WO2019022608A1 - Accommodating intraocular lens with free form optical surfaces - Google Patents

Accommodating intraocular lens with free form optical surfaces Download PDF

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Publication number
WO2019022608A1
WO2019022608A1 PCT/NL2018/050524 NL2018050524W WO2019022608A1 WO 2019022608 A1 WO2019022608 A1 WO 2019022608A1 NL 2018050524 W NL2018050524 W NL 2018050524W WO 2019022608 A1 WO2019022608 A1 WO 2019022608A1
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WO
WIPO (PCT)
Prior art keywords
optical
lens construction
construction according
eye
lens
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PCT/NL2018/050524
Other languages
French (fr)
Inventor
Michiel Christiaan Rombach
Original Assignee
Akkolens International B.V.
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Publication of WO2019022608A1 publication Critical patent/WO2019022608A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • A61F2/1632—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing radial position, i.e. perpendicularly to the visual axis when implanted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1637—Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
    • A61F2/164—Aspheric lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1648—Multipart lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1602—Corrective lenses for use in addition to the natural lenses of the eyes or for pseudo-phakic eyes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1602—Corrective lenses for use in addition to the natural lenses of the eyes or for pseudo-phakic eyes
    • A61F2/1605—Anterior chamber lenses for use in addition to the natural lenses of the eyes, e.g. iris fixated, iris floating

Definitions

  • the invention relates to an accommodating intraocular lens. More in particular it relates to such a lens with at least two optical elements of which at least one element is adapted to move in at least one direction with optical surfaces providing variation of defocus aberration with the optical elements comprising at least one set of at least two free-form optical surfaces shaped according to a Zernike polynomial which order exceeds third order Zernike polynomials.
  • AIOL accommodating intraocular lens construction
  • Such an AIOL has an optical axis with the construction comprising at least two optical elements of which at least one element is adapted to move in at least one direction, for example, shifts in a direction substantially perpendicular to the optical axis.
  • the optical surfaces provide variation of at least one optical aberration of the lens with a degree of variation which is dependent on the degree of translation of the at least one of the optical elements.
  • Such accommodating AIOL's are well known from other documents, for example from NL-2012133, NL-201242, EP1871299, EP1932492. Designs of such AIOLs, and clinical results are disclosed in, Alio et al ,Am. J. Ophthamol. 2016 Apr, 164: 37-48.
  • AIOLs are restricted to the concept which include at least two cubic optical surfaces, that are optical surfaces including Zernike third order surfaces, of which the basic, free-form, non-rotational symmetric, shapes are known from Alvarez US-3305294, which provides the original concept for a variable lens, for laterally shifting optical elements, and Baker CA-1252655, for derived fan-like rotational shifting optical elements.
  • Alvarez US-3305294 which provides the original concept for a variable lens, for laterally shifting optical elements
  • Baker CA-1252655 for derived fan-like rotational shifting optical elements.
  • optical surfaces disclosed in the present document comprise at least one set of at least two free-form, meaning: rotational asymmetrical, optical surfaces with these surfaces shaped according to a Zernike polynomial which order exceeds third order Zernike polynomial (as in said Alvarez US33052294) with at least one such surface fitted to each optical element.
  • One of the present preferred embodiments comprises for example four surfaces each fitted with a fourth order polynomial surface with each element of the lens fitted with two such surfaces, one surface fitted to each side of the element.
  • Said optical surfaces can include at least one optical shape according to a polynomial of the fourth degree, for example, in the most basic form, without any additional terms: " ⁇ ⁇ ° ⁇ A ' - ⁇ ⁇ + x ⁇ with z being the sag of the optical surface, with x and y the values of X,Y coordinates presenting the plane perpendicular to the optical axis, the Z coordinate, and with A being a constant.
  • Said optical surfaces shaped according to a Zernike polynomial which order exceeds third order Zernike polynomial which set provides variable focus, defocus can be combined with additional sets of optical surfaces of any Zernike order to variably correct for any other optical aberration, for example, for variable optical cylinder, for variable optical coma or for variable optical aspherical aberration, lens fitted with two such surfaces, one surface fitted to each side of the element.
  • Said optical surfaces can include at least one optical shape according to a polynomial of the fourth degree, for example, in the most
  • Such lenses can also provide, by movement of at least one of the optical elements, a variable extension of accommodation, and/or variable focus, and/or variable spherical aberration.
  • Such movement can be achieved, but not restricted to, principles as disclosed in US-2009062912 and WO-2005084587, and the same concept, with various adaptations in, for example, US-2014074233, WO- 2014058316, EP-2765952, NL-2012257278, US-2010131955, US-2010106245, NL-1029548 and references made therein and related documents, which principles have been shown to function when fitted to an accommodating intraocular lens in the human eye.
  • such lenses can incorporate at least two optical elements with each element with at least one optical surface with an optical shape according to a polynomial of the fourth degree.
  • Said optical surfaces can be distributed over any combination of anterior sides and posterior sides of said optical elements in an arrangement to provide a third degree optical function, also: a third degree wavefront, which is a configuration not foreseen by any prior art.
  • the optics of the lens construction for example, the set of fourth order optical surfaces, can be adapted to provide correction for accommodation, meaning:
  • the translation of at least one of the optical elements is a shift, meaning: sliding, of the element in a direction perpendicular to the optical axis, as set forth in, for example WO2005084587, or, alternatively, a partial rotation in a plane
  • the lens construction can comprise at least one anchoring haptic, meaning: a mechanical component adapted to provide positioning and anchoring of the optical elements in the anterior chamber or the posterior chamber of the eye.
  • haptics are included in almost every intraocular lens, ⁇ 01_', which haptics can be for example plate haptics or C-loops for monofocal lOLs and multifocal lOLs, which are lOLs which do not require any movement in the eye.
  • Examples of haptics translating a component of the IOL, AIOL are the elastic loops as in WO- 2005084587.
  • the present lens construction should comprise at least one translation haptic, meaning: a mechanical component adapted to provide, by coupling to translation of at least one optical element by transfer of movement of at least one component in the eye, a component preferably related to accommodation, to at least one of the optical elements.
  • the construction can comprises at least one haptic coupled to a natural component of the eye which component is the ciliary mass of the eye, as in WO-2005084587, or, alternatively, at least one haptic is coupled to a natural component of the eye which component is the capsular bag of the eye, or, alternatively, at least one haptic is coupled to a natural component of the eye which component is the zonula network of the eye, or, alternatively, at least one haptic is coupled to a natural component of the eye which component is the iris of the eye as in WO-2007027091 , or, alternatively, at least one haptic is adapted to translate at least one of the optical elements by liquid pressure generated in the posterior chamber of the eye, as in, for example, HK-1066160, or, alternatively, an flexible optical element which changes shape by infusion of liquids from containers coupled to the optical element, as in for example US-201 1282443, or, alternatively, any combination of means of translation including but not restricted to the examples cited
  • At least one haptic of the present invention can be coupled to a MEMS, meaning: micro-electro-mechanical system, which MEMS is adapted to provide movement of at least one optical element.
  • Such movement can adjust at least one of the elements to a fixed position, fixed endpoint, for example, a fixed resting position to adjust emmetropia of the eye, or, alternatively, set fixed positions for the range of accommodation, or, alternatively, provide leverage for accommodative power driven by ciliary muscle contractions or by external signals, for example signals from a smartphone.
  • the phone can have three buttons marked 'far vision', 'intermediate vision' and 'reading'.
  • the accommodation could also be driven by signals from brain waves of the wearer of the lens which sounds farfetched, but which concept is well known to a man skilled in the art.
  • the power for such MEMS can be supplied by an electric power generator, being a combination of at least one micro-magnet and one micro-coil which generates electric current during accommodation of the eye, or, alternatively, a micro-coil which generates current by external power sources such as a dedicated external magnetic wave generator, as in, for example, WO-2017039672 or, alternatively, by power generated by mobile telephones.
  • an electric power generator being a combination of at least one micro-magnet and one micro-coil which generates electric current during accommodation of the eye, or, alternatively, a micro-coil which generates current by external power sources such as a dedicated external magnetic wave generator, as in, for example, WO-2017039672 or, alternatively, by power generated by mobile telephones.
  • the lens construction can comprise at least one single circulating oblong flexible haptic which is adapted to change shape when the driving means are active such that the ratio of the length of the chief axis and the length of the transverse axis of said haptic decreases when the driving means are active with said ratio increasing when the driving means are inactive.
  • the lens construction can comprise at least one single circulating oblong flexible haptic, as in, for example, WO-2014058316, which is adapted to change shape when the driving means are active such that the ratio of the length of the major axis and the length of the transverse axis of said haptic decreases when the driving means are inactive with said ratio increasing when the driving means are active.
  • the lens construction comprises at least one combination of connection points which combination comprises at least one optics connection point and at least one driving connection point, both connected to the haptic at the point where the chief axis of the haptic transverses the transverse axis with said combination adapted to provide translation of movement of driving means into movement of at least one optical element along the chief axis.
  • the lens construction comprises at least one combination of connection points which combination comprises at least one optics connection point and at least one driving connection point, both connected to the haptic at the point where the chief axis of the haptic transverses the transverse axis with said combination adapted to provide translation of movement of driving means into movement of at least one optical element along the transverse axis.
  • the lens construction comprises at least one haptic adapted to urge the optical element back to a resting position, a position of decreased optical power, when the driving means are inactive, or, alternatively, the lens construction can comprise at least one haptic adapted to urge the optical element back to a resting position, a position of decreased optical power, when the driving means are active.
  • the optical elements can also comprise at least one fixed power optical surface to correct for any fixed optical disorder of the eye, for example, correct for presbyopia, also: reading far-sightedness, or, alternatively, correct for myopia, nearsightedness, or, alternatively, correct for variable disorder is a variable disorder generated by the lens construction, or, alternatively, is adapted to provide correction of any combination of disorders of the eye, or, alternatively, the lens construction can comprise an additional fixed power optical element which provides fixed optical power and at least one optical element which element is a multifocal lens, providing at least two distinct foci, which lens is adapted to provide different optical powers at different relative positions in a plane perpendicular to the optical axis, or, alternatively, the lens construction can comprise a pinhole-component adapted to provide extended depth of field.
  • the lens construction can be adapted to provide correction of any combination of variable and fixed disorders of the eye.
  • the ciliary muscle of the eye pulls the, gel-like, natural lens of the eye to a flattened shape to focus the eye at distance. Once the ciliary muscle relaxes, to focus the eye at closer distance, the natural lens regains its shape, the resting state, by the elasticity of the natural lens.
  • the mechanism for a lens construction as presented in this document can be as follows: - at least one of the translation haptics of the lens can be fitted, at manufacturing, with at least one suture adapted to fixate the translation haptics of the lens in a compressed shape, meaning: a shape resulting in an increased optical power, - the suture is released by any releasing means after implant in the eye, meaning: released post-op, after the peripheral remnants of the capsular bag have fused with the haptics, generally after approximately a month post-op, fusion with said haptic or dedicated part thereof, - for vision at distance the bag expands, flattens, by natural means, meaning:
  • the suture can be adapted to be released by mechanical means, meaning:
  • the suture is adapted can be released by optical, meaning: releasing by laser light, by laser suturolysis, for example by laser light suitable to affect a vicryl material suture.
  • optical meaning: releasing by laser light, by laser suturolysis, for example by laser light suitable to affect a vicryl material suture.
  • the present document discloses an accommodating intraocular lens construction, lens adapted to be implanted in the human eye, inside the capsular bag of the eye, or, alternatively, at the sulcus plane of the eye in front of the capsular bag, or, alternatively, at any location in the eye with the lens having an optical axis with the construction comprising at least two optical elements of which at least one element is adapted to move with the optical surfaces adapted to vary at least one optical aberration of the lens with a degree of variation which is dependent on the degree of movement of the at least one of the optical elements, which movement can be in at least one direction largely perpendicular to the optical axis, with the construction comprises a set of at least two free-form, meaning:
  • rotational asymmetrical, optical surfaces with these surfaces shaped according to a Zernike polynomial which order exceeds any third order Zernike polynomial, with at least one such surface fitted to each optical element, with the set of optical surfaces providing correction for accommodation, meaning: variable defocus aberration, of the eye and with the translation of at least one of the optical elements is a shift, meaning: sliding, of the element in a direction perpendicular to the optical axis or the translation of at least one of the optical elements a rotation in a plane perpendicular to the optical axis which can be a translation of at least one of the optical elements is wedging in a plane largely perpendicular to the optical axis, or, a translation of at least one of the optical elements is any combination of any movements movement in a plane largely perpendicular to the optical axis, with the construction comprising at least one anchoring haptic, meaning: a mechanical component adapted to provide positioning and anchoring of the optical elements in the anterior chamber or the posterior chamber of
  • an accommodating intraocular lens construction lens adapted to be implanted in the human eye, with the lens having an optical axis with the
  • construction comprising at least two optical elements of which at least one element is adapted to translate in at least one direction largely perpendicular to the optical axis with the optical surfaces adapted to vary at least one optical aberration of the lens with a degree of variation which is dependent on the degree of shift of the at least one of the optical elements
  • a construction comprises a set of at least two free-form, meaning: rotational asymmetrical, optical surfaces with these surfaces shaped according to any Zernike polynomial of any order, including 3rd order Zernike polynomials.
  • Such accommodating intraocular lens construction can be fitted with at least one flange which is fitted to the posterior optical element, which flange is adapted to provide a connection of the construction to the anterior section of capsular bag in the eye.
  • the flange can be adapted to be positioned under the rim of the capsullorhexis in the capsular bag, meaning: in between the anterior capsular bag and any optical element inside the capsular bag.
  • Said flange can be of another material as the material of which the accommodating intraocular lens construction is made.
  • the construction can be made of any flexible acrylate material, while the flange can be made of, for example, sturdy PMMA material or a metal fixed to the construction, by, for example, a pin-in- hole connection.
  • the accommodating intraocular lens is an optical addition to any optical element in the capsular bag, additional to, for example, the natural lens of the eye, or, alternatively, to any artificial lens implanted in the bag prior to implantation of the accommodating intraocular lens.
  • Such accommodating intraocular lens construction can also includes at least one additional optical surface fitted to at least one optical surface, for example, a spherical optical surface adapted to provide correction of the refraction of the eye, or, alternatively, a toric optical surface adapted to provide correction of astigmatism of the eye, or, alternatively, any combination of additional surfaces adapted to provide correction of any combination of aberrations of the eye.
  • a spherical optical surface adapted to provide correction of the refraction of the eye
  • a toric optical surface adapted to provide correction of astigmatism of the eye
  • any combination of additional surfaces adapted to provide correction of any combination of aberrations of the eye.
  • Such accommodating intraocular lens construction can be firmly coupled to any optical element in the capsular bag, for example, by a pin-in-hole system with the optical element in the capsular bag being any artificial lens implanted prior to implantation of the accommodating intraocular lens construction.

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Abstract

The present invention relates to an accommodating intraocular lens construction, adapted to be implanted in the human eye, and comprising a lens adapted to be located in the capsular bag of the eye, or, alternatively, at the sulcus plane in front of the capsular bag, the lens having an optical axis and comprising at least two optical elements, each comprising at least one optical surface, and of which at least one element is adapted to move relative to the other element with the optical surfaces adapted to vary at least one optical aberration of the lens, in which the rate of variation depends on the rate of movement, wherein each of the optical elements comprises at least one free-form surface shaped according to a Zernike polynomial of which the order exceeds any third order Zernike polynomial.

Description

Accommodating intraocular lens with free form optical surfaces
The invention relates to an accommodating intraocular lens. More in particular it relates to such a lens with at least two optical elements of which at least one element is adapted to move in at least one direction with optical surfaces providing variation of defocus aberration with the optical elements comprising at least one set of at least two free-form optical surfaces shaped according to a Zernike polynomial which order exceeds third order Zernike polynomials. This document discloses an accommodating intraocular lens construction (AIOL), a lens implanted in the human eye to replace the natural lens of the eye and to restore accommodation. Such an AIOL has an optical axis with the construction comprising at least two optical elements of which at least one element is adapted to move in at least one direction, for example, shifts in a direction substantially perpendicular to the optical axis. The optical surfaces provide variation of at least one optical aberration of the lens with a degree of variation which is dependent on the degree of translation of the at least one of the optical elements.
Such accommodating AIOL's are well known from other documents, for example from NL-2012133, NL-201242, EP1871299, EP1932492. Designs of such AIOLs, and clinical results are disclosed in, Alio et al ,Am. J. Ophthamol. 2016 Apr, 164: 37-48.
However, these AIOLs are restricted to the concept which include at least two cubic optical surfaces, that are optical surfaces including Zernike third order surfaces, of which the basic, free-form, non-rotational symmetric, shapes are known from Alvarez US-3305294, which provides the original concept for a variable lens, for laterally shifting optical elements, and Baker CA-1252655, for derived fan-like rotational shifting optical elements. These are all various variations on the formula according to Alvarez, t=A(xy2+x3/3, see US3305294 for details and notations). Note that all these documents refer to only the Zernike third order formulas.
The optical surfaces disclosed in the present document comprise at least one set of at least two free-form, meaning: rotational asymmetrical, optical surfaces with these surfaces shaped according to a Zernike polynomial which order exceeds third order Zernike polynomial (as in said Alvarez US33052294) with at least one such surface fitted to each optical element. One of the present preferred embodiments comprises for example four surfaces each fitted with a fourth order polynomial surface with each element of the lens fitted with two such surfaces, one surface fitted to each side of the element. Said optical surfaces can include at least one optical shape according to a polynomial of the fourth degree, for example, in the most basic form, without any additional terms: " ~ ^°^A' - ~ ^ + x^ with z being the sag of the optical surface, with x and y the values of X,Y coordinates presenting the plane perpendicular to the optical axis, the Z coordinate, and with A being a constant. Said optical surfaces can be arranged such that the arrangement a third order optical function, as in: 5> = 5°(λ' + y) and Sl = S(> -x + Ax' },) , of which a combination results in ^ ~ 2ΑΔχ(χ + y ) optical function provides said variable optical power.
Said optical surfaces shaped according to a Zernike polynomial which order exceeds third order Zernike polynomial which set provides variable focus, defocus, can be combined with additional sets of optical surfaces of any Zernike order to variably correct for any other optical aberration, for example, for variable optical cylinder, for variable optical coma or for variable optical aspherical aberration, lens fitted with two such surfaces, one surface fitted to each side of the element. Said optical surfaces can include at least one optical shape according to a polynomial of the fourth degree, for example, in the most
Such lenses can also provide, by movement of at least one of the optical elements, a variable extension of accommodation, and/or variable focus, and/or variable spherical aberration. Such movement can be achieved, but not restricted to, principles as disclosed in US-2009062912 and WO-2005084587, and the same concept, with various adaptations in, for example, US-2014074233, WO- 2014058316, EP-2765952, NL-2012257278, US-2010131955, US-2010106245, NL-1029548 and references made therein and related documents, which principles have been shown to function when fitted to an accommodating intraocular lens in the human eye.
Alternatively, such lenses can incorporate at least two optical elements with each element with at least one optical surface with an optical shape according to a polynomial of the fourth degree. Said optical surfaces can be distributed over any combination of anterior sides and posterior sides of said optical elements in an arrangement to provide a third degree optical function, also: a third degree wavefront, which is a configuration not foreseen by any prior art.
The optics of the lens construction, for example, the set of fourth order optical surfaces, can be adapted to provide correction for accommodation, meaning:
providing variable defocus to correct for defocus aberrations of the eye. The translation of at least one of the optical elements is a shift, meaning: sliding, of the element in a direction perpendicular to the optical axis, as set forth in, for example WO2005084587, or, alternatively, a partial rotation in a plane
perpendicular to the optical axis, as set forth in CA1252655, or, alternatively, a wedge shaped movement, that is a combination of a rotation and a translation of the optical elements in a plane largely perpendicular to the optical axis, or, alternatively, any combination of any movements movement in a plane largely perpendicular to the optical axis.
The lens construction can comprise at least one anchoring haptic, meaning: a mechanical component adapted to provide positioning and anchoring of the optical elements in the anterior chamber or the posterior chamber of the eye. Such haptics are included in almost every intraocular lens, Ί01_', which haptics can be for example plate haptics or C-loops for monofocal lOLs and multifocal lOLs, which are lOLs which do not require any movement in the eye. Examples of haptics translating a component of the IOL, AIOL, are the elastic loops as in WO- 2005084587.
Hence, the present lens construction should comprise at least one translation haptic, meaning: a mechanical component adapted to provide, by coupling to translation of at least one optical element by transfer of movement of at least one component in the eye, a component preferably related to accommodation, to at least one of the optical elements. For example, the construction can comprises at least one haptic coupled to a natural component of the eye which component is the ciliary mass of the eye, as in WO-2005084587, or, alternatively, at least one haptic is coupled to a natural component of the eye which component is the capsular bag of the eye, or, alternatively, at least one haptic is coupled to a natural component of the eye which component is the zonula network of the eye, or, alternatively, at least one haptic is coupled to a natural component of the eye which component is the iris of the eye as in WO-2007027091 , or, alternatively, at least one haptic is adapted to translate at least one of the optical elements by liquid pressure generated in the posterior chamber of the eye, as in, for example, HK-1066160, or, alternatively, an flexible optical element which changes shape by infusion of liquids from containers coupled to the optical element, as in for example US-201 1282443, or, alternatively, any combination of means of translation including but not restricted to the examples cited above.
Also, at least one haptic of the present invention can be coupled to a MEMS, meaning: micro-electro-mechanical system, which MEMS is adapted to provide movement of at least one optical element. Such movement can adjust at least one of the elements to a fixed position, fixed endpoint, for example, a fixed resting position to adjust emmetropia of the eye, or, alternatively, set fixed positions for the range of accommodation, or, alternatively, provide leverage for accommodative power driven by ciliary muscle contractions or by external signals, for example signals from a smartphone. To illustrate this concept: the phone can have three buttons marked 'far vision', 'intermediate vision' and 'reading'. The accommodation could also be driven by signals from brain waves of the wearer of the lens which sounds farfetched, but which concept is well known to a man skilled in the art.
The power for such MEMS can be supplied by an electric power generator, being a combination of at least one micro-magnet and one micro-coil which generates electric current during accommodation of the eye, or, alternatively, a micro-coil which generates current by external power sources such as a dedicated external magnetic wave generator, as in, for example, WO-2017039672 or, alternatively, by power generated by mobile telephones.
The lens construction can comprise at least one single circulating oblong flexible haptic which is adapted to change shape when the driving means are active such that the ratio of the length of the chief axis and the length of the transverse axis of said haptic decreases when the driving means are active with said ratio increasing when the driving means are inactive. The lens construction can comprise at least one single circulating oblong flexible haptic, as in, for example, WO-2014058316, which is adapted to change shape when the driving means are active such that the ratio of the length of the major axis and the length of the transverse axis of said haptic decreases when the driving means are inactive with said ratio increasing when the driving means are active. The lens construction comprises at least one combination of connection points which combination comprises at least one optics connection point and at least one driving connection point, both connected to the haptic at the point where the chief axis of the haptic transverses the transverse axis with said combination adapted to provide translation of movement of driving means into movement of at least one optical element along the chief axis.
The lens construction comprises at least one combination of connection points which combination comprises at least one optics connection point and at least one driving connection point, both connected to the haptic at the point where the chief axis of the haptic transverses the transverse axis with said combination adapted to provide translation of movement of driving means into movement of at least one optical element along the transverse axis. The lens construction comprises at least one haptic adapted to urge the optical element back to a resting position, a position of decreased optical power, when the driving means are inactive, or, alternatively, the lens construction can comprise at least one haptic adapted to urge the optical element back to a resting position, a position of decreased optical power, when the driving means are active.
The optical elements can also comprise at least one fixed power optical surface to correct for any fixed optical disorder of the eye, for example, correct for presbyopia, also: reading far-sightedness, or, alternatively, correct for myopia, nearsightedness, or, alternatively, correct for variable disorder is a variable disorder generated by the lens construction, or, alternatively, is adapted to provide correction of any combination of disorders of the eye, or, alternatively, the lens construction can comprise an additional fixed power optical element which provides fixed optical power and at least one optical element which element is a multifocal lens, providing at least two distinct foci, which lens is adapted to provide different optical powers at different relative positions in a plane perpendicular to the optical axis, or, alternatively, the lens construction can comprise a pinhole-component adapted to provide extended depth of field. The lens construction can be adapted to provide correction of any combination of variable and fixed disorders of the eye. The ciliary muscle of the eye pulls the, gel-like, natural lens of the eye to a flattened shape to focus the eye at distance. Once the ciliary muscle relaxes, to focus the eye at closer distance, the natural lens regains its shape, the resting state, by the elasticity of the natural lens. So, the mechanism for a lens construction as presented in this document can be as follows: - at least one of the translation haptics of the lens can be fitted, at manufacturing, with at least one suture adapted to fixate the translation haptics of the lens in a compressed shape, meaning: a shape resulting in an increased optical power, - the suture is released by any releasing means after implant in the eye, meaning: released post-op, after the peripheral remnants of the capsular bag have fused with the haptics, generally after approximately a month post-op, fusion with said haptic or dedicated part thereof, - for vision at distance the bag expands, flattens, by natural means, meaning:
relaxation driven by the ciliary muscle and zonulae which connect the bag to the ciliary mass, and, for vision closer, the ciliary muscle/mass contracts and the lens construction regains its resting state, meaning an optical power for close vision, while also pulling the bag inwards because of the fusion between haptic and bag. The suture can be adapted to be released by mechanical means, meaning:
releasing by surgery, or, alternatively, the suture is adapted can be released by optical, meaning: releasing by laser light, by laser suturolysis, for example by laser light suitable to affect a vicryl material suture. Such fusion of bag and lens is known from prior art, US-1 1562035 and US-20040243233A1 , but only for a different mechanical concept, restricted to expansion of the bag, and not for contraction of the bag, which is a novel concept disclosed in the present document.
So, in summary, the present document discloses an accommodating intraocular lens construction, lens adapted to be implanted in the human eye, inside the capsular bag of the eye, or, alternatively, at the sulcus plane of the eye in front of the capsular bag, or, alternatively, at any location in the eye with the lens having an optical axis with the construction comprising at least two optical elements of which at least one element is adapted to move with the optical surfaces adapted to vary at least one optical aberration of the lens with a degree of variation which is dependent on the degree of movement of the at least one of the optical elements, which movement can be in at least one direction largely perpendicular to the optical axis, with the construction comprises a set of at least two free-form, meaning:
rotational asymmetrical, optical surfaces with these surfaces shaped according to a Zernike polynomial which order exceeds any third order Zernike polynomial, with at least one such surface fitted to each optical element, with the set of optical surfaces providing correction for accommodation, meaning: variable defocus aberration, of the eye and with the translation of at least one of the optical elements is a shift, meaning: sliding, of the element in a direction perpendicular to the optical axis or the translation of at least one of the optical elements a rotation in a plane perpendicular to the optical axis which can be a translation of at least one of the optical elements is wedging in a plane largely perpendicular to the optical axis, or, a translation of at least one of the optical elements is any combination of any movements movement in a plane largely perpendicular to the optical axis, with the construction comprising at least one anchoring haptic, meaning: a mechanical component adapted to provide positioning and anchoring of the optical elements in the anterior chamber or the posterior chamber of the eye or the construction comprising at least one translation haptic, meaning: a mechanical component adapted to provide translation of at least one optical element by transfer of movement of at least one component in the eye to at least one of the optical elements, or, the construction comprising at least one haptic adapted to provide a combination of positioning and translation, with at least one haptic is coupled to a natural component of the eye which component is the ciliary mass of the eye, which is a natural component of the eye which component is the capsular bag of the eye, or, the zonula network of the eye, or, the iris of the eye, or, liquid pressure generated in the posterior chamber of the eye, or, a MEMS, meaning: micro- electro-mechanical system, which MEMS is adapted to provide movement of at least one optical element, or, with the lens construction comprises at least one single circulating oblong flexible haptic which is adapted to change shape when the driving means are active such that the ratio of the length of the chief axis and the length of the transverse axis of said haptic decreases when the driving means are active with said ratio increasing when the driving means are inactive, or, with the lens construction comprises at least one single circulating oblong flexible haptic which is adapted to change shape when the driving means are active such that the ratio of the length of the major axis and the length of the transverse axis of said haptic decreases when the driving means are inactive with said ratio increasing when the driving means are active, or, with the lens construction comprises at least one combination of connection points which combination comprises at least one optics connection point and at least one driving connection point, both connected to the haptic at the point where the chief axis of the haptic transverses the transverse axis with said combination adapted to provide translation of movement of driving means into movement of at least one optical element along the chief axis, or, that the lens construction comprises at least one combination of connection points which combination comprises at least one optics connection point and at least one driving connection point, both connected to the haptic at the point where the chief axis of the haptic transverses the transverse axis with said combination adapted to provide translation of movement of driving means into movement of at least one optical element along the transverse axis with the lens construction comprises at least one haptic adapted to urge the optical element back to a resting position, a position of decreased optical power, when the driving means are inactive, or, that the lens construction comprises at least one haptic adapted to urge the optical element back to a resting position, a position of decreased optical power, when the driving means are active, with, in addition that the optical elements also comprise at least one optical surface to correct for any fixed optical disorder of the eye, with the fixed optical disorder being presbyopia, also: reading far-sightedness, with the lens construction adapted for implant in the human eye to correct for at least one variable optical disorder of the eye with the variable disorder being a variable disorder generated by the lens construction, or, correction of any combination of at least one variable and at least one fixed disorder of the eye, with, alternatively, for implantation in the capsular bag the haptics are fitted, at manufacturing, with at least one suture adapted to fixate at least one of the translation haptics of the lens in a compressed shape, meaning: a shape resulting in an increased optical power, with the suture is adapted to be released by any releasing means after implant in the eye, meaning: released post-op, with the suture is adapted to be released by mechanical means, meaning: releasing by surgery, or, with the suture is adapted to be released by optical, meaning: releasing by laser light, by laser suturolysis, with preferably the suture is a vicryl material suture.
Also, an accommodating intraocular lens construction, lens adapted to be implanted in the human eye, with the lens having an optical axis with the
construction comprising at least two optical elements of which at least one element is adapted to translate in at least one direction largely perpendicular to the optical axis with the optical surfaces adapted to vary at least one optical aberration of the lens with a degree of variation which is dependent on the degree of shift of the at least one of the optical elements can be a construction comprises a set of at least two free-form, meaning: rotational asymmetrical, optical surfaces with these surfaces shaped according to any Zernike polynomial of any order, including 3rd order Zernike polynomials.
Such accommodating intraocular lens construction according can be fitted with at least one flange which is fitted to the posterior optical element, which flange is adapted to provide a connection of the construction to the anterior section of capsular bag in the eye. For example, the flange can be adapted to be positioned under the rim of the capsullorhexis in the capsular bag, meaning: in between the anterior capsular bag and any optical element inside the capsular bag. Said flange can be of another material as the material of which the accommodating intraocular lens construction is made. For example, the construction can be made of any flexible acrylate material, while the flange can be made of, for example, sturdy PMMA material or a metal fixed to the construction, by, for example, a pin-in- hole connection.
So, the accommodating intraocular lens is an optical addition to any optical element in the capsular bag, additional to, for example, the natural lens of the eye, or, alternatively, to any artificial lens implanted in the bag prior to implantation of the accommodating intraocular lens.
Such accommodating intraocular lens construction can also includes at least one additional optical surface fitted to at least one optical surface, for example, a spherical optical surface adapted to provide correction of the refraction of the eye, or, alternatively, a toric optical surface adapted to provide correction of astigmatism of the eye, or, alternatively, any combination of additional surfaces adapted to provide correction of any combination of aberrations of the eye.
Such accommodating intraocular lens construction can be firmly coupled to any optical element in the capsular bag, for example, by a pin-in-hole system with the optical element in the capsular bag being any artificial lens implanted prior to implantation of the accommodating intraocular lens construction.
All documents and their illustrations referred to in this document are considered to be incorporated in this document.

Claims

Claims
1. Accommodating intraocular lens construction, adapted to be implanted in the human eye, and comprising a lens adapted to be located in the capsular bag of the eye, or, alternatively, at the sulcus plane in front of the capsular bag, the lens having an optical axis and comprising at least two optical elements, each comprising at least one optical surface, and of which at least one element is adapted to move relative to the other element with the optical surfaces adapted to vary at least one optical aberration of the lens, in which the rate of variation depends on the rate of movement,
characterized in that each of the optical elements comprises at least one free- form surface shaped according to a Zernike polynomial of which the order exceeds any third order Zernike polynomial.
2. Lens construction according to claim , characterized in that the set of optical surfaces is adapted to provide correction for accommodation, variable defocus aberration, of the eye.
3. Lens construction according to claim 1 or 2, characterized in that the relative translation of the optical elements is a relative shift of the optical elements in a direction perpendicular to the optical axis.
4. Lens construction according to claim 1 or 2, characterized in that the relative translation of the optical elements is a relative rotation in a plane perpendicular to the optical axis.
5. Lens construction according to claim 1 or 2 , characterized in that the relative translation of the optical elements is a relative wedging in a plane largely perpendicular to the optical axis.
6. Lens construction according to one of the claims 1 5, characterized in that the relative movement of the optical elements is any combination of any
movements.
7. Lens construction according to any of the claims 1 -6, characterized by at least one anchoring haptic, being a mechanical component connected to at least one of the optical elements and adapted to provide positioning and anchoring of the optical elements in the anterior chamber or the posterior chamber of the eye.
8. Lens construction according to claim 7, characterized in that at least one of the haptics is a translation haptic, that is a haptic adapted to provide translation of at least one optical element by transfer of movement of at least one component in the eye to at least one of the optical elements.
9. Lens construction according to claim 7 or 8, characterized in that at least one haptic is adapted to provide a combination of positioning and transfer of movement.
10. Lens construction according to claim 7, 8 or 9, characterized in that at least one haptic is adapted to be coupled to a natural component of the eye which component is the ciliary mass of the eye.
1 1. Lens construction according to claim 7, 8 or 9, characterized in that at least one haptic is adapted to be coupled to a natural component of the eye which component is the capsular bag of the eye.
12. Lens construction according to claim 7, 8 or 9, characterized in that the at least one haptic is adapted to be coupled to a natural component of the eye which component is the zonula network of the eye.
13. Lens construction according to any claim 7, 8 or 9, characterized in that the at least one haptic is adapted to be coupled to a natural component of the eye which component is the iris of the eye.
14. Lens construction according to claim 7, 8 or 9, characterized in that the at least one haptic is adapted to translate at least one of the optical elements by liquid pressure generated in the posterior chamber of the eye.
15. Lens construction according to any claim 7, 8 or 9, characterized in that the at least one haptic is coupled to a MEMS, adapted to provide movement of at least one optical element.
16. Lens construction according to any of the foregoing claims, characterized in that the lens construction comprises at least one single circulating oblong flexible haptic which is adapted to change shape when the driving means are active, such that the ratio of the length of the main axis and the length of the transverse axis of said oblong flexible haptic decreases when the driving means are active, and said ratio increases when the driving means are inactive.
17. Lens construction according to any of the claims 1 -15 characterized in that the lens construction comprises at least one single circulating oblong flexible haptic which is adapted to change shape when the driving means are active, such that the ratio of the length of the main axis and the length of the transverse axis of said haptic decreases when the driving means are inactive, and said ratio increases when the driving means are active.
18. Lens construction according to claim 16 or 17, characterized in that the lens construction comprises at least one combination of connection points which combination comprises at least one optics connection point and at least one driving connection point, both connection points being connected to the haptic at the location where the main axis of the haptic transverses the transverse axis and said combination being adapted to provide translation of movement of driving means into movement of at least one optical element along the main axis.
19. Lens construction according to claim 16 or 17, characterized in that the lens construction comprises at least one combination of connection points which combination comprises at least one optics connection point and at least one driving connection point, both connections points being connected to the haptic at the location where the chief axis of the haptic transverses the transverse axis with said combination adapted to provide translation of movement of driving means into movement of at least one optical element along the transverse axis.
20. Lens construction according to any of the foregoing claims, characterized by at least one haptic adapted to urge the optical element back to a resting position, a position of decreased optical power, when the driving means are inactive.
2 . Lens construction according to any of the claims 1 -19, characterized in by at least one haptic adapted to urge the optical element back to a resting position, a position of decreased optical power, when the driving means are active.
22. Lens construction according to any of the foregoing claims characterized in that the optical elements also comprise at least one optical surface to correct for any fixed optical disorder of the eye.
23. Lens construction according to claim 22, characterized in that the fixed optical disorder is presbyopia, also: reading far-sightedness.
24. Lens construction according to any of the foregoing claims, characterized in that the lens construction is adapted to correct for at least one variable optical disorder of the eye.
25. Lens construction according to claim 24, characterized in that the variable disorder is a variable disorder generated by the lens construction.
26. Lens construction according to claim 24, characterized in that the lens is adapted to provide correction of a combination of at least one variable and at least one fixed disorder of the eye.
27. Lens construction according to claim 12, characterized in that the lens construction is adapted for implantation in the capsular bag, and that the haptics are fitted, at manufacturing, with at least one suture adapted to fixate at least one of the translation haptics of the lens in a compressed shape, meaning: a shape resulting in an increased optical power.
28. Lens construction according to claim 27, characterized in that the suture is adapted to be released by any releasing means after implant in the eye, meaning: released post-op.
29. Lens construction according to claim 28 characterized in that the suture is adapted to be released by mechanical means, meaning: releasing by surgery.
30. Lens construction according to claim 28 characterized in that the suture is adapted to be released by optical, meaning: releasing by laser light, by laser suturolysis.
3 . Lens construction according to claim 30 characterized in that the suture is a vicryl material suture.
32. Accommodating intraocular lens construction, lens adapted to be implanted in the human eye, with the lens having an optical axis with the construction comprising at least two optical elements of which at least one element is adapted to translate in at least one direction largely perpendicular to the optical axis with the optical surfaces adapted to vary at least one optical aberration of the lens with a degree of variation which is dependent on the degree of shift of the at least one of the optical elements characterized in that the construction comprises a set of at least two free-form, meaning: rotational asymmetrical, optical surfaces with these surfaces shaped according to any Zernike polynomial of any order.
33. Accommodating intraocular lens construction according to claim 32, characterized in that at least one flange is fitted to the posterior optical element which flange is adapted to provide a connection of the construction to the capsular bag in the eye.
34. Accommodating intraocular lens construction according to claim 33
characterized in that the flange is adapted to be positioned under the rim of the capsullorhexis in the capsular bag, meaning: in between the anterior capsular bag and any optical element inside the capsular bag.
35. Accommodating intraocular lens construction according to claim 34
characterized in that the accommodating intraocular lens construction is an optical addition to any optical element in the capsular bag.
36. Accommodating intraocular lens construction according to claim 32, 33 or 34, characterized in that the optical element in the capsular bag is the natural lens of the eye.
37. Accommodating intraocular lens construction according to claim 36, characterized in that the optical element in the capsular bag is any artificial lens.
38. Accommodating intraocular lens construction according to any of the claims 32-37, characterized in that the construction also includes at least one additional optical surface fitted to at least one optical surface.
39. Accommodating intraocular lens construction according to claim 38, characterized in that the additional surface is a spherical optical surface adapted to provide correction of the refraction of the eye.
40. Accommodating intraocular lens construction according to claim 38, characterized in that the additional surface is a toric optical surface adapted to provide correction of astigmatism of the eye.
41. Accommodating intraocular lens construction according to claim 38, characterized in that the additional surface is any optical surface adapted to provide correction of any aberration of the eye.
42. Accommodating intraocular lens construction according to any of the claims 32-41 , characterized in that the construction is coupled to any optical element in the capsular bag.
43. Accommodating intraocular lens construction according to claim 42, characterized in that the optical element in the capsular bag is any artificial lens implanted prior to implantation of the accommodating intraocular lens construction.
PCT/NL2018/050524 2017-07-27 2018-07-26 Accommodating intraocular lens with free form optical surfaces WO2019022608A1 (en)

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Publication number Priority date Publication date Assignee Title
WO2020197386A1 (en) 2019-03-25 2020-10-01 Akkolens International B.V. Intraocular lens combination for restoration of refraction and accommodation
NL2025405A (en) * 2019-04-23 2020-10-30 Akkolens Int B V Accommodating intraocular lens with elastically contracting haptics
WO2021034187A1 (en) 2019-08-19 2021-02-25 Akkolens International B.V. Accommodative intraocular lens combination with independent fixed and variable power lens sections
DE112020003939T5 (en) 2019-08-19 2022-05-19 Akkolens International B.V. Accommodative intraocular lens combination with independent fixed and variable power lens parts
NL2027301A (en) 2020-01-13 2021-08-17 Akkolens Int B V Mechanical means for accommodative intraocular lens
WO2021246870A1 (en) 2020-06-04 2021-12-09 Akkolens International B.V. Accommodating intraocular lenses with rigid tapered flanges

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