WO2018217579A1 - Procédés et systèmes de chirurgie ophthalmique - Google Patents

Procédés et systèmes de chirurgie ophthalmique Download PDF

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Publication number
WO2018217579A1
WO2018217579A1 PCT/US2018/033464 US2018033464W WO2018217579A1 WO 2018217579 A1 WO2018217579 A1 WO 2018217579A1 US 2018033464 W US2018033464 W US 2018033464W WO 2018217579 A1 WO2018217579 A1 WO 2018217579A1
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WIPO (PCT)
Prior art keywords
eye
carried out
capsular bag
ocular tissue
positioning
Prior art date
Application number
PCT/US2018/033464
Other languages
English (en)
Inventor
Tsontcho Alexandrov IANCHULEV
Scott CHAMNESS
Alexander IANCHULEV
Phillip IANCHULEV
Luke W. Clauson
Original Assignee
Iantech, Inc.
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 Iantech, Inc. filed Critical Iantech, Inc.
Publication of WO2018217579A1 publication Critical patent/WO2018217579A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A61F9/00754—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments for cutting or perforating the anterior lens capsule, e.g. capsulotomes

Definitions

  • the present technology relates generally to devices and methods for ophthalmic surgery. More particularly, the technology relates to facilitating a capsulotomy or
  • An accepted intervention for the treatment of cataracts is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens (IOL).
  • IOL intraocular lens
  • the majority of cataractous lenses are removed by a surgical technique called phacoemulsification wherein the lens is divided into pieces and removed.
  • an opening, or rhexis Prior to removing the cataractous lens, an opening, or rhexis, must be made in the anterior capsule, a thin membrane that surrounds the lens. Currently, this opening is created by manually tearing the membrane with a surgical instrument.
  • a continuous cut or tear ('rhexis) without "tags,” is a critical step in a safe and effective phacoemulsification procedure.
  • the capsule is opened with numerous small capsular tears, the small tags that remain can lead to radial capsular tears, which may extend into the posterior capsule.
  • a radial tear constitutes a complication since it destabilizes the lens for further cataract removal and safe intraocular lens placement within the lens capsule later in the operation.
  • the vitreous may gain access to the anterior chamber of the eye. If this happens, the vitreous must be removed by an additional procedure with special instruments. The loss of vitreous is also associated with an increased rate of subsequent retinal detachment and/or infection within the eye. Importantly, these complications are potentially blinding.
  • the size and/or position of the capsular opening may present a problem.
  • a capsular opening that is too small can impede the safe removal of the lens nucleus and cortex and prevent proper intraocular lens insertion into the lens capsule.
  • the additional stresses necessary to accomplish the operation with a small or misplaced capsular opening put the eye at risk for zonular and capsular breakage. Either of these complications will likely increase the length and complexity of the operation and may result in vitreous loss.
  • a continuous, properly positioned, and predictably-shaped opening is thus highly desirable because it results in: (1) a significant reduction in radial tears and tags within the anterior capsule, (2) capsule integrity necessary for proper centering of a lens implant; and (3) safe and effective hydrodissection.
  • the capsulorhexis should be properly dimensioned relative to the diameter of the IOL being implanted in order to reduce the chances of a secondary cataract, also called posterior capsule opacification ("PCO”) and for use with proposed novel accommodative IOL designs that require close contact with the capsule. Therefore, there is a continuing need for improved devices for performing a continuous curvilinear capsulorhexis.
  • a method for capsular stabilization and capsulorhexis guidance includes inserting an intraocular ferromagnetic device in an anterior chamber of an eye having a lens capsule; and positioning the intraocular ferromagnetic device on the lens capsule.
  • the method can further include positioning, segmentally or non-segmentally an extraocular magnetic coupling device on or above an ocular surface para-limbally on top of sclera or conjunctiva of the eye providing a magnetic stabilization force.
  • the method can further include fixating and centering the intraocular device on lens capsule by the magnetic stabilization force.
  • the method can further include modulating a direction and strength of the magnetic force for lateral and vertical capsular positioning.
  • the intraocular ferromagnetic device can be circular or non-circular in shape. The shape can be continuous or non- continuous.
  • the intraocular ferromagnetic device can have a surface area of contact with the capsular bag, the surface area of contact minimized in order to maximize a contact force against the capsular bag.
  • the intraocular ferromagnetic device can include a memory- shaped material or be non-memory shaped.
  • the intraocular ferromagnetic device can be combined with non-ferromagnetic materials.
  • the intraocular ferromagnetic device can be configured to provide traction and/or stabilization relative to the capsular bag.
  • the intraocular ferromagnetic device can be configured to cut ocular tissues.
  • the method can further include using a delivery mechanism to insert the intraocular ferromagnetic device.
  • the intraocular ferromagnetic device can further include a micro- surgical instrument.
  • a method of stabilizing an aspect of the eye during a procedure on the eye include introducing a first element into the eye, the first element being magnetically repelled by a second element; and positioning the second element adjacent to the eye with an ocular tissue structure between the first element and the second element.
  • the introducing can be carried out with the first element positioned inside the eye with the ocular tissue being the capsular bag of the eye; and the positioning can be carried out so that the first element provides traction on and fixation of the capsular bag.
  • the positioning can be carried out with the second element being in contact with the external ocular tissue, the second element being adjacent to the ocular tissue so that the second element and the first element magnetically repel one another.
  • a method of stabilizing the eye during a procedure on the eye includes introducing a first element on or above a surface of the eye, the first element being magnetically coupled to a second element; and positioning the second element adjacent to the surface of the eye so that the first element applies compression to the surface of the eye.
  • the introducing can be carried out with the surface being the lens capsule.
  • the introducing can be carried out with the surface being the lens.
  • the positioning can be carried out with the second element positioned adjacent an external surface of the eye.
  • the method can further include cutting an opening in a capsular bag.
  • the introducing can be carried out with the first element forming a ring that defines an open area; and the cutting can be carried out to cut the opening in the capsular bag within the open area of the ring.
  • a device for stabilizing the eye during a procedure on the eye includes a first element configured to be positioned in an eye adjacent to an ocular tissue; and a second element that is magnetically coupled to the first element.
  • the second element is configured to be positioned adjacent to the eye with an ocular tissue between the first element and the second element.
  • the first element can be configured to be positioned inside the eye with the ocular tissue being the capsular bag so that the first element provides traction on the capsular bag due its magnetic coupling to the second element.
  • the second element can be configured to be positioned adjacent to, but not in contact with the ocular tissue.
  • a device for stabilizing the eye during a procedure on the eye includes a first element configured to be placed on or above a surface of the eye; and a second element that is magnetically coupled to the first element.
  • the second element is positioned adjacent to the external surface of the eye so that the first element applies compression to the surface of the eye due to the magnetic coupling to the second element.
  • the first element can be configured to be placed on the lens capsule.
  • the first element can be configured to be placed on the lens.
  • the first element can be configured to be placed between the capsular bag and an anterior surface of the lens.
  • the first element can form a ring that defines an open area through which the capsular bag is cut to form an opening in the capsular bag.
  • the first element can be an intraocular ferromagnetic fluid-encapsulated ring that is turned from a liquid to a solid and back again by the application and removal of a magnetic field.
  • a method of controlling the eye during a procedure on the eye includes introducing a first element into an eye adjacent an ocular tissue; and positioning a second element adjacent to the first element, the first element and the second element exerting a magnetic force on one another, the first element exerting a force on the ocular tissue due to the magnetic force.
  • the introducing can be carried out with the first element positioned inside the eye with the ocular tissue being the capsular bag.
  • the positioning can be carried out so that the first element provides traction on the capsular bag.
  • the positioning can be carried out with the second element not being in contact with the ocular tissue, the second element being adjacent to the ocular tissue so that the second element and the first element exert the magnetic force on one another.
  • the positioning can be carried out with the magnetic force between the first element and the second element being repulsion.
  • the positioning can be carried out with the magnetic force between the first element and the second element being attraction.
  • the positioning can be carried out so that the first element applies compression to the ocular tissue.
  • the introducing can be carried out with the first element positioned posterior to the ocular tissue and positioned against a posterior surface of the ocular tissue.
  • the introducing can be carried out with the first element positioned anterior to the ocular tissue and positioned against an anterior surface of the ocular tissue.
  • the positioning can be carried out so that the first element applies tension to the ocular tissue.
  • a method of controlling tissue of the eye during a procedure on the eye includes introducing a first element into an eye adjacent to an aspect of the eye; and positioning a second element in proximity to the first element so that the first element and the second element exert a magnetic force on one another causing the first element to exert a force on the aspect of the eye.
  • the positioning can be carried out so that the magnetic force exerted on the first element causes the first element to exert a force on the aspect of the eye.
  • the introducing can be carried out with the aspect being a surface of a lens capsule.
  • the positioning can be carried out with the second element positioned on an external surface of the eye.
  • the introducing can be carried out with the first element being inside the eye; and the positioning can be carried out with the second element positioned outside the eye and spaced apart from an external surface of the eye.
  • the method can further include cutting a capsular bag to form an opening in the capsular bag.
  • the introducing can be carried out with the first element forming a ring which defines an open area.
  • the method can further include cutting an opening in a capsular bag.
  • the introducing can be carried out with the first element positioned in contact with an anterior surface of the capsular bag.
  • the introducing can be carried out with the first element positioned against an anterior surface of the lens.
  • the positioning can be carried out with the magnetic force pressing the first element toward the lenticular capsule to center the first element on the lenticular capsule.
  • the introducing can be carried out with the first element inserted into a capsular bag and positioned between an anterior surface of the lenticular capsule and the capsular bag.
  • the introducing can be carried out so that the first element is in the eye; and the positioning can be carried out with the second element being outside the eye in proximity to the first element.
  • a first element is configured to be positioned in an eye adjacent to an ocular tissue; and a second element is configured to be positioned in proximity to the first element.
  • the first element and the second element exerting a magnetic force on one another.
  • the magnetic force on the first element causing the first element to apply a force to the ocular tissue.
  • the first element can be positioned inside the eye with the ocular tissue being the capsular bag.
  • the first element can provide traction on the capsular bag.
  • the second element can be configured to be positioned adjacent to but not in contact with the ocular tissue.
  • the first element and the second element can exert the magnetic force on one another in repulsion.
  • the first element and the second element can exert the magnetic force on one another in attraction.
  • the first element can apply compression to the ocular tissue.
  • the first element can be configured to be inserted into the eye and positioned posterior to the ocular tissue.
  • the first element can apply tension to the ocular tissue.
  • a device for controlling the eye during a procedure on the eye includes a first element configured to be placed against a surface of an aspect of the eye; and a second element positioned adjacent to the first element in use.
  • the first element and the second element exert a magnetic force on one another to cause the first element to exert a force on the aspect of the eye.
  • the first element can apply compression to the aspect of the eye due to the magnetic force on the first element.
  • the first element can be shaped to be placed against an anterior surface of the lens capsule in use.
  • the first element can be shaped to be placed against an anterior surface of a lens.
  • the second element can be shaped to be placed against an external surface of the eye.
  • the first element can form a ring which defines an open area.
  • the ring can stabilize the capsular bag when the capsular bag is cut to form an opening in the capsular bag.
  • the first element can be shaped to be positioned against an anterior surface of the lenticular capsule.
  • the first element and the second element can exert the magnetic force on one another in repulsion.
  • the first element and the second element can exert the magnetic force on one another in attraction.
  • the first element can apply compression to the ocular tissue in use.
  • the first element can be shaped to be positioned between the capsular bag and an anterior surface of the lens.
  • the first element can apply a compressive force on the lens capsule due to the magnetic force.
  • the first element can be centered on the lens capsule by the compressive force.
  • the second element can be an extraocular element positioned in proximity to the first element in use.
  • the second element need not contact the eye.
  • the first element can include a ferromagnetic fluid that is influenced by the second element, the ferromagnetic fluid being in a relaxed state when the magnetic field of the second element is not influencing the first element, the first element being more rigid when the second element is in proximity to the first element so that the magnetic force is exerted on one another.
  • the ferromagnetic fluid can be contained in a bag and introduced into the eye in a relaxed state.
  • the ferromagnetic fluid can be exposed to a magnetic field after introduction and placement in the eye in use.
  • the ferromagnetic fluid can be contained in the flexible bag that moves from the relaxed state toward a predetermined shape when the magnetic field is applied to the ferromagnetic fluid.
  • the second element can have a magnetic field that changes the state of the flexible bag from the relaxed state toward the predetermined shape.
  • the introducing can be carried out with the first element inserted inside the capsular bag of the eye for internal capsular stabilization.
  • the positioning can be carried out to selectively exert the magnetic force on the first element to stabilize the capsular bag.
  • FIG. 1 is a perspective cut-away view of an eye with an opacified lens capsule
  • FIG. 2 shows an anterior view of an implementation of a stabilization and guidance device positioned on an eye
  • FIG. 3 A shows a cross-sectional view of an implementation of a stabilization and guidance device positioned on an eye
  • FIG. 3B shows in schematic potential magnetic forces applied between intraocular and extraocular portions of the device of FIG. 3 A;
  • FIG. 4A shows deployment of an intraocular portion into the eye
  • FIG. 4B shows a ring-shape of the deployed intraocular portion
  • FIG. 5A shows an implementation of an intraocular portion in a collapsed
  • FIG. 5B shows the intraocular portion of FIG. 5 A in an expanded configuration upon deployment;
  • FIG. 6A shows an implementation of an intraocular portion in a narrow, collapsed configuration folded for insertion;
  • FIG. 6B shows the intraocular portion of FIG. 6A in an expanded configuration upon deployment
  • FIG. 7 shows an implementation of a frame for positioning the extraocular portion.
  • Described herein are methods, devices, and systems for ophthalmic surgery. More specifically, the methods, devices, and systems relate to facilitating a capsulotomy or capsulorhexis during cataract surgery using magnetic force to control ophthalmic tissue.
  • a stabilization system including an intraocular element and an extraocular element configured to exert a magnetic force on one another.
  • the elements may incorporate ferromagnetic elements to facilitate a capsulotomy during a cataract procedure and/or for structural stability and traction.
  • the methods, devices, and systems provide capsular stability during cataract surgery whereby an extraocular magnetized device is used to positionally fixate (secure) a ferromagnetic intraocular capsulotomy assist ring.
  • the intraocular ring may incorporate a memory-shaped material that allows it to be inserted through the incision into the eye and then to assume a circular form as it is positioned on the lens capsule.
  • a pull-wire or temperature-activated material, or super-elastic material, or any other shape-changing means may be utilized to cause the intraocular device to transition from its insertion geometry to a circular form.
  • the intraocular ring can return to a shape that allows it to pass back out of the incision in a reverse manner that allowed it to be inserted and assume a circular geometry.
  • ring refers general to a substantially circular shape (e.g. a circle, oval, or ellipse), but not necessarily one without small gaps or openings.
  • a ring as described herein need not be a complete closed loop.
  • proximal and distal refer to the portion furthest from, and closest to, the patient, respectively.
  • anterior andposterior are used herein refer to position in relation to the lens of the eye.
  • any percentage range, size range, or ratio range recited herein is to be understood to include percentages, sizes, or ratios of any integer within that range and fractions thereof, such as one tenth and one hundredth of an integer, unless otherwise indicated.
  • any number range recited herein relating to any physical feature, such as size or thickness are to be understood to include any integer within the recited range, unless otherwise indicated.
  • the terms “a” and “an” as used above and elsewhere herein refer to “one or more" of the enumerated components.
  • a polymer refers to either one polymer or a mixture comprising two or more polymers.
  • the term “about” means ⁇ 15%.
  • FIG. 1 shows the human eye 10 includes a cornea 12, iris 14, sulcus 16, ciliary muscle 18, zonules 20, a lens 21 contained within a capsular bag 22 having an anterior lenticular surface 23 and posterior lenticular surface 24.
  • the sclera 28 is shown adjacent the cornea 12.
  • the human lens can be afflicted with one or more disorders that degrade its functioning in the vision system.
  • a common lens disorder is a cataract which consists of the opacification of the normally clear, natural crystalline lens matrix 26. The opacification can result from the aging process but can also be caused by heredity, diabetes, or trauma.
  • FIG. 1 shows the human eye 10 includes a cornea 12, iris 14, sulcus 16, ciliary muscle 18, zonules 20, a lens 21 contained within a capsular bag 22 having an anterior lenticular surface 23 and posterior lenticular surface 24.
  • the sclera 28 is shown adjacent the cornea 12.
  • the human lens can be afflicted with
  • FIG. 1 shows a lens capsule comprising a capsular bag 22 with an opacified, crystalline lens nucleus 26.
  • the crystalline lens matrix 26 is removed leaving intact the thin walls of the anterior and posterior capsules together with zonular ligament connections to the ciliary body and ciliary muscles 18.
  • the crystalline lens core can be removed by phacoemulsification through a curvilinear capsulorhexis, i.e., the removal of an anterior portion 23 of the capsular sac.
  • the terms lenticular capsule, lens capsule and capsular bag are interchangeable as used herein.
  • a capsular stabilization and/or capsulorhexis guidance device 100 including a first element 105 that forms an intraocular portion of the device 100 and a second element 110 that forms an extraocular portion of the device 100 (see FIG. 2).
  • the first element 105 may be referred to herein as an intraocular portion and the second element 110 may be referred to herein as an extraocular portion.
  • Both the intraocular portion 105 and the extraocular portion 110 can be magnetic.
  • one of the portions 105, 110 can be magnetic and the other portion can be ferromagnetic.
  • the intraocular portion 105 can be ferromagnetic and the extraocular portion 110 can be magnetic.
  • the intraocular portion 105 can be a magnetic device (ferromagnetic or non- ferromagnetic) configured to be inserted into the anterior chamber onto the lens capsule 22.
  • the extraocular portion 110 can be a magnetic coupling device configured to be positioned, segmentally or non-segmentally on or above an ocular surface, for example, para-limbally on top of the sclera 28 or conjunctiva of the eye 10.
  • the extraocular portion 110 can provide a magnetic stabilization force relative to the intraocular portion 105.
  • the direction and strength of the magnetic strength can be modulated, for example, via lateral and/or vertical capsular positioning as well as by changing the spacing between the magnets.
  • the extraocular portion 110 can be adjustable to be positioned more posteriorly or more anteriorly relative to the intraocular portion 105 and, as such, the magnetic force is modulated.
  • the relative position of the intraocular portion 105 and extraocular portion 110 depend on whether the magnetic forces between them is attraction or repulsion.
  • the extraocular portion 110 can be positioned posteriorly relative to the intraocular portion 110 positioned on the anterior surface 23 of the capsular bag 22 (see FIG. 3 A).
  • the poles of the magnets can be arranged to provide an attractive magnetic force between the rings to pull the intraocular portion 110 posteriorly against the anterior surface 23 of the capsular bag 22.
  • the extraocular portion 110 can be positioned anteriorly relative to the intraocular portion 110 positioned on the anterior surface 23 of the capsular bag 22 (see FIG. 7).
  • the poles of the magnets be arranged to provide a repulsive magnetic force between the rings to push the intraocular portion 110 posteriorly against the anterior surface 23 of the lens 22. Providing the repulsive force slightly anterior or above the plane of the intraocular portion 105 can be generally more stable and less likely to cause inadvertent movements of the intraocular portion 105 away from its intended target.
  • the extraocular portion 110 can be mounted to a frame 140 that is configured to be fixed relative to the eye 10.
  • the extraocular portion 110 can be movable on the frame 140 in anterior and posterior directions relative to the eye 10 and relative to the intraocular portion 105 to modulate the amount and direction of the magnetic force generated between the two portions 105, 110.
  • the intraocular portion 105 can be circular or non-circular in shape, which can be continuous or non-continuous.
  • the intraocular portion 105 can have a surface area of contact with the capsular bag 22 that is minimized in order to maximize a contact force against the capsular bag 22.
  • the intraocular portion 105 can have a cross-sectional shape along a vertical plane of the eye (a plane cutting through the cornea anterior to posterior of a supine patient) that is generally triangular (see FIG. 3 A).
  • a vertex of the triangle can be positioned against the anterior surface 23 of the capsular bag 22 to provide a circular line or pointed contact with the eye.
  • the cross-sectional shape is shown as being triangular, other shapes are considered herein including more curved shapes such as a half- circle, half-oval, or half-ellipse shape.
  • the cross-sectional shape can also be polygonal having a narrowed or chiseled or knife-shaped edge configured to contact the capsular bag 22.
  • the center of the intraocular portion 105 can be generally cylindrical in shape to allow for full visibility of the inner diameter being circumscribed by the ring.
  • the cross-sectional shape of the intraocular portion 105 is selected to provide the best visibility on the inner diameter, a line- or pointed-contact at a lower edge, and a sufficient body to contain magnetic elements.
  • the intraocular portion 105 can include a memory-shaped material or be non-memory shaped.
  • the intraocular portion 105 can be a ferromagnetic device or can be combined with other magnetic materials such as a permanent magnet.
  • the intraocular portion 105 can be configured to provide traction and/or stabilization relative to the capsular bag 22. It can also be configured to cut ocular tissues such as the capsular bag 22.
  • the device 100 can be configured for stabilizing an aspect of the eye 10 during a procedure on or in the eye 10.
  • the device 100 can include a first element 105 being magnetically repelled by a second element 110.
  • the first element 105 can be introduced into the eye 10 and the second element 110 can be positioned adjacent to the eye 10 with the ocular tissue structure extending between the first and second elements 105, 110.
  • the first element 105 can provide traction on and fixation of the capsular bag 22.
  • the second element 110 can be positioned adjacent to the ocular tissue so that the second element 110 and the first element 105 magnetically repel one another.
  • the forces between the first and second elements 105, 110 can be repulsion or attraction.
  • the result of the force to the tissue positioned between the first and second elements 105, 110 can be compression or tension (i.e. traction).
  • the result can also be cutting as in cutting an opening in the lens capsule 22.
  • the first and second element 105, 110 can be magnetically coupled to one another such that the ocular tissue between them is under traction due to the magnetic coupling between the first and second elements 105, 110.
  • the second element 110 can be configured to be positioned adjacent to, but not in contact with the ocular tissue (such as the capsular bag 22).
  • the magnetic coupling between the two elements 105, 110 can apply compression to the surface of the eye 10.
  • the first element 105 can be placed on the lens capsule 22 or the lens 21.
  • the first element 105 is configured to be placed between the capsular bag 22 and the anterior surface of the lens 21.
  • the first element 105 can define an open area through which the capsular bag 22 is cut to form an opening in the capsular bag 22.
  • the intraocular device 105 can be placed on top of the anterior capsule 23 and circumscribes a circular area of the capsular bag 22.
  • the circular area circumscribed can have a diameter greater than 0.5 mm and smaller than 7 mm.
  • the diameter of the circular area circumscribed is at least about 4.3 mm, 4.5 mm, 5.0 mm, 5.3 mm, 5.5 mm, 6.0 mm, 6.3 mm, 6.5 mm, up to about 7.0 mm, for example, between about 4.75 mm - 6.0 mm, or between about 5.0 mm - 4.3 mm.
  • the magnetic repulsive forces between the extraocular magnetic device 110 that is located on the outside the eye 10 and the intraocular ring 105 can result in a posterior or downward force that centers and fixates the intraocular device 105 on the lenticular capsule 22.
  • the ring/capsule 105 approximation force may facilitate a precise, well-centered, consistent and properly-formed capsulorhexis, minimizing the potential for extensions and tears.
  • the magnetic extraocular device 110 is circular and is of a diameter that allows it to be positioned on the surface of or above the eye anterior (above) the limbus 29.
  • the magnetic interaction between the intraocular and extraocular devices 105, 110 can result in a non-contact repulsive force that presses the intraocular ring 105 against the anterior capsular bag 23.
  • the extraocular device 110 can include magnetic elements having, for example, north poles facing towards the inner diameter of the ring and, thus, the south poles facing towards an outer diameter of the ring.
  • the intraocular device 105 can be designed such that magnetic force with the extraocular device 110 is repulsive and the north poles facing towards the outer diameter of the ring and the south poles facing towards the inner diameter of the ring.
  • the north poles of the extraocular device 110 and the north poles of the intraocular device 105 resist one another around their circumference such that the intraocular device 105 is stabilized within the center field of the extraocular device 110.
  • the south poles of the intraocular device 105 can be facing towards the outer diameter such that they are magnetically attracted to the north poles of the extraocular device 110.
  • this arrangement is less stable and can result in unintentional movement between the inner and outer rings.
  • both portions 105, 1 10 can be magnetic or only one of the portions 105, 110 can be magnetic and the other ferromagnetic.
  • the extraocular portion 110 can be larger and thus may be useful to provide a larger magnet capable of greater magnetic forces.
  • the extraocular portion 110 can incorporate the magnet outside the eye and the intraocular portion 105 can be ferromagnetic as it is generally limited in size due to the anatomy it is being inserted through. In order to maximize the repulsive or attractive forces between the portions 105, 110, both can be magnetic.
  • the repulsive force is preferred because the magnetic forces between the portions 105, 110 is self-centering and provides a more stable orientation.
  • the magnetic force between the intraocular portion 105 and the extraocular portion 110 can be decoupled either by switching off the magnetic force of the extraocular portion 110 if it is an electromagnet or by increasing its distance from the intraocular device 105 if it is a permanent magnet.
  • the magnetic coupling forces between the intraocular and extraocular devices 105, 110 may be adjustable as necessary to provide the requisite interactive forces for centration, stability, and traction against the capsular bag 22.
  • the intraocular portion 105 can be inserted inside the capsular bag 22 for internal capsular stabilization.
  • the extraocular portion 110 can be positioned segmentally outside the sclera 28 to create the necessary magnetic stabilization forces. In cases of capsular dislocation, this can create necessary capsular traction for stability during surgery.
  • FIG. 4A shows an insertion sheath or introducer 130 may be used to introduce the intraocular portion 105 atraumatically to the proper location over the anterior surface 23 of the capsular bag 22.
  • the introducer 130 can be inserted through a clear corneal incision near the limbus 29 such that a distal opening of the introducer 130 is positioned within the anterior chamber.
  • the intraocular portion 105 can be in a compressed configuration within a lumen of the introducer 130 and can be deployed onto the anterior surface 23 of the capsular bag 22 by urging the intraocular portion 105 out from the lumen as is known in the art.
  • the ring 105 may have a first end 132 and a second end 133 (see also FIG. 4B).
  • the first end 132 can be positioned distal to the second end 133 within the lumen of the introducer such that the first end 132 is urged out of the lumen toward the lens capsule 22.
  • the intraocular portion 105 can have shape memory such that the compressed configuration of the intraocular portion 105 relaxes into a ring shape upon exiting the introducer. As the intraocular portion 105 exits the introducer 130, the first end 132 begins to curve.
  • the intraocular portion 105 achieves its ring-like shape upon complete deployment from the introducer 130 and the first end 132 and second end 133 are brought together inside the eye 10.
  • the intraocular portion 105 can be delivered in a linear configuration through the introducer 130 and once inside the eye 10 can form the ring shape in any suitable manner.
  • the ring shape can be via a shape memory, superelastic material of the device, or other manner as described elsewhere herein.
  • the ring shape of the intraocular portion 105 can be achieved using a ferromagnetic fluid.
  • the first element 105 can be an intraocular ferromagnetic fluid-encapsulated ring that is turned from a liquid to a solid and back again by application and removal of a magnetic field.
  • the ring-shape is provided using a ferromagnetic fluid 120 encapsulated in a thin-walled, doughnut-shaped, compliant bag 115.
  • the bag 1 15 is flaccid (see FIG. 5 A) and can easily be folded and introduced into position on the surface of the capsule 22.
  • the ferromagnetic fluid 120 within the bag 115 can essentially become more rigid (solidify) into the circular form (see FIG. 5B), providing the structure desired to facilitate the creation of a consistent capsulotomy.
  • the magnetic field can be turned off.
  • the magnetic fluid 120 once again becomes flaccid allowing easy removal of the element 105 from the eye 10.
  • the first element 105 includes a ferromagnetic fluid 120 that is influenced by the second element 110.
  • the ferromagnetic fluid 120 can be in a relaxed state when the magnetic field of the second element 110 is not influencing the first element 105.
  • the first element 105 can be more rigid when the second element 110 is in proximity to the first element 105 so that the magnetic force is exerted on one another.
  • the ferromagnetic fluid 120 can be contained in a bag 115 and introduced into the eye 10 in a relaxed state. The ferromagnetic fluid 120 can be exposed to the magnetic field after introduction and placement in the eye 10.
  • the ferromagnetic fluid 120 contained in the flexible bag 115 moves from the relaxed state toward a predetermined shape when the magnetic field is applied to the fluid 120.
  • the second element 110 can have a magnetic field that changes the state of the flexible bag 115 from the relaxed state toward the predetermined shape.
  • FIGs. 6A-6B shows an intraocular portion 105 having four magnets 125 over-molded with living hinges 135 between them.
  • FIG. 6A shows the intraocular portion 105 in a collapsed configuration as shown for introduction.
  • FIG. 6B shows the intraocular portion 105 in an expanded configuration after release from the introducer 130.
  • One or more components of the devices described herein can be formed of a polymer including medical grade silicone, hydrophobic acrylic, hydrophilic acrylic, and other common medical grade polymers. Also considered herein are biologically compatible synthetic materials (e.g., medical-grade stainless steel, titanium and other metals; exogenous polymers, such as polyurethane, silicon, PLA, PLGA, PGA, PCL), other materials, Nitinol, or other shape memory materials. At least a portion of the device can be formed of flexible polymer and at least a portion of the device can be formed of more rigid materials. At least a portion of the device can be formed of magnetic materials including ferromagnetic materials including iron, nickel, cobalt, gadolinium, dysprosium, neodymium, and their alloys.
  • the method includes making a clear corneal incision and inserting the intraocular portion 105 of the device 100 through the incision.
  • a microincision is one that is equal to or less than about 2.4 mm.
  • the intraocular portion 100 can be inserted through a 1 mm paracentesis. The intraocular portion 105 can then positioned over an ocular anterior lens capsule 23 defining an area for capsulorhexis.
  • a method for capsular stabilization and capsulorhexis guidance includes inserting the intraocular portion 105 including a ferromagnetic element into an anterior chamber of the eye 10.
  • the intraocular portion 105 can be positioned on the lens capsule 22.
  • the extraocular magnetic coupling device 110 can be positioned, segmentally or non-segmentally on or above the ocular surface, for example, para-limbally on top of the sclera 28 or conjunctiva of the eye 10. This provides a magnetic stabilization force.
  • the method can further include fixating and centering the intraocular portion 105 on the lens capsule 22 by the magnetic stabilization force provided between the two portions 105, 110.
  • the direction and strength of the magnetic force can be modulated for lateral and/or vertical capsular positioning.
  • the intraocular ferromagnetic device 105 can be circular or non-circular in shape. The shape can be continuous or non-continuous.
  • the intraocular ferromagnetic device 105 can have a surface area of contact with the capsular bag 22. The surface area of contact can be minimized in order to maximize the contact force against the capsular bag 22.
  • the intraocular ferromagnetic device 105 can be configured to provide traction and/or stabilization relative to the capsular bag 22.
  • the device 105 can be configured to cut the ocular tissues such as the capsular bag tissues.
  • the intraocular ferromagnetic device can include a memory-shaped material or can be non-memory shaped.
  • the intraocular ferromagnetic device can be combined with non-ferromagnetic materials.
  • the method can further include using a delivery mechanism or introducer 130 to insert the intraocular device 105.
  • the guidance device 100 can further include a microsurgical instrument.
  • the method can include stabilizing an aspect of the eye 10 during a procedure on the eye.
  • the method can include introducing a first element 105 into the eye 10 that is magnetically repelled by a second element 110.
  • the method can include positioning the second element 110 adjacent the eye 10 with the ocular tissue structure, such as the capsular bag 22 between the first and second elements 105, 110.
  • the second element 110 can be in contact with external ocular tissue.
  • the second element 110 can be positioned adjacent to the ocular tissue so that the second element 110 and the first element 105 magnetically repel one another. It should be appreciated that the second element 110 need not be in contact with the eye 10 and in some implementation does not contact eye tissue.
  • the first element 105 can be introduced on or above a surface of the eye 10 and the second element 110, which is magnetically coupled to the first element 105, is positioned adjacent to the surface of the eye 10 so that the first element 105 applies compression to the surface of the eye 10.
  • the surface the first element 105 is introduced on can be a surface of the lens capsule 22 or a surface of the lens 21.
  • the second element 110 can be positioned on the external surface of the eye 10.
  • the method can further include cutting an opening in the capsular bag 22.
  • the first element 105 can form a ring that defines an open area. Then, the cutting can be carried out to cut the opening in the capsular bag 22 within the open area of the ring.
  • relative terms may denote a relative position or direction.
  • distal may indicate a first direction away from a reference point.
  • proximal may indicate a location in a second direction opposite to the first direction.
  • such terms are provided to establish relative frames of reference, and are not intended to limit the use or orientation of an anchoring delivery system to a specific configuration described in the various implementations.
  • phrases such as "at least one of or "one or more of may occur followed by a conjunctive list of elements or features.
  • the term “and/or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited elements or features.
  • the phrases “at least one of A and ⁇ ;” “one or more of A and ⁇ ;” and “A and/or B” are each intended to mean "A alone, B alone, or A and B together.”
  • a similar interpretation is also intended for lists including three or more items.
  • phrases “at least one of A, B, and C;” “one or more of A, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.”
  • Use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.

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

Abstract

L'invention concerne des dispositifs, des systèmes et des procédés permettant d'effectuer une intervention ophtalmique dans un oeil.
PCT/US2018/033464 2017-05-20 2018-05-18 Procédés et systèmes de chirurgie ophthalmique WO2018217579A1 (fr)

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US201762509098P 2017-05-20 2017-05-20
US62/509,098 2017-05-20

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10603213B2 (en) 2017-05-04 2020-03-31 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for ocular surgery
US10932951B2 (en) 2017-12-14 2021-03-02 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for ocular surgery
US11166844B2 (en) 2019-04-25 2021-11-09 Alcon Inc. Retinal patch graft and biopsy device
US11241335B2 (en) 2019-02-01 2022-02-08 Carl Zeiss Meditec Cataract Technology Inc. Ophthalmic cutting instruments having integrated aspiration pump
US11413188B2 (en) 2016-10-26 2022-08-16 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for cutting a lens in an eye
WO2022223172A1 (fr) * 2021-04-19 2022-10-27 Carl Zeiss Ag Système de phacoémulsification, autre système de phacoémulsification, autre système de phacoémulsification, procédé de phacoémulsification d'une lentille d'un œil, autre procédé de phacoémulsification d'une lentille d'un œil, et procédé de surveillance de la phacoémulsification d'une lentille d'un œil
US11638660B2 (en) 2018-06-05 2023-05-02 Carl Zeiss Meditec Cataract Technology Inc. Ophthalmic microsurgical tools, systems, and methods of use
US11730625B2 (en) 2019-05-17 2023-08-22 Carl Zeiss Meditec Cataract Technology Inc. Ophthalmic cutting instruments having integrated aspiration pump
US11801163B2 (en) 2019-06-07 2023-10-31 Carl Zeiss Meditec Cataract Technology Inc. Multi-stage trigger for ophthalmology cutting tool

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US4706669A (en) * 1984-01-30 1987-11-17 Schlegel Hans Joachim Device for perforating the lens capsule front wall in the eye of living beings
US5800533A (en) * 1996-03-18 1998-09-01 Harry C. Eggleston Adjustable intraocular lens implant with magnetic adjustment facilities
US20120158130A1 (en) * 2010-12-16 2012-06-21 Ala Moradian Capsulotomy device and method using electromagnetic induction heating
US20130066351A1 (en) * 2011-03-08 2013-03-14 Christopher Kenneth Giardina Apparatus for creating an annular incision in soft tissue
US20150245946A1 (en) * 2012-11-16 2015-09-03 The University Of Melbourne Method of positioning an intraocular device
US20170042734A1 (en) * 2014-04-28 2017-02-16 Vossamed Gmbh & Co. Kg Device for producing cuts or perforations on an eye

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4706669A (en) * 1984-01-30 1987-11-17 Schlegel Hans Joachim Device for perforating the lens capsule front wall in the eye of living beings
US5800533A (en) * 1996-03-18 1998-09-01 Harry C. Eggleston Adjustable intraocular lens implant with magnetic adjustment facilities
US20120158130A1 (en) * 2010-12-16 2012-06-21 Ala Moradian Capsulotomy device and method using electromagnetic induction heating
US20130066351A1 (en) * 2011-03-08 2013-03-14 Christopher Kenneth Giardina Apparatus for creating an annular incision in soft tissue
US20150245946A1 (en) * 2012-11-16 2015-09-03 The University Of Melbourne Method of positioning an intraocular device
US20170042734A1 (en) * 2014-04-28 2017-02-16 Vossamed Gmbh & Co. Kg Device for producing cuts or perforations on an eye

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11413188B2 (en) 2016-10-26 2022-08-16 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for cutting a lens in an eye
US11622888B2 (en) 2017-05-04 2023-04-11 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for ocular surgery
US11051981B2 (en) 2017-05-04 2021-07-06 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for ocular surgery
US11278450B2 (en) 2017-05-04 2022-03-22 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for ocular surgery
US11607338B2 (en) 2017-05-04 2023-03-21 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for ocular surgery
US10603213B2 (en) 2017-05-04 2020-03-31 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for ocular surgery
US11622887B2 (en) 2017-05-04 2023-04-11 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for ocular surgery
US10932951B2 (en) 2017-12-14 2021-03-02 Carl Zeiss Meditec Cataract Technology Inc. Devices and methods for ocular surgery
US11638660B2 (en) 2018-06-05 2023-05-02 Carl Zeiss Meditec Cataract Technology Inc. Ophthalmic microsurgical tools, systems, and methods of use
US11241335B2 (en) 2019-02-01 2022-02-08 Carl Zeiss Meditec Cataract Technology Inc. Ophthalmic cutting instruments having integrated aspiration pump
US11166844B2 (en) 2019-04-25 2021-11-09 Alcon Inc. Retinal patch graft and biopsy device
US11730625B2 (en) 2019-05-17 2023-08-22 Carl Zeiss Meditec Cataract Technology Inc. Ophthalmic cutting instruments having integrated aspiration pump
US11801163B2 (en) 2019-06-07 2023-10-31 Carl Zeiss Meditec Cataract Technology Inc. Multi-stage trigger for ophthalmology cutting tool
WO2022223172A1 (fr) * 2021-04-19 2022-10-27 Carl Zeiss Ag Système de phacoémulsification, autre système de phacoémulsification, autre système de phacoémulsification, procédé de phacoémulsification d'une lentille d'un œil, autre procédé de phacoémulsification d'une lentille d'un œil, et procédé de surveillance de la phacoémulsification d'une lentille d'un œil

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