A device that holds an intraocular lens along its optical axis

Abstract

A device configured to be implanted within the capsular bag of a human eye, securely holding an intraocular lens (IOL) and operable to displace the IOL relative to its optical axis, the device comprising: a first member configured to be fixedly positioned within the capsular bag; a second member to which the IOL can be fixedly attached; and a bendable structure attached at a first end to the first member and at a second end to the second member, the bendable structure configured to be remotely controllably bent at different bending levels to displace the position of a periphery of the IOL along the optical axis of the IOL when the IOL is attached to the second member.

Description

[Technical Field]

[0001] The present invention is in the field of medical devices, and more particularly relates to devices configured to retain intraocular lenses in vivo. [Background technology]

[0002] A variety of vision- and sight-related conditions are treated by replacing the natural lens of the eye with an artificial intraocular lens (IOL). Eye problems such as cataracts, eye trauma, and refractive errors such as hyperopia, myopia, and astigmatism can be resolved with IOL replacement surgery. This treatment can also be effective for other eye conditions in people who cannot undergo laser treatment.

[0003] Cataracts are the most common eye disease in the world, causing half of all blindness and one-third of all visual impairments worldwide. Approximately 25 million patients worldwide undergo cataract surgery each year.

[0004] Typically, implanted IOLs are selected with a focal length and optical power that will provide patients with fairly good vision. However, accurately predicting the lens characteristics needed to correct diminished vision is often difficult. For example, even with the latest multifocal and other presbyopia-correcting intraocular lenses, fewer than 50% of patients currently achieve their target visual acuity after treatment. As a result, postoperative patients often require the use of glasses for reading and distance vision.

[0005] IOL replacement surgery is a common procedure, but it presents several challenges, including accurate prediction of lens properties (ELP), intraoperative lens positioning errors, tilt and misalignment after surgery and during the eye's healing process, and changes in corneal cylinder in elderly patients. Several types of IOLs are used to correct visual impairments, including monofocal, multifocal, and toric lenses (which can be combined in the same lens). After placement and healing, all types of IOLs may shift and deviate from their designed optical axis, necessitating correction to optimize the IOL's position within the capsular bag. It may also be necessary to reposition the IOL around its optical axis to correct astigmatism or along its optical axis to correct focus issues. Several invasive and non-invasive techniques are used to perform the correction, including repeated surgery to move the IOL, the use of a unique UV-sensitive polymer that achieves correction by retropositioning the lens, and / or modifying the IOL shape with laser irradiation. Summary of the Invention

[0006] The present invention provides a technique for post-adjustment and optimization of the position of an intraocular lens (IOL) already placed in the capsular bag, where IOL essentially refers to the optical lens itself, without the cradle that holds the IOL.

[0007] The techniques, systems, and devices described herein allow for non-invasive, remote, and repeatable correction of the position and / or orientation (tilt) of an IOL relative to the optical axis of the lens, making the procedure relatively easy and quick to perform, for example, in a clinic, eliminating the need for additional invasive surgical procedures.

[0008] The present invention provides an IOL holding / supporting system / device (e.g., in the form of a cradle) that includes / integrates a translation system / mechanism / assembly operable to displace and adjust the position / orientation of the IOL along its optical axis, configured to be remotely actuated from outside the eye and to apply a correction to the IOL position in the optical axis direction (also referred to herein as the axial or Z-direction), thereby displacing / changing at least the focal position of the IOL along the Z-direction.

[0009] This invention allows physicians to precisely adjust the position of an IOL based on the exact amount of vision correction needed to achieve the desired visual acuity. The systems / devices disclosed herein are compact and allow remote access to the integrated motion system / mechanism / assembly through the eye's pupil. The pupil diameter dilates from approximately 2 mm to approximately 4 mm in bright light and from approximately 4 mm to approximately 8 mm in dark light. Therefore, the described systems / devices can accommodate IOLs with diameters ranging from approximately 3.5 to 6 mm. The technology of the present invention allows for the realization of a desired range of small axial step distances and / or small tilt angles.

[0010] Furthermore, the described systems and devices are resilient and foldable, at least within the operating temperature range, allowing for easy insertion and implantation into the ocular capsule.

[0011] Thus, according to one aspect, there is provided a device configured for implantation within the capsular bag of a human eye, operable to securely hold an intraocular lens (IOL) and to displace the IOL relative to an optical axis of the IOL, the device comprising: a first member configured to be fixedly positioned within the lens capsule; a second member to which the IOL can be fixedly attached; and and a bendable structure attached at its first end to the first member and attached at its second end to the second member, the bendable structure configured to be remotely controllably bent at various bending levels when the IOL is attached to the second member to displace the position of the periphery of the IOL along the optical axis of the IOL.

[0012] In some embodiments, the device includes a locking mechanism that is remotely controllable and operable to at least partially lock or release one or more portions of the bendable structure relative to / from either the first or second member to displace a position of a periphery of the IOL along the optical axis of the IOL when the IOL is attached to the second member. The locking mechanism can be operable to at least partially lock or release one or more portions of the bendable structure relative to / from either the first or second member such that first and second planes defined by the first and second members, respectively, remain parallel therebetween and perpendicular to the optical axis of the IOL while displacing a position of a periphery of the IOL along the optical axis of the IOL.

[0013] In some embodiments, the locking mechanism is operable to at least partially lock or release one or more portions of the bendable structure relative to / from either the first member or the second member such that a first plane defined by the first member is tilted relative to a second plane defined by the second member while displacing the position of the peripheral portion of the IOL along the optical axis of the IOL.

[0014] In some embodiments, the locking mechanism includes a plurality of remotely controllable rockers, each configured to lock or release a portion of the bendable structure to either the first member or the second member.

[0015] In some embodiments, the bendable structure includes a plurality of elongated bendable members, each having a first end permanently attached to the first member and a second end permanently attached to the second member.

[0016] In some embodiments, the locking mechanism includes at least two groups of remotely controllable rockers, the bendable structures each including at least two elongated bendable members, each of the groups of controllable rockers operable to lock or release a respective elongated bendable member to / from either the first member or the second member, each of the groups of controllable rockers including a plurality of controllable rockers arranged in a rocker array, and sequential actuation of rockers in the rocker array locks or releases respective portions of the elongated bendable members.

[0017] Symmetric actuation of individual controllable rockers from different controllable rocker groups displaces the position of the IOL's periphery perpendicular to the optical axis of the IOL, and asymmetric actuation of individual controllable rockers from different controllable rocker groups displaces the position of the IOL's periphery obliquely to the optical axis of the IOL.

[0018] In some embodiments, the locking mechanism comprises a third member adjacent to the first member, the bendable structure being sandwiched between the first and third members, and rotating the third member relative to the first member locks or releases one or more portions of the bendable structure relative to the first member to change the position of the periphery of the IOL along the optical axis of the IOL.

[0019] In some embodiments, the bendable structure comprises a plurality of elongated, bendable members, at least some of which have first ends permanently attached to the first member and at least some of which have second ends permanently attached to the second member, each of the plurality of elongated, bendable members being twistable about its longitudinal axis, the elongated, bendable members being arranged in one or more pairs with two elongated, bendable members of the pair positioned on opposite sides of the second member, and the degree of twisting of the two elongated, bendable members of the pair being remotely controlled to tilt the IOL about an axis passing through the two elongated, bendable members of the pair when attached to the second member.

[0020] In some embodiments, the device is configured and operable to displace the IOL at least one of anteriorly and posteriorly relative to the first member when attached to the second member.

[0021] In some embodiments, the device is configured and operable to at least partially reversibly displace the IOL when attached to the second member.

[0022] In some embodiments, the bendable structure is made from a shape memory material that has been treated so that the default shape of the bendable structure is a fully open state, and the locking mechanism is operable to change the position of the bendable structure between a fully closed state and a fully open state.

[0023] In some embodiments, each of the controllable rockers is made from a shape memory material that has been treated so that at body temperature the rocker is in a closed state that locks portions of the bendable structure, and when heated to a predetermined temperature by absorbing energy from a remote energy source, the rocker transitions to an open state that releases portions of the bendable structure. The bendable structure may be made from a shape memory material that has been treated so that at body temperature the default shape of each elongate bendable member is in a fully twisted state, and when heated to a predetermined temperature by absorbing energy from a remote energy source, the elongate bendable member transitions to a less twisted state.

[0024] In some embodiments, the shape memory material comprises nitinol.

[0025] In some embodiments, the device is about 2.54 mm 2 Alternatively, it is foldable so that it can be passed through a cross section with a circular diameter of about 1.8 mm.

[0026] In some embodiments, the locker is configured to be mechanically attachable to a corresponding portion of the first or second member. In some embodiments, the locker is mechanically attachable to the first or second member by a clip or a male-female setup. In some embodiments, the mechanical attachment is reversible.

[0027] In some embodiments, the bendable member has a series of grooves and protrusions on its side facing the first or second member (if any) that match a series of protrusions and grooves on the opposite side of the first or second member, and the locker aligns with the protrusions of the bendable member in the locked state and with the protrusions of the first or second member in the unlocked state.

[0028] According to another aspect, an IOL adjustment system is provided, the system comprising: Any of the above devices, and a remote energy source configured and operable to provide the energy for heating one or more portions of the device.

[0029] In some embodiments, the remote energy source comprises a radiating element.

[0030] In some embodiments, the remote energy source comprises a laser source.

[0031] In some embodiments, the laser source is configured and operable to provide continuous laser radiation.

[0032] In some embodiments, the laser source is configured as an argon laser source operable to provide light in the green spectrum.

[0033] In some embodiments, the laser source is configured and operable to provide a laser power of 0.1 to 5 watts and a laser pulse width of 200 to 1000 ms.

[0034] In some embodiments, the remote energy source includes an electromagnetic radiation transmitter and one or more portions of the device include a respective electromagnetic radiation receiver. [Brief explanation of the drawings]

[0035] For a better understanding of the subject matter disclosed herein, and to illustrate 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: [Figure 1] 1A-1L illustrate a first non-limiting example of a device according to the present invention configured to hold an IOL and operable to remotely adjust the position of the IOL after it has been implanted in the eye. [Figure 2] 2A-2E illustrate a second non-limiting example of a device according to the present invention configured to hold an IOL and operable to remotely adjust the position of the IOL after it has been implanted in the eye. [Figure 2A] 2AA-2AD illustrate a third non-limiting example of a device according to the present invention configured to hold an IOL and operable to remotely adjust the position of the IOL after it has been implanted in the eye. [Figure 3] 3A-3C illustrate a fourth non-limiting example of a device according to the present invention configured to hold an IOL and operable to remotely adjust the position of the IOL after it has been implanted in the eye. [Figure 4] 4A-4C illustrate a fifth non-limiting example of a device according to the present invention configured to hold an IOL and operable to remotely adjust the position of the IOL after it has been implanted in the eye. [Figure 5] 5A-5D illustrate non-limiting examples of devices according to the present invention configured to protect functional portions of any of the above devices. DETAILED DESCRIPTION OF THE INVENTION

[0036] The present invention aims to provide an intraocular lens (IOL) retention device that allows remote, non-invasive, and controlled post-adjustment of the position of the implanted lens relative to the IOL optical axis.

[0037] 1A-1L, a first non-limiting example of a device 10A incorporating principles of the present technology is illustrated schematically. Device 10A is configured to be implanted within the capsular bag of a human eye, securely retain an intraocular lens (IOL), and is operable to displace at least a portion of the IOL along its optical axis by absorbing energy from a remote energy source (which is not part of device 10A and, as described in more detail below, may be selected from a variety of suitable energy sources, such as a number of laser sources, ultrasound sources, etc.).

[0038] FIG. 1A is a perspective view of device 10A in an open state with maximum displacement of the IOL-retaining portion along the optical axis (OA) / Z direction. FIG. 1B is a perspective view of device 10A in a closed state with zero displacement of the IOL-retaining portion along the optical axis / Z direction. FIGS. 1A1 and 1B1 are enlarged views of the functional portions of device 10A. FIGS. 1C and 1E are side views of device 10A in an open state with an IOL retained. FIG. 1D is a perspective view of device 10A in a closed state with an IOL retained. FIGS. 1F-1L illustrate examples of stepwise / gradual displacement of the IOL-retaining portion of device 10A along the axial direction Z.

[0039] Typically, device 10A is implanted within the ocular capsule in the closed state shown in Figures 1B and 1D. When correction of the IOL position is required, device 10A is actuated to move stepwise to one of the open states shown in Figures 1F-1K.

[0040] 1A, device 10A includes a first member 100A, a second member 200A, and a structure 300A connecting between the first and second members. In this non-limiting example, the device includes a locking mechanism 400A configured to control structure 300A (e.g., its three-dimensional shape), as described below.

[0041] The first member 100A is configured to be fixedly positioned within the capsular bag. The second member 200A is configured to fixably hold an IOL. In this example, the second member 200A includes a cavity 202A configured to receive the IOL.

[0042] In this and other embodiments below, the device follows a substantially circular shape, with the first member 100A substantially forming an outer ring and the second member 200A substantially forming an inner ring that resides inside the outer ring of the first member in the closed state of the device. However, it should be noted that the first and second members, or both, can each have other shapes, and in particular, can have open shapes rather than just closed shapes as in this embodiment. For example, the first member and / or the second member can be configured as an open shape (e.g., an open arc).

[0043] The devices of the present invention are typically implanted within the anatomical capsular compartment, retaining an IOL, or within the anatomical sulcus if the capsular bag is damaged or fractured. The implantation of the IOL into the human eye is typically supported by one or more haptics attached to the device that can secure the device and IOL to the implantation site. In some embodiments, the first member includes at least two integral haptics (not shown) on its exterior. In other embodiments, the first member includes at least two attachment portions (not shown) on its exterior configured to attach two corresponding haptics. These haptics can be tailored to the specific implantation anatomical site.

[0044] The dimensions of the device of the present invention are selected to allow secure retention of a lens, including a pre-fabricated lens, and to ensure safe implantation and effective displacement of the IOL after implantation. The device is configured to hold the IOL in a permanent position until the device is activated to displace the IOL.

[0045] The structure 300A and the locking mechanism 400A form a translation mechanism / assembly that is responsible for displacing the second member 200A and the IOL held thereby along / with respect to the Z direction relative to the first member 100A.

[0046] Structure 300A is a bendable structure having a first end (e.g., 300AF) fixedly / permanently attached to first member 100A and a second end (e.g., 300AS) fixedly / permanently attached to second member 200A. Bendable structure 300A is configured to be remotely controllably bent through various bending levels when the IOL is attached to the second member, thereby varying the position of the IOL's periphery along the IOL's optical axis.

[0047] In some embodiments, the bendable structure is made partially or entirely from a shape memory and / or superelastic material (e.g., nitinol, bimetal, described further below) and treated so that the default shape of the bendable structure is a fully open state, e.g., as shown in Figure 1A. The locking mechanism is operable to change the position and / or three-dimensional shape of the bendable structure between a fully closed state, e.g., as shown in Figure 1B, and a fully open state, e.g., as shown in Figure 1K.

[0048] The locking mechanism can be remotely controlled to lock or unlock one or more portions of the bendable structure to either the first or second member, thereby collapsing or extending at least a portion of the bendable structure along the Z direction, or displacing the second member relative to the first member, thereby changing the position of at least a portion / periphery of the IOL attached to the second member along the Z direction / IOL optical axis OA. In this non-limiting example, the locking mechanism 400A is remotely controlled to release one or more portions of the bendable structure 300A from the first member 100A, thereby extending at least a portion of the bendable structure 300A along the Z direction, and displacing the second member 200A relative to the first member 100A, thereby changing the position of at least a portion / periphery of the IOL attached to the second member along the Z direction / IOL optical axis OA.

[0049] In some embodiments, a locking mechanism is operable to at least partially lock or release one or more portions of the bendable structure to / from either the first member or the second member such that first and second planes defined by the first and second members, respectively, remain parallel therebetween and perpendicular to the IOL's optical axis while displacing the position of the IOL's periphery along the IOL's optical axis. In the described example, as shown in Figures 1A and 1C, for example, locking mechanism 400A is operable to release one or more portions of bendable structure 300A from first member 100A such that plane P1 defined by first member 100A and plane P2 defined by second member 200A remain parallel therebetween and perpendicular to the IOL's optical axis Z / OA while displacing the position of the IOL's periphery along the IOL's optical axis.

[0050] In some embodiments, the locking mechanism is operable to at least partially lock or release one or more portions of the bendable structure relative to / from either the first member or the second member such that a first plane defined by the first member is tilted relative to a second plane defined by the second member while displacing the position of the IOL's periphery along the IOL's optical axis. This is shown, for example, in FIG. 1E, where planes P1 and P2 are tilted relative to each other. This can be achieved, for example, by asymmetrically actuating different portions of the locking mechanism, as further shown in FIG. 1L. It will be understood that the device can be configured to be tiltable in the X and / or Y directions.

[0051] In some embodiments, the bendable structure includes a plurality of elongated bendable members, each having a first end permanently / fixedly attached to a first member and a second end permanently / fixedly attached to a second member. In this non-limiting example, the bendable structure includes four elongated bendable members 300A1-300A4 distributed around the circular circumference of the first and second members, with each elongated bendable member permanently connected to the first member at its first end and to the second member at its second end, as shown. Also as shown, each elongated bendable member is a continuous, single element.

[0052] In some embodiments, the locking mechanism includes a plurality of remotely controllable lockers, each configured to lock / release a portion of the bendable structure to either the first member or the second member. This is illustrated in this example, where locking mechanism 400A includes 28 individually controllable lockers, such as lockers 400A1 and 400A2 shown in FIG. 1A1. More information regarding lockers is provided below.

[0053] In some embodiments, the locking mechanism includes at least two remotely controllable groups of lockers, and each bendable structure includes at least two elongated, bendable members. In this non-limiting example, there are four groups of lockers 400AA-400AD and four elongated, bendable members 300A1-300A4 (illustrated in FIG. 1K). Each controllable group of lockers includes an array of seven individual lockers operable to lock or release a respective elongated, bendable member relative to / from first member 100A. Individual lockers in the locker array lock respective portions of the elongated, bendable members and are sequentially actuated to release respective portions of the elongated, bendable members. For example, when lockers 400A1, 400A2, and 400A3 shown in FIG. 1B1 are actuated in that order, they release respective portions of elongated, bendable member 300A1, resulting in the open configuration shown in FIG. 1A1.

[0054] Symmetric actuation of individual controllable rockers in different controllable rocker groups changes the position of the IOL's periphery perpendicular to the IOL's optical axis. This is illustrated in Figures 1F-1K. For example, as shown in Figure 1F, the first rocker in each of the four rocker arrays is actuated to release the first portion of its respective elongated member. As shown in Figure 1G, the second rocker in each group is actuated to release the second portion of its respective elongated member. In Figures 1H-1K, the third, fourth, fifth, and sixth rockers in each group are actuated to release the third, fourth, fifth, and sixth portions of their respective elongated members. The size, spacing, and number of rockers all affect the displacement distance along the IOL's optical axis for a given length and default shape of the elongated, bendable member. Thus, it is understood that maintaining a constant distance between adjacent rockers results in a constant displacement distance, while varying the distance between rockers within an array will result in a change in displacement distance. This is true for all embodiments herein that employ locking mechanisms in the form of one or more rocker arrays.

[0055] On the other hand, asymmetric actuation of individual controllable rockers in different groups of controllable rockers will result in a tilted position of the IOL's periphery relative to the optical axis of the IOL. This is the case, for example, as shown in Figure 1L, where groups 400AB and 400AC are actuated one more time than groups 400AA and 400AD. Control of the tilt angle can be achieved, for example, based on the size, spacing, and number of rockers for a given length and default shape of the elongated bendable member.

[0056] It is understood that the device, bendable structure, and locking mechanism can be designed to allow the second member and its attached IOL to be displaced only in the anterior direction (toward the cornea), only in the posterior direction (toward the retina), or in both directions.

[0057] In accordance with the present invention, displacement of the IOL occurs remotely upon exposure of one or more actuatable portions of the device to energy from an external energy source.

[0058] In some embodiments, the locking mechanism (particularly the controllable locker) is made from a shape memory material (e.g., nitinol, as described below) that has been treated so that at body temperature, the rocker is in a closed state that locks the portions of the bendable structure, and when heated to a predetermined temperature by absorbing energy from a remote energy source, the rocker transitions to an open state that releases the portions of the bendable structure. Two spatial configurations of the rocker are shown in Figure 1B1, showing the closed, locked state, and in Figure 1A1, showing the open, unlocked state.

[0059] As mentioned above, the bendable structure and / or locking mechanism may comprise a shape memory / superelastic material that allows the device, or a major portion thereof, to become collapsible when a certain amount of external force is applied and to return to its original shape without deformation when the external force is removed.

[0060] In some embodiments, the shape memory material is a specially engineered Nitinol (nickel-titanium alloy) selected for its biocompatibility and design flexibility, hi some embodiments, the superelastic material is a specially engineered Nitinol or bimetal.

[0061] Nitinol can be engineered to act as a superelastic material over a specific temperature range and as a shape-memory material over a specific temperature range. Typically, Nitinol is engineered to change structure from martensite to austenite over a gradient of several degrees Celsius. The temperature gradient and phase transformation temperature can be programmed to meet specific requirements. For example, Nitinol alloys can be engineered to remain plastic in the martensite phase up to approximately 40°C (close to body temperature) and be molded into desired shapes when an external force is applied, such as to form bendable structures. However, increasing the temperature to approximately 60°C triggers a phase transition to the austenite phase, allowing Nitinol to "memorize" a shape (deform) even under a constant external force, such as opening and unlocking a locking mechanism. When the temperature returns to approximately 40°C, Nitinol returns to its soft state and can be reshaped as desired, allowing the locking mechanism to close and lock. The bendable structure, first member, second member, and locking mechanism can be designed to be superelastic at room temperature and near body temperature so that the device can bend while inserted into the capsular bag. For example, the device can be designed to be approximately 2.54 mm 2 (corresponding to a circle with a diameter of 1.8 mm, but the cross section can be elliptical).

[0062] The remote energy source is configured and operable to provide activation energy to multiple lockers of the locking mechanism. Typically, each locker is activated individually. In some embodiments, the remote energy source requires a direct / uninterrupted line of sight / path between the remote energy source and the locker being remotely activated, while in other embodiments, this is not required and activation can be achieved without a direct line of sight. In some embodiments, the remote energy source is configured and operable to provide activation energy in the form of heat. This is particularly important when the actuators are made of Nitinol, as described above. In some embodiments, the remote energy source includes at least one radiating element operable to heat the locker by irradiating it. In some embodiments, the remote energy source includes an electromagnetic radiation transmitter, and the multiple 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 light in the green spectrum (a so-called argon laser). In some embodiments, the laser source is configured and operable to generate a laser having a laser power of 0.1 to 5 watts and a laser pulse width of 200 to 1000 ms.

[0063] 2A-2E, another non-limiting example of a device 10B incorporating features of the present invention is shown. As can be seen, device 10A is configured to displace an IOL unidirectionally along the Z / OA direction. In contrast, as will be described below, device 10B is configured to displace an IOL bidirectionally along the Z / OA direction.

[0064] FIG. 2A is a top perspective view of device 10B in a closed state with an IOL attached and ready for implantation into the ocular capsule, FIGS. 2B-2C are diagrams showing two-stage displacement of the IOL along one Z / OA direction, and FIGS. 2D-2E are diagrams showing two-stage displacement of the IOL along the opposite Z / OA direction.

[0065] 2A, device 10B includes a first member 100B configured to be fixedly positioned within the capsular bag, a second member 200B including a cavity 202B configured to fixably hold an IOL, and a bendable structure 300B connecting between the first and second members. Device 10B also includes a locking mechanism 400B configured to control structure 300B, as described below.

[0066] Bendable structure 300B includes two branches 300BA and 300BB that are responsible for displacing the second member and the IOL in opposite Z directions. The first bendable structure branch 300BA includes two first elongated bendable members 300BA1 and 300BA2 that are responsible for displacing the IOL in a first Z direction, and the second bendable structure branch 300BB includes two second elongated bendable members 300BB1 and 300BB2 that are responsible for displacing the IOL in a second, opposite Z direction. Movement in the +Z and -Z directions is governed by the free, unlocked, and default shapes of the associated bendable members.

[0067] Locking mechanism 400B includes two rocker array branches 400BA and 400BB associated with two bendable structure branches 300BA and 300BB, respectively. Rocker array branch 400BA is attached to inner member 200B, and rocker array branch 400BB is attached to outer member 100B. Each rocker array branch includes two rocker arrays associated with the two elongated, bendable members of each bendable structure branch. Each of the two rocker arrays of a rocker array branch includes five individually controllable rockers. Note that there can be a different number of rockers in each rocker array based on specific applications and needs. As shown in FIGS. 2B and 2B1, for example, the first rocker in rocker array 400BB1 is actuated by remote energy to release elongated, bendable member 300BB1. Simultaneously, not shown, a first rocker of rocker array 400BB2 is actuated by remote source energy to release elongated bendable member 300BB2 to keep the first and second members parallel and perpendicular to the OA direction, thus displacing the second member and IOL in the +Z direction.

[0068] FIG. 2C illustrates a second actuation of subsequent rockers in arrays 400BB1 and 400BB2, causing a second step displacement in the +Z direction by further releasing another portion of elongated bendable members 300BB1 and 300BB2.

[0069] 2D, 2D1 and 2E show two successive step displacements of the second member and IOL in the −Z direction, where the rockers of rocker arrays 400BA1 and 400BA2 are actuated to release elongated bendable members 300BA1 and 300BA2, respectively.

[0070] It will be appreciated that device 10B allows for reversible displacement of the IOL. In other words, if a particular Z-direction displacement is too large, the displacement direction can be reversed and corrected in the opposite direction. For example, if rocker arrays 400BB1 and 400BB2 are actuated to displace the IOL x steps in the +Z direction, and a correction of (x-1) steps in the +Z direction is required, rocker arrays 400BA1 and 400BA2 can be actuated to displace the IOL one step in the -Z direction, resulting in an overall displacement of (x-1) steps in the +Z direction.

[0071] All features described with respect to device 10A are also applicable with respect to device 10B, unless specifically described otherwise. For example, asymmetric actuation of the rockers of rocker arrays 400BA1 and 400BA2 results in tilted displacement of the IOL along the IOL optical axis.

[0072] 2AA-2AD, another non-limiting example of a device 10X incorporating features of the present invention is shown. As will be appreciated, like device 10B, device 10X is configured to bidirectionally displace an IOL along the Z / OA directions, as described below.

[0073] Figure 2AA is a top perspective view of device 10X in a closed state with an IOL attached and ready for implantation into the ocular capsule, Figures 2AB-2AC show displacement of the IOL along the first and second (opposite) Z / OA directions, respectively, and Figure 2AD shows additional features of the device of the present invention exemplified in device 10X.

[0074] 2AA, device 10X includes a first (outer) member 100X configured to be fixedly positioned within the capsular bag, a second (inner) member 200X including a cavity 202X configured to fixably hold an IOL, and a bendable structure 300X connecting between the first and second members. Device 10X also includes a locking mechanism 400X configured to control structure 300X, as described below.

[0075] 2AB and 2AC, bendable structure 300X includes two branches 300XA and 300XB responsible for displacing the second member and the IOL in opposite Z directions. First bendable structure branch 300XA includes two first elongated bendable members 300XA1 and 300XA2 responsible for displacing the IOL in a first Z direction, and second bendable structure branch 300XB includes two second elongated bendable members 300XB1 and 300XB2 responsible for displacing the IOL in a second, opposite Z direction. Movement in the +Z and −Z directions is governed by the free, unlocked, and default shapes of the associated bendable members.

[0076] Locking mechanism 400X includes two rocker array branches 400XA and 400XB associated with two bendable structure branches 300XA and 300XB, respectively. Rocker array branch 400XA is attached to outer member 100X, and rocker array branch 400XB is attached to inner member 200X. Each rocker array branch includes two rocker arrays associated with the two elongated bendable members of each bendable structure branch. For example, rocker array branch 400XB includes two rocker arrays 400XB1 and 400XB2 associated with the two elongated bendable members 300XB1 and 300XB2 of bendable structure branch 300XB. Each of the two rocker arrays of a rocker array branch includes, in this non-limiting example, five individually controllable rockers. Note that there can be a different number of rockers in each rocker array based on specific applications and needs. It is also understood that the magnitude of the step (displacement) is equal or different when the spacing between the rockers is equal or different. As described above, to keep the first member 100X and the second member 200X parallel and perpendicular to the OA direction, the same number of rockers in two rocker arrays belonging to the same rocker array branch are actuated by a remote energy source, and the elongated bendable members of the same bendable structure branch are symmetrically released. When the rockers are actuated in this manner, the inner member moves incrementally in the +Z or -Z direction with each actuation of an individual rocker. At the same time, it is understood that asymmetric actuation of rockers belonging to the same rocker array branch will cause tilting of the inner member 200X relative to the outer member 100X. It is also understood that asymmetric or symmetric actuation of rockers belonging to two rocker array branches (e.g., the first rockers in each array) will cause tilting of the inner member 200X relative to the outer member 100X.

[0077] It is understood that device 10X allows for reversible displacement of the IOL. In other words, if a particular Z-direction displacement is too large, the direction of displacement can be reversed and corrected in the opposite direction. For example, if rocker arrays 400XA1 and 400XA2 are actuated to displace the IOL x steps in the +Z direction, and a correction of (x-2) steps in the +Z direction is required, rocker arrays 400XB1 and 400XB2 can be actuated to displace the IOL 2 steps in the -Z direction, resulting in an overall displacement of (x-2) steps in the +Z direction.

[0078] FIG. 2AD illustrates two additional features of device 10X that can be implemented in all devices of the present invention. Close-up view AD1 shows locker 400XBA. Locker 400XBA includes a back portion 400XBB configured to mechanically connect to inner member 200X in a reversible manner, allowing for mechanical attachment and detachment of the locker. In this non-limiting example, the locker includes two protrusions / legs 400XBL that can be bent and inserted into corresponding recesses 200XD formed in the inner member. Upon bending and insertion, these legs return to their default shape and are securely locked into the recesses at corresponding locking points. In other words, the locker is attached using a clip mechanism. For example, as described above, the locker legs can be made from flexible nitinol (e.g., nitinol in the martensitic phase at an appropriate temperature range, including room temperature and body temperature). It is understood that other non-permanent attachment mechanisms are also possible, such as those based on male-female attachments. In comparison to other attachment mechanisms applicable in some embodiments herein, specifically permanent mechanisms such as welding, laser welding, adhesives, soldering, or combinations thereof, this mechanical attachment provides reliable, precise, repeatable, and controllable positioning and alignment of the rocker. Because the legs (albeit made of Nitinol) are fixed in the recesses, it will be appreciated that only the front portion 400XBF of the rocker is actuated by an external energy source to deform and release the associated portion of the bendable member.

[0079] Another feature is also shown in Figure AD1. The inner or outer member and bendable member associated with each rocker array are shaped with corresponding grooves and protrusions (or valleys and hills). Each protrusion on the outer / inner member aligns with a corresponding groove on the bendable member. In this example, the inner member 200X and bendable member 300XB1 associated with rocker array 400XB1 are shaped with corresponding grooves and protrusions. As shown in close-up view AD2, the front portion 400XAF of each locker in rocker array 400XA1 aligns with a protrusion formed on bendable member 300XA1 and a corresponding groove formed on outer member 100X when in the closed, locked state. In the open, unlocked state, the front portion of the locker aligns with a protrusion on the inner or outer member, as applicable. This specific shape and alignment allows for secure locking of the bendable member by the rocker, given the compactness of the rocker and bendable member, thereby enabling the manufacture of compact devices of the present invention while maximizing their functionality. Additionally, the movement required between the locked and unlocked states of the locker can be minimized, optimizing energy usage and shape memory material usage.

[0080] Other features described with respect to devices 10A and 10B are also applicable with respect to device 10X, although not specifically described.

[0081] 3A-3C, another non-limiting example of a device 10C incorporating features of the present invention is shown: Fig. 3A is a front view of device 10C, Fig. 3A1 is an enlarged view of a portion of device 10C, Fig. 3B is a diagram showing device 10C holding an IOL with zero Z-direction displacement, and Fig. 3C is a diagram showing device 10C holding an IOL with Z-direction displacement.

[0082] As shown in Figures 3A and 3A1, device 10C includes a first member 100C configured to be fixedly positioned within the lens capsule, a second member 200C configured to hold an IOL, and a bendable structure 300C (Figure 3C) interconnected between the first and second members.

[0083] In this non-limiting example, displacement of the IOL's periphery along the z-direction is achieved by locking mechanism 400C, which, when rotated clockwise or counterclockwise, releases or locks bendable structure 300C, using the rotational movement of locking mechanism 400C to at least partially release or lock the bendable structure relative to first member 100C.

[0084] Specifically, as shown, the locking mechanism 400C includes a third member 402C adjacent to (specifically, on top of) the first member 100C, with the bendable structure 300C sandwiched / enclosed between the first and third members. The locking mechanism 400C includes one or more lockers (e.g., 400C1 and 400C2) that lock or release one or more portions of the bendable structure, such as the elongated bendable members 300C1 and 300C2, as the third member 402C rotates relative to the first member 100C, thereby changing the position of the IOL periphery along the Z / OA direction. As shown, the lockers 400C1 and 400C2 can be configured as localized protrusions along the inner circumference of the third member 402C.

[0085] Figure 3B shows an initial closed state in which the bendable structure is locked to the first member, while Figure 3C shows counterclockwise rotation of the third member 402C and rockers 400C1 and 400C2, gradually releasing the elongated bendable members 300C1 and 300C2, respectively. It will be appreciated that clockwise rotation of the rockers 400C1 and 400C2 gradually relocks the elongated bendable members 300C1 and 300C2 to the first member, thereby reducing peripheral displacement of the IOL along the optical axis. It will also be appreciated that this example illustrates symmetric displacement of the IOL, such that the IOL remains perpendicular to the optical axis without tilt.

[0086] Rotation of the third member 402C carrying the lockers 400C1 and 400C2 is achieved with the aid of a rotation mechanism 450C that is included in the locking mechanism and remotely controllable by a remote energy source. As shown in Figures 3A and 3A1, the rotation mechanism 450C includes two rotation sub-mechanisms: a first sub-mechanism 450C1 that rotates the third member 402C counterclockwise, and a second sub-mechanism 450C2 that rotates the third member 402C clockwise.

[0087] Rotation mechanism 450C can be implemented in a variety of ways. In this non-limiting example, rotation mechanism includes an actuator, such as 452C1 of sub-mechanism 450C1, fixedly connected to third member 402C, configured to be remotely actuated by a remote energy source to engage interaction region 454C1 fixedly connected to first member 100C, which engagement causes rotational movement of third member 402C.

[0088] For example, as shown, the interaction region 454C1 includes a series of teeth / ridges and valleys with which the actuator 452C1 interacts. The interaction region can extend over a predetermined distance defined by the length of the elongated, bendable member. The size of the teeth also defines the step size of the rotational movement that occurs and the corresponding release or lock portion of the bendable structure. More specifically, the actuator 452C1 is made from a shape-memory material (e.g., Nitinol) and is configured such that, upon heating with energy absorbed from a remote energy source, it moves from a disengaged position to an engaged position, causing the actuator to push against the teeth of the interaction region and rotate the third member 402C. A similar configuration of a rotation mechanism is described in commonly assigned WO2018229766A1.

[0089] It will be appreciated that the above-described rotation mechanism(s) can be incorporated into any of the above-described devices in addition to the bendable structure to allow for independent displacement of the IOL along the θ direction, i.e., to allow for rotation of the IOL about the optical axis, so as to obtain two independent displacements both along and about the optical axis.

[0090] 4A-4C, another non-limiting example of a device 10D incorporating features of the present invention is shown: Figure 4A is a front view of device 10D, Figure 4A1 is a close-up view of the bendable structure of device 10D, Figure 4B is a diagram illustrating tilt of the IOL about a first axis, and Figure 4C is a diagram illustrating tilt of the IOL about a first second axis.

[0091] This device 10D shows a pure tilt mechanism, however it will be appreciated that it can also be integrated with any of the Z-displacement mechanisms described above.

[0092] As shown in FIG. 4A, device 10D includes a first member 100D configured to be fixedly positioned within the lens capsule, a second member 200D including a cavity 202D configured to hold an IOL, and a bendable structure 300D connecting between the first and second members.

[0093] The bendable structure 300D includes a plurality of elongated bendable members, specifically two bendable members 300DY1 and 300DY2, each having a first end (300DFE in FIG. 4A1 ) permanently / fixedly attached to the first member 100D and a second end 300DSE permanently / fixedly attached to the second member 200D (specifically, the first portion 200D1 of the second member). The pair of two flexure members 300DY1, 300DY2 are positioned on opposite sides of the second member and, when worn, the IOL. Each bendable member can twist about its longitudinal axis. As shown, in a default initial configuration, in the absence of Z-axis displacement at the IOL's periphery, each bendable member is preloaded by twisting about its longitudinal axis. The bendable members are at least partially made of a shape-memory material that can be controlled to change shape upon absorbing energy from a remote energy source. A first bendable member (e.g., 300DY1) can apply a fixed amount of twist in a clockwise direction, and with each actuation, one twist is released, which then translates into a defined degree of tilt of the IOL in a counterclockwise direction. A second bendable member 300DY2 can apply a fixed amount of twist in a counterclockwise direction, and with each actuation, one twist is released, which then translates into a defined degree of tilt of the IOL in a clockwise direction. This is shown in Figure 4B. Figure 4B1 includes two bendable members 300DY1, 300DY2, which allow rotation of a single second member 200D about one axis S1.

[0094] In some embodiments, such as this non-limiting example, the second member includes two portions that are rotatable relative to one another, thereby adding another dimension of tilt direction for the IOL. As shown in FIG. 4C, the second member 200D includes a first portion 200D1 that is rotatable in the S1 direction using a first pair of bendable members 300DY1, 300DY2, and a second portion 200D2 that is rotatable in the S2 direction using a second pair of bendable members 300DX1, 300DX2.

[0095] In some embodiments, devices of the invention, such as those described above, are housed within a housing that helps protect and shield the moving and functional parts of the device, such as the flexible structures and locking mechanisms, preventing the risk of clogging or immobilization due to their interaction with the physiological medium within the body (e.g., the ocular capsule that receives the device holding the IOL).

[0096] Referring to FIGS. 5A-5B, a first non-limiting example of a device 20 incorporating features of the present invention is shown. As shown, device 20 includes a housing / cover / shell 200 that is transparent to incident light, at least on sides / surfaces 210A and 210B that interfere with the optical path of light entering the eye, and that is intended to house and protect any of the devices described above. Specifically, device 20 protects the moving and functional parts of the devices, such as bendable structures and locking mechanisms, to prevent the risk of jamming or immobilization due to interaction of the moving and functional parts with the physiological medium in the body. In this non-limiting example, device 20 is shown with device 10B encapsulated within housing 200, as shown in FIG. 5B, with a portion of device 20 removed. The illustrated device 20 also includes two peripheral haptics 220 that aid in implantation of device 20 with encapsulated device 10B within the ocular capsule. It is understood that device 20 can be configured as an enclosed device and can be configured in a variety of ways.

[0097] Referring to Figures 5C-5D, second and third non-limiting examples of devices 30A and 30B incorporating features of the present invention are shown. As shown in Figure 5C, device 30A includes a housing 310A having walls 310A1 and 310A2 extending along axis Z above and below device 10B, and having no transparent surfaces / covers that would interfere with the optical path of light entering the eye. As shown in Figure 5D, device 30B includes a housing 310B having walls 310B1 and 310B2 extending along axis Z above and below device 10B, and having no transparent surfaces / covers that would interfere with the optical path of light entering the eye. Specifically, devices 30A and 30B protect the moving and functional parts of the devices (e.g., the bendable structures and locking mechanisms) described above and prevent the ocular capsule wall from collapsing onto the moving and functional parts of device 10B, thereby preventing the risk of jamming or immobilization of the moving and functional parts. In the specific example of FIG. 5D , device walls 310B1 and 310B2 are configured with a wave-like structure (e.g., hills 310BH and valleys 310BV) that facilitates device 30B's flexibility and insertion into the ocular capsule through the smallest possible slit in the eyeball wall. Device 30B has three hills (protrusions) and three valleys on each wall. Each hill on wall 310B1 faces a valley on wall 310B2. In these non-limiting examples, devices 30A and 30B include two peripheral haptics 320A and 320B, respectively, that assist in implanting devices 30A and 30B with enclosed device 10B within the ocular capsule. It is understood that devices 30A and 30B can be tailored as sealed devices and can be configured in a variety of ways.

[0098] It can thus be seen that the present invention provides a powerful technique for controllably and precisely remotely displacing an IOL along its optical axis after it has been implanted in order to adjust its position and function properly.

Claims

1. 1. A device configured for implantation within a capsular bag of a human eye, the device securely retaining an intraocular lens (IOL) and operable to displace the IOL relative to an optical axis of the IOL, the device comprising: a first member configured to be fixedly positioned within the lens capsule; a second member to which the IOL can be fixedly attached; a bendable structure attached at a first end to the first member and at a second end to the second member, the bendable structure configured to be remotely controllably bent at various bending levels when the IOL is attached to the second member to displace the position of a peripheral portion of the IOL along an optical axis of the IOL.

2. 10. The device of claim 1, wherein the device includes a locking mechanism that is remotely controllable and operable to at least partially lock or release one or more portions of the bendable structure relative to / from either the first member or the second member to displace the position of a peripheral portion of the IOL along the optical axis of the IOL when the IOL is attached to the second member.

3. 3. The device of claim 2, wherein the locking mechanism is operable to at least partially lock or release one or more portions of the bendable structure to / from either the first member or the second member so that first and second planes defined by the first and second members, respectively, remain parallel therebetween and perpendicular to the optical axis of the IOL while displacing the position of the peripheral portion of the IOL along the optical axis of the IOL.

4. 3. The device of claim 2, wherein the locking mechanism is operable to at least partially lock or release one or more portions of the bendable structure relative to / from either the first member or the second member such that a first plane defined by the first member is tilted relative to a second plane defined by the second member while displacing a position of a peripheral portion of the IOL along the optical axis of the IOL.

5. 3. The device of claim 2, wherein the locking mechanism includes a plurality of remotely controllable rockers, each configured to lock or release a portion of the bendable structure to either the first member or the second member.

6. 10. The device of claim 1, wherein the bendable structure includes a plurality of elongated bendable members, each having a first end permanently attached to the first member and a second end permanently attached to the second member.

7. 3. The device of claim 2, wherein the locking mechanism includes at least two groups of remotely controllable rockers, the bendable structure each including at least two elongated, bendable members, each of the groups of controllable rockers operable to lock or release a respective elongated, bendable member to / from either the first member or the second member, and each of the groups of controllable rockers including a plurality of controllable rockers arranged in a rocker array, wherein sequential actuation of rockers in the rocker array locks or releases respective portions of the elongated, bendable members.

8. 8. The device of claim 7, wherein symmetric actuation of individual controllable rockers from different groups of controllable rockers displaces the position of the periphery of the IOL perpendicular to the optical axis of the IOL.

9. 8. The device of claim 7, wherein asymmetric actuation of individual controllable rockers from different controllable rocker groups results in a displacement of the peripheral edge of the IOL in an oblique direction relative to the optical axis of the IOL.

10. 3. The device of claim 2, wherein the locking mechanism comprises a third member adjacent to the first member, the bendable structure being sandwiched between the first and third members, and wherein rotating the third member relative to the first member locks or releases one or more portions of the bendable structure relative to the first member, thereby changing the position of the periphery of the IOL along the optical axis of the IOL.

11. 2. The device of claim 1, wherein the bendable structure comprises a plurality of elongated, bendable members, at least some of which have first ends permanently attached to the first member and at least some of which have second ends permanently attached to the second member, each of the plurality of elongated, bendable members being twistable about its longitudinal axis, the elongated, bendable members being arranged in one or more pairs with two elongated, bendable members of the pair positioned on opposite sides of the second member, and the degree of twisting of the two elongated, bendable members of the pair being remotely controlled to tilt the IOL about an axis passing through the two elongated, bendable members of the pair when attached to the second member.

12. The device of claim 1 , wherein the device is configured and operable to displace the IOL at least one of anteriorly and posteriorly relative to the first member when attached to the second member.

13. The device of claim 1 , wherein the device is configured and operable to at least partially reversibly displace the IOL when attached to the second member.

14. 3. The device of claim 2, wherein the bendable structure is made from a shape memory material that has been treated so that the default shape of the bendable structure is a fully open state, and the locking mechanism is operable to change the position of the bendable structure between a fully closed state and a fully open state.

15. 6. The device of claim 5, wherein each of the controllable rockers is made from a shape memory material that has been treated so that at body temperature the rocker is in a closed state in which it locks the respective portions of the bendable structure, and when heated to a predetermined temperature by absorbing energy from a remote energy source, the rocker transitions to an open state in which it releases the respective portions of the bendable structure.

16. 12. The device of claim 11, wherein the bendable structure is made from a shape memory material that has been treated so that at body temperature the default shape of each elongated bendable member is in a fully twisted state, and when heated to a predetermined temperature by absorbing energy from a remote energy source, the elongated bendable member transitions to a less twisted state.

17. 17. The device of claim 14, 15 or 16, wherein the shape memory material comprises nitinol.

18. The device is approximately 2.54 mm ２ 10. The device of claim 1, wherein the device is foldable so that it can be passed through a cross section having a circular diameter of about 1.8 mm or less.

19. 6. The device of claim 5, wherein the rocker is configured to be attachable to a corresponding location on the first or second member mechanically, by laser welding or adhesive, or a combination thereof.

20. 20. The device of claim 19, wherein the rocker is reversibly mechanically attachable to the first or second member by a clip or male-female setup.

21. 12. The device of claim 11, wherein the bendable member has a series of grooves and protrusions on a side thereof facing the first or second member that mate with a series of protrusions and grooves on an opposite side of the first or second member, and the locking mechanism comprises a plurality of remotely controllable rockers, each rocker configured to lock and release a portion of the bendable member to / from the first or second member, the rockers aligning with the protrusions of the bendable member in a locked state and aligning with the protrusions of the first or second member in an unlocked state.

22. 1. An IOL adjustment system, comprising: A device according to any one of claims 1 to 21; a remote energy source configured and operable to provide energy to heat one or more portions of the device.

23. 23. The system of claim 22, wherein the remote energy source comprises a radiating element.

24. The system of claim 22 , wherein the remote energy source comprises a laser source.

25. 25. The system of claim 24, wherein the laser source is configured and operable to provide continuous laser radiation.

26. 26. The system of claim 25, wherein the laser source is configured as an argon laser source operable to provide light in the green spectrum.

27. 25. The system of claim 24, wherein the laser source is configured and operable to provide a laser power of 0.1 to 5 watts and a laser pulse width of 200 to 1000 ms.

28. 23. The system of claim 22, wherein the remote energy source includes an electromagnetic radiation transmitter and one or more portions of the device include a respective electromagnetic radiation receiver.

Images