WO2025186802A1

WO2025186802A1 - Improvements in hybrid accommodating intraocular lens assemblages

Info

Publication number: WO2025186802A1
Application number: PCT/IL2025/050190
Authority: WO
Inventors: Joshua Ben Nun
Original assignee: Jb & Dh LP
Current assignee: Jb & Dh LP
Priority date: 2024-03-06
Filing date: 2025-02-25
Publication date: 2025-09-12
Anticipated expiration: 2026-09-06
Also published as: WO2025186802A8; IL311300A

Abstract

The present invention is directed towards hybrid Accommodating Intraocular (AIOL) assemblages including a discrete base member having a composite construction including a generally right cylindrical base member centerpiece formed with a biocompatible fluid filled cavity sealed by an ultra-thin highly flexible membrane for facilitating distance vision.

Description

IMPROVEMENTS IN HYBRID ACCOMMODATING INTRAOCULAR LENS ASSEMBLAGES

Field of the Invention

This invention relates to accommodating intraocular lens assemblages in general and in-the-bag accommodating intraocular lens assemblages in particular.

Background of the Invention

Referring to Figure 1 and Figure 2, the structure and operation of a human eye are described as context for the present invention. Figure 1 and Figure 2 are cross section views of an anterior part of a human eye 10 having a visual axis VA for near vision and distance vision, respectively, in an axial plane of the human body. The human eye 10 has an anterior transparent cap like cornea 11 connected at its circumferential periphery to a spherical exterior sclera 12 made of tough connective tissue at an annular corneal limbus 13. An iris 14 inwardly extends into the human eye 10 from its root 16 at the corneal limbus 13 to divide the human eye’s anterior part into an anterior chamber 17 and a posterior chamber 18. The iris 14 is a thin annular muscle structure with a central pupil. The iris 14 is activated by inter alia ambient light conditions, focusing for near vision, and other factors for a consequential change in pupil diameter. An annular ciliary body 19 is connected to zonular fibers 21 which in turn are peripherally connected to an equatorial edge of a capsular bag 22 having an anterior capsule 23 and a posterior capsule 24 and containing a natural crystalline lens 26.

Contraction of the ciliary body 19 allows the lens 26 to thicken to its natural thickness T1 along the visual axis VA for greater positive optical power for near vision (see Figure 1). Relaxation of the ciliary body 19 tensions the zonular fibers 21 which circumferentially draws the capsular bag 22 radially outward as shown by arrows A for compressing the lens 26 to shorten its thickness along the visual axis VA to T2<T1 for lower positive optical power for distance vision (see Figure 2). Cataract surgery involves capsulorhexis in an anterior capsule 23 for enabling removal of a natural crystalline lens 26. Capsulorhexis typically involves preparing an about 5mm diameter circular aperture in an anterior capsule 23 to leave an annular anterior capsule flange 27 and an intact posterior capsule 24. Figure 1 and Figure 2 denote the boundary of the circular aperture by arrows B.

Near vision is defined at a distance range of between about 33 cm to 40 cm and requires an additional positive optical power of between about 2.5 Diopter to 23 Diopter over best corrected distance vision. Healthy human eyes undergo pupillary miosis to about 2 mm pupil diameter for near vision from an about 3 mm to 6 mm pupil diameter for distance vision corresponding to ambient illumination conditions. Ciliary body relaxation in healthy human eyes is capable of application of a patient specific accommodative physiological force on a natural crystalline lens. Maximal accommodative physiological forces occur for distance vision with the ciliary muscles relaxed and the capsular bag circumferentially stretched by the zonuli connecting the ciliary body to the lens capsule. Maximal accommodative physiological forces are estimated to be in the 10 gram force range depending on a patient’s age, eye size, and other factors. Minimal near zero gram force accommodative physiological forces occur for near vision with the zonuli being untaut.

PCT International Publication No. WO 2017/203517 Al entitled Hybrid Accommodating Intraocular Lens Assemblages and PCT International Publication No. WO 2020/089657 Al entitled Hybrid Accommodating Intraocular Lens Assemblages Including Discrete Lens Unit with Segmented Lens Haptics disclose hybrid accommodating intraocular lens (AIOL) assemblages having two discrete component parts in the form of a discrete base member for initial implantation in a vacated capsular bag and a discrete lens unit for subsequent implantation in the vacated capsular bag for anchoring thereonto.

The discrete base member has a generally right cylindrical solid monolithic base member centerpiece with an anterior base member centerpiece surface and a posterior base member centerpiece surface, and an elevated circumferential retainer bounding a circumferential groove. The discrete lens unit has a lens optic axis intended to be co-axial with the base member axis on mounting the discrete lens unit on the discrete base member. The discrete lens unit includes a lens optic having an anterior lens optic surface and a posterior lens optic surface, and two diametrical pairs of identical shape memory resiliency flexible lens haptics radially outwardly extending therefrom for anchoring in the circumferential groove. The discrete base member and the lens optic necessarily have the same refractive index. In an in-the- hand assembled hybrid AIOL assemblage, the two diametrical pairs of lens haptics are sufficiently stiff to hold the lens optic away from the discrete base member in their unflexed state. In a relaxed ciliary body state for distance vision, a circumferentially stretched vacated capsular bag flexes the lens haptics substantially along their entire lengths for urging the lens optic towards the discrete base member such that the posterior lens optic surface is in intimate contact with the anterior base member centerpiece surface to create a single refractive index optical continuum.

The present invention is directed towards improved hybrid AIOL assemblages for facilitating distance vision.

Summary of the Invention

The present invention is directed towards an improvement to the WO 2017/203517 and/or the WO 2020/089657 hybrid AIOL assemblages. The improvement is directed towards a discrete base member having a composite construction including a generally right cylindrical base member centerpiece formed with a biocompatible fluid fdled cavity sealed by an ultra-thin highly flexible membrane. In a relaxed ciliary body state for distance vision, the discrete base member facilitates complete immersion of a posterior lens optic surface into the biocompatible fluid fdled cavity in comparison to the above-described WO 2017/203517 and WO 2020/089657 intimate contact between a posterior lens optic surface and an anterior base member centerpiece surface. The complete immersion advantageously requires a smaller accommodative physiological force compared to the accommodative physiological force required for the above-described WO 2017/203517 and WO 2020/089657 intimate contact. The complete immersion of a posterior lens optic surface into a biocompatible fluid filled cavity is evidenced by the ultra-thin highly flexible membrane circumferentially bulging around the posterior lens optic surface in an anterior direction. The discrete base member has a refractive index preferably identical to the lens optic. The biocompatible fluid and the highly flexible membrane can have a refractive index preferably similar to the lens optic or alternatively different therefrom.

Brief Description of Drawings

In order to understand the invention and to see how it can be carried out in practice, a preferred embodiment will now be described, by way of a non-limiting example only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which:

Fig. 1 is a cross section of an anterior part of a human eye in its natural near vision condition in an axial plane of the human body.

Fig. 2 is a cross section of an anterior part of a human eye in its natural distance vision condition in an axial plane of the human body.

Fig. 3 is a perspective front view of a WO 2017/203517 hybrid AIOL assemblage before assembly corresponding to WO 2017/203517 Figure 3.

Fig. 4 is a top plan view of a discrete lens unit of the WO 2017/203517 hybrid AIOL assemblage corresponding to WO 2017/203517 Figure 4.

Fig. 5 is a transverse cross section of the WO 2017/203517 discrete lens unit along line 5-5 in Figure 4 co-directional with a lens optic axis of the discrete lens unit corresponding to WO 2017/203517 Figure 5. Fig. 6 is a transverse cross section of another discrete base member co- directional with a base member axis of the discrete base member corresponding to WO 2017/203517 Figure 10.

Fig. 7 is a cross section of an implanted WO 2017/203517 hybrid AIOL assemblage for near vision corresponding to WO 2017/203517 Figure 11.

Fig. 8 is a cross section of an implanted WO 2017/203517 hybrid AIOL assemblage for distance vision corresponding to WO 2017/203517 Figure 12.

Fig. 9 is a cross section of a WO 2020/089657 hybrid AIOL assemblage for near vision.

Fig. 10 is a cross section of the WO 2020/089657 hybrid AIOL assemblage for distance vision.

Fig. 11 is a cross section of the WO 2020/089657 hybrid AIOL assemblage with a modified discrete lens unit for near vision.

Fig. 12 is a cross section of the WO 2020/089657 hybrid AIOL assemblage with the modified discrete lens unit for distance vision.

Fig. 13 is a cross section of an improved hybrid AIOL assemblage for near vision.

Fig. 14 is a cross section of the improved hybrid AIOL assemblage for distance vision.

Fig. 15 is a cross section of an implanted improved hybrid AIOL assemblage for near vision.

Fig. 16 is a cross section of an implanted improved hybrid AIOL assemblage for distance vision.

Detailed Description of Drawings

The present description includes three sections as follows:

Section 1: WO 2017/203517 Al Hybrid AIOL Assemblages

Section 2: WO 2020/089657 Al Hybrid AIOL Assemblages including Discrete Lens Unit with Segmented Lens Haptics Section 3: Improvements in Hybrid AIOL Assemblages

Section 1: WO 2017/203517 Al Hybrid AIOL Assemblages

Figure 3 to Figure 5 show a hybrid AIOL assemblage 30 including a discrete lens unit 40 and a discrete base member 60 for in situ assembly in a capsular bag during cataract surgery. The hybrid AIOL assemblage 30 is entirely made from implantable presently commercially available biocompatible material suitable for intraocular lenses.

The discrete lens unit 40 includes a lens optic 41 and two diametric pairs of equispaced shape memory resiliency flexible lens haptics 42 radially outward extending from the lens optic 41. The discrete lens unit 40 can be manufactured as a monolithic structure. Alternatively, the lens haptics 42 can be manufactured separately from the lens optic 41 and attached thereto using industry known attachment technologies. The lens optic 41 has a lens optic axis 43 for co-axial alignment with a human visual axis VA, an anterior lens optic surface 44, a posterior lens optic surface 46 and a lens optic edge 47. The posterior lens optic surface 46 includes a central circle 48 having an approximate 2.5 mm diameter around the lens optic axis 43 corresponding to near vision pupil size under normal reading illumination conditions and a surrounding annular multi-focal segment 49.

The lens haptics 42 has a lens haptics free end 51 with a lens haptics curved edge corresponding to a curvature of an anchoring interface of the discrete base member 60. Each lens haptics 42 preferably has a manipulation aperture 53 and an elongated anterior spacer pair 54 adjacent to the lens optic 41. The discrete lens unit 40 preferably has an optical axis marker 56 for assisting correct alignment with respect to a human visual axis VA on implantation.

The discrete base member 60 has a base member axis 61 and a generally right cylindrical shape. The discrete base member 60 includes a base member centerpiece 62 and a base member surround 63. The base member 60 can be manufactured as a monolithic structure. Alternatively, the base member surround 63 can be manufactured separately from the base member centerpiece 62 and attached thereto using industry known attachment technologies. The base member centerpiece 62 has a flat circular anterior base member centerpiece surface 64 and a flat circular posterior base member centerpiece surface 66. The base member surround 63 is formed with an elevated circumferential retainer 67 for forming a circumferential groove 68 with the anterior base member centerpiece surface 64 for receiving the lens haptics free ends 51 for anchoring the discrete lens unit 40 on the discrete base member 60.

Figure 6 shows an elevated circumferential retainer 67 in the form of a pliable rim 69 designed to be flexed towards the anterior base member centerpiece surface 64 by the anterior capsule flange 27 as denoted by arrow C.

Figure 7 and Figure 8 are cross sections of an implanted WO 2017/203517 hybrid AIOL assemblage correspondingly for near vision and distance vision.

Section 2: WO 2020/089657 Al Hybrid AIOL Assemblages including Discrete Lens Unit with Segmented Lens Haptics

Figure 9 and Figure 10 show a WO 2020/089657 hybrid AIOL assemblage 70 correspondingly for near vision and distance vision. The WO 2020/089657 hybrid AIOL assemblage 70 includes a discrete lens unit 80A and the discrete base member 60. The discrete lens unit 80A is similar in construction to the discrete lens unit 40 and therefore similar parts are likewise numbered. The discrete lens unit 80A differs from the discrete lens unit 40 insofar as it includes two diametric pairs of equispaced shape memory resiliently flexible segmented lens haptics 81. Each segmented lens haptics 81 has an anterior lens haptics surface 82 in the direction of the anterior lens optic surface 44 and a posterior lens haptics surface 83 in the direction of the posterior lens optic surface 46. Each segmented lens haptics 81 has localized flexible lens haptics segments 84 formed by generally circumferential grooves 86 in the posterior lens haptics surface 83 with respect to the discrete lens unit axis 43 and inflexible lens haptics segments 87. In an absence of an accommodative physiological force, each segmented lens haptics 81 has a staggered arcuate shape due to the presence of the three circumferential grooves 86 between the inflexible lens haptics segments 87 (see Figure 9). On application of an accommodative physiological force F, each segmented lens haptics 81 becomes a rigid arched structure such that the discrete lens unit 80A as a whole becomes a rigid structure (see Figure 10).

Figure 11 and Figure 12 show the WO 2020/089657 hybrid AIOL assemblage 70 with a modified discrete lens unit 80B correspondingly for near vision and distance vision. The modified discrete lens unit 80B differs from the discrete lens unit 80A insofar as the former 80B includes one or more circumferential grooves 86 in the anterior lens haptics surface 82 instead of the posterior lens haptics surface 83.

Section 3: Improvements in Hybrid AIOL assemblages

Figure 13 and Figure 14 show an in-the-hand improved hybrid AIOL assemblage 90 correspondingly for near vision and distance vision. Figure 15 and Figure 16 show the implanted improved hybrid AIOL assemblage 90 correspondingly for near vision and distance vision.

The hybrid AIOL assemblage 90 includes the discrete lens unit 80A and a discrete base member 100 comparable to the discrete base member 60 and differing therefrom insofar as it has a composite construction. The discrete base member 100 has a base member centerline 101, an anterior base member surface 102, a posterior base member surface 103 and a peripheral base member surface 104 between the anterior base member surface 102 and the posterior base member surface 103.

The discrete base member 100 includes a generally right cylindrical base member centerpiece 106 having a base member centerpiece refractive index, an anterior base member centerpiece surface 107 and a posterior base member centerpiece surface 108. The discrete base member 100 includes an elevated circumferential retainer 109 bounding a circumferential groove 111 with the anterior base member surface 102 for receiving the lens haptics free ends 51 therein for anchoring the discrete lens unit 80 A on the discrete base member 100. In an in- the-hand assembled hybrid AIOL assemblage 90, the two diametrical pairs of lens haptics 42 in their unflexed state are sufficiently stiff to hold the lens optic 41 away from the discrete base member 100.

The discrete base member 100 includes a central generally right cylindrical cavity 112 for defining an annular base member rim 113. The cavity 112 is filled with bio-compatible fluid 114 and sealed by an ultra- thin highly flexible membrane 116. The ultra-thin highly flexible membrane 116 is typically flush with the anterior base member centerpiece surface 107. The cavity 112’s diameter is greater than the lens optic 41 ’s diameter for enabling reciprocation of the lens optic 41 relative to the discrete base member 100 between Figure 13 ’s position for near vision and Figure 14’s position for distance vision but at the same time leaving a wide enough base member rim 113 for supporting the lens haptics free ends 51. The discrete base member 100 typically has the following external dimensions: Diameter about 8.0 mm and height 1.0 mm. The cavity 101 has exemplary dimensions: Diameter about 7.0 mm and height about 0.5 mm.

The generally right cylindrical base member centerpiece 106 is preferably formed from the same material as the lens optic 41, and has the same refractive index as the lens optic 41 ’s refractive index. The biocompatible fluid 114 and the ultra-thin highly flexible membrane 116 each have a refractive index preferably similar to the lens optic 41 ’s refractive index or alternatively different therefrom.

Figure 14 and Figure 16 show the hybrid AIOL assemblage 90 is designed to facilitate complete immersion of the posterior lens optic surface 46 into the biocompatible fluid filled cavity 101 in a relaxed ciliary body state for affording an optimum optical continuum between the lens optic 41 and the discrete base member 100 for distance vision. The complete immersion is evidenced by the biocompatible fluid filled highly flexible membrane 116 circumferentially outwardly bulging around the posterior lens optic surface 46 between the lens optic 41 and the base member rim 113 in an anterior direction away from the generally right cylindrical base member centerpiece 106. Additionally, the complete immersion is evidenced by at least the posterior lens optic surface 46’s central circle 48 being urged between the anterior base member centerpiece surface 107 and the posterior base member centerpiece surface 108.

While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.

Claims

Claims:

1. A discrete base member for use with a discrete lens unit in a hybrid accommodating intraocular lens assemblage for implantation in a post- capsulorhexis human eye having a visual axis, an annular ciliary body, and a vacated capsular bag having an annular anterior capsule flange and an intact posterior capsule, the ciliary body having a relaxed ciliary body state for distance vision and a contracted ciliary body state for near vision, the ciliary body peripherally tensioning the capsular bag on its relaxation from its contracted ciliary body state to its relaxed ciliary body state, the discrete lens unit including: i) a lens optic having a lens optic refractive index, a lens optic axis for co-axial alignment with the visual axis, an anterior lens optic surface with a primary optical power for distance vision and a posterior lens optic surface having a central circle with an additional optical power to the primary optical power for near vision; and ii) at least two spaced apart resiliency flexible lens haptics radially extending from the lens optic, the at least two spaced apart resiliency Cexible lens haptics each having a free end remote from the lens optic, the discrete base member having a base member centerline, an anterior base member surface, a posterior base member surface, and a peripheral base member surface between the anterior base member surface and the posterior base member surface, the discrete base member comprising: a) a generally right cylindrical base member centerpiece having a base member centerpiece refractive index, an anterior base member centerpiece surface and a posterior base member centerpiece surface; and b) an elevated circumferential retainer bounding a circumferential groove with the anterior base member surface, the hybrid accommodating intraocular lens assemblage being such that pursuant to an initial implantation of the discrete base member in the vacated capsular bag and a subsequent implantation of the discrete lens unit in the vacated capsular bag between the discrete base member and the anterior capsule flange including insertion of the at least two spaced apart resiliently flexible lens haptics free ends in the circumferential groove for anchoring the discrete lens unit on the discrete base member for urging the lens optic away from the discrete base member for separating the posterior lens optic surface from the anterior base member centerpiece surface and enabling rotation of the discrete lens unit to a predetermined position relative to the discrete base member stationary in the post-capsulorhexis human eye, whereupon, in the relaxed ciliary body state, the vacated capsular bag urges the lens optic and the discrete base member towards each other such that the posterior lens optic surface is in intimate contact with the anterior base member centerpiece surface for creating a single refractive index optical continuum nullifying the posterior lens optic surface’s optical power whereby the hybrid accommodating intraocular lens assemblage has optical power for distance vision only, and in the contracted ciliary body state, the vacated capsular bag enables the at least two spaced apart resiliently flexible lens haptics to space apart the lens optic and the discrete base member such that the posterior lens optic surface is spaced apart from the anterior base member centerpiece surface for adding the central circle’s additional optical power to the anterior lens optic surface’s primary optical power whereby the hybrid accommodating intraocular lens assemblage has a combined optical power for near vision, characterized in that the generally right cylindrical base member centerpiece has a composite construction and further includes: i) a central generally right cylindrical biocompatible fluid filled cavity defining an annular base member rim, and ii) a highly flexible membrane sealing the central generally right cylindrical biocompatible fluid filled cavity such that, in the relaxed ciliary body state, the posterior lens optic surface is completely immerged in the central generally right cylindrical biocompatible fluid filled cavity to cause the biocompatible fluid filled highly flexible membrane to circumferentially bulge between the lens optics and the annular base member rim in an anterior direction away from the generally right cylindrical base member centerpiece.

2. The discrete base member according to claim 1 wherein the biocompatible fluid has a refractive index similar to the lens optic’s refractive index.

3. The discrete base member according to claim 2 wherein the highly flexible membrane has a refractive index similar to the lens optic’s refractive index.

4. A hybrid accommodating intraocular lens assemblage for implantation in a post-capsulorhexis human eye having a visual axis, an annular ciliary body, and a vacated capsular bag having an annular anterior capsule flange and an intact posterior capsule, the hybrid accommodating intraocular lens assemblage comprising:

(a) a discrete base member according to any one of claims 1 to 3; and

(b) a discrete lens unit for mounting on the discrete base member.