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WO2007123644A2 - Delaminateur epithelial partiellement lubrifie - Google Patents

Delaminateur epithelial partiellement lubrifie Download PDF

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Publication number
WO2007123644A2
WO2007123644A2 PCT/US2007/007862 US2007007862W WO2007123644A2 WO 2007123644 A2 WO2007123644 A2 WO 2007123644A2 US 2007007862 W US2007007862 W US 2007007862W WO 2007123644 A2 WO2007123644 A2 WO 2007123644A2
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WO
WIPO (PCT)
Prior art keywords
delaminator
epithelium
epithelial
cornea
edge
Prior art date
Application number
PCT/US2007/007862
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English (en)
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WO2007123644A3 (fr
Inventor
Edward Perez
Original Assignee
Tissue Engineering Refraction, Inc.
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Filing date
Publication date
Application filed by Tissue Engineering Refraction, Inc. filed Critical Tissue Engineering Refraction, Inc.
Publication of WO2007123644A2 publication Critical patent/WO2007123644A2/fr
Publication of WO2007123644A3 publication Critical patent/WO2007123644A3/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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/013—Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
    • A61F9/0133—Knives or scalpels specially adapted therefor

Definitions

  • epithelial delaminators Described herein are epithelial delaminators, applicators, lens inserters and methods of using those devices for separating an epithelium from a cornea and for introducing an ocular device beneath a corneal epithelium.
  • the devices may be used to lift a section or portion of the corneal epithelium and, variously, to insert a lens or other ocular correction device beneath the lifted epithelium in a single application stroke to introduce a medicine or diagnostic material beneath the epithelium, or simply to lift the epithelium for other treatment or for conducting reformation of the cornea, perhaps using a laser or mechanical device.
  • the described devices and methods for using them involve separating or lifting corneal epithelium from the eye in a substantially continuous layer to form a flap or pocket.
  • the described delaminator that separates the epithelium from the cornea may be at least partially covered with a lubricious material on at least one surface, often the surface adjacent to the epithelium.
  • the devices and methods may comprise a combined epithelial delaminator and ocular device inserter.
  • the combined delaminator and inserter may be configured to separate the epithelium from the cornea, e.g., between the epithelium and the corneal stroma (Bowman's membrane) in the region of the lamina lucida, and also to introduce an ocular device on the eye without the need for an additional inserter or an additional insertion step.
  • the devices and methods described herein may be used as part of an ocular therapy including ocular corrective surgery and laser eye corrective surgery.
  • Refractive surgery refers to a set of surgical procedures that change the native optical or focusing power of the eye. The result of these procedures often alleviates the need for glasses or contact lenses that an individual might otherwise be dependent on for clear sight.
  • the majority of the focusing power in the human eye is dictated by the curvature of the air- liquid interface, where there is the greatest change in the index of refraction.
  • This curved interface is the outer surface of the cornea.
  • the refractive power of this interface accounts for approximately 70% of the total magnification of the eye.
  • Light rays making up seen images pass through the cornea, the anterior chamber, the crystalline lens, and the vitreous humor before being focused on the retina to form an image. It is the magnifying power of this curved, air-cornea interface that provided the field of refractive surgery with the opportunity to surgically correct visual deficiencies.
  • RK radial keratotomy
  • epikeratophakia A largely flawed and failed procedure called epikeratophakia was developed in the era of RK. It is now essentially an academic anomaly.
  • Epikeratophakia provided a new curvature to the outer curvature of the cornea by grafting onto the cornea a thin layer of preserved corneal tissue.
  • the processed corneal tissue was freeze-dried and during the process of freeze drying, the cornea was also ground to a specific curvature.
  • the resulting lens was surgically placed into the eye.
  • An annular 360° incision was made in the cornea after the epithelium was completely removed from the site where the epikeratophakic lens would eventually reside. The perimeter of this lens would be inserted into the annular incision and held in place by a running suture.
  • epikeratophakia There were several problems with epikeratophakia: 1) the lenses remained cloudy until host stromal fibroblasts colonized the lens, which colonization possibly would take several months; 2) until migrating epithelium grew over the incision site onto the surface of the lens, the interrupted epithelium was a nidus for infection; and 3) epithelium healing onto the surgical site sometimes moved into the space between the lens and the host cornea.
  • epikeratophakia is limited in its use. It is now used in pediatric aphakic patients who are unable to tolerate very steep contact lenses.
  • PRK photorefractive keratectomy
  • LASIK PRK corneal laser ablation
  • the LASIK procedure also known as laser in situ keratomileusis, is currently synonymous in the public mind with laser vision correction.
  • an outer portion (or chord-like lens-shaped portion) of the cornea 80 to 150 microns thick is surgically cut from the corneal surface. This step is performed by a device known as a microkeratome.
  • the microkeratome cuts a circular flap from the surface of the cornea, leaving the flap comprising both epithelial and corneal tissue hinged at one edge.
  • This flap is folded or reflected back and an ablative laser (e.g., an excimer laser) is used to remove or to reform a portion of the exposed surgical bed.
  • the flap is laid back into place.
  • the cornea achieves a new curvature because the flap conforms to the laser-modified surface.
  • epithelial cells are not removed or harmed.
  • the epithelial cells have simply been incised at the edge of this flap.
  • the flap When the flap is placed back onto the corneal bed, the epithelium heals back at the incision site. There is essentially no recuperative time and the results are almost immediate. Because there is very little surgical time (often about 15 minutes for each eye) and because there are lasting and very accurate results, LASIK is currently considered the premier manner of performing refractive surgery.
  • LASEK Laser Assisted Subepithelial Keratomileusis
  • the corneal epithelium is a multilayered epithelial structure typically about 50 ⁇ m in thickness. It is non-cornified. The outer cells are living, although they are squamous in nature. The basal epithelial cells are cuboidal and sit on the stromal surface on a structure known as Bowman's membrane.
  • the basal cell layer is typically about 1 mil thick (0.001")-
  • the basal cells produce the same keratins that are produced in the integument, i.e., skin.
  • the basal epithelial cells express keratins 5 and 14 and have the potential to differentiate into the squamous epithelial cells of the corneal epithelium that produce keratins 6 and 9.
  • the corneal epithelium has a number of important properties: 1) it is clear; 2) it is impermeable; 3) it is a barrier to external agents; and 4) it is a highly innervated organ. Nerves from the cornea directly feed into the epithelium, and thus, defects of this organ produce pain.
  • Epithelial cells are attached side-to-side by transmembrane molecules called desmosomes.
  • Another transmembrane protein, the hemidesmosome connects to collagen type 7 and is present on the basolateral surface of basal epithelial cells.
  • Hemidesmosomes anchor epithelium to the underlying collagenous portion of the stroma.
  • the junction between the epithelium and corneal stroma is referred to as basement membrane zone (BMZ).
  • BMZ basement membrane zone
  • the epithelial cells contact with the solution causes the epithelial cells to lose their adherence at the BMZ, most likely by destroying a portion of that cell population.
  • the epithelium is then raised by pushing the epithelium back in a manner similar to chemically stripping a wall of paint.
  • the exposed collagenous portion of the corneal stroma is then ablated to reshape its surface.
  • a weakened epithelium is then rolled back into place to serve as a bandage.
  • this "bandage" fails to restore the epithelium to its original state, i.e., it does not preserve the integrity of the epithelium, thereby reducing its clarity, impermeability to water, and barrier function.
  • the ability of the epithelium to adhere to the corneal stromal surface is impaired.
  • the written description here includes description of devices for separating a portion of the corneal epithelium from the cornea and optionally inserting a lens or other medical device beneath that lifted corneal epithelium or conducting a medical procedure or introducing a medicine or diagnostic material beneath the epithelium. Portions of that separator or delaminator may have enhanced lubricity; particularly the portion or portions that contact the epithelium during the separation step.
  • This written description further includes description of certain components (and combinations of components with the applied or appliable lenses) that may be used in an integrated system.
  • the integrated system may comprise a system for introducing the lens or other medical device beneath the lifted epithelium, although the description is not so limited in its scope.
  • the component that separates the corneal epithelium from the cornea at the lamina lucida may include an edge configured to mechanically separate a layer of the corneal epithelium from a cornea while maintaining the epithelial layer in at least partial attachment to the cornea.
  • the epithelial delaminator may comprise a suitably, strong and stiff material, e.g., metals, alloys, polymeric materials, filled or reinforced polymeric materials, composite or mixed polymeric materials, and their mixtures having an edge configured to separate the epithelium from the cornea without cutting or removing corneal tissue from the eye.
  • the epithelial delaminator may comprise a leading blade-like structure; e.g., a spatula-like shape configured to separate epithelium in the form of a pocket, or may comprise a parallel or skewed blade-like structure, e.g., a blade that moves linearly across the eye at an angle that is a right-angle to the blade edge or, when skewed, at an angle not at a right angle to the blade edge.
  • the epithelial delaminator need not be blade-like, i.e., a structure having a width-to- thickness ratio of, perhaps, greater than about 5:1, usually more than 10:1.
  • the epithelial delaminator may comprise a wire-like structure, having a width-to-thickness ration of 0.5:1 to about 3:1, usually about 1:1. Such wire-like structures may approach the eye and delaminate the epithelium by moving across the eye in the manner of a cheese-cutter or by using the end of a wire moving back-and-forth to separate the epithelium.
  • the epithelial delaminator may further comprise a block-like structure having a blunt prow to separate the epithelium.
  • the delaminator structure having regions adjacent the epithelium during operation and regions remote from the epithelium, may be fully or partially lubricous. Different lubricity, with the more lubricious portion being adjacent the epithelial contact region, may be a feature of the delaminator.
  • the epithelial delaminator When used to place a contact lens, or other ocular device, beneath the epithelium, it may also comprise an ocular device holder configured to hold an ocular device.
  • the ocular device holder may be configured to place the ocular device onto the cornea, beneath the separated layer of the corneal epithelium.
  • the ocular device holder secures the ocular device in the inserter until the ocular device is placed on the cornea.
  • the ocular device holder may be further configured to replace the epithelial layer over the implanted ocular device after the ocular device has been placed onto the cornea.
  • the ocular device holder may comprise a recessed region into which all or a part of the ocular device may fit.
  • Examples of ocular devices that may be inserted using the devices and methods described herein include any biocompatible ocular device, such as lenses (e.g. contact lenses, implantable lenses, etc. of various compositions including hydrophilic and hydrophobic polymers and their mixtures), filters (polarizers, diffraction filters, etc), inserts, and the like.
  • lenses e.g. contact lenses, implantable lenses, etc. of various compositions including hydrophilic and hydrophobic polymers and their mixtures
  • filters polarizers, diffraction filters, etc
  • the epithelial delaminator may be used to introduce non-ocular implants that comprise or release, for instance, medical treatment or diagnostic compositions beneath the corneal epithelium.
  • the devices may be used to provide an application of such compositions in a liquid, gel, solid, or other form, to the separated region beneath the corneal epithelium.
  • Integrated devices containing the epithelial delaminator may comprise the following components: a.) delaminator for separating the corneal epithelium from the cornea, and, when used as an inserter, configurates for carrying the lens to the sub-epithelial region so- created, for controllably releasing the lens in that site, and for withdrawing from the site without removing the lens; b.) an eye-indexing component or assembly for fixing the position of the inserter/delaminator with respect to the cornea so that it separates the corneal epithelium from the cornea and forms an acceptable sub-epithelial delivery site as a result of the generally movement of the inserter/delaminator, c.) an optional applanator for providing a consistent epithelial surface ahead of the delaminator as it passes along the cornea, and d.) an oscillator for vibrating the delaminator in a way that provides acceptable epithelial delamination.
  • At least one edge of the epithelial delaminator is adapted to delaminate the epithelial layer from the cornea. This edge may be substantially blunt or dull. The edge may be rounded.
  • the inserter lifts the epithelial layer without cutting either the epithelium or the cornea.
  • the edges of the epithelium patch separated from the cornea are considered to be stretched beyond the epithelium's plastic limit by stretching of the epithelium during the physical lifting of the membrane or separated or torn during the initial passage of the delaminator edge through the epithelium.
  • the delaminating edge is sufficiently dull that it does not cut the cornea in use.
  • the edge is sufficiently sharp to separate the epithelium from the limn of the Bowman's layer without leaving substantial (or, preferably, any) epithelial tissue on the corneal bed or surface. At least part of the edge may be stainless steel.
  • the delaminator may be spatula shaped, so that the edge configured to delaminate the cornea is located at the end region of the spatula shape.
  • the delaminator may be comprised of one or more sub-components assembled to form a thin device having fluid flow channels or regions for communicating vacuum from a remote source (e.g., for holding a lens) or passing fluids to the distal area of the delaminator for releasing a lens or promoting epithelial delamination or passing medications to beneath the epithelium.
  • the delaminator may be configured to create a loose epithelial flap, so that the portion of the corneal epithelial layer mechanically separated by the inserter remains attached to the cornea for 10% to 50% of the edge of the separated epithelial layer.
  • the delaminator may be configured to create an epithelial flap, so that the portion of the corneal epithelial layer that is mechanically separated remains attached to the cornea for 50% to 75% of the edge of the separated epithelial layer.
  • the delaminator may be configured to create an epithelial pocket, so that the portion of the corneal epithelial layer mechanically separated by the delaminator remains attached to the cornea for 50% to 95% of the edge of the separated epithelial layer.
  • the delaminator may be configured so that the edge oscillates. Oscillation may help in separating the epithelial layer from the cornea. For example, the delaminator may oscillate the separating (or leading) edge side to side, backwards or forwards, in a circular (or partially circular) motion, or some combination thereof. Oscillation may be in the plane of the delaminator edge, or out of the plane of the delaminator edge.
  • one or more selected regions of the delaminator comprise at least one low-friction surface.
  • placing a low-friction surface on any portion of the delaminator that contacts the delaminated epithelial layer often provides some advantage in quality of the resulting delaminated region and, when the delaminator is also used as a lens inserter, the low-friction surface provides greater predictability of lens displacement onto the cornea.
  • a low-friction surface is also considered to reduce the potential for damage (e.g. tearing) to the delaminated epithelium as the inserter is used.
  • the pertinent surface or surfaces may be coated with friction-reducing substances such as lubricious polymers (e.g., a suitable polyfluoroethylene (e.g., PTFE) or polyxyxylene (e.g., PARALENE) or polyurethanes or polysilicone), biocompatible lubricants such as Silicones or hyaluronic acids, slick inorganic coatings such as diamond, carbon nitride, silicon carbide, diamond-like carbon (DLC), and various other vapor-deposited or pyrolytic carbon films.
  • lubricious polymers e.g., a suitable polyfluoroethylene (e.g., PTFE) or polyxyxylene (e.g., PARALENE) or polyurethanes or polysilicone
  • biocompatible lubricants such as Silicones or hyaluronic acids
  • slick inorganic coatings such as diamond, carbon nitride, silicon carbide, diamond-like carbon (DLC),
  • the delaminator may be indexed to the eye with an indexing component in such a way that when the delaminator is axially moved across the eye, the edge of the delaminator separates the epithelium from the cornea as otherwise described here.
  • One such indexing device comprises a vacuum device, e.g., a ring or column or other device perhaps having a "view" window for the cornea, cooperatively adapted to place the delaminator edge in a specific physical relationship to the eye.
  • a vacuum device may comprise a ring with an opening that allows the user to view the cornea during operation. It may comprise a column with a similar opening.
  • the vacuum device may be sealed with a window, as mentioned just above.
  • the indexing device may comprise non-vacuum fixation devices involving friction or barbs to maintain relative positioning between the eye and delaminator.
  • An applanator having a form such as a roller, a flat plate, or having a curved surface may be included in a position tending to provide a smoothed epithelium surface ahead of or leading the moving edge of the delaminator.
  • kits containing an epithelial delaminator and methods for delaminating an epithelial layer from an eye using the described devices are described herein.
  • Figures IA and IB, 2 A and 2B, and 3 A show front views of an eye depicting various conventions used in explaining corneal delamination herein.
  • Figures 1C, 2C, and 3B show side-views of the views shown in Figures IA 5 2 A, and 3 A, respectively.
  • Figure 4 shows a stylized procedure for placing a lens beneath the corneal epithelium using the devices described herein.
  • Figures 5A-5G show, respectively, for one variation, a lens and delaminator side-view cross-section, a top view of a delaminator, a top lens view, a top view of a sealing plate component, a bottom view of a delaminator, a top view of an alternative sealing plate, and an end view of an alternative sealing plate component.
  • Figures 6A-6E show, respectively, for another variation, a lens and a delaminator side-view cross-section, a bottom view of the delaminator, a top lens view, a bottom view, and a side-view cross-section of the delaminator.
  • Figures 7A-7C show, respectively, for another variation, a top view of a delaminator., a side-view of a delaminator, and a bottom view of the delaminator.
  • Figures 8A-8C show, respectively, for another variation, a top view of the delaminator, a bottom view of the delaminator, and a side-view of the delaminator.
  • Figures 9A-9B show, respectively, for another variation, a top view of a delaminator and an end view of the delaminator.
  • Figures 10A- 1OB show, respectively, a schematic depiction of the before and after cross-sections of an effective delaminator leading edge.
  • Figure 11 is a close-up cross-section of the leading edge of the Fig. 5 A delaminator.
  • Figures 12A-12E show, respectively, the top view, a cutaway side-view, a cutaway end view, a partial cutaway side-view showing a single lubricious surface, and a partial side-view cutaway showing more than one lubricious surface, all of a spatula shaped epithelial delaminating member.
  • Figure 13A shows a top view of a circular epithelial delaminator.
  • Figure 13B shows a cross-section side-view;
  • Fig. 13C shows an end view cross-section;
  • Figures 13D and 13E show partial side-view cutaways depicting single and multiple lubricious surfaces to the Figure 13 A delaminating element.
  • Figure 14A shows a top view of another variation of a block-like epithelial delaminator.
  • Figure 14B shows a side-view of that delaminating member.
  • Figures 14C and 14D show partial cross-sectional side-views of the delaminator with lubricious coverings, respectively, on the epithelial contact regions and on the whole delaminator.
  • Figure 15 A shows a top view of a corneal epithelial delaminator having a dome shaped area and a recess opposite the dome area.
  • Figure 15C shows a side-view of the Figure 15A delaminating member.
  • Figure 15B shows a cross-section end view.
  • Figure 15D shows a side-view cross-section of the Figure 15A delaminating member.
  • Figures 15E and 15F show, respectively, the Figure 15 A delaminator with a single lubricious surface and multiple lubricious surfaces.
  • Figures 16A shows a top view of a wire-based epithelial delaminator.
  • FIG. 16B shows a partial cross-section of the Figure 16A delaminating assembly.
  • Figures 16C and 16D show cross-sections of the delaminating member having single lubricious surface and high coverage lubricious surfaces.
  • Figure 16E provides a schematic explanation of the delaminating step using the Figures 16A delaminating assembly.
  • Figures 17A shows a variation of the Figures 16A delaminating device having an elongated or oval delaminating member.
  • Figure 17B shows a partial cross-section of the Figure 17A assembly.
  • Figures 17C and 17D show a cross-section of the delaminating member having lubricious covering adjacent the epithelial surface.
  • Figures 17D shows a delaminating member with lubricious layer coverage over all surfaces contacting the eye.
  • Figure 18 A shows a top view of a wire whip epithelial delaminating member.
  • Figure 18B shows a free movement of the whip of the delaminating member.
  • Figure 18C shows constrained movement of the whip delaminating member of Figure 18A and the shape of one lifted epithelial region created using moving constraint point.
  • Figure 18D shows the wire delaminating member having lubricious material adjacent the epithelium.
  • Figure 18E shows the wire delaminator member with lubricious coating over its surface.
  • Figure 19A shows a small oval delaminating member.
  • Figures 19B, 19C, 19D, and 19E show various movements suitable for use with the Figure 19A delaminating member and certain lifted epithelial regions made using the combined motions.
  • Figures 19F and 19G show, respectively, cross-sections of the delaminating member of Figure 19A having the epithelial surfaces coated with lubricous material and all the surfaces coated with lubricious material.
  • epithelial delamination devices that may be used to raise at least a portion of the epithelial layer found on the surface of the eye's cornea by cleaving the margin between that epithelium and the cornea.
  • One use of such device involves the placement of an ocular device, e.g., a corrective lens, beneath the raised epithelium optionally in the same trip the device makes in raising the epithelium.
  • the described devices may be used in other ways, of course, e.g., in conjunction with laser reformation of the cornea, subepithelial placement of medicinal treatment or diagnostic materials (e.g., liquids, gels, solids, suspensions, etc.).
  • the various epithelial delamination devices described here have a multiple utility in that they function variously to separate the epithelium from the eye and to introduce the lens, medicine, ocular device, or the like, while doing so and then retreat from the eye without substantially disturbing the so-placed material.
  • Integrated devices may comprise the following components: a.) an epithelial delaminator component for separating the corneal epithelium from the cornea, optionally for carrying the deposited device or material to the sub-epithelial region so-created, for controllably releasing that deposited device or material in that site, and for withdrawing from the site without substantially disturbing the so-placed device or material; b.) an optional eye- indexing component or assembly for fixing the position of the delaminator with respect to the cornea so that it separates the corneal epithelium from the cornea and forms an acceptable subepithelial delivery site as a result of the generally linear movement of the delaminator, c.) an optional track component for providing translational movement to the inserter/delaminator, d.) an optional applanator for providing a consistent epithelial surface ahead of the epithelial delaminator as it passes along the cornea, e.) an optional oscillator for vibrating the epithelial delaminator in a way
  • a lubricious material Central to the described epithelial delaminator is the presence of a lubricious material, variously permanent (i.e., lasting at a substantially constant thickness throughout the epithelial delamination step), temporary (i.e., a solid, gel, or particulate material, perhaps suspended in a fluid that decreases in volume or thickness during the epithelial delamination step), reactive (i.e., a hydrogel or other polymeric material reacting with water to form a slippery material during or just prior to the epithelial delamination step), fluid lubricant (i.e., a fluid introduced with the delaminator).
  • a lubricious material variously permanent (i.e., lasting at a substantially constant thickness throughout the epithelial delamination step)
  • temporary i.e., a solid, gel, or particulate material, perhaps suspended in a fluid that decreases in volume or thickness during the epithelial delamination step
  • reactive i.e.,
  • the delaminator may, during the procedure, be completely covered with the lubricious material, or may be partially covered with the lubricious material.
  • the portion of the delaminator that contacts the epithelium during the epithelial delamination may comprise a lubricious material.
  • the epithelial delaminator may be used for purposes and for procedures other than for the placement of subepithelial materials and devices, e.g., in relation to physical surgery or laser-based surgery or other electromagnetic radiation-based surgery.
  • the mention of a particular use or of a particular benefit in this description, whether specific to the described epithelial delaminator or not, is not to be taken as a waiver of or the abandonment of other rights that the inventors may have, based upon this description.
  • a continuous layer of corneal epithelium may be separated from or lifted from the anterior surface of the eye by applying various mechanical forces to this anterior surface, or to the basal cell layer, or to the junction between the basal cell layer and the Bowman membrane (the "lamina lucida").
  • the term "continuous” as used herein means "uninterrupted.” More or less epithelium may be separated from the cornea.
  • the devices and methods disclosed herein may be used to create a loose flap of corneal epithelium, leaving less than 50% (e.g., between 10% and 50%) of the edge of the delaminated epithelium attached to the cornea.
  • Figure IA shows the front view of an eye (10) having a lifted region (12) of epithelium having an edge (14) with a hinge area (16).
  • the edge (14) in this instance comprises about 90% of the edge of the lifted region (12).
  • Fig. IB shows the eye (10) as depicted in Fig. IA with the lifted region (12) of the epithelium rotated away from the then-denuded cornea (18).
  • Fig. 1C shows a side-view of the eye (10) where the lifted epithelial region (12) has been rotated about the hinge area (16).
  • a flap of corneal epithelium may be made from the corneal epithelium, leaving between about 50% and 75 % and up to about 90-95%, of the edge of the delaminated epithelium attached to the cornea.
  • FIG. 2 A shows a front view of an eye (20) having a region (22) of the epithelium that has been lifted or separated from the cornea.
  • the separated edge or limn (24) of the separated region (22) comprises about 50% of the edge of the separated region (212).
  • about 50% of the separated region (22) remains attached (26) to the cornea (28-seen in Figs. 2B & 2C).
  • the attached edge (26) defines a partially confined region (30) situated between the cornea (28) and the separated epithelium (22) adjacent the attached edge (26).
  • Fig. 2B shows a front view of the Fig. 2 A eye (20) with the separated or lifted epithelium adjacent the non-attached edge (32) rotated or pushed out of contact with the eye (10).
  • Fig. 2B also shows the position of the denuded cornea (28).
  • Fig. 2C shows a side-view of the eye (20) found in Figs. 2A & 2B, the de-nuded corneal surface (28), and the confined region (perhaps a "pocket") (30), adjacent the attached edge (26).
  • Figs. 3 A and 3B typically provides support or acts as a retainer for an implant.
  • the de-nuded cornea (18 in Figs. IA 3 IB, and 1C and 28 in Figs. 2A, 2B and 2C) is readily available as a site for laser treatments or classical surgical techniques.
  • a half flap or less, a pocket or tight pocket, of delaminated corneal epithelium may also be formed by leaving between 50% and 95% of the edge of the delaminated epithelium attached to the cornea.
  • Figs. 3 A and 3B show, respectively, front and side-views of an eye (40) having a separated epithelial region (42) and a separated edge (44) and a connected edge (46) to the region (42).
  • the separated edge (44) typically would be the entry point for the epithelial delaminator discussed elsewhere in this description.
  • more than 50% of the total edge of the separated epithelial region (42), perhaps 90-95% as depicted in Fig. 3 A makes up the connected edge (46).
  • This configuration forms a closed region (48 in Fig. 3B) that maintains any included implants in position.
  • the epithelial delaminators described herein may also be used to insert various implants or materials, including ocular devices, onto the region of the cornea that has been delaminated of epithelium from the corneal stroma.
  • the delaminators described herein permit placement of such implants and materials onto the delaminated cornea, beneath the epithelium that was separated from the cornea. The separated epithelium may then be placed upon or situated atop the inserted implant.
  • ocular device is intended to include any temporary or permanent implantable passive or active ocular device, including ocular devices intended to modify, improve, or correct vision in a patient in need of such modification, improvement or correction.
  • ocular devices include: lenses (such as contact lenses, implantable lenses, etc.), filters (e.g. diffraction gratings, polarizers, etc.), implants (e.g. implants to reshape the eye surface), and the like.
  • Figure 4 shows a stylized version of a typical procedure for inserting a corrective lens using a variation of the delaminator component described herein. This depiction is used to allow a generic functional explanation of one important use of the device.
  • Shown in Fig. 4 is an eye (100) having a cornea (102) and an epithelial layer
  • step (104) of Fig. 4 may be seen a delaminator (106) having an ancillary function as a lens inserter having a distal end (108) with a leading edge (110) configured initially to pass through the epithelial layer (104) and then to separate the epithelial layer (104) from the Bowman's layer of the eye.
  • the delaminator (106) shown also includes a more-proximal shaft (112) that connects it to the selected mechanical drivers, motors, oscillators, or other motion- providing translators.
  • the lens (114) to be implanted or released on the corneal surface beneath the lifted and separated epithelial layer (104) is shown to be situated on the upper surface of the inserter/delaminator (106). As is discussed elsewhere, the lens (114) may be held in position during the step of forming a region beneath the separated epithelial layer (104) via the assistance of releasable vacuum, temporary releasable adhesives, or the like upon the lens (114) or with the inclusion of modest insets or chamfers or the like on the surface of the delaminator (106).
  • step (a) the delaminator (106) approaches the eye (100).
  • step (b) the delaminator (106) has penetrated the epithelial layer (104) and begun its traverse across the cornea (102) separating the epithelium (104) from that surface while carrying the lens (114) toward its desired destination.
  • Step (c) depicts the stage in this procedure where the delaminator (106) and its attendant lens (114) have reached the desired site, the site on the eye where the user wishes to release the lens (114).
  • the epithelium (104) remains atop the lens (114) and may be seen as being situated within an "epithelial pocket" on the eye (100).
  • the lens (114) is freed from the grasp of the delaminator (106) via, e.g., release of a holding vacuum or adhesive or perhaps introduction of a fluid such as saline or water into the delaminator (106).
  • Step (d) of Fig. 4 shows completion of the procedure.
  • the delaminator (106) has been withdrawn from the separated region beneath the epithelium (104) leaving the lens (114) in position upon the cornea (102).
  • the procedure shown in Fig. 4 may be used to situate other solid and gel materials and devices, e.g., implants that deliver medicines, drugs, diagnostics, etc., or may be used to deliver materials in the form of gels, oils, waxes, liquids, etc. for various reasons beneath the epithelium (104).
  • Fig s - 5A-5D show a variation of the delaminator (200) useful also in simultaneously placing implanted lens, its subcomponent parts, and the carried lens (202).
  • Fig. 5A shows, in cross-section, a delaminator (200) and the carried lens (202).
  • the lens (202) is shown in slight separation from the face of the delaminator (200) for clarity of explanation and portrayal.
  • the delaminator (200) shown comprises a domed section (204) and a sealing plate (206). Top and bottom views of the domed section (204) are shown respectively in Figs. 5B and 5E, the former drawing with the lens (202) removed and the latter with the sealing plate (206) removed.
  • the lens (202) is shown in isolation in top view in Fig. 5C.
  • the sealing plate (206) is shown in isolation in top view in Fig. 5D.
  • this variation is adapted to carry the lens on the upper surface (208).
  • the upper surface (208) may be formed to at least approximately replicate the under surface (210) of the lens (202). Passageways (212) of various sizes and positions are shown allowing communication of vacuum from the lower surface (214) to the upper surface (208) and to the lens (202). The vacuum may be used to hold the lens (202) in position until delivery.
  • the upper surface (208) may include an inset (500) to allow the edge of lens (202) to pass more easily across the underside of the epithelium during insertion.
  • the upper surface (208) may include a lubricious covering or coating (502) on at least the surfaces contacting the lens (202) and those surfaces contacting the epithelium during introduction of the delaminator (200) and during its withdrawal.
  • the remainder of the delaminator (200) may also be treated to be lubricious, but we have found such treatment to be of limited added benefit.
  • Figs. 5 A, 5B, and 5E each show a leading edge (232) that has the function of initially penetrating the epithelium and then separating the epithelium from the cornea, the Bowman's layer.
  • the shape of the edge, the cross-section and the adjacent ramp, is discussed below.
  • domed section (200) may also be used to allow passage of fluid such as saline or water (and medicaments, if desired) to push the lens (202) from the upper surface (208) as a portion of the release step.
  • fluid such as saline or water (and medicaments, if desired)
  • the chamber (216) may be separated into a number of independent chambers, if so desired, and accessed by independent passages through the drive leg (220).
  • the independent passages (222, 224) in the drive leg (220) may be placed there by machining, casting, etc.
  • the chamber (216) may be separated into independent chambers (226, 228) by a wall or walls (230) projecting upwardly from sealing plate (206).
  • Figs. 5F and 5G show top and end views of such a variation.
  • a single meandering wall (230) provides two chambers (226, 228), in this example accessing separate sets of passageways (210) through the domed section.
  • One chamber (228) accesses the outer circle of openings (210) and the central opening (210).
  • the other chamber accesses the other four openings (212) in the domed section (204) shown in Figs. 5B and 5E.
  • the passageways and chambers may be isolated to permit separate access by, e.g., the vacuum or the saline, to separate passageways (210) in the domed section (204). We have found that such separate access is sometimes desirable.
  • Distributed vacuum at the edge of the lens provided by numerous passageways at the edge of domed section (204), appears to help with lens stability during insertion of the inserter/delaminator (200).
  • a large passageway (210) at the center of the domed section (204) for passage of water or saline appears to assist in releasing the lens when desired.
  • Fig. 5B shows a top view of the domed section (204) of Fig. 5 A.
  • Fig. 5C shows a top view of the selected lens (202).
  • the lenses suitable for use with this device are not limited in any way. They may be soft, flexible, or they may be hard lenses as those terms are used in opthamology.
  • the lenses may be of hydrophilic or hydrophobic polymers or of their mixtures, block or random copolymers of those materials, composites, multi-layer constructs, and the like.
  • One variation of the device involves the use of a lens as a leading edge in the domed section.
  • Fig. 5D shows the top view of a sealing plate (206).
  • Fig. 5E shows a bottom view of the domed section (204) with the sealing plate
  • Figs. 6A-6E show another variation of the delaminator (250), in particular, a domed section (252) and its attendant lens (254). This variation carries the implant lens (254) beneath the domed section (252).
  • Fig. 6A shows a side-view cross-section of the delaminator (250), the domed section (252), a sealing plate (256), and its attendant lens (254).
  • the chamber (258) beneath the domed section (252) may be adapted or configured to retain the lens (254) during delivery and to controllably release the lens (254) when the desired deployment site is attained, generally as shown in Fig. 4.
  • FIG. 6B One way to retain the lens (254) within the domed section (252) during delivery is depicted in the bottom view shown in Fig. 6B.
  • Various recesses (260) may be placed in the underside (262) of the domed section (252).
  • the recesses (262) may be connected to a passageway (264) found in the arm (268) beneath the sealing plate (256) for passage of vacuum to the recesses.
  • Those same passageways and recesses may be used to apply fluids such as water or saline to release the lens (254 in Figs. 6A and 6C).
  • Figs. 6A and 6B show the leading edge (270) of the delaminator (250) that has the function of initially penetrating the epithelium and then separating the epithelium from the cornea, the Bowman's layer.
  • the shape of the edge, the cross-section and the adjacent ramp, is discussed below.
  • Fig. 6C shows a top view of lens (254).
  • Fig. 6D shows a top view of domed section (252).
  • Fig. 6 E shows a partial close-up, cross-section of the epithelial delaminator
  • Fig. 6E shows the presence of a lubricious coating (278) on the upper surface of the delaminator in the regions where the delaminator blade contacts the epithelium during the delaminating procedure.
  • Figs. 7A-7C show another variation of the delaminator (300) having the concurrent function of lens or implant insertion.
  • these delaminators have an elongated shape terminating in an edge region (302).
  • this version of the delaminator (300) is shown to be substantially flat, as shown in the side-view of the delaminator (300) in Figure 7B.
  • This delaminator (300) includes a top, or upper, surface (304) and a lower, or bottom, surface (306).
  • Fig. 7C shows the bottom surface (306).
  • the delaminator (300) is shown to be substantially flat, and having a uniform thickness (310) across and along its length, although other shapes (e.g.
  • Figure 7C also shows a holding region, cavity (320), in the bottom surface (306) into which at least a portion of an ocular device may be placed.
  • the delaminator may be described herein as flat or planar, these terms should be understood to specifically include shapes having a curvature in one axis (e.g. side to side) and in another axis (e.g. front to back) as appropriate to ease the mechanical separation of the epithelium from the corneal surface.
  • the delaminator may also be adapted to enhance the function of the inserter by decreasing the rubbing friction of the respective surfaces.
  • the top surface (304) of the delaminator may be adapted to reduce friction between the inserter/delaminator and the delaminated corneal epithelial layer by smoothing the top surface (304) via polishing or by coating with a lubricious material as discussed elsewhere herein.
  • Friction between the top of the delaminator and the delaminated epithelium may also be reduced by decreasing the overall bulk, volume, or size of the surface area which contacts the delaminated epithelium.
  • FIGs. 8 A and 8B show a delaminator (330) in which a ring (334) comprises the edge (332).
  • friction is reduced because the opening (310) in the top surface (304) of the top of the delaminator (330) effectively reduces the surface area with respect to a delaminator such as is shown in Fig. 5 A.
  • Figures 8 A and 8B also show an attachment site (314) by which the delaminator
  • FIG. 9A shows the top view of another version of a delaminator (360). This version includes a recess (362) in the bottom surface (364) of the delaminator (360) configured to act as a holding region for the implant or lens to be delivered.
  • the holder recess (362) releasably secures an ocular device on (or in) the delaminator (360).
  • the holder recess (362) is adapted to release a secured implant, e.g., an ocular device, once the delaminator (360) has sufficiently separated the epithelium from the cornea so that the implant fits into the delaminated region.
  • the various epithelial delaminators discussed herein may be adapted or configured to secure an implant during the implantation and delamination step and to release the implant.
  • the implant is held in the delaminator by applying a vacuum to the implant.
  • Positive fluid pressure may be applied through the same channel(s) to release the implant.
  • air or other gas
  • Fluid e.g., water or saline or other suitable fluid, may be used to release the ocular device.
  • the securing and releasing configurations may be used to apply useful substances (e.g. liquids such as saline, medicaments, etc.) to the cornea.
  • the implant may be held to the epithelial delaminator by a releasable adhesive.
  • a dissolvable adhesive may be used.
  • a water-soluble material may be used to secure the ocular device until it is ready to be released after insertion.
  • water-soluble materials having adhesive properties include, but are not limited to: polymers such as polyvinylalcohol, biopolymers such as hyaluronic acid (HA), and various polysaccharides.
  • Application of a fluid that releases the adhesive e.g., saline or other beneficial fluid) causes the adhesive to dissolve or otherwise release, allowing implantation of the ocular device.
  • a fluid that releases the adhesive e.g., saline or other beneficial fluid
  • Such a solution may be applied locally or over a larger area of the cornea.
  • the various leading edge regions of the delaminators are the regions which mechanically interact with the cornea to cleave or to delaminate and to separate some portion of the epithelium from the surface of the cornea, the Bowman's layer.
  • the edge is one that performs such a function.
  • the edge is of a shape that is sufficiently blunt to permit and to cause separation of the epithelium from the cornea but does not cut any corneal tissue during such a procedure.
  • the edge may be considered as having a bluntness appropriate to separate the epithelium from the cornea and produce a delaminated epithelial layer without substantial corneal tissue attached.
  • the edge may be sufficiently blunt to produce a separated epithelial layer has only an insignificant amount of corneal tissue attached. Best is an edge that produces a separated epithelium layer having no corneal tissue attached.
  • Fig. 1OB shows an edge profile or cross-section that has proven to result in epithelial pockets of comparatively higher quality, i.e., having little extraneous epithelial tissue on the corneal surface after passage of the delaminator. It is quite blunt to touch by hand. It is produced by electropolishing an edge blank (400) having a profile such as is shown in Fig. 1OA and producing the blunt, but rounded, edge shown in Fig. 1OB. Such an edge profile (232) is also shown in Fig. 11.
  • the cross-sectional profile of the delaminating edge may also vary over the length of the edge.
  • the region just adjacent the edge i.e., the ramp (404 in Fig. 10B) may be generally wedge-shaped.
  • the angle of such ramp may also vary over a reasonable range.
  • the ramp is shown having an angle of about 20° from the horizontal (70° from the vertical).
  • the ramp angle may range from about 5° to greater than 45°. That angle may be constant over the entire device or may vary.
  • the portion of the ramp closest to the bottom surface may be around 20°, while the angle decreases as the edge approaches the upper surface.
  • the ramp angle may be chosen so that there is no visible transition from the edge to the upper surface.
  • the transition between the edge region and the lower and upper surface may be blunt (e.g. smooth), or sharp (e.g. angular).
  • the leading edge of the delaminator may comprise any material suitable for carrying out the specified function, i.e., as it delaminates the epithelial layer from the cornea.
  • the edge region may comprise metals, alloys, ceramics, or polymers, composites of one o more of these classes and may further be coated or otherwise with other materials to enhance some property of the leading edge. For instance, selected materials or coatings may be included to enhance the ability of the edge to delaminate the epithelium from the cornea without damaging either the cornea or the epithelial cells.
  • the edge may comprise stainless steel, perhaps polished (e.g. electropolished) or coated.
  • the edge material may also be made of the same material as the shaft region of the inserter, or it may be made from a different material.
  • Delaminators intended for use with living tissue may be made of a material which can be sterilized.
  • the edge may also include a material which incorporates therapeutic properties (e.g. medicaments, growth factors, etc.) to assist the healing process, reduce pain, or to help the cornea in accepting an optical implant.
  • therapeutic properties e.g. medicaments, growth factors, etc.
  • the edge region (or any region of the delaminator) may be configured to release a medicament from a polymeric matrix coating while in contact with the eye.
  • Fig. 11 shows a close-up cross-section of a leading edge and adjacent structures of the delaminating device shown in Fig. 5 A specifically showing a lubricious coating (502) on the surfaces that contact the epithelium during use: the leading edge (232) during the passage delaminating the epithelium and the recess (500) that contacts the epithelium after the lens (or implant) (202) has been ejected from the delaminator and the delaminator is being withdrawn from beneath the epithelium.
  • a lubricious coating 502
  • Fig. 12A shows a top view of a spatula shaped delaminator (600).
  • the delaminator (600) may be oscillated from side-to-side or axially front-to-back and in combinations of the two.
  • Fig. 12B shows a side-view cross-section of the delaminator (600) with a substantially flat bottom (602) situated adjacent the eye and cornea during use.
  • the non- cutting leading edge (604) is also seen, as is a rounded top surface (606)
  • Fig. 12C shows a front- view cross-section of the delaminator (600) and the sloping, rounded shape of the top surface (606).
  • the top surface (606) is adjacent the epithelium during the step of delaminating the epithelium.
  • Fig. 12D shows a partial cross-section of the delaminator (600) and, specifically, the blade substrate (608) with a lubricious layer (610) situated on the side of the delaminator (600) that is adjacent the epithelium during use.
  • Fig. 12E shows a partial cross-section of the delaminator (600) with the blade substrate (608) having lubricious layers (610) on both sides of the substrate (608).
  • Fig. 13 A shows a top view of an epithelial delaminator (620) having an active end that is substantially circular. As was the case with the delaminator shown in Fig. 12 A, this variation may be oscillated from side-to-side or axially front-to-back or in combinations of the two movements.
  • the leading edge (622) need be configured having a separating shape only in the marked region (624).
  • Fig. 13B shows a side-view cutaway of delaminators (620) with leading edge (624). The shape is seen to be somewhat dome-shaped in the body or substrate (626) of the delaminator (620).
  • Fig. 13C shows a cross-section front view of delaminator (620) and the dome- shaped substrate (626).
  • Fig. 13D shows a partial cross-section of delaminator (620) and, specifically, the blade substrate (626).
  • the lubricious layer (628) is shown situated on the side or region of the delaminator (620) adjacent the epithelium during use.
  • Fig. 13E shows a partial cross-section of delaminator (620) having a lubricious layer (628) on both sides of delaminator substrate (626).
  • Fig. 14A shows a top view of a delaminator (630) having a leading portion (632) in the nature of a prow.
  • This delaminator may be used to produce the substantially hinged epithelial flat (12) as is shown in Figs. IA, IB, and 1C.
  • Delaminator (630) may be oscillated from side-to-side or axially front-to-back during use but is typically used only with a front-to- back oscillation.
  • Fig. 14C shows a partial side-view, cross-section of delaminator (630) having a blade substrate (634) and a layer of lubricious material (636) only on those portions tending to contact the epithelium during the delamination step.
  • Fig. 14D shows a delaminator (630) with a substrate (634) and a lubricious coating (636) on all surfaces contacting the eye during use.
  • Fig. 15A shows a top view of a delaminator (650) that is somewhat spatula- shaped but includes a dome shaped region (652) on its top side and, as will be seen in Fig. 15B, a concave shaped portion (654) on its bottom side (656).
  • the epithelial delaminator (652) includes a leading edge (656) having an edge configured to separate the epithelium from the Bowman's layer without cutting the cornea or leaving substantial epithelial tissue on the cornea or corneal tissue on the underside of the epithelium.
  • Fig. 15B shows a front cross-sectional view of delaminator (650) showing both the dome (652) and the concave region (654).
  • Fig. 15C shows a side-view of delaminator (650) in the presence of the dome
  • Fig. 15D shows a partial, side-view, cross-sectional view of the delaminator
  • Fig. 15E shows a partial cross-sectional view of delaminator (650) blade substrate (658) and a lubricious layer (660) on the dome-shaped region.
  • the dome-shaped region of delaminator (650) contacts the underside of the epithelium during the delamination step.
  • Fig. 15F shows a partial, cross-sectional, side-view of delaminator (650) and, in this instance, shows a lubricious layer (660) on both sides of blade substrate (658).
  • Fig. 16A shows a top section of a delaminator (670) shaped substantially in the form of a cheese slicer. The delaminating element is the wire (672) found between the arms
  • Fig. 16B shows a blowup of a one arm (654) of the delaminator (670) and the delaminating wire (672).
  • Fig. 16C shows a cross-section of the delaminating wire (672) with a substrate
  • Fig. 16D shows another variation of a delaminating wire (672) having substrate
  • Fig. 16E is a cross-sectional side-view of delaminator (670) and the delaminating wire (672) passing beneath the epithelium of an eye (674).
  • Fig. 17A shows a delaminator assembly (680) having a delaminator element
  • Fig. 17C shows a cross-section of a delaminating element (682) with the substrate (686) and where a lubricious covering (688) is found on the section of the delaminating element (682) that contacts the epithelium, the underside of the epithelium, during the step of delaminating.
  • the arrow (690) found in Fig. 17C shows the direction of travel of the element (682) during the delamination step.
  • Fig. 17D shows a delaminating element (682) having a lubricious coating (688) on substantially all of the surface of the substrate (682) that would contact the eye during delamination.
  • Fig. 18A shows a simple wire whip delaminator element (700) that is oscillated back and forth as shown in Fig. 18B to form a region of separated epithelium.
  • Fig. 18C shows one shape of a separated epithelial region (702) that may be produced by varying the "whip point" (704) position as the wire is moved axially beneath the epithelium (706).
  • Fig. 18D shows the substrate wire (708) and the partial lubricious coating (710) on the sections of wire acting as the delaminating element (700).
  • Fig. 18E shows the delaminating wire elements (700) with a substrate (708) and the lubricious covering (710) covering substantially all of the substrate (708).
  • Fig. 19A shows an epithelial delaminator (720) having a substantially oval cross-sectional area.
  • the side-to-side dimension of the oval in this variation would typically be substantially smaller, e.g., less than 10% of, the diameter of the epithelium of the eye for which is separated epithelial region is desired.
  • Fig. 19B shows a limited rotation motion (712) for the epithelial delaminator element (710).
  • Fig. 19C shows a side-to-side movement (714) for the epithelial delaminator element (710).
  • Fig. 19D shows a combination motion for the epithelial delaminating member
  • FIG. 19E shows epithelial pocket having an attached edge (720) and a small opening (722) made by introducing delaminator (710) beneath the epithelium and both rotating it about a pivot point near the mouth (722) and withdrawing the delaminator (710) at the extreme angles of motion to form the region shown there.
  • This combination of rotatory and axial movement of the delaminator (710) is useful in producing a pocket having a small opening and a large and closed region beneath the epithelium.
  • Fig. 19F depicts a cross-section of delaminating element (710) with the blade substrate (730) and a coating of lubricious material (732) on the face of the delaminating element that is the contact of the epithelium.
  • Fig. 19G shows cross-section of the delaminating element (710) with a substrate
  • the delaminator described here device may be fabricated from separate parts
  • the delaminator may be injection molded and/or micro-stamped into shape.
  • the size of the delaminator is chosen by the designer and depends in large part upon the intended use of the delaminator, e.g., dependent upon the size of the device to be implanted or the material to be placed beneath the epithelium.
  • the delaminator may have an overall thickness similar to the thickness of the basal cell layer, e.g., about 1/2 mil to 3.5 mils. (0.0005 to 0.0035"), but often about 1.0 mil to 3.0 mils (0.001 to 0.003").
  • the edge of the inserter may have a thickness around 2.0 mils.
  • the delaminator is used to insert an ocular device beneath a substantially intact sheet of the epithelium, that is to say: the portion of the epithelium that passes to the anterior side of the dissector is continuous.
  • the delaminator may be used in less elegant ways. For instance, the delaminator may be used to remove selected portions of that membrane. Indeed, when this device is used in conjunction with a LASEK procedure, the epithelium may be removed in the form of a soft flap allowing for ease of replacement or repositioning once any corneal laser remodeling is completed. In some instances it may be desirable to also apply heat to the anterior surface of the eye to enhance the mechanical epithelial delamination or to apply cooling fluids to the device and to the epithelium to enhance the viability of the epithelium after the conclusion of the procedure.
  • the devices described here may be used to delaminate epithelium during the described procedure into the shape of a pocket, i.e., a structure having more than 50% of the periphery of the separated epithelium remains attached to the cornea.
  • the pocket remains above and surrounding the inserted material or ocular device.
  • the devices may also be used to produce epithelial flaps that may be at least partly folded away from the surface of the eye. After placement of the ocular device (or after completion of a procedure such as laser corrective surgery), the delaminated epithelium may be replaced.
  • the structure and physiologic properties for my invention, as well as certain of the benefits particular to the specific variations of this epithelial delaminating device, have been described. This manner of describing the invention should not, however, be taken as limiting the scope of the invention in any way.

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Abstract

La présente invention concerne des dispositifs et des procédés utiles dans le domaine de l'ophtalmologie. Elle concerne des délaminateurs épithéliaux, des applicateurs, des dispositifs d'insertion de lentilles et des procédés d'utilisation de ces dispositifs pour séparer un épithélium d'une cornée et pour introduire un dispositif oculaire au-dessous d'un épithélium cornéen. De manière classique, les dispositifs peuvent être utilisés pour soulever une partie dudit épithélium et, différemment, pour insérer une lentille ou un autre dispositif de correction oculaire au-dessous de l'épithélium soulevé lors d'une manœuvre unique pour introduire un matériau médicinal ou de diagnostic au-dessous de l'épithélium, ou bien simplement pour soulever l'épithélium pour un autre traitement ou pour réaliser une reformation de la cornée, éventuellement à l'aide d'un laser ou d'un dispositif mécanique. Les dispositifs et les procédés décrits pour les utiliser concernent la séparation ou le soulèvement dudit épithélium à partir de l'œil dans une couche sensiblement continue pour former un rabat ou une poche. Ledit délaminateur qui sépare l'épithélium de la cornée peut être au moins partiellement recouvert d'un matériau lubrifiant sur au moins une surface, souvent la surface adjacente à l'épithélium. Les dispositifs et les procédés peuvent comprendre un délaminateur épithélial et un dispositif d'insertion de dispositif oculaire combinés qui peuvent être configurés pour séparer l'épithélium de la cornée, par exemple entre l'épithélium et le stroma cornéen (membrane de Bowman) dans la région de la lamina lucida, et également pour introduire un dispositif oculaire sur l'œil sans avoir besoin d'un dispositif d'insertion supplémentaire ou d'une étape d'insertion supplémentaire. Les dispositifs et les procédés décrits aux présentes peuvent faire partie d'une thérapie oculaire comprenant la chirurgie corrective oculaire et la chirurgie corrective oculaire au laser.
PCT/US2007/007862 2006-03-28 2007-03-28 Delaminateur epithelial partiellement lubrifie WO2007123644A2 (fr)

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WO2010112040A1 (fr) * 2009-04-01 2010-10-07 Wavelight Gmbh Dispositif de découpe d'un volet cornéen dans l'oeil
US8337489B2 (en) 2009-04-01 2012-12-25 Wavelight Ag Apparatus for cutting a flap in the cornea of an eye
JP2016064133A (ja) * 2015-11-04 2016-04-28 マニー株式会社 ストレートナイフの製造方法

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EP1175879A1 (fr) * 2000-02-02 2002-01-30 Ooo Meditsinsky Nauchno-Issledovatelsky Oftalmolog Ichesky Tsentr "Novy Vzglyad" Canule de kourenkov destinee a une methode d'operation de keratectomie photorefractive intrastromale par laser excimere
AU2003268558B2 (en) * 2002-09-09 2009-01-08 Alexander Dybbs Ophthalmic surgical system
CN1761436A (zh) * 2002-12-10 2006-04-19 视锐有限公司 将上皮层从眼角膜上分离的一次性分离器
EP1706080A2 (fr) * 2003-11-14 2006-10-04 Tissue Engineering Refraction, Inc. Methodes de traitement de l'epithelium et dispositifs de traitement de l'epithelium

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Publication number Priority date Publication date Assignee Title
WO2010112040A1 (fr) * 2009-04-01 2010-10-07 Wavelight Gmbh Dispositif de découpe d'un volet cornéen dans l'oeil
US8337489B2 (en) 2009-04-01 2012-12-25 Wavelight Ag Apparatus for cutting a flap in the cornea of an eye
JP2016064133A (ja) * 2015-11-04 2016-04-28 マニー株式会社 ストレートナイフの製造方法

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