WO2019094768A1

WO2019094768A1 - Intraocular lens

Info

Publication number: WO2019094768A1
Application number: PCT/US2018/060095
Authority: WO
Inventors: Manus KRAFF
Original assignee: Kraff Manus
Priority date: 2017-11-10
Filing date: 2018-11-09
Publication date: 2019-05-16

Abstract

The present disclosure includes intraocular implants, including anterior and posterior chamber intraocular lenses. Specifically, what is disclosed is an intraocular lens for placement in the anatomic angle of the eye, the implant including a refractive lens having a front surface and a back surface. Additionally, the implant has at least three haptic projections for positioning into the anatomic angle of the eye, wherein each haptic includes a contact pad for engaging the anatomic angle.

Description

INTRAOCULAR LENS

BACKGROUND

[0001] The present disclosure relates generally to a refractive intraocular implant for placement in either the anterior or posterior chamber of an eye. The present disclosure is further directed to a method for treating refractive errors in a patient by anchoring the intraocular lens into the anterior or posterior chamber of the eye.

[0002] For intraocular lens implantation, it was assumed in the art that the preferred location of the implant was in the posterior chamber. Intraocular implants for the posterior chamber have been designed to treat myopia (nearsightedness), astigmatism, and hyperopia (farsightedness), but are predominantly designed to replace a previously or simultaneously removed crystalline lens (aphakic eye) in a cataract patient. Intraocular lenses are surgically implanted into the aphakic eye in order to take the place of the previously or simultaneously removed natural crystalline lens. These intraocular lenses are implanted into the posterior chamber of the eye to compensate for refractive errors or to create a specific refraction to assist in visual function. Anterior chamber lenses are also available for complicated cases.

[0003] The anterior chamber of an eye is an area in front of the iris and behind the cornea. The iris acts as a divider between the anterior chamber and the posterior chamber with the iris constricting and expanding an aperture (pupil) to affect the amount of light captured by the eye. Intraocular lenses have not been predominately designed for the phakic eye (crystalline lens not removed) in the anterior chamber of eye as certain difficulties have been associated with implanting in the phakic eye. Such difficulties include the fact that the phakic eye is a substantially more reactive environment than the aphakic eye. Inflammatory reactions tend to be greater in the anterior chamber of the phakic eye. Such damage may include uveitis hyphemia glaucoma (UGH) syndrome, cataracts, pain, corneal edema, progressive endothelial cell loss, and discomfort.

[0004] Some of these effects may be due to poor lens design or may be due to the presence of the natural crystalline lens in the phakic eye crowding the anterior chamber. The phakic eye has a shallower anterior chamber than the aphakic eye, and the iris is in broad posterior contact with the natural crystalline lens. Therefore, if an inflammatory reaction occurs in the phakic eye, there can be adherence of the iris to an anterior surface of the intraocular lens.

[0005] Another difficulty, when intraocular lens implants are inserted into the anterior chamber of the eye, temporary or permanent adhesions of the implant to iris tissue may result, causing damage to these structures to ensue either immediately or over the long term affecting pupillary mobility and contour. This makes subsequent removal of the implant a complex, dangerous surgical procedure. In addition, the implants may obstruct normal iris contraction causing an accordion like effect on the iris periphery resulting in an elongated or "cat's eye" pupil. Furthermore, the implants may cause vascularization in the area between the cornea and the iris (anatomic angle) causing bleeding or even glaucoma.

[0006] Thus, the failures and pervasive defects of the prior art show a clear need for improved anterior chamber intraocular lenses. The various embodiments of the disclosure address the many deficiencies left by the prior art by providing an intraocular lens designed to provide smooth and uniform contact area where the haptic engages the anatomic angle. SUMMARY

[0007] The following presents a simplified summary of the disclosure in order to provide a basic understanding of some aspects of the disclosure. This summary is not an extensive overview of the disclosure. It is not intended to identify critical elements of the disclosure or to delineate the scope of the disclosure. Its sole purpose is to present some concepts of the disclosure in a simplified form as a prelude to the more detailed description that is presented elsewhere.

[0008] Novel and unobvious intraocular lenses are set forth herein, as will be evident from reviewing the description below and the accompanying drawings. The intraocular lens of the present disclosure may be appropriate for implantations of a primary lens to be used after cataract extraction for optical correction of the eye.

[0009] The disclosed intraocular lens has at least three angled fixation haptics that support any type of optic body including a negative, positive, astigmatic, or multifocal power lens to correct refractive errors resulting from conditions such as myopia, hyperopia, presbyopia, astigmatism or previous surgery. The haptic design precludes necrosis of angle tissue and does not distort the iris's architecture.

[0010] The disclosed intraocular lens includes a refractive lens having a front surface and a back surface, and at least three haptics for positioning into the anatomic or iridocorneal angle of the eye. The distal end of each haptic includes a contact pad for engaging the anatomic angle, the width or radius of the contact pad being greater than that of the haptic. Preferably, the haptic is curved in both a horizontal and vertical direction, such that the haptic slopes downward in a curved or spiral shape. In one embodiment, three haptics are positioned away from the lens such that the center of each contact pad at the distal end of each haptic forms an end to an imaginary equilateral triangle. This positioning ensures that the refractive ocular lens is centered on the eye. Moreover, the sloped nature of the haptics ensures that the refractive lens is suspended over the eye, creating a vault between the eye and the refractive lens. The vertical and horizontal curvature of the haptics, as well as the positioning of the contact pads, provides both columnar and cantilever support, ensuring that the refractive lens will not rotate in the eye, even when external pressure is applied. As the refractive lens is supported by the anatomic angle, it does not require sutures to anchor the lens to the eye, and therefore is easier to implant as well as extract (if needed). Moreover, the large footprint of the contact pads ensures that that the contact pads do not adhere to the anatomic angle structures, thus avoiding intraocular damage.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The drawings constitute a part of this specification and may include exemplary embodiments of the present disclosure and illustrate various objects and features thereof. A further understanding of the disclosure may be had by reference to the accompanying drawing in which:

[0012] Fig. 1 is a front view of an anterior chamber intraocular lens according to an embodiment.

[0013] Fig. 2 is a side view of the anterior chamber intraocular lens of Fig. 1.

[0014] Fig. 3A is a cross section view of the intraocular lens of Fig. 1 in use in a phakic eye.

[0015] Fig. 3B is a cross section view of the intraocular lens of Fig. 1 in use with an aphakic eye.

[0016] Fig. 4 is a front view of an intraocular lens according to a second embodiment. [0017] Fig. 5 is a front view of an intraocular lens according to a third embodiment. DETAILED DESCRIPTION

[0018] Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings. It is to be understood that other embodiments may be utilized and structural and functional changes may be made. Moreover, features of the various embodiments may be combined or altered. As such, the following description is presented by way of illustration only and should not limit in any way the various alternatives and modifications that may be made to the illustrated embodiments. In this disclosure, numerous specific details provide a thorough understanding of the subject disclosure. It should be understood that aspects of this disclosure may be practiced with other embodiments not necessarily including all aspects described herein, etc.

[0019] In a preferred embodiment of this invention, as depicted in Figs. 1-3, an embodiment of a refractive anterior chamber ocular implant 1 having three haptics 11, 11 ', 11" being integral or attached to the refracting lens 14. When implanted into the anterior chamber 16 of a phakic eye 18, the lens 14 is positioned and maintained by the haptics 1 1, 11 ', 11" to prevent contact between it and other anatomical bodies such as the anatomical crystalline lens or other intraocular implant 20, the iris 22, and the corneal endothelium 24 (Fig. 3A). The optic lens 14 is in a plane perpendicular to the optic axis 4 of the eye 18, and the three points of contact B, C, D of the haptic 11, 11 ', 11" are distributed on the circumference of the iridocorneal or anatomic angle 31. More particularly, the ends 26, 26', 26" of the respective haptics 11, 11 ', 11" may be configured to situate within the iris plane or angle 31 to prevent irritation of consequential anterior synechia formation, fibrosis and anisocoria. It is foreseen that the implant 1 may be implanted into an individual that either has no crystalline lens 20 or pseudophake (surgically implanted lens to replace crystalline lens), as both the lens and capsule may have been removed, such as through a surgery, i.e. intracapsular cataract extraction (ICCE). The intraocular lens 1 is shown in Fig. 3B in use positioned within the capsular bay (aperture left from crystalline lens removal) of the posterior chamber or posterior chamber configuration.

[0020] The lens 14 may be concave, convex, aspheric, multi-order diffractive, planar, or any combination thereof, in order to achieve the desired degree of corrective refraction. The optical portion of lens 14, may be fabricated from compounds such as silicone polymer, HEMA, acrylic, polymethylmethacrylate (PMMA), polyimide, hydrogel (formed from a certain percentage of water). The artificial refracting lens 14 of the present invention may be foldable (elastic), rigid, or a combination, depending upon the particular selected composition of the lens. The lens 14 may be folded and inserted into a cartridge to be injected into the anterior chamber. After insertion of the implant 1, the flexible lens 14 may be released and recover to its initial shape.

[0021] The refracting lens 14 of the inventive implant has a lens shape with two surfaces, a front and a back surface 30, 32, such that the combined refractive powers of the two surfaces provides the desired degree of refraction. Lenses 14 having at least one convex surface are typically employed to correct hyperopia. Lenses 14 having at least one concave surface are typically employed to correct myopia. Lenses 14 may have astigmatic correction on either surface. The lens 14 may have a diameter between 5.0 mm and 7.0 mm, preferably at 6.0 mm. In one embodiment, the implant surfaces 30, 32 may be coated with a biocompatible polysaccharide medicament. Other compounds well known to those skilled in the art may also be used in fabricating the anterior chamber ocular implant employed in this invention. [0022] When positioning the implant 1 within the anterior chamber of the phakic eye, it is important to avoid contact with the crystalline lens 20 and the iris 22. The haptics 11, 11 ', 11" slope downward, preferably in a curved, parabolic, or spiral shape, suspending the lens 14 in the anterior chamber 16 of the eye 18 at a vault V between the range of 0.6 mm to 1.0 mm, preferably 0.8 mm. This configuration prevents contact of the refracting lens 14 with the natural crystalline lens 20 or iris 22, and prevents pupillary occlusion. The vault V is measured in relation to a flat bottom surface 40, 40, 40" of respective contact pads, duct plate, or footplates 34, 34', 34" and the back surface 32 of the optic 14, when the implant 1 is in a resting position or implanted in the eye 18. Displacement may be either positive or negative along a sagittal direction. The change in position of the optic 14 from a resting position to a position in a posterior or anterior direction to the anatomic crystalline lens 20.

[0023] The haptics 11, 11 ', 11" also have a curved, parabolic, or spiral configuration in the horizontal direction. In one embodiment, the haptics 11, 11 ', 11" are designed having one or more extension pad or contact pads 34, 34', 34" that radially extend or curve at angle A from the lens 14 while maintaining uniformity in thickness in a radial direction to anchor the implant 1 in an anatomic or iridocorneal angle 31 of the eye near the scleral spur and beneath Schwalbe's line. It is foreseen that the thickness of the haptics 11, 11 ', 11" may taper towards the contact pads 34, 34', 34". The thickness of the optic lens 14 will change dependent on refractive power of lens. The extension pads 34, 34', 34" create three points of contact with the iridocorneal angle 31 as will be further discussed below.

[0024] The haptics 11, 11 ', 11" are illustrated with a left handed orientation, but just as easily may switch to a right handed orientation (Fig. 4). Having the extension pads 34, 34', 34" radially extending in an outward direction to the iris reduces axial displacement of the implant 1 and leaves the iris free to dilate and constrict without restriction, thus avoiding the cat's eye effect.

[0025] The haptics 11, 11 ', 11" may be attached to the lens 14 at three points B, C, D that if linearly connected substantially create an equilateral triangle. This means that point B may be equally spaced or equal arc lengths 35, 35' from both points C and D and C is equally spaced from D. The haptics 11, 11 ', 11" have a blend zone or transition 12, 12', 12" at an end of the haptics 11, 11 ', 11" that connects to the lens 14. The transition 12, 12', 12" preferably has a larger width or radius than the hap tic arm 15, 15 ', 15". The haptics 11, 11 ', 11" may have an inner arc length 17, 17, 17" from transition 12, 12', 12" to respective ends 26, 26', 26" that is substantially equivalent to the arc length 35, 35', 35" between contact points B, C, and D (or the arc length between transition points 12, 12', and 12"). The haptics arc length 17, 17', 17" may be dependent upon the iris 22 of the patient it is to be implanted in. The transitional portion 12, 12', 12" of the haptics 11, 1 Γ, 11" creates a difference in plane between the proximal and distal ends 26, 26', 26" of the haptics 11, 11 ', 11" to reduce risk of: endothelial cell 24 damage, damage to the natural crystalline lens 20 during and after surgical implantation in the anterior chamber of a phakic eye 18, glare and haloing, and ovaling of the pupil 23.

[0026] The contact or extension pads 34, 34', 34" are located at haptic distal ends 26, 26', 26". In one embodiment, the center 38, 38', 38" of each haptic end 26, 26', 26" runs tangential to two of the three points B, C, D. An imaginary linear connection of each center 38, 38', 38" of the haptic ends 26, 26', 26" creates an equilateral triangle. An imaginary circular connection of each center 38, 38', 38" of haptic ends 26, 26', 26" creates a circle. This outer circle may have a diameter of 12.0 mm, if the lens 14 diameter is 6.0 mm, i.e. about double the lens diameter. Put another way, the distance from the center of the lens to the haptic ends 26, 26', 26" is twice the radius of the lens. The contact pads 34, 34', 34" have an outer radii 42, 42', 42" that corresponds with the contour of the anatomic angle 31.

[0027] The vertical and horizontal curvature of the haptics 11, 11 ', 11", as well as the positioning of the contact pads 34, 34', 34", provides both columnar and cantilever support to the implant 1, ensuring that the implant 1 will not rotate in the eye, even when external pressure is applied. As the refractive lens is supported by the anatomic angle 31 , it does not require sutures to anchor the lens to the eye, and therefore is easier to implant as well as extract (if needed). The three-point attachment of the three contact or extension pads 34, 34', 34 minimizes contact with or adherence to the anatomic angle 31 and iris 22, and minimizes or eliminates damage to the corneal endothelium 24.

[0028] The haptics 11, 11 ', 11" may be made from highly flexible material, semi- flexible material, or material having varying degrees of flexibility or elasticity. The haptics 11, 11 ', 11" may be made of the same material as described above for the optical portion 14 of the implant 1, or may be made of materials such as polypropylene or medical grade silicone. Depending on the composition selected, elasticity of each the haptics 11, 11 ', 11" may be varied. The implant 1 may be made from a material that is invisible to someone looking at an eye 18 with an implant 1 rooted. The thickness T of each haptic 11, 11 ', 11" is greater than its width or radius in order to reduce displacement of the implant 1 under diametrical compression. The thickness T is between 0.1 mm and 1.0 mm, preferably around 0.6 mm.

[0029] Referring now to Fig. 4, another embodiment of an intraocular lens implant 101 is illustrated. The implant 101 and the components of the implant 101 are substantially similar to the counterparts in implant 1 , except as specifically noted and/or shown, or as would be inherent. The intraocular lens implant 101 is substantially similar to the intraocular implant 1 as discussed above, with the exception that haptics 111, 111 ', 111" may have a body or frame 133. The body 133 has an aperture 140 through the center defined by an inner surface 142. The inner surface 142 surround a lens (not shown) and the haptics 111, 111 ', 111" are attached therein at points B', C, D' (Fig. 4) on the body 133. The haptics 1 11, Π Γ, 111" are illustrated with a right hand orientation or curvature.

[0030] Referring now to Fig. 5, another embodiment of an intraocular lens implant 101 is illustrated. The implant 201 and the components of the implant 101 are substantially similar to the counterparts in implant 1 , except as specifically noted and/or shown, or as would be inherent. The intraocular lens implant 201 is substantially similar to the intraocular implant 1 as discussed above, with the exception that haptics 211, 211 ', 211", 21 Γ" are located 90 degrees apart and an equal or substantially equal arc length apart and there is a fourth haptic 21 Γ". The haptics 211, 211 ', 211", 211"' are attached at points B", C", D", E" on the lens 14. The haptics 111, 111 ', 111" are illustrated with a left hand orientation or curvature.

[0031] In one embodiment of a method of implanting the above described implants, the implants are constructed from a soft and flexible material, and are inserted into an eye via a 1.0 to 3.0 mm incision made in the eye via methods known in the art. Prior to the incision, the pupil is constricted to 1.0-1.5 mm via methods known in the art. The implant is then folded or rolled into a configuration that can be inserted into the cartridge of an intraocular lens delivery system. After being loaded into the cartridge, the cartridge is inserted into the eye via the incision. The implant is then expelled from the cartridge and deposited into the anterior or posterior chamber of the eye, depending on whether the treated eye is phakic or aphakic. Upon being deposited, the intraocular implant will unfold or unroll into its original shape. The intraocular implant is then manipulated such that the lens of the intraocular implant is centered on the eye and the contact pads of the intraocular implant are positioned on the anatomic angle of the eye.

[0032] Since the intraocular implant is positioned on the eye via contact pads, there is no need to anchor the intraocular implant to the eye via sutures. Given this, the procedure can be easily reversed. Upon explantation the intraocular implant will fold on itself and have a thickness of approximately 0.2 mm, allowing the implant to be removed with ease.

[0033] Many different arrangements of the various components depicted, as well as components not shown, are possible without departing from the spirit and scope of the present disclosure. Embodiments of the present disclosure have been described with the intent to be illustrative rather than restrictive. Alternative embodiments will become apparent to those skilled in the art that do not depart from its scope. A skilled artisan may develop alternative means of implementing the aforementioned improvements without departing from the scope of the present disclosure. Further, it will be understood that certain features and subcombinations may be of utility and may be employed within the scope of the disclosure. Further, various steps set forth herein may be carried out in orders that differ from those set forth herein without departing from the scope of the present methods. This description shall not be restricted to the above embodiments.

Claims

C L A I M S What is claimed is:

1. A refractive ocular implant for placement in an eye, said eye having an anatomic angle located between a cornea and an iris, said implant comprising:

a refractive lens having a front surface and a back surface;

at least three haptic arms for positioning into said anatomic angle of said eye, said haptic arms extending radially from said lens;

wherein said haptic arms have distal ends and proximal ends;

wherein said distal ends of each of said haptic arms further comprise at least one contact pad for engaging said anatomic angle; and

wherein said proximal ends of said haptic arms further comprise haptic transition points.

2. The refractive ocular implant of claim 1, wherein said lens is circular.

3. The refractive ocular implant of claim 1, wherein said haptic arms extends horizontally from said lens in a curved configuration, and extend downward from said lens in a curved configuration.

4. The refractive ocular implant of claim 1, wherein said refractive ocular implant is placed in the anterior chamber of a phakic eye.

5. The refractive ocular implant of claim 1, wherein said refractive ocular implant is placed in the posterior chamber of an aphakic eye.

6. The refractive ocular implant of claim 1, wherein said refractive ocular implant is placed into the anterior chamber of a pseudophake eye.

7. The refractive ocular implant of claim 2, wherein said implant further comprises a first, second, and third haptic arm; wherein said first haptic arm further comprises a first haptic transition point centered at said proximal end of said first haptic arm, and a first contact pad centered on said distal end of said first haptic arm;

wherein said second haptic arm further comprises a second haptic transition point centered at said proximal end of said second haptic arm, and a second contact pad centered on said distal end of said second haptic arm;

wherein said third haptic arm further comprises a third haptic transition point centered at said proximal end of said third haptic arm, and a third contact pad centered on said distal end of said first haptic arm;

wherein the centers of said first, second, and third contact pads are positioned equally away from said refractive lens such that said centers of said first, second, and third contact pads form the ends of an imaginary equilateral triangle.

8. The refractive ocular implant of claim 7, wherein said first, second, and third haptic transition points are connected to said lens, and said first, second, and third haptic transition points are positioned equidistant from one another such that said first, second, and third haptic transition points form the ends of an imaginary equilateral triangle.

9. The refractive ocular implant of claim 8, wherein said haptic arms extend from said lens in a semi-circular configuration; and

wherein the arc length between said first haptic transition point and said second haptic transition point is substantially equal to the arc length between said proximal and said distal ends of said first, second, or third haptic arms.

10. The refractive ocular implant of claim 1, wherein said lens is a concave lens, a convex lens, an aspheric lens, a multi-order diffractive lent, a planar lens, or combinations thereof.

11. The refractive ocular implant of claim 1, wherein said lens and said haptic arms are fabricated from silicone polymer, 2-hydroxyethyl methacrylate (HEMA), acrylic, polymethylmethacrylate (PMMA), polyimide, or hydrogel.

12. The refractive ocular implant of claim 1, wherein said lens and said haptic arms are foldable, rigid, or partially foldable.

13. The refractive ocular implant of claim 2, wherein said lens has a diameter between 5.0 mm and 7.0 mm.

14. The refractive ocular implant of claim 13, wherein said lens has a diameter of 6.0 mm.

15. The refractive ocular implant of claim 2, wherein the distance from the center of said circular lens to said distal ends of said haptic arms is about twice the radius of said circular lens.

16. The refractive ocular implant of claim 1, wherein said front surface of said lens and said back surface of said lens are coated with a biocompatible polysaccharide medicament.

17. The refractive ocular implant of claim 1, wherein said haptic arms slope downward to suspend said lens in said anterior chamber of said eye, forming a vault between said lens and the natural crystalline lens or iris of said eye, said vault having a height between 0.6 mm and 1.0 mm.

18. The refractive ocular implant of claim 17, wherein the height of said vault is 0.8 mm.

19. The refractive ocular implant of claim 1, wherein said haptic arms taper in thickness towards said distal contact pads.

20. The refractive ocular implant of claim 1, wherein said hap tics arms maintain a uniform thickness towards said distal contact pads.

21. The refractive ocular implant of claim 1, wherein said haptic arms have a thickness between 0.1 mm and 1.0 mm.

22. The refractive ocular implant of claim 21, wherein said haptic arms have a thickness of 0.6 mm.

23. The refractive ocular implant of claim 1 , wherein the width of said haptic transition points is greater than the width of said haptic arms.

24. The refractive ocular implant of claim 1, wherein said refractive ocular implant further comprises an annular body;

wherein said annular body surrounds said lens; and

wherein said haptic transition points are connected to said annular body.

25. A method of implanting a refractive ocular implant in an eye, said method comprising the steps of:

folding a flexible refractive ocular implant into a shape capable of being inserted into a cartridge, said refractive ocular implant comprising:

a refractive lens having a front surface and a back surface;

wherein said haptic arms have distal ends and proximal ends;

wherein said distal ends of said haptic arms further comprise at least one contact pad for engaging said anatomic angle; and

wherein said proximal ends of said haptic arms further comprise haptic transition points; inserting said refractive ocular implant into said cartridge;

constricting the pupil of said eye to a size of 1.0-1.5 mm;

creating a 1.0 mm to 3.0 mm incision in said eye;

inserting said cartridge into said eye; releasing said refractive ocular implant from said cartridge such that said refractive ocular implant is deposited in the eye and is returned to its original shape;

positioning said refractive ocular implant such that said lens is centered on said eye and said contact pads engage said anatomic angle of said eye.

26. The method of claim 25, wherein said refractive ocular implant is inserted into the anterior chamber of a phakic eye.

27. The method of claim 25, wherein said refractive ocular implant is inserted into the posterior chamber of an aphakic eye.

28. The method of claim 25, wherein said refractive ocular implant is inserted to treat myopia, hyperopia, presbyopia, astigmatism, or complications from previous surgery.