Source: http://www.google.com/patents/US7655002?dq=5435091
Timestamp: 2016-05-30 14:45:57
Document Index: 724782585

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'art 2', 'art 2', 'art 1', 'art 1']

Patent US7655002 - Lenticular refractive surgery of presbyopia, other refractive errors, and ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsMethods for the creation of microspheres treat the clear, intact crystalline lens of the eye with energy pulses, such as from lasers, for the purpose of correcting presbyopia, other refractive errors, and for the retardation and prevention of cataracts. Microsphere formation in non-contiguous patterns...http://www.google.com/patents/US7655002?utm_source=gb-gplus-sharePatent US7655002 - Lenticular refractive surgery of presbyopia, other refractive errors, and cataract retardationAdvanced Patent SearchPublication numberUS7655002 B2Publication typeGrantApplication numberUS 10/750,789Publication dateFeb 2, 2010Filing dateJan 2, 2004Priority dateMar 21, 1996Fee statusPaidAlso published asUS20040199149, US20100114079, US20120016350Publication number10750789, 750789, US 7655002 B2, US 7655002B2, US-B2-7655002, US7655002 B2, US7655002B2InventorsRaymond I. MyersOriginal AssigneeSecond Sight Laser Technologies, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (337), Non-Patent Citations (165), Referenced by (79), Classifications (17), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetLenticular refractive surgery of presbyopia, other refractive errors, and cataract retardation
US 7655002 B2Abstract
The application claims benefit to and is a Continuation-in-Part of U.S. patent application Ser. No. 09/897,585 filed Jun. 29, 2001, now abandoned, which is a Continuation of U.S. patent application Ser. No. 09/312,518, filed May 14, 1999, now abandoned, which in turn is a Continuation of U.S. patent application Ser. No. 08/821,903, filed Mar. 21, 1997, now abandoned, which claims priority to U.S. Provisional Application No. 60/036,904, filed Feb. 5, 1997, and U.S. Provisional Application No. 60/013,791, filed Mar. 21, 1996.
The traditional solution for the correction of presbyopia and other refractive errors is to provide distance glasses, reading glasses, or a combination of the two called bifocals. Other forms of correction include the following: a) variable focus bifocal or progressive spectacles, b) contact lenses, c) aspheric corneal refractive surgery, and d) intraocular implant lenses for aphakic (absence of the ocular lens) individuals. Bifocal contact lenses are uncommonly used because, for fitting or for technical reasons, they are optically inferior to bifocal spectacles. An additional corrective method using contact lenses called “monovision” corrects one eye for near and the other for far, and the wearer learns to alternate using each eye with both open. Aspheric photorefractive keratectomy (such as is described in Ruiz, U.S. Pat. No. 5,533,997 and King, U.S. Pat. No. 5,395,356, the entire disclosures of which are specifically incorporated herein by reference to the extent not inconsistent with the disclosures of this patent) provides variable focus capabilities through an aspheric reshaping of the cornea. Similar to this optical correction, some aspherical intraocular implant lenses take the place of the natural ocular lens in individuals whose lens has been removed during cataract surgery. All of these techniques have one or more of the following disadvantages: a) they do not have the continuous range of focusing that natural accommodation provides; b) they are external devices placed on the face or eye; or c) they cut down the amount of light that normally focuses in the eye for any one particular distance, a particular problem because middle-aged individuals actually need more light because of light loss due to the development of light scattering, as described above.
A reason that laser surgery is of particular interest is that much of the ocular media is transparent to the visible light spectrum, i.e., wavelengths of 400-700 nanometers (nm); thus, light of wavelengths in this range pass through the anterior eye without effect. While the near-visible spectrum on either side of the visible range, including ultraviolet and infrared light, has certain absorptive characteristics in various ocular tissues and may cause changes in the tissue, the safety of light irradiation can be specified according to a threshold energy level below which particular tissues will not be adversely affected. Above the threshold, ultraviolet or infrared light can cause damage to the eye, including the establishment of cataracts or even tissue destruction. The ability to destroy ocular tissue, however, can be made to be quite beneficial, and is a major premise underlying eye surgeries using light energy. As described below, light energy can be focused to a specific point, where the energy level at that point (expressed as a energy density) is at or above the threshold for tissue destruction. Energy in the light beam prior to focusing can be maintained at a energy density below the threshold for tissue destruction. This “pre-focused” light can be referred to using the term subthreshold bundles (described by L'Esperance, U.S. Pat. No. 4,538,608, the entire disclosure of which is specifically incorporated herein by reference to the extent not inconsistent with the disclosures of this patent), wherein the “bundles” are not destructive to tissue.
The invention consists of methods for treating the clear, intact crystalline lens of an eye through the creation of microspheres, i.e., small, generally spherical pockets of gas within the lens (i.e., bubbles) for the purpose of correcting presbyopia, other refractive errors such as but not limited to myopia, hyperopia, regular and irregular astigmatism, for the retardation and prevention of cataracts, and treatment of other ocular anomalies. The creation of microspheres in the crystalline lens provides for changes in an ocular lens that may include but are not limited to changes in flexure, mass, and shape. Changes provided by the creation of microspheres generally improve visual acuity of the eye in a manner exemplified by but not limited to the ability to focus more clearly and with a greater range, and to transmit light without scatter and without distortion. The invention recognizes that the intact crystalline lens safely can be treated with a focused, scanning laser, and that treatment of the crystalline lens for correction of ametropias (including presbyopia) may be a superior methodology to refractive surgery on other structures of the eye, including the cornea or sclera, or the implantation of a flexible intraocular (crystalline) lens implant or gel. To enhance safety, the present invention may include concomitant use of antioxidative therapy to minimize any possible side-effects of acute laser radiation exposure during treatment.
FIG. 1 shows the gross anatomy of the eye.
FIG. 3 provides a basic illustration of the instrument (400) used to perform lenticular refractive surgery (LRS). A laser (402) produces a collimated beam (410) of light having essentially a single wavelength. The laser (402) preferably generates a beam of short duration, high frequency pulses such as discussed in Lin (U.S. Pat. No. 5,520,679), the entire disclosure of which is specifically incorporated herein by reference to the extent not inconsistent with the disclosures of this patent, but may be any laser that provides a beam of sufficient energy and that can be controlled to perform the treatment herein described. The laser beam (410) passes through a beam control system (406), likely comprising mirrors and lenses, for example mirrors (405) and lenses (407), that direct the light in three spatial dimensions and create vergence in the beam. The output from the beam control system (406) is a converging beam (412) that passes through a patient's cornea (420) and is focused on the surface of or within a patient's ocular lens (424) for purposes of treating ametropias and retarding cataractogenesis. The focal point (426) of the converging beam (412) is capable of traversing any point within the three-dimensional space occupied by the ocular lens (424). The surgeon combines knowledge of the patient, the expected ametropias (including presbyopia) to be altered, and lens biometric measurements determined by standard ophthalmic instruments to develop a treatment strategy. Certain of this data is transformed by a computer algorithm that controls the instrument (400) during the treatment, including control of laser parameters such as focal point location, energy level, and pulse duration and frequency. Focal point location during treatment is determined by a scanning program that may be used to reduce unwanted, short-term effects on lens tissue by moving the laser focal point among various areas of the lens, instead of treating immediately adjacent lens areas. A detailed description of an instrument similar to the one shown in FIG. 3, but used for cataract removal, is provided by L'Esperance, Jr. in U.S. Pat. No. 4,538,608, the entire contents of which are specifically incorporated herein to the extent not inconsistent with the disclosures of this patent. Note that in a preferred embodiment the surgeon would receive real-time feedback regarding the precise location of the focal point within the ocular lens and the structural changes as they are occurring. Such data may be obtained by the surgeon through the use of instruments and methods now known to one skilled in the art, or which may be later developed. Advances in eye surgical procedure may easily be incorporated into a procedure that utilizes an embodiment of the present invention.
The basis of LRS treatment is the laser induced photodisruption process occurring in the crystalline lens and depicted in FIG. 4. Note that the ocular lens with all of its internal structure (shown in FIG. 2) forms a single unitary structure such that reference to locations “in” or “within” the lens include locations “on” the lens, and the former terms (in and within) will generally be used throughout this patent to include the latter (on).
The photodisruption process is described as follows, beginning with reference to FIG. 3. The convergent laser beam (412) enters the eye through the cornea (420) as light waves, which have been described by L'Esperance (U.S. Pat. No. 4,538,608) as bundles of energy. The laser beam (412) passes through the cornea (420) without damage to that tissue because the energy density (referred to generally as “energy” and also called fluence or fluxure) of the laser within this tissue is at subthreshold levels. That is, only above a threshold energy density not obtained by the laser beam (412) within the cornea (420) will tissue damage occur. See Lin (U.S. Pat. No. 5,520,679) and L'Esperance (U.S. Pat. No. 4,538,608). During LRS treatment, however, the threshold energy level (energy density) is attained or surpassed at the focal point (426) of the converging laser beam (412) within the ocular lens (424). Given that sufficient energy is incident at the focal point (426) the process of photodisruption occurs.
Photodisruption as the term is used herein is a complex, multistep, sequential process, as illustrated in FIG. 4. When a laser pulse (502) traveling the path of the converging beam (412) reaches a first focal point (426) a very small amount of lens tissue (510) is destroyed in a volume essentially centered on that first focal point (426). The volume of lens tissue (510) destroyed depends upon the characteristics of the particular laser pulse (502) (pulse width, wavelength, energy, etc.) incident on the lens (424) and the characteristics of the lens tissue itself. For typical LRS procedures using today's laser technology this volume is likely in a range from about 0.1-500 μm3 (e.g., a sphere having a diameter of 0.5-10 μm). The laser energy incident at the first focal point (426) breaks molecular bonds and ionizes molecules and atoms, converting the tissue (510) at the first focal point (426) from a solid to a plasma (512). At the relatively high energy level of the plasma (512), the matter that has been converted occupies significantly more volume than it did as the solid tissue. Thus, there is a substantial, rapid expansion of the volume occupied by the converted matter, which generates a “hole” in the lens (occupied by the plasma (512)) and creates a shock wave (514) that resonates outwardly from the first focal point (426) into the surrounding tissue. For typical LRS procedures using today's laser technology the shock wave may extend from about 10-500 μm from the focal point. Note that the distance the shock wave travels is highly dependent on the pulse width of the laser.
In another embodiment of the present invention, the results of which are illustrated in FIG. 7, microspheres are created within the ocular lens (3) in close proximity to one another in a generally sequential pattern from posterior to anterior positions in the lens. In this embodiment the microspheres are created at positions within the lens that are separated by an insufficient distance to maintain the individuality of the microspheres. Not only are the individual microspheres created close enough to one another that they do coalesce, but also according to this embodiment the small volumes of tissue removed (e.g., volume 510 in FIG. 4) are contiguous. By moving the laser focal point generally in an anterior direction from the starting point (534), and removing contiguous volumes of tissue (e.g., volume 510 in FIG. 4), an open channel (530) in the lens tissue can be created. This open channel (530) is referred to as a microchannel (530) and is different from the embodiment described above and illustrated in FIG. 6 in which the microspheres are placed close enough to coalesce but in which the small volumes of tissue removed are not contiguous. An additional difference from the embodiment illustrated in FIG. 6 is that a microchannel of this embodiment traverses a path generally perpendicular to the length of the fibers. Even though some of the gas created in the microchannel during the photodisruption process may be absorbed by the remaining lens tissue, sufficient lens tissue mass has been removed along the path of the microchannel that even with some reduction in channel volume due to gas absorption, the channel remains generally open. Also different from the embodiment of FIG. 6, the microchannels of this embodiment are created in such dimension—i.e., sufficient tissue volume is removed—that they remain as open channels long after the surgery, possibly on the order of years or longer.
As a first step, a precision technique was verified on 36 human cadaver lenses, where the age-dependent, flexural characteristics of the lenses were compared with results in studies of other designs. In the second step, an Nd-YAG laser was used to produce a 2-4 mm annulus in one of a pair of lenses from 11 donors while the fellow lens was kept as the control. The Nd-YAG pulse produced microspheres in the range of 50-500 μm diameter. An annular laser pulse pattern of 100 suprathreshold pulses were placed in the center of the treated lens, to produce a doughnut shaped pattern of microspheres. A simulated accommodation was created using a rotating base upon which the lens revolved at up to 1000 rpm. Rotational deformation was measured by changes in the central thickness and in anterior lens curvature as measured by two different techniques. When comparing the matched lenses, lens flexibility differences were demonstrated by statistically significant differences in lens curvature and thickness. That is, rotational deformation flattened the curvature and decreased the thickness of the treated lens, compared to the untreated, less flexible lens. Dioptric changes were calculated at as much as 8 diopters of change. The greater lens formation among laser treated lenses compared to their fellow untreated control lenses showed that the first demonstrated example of increasing flexure and accommodation by laser treatment of the crystalline lens, and therefore photophakomodulation may be a possible lens treatment for presbyopia.
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ClassificationA61F2009/00897, A61F2009/00887, A61F9/00838, A61F9/00736, A61F9/00804, A61F9/008, A61F2009/00895, A61F2009/00872, A61F2009/0087, A61F9/009European ClassificationA61F9/008D5, A61F9/008A1P, A61F9/008Legal EventsDateCodeEventDescriptionMay 17, 2004ASAssignmentOwner name: SECOND SIGHT LASER TECHNOLOGIES, INC., ILLINOISFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MYERS, RAYMOND I.;KRUEGER, RONALD;REEL/FRAME:015332/0366Effective date: 20040425Owner name: SECOND SIGHT LASER TECHNOLOGIES, INC.,ILLINOISFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MYERS, RAYMOND I.;KRUEGER, RONALD;REEL/FRAME:015332/0366Effective date: 20040425Feb 8, 2011CCCertificate of correctionJun 13, 2013FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services