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WO2025154061A1 - Dispositif et procédé de fixation de lentille intraoculaire - Google Patents

Dispositif et procédé de fixation de lentille intraoculaire

Info

Publication number
WO2025154061A1
WO2025154061A1 PCT/IL2025/050048 IL2025050048W WO2025154061A1 WO 2025154061 A1 WO2025154061 A1 WO 2025154061A1 IL 2025050048 W IL2025050048 W IL 2025050048W WO 2025154061 A1 WO2025154061 A1 WO 2025154061A1
Authority
WO
WIPO (PCT)
Prior art keywords
iol
grasper
jaws
tool
grasping
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IL2025/050048
Other languages
English (en)
Inventor
Asaf FRIEHMANN
Alexander RUBOWITZ
Gal HAREL
Milad HAMISA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Afeka Yissumim Ltd
Mor Research Applications Ltd
Original Assignee
Afeka Yissumim Ltd
Mor Research Applications Ltd
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 Afeka Yissumim Ltd, Mor Research Applications Ltd filed Critical Afeka Yissumim Ltd
Publication of WO2025154061A1 publication Critical patent/WO2025154061A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/128—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/28—Surgical forceps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/30—Surgical pincettes, i.e. surgical tweezers without pivotal connections
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1662—Instruments for inserting intraocular lenses into the eye
    • A61F2/1664—Instruments for inserting intraocular lenses into the eye for manual insertion during surgery, e.g. forceps-like instruments
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406—Pledgets
    • 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
    • A61F9/00709—Instruments for removing foreign bodies

Definitions

  • the present invention in some embodiments thereof, relates to methods of manipulating intraocular objects such as an intraocular lens (IOL) and, more particularly, but not exclusively, to an IOL fixation tool.
  • IOL intraocular lens
  • Fixation of the IOL in the posterior chamber can be also done by placing the IOL and its haptics in the sack-like structure formed by the intact posterior and peripheral walls of the lens capsule and compressing the haptics against the periphery of the lens capsule.
  • the IOL can be placed in front of and outside the lens capsule by placing the haptics between the iris and the zonules, in the region of the ciliary sulcus to hold the lens in place.
  • Fixation of the IOL in the anterior chamber is associated with several complications including, hyphema, uveitis, iris chaffing, glaucoma and more, which require more frequent replacements than the posterior chamber lenses.
  • an intraocular lens (IOL) fixation tool comprising: implantable tissue grasper device comprising:
  • a bendable elongated body the bendable elongated body has a proximal end and a distal end, wherein the distal end is connected to the implantable grasper, and wherein the proximal end comprises a barrier having a diameter which exceeds a maximal diameter of the grasper when the grasper is closed.
  • the anchoring of the proximal end of the grasper is to an outer surface of the sclera.
  • anchoring is performed 1.5-2 mm posterior to limbus.
  • the method further comprising adjusting an angle between the grasper and the IOL.
  • the method further comprising choosing and setting an angle between the grasper and the inner surface of the sclera prior to the anchoring.
  • grasping is effected by approximating the two grasping surfaces towards each other.
  • the method prior to the grasping the method further comprising: (a) moving the grasping surfaces until the IOL is between the surfaces, and
  • the grasping is of an haptic of the IOL.
  • grasping is of a lens of the IOL.
  • grasping is effected by changing the configuration of the grasper to a closed configuration.
  • the method further comprising generating a trans- scleral hole having a diameter sufficient for inserting the fixation tool.
  • the method further comprising detaching the proximal end of the grasper from an elongated body of the fixation tool.
  • the detaching is effected by diathermia.
  • anchoring is to an outer surface of the sclera and is performed by diathermia or a trans-sclera thread.
  • the method further comprising identifying an IOL dislocation in a subject prior to the inserting in step (a).
  • inserting is through the sclera in a close proximity to the limbus.
  • inserting the tool e.g., the fixation tool
  • the tool e.g., the fixation tool
  • inserting the tool is performed in or at the Pars-plana.
  • inserting the tool is performed in or at the limbus.
  • inserting the fixation tool is performed into the vitreous cavity.
  • the method further comprising selecting a position for the inserting based on position of the haptic.
  • the grasper has a closed configuration and an open configuration, and wherein a maximal proximity between the two grasping surfaces in the closed configuration is suitable for anchoring the haptic and/or the IOL between the grasping surfaces while minimizing pinching forces.
  • the means for approximating the arms towards each other comprise:
  • a combined length of the trans- scleral element and the grasper does not exceed 5.2 millimeter (mm).
  • a combined length of the trans- scleral element and the grasper does not exceed 3.0 millimeter (mm).
  • the bendable elongated body and the barrier comprise a non-degradable biocompatible polymer.
  • FIG. 1 A is a flow chart of a method of fixation an IOL according to some embodiments of the invention
  • FIGs. 12A-G are schematic illustrations of an implantable part of an IOL fixation tool according to some embodiments of the invention.
  • FIG. 15 is a general flow chart of a method of fixation or manipulation of an IOO according to some embodiments of the invention.
  • the IOO is a tissue or an object within the eye.
  • the IOO is an intraocular optic such as an intraocular lens (IOL), an intraocular telescope, and/or an intraocular microscope.
  • the IOO is an intraocular tissue, or a device that can be grasped by jaws of the grasper of some embodiments of the invention.
  • the IOO is a foreign (e.g., exogenous) body within the eye.
  • the IOO is an IOL.
  • the IOL mimics the structure and function of a natural lens of an eye.
  • grasping is of an IOL which has only one haptic connected thereto. According to some embodiments of the invention, grasping is of an IOL which has no haptic connected thereto.
  • the implantable grasper is made of a material which is compatible for implantation within an eye (e.g., a bio-compatible material).
  • the material (and implanted part of grasper) is non-metallic, for example, being formed of a polymeric material, such as plastic or silicone.
  • the implantable grasper has a shape that is designed to minimize unintentional damage to the eye.
  • the implantable grasper is ocular-safe.
  • the flexible strand can be anchored to the sclera while allowing adjustment of the angle between the IOO and the sclera prior to final fixation of the IOO within the eye. According to some embodiments of the invention the flexible strand can be anchored to the sclera while allowing adjustment of the angle between the IOO and the grasper prior to final fixation of the IOO within the eye. According to some embodiments of the invention the flexible strand can be anchored to the sclera while adjusting the angle between an IOL and a haptic connected thereto.
  • the flexible strand can be anchored to the sclera while adjusting the angle between the longitudinal axis of the grasper and the plane which is tangent to the sclera at the point where the grasper passes from the sclera into the eye. This can happen, for example, if one side of the IOL is grasped and anchored while a second side is being manipulated.
  • the flexible strand is anchored to the sclera by applying diathermia and creating a suture with a diathermia dome.
  • Anchoring via diathermia has several advantages, including, but not limited to, reducing irritation to the ocular tissue, being minimally invasive and standard to use.
  • the grasper can be in an open configuration for fishing around for an IOO within the eye, in a closed configuration while inserting the grasper into the eye and while grasping the IOO, or in a locked configuration after grasping the IOO, such as for permanently fixing the position or the relative orientation of the IOO within the eye.
  • opening or closing of the grasper is achieved by controlling the position of a sheath that surrounds the jaws of the grasper, along a longitudinal axis of the grasper.
  • a ring may be used for such control and/or be used to permanently lock the grasper in a locked, closed position.
  • An aspect of some embodiments of the invention relates to locking of jaws of an intraocular grasper using an axially advanceable locking ring.
  • locking is achieved by advancing the locking ring in a distal direction of the jaws until the locking ring reaches a step or other geometry which interferes with the ring from moving back in the proximal direction.
  • a safety pin also referred to as a “locking pin” below
  • grasping is effected by approximating the jaws towards each other, e.g., by approximating the facing surfaces towards each other.
  • An aspect of some embodiments of the invention relates to anchoring grasper or other tool in the eye, to the sclera or other external structure, using a flexible joint optionally created by a flexible suture (e.g., in the form of a thread).
  • a flexible suture e.g., in the form of a thread.
  • This can allow the attachment to be rotationally flexible, allowing the grasper to be positionally anchored to the sclera, while able to be at various angles to the sclera.
  • This can provide flexibility in choosing an insertion location (across the sclera) for the grasper, as the angle of access to the IOL is not as strictly limited by the desired grasping location, and there is potentially more freedom in the final IOL location in view of scleral passage location.
  • an IOL dislocation can be identified by a clinical examination in a slit ophthalmic microscope or by an imaging tool such as fundus photography, anterior segment photography, anterior segment OCT, ocular ultrasound and ocular CT/MRI. Following are some examples of disorders that may be repaired using a grasper and/or methods as described herein.
  • a subject with IOL dislocation may suffer from pseudoexfoliation (PXF), trauma to the eye or myopia.
  • PXF pseudoexfoliation
  • the IOL dislocation comprises decentration.
  • the IOL dislocation is a partial subluxation.
  • the IOL dislocation is a complete dislocation of the lens within and outside of the bag, due to total zonular or capsular instability.
  • the method comprises a step of adjusting the position and/or angle of the IOL within the eye.
  • the method comprises inserting a fixation or a manipulation tool to the eye. Exemplary components of the fixation or manipulation tool are described in a schematic form in Figures 1B-1H, which is described hereinunder.
  • the method comprises positioning the IOL in a desired location within the eye, which is performed by grasping the IOL or the haptic of the IOL (termed “haptic” hereinunder) by the grasper.
  • Figure IB describes tool (100) for fixation or manipulation of an IOL.
  • Tool (100) comprises jaws (120) for grasping an IOL or a haptic between them.
  • Tool (100) has a small diameter, e.g., tool (100) optionally has dimensions which can fit through a trans-scleral hole.
  • the diameter of tool (100) while in a closed configuration is between 0.48-1.5 mm. According to some embodiments of the invention the diameter of tool (100) while in a closed configuration is between 0.48 and 1 mm. According to some embodiments of the invention the diameter of tool (100) while in a closed configuration is about 0.48 mm.
  • the length of the implantable grasper of tool (100) is between 0.5-5 mm. According to some embodiments of the invention the length of the implantable grasper of tool (100) is up to 4 mm. According to some embodiments of the invention the length of the implantable grasper of tool (100) is up to 3.5 mm. According to some embodiments of the invention the length of the implantable grasper of tool (100) is up to 3.0 mm. According to some embodiments of the invention the length of the implantable grasper of tool (100) is up to 2.5 mm.
  • Jaws (120) are for grasping and holding an intra-ocular object there-between, e.g., jaws (120) can grasp the IOL or the haptic there-between. Jaws (120) optionally comprise two facing surfaces which are capable of grasping an IOL or an haptic by approximating the jaws towards each other. According to some embodiments of the invention, jaws (120) are flat facing surfaces.
  • facing surfaces refers to two surfaces which generally face each other, for example, the two surfaces can be attached to a pivot point and move towards each other.
  • flat surface is a surface that is planar, meaning that it has a consistent, even plane with minimal deviation. While some deviation may be allowed, especially for teeth or other protrusions for increasing friction, or for holes, or for rounding at edges, the surface (or a geometrical surface tangent to the projection, if any) defines a flat plane.
  • a jaw may have several flat surfaces and/or include a curved surface section.
  • a jaw includes a flat surface covering at least 50% of the area intended for contacting an IOO on a jaw. Both jaws may be flat with matching flat sections. It is noted that for some IOOs a non-flat surface may be preferred.
  • Jaws (120) optionally have teeth along at least part of their surface to assist in grasping the IOL and/or the haptic. Jaws (120) optionally have a blunted tip to reduce the risk to damage tissue within the eye. Jaws (120) optionally have a segment which, when the jaws approximate towards each other the two parallel segments close against each other and maintain the same distance between the surfaces along the entire length of the segments, in order to reduce potential crushing forces on the intraocular object grasped by the jaws.
  • Jaws (120) are in an open configuration when searching for an haptic or an IOL, and in a closed configuration before or after gasping the IOL or the haptic. Jaws (120) are in a locked configuration after grasping the haptic or the IOL. When in a closed or locked configuration jaws (120) do not apply enough pressure to damage the IOO there-between.
  • tool (100) is selected according to the sensitivity of the IOO being manipulated.
  • Tool (100) optionally comprises a mechanism (122) for opening, closing and/or locking jaws (120), e.g., described in Figure IF.
  • Tool (100) optionally comprises an anchor (124) for anchoring jaws (120) while in the locked configuration within the eye, (e.g., as described in Figures IB and 1C).
  • Anchor (124) has a proximal end which is designed to be at the outer surface of the sclera and a distal end attached directly or indirectly to jaws (120).
  • indirect attachment of jaws (120) with anchor (124) can be by strand (127) (e.g., described in Figure 1C).
  • Tool (100) optionally comprises mechanism (126) for detaching anchor (124) from the remaining proximal end of strand (127) which is outside of the sclera (e.g., as described in Figure 1C).
  • Detachment of the anchor from the remaining proximal end of strand (127) can be performed by various methods such as diathermia or mechanical detachment. Such methods are schematically described in Figures 2F, 2G and 2H.
  • jaws (120) remain within the eye part of strand (127) crosses the sclera, and from its tip anchor (124) may be formed.
  • Figure 1C depicts tool (100) for fixating or manipulation of an IOL within the eye, in which strand (127) is attached to anchor (124).
  • Strand (127) can be flexible, e.g., bendable. Once the anchor is formed, the distance between jaws (120) and the sclera depends on the length of strand (127). The remainder strand (157) which is proximal to the anchor can be detached from anchor (124) after fixation of the IOL within the eye.
  • Strand (127) can be connected to mechanism (122) (e.g., described in Figure IF) and/or to mechanism (126).
  • mechanism (126) is attached to anchor (124) and/or to remainder strand (157) for detaching anchor (124).
  • mechanism (122) can open jaws (120).
  • mechanism (122) can close jaws (120).
  • mechanism (122) can lock jaws (120).
  • Figure ID depicts grasper (125) which can be part of fixation tool (100).
  • Grasper (125) includes jaws (120) and base (133).
  • Grasper (125) can be operated like standard forceps, by approximating jaws (120) towards each other.
  • Grasper (125) can be implantable within the eye.
  • grasper (125) is implantable posterior to the iris within the eye.
  • grasper (125) is bio-compatible.
  • the grasper (125) has a shape that is designed to minimize unintentional damage to the eye.
  • grasper (125) is ocular-safe.
  • Base (133) controls opening and closing of jaws (120).
  • Base (133) comprises joint(s) (described in Figure 1G) which allow(s) jaws (120) to open.
  • Base (133) also maintains jaws (120) connected to fixation tool (100).
  • Figure IE depicts tool (100) following detachment of remainder strand (157) from the proximal end of anchor (124).
  • barrier (128) is formed at the proximal end of the trans- scleral element (105).
  • barrier (128) is a deployed element, e.g., a locking bead.
  • Barrier (128) can be configured such that it is unable to enter the trans-scleral hole.
  • Barrier (128) optionally has a dome shape, e.g., such as a dome formed by diathermia. According to some embodiments the largest diameter of the dome shape of barrier (128) exceeds the diameter of the trans-scleral hole.
  • Barrier (128) optionally has a shallow dome shape, wherein the largest diameter of the shallow dome shape exceeds the diameter of the trans- scleral hole.
  • barrier (128) has a diameter between 0.6-2.0 mm. According to some embodiments of the invention, barrier (128) has a diameter which is larger than 1.5 mm, but not exceeding 2.0 mm.
  • barrier (128) comprises a nonabsorbable suture.
  • Figure IF depicts an exemplary mechanism (122) for controlling jaws (120) which can be used according to some embodiments of the invention.
  • Mechanism (122) comprises over-tube (350), shaft (355), and base (133).
  • Over-tube (350) covers at least part of jaws (120).
  • Shaft (355) holds strand (127).
  • Base (133) comprises hole (340). Hole (340) allows room for movement of proximal ends of jaws (120) while opening.
  • mechanism (122) also comprises ring (330) which maintains jaws (120) in a locked configuration.
  • shaft (355) comprises fingers (329) at a distal end thereof, which can apply force towards the middle of strand (127) in order to frictionally engage the strand and prevent premature release of the grasper.
  • the fingers define a geometry which geometrically interferes with pulling back of the fingers axially from the grasper.
  • the strand, between the fingers may serve to prevent elastic deformation of the fingers in a way which will allow such pulling back of the fingers.
  • base (133) can optionally comprise joint (323), which allows opening of jaws (120) within hole (340).
  • Joints (323) optionally have protrusion (359) at a proximal end thereof to which finger (329) can fit.
  • the two jaws (120) approximate towards each other until they reach a closed configuration in which there is a minimal distance between the surfaces of the jaws which on one hand holds the IOL or the haptic between the surfaces, and on the other hand, prevents introducing detrimental forces on the IOL or the haptic;
  • tool (100) is anchored to the sclera and the remainder part (i.e., on the proximal end) of tool (100) is detached.
  • the method is effected using a surgical microscope or another magnification tool used for imaging the eye during surgery.
  • the method comprises identifying an IOL dislocation in a subject (as explained hereinabove).
  • the method comprises deciding how to access the eye.
  • determination of the right place to access the eye depends on the position of the IOL and/or the haptic, presence or absence of haptics, and access angle while trying to reduce risk of damaging tissue within the eye.
  • the access points are determined by placement of trocars for vitreoretinal surgery in the generally accepted position (e.g., 2.0-4.0 mm posterior to the limbus) as part of the vitrectomy surgery usually indicated in these cases.
  • the fixation device may be used independently and not as part of vitrectomy surgery (e.g., insertion of a fixation tool or to reposition and centralize a subluxated IOL) either through a sclerotomy or a trocar. It is a potential advantage of some embodiments of the invention that vitrectomy may be avoided when using the instant grasping tool for IOL fixation. In such uses, a single access opening through which only one tool is inserted may be sufficient for IOL fixation/repositioning.
  • a potential advantage of flexible anchoring using a flexible strand is that after anchoring the grasper can be at a wide range of angles relative to the sclera.
  • Figure 2C describes exemplary steps of grasping the IOL or the haptic:
  • the method comprises opening jaws (120) of grasper (125).
  • the method comprises opening jaws (120) of grasper (125), optionally by releasing jaws (120) from over-tube (350) and switching grasper (125) into an open configuration.
  • This can be performed for example by retracting tube (350) which covers part of grasper (125) towards the exterior part of the sclera so as to release jaws (120) from over-tube (350) and to switch grasper (125) into an open configuration.
  • the method comprises fishing around for the IOL or haptic.
  • fishing around is performed using a surgical microscope or other magnification tool used for imaging the eye during surgery;
  • the method comprises grasping the IOL or the haptic with jaws (120) (e.g., as described in Figure 2D).
  • the method comprises engaging ring (330) over jaws (120) so that they stay locked even when over-tube (350) is further retracted.
  • Figure 2E describes exemplary method steps for positioning the IOL in the right position.
  • checking if the IOO e.g., IOL
  • the IOO is indeed in a correct position and/or angle with respect to the cornea.
  • checking if the IOO is in a correct position and/or angle with respect to the inner surface of the sclera.
  • the grasper (125) is fixated such that the lens of the IOL which is directly or indirectly (e.g., via the haptic) connected thereto remains in the right position.
  • Exemplary option I (flow chart 240, described in Figure 2F) comprises at 242, attaching the proximal end of grasper (125) or the proximal end of a trans-scleral element (105) to the sclera or to the outer surface of the sclera.
  • Exemplary option II (flow chart 245, described in Figure 2G) comprises at 246, detaching the proximal end of the remainder strand (157) from the proximal end of grasper (125) or from the proximal end of the trans-scleral element (105). At 248, attaching the proximal end of grasper (125) or trans-scleral element (105) to the sclera or to the outer surface of the sclera.
  • Means for employing diathermia include, but are not limited to, electrical current heated devices, use of any external thermal/heated devices, or laser heated devices.
  • Tool (300) further comprises grasper (325) (an example of grasper 125) in a closed configuration which comprises jaws (320) in close proximity to each other, hole (340), and base (333).
  • Tool (300) further comprises ring (330). While in the closed configuration ring (330) is located distally to hole (340).
  • Jaws (320) optionally comprise step (311) which fits the size of ring (330) and is configured to prevent movement of ring (330) in the proximal direction while in the locked configuration as is further described in Figures 3D-F and Figures 5A-D.
  • Figures 4A-B describe the fixation tool (300) according to some embodiments of the invention as described in Figure 3A-F yet in an open configuration, when searching for the IOO (e.g., the haptic or the IOL) within the eye.
  • Figure 4B is a transparent view of the opaque image shown in Figure 4A.
  • IOL fixation tool (300) comprises strand (327), tube (350), shaft (355), ring (330) and grasper (325). While in an open configuration of tool (300) strand (327) is partially covered by tube (350) (shown in yellow) and shaft (355) (shown in brown).
  • Grasper (325) comprises jaws (320) and hole (340). Jaws (320) are elastically predisposed to be open.
  • Grasper (325) is in an open configuration in which jaws (320) are spaced apart from each other.
  • Hole (340) is designed such that it allows room for movement of jaws (320) when jaws (320) are spaced apart from each other to form an open configuration.
  • the distal end of shaft (355) is located more proximal to ring (330).
  • Shaft (355) is positioned such that it does not prevent jaws (320) from elastically opening.
  • Ring (330) is currently positioned more proximal to hole (340) and thus does not lockjaws (320) in a locked position.
  • Fixation tool (300) comprises grasper (325) with jaws (320) that are shown in a closed configuration, wherein jaws (320) are held in a close proximity to each other.
  • Figure 5B shows fixation tool (300) in which shaft (355) covers part of strand (327) and tube (350) covers part of shaft (355).
  • fingers (329) of shaft (355) are released from the hold of base (333).
  • Figures 5A-D when the fixation tool is in a locked configuration
  • Figures 3 A-C when the fixation tool is in a closed configuration
  • ring (330) maintains grasper (325) in a locked configuration.
  • step (311) which is visible in Figure 4B, is designed such that once ring (330) is advanced in the distal direction of fixation tool (300) it passes step (311) and step (311) geometrically interferes with proximal motion of ring (330).
  • step (311) the grasper (325) is in a locked configuration.
  • FIG. 5D shows IOL fixation tool (351) which comprises element (305), barrier (328) and grasper (325).
  • Element (305) fits into the trans-scleral hole used to insert IOL fixation tool (350), and connects to barrier (328) at the proximal end and to grasper (325) at the distal end thereof.
  • Barrier (328) can be formed by a trans-scleral element (e.g., 305), by applying diathermia thereto. When formed by diathermia, barrier (328) has a dome-shape or ball-shape with a diameter larger than the diameter of a trans-scleral hole which is used for inserting the IOL fixation tool to the eye.
  • biocompatible polymer refers to a non-toxic polymer which does not cause any adverse reactions when in contact with a living tissue or organism such as a human subject, e.g., an eye of a human subject.
  • biocompatible polymers include polyethylene, polypropylene, polyurethane, polyvinyl chloride, polytetrafluoroethylene, and polylactic acid.
  • Figure 6 describes some embodiments of the method of fixating an IOL as described in Figures 3-5.
  • the method comprises inserting the fixation tool into the eye.
  • the fixation tool can be inserted at a position posterior to the iris. It is noted that the fixation tool is optionally inserted into the eye while jaws (120) are in a closed configuration so that they fit into the trans-scleral hole.
  • the IOL or the haptic grasper (325) is in an open configuration.
  • the method comprises grasping the IOL or the haptic with jaws (120) and at 610, closing of jaws (120) which grasp the IOL or the haptic therebetween by advancing tube (350) towards the distal end of the IOL fixation tool over at least a portion of grasper (325) to force closure of jaws (120).
  • the method comprises the step (612) of engaging ring (330) over grasper (325) to secure grasper (325) in a locked configuration with jaws (120) in close proximity to each other while grasping the IOL or the haptic.
  • the method comprises manipulating the position and/or angle of grasper (325), which is connected to the IOL and/or the haptic.
  • the method comprises anchoring strand (327) (also referred to as an “elongated body” or “filament” herein) in anchor (124) at the outer surface of sclera, optionally forming barrier (128).
  • anchoring strand (327) to the outer surface of the sclera can be effected by inducing diathermia, resulting in barrier (128) which prevents movement of the IOL fixation tool within the eye.
  • the method comprises detaching the remainder strand (157) which is proximal to anchor (124) from anchor (124) or from barrier (128).
  • the anchoring and the detachment occur concomitantly by inducing diathermia on elongated body (327) from the outer surface of the sclera.
  • Figure 7 depicts tool (700) which grasps an IOL.
  • Tool (700) comprises jaws (720) with ring (730) on jaws (720), trans-scleral portion (705) of strand (727) attached to jaws (720) on the proximal end after removal of over-tube (750) from tool (700).
  • Trans-scleral element (705) of the strand has barrier (728) designed to anchor tool (700) to the sclera (not shown here).
  • laws (720) grasp haptic (757) of the IOL (756).
  • IOL 856
  • haptic 857) of the IOL within the eye.
  • Trocar 838 in inserted through the sclera behind the iris of the eye at penetration site (835).
  • penetration site (835) into the sclera of the eye is at the limbus.
  • penetration site (835) into the sclera of the eye is at the posterior chamber of the anterior segment.
  • penetration site (835) can be near or at the sulcus.
  • penetration site (835) into the sclera of the eye is at the vitreous cavity.
  • penetration site (835) into the sclera depends on the position of IOL (856) or haptic (857).
  • Figure 8C shows haptic (857) of IOL (856) (shown in Fig. 8B) after implantation within the eye.
  • Jaws (820) of tool (800) grasp the haptic (857) and are in a locked configuration with ring (830) preventing jaws (820) from releasing haptic (857).
  • Trans-scleral element (805) of the strand which is connected to jaws (820) is fixed to the sclera using anchor (824).
  • FIGS 9A-D depict an IOL fixation tool (900) according to some embodiments of the invention.
  • Figure 9B is a cross section of tool (900) shown in Figure 9A.
  • Shaft (955) shown in Fig. 9A
  • Mechanism (916) includes locking pin (917, shown herein an exemplary location as part of mechanism (916)).
  • Locking pin (917) which is also referred herein as “safety pin” prevents locking of jaws (920). In some embodiments, locking pin (917) can prevent movement of ring (930) in a distal direction.
  • Figure 9C shows ring (930) over jaws (920), maintaining jaws (920) in a locked configuration.
  • Tool (1000) is similar to tool (900) except that jaws (1020) comprise segment (1021) configured to reduce over-pressure or pinching forces on intraocular objects captured therebetween.
  • Tool (1000) comprises actuator (1010) with arms (1014), over-tube (1050), coupler (1012), hinge (1013) and jaws (1020).
  • jaws (1020) approximate towards each other the space between them remains equal along the entire length of segment (1021).
  • Jaws (1020) further comprise step (1011) for holding ring (1030).
  • Figure 10C shows a cross section of tool (1000) showing strand (1027) [as strand (327) in Figures 3-5], ring (1030) [as ring (330) in Figures 3-5], step (1011) [as step (311) in Figures 3-5] of jaws (1020) [as jaws (320) in Figures 3-5], and segment (1021).
  • Figures 10D-E show tool (1000) with locking pin (1017).
  • Figure 10D shows locking pin (1017) inserted into shaft (1055).
  • Figure 10E shows locking pin (1017) when removed from shaft (1055). When locking pin (1017) is pushed inside shaft (1055) it prevents the shaft (1055) to move in a distal direction.
  • Figure 10G shows jaws (1020) in a locked configuration with ring (1030) over jaws (1020).
  • Barrier (1138) has a dome-like shape having a diameter which is larger than the diameter of hole (1131), thus preventing the further passing of the distal end of strand (1127) through hole (1131) in the proximal direction. In Figure 1 IE barrier (1138) remains in the distal end of hole (1131).
  • the physician/surgeon can assemble tool (1100) in the operating room in order to select a specific strand (suture) to be used.
  • Jaws (1220) have a shape which is suitable for positioning ring (1230) in three different locations along jaws (1220).
  • Location (1218) is at the further proximal end of jaws (1220) and can hold ring (1230) on the top of loop (1232).
  • Safety pin (1217) is designed to fit into loop (1232).
  • ring (1230) (not shown here) is at location (1218) jaws (1220) are maintained in a closed configuration.
  • jaws (1220) are in a closed configuration when tool (1200) is inserted into the eye through the sclera.
  • Location (1215) is more distally with respect to location (1218) and forms a socket in jaws (1220).
  • safety pin (1217) is within loop (1232) pressure applied on or released from the arms of the actuator (as described in Figures 10A-H) results in the movement of ring (1230) between areas (1218), (1215) and (1219) along jaws (1220).
  • Figures 12A and 12B show tool (1200) in two different views, in which jaws (1220) are in an open configuration.
  • Figure 12C tool (1201) represents half of tool (1200). Shown is a vertical view of tool (1201) with magnification of teeth (1234) on jaw (1220). Also shown is half of hole (1231) and loop (1232).
  • the distance between the two outer surfaces of jaws (1220) when the jaws are in the closed configuration is between for example between 0.25 and 2.0 mm, between 0.25 and 1.0 mm, between 0.48-1.0 mm, e.g., about 0.48 mm.
  • the distance between the two outer surfaces of jaws (1220) when the jaws are in the open configuration is between for example between 0.55 and 4.50 mm, between 0.75 and
  • Figure 12F shows tool (1200) after locking jaws (1220) with ring (1230).
  • Ring (1230) is at location (1211) and jaws (1220) are in a locked configuration.
  • the distance between the two inner surfaces of jaws (1220) when the jaws are in the locked configuration (marked by a dashed double arrow and the letter “E”) is for example, between 0.0- 1.0 mm, between 0.1-1 mm, e.g., between 0.38-1.00, e.g., about 0.38 mm, e.g., about 1 mm.
  • Figure 12G shows tool (1200) according to some embodiments of the invention, of which the total length of jaws (1220) is about 4 mm (e.g., 4 mm).
  • the length of the distal part of jaws (1220) from step (1211) until the distal end is about 1.5 mm. In some embodiments the length of the distal part of jaws (1220) from step (1211) until the distal end is smaller than 1.5 mm. In some embodiments the length of the distal part of jaws (1220) from step (1211) until the distal end is up to 50% smaller than 1.5 mm.
  • the total length of the grasper is smaller than 4 mm. In some embodiments the total length of jaws (1220) is up to 50% smaller than 4 mm. In some embodiments the total length of the grasper is up to 2.5 mm. In some embodiments the total length of the grasper is about 2.5 mm.
  • Figures 13A-G showing fixation and/or manipulation tool (1300) in open, closed or locked configurations.
  • Figures 13A-B show tool (1300) in a closed configuration prior to release of safety pin (1317) by the eye surgeon.
  • Figure 13A shows tool (1300) with grasper (1325) having jaws (1320) in a closed configuration.
  • Safety pin (1317) is secured within the shaft of tool (1300).
  • Figure 13B shows ring (1330) over part of jaws (1320) while in the closed configuration.
  • Figures 13C-D show tool (1300) in a locked configuration after the release of safety pin (1317) by the eye surgeon. It is noted that in Figure 13D, which is after the release of safety pin (1317), ring (1330) is advanced more distally as compared to its location in Figure 13B when the tool (1300) is in the closed configuration (prior to release of safety pin (1317)).
  • Figures 13E-G show tool (1300) after release of safety pin (1317) from the tool.
  • Figure 13E shows tool (1300) in a locked configuration and after the release of strand (1327) from the proximal part of tool (1300).
  • Figure 13F is a cross section of tool (1300) while in the locked configuration with arrow (1331) pointing at the minimal separation (e.g., gap) between the upper and lower arms of the tool.
  • the gap comprises a safety pin (1317) that prevents the arms of the tool from closing completely. When the safety pin is removed, the two wings (e.g., arms) of the tool can be closed and then the locking ring is pushed forward (in a distal direction).
  • the two coupler parts (1312) can be pushed towards each other, to cause over-tube (1350) to be pushed in the distal direction.
  • Figure 13G is an overview of tool (1300) while in the locking configuration, showing withdrawal of part of over- tube (1350) in the proximal direction.
  • Figures 14A-C show tool (1400) according to some embodiments of the invention.
  • Tool (1400) comprises a locking mechanism (1470) which allows to secure the IOO in between the jaws (1420) in a locking configuration.
  • Locking mechanism (1470) may comprise 2 locking members (1471) and (1472) which together secure locking of jaws (1420) with the IOO there-between.
  • Locking member (1471) can include a tab or a protrusion which is inserted into a slot or a recess in locking member (1472).
  • the tab or protrusion of locking member (1471) slides past a threshold or a ridge in locking member (1472) and then sits in a recess of locking member (1472). It is noted that once the tab or the protrusion of locking member (1471) sits within the recess of locking member (1472) elastic forces securely hold the connection between the two locking members.
  • Locking members (1471) and (1472) can be made of plastic.
  • arms (914) of actuator (910) are squeezed by the eye surgeon, resulting in the two jaws approaching towards each other.
  • safety pin (1317) is safely secured in place (e.g., within the shaft of tool (1400))
  • squeezing of the arms (914) cannot result in locking of the jaws by locking mechanism (1470).
  • squeezing of arms (914) can allow locking of the jaws by locking mechanism (1470), by inserting the protrusion of locking member (1471) into the recess of locking member (1472).
  • Figure 14A shows tool (1400) in an open configuration with the two members (1471) and (1472) of locking mechanism (1470) are spaced apart from each other.
  • Figure 14C shows tool (1400) in a locked configuration in which protrusion in the up-right arm of locking member (1471) is inserted into the recess of locking member (1472) in a snap- locked position which prevents opening of locking mechanism (1470).
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

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Abstract

Est prévu un procédé de fixation d'une lentille intraoculaire (LIO) consistant à : (a) insérer un outil de fixation derrière l'iris ; (b) saisir la LIO entre deux surfaces opposées plates d'un dispositif de préhension dudit outil de fixation ; et (c) ancrer une extrémité proximale dudit dispositif de préhension à une sclère. Est également prévu un outil de fixation de lentille intraoculaire (LIO), comprenant : (a) un corps allongé comprenant un élément trans-scléral ; (b) un dispositif de préhension au niveau d'une extrémité distale dudit corps comprenant : (i) au moins deux bras s'étendant axialement qui définissent des surfaces de préhension opposées plates, (ii) des moyens pour approcher lesdits bras l'un vers l'autre de sorte qu'ils saisissent.
PCT/IL2025/050048 2024-01-15 2025-01-15 Dispositif et procédé de fixation de lentille intraoculaire Pending WO2025154061A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL31016924 2024-01-15
IL310169 2024-01-15

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WO2025154061A1 true WO2025154061A1 (fr) 2025-07-24

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160022488A1 (en) * 2013-03-08 2016-01-28 Optic Logik Llc Intraocular lens fixation correction methods and devices
US20180368911A1 (en) * 2015-12-15 2018-12-27 Netvlieschirurg B.V. Microsurgical fine gripping and diathermy forceps and diathermy cutting device for intraocular surgery
WO2022079710A1 (fr) * 2020-10-14 2022-04-21 Rambam Medtech Ltd. Dispositif de fixation de lentille intraoculaire

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160022488A1 (en) * 2013-03-08 2016-01-28 Optic Logik Llc Intraocular lens fixation correction methods and devices
US20180368911A1 (en) * 2015-12-15 2018-12-27 Netvlieschirurg B.V. Microsurgical fine gripping and diathermy forceps and diathermy cutting device for intraocular surgery
WO2022079710A1 (fr) * 2020-10-14 2022-04-21 Rambam Medtech Ltd. Dispositif de fixation de lentille intraoculaire

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