MXPA06003089A - Corneal retention device or corneal stabilizing tool - Google Patents

Abstract

Described hereis a surgical device that typically is used to releasably hold the cornea of a human eye (and hence that eye) in such a way as to modestly deform the cornea and the eye, to maintain the eye's position for procedures upon the epithilial layer of the cornea, and to allow ease of replacement of an epithilial flap should one be produced. It may be used in combination with a supplemental device, such as an epithilial delaminating tool. The stabilization device permits ready access to and creation of flaps or pockets of epithelium for later introduction of correcting lenses or subtractive procedures such as LASIK or LASEK, prior to replacement of epithelium over the lens or site of laser induced or surgically-induced corrective procedure.

Description

CORNEAL RETENTION DEVICE OR CORNEAL STABILIZATION TOOL FIELD OF THE INVENTION A surgical device is described herein which is typically used to releasably hold the cornea of a human eye (and therefore that eye) in a manner such as to modestly deform the cornea and the eye. , to maintain the position of the eye for procedures on the epithelial layer of the cornea, and to allow the ease of replacement of an epithelial flap if one should be produced. This can be used in combination with an epithelial delamination tool, or an eye device insertion tool. The stabilization device allows easy access to and creation of epithelial flaps or pouches for the subsequent production of correction lenses (e.g., using an eyepiece insertion tool) or subtractive procedures such as LASIK or LASEK, prior to replacement of the epithelium on the corrective lens or on the site of the corrective procedure induced by laser or surgically induced. BACKGROUND OF THE INVENTION Refractive surgery refers to a group of surgical procedures that change the optical power or REF.:171444 of native eye focus. These changes alleviate the need for glasses or contact lenses from which an individual may be otherwise dependent for a clear vision. 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 refractive index. This curved interface is the outer surface of the cornea. The refractive power of this interface represents approximately 70% of the total amplification of the eye. The light rays that make up the images we see pass through the cornea, the anterior chamber, the lens of the lens and the vitreous humor before being focused on the retina to form an image. It is the power of amplification of this curved air-cornea interface, which provides the field of refractive surgery with the opportunity to surgically correct visual deficiencies. A widely flawed and failed procedure called epicardofacial was developed in the RK era. This is now essentially an academic anomaly. The epicardrophoria provided a new curvature to the outer curvature of the cornea by grafting a thin layer of preserved corneal tissue onto the cornea. The lens or epineotrophic lens was placed in the eye surgically. An annular 360 ° excision was made in the cornea after the epithelium was completely removed from the epicarbothic lens site. The perimeter of this lens could be inserted into the annular excision and held in place by a running suture. There were several problems with the epicardrophyte: 1) the lenses remained cloudy until the stromable fibroblasts of the host colonized the lenses, whose colonization could take several months; 2) until the migrating epithelium could develop over the cleavage site on the surface of the lens or lens, the interrupted epithelium was bound for infection; and 3) the healing of the epithelium on the surgical site sometimes moved towards the space between the lens and the cornea of the host. Currently, the epicardiofacia is limited in its use. This is now used in pediatric patients who are able to tolerate very high contact lenses. Most of the industrial research efforts attempted to produce a synthetic version of the epicarcotic graft called the synthetic layer in a synthetic epilente. Different synthetic polymers (hydroxyethyl methacrylate, polyethylene oxide, Lidofilcon, polyvinyl alcohol) were used. The hydrogels of these materials usually do not have an easily conductive surface to the growth and adhesion of epithelial cells on their synthetic surfaces. This was one of the major drawbacks of the synthetic layers. Epithelial cells may not heal properly on these lenses. Another problem with these synthetic lenses is that they would not look good on the surface of the eye. The conventional structure is difficult and the use of biological adhesives is limited. The glues were not ideally biocompatible in the cornea. At the end, the permeability of these hydrogels was significantly limiting. Living epithelial cells on the surface had difficulty in achieving adequate nutrition. The corneal epithelial nutritional flow flows from the aqueous humor, through the cornea, and out of the epithelial cells. In sum, industrial efforts until then have failed to develop a suitable synthetic epicar- to-phacic lens. Around the mid-1990s, procedures that sculpted the cornea with lasers were sufficiently successful as they began to replace radial keratotomy. The first generation of laser ablation of the cornea was called photorefractive keratectomy (PRK, for its acronym in English). In the PRK, an ablative laser (for example, an excimer laser) is focused on the cornea to sculpt a new curvature on the surface. In the PRK, the epithelium is destroyed when a new outer surface curve is obtained. - In the following post-operative days, the epithelium develops or heals again in its place. This phase of epithelial healing was problematic for the majority of patients, since the epithelially stripped and ablative cornea was painful. The patient's vision is initially poor; This "recovery time" can last from days to a week or more. A subsequent variation of PRK corneal ablation, LASIK, has become very popular. The LASIK procedure also known as laser in situ keratomileusis (Laser In Situ Keratomileusis, by its meaning in English), is synonymous in the public knowledge with the correction of the vision with laser. In LASIK, an outer portion (or portion in the form of a lens) similar to a cord, of the cornea (80 to 150 micrometers thick) is surgically cut from the corneal surface. This step is performed using a device called a microkeratome. The microkeratome cuts a circular flap of the surface of the cornea, the flap of which contains the corneal tissue and epithelium, remains hinged on one edge. This flap is reflected (or folded) back and an ablative laser (excimer) is used to remove or reform a portion of the exposed surgical site. The corneal flap is stretched back into place. When this flap is stretched back into place, the cornea obtains a new curvature because the flap that forms the surface modified with the laser. In this procedure, the epithelial cells are not removed or damaged. The epithelial cells have simply undergone excision at the edge of this flap. When the flap is placed back on the corneal bed, the epithelium heals again at the site of the excision. There is essentially no recovery time, and the results are almost immediate. Because there is little surgical time (15 minutes for each eye) and because there are long-lasting and very accurate results, LASIK is currently considered the first way to perform refractive surgery. The newest technique that is evaluated in high-volume refractive surgical practices and in some academic centers is a procedure called Laser Assisted Subepithelial Keratomileusis (LASEK). a "flap" of epithelium only, this layer of epithelium is brought into contact with an ethanol solution and is lifted from the cornea in a manner similar to LASIK.The ablative laser is focused just above the surface of the stripped cornea (from the However, this epithelial flap is left physically intact, for example, the epithelium is not destroyed, but the epithelial cells are not truly viable, see for example, T-ves igrative Ophtalmology & Visual Science, by Chen et al. (Vol 43: 8 pp. 2593-2602, August 2002) This is simply rolled back on the site after the formation of the p Anterior anterior recurvation of the cornea, resulting in a much shorter recovery time than with PRK. Current LASEK methods are not as good as LASIK, but the results are better than with PRK. The corneal epithelium is a multilayer epithelial structure typically around 50 μm thick. This one is not cornified. The outer cells are alive, although these are scaly by nature. The basal epithelial cells are curved and settle on the stromal surface on a structure known as the Bowman's membrane. The basal cell layer is typically about 25.4 μm (1 mil) (0.001") in thickness.The basal cells produce the same keratins that are produced in the integument, eg, the 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) is a highly innervated organ.The nerves coming from the cornea are directly fed into the epithelium, and in this way, the defects of this organ produce pain.The epithelial cells are coupled side by side by the transmembrane molecules called desmosomes Another transmembrane protein, the hemidesmosome, connects type 7 collagen and is present on the basolateral surface of basal epithelial cells. The hemi des mamnas anchor the epithelium to the underlying collagenous portion of the stroma. The junction between the epithelium and the corneal stroma is referred to as the zone of the basement membrane (BMZ, for its acronym in English). When LASEK is performed, a physical well is placed or formed on the epithelium and filled with a selection of 20 percent ethanol and balanced salt solution. Contact with the solution causes the epithelial cells to lose their adhesion in the BMZ, more likely by the destruction of a portion of this cell population. The epithelium is then elevated by pushing the epithelium, for example, with a Weck sponge, in a similar manner to remove a wall of paint. The exposed collagenous portion of the corneal stroma is then subjected to ablation to reshape its surface. A weakened epithelium is then • rolled back on the site to serve as a bandage. However, this "bandage" fails to restore the epithelium to its original state, for example, it does not preserve the integrity of the epithelium, which reduces its clarity, impermeability to water and the barrier function. In addition, the ability of the epithelium to adhere to the corneal stromal surface is impaired. U.S. Patent Nos. 6,009,541 and 6,030,398 to Klopotek describe a microkeratome apparatus and the method for cutting a corneal epithelial layer to prepare the eye for LASIK or other procedures for reshaping. The epithelium, if replaced, is coupled using surgical techniques. None of the cited references show or suggest the device and the methods described herein. BRIEF DESCRIPTION OF THE INVENTION [0002] A vacuum stabilization device for clamping, stabilizing, and modestly deforming the front portion of a human cornea (hereinafter referred to as a "stabilization device" or "stabilizer") is described. The stabilization device allows access to the cornea with a supplementary device such as an epithelial delaminator, ocular device inserter, or flattened device. The device can also guide, assist or regulate the movement of these devices and others with respect to the cornea. In general, the described stabilization device includes an annular ring having at least two surfaces that contact the surface of the eye and define an annular region. An outer radial surface is located or configured such that it typically first contacts the surface of the eye when the stabilization device is introduced to the surface of the eye. In many variations of the described device, the internal radial surface defining the annular void area typically does not contact the eye until the cornea and the eye itself is slightly deformed. In some versions, the internal radial surface defines the annular vacuum area does not contact the eye until the stabilization device is slightly deformed, or until the eye and stabilization device are slightly deformed. The device includes a typically circular opening which is internal to the internal radial surface and therefore not under the influence of vacuum, and provides a stable region for, for example, for raising the epithelium.

The open central area may, in some variations, be coupled with a separate component - "a vacuum former" - to allow or to cause a vacuum that is imposed on the annular region to also communicate with that circular area and change the shape of the eye, and cause the cornea to protrude modestly from that open central area. The "vacuum former" may be a separate component or it may be the thumb of the operating physician, or the like. In some versions, the vacuum is formed merely by pressing the stabilization device over the eye. The corneal stabilizer can be used in conjunction with epithelial delaminators as can be found in published International Application WO 03/061518, published on July 31, 2003, the entirety of this document is incorporated by reference. The corneal stabilizer can be used in conjunction with an eye device inserter as can be found in the United States Patent Application entitled OCULAR DEVICE APPLICATOR by Pérez (presented on '9/8/04) and the United States Patent Application entitled COMBINED EPITHELIAL DESLAMINATOR AND INSERT, for Pérez et al. (filed on 9/8/04); All of these documents are incorporated by reference herein.

The stabilization device may also include an index, or guide configured to provide support, guidance, assistance or regulation of the movement of these devices and others with respect to the cornea, and with respect to the stabilization device. In one version, the guide is a sliding guide. In one version, the guide is configured to be coupled to another device (for example, an epithelial delaminator, inserter, etc.). Also included are apparatus equipment, for example, the stabilization device described in combination with an epithelial delaminator configured to completely remove a section of the epithelium, an epithelial delaminator configured to remove a flap from the epithelium, or an epithelial delaminator configured to produce an epithelial delaminator. Limited flap or epithelial bag with one or more openings. Equipment including this described and detailed corneal stabilizer may also include a vacuum maker, suitable for closing the opening that otherwise provides access to the front of the cornea. Also described herein are methods for the use of the described corneal stabilizer including the steps of: (a) providing a corneal stabilizer described, (b) placing the corneal stabilizer over an eye in an appropriate region of the eye, eg, in general centered around the cornea of the eye, (c) the provision of a vacuum to the annular space of the stabilizer, (d) the optional closing of the open region on the front of the stabilizer to distribute the vacuum and to deform the eye (or simply by pressing down on the stabilizer) to cause the eye to make contact with the radial inner surface of the stabilizer and seal the annular space in the vacuum stabilizer, whereupon the stabilizer is fixed to the eye, (e) the proportion of a epithelial delaminator, (f) the separation of at least a portion of the epithelium from the cornea, and (g) carrying out a procedure to correct the optical characteristics of the eye. The various final steps are optional for this described procedure. The method may include a variety of laser or tool-induced corrective procedures, or may include the simple step of placing a contact lens of some type on the de-epithelialized corneal surface. In each case, it is desirable that the epithelium be replaced over the surgically altered site or the contact lens. BRIEF DESCRIPTION OF THE FIGURES Figure IA is a perspective view of a typical corneal stabilization device and the associated vacuum creator. Figure IB shows a cross-sectional view of the stabilizer found in Figure 1A.

Figure 2A shows yet another variation of the stabilizer. Figure 2B shows a view in. cross section of the stabilizing ring found in Figure 2A. Figure 3A shows yet another variation of the stabilizer. Figure 3B shows a cross-sectional view of the stabilizing ring found in Figure 3A. Figures 4A and 4B show surfaces that could be appropriate for the outer radial surface of the described stabilizer. Figures 4C and 4D show surfaces that could be appropriate for the internal radial surface of the described stabilizer. Figures 4E and 4F show cross sections through variations of the external radial surface of the described stabilizer. Figures 5A to 5D show a typical procedure for the use of the stabilizer. Figures 6A and 6B show another version of a method for the use of the stabilizer. Figures 7A and 7B show some delamination devices that can be used variously in conjunction with the stabilizer described or as a portion of the equipment. Figure 8 shows a cross-sectional view of yet another version of the stabilizer. Figures 9A to 9B show cross-sectional views of other variations of the stabilizer. DETAILED DESCRIPTION OF THE INVENTION Figure IA shows a perspective view of a variation (100) comprising a base (102) and a vacuum forming component (104). The base itself includes a line (104) to a vacuum source. The vacuum line (104) can be used as a handle and typically could be provided with a vacuum breaker hole (106), allowing the user to manipulate or break the vacuum towards the device, when a removal is desired. The base section (102) has an opening (108) through which the human cornea protrudes after the device is fully deployed on the eye. As can best be observed in the later figures, the base (102) has an internal radial surface (110) which is configured to make contact with the eye during the operation, and to provide a seal for the vacuum and an external radial surface ( 112), which also makes contact with the eye. The device can be automated, for example, vacuum control can be automatically controlled.

Figure IB shows the base member (102) in cross section. The profile of an eye is shown in profile simply with a cornea (114), a limbus (116), and the sclera (118) for clarity of explanation. The base (102) is shown with the external radial surface (112), in the position in which the described stabilizer first contacts the eye. The internal radial surface (110) is also shown but it should be understood that, at this point, the inner radial surface (110) does not contact the eye or, at least it is not sealed against the eye and forms a seal or distributes some vacuum supplied. The device is configured so that when a vacuum is applied through the vacuum line (106) inside the chamber (120) substantially annular, and the opening (108) is closed, the anterior portion of the cornea is pulled upwardly in contact with the internal radial surface (110). The relative size and placement of these two surfaces (110 and 112) provide for the revision of the shape of the eye in a coarse and temporary sense, and cause movement of the cornea towards the open front opening (108), and fixes the device in position (102) with respect to the eye. These modest alterations of the corneal shape provide a 'surface of the cornea protruding from (or extending from) the front of the stabilizing device (112). This is an easy surface on which to perform a procedure.

Although it is not desired to be compromised by the range of these values, the vacuum ranges that are suitable to be operable in this device include: vacuum values of up to 300 mmHg, and values in the vicinity of 150 mmHg. Also, values in the range of 100 to 250 mmHg and 125 to 175 mmHg are suitable. As can be easily understood, the higher the applied vacuum value, the firmer the front surface of the cornea becomes. In addition, it has been found that a distance between the internal radial surface and the corneal surface of approximately 15.87 mm (1/16 inch) is appropriate in these devices. That is, an adequate clearance between the inner radial surface (110) and the cornea before the time the vacuum is applied may be 15.87 mm (0.625 inches) +/- 0.76 mm (0.03 inches). Figure 2A shows yet another variation of the stabilizer (150) of the invention. In this case, the base member (152) does not provide as much of an open annular vacuum volume as does the variation shown in the Figures IA and IB. However, the components are substantially the same. That is, the variation has a base member (150), an internal radial surface (154), an external radial surface (156), an opening (158) to access the anterior corneal surface of an eye, a vacuum line (160), and a vacuum breaker (162). As just noted above, the presence of some open vacuum volume between the internal radial surface (154) and the external radial surface (156) is desirable. Figures 3A and 3B show yet another variation of the stabilizer (170). In this version, the base member (152) is coupled to a positioning member (172). The vacuum line (162) can apply a vacuum between the inner radial surface and an outer radial surface, as previously described. The positioning member can be connected to a fastener, or an automatic positioner. In some versions, the positioning member is configured by a handle. In some versions of the stabilizer, there is no positioning member, and the stabilizer is merely connected to a vacuum line. Figures 4A and 4B show suitable external radial surfaces. The shape of the external radial surfaces provided in Figures IB and 2B, as well as in Figures 5A to 5D are acceptable. The surface (180) shown in Figure 4A can be straight or slightly curved to cooperate with the shape of the eye, where it makes contact. The contact surface of (182) shown in Figure 4B is a simple corner and is also acceptable although obviously providing an opportunity for more pronounced trauma to the eye.

Figure 4C shows a variation of the internal radial surface (184) in which the surface is extended in an upward direction to provide a wider support region that might otherwise be available 'simply by machining a corneal shape from the manufacturing material. Form (184) may be desirable in certain cases in which due to, for example, significant astigmatism, the cornea is uniquely shaped. Figure 4D shows an external radial surface (186) which is simply a 45 ° cut. In some versions, the surfaces of the device that come in contact with the eye comprise a layer (e.g., a coating) to prevent damage to the eye. For example, the internal radial surface and the external radial surface can be polished to prevent damage to the surface of the eye. In some versions, the radial inner and outer surfaces comprise a coating. For example, the radial inner and outer surfaces that make contact with the eye can be coated with a friction reducing material, or a lubricant. In yet another version, the internal and external radial surfaces may include a fluid material, gel, or gel-like material (such as HA) that aids in the formation or sealing of the vacuum.

Figures 4E and 4F show external radical surfaces in which the region that makes contact with the eye (188 and 190) comprises a flexible material. In Figure 4E the flexible material is shown as a package on the stabilizer comprising the external radial surface (188). In Figure 4F, a flexible material comprises an integral part of the stabilizer to encompass the outer radial surface (190). A variation of the described method shown in Figures 5A-5D. In Figure 5A, the base member (200) comprises a substantially annular shaped member, having an outer radial surface (204) configured to contact and form a seal with an eye (206) and an internal radial surface (208) configured to contact the eye (206) after the device (204) has been deployed. In general, the two surfaces, the external radial surface (204) and the internal radial surface (208), are chosen in a size and placement within the base member (200), such that when the base member (202) makes first contact with the eye (206), the external radial surface (204) is in contact with the eye, and the internal radial surface (208) is not. The external radial surface (204) is configured to contact the eye on the sclera (118), although this is not a requirement of this device. The external radial surface (204) can make contact with the eye in or on the limbus (116) or, in certain circumstances, on the cornea (114) itself. In any case, during the initial step, the internal radial surface (208) is adjusted to size and positioned, radially and anteriorly with respect to the external radial surface (204), which does not contact or contact the eye , in such a way as to form a seal with the cornea. After the device has been fully deployed, and the shape of the eye has been transformed, the inner radial surface (208) then contacts the eye and helps form the annular vacuum volume. The internal radial surface (208) may contact some portion of the cornea, however, before deployment. The internal radial surface (208) is configured so that it will contact the cornea surface after the desired temporary reformation of the cornea has been achieved, and to form a seal with the cornea. The annular vacuum volume (210) is defined as between the internal radial surface (208) and the external radial surface (204). The vacuum is introduced to the annular vacuum volume (210) by the vacuum line (212) which, as noted above, can also serve as a device handle.

The configuration described above with respect to the base member (200), particularly the spatial relationship between the external radial surface (204), the external radial surface (208), and the contact region of the cornea where the internal radial surface will seal , is functionally the same in the case where a vacuum former (214) is used to initiate the sealing of the annular void volume (210) or if the base member (200) is merely pressed into the eye to deform the eye slightly, but significantly, to cause the cornea to contact the inner radial surface (208) and seal the annular vacuum volume (210). The equipment including the base member (200) and a component (214) is a variation of the described material. Figures 5A to 5D show an extended version of a variation of the present method. Figure 5A shows the first step of positioning the base member (200) on an eye (206). Note that the external radial surface (204) makes contact with the eye and still the inner radial surface (208) has not yet made contact with the eye. The vacuum manufacturing component (214) is shown approaching the front surface (216) of the base (200). Figure 5B shows the contact of the vacuum processing member (214) with the front surface of the base (200) after the application of the vacuum through the line (212). It should be noted that the closing of this volume of the system by application of vacuum within the annular volume (210) causes the eye (206) and in particular the cornea (114) to move forward in contact with the inner radial surface (208) as shown by the movement arrows (220). Figure 5C shows the complete deployment of the device described and the presentation of a portion of the anterior corneal surface (114) through the central area open for a procedure. The anterior surface of the cornea remains protruding from the front surface (216) of the base (200) of the device. It should be noted that the device can also be adjusted to the size in such a way that the inner radial surface (218) makes contact with the eye in the limbus (116) or even below the sclera (118). In any case, the internal radial surface (208) and the external radial surface (204) in this variation form an annular vacuum volume (210) which, in combination, fix the base member (200) with respect to the eye (206) in a way such as to stabilize the eye; that is, to prevent relative movement of the eye with respect to a subsequent procedure performed by the epithelium, to slightly reshape the eye to provide a measurement of stiffness to the inner portion of the cornea (114) on which the process.

Figure 5D shows the deployed device and the base member (200) in contact with the eye, as described with reference to Figure 5C just described. In this step, an epithelial delaminator (230) is shown to remove the epithelium from the surface of the cornea and to form an epithelial flap (232). Yet another version of the method described herein for applying the stabilizer to the corneal surface is shown in Figure 6A and 6B. Figures 6A and 6B show that the application of pressure (or force) on the stabilizer may be adequate to form a vacuum in the annular void volume, and therefore secure the stabilizer on the eye. The step of delaminating the epithelial layer (232) of the corneal surface may involve any of the following variations. The epithelium can be simply separated from the cornea. This can be lifted from the corneal surface. The separation or removal may further include removal of the epithelium away from the cornea or may involve the fabrication of a flap having a hinge area in which the epithelium may be of a shape that can be rotated about the hinge with respect to the front. of the cornea. This may be the formation of a simple pouch in which the only apparent and only slightly visible manifestations of the epithelial separation, are the openings (or the opening) inside the bag. In some variations of subsequent procedures, a lens can be inserted into the bag. A device, perhaps with optical qualities, and perhaps not, can be introduced into the bag or under the flap. It is likely that due to the nature of the devices used to measure the optical capabilities of the cornea and associated lenses, that the removal of the described stabilizer is desired prior to so-called "subtractive" procedures, used to correct vision. Such procedures include LASIK and LASEK. Figure 7A shows, for purposes of summary only, an epithelial delamination device (300), having a clevis (302) and a wire (304). The wire (304) provides a mechanism by which the epithelium can be mechanically separated from the cornea. The wire (304) can be vibrated in some way. The described vacuum stabilization device may further comprise a guidance or indexing or regulation platform, to assist or restrict (or to provide a regulated direction for) the movement of supplementary devices (such as an epithelial delayer or device inserter). ocular) when using the stabilization device on one eye. By "indexing" or "regulation" is meant the provision of a stable group of coordinates between the stabilization device described, the eye and any supplementary devices. In one version, the guide is a sliding guide configured to communicate with a portion of the supplementary device. For example, the vacuum device may comprise a grooved sliding guide located on a portion of the outer surface of the base region (102). The guide can be integral to the base region, or it can be projected from the base region. In one version, a supplementary device (e.g., delaminator) comprises pins that fit within the slide guide region of the stabilizer, and guide the movement of the supplementary device relative to the eye. In one version, the movement of the supplementary device along the trajectory can be regulated by the stabilization device. For example, the guide (eg, slide guide) can determine the "approach angle" of a delaminator, as well as the angle from which delamination can occur. In some versions, the guide can be adjustable by the user, or automatically adjustable. Additional supplementary devices (for example, an inserter) can use the same, or a different guide on a simple stabilization device. In this way, an eye can be delaminated in a controlled manner, the delaminator can be removed, and an inserter can be used to apply an ocular device below the delaminated epithelium, following the same path of the delaminator in the same eye. In one version, the stabilization device comprises separate guides for a delaminator and an inserter. Figure 7A shows a variation of an epithelial delamination device that can be used with the described stabilizers. Figure 7B shows yet another variation of an epithelial delamination device (310) having a vibrating or oscillating wire (312) that can be used to make bags below the epithelium. Examples of suitable epithelial delamination devices are described in the published PCT application WO 03/061518, the entirety of which is incorporated by reference herein. As described above, the stabilization device can also be configured to conform to a variety of different eye shapes or sizes. In some versions, the base region (102) further comprises a conformable "skirt". Figure 8 shows a version of the device in which at least one of the annular contact surfaces with the eye (shown as on the external radial surface (605)) includes a skirt region (610) that is sufficiently flexible to conform to the surface of the eye, particularly under the force of an applied annular vacuum. The "skirt" region can allow a greater contact surface between the device and the eye, helping to prevent the loss of the vacuum. In addition, the flexible skirt allows the device to adapt to an interval to a larger form of eye shapes (e.g., irregularly shaped eyes) or eye sizes. Although the outer radial surface is shown having a skirt, the inner radial region (610) may also comprise a conformable skirt. The conformable skirt can comprise any material sufficiently foldable to fit over the surface of the eye, still being able to maintain the vacuum within the device. Examples of materials include elastomeric materials, rubbers, mild polymers and the like. In one version, the skirt is integral to the annular region (e.g., the inner annular region or the outer annular region). In one version, the entire annular region may act as a "skirt", conforming at least partially to the surface of the eye under an applied vacuum. The stabilization device may also comprise more than one "external" annular region, to allow the device to be used with a wide variety of eye sizes. Figures 9A and 9B show said alternatives of the device in which an additional "intermediate" annular region (701) is included between an internal annular region (705) and an external annular region (710). The intermediate annular region may allow the device to conform to narrower (or smaller) eyes for which the outer annular region may be larger. With larger (or wider) eyes the intermediate annular region initially does not contact the eye, as shown in Figure 9A. In some versions, the intermediate annular region can also help support the device when a vacuum is applied. Figure 9B shows yet another version of a device having an intermediate annular region (701) which also comprises a flexible skirt. Figure 9B shows the device under a vacuum, in which the intermediate annular region has been sealed around the eye, and the skirt region has been shaped to part of the surface of the eye. In addition, the described device can be included in a computer system. In particular, the base member optionally with a vacuum former and optionally with epithelial delamination tools are examples of the system or equipment described. It is noted that in relation to this date, the best known method for carrying out the aforementioned invention is that which is clear from the present description of the invention.

Claims (22)

CLAIMS Having described the invention as above, the content of the following claims is claimed as property:

1. A corneal stabilizer configured to be placed on an eye, characterized in that it comprises: (a) at least one external radial surface adapted to contact the surface of the eye, and cooperate with an internal radial surface to form a vacuum seal with that surface; (b) the internal radial surface adapted to make contact with the surface of the eye after the deformation of the eye, but not to make contact with the eye during initial placement, (c) an annular void volume defined at the edges by the surfaces internal and external radial, and (d) an interior opening to the internal radial surface, which allows the extension of an inner corneal surface through it when the stabilizer is in contact with the eye with the internal radial surface and at least one external . The device according to claim 1, characterized in that it also comprises a vacuum source. The device according to claim 1, characterized in that it also comprises a handle suitable for handling by a user. 4. The device according to claim 1, characterized in that it further comprises a guide configured to mate with at least one supplementary device. 5. The device according to claim 4, characterized in that the supplementary device comprises an epithelial delaminator. The device according to claim 1, characterized in that it further comprises a vacuum former configured to close the opening through which the cornea is to be extended, and to thereby deform the eye of the subject, causing the extension or corneal projection. The device according to claim 1, characterized in that the internal radial surface is positioned to be spaced from the eye of the subject when the external radial surface makes contact with the eye of the subject without applying a vacuum. The device according to claim 7, characterized in that the internal radial surface is positioned to be spaced from the subject's eye at a distance of 1587 mm (0.0625 inches) +/- 0.762 mm (0.030 inches) when the external radial surface makes contact with the eye of the subject without applying a given vacuum. The device according to claim 1, characterized in that the external radial surface is at least partially flexible. The device according to claim 1, characterized in that the external radial surface is substantially rigid. 11. The device according to claim 1, characterized in that there is exactly one external radial surface. 1

2. The device according to claim 1, characterized in that there is more than one external radial surface. 1

3. A device, characterized in that the device according to any of claims 1 to 12, in combination with a vacuum former adapted to close the open region. 1

4. A device comprising the device according to any of claims 1 to 12, and characterized in that it further comprises a lens. 1

5. A device comprising the device according to any of claims 1 to 12, and characterized in that it further comprises an epithelial delaminator. 1

6. The equipment according to claim 15, characterized in that the epithelial delaminator is adapted to form an epithelial flap. 1

7. The equipment in accordance with the claim 15, characterized in that the epithelial delaminator is adapted to form an epithelial pocket. 1

8. A method for stabilizing the cornea of a selected eye, characterized in that the method comprises the step of: a) providing a stabilization device selected from those found in claims 1-12, b) providing vacuum to the annular vacuum volume, and c) deforming the eye to cause the inner radial surface to contact the eye and seal the stabilization device against the eye and to stabilize the cornea. 1

9. The method according to claim 18, characterized in that it further comprises the step of separating at least a portion of the epithelium from the selected eye. The method according to claim 19, characterized in that the epithelial separation step includes the formation of a member selected from the group consisting of a separate epithelium, an epithelial flap having a hinge, and an epithelial pocket having a more openings. The method according to claim 20, characterized in that it also includes a step of performing a subtractive procedure on the corneal surface, and replacing the epithelium on that surface. 22. The method according to claim 20, further characterized in that it comprises the step of introducing a lens on the corneal surface, and covering it with the separated epithelium.