Patent Application
20240024095
This application is directed to methods and apparatuses to improve positional stability in intraocular lens systems when implanted in the capsular bag.
Cataract is a common cause for vision loss in aging individuals. Cataract is a progressive condition in which the natural lens within the eye becomes opaque. This process can eventually lead to blurred, obscured vision and even blindness as the condition progresses further. The good news for many patients is that a well-known procedure can restore vision to a great extent. The procedure involves removing the natural lens containing the cataract and thereafter replacing the focusing function of the natural lens with a prosthetic lens, commonly referred to as an intraocular lens or an “IOL”. The membrane containing the natural lens, called the “capsular bag”, is not affected by the cataracts and is left intact, except for an opening in the anterior side needed to accommodate removal of the natural lens and insertion of the IOL.
IOLs are usually formed by a single piece that contains the optical part (which provides the focusing function mentioned above) and a device to fixate the IOL in the capsular bag. For example, the TECNIS® family of IOLs has a 13 mm dimension in a larger axis (between ends of the haptics) and the optical part has a 6mm diameter optical zone. IOLs can be formed by more pieces (e.g., two lenses) and/or more complex platforms (e.g., to provide for displacement of lenses with respect to each other). The device is fixated in the capsular bag by applying force in the inner part of the capsular bag.
Typically the lenses are inserted into the eye in an injector apparatus that is similar to a syringe but with a larger bore and usually with some structure for folding the IOL. More complex, larger IOLs tend to call for larger bore injectors which is counter to most patient and surgeon preference.
There is a need for a new technology for improving positional stability of IOLs. Rotation in toric IOLs, axial position, tilt and decentration are major causes of residual refractive errors after surgery. Moreover, embodiments disclosed herein enable larger size IOLs which deliver more functionality to be placed in the eye without excessive trauma or other complications. In various embodiments, IOLs can be configured to be assembled within the eye to provide advantageous implantation and performance.
In one embodiment, a multi-piece IOL assembly is provided that includes a platform and an optic. The platform has an outer periphery configured to couple with an inner periphery of an eye (e.g., an inner periphery of a capsular bag, or a periphery of the anterior chamber or the posterior chamber of the eye). The platform has an inner periphery surrounding an inner zone of the platform. The optic has an optical zone, an outer periphery and a retention mechanism disposed on the outer periphery. The optic is configured to be disposed in the inner zone of the platform and to extend to a location between the inner periphery and the outer periphery of the platform to be secured to the platform at the location.
In another embodiment, a method of implanting an IOL in an eye is provided. In the method, an interior space, e.g., an anterior chamber or a posterior chamber, of an eye is accessed. A platform is advanced into the interior space, e.g., into the anterior or posterior chamber. The platform has an outer periphery and an inner periphery surrounding an inner zone of the platform. The platform is coupled with an inner periphery of the eye. An optic is advanced into the interior space, e.g., into the anterior or posterior chamber of the eye after the platform is advanced into the interior space, e.g., into the anterior or posterior chamber. The optic has an optical zone and an outer periphery. The optical zone of the optic is advanced into the inner zone of the platform. The outer periphery of the optic is advanced to a location of the platform between the outer periphery and the inner periphery thereof.
In another embodiment, a platform to place the IOL is created or formed in the capsular bag by femtosecond laser or other segmenting or emulsifying device. During the cataract surgery, an inner part of the crystalline lens disposed about the optical axis of the eye is removed leaving a platform structure in the outer part of the crystalline lens. The outer part can be configured with an inner periphery that is configured for placing and for securing the IOL inside the capsular bag.
In one example, a method of improving a patient's vision is provided. A platform is provided for supporting an optic in an eye of a patient. The platform has a one or a plurality of notches. An optic is coupled with the platform such that an optical zone thereof is central portion of the platform. A retention mechanism of the optic is disposed in the notch or in one of the notches of the plurality of notches in an initial position. Following placement of the optic, an observation is made as to whether a more anterior or more posterior position could provide better optical performance. The platform is modified to allow the optic to move from the initial position to an adjusted position to provide better optical performance.
In the foregoing methods, one or more notches can be formed or eliminated to allow the optic to move from the initial position to the adjusted position.
In another method, cutting energy is directed into an eye to remove a central portion of a natural lens capsule from the eye. Cutting energy is directed into the eye to form an inner periphery in a portion of the lens capsule that is to remain after the central portion thereof has been removed. The inner periphery has one or more notches configured to receive retention structures of an optic to be coupled with the inner periphery of the remaining portion.
In one embodiment, the IOL is fixed in to the capsular bag by photobonding. The photobonding is applied to the outer part of the platform to the inner part of the capsular bag to prevent IOL rotation and displacement.
In another embodiment, the piggyback IOL is fixed in an existing IOL implanted in the capsular bag by photobonding.
The systems, methods and devices may be better understood from the following detailed description when read in conjunction with the accompanying schematic drawings, which are for illustrative purposes only. The drawings include the following figures:
This application is directed to apparatuses, systems and methods that enable a broader range of IOL design freedom. Broader design freedom is provided at least in part by enabling a more voluminous IOL to be implanted without requiring a much larger incision size. IOL designs have heretofore been limited by a maximum size of a corneal incision that is used to deliver the IOL into the eye, specifically into the capsular bag of the eye. Smaller incisions of a diameter of about 2.75 mm to 3.2 mm are preferred by surgeons in order to reduce the risk of complications during surgery. Examples of complications that can arise from larger incisions are surgically induced astigmatism and post-operative trauma. This small size constrains the possibilities of new IOL designs for example in terms of the optical zone diameter and the central thickness of the optical part of the IOL.
Additionally, this application also addresses methods to increase positional stability inside the capsular bag. Although different platforms are available in the market, rotation in toric IOLs, displacement in the axial position, tilt and decentration, are still major causes of post-operative refractive errors (defocus, astigmatism and higher order aberrations). The methods can be also applied to piggyback IOLs designs that can be used to correct existing post-operative refractive errors from a previous cataract surgery, or to provide new features to an implanted IOL design in pseudophakic patient (e.g. a multifocal design in a patient previously implanted with a monofocal IOL).
The platform 104 includes an outer periphery 108 and an inner periphery 112. The outer periphery 108 surrounds the inner periphery 112 and also surrounds an inner zone 116. The outer periphery 108 can be circular with a diameter of 10 mm. In one embodiment, the inner periphery 112 also is circular and has a diameter of between about 4 mm and about 9 mm, in some cases between 5 mm and 8 mm, and in one specific example about 6.5 mm. The inner zone 116 can be a through hole in a central zone of the platform 104. The inner zone 116 can be surrounded by the inner periphery 112 of the platform 104. The outer periphery 108 can be configured to couple with an inner periphery of an eye. For example, the outer periphery 108 can be configured to couple with the inside surface of the capsular bag 18 or with a sulcus S of the eye.
The platform 104 is configured to be assembled with the optic 130 in the eye in certain techniques. The platform 104 can have a location 146 configured for securing the optic 130. The location 146 can be an annular zone of the platform 104 between the outer periphery 108 and the inner periphery 112. The location 146 can comprise one or more grooves or slots that can hold one or more optics. The location 146 can include a mechanical interface such as a projection or protrusion as discussed further below.
The platform 104 and the optic 130 can comprise materials that have different light transmission characteristics. For example, the platform 104 can have zero transmittance in at least the visible wavelengths of light to block transmission of at least visible wavelengths of incident. As another example, the platform 104 can comprise materials that transmit less than or equal to about 10% of the incident light. In some embodiments, the platform 104 can be configured to transmit less than 1% of light in the visible wavelength range, less than 2% of light in the visible wavelength range, less than 3% of light in the visible wavelength range, less than 5% of light in the visible wavelength range.
The optic 130 can comprise materials that transmit substantially all the incident light in the visible wavelength range. For example, the optic 130 can comprise materials that transmit greater than or equal to 80% of the incident light in the visible wavelength range, greater than or equal to 85% of the incident light in the visible wavelength range, greater than or equal to 90% of the incident light in the visible wavelength range, greater than or equal to 95% of the incident light in the visible wavelength range, or greater than or equal to 99% of the incident light in the visible wavelength range.
The optic 130 can be configured to have visible light transmittance in a central vision zone and reduced visible light transmittance towards the periphery of the optic 130. In some embodiments, the visible light transmittance can decrease in a determined manner from the center of the optic 130 to the periphery of the optic 130. The optic 130 can comprise materials that have UV filtering characteristics. For example, the optic 130 can be configured to block incident UV light. As another example, the optic 130 can be configured to transmit less than or equal to 5% (e.g., less than or equal to 3%, less than or equal to 2%, or less than or equal to 1%) of the incident UV.
In certain embodiments, the platform 104 includes at least one slot 124 disposed therein. The slot 124 can be enclosed at a radially outward position by a recessed portion of the inner periphery 112. The recessed portion can be enclosed by the outer surface 118.
Referring to
An aperture 172 can be provided as one example of a structure for rotationally positioning the platform 104. If the indicia 160 are configured as anatomical indicia, it may be desirable to rotate the platform 104 after it has been placed in the eye against the interior periphery to which it is to be coupled. A slender surgical instrument such as a curette can be inserted into the aperture 172 to engage the platform 104 so that the platform 104 can be rotated within the eye. Once positioned, the instrument can disengage the aperture 172 leaving the platform 104 in place. The amount of rotation by engagement with the aperture 172 can be guided by the indicia 160 if configured as anatomical indicia.
It may be possible to use the indicia 160 for both rotationally positioning the platform 104 to the ocular anatomy and for positioning the optic 130. In some embodiments two separate indicia are provided. A first indicia 160a is provided for aligning with the anatomy and a second indicia 160b is provided for aligning the optic 130 to the platform 104 as depicted in
In some embodiments the indicia 160 is/are disposed on the anterior surface (e.g., surface 120 of
Photocuring is a technique in which the components to be secured are brought into contact and exposed to UV radiation or visible radiation. The polymer properties of one or both components to be secured can be altered as a result of exposure to UV radiation. For example, one or both components can harden and/or cross-linking of the molecules of the material of one or both components can occur which can facilitate bonding.
An example of ophthalmic applications of photocuring is treatment for keratoconus in which Vitamin B is applied to the cornea, where after it is exposed to UV light causing corneal crosslinking and/or strengthening the cornea.
Some implementations of the platform 104 can comprise materials that can harden and/or exhibit cross linking when exposed to UV radiation and adhere to the capsular bag 18. In some embodiments, a chemical that can harden and/or exhibit cross linking when exposed to UV radiation can be disposed between the platform 104 and the capsular bag 18. The chemical can facilitate bonding between the platform 104 and the capsular bag 18 when exposed to UV radiation. Various materials that can be photocured are described in U.S. Pat. No. 7,276,544 which is incorporated herein by reference in its entirety.
Laser fusion is a technique in which different layers of material are bonded by optical energy. One or more outer layers of material on which the laser light is incident can be configured to transmit the incident laser light and one or more inner layers of material are configured to absorb the light transmitted by the one or more outer layers. The one or more inner layers of material can melt as a result of the absorbed optical energy and fuse with the one or more outer layers. In this manner the different layers or materials are welded or joined together.
Lasers that emit radiation in the far ultraviolet spectral region, such as, for example, an excimer laser or lasers that emit radiation in the far infrared spectral region, such as, for example, a C02 laser can be used for laser fusion.
If chemical agent (e.g., a dye) is applied to or released from one or both the components that are being fused (e.g., the platform) to facilitate or enhance bonding, then lasers that emit radiation in wavelength ranges which activate the chemical agent can be used.
Other lasers that can be used for laser fusion include an argon ion laser, Nd:YAG laser and/or KTiOPO4 (potassium titanyl phosphate) laser.
Example photobonding techniques that can be used to join the platform 104 along the interface 119 are discussed in WO2016/142490A1, the entire contents of which are hereby incorporated by reference herein. In some embodiments, the platform 104 can be joined to the inside surface of the capsular bag 18 by a surface adherent that can self-adhere to the inside surface of the capsular bag 18. US2011/0029074 provides examples of surface adherents that can be provided on the outer surface 118 of the platform 104. For example, gecko feet microfibers as described in US Publication No. 2011/0029074 which is incorporated herein in its entirety can be used as a surface adherent. These surface adherents preferably provide enhanced positional stability and can be configured to be permanent due to the ability to change the optical properties of the optic 130 and/or add a second lens as a piggyback lens. Although the foregoing discussion has been focused on bonding or securing to the inside surface of the capsular bag 18, these techniques can also be applied to the sulcus S or another stable inner periphery of the inside of the eye 10.
The first optic 130 or the second optic 132 (or additional optics) can provide therapy other than restoring proper refraction. In one embodiment, the first optic 130 and the second optic 132 are configured along with the platform 104 to provide varying power. One or both of the first optic 130 and the second optic 132 are configured to move transverse to, e.g., perpendicular to, the optical axis OA. Such movement can cause highest power regions of the optical zone 134 of the first and second optics 130, 132 to overlap more (yielding increased power) or to overlap less (yielding decreased optical power). The transverse movement can be provided during the surgery prior to fully engaging the first and second optics 130, 132 to the platform 104 or can be facilitated by configuring the platform 104 to be sufficiently flexible to be moved or deformed by the zonules 26 and/or the ciliary body 25 to provide accommodation. Further details of such power change are discussed in U.S. Pat. No. 3,305,294, which is incorporated by reference herein in its entirety.
In a two optic embodiment, the optic 130 can include a 6.5 mm diameter. The optic 130 can be configured to optically compensate for corneal aberrations. For example, the optic 130 can include an aspheric anterior surface to compensate for corneal spherical aberrations. The power of the optic 130 can be around +10 diopter (D), around +20 D, around +30 D, as examples. The optic 130 can have a spherical posterior surface in some examples. The second optic 132 can include a 6.5 mm diameter. The second optic 132 can have an aspheric anterior surface to provide zero spherical aberration in one embodiment. The second optic 132 can have powers in the range of −5 D to +5 D. The second optic 132 can have a spherical posterior surface. In a kit, a plurality of optics 130 can be provided, e.g., +10 D, +20 D, +30 D, a plurality of second optic 132 can be provided, e.g., −5 D to +5 D in 0.5 D increments, and the platform 104 can be provided.
The optic 130 can also incorporate optics that deflect the focal point of the eye away from the natural focal area, which is referred to as the fovea. In some conditions such as macular degeneration, retinal cells at the fovea do not function properly. Most eyes benefit from additional locations on the retina, sometimes referred to as peripheral retinal locations because these locations are spaced away from the fovea, where a focused image can be detected and interpreted by the brain. Thus, there is an opportunity to configure the optic 130 with the optical zone 134 being able to deflect light away from the fovea to one of these peripheral locations. The optical zone 134 thus can be configured to address macular degeneration and other diseases that reduce or eliminate the ability to detect an image focused at the fovea. Examples of such lenses are discussed in U.S. Publication No. 2015/0250583 which is incorporated herein by reference in its entirety.
Even for patients without any foveal function concern, the optic 130, the second optic 132, or both the optic 130 and the second optic 132 can be configured to provide enhanced image quality for a larger field of view by reducing, e.g., by minimizing or eliminating, peripheral aberrations. Examples of such lens are discussed in U.S. Publication No. 2015/0320547 which is incorporated herein by reference in its entirety.
The optic 130 or the second optic 132 can incorporate any optical design, such as multifocal, extended range of vision, toric, and other designs. Toric lenses are susceptible to rotation after implantation. Since, the astigmatic correction provided by the tonic lens can vary with rotational alignment of the toric lens, rotational stability of toric lenses is advantageous. The platform 104 and/or 204 can advantageously increase the rotational stability of toric lenses.
The projection 143 and recess configuration of the retention mechanism 142 and the platform 104 can provide a tactile feedback benefit to the surgeon. For example, if the surgeon moves the optic 130 about the optical axis OA within the platform 104 from a first rotational position to a second rotational position, the surgeon will be able to feel the retention mechanism 142 engaging the recess in the slot 124, the slot 125, or the slot 126 of the platform 104. The engagement of the retention mechanism 142 can assure that a rotationally asymmetric optical zone 134 (e.g., as in a toric lens) will continue to remain at the proper orientation. This is because the platform 104 can be securely affixed to an inner periphery of the eye 10 using any of the techniques discussed herein. The engagement between the retention mechanism 142 with the platform 104, e.g., projections 143 of the retention mechanism 142 with recesses in the platform 104 can assure that the rotational position of the optic 130 (or the second optic 132 or other optics in the platform 104) is maintained.
The platform 104 and the optic 130 can be configured to reduce, minimize or eliminate aberrations around the inner periphery 112. For example, as discussed above, the platform 104 and the optic 130 can have different transmittance characteristics. The platform 104 can be at least partially opaque. The platform 104 can be configured to prevent transmission of substantially all incident light. The platform 104 can be tinted sufficiently to prevent light from propagating out of the optic, e.g., through internal reflection toward the retina or out of the eye through the platform 104. Some embodiments provide a variation, e.g., a gradual change, in transmittance between the optical axis OA and the inner periphery 112 of the platform 104. This allows the platform 104 to block reflected light that could create aberrations due to the optical behavior of the platform 104 but prevent the presence of a drastic difference in opacity between the platform 104 and the optic 130 from creating other aberrations.
The peripheral portion 304 can define an inner periphery 312 of the platform P in the eye. The inner periphery 312 can include a profile not found in the ocular anatomy. The inner periphery 312 can include one or a plurality of notches 316. The notches 316 can be separated along the optical axis OA. In one embodiment, the notches 316 are spaced from each other by a separation distance or spacing that provide a noticeable change in focal point at the retina. Such spacing can be sufficient to provide the equivalent of a change in power, e.g., +/−0.25 diopters, +/−0.5 diopters, +/−0.75 diopters or any other increment but generally less than 1 diopter between adjacent notches.
By preparing the lens L in the foregoing manner with notches 316 built into the peripheral portion 304 greater stability and selectability can be provided for implanting lenses. The peripheral portion 304 can be much thicker in the equatorial plane (e.g., the plane transverse to the optical axis OA that intersects the widest part of the lens L. This greater thickness enables the platform P formed in the eye 10 to retain much more rigidity than a conventional capsular bag 18 formed in an eye using standard techniques such as phacoemulsification or even using a femtosecond laser. The notches 316 can be configured to engage peripheral portions of optics as discussed further below. So in addition to being more rigid than a conventional capsular bag, the platform P can engage optics in a way that provides for their rotational stability.
As discussed elsewhere herein, photobonding and related procedures can be used to secure an implanted structure in the eye 10. For example,
The second optic 132 can be provided with optics that cancel any aberrations that arise in the patient due to an advancing condition or that arise due to unexpected sub-optimal performance of the optic 130.
As in the optic 130, the optic 132 can be secured in the platform P′ using a retention mechanism 142. The retention mechanism 142 of the second optic 132 can include a detent or other protrusion that engages a portion of one of the notches 316. In some embodiments, the second optic 132 can be secured using photobonding or another adherent.
The foregoing embodiments can be used in a method of addressing vision problems by implanting the multi-piece IOL assembly 100 using various methods.
After the capsular bag has been prepared the platform 104 is advanced into the anterior chamber 14. The platform 104 and other components of the IOL assembly 100 can include elastic compression to inject through a small incision, e.g., through an incision of about 2.75 mm to 3.2 mm. Following injection, components of the multi-piece IOL assembly 100 can elastically expand. Thereafter the multi-piece IOL assembly 100 can be assembled in the eye. For example, upon release from the injector apparatus, the outer periphery 108 and the inner periphery 112 of the platform 104 expand to an uncompressed state. The platform 104 can be moved into engagement with an inner periphery of the eye such that the inner zone 116 of the platform 104 is centered on the optical axis OA.
The platform is coupled with the sulcus S, the inside surface of the capsular bag 18 or with another inner periphery of the eye 10. Many different methods could be used for such coupling of the platform 104 with the inner periphery of the eye 10. As discussed above, the interface 119 between the outer surface 118 and the inner periphery of the eye 10 can be secured by laser fusion, photocuring, or another form of photobonding. Laser fusion can advantageously be performed at least in part by emitting light from a location outside the eye onto the zone where the interface 119 is to be formed. In at least this respect, laser fusion and other forms of photobonding are among the less invasive approaches to couple the platform 104 to the inner periphery of the eye 10. The interface 119 between the outer surface 118 and the inner periphery of the eye 10 can be secured by chemical gluing. Chemical gluing is advantageous in not requiring a light source to be directed into the eye. This can enhance safety in not requiring high energy light to be directed into the eye and also eliminates the need for this equipment when it is not otherwise in the operating room. Chemical bonding may require a cannula to deliver a chemical adhesive into the eye in a controlled manner. The interface 119 between the outer surface 118 and the inner periphery of the eye 10 can be secured by providing an adherent on the outer surface 118 of the platform 104. Providing an adherent on the outer surface 118 is advantageous in not requiring delivery of any adhesive into the eye via a cannula. An adherent may provide great security immediately upon placement.
After the platform 104 is coupled with the inner periphery of the eye 10, the optic 130 can be advanced into the anterior chamber of the eye. The optic 130 can be elastically compressed in an injector apparatus. The optic 130 can be inserted in the same injector apparatus as the platform 104. The optic 130 and the platform 104 can be injected sequentially without removing the tip of the injector apparatus from the anterior chamber 14.
After the optic 130 has regained an uncompressed state, the optic 130 can be coupled with the platform 104. The optical zone 134 of the optic 130 can be positioned in the inner zone 116 of the platform 104. In one technique, the outer periphery 138 is inserted into one of the slot 124, the slot 125, and the slot 126. In some methods, optical measurements can be used to determine into which of the slots 124, 125, 126 the optic 130 should be inserted. In one approach an aberrometry technique is used to determine the aphakic power of the eye 10. The aphakic power combined with the relative positions of the slots 124, 125, 126, the shape of the eye 10 and other factors can determine which of the slots 124, 125, 126 would provide the best refractive outcome. Thereafter the optic 130 can be placed in the slot that is chosen.
Advantageously the connection between the optic 130 and the platform 104 can be secured but releasable. For example, as discussed above the connection can be similar to a detent mechanism. Accordingly, in some techniques, a pseudophakic aberrometric measurement (with the optic 130 in place) can be made to confirm that the selected position provides the refractive result desired. If the result is not as desired, an action can be taken such as moving the optic 130 to a slot that is anterior or posterior of the initially selected and aberrometrically tested slot. Or, the second optic 132 can be placed in a more anteriorly located slot as discussed further below.
The manner of connecting the optic 130 to the platform 104 can include moving the outer periphery 138 of the optic 130 into one of the slots, e.g., into the slot 124. As the outer periphery 138 of the optic 130 is advanced to the location 146 of the platform 104 between the outer periphery 108 and the inner periphery 112 the optical zone 134 of the optic 130 comes to reset in the inner zone 116 of the platform 104. This position surrounds the optical axis OA of the eye and the multi-piece IOL assembly 100.
The multi-piece IOL assembly 100 can be assembled within the eye in several ways. They individual components can be completely separate prior to assembly and can thereafter be assembled in the eye using instruments. The platform 104 and the optic 130 and in some cases secondary lenses such as the second optic 132 can be inserted using the same inserter system to reduce, e.g., to minimize, the number of times the surgeon enters the eye. In other embodiment, the platform 104, the optic 130, and if present additional lenses such as the second optic 132, can be semi-assembled during insertion so that they can be inserted at once. Once in place, these components can be fixed together by pulling on strings that couple the components together after implantation.
The above presents a description of systems and methods contemplated for carrying out the concepts disclosed herein, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use this invention. The systems and methods disclosed herein, however, are susceptible to modifications and alternate constructions from that discussed above which are within the scope of the present disclosure. Consequently, it is not the intention to limit this disclosure to the particular embodiments disclosed. On the contrary, the intention is to cover modifications and alternate constructions coming within the spirit and scope of the disclosure as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of embodiments disclosed herein.
Although embodiments have been described and pictured in an exemplary form with a certain degree of particularity, it should be understood that the present disclosure has been made by way of example, and that numerous changes in the details of construction and combination and arrangement of parts and steps may be made without departing from the spirit and scope of the disclosure as set forth in the claims hereinafter.
This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62/556,853, filed Sep. 11, 2017, which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62556853 | Sep 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16128434 | Sep 2018 | US |
| Child | 18356105 | US |
