiding system to be moved in x- and/or y-direction.
  • the positioning means generally include, for example, one or more moving means such as screws (40, 45) for aligning the diagnostic and/or therapeutic device mounting means in x- or y-direction and, optionally also in z-direction.
  • additional guiding means may be comprised.
  • two guiding means (22, 24) such as guiding rails are provided for the x- and y-direction respectively. More particularly, the lower part of this system provides the guiding for the movement in y- direction.
  • the guiding for the x- direction is placed.
  • the movement of the platform (30) in either direction is facilitated by moving means 40 having a flexible shaft that has a handle on one end, and being fixed to the positioning system by a screw and nut mechanism on the other end.
  • moving means 40 having a flexible shaft that has a handle on one end, and being fixed to the positioning system by a screw and nut mechanism on the other end.
  • By turning the flexible shaft clockwise or counter clockwise a movement of the table in either +x or -x direction is initiated.
  • the movement is guided by the guiding means (24).
  • the same mechanism is used for aligning the platform in y-direction.
  • the platform (30) which is placed on top of the x/y-guiding system bears four holes that can be used to mount a therapeutic or diagnostic instrument that, after assembling, can be positioned in relation to the eye.
  • the holes may have an inner thread to use a screw for the mounting of the therapeutic or diagnostic devices.
  • the platform can also bear a third axis (z-axis) which would allow a positioning of a therapeutic or diagnostic instrument not only in two dimensions, but in three dimensions. That means that the diagnostic or therapeutic device mounting means can be variable in its position relative to the direction in which the light falls into the eyeball.
  • a lift plate can be used for the alignment in the third direction.
  • the position of the platform can, for example, be varied in z-direction by lifting the platform via a screwing mechanism;
  • the position of the diagnostic or therapeutic device relative to the z- axis may also be adjustable by using different spacers, such as small plates, positioned between the plate and the diagnostic or therapeutic device in different thickness.
  • an alternative embodiment of a three-dimensional positioning system of the first aspect comprises a hemispherical positioning means.
  • Figure 2 shows such an alternative embodiment of a three-dimensional positioning system in a cross-sectional view and a perspective view. More particularly, an eye ring (11) as fixation means is shown in its cross-sectional view in Figure 2. Instead of an eye ring any other fixation means such as a suction ring as described beforehand can be used.
  • the eye ring (11) bears a ring-like or hemisphere-like support structure (21) on top of it that can be moved on a sphere relative to the position of the eye ring (11).
  • the support structure (21) is further equipped with an integrally formed ring-like platform (31) having holes for mounting diagnostic or therapeutic devices. The holes may have an inner thread.
  • a Bowden cable (51) extends from the assembly.
  • This Bowden cable is used to operate the immobilization means of the positioning system.
  • the support structure (21) can be immobilized relative to the eye ring (11) by operating the Bowden cable (51) of the positioning system as described in the following.
  • a wedge (41) is placed behind a spring (42). In its zero position the spring exerts force to the wedge at position (43) causing the wedge to lock the positioning system. If the operator compresses the grip assembly at the end of the Bowden cable (51), the spring (42) is released and the positioning system is unlocked, hence allowing the operator to adjust the position of the ring-like support structure (21).
  • the ring-like support structure (21) can freely be moved on the eye ring (11) and can be fixed in any position, which is wanted.
  • the ring-like support structure (21) having a platform for mounting the diagnostic or therapeutic devices can be freely and accurately positioned in the three-dimensional room and fixed at the desired position by the immobilization means (41) as described beforehand.
  • the positioning system of the first aspect of the invention can be used for connecting one or more diagnostic or therapeutic devices to an eye fixation device.
  • the positioning system can rigidly connect two or more devices to an eye fixation device and can suitably be adjusted such that the diagnosis and/or treatment site can be accurately aligned in one, two or three directions.
  • the invention relates to an ophthalmic therapeutic apparatus comprising a fixation device fixing an eye, an implant insertion means, a positioning system and optional further devices.
  • the fixation device and the positioning system may be the same as described in the first aspect.
  • the implant insertion means is a means for holding and inserting an ophthalmic implant into a purposely prepared opening in a tissue of the eye.
  • An ophthalmic implant can be in the sense of the present invention, any implant known to be inserted into an eye.
  • lenses such as lenses for treating cataracts, a polymeric insert such as a polymeric ring or polymeric segment used for treating astigmatism, corneal inlays or onlays can be mentioned.
  • FIG. 3 An exemplary construction of such an apparatus of the second aspect is shown in Figure 3.
  • the fixation device for fixing the eyeball is an eye ring (100) which is applied to an eyeball (500) and mechanically holds the eyeball in position so that it cannot move relative to the eye ring.
  • the eye ring (100) comprises a vacuum adapter (250) to apply vacuum to the eye ring to avoid any motion of the eyeball (500) when the eye ring is fixed.
  • Figure 3 further shows a cylindrical bushing (200) that is rigidly connected to the eye ring (100). The inner opening of the bushing (200) acts as guiding for a shaft (220) that can move relative to the bushing in x-direction.
  • the implant insertion device comprises implant holding means for holding the implant by friction.
  • Friction means in the context of the present invention a surface force that opposes relative motion.
  • the surface force may be adjusted by means of a specific frictional surface adapted to apply a friction between the implant and the surface higher than the friction between the implant and the tissue of the eye, when inserting the implant, and a friction between the implant and the surface lower than the friction between the implant and the tissue, when releasing the implant at the desired site.
  • a specific frictional surface adapted to apply a friction between the implant and the surface higher than the friction between the implant and the tissue of the eye, when inserting the implant, and a friction between the implant and the surface lower than the friction between the implant and the tissue, when releasing the implant at the desired site.
  • the skilled person knows several alternative surfaces fulfilling this condition and as example, it can be imagined a surface having a specific surface roughness or a specific surface microstructure.
  • the implant holding means (260) holds the ophthalmic implant (400) by means of friction because the surface at the front part of the insertion device bears a microstructure that has the shape of saw teeth (340). This saw teeth structure allows that the friction between the implant and the implant
  • the front part of the implant insertion device has an upper portion (330) and a lower portion (350) which can be moved against each other by means of the pin (370). Thereby, after the insertion of the implant (400), the lower portion (350) can be moved backwards and, thus, can wipe off the implant (400) by means of the upper portion (330).
  • the implant insertion device comprises an implant holding means reversibly holding the implant, by vacuum suction.
  • FIG. 6 shows an embodiment of such an implant holding means (260) holding the ophthalmic implant in place during the insertion process by applying vacuum suction to the implant provided on the implant holding means.
  • the front side of the implant holding means contains multiple vacuum holes (390) at the area on which the implant (not shown) is placed. These holes (390) are internally connected to a vacuum connector (360) that connects the implant holding means with a vacuum source. During the insertion process the vacuum is switched on to hold the implant in place. After the implant holding means has reached its final position in the eye, vacuum is switched off.
  • the lower portion of the implant holding means (having the vacuum holes) can now be retracted while the upper portion with the semi-circular support structure remains in position and, hence, wipes off the implant from the lower portion of the implant holding means.
  • the implant holding means of the implant insertion device mechanically holds the ophthalmic implant.
  • the implant holding means of the implant insertion device mechanically holds the ophthalmic implant.
  • the top clamping sheet layer (315) can be cut out semi-circular at its front side, hence touching the implant such as a lens only on a small surface portion of its periphery. It is also bent in such a way that it acts like a forceps, fixing the implant in place.
  • Exemplary materials for the clamping sheet layer are metals, ceramics, or polymers as long as it can clamp the implant on the base insertion means.
  • the apparatus additionally comprises a blade (600) for surgical opening the tissue before or during the insertion of the implant.
  • Figure 8 shows a combination of an implant holding means (260) and a blade (600) for the use in such an embodiment.
  • the apparatus includes a blade (600) that is placed just underneath the implant holding means (260). While the implant holding means holds the ophthalmic implant (400) such as a lens at the front side, the cutting edge (610) of the blade (600) extends further out so that the opening in the eye can be created by this blade just shortly before the implant holding means with the ophthalmic implant follows.
  • the Figure 8 also shows a blade holder (620) that is fixed perpendicular to the face of the blade (600). The blade holder is used to allow coupling of the blade (600) to a motor that initiates blade oscillation. It is further used to precisely guide the blade (600) in a cutting head assembly (not shown in the drawing) that facilitates the forward movement of the complete assembly.
  • the blade holder (620) is fixed to the blade (600) on two sides and bears an opening in the middle so that the implant holding means (360) does not have to oscillate with the blade and may be moved in the insertion direction independently from the blade.
  • the invention relates to an ophthalmic diagnostic or therapeutic apparatus comprising a fixation device fixing an eye, a diagnostic or therapeutic device or two or more of these devices in combination, a positioning system and optional further devices.
  • fixation device and the positioning system may be the same as described in the first aspect.
  • diagnostic or therapeutic devices which can be used in the apparatus of the third aspect of the invention either alone or in combination with each other can be the same as described in the first aspect.
  • the positioning system is preferably a system which can align one or more devices connected to the apparatus accurate in at least two or three dimensions. Therefore, the positioning system of the first aspect can suitably be used in the apparatus of the third aspect.
  • the apparatus of the third aspect can be adapted such that each diagnostic or therapeutic device may be positioned separately or two or more devices are positioned together in a fixed or congruent manner.
  • each diagnostic or therapeutic device may be positioned separately or two or more devices are positioned together in a fixed or congruent manner.
  • this can, for example, be achieved by using one platform or plate on which the devices are mounted in a fixed position.
  • the ⁇ devices should be aligned separately or . congruently, they should be mounted on separate positioning means which can be controlled independently from each other.
  • a method of handling the therapeutic apparatus according to the second aspect is provided. The method can be used for the insertion of an ophthalmic implant into a purposely prepared opening in a tissue of an eye, wherein said method comprising at least the steps of:
  • the eye ring (100) is applied to an eyeball (500) in order to fix the eye to be diagnosed or treated in the eye-holding means of the eye ring. Thereby, the eyeball is mechanically held in position so that it cannot move relative to the eye ring.
  • the step of fixing the eye is achieved by applying vacuum through a vacuum adapter (250) to the eye ring to avoid any motion of the eyeball when the eye ring is fixed.
  • the implant insertion device (300) is provided with an ophthalmic implant (400) in the next step. More particularly, as shown in Figure 3, the implant is usually laid down on the front part of the implant holding means (260) and can be held by means of friction or can be mechanically held, for example. [0063] The implant insertion device (300) is then aligned relative to the eye ring fixing the eye.
  • a cylindrical bushing (200) is rigidly connected to the eye ring (100). The inner opening of the bushing acts as guiding for a shaft (220). On one end of the shaft there is a handle (240) that the operator will use to conduct the insertion process.
  • the implant holding means (260) On the other end of the shaft, the implant holding means (260) is fixed which holds and conveys the ophthalmic implant (400).
  • the operator will move the shaft (220) with the implant holding means (260) towards the center of the eye ring (100) so that the implant holding means with the ophthalmic implant (400) will slide into an opening (550) of the eye that was previously created by the operator.
  • the shaft is during its movement guided during the insertion step relative to the bushing (200) in x-direction.
  • the implant surgeon will release the ophthalmic implant (400) from the implant holding means (260) . at the desired position in the tissue of the eye and, thereafter, the implant holding means will retracted from the eye so that it will move out of the opening (550).
  • the implant will remain in the eye.
  • a specific friction between the implant and the surface of the holding means either when inserting or when moving out could be used.
  • FIG. 4 an implant holding means having a surface bearing a microstructure that has the shape of saw teeth (340) is shown.
  • This saw teeth structure allows that the friction between the implant and the implant holding means is high during the insertion process so that there will be no relative movement between the implant holding means and the implant.
  • the implant insertion device is retracted, the friction between the implant and the implant holding means is low, allowing the implant holding means to be moved out of the surgical opening in the eye while the implant stays at its designated implant position.
  • the method of this aspect can be carried out with any of the implant holding means as described before.
  • the aligning step can also be carried out after the insertion step so that the exact position of the implant in the eye can be adjusted more accurately at the site of the placement.
  • the aligning step can be carried out before and after the insertion step so that a fine correcting step can be carried out for further improving the accuracy of the positioning procedure.
  • a method of handling the apparatus according to third aspect is provided.
  • the method of this aspect can be used for positioning a diagnostic or therapeutic device at a desired position for applying a diagnostic or therapeutic treatment to a patient's eye.
  • the method comprises at least the steps of:
  • the method of this aspect can suitably be used for aligning one or more diagnostic and/or therapeutic devices relative to the fixation device in one, two, or three dimensions, such as in the x- or y- direction, the x- and z-direction or the x-, y- and z-direction.
  • the diagnostic or therapeutic treatment can be carried out in an improved accuracy at the " desired site of treatment. Due to the high accuracy in this method, the diagnosis or therapy can be carried out not only by a person who is highly trained in manually handling operations or diagnostic treatments, but can be carried out by any person who knows the exact treatment site without the need of manually handling any diagnostic or therapeutic instrument. Therefore, this method is more comfortable than the common manual treatments of the eye in which the diagnostic or therapeutic devices are usually manually handled.
  • the positioning system, the ophthalmic apparatuses and the methods as described herein are suitable for, but not limited to, any surgical or non-surgical diagnosis or treatment of the eye such as measuring the cornea, the osmotic pressure of the eyeball, PRK, LASI , the insertion of ophthalmic implants such as lenses, corneal inlays or onlays, and so forth.

Abstract

The present invention generally relates to the field of ophthalmic diagnostic or therapeutic apparatuses which can be used for the insertion of an ophthalmic implant into an opening of an eye or for applying a diagnostic or therapeutic treatment to an eye of a patient. In addition, positioning systems for the use with such a diagnostic or therapeutic apparatus and methods of handling the apparatus are described.

Description

OPHTHALMIC DIAGNOSTIC OR THERAPEUTIC APPARATUS OPTIONALLY INCLUDING AN IMPLANT INSERTION DEVICE, POSITIONING SYSTEM AND METHOD OF HANDLING THE APPARATUS
FIELD OF THE INVENTION
[001] The present invention relates to an ophthalmic diagnostic or therapeutic apparatus which can be used for the insertion of an ophthalmic implant into an opening of an eye or for applying a diagnostic or therapeutic treatment to an eye of a patient. The invention further relates to a positioning system for use with such a diagnostic or therapeutic apparatus. Moreover, the invention relates to methods of handling the apparatus for insertion of an ophthalmic implant into a prepared opening in a tissue of an eye or for positioning the diagnostic or therapeutic device at a desired position for applying a diagnostic or therapeutic treatment to an eye of a patient.
BACKGROUND OF THE INVENTION [002] Ophthalmic diagnostic or therapeutic methods are well known techniques used to make a diagnosis or an external or internal treatment of the eye. Examples of such diagnosis or treatments are surgical methods or non-surgical methods. Examples of non-surgical methods are methods for measuring the curvature of the cornea, the measuring of the osmotic pressure of the eye etc. Usually, these methods are used for diagnosis only, but can also be used to make a map of the eye before a surgical treatment of the eye is carried out. In some of the surgical methods, the eye is partly or fully opened to treat the cornea or the lens of a patient's eye. For example, the curvature of the cornea can be treated or the lens can be replaced by a new one.
[003] All the known techniques are based on a manual handling of the diagnosis or treatment instruments. Sometimes, it is necessary, to fix the patient's eye to avoid any movement of the eye during the manual diagnosis or treatment of the eye. The fixation of the eye can, for example, be made by using a corneal ring supporting the cornea of the patient's eye. Many corneal ring technologies and designs are known in the field of ophthalmic diagnostic and therapeutic devices. If such corneal rings are fixed at the patient's eye by means of vacuum, they are called vacuum suction rings. Examples of suction rings for the general use in ophthalmic surgical processes are described in DE 198 47 089 Al, EP 1 350 492 A2, and EP 0 873 735 Al, for example. [004] An example of a surgical treatment method in which corneal rings are typically used, is the laser-assisted in situ keratomileusis LASIK treatment for the correction of myopia established since about the beginning of 1990. In this treatment, a thin lamella of corneal tissue is typically cut from the surface of the cornea using a blade which is called mikrokeratome. The corneal lamella usually remains attached by a hinged portion of corneal tissue to form a flap. The flap is then held back and a laser beam is used for the treatment of the inside tissue of the cornea. For example, the curvature of the surface of the cornea can be changed by using a laser beam to adjust the visual acuity. After the reshaping of the cornea tissue, the flap is repositioned on the cornea and held in place by osmotic forces. [005] In the last years, corneal implants have become significant impact in ophthalmology, especially in case the vision abnormalities cannot easily be corrected by the above-mentioned laser-based procedures, e.g. photorefractive keratectomy (PRK) or LASIK. Another common condition in which a corneal implant can be used to improve the patient's comfort is a cataract. If the patient is suffering at a cataract, the natural crystalline lens is clouded such that the passage of light rays through the lens to the retina is obstructed or blocked.
[006] The corneal implant can in these treatments be a refractive intraocular lens. The intraocular lens usually is inserted into a patient's eye via a small incision in the cornea. EP 1 491 163 A2 describes, for example, a suitable ophthalmic instrument including a lens insertion assembly and an insertion actuator to inert a foldable intraocular lens into a patient's eye. The insertion assembly and the actuator are manually handled by the operator to enable him the exact positioning of the lens in the eye. After the insertion of the folded lens into the eye, the lens is automatically unfolded by elastic strain energy, for example. Some of the lenses are designed such that they are automatically positioned in a central position in the eye by means of some small filaments after they have been inserted into the anterior chamber of the eye.
[007] In the last few years, new lenses have been developed which are not inserted into the inner of the eye, but which are implanted into the corneal tissue. They are called corneal inlays or corneal onlays. These corneal implants can be lenses or corneal rings having a diameter of 2-5 mm and a thickness of 10-150 μπι. Some different shape forms of such implants are described in WO 96/40005 Al, for example, wherein the shape mainly depends on the function of such an implant. The implants can be used, for example, to correct the typical vision abnormalities such as myopia, hyperopia, astigmatism, or presbyopia. The implantation process typically starts with the opening of the corneal tissue, followed by inserting the corneal implant at the desired depth of the cornea. The opening can be made either by means of cutting the corneal tissue with a blade, such as a mikrokeratom or by using a laser, e.g. a femtosecond laser. The form of the opening can be a linear or circular cut such that the corneal tissue can either be displaced like a flap or the implant can be inserted into a pocket or channel made beforehand in the corneal tissue. WO 96/40005 describes the insertion of several implants in the corneal tissue using a circumferential intrastromal channel as opening. Thereby, each implant needs to be exactly positioned to a predetermined position. The operator handles the insertion device manually to control the exact positioning of the implant. [008] The insertion of such corneal inlays or onlays is a minimal invasive process in which the eye is not completely opened. In addition, there is usually no irreversible damage of any corneal tissue such as necessary in the laser-based abrasions methods, e.g. LASIK. The implants can be replaced if they are no longer needed or need to be replaced by new ones.
[009] Considering the above common technology, it is an object of the present invention to overcome at least some of the above-mentioned problems of the common technology and, more particular, to provide an apparatus allowing an accurate handling of the diagnostic or therapeutic instrument at or in the eye of a patient.
SUMMARY OF THE INVENTION
[0010] According to a first aspect of the invention, a positioning system for the use with a diagnostic or therapeutic apparatus is provided. The system comprises at least a fixation device mounting means reversibly connecting a fixation device fixing an eye to be diagnosed or treated with the positioning system, a diagnostic or therapeutic device mounting means reversibly connecting a diagnostic and/or therapeutic device with the positioning system, and one or more positioning means adapted to align the diagnostic and/or therapeutic device relative to the fixation device in at least two dimensions.
[0011] According to a second aspect of the invention, an ophthalmic therapeutic apparatus which can optionally be used with the positioning system of the first aspect is provided. The apparatus comprises at least a fixation device fixing an eye to be treated in an eye -holding means of the fixation device, an implant insertion device holding an ophthalmic implant for inserting it into a purposely prepared opening in a tissue of the eye, and a positioning system aligning the implant insertion device relative to the fixation device. [0012] According to a third aspect of the invention, an ophthalmic diagnostic or therapeutic apparatus which can optionally be used with the positioning system of the first aspect is provided. The apparatus of this aspect comprises at least a fixation device fixing an eye to be diagnosed or treated in an eye-holding means of the fixation device, a diagnostic and/or therapeutic device, and a positioning system aligning the diagnostic or therapeutic device relative to the fixation device in at least two dimensions.
[0013] According to a fourth aspect of the invention, a method of handling the therapeutic apparatus according to the second aspect is provided. The method can be used for the insertion of an ophthalmic implant into a purposely prepared opening in a tissue of an eye, wherein said method comprising at least the steps of:
- fixing an eye to be treated in an eye-holding means of the fixation device,
- providing the implant insertion device with an ophthalmic implant,
- aligning the implant insertion device relative to the fixation device, and
- inserting the ophthalmic implant into the purposely prepared opening in the tissue of the eye.
[0014] According to a fifth aspect of the invention, a method of handling the apparatus according to the third aspect is provided. The method of this aspect can be used for positioning a diagnostic or therapeutic device at a desired position for applying a diagnostic or therapeutic treatment to a patient's eye. The method comprises at least the steps of:
- fixing an eye to be diagnosed or treated in an eye-holding means of the fixation device,
- positioning the diagnostic or therapeutic device relative to the desired position, and optionally
- applying the diagnostic or therapeutic treatment at the eye.
[0015] Alternative embodiments as well as further aspects and features of the present invention are described in the dependent claims and will become more apparent from the following description of non-limiting embodiments of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The invention will be better understood with reference to the detailed description when considering it in conjunction with the accompanying drawings, which show the following: [0017] Figure 1 shows a positioning system according to an embodiment of the present invention comprising an eye ring (10), a positioning system including positioning means (20) which can be separately moved in two directions and a platform (30) for mounting diagnostic or therapeutic devices. The platform can be moved in x-direction by means of a first screw (40) and in y-direction by means of a second screw (45) of the positioning system.
[0018] Figure 2 shows an alternative embodiment of a three-dimensional positioning system of the present invention and, more particularly, a cross-sectional view of an eye ring (11) that bears a ring-like support structure (21) on top of it that can be moved on a sphere relative to the position of the eye ring (11). The support structure (21) can be immobilized relative to the eye ring (11) by operating the Bowden cable (51) of the positioning system. The support structure is further equipped with an integrally formed ring-like platform (31) having holes for mounting diagnostic or therapeutic devices.
[0019] Figure 3 shows an ophthalmic therapeutic apparatus according to an embodiment of the present invention. The drawing shows an eye ring (100) as the fixation device for fixing the eyeball (500) in a fixed position relative to the eye ring. A cylindrical bushing (200) is rigidly connected to the eye ring (100) in order to align an implant insertion device (300) relative to the fixation device and a corneal opening (550) formed in the cornea of the eye. The Figure shows an ophthalmic implant (400) held on the front part of the implant holding means (260).
[0020] Figure 4 shows an enlarged view of an embodiment of the implant holding means (260) of an implant insertion device (300) used in the ophthalmic therapeutic apparatus shown in Figure 3. The implant holding means (260) is adapted to hold the ophthalmic implant (400) by means of a specific microstructure (340) at its front side.
[0021] Figure 5 shows an enlarged view of an alternative embodiment of an implant holding means (260) provided at the front part of an implant insertion device which could be mounted at an ophthalmic therapeutic apparatus of the present invention. This embodiment has an upper portion (330) and a lower portion (350) which can be moved against each other by means of the pin (370) to release the implant (400) from the lower portion (350).
[0022] Figure 6 shows an enlarged view of a further alternative embodiment of an implant holding means (260) which could be mounted at the front part of an implant insertion device of an ophthalmic therapeutic apparatus of the present invention. In this embodiment the ophthalmic implant (not shown in the drawing) is held in place during the insertion process by means of applying vacuum via the vacuum connector (360) at the front side of the implant insertion device (380) having holes (390) for applying vacuum suction to the implant. [0023] Figure 7 shows an enlarged view of a further alternative embodiment of an implant holding means (260) which could be mounted at the front part of an implant insertion device of an ophthalmic therapeutic apparatus of the present invention. In this embodiment, the ophthalmic implant (400) is mechanically held at its front tip by means of the first clamping sheet (305) and the second clamping sheet (315). The front tip can be opened and closed by means of moving a wedge (310) between or away from the two clamping sheets using the pin (375).
[0024] Figure 8 shows an enlarged view of an implant holding means (260) of an implant insertion device to which a blade (600) is additionally mounted underneath the insertion device (320) to create an opening in the eye.
DETAILED DESCRIPTION OF THE INVENTION
[0025] According to a first aspect, the present invention relates to a positioning system for the use with a diagnostic or therapeutic apparatus. The positioning system comprises a fixation device mounting means, a diagnostic or therapeutic device mounting means, one or more positioning means adapted to align the diagnostic and/or therapeutic device relative to the fixation device, and optional further means or devices, if necessary.
[0026] In the context of the present invention, a diagnostic or therapeutic apparatus is an ophthalmic instrument for the use in diagnosis or therapy of a patient's eye. Diagnosis means herein a process of attempting to determine the identity of a possible disease or disorder of a patient's eye and to the opinion reached by this process. Diagnosis can be made by a clinician, but is not restricted thereto. For example, an optician may also use the diagnostic apparatus according to the present invention to determine specific conditions of the eye. Therapy or therapeutic treatment is in the context of the present invention the attempted remediation of a health problem of a patient's eye, usually following a diagnosis. However, therapeutic treatment may also a supportive therapy that does not treat or improve the underlying condition, but instead increases the patient's comfort.
[0027] A positioning system is in the context of the present invention a system for controlling and/or steering the site in or at the eye where the diagnosis or treatment should be applied to with high accuracy. The site can, for example, be positioned with accuracy in the range from one or more millimeters to a sub-millimeter range, including the range from about 1 μιη to about 5 mm, more particularly from 1 μπι to 1 mm, 10 μπι to 500 μπι, and 20 μπι to 100 μπι. [0028] According to the invention, the fixation device which can be mounted on the positioning system of the present invention can be any device fixing an eye to be diagnosed and/or treated such that the eyeball cannot be moved within the fixation device after its fixation therein. Examples of fixation means can be described as vacuum fixation means or friction fixation means such as a corneal suction ring or an eye ring or an eye ring having a frictional surface on the side in contact with the eyeball. Another fixation means can be fixed at the eyeball with an eye holding surface reversibly holding the eye using glue. By means of the glue, the eye ring can be fixed on the eyeball and, after the treatment, removed by washing the glue away. [0029] The fixation device mounting means being part of the positioning system of the first aspect can be any means adapted for connecting the positioning system of the invention with such a fixation device. The fixation device mounting means can either reversibly connect the fixation device with the positioning system or can be integrally formed with the fixation device. [0030] In the context of the invention, the diagnostic or therapeutic device mounting means can be any means adapted for reversibly connecting one or more diagnostic and/or therapeutic devices to the positioning system. As exemplary embodiments, it can be mentioned that the diagnostic or therapeutic device mounting means can be a platform or plate having fixing means such as holes or pins for mounting one or more diagnostic or therapeutic devices. For example, the diagnostic or therapeutic devices may be plugged on the platform or fixed with screws to the platform such that they are in a fixed position on the platform. A diagnostic device for being mounted on the platform can be any ophthalmologic diagnosis instrument for making a diagnosis of a patient's eye. A therapeutic device may be any instrument for applying a therapy at a patient's eye, for example a treatment at the surface of the eyeball, the corneal tissue, or the inner tissues or parts of the eye such as the lens or the retina.
[0031] The positioning means included in the positioning system of the first aspect can, in the context of the present invention, be any means which allows an aligning of the diagnostic and/or therapeutic device relative to the fixation device in at least one direction. The positioning system can also be adjusted to be a two or more dimensional positioning system. In the following the x-direction is used for defining the first dimension and the y-direction is used for defining the second dimension perpendicular to the x-direction. That means that a two-dimensional positioning system can adjust the diagnosis and/or treatment site in a plane, i.e. in x- and y-direction (cf. Figure 1). A three-dimensional system can additionally adjust the diagnosis and/or treatment site in z-direction perpendicular to the x-y-plane. In this regard, z- direction is in the sense of the following description the direction in which the light falls into the eyeball and the x- and y-directions are perpendicular thereto.
[0032] It can be suitable to adjust the position in each direction in a grid interval, but for a higher accuracy it may be preferable to adjust the position in each direction continuously. Of course, both methods could be combined in any manner such that, for example, in z-direction a continuously alignment is possible, while in the x- and y-direction an alignment is possible in a specific grid interval. All other possibilities would also work in a two-dimensional as well as in a three-dimensional alignment system and can be used dependent on the application of the positioning system. Sometimes a fixed grid interval could be more practical when a diagnosis of the eye is carried out because a raster can be scanned. However, a continuous positioning could be convenient during implant insertions, for example.
[0033] In the embodiment of the positioning system of the first aspect which is shown in Figure 1, the fixation device fixing the patient's eye (not shown) is integrally provided with the fixation device mounting means (10). In this system, the fixation device is a corneal suction eye ring. The positioning means (20) including guiding means (22, 24) and screws (40, 45) for moving the platform (30) are provided on the top of the fixation device mounting means (10). At the back of the eye ring, there is a vacuum connection (25) standing out vertically from the face of the eye ring. In this embodiment of the invention, the vacuum connection is used to connect the eye ring to a vacuum pump by means of a vacuum tubing so that the eye ring can be fixed to an eyeball by means of applying vacuum.
[0034] On top of the eye ring, and mechanically fixed to the eye ring, a system of positioning means is shown that enables a platform (30) which is placed on top of the guiding system to be moved in x- and/or y-direction. The positioning means generally include, for example, one or more moving means such as screws (40, 45) for aligning the diagnostic and/or therapeutic device mounting means in x- or y-direction and, optionally also in z-direction. For a better guidance, additional guiding means may be comprised. In this embodiment, two guiding means (22, 24) such as guiding rails are provided for the x- and y-direction respectively. More particularly, the lower part of this system provides the guiding for the movement in y- direction. Directly on top of this y-guiding, and perpendicular to it, the guiding for the x- direction is placed. The movement of the platform (30) in either direction is facilitated by moving means 40 having a flexible shaft that has a handle on one end, and being fixed to the positioning system by a screw and nut mechanism on the other end. By turning the flexible shaft clockwise or counter clockwise a movement of the table in either +x or -x direction is initiated. The movement is guided by the guiding means (24). The same mechanism is used for aligning the platform in y-direction.
[0035] The platform (30) which is placed on top of the x/y-guiding system bears four holes that can be used to mount a therapeutic or diagnostic instrument that, after assembling, can be positioned in relation to the eye. The holes may have an inner thread to use a screw for the mounting of the therapeutic or diagnostic devices.
[0036] The platform can also bear a third axis (z-axis) which would allow a positioning of a therapeutic or diagnostic instrument not only in two dimensions, but in three dimensions. That means that the diagnostic or therapeutic device mounting means can be variable in its position relative to the direction in which the light falls into the eyeball. For example, a lift plate can be used for the alignment in the third direction. When using a lift plate, the position of the platform can, for example, be varied in z-direction by lifting the platform via a screwing mechanism; However, the position of the diagnostic or therapeutic device relative to the z- axis may also be adjustable by using different spacers, such as small plates, positioned between the plate and the diagnostic or therapeutic device in different thickness.
[0037] As the eye and the eye's cornea are not flat but rather follow the geometry of a sphere, it can be useful to position a therapeutic or diagnostic instrument spherically in relation to the eyeball or cornea. Therefore, an alternative embodiment of a three-dimensional positioning system of the first aspect comprises a hemispherical positioning means.
[0038] Figure 2 shows such an alternative embodiment of a three-dimensional positioning system in a cross-sectional view and a perspective view. More particularly, an eye ring (11) as fixation means is shown in its cross-sectional view in Figure 2. Instead of an eye ring any other fixation means such as a suction ring as described beforehand can be used. [0039] In this embodiment the eye ring (11) bears a ring-like or hemisphere-like support structure (21) on top of it that can be moved on a sphere relative to the position of the eye ring (11). The support structure (21) is further equipped with an integrally formed ring-like platform (31) having holes for mounting diagnostic or therapeutic devices. The holes may have an inner thread. A Bowden cable (51) extends from the assembly. This Bowden cable is used to operate the immobilization means of the positioning system. The support structure (21) can be immobilized relative to the eye ring (11) by operating the Bowden cable (51) of the positioning system as described in the following. [0040] At the end of the Bowden cable (51), a wedge (41) is placed behind a spring (42). In its zero position the spring exerts force to the wedge at position (43) causing the wedge to lock the positioning system. If the operator compresses the grip assembly at the end of the Bowden cable (51), the spring (42) is released and the positioning system is unlocked, hence allowing the operator to adjust the position of the ring-like support structure (21). As can be imagined, the ring-like support structure (21) can freely be moved on the eye ring (11) and can be fixed in any position, which is wanted. Thus, the ring-like support structure (21) having a platform for mounting the diagnostic or therapeutic devices can be freely and accurately positioned in the three-dimensional room and fixed at the desired position by the immobilization means (41) as described beforehand.
[0041] In the light of the above, the positioning system of the first aspect of the invention can be used for connecting one or more diagnostic or therapeutic devices to an eye fixation device. The positioning system can rigidly connect two or more devices to an eye fixation device and can suitably be adjusted such that the diagnosis and/or treatment site can be accurately aligned in one, two or three directions.
[0042] According to a second aspect, the invention relates to an ophthalmic therapeutic apparatus comprising a fixation device fixing an eye, an implant insertion means, a positioning system and optional further devices. The fixation device and the positioning system may be the same as described in the first aspect. [0043] The implant insertion means is a means for holding and inserting an ophthalmic implant into a purposely prepared opening in a tissue of the eye. An ophthalmic implant can be in the sense of the present invention, any implant known to be inserted into an eye. As examples of such implants, lenses such as lenses for treating cataracts, a polymeric insert such as a polymeric ring or polymeric segment used for treating astigmatism, corneal inlays or onlays can be mentioned.
[0044] An exemplary construction of such an apparatus of the second aspect is shown in Figure 3. The fixation device for fixing the eyeball is an eye ring (100) which is applied to an eyeball (500) and mechanically holds the eyeball in position so that it cannot move relative to the eye ring. In this exemplary embodiment, the eye ring (100) comprises a vacuum adapter (250) to apply vacuum to the eye ring to avoid any motion of the eyeball (500) when the eye ring is fixed. Figure 3 further shows a cylindrical bushing (200) that is rigidly connected to the eye ring (100). The inner opening of the bushing (200) acts as guiding for a shaft (220) that can move relative to the bushing in x-direction. On one end of the shaft (220) there is a handle (240) that the operator will use to conduct the insertion process. On the other end of the shaft (220), an implant holding means (260) is fixed which holds and conveys the ophthalmic implant (400). [0045] In an embodiment of the apparatus of the second aspect, the implant insertion device comprises implant holding means for holding the implant by friction. Friction means in the context of the present invention a surface force that opposes relative motion. The surface force may be adjusted by means of a specific frictional surface adapted to apply a friction between the implant and the surface higher than the friction between the implant and the tissue of the eye, when inserting the implant, and a friction between the implant and the surface lower than the friction between the implant and the tissue, when releasing the implant at the desired site. To achieve this object, the skilled person knows several alternative surfaces fulfilling this condition and as example, it can be imagined a surface having a specific surface roughness or a specific surface microstructure. [0046] As it is shown in the exemplary embodiment of Figure 4 the implant holding means (260) holds the ophthalmic implant (400) by means of friction because the surface at the front part of the insertion device bears a microstructure that has the shape of saw teeth (340). This saw teeth structure allows that the friction between the implant and the implant holding means is high during the insertion process so that there will be no relative movement between the implant holding means and the implant.
[0047] When the implant insertion device is retracted, the friction between the implant and the implant holding means is low, allowing the implant holding means to be moved out of the surgical opening in the eye while the implant stays at its designated implant position.
[0048] In another variation of the implant insertion device suitable for the apparatus of the second aspect, which is shown in Figure 5, the front part of the implant insertion device has an upper portion (330) and a lower portion (350) which can be moved against each other by means of the pin (370). Thereby, after the insertion of the implant (400), the lower portion (350) can be moved backwards and, thus, can wipe off the implant (400) by means of the upper portion (330). [0049] In another embodiment of the apparatus of the second aspect, the implant insertion device comprises an implant holding means reversibly holding the implant, by vacuum suction. Figure 6 shows an embodiment of such an implant holding means (260) holding the ophthalmic implant in place during the insertion process by applying vacuum suction to the implant provided on the implant holding means. The front side of the implant holding means contains multiple vacuum holes (390) at the area on which the implant (not shown) is placed. These holes (390) are internally connected to a vacuum connector (360) that connects the implant holding means with a vacuum source. During the insertion process the vacuum is switched on to hold the implant in place. After the implant holding means has reached its final position in the eye, vacuum is switched off. In this embodiment of the invention, the lower portion of the implant holding means (having the vacuum holes) can now be retracted while the upper portion with the semi-circular support structure remains in position and, hence, wipes off the implant from the lower portion of the implant holding means.
[0050] Alternatively, it is also possible to switch from vacuum suction to an overpressure when the implant insertion device has been inserted to the desired site. Then the implant will be pressed from the implant insertion device directly to the desired site in the tissue. Thereafter, the implant insertion device can be retracted from the opening. [0051] In a further embodiment of the apparatus of the second aspect, the implant holding means of the implant insertion device mechanically holds the ophthalmic implant. For example, as it is shown in the embodiment of Figure 7, there is a clamping sheet layer (315) on top of the base insertion means (305) which holds the implant (400) at its front tip. The top clamping sheet layer (315) can be cut out semi-circular at its front side, hence touching the implant such as a lens only on a small surface portion of its periphery. It is also bent in such a way that it acts like a forceps, fixing the implant in place. Exemplary materials for the clamping sheet layer are metals, ceramics, or polymers as long as it can clamp the implant on the base insertion means.
[0052] After the implant holding means of the implant insertion device has reached the dedicated implant position in the eye, the pin (375) on top of the implant holding means is pushed towards the front side which causes a wedge (310) that is fixed to said pin to move between the base insertion means (305) and clamping sheet layer (315) so that the clamping sheet layer will move away from the base insertion means and, thus, releases the ophthalmic implant (400). [0053] In a further embodiment of the apparatus of the second aspect, the apparatus additionally comprises a blade (600) for surgical opening the tissue before or during the insertion of the implant. [0054] Figure 8 shows a combination of an implant holding means (260) and a blade (600) for the use in such an embodiment. The apparatus includes a blade (600) that is placed just underneath the implant holding means (260). While the implant holding means holds the ophthalmic implant (400) such as a lens at the front side, the cutting edge (610) of the blade (600) extends further out so that the opening in the eye can be created by this blade just shortly before the implant holding means with the ophthalmic implant follows. The Figure 8 also shows a blade holder (620) that is fixed perpendicular to the face of the blade (600). The blade holder is used to allow coupling of the blade (600) to a motor that initiates blade oscillation. It is further used to precisely guide the blade (600) in a cutting head assembly (not shown in the drawing) that facilitates the forward movement of the complete assembly.
[0055] The blade holder (620) is fixed to the blade (600) on two sides and bears an opening in the middle so that the implant holding means (360) does not have to oscillate with the blade and may be moved in the insertion direction independently from the blade.
[0056] According to a third aspect, the invention relates to an ophthalmic diagnostic or therapeutic apparatus comprising a fixation device fixing an eye, a diagnostic or therapeutic device or two or more of these devices in combination, a positioning system and optional further devices.
[0057] The fixation device and the positioning system may be the same as described in the first aspect. The diagnostic or therapeutic devices which can be used in the apparatus of the third aspect of the invention either alone or in combination with each other can be the same as described in the first aspect.
[0058] In the apparatus of the third aspect, the positioning system is preferably a system which can align one or more devices connected to the apparatus accurate in at least two or three dimensions. Therefore, the positioning system of the first aspect can suitably be used in the apparatus of the third aspect.
[0059] In the context of the present invention, the apparatus of the third aspect can be adapted such that each diagnostic or therapeutic device may be positioned separately or two or more devices are positioned together in a fixed or congruent manner. In case two or more devices should be positioned in a fixed manner, this can, for example, be achieved by using one platform or plate on which the devices are mounted in a fixed position. If, however, the^ devices should be aligned separately or . congruently, they should be mounted on separate positioning means which can be controlled independently from each other. [0060] According to a fourth aspect of the invention, a method of handling the therapeutic apparatus according to the second aspect is provided. The method can be used for the insertion of an ophthalmic implant into a purposely prepared opening in a tissue of an eye, wherein said method comprising at least the steps of:
- fixing an eye to treated in an eye-holding means of the fixation device,
- providing the implant insertion device with an ophthalmic implant,
- aligning the implant insertion device relative to the fixation device, and
- inserting the ophthalmic implant into the purposely prepared opening in the tissue of the eye. [0061] This method will in general be explained by referring to the apparatus shown in Figure 3. The eye ring (100) is applied to an eyeball (500) in order to fix the eye to be diagnosed or treated in the eye-holding means of the eye ring. Thereby, the eyeball is mechanically held in position so that it cannot move relative to the eye ring. In this exemplary embodiment, the step of fixing the eye is achieved by applying vacuum through a vacuum adapter (250) to the eye ring to avoid any motion of the eyeball when the eye ring is fixed.
[0062] The implant insertion device (300) is provided with an ophthalmic implant (400) in the next step. More particularly, as shown in Figure 3, the implant is usually laid down on the front part of the implant holding means (260) and can be held by means of friction or can be mechanically held, for example. [0063] The implant insertion device (300) is then aligned relative to the eye ring fixing the eye. In the apparatus shown in Figure 3, a cylindrical bushing (200) is rigidly connected to the eye ring (100). The inner opening of the bushing acts as guiding for a shaft (220). On one end of the shaft there is a handle (240) that the operator will use to conduct the insertion process. On the other end of the shaft, the implant holding means (260) is fixed which holds and conveys the ophthalmic implant (400). During the procedure, the operator will move the shaft (220) with the implant holding means (260) towards the center of the eye ring (100) so that the implant holding means with the ophthalmic implant (400) will slide into an opening (550) of the eye that was previously created by the operator. The shaft is during its movement guided during the insertion step relative to the bushing (200) in x-direction. [0064] The implant surgeon will release the ophthalmic implant (400) from the implant holding means (260) . at the desired position in the tissue of the eye and, thereafter, the implant holding means will retracted from the eye so that it will move out of the opening (550). The implant will remain in the eye. For example, for easy releasing the implant, a specific friction between the implant and the surface of the holding means either when inserting or when moving out could be used.
[0065] When the surface is like a saw teeth, for example, there could be different friction values which allows an easy insertion process. In Figure 4, an implant holding means having a surface bearing a microstructure that has the shape of saw teeth (340) is shown. This saw teeth structure allows that the friction between the implant and the implant holding means is high during the insertion process so that there will be no relative movement between the implant holding means and the implant. When the implant insertion device is retracted, the friction between the implant and the implant holding means is low, allowing the implant holding means to be moved out of the surgical opening in the eye while the implant stays at its designated implant position. However, the method of this aspect can be carried out with any of the implant holding means as described before.
[0066] In the method of the fourth aspect, the aligning step can also be carried out after the insertion step so that the exact position of the implant in the eye can be adjusted more accurately at the site of the placement. In another alternative, the aligning step can be carried out before and after the insertion step so that a fine correcting step can be carried out for further improving the accuracy of the positioning procedure.
[0067] According to a fifth aspect of the invention, a method of handling the apparatus according to third aspect is provided. The method of this aspect can be used for positioning a diagnostic or therapeutic device at a desired position for applying a diagnostic or therapeutic treatment to a patient's eye. The method comprises at least the steps of:
- fixing an eye to be diagnosed or treated in an eye-holding means of the fixation device,
- positioning the diagnostic or therapeutic device relative to the desired position, and optionally
- applying the diagnostic or therapeutic treatment at the eye.
[0068] The method of this aspect can suitably be used for aligning one or more diagnostic and/or therapeutic devices relative to the fixation device in one, two, or three dimensions, such as in the x- or y- direction, the x- and z-direction or the x-, y- and z-direction. Thereby, the diagnostic or therapeutic treatment can be carried out in an improved accuracy at the "desired site of treatment. Due to the high accuracy in this method, the diagnosis or therapy can be carried out not only by a person who is highly trained in manually handling operations or diagnostic treatments, but can be carried out by any person who knows the exact treatment site without the need of manually handling any diagnostic or therapeutic instrument. Therefore, this method is more comfortable than the common manual treatments of the eye in which the diagnostic or therapeutic devices are usually manually handled. [0069] The positioning system, the ophthalmic apparatuses and the methods as described herein are suitable for, but not limited to, any surgical or non-surgical diagnosis or treatment of the eye such as measuring the cornea, the osmotic pressure of the eyeball, PRK, LASI , the insertion of ophthalmic implants such as lenses, corneal inlays or onlays, and so forth.

Claims

Claims
1. A positioning system for use with a diagnostic or therapeutic apparatus, comprising of at least:
a fixation device mounting means reversibly connecting a fixation device fixing an eye to be diagnosed or treated with the positioning system,
- a diagnostic or therapeutic device mounting means reversibly connecting a diagnostic and/or therapeutic device with the positioning system, and
one or more positioning means adapted to align the diagnostic and/or therapeutic device relative to the fixation device in at least two dimensions.
2. The positioning system of claim 1, wherein a fixation device fixing an eye is integrally provided with the fixation device mounting system.
3. The positioning system of claim 1 or 2, wherein the diagnostic or therapeutic device mounting means is a plate having fixing means for mounting the diagnostic or therapeutic device in a fixed position.
4. The positioning system of anyone of claims 1 to 3, wherein the diagnostic or therapeutic device mounting means is variable in its position relative to the direction in which the light falls into the eyeball.
5. An ophthalmic therapeutic apparatus comprising of at least:
a fixation device fixing an eye to be treated in an eye -holding means of the fixation device,
- an implant insertion device holding an ophthalmic implant for inserting it into a purposely prepared opening in a tissue of the eye, and
- a positioning system aligning the implant insertion means relative to the fixation device.
6. The apparatus of claim 5, wherein the implant insertion device comprises mechanical implant holding means.
7. The apparatus of claim 5 or 6, wherein the implant insertion device comprises an implant holding means having a frictional surface adapted to apply a friction between the implant and the surface higher than the friction between the implant and the tissue of the eye, when inserting the implant, and a friction between the implant and the surface lower than the friction between the implant and the tissue of the eye, when releasing the implant at the desired site in the eye.
8. The apparatus of anyone of claims 5 to 7, wherein the implant insertion device comprises an implant holding means reversibly holding the implant by vacuum suction.
9. The apparatus of anyone of claims 5 to 8, further comprising a blade for surgical opening the tissue before or during the insertion of the implant.
10. An ophthalmic diagnostic or therapeutic apparatus comprising of at least:
- a fixation device fixing an eye to be diagnosed or treated in an eye-holding means of the fixation device,
a diagnostic and/or therapeutic device, and
- a positioning system aligning the diagnostic or therapeutic device relative to the fixation device in at least two dimensions.
11. The apparatus of anyone of claims 5 to 10, wherein the positioning system is the positioning system according to anyone of claims 1 to 4.
12. The apparatus of anyone of claims 5 to 11, wherein the fixation device comprises a vacuum fixation means and/or a friction fixation means.
13. The apparatus of claim 12, wherein the fixation device comprises a corneal suction ring.
14. The apparatus of anyone of claims 5 to 13, wherein the fixation device comprises an eye holding surface reversibly holding the eye by means of glue.
15. A method of handling the apparatus according to anyone of claims 5 to 9 and 11 to 14 for inserting an ophthalmic implant into a purposely prepared opening in a tissue of an eye, said method comprising at least the steps of:
- fixing an eye to be treated in an eye-holding means of the fixation device,
- providing the implant insertion device with an ophthalmic implant,
aligning the implant insertion device relative to the fixation device, and
- inserting the ophthalmic implant into the purposely prepared opening in the tissue of the eye.
16. The method of claim 15, further comprising the step of releasing the ophthalmic implant from the implant insertion device at the desired position in the tissue of the eye. A method of handling the apparatus according to anyone of claim 10 to 14 for positioning the diagnostic or therapeutic device at a desired position for applying a diagnostic or therapeutic treatment to an eye of a patient, said method comprising at least the steps of:
- fixing an eye to be diagnosed or treated in an eye-holding means of the fixation device,
- positioning the diagnostic or therapeutic device relative to the desired position, and optionally
- applying the diagnostic or therapeutic treatment at the eye.
PCT/IB2010/001096 2010-05-12 2010-05-12 Ophthalmic diagnostic or therapeutic apparatus optionally including an implant insertion device, positioning system and method of handling the apparatus WO2011141760A1 (en)

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Citations (7)

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Publication number Priority date Publication date Assignee Title
US4423728A (en) * 1982-02-26 1984-01-03 Lieberman David M Cam-guided trephine
DE3433581A1 (en) * 1984-09-13 1986-03-20 Fa. Carl Zeiss, 7920 Heidenheim DEVICE FOR LAMINATING, REFRACTIVE CORNEAL SURGERY
WO1993004642A1 (en) * 1991-09-12 1993-03-18 Thompson Keith P Reprofiling of synthetic lenticules
US20020120285A1 (en) * 2001-02-23 2002-08-29 Ras Holding Corp Surgical blade for use with a surgical tool for making incisions for scleral eye implants
WO2004096106A1 (en) * 2003-05-02 2004-11-11 Albert Daxer Device for cutting the cornea of an eye
WO2007112130A2 (en) * 2006-03-28 2007-10-04 Tissue Engineering Refraction, Inc. Automatic epithelial delaminator and lens inserter
US20080097596A1 (en) * 2006-10-18 2008-04-24 Christ F Richard Injection of anti-presbyopia corrective element precursor

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4423728A (en) * 1982-02-26 1984-01-03 Lieberman David M Cam-guided trephine
DE3433581A1 (en) * 1984-09-13 1986-03-20 Fa. Carl Zeiss, 7920 Heidenheim DEVICE FOR LAMINATING, REFRACTIVE CORNEAL SURGERY
WO1993004642A1 (en) * 1991-09-12 1993-03-18 Thompson Keith P Reprofiling of synthetic lenticules
US20020120285A1 (en) * 2001-02-23 2002-08-29 Ras Holding Corp Surgical blade for use with a surgical tool for making incisions for scleral eye implants
WO2004096106A1 (en) * 2003-05-02 2004-11-11 Albert Daxer Device for cutting the cornea of an eye
WO2007112130A2 (en) * 2006-03-28 2007-10-04 Tissue Engineering Refraction, Inc. Automatic epithelial delaminator and lens inserter
US20080097596A1 (en) * 2006-10-18 2008-04-24 Christ F Richard Injection of anti-presbyopia corrective element precursor

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