MX2008010706A

MX2008010706A - Method of forming a corneal pocket.

Info

Publication number: MX2008010706A
Application number: MX2008010706A
Authority: MX
Inventors: Vladimir Feingold
Original assignee: Biovision Ag
Priority date: 2006-02-21
Filing date: 2007-02-21
Publication date: 2008-10-31
Also published as: IL193588A0; WO2008023274A4; RU2008137469A; WO2008023274A3; WO2008023274A2; KR20080112238A; BRPI0708135A2; EP1999675A4; EP1999675A2; JP2009527312A; AU2007287354A1; CA2643106A1

Abstract

Methods for correcting the vision of a patient are provided that include the use of a refractive intracorneal lens that may be easily inserted into a corneal pocket. The intracorneal lens includes a corrugated haptic region that facilitates inserting and maintaining the intracorneal lens in the desired position within the cornea. A variety of corneal pocket configurations may be used accommodate various corneal lens shapes and sizes.

Description

METHOD FOR FORMING A CORNEAL BAG Field of the Invention The present invention relates generally to methods for forming a corneal pocket for receiving intracorneal refractive lenses and, more particularly to corneal bag configurations for receiving such lenses.

BACKGROUND OF THE INVENTION Intraocular or intracorneal refractive lenses provide a viable alternative to eyeglasses and extra-ocular contact lenses to correct deficiencies in visual acuity and refractive errors. The intra-ocular lenses (IOLs) of the prior art typically comprise an optical portion for refraction and a haptic portion for supporting the IOL in the anterior or posterior chamber of the eye. All or part of an IOL can be constructed from a deformable or flexible material. A deformable IOL has the advantage that it can be inserted into the eye by means of a smaller incision than an incision required to insert non-deformable or rigid IOLs of comparable dimensions. The larger incisions in the eye have many disadvantages including longer recovery times of the patient, astigmatism and increased risk ef. 195961 of infection. However, the flexible nature of the deformable IOLs typically presents problems in the IOL maneuver during an insertion procedure, and in the retention of the IOL in the correct position within the eye. To prevent the risk of damage or necrosis of ocular tissue after contact with or penetration by, a portion of an IOL, stiff and / or pointed structures should be avoided. However, in an attempt to anchor the IOL at the site within the eye, IOLs of the prior art have used clips or staples, sharp points, and the like that penetrate the tissue of the iris. For example, U.S. Patent No. 6,755,859 B2 to Hoffmann et al., Discloses an intra-ocular lens having an optical portion and two or more haptic elements for supporting the optic portion in the eye by means of a tissue staple. on each haptic element. U.S. Patent Application Publication No. 2002/0103537 Al (Willis et al.) Discloses an intra-ocular lens having an optic and a haptic, wherein the distal end of the haptic includes a sharp tip constructed and accommodated for penetrate the iris. In a second embodiment of Willis et al., The intraocular lens is coupled to the iris by a staple. The United States Patent Application Publication No. 2004/0085511 Al (Uno et al.) Discloses an intraocular lens having at least one pore near the center of the optical portion of the lens, and a plurality of channels on the posterior surface of the lens in a region that will contact with the lens. The channels allow fluid to flow into the pores, and the pores allow fluid to flow through the lens. The intra-ocular lens of Uno et al. , may also have circumferentially spaced protrusions, accommodated at the boundary between the optical part and the lens support portion, in an attempt to separate the optical part of the lens from the IOL. The diameter of the pores is restricted by the potential deterioration in the optical characteristics of the optical portion, for example, the reflection of the incident light on the periphery of the pores. The location of the protuberances is limited by their potential to interfere with or restrict the deformability of the lenses for insertion into the eye. U.S. Patent No. 6, 106, 553 to Feingold discloses an intra-ocular lens having a shape that is predetermined with respect to a lens shape of the lens to form a spacing between at least part of the IOL and the lens . For example, the arc radius of the back surface of an optical portion of the IOL may be smaller than the radius of the arc of the surface posterior of a body portion of the IOL, so that the optical portion has an arched or vaulted relationship to the anterior surface of the lens at the position of the pupil. In this relation (eg, Fig. 28 of the '553 patent), the body portion of the IOL is in contact with the lens at a radially external position of the pupil. The IOL can have a circular channel that allows fluid circulation in the eye (Figures 20 and 21 of the patent v 553). Intracorneal refractive lenses offer a number of advantages to correct deficiencies in visual acuity. An intracorneal lens can be inserted into an opening in the cornea of an eye that has visual abnormalities. Some previous techniques based on the cornea have involved the surgical reshaping of the inner portions of the cornea to correct visual deficiencies. However, such a surgical relationship is not reversible, resulting in some risk of creating permanent visual aberrations for the patient. In contrast, the procedures used with intracorneal lenses are reversible. Also, in typical surgical corneal reshaping surgery a complete flap of the cornea is raised to allow access for subsequent surgical modification of the cornea. In the surgery used to insert intracorneal lenses, a flap of the cornea it is not lifted, but rather a pocket is formed in the corneal tissue, which leaves more of the intact corneal surface, thereby simplifying the healing. However, the surgical preparation of such an intracorneal lens bag is difficult to perform accurately. Also, some lenses that are available for such vision correction are not completely satisfactory for a variety of reasons, including a tendency to shift out of position after placement, to deteriorate the diffusion of the transcorneal gas, to be excessively thick, or to be unable to correct presbyosis or astigmatism. U.S. Patent No. 6, 599, 305 to Feingold discloses a corneal bag keratome device for forming a corneal bag, and a lens to be inserted and retained in the corneal bag, to effect correction. The corneal bag keratome creates a bag of precise dimensions in the cornea. The corneal bag keratome includes a drive unit having cutting head elements that contact the eye of the subject during the formation of the corneal pocket, and also includes a blade assembly that oscillates laterally while extending into the body. cornea to form the bag. Intracorneal lenses are also described in U.S. Patent No. 6, 599, 305 which may include a feature to prevent accidental movement of the lens after the lens is placed inside the corneal bag, such features may include a swelling after insertion or a circumferential irregularity. As can be seen, there is a need for a method for correcting visual abnormalities through surgical implantation of an appropriate corrective lens, within the cornea in a precisely predictable and repeatable manner, and in such a manner that the lens will remain properly positioned. and oriented. There is also a need for a method of correcting visual abnormalities that can be reversed and that makes it possible to correct a wide range of visual abnormalities. There is a further need for a method of inserting an intracorneal lens, such that it can be maintained at a desired intracorneal site, without penetrating or damaging other ocular tissue. There is also a need for a method of creating a corneal pocket and the configurations of such a pocket. They effectively position and retain a variety of intracorneal lenses.

BRIEF DESCRIPTION OF THE INVENTION In one aspect of the present invention, there is provided a method for correcting a patient's vision, comprising the provision of an intracorneal lens. refractive, wherein the intracorneal lens comprises an optical portion and a haptic portion, and wherein the haptic portion is corrugated; the formation of a corneal pocket in one eye of the patient, and the insertion of the intracorneal lens into the corneal pocket. In still another aspect of the present invention, there is provided a method for correcting a patient's vision, comprising the provision of a refractive intracorneal lens; training with a laser from a corneal pocket on a patient's cornea; and inserting the lens into the corneal pocket. In a further aspect of the present invention, a corneal bag comprises an arcuate portion, and a straight portion adjacent to the arcuate portion. In a further aspect of the present invention, a corneal bag in a cornea comprises a straight portion that extends through a totality of the cornea. These and other features, aspects and advantages of the present invention will be better understood with reference to the following drawings, descriptions and claims.

Brief description of the figures Figure 1 is a sectional view of the anterior portion of an eye having a corrugated lens placed within the cornea of the eye, according to an embodiment of the invention; Figure 2 is a sectional view of the anterior portion of an eye having a lens positioned within the cornea of the eye according to yet another embodiment of the invention; Figure 3 schematically represents a series of steps involved in a method for the insertion of a lens in the cornea of a patient, according to another embodiment of the invention; Figure 4 is a cross-sectional view of a corneal bag according to an embodiment of the present invention; and Figures 5A-5I describe exemplary embodiments of a corneal bag according to various embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION The following detailed description is of the modalities currently contemplated to carry out the invention. The description does not have to be considered in a limiting sense, but must be done merely for purposes of illustration of the general principles of the invention, since the scope of the invention is better defined by the appended claims.

Broadly, the present invention relates to methods for correcting a visual impairment of a patient. The present invention also relates to methods for inserting an intracorneal lens into a corneal pocket in a patient's eye. The present invention further relates to corneal pockets configured to facilitate the insertion of an intracorneal lens therein. In contrast to the prior art, in some embodiments of the present invention, a variety of different forms of corneal pockets can be employed to further increase the ease of insertion of an intracorneal lens, and to maximize the surface of the cornea that is left intact, which facilitates the healing. Figure 1 is a sectional view of the anterior portion of an eye 100"'having a corrugated intracorneal lens 10 placed therein, according to one embodiment of the invention. In the embodiment of the invention shown in Figure 1, the Lens 10 can be placed inside the cornea 110, which can partially enclose the anterior chamber 114. An iris 108 is also shown in Figure 1. As an example, the lens 10 can be inserted into the cornea 110 after forming of a corneal bag, which can be formed, for example, using a laser or a corneal bag keratome device as described in U.S. Patent No. 6,599,305, mentioned above, the disclosure of which is hereby incorporated by reference in its entirety. For insertion into the cornea 110, the lens 10 may have a haptic portion 30, which may be opaque and may be located outside the optical zone of the eye 100"', whereby interference with the patient's vision with the portion Haptic 30 can be avoided In an alternative embodiment, the haptic portion can be eliminated, whereby the lens 10/10"can consist essentially of the optical portion 20 (see for example, Figure 2). The optical portion 20 is not restricted to the configuration shown in the figures, but may have various shapes, such as circular or oval, wherein the optical portion 20 may be elongated in the horizontal direction (x axis) or shortened in the vertical direction (Axis y) . In some embodiments, the optical portion 20 may have a donut-shaped configuration. The size and shape of the lens 10 can, in some cases, determine the size and shape of the corneal pocket. Various embodiments of such corneal bags are described below and shown in Figures 5A-5I. The lens 10 can be preferably formed of a biocompatible material that allows sufficient diffusion of gases to allow adequate oxygenation of the tissues of the inner eye. Such materials may include silicones, hydrogels, urethanes or acrylics. It may also be desirable for the lens to be made of a hydrophilic material which swells to a certain extent when hydrated. Such materials, for example, hydrogels, are well known and are used in some current contact lenses. The optical characteristics of the optical portion 20 can be selected to correct different visual deficiencies, including without limitation: myopia (short view), hyperopia (distant view), presbyopia and astigmatism. As an example, the optical portion 20 can have a power or diopter value in the range of +15 to -30. The optical portion 20 can be customized for a particular patient, to provide optical characteristics to correct a specific visual defect of a patient. The optical portion 20 can be multi-focal. The lens 10 can also be provided as an off-shelf unit with predetermined optical characteristics. It should be understood that the present invention is not limited to the treatment of the aforementioned visual defects, and that the treatment of other ocular conditions is also within the scope of the invention. The haptic portion 3 0 may surround the optical portion 2 0 and may be corrugated. The haptic portion 3 0 canvary in the number and configuration of the corrugations and can be adapted to support the optical portion 20 and to retain the lens 10 at a desired position on the cornea 110. Typically, the number of corrugations within the haptic portion 30 can be in the range of about 1 to about 5. In general, a greater number of corrugations of the haptic portion 30 can lead to increased flexibility and increased deformability in the horizontal direction. In addition, the haptic portion 30 may have corrugations oriented in directions different from those shown in Figure 1. The increased rigidity of the haptic portion 30 can provide improved retention of the lens 10 at a desired intracorneal site. The deformation of the lens 10 allows it to be inserted into the cornea of a patient via a small incision (approximately 3 mm). The corrugation of the haptic portion 30 can cause the lens 10 to behave like a spring when it is distorted, from a relaxed configuration to a flexed configuration. Figure 2 is a sectional view of the anterior portion of an eye 100"'having a lens 10" positioned therein, according to yet another embodiment of the present invention. The lens 10"may comprise an optical portion 20. At least a portion of the haptic portion 30 (e.g., Figure 1) may be absent or removed in the lens 10. As one example, the 10"lens may not have the haptic portion, or a vestigial haptic portion 30 (Figure 2). The lens 10"can be inserted into the cornea 110 after the formation of a corneal pocket, for example, as described with reference to Figure 1. The optical portion 20 in the embodiment of Figure 2, can have several features , features, and elements in common with other embodiments of the present invention as described hereinabove, For example, an optical portion 20 for insertion into the cornea 110 may have a donut-shaped configuration comprising a peripheral optical zone. 22 having optical power and an internal non-optical area 24 having no optical potential Figure 3 schematically represents a series of steps involved in a method 400 for inserting a lens into the cornea of a patient, according to another embodiment of the invention. The invention, wherein step 402 may involve the provision of a lens, The lens, eg, an intracorneal lens provided in step 402, may have features that are n general as previously described herein. As an example, the lens provided in step 402 may include an optical portion having a peripheral optical zone having optical power, and an internal non-optical region having no optical power. In some embodiments, the lens provided in step 402 may lack a haptic portion, for example, the lenses may consist essentially of an optical portion. The lens can be inserted into the cornea to correct the patient's vision. The lens provided in step 402 can be adapted to be deformable in order to facilitate insertion of the lens into the cornea. Step 404 may involve the formation of an incision in the cornea of the eye. Step 404 may involve the formation of a corneal flap or a corneal pocket. The formation of corneal flaps and corneal bags is known in the ophthalmic surgery technique. As an example, a corneal flap can be formed using a laser. The laser can be used and guided under computer control, as is well known in the art. A corneal flap can be formed by methods similar to those used during in situ or laser-assisted keratomileusis (LASIK) procedures). A corneal pocket can be formed by tunneling the cornea, for example, using a microkeratome having a rocking metal blade. A corneal bag keratome device was described in United States Patent No. 6, 599, 305, the disclosure of which is incorporated by reference herein in its entirety. In alternative embodiments, a corneal pocket can be formed by a laser.

Alternatively, a corneal bag can be manually formed by the surgeon using manual instruments. An exemplary corneal bag 116 formed by an incision is described in the cross section in Figure 4. Step 406 may involve lens insertion into the cornea (see for example, Figure 2). In alternative embodiments, step 406 may involve inserting the lens into a corneal pocket. Step 406 may further involve temporarily deforming the preparatory lens upon introduction of the lens into the eye. The lenses can be deformed by rolling, folding and the like. The lenses of the invention may have prescribed memory characteristics that allow the lenses to return to their original size and configuration after insertion into the eye, while retaining the optical characteristics of the optical portion. Corrugations of the haptic portion of the lenses can facilitate maneuvering of the lenses during step 406 by providing rigidity of the lenses by allowing the surgeon to hold the haptic portion by the corrugations. As described above, the lenses can be made of a hydrophilic material that swells when hydrated. The lenses can be inserted fully hydrated to fit elastically within a corneal bag or while at least partially dehydrated, such that subsequent hydration helps ensure the fit in the bag. Various configurations of the corneal bags can be employed in the present invention, such as those bags 116 described in Figures 5A to 51 which are top views of the bags 116 formed in the cornea 110.

The various configurations are adapted to be used with lenses of various shapes and sizes. The corneal bags 116 are also configured to facilitate insertion of the lenses and to minimize the size of the incision for improved post-surgical corneal healing. The corneal bags shown in Figures 5A a 5G and 51 include an arcuate portion 118 near a center of the bag, in addition to a straight portion 120 adjacent to the arcuate portion 118. In Figure 5H, the corneal bag includes a straight portion 122 that extends through the entire cornea. In conjunction with the corneal pocket, a release area 124 (described in Figures 5D-5H as arcuate lines) may optionally be provided in the cornea 110 to thereby provide a means of expansion and contraction when the lens is inserted and placed in the corneal pocket.

The arched incision in combination with the pouch can also reduce the induced astigmatism. The areas of Release 124 may comprise elaborate incisions in the cornea 110. These arcuate incisions are made by the laser at the same time the pouch is created, so that the patient may need to return to the surgeon to improve his vision due to astigmatism. As can be appreciated by those of skill in the art, the present invention can provide a method for correcting the vision of a patient with a refractive intracorneal lens that can be easily inserted into a corneal pocket. The intracorneal lens can be effectively placed and held in place by the use of a corrugated haptic region. A wide variety of corneal bag configurations can be used to accommodate various shapes and sizes of corneal lenses. It should be understood, of course, that the above refers to the exemplary embodiments of the invention, and that modifications may be made without departing from the spirit and scope of the invention as described in the following claims. It is stated that in relation to this date the best. The method known to the applicant for carrying out said invention is that which is clear from the present description of the invention.

Claims

CLAIMS Having described the invention as above, the content of the following claims is claimed as property: 1. A method for correcting the vision of a patient, acterized in that it comprises: the provision of a refractive intracorneal lens, wherein the intracorneal lens comprises a optical portion and a haptic portion and wherein the haptic portion is corrugated; the formation of the corneal pocket in one eye of the patient; and the insertion of the intracorneal lens in the corneal pocket. The method according to claim 1, acterized in that the insertion step of the corneal lens further comprises: the deformation of the corneal lens from an extended configuration to a deformed configuration prior to insertion of the intracorneal lens, and the release of the intracorneal lens where it returns to the extended configuration after insertion into the corneal pocket. 3. The method according to claim 1, acterized in that the step of forming a corneal bag also comprises the formation of the corneal bag using a laser. 4. The method according to claim 1, acterized in that the step of forming a corneal bag further comprises forming the corneal pocket using a microkeratome. The method according to claim 1, acterized in that the intracorneal lens is made of a hydrophilic material and is partially hydrated such that the lens swells after the insertion of the corneal bag. 6. The method of compliance with the claim 1, acterized in that it also comprises the formation of at least one area of release in the cornea. The method according to claim 1, acterized in that the step of forming a corneal bag further comprises forming a corneal pocket having an arc-shaped portion and a straight portion. The method according to claim 1, acterized in that the step of forming the corneal bag comprises the formation of a corneal bag having straight parallel portions. 9. A method for correcting a patient's vision, acterized in that it comprises: the provision of a refractive lens having an optical portion and a haptic portion; the formation of a corneal bag with a laser, in a cornea of a patient; and inserting the lens into the corneal pocket. 10. The method of compliance with the claim 9, acterized in that the provision step of a refractive lens further comprises the provision of a refractive lens having an optical portion and a haptic portion, which is at least partially opaque. 11. The method according to the claim 10, acterized in that the provisioning step of a refractive lens further comprises the provision of a refractive lens having a haptic portion that is corrugated. The method according to claim 9, acterized in that the step of inserting the lens further includes: the deformation of the lens from an extended configuration to a deformed configuration prior to lens insertion; and the release of the lens where it returns to the extended configuration after insertion into the corneal pocket. The method according to claim 9, acterized in that the lens is comprised of a hydrophilic material that is partially hydrated, such that the lens swells after insertion into the corneal bag. 14. The method according to the claim 9, acterized in that it also comprises the formation of at least one area of release in the patient's cornea. fifteen . The method according to claim 14, acterized in that the step of forming at least one area of release in the cornea further comprises the formation of an arc-shaped release area. 16 The method according to claim 9, acterized in that the step of forming a corneal bag further comprises forming a corneal pocket having an arc-shaped portion and a straight portion. 17 The method according to claim 9, acterized in that the step of forming a corneal bag comprises the formation of a corneal bag having straight parallel portions. 18 A corneal bag, acterized in that it comprises: an arched portion; and a straight portion adjacent to the arcuate portion. 19 The corneal bag according to claim 18, characterized in that the straight portion includes a straight portion extending radially away from the arcuate portion. twenty . The corneal bag according to claim 19, characterized in that the straight portion further comprises first and second straight portions that are They extend radially from the arcuate portion and are positioned on opposite sides of the arcuate portion. twenty-one . The corneal bag according to claim 18, characterized in that the straight portion comprises parallel edges extending radially away from the arcuate portion. 22 The corneal bag according to claim 18, characterized in that the straight portion comprises non-parallel edges extending away from the arcuate portion. 2. 3 . The corneal bag according to claim 18, characterized in that it further comprises at least a separate release portion of the arcuate portion and the straight portion. 24 The corneal bag according to claim 23, characterized in that the delivery portion comprises an arc-shaped corneal incision. 25 The corneal bag according to claim 18, characterized in that it is formed by a laser or by a microkeratome. 26 A corneal pocket in a cornea, characterized in that it comprises: a straight portion that extends through the entire cornea. 27 The corneal bag in accordance with the claim 26, characterized in that it further comprises at least a separate release portion of the straight portion. 28 The corneal bag according to claim 27, characterized in that the release portion is an arc-shaped corneal incision. 29 The corneal bag according to claim 26, characterized in that it is formed by a laser or by a microkeratome. 30. A method for correcting a patient's vision, characterized in that it comprises: the provision of a refractive intracorneal lens, wherein the intracorneal lens comprises an optical portion; the formation of a corneal pocket in one eye of the patient; and the insertion of the intracorneal lens in the corneal pocket. 31. A method for correcting a patient's vision, characterized in that it comprises: the provision of a refractive intracorneal lens, wherein the intracorneal lens comprises an optical portion and a non-optical portion; the formation of a corneal pocket in one eye of the patient; and the insertion of the intracorneal lens in the corneal pocket. 32. A refractive lens for correcting a patient's vision, characterized by an optical portion; The lens is provided to be inserted into a corneal pocket in a patient's cornea. 33. The lens according to claim 32, characterized in that it also comprises a non-optical portion. 34. The lens according to claim 32, characterized in that it further comprises a haptic portion. 35. The lens in accordance with the claim 34, characterized in that the haptic portion is corrugated. 36. The lens in accordance with the claim 35, characterized in that the lens is provided to be deformed from an extended configuration to a deformed configuration before the intracorneal lens is inserted, and provided to return to the extended configuration after being released after insertion into the corneal pocket. 37. The lens according to claim 34, characterized in that the haptic portion is at least partially opaque. 38. The lens according to claim 34, characterized in that it is provided to be deformed from an extended configuration to a deformed configuration before being inserted, and to return to the extended configuration after being released, after insertion into the corneal pocket. 39. The lens according to claim 34, characterized in that it comprises a hydrophilic material that is partially hydrated, such that the lens swells after insertion into the corneal bag. 40. The lens according to claim 34, characterized in that it is provided to be inserted into a corneal bag having an arc-shaped portion and a straight portion. 41. The lens according to claim 34, characterized in that it is provided to be inserted in a corneal bag having straight parallel portions. 42. The lens according to claim 34, characterized in that it is provided to be inserted in a corneal bag having an arcuate portion; and a straight portion adjacent to the arcuate portion. 43. The lens in accordance with the claim 42, characterized in that it is provided to be inserted into a corneal pocket wherein the straight portion includes a straight portion extending radially away from the arcuate portion. 44. The lens in accordance with the claim 43, characterized in that it is provided to be inserted in a correal bag where the straight portion comprises further first and second straight portions extending radially from the arcuate portion and which are positioned on opposite sides of the arcuate portion. 45. The lens according to claim 40, characterized in that it is provided to be inserted into a corneal pocket wherein the straight portion comprises parallel edges extending radially away from the arcuate portion. 46. The lens according to claim 40, characterized in that it is provided to be inserted into a corneal pocket wherein the straight portion comprises non-parallel edges extending away from the arcuate portion. 47. The lens according to claim 40, characterized in that it is provided to be inserted into a corneal bag which further comprises at least a separate release portion of the arcuate portion and the straight portion. 48. The lens according to claim 40, characterized in that it is provided to be inserted into a corneal pocket wherein the release portion comprises an arc-shaped corneal incision. 49. The lens according to claim 40, characterized in that it is provided to be inserted in a corneal bag formed by a laser or a microkeratome. 50. The lens according to claim 34, characterized in that it is provided to be inserted into a corneal pocket where the straight portion extends through a whole of the cornea. 51. The lens according to claim 34, characterized in that it is provided to be inserted into a corneal bag which further comprises at least a separate release portion of the straight portion. 52. The lens according to claim 51, characterized in that it is provided to be inserted into a corneal pocket wherein the release portion is an arc-shaped corneal incision.