WO2000007525A1 - Implant corneen comportant un insert empechant la migration - Google Patents

Implant corneen comportant un insert empechant la migration Download PDF

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Publication number
WO2000007525A1
WO2000007525A1 PCT/US1999/017762 US9917762W WO0007525A1 WO 2000007525 A1 WO2000007525 A1 WO 2000007525A1 US 9917762 W US9917762 W US 9917762W WO 0007525 A1 WO0007525 A1 WO 0007525A1
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WIPO (PCT)
Prior art keywords
implant
comeal
cross
section
main
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PCT/US1999/017762
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English (en)
Inventor
Thomas A. Silvestrini
Original Assignee
Keravision, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Keravision, Inc. filed Critical Keravision, Inc.
Priority to AU53390/99A priority Critical patent/AU5339099A/en
Publication of WO2000007525A1 publication Critical patent/WO2000007525A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/147—Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants

Definitions

  • the present invention relates to corneal implants generally. More specifically, the present invention relates to corneal implants to effect refractive correction of an eye.
  • BACKGROUND OF THE INVENTION Anomalies in the overall shape of the eye can cause visual disorders.
  • Hyperopia occurs when the front-to-back distance in the eyeball is too short. In such a case, parallel rays originating greater than 20 feet from the eye focus behind the retina. In contrast, when the front-to-back distance of eyeball is too long, myopia
  • Astigmatism is a condition which occurs when the parallel rays of light do not focus to a single point within the eye, but rather have a variable focus due to the fact that the cornea refracts light in a different meridian at different distances. Some degree of astigmatism is normal, but where it is pronounced, the astigmatism should be corrected.
  • Hyperopia, myopia, and astigmatism are usually corrected by glasses or contact lenses.
  • Surgical methods for the correction of such disorders are known. Such methods include radial keratotomy (see, e.g., U.S. Patents Nos. 4,815,463 and 4,688,570) and laser corneal ablation (see, e.g., U.S. Patent No. 4,941,093).
  • Another method for correcting such disorders is by implanting a biocompatible material into a the cornea, such as into a channel formed between stromal layers of the cornea to change the curvature of the cornea.
  • the material may be in the form of, for example, intrastromal corneal ring segments.
  • one or more segments of a ring may be implanted at the corneal periphery.
  • Ser. No. 08/101,440, and WO 95/03755, entitled “Segmented Preformed Intrastromal Corneal Insert”, corresponding to U.S. Ser. No. 08/101,438 disclose implanting one or more segments of rings into a circumferential interlamellar channel made within the cornea.
  • U.S. Pat. No. 5,733,334 to Lee entitled “Method and Apparatus for Adjusting Corneal Curvature” discloses adjusting corneal curvature by implanting in the cornea an adjustable split ring formed of an elastic hollow shell. The ring is filled with a predetermined amount of biocompatible material to alter the thickness or diameter of the ring to thereby adjust the corneal curvature.
  • the first step is to cut a very small incision in the patient's eye.
  • the incision penetrates into the cornea a distance of approximately 2/3 of the thickness of the cornea, i.e. the incision cuts through some but not of the corneal stroma layers or lamellae.
  • Dissector blades may then inserted into the small incision to separate the lamellae and form channels when the dissector blades are rotated.
  • the small incision may then be sutured.
  • gaps unfilled by the segments may result between the segments and/or between a segment and an end of the channel.
  • One or more of the segment may migrate toward an adjacent segment or toward an end of the channel. Such migration may be undesirable as it may affect the change in the corneal curvature.
  • one or more of the segments may tend to migrate toward the location of the incision made through the corneal surface. Migration of a segment to a location directly under the incision may be especially undesirable as such migration may hinder the flow of nutrients through the interlamellar layers of the cornea and thereby hinder wound healing at the incision.
  • the channel may be formed by making an initial incision through the comeal surface and then forming two portions of the channel extending in opposite circumferential directions from the incision, as described in International Pub. No. WO 95/18569, entitled "System for
  • the layers defining the interlamellar channel are separated by the segment where the segment is disposed as well as in a transition region extending beyond each end of the segment. In the transition region beyond each end of the segment, the layers do not yet converge and a space unfilled by the segment is thereby defined, hereinafter an "unfilled space". Beyond the transition region, the layers once again converge.
  • the two segments may be sufficiently distanced apart within the channel such that the transition regions of the two segments do not overlap and thus the lamellar layers converge between the two segments.
  • the convergence of the lamellar layers thus forms two discontinuous unfilled spaces between the two segments.
  • the convergence of the lamellar layers prevents or reduces migration of one or both of the segments toward the other segment.
  • Simon. Simon discloses gel injection adjustable keratoplasty by interlamellar injection of a gel at the comeal periphery. Simon discloses injecting a gel into an intracomeal channel which conforms to the channel shape and then hardens or solidifies.
  • the hardened gel of Simon may also suffer from the above-described migration problems. In particular, after the gel has hardened, unfilled spaces are defined in the transition region extending beyond each end of the hardened gel. The hardened gel may similarly migrate toward, for example, a location under the incision.
  • the present invention is directed to a comeal implant comprising one or more intrastromal comeal inserts adapted for implantation within an interlamellar channel made within the cornea of a mammalian eye, wherein at least one of the inserts has migration preventer to reduce or prevent migration of the insert after implantation within the channel.
  • the insert including migration preventer, subtends at least a portion of a ring, or "arc", encircling the anterior cornea outside of the cornea's field of view but within the cornea's frontal diameter.
  • the inserts may also be used in multiples such that the inserts, including migration preventer, form a partial or complete ring and/or form constructs of varying thickness.
  • the one or more physiologically compatible inserts each comprises a main section providing most or all of the adjustment to the comeal curvature to thereby correct vision abnormalities.
  • the main sections are configured to effect change in the comeal curvature, topography or refractive correction to treat or correct vision abnormalities such as astigmatism, myopia, and hyperopia.
  • At least one of the inserts further comprises one or two migration preventing extension sections each coupled to an end of the main section. After implantation in the intracomeal channel, each extension section extends from an end of the main section along the arc angle of the channel. Each extension section may extend from the main section of an insert and be disposed near or abut either the main section of another insert or an end of the channel. In either case, the extension section serves as a stop to prevent or reduce the migration of one or both of the inserts within the channel.
  • an insert may comprise an extension section on each of the two ends of the main section.
  • An insert with two extension portions may especially be desirable, for example, where three or more inserts are to be inserted within a single intracomeal channel.
  • Fig. 1 is a schematic representation of a horizontal section of the eye
  • Fig. 2 is a schematic illustration of the anterior portion of the eye showing the various layers of the cornea
  • Fig. 3 shows the comeal implant of the present invention
  • Fig. 4 shows the comeal implant of FIG. 3 implanted in the cornea of a human eye through an incision
  • Fig. 5 A shows the cross-sectional view at line 5A-5A of Fig. 3
  • Fig. 5B shows the cross-sectional view at line 5B-5B of Fig. 3
  • Fig. 5C shows a detailed perspective view of a portion of the comeal implant of Fig.
  • Fig. 6 shows an alternative embodiment of the comeal implant of the present invention comprising a single insert
  • Fig. 7 shows yet another alternative embodiment of the comeal implant of the present invention comprising an extendable and compactable migration preventing extension section;
  • Fig. 8 shows another alternative embodiment of the comeal implant of the present invention comprising a migration preventing extension section formed from injecting a suitable settable material into the intracomeal channel.
  • Fig. 1 shows a horizontal section of the eye.
  • Globe 11 of the eye resembles a sphere with an anterior bulged spherical portion representing cornea 12.
  • Globe 11 consists of three concentric coverings enclosing the various transparent media through which the light must pass before reaching the sensitive retina 18.
  • the outermost covering is a fibrous protective portion the posterior five-sixths of which, the sclera 13, is white and opaque, and is sometimes referred to as the white of the eye where visible to the front.
  • the anterior one-sixth of this outer layer is the transparent comea 12.
  • a middle covering is mainly vascular and nutritive in function and is comprised of the choroid 14, ciliary body 16 and iris 17.
  • Choroid 14 generally functions to maintain retina 18.
  • Ciliary body 16 is involved in suspending lens 21 and accommodation of the lens.
  • Iris 17 is the most anterior portion of the middle covering of the eye and is arranged in a frontal plane. It is a thin circular disc corresponding to the diaphragm of a camera, and is perforated near its center by a circular aperture called the pupil 19. The size of the pupil varies to regulate the amount of light which reaches retina 18. It contracts also to accommodation, which serves to sharpen the focus by diminishing spherical aberration.
  • retina 17 divides the space between comea 12 and lens 21 into an anterior chamber 22 and a posterior chamber 23.
  • the innermost portion of covering is retina 18, consisting of nerve elements which form the true receptive portion for visual impressions.
  • Retina 18 is a part of the brain arising as an outgrowth from the fore-brain, with optic nerve 24 serving as a fiber tract connecting the retina part of the brain with the fore- brain.
  • optic nerve 24 serving as a fiber tract connecting the retina part of the brain with the fore- brain.
  • a layer of rods and cones, lying just beneath a pigmented epithelium on the anterior wall of the retina serve as visual cells or photoreceptors which transform physical energy (light) into nerve impulses.
  • Vitreous body 26 is a transparent gelatinous mass which fills the posterior four- fifths of globe 11. At its sides it supports ciliary body 16 and retina 18. A frontal saucer- shaped depression houses the lens.
  • Lens 21 of the eye is a transparent bi -convex body of crystalline appearance placed between iris 17 and vitreous body 26. Its axial diameter varies markedly with accommodation.
  • this outermost fibrous transparent coating resembles a watch glass. Its curvature is somewhat greater than the rest of the globe and is ideally spherical in nature. However, often it is more curved in one meridian than another giving rise to astigmatism.
  • the central portion of the comea is called the optical zone with a slight flattening taking place outwardly thereof as the comea thickens towards its periphery. Most of the refraction of the eye takes place through the comea.
  • Fig. 2 is a more detailed drawing of the anterior portion of the globe and further including one embodiment of the comeal implant 10 of the present invention inserted therein.
  • Fig. 2 shows the various layers of comea 12 comprising an epithelium 31. Epithelial cells are rich in glycogen, enzymes and acetylcholine and their activity regulates the comeal corpuscles and controls the transport of water and electrolytes through the lamellae of the stroma 32 of comea 12.
  • An anterior limiting lamina 33 referred to as Bowman's membrane or layer, is positioned between the epithelium 31 and stroma 32 of the comea.
  • Stroma 32 is comprised of lamella having bands of fibrils parallel to each other and crossing the whole of the comea. While most of the fibrous bands are parallel to the surface, some are oblique, especially anteriorly.
  • a posterior limiting lamina 34 is referred to as Descemet's membrane. It is a strong membrane sharply defined from stroma 32 and resistant to pathological processes of the comea.
  • the endothelium 36 is the most posterior layer of the comea and consists of a single layer of cells. Endothelium cells function to maintain the transparency of comea 12.
  • Limbus 37 is the transition zone between the conjunctiva 38 and sclera 13 on the one hand and comea 12 on the other.
  • Fig. 3 shows the comeal implant 10 of the present invention
  • Fig. 4 shows the comeal implant 10 inserted or implanted in an appropriately prepared interlamellar, intrastromal channel made within the comea of a mammalian eye.
  • Comeal implant 10 may comprise one or more intrastromal comeal inserts 40, 50 each comprising a main section 42, 52, respectively. Insert 40 further comprises a first and a second migration preventing extension section or haptic 44, 46.
  • First extension section 44 serves as a stop to reduce or prevent migration of inserts 40, 50 toward each other after implantation within the channel such that neither of main sections 42, 52 would migrate to a location directly under incision 100.
  • extension section 46 serves as a stop to reduce or prevent migration of insert 40 toward an end of the channel after implantation therein.
  • Each of intrastromal co eal inserts 40, 50 may also provide an orifice 53 at each end portion of main sections 42, 52, respectively.
  • Each orifices 53 is configured to be engageable with a hooked or curved end of a tool (not shown).
  • the one or more orifices 53 facilitate the insertion of the corresponding insert 40 or 50 into the intracomeal channel as well as the removal of the corresponding insert 40 or 50 from the intracomeal channel.
  • Each of main sections 42, 52 preferably has an arc angle ⁇ , radius of curvature, matching or mismatching cone angles, cross-sectional shape, thickness, width, and/or modulus of elasticity, or combinations thereof for changing the refractive properties of an eye. Examples and definitions of these parameters are disclosed in Publication No. WO 97/28759 entitled "Segmented Intrastromal Comeal Insert for Altering Comeal Refractive Properties and Methods Thereof corresponding to U.S. Ser. No. 08/599,014
  • the arc angle ⁇ of each of main sections 42, 52 refers to the portion of the circumference of the comea (at a chosen radius) within the intracomeal channel which each main section subtends.
  • the value of ⁇ may be any of a wide range of values selected based upon a variety of factors such as the indication to be corrected, the number of insert(s) and the physical arrangement of the insert(s) as they are implanted in the eye.
  • the total value of arc angles ⁇ of the inserts is preferably less than 360° and may be any desired value such as less than about 270°, between 20° and 90°, between 60° and 90°.
  • each insert is preferably less than 180°.
  • each insert preferably has an arc angle ⁇ of less than 175° and more preferably approximately 165°.
  • each insert preferably has an arc angle ⁇ between approximately 45° and 90°.
  • each insert preferably has an arc angle ⁇ between approximately 90° and 180°.
  • each end of a main section does not meet when the insert is inserted into an intrastromal channel.
  • each end of a main section may overlap with an end of another main section, such as in the form of a mitre joint, may abut another main section, or may be parallel with another main section when placed in an intrastromal channel.
  • the cross-section of each of main sections 42, 52 may be hexagonal, rectangular, square, elliptical, circular, or any other appropriate shape and the cross-sectional shape may be symmetrical or asymmetrical.
  • the cross-section of main section 42 may be generally hexagonal with two parallel surfaces 102, 104 and four side surfaces 106, 107, 108, 109, each at an approximate 135° angle relative to the corresponding one of the two parallel surfaces 102, 104.
  • the generally hexagonal cross-section has a width w of approximately 0.80 mm.
  • the generally hexagonal cross-section also has a height h and the two parallel surfaces 102, 104 has a length ⁇ such that the sum of height h and length A is preferably approximately 0.60 mm.
  • each of the four side surfaces 106, 107, 108, 109 of the main section 42 is preferably rounded with a radius of curvature of approximately 1.25 times the height h or between approximately 0.25 mm and 0.688 mm.
  • an extension section may be disposed between the main section and an end of the channel or between two main sections of two adjoining inserts.
  • the extension section serves as a stop to reduce or prevent migration of one or more inserts.
  • a comeal implant of the present invention comprises an insert including an extension section disposed at a location directly under the incision to prevent such migration of the main section.
  • the comeal implant of the present invention may be utilized where one or more intracomeal channels are formed in the eye and where the channel extends in one or two directions (clock-wise and/or counter clock-wise) from the initial incision through the comeal layers.
  • the comeal implant of the present invention may comprise multiple inserts, wherein each insert may be used in isolation, in isolated multiples, in cooperative multiples, or as inserts in a larger assemblage encircling at least a portion of the comea. With multiple inserts, the main sections of two adjoining inserts may also overlap to provide an added thickness at a desired location to thereby form constructs of varying thickness.
  • Each of extension sections 42, 52 may also have an arc angle, radius of curvature, cross-sectional shape, thickness, width, and or modulus of elasticity, or combinations thereof. Each of these parameters may be the same or different from that of each of main sections 42, 52, except that the cross-sectional size of each of extension sections 42, 52 is substantially less than that of each of main sections 42, 52, as discussed below.
  • the radius of curvature of each of extension sections 42, 52 is approximately the same as that of the corresponding main sections 40, 50 such that each insert 40, 50 maintains an approximately constant radius of curvature from the main section to the extension section.
  • each of extension sections 44, 46 may be approximately less than one-half that of the main section 42 and is typically approximately one-fifth that of the main section 42 or less.
  • the smaller cross-sectional area of extension sections 44, 46 ensures that when an extension section is disposed directly under the incision, the extension section does not significantly hinder the flow of nutrients through the interlamellar layers of the comea nor significantly hinder wound healing at the incision.
  • Figs. 5B and 5C show, respectively, a cross-sectional view along line 5B-5B in Fig. 3 and a perspective view of a portion of the comeal implant 10 of Fig. 3 showing the extension section 44 in more detail.
  • extension section 44 is shown in Figs. 5B and 5C, the following description similarly applies to extension section 46.
  • the cross-sectional shape of each of extension sections 44, 46 may be the same as or different from that of main section 42 or 52.
  • each extension sections 44, 46 does not provide any significant adjustment of the comeal curvature for correction of vision abnormalities, although extension sections 44, 46 may provide a small amount of adjustment to the comeal curvature.
  • the cross-sectional shape of each of extension sections 44, 46 is selected based upon the materials of each main and extension section, ease of manufacturability, and ability to reduce or prevent migration of main sections 42, 52.
  • each of extension sections 44, 46 may be rectangular, hexagonal, square, elliptical, circular, or any other appropriate shape and may be may be the same or different from each other and or may be the same or different from the corresponding main section 42, 52.
  • extension section 44 has a rectangular cross-sectional shape.
  • the extension section 44 has a width B. It is desirable to minimize the width B of extension section 44 in order to minimize blockage of the nutrient flow in the comea. However, the width B of extension section 44 should be sufficiently large to maintain a sufficient level of structural stability such that the extension section 44 can serve as a migration preventor. For example, in a currently preferred embodiment, the width B of the extension section may be 0.20 mm where the width w of the main section is 0.80 mm.
  • the extension section 44 has a height C which is preferably approximately 0.30 mm where a corresponding main section 42 has a height h greater than approximately 0.30 mm. Further, where height h of the main section 42 is greater than approximately 0.30 mm, extension section 44 preferably has fillets 110, 112 and chamfer 114 at the interface between the main section 42 and the extension section 44. Fillets 110, 112 and chamfer 114 allow for the smooth transition from the main section 42 to the extension section 44 and also provide additional stmctural support to reduce the risks of the extension section 44 breaking off of the main section 42. However, regardless of whether the extension section has fillets and/or chamfer at the interface between the main section and the extension section, the cross-sectional area of each insert decreases substantially stepwise from the main section to the extension section
  • extension section 44 preferably does not include any fillets or chamfers.
  • the extension section 44 may extend a length of approximately 1.5 mm to 2.5 mm from the corresponding main section 42 and has a cross-sectional area approximately one- fifth that of the main section 42.
  • the extension section 44 extends an arc angle of approximately 50° or less.
  • the comeal layers defining the intracomeal channel typically converge in the space unfilled by a main section, i.e. the channel space between two main sections, to thereby maintain the respective main sections in place.
  • a main section i.e. the channel space between two main sections
  • an extension section would generally be unnecessary.
  • the arc angle of the corresponding extension section is preferably approximately equal to the arc angle of the spacing between two adjacent main sections.
  • the arc angle of the extension section after implantation in the intracomeal channel, may be any arc angle, preferably less than approximately 50°, such as less than 30°, less than 20°, or between 5° and 10°.
  • the extension section 44 preferably extends from the main section 42 such that it is centered relative to the width w of the main section 42 while it is off-centered relative to the height h of the main section 42.
  • the extension section 44 is preferably closer to surface 104 than to the surface 102 of the main section 42 such that extension section 42 is flush with surface 104 and further from the anterior comeal surface. Locating the extension section 44 away from the anterior comeal surface thus locates the extension section 44 away from the incision 100 and thereby minimizes any hindrance to wound healing at the incision 100.
  • the extension section 42 may have a height C equal to main section height h, i.e. the extension section extends along the entire height h of the main section 42, because extension section having a small width B already minimizes the hindrance to wound healing at the incision 100.
  • extension section 44 comprises a thin wire made of metal or other materialse, fibers, or other filamentary materials
  • the extension section 44 is preferably centrally disposed relative to both the width w and the height h of the cross-section of the main section 42. Centrally locating extension section 44 thus facilitates in the abutment of the extension section 44 against an end of the adjacent main section 52. Examples of alternative embodiments of comeal implant 10 are shown in Figs. 6-8.
  • the comeal implant of the present invention may comprise a single insert 60 comprising main section 62 and one extension section 64 to reduce or prevent migration of the main section toward the location of the incision 100.
  • extension section 84 of insert 80 is extendable and compactable.
  • Comeal implant 10C comprises inserts 80, 90, wherein extendable and compactable extension section 84 of insert 80 is coupled to main section 82.
  • Extension section 84 abuts main section 92 of insert 90 to reduce or prevent inserts 80, 90 from migration. Because extension section 84 is extendable and compactable, the separation distance between inserts 80, 90 is adjustable by the operator. Extendable and compactable extension section 84 thus provides a range of separation distances between inserts 80, 90, for example, between 0.25 mm and 25 mm. Further, the radius of the overall comeal implant 10C may also be adjustable.
  • Extendable and compactable extension section 84 may also be coupled to main section 92 of insert 90 to facilitate adjustment of the separation distance by the operator after implantation of comeal implant lOOC. Such coupling ensures that the main section 92 adjoins the extension section 84.
  • extendable and compactable extension section 84 may abut an end of the intracomeal channel such that the distance from incision 100 is adjustable by the operator.
  • Extension section 84 preferably has a serrated, saw-toothed or coiled configuration and preferably is made of a relatively ductile material capable of retaining its configuration over time.
  • extension section 84 may be made of certain metals, fibers, plastics, or other polymers such as polymethylmethacrylate (PMMA), polycarbonate and nitinol.
  • PMMA polymethylmethacrylate
  • nitinol nitinol
  • Extension section may alternatively be formed by injecting a settable material into the intracomeal channel after insertion of the insert 10 therein.
  • injected extension section 74 is disposed between an end of main section 72 of insert 70 and incision 100.
  • extension section 74 is formed by injecting a settable soft polymer, gel, collogen, fibrinogin, or glue preformed hydrogel through incision 100 into the intracomeal channel. After the injected material sets, extension section 74 thus reduces or prevents migration of main section 72 toward incision 100.
  • Suitable injectable polymers are well known and include polyHEMA hydrogel, cross-linked collagen, cross-linked hyaluronic acid, siloxane gels, and organic- siloxane gels such as cross-linked methy vinyl siloxane gels.
  • Each of inserts 40, 50 is made of a physiologically compatible material for effecting change in the comeal curvature, topography or refractive correction to treat or correct vision abnormalities such as astigmatism, myopia, and hyperopia.
  • a main section may be of one or more nontissue materials, synthetic or natural polymers, hydrophilic or hydrophobic, or a hybrid comprising layered materials.
  • the main sections may comprise of one or more polymers having a high and/or low modulus of elasticity.
  • the main section may have an inner portion or be hollow or adapted to be fillable with a biologic agent, drug or other liquid, emulsified, or time-release eye treatment or diagnostic material, or gel or settable polymer.
  • An arcuate main section has sufficient stmctural integrity to approximate the shape of some portion of the channel.
  • the arcuate main section is of selected size, arc angle and or radius of curvature.
  • the materials used in an arcuate main section may be relatively stiff (high modulus of elasticity) physiologically acceptable polymers such as polymethyl- methacrylate (PMMA), TEFLON, polycarbonate, polysulfones, epoxies, or polyolefins such as polyethylene, polypropylene, polybutylene, and their mixtures and interpolymers.
  • PMMA polymethyl- methacrylate
  • TEFLON polycarbonate
  • polysulfones polysulfones
  • epoxies epoxies
  • polyolefins such as polyethylene, polypropylene, polybutylene, and their mixtures and interpolymers.
  • Such high modulus of elasticity materials have moduli of elasticity of greater than about 3.5 kp
  • any polymer which is physiologically suitable for introduction into the body is useful in the inserts of this invention.
  • Many of the listed polymers are known to be suitable as hard contact lenses.
  • PMMA has a long history in ophthalmological usage and consequently is quite desirable for use in these main sections.
  • the polymeric material making up the main sections may be pliable.
  • a pliable main section is such that prior to its insertion into the intracomeal channel, it is quite flexible and need not be preformed to the shape and curvature of the intrastromal channel. The pliable main section will, after insertion into the interlamellar channel, conform to the shape of the channel.
  • the pliable main section will easily transform from a preinsertion shape to the shape of the intrastromal channel only by imposition of the force inherently exerted by the intrachannel walls.
  • the materials used in pliable main sections are physiologically acceptable, low modulus polymers, e.g., materials having a modulus of elasticity below about 3.5 kpsi, more preferably between 1 psi and 1 kpsi, and most preferably between 1 psi and 500 psi, which are physiologically compatible with the eye.
  • Most polymeric materials used in soft contact lenses are suitable for the pliable main sections of the present invention.
  • the class includes physiologically compatible elastomers and such crosslinked polymeric gels as polyhydroxyethylmethyl acrylate (Poly HEMA) or polyvinylpyrrolidone (PVP), polyethylene oxide, or polyacrylates, polyacrylic acid and its derivatives, their copolymers and interpolymers, and the like as well as biologic polymers such as crosslinked dextran, crosslinked heparin or hyaluronic acid.
  • the main sections may be a hybrid, i.e. the main sections are made up of a number of polymeric layers often with a soft or hydratable polymer on their outer surface. Examples of such hybrids are disclosed in International Pub. No.
  • both the inner and outer portions may comprise variously one or more high or low modulus, physiologically compatible polymers or a composite of a low modulus polymer and a high modulus polymer.
  • the inner portion may comprise a gel or a polymeric material which is polymerized in situ after introduction into a hollow center layer.
  • hydratable polymers are used, they may be hydrated before or after introduction into the intrastromal channel created by the surgical device used to introduce these comeal inserts into the eye. If the main section is made of a hydratable polymer and the outer layer is hydrated before insertion into the eye, the final size of the main section will be set before insertion. If the hydratable polymers are allowed to hydrate within the comeal space, the comeal implant (if appropriate polymers are chosen) will swell within the eye to its final size.
  • the outer layer of the main section often provides a measure of lubricity to the comeal implant, allowing it to be implanted in to the intracomeal channel with greater ease. It is usually desirable to at least partially hydrate the hybrid intrastromal main section in that, otherwise, the main section during its traverse through the channel may desiccate the path and stick to the interior wall of the channel.
  • Suitable hydrophilic polymers include polydroxyethylmethacylate (pHEMA), N- substituted acrylamides, polyvinylpyrrolidone (PVP), polyacrylamide, polyglycerylmethacrylate, polyethyleneoxide, polyvinyl alcohol, polyacrylic acid, polymethacrylic acid, poly (N, N-dimethyl amino propyl-N'-acrylamide) and their copolymers and their combinations with hydrophilic and hydrophobic comonomers, crosslinks, and other modifiers.
  • Thermoplastic hydrogels include hydropolyacrylonitrile, polyvinyl alcohol derivatives, hydrophilic polyurethanes, styrene-PVP block copolymers and the like.
  • Each main section may be lubricated with suitable ocular lubricants such as hyaluronic acid, methylethyl cellulose, dextran solutions, glycerine solutions, polysaccharides, or oligosaccharides upon its introduction to help with the insertion particularly if one wishes to insert intrastromal main section of hydrophilic polymers without prior hydration.
  • suitable ocular lubricants such as hyaluronic acid, methylethyl cellulose, dextran solutions, glycerine solutions, polysaccharides, or oligosaccharides upon its introduction to help with the insertion particularly if one wishes to insert intrastromal main section of hydrophilic polymers without prior hydration.
  • Low modulus polymers used in the present invention are often absorbent, particularly if they are hydratable, and may be infused with a drug or biologic agent which may be slowly released from the comeal implant after implantation of the intrastromal inserts.
  • the low modulus polymer may be loaded with a drug such as dexamethasone to reduce acute inflammatory response to implanting the comeal inserts.
  • This drug helps to prevent undesirable scarring or vascular ingrowth toward the intrastromal insert.
  • heparin, corticosteroids, antimitotics, antifibrotics, antiinflammatories, anti-scar-forming, anti-adhesion, and antiangiogenesis factors may be included to reduce or prevent angiogenesis and inflammation.
  • NAD+ nicotine adenine dinucleotide
  • the main section may contain filamentary material in the form of a single or multiple threads, randomly included filaments, or woven mattes to reinforce the insert during, e.g., insertion or removal from the intrastromal channel.
  • the extension section may also be a mere continuation(s) of some or all of the filamentary material.
  • Comeal implant 10 may be formed with a predetermined arcuate shape and/or pliable so that its arcuate shape may be readily changed.
  • main sections 42, 52 may be made of different materials, main sections 42, 52 are preferably both arcuate or both pliable and made of the same or similar materials.
  • extension sections 44, 46 may be made of different materials, extension sections 44, 46 are preferably both made of the same or similar materials.
  • each of extension sections 44, 46 may be made integrally of the same materials as main section 42.
  • comeal implant 10 may be extruded from one material and then machining or otherwise removing material from the extruded piece to form the extenion section(s). Even if extension sections 44, 46 were not formed of the same materials as main section 42, the examples of suitable materials for forming an arcuate main section and a pliable main section, as set forth below, may also be utilized in forming extension section 44 and/or 46.
  • suitable materials for forming a main section may be utilized in integrally forming an extension section of the same material as the main section.
  • the extension section is not integrally formed of the same material as the main section, other materials which are suitable for forming a main section may be utilized in forming the extension section.
  • each of extension sections 44, 46 may be single or multiple strands embedded at an end of main section 42.
  • the stands may be made of one or more metals, plastics, filamentary materials and/or polymers, such as materials use for hip joints such as cobalt-chrome alloys.
  • the geometric center of the comea is marked with a blunt instrument (e.g., a Sinskey hook) using an operating microscope for fixation .
  • a zone marker e.g., an 11 mm zone marker
  • a sterile marking pen may be used to enhance the mark. This center mark is used as the reference point throughout the surgical procedure.
  • the contact surface of an incision and placement marker is marked, using a sterile marking pen, for example.
  • the incision and placement marker is then centered on the center mark created at the geometric center described above, by lining up the reticle of the incision and placement marker with the center mark.
  • the contact surface of the marker is contacted lightly against the comea, making an inked marking of where the radial incision will be made and, in the case of segments, where the segments will be positioned.
  • a visual verification is made that the marks are at least 1 mm from the limbus in all directions. If the marks are too close to the limbus, re-marking of the geometric center of the comea is required, to get closer to the actual geometric center.
  • a pachymetry measurement is made to determine the thickness of the comeal tissue at the incision site.
  • a calibrated, diamond knife is set to 0.430 mm (430 ⁇ ) or 68% of the intraoperative pachymetry reading taken at the incision site.
  • the diamond should either have an angled cutting edge of 15° or less, or have a rectangular blade of 1 mm width or less.
  • a radial incision is made by tracing to the outside edge of the incision mark.
  • the incision length may range from about 1.0 to 1.8 mm, and is preferably about 1.3 mm.
  • a specialized pocketing tool such as those described in co-pending U.S. application titled “CORNEAL POCKETING TOOL", filed on December 18, 1997, is next used to separate the stromal layers at the appropriate depth at the base of the incision. After placing the pocketing tool instrument in the incision, the pocketing tool is rotated to create an intrastromal separation or pocket.
  • the pocket may be enlarged as desired using a stromal spreader such as is described in co-pending U.S. Application Serial No. 08/896,792 filed on July 18, 1997 titled "OPTHALMOSURGICAL INSTRUMENTS AND METHODS OF USE".
  • the tip of the spreader is inserted vertically down into the incision until it contacts the bottom of the incision.
  • a blunt dissection or enlarged pocket is then created on one side of the base of the incision by carefully rotating the blade of the spreader instrument within a single stromal plane.
  • the procedure is then repeated on the other side of the incision base.
  • the resultant pockets should be at the same depth as the incision base, as wide as the full incision length, and extend to the full length of the spreader tip.
  • Comeal thickness gauges may be used to estimate the depth of both pockets. If the pockets are not deep enough in the comeal stroma, the incision is made slightly deeper with the diamond knife and a second pocket or set of pockets are then created at a deeper level with the pocketing tool and spreader in the manner described above.
  • the incision and placement marker is next indexed into a vacuum centering guide (VCG) such as those described in Loomas, U.S. Patent No. 5,403,335 or pending U.S. Patent Application No. 08/796,595, for example.
  • VCG vacuum centering guide
  • the reticle is aligned with the center mark to center the VCG on the center mark.
  • the VCG is then lowered to contact the sclera of the eye while maintaining centration, and then vacuum is slowly applied. Placement of the VCG over the incision and placement marker, together with proper alignment of the marker on both the center mark and the actual incision, ensure that a window in the VCG is centered about the incision site.
  • the vacuum should start in the range of 12-15 inches of
  • a counterclockwise (CCW) dissector such as that described in copending U.S. Application No. 08/676,377, is inserted into the VCG.
  • the dissector body should be rotated until the tip of the dissector blade is adjacent to the incision site.
  • a counterclockwise glide such as described in U.S. Application No.
  • 08/896,792 for example, is inserted in the incision, at least 1 mm into the pocket and the dissector tip is rotated under the foot of the glide. Counterclockwise rotation of the dissector body allows the dissector tip to enter the pocket underneath the glide. The dissector blade is then advanced approximately 1 mm to 2 mm, then stopped. The glide is removed while leaving the dissector tip in position in the pocket.
  • the dissector While holding the VCG vertically with one hand, the dissector is rotated counterclockwise from the incision to create a stromal channel. Rotation of the dissector in a counterclockwise direction is continued until the support spoke of the dissector blade contacts the incision edge. Then the dissector blade is removed from the channel by rotating the dissector body clockwise until the dissector tip exits the channel. The dissector is then removed from the VCG. While maintaining the position of the VCG, a clockwise (CW) dissector, such as that described in copending U.S. Application No. 08/676,377, is inserted into the VCG.
  • CW clockwise
  • the dissector body is rotated until the tip of the dissector is adjacent to the incision site.
  • a clockwise (CW) glide such as described in U.S. Application No. 08/896,792, for example, is inserted at least 1 mm into the opposite pocket and the dissector tip is rotated under the foot of the glide.
  • Clockwise rotation of the dissector body drives the dissector tip into the pocket.
  • the dissector tip should be inserted underneath the glide foot to enter the pocket.
  • the glide blade is next advanced approximately 1 mm to 2 mm, then stopped in its position. The glide is removed while leaving the dissector tip in position in the pocket.
  • the dissector While holding the VCG vertically with one hand, the dissector is rotated clockwise from the incision to create a second stromal channel. The clockwise rotation of the dissector is continued until the support spoke of the dissector blade contacts the incision edge. Then the dissector blade is removed from the channel by rotating the dissector body counterclockwise until the dissector tip exits the channel. The dissector is then removed from the VCG.
  • the vacuum is next released and the VCG is removed from the eye. Any stromal debris from the incision site is removed and the incision area is again thoroughly irrigated, using balanced salt solution, prior to insertion of each segment into the stromal channel.
  • a small amount of Celluvisc® or an equivalent lubricating agent may be applied to the surface of the comea, to avoid direct contact of the segments with the epithelium, although this is not preferred.
  • Each segment, or the ring is picked up using forceps, such as those described in copending U.S. application no. 08/896,792, for example.
  • the leading end of each segment, or of the split ring is fed, into the stromal channel from the incision.
  • One segment is rotated clockwise and the second segment is rotated counterclockwise.
  • a ring may be inserted in either a clockwise or counterclockwise manner.
  • the segments have an anterior/posterior orientation.
  • the segment should be placed in the stroma concave side down, such that the cone angle of the segment is most closely matched with the curvature of the comea.
  • the ring or the segments are manipulated into the desired location within the channel, aligning the outside edge of the segments with the appropriate ink markings left by the incision and placement marker, and the leading ends of the segments are aligned with the appropriate ink markings created by the incision and placement marker.
  • any stromal debris is removed from the incision area, and the incision area is thoroughly irrigated with balanced salt solution.
  • the tissue edges of the incision are gently approximated to close, and the incision may be closed with one to two interrupted sutures using an ophthalmic suture, preferably 10-0 or 11-0 nylon or equivalent.
  • the suture depth should be to the level of the stromal pocket. Care should be taken to avoid microperforation by the suture needle. If two sutures are placed, the sutures should trisect the incision line from the superior and inferior aspects of the incision to insure apposition of the anterior edges of the incision.
  • anterior incision edges must be opposed to prevent epithelial cells from entering the incision. Care should be taken to ensure that tension across the sutures is evenly applied, however overtightening of the sutures should be avoided as this may induce astigmatism.

Abstract

L'invention concerne un implant cornéen comprenant un ou plusieurs inserts physiologiquement compatibles conçus pour être implantés à l'intérieur d'un canal interlamellaire pratiqué dans la cornée de l'oeil d'un mammifère. Chaque insert comporte une partie principale permettant d'effectuer pratiquement la totalité des réglages d'incurvation cornéenne afin de corriger des anomalies de vision. Au moins un de ces inserts comprend, de plus, une ou deux parties prolongées empêchant la migration, accouplées chacune à une extrémité de la partie principale. Après l'implantation à l'intérieur du canal intracornéen, la partie prolongée s'étend depuis une extrémité de la partie principale et est située à proximité soit de la partie principale d'un autre insert, soit d'une extrémité du canal intracornéen, ou vient en butée contre ladite partie ou contre ladite extrémité. La partie prolongée sert de butée servant à limiter ou à empêcher la migration d'un insert ou des inserts après l'implantation à l'intérieur du canal intracornéen.
PCT/US1999/017762 1998-08-05 1999-08-05 Implant corneen comportant un insert empechant la migration WO2000007525A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU53390/99A AU5339099A (en) 1998-08-05 1999-08-05 Corneal implant with migration preventer

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12960098A 1998-08-05 1998-08-05
US09/129,600 1998-08-05

Publications (1)

Publication Number Publication Date
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WO2002047580A2 (fr) 2000-12-15 2002-06-20 Penn, Ian, M. Systeme d'amenee d'une prothese endovasculaire
WO2006066103A3 (fr) * 2004-12-16 2006-09-08 Iscience Surgical Corp Implant ophtalmique pour traitement du glaucome
US7740604B2 (en) 2007-09-24 2010-06-22 Ivantis, Inc. Ocular implants for placement in schlemm's canal
US7828844B2 (en) 2002-09-13 2010-11-09 Forsight Labs, Llc Inserting lenses into corneal epithelial pockets to improve vision
US8267882B2 (en) 2008-03-05 2012-09-18 Ivantis, Inc. Methods and apparatus for treating glaucoma
US8337509B2 (en) 2007-11-20 2012-12-25 Ivantis, Inc. Methods and apparatus for delivering ocular implants into the eye
US8372026B2 (en) 2007-09-24 2013-02-12 Ivantis, Inc. Ocular implant architectures
US8425449B2 (en) 2009-07-09 2013-04-23 Ivantis, Inc. Ocular implants and methods for delivering ocular implants into the eye
US8512404B2 (en) 2007-11-20 2013-08-20 Ivantis, Inc. Ocular implant delivery system and method
US8657776B2 (en) 2011-06-14 2014-02-25 Ivantis, Inc. Ocular implants for delivery into the eye
US8663150B2 (en) 2011-12-19 2014-03-04 Ivantis, Inc. Delivering ocular implants into the eye
US8734377B2 (en) 2007-09-24 2014-05-27 Ivantis, Inc. Ocular implants with asymmetric flexibility
US8808222B2 (en) 2007-11-20 2014-08-19 Ivantis, Inc. Methods and apparatus for delivering ocular implants into the eye
US9358156B2 (en) 2012-04-18 2016-06-07 Invantis, Inc. Ocular implants for delivery into an anterior chamber of the eye
US9510973B2 (en) 2010-06-23 2016-12-06 Ivantis, Inc. Ocular implants deployed in schlemm's canal of the eye
US9579234B2 (en) 2009-10-23 2017-02-28 Ivantis, Inc. Ocular implant system and method
US9693899B2 (en) 2009-07-09 2017-07-04 Ivantis, Inc. Single operator device for delivering an ocular implant
WO2017117689A1 (fr) * 2016-01-05 2017-07-13 Fernandez Telleria, Fernando Agencement de segments intrastromaux
US10159601B2 (en) 2000-05-19 2018-12-25 Ivantis, Inc. Delivery system and method of use for the eye
US10617558B2 (en) 2012-11-28 2020-04-14 Ivantis, Inc. Apparatus for delivering ocular implants into an anterior chamber of the eye
US10709547B2 (en) 2014-07-14 2020-07-14 Ivantis, Inc. Ocular implant delivery system and method
US11197779B2 (en) 2015-08-14 2021-12-14 Ivantis, Inc. Ocular implant with pressure sensor and delivery system
US11540940B2 (en) 2021-01-11 2023-01-03 Alcon Inc. Systems and methods for viscoelastic delivery
US11744734B2 (en) 2007-09-24 2023-09-05 Alcon Inc. Method of implanting an ocular implant
US11938058B2 (en) 2015-12-15 2024-03-26 Alcon Inc. Ocular implant and delivery system

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US10687978B2 (en) 2000-05-19 2020-06-23 Ivantis, Inc. Delivery system and method of use for the eye
WO2002047580A2 (fr) 2000-12-15 2002-06-20 Penn, Ian, M. Systeme d'amenee d'une prothese endovasculaire
US7828844B2 (en) 2002-09-13 2010-11-09 Forsight Labs, Llc Inserting lenses into corneal epithelial pockets to improve vision
WO2006066103A3 (fr) * 2004-12-16 2006-09-08 Iscience Surgical Corp Implant ophtalmique pour traitement du glaucome
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