HK1210741B

HK1210741B - Hydrophilicity alteration system and method

Info

Publication number: HK1210741B
Application number: HK15111537.0A
Authority: HK
Inventors: R.扎勒; S.Q.周; J.F.比勒
Original assignee: 完美Ip有限公司
Priority date: 2012-11-14
Filing date: 2013-10-09
Publication date: 2018-02-23

Description

Hydrophilicity alteration systems and methods

Cross Reference to Related Applications

The present application claims benefit of U.S. provisional patent applications entitled "HYDROPHILICTY ALTERATION SYSTEM AND METHOD" filed 11, 14.2012 by inventors Ruth Sahler, Stephen Q.ZHou, and Josef F.Bille to USPTO, serial No. 61/726,383, case No. AAARE.0105P (original case No. AAARE.0107P), and incorporated herein by reference.

The present application claims the benefit of U.S. utility patent application serial No. 13/843,464, case No. aaare.0105, entitled "hydroophilic energy conversion SYSTEM AND METHOD", filed by inventors Ruth Sahler, Stephen q.zhou, and Josef f f.bille to USPTO on 15/3/2013, and incorporated herein by reference.

Partial abandonment of copyright

All material in this patent application is subject to copyright protection under the copyright laws of the united states and other countries. Since the first filing date of this application, this material was protected as unpublished material.

However, permission to copy the material is hereby granted to the extent that the copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the U.S. patent and trademark office patent file or records, but otherwise reserves all copyright rights whatsoever.

Statement regarding federally sponsored research or development

Not applicable to

Reference to the microfilm Appendix (Microfiche Appendix)

Not applicable to

Technical Field

The present invention relates to modification of hydrophilicity of materials. The hydrophilicity of the material is altered by exposing the material to the targeted laser pulse. The laser pulse is absorbed and changes the chemical bonds of the molecules within the material. The material (if hydrophobic) either absorbs water due to a change in molecular structure or repels water (if the material is hydrophilic). By way of example only, the present invention teaches a laser system and method for modifying the hydrophilicity of an optical lens in a predetermined region inside the lens body with or without a change in hydrophilicity on the lens surface. The material used in the experiments described herein as applied to the present invention is Polyacrylic Lens Material (PLM), but this material selection is exemplary and should not be considered as a limitation of the present invention.

Background art (0100) - (0400)

Conventionally, intraocular lenses are manufactured using cutting or molding techniques to make polymer-based lenses, which may require an abrasive tumbling step to achieve optical-grade quality. The optical lens may be surface modified by physical and chemical means.

Physical methods include, but are not limited to, plasma, corona discharge, and microwave treatment. This treatment may alter the hydrophilicity of the lens surface. For example, U.S. patent 5,260,093 entitled "METHOD OF creating biocompatable, SURFACE MODIFIED MATERIALS," issued to Ihab Kamel and David b.soll at 11/9 OF 1993, discloses a METHOD for permanently modifying the SURFACE OF a substrate material by means OF radio frequency plasma. One of the substrates disclosed in this patent is an intraocular lens.

Chemical modification of optical lenses is also well known. Chemical modification of an optical lens can change the chemical composition on the surface, which therefore changes not only the hydrophilicity of the lens surface, but also the physical and chemical properties of the surface. FOR example, U.S. patent 6,011,082 entitled "PROCESS FOR THE MODIFICATION OF ELEMENTS WITH SURFACE INTERPRETING POLYMERNEETWORKS AND ELEMENTS FOR THE THEREFROM", filed on 4.1.2000 by Yaning Wang, Robert van Boxtel AND Stephen Q.Zhou, discloses a method OF chemically modifying a polymerized silica gel intraocular lens to a hydrophilic SURFACE by heparin AND other hydrophilic agents.

However, the above prior art methods can only be used to treat the lens surface. They cannot be used to modify the hydrophilicity of the lens body below the surface. In other words, they cannot be used to treat predetermined areas inside the lens material.

In contrast, recent laser technology makes it possible to selectively useTo a predetermined area inside a material, including an optical lens material, without altering the lens surface. For example, U.S. patent application publication US2002/0117624A entitled "PLASTIC OBJECT" issued by inventors Shigeru Katayama and Mika Horiike at 29.8.2002, discloses a general method of making a PLASTIC OBJECT using a laser that passes 10 through a portion of its inner body^-12A laser of ultrashort pulse duration of seconds or less. Examples of internal structures created using this prior art technique are generally illustrated in fig. 1(0100) and fig. 2 (0200).

A recent application in US patent application publication US2008/0001320a1, entitled "OPTICAL MATERIAL AND METHOD FOR MODIFYING OPTICAL fiber INDEX", issued by the inventors Wayne h.knox, Li Ding, Jay Friedrich Kunzler and dharmandra m.jani on 3.2008, month, 1, discloses a METHOD FOR MODIFYING the refractive INDEX of an OPTICAL polymer material, which METHOD comprises irradiating selected regions with femtosecond laser pulses (using a system configuration as generally exemplified in fig. 3 (0300)) resulting in a refractive OPTICAL structure forming a laser treated region, which refractive OPTICAL structure is characterized by a positive change in refractive INDEX. The patent application publication also discloses that the calculated refractive index change (Δ n) is positive, in the range of 0.03 to 0.06. This prior art teaches that if the selected treated region is convex-flat shaped, it will create a positive lens, whereas if the treated region is biconcave shaped, it will be a negative lens. This is illustrated in the drawings disclosed in US2008/0001320a1 patent application and reproduced herein as fig. 4 (0400).

The prior art does not address the modification of the hydrophilicity of the interior regions of the material.

Disadvantages of the prior art

Although the prior art as detailed above can theoretically be used to form an optical lens, it has the following disadvantages:

● for a lens 200 microns thick and 6mm in diameter, the prior art limited the lens formed in the lens material to a change of 2.65 diopters, while the present invention creates a 20 diopter lens with the same lens diameter.

● the prior art requires several hours to create a 2.65 diopter lens, while the present invention will produce the same lens in a few minutes. Prior art paper publications show a forming speed of 0.4um/s for high refractive index changes. The following parameters were used: spot size on XY is 1um, spot size on Z is 2.5um, convex lens diameter is 6mm, lens depth is 200 um. The source is as follows: "LARGEREFRACTIVE INDEX CHANGE IN SILICONE-BASED AND NON-SILICONE-BASED HYDROGELPEL POLYMERS INDUCED BY FEMTOSECOND LASER MICRO-MACHINING" BY Li Ding, Richard Black well, Jay F.Kunzler AND Wayne H.Knox.

● the prior art uses a convex lens to produce only positive power changes, whereas the present invention uses a convex lens to produce only negative power changes.

● the prior art is limited to one lens within the material, and the present invention may stack multiple lenses to add power changes or change asphericity, toricity or other lens properties.

● the prior art does not disclose the relationship between hydrophilicity modification and UV absorption, whereas the present invention relies on UV absorption to achieve hydrophilicity modification.

● the prior art does not alter hydrophilicity, whereas the present invention relies on the alteration of hydrophilicity to effect changes in the material. To date, the prior art has not completely addressed these deficiencies.

Object of the Invention

It is therefore an object of the present invention to circumvent (among other objects) the drawbacks of the prior art and to achieve the following object:

(1) providing a system and method that allows modification of the hydrophilicity of the interior of a material with or without modification of the hydrophilicity of the surface of the material;

(2) providing a system and method for altering the hydrophilicity of an entire predetermined three-dimensional region within a polymeric material;

(3) a system and method of manufacturing an optical lens is provided; and

(4) a system and method for altering the hydrophilicity of a predetermined interior region of an implanted intraocular lens, thereby altering the refractivity of the implanted intraocular lens as required by an individual patient for a desired vision result, is provided.

While these objects should not be construed as limiting the teachings of the present invention, they are generally achieved in part or in whole by the disclosed invention as discussed in the following sections. Those skilled in the art will no doubt be able to select the various aspects of the invention disclosed to achieve any combination of the above objectives.

Summary of The Invention

The present invention relates to a system, method and product to process characterization method wherein a pulsed laser system is used to modify the hydrophilicity of a polymeric material (all materials used in the experiments discussed are polymeric acrylic polyacrylic acid polymers ("PLM"), however this material is used as an example and not a limitation of the scope of the invention). The change in hydrophilicity can be used to:

● forming an optical lens having a predetermined refractive power;

● creating hydrophilic regions with additional hydrophobic materials; or

● create hydrophilic regions with additional hydrophilic material.

The present invention is particularly useful for describing, but not limited to, the process of creating a very thin, multi-layer, microstructured customized intraocular lens inside a PLM. This technique can be used for, but is not limited to, the modification of existing lenses currently implanted in the human eye. The modification can adjust the diopter and/or add additional properties, such as toricity and asphericity. The present invention enables the creation of a new type of lens that is thinner than existing products and can be injected through a small incision. Specifically, a system and method for modified, intra-lens refractive index shaping based on the hydrophilicity of the material is disclosed.

A laser system and method for modifying the hydrophilicity of a predetermined interior region of a PLM that can be used as an optical lens is described. The invention can be used to modify the optical properties of an optical lens by increasing (or decreasing) the optical power of the optical lens or changing its asphericity, multifocal, toricity and other optical properties. A typical application of the present invention may include correcting post-operative residual refractive error of an intraocular lens that has been implanted in an eye of a patient.

Despite the best efforts of the surgeon, residual refractive error is inevitable in many cases due to deviations in lens power selection, the patient's history of past ophthalmic surgery (such as LASIK surgery), surgically-induced astigmatism, and progressive changes in the patient's vision. Currently, surgeons use LASIK, an operation to reshape a patient's cornea by destroying a portion of the cornea with a laser beam to correct residual refractive error after cataract surgery. Alternatively, the patient may need to wear glasses to correct the postoperative refractive error. The present invention facilitates situations where these optical imperfections can be corrected in situ after cataract surgery is complete.

It is within the scope of the present invention to manufacture customized intraocular lenses by reducing the lens thickness and the required incision size using all-optical processes or a combination of conventional manufacturing and optical processes. The optical treatment is generally employed by using a femtosecond laser having a pulse energy of 0.17 to 500 nanojoules and a repetition rate of 1 to 100 mhz.

The focal spot of the laser beam is moved inside the lens material to create a changing pattern in the material, creating a three-dimensional lens. Different patterns will provide different lens properties, for example, a toric or aspheric lens.

Drawings

For a fuller understanding of the advantages provided by the present invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings in which:

FIG. 1 illustrates a prior art method of internal plastic modification as taught in U.S. patent application publication US 2002/0117624A;

FIG. 2 illustrates a prior art method of internal plastic modification as taught in U.S. patent application publication US 2002/0117624A;

FIG. 3 illustrates a prior art lens forming system taught by U.S. patent application publication US2008/0001320A 1;

FIG. 4 illustrates a prior art lens form as taught in U.S. patent application publication US2008/0001320A 1;

FIG. 5 illustrates an exemplary system block diagram depicting a preferred exemplary system embodiment of the present invention;

FIG. 6 illustrates an exemplary system block diagram of a preferred exemplary system embodiment of the present invention depicting a typical inventive application set-up environment;

FIG. 7 illustrates a detailed system block diagram that illustrates system components that may be used to implement some preferred inventive embodiments;

FIG. 8 illustrates a comparison of a prior art lens configuration that uses a convex lens for optical convergence and a lens configuration of the present invention that uses a concave lens for optical convergence;

FIG. 9 illustrates the use of the present invention to modify the hydrophilicity of PLMs in both monolayer and multilayer configurations;

FIG. 10 illustrates an exemplary convex/biconvex lens structure of the present teachings;

FIG. 11 illustrates an exemplary concave/biconcave lens structure in accordance with the teachings of the present invention;

FIG. 12 illustrates exemplary phase-wrapping lens structures that can be formed using the teachings of the present invention;

FIG. 13 illustrates refractive index patterns associated with exemplary phase-wrapped lens structures that can be formed using the teachings of the present invention;

FIG. 14 illustrates an exemplary PLM hydrophilicity variation method used in some preferred embodiments of the invention;

FIG. 15 illustrates an exemplary lens shaping/forming method flow diagram used in some preferred embodiments of the present invention;

FIG. 16 illustrates an exemplary lens calculation method used in some preferred embodiments of the present invention;

FIG. 17 illustrates an exemplary experimental sample PLM structure in accordance with the teachings of the present invention;

FIG. 18 illustrates a plot of water absorption measurements of PLM measured experimentally;

FIG. 19 illustrates an exemplary diffraction grid pattern in accordance with the teachings of the present invention;

FIG. 20 illustrates an exemplary experimental refractive index measurement setup of the present teachings;

FIG. 21 illustrates an exemplary experimental refractive index profile of the present teachings;

FIG. 22 illustrates exemplary experimentally measured diffraction grating power measurements over time of the present teachings;

FIG. 23 illustrates an exemplary experimentally measured diffraction grating 0 order power measurement of the present teachings;

FIG. 24 illustrates an exemplary experimentally measured desorption by hydrolysis curve of the present teachings;

FIG. 25 illustrates a convex phase-wrapped DIC and theoretical side view of an exemplary experimental configuration of the present teachings;

FIG. 26 illustrates NIMO diopter readings for a convex phase-wrapped DIC and theoretical side views of exemplary experimental configurations of the present teachings;

FIG. 27 illustrates a concave phase wrap DIC and theoretical side view of an exemplary experimental configuration of the present teachings;

FIG. 28 illustrates NIMO diopter readings for a concave phase-wrapped DIC and a theoretical side view for an exemplary experimental configuration of the present teachings;

fig. 29 illustrates a top view of an exemplary experimental 3mm convex phase wrap lens constructed;

FIG. 30 illustrates exemplary experimentally measured diopter readings related to water absorption comparison of the present teachings depicting the difference between air drying and hydration in the measured lens diopter readings;

FIG. 31 illustrates an exemplary experimentally measured water absorption curve for water and its variation over time and ambient temperature as taught by the present invention;

figure 32 illustrates an exemplary experimentally measured dependence of water absorption power of the present teachings;

FIG. 33 illustrates an exemplary method flow diagram depicting a generalized intra-body lens shaping method implemented by a preferred embodiment of the present invention;

FIG. 34 illustrates an exemplary method flow diagram depicting details of the preparation of an intracorporeal lens forming method implemented by a preferred embodiment of the present invention;

FIG. 35 illustrates an exemplary method flow diagram depicting lens data creation details of an intracorporeal lens shaping method implemented by a preferred embodiment of the present invention;

FIG. 36 illustrates an exemplary method flow diagram depicting patient interface details of an intracorporeal lens shaping method implemented by a preferred embodiment of the present invention;

FIG. 37 illustrates an exemplary method flow diagram depicting initial initialization details of an intracorporeal lens shaping method implemented by a preferred embodiment of the present invention;

FIG. 38 illustrates an exemplary method flow diagram depicting diagnostic details of an intracorporeal lens shaping method implemented by a preferred embodiment of the present invention;

FIG. 39 illustrates an exemplary method flow diagram depicting lens shaping details of an in vivo lens shaping method implemented by a preferred embodiment of the invention;

FIG. 40 illustrates an exemplary method flow diagram depicting verification details of an intracorporeal lens shaping method implemented by a preferred embodiment of the present invention;

FIG. 41 illustrates an exemplary method flow diagram depicting a generalized manufacturing custom lens shaping method implemented by a preferred embodiment of the present invention;

FIG. 42 illustrates an exemplary method flow diagram depicting details of preparation for a method of manufacturing a custom lens shaping as practiced by a preferred embodiment of the present invention;

FIG. 43 illustrates an exemplary method flow diagram depicting lens data creation details of a method of manufacturing a custom lens shaping as practiced by a preferred embodiment of the present invention;

FIG. 44 illustrates an exemplary method flow diagram depicting positioning details of a method of manufacturing a custom lens shaping as practiced by a preferred embodiment of the present invention;

FIG. 45 illustrates an exemplary method flow diagram depicting initial initialization details of a method of manufacturing a custom lens shaping as practiced by a preferred embodiment of the present invention;

FIG. 46 illustrates an exemplary method flow diagram depicting diagnostic details of a method of manufacturing a custom lens shaping as practiced by a preferred embodiment of the present invention;

FIG. 47 illustrates an exemplary method flow diagram depicting lens shaping details of a method of manufacturing custom lens shaping as practiced by a preferred embodiment of the present invention;

FIG. 48 illustrates an exemplary method flow diagram depicting verification/shipping details of a method of manufacturing custom lens shaping as practiced by a preferred embodiment of the present invention.

Detailed Description

While this invention is susceptible of embodiment in many different forms, there is shown in the drawings and will herein be described in detail preferred embodiments of the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiments illustrated.

Many of the innovative teachings of the present application will be described with particular reference to the presently preferred embodiments, wherein these innovative teachings are advantageously applied to the particular problem of "hydraulicity alternating SYSTEM AND METHOD". However, it should be understood that this embodiment is merely one example of the many advantageous uses of the innovative teachings herein. In general, statements made in the specification of the present application do not necessarily limit any of the various claimed inventions. Moreover, some statements may apply to some inventive features but not to others.

Hydrophilic (non-limiting)

Within the context of the present invention, the term "hydrophilic" will be defined as the property of a material "having a strong affinity for water or tending to dissolve in, mix with, or be wetted by water".

Material (PLM) (non-limiting)

The present invention may incorporate a wide range of materials (including, but not limited to, PLM) within the scope of contemplated embodiments, many of which may be application specific. The PLM may in many preferred embodiments incorporate the use of Ultraviolet (UV) absorbing materials (typically 300-400nm wavelength) to amplify the absorption of the pulsed laser energy by the PLM, thereby effecting a change in the hydrophilicity of the PLM. PLM as used herein should not be constrained such that its use is limited to materials that form optical lenses. In particular, the term "Polymeric Material (PM)" may be used herein to denote an application of the inventive system/method/product that is not necessarily limited to the production of optical lenses. Thus, "PM" may encompass broader application of the inventive concept than "PLM", but the materials may be the same. Thus, the terms "Polymeric Lens Material (PLM)", "Polymeric Material (PM)" and their equivalents should be given the broadest possible meaning within the context.

Ultraviolet absorber (non-limiting)

The PLM may comprise several materials that may enhance the UV absorption of the PLM, thereby enhancing the change in hydrophilicity of the PLM when the PLM is irradiated by the pulsed laser radiation. The invention is not limited as to the type and amount of chemicals used to achieve this behavior, and the descriptions of these chemicals within this document are merely illustrative of those chemicals contemplated.

Laser radiation (non-limiting)

The present invention may include a variety of laser radiation to effect the alteration of hydrophilicity within the lens-forming PLM described herein. Thus, the term "laser radiation" and its equivalents should be given the broadest possible meaning within the context, and are not limited to near-infrared laser radiation.

Laser source (non-limiting)

The present invention may incorporate a variety of laser radiation sources to provide the desired pulsed laser radiation for use within the disclosed invention. Within this context, the term "laser source" may also include, in combination, an acousto-optic modulator (AOM) (also known as a Bragg cell) that uses the acousto-optic effect to disperse and shift the frequency (typically radio frequency) of laser light generated using acoustic waves. Within this context, a "laser source" may be broadly defined to include a laser radiation source, and optionally an AOM, regardless of whether the AOM is physically incorporated into the laser radiation source hardware. Thus, the term "laser source" and its equivalents should be given the broadest possible meaning within this context.

Acousto-optic modulators (AOM) (non-limiting)

Various embodiments of the invention may use an acousto-optic modulator (AOM) to act as a switch that enables/disables or throttles the amount of laser radiation pulse streams directed to a laser scanner within the context of the invention. Within the context, an AOM may comprise a "grey scale" modulation, wherein a switching function is used to switch a part of the laser radiation pulse train to the laser scanner, thus making it possible to reduce the effective laser power applied to the targeted PLM for which the hydrophilicity is to be modified. Thus, the use of "gray-scale AOM" components for modulating the intensity of laser radiation is expressly contemplated within the scope of the present invention.

The AOM as depicted in the present invention acts as a shutter and a variable attenuator, and as such can be replaced by another equivalent component that simulates the same function as described above.

Laser scanner (non-limiting)

Laser scanners the use within preferred inventive embodiments described herein may include many different kinds of scanners, including, but not limited to, flying spot scanners (generally, vector-based modes) and raster scanners (generally, raster-based modes). The scanner is used to distribute the laser pulses to the correct locations within the size of the field of view of the objective lens. The present invention is not limited in the type of laser scanner that can be used in this context.

Microscope objective (non-limiting)

The discussion herein of "microscope objective" may equally utilize "microscope objective or other focusing means" to accomplish these functions. The term "microscope objective" should therefore be given its broadest possible interpretation within the context of the present application.

Patient (non-limiting)

The present invention may be applied to situations where a lens placed in a living being is modified in situ without removal from the eye of the living being to correct/modify the refractive properties of the lens. Within the context, the term "patient" should be interpreted broadly and should not be limited to application to humans only.

Lens form (non-limiting)

The present invention may include a variety of lenses formed to achieve optical light bending, thereby achieving overall lens forming configurations. Although exemplary embodiments of the present invention are described herein for constructing convex, biconvex, concave, biconcave, and planar lens structures, these structures are merely illustrative of the wide variety of lens forms that may be constructed by the present invention. Thus, the term "lens forming" and its equivalents should be given the broadest possible meaning within the context.

Two dimensions (non-limiting)

The present invention may include the use of two-dimensional mode structures within the PLM for forming diffraction gratings and other thin planar structures that, while technically three-dimensional, will be referred to herein as two-dimensional. While modification of PLM hydrophilicity cannot strictly occur in the zero thickness plane, the term two-dimensional will refer to the creation of structures that appear within the PLM that do not require Z-axis intersection repositioning on the X-Y plane perpendicular to the optical axis. Thus, two-dimensional modification of the PLM refractive index can occur along a non-planar boundary that includes a single Z-axis focal length of the laser pulse. Thus, the term "two-dimensional" and its equivalents should be given the broadest possible meaning within the context.

Three dimensions (non-limiting)

The present invention may include the use of three-dimensional mode structures within the PLM to form complex optical structures. These three-dimensional modal structures and their associated volumes may include multiple layers with interstitial PLM having a hydrophilicity that has not been modified by irradiation with laser pulses. Thus, the three-dimensional structure may comprise unmodified regions with unmodified or slightly modified layers, or a plurality of layers of varying degrees of hydrophilicity, and the resulting refractive index is altered. Thus, the term "three-dimensional" and its equivalents should be given the broadest possible meaning within the context.

Intraocular lens (non-limiting)

The present invention may be advantageously applied to dynamically adjustable optical lens constructions comprising a wide range of materials. The mechanism by which the various materials are included in the optical lens is not limited by the present invention. Thus, the terms "intraocular lens" and "optical lens (which will include contact lenses)" and their equivalents should be given the broadest possible meaning within the context.

Description of the Integrated System

The present invention can be broadly described as utilizing a laser system comprised of a femtosecond laser source, an AOM, a scanner, and an objective lens that delivers laser pulses into a predetermined area. The laser source preferably has a pulse duration of about 350fs or less, a wavelength in the range of 690 to 1000nm, and a repetition rate of between about 0.1 to 100 MHz. The pulse energy is typically in the range of 0.17 to 500 nanojoules. Those skilled in the art understand that these laser parameters can be adjusted and re-balanced to the outer above specified ranges, but still achieve the same level of energy delivered to the targeted region of the lens material. For example, a tunable laser unit, such as a Ti sapphire oscillator (Mai Tai at Oldham, Calif.), may provide a variable wavelength in the range of approximately 690-1040nm, pulse widths as low as 70fs, and source powers as high as 2.9W.

Generalized hydrophilic modification system (0500)

A preferred exemplary system embodiment (0500) of the present invention is generally illustrated in fig. 5, wherein material (0501) is irradiated (0515) to generate a change in hydrophilicity in selected regions (0502) within PLM (0501). The system (0500) generally incorporates a laser source (0511), the laser source (0511) configured to generate pulsed laser radiation that can be controlled/throttled/modulated/switched by an acousto-optic modulator (AOM) (0512) to generate a predetermined laser pulse train having prescribed energy and pulse timing characteristics. In some inventive embodiments, the laser source (0511) and the AOM (0512) may be integrated into a single laser source module. The pulsed laser radiation generated by the laser source (0511)/AOM (0512) is then transmitted to the laser scanner (0513), the laser scanner (0513) being configured to distribute laser pulses in the X-Y plane over the input area of the microscope objective (0514). The microscope objective (0514) incorporates a numerical aperture configured to accept the distributed pulsed laser radiation and generate a focused laser radiation output (0515). The focused laser radiation output (0515) is then conveyed by the microscope objective (0514) to the region (0502) of Polymerized Lens Material (PLM) (0501) where the hydrophilicity of the PLM (0501) is to be altered. The position of the hydrophilically modified PLM regions (0502) can be defined by the laser scanner (0513) and the sample loading/positioning system (0516), the sample loading/positioning system (0516) mechanically positions the PLM (0501) so that the focused laser pulse (0515) can be appropriately localized within the desired internal region (0502) of the PLM (0501).

The system can operate optimally under the control of a computer control system (0520), which includes a computer (0521), the computer (0521) executing software read from a computer readable medium (0522), and providing a Graphical User Interface (GUI) (0523) from which an operator (0524) can direct the overall operation of the hydrophilicity alteration (0502) within the PLM (0501) (0523).

System/method application context application Environment overview (0600)

A typical environment of use for the present invention is generally illustrated in fig. 6(0600), wherein the present invention is incorporated in a hydrophilicity varying system (0610) for constructing a patient's lens. The hydrophilicity varying system (0610) generally includes a laser source (0611) that produces pulsed laser output that is then distributed in the X-Y plane using a laser scanner (0613) and then focused using a microscope objective (0614) (or other focusing device). This distributed and focused pulsed laser radiation (0615) is transmitted within a lens structure (0601) having a certain portion made of a material (PLM) (0602). This PLM (0602) is irradiated in a two-or three-dimensional pattern (0603) within the PLM structure (0602) to modify the hydrophilicity. Any modification of hydrophilicity will create some change in the refractive index of the inner region of the PLM (0603). This refractive index change produced by the focused laser pulse (0614) causes a two-dimensional or three-dimensional pattern (0603) to form an optical lens function within the overall lens structure (0601).

In conjunction with this overall system/method configuration, lens structure (0601) may be included (0604) in the human eye (0605) and PLM (0602), as generally illustrated in the figures, with the PLM (0602) being modified in situ after surgical implantation of lens structure (0601) in the patient's eye.

The hydrophilicity varying system (0610) described operates generally under the control of a computer system (0621), which executes the instructions of the computer-readable medium (0622) (0621). This computerized control (0621) preferably incorporates a graphical user interface (0623), which (0623) allows the system operator (0624) to interface with the entire system and direct its operation. With respect to the above-mentioned in situ lens forming application, the control software (0622) may incorporate software that includes implementation of methods that perform automated patient eye examination to determine non-ideal conditions in the patient's vision (0625), from which optical correction maps necessary to improve the patient's vision are generated (0626), followed by automated laser pulse/position control procedures to change the refractive index of the PLM within the patient's lens in situ to adequately correct the patient's vision (0627).

System/method application Environment details (0700)

A more detailed system configuration of a preferred invention application environment is provided in fig. 7(0700), wherein a computer system (0720) operating under the control of software read from a computer readable medium (0721,0722) is used to control and supervise the overall lens manufacturing process. Within this application environment, the following components generally make up the system:

● laser source (0701) with a wavelength suitable for handling the desired material, and a per pulse energy sufficient to change the refractive index of the target area provided by the objective lens (0710) used.

● A dispersion compensator (0702) is used to compensate the beam so that the pulse width is approximately 100 fs. Without this feature, the pulse width at the target would be larger because the pulse width becomes larger when passing through the optical medium (e.g., lens). Longer pulses with more heat will appear on the treatment area, making the treatment less accurate and making the treatment time longer. This feature is therefore optional, but part of RIS optimization.

● Beam shaping 1(0703) unit may be used to modify the laser beam diameter to fit the AOM specification. This also makes it possible to exchange the laser sources without additional modification after the beam shaping 1 unit.

● AOM (0704) is used to modulate the number of pulses and the energy of each pulse that will be delivered to the treatment area. Depending on the received signal (typically 0 to 5V), the energy will be distributed to the 0 th order or 1 st order of the AOM. These orders are two different beams coming out of the AOM, making an angle between them. The 1 st order beam is typically one that enters the target area and the 0 th order beam stops directly after the AOM. The received signal from the AOM driver is at a maximum (e.g., 5V), the maximum energy per pulse is in the 1 st order beam, when the driver signal is at maximum, the 1 st order beam will have 0% energy, and everything will be delivered to the 0 th order.

● Beam shaping 2, additional beam shaping is required to fit the system after the beam has passed through the AOM. For example, the beam diameter must be enlarged to fit the objective lens (0710) used so that the numerical aperture of the objective lens can be used.

● the diagnostic (0705) system is used to measure the wavelength, energy per pulse, and pulse width of the laser beam. The inclusion of this feature makes it possible to safely and repeatably use the system. If one of the variables is not executed as calculated, the system will shut down.

● laser microscope coupling (mirror Arm) (0706) is used to redirect the laser beam into the laser microscope head. Depending on the system setup and laser orientation, it may be included between one mirror and multiple mirrors to redirect the laser beam to a desired location.

● A camera system (0707) is used to position the sample towards the microscope objective. It is also used to find the correct Z position based on the material curvature. In addition, a camera may be used for tracking purposes.

● A scanner (0708) is used to distribute the laser spot in the XY plane. Different scanners may be used for this purpose. Depending on the scanner type, the untreated region will still be covered, but not with every pulse of laser energy, or only the treated region will be covered. For this purpose, the software control will also control the AOM, since the scanner software will locate the spot and the AOM will contribute energy per pulse to the spot.

● Z module (0709) may be used to allow for additional focusing elements in the system, which may be used for tracking purposes, for example, for planes at Z positions different from the shaping plane. It can also be used to change the Z position during the forming process.

● objective lens (0710) focuses the beam on the sample and determines the spot size. The larger the spot size, the more energy is required per pulse, so it must be matched to the required precision of the laser source and process. In addition, it provides the field size of the shaping process, which requires additional hardware for lens shaping if the field size of the objective lens is smaller than the desired lens.

● objective lens and sample interface (0711) depend on the application. For lens manufacturing, the space between the sample and the objective lens is filled with water to reduce sputtering and allow for additional cooling elements. For other applications, different methods of contact with other media (e.g., eye gel) may be used.

● sample (0712) can be made of different optical media and can be for example a hydrophobic polymer placed in front of the objective lens. Depending on the application, the sample will be directly behind the objective lens and sample interface, or deeper inside the additional media combination (e.g., eyeball).

● positioning system (0713) can be used to position the blocks consisting of the objective field size towards each other so that larger structures can be shaped. It can also be used to move the sample in the Z direction.

Those skilled in the art will recognize that particular inventive embodiments may include any combination of the above components, and in some cases may omit one or more of the above components in an overall system implementation.

Comparison of Prior Art/invention (0800)

A comparison of prior art and present methods for achieving optical convergence within a lens structure is generally illustrated in fig. 8 (0800). The prior art, depicted generally in fig. 8(0800, 0810), uses a convex lens forming method to produce the optical convergence shown in this example. It is important to note that the prior art does not change the hydrophilicity of the lens material, but only the refractive index of the material. In contrast, the present invention uses the change in hydrophilicity of the PLM, generally illustrated in fig. 8(0800, 0820), to produce optical convergence. While both techniques can use multiple lens structures, the present invention relies on negative diopter material modification (0821) to create these lenses (all increases in hydrophilicity lower the refractive index of the material, while all prior art makes changes in the material that create positive diopter material modification (0811)).

Exemplary application Environment overview (0900)

As generally depicted in fig. 9(0900), the present invention uses a femtosecond pulsed laser (0911) to enable hydrophilicity changes (0912) to occur inside the PLM (0913). As depicted generally in fig. 9(0900), the three-dimensional layer of altered (changed) hydrophilicity (0922) may be formed in the PLM (0921) using an XYZ stage system. The depth of this layer is predetermined in the software. The layer may be positioned at the surface (0923) or at the intermediate layer (0924, 0925).

The present invention also contemplates a system configured to form an optical lens with PLM, a method by which a lens can be formed using PLM, and a lens formed by the method using PLM. Any of these inventive embodiments may be applied to situations where a lens implanted in a human eye (or in an eye of another living being) may be modified and/or corrected in situ without removing the lens from the patient.

The present invention can also be used to create hydrophilic channels within the PLM. Such regions may be used to facilitate the entry or exit of other chemicals into or out of such materials.

Exemplary lens Forming structures (1000) - (1300)

Although the present invention is applicable to the formation of a variety of lens structures in many contexts, several forms are preferred. These include, but are not limited to, convex (1001) and biconvex (1002) structures as depicted in the outline shape of fig. 10; concave (1101) and double concave (1102) structures as depicted in the shape profile of fig. 11; and phase wrap convex (1201) and phase wrap concave (1202) structures as depicted in the shape profile of fig. 12. Those skilled in the art will recognize that these lens structures are merely illustrative of the wide variety of lenses that can be formed using the teachings of the present invention. In addition, the layering of the PLM-modified structures as depicted in fig. 9(0900,0921) may allow for layering into multiple lens structures within a single PLM.

Phase winding crystalline lens (1200, 1300)

The present invention can be used to form phase wrapped lenses as generally depicted in the phase wrapped convex (1201) and concave (1202) structures depicted in fig. 12(1200), and the associated exemplary refractive indices depicted in fig. 13 (1300). The phase wrap lens uses the same theoretical concept as the Fresnel lens (1204). Differences in quality can be summarized in three different factors:

● original lens curvature is preserved for the phase-wrapped lens;

● the laser forming technique allows a 90 degree angle to be maintained at each zone for a phase wrap lens; and

the ● phase wrap lens can be formed to micron precision.

In contrast, the constraints on the Fresnel lens (1205) are generally derived from the manufacturing process that created it. The main manufacturing differences of the phase wrap and Fresnel lenses are shown in image 1206.

Refractive index gradient lens (1300)

The present invention may be used to form a refractive index gradient lens (1300) as generally depicted in fig. 13. The information of the lens curvature in this concept is stored in a single layer. The gray scale value is used to represent the energy of each pulse. Thus, 256 variations in power between 0% and 100% are possible and make it possible to shape a single layer lens accurately. A top view of the refractive index lens (1301) shows different regions of the original convex phase wrapped lens. The data information for each of the original lens types in question can be compressed into one layer. A side view of the refractive index gradient lens (1302) shows the energy distribution at each spot with respect to one horizontal slice through the center of the lens.

Modulation of the pulse energy may be achieved using an AOM or an automatic variable attenuator.

PLM method (1400)

The present method contemplates many variations on the basic implementation theme, but can be generalized as depicted in fig. 14(1400) to a lens forming method using hydrophilicity variation, the method comprising:

(1) generating a pulsed laser radiation output (1401) from a laser source;

(2) distributing pulsed laser radiation output over an input area of a microscope objective (1402);

(3) admitting the distributed pulsed laser radiation into a numerical aperture within a microscope objective to generate a focused laser radiation output (1403); and

(4) the focused laser radiation output is transmitted into the PLM to modify hydrophilicity within the PLM (1404).

The general method can be modified in large part based on several factors, and rearrangement of steps and/or addition/deletion are within the contemplation of the scope of the invention. Integration of this and other preferred exemplary embodiment methods with the various preferred exemplary embodiment systems described herein is contemplated within the full scope of the present invention. As described elsewhere herein, this and other methods described herein are best performed under the control of a computer system that reads instructions from a computer-readable medium.

As generally depicted in fig. 9(0900,0912), this hydrophilicity-altering region can form any optical lens structure as generally depicted in fig. 10(1000) -13 (1300) having a plurality of hydrophilicity-altering optically inner layers as generally depicted in fig. 9(0900,0921).

Lens forming/forming method (1500)

The present invention also teaches a lens forming/forming method wherein lenses of any complexity can be formed within the PLM. The lens shaping is made up of different parts. First, lens power and curvature must be calculated based on the selected material. The laser wavelength is thereafter also adjusted for the material. The AOM acts as a shutter in the setup, but also as a variable power attenuator so that (in combination with the scanner) the lens structure can be precisely shaped inside the polymer. The AOM is controlled by the calculated input image of the lens information, providing laser power information for each (micron) of the illuminated area. The scanner then distributes the power to the correct position and the microscope objective focuses the pulsed laser beam to the desired focal spot inside the polymer. The PLM sample is held in a sample holder behind the microscope objective and optionally positioned on a stage system (motorized X/Y/Z positioning system) to allow shaping of larger lens structures. The stage system may also be replaced with a mirrored laser arm terminating with the microscope objective. The mirror arm in this case will replace not only the stage system but also the entire camera and scanner plate.

The inventive method may include an embodiment of such a lens forming/forming method as depicted in fig. 15(1500), the method comprising:

(1) performing lens calculations to determine the form and structure of the lens to be created (1501);

(2) selecting a laser wavelength suitable for the desired hydrophilicity change in the PLM (1502);

(3) shuttling and/or power conditioning the laser using an AOM or equivalent modulator to produce laser pulses (1503);

(4) scanning the laser pulse (1504) on a microscope objective;

(5) forming a laser spot size and precisely positioning the focused laser within the PLM using a microscope objective (1505);

(6) holding/clamping the PLM for changing hydrophilicity by a laser pulse stream (1506); and

(7) the target PLM sample is optionally located (1507) using an X/Y/Z location system.

The general method can be modified in large part based on several factors, and rearrangement of steps and/or addition/deletion are within the contemplation of the scope of the invention. Integration of this and other preferred exemplary embodiment methods with the various preferred exemplary embodiment systems described herein is contemplated within the full scope of the present invention.

The method may be applied to one or more layers within the PLM to achieve the formation of lens structures of arbitrary complexity. The lens calculations associated with the process identified in step (1) are detailed in fig. 16 and are described below.

Lens calculating method (1600)

The present invention also teaches a lens calculation method wherein lens parameters are used to determine an internal PLM lens structure tailored to a particular patient and their unique optical requirements. The method generally involves the steps of:

● calculating the curvature of the lens to be formed;

● determining the desired lens depth;

● calculating the number of zones that must be treated by the laser;

● determining a zone radius for each zone to be processed;

● creating a phase wrap lens data file for the laser; and

● load these data files into the RIS mapping system.

These steps will now be discussed in more detail:

before lens parameters for a custom intraocular lens (IOL) can be calculated, the patient needs to be examined, different existing aberrations can be measured, and the required change in diopter (Dpt) can be estimated. The material (n) used for the shaping process must be known for calculating the lens curvature (C).

Where n is the refractive index of the original IOL material and n' is the refractive index after RIS formation, and thus, the refractive index of the new lens.

The curvature is related to the lens radius (r), which may be the lens diameter2w_LensAnd lens depth h_LensAnd (4) calculating.

Thereafter, phase wrap-around lens information is calculated for the given information, and an output image is created. All the acquired information about the phase wrapped lens is already present in the information of the original lens and its curvature. The phase wrap depth of the lens is determined by the amount of change in refractive index. Thereafter, the radius of each region and curvature information of each region can be easily calculated. According to the shaping technique, the lens power may be greater than the objective field size, in which case the stage system (as described above) is used to align the different zones for lens shaping. To allow this technique, the input images are cut to their image size to represent a block system.

The lens calculation method described above and generally depicted in fig. 15(1500,1501) can be implemented in many forms, but several preferred embodiments of the present invention can implement such a method as depicted in fig. 16(1600) using the following steps:

(1) measuring or determining a lens property required for a desired optical performance (1601);

(2) selecting a lens material suitable for lens manufacture (1602);

(3) calculating a desired lens curvature (1603);

(4) calculating phase wrap lens information necessary to form the lens (1604);

(5) creating an output image corresponding to the desired phase wrap around lens characteristics (1605);

(6) determining whether the lens treatment area is larger than the objective field size, if not, proceeding to step (8) (1606);

(7) slicing (1607) the output image into segments suitable for placement within the field of view size;

(8) determining if the patient (or lens formation) requires additional lens properties, and if so, proceeding to step (1) (1608); and

(9) the lens calculation method is terminated (1609).

The method may be applied to the formation of a lens held/gripped by an objective device, or in some cases, a lens shaping/forming process may be performed in situ within a patient's eye. In this case, the lens PLM may be surgically inserted into the patient while the PLM is in a substantially unmodified (or previously modified) state, and then "dialed in" to provide the patient with optimal vision.

Application # 1-optical lens (1700) - (1800)

The following experimental application examples discuss the internal hydrophilicity changes for polyacrylic acid polymers suitable for making optical lenses.

Step 1-preparation of test optical materials

Free radical polymerization of the following materials to form small pieces of crosslinked polymerized copolymer can be carried out in a glass mold sealed with a silicone tube for a cure cycle starting at 65 ℃ up to 140 ℃ for a total time of about 14 hours:

(1) 140 grams of a mixture of butyl acrylate, ethyl methacrylate, N-benzyl-N-isopropylacrylamide, and ethylene glycol dimethacrylate;

(2)11.4 g of ethyl 2- [3- (2H-benzotriazol-2-yl) -4-hydroxyphenyl ] methacrylate; and

(3) less than 0.5% yellow dye.

The yellowish, approximately 2mm thick transparent sheet thus obtained can be cut into circular buttons which can be further machined into intraocular lenses. Alternatively, small slices may also be cut out of the sheet or buttons for laser treatment. The refractive index of the yellow sheet or button so prepared is about 1.499.

Step 2-Pre-impregnation

Small sections (1.91 mm. times.1.33 mm. times.14.35 mm) of the optically clear lens material prepared above weighed 38.2 mg. This slice of lens material was soaked in water until no further weight increase (indicating saturation at room temperature). The saturated slices weighed 38.3mg after water droplets on their surface were wiped off with a dry paper towel, indicating a water saturation of about 0.3%.

Step 3-laser treatment

The water-saturated slices were then exposed to laser pulses from a femtosecond laser source (pulse width: 200fs, repetition rate: 50MHz, energy per pulse: 5.4nJ, wavelength: 780 nm). Only a predetermined region (2mm × 2mm × 165 μm) as generally illustrated in fig. 17(1700) is treated. After disposal, the slices were allowed to saturate with water and then weighed again. The slice was 38.9mg, an increase of 0.2mg, which indicated that the water absorption of the treated area was about 30% (0.2mg ÷ 2 × 1.9 × 0.165 ═ 0.318 ═ 32%). After the first area was treated, a second area of the same size was created and another 0.2mg increase was observed. Thus, a total of 3 regions were treated, the last slice weighing 38.9 mg. The weight gain after each laser treatment is summarized in the graph depicted in fig. 18 (1800).

Application # 2-diffraction Grating (1900) - (2400)

The following experimental application examples discuss the use of the invention to the effect dependence of diffraction gratings on water absorption.

Step 1

The diffraction grating is shaped inside an acrylic polymer material as generally depicted in fig. 19 (1900). In this example, the grid size is 3mm and the X spacing is 18 μm.

Step 2

The sample was then allowed to reach water saturation.

Step 3

The efficiency of the index grating was measured (2103) using the settings for different scan speeds depicted in fig. 20 (2000). A red (640nm) laser was placed in front of the sample. The sample was mounted on a set of XY stages so that the grating could be positioned relative to the laser. At some distance, the screen (2101 and 2103) is placed and, as depicted in fig. 22(2200), the power of different orders of the raster is recorded for different times (as depicted in fig. 21 (2100)). As shown in fig. 22(2200), the power of 1 to 10 orders decreases with water saturation, while the energy goes to zero (0) order as generally depicted in fig. 23 (2300).

This can be compared to the water desorption curve of the acrylic polymer material as depicted in fig. 24, which shows the weight loss of the material due to water desorption. The graph in fig. 24(2400) shows the average sample weight measurement in percent for 10 samples. Important information is shown in the first five (5) hours. Comparing the graphs in fig. 23(2300) and fig. 24(2400), the major change occurred in the first five hours. The diffraction grating starts to fall slowly because the grating is formed inside the material and it takes some time for water to desorb before water desorption will be noticed in the measurement. After the main amount of water is desorbed, the diffraction grating becomes very weak.

Application # 3-phase winding convex lens (2500) - (2900)

The following experimental application examples discuss negative refractive index changes due to changes in hydrophilicity.

Step 1

Phakic shaping of the phase-wrapped convex lens was produced as depicted in fig. 25 (2500). The phase-wrapped concave lens shows negative refractive index changes induced by hydrophilic changes inside the material. The NIMO diopter readings for this structure are depicted in fig. 26 (2600).

The convex phase wrapped lenses show negative diopter readings, while the concave phase wrapped lenses, as generally depicted in fig. 27(2700), show positive diopter readings. The NIMO diopter readings for this structure are depicted in fig. 28 (2800).

The image depicted in fig. 29(2900) illustrates a top view of an exemplary 3mm convex phase wrapped lens as constructed.

Application # 4-Water saturated (3000) - (3100)

The following experimental application examples discuss full diopter readings only after water saturation of the material.

Step 1

A concave lens with positive diopter readings is shaped.

Step 2

Lens power was measured after shaping.

Step 3

The lenses were stored not in water but in air for 18 days, after which the lenses were placed in water.

Step 4

The diopter readings of the lens after being placed in water are measured.

The diopter reading of the lens at the latter moment of shaping is minimal. The material must still be saturated with water before a final diopter reading is possible. During the shaping process it may already absorb some water, so some diopter readings will be possible after shaping, but full diopter readings will anyway only be possible after complete water saturation of the material.

After the lens was placed in water, the lens power was fully restored after 24 hours. Figure 30(3000) depicts diopter readings for a 5 diopter 2mm lens. The first diopter measurement at the moment after shaping is only 1.5D.

For comparison, the graph in fig. 31(3100) depicts the water saturation curve for a polymeric material and its relationship to time.

Application # 5-Pre-preg

The following experimental application examples discuss the diopter readings of pre-soaked samples.

The saturation period can be shortened if the sample is pre-soaked in water prior to lens formation. At the latter moment of shaping, the lens showed a larger diopter reading and the return to full diopter values would be much faster than for the non-presoaked sample. The pre-water soak will only shorten the time period for the sample to be fully saturated. It will not change the final diopter reading of the lens.

Application # 6-temperature dependence (3100)

The following experimental application examples discuss the temperature dependence of lens power.

The water saturation of the material is dependent on the ambient temperature. An oven may be used to change the sample temperature. After allowing the sample sufficient time to accommodate the temperature change, the lens power was measured and differences up to ± 1D were observed for different temperature settings.

Water saturation is temperature dependent and therefore the diopter reading of the lens is also temperature dependent. This can be seen from the graph in fig. 31(3100), where more than 22 degrees celsius is absorbed for 35 degrees celsius.

Application # 7-diopter memory (3200)

The diopter of the treated region is fixed. The sample can be kept in an air reservoir, which is never allowed to exhibit full lens power, but when placed in water, the full power of the lens will return to the full power, theoretically calculated power after saturation.

The diopter readings of the samples increased as the samples hydrated, after dehydration of the samples, as depicted in fig. 32(3200), the lens was initially at about 0D and the diopter reading increased to its full-scale-6D in 27 hours, which is according to the image in fig. 31 (3100).

Intracorporeal lens forming method (3300) - (4000)

The present invention contemplates that a lens may be formed/shaped in vivo using the systems/methods described herein as generally illustrated in fig. 33(3300), including the steps of:

(1) preparing (3391);

(2) lens data creation (3392);

(3) a patient interface connection (3393);

(4) start initialization (3394);

(5) diagnosing (3395);

(6) phakic molding (3396); and

(7) and (3) verifying (3397).

As generally illustrated in fig. 34(3400) -40 (4000), these generalized steps may be further defined by the following more detailed steps:

(1) patient existing lens material determination (3401), wherein the information is used to determine laser properties and calculate refractive index material changes induced by refractive index shaping.

(2) Patient aberration measurements (3402), wherein different patient-specific aberrations are determined.

(3) The patient selects which aberrations need to be treated (3403), where the selection may be, but is not limited to, common visual defects such as myopia, hyperopia, and astigmatism.

(4) The surgeon selects the desired lens information and lens material (3504), wherein the selection is dependent on the negotiation with the needs of the patient and the available options.

(5) It is determined whether the desired lens information is present and if this information is already present, step (11) is entered (3505). This part is completely software-based and inaccessible to the doctor or patient. This step is integrated for the case where the patient has a unique diopter value that is not pre-loaded into the system.

(6) Calculating a lens curvature (3506), wherein the curvature depends on the desired lens power, the refractive index change induced by the refractive index shaping, and the surrounding refractive index change of the material.

(7) A phase weighted height is determined (3507), wherein the height depends on the difference in induced refractive index changes and, therefore, also on the surrounding material.

(8) Phase wrap lens creation (3508), wherein information of the phase wrap lens is given by the phase wrap lens height and the original lens curvature information. For each layer, the radius of each zone may be determined using this information.

(9) Data output file creation (3509) will use information from the phase wrapped lenses to create information about each layer and possibly each block of each layer (3508).

(10) Data loading (3510) of the system, wherein the loading of data files (3509) into existing software to be analyzed may require additional time, and depending on the material, the line spacing may be used to populate a 3-dimensional structure.

(11) The patient is oriented towards the system (3611), where the positioning is an initial step of patient interface positioning. The patient's head is aligned towards the index shaping station.

(12) The doctor positions the objective lens towards the iris of the patient (3612). The doctor can use the camera module to get a good idea of positioning the objective lens towards the iris. This is an important step since this position will also be used for tracking.

(13) The physician enters the patient ID into the system (3713), where the software will display the patient's information and preselected shaping options.

(14) The physician verifies the information and chooses to start (3714), where the physician verifies the identity of the patient in a first step, after which the selected treatment option is verified.

(15) The system checks if the laser wavelength is correct (3815), where the laser wavelength is selected for the original lens material. The diagnostic tool of the system thereafter checks whether the displayed wavelength matches the real-time value of the system;

(16) the system checks whether the energy is stable (3816), where the laser energy is measured. The diagnostic tool of the system then checks whether the theoretically calculated energy and the real-time value of the system match.

(17) The system checks whether the pulse width is stable (3817), wherein the diagnostic tool is used for internal checking that the pulse width of the system has not changed.

(18) A Z module is used for Z positioning (3918) of the focal spot, wherein the Z module is used to change the distance between the lens forming focal spot and the iris tracking focal spot. The IOL inside a patient's eye can settle differently and, in addition, the patient's corneal thickness and anterior chamber thickness are variable, so the Z-module is used to find the correct position for the refractive index-shaping lens.

(19) The scanner is used for focal spot positioning (3919), wherein the scanner positions the focal spot to a correct shaping position.

(20) The AOM is used for energy distribution (3920), where the AOM provides the correct energy per pulse for the scanner position. And

(21) verification of new lens diopters (4021), where new diopter readings of the patient are measured and verified.

Method of manufacturing custom lens forming (4100) - (4800)

The present invention contemplates that the system/method described herein and custom manufacturing process as generally illustrated in fig. 41(4100) may be used to form/shape the lens, including the steps of:

(1) preparation (4191);

(2) lens data creation (4192);

(3) positioning (4193);

(4) starting initialization (4194);

(5) diagnosing (4195);

(6) phakic shaping (4196);

(7) verification/shipping (4197).

As generally illustrated in fig. 42(4200) -48 (4800), these generalized steps may be further defined by the following more detailed steps:

(1) a patient selection lens material determination (4201) wherein the patient has the option to select a material to be used from a list of available options.

(2) Patient aberration measurement (4202), wherein the patient's aberrations are measured.

(3) The patient selects which aberrations require treatment (4203), wherein treatment options are selected according to the patient's requirements or availability.

(4) The surgeon selects the desired lens information and lens material (4304), wherein the patient's choice of materials and desired changes are revised, re-selection is required if necessary, and the new choice will be discussed with the patient.

(5) It is determined if the required lens information is present and if this information is already present, step (11) is entered (4305) in which the software internally checks if the required aberration code is already present or if a new code must be created for the patient.

(6) Calculating a lens curvature (4306), wherein the curvature depends on the desired lens power, the refractive index change induced by the refractive index shaping, and the surrounding refractive index change of the material.

(7) A phase weighted height (4307) is determined, wherein the height depends on the difference in induced refractive index changes and, therefore, also on the surrounding material.

(8) Phase wrapped lens creation (4308), where information of the phase wrapped lens is given by the phase wrapped lens height and the original lens curvature information. For each layer, the radius of each zone may be determined using this information.

(9) A data output file is created (4309) where information about each layer and possibly each block of each layer will be created using information from the phase wrapped lenses (3508).

(10) Data loading of the system (4310) wherein the lens/blank is positioned inside the system.

(11) The lens/blank is positioned in a manufacturing system (4411), wherein the system selects a starting position for lens formation.

(12) The technician enters the customer ID (4512) where the software will display the patient's information and pre-selected shaping options.

(13) The technician verifies the information and selects start (4513), wherein the technician verifies the identity of the patient in a first step, after which the selected treatment option is verified.

(14) The system checks if the laser wavelength is correct (4614), where the laser wavelength is selected for the original lens material. The diagnostic tool of the system thereafter checks whether the displayed wavelength matches the real-time value of the system;

(15) the system checks whether the energy is stable (4615) and measures the laser energy. The diagnostic tool of the system then checks whether the theoretically calculated energy and the real-time value of the system match.

(16) The system checks whether the pulse width is stable (4616), wherein the diagnostic tool is used for internal checking that the pulse width of the system has not changed.

(17) The Z module is for Z positioning of the focal spot (4717), wherein the Z module is for changing a distance between the lens forming focal spot and the iris tracking focal spot. The IOL inside the patient's eye can be placed differently (simple), and furthermore, the patient's corneal thickness and anterior chamber thickness are variable, so the Z-module is used to find the correct position of the refractive index shaping lens.

(18) The scanner is used for focal spot positioning (4718), wherein the scanner positions the focal spot to the correct shaping position.

(19) The AOM is used for energy distribution (4719), where the AOM provides the correct energy per pulse for the scanner position.

(20) An X and Y stage system is used to support a larger treatment region (4720), wherein the X and Y stages are used to shape a lens larger than the shaped region of a given objective lens.

(21) The Z stage is used to allow movement between layers (4721), wherein the Z stage may additionally be used for Z movement of different layers of the lens.

(22) New lens power is verified (4822), wherein new power readings for the IOL are measured and verified.

(23) The lens is packaged and shipped to a doctor (4823) where the product is packaged and shipped.

PM System overview

The present invention may be broadly summarized as a system for changing the hydrophilicity of an interior region of a polymeric material, the system comprising:

(a) a laser source;

(b) a laser scanner; and

(c) a microscope objective lens;

wherein the content of the first and second substances,

the laser source is configured to emit a pulsed laser radiation output;

the laser scanner is configured to distribute the pulsed laser radiation output over an input area of the microscope objective;

the microscope objective further comprises a numerical aperture configured to accept the distributed pulsed laser radiation and generate a focused laser radiation output; and is

The focused laser radiation output is transmitted by the microscope objective to an interior region of the Polymer Material (PM);

the focused laser radiation output changes the hydrophilicity within the interior region of the PM.

The general system may be augmented with the various elements described herein to generate a variety of inventive embodiments consistent with the overall design description.

PLM System overview

The inventive system contemplates many variations in the basic construction subject, but may be generalized to a lens forming system comprising:

(a) a laser source;

(b) a laser scanner; and

(c) a microscope objective lens;

wherein the content of the first and second substances,

the laser source is configured to emit a pulsed laser radiation output;

The focused laser radiation output is transmitted by the microscope objective to the PLM;

the focused laser radiation output interacts with the polymer within the PLM and causes a change in hydrophilicity within the PLM.

PM method summary

The method of the present invention may be broadly summarized as a method for changing the hydrophilicity of an interior region of a polymeric material, the method comprising:

(1) generating a pulsed laser radiation output from a laser source;

(2) distributing pulsed laser radiation output over an input area of a microscope objective;

(3) admitting the distributed pulsed laser radiation into a numerical aperture within a microscope objective to generate a focused laser radiation output; and

(4) the focused laser radiation output is delivered to an interior region of a polymeric material ("PM") to modify the hydrophilicity of the interior region of the PM.

PLM method summary

The inventive method contemplates variations in the basic implementation subject matter, but may be generalized to a lens forming method comprising:

(1) generating a pulsed laser radiation output from a laser source;

(4) the focused laser radiation output is transmitted into the PLM to modify the hydrophilicity within the PLM.

Process defined PM product

The inventive method may be applied to the modification of the hydrophilicity of any polymeric material, wherein the process-defined product is a modified Polymeric Material (PM) comprising a synthetic polymeric material further comprising a plurality of modified hydrophilic regions formed within the Polymeric Material (PM), the plurality of modified hydrophilic regions being created using a method comprising the steps of:

(1) generating a pulsed laser radiation output from a laser source;

(4) the focused laser radiation output is delivered to an interior region of a Polymeric Material (PM) to modify hydrophilicity within the interior region of the PM.

The general process of the process-defined product can be modified to a large extent depending on several factors, the rearrangement of steps and/or the addition/deletion being within the contemplation of the scope of the invention. Integration of this and other preferred exemplary embodiment methods with the various preferred exemplary embodiment systems described herein is contemplated within the full scope of the present invention.

Method defined PLM product

The present methods may be applied to the formation of an optical lens wherein the process-defined product is an optical lens comprising a synthetic polymeric material further comprising a plurality of optical zones formed within the PLM, the plurality of optical zones created using a lens forming method comprising the steps of:

(1) generating a pulsed laser radiation output from a laser source;

System/method-defined product variations

The present invention contemplates many variations in the basic construction subject matter. The examples presented in the foregoing do not represent the full range of possible uses. They are intended to cite a few of the almost unlimited possibilities.

The basic system, method and product defined by the method can be augmented with various ancillary embodiments, including but not limited to:

● wherein the distribution of the focused laser radiation output is configured to be larger than the field of view size of the microscope objective by using an X-Y stage configured to position the microscope objective.

● wherein the laser source further comprises an embodiment of a femtosecond laser source that emits laser pulses at a megahertz repetition rate.

● where the pulsed laser radiation output has an energy in the range of 0.17 to 500 nanojoules.

● where the pulsed laser radiation output has a repetition rate in the range of 1MHz to 100 MHz.

● where the pulsed laser radiation output has a pulse width in the range of 10fs to 350 fs.

● wherein the focused laser radiation output has a spot size in the X-Y direction in the range of 0.5 to 10 microns.

● where the focused laser radiation output has a spot size in the Z direction in the range of 0.01 to 200 microns.

● wherein the PLM is shaped in the form of a lens.

● example in which the PLM is water saturated.

● wherein the PLM includes an intraocular lens contained within an optic material.

● wherein the PLM includes an intraocular lens contained within an optic material disposed within the eye of the patient.

● where the laser scanner is configured to distribute the focused laser radiation output in a two-dimensional pattern within the PLM.

● where the laser scanner is configured to distribute the focused laser radiation output in a three-dimensional pattern within the PLM.

● wherein the laser scanner is configured to distribute the focused laser radiation output in a three-dimensional pattern within the PLM that forms a convex lens within the PLM.

● wherein the laser scanner is configured to distribute the focused laser radiation output in a three-dimensional pattern within the PLM that forms a biconvex lens within the PLM.

● wherein the laser scanner is configured to distribute the focused laser radiation output in a three-dimensional pattern within the PLM that forms a concave lens within the PLM.

● wherein the laser scanner is configured to distribute the focused laser radiation output in a three-dimensional pattern within the PLM that forms a biconcave lens within the PLM.

● where the laser scanner is configured to distribute the focused laser radiation output in a three-dimensional pattern within the PLM; the focused laser radiation creates a hydrophilic change in a volume associated with the three-dimensional mode; and the change in hydrophilicity results in a corresponding change in the refractive index of the volume associated with the three-dimensional mode.

● where the refractive index change is negative for PLM with an initial refractive index greater than 1.3.

● where the change in refractive index is greater than 0.005.

● where the three-dimensional pattern includes multiple layers within the PLM.

● examples wherein the PLM comprises a cross-linked polymeric copolymer.

● examples where the PLM comprises a crosslinked polyacrylic acid polymer.

● wherein the laser source further comprises an acousto-optic modulator (AOM).

● wherein the laser source further comprises a grayscale acousto-optic modulator (AOM).

● example in which the PLM has been pre-soaked in a solution comprising water.

● where the PLM includes an Ultraviolet (UV) absorbing material.

Those skilled in the art will recognize that other embodiments are possible based on combinations of elements taught within the above description of the invention.

Generalized computer usable medium

In various alternative embodiments, the present invention may be implemented as a computer program product for use with a computerized computing system. Those skilled in the art will readily appreciate that the programs defining the functions defined in this invention can be written in any suitable programming language and delivered to a computer in many forms, including, but not limited to: (a) information permanently stored on non-writable storage media (e.g., read-only memory devices such as ROM or CD-ROM disks); (b) information alterably stored on writable storage media (e.g., floppy disks and hard drives); and/or (c) information conveyed to a computer by a communications medium, such as a local area network, telephone network, or public network, such as the internet. Such computer-readable media, when carrying computer-readable instructions that implement the methods of the present invention, represent alternative embodiments of the present invention.

As generally illustrated herein, system embodiments of the present invention can include a variety of computer-readable media, including computer-usable media having computer-readable code means embodied therein. Those skilled in the art will recognize that the software associated with the various processes described herein may be embodied in a variety of computer-accessible media from which the software is loaded and launched. This type of computer-readable medium is contemplated by and is included within the scope of the present invention according to Inre Beauregard,35 USPQ2d 1383 (U.S. Pat. No. 5,710,578). In accordance with Inre Nuijten,500F.3d 1346(Fed. cir.2007) (U.S. patent application S/N09/211,928), the scope of the invention is not limited to computer-readable media, where the media is both tangible and non-transitory.

Summary of the invention

Systems/methods are disclosed that allow for hydrophilic modification of Polymeric Materials (PM). The hydrophilic modification (i) reduces the PM refractive index, (ii) increases the PM conductivity, and (iii) increases the PM weight. The system/method includes a laser radiation source that generates focused laser pulses within a three-dimensional portion of the PM to effect these changes in PM properties. The system/method may be applied to form a customized intraocular lens comprising a material (PLM), wherein the lens created using the system/method is surgically positioned within the eye of a patient. The refractive index of the implanted lens may then optionally be varied in situ with the laser pulse to alter the optical properties of the implanted lens to achieve optimal corrected patient vision. The system/method allows for many in situ modifications to the implanted lens as the patient's vision changes with age.

Also disclosed are lens forming systems/methods that allow for dynamic in situ modification of the hydrophilicity of the PLM. The system/method includes a laser that generates focused pulses within a three-dimensional portion of the PLM to modify the hydrophilicity, thereby modifying the refractive index of the PLM, thereby creating a customized lens of arbitrary configuration. The system/method may be applied to form a customized intraocular lens wherein an optic material comprising a homogeneous PLM is surgically positioned within the eye of a patient. The patient's vision is analyzed by the mounted lens, and the homogeneous PLM is then irradiated in situ with laser pulses to modify the internal refractive properties of the PLM to achieve the best corrected patient's vision. This exemplary application may allow for in situ modification of intraocular lens properties based on patient age dynamically.

Statement

Although preferred embodiments of the present invention have been illustrated in the accompanying drawings and described in the foregoing detailed description, it will be understood that the invention is not limited to the embodiments disclosed, but is capable of numerous rearrangements, modifications and substitutions without departing from the spirit of the invention as set forth and defined by the following claims.

Claims

1. A method of increasing the hydrophilicity of only an interior region of a Polymeric Material (PM) having a UV absorbing material, the method comprising:

(1) generating a pulsed laser radiation output from a laser source having a wavelength selected to interact with a UV absorbing material within an interior region of the PM;

(2) distributing the pulsed laser radiation output over an input area of a microscope objective;

(3) admitting the distributed pulsed radiation into a numerical aperture within the microscope objective to generate a focused laser radiation output;

(4) delivering the focused laser radiation output to an interior region of the PM to increase hydrophilicity of the interior region of the PM;

(5) exposing the interior region to water; and

(6) allowing the PM to absorb water thereby reducing the index of refraction of the interior region of the PM.

2. The method of claim 1, wherein the distribution of the pulsed laser radiation output is configured to be larger than a field of view size of the microscope objective by using an X-Y stage configured to position the microscope objective to sequential regions within the PM.

3. The method of claim 1, wherein the laser source further comprises a femtosecond laser source emitting laser pulses.

4. The method of claim 1, wherein the pulsed laser radiation output has an energy in the range of 0.17 to 500 nanojoules.

5. The method of claim 1, wherein the pulsed laser radiation output has a repetition rate in a range of 1MHz to 100 MHz.

6. The method of claim 1, wherein the pulsed laser radiation output has a pulse width in the range of 10fs to 350 fs.

7. The method of claim 1, wherein the polymeric material comprises a hydrophobic material.

8. The method of claim 1, wherein delivering the focused laser radiation further comprises achieving optical properties of the PM.

9. The method of claim 8, wherein the step of achieving optical performance further comprises changing a diopter value, asphericity, or toricity of the PM.

10. A method of reducing the refractive index of an interior region of a Polymeric Material (PM), the interior region comprising a UV absorbing material, the method comprising:

(1) generating a pulsed laser radiation output from a laser source having a wavelength selected to interact with UV absorbing material within the PM;

(3) admitting the distributed pulsed laser radiation into a numerical aperture within the microscope objective to generate a focused laser radiation output that is focused on an interior region of the PM;

(4) introducing the focused laser radiation into the interior region;

(5) exposing the interior region to water; and

11. The method of claim 10, wherein the distribution of the pulsed laser radiation output is configured to be larger than a field of view size of the microscope objective by using an X-Y stage configured to position the microscope objective to sequential regions within the PM.

12. The method of claim 10, wherein the laser source further comprises a femtosecond laser source emitting laser pulses.

13. The method of claim 10, wherein the pulsed laser radiation output has an energy in the range of 0.17 to 500 nanojoules.

14. The method of claim 10, wherein the pulsed laser radiation output has a repetition rate in the range of 0.1MHz to 100 MHz.

15. The method of claim 10, wherein the pulsed laser radiation output has a pulse width in the range of 10fs to 350 fs.

16. The method of claim 10, wherein the polymeric material comprises a hydrophobic material.

17. The method of claim 10, wherein delivering the focused laser radiation further comprises achieving optical properties of the polymeric material.

18. The method of claim 17, wherein the step of achieving optical properties further comprises changing a diopter value, asphericity, or toricity of the polymeric material.

19. The method of claim 10, wherein the step of reducing the refractive index further comprises forming a lens.