IL315430B2

IL315430B2 - Devices for holding and displacing intraocular lens about an optical axis thereof

Info

Publication number: IL315430B2
Application number: IL315430A
Authority: IL
Original assignee: Eyemed Tech Ltd
Priority date: 2024-09-03
Filing date: 2024-09-03
Publication date: 2025-08-01
Also published as: IL315430B1; IL315430A

Description

DEVICES FOR HOLDING AND DISPLACING INTRAOCULAR LENS ABOUT AN OPTICAL AXIS THEREOF TECHNOLOGICAL FIELD The present invention is in the field of medical devices, and relates specifically to devices configured for securely holding and remotely displacing intraocular lenses in vivo.

BACKGROUND Various medical conditions related to vision and eyesight are treated by replacement of the natural eye lens with an artificial intraocular lens (IOL). Eye-related problems such as cataract, eye trauma, vision refractive errors including far-sightedness (hyperopia), near-sightedness (myopia) and astigmatism can be solved by IOL replacement surgery. The replacement of the natural eye lens with an IOL can be beneficial also in other eye conditions in people who are not suitable for laser treatment.

Cataracts are the most prevalent ocular disease worldwide, being the cause of half of blindness and third of visual impairment in the world. About twenty-five million patients worldwide undergo cataract surgery on annual basis.

The typically implanted IOL provides selected focal length and optical power that should allow the patient to have a fairly good vision. However, it is often difficult to predict the exact characteristics of the lens necessary to correct the impaired vision. For example, currently, less than 50% of patients achieve their targeted vision after treatment, even with state-of-the-art multi-focal and other presbyopia correcting intraocular lenses, resulting in that post-surgery patients should often wear glasses for reading or distance vision.

Although it is a frequent surgical procedure, IOL replacement surgery involves several challenges, for example: prediction of exact lens characteristics (ELP); lens-positioning error during the surgery; tilt or shift after the surgery and during eye healing 25 process; and change of the corneal cylinder in the elderly. There are a few types of IOLs used to correct visual impairment, such as Mono-focal, Multi-focal and Toric (with possible combinations in the same lens). Following the installation and healing process, all kinds of IOL may move and deviate from the designed optical axis, hence requiring compensation by optimizing the IOL location, along or/and about (around) the optical axis, inside the lens capsule. Modification of the IOL location may be needed around the optical axis of the IOL, to correct for astigmatism issues, or along the optical axis of the IOL, to correct focusing problems. There are several techniques, both invasive and non-invasive, used to implement the compensations, such as repeated surgery to displace the IOL; use of a unique UV sensitive polymer that enables compensation by post deforming of the lens; and/or modification of the IOL optical properties (such as changing IOL coefficient of refraction locally) by use of optical (laser) radiation.

GENERAL DESCRIPTION The present invention provides techniques for post adjustment and optimization of position of an intraocular lens (IOL) that has been already implanted inside the lens capsule. By IOL, the applicant refers basically, herein in the text, to the optical lens itself which does not include the device/cradle that holds the IOL and operable to adjust the position of the IOL after being implanted. The described techniques, systems and devices enable non-invasive, remote, and repeated corrections of the IOL position relative to the optical axis of the IOL, specifically around/about the optical axis of the IOL, enabling the procedure to be performed relatively easily and in short time, e.g. in the clinic, while eliminating the need for additional invasive surgical procedures. The invention provides IOL holding/supporting systems/devices (e.g. in the form of a cradle) that include/integrate a movement system/mechanism/assembly operable to displace and adjust the position of the IOL around/about its optical axis. The movement system/mechanism/assembly is configured to be operated remotely from outside the eye and apply correction of the IOL position around the optical axial (also called the theta direction). This is also referred to as a Toric IOL. The invention enables doctors to precisely adjust the position of the IOL based on the exact amount of visual correction needed to achieve the desired vision and treat astigmatism. The systems/devices disclosed herein are miniature enabling remote access to the integral movement system/mechanism/assembly through the pupil of the eye. The diameter of the pupil extends between about 2mm to about 4mm in light conditions and between about 4mm to about 8mm in dark conditions. Accordingly, the described systems/devices allow for accommodating an IOL having a diameter in the range of about 3.5-6mm. The technique of the present invention enables achieving tiny rotational/angular stepped distances in a desired angular range(s). Additionally, the described systems and devices are elastic and foldable, at least in a working range of temperature, hence facilitating insertion and implantation in the eye capsule. Generally, the devices described are thin enough (in their height dimension that extends along the optical axis), so as to enable folding the device for insertion and to enable full recovery of the device default shape and function after implantation. In some embodiments, the device’s height is between 20-150µm. In WO2018229766A1 and WO2023139589A1, both assigned to the assignee of this application, various devices and systems for holding and displacing an IOL, in vivo, around the optical axis, are described. As will be appreciated herein below, those systems and devices, while completely valid, are more complicated than the systems and devices of the present invention. For example, the previously described devices involve a higher number of components that require complex manufacturing techniques and more complex operation. On the other hand, the devices described herein accomplish simpler configurations and designs while keeping or enhancing operation. Specifically, the present invention utilizes devices that transform a linear increase or decrease in a length of a first part into a rotational movement of a second part that is connected to the first part. Both of the linear increasing/decreasing and rotational movement happen in the same plane (cartesian) in space. Thus, according to one aspect, there is provided a device configured to be implanted in a lens capsule of a human eye and securely hold an intraocular lens (IOL), and operable to rotate the IOL about an optical axis of the IOL, the device comprising: - an outer portion configured to be fixedly positioned inside the lens capsule; - an inner portion to which the IOL is fixedly attachable before implanting the device in the lens capsule; and - an intermediate portion extending between and fixedly connected to a first point on the outer portion and a second point on the inner portion, the intermediate portion comprising at least one remotely controllable unit being controlled from outside the body with energy, after implanting the device, to change a length of the remotely controllable unit to cause either a clockwise or a counterclockwise rotation of the inner portion with respect to the outer portion, thereby rotating the attached IOL in a respective clockwise or counterclockwise rotation about its optical axis. In some embodiments, the at least one remotely controllable unit comprises two groups of remotely controllable units, the first group comprising one or more remotely controllable units being controlled to cause the clockwise rotation of the attached IOL about its optical axis and the second group comprising one or more remotely controllable units being controlled to cause the counterclockwise rotation of the attached IOL about its optical axis. The first group or/and the second group may comprise(s) a plurality of adjacent remotely controllable units. The changes in the lengths of the remotely controllable units may be fixed and correspond to respective fixed angular rotations of the IOL about its axis. In some embodiments, the at least one remotely controllable unit has its length controllably increased to cause the clockwise or counterclockwise rotation of the IOL about its optical axis. The remotely controllable unit may comprise an elastic portion being in a loaded state when the device is implanted in the lens capsule, and when the elastic portion is remotely unloaded, after the device is implanted in the lens capsule, its length is increased causing the clockwise or counterclockwise rotation of the IOL about its optical axis. The remotely controllable unit may comprise one or more locking elements that hold(s) the elastic portion in the loaded state and is(are) remotely deactivated so that the elastic portion is unloaded and its length is increased causing the clockwise or counterclockwise rotation of the IOL about its optical axis. The locking element may be remotely deactivated, to release the elastic portion, by absorbing energy in the form of heat from an external energy source. The locking element may be in the form of a wire tied to hold the elastic portion in the loaded state, the wire is configured to be remotely torn by absorbing energy in the form of heat from an external energy source, to release the elastic portion resulting in the increase of the length of the elastic portion and causing the clockwise or counterclockwise rotation of the IOL about its optical axis.

In some embodiments, the wire may be made from biocompatible nylon or polypropylene or polyester or a combination thereof. In some embodiments, the remotely controllable unit has its length controllably decreased to cause the clockwise or counterclockwise rotation of the IOL about its optical axis. The remotely controllable unit may comprise a shape memory portion being in an extended state at room and body temperature and when remotely heated, after implanting the device, its length is decreased causing the clockwise or counterclockwise rotation of the IOL about its optical axis. In some embodiments, the device is planar, the outer, inner and intermediate portions are located in same plane being in a perpendicular direction to the IOL optical axis. In some embodiments, the device is reversibly foldable, such that it is foldable upon being introduced into the lens capsule and fully recoverable upon being implanted inside the lens capsule. In some embodiments, the device is foldable such that it can be passed through a cross-section of about 2.54mm2 or about 1.8mm circular diameter. In some embodiments, the device has a unibody structure being manufactured from a single sheet of material. The single sheet of material may be NiTinol or Bi-metal. The unibody structure may be produced using physical vapour deposition. In some embodiments, a maximal height dimension of the device along the IOL optical axis is between 20-150µm. In some embodiments, the device further comprises an anterior or/and posterior cover(s) for the remotely controllable unit, that protects the remotely controllable unit and maintains the change in the length of the remotely controllable unit along a perpendicular direction to the IOL optical axis. In this case, when a wire is tied to hold the elastic portion, the wire may be tied over the anterior or/and posterior cover(s) and the elastic portion beneath. According to another aspect, there is provided a device configured to be implanted in a lens capsule of a human eye and securely hold an intraocular lens (IOL), and operable to rotate the attached IOL about an optical axis of the IOL, the device comprising at least one remotely controllable unit being controlled from outside the body with energy, after implanting the device, the remotely controllable unit comprising an elastic portion being held by a wire in a loaded state when the device is implanted in the lens capsule, the wire is configured to be remotely torn by absorbing energy in the form of heat from an external energy source, to release the elastic portion resulting in the increase of the length of the elastic portion and causing a clockwise or counterclockwise rotation of the IOL about its optical axis. According to another aspect, there is provided a device configured to be implanted in a lens capsule of a human eye and securely hold an intraocular lens (IOL), and operable to rotate the attached IOL about an optical axis of the IOL, the device comprising at least one remotely controllable unit being controlled from outside the body with energy, after implanting the device, the remotely controllable unit comprising a shape memory portion being in an extended state at room and body temperature and when remotely heated, after implanting the device, its length is decreased causing the clockwise or counterclockwise rotation of the IOL about its optical axis. According to another aspect, there is provided a device configured to be implanted in a lens capsule of a human eye and securely hold an intraocular lens (IOL), and operable to rotate the attached IOL about an optical axis of the IOL, the device having a flat/planar unibody structure and comprising at least one remotely controllable unit being controlled from outside the body with energy, after implanting the device, to change a length of the remotely controllable unit to cause either a clockwise or a counterclockwise rotation of the attached IOL about its optical axis. According to another aspect, there is provided an IOL adjustment system comprising: one of the devices described above; and a remote energy source configured and operable to provide energy to heat one or more portions of the remotely controllable unit(s) of the device. In some embodiments, the remote energy source comprises a radiating element. In some embodiments, the remote energy source comprises a laser source. The laser source may be configured and operable to provide continuous laser radiation. The laser source may be configured as an Argon laser source operable to provide light of a green spectrum. The laser source may be configured and operable to provide laser power between 0.1 – 5 watt, and/or laser pulse width between 10-1000ms, and/or laser spot diameter between 50-500 micrometer. The laser source may be configured as an Nd:Yag laser source operable to provide light of a green spectrum (e.g., 532nm), with a power of 0.3-10mJoule, laser pulse width of 1-10nsec and laser spot diameter of 1-10micrometer.

BRIEF DESCRIPTION OF THE DRAWINGS In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which: Figs. 1A1-1J2 illustrate a first non-limiting example of a device configured to hold an IOL and operable to remotely adjust position of the IOL about its optical axis, after it has been implanted inside an eye, in accordance with the invention; Figs. 2A-2D2 illustrate a second non-limiting example of a device configured to hold an IOL and operable to remotely adjust position of the IOL about its optical axis, after it has been implanted inside an eye, in accordance with the invention.

DETAILED DESCRIPTION OF EMBODIMENTS The present invention is aimed at providing intraocular lens (IOL) holding devices that enable remote, non-invasive, and controlled post-adjustment of the position of the implanted lens, specifically the angular position, with respect to the IOL optical axis. Reference is made to Figs. 1A1-1J2, schematically illustrating a first non-limiting example of a device 100, incorporating the principles of the technique of the present invention, the device 100 being configured to be implanted in a lens capsule of a human eye, securely hold an intraocular lens IOL and operable to rotate the IOL about an optical axis OA (Z) of the IOL, by being remotely subjected to energy from an external energy source ES (which is located outside the body and is not part of the device 100 and can be selected from a variety of suitable energy sources, such as some laser sources, ultrasound sources, as will be further described below). Fig. 1A1 is an isometric view of the device 100 in the default implantation state; the device 100 includes the IOL holding and manipulating device 100A and a haptics assembly 100H that aids in implanting the device 100 in the eye. The devices of the present invention, while holding the IOL, are typically implanted in the anatomical lens capsule compartment, or in the anatomical sulcus in case the lens capsule is damaged/ruptured. Usually, the implantation of the IOL in the human eye is supported by one or more haptics that are attached to the device and that can anchor the device holding the IOL to the implantation site. In some embodiments, the devices include integral haptics on the outer side thereof. In some other embodiments, the devices include attachment portions, on the outer side thereof, configured for attaching thereto corresponding haptics. The haptics may be adjusted to the specific implantation anatomical site. In the described non-limiting example, as shown in Figs. 1A1 and 1A2, the haptics assembly 100H includes a front part 100HF and a back part 100HB (the order is exchangeable) that enclose the outer side/portion of the device 100A that has its outer side sandwiched between the front and back parts. As shown, the device 100A includes four attachment portions 100HA1-100HA4 that are larger than the remaining outer side/portion of the device 100A, and this helps in achieving a stronger attachment of the haptics assembly 100H to the device 100A. The back part 100HB includes two peripheral arms 100HB1 and 100HB2 that engage with the living tissue of the lens capsule to fixate and stabilize the device 100 at the implantation site. The arms are configured to be relatively flexible to aid in the implantation while still having the required rigidity to hold the IOL without deformation. The dimensions of the devices of the present invention are selected to enable secure holding of lenses, including off-the-shelf lenses, and to insure secure implantation and effective rotation / angular displacement of the IOL after the implantation. The devices are configured to hold the IOL in a permanent position until the device is activated to rotate the IOL. The described systems/devices allow for accommodating an IOL having a diameter LD (Fig. 1D) in the range of about 3.5-6mm. The outer diameter OD of the device (in the Y direction, which is bigger than in the X direction) can be about 6-10 mm. The size of the device is affected by the maximal pupil opening that still enables exposing and controlling the portions of the device responsible for the IOL position adjustment. The overall diameter of the IOL including the haptics may be around 11-13 mm. In some embodiments, the height of the devices of the present invention, H in Fig. 1B, is such that the devices can be folded during insertion and can recover back to their basic shape in the closed state after being implanted in the body. In some embodiments, the height H is in the range of 20-150µm. In some embodiments, the different portions of the devices of the present invention, i.e. the outer portion, the inner portion and the intermediate, have different heights. In some embodiments, the different portions have the same height. The latter is especially true when the device, as appreciated from the figures and as will be described further below, has a unibody/integrated structure, e.g. being manufactured from a single piece/sheet of material. Typically, the device 100A is implanted in the eye capsule, when in the default closed state shown for example in Figs. 1B (isometric view) and 1C (front view). If a correction of the IOL position is warranted, the device 100A is activated to thereby move incrementally into one of the open states, such as shown in Figs. 1D, 1E, 1J, 1I and 1K. As shown in Figs. 1B and 1C, the device 100A includes an outer portion 102, an inner portion 104, and an intermediate portion 106 extending and connecting between the outer and inner portions. As discussed herein in the various embodiments, the intermediate portion is responsible to cause a rotation of the inner portion relative to the outer portion. The rotation can be clockwise or counterclockwise. In some embodiments, the rotation can be done in increments in either direction, and can be equal or unequal overall, in the opposite directions. The outer portion 102 is configured to be fixedly positioned inside the lens capsule, i.e. to have a fixed position with respect to the optical axis of the IOL. Typically, the device 100A is oriented in a perpendicular direction to the optical axis OA of the IOL, i.e. in XY plane (Fig. 1C). The inner portion 104 is configured to hold the IOL fixedly. In this example, as shown in Fig. 1C, the device 100A includes a cavity 108, within the inner portion 104, configured to receive the IOL. The intermediate portion 106 extends between and is fixedly connected to a first point 102P on the outer portion and a second point 104P on the inner portion, the intermediate portion 106 includes at least one remotely controllable unit (RCU) being controlled from outside the body (e.g. by the energy source ES), after implanting the device 100A. When remotely controlled, the at least one remotely controlled unit (RCU) goes through a change in its length, either an increase or a decrease in the length, and causes either a clockwise (CW) or a counterclockwise (CCW) rotation of the inner portion 104 with respect to the outer portion 104, thereby rotating the IOL, attached to the inner portion 104, in a respective clockwise or counterclockwise rotation about its optical axis OA. It is noted that the intermediate portion can include one or more remotely controllable units. Generally speaking, each RCU, when controlled, will cause one of clockwise and counterclockwise rotations but not both. Accordingly, to enable both CW and CCW rotations, the intermediate portion includes at least one RCU for the CW direction and at least one RCU for the CCW direction. In some embodiments, the intermediate portion includes more than one RCU for each of the CW and CCW directions, this enables enhanced control on incremental angular displacements of the IOL, as the physician sees necessary. In some embodiments, changes in the lengths of the RCUs are fixed/equal and correspond to respective fixed/equal angular rotations of the IOL about its axis. For example, the device can be designed such that each change in the length of the RCU translates into a certain degree value, e.g. 5 degrees, of the IOL rotation about its optical axis. In this non-limiting example, the intermediate portion 106 includes six remotely controllable units, three RCUs, 106C1-106C3, are remotely operable to rotate the IOL in the CW direction, and three RCUs, 106CC1-106CC3 are remotely operable to rotate the IOL in the CCW direction. It is understood that the first point 102P, being located on the outer portion, remains fixed in space, while the second point 104P, being located at the other side of the intermediate portion and on the inner portion, is displaced due to the change(s) in the length of the remotely controllable unit(s) which translate(s) into a change in the overall length of the intermediate portion which is represented by the linear distance between the first and second points 102P and 104P. This will be illustrated further below. In the present and other following examples, in view of the circular shape of the IOL, the device 100A substantially traces a circular shape as well. The inner portion 104 substantially forms an inner ring. The outer portion 102 may substantially form an outer ring, however in this example, the outer portion has arc shapes on the top and bottom sides 102T and 102B and it is flat, straight, on the left and right sides 102L and 102R. This particular configuration serves in minimizing the size of the device at the regions that do not include the functional portions (the remotely controllable units) of the intermediate portion (here, the left and right sides of the device. The intermediate portion is enclosed between the outer and inner portions and has a substantially circular shape. It is noted, however, that in some embodiments the outer and inner portions, each or both, can take other shapes, and they can have, inter alia, open shapes and not necessarily closed shapes as in the present example. For example, the outer and inner portions may be constituted by one or more open shapes, e.g. open arcs. In some embodiments, the intermediate portion may be constituted of two or more sub-portions distributed along the substantially round shape of the device 100A.

In some embodiments, the remotely controllable unit of the intermediate portion has its length remotely and controllably increased to cause the clockwise or counterclockwise rotation of the IOL about its optical axis. In some embodiments, the RCU includes an elastic portion being in a loaded state when the device is implanted in the lens capsule, and when the elastic portion is remotely unloaded, after the device is implanted in the lens capsule, its length is increased causing the clockwise or counterclockwise rotation of the IOL about its optical axis. The elastic portion has characteristics of a spring that can be loaded by compression and then relaxed by being unloaded. Looking at Fig. 1D, the RCU 106CC3 is illustrated. All of the RCUs in this example share the same structure and functionality. As shown, the RCU 106CC3 includes an elastic portion CC3E, being held in a loaded state when the device is implanted in the lens capsule, and when the elastic portion CC3E is remotely unloaded, after the device is implanted in the lens capsule, its length is increased causing the clockwise or counterclockwise rotation of the IOL about its optical axis. In some embodiments, the RCU includes one or more locking elements that hold(s) the elastic portion in the loaded state and is(are) remotely deactivated so that the elastic portion is unloaded and its length is increased causing the clockwise or counterclockwise rotation of the IOL about its optical axis. The locking element is remotely deactivated, to release the elastic portion, by absorbing energy (typically in the form of heat) from an external energy source. In some embodiments, the locking element is in the form of a wire/string/thread tied to hold the elastic portion in the loaded state, the wire is configured to be remotely torn by absorbing energy in the form of heat from an external energy source, to release the elastic portion resulting in the increase of the length of the elastic portion and causing the clockwise or counterclockwise rotation of the IOL about its optical axis. In the described example, the RCU 106CC3 includes the locking element / wire CC3W that holds the elastic portion CC3E in a loaded state, and when the wire CC3W is torn/cut by the external energy source, the elastic portion CC3E extends from the compressed state into a relaxed state. This will be illustrated further below. In this case, when referring to the front side of the device, illustrated in Fig. 1C, the tearing of the wire CC3W causes a counterclockwise rotation of the inner portion and the IOL attached thereto, by an angular magnitude determined by the specifications of the elastic, spring-like, element CC3E.

The wire/string/thread can be made from different biocompatible materials. In some non-limiting embodiments, the wire is made from a biocompatible mono-filament. In some non-limiting embodiments, the wire is made from Nylon. In some non-limiting embodiments, the wire is made from Polypropylene. In some non-limiting embodiments, the wire is made from Polyester. In some non-limiting embodiments, the wire has a diameter of between 0.01-0.1mm. The elastic portion of the RCU extends between two rigid portions of the intermediate portion 106, and the locking element / wire can be attached / bonded to two attachment points located respectively on the two rigid portions located on both sides of the elastic portion. In some embodiments, such as in the present example, the two attachment points on the rigid portions are in the form of a pair of holes, through which the wire is passed and tied/bonded. In some embodiments, the two sides of the wire are tied together, e.g. similar to tying a shoelace, to form a knot. In some embodiments, each one of the sides of the wire is inserted through the hole and is then heated to form a ball-like or disk-like shape bigger than the hole and by this the wire is locked in the holes while compressing the elastic portion between the two rigid portions. In the present example, the elastic portion CC3E is located between the rigid portions CC3R1 and CC3R2. It is noted that in this example of the device, the intermediate portion is composed of a series of rigid portions interspaced by elastic portions. Accordingly, adjacent RCUs share one rigid portion in between. For example, the rigid portion CC3R2 is common to RCUs 106CC3 and 106CC2, or in other words, a first side of the rigid portion CC3Rbelongs to the RCU 106CC3 and a second side of the rigid portion CC3R2 belongs to the RCU 106CC2. In some embodiments, whenever the lockers are wires as discussed above, the external energy source can be configured as a laser source that cuts the wire, probably not by heating but by mechanical tearing. In some embodiments, the laser source can be an Nd:Yag laser source operable to provide light of a green spectrum (e.g. 532nm achieved by doubling the frequency of the 1064nm red ND:Yag), with a power of 0.3-10mJoule, laser pulse width of 1-10nsec and laser spot size of 1-10micrometer. Turning to Figs. 1E1-1E2 showing the front side of the device 100A and the activation of one RCU. This figure illustrates the clockwise rotation of the inner portion and the IOL, when attached thereto, due to the remote control of the RCU 106C1. As shown, the reference point 104RP located on the inner portion is displaced clockwise (Fig. 1E1) with respect to the vertical axis X1 that passes through the point 104RP (Fig. 1E2) before the cutting of the wire C1W. Although not shown, in some embodiments, one or more markings are made on the IOL that aid the doctor in discerning the IOL’s rotational position before/after a change is made. It is appreciated that the length of the elastic portion C1E is increased (Fig. 1E1) after being unloaded due to the cutting of the wire C1W. In some embodiments, the devices of the present invention further include an anterior (front) or/and posterior (back) cover(s) for the remotely controllable unit, that protect(s) the remotely controllable unit and maintains the change in the length of the remotely controllable unit along a perpendicular direction to the IOL optical axis. The cover(s) maintain(s) the change in the XY plane and prevents unintended movement of the elastic portion in the Z direction, This is illustrated in Figs. 1F1-1J2. As shown for example, referring to RCU 106CC3, a front cover CC3CF protects the RCU 106CC3 on the front side of the device, as shown in Fig. 1F1, and a back cover CC3CB protects the RCU 106CC3 on the back side of the device, as shown in Fig. 1F2. Fig. 1G illustrates the protective covers, CC3CF and CC3CB, in an exploded view while revealing the rigid portions, CC3R1 and CC3R2, and the elastic portion CC3E of the RCU 106CC3. Also shown are two pins, CC3P1 and CC3P2, that pass through holes in the rigid portion CC3R1 and matching holes in the front and back covers to fixate the covers to the rigid portion CC3R1 (see dashed lines) and one elongated insert CC3I that passes through an elongated hole (langloch) CC3L in the rigid portion CC3R2 and through corresponding elongated holes (langlochs) in the front and back cover to enable the movement/sliding of the covers when the elastic portion is unloaded and the distance between the rigid portions increases. In this configuration, the wire CC3W is passed through two holes and tied over the rigid portion CC3R2 and the two covers to hold the elastic portion in the loaded state. Once the wire is cut, the elastic portion is relaxed and the covers slide counterclockwise together with the rigid portion CC3R1 that is part of the inner portion 104. Reference is made to Figs. 1H1 – 1J2 illustrating various rotations of the inner portion and the IOL, attached thereto, with respect to the optical axis of the IOL. Fig. 1H1 shows the default state of the device when all RCUs are locked / in loaded states. Fig. 1H2 shows a clockwise rotation of the inner portion by an angular magnitude determined by the elastic portion’s properties, as illustrated by the vertical axis X1 (passing through the reference point 104RP in Fig. 1H1), after unlocking/unloading the RCU 106C1. Fig. 1I1 shows the default state of the device when all RCUs are locked / in loaded states. Fig. 1I2 shows a counterclockwise rotation by a magnitude determined by the elastic portion’s properties, as illustrated by the vertical axis X1 (passing through the reference point 104RP in Fig. 1I1), after unlocking/unloading the RCU 106CC3. Fig. 1J1 shows the default state of the device when all RCUs are locked / in loaded states. Fig. 1J2 shows the fully open state of the device when all RCUs are unlocked / in unloaded states. Fig. 1J2 shows that the three incremental clockwise rotations, caused by the three unlockings of RCUs 106C1-106C3 are cancelled out by the three incremental counterclockwise rotations, caused by the three unlockings of RCUs 106CC1-106CC3. This assumes that the angular displacements in the clockwise and counterclockwise directions are equal, however this should not be limiting the invention. As described earlier, the incremental angular rotation may be 5 degrees or any other angle value. The number of RCUs in each direction can be one or more. In this particular example, there are three RCUs in each direction. As described above, the devices of the present invention, or major portions thereof, are configured to be foldable under application of certain amount of external forces and to return to their original shape without deformation once the external forces are removed. As such, the devices may include super-elastic materials which enable the device to be reversibly foldable, and enable the elasticity and spring-like properties of functional parts of the device, such as the elastic portions in the example of Figs. 1A1-1J2. The skeleton of devices of the present invention can be designed to be super-elastic around room temperature and around body temperature, such that they can be folded while being inserted into the lens capsule. For example, the device can be configured to be foldable such that it can be passed through a cross-section of about 2.54mm (equivalent to 1.8mm circular diameter, though the cross-section can take an oval-like shape). In some embodiments, the super-elastic material is a specifically designed Nitinol (Nickel Titanium alloy), or a bi-metal, chosen for its biocompatibility and design flexibility. Nitinol can be designed to be a super-elastic material at a specific temperature range, e.g. a range including room temperatures and body temperature.

In some embodiments, the various devices of the present invention, including the outer portion, the inner portion and the intermediate portion, are made from a single sheet of material, such as Nitinol, by laser cutting. In some embodiments, the device is manufactured using deposition techniques, such as physical vapour deposition, specifically magnetron sputtering. Accordingly, as described above, the device has a unibody structure, increasing its stability, strength and flexibility. It is noted that some additional structural features, such as the holes used for the binding wires, are obtained during the same process of laser cutting or physical vapour deposition. Additionally or alternatively, other techniques may be used to obtain the basic structure of the device, whether unibody or multi-part, and the above-mentioned techniques should not be limiting the scope. Reference is now made to Figs. 2A-2D2, schematically illustrating a second non-limiting example of a device 200, incorporating the principles of the technique of the present invention, the device 200 being configured to be implanted in a lens capsule of a human eye, securely hold an intraocular lens IOL and operable to rotate the IOL about an optical axis OA (Z) of the IOL, by being remotely subjected to energy from an external energy source ES (which is located outside the body and is not part of the device 200 and can be selected from a variety of suitable energy sources, such as some laser sources, ultrasound sources, as will be further described below). Fig. 2A is an isometric view of the device 200 in the default implantation state; the device 200 includes the IOL holding and manipulating device 200A and a haptics assembly 200H (similar in structure and function to haptics 100H described above). Every reference number used herein and having a difference of 100 to the reference numbers used to describe elements and features of the device 100, is used to describe the same element and feature. For example, 202 is an outer portion like outer portion 102 described above. Unless a clear difference is stated here with respect to device 200A, it is understood that the mentioned / described element, even without clear explanation, has similar properties to those described with reference to device 100A. Fig. 2B is a front view of the device 200A. Typically, the device 200A is implanted in the eye capsule, when in the default state (open state) shown for example in Figs. 2A (isometric view) and 2B (front view, but with the haptics 200H added to it). If a correction of the IOL position is warranted, the device 200A is activated to thereby move incrementally into one of the altered states (closed states), such as shown in Figs. 2C1-2D1. As shown in Fig. 2B, the device 200A includes an outer portion 202, an inner portion 204, and an intermediate portion 206 extending and connecting between the outer and inner portions. As discussed herein in the various embodiments, the intermediate portion is responsible to cause a rotation of the inner portion relative to the outer portion. The rotation can be clockwise or counterclockwise. In some embodiments, the rotation can be done in increments in either direction, and can be equal or unequal overall, in the opposite directions. The outer portion 202 is configured to be fixedly positioned inside the lens capsule, i.e. to have a fixed position with respect to the optical axis of the IOL. Typically, the device 200A is oriented in a perpendicular direction to the optical axis OA of the IOL, i.e. in XY plane. The inner portion 204 is configured to hold the IOL fixedly. In this example, the device 200A includes a cavity 208, within the inner portion 204, configured to receive the IOL. The intermediate portion 206 extends between and is fixedly connected to a first point 202P on the outer portion and a second point 204P on the inner portion, the intermediate portion 206 includes at least one remotely controllable unit (RCU) being controlled from outside the body (e.g. by the energy source ES), after implanting the device 200A. In this non-limiting example, the intermediate portion 206 includes six remotely controllable units, three RCUs, 206C1-206C3, are remotely operable to rotate the IOL in the CW direction, and three RCUs, 206CC1-206CC3 are remotely operable to rotate the IOL in the CCW direction. It is understood that the first point 202P, being located on the outer portion, remains fixed in space, while the second point 204P, being located at the other side of the intermediate portion and on the inner portion, is displaced due to the change(s) in the length of the remotely controllable unit(s) which translate(s) into a change in the overall length of the intermediate portion which is represented by the linear distance between the first and second points 202P and 204P. This will be illustrated further below. The top side 202T, the bottom side 202B, the right side 202R and the left side 202L have same specifications as the corresponding sides in device 100A described above.

In this non-limiting example, the RCUs of the intermediate portion 204 have their lengths remotely and controllably decreased to cause the clockwise or counterclockwise rotation of the IOL about its optical axis. As shown in Figs. 1C1-1C2, the RCU 206CC1 that is remotely controlled, with the external energy source, is illustrated. The rest of the RCUs are similar in their structure. The RCU 206CC1 includes a first rigid portion CC1R1 of the intermediate portion 206, a second rigid portion CC1R2 of the intermediate portion 206, and a shrinkable portion CC1A (also called herein "the activable portion") of the intermediate portion 206 located between the first and second rigid portions. The shrinkable portion CC1A is in its default open/extended state, when the device 200 is implanted in the eye, as shown in Fig. 1C1. After implantation, if the doctor decides that the IOL should be displaced counterclockwise about the optical axis, the shrinkable/activable portion CC1A is subjected to energy from the external energy source to decrease its length, as shown in Fig. 2C2, and cause a CCW rotation of the inner portion 204 and the IOL attached thereto about the optical axis. This is further illustrated in the figures by the vertical axis X2 and the reference point 204RP. Figs. 2D1-2D2 illustrate the default open state of the device 200A, in Fig. 2D1, and the fully closed state of the device 200A, in Fig. 2D2, after activation of all of the six RCUs. As appreciated, the CW and CCW rotations (being equal in number and magnitude) cancel each other such that the reference point 204RP returns to the default position. In some embodiments, the device or the RCUs include stabilizing parts/elements/assemblies that aid in maintaining the device in the closed states after activation of the activable portion(s) of the RCU(s). The stabilizing assembly is recommended in cases where the strength/rigidity of the activable portion is weakened after activation and shrinking. This characteristic will be explained further below. As shown in Figs 2D1-2D2, referring to the RCU 206CC1, the stabilizing assembly includes a latch CC1L that forms part of the outer portion 202 (and for the rest of RCUs, the respective latches form part of the inner portion, and this is a design non-limiting choice). For each RCU, the stabilizing assembly also includes a depression in the rigid portion of the intermediate portion 206. As shown, the rigid portion CC1R1 includes a depression facing the outer portion 202. By default, the latch is elastic and designed to protrude from the outer or inner portion, as the case may be, as shown in Fig. 2D2. However, in the default state of the device before implantation, the latch CC1L is pressed down by the rigid portion (or by the activable portion in some cases), as shown in Fig. 2D1, and when the shrinkable/activable portion’s length is decreased and the rigid portion moves (in this example CCW), the latch opens back to its default protruding position and pushes against the depression wall to prevent CW rotation and backward regression. As mentioned above, the devices of the present invention can be made from a single sheet of material (such as Nitinol) and can have elastic / super elastic properties. In the case of the device 200A, Nitinol can be treated to have super-elastic properties at a specific temperature range and have shape-memory properties at a specific temperature range. In general, Nitinol is configured to change its structure from martensitic phase to austenitic phase under gradient of a few Celsius degrees. The gradient of temperatures and the phases transformation temperatures can be programmed according to the requirements. For example, the Nitinol Alloy can be designed such that up to about 40°C (close to the body temperature) it is in martensite phase being fictile and can be shaped to a desired shape under external forces, e.g. forming the default shape of the activable portion of the RCU (as shown in Fig. 2C1 for example). On the other side, raising the temperature to about 60°C causes phase transition into austenite phase where Nitinol changes its shape (deforms) to take a shape saved in its "memory" even while under certain amount of external forces, e.g. forming the closed / shortened / shrinked state of the activable portion (as shown in Fig. 2D2 for example). Once the temperature returns to about 40°C, the Nitinol returns back to its fictile state and can be reshaped as desired. In order to maintain the activable portion in the short form, the stabilizing assembly is used as described above. In some embodiments, the activable portions of the RCUs in device 200A are integral portions of the unibody configuration of the device. In some embodiments, the activable portions are separately made and added. In this case, the activable portion may be attached to the adjacent rigid portions of the intermediate portion in a clipping mechanism. As appreciated, other non-permanent attachment mechanisms, e.g. based on male-female attachments, are also possible. In some embodiments, other attachment mechanisms, specifically permanent mechanisms such as welding or laser welding or gluing or soldering or a combination thereof, can be applied. Both permanent and non-permanent attachments provide secure, accurate, repeatable and controllable positioning and alignment.

In some embodiments of the invention, though not shown in the figures, the device 100A can be integrated with a device as described in PCT/IL2024/050267, assigned to the assignee of the present invention, to form one device that enable displacements of the IOL both about the optical axis (+/-theta) of the IOL, as described herein, and along the optical axis (+/-Z) of the IOL, as described in the above-mentioned PCT application, by remotely and selectively cutting the wires that hold the elastic portions and bendable structures in the default implantation state to thereby displace the IOL about or along the optical axis thereof. The remote energy source ES is configured and operable to provide energy to cut the wires or to activate the activable portions of the RCUs. Typically, each wire is cut/unlocked or each activable portion is activated/energized individually. In some embodiments, the remote energy source requires direct / uninterrupted line of sight /route between the remote energy source and the wire or activable portion, while in some other embodiments, there is no such requirement and the activation can be achieved without direct line of sight. In some embodiments, the remote energy source is configured and operable to provide the activation energy in the form of heat. This is particularly important in case the activable portions are made from shape-memory materials. In some embodiments, the remote energy source includes at least one radiating element operable to heat the activable portions by irradiating them. In some embodiments, the remote energy source includes an electromagnetic radiation transmitter and the plurality of actuators include corresponding electromagnetic radiation receivers. In some embodiments, the remote energy source is a laser source. In some embodiments, the laser source is configured and operable to provide continuous laser radiation. In some embodiments, the laser source is configured and operable to provide a green spectrum of light (e.g. having wavelength between 495-570nm). In some embodiments, the laser source is configured and operable to produce laser having one or more of the following parameters: laser power between 0.1 – 5 watt, laser pulse width between 10-1000ms, laser spot diameter between 50-500 micrometer. In some embodiments, the laser source is configured and operable to provide light of a green spectrum, with a power of 0.3-10mJoule, laser pulse width of 1-10nsec and laser spot diameter of 1-10micrometer. In some embodiments, the device of the invention, such as the devices described above, is enclosed within an enclosure that helps to protect and shield the movable and functional parts of the device, and prevents risks of clogging and immobilization due to interaction of the movable and functional parts with physiological medium inside the body, e.g. inside the eye capsule that receives the device holding the IOL. Accordingly, it is appreciated that the present invention provides a powerful technique for controllable and precise remote displacement of an IOL about its optical axis, after the IOL has been implanted, to adjust the IOL position and enable it to function properly.

Claims

- 21 - CLAIMS:

1. A device configured to be implanted in a lens capsule of a human eye and securely hold an intraocular lens (IOL), and operable to rotate the IOL about an optical axis of the IOL, the device comprising: - an outer portion configured to be fixedly positioned inside the lens capsule; - an inner portion to which the IOL is fixedly attachable before implanting the device in the lens capsule; and - an intermediate portion extending between and fixedly connected to a first point on the outer portion and a second point on the inner portion, the intermediate portion comprising at least one remotely controllable unit being controlled with energy from outside the body, after implanting the device, to change a length of the remotely controllable unit to cause either a clockwise or a counterclockwise rotation of the inner portion with respect to the outer portion, thereby rotating the attached IOL in a respective clockwise or counterclockwise rotation about its optical axis.

2. The device of claim 1, wherein said at least one remotely controllable unit comprises two groups of remotely controllable units, the first group comprising one or more remotely controllable units being controlled to cause the clockwise rotation of the attached IOL about its optical axis and the second group comprising one or more remotely controllable units being controlled to cause the counterclockwise rotation of the attached IOL about its optical axis.

3. The device of claim 2, wherein the first group or/and the second group comprise(s) a plurality of adjacent remotely controllable units.

4. The device of claim 2 or 3, wherein said changes in the lengths of the remotely controllable units are fixed and correspond to respective fixed angular rotations of the IOL about its axis.

5. The device of any one of the claims 1 to 4, wherein said at least one remotely controllable unit having its length remotely controllably increased to cause the clockwise or counterclockwise rotation of the IOL about its optical axis. - 22 -

6. The device of claim 5, wherein said remotely controllable unit comprises an elastic portion being in a loaded state when the device is implanted in the lens capsule, and when the elastic portion is remotely unloaded, after the device is implanted in the lens capsule, its length is increased causing the clockwise or counterclockwise rotation of the IOL about its optical axis.

7. The device of claim 6, wherein said remotely controllable unit comprises one or more locking elements that hold(s) the elastic portion in the loaded state and is(are) remotely deactivated so that the elastic portion is unloaded and its length is increased causing the clockwise or counterclockwise rotation of the IOL about its optical axis.

8. The device of claim 7, wherein said locking element is remotely deactivated, to release the elastic portion, by absorbing energy in the form of heat from an external energy source.

9. The device of claim 7, wherein said locking element is in the form of a wire tied to hold the elastic portion in the loaded state, the wire is configured to be remotely torn by absorbing energy in the form of heat from an external energy source, to release the elastic portion resulting in the increase of the length of the elastic portion and causing the clockwise or counterclockwise rotation of the IOL about its optical axis.

10. The device of claim 9, wherein said wire is made from biocompatible nylon or polypropylene or polyester or a combination thereof.

11. The device of any one of the claims 1 to 4, wherein said remotely controllable unit having its length remotely controllably decreased to cause the clockwise or counterclockwise rotation of the IOL about its optical axis.

12. The device of claim 11, wherein said remotely controllable unit comprises a shape memory portion being in an extended state at room and body temperature and when remotely heated, after implanting the device, its length is decreased causing the clockwise or counterclockwise rotation of the IOL about its optical axis. - 23 -

13. The device of any one of the claims 1 to 12, wherein the device is planar, the outer, inner and intermediate portions are located in same plane being in a perpendicular direction to the IOL optical axis.

14. The device of claim 13, wherein said increase or decrease in the length of the remotely controllable unit and said clockwise or a counterclockwise rotation of the inner portion happen in the same plane of the device.

15. The device of any one of the claims 1 to 14, wherein the device is reversibly foldable, such that it is foldable upon being introduced into the lens capsule and fully recoverable upon being implanted inside the lens capsule.

16. The device of claim 1, wherein said device is foldable such that it can be passed through a cross-section of about 2.54mm or about 1.8mm circular diameter.

17. The device of any one of the claims 1 to 16, wherein the device has a unibody structure being manufactured from a single sheet of material.

18. The device of claim 18, wherein said single sheet of material is NiTinol or Bi-metal.

19. The device of claim 17 or 18, wherein said unibody structure is produced using physical vapour deposition.

20. The device of any one of the claims 1 to 19, wherein a maximal height dimension of the device along the IOL optical axis is between 20-150µm.

21. The device of any one of the claims 1 to 20, further comprising an anterior or/and posterior cover(s) for said remotely controllable unit, that protect(s) the remotely controllable unit and maintains the change in the length of the remotely controllable unit along a perpendicular direction to the IOL optical axis.

22. The device of claim 21, when depending from claim 9, wherein said wire is tied over the anterior or/and posterior cover(s) and the elastic portion beneath. 25 - 24 -

23. An IOL adjustment system comprising: the device of any one of the claims 1 to 22; and a remote energy source configured and operable to provide energy to heat one or more portions of the remotely controllable units of the intermediate portion of the device.

24. The system of claim 23, wherein said remote energy source comprises a radiating element.

25. The system of claim 23, wherein said remote energy source comprises a laser source.

26. The system of claim 25, wherein said laser source is configured and operable to provide continuous laser radiation.

27. The system of claim 25, wherein said laser source is configured as a laser source operable to provide light of a green spectrum.

28. The system of claim 25, wherein said laser source is configured and operable to provide laser power between 0.1 – 5 watt, and/or laser pulse width between 10-1000ms, and/or laser spot diameter between 50-500 micrometer.

29. The system of claim 25, wherein said laser source is configured as an Nd:Yag laser source operable to provide light of a green spectrum, with a power of 0.3-10mJoule, laser pulse width of 1-10nsec and laser spot diameter of 1-10micrometer.