TW200803820A - Partially lubricious epithelial delaminator - Google Patents

Abstract

The described devices and methods are useful in the field of ophthalmology. 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. Typically, 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.

Description

200803820 IX. Description of the invention: [Technical field to which the invention pertains] The n-pieces and methods described are applicable to the field of ophthalmology. The methods of epithelial stratification, applicators, lens inserters, and the use of such devices to separate the epithelium from the cornea and introduce a visual device into the corneal epithelium are described herein. A# can be used to raise a segment or a portion of the corneal epithelium in a single-applying action, and a lens or other visually aligning device is placed under the elevated epithelium at different times to The drug or diagnostic material is introduced under the epithelium 'or just elevated the epithelium for other treatments or for corneal reformation, which may use a laser or mechanical device. The device described and its separation of the corneal epithelium from the eye or the elevation of the corneal epithelium from the eye in a substantially continuous layer to form a patch or pocket. The described layerer for separating the epithelium from the cornea may be at least partially covered with a lubricating material on at least one surface, typically the surface is adjacent to the epithelium. The devices and methods can include a combined epithelial stratifier and a vision device inserter. The combined layerer and inserter can be configured to separate the epithelium from the cornea, for example, between the epithelium and the corneal stroma (Baumann's membrane) in the region of the transparent plate, and also - the visual device It's eye-catching, without the need for an extra device or an extra placement step. The devices and methods described herein can be used as part of a visual treatment including vision correction surgery and laser eye correction surgery. [Prior Art] Refractive surgery refers to a group of surgical procedures that alter the natural optics or focusing power of the eye. The results of such procedures generally reduce the need for glasses or contact lenses that individuals may otherwise rely on for clear vision. The majority of the human eye 119800.doc 200803820 The ability to focus is governed by the curvature of the air-liquid interface where maximum diopter changes exist. 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. The light that forms the image of the image passes through the cornea, anterior chamber, lens, and vitreous before focusing on the retina to form an image. This ability to flex and air the corneal interface provides the possibility of surgical correction of visual impairment in the field of refractive surgery. Early refractive surgery procedures corrected myopia by smoothing the curvature of the cornea. The first procedure with some success was called radial keratotomy (RK). In the 1970s and early 1980s, RK was widely used and contained radially oriented incisions in the periphery of the cornea. These incisions are made to reshape the surrounding cornea by flattening the peripheral cornea outwards, thereby smoothing the central optic zone of the cornea. This procedure is fairly simple and therefore popular, but it only reduces people's dependence on glasses or contact lenses. During the RK period, a procedure with a large defect and unsuccessful development called epicarrat 〇phakia was developed. It is now basically an academic anomaly. The superficial corneal lens graft provides a new curvature to the outer curvature of the cornea by grafting a thin layer of preserved corneal tissue onto the cornea. The treated corneal tissue is freeze dried and the cornea is also ground to a specific curvature during the freeze drying process. The resulting lens is placed in the eye by surgery. After the epithelial self-surface corneal lens is completely removed from where it ultimately resides, a dome 360 is created in the cornea. incision. By continuous stitching, the periphery of the lens is placed into the annular slit and held in place. There are several problems with superficial corneal lens transplantation: i) the lens remains blurred until the main matrix fiber 119800.doc 200803820 is implanted into the lens, which may take several months; 2) it will grow on the incision Before the epithelium is moved to the surface of the lens, the interrupted epithelium is the lesion of the wood, and 3) the healing epithelium sometimes moves into the space between the lens and the main cornea at the surgical site. When _, superficial corneal lens transplantation is forked to limit in its use. It is now used in pediatric aphakic patients who cannot tolerate very steep contact lenses. Around the mid-1990s, the procedure for etching the cornea with a laser was so successful that it began to replace radial keratotomy. The first generation of corneal laser ablation is called laser refractive keratectomy (pRK). In this, an ablative laser (e.g., an excimer laser) is focused on the cornea to etch a new curvature in the surface. In the PRK, the epithelium is destroyed when a new outer surface bend is reached. During the postoperative period, the epithelium grows or heals back to the proper position. This epithelial healing stage is problematic for most patients due to the pain of exfoliation and removal of the epithelial cornea. After PRK, patients often find initial difficulty in vision, and this, recovery time can last from a few days to a week or longer. One of the subsequent variants of PRK corneal laser ablation (LASIK) has become Very popular. Currently, in the public opinion, the LASIK procedure (also known as laser in situ keratoplasty) is synonymous with laser vision correction. In LASIK, the cornea is surgically cut from the corneal surface (80 to 150 microns thick). The outer portion (or string-like lens-shaped portion). This step is performed by a device known as a corneal micro-cutter. This corneal micro-cutter cuts a round piece of skin from the surface of the cornea to make the spoon epithelium And the flap of the corneal tissue is hinged at an edge. The flap is folded or folded back and removed using an ablative laser (eg, excimer laser) or 119800.doc 200803820 re-exposure surgery Part of the bed. Put the piece back in place. When the piece is returned to the proper position, the cornea reaches a new curvature because the skin is in the same shape as the laser-corrected corneal surface. In this procedure , epithelial cells have not been removed or subjected to To the injury. Only the epithelial cells are cut at the edge of the skin. When the skin is placed back on the corneal bed, the epithelium heals at the incision. There is basically no recovery time, and the result is almost immediate. Because there is very little The operative time (usually about 15 minutes per eye) and because of the long-lasting and very accurate results, currently [881& is considered the primary way to perform refractive surgery. In the practice of refractive surgery and in some The latest technology evaluated in the academic center is a procedure called Laser Refractive Corneal Remodeling (LASEK). In LASEK, the ''skin') is made only from the epithelium. The epithelial layer was lifted off the cornea in a manner similar to lasik but using an ethanol detergent. Only the ablation laser is focused on the surface of the exfoliated cornea (in the same manner as performed by PRK). However, this epithelial sheet remained intact, i.e., the epithelial solid structure was not destroyed, but cell viability was largely destroyed. After forming the weight of the cornea, the test piece, such as the part, it is simply rolled back into place, which results in much less recovery time than using PRK. The current LASEK method is not as good as LASIK, but the result is better than using PRK. The corneal epithelium is a multilayered epithelial structure typically having a thickness of about 5 〇 μπι. It is non-keratinous. The outer cell is active, although it is scaly in nature. The basal epithelial cells are cuboidal and are placed on the surface of the substrate known as the structure of the Bowman's membrane. The basal cell layer is typically about 1 mil thick (〇〇〇1,,). Basal cells produce the same keratin as produced in the rind (i.e., the skin). Basal 119800.doc 200803820 Epithelial cells exhibit keratin 5 and 14 and have the potential to differentiate into squamous epithelial cells that produce corneal epithelium of keratin 6 and 9. The corneal epithelium has an important characteristic. 1) it is clear; 2) it is not permeable; 3) it is a barrier to the external agent; and 4) it is a highly innervated organ. The nerves from the cornea are fed directly into the epithelium, and as a result, the defects of this organ cause pain. Epithelial cells are laterally flanked by transmembrane molecules called desmosomes. Another transmembrane protein (hem ides mo some) is attached to collagen type 7 and is present on the bacal outer surface of basal epithelial cells. The hemides anchor the epithelium to the collagen portion beneath the matrix. The junction between the epithelium and the corneal stroma is called the basement membrane band (BMZ). When LASEK is performed, the physical well is placed or formed on the epithelium and filled with the selected 20% ethanol and balanced salt solution. Contact with the solution causes the epithelial cells to lose their adhesion at the BMZ, much like it is due to the destruction of a portion of the cell population. The epithelium is then raised by pushing the epithelium back in a manner similar to the paint on the chemical stripping wall. The exposed collagen portion of the corneal stroma is then excised to reshape its surface. The weakened epithelium is then rolled back into place to act as a bandage. However, this "bandage" does not restore the epithelium to its original state', i.e., it does not preserve the integrity of the epithelium, thereby reducing its clarity, impermeability, and barrier function. In addition, the ability of the epithelium to adhere to the surface of the corneal stroma is impaired. references

Kiistala, U. (1972). ^Dermal-Epidermal Separation. II. External Factors in Suction Blister Formation with Special 119800.doc 200803820

Reference to the Effect of Temperature,’’ Ann Clin Res 4(4): 236-246 〇

Azar et al. (2001). H Laser Sub epithelial Keratomileusis: Electron Microscopy and Visual Outcomes of Flap Photorefractive Keratectomy, '' Curr Opin Ophthalmol 12(4): 323-328 〇

Beerens et al. (1975) · "Rapid Regeneration of the Dermal-Epidermal Junction After Partial Separation by Vacuum: An Electron Microscopic Study 5ff J Invest Dermatol 65(6):513-521 〇

Willsteed et al. (1991). 'An Ultrastructural Comparison of Dermo-Epidermal Separation Techniques,' J Cutan Pathol 18(1): 8-12.

Van der Leirn et al. (1974). ’’Repair of Dermal-Epidermal Adherence: A Rapid Process Observed in Experiments on Blistering with Interrupted Suction,” J Invest Dermatol 63(5): 397-401 °

Katz SI. (1984). !,The Epidermal Basement Membrane: Structure,Ontogeny and Role in Disease,’’ Ciba Found Symp 108:243-259 °

Green et al. (1996). "Desmosomes and Hemidesmosomes: Structure and Function of Molecular Components," FASEB J 10(8): 871-881. None of the cited references teach or suggest devices and procedures as described herein, 119800.doc -10- 200803820. SUMMARY OF THE INVENTION The written description herein includes for separating a portion of the corneal epithelium from the cornea and optionally placing a lens or other medical device under the elevated corneal epithelium or performing a medical procedure or administering a drug or diagnostic material. A description of a piece introduced under the epithelium. Portions of the separator or delaminator (specifically, the portion or portions that contact the epithelium during the separation step) may have enhanced lubricity. This written description includes a description of certain components that can be used in an integrated system (and combinations of components with applied or applicable lenses). The integrated system can include a system for introducing a lens or other medical device under the elevated epithelium 'but the description (4) is not limited thereto. The assembly for separating the corneal epithelium from the cornea at the transparent plate can include an edge configured to mechanically separate the corneal epithelium from the cornea while allowing the upper

The cortex is maintained until at least a portion of the cornea adheres. The epithelial delaminator may comprise a suitable strong and hard material, such as a metal, an alloy, a polymeric material, a filled or reinforced polymeric material, a composite or a hybrid polymeric material, and mixtures thereof, which have been configured To separate the epithelium from the cornea without cutting or removing the edge of the corneal tissue from the eye. The epithelial delaminator may comprise a front blade-like structure; for example, ''3 2, in the form of a tongue-like shape configured to separate the epithelium, or a parallel or skewed tongue-and-split plate shape The structure, for example, is a blade that moves linearly with one of the first fish when it is at the same angle as the first fish or when it is skewed at a right angle to the edge of the blade. The epithelial stratifier angle is in the eye, A Hungarian blade is strong, that is, it may be greater than 5··; [(usually greater than 10··υ width to thick sound ratio: 119800.doc 200803820 width pair = layer s can contain - having a G.5:1 to about 3:1 (usually about 1:1) by the daisy I: a linear structure. This linear structure can be moved close to the eye and moved on the eye by means of a telephone Or by using the end of the line that moves back and forth to make the upper epithelium/knife layer. The epithelial stratification step comprises a piece-like structure with a blunt protruding front end (Prow) to make the epithelium Separate -,, 饤N / brother, the delaminator structure with adjacent parts, sill areas and areas away from the epithelium during operation can be completely or identical lubricity (where the more lubricated parts are adjacent to the epithelial contact &; domain) can be a feature of the layerer. When the skin knife layer is used to place contact lenses or other visual devices on the upper Du's, it can also contain - configured to hold - visual device vision 11 ° The vision device holder can be configured to place the vision device on the cornea, in the cornea Is the underside of the layer. The vision device holds the Vision device in the U for placement until the Vision device is placed on the cornea. The Vision Holder can be further configured to have The visual device is placed over the cornea to replace the epithelial layer on the implanted optic device. The visual device holder can include a recessed region into which all or a portion of the visual device can be mated. The devices and methods described herein can be used. Examples of implanted visual devices include any biocompatible visual device, such as a lens (eg, a contact lens comprising various compositions of hydrophilic and hydrophobic polymers and mixtures thereof, implantable lenses, etc.), twilight Tablets (polarizers, diffracted calenders, etc.), implants, and the like. The epithelial delaminator can be used to introduce or release, for example, a medical or diagnostic composition 119800.doc -12. 200803820 Non-visual implants under the corneal epithelium. These devices may be used to provide for the application of such compositions in liquid, gel, solid or other form to the isolated areas of the horn epithelium. The integrated device of the skin stratifier may comprise the following components: a q-layering device for separating the corneal epithelium from the cornea, and when used as an introducer 2: configured to carry the lens to the subepithelial region thus established For releasably releasing the lens there and for extracting therefrom without removing the lens; b" two eye pointing assembly or assembly for securing the implant/layerer phase cornea Position such that it separates the corneal epithelium from the cornea and results in an acceptable subepithelial delivery 'c〇-optional applicator' as it is used as a result of the general movement of the thief/layerer A uniform epithelial surface 'and d' an oscillator is provided in front of the delaminator along the keratome for vibrating the stratifier in a manner that provides acceptable epithelial delamination. At least the edge of the 5th epithelial stratifier is adapted to stratify the epithelial layer and the cornea. This edge can be substantially blunt. The edge can be circular. Typically, s 'the implant raises the epithelial layer' without cutting the epithelium or cornea. The edge of the epithelial patch separated from the cornea can be considered to stretch beyond the limits of the epithelium. : It is due to the stretching of the epithelium during the physical elevation of the membrane or the separation or tearing during the initial passage of the epithelium at the edge of the layer. Functionally, the layered edges are sufficiently pure that they do not cut the cornea in use. The edge is sharp enough to cause the boundary 1 between the epithelium and the Baumann layer to be separated' without leaving a large amount (or preferably any) of epithelial tissue on the sacral bed or surface. At least part of the edge may be unrecorded steel. When an epithelial pocket is desired, the delaminator can be in the shape of a tongue, so that the edge is configured such that the edge 119800.doc -13·200803820 = delamination is located at the end region of the tongue depressor. The stratifier can be packaged as (a)--a thin device having a fluid flow path or region - or a sub-assembly for making a true source from a remote source, for example, for holding a lens or The fluidic communication is communicated to the distal region of the delaminator for releasing the lens or promoting epithelial stratification or delivering the drug to the underside.

The knife layer can be configured to create a loose skin sheet such that a portion of the corneal epithelial layer mechanically separated by the insert remains attached to the cornea at an edge of 10% to 50 / inch of the separated epithelial layer. The delaminator can be configured to create a dermatoglyphic sheet such that a portion of the mechanically separated corneal epithelial layer remains attached to the cornea at an edge of between 5% and 75% of the epithelial layer. The sub-set can be configured to create an epithelial recess so that portions of the corneal epithelial layer that are mechanically separated by the layerer remain attached to the cornea at the %% edge of the separated epithelial layer. The tierer can be configured to oscillate the edges. Oscillation helps to separate the epithelial layer from the cornea. For example, the delaminator can oscillate the separation (or front) edge side to side, back and forth, in a circumferential (or partial circumference) motion, or some combination thereof. The oscillation can be in the plane of the edge of the layerer or outside the plane of the layerer: edge. In some versions of the device, one or more selected regions of the delaminator package = at least - a low friction surface. In particular, placing the low-friction surface on any part of the layered contact layer of the layerer often provides some advantages to the quality of the resulting layered area, i when the layerer is also used as a lens The low friction surface provides a large predictable 119800.doc 200803820 lens movement on the cornea. Low friction surfaces may also be considered to reduce the potential for damage (e.g., tearing) of the layered epithelium when the introducer is used. For example, the or related surfaces may be coated with a friction reducing material, such as a lubricating polymer (eg, suitable polyvinyl fluoride (eg, PTFE) or polyxylene (P〇lyxyxylene) (eg, pARALENE) Or a polyurethane or polyoxo), a biocompatible lubricant such as polyoxo or uronic acid, such as diamond, carbon nitride, tantalum carbide, diamond-like carbon (DLC) ) and various other steaming

A smooth inorganic coating of a gas deposited or pyrolytic carbon film. Other low friction surfaces include polished surfaces. The delaminator can be pointed at the eye by a pointing assembly in such a manner that when the delaminator is moved axially on the eye, the edge of the delaminator separates the epithelium from the cornea (as described elsewhere herein) . One such pointing device comprises a vacuum device 'eg a ring or a column or the like, which may have a "window" window for the cornea and cooperatively adapted to be placed in a specific entity I of the eye. The edge of the delaminator. The vacuum device can include an opening: the opening allows the user to view the film during operation. It can include a column having an opening similar to that of the opening. The vacuum device can be as mentioned above The window can be sealed. The pointing device can include a non-straight-faced/two-portion (including friction or barb) to maintain the relative positioning between the eye and the delaminator. It can also be used for vibration and (4) In the position of the top surface of the stratified 四 (4) before the edge of the stratified 四 (4), the position of the skin is Η 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动 移动For example, in the form of a roll or a flat plate or a flattener with a curved watch H9800.doc -15- 200803820. Cry, say a set of epithelial delaminators and use the described " pieces to make the epithelial layer The method of stratifying the eyes. 】]七田述 can be used to open the boundary between the epithelium and the cornea. • Coffee: at least a part of the epithelial layer on the surface of the cornea of the eye. One of the uses of this device is included A visual device (eg, a corrective lens) is placed under the elevated epithelium during the same-stroke performed by the device in raising the smear. Of course, the squid can be described in other ways. For example, in combination with corneal laser reforming, medical or diagnostic materials (eg, liquids, gels, solids, suspensions, etc.) placed subcutaneously. The various epithelial layered devices described herein have multiple systems in which Acting between the different k to separate the epithelium from the eye, and at the same time introducing a lens, drug, visual device or the like, and then exiting from the eye without substantially interfering with the material so placed. #集成装置The following components may be included: a)) an epithelial delaminator assembly for separating the corneal epithelium from the cornea, optionally for transporting the deposited device or material to the subepithelial region thus established And means for controllably releasing the deposited device or material therefrom and for extracting therefrom without substantially interfering with the device or material so placed; b.) an optional eye pointing component or total In order to fix the position of the layerer relative to the cornea such that it separates the corneal epithelium from the cornea and as a result of the overall linear movement of the layerer 'forms an acceptable subepithelial delivery, c) An optional track assembly for knowing: translational movement to the inserter/layering device, d) an optional flattening 119800.doc -16-200803820 benefit, when used along the cornea* The resulting epithelial surface, e) 2: provided before the epithelial delamination - an epithelial stratification in the manner of the epithelium 1:! It is used to provide an acceptable preparation and fluid or vacuum source ' and 5.) various optional aids A vacuum source is provided which is used during operation to operate the integrated device, for example, and the fluid source, to release material from the delaminator after it is properly parked under the separated epithelium. In the field of the epithelium described; crying

U exists—lubricating material, which may be differently long-watered (ie, in a thickness of - substantially the entire upper two-layer step), at the time of fe (ie, solid, gel or particulate material, possibly Suspended in a fluid having a reduced volume or thickness during the epithelial delamination step) reactive (ie, a hydrogel that reacts with water during the epithelial delamination step or just in the scalpel step to form a smooth material or Other polymeric materials), fluid lubricants (ie, the fluid layerer introduced by the delaminator can completely cover the lubricating material during the procedure, or can lubricate the partial coverage of the two materials. In particular, the delaminator is in the epithelium The portion of the epithelium that is in contact with (4) may comprise a lubricating material. The epithelial delaminator may be used for purposes other than the placement of subepithelial materials and devices, as explained in the remainder of this description. For example, with regard to surgery or laser-based surgery or surgery based on other electromagnetic radiation. The specific use in this description should not be used, whether or not specifically for the described epithelial stratifier. References to the way or specific benefits are to be regarded as a waiver or waiver by the inventor of other rights that may be present based on this description. By prior art, various mechanical forces may be applied to the front surface or to 119800.doc -17-200803820 Applied to the basal cell layer or to the junction between the basal cell layer and the Baumann film (, transparent plate) to separate or lift a continuous layer of the corneal epithelium from the anterior surface of the eye. The term "continuous" means that no more or less epithelial separation from the cornea is provided without interruption. For example, the devices and methods disclosed herein can be used to create a loosened sheet of corneal epithelium that is stratified. The edge of the epithelium of less than 5% (for example, between 1% and 5%) adheres to the cornea. Figure 1A shows an eye with an edge (the elevation of the haiku epithelium (12) (ίο The front view, the edge (14) has a hinge region (16), in which case the edge (14) contains about 90% of the edge of the raised region (12). Figure 1B shows the eye as depicted in Figure VIII. (1〇)' where the epithelial elevation area (12) is rotated Leaving the subsequently peeled cornea (18). Figure 1C shows a side view of the eye (10) with the elevated epithelial region (12) rotated about the hinge region (16). Similarly, the corneal epithelium can be The corneal epithelium is formed such that between about 50% and 75% of the layered epithelium and up to about 9% to 95% of the edges adhere to the cornea. Figure 2A shows the area of the epithelium that has been raised or separated from the cornea (22) Front view of the eye (20). The separated edge or bound (24) of the separation region (22) contains about 50% of the edge of the separated region (22). In this variant, about 5% The separation region (22) remains attached (26) to the cornea (28, see Figures 2; 6 and 2C). The attachment edge (26) defines a separate epithelium located at the cornea (28) adjacent to the attachment edge (26) (22) Locally restricted area (3〇) between. Figure 2B shows a front view of the eye (20) of Figure 2A, wherein the separated or raised epithelium adjacent to the unattached edge (32) is rotated or pushed out of contact with the eye 119800.doc • 18-200803820 (10) outer. Figure 2B also shows the location of the stripped cornea (28). Figure 2C shows the eye (20), the stripped corneal surface (28), and the restricted area (possibly a, pocket) adjacent to the attachment edge (26) found in Figures 2A and 2B (30) Side view. Although not required, the recesses seen in Figures 2A, 2B and 2C and Figures 3A and 3B generally provide support for an implant or as a holder for an implant. The exposed cornea (18 in Figures 1A, 1B and 1C and 28 in Figures 2A, 2B and 2C) is readily used as a laser treatment or conventional surgical technique. By layering the epithelium The edge between 5〇% and 95% adheres to the cornea, and can also form a half skin piece of the layered corneal epithelium or smaller, a small hole or a tight cavity. Figures 3A and 3B respectively show one Front and side views of the separated epithelial region (42) and a separate edge (44) and the eye (4〇) of the connecting edge (46) of the region (42). The separation edge (44) is generally in this description The entry point of the epithelial stratifier discussed elsewhere. In this variant, greater than 〇% of the total edge of the isolated epithelial region (42) (possibly 9〇% to 95%, as depicted in Figure 3A, constitutes a connecting edge (46). This configuration forms a closed region (48 in Figure 3B) that maintains any included implant in place. The epithelial delaminator described can also be used to place various implants or materials (including visual devices) into the area of the cornea that has stratified the epithelium and corneal stroma. In particular, the stratifiers described herein permit The implants and materials are placed on the stratified cornea under the epithelium separated from the cornea. The separated epithelium can then be placed on the implant placed or positioned On top of the implant. U9800.d〇c •19- 200803820 The term “π vision device” is intended to include any temporary or permanent implantable passive or active vision device, including the intended use for correction, improvement or correction. Or a visual device that corrects the vision of the patient. One such suitable visual state is described in Perez on April 8, 2003, entitled Prefabricated Corneal Lens and Method of Corneal Overlay to

</ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; For example, a diffraction grating, a polarizer, etc., an implant (eg, an implant that reshapes the surface of the eye), and the like. Figure 4 shows a variant for use with one of the layerer assemblies described herein. A stylized version of a typical procedure for a corrective lens. This is a general functional explanation to allow one of the important uses of the device. Figure 4 shows a cornea (1〇2) and an epithelial layer ( 1〇4) Eye (100). In step (a) of Figure 4, a delaminator having an auxiliary function as a lens inserter having a distal end (108) can be seen (1〇6) The distal end (108) has a leading edge (11〇) configured to initially pass through the epithelial layer (104) and then separate the epithelial layer (1〇4) from the Bowman layer of the eye. The illustrated layerer (106) also includes a more proximal axis (ι 12) that connects the layerers (1〇6) The selected mechanical drive, motor, oscillator or other motion provides a translator. The lens (114) to be implanted or released onto the corneal surface under the elevated and separated epithelial layer (1〇4) is shown as Positioned on the top surface of the inserter/layerer (1〇6). As discussed elsewhere, it can be released on the lens (114). 119800.doc -20· 200803820 Empty, temporary releasable adhesive or The step of forming an area under the separated epithelial layer (104) by the aid of its analog or by including a moderate insert or bevel or the like on the surface of the introducer/layerer (106) , the lens (114) can be held in place. In step (a), the delaminator (106) is close to the eye (1〇〇). In step (b), the delaminator (106) has penetrated The cortex (1〇4) and begins its traverse on the cornea (1〇2)' which separates the epithelium (104) from the surface while carrying the lens (114) towards its desired destination. Step (c) depicts this The layerer (1〇6) in the program and its accompanying lens (114) have arrived at the desired place (user hope The stage at which the lens (114) is released from the eye. The epithelium (104) remains on top of the lens (114) and can be viewed as being positioned on the eye (1〇〇), inside the epithelial pocket &quot; Here, the lens (114) is detached from the delaminator (for example) by, for example, holding a vacuum or release of the adhesive or possibly introducing a fluid such as saline or water into the delaminator (1〇6). Grab the grip. Step (d) of Figure 4 shows the completion of the procedure. The delaminator (1〇6) has been removed from the separation area under the epithelium (104), leaving the lens (1) 4) in place on the cornea. . As indicated elsewhere, the procedure shown in Figure 4 can be used to position other solid and gel materials and devices (e.g., implants that deliver drugs, drugs, diagnostics, etc.) or can be used to gel for a variety of reasons, Materials in the form of oil, liquid, liquid, etc. are delivered to the epithelial ridge 4). Figure 5A to Figure 5D show that the Yitian Shirenkou Shichen Ding is also suitable for the placement of the implanted lens, its sub-assembly parts and the layerer (2) of the clock gr (202) One variant. 119800.doc -21- 200803820 Figure 5A shows the delaminator (200) and the carried lens (202) in cross section. For clarity of illustration and description, the lens (202) is shown as being slightly separated from the face of the delaminator (200). The illustrated layerer (200) includes a dome section (204) and a sealing plate (206). The top and bottom views of the dome section (204) are shown in Figures 5B and 5E, respectively, with the former removing the lens (202) and the latter removing the sealing plate (206). The lens (202) is shown separately in top view in Figure 50:. The sealing plate (206) is shown separately in top view in Figure 5D. Returning to the dome section (204) of Figure 5A, the variant is adapted to carry the lens on the upper surface (208). The upper surface (208) can be formed to at least substantially replicate the lower surface (210) of the lens (202). Aisles of various sizes and locations (2 12) are shown to allow vacuum communication from the lower surface (214) to the upper surface (208) and to the lens (2〇2). This vacuum can be used to hold the lens (2〇2) in place until delivery. As shown in greater detail below, the upper surface (208) can include an insert (500) to allow the edges of the lens (202) to more easily pass through the underside of the epithelium during implantation. In addition, the upper surface (208) may include a lubricating covering or coating on at least the surface of the contact lens (202) and the surfaces contacting the epithelium during the introduction of the delaminator (200) and during its withdrawal. 502). The remainder of the delaminator (200) can also be treated as lubricated, but we have found this treatment to have limited additional benefits. Figures 5A, 5B, and 5E each show a leading edge (232) having a function of initially penetrating the epithelium and then separating the epithelium from the cornea (Bauman layer). The shape of the edges, cross sections and adjacent slopes are discussed below. Returning again to Figure 5A, the chamber (216) formed between the sealing plate (206) and the lower side (214) of the dome segment (204) 119800.doc-22-200803820 can also be used to allow for, for example, saline or water. The fluid (and drug, if desired) is passed to push the lens (2〇2) from the upper surface (208) as part of the release step. As shown in Figures 5F and 5G, the chamber (216) can be divided into a plurality of separate chambers (if needed), and the chamber (216) can be driven by a drive leg ( 220) and accessed by an independent path. Separate passages (222, 224) in the drive leg (220) can be placed there by machining, casting, and the like. Similarly, the chamber (216) may be divided into one or more walls (230) by self-sealing plates (2, 6) into separate chambers (226, 228). Figure 5ρ and the figure show the top and end views of this variant. In this variation, a single tortuous wall (230) provides two chambers (226, 228), in this example, a different set of aisles (21 inches) are accessed via the dome segments. A chamber (228) receives the outer circumference of the opening (21 〇) and the central opening (210). The other chamber receives the other four openings (212) in the dome section (204) shown in Figures 5B and 5E. The aisle and chamber may be isolated to permit separation of the aisle (21〇) in the dome section (204) by separate access, for example, by vacuum or saline. We have found that this single access is sometimes desirable. The decentralized vacuum at the edge of the lens provided by the plurality of aisles at the edge of the dome segment (204) appears to contribute to lens stability during placement of the inserter/layerer (2〇〇) . A large aisle (210) at the center of the dome section (204) for the passage of water or saline appears to assist in releasing the lens (when needed). Figure 5B shows a top view of the dome section (204) of Figure 5A. The edge of the insert (500) (as seen in Figure u) and various open aisles (21〇) can be seen. Figure 5C shows a top view of the selected lens (202). It is not limited in any way. 119800.doc -23- 200803820 A lens suitable for use with this device. When these terms are used in ophthalmology, they may be soft, flexible, or they may be rigid lenses. Such lenses may have hydrophilic or hydrophobic polymers or mixtures thereof, lumps or random copolymers of such materials, composites, multilayer constructions, and the like. A variant of the device includes the use of a lens as the front edge of the dome segment. The material properties of the lens selected, such as the edge, will necessarily be selected to perform this task, for example, by appropriate hardness. For humans, the lens typically applied using this device is typically in the range of 6 to 12111111. Figure 5D shows a top view of the sealing plate (206). Figure 5E shows a bottom view of the dome segment (204) with the seal The plate (2〇6 in the figure) is removed. The notch (226) for supporting the edge of the sealing plate (2〇6) can be seen. It can also be seen through the dome segment (2〇4) Various aisles (21〇). Figure 6E shows another variation of the layerer (250), in particular, the dome &amp; (252) and its accompanying lens (254). This variant The implant lens (254) is downloaded at the dome section (252). Figure 6A shows a side cross-section of the delaminator (250), the dome section (252), the sealing plate (256), and its attached lens (254). The chamber (258) under the dome section (252) is adaptable or configured to retain the lens (254) during transfer and to be large when the desired arrangement is obtained. The controllable release of the lens (254) as shown in Figure 4 is depicted in the bottom view shown in Figure 6B by retaining the lens (254) within the dome section (252) during delivery. A recess (26〇) is placed in the lower side (262) of the dome section (252). The recess (260) can be attached to the arm (268) under the sealing plate 119800.doc •24-200803820 (256) The aisles (264) found in the passages are used to allow vacuum to pass through the pockets. The same aisles and recesses can be used to apply a fluid such as water or saline to release the lens (254 of Figures 6A and 6C) Figures 6A and 6B show the front edge (270) of the delaminator (250) with the function of initially penetrating the epithelium and then separating the epithelium from the cornea (Bauman layer). &quot; Edge, cross section and proximity The shape of the ramp is discussed below. - Figure 6C shows a top view of the lens (254). Figure 6D shows a top view of the dome section (252). Figure 6E shows a portion of the epithelial delaminator (250) shown in Figure 6A. Close-up cross-section. In detail, Figure 6E shows the area where the delaminator blade contacts the epithelium during the delamination procedure, A lubricating coating (278) is present on the upper surface of the delaminator. Figures 7A-7C show another variation of the delaminator (300) having the concurrent function of lens or implant placement. In general, this The equal layerer has an elongated shape terminating in an edge region (302). In general, the pattern of the layerer (300) is shown as being substantially flat, as in the layerer (300) of Figure 7B. Shown in side view, the delaminator (300) includes a top or upper surface (304) and a lower or bottom surface (306). Figure 7C shows the bottom surface (306). - The delaminator (300) is shown as being generally flat and has a uniform thickness (310) along its length and along its length, but other shapes (eg, non-uniform thickness, π wedge π shape, etc.) are also intended to be included In this description. Figure 7C also shows one of the holding areas - holes (320) in the bottom surface (306), in which at least a portion of a visual device can be placed in the cavity (320). Although the layerer is described herein as being flat or flat, it should be understood that this 119800.doc -25-200803820 is specifically included in one axis (eg, side to side) and another axis (eg, forward to There is a curvature in the back) (in a shape suitable for easily separating the epithelium from the corneal surface). The top surface (304) and bottom surface (306) of the delaminator (including the shaft region (3 14)) may also be adapted to enhance the function of the insert by reducing the sliding friction of the respective surfaces. In particular, the top surface (3〇4) of the delaminator can be adapted to smooth the top surface (3〇4) by polishing or by coating with a lubricating material (as discussed elsewhere herein) The friction between the inserter/layerer and the layered corneal epithelial layer is reduced. Friction between the top of the delaminator and the layered epithelium can also be reduced by reducing the overall volume, volume, or surface area of the layered epithelium. Figures 8A and 8B show a layerer (330) in which a ring (334) includes a rim (332). In this version, the friction is reduced because the opening (3 10) in the top surface (304) of the top of the delaminator (33〇) is effectively reduced relative to a delaminator such as that shown in Figure 5A. Surface area. 8A and 8B also show an attachment (314) by which the delaminator (330) can be attached to an implant base. In one version, the layered (3 30) is attached to a base at the end of the layerer (330) furthest from the edge of the layer. In this version, a mechanical drive is coupled to the attachment (314) that is configured to oscillate the entire stratifier or primarily to edge regions of the delaminator (3 3 0) due to amplitude (3 32) oscillation. Figure 9A shows a top view of another version of a layerer (360). This version includes a recess (362) in the bottom surface (364) of the delaminator (360), and the recess 119800.doc -26 - 200803820 seat (362) is configured to serve as an implant to be delivered or The holding area of the lens. In general, the holder recess (362) releasably secures a vision device to (or in) the blade (360). The holder recess (362) is adapted to release the secured implant (eg, a visual device) once the layerer (360) has sufficiently separated the epithelium from the cornea to cause the implant to mate to the layer within the area. The various epithelial stratifiers discussed herein are adaptable or configured to secure the implant and release the implant during the implantation and delamination steps. In various versions shown herein, the implant is retained in the delaminator by applying a vacuum to the implant. Positive fluid pressure can be applied via the same channel to release the implant. For example, air (or other gas) can be applied via the provided channels to release the implant. A fluid (e.g., water or saline or other suitable fluid) can be used to release the visual device. Additionally, the fastening and release configurations can be used to apply a useful substance (e.g., a liquid such as saline, a drug, etc.) to the cornea. The implant can be held to the epithelial delaminator by a releasable adhesive. In particular, a dissolvable adhesive can be used. For example, a diaper material can be used to secure the vision device until it is ready for release after placement. Examples of the water-soluble material having adhesiveness include, but are not limited to, a polymer such as polyvinyl alcohol, a biopolymer such as hyaluronic acid (HA), and various polysaccharides. Application of a fluid that releases one of the adhesives (e. g., saline or other beneficial fluid) causes the adhesive to dissolve or otherwise release, which allows implantation of the visual device. This solution can be applied locally or over a large area of one of the corneas. The various anterior marginal regions of the layered are mechanically interacting with the cornea to open or stratify and separate portions of the 119800.doc -27-200803820 epithelium from the surface of the cornea (Bomman layer). Functionally, the edge can perform this function. The rim has a shape that is sufficiently pure to permit and cause separation of the epithelium from the cornea but does not cut any corneal tissue during this procedure. The handle can be considered to have an appropriate dullness to separate the epithelium from the cornea and create a layered epithelial layer without adhering to a large amount of corneal tissue. 4 The edges may be sufficiently blunt to create a separate epithelial layer with only a small amount of corneal tissue attached. The best is to create an edge of the isolated epithelial layer of unattached corneal tissue. By electrolytic polishing, an edge blank having a distribution such as that shown in Fig. 10A

Distribution (232) is also shown in Figure I!. Fig. 10B shows an edge distribution or cross section of the concavity eight which has been shown to result in a relatively high quality (i.e., having very little extraneous epithelial tissue on the corneal surface after the layerer Lk). It is very blunt and can be touched by hand. Lending

7〇°) angle. The scope. The 7, slopes are shown to have about 2 inches from the horizontal line. (From the vertical line, the slope angle can be from about 5 to more than 45.

. For example, the slope can be selected as the edge approaches the upper surface slope angle to allow the material to exist from the edge 119800.doc -28- 200803820. The visible transition to the upper surface. The edge zone transition can be blunt (eg, the front edge of the delaminator between the face and the upper surface (eg, illusory. The epithelial layer and the cornea are subdivided to perform the specified function (ie, when the pelvic layer is Any of the fields /, = alloys, (four) or polymers, these contain gold., and may further strengthen the characteristics of the front edge with other materials. For example, the +8 method is used to add layers. To enhance the edge to make the epithelial angle. 'Can include the selected material or coating /, the lunate layer without damaging the ability. The edge can cover human, skin cells

It can be said that 3 may be polished (for example, electrolytic throwing, U cloth is not recorded steel, edge material may also be first released by nl) or paint, or it may be used by different screens of different materials. π /,, into. The knife layer that is intended to be used together with the living tissue can be made of materials that can be read by τ 孝 片, 死, Λ 杈 杈. The edge may also include sub-therapeutic properties (e.g., sputum m... growth factors, etc.) to aid in healing the underlying &gt; pain or to assist the cornea to be grafted and to learn the implanted material. For example: the edge region (or any region of the delaminator) can be configured to release the drug from the polymeric matrix coating while in contact with the eye of the eye. Figure 1 is a close-up cross-section of the front edge and adjacent structures of the layered device not shown in Figure 5A. It specifically shows the lubricating coating (502) on the surface contacting the epithelium in use: in the lens (or implant When the (2〇2) has been ejected from the delaminator and the delaminator is being withdrawn from the epithelium, the front edge (232) stratifies the epithelium with the recess (5〇〇) that contacts the epithelium during passage. The remaining figures show the placement of various layerers and lubricated materials, and in some cases the potential shape of the epithelial regions formed. Figure 12A shows a top view of a tongue depressor delaminator (6 turns). The 119800.doc -29-200803820 layerer (600) can be oscillated from side to side or axially front and back and a combination of the two. Figure 12B shows a side cross-sectional view of a stratifier (600) having a generally upper flat bottom (602) positioned adjacent to the eye and cornea in use. Because of the rounded top surface (606), the uncut front edge (604) can also be seen. Figure 12C shows the front view of the delaminator (600) and the slope of the top surface (6〇6), circle Shape. During the step of layering the epithelium, the top surface (6〇6) is adjacent to the epithelium. Figure 12D shows a layerer (600), and in particular, a partial cross-section of a blade substrate (608) having a lubricating layer (61) positioned on the side of the layerer (600) adjacent to the epithelium in use. section. Figure 12E shows a partial cross-section of a delaminator (6 〇〇) having a blade substrate (6 〇 8) with a lubricating layer (610) on both sides of the substrate (608). Figure 13A shows A generally planar view of the circular active epithelial stratifier (620). As in the case of the delaminator shown in Fig. 12A, this variant can be oscillated from side to side or axially front to back or a combination of two movements. The front edge (622) needs to be configured to have a separate shape only in the marking area (624). Figure 13B shows a side cross-sectional view of a stratifier (620) having a leading edge (622). In the body or substrate (626) of the delaminator (62 〇), the shape is slightly dome-shaped. Figure 13C shows a cross-sectional front view of the delaminator (62 〇) and the dome shaped substrate (626). Figure 13D shows a partial cross section of the layerer (620) (and in particular, the blade substrate (626)) of H9800.doc -30 - 200803820. The lubricating layer (628) is shown as being located on the side or region of the delaminator (620) adjacent the epithelium in use. Figure 13E shows a partial cross section of a delaminator (620) having a lubricating layer (628) on both sides of the layerer substrate (626). Figure 14A shows a top view of a layerer (630) having a front portion (632) (essentially a protruding front end). This delaminator can be used to create a generally articulated epithelial plane (12) as shown in Figures 1A, 1B, and 1C. In use, the delaminator (630) can be oscillated from side to side or axially back and forth, but is typically only used before and after oscillation. Figure 14C shows a partial side cross-sectional view of a delaminator (630) having a blade substrate (634) and a layer of lubricating material (636) only on portions of the epithelium that tend to contact during the delamination step. Figure 14D shows a delaminator (630) having a substrate (634) and a lubricating coating (636) that contacts all surfaces of the eye during use. Figure 15A shows a top view of a delaminator (650) that is slightly tongue-shaped, but includes a dome-shaped region (652) on its top surface and (as seen in Figure 15B) ) includes a concave portion (654) on its bottom surface (656). The epithelial delaminator (650) includes an edge leading edge (656) configured to separate the epithelium from the Baumann layer without cutting the cornea or leaving a large amount of epithelial tissue on the cornea or corneal tissue Leave on the underside of the epithelium. Figure 15B shows a front cross-sectional view of the delaminator (650) showing a dome region (652) and a concave region (654). Figure 15C shows a side view of a delaminator (650) with a dome (652). Figure 15D shows a partial side cross-sectional view of a delaminator (650) having a dome region (652) and a concave region 119800.doc - 31 - 200803820 field (654) on the bottom surface (656). Figure 15E shows a partial cross-sectional view of a delaminator (650) having a blade substrate (658) and a lubricating layer (660) on the dome shaped region. The rounded region of the delaminator (650) contacts the underside of the epithelium during the delamination step. Figure 15F shows a partial cross-sectional side view of the delaminator (650), and in this case, a lubricating layer (660) on both sides of the blade substrate (65 8). - Figure 16A shows the top section of a delaminator (670) that is generally shaped in the form of a cheese slicer. The layered elements are lines (672) found between the _ arms (674) that make up the yoke of the delaminator (670). Figure 16B shows an enlarged view of one arm (654) and layered line (672) of the layerer (670). Figure 16C shows a cross-section of a layered line (672) having a substrate (674) and a lubricating coating (676) on the surface of the line (672) that contacts the epithelium during use. Figure 16D shows another variation of a layered line (672) having a substrate (674) and a lubricious cover (676) on all surfaces of the substrate (674). Figure 16E is a cross-sectional side view of the delaminator (670) and the layered line (672) that passes under the eye (674). Figure 17A shows a delaminator assembly (680) having a delaminator element (682) having a generally elliptical cross-section and mounted between arms (684) of a yoke similar to that seen in Figure 16A. Figure 17C shows a cross section of a layered element (682) having a substrate (686), and wherein - a lubricating covering (688) is found in the layering element (682) that contacts the epithelium during the delamination step (under the epithelium) On the side of the side). The 119800.doc -32-200803820 arrow (690) found in Figure 17C shows the element (682) during the stratification step. Figure 17D shows a layered component (682) having a lubricating coating (688) on substantially all surfaces of the substrate (682) that will contact the eye during delamination. Figure 18A shows a simple stranded layerer element (7〇〇) that is oscillated back and forth (as shown in Figure 18A) to form a region of the separated epithelium. Figure 1C shows the shape of one of the separated epithelial regions (7〇2) that can be created by changing the "splicing point" (704) as the wire moves axially under the epithelium (7〇6). Figure 1 8D A substrate line (708) and a partially lubricious coating (710) on the line segment acting as a layering element (7〇〇) are shown. Figure 18A shows lubrication with a substrate (7〇8) and covering substantially all of the substrate ρ(10)) Layered line element (7〇〇) of the cover (710). Figure 19A shows an epithelial layerer (720) having a generally elliptical cross-sectional area. The side of the ellipse in this variant is side to side The size is generally substantially small, for example, less than 1% of the diameter of the epithelium of the eye for which a separate epithelial region is required. Figure 19A shows a limited rotational motion of the epithelial stratifier element (71〇) (712 Figure 19C shows side-to-side movement (714) of the epithelial stratifier element (71〇). S 19D shows the combined movement of the epithelial layered component (7丨〇) with side-to-side rotational motion and axial motion The combination is combined to create an elevated epithelial region having a connecting edge (716) to the epithelium and an opening (718). This configuration can be used to create a pocket with a large opening. Figure 19A shows an attached edge (720) and a small opening (722) on the top of the skin by introducing a delaminator (71〇) The epithelium is formed under the pivot point of one of the portions around the mouth 119800.doc -33 - 200803820 (722) and the stratifier (710) is withdrawn at the extreme angle of motion to form the region shown at 5 hr. This combination of rotation and axial movement of the layerer is suitable for creating a pocket having a small opening and a large and closed area under the epithelium. Figure 19F depicts a blade substrate (73〇) and contact with the layered elements Cross section of the layered component (71〇) of the lubricant coating (732) on the top of the epithelium. Figure 19G shows the contact with a substrate (73〇) and a cover layer element (71〇)

Cross section of the layered component (7丨〇) of the lubricating coating (732) on all surfaces of the eye. The delaminators described herein can be fabricated and assembled from separate parts (e.g., edges, retainers, etc.). The delaminator can be formed by injection molding and/or micro-stamping. The size of the stratifier is chosen by the designer and depends to a large extent on the size of the stratifier, for example, depending on the size of the device to be implanted and the material to be placed under the epithelium. However, the stratifier may have a total thickness similar to the thickness of the basal cell layer, for example, about 1/2 to 3 5 mn (〇 $ $ to 00 .0035 ), but usually about U mil to 3.0 mil (0.001 to 〇·003,,). For example, 5, the edge of the insert can have a thickness of about 2.0 mils. Usually, the layerer is used to place the -visual device on the substantially intact epithelium (ie, the portion of the epithelium leading to the front side of the image tube is continuous), and can be less elaborate. The way to use this layering _. For example, a layerer can be used to remove selected portions of the film, and the LASEK program can allow easy replacement or repositioning when using this device, if any of the corneal laser remodeling is completed. The epithelium is removed in the form of a soft skin. In some cases, 'at the end of the procedure, it may be necessary to add heat 119800.doc -34- 200803820 to the front surface (4) to enhance mechanical epithelial stratification or apply cooling fluid to the device and epithelium to enhance epithelial viability. . The device described herein can be used to stratify the epithelium into a shape of a recess during the procedure described, i.e., a structure having more than 50% of the periphery of the isolated epithelium remains attached to the cornea. The pocket remains on and around the placed material or visual device. The article can also be used to create an epithelial sheet that can be at least partially folded away from the surface of the eye. After placement of the vision device (or

The layered epithelium can be replaced after completion of the procedure such as t(four) surgery. The structural and physiological properties of the invention of σ and the specific benefits specific to this particular variant of the epithelial layered device have been described. However, this aspect of the invention should not be construed as limiting the scope of the invention in any way. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1A and Fig. 1A, Fig. 2A and Fig. 2A and Fig. 3B show a front view of the eye, which is depicted in the various conventions used to explain the cornering layering herein. 1C, 2C and 3B show side views of the views shown in Figs. 1A, 2A and 3A, respectively. Figure 4 shows a program for stylizing a lens placed under the corneal epithelium using the device described herein. 5A to 5G respectively show a side cross-sectional view of a lens and a layerer for a variant, a top view of the layerer, a top view of the lens, a top view of the sealing plate assembly, a bottom view of the delaminator, an alternative sealing plate Top view and end view of the replacement seal plate assembly. Figures 6A-6E show the lens and layerer side of another variant, respectively, 119800.doc • 35 - 200803820, the horizontal cross-sectional view, the bottom view of the delaminator, the top view of the lens, the bottom view, and the side of the delaminator A cross-sectional view. Figures 7A through 7C show top views of a delaminator for another variant, a side view of a delaminator, and a bottom view of the delaminator, respectively. Figures 8A-8C show top views of a delaminator for another variation, a bottom view of the delaminator, and a side view of the delaminator, respectively. Figures 9A-9B show top views of the delaminator for another variant and an end view of the delaminator, respectively. Figures 10A through 10B respectively show a schematic depiction of the front and rear cross-sections of a front edge of a layered occupant. Figure 11 is a close-up cross section of the front edge of the layerer of Figure 5A. 12A to 12E respectively show a top view, a cross-sectional side view, a cross-sectional end view, a partial cross-sectional side view, and a partial side cross-sectional view showing more than one full-slip surface, each having a pressure, showing a single flat/slip surface. A tongue-shaped epithelial layered component. Figure 13A shows a top view of a circular upper split screen crying ^ 乂 anti-knife layer state. Figure 13B shows a cross-sectional side view; Figure 13C shows a bismuth molybdenum p Λ 不 不 ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; View the section. Figure 14A shows a top view of another variant of the block-shaped epithelial layering crying. Figure 14A shows a side view of the layered component. Solid 14C and Figure 14D show a partial cross-sectional side view of the layered seal with a lubricious covering on the epithelial contact area and over the entire segment; Figure 15A shows a top view of a corneal epithelial delaminator having a dome-shaped region 119800.doc-36-200803820. Figure 15C shows a side view of the layered component of Figure 15A. Figure 15B shows a cross-sectional end view. Figure 15D shows a side cross-sectional view of the layered component of Figure 15A. Figures 15E and 15F show the delaminator of Figure 15A, respectively, having a single lubricating surface and a plurality of lubricated surfaces. Figure 16A shows a top view of a line based epithelial stratifier. Figure 16B shows a partial cross section of the layered assembly of Figure 16A. Figure 16C and Figure 16] shows a cross-section of a layered component having a single lubricated surface and a high coverage lubricated surface. Figure 16E provides a schematic illustration of the layering step using the layered assembly of Figure 16A. Figure 17A shows a variation of the layered device of Figure A having an elongated or elliptical layered component. Figure 17B shows a partial cross-section of the assembly of Figure 17A. Figures 17C and 17D show lubrication adjacent to the epithelial surface. A cross-section of the layered component of the cover. Figure 17D shows a layered component with a lubricating layer covering over the entire surface of the contact eye. Figure 18A shows a top view of a layered component of a stranded wire. Figure 18B shows the layered component. The free movement of the strands. Figure 18c shows the constrained movement of the stranded layered component of Figure 18A and the shape of an elevated epithelial region established using the moving constraint points. Figure 18D shows the line with the lubricating material adjacent to the epithelium. Layered component. Figure 18E shows a wire layerer component with a lubricious coating on its surface. Figure 19A shows a small elliptical layered component. Figures 19B, 19B, 19D and i9E show fit and view The layered device of 19A is used together with various movements and combinations of motion to form certain elevated epithelial regions. Figures 19F and 19G respectively show the surface of the epithelial surface coated with a lubricating material and 119800.doc 37- 200803820 Cross section of the layered part of Fig. 19A with the surface coated with lubricating material [Main component symbol description] 10 Eye 12 Epithelial elevation area / Epithelial plane 14 Edge '16 Hinge area ' 18 Corneal 20 Eye 10 22 Separation area 24 Separated edge or boundary 26 Attachment edge 28 Cornea 30 Restricted area 32 Unattached edge 40 Eye 42 Epithelial area • 44 Separation edge 46 Connection edge. 48 Closed area 100 Eye 102 Corneal 104 Epithelium 106 Layerer 108 Remote 119800.doc -38- 200803820

110 Front edge 112 Axis 114 Lens 200 Plunger/layerer 202 Lens 204 Dome segment 206 Sealing plate 208 Upper surface 210 Aisle 212 Opening 214 Lower side 216 Chamber 220 Driving leg 222 Pathway 224 Pathway 226 Chamber/slot Port 228 chamber 230 wall 232 front edge 250 epithelial delaminator 252 dome segment 254 lens 256 sealing plate 258 chamber -39- 119800.doc 200803820

260 recess 262 recess 264 aisle 270 front edge 278 lubricious coating 300 delaminator 302 edge region 304 top surface 306 bottom surface 310 opening 314 attachment 320 cavity 330 delaminator 332 edge region 334 ring 360 delaminator 362 Holder recess 364 Bottom surface 400 Edge description 404 Ramp 500 Recess 502 Lubrication coating 600 Layerer 602 Flat bottom -40 - 119800.doc

200803820 604 606 608 610 620 ' 622 ' 624 626 10 628 630 632 634 636 650 652 654 656 658 660 670 672 674 676 680 Front edge top surface substrate lubrication layer delaminator front edge marking area substrate lubrication layer delaminator front Substrate Lubrication Coating Layerer Solid Top Area Concave Area Bottom Blade Substrate Lubrication Layerer Layered Line Substrate/Eye Lubrication Coating Layerer Assembly 119800.doc -41 - 200803820

682 684 686 688 690 700 - 702 704 _ 706 708 710 712 714 716 718 720 722 730 732 Layered element arm substrate lubrication coating arrow stranding layerer element separation of the epithelial area hinge point epithelial substrate layering element rotational motion Side to side moving connection edge opening attachment edge opening substrate lubricating material coating 119800.doc -42-

Claims (1)

200803820 X. Patent application scope: 1. A type of epithelial delaminator for separating at least a portion of a corneal epithelium from a cornea having an epithelium, comprising: a knife layer #, having ^)_ An edge configured to mechanically separate the corneal epithelium from the cornea, (4) to hold the separated upper g to at least a portion of the corneal membrane, b•optical epithelial component surface, 1 azole仞^ v , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , The material 'which contacts at least a portion of the surface of the epithelial component during the separation procedure. 2. For example: Item 1 Epithelial delaminator, wherein the lubricating material is a solid. 3. The skin delaminator of claim 1 wherein the lubricating material is a gel. 4. ^ Clear the epithelial stratifier, where the lubricating material contains a suspension 5 · As requested in item 1, the epithelium is crying, Gans #, Μ body. The counter-knife layer is, wherein the § hai lubricating material contains a liquid 6. The request item 丨 epithelial stratifier, 7 · the request item 1 epithelial stratifier, 8 · the request item 1 epithelial stratifier 0 9. As claimed in claim 1, the epithelial layerer slides the material partially. 1〇·If requested... The lining of the suede where the lubricating material is permanent. Wherein the lubricating material is temporary. Wherein the lubricating material is reactive wherein the surface of the epithelial component is substantially completely covered by the lubricant material, wherein the surface of the epithelial component is substantially completely covered by the lubricant material. 11. The skin delaminator of claim 1 wherein the layered component is substantially completely covered by the lubricating material. 119800.doc