HK1099680A - Corneal retention device or corneal stabilizing tool - Google Patents

Description

Corneal holding device or corneal stabilizing tool

Technical Field

The present invention relates to a surgical device typically used to releasably hold the cornea of a human eye (and thus the eye) in a manner that moderately deforms the cornea and eye, maintains the position of the eye for surgery on the epithelial layer of the cornea, and allows an epithelial flap (an epitalial flap) to be easily repositioned if it is created. Such surgical devices may be used in conjunction with epithelial delamination tools or visual device insertion tools. This stabilization device allows easy access to, and creation of, the flap or pocket of the epithelium prior to repositioning the epithelium on the corrective lens or in the location of a laser-induced or surgically-induced corrective procedure, for later introduction of the corrective lens (e.g., using an ocular device insertion tool) or a subtractive procedure such as LASIK or LASEK.

Background

Refractive surgery (refractive surgery) refers to a group of surgical procedures that change the original optical or focusing power of the eye. These changes reduce the need for lenses or contact lenses that one might otherwise rely on to see clearly. The focusing power of the human eye is determined primarily by the curvature of the air-liquid interface, where there is the greatest change in refractive index. This curved interface is the outer surface of the cornea. The refractive power of such an interface accounts for approximately 70% of the total power of the eye. The light rays that make up the image we see pass through the cornea, the anterior chamber, the crystalline lens and the vitreous humor of the eye, and are then focused on the retina to form the image. It is this curved air-corneal interface's power of magnification that provides the field of refractive surgery with the opportunity to surgically correct vision defects.

In the RK era, a largely defective and failed procedure called epikeratophakia was developed. This operation is now essentially an academic metamorphosis (anacademic anally). Epikertophakia allows the outer curvature of the cornea to have a new curvature by transplanting a thin layer of preserved corneal tissue onto the cornea.

An epikeratophakia lens is surgically placed into the eye. After complete removal of the epithelium from the site of the epikeratophakia lens, a 360 degree circular incision is made in the cornea. The periphery of this lens may be inserted into the annular cut out and held in place by continuous stitching. There are several problems with epikeratophakia: 1) the lens is cloudy until the maternal stromal fibroblasts colonize the lens, which may take months; 2) the broken epithelium remains the focus of infection until the engrafted epithelium is able to grow onto the surface of the lens at the site of the incision; and 3) epithelium healing onto the surgical site sometimes moves into the space between the lens and the parent cornea. Currently, epikeratophakia is limited in its use. This procedure is now used in pediatric patients with a missing lens who cannot tolerate a very irrational contact lens.

A great deal of industrial research has attempted to create a synthetic approach to epikeratophakia transplantation, which is known as the synthetic surface coating in synthetic epiliens. Different synthetic polymers (hydroxyethyl methacrylate, polyethylene oxide, Lidofilcon, polyvinyl alcohol) were used. Hydrogels of these materials generally do not have a surface that can readily grow epithelial cells and adhere them to their synthetic surfaces. This is one of the major drawbacks of the synthetic surface coatings. Epithelial cells do not heal onto these lenses sufficiently.

Another problem with these synthetic lenses is that they do not adhere well to the surface of the eye. Traditional suturing is difficult and the use of biological glue is still limited. Biogel is not ideally biocompatible in the cornea.

Finally, these hydrogels have very limited permeability capabilities. It is difficult for viable epithelial cells on the surface to obtain adequate nutrition. The nutrient flow of the corneal epithelium flows out from the aqueous vitreous body through the cornea to the epithelial cells. In summary, current industrial research has failed to develop a suitable synthetic epikeratophakia lens.

In the mid-nineties of the last century, procedures for laser treatment of the cornea were quite successful, and thus these procedures began to replace radial keratotomy. The first generation of laser corneal ablation was referred to as photorefractive keratectomy (PRK). In PRK, an ablative laser (e.g., an excimer laser) is focused on the cornea to treat the surface with a new curvature. In PRK, the epithelium is destroyed while a new curvature of the outer surface is obtained. In some days after surgery, the epithelium either grows, or heals back to its original state. This epithelial healing phase is problematic for most patients because the epithelium is bare and the ablated cornea is painful. The patient's vision begins to be poor; this "recovery period" may last from a few days to a week or more.

Later modifications of LASIK for PRK corneal laser ablation have become widespread. LASIK surgery is also known as LASIKLAser In Situ Keastomileuss, is synonymous with laser vision correction in the public mind. In LASIK, the outer portion of the cornea (or the chordal lens-shaped portion) is surgically cut away (80-150 microns thick) from the corneal surface. This procedure is performed using a device known as a microkeratome (microkeratome). The microkeratome cuts a circular flap from the surface of the cornea, which flap contains corneal tissue and epithelium and remains hinged at one edge. This flap is folded back and a portion of the exposed surgical area is removed or deformed using an ablative laser (excimer laser). The flap is then replaced. When the corneal flap is placed back in place, the cornea acquires a new curvature because the flap conforms to the shape of the surface altered by the laser. In this procedure, epithelial cells are not removed or damaged. The epithelial cells are simply cut at the edge of this flap. When the flap is placed back over the area of the cornea, the epithelium heals at the cut site, returning to its original state. There is essentially no recovery period and it takes almost immediate effect. Because of the very short time of surgery (15 minutes for each eye), and because of the long-lasting and very precise effects, LASIK is currently considered the primary way to perform refractive surgery.

In a number of refractive surgical practices and in certainThe latest technology being evaluated in academic centers is calledLaser Assisted SubepithelialKOperation of eatomileus (LASEK). In LASEK, a "flap" consists only of epithelium. This layer of epithelium is contacted with an ethanol solution and, in a manner similar to LASIK, the layer of epithelium is raised away from the cornea. The ablative laser is just focused on the surface of the bare cornea (in the same manner as surgery with PRK). However, this epithelial flap remains physically intact, i.e., the epithelium is undamaged, but the epithelial cells are not truly viable. See, for example, Investigative opthalmology&Visualscience, by Chen et al (Vol 43: 8pp.2593-2602, August 2002). After the anterior portion of the cornea, which already has a new curvature, is formed, it is simply rolled back to its original state, achieving a much shorter recovery time than with PRK. The current method of LASEK is not as good as LASIK, but the results are better than with PRK.

The epithelium of the cornea is a multilayered epithelial structure, typically about 50 microns thick. It is non-keratinizing. The outer cells are living, however, these cells are squamous in nature. The basal epithelial cells are cubic and sit on the surface of the stroma on a structure called the Bowman's membrane. The basal cell layer is typically about 1 mil thick (0.001 inch) basal cells produce the same keratin as that produced in the dermal membrane, i.e., skin. Basal epithelial cells are denoted as keratin 5 and 14 and have the ability to differentiate into squamous epithelial cells of the corneal epithelium, which produce keratin 6 and 9. The epithelium of the cornea has a number of important properties: 1) it is clean; 2) it is impermeable; 3) it is a barrier to foreign objects; and 4) it is a highly innervated organ. Nerves from the cornea feed directly into the epithelium, and thus, defects in this organ will produce pain.

Transmembrane molecules called intercellular desmosomes attach epithelial cells laterally (or left-right). Another transmembrane protein, hemidesmosomes, is linked to collagen of type 7 and appears on the basophilic side of the basal epithelium. Hemidesmosomes secure the epithelium to the underlying collagen portion of the stroma. The junction between the epithelium and the corneal stroma is called the Basal Membrane Zone (BMZ).

When performing LASEK surgery, a physical well is placed on the epithelium, or such a well is formed on the epithelium, and the well is filled with a selected 20% ethanol and 80% stabilized saline solution. Contact with this solution causes the epithelial cells to lose their cohesiveness in the BMZ region, most likely due to damage to a portion of the cell population therein. The epithelium is then raised by pushing it, for example with a Weck sponge, in a manner similar to stripping a painted wall. The exposed collagen portion of the corneal stroma is then ablated to reshape its surface. The already weakened epithelium is then rolled back into place to be used as a bandage. However, such "bandages" do not restore the epithelium to its original state, i.e., it does not preserve the integrity of the epithelium, thereby reducing its clarity, water-impermeability, and barrier function. Further, the ability of the epithelium to adhere to the stromal surface of the cornea is also impaired.

U.S. patent nos. 6099541 and 6030398 to Klopotek describe a device and method for cutting a layer of corneal epithelium to prepare the eye for LASIK or other reshaping procedures. If replacement is to be performed, the epithelium is attached using surgical techniques.

None of the above-cited references show or suggest the apparatus and steps described herein.

Disclosure of Invention

Described herein is a vacuum stabilization device for holding, stabilizing, and moderately deforming an anterior portion of a human eye's cornea (hereinafter such a device is referred to as a "stabilization device" or "stabilizer"). The stabilization device allows access to the cornea with an auxiliary device such as an epithelial delaminating device, an ocular device inserter, or an aplaner device. The device may also guide and assist in or address (index) the movement of these or other devices relative to the cornea.

In general, the stabilization device described comprises an annular ring having at least two surfaces that contact the surface of the eye and form an annular region. The outer radial surface is located on, or otherwise configured such that when the stabilization device is introduced onto the surface of the eye it will typically first contact the surface of the eye. In many variations of the device shown, the inner radial surface forming the annular vacuum region is typically not in contact with the eye until the cornea and eye itself are slightly deformed. In some forms, the inner radial surface forming the annular vacuum region does not contact the eye until the stabilization device is slightly deformed, or until both the eye and the stabilization device are slightly deformed. The device comprises an opening, typically a circular opening, which is inside the inner radial surface, thus being unaffected by the vacuum and providing a motionless area for e.g. the lifting of the epithelium.

In certain variations, this open central region is combined with a separate component, the "vacuum forming device", so that the vacuum applied to the annular region can also communicate with that circular region and change the shape of the eye and cause the cornea to protrude moderately from that open central region. The "vacuum forming means" may be a separate component or may be the thumb or the like of the operator. In some forms, the vacuum is created simply by pressing the stabilization device down onto the eye.

The corneal stabilizing device may be used in conjunction with an epithelial delaminating device, such as that found in international application WO 03/061518, published on 31/7/2003, which is incorporated by reference in its entirety. The corneal stabilizing DEVICE may be used in conjunction with an OCULAR DEVICE inserter, as may be found in U.S. patent application attorney entitled OCULAR DEVICE APPLICATOR, registered by Perez at 9/8/04, and U.S. patent application entitled composite OCULAR delivery or ANDINSERTER, registered by Perez et al at 9/8/04; these documents are incorporated herein by reference in their entirety.

The stabilization device may also include an addressing device or guide configured to provide support, guidance, assistance, or addressing of the movement of the device or other devices relative to the cornea and relative to the stabilization device. In one form, the guide is a rail. In one form, the guide is configured to be coupled to another device (e.g., an epithelial delaminating device, an inserter, etc.).

Also included are kits of devices, i.e., the disclosed stabilization devices in combination with an epithelial delamination device configured to completely remove a section of epithelium, an epithelial delamination device configured to remove a flap of epithelium, or an epithelial delamination device configured to create a limited flap or an epithelial pocket with one or more openings. A kit including the corneal stabilizing device disclosed and described herein may also include a vacuum forming device adapted to close an opening that would otherwise provide access to the anterior portion of the cornea.

Also described herein is a procedure using the described corneal stabilizing device, comprising the steps of: (a) providing a corneal stabilizing device as described, (b) placing the corneal stabilizing device on the eye at a location on the appropriate region of the eye that is substantially centered, for example, with respect to the cornea of the eye, (c) applying a vacuum to the annular space of the stabilizing device, (d) optionally closing the open region at the front of the stabilizing device, spreading the vacuum and deforming the eye (or simply pressing down on the stabilizing device) such that the eye contacts the inner radial surface of the stabilizing device and seals the annular space of the stabilizing device with respect to the vacuum to thereby secure the stabilizing device to the eye, (e) providing an epithelial delaminating device, (f) separating at least a portion of the epithelium from the cornea, and (g) performing an operation to correct the optical characteristics of the eye. The last few steps are optional for this described procedure. The surgery may include a variety of corrective procedures, either laser or tool, or may include the simple step of placing some type of contact lens on the de-epithelialized corneal surface. In each case, the epithelium is required to be replaced at the surgically altered site or on the contact lens.

Drawings

FIG. 1A is a perspective view of a typical corneal stabilizing device and associated vacuum-forming device;

FIG. 1B shows a cross-sectional view of the stabilization device appearing in FIG. 1A;

FIG. 2A shows another variation of the stabilization device;

FIG. 2B shows a cross-sectional view of the stabilizing ring appearing in FIG. 2A;

FIG. 3A shows another variation of the stabilization device;

FIG. 3B shows a cross-sectional view of the stabilizing ring appearing in FIG. 3A;

FIGS. 4A and 4B illustrate surfaces that may be suitable for the outer radial surface of the stabilization device described;

FIGS. 4C and 4D show surfaces that may be suitable for the inner radial surface of the described stabilization device;

figures 4E and 4F show sections through variants of the outer radial surface of the described stabilization device;

FIGS. 5A through 5D are typical procedures using a stabilization device;

FIGS. 6A and 6B illustrate another procedure using the stabilization device;

FIGS. 7A and 7B illustrate certain delamination devices that may be used in different ways in conjunction with the described stabilization devices or as part of a kit;

FIG. 8 shows a cross-sectional view of another stabilization device; and

fig. 9A and 9B show cross-sectional views of another stabilization device.

Detailed Description

FIG. 1A shows a perspective view of a modified version 100 of a stabilization device that includes a base 102 and a vacuum-forming member 104. The base itself includes a tube (or conduit) 104 that is connected to a vacuum source. The vacuum tube 104 may be used as a handle and it is typically provided with a vacuum break hole 106 so that the user can manipulate or interrupt the vacuum to the stabilization device when removal is desired. The base portion 102 has an opening 108 through which the cornea of the human eye protrudes after the stabilization device is fully placed on the eye. As can be seen more clearly in the subsequent figures, the base 102 has an inner radial surface (or inner radial surface) 110 that is configured to contact the eye during surgery and provide a seal for vacuum, and an outer radial surface 112 that also contacts the eye. The stabilizing device may be an automatic device, e.g. the vacuum may be controlled automatically.

Figure 1B shows the base member 102 in cross-section. For clarity of explanation, the outline of the eye with the cornea 114, the cornea-sclera junction edge 116, and the sclera 118 is shown in brief outline. The base 102 is shown with the outer radial surface 112 in a position where the disclosed stabilization device first contacts the eye. Inner radial surface 110 is also shown, but it should be understood that in this position, inner radial surface 110 does not contact, or at least does not seal against, the eye, does not form a seal, or distribute any applied vacuum. The device is configured such that when vacuum is applied to the substantially annular chamber 120 through the vacuum tube 106 and the aperture 108 is closed, the anterior portion of the cornea is pulled upward into contact with the inner radial surface 110. The relative size and relative position of the two surfaces 110 and 112 effect a change in the shape of the eye in a global and temporal sense and cause the cornea to move toward the open anterior opening 108 and secure the device in position 102 relative to the eye. These modest changes in the shape of the cornea cause the surface of the cornea to rise above (or extend from) the anterior face 112 of the stabilization device. This is a surface on which surgery is easily performed.

While not wishing to be bound by these numerical ranges, vacuum ranges suitable for operation in the apparatus described herein include: vacuum up to 300 mm Hg and vacuum around 150 mm Hg. Similarly, vacuum in the range of 100 to 250 mm Hg and 125 to 175 mm Hg is also suitable. As can be readily appreciated, the higher the value of the applied vacuum, the harder the anterior surface of the cornea becomes. Further, it has been found that a distance of about 1/16 inches between the inner radial surface and the corneal surface is suitable in these devices. That is, a suitable gap between the inner radial surface 110 and the cornea prior to the time the vacuum is applied may be 0.0625 inches +/-0.03 inches.

Fig. 2A shows another modification of the stabilization device 150 of the present invention. In this case, the base member 152 does not provide an open annular vacuum volume as large as in the case of the stabilization device modification shown in fig. 1A and 1B. Nevertheless, the components are substantially identical. That is, the modification has a base member 150, an inner radial surface 154, an outer radial surface 156, an opening 158 for accessing the anterior corneal surface of the eye, vacuum tubing 160, and a vacuum break device 162. As explained above, it is desirable that there be some open vacuum volume between the inner radial surface 154 and the outer radial surface 156.

Fig. 3A and 3B show yet another modification of the stabilization device 170. In this modification, the base member 152 is attached to a positioning member 172. Vacuum tube 162 may apply a vacuum between the inner and outer radial surfaces as previously described. The positioning element may be connected to a holding device or to an automatic positioning device. In some variants, the positioning element is configured as a handle. In some versions of the stabilizer, there are no locating members and the stabilizer is attached to only one vacuum tube.

Fig. 4A and 4B show suitable outer radial surfaces. The shape of the outer radial surface provided in fig. 1B and 2B and in fig. 5A to 5D is acceptable. The surface 180 shown in fig. 4A may be straight or slightly curved to cooperate with the shape of the eye when in contact with the eye. The contact surface 182 shown in fig. 4B is a simple corner, which is also acceptable, but it clearly creates a greater chance of damage to the eye.

Fig. 4C shows a modification 184 of the inner radial surface in which the surface extends upwardly to provide a wider area of support than would otherwise be obtainable simply by machining a shape from the material of manufacture to conform to the eye. In some cases, shape 184 may be desirable, in which case the cornea may need to be individually shaped due to, for example, significant astigmatism.

Figure 4D shows the outer radial surface 186 as a simple 45 degree cut.

In certain variations, the surface of the device that contacts the eye comprises a layer (e.g., a coating) to prevent damage to the eye. For example, the inner and outer radial surfaces may be polished to prevent damage to the surface of the eye. In certain variations, the inner and outer radial surfaces include a coating. For example, the inner and outer radial surfaces that contact the eye may be coated with a friction reducing material or a lubricant. In another variation, the inner and outer radial surfaces may include a fluid, gel, or gel-like material (such as HA) that aids in the formation or sealing of the vacuum.

In the outer radial surface shown in fig. 4E and 4F, the eye-contacting surface 188 or 190 comprises a flexible material. The flexible material shown in fig. 4E is a pad on the stabilization device that includes a radial surface 188. In fig. 4F, the flexible material includes a portion integral with the stabilization device that includes an outer radial surface 190.

A variation of the described device and procedure is shown in fig. 5A-5D. In figure 5A, the base member 200 comprises a substantially annular member having an outer radial surface 204 configured to contact and form a seal with the eye 206 and an inner radial surface 208 configured to contact the eye 206 after the device 204 has been applied. Generally speaking, the two surfaces, namely the outer radial surface 204 and the inner radial surface 208, are selected in size and arrangement within the base member 200 such that when the base member 202 first contacts the eye 206, the outer radial surface 204 contacts the eye while the inner radial surface 208 does not contact the eye. Outer radial surface 204 is configured to contact the eye on sclera 118, but this is not a requirement of such a device. The outer radial surface 204 may contact the eye in or on the cornea to sclera connection 116, or in some cases on the cornea 114 itself. In any event, at an initial stage, the inner radial surface 208 is sized and positioned radially and axially forward relative to the outer radial surface 204 so that it does not contact the eye, or otherwise contact the eye in a manner that forms a seal with the cornea. After the device has been fully placed and the shape of the eye has been reshaped, inner radial surface 208 will contact the eye and help form an annular vacuum volume. However, prior to application, the inner radial surface 208 may be in contact with some portion of the cornea.

The inner radial surface 208 is configured so that it will contact the surface of the cornea after the desired temporary deformation of the cornea has been achieved and a seal with the cornea has been formed. An annular vacuum volume 210 is formed between inner radial surface 208 and outer radial surface 204. Vacuum is introduced into the annular vacuum volume 210 through vacuum tube 212, which can also serve as a handle for the device, as explained above.

The configuration described above with respect to the base member 200, particularly the spatial relationship between the outer radial surface 204, the inner radial surface 208, and the contact area of the cornea, is functionally the same in that the radial surfaces effect a seal in the contact area where the vacuum forming device 214 is used to initiate a seal of the annular vacuum volume 210, or if the base member 214 is simply pressed into the eye to deform the eye slightly, but significantly, so that the cornea contacts the inner radial surface 208 and seals the annular vacuum volume 210.

The kit comprising the base member 200 and the member 214 is a modification of the materials described.

Fig. 5A to 5D show an extension of a modification of the operation. Figure 5A shows a first step in which the base member 200 is placed on the eye 206. Note that the outer radial surface 204 is in contact with the eye, while the inner radial surface 208 is not yet in contact with the eye. The vacuum-forming member 214 is shown approaching the front surface 216 of the base member 200.

Figure 5B shows that after the vacuum is applied through the tube 112, the vacuum forming member 214 is in contact with the front surface of the base member 200. It should be noted that by applying a vacuum into the annular volume 210, the volume of this system is closed such that the eye 206, and in particular the cornea 114, moves forward into contact with the inner radial surface 208, as indicated by the motion arrows 220.

Fig. 5C shows the device as described fully on and with a portion of the anterior corneal surface 114 across the open central area for surgery. The anterior surface of the cornea is raised above the anterior surface 216 of the device base 200. It should be noted that the device may also be sized so that inner radial surface 208 contacts the eye on the corneal-scleral junction 116 or even down on sclera 118.

In any case, the inner and outer radial surfaces 208, 204 in this modification form an annular vacuum volume 210 that combines to fix the base member 200 relative to the eye 206 in a manner that stabilizes the eye; that is, relative movement of the eye with respect to a posterior surgery on the epithelium is prevented, the eye is slightly deformed, and the anterior portion 114 of the cornea on which the surgery has been performed is given a certain rigidity.

Figure 5D shows the added device and base member 200 in contact with the eye, as described immediately above with reference to figure 5C. At this step, the epithelial delaminating device 230 is shown removing the epithelium from the surface of the cornea and forming an epithelial flap 232.

Another version of the procedure described herein for applying a stabilization device to a corneal surface is shown in fig. 6A and 6B. Fig. 6A and 6B illustrate that it may be appropriate to apply pressure (or force) downward on the stabilization device, thereby creating a vacuum in the annular vacuum volume and thus securing the stabilization device to the eye.

The step of delaminating the epithelial layer 232 from the corneal surface may require any of the following modifications. The epithelium may simply be separated from the cornea. It can be elevated from the corneal surface. These steps of separation or elevation may also include removing the separated epithelium from the cornea, or it may be desirable to create a flap with a hinged region, in which case the epithelium may be in the form of a hinge about which it can rotate about the anterior aspect of the cornea. It may be that a simple pouch is formed in which the only obvious and only slightly visible representation of the separation of the epithelium is a few (or one opening) into the pouch. In some variations of the subsequent procedure, a lens may be introduced into the capsular bag. A device, which may or may not be of optical quality, may be introduced into the capsular bag or under the flap. It is possible that, due to the means used to measure the optical power of the cornea and the associated lens, it is desirable to remove the described stabilization means before the so-called "subtraction" procedure used to correct vision. Such procedures include LASIK and LASEK.

Figure 7A shows, for purposes of overview only, an epithelial delaminating device 300 having a yoke 302 and a wire 304. The line 304 provides a mechanism by which the epithelium may be mechanically separated from the cornea. The wire 304 may be vibrated in some manner.

The described vacuum stabilization device may further include a guide or addressing platform (addressing platform) that assists or limits movement (or provides addressing direction for such movement) of an ancillary device, such as an epithelial delaminating device or an ocular device inserter, when the stabilization device is used on an eye. The term "addressing" is used to indicate providing a stable set of coordinates in the described stabilization device, the eye, and any auxiliary devices. In one form, the guide is a rail configured to communicate with a portion of the auxiliary device. For example, the vacuum device can include a slotted guide rail disposed on a portion of the outer surface of the base member 102. The guide may be integral with the base region or may extend from the base region. In one form, the supplemental device (e.g., the delamination device) includes pins that can be fitted into the guide track area of the stabilization device and that guide the motion of the supplemental device relative to the eye. In one form, movement of the auxiliary device along the track may be adjusted by the stabilising device. For example, the guides (e.g., rails) may determine the "angle of approach" of the delamination apparatus, as well as the angle at which the delamination apparatus may appear. In some forms, the guide may be user adjustable or may be automatically adjustable.

Additional auxiliary devices (e.g., inserters) may use the same guide or a different guide on a single stabilization device. Thus, the eye can be delaminated in a controlled manner, the delaminating device can be removed, and an inserter can be used to place the ocular device under the already delaminated epithelium along the same path of the delaminating device in the same eye. In one form, the stabilization device includes separate guides for the delamination device and the inserter.

FIG. 7A shows a modification of the epithelial delaminating device that may be used with the described stabilization device. Figure 7B shows another variation 310 of the epithelial delaminating device having a vibrating or swinging wire 312 that can be used to form the capsular bag beneath the epithelium. Examples of suitable epithelial delamination devices are described in published PCT application WO 03/061518, the entire disclosure of which is incorporated by reference.

As described above, the stabilization device may also be configured to conform to a variety of different eye shapes or sizes. In some forms, the base region 102 also includes a "skirt" that is uniformly shaped. Figure 8 illustrates one form of device in which at least one of the annular eye-contacting surfaces (shown as outer radial surface 605) includes a skirt region 601 which is sufficiently flexible to conform to the shape of the eye surface, particularly under the action of the applied annular vacuum. The "skirt" region may allow for a larger contact surface between the device and the eye, helping to prevent loss of vacuum. In turn, the flexible skirt allows the device to be used with a wider range of eye shapes (e.g., irregularly shaped eyes) or sizes. Although the outer radial surface is shown with a skirt, the inner radial surface 610 may also include a skirt that is uniformly shaped.

The conformable skirt may comprise any material that is sufficiently flexible to fit over the surface of the eye and maintain a vacuum within the device. Examples of materials include elastomeric materials, rubbers, soft polymers, and the like. In one form, the skirt is integral with an annular region (e.g., an inner annular region or an outer annular region). In one form, the entire annular region may serve as a "skirt" that at least partially conforms to the surface shape of the eye under the applied vacuum.

The stabilization device may also include more than one "outer" annular region, thereby allowing use with a wide range of eye sizes. Figures 9A and 9B show views of additional devices in which an additional "intermediate" annular region 701 is included between inner annular region 705 and outer annular region 710. This intermediate annular region allows the device to conform to the shape of a narrower (or smaller) eye for which the outer annular region may be too large. For larger (or wider) eyes, initially, the middle annular region is not in contact with the eye, as shown in fig. 9A. In some forms, the intermediate annular region may also help support the device when a vacuum is applied. Figure 9B shows another form of device having an intermediate annular region 701 which also includes a flexible skirt. Figure 9B shows the device under vacuum wherein the intermediate annular region has sealed around the eye and the skirt region has conformed to a portion of the eye surface.

Furthermore, the described apparatus may be included in a system of a kit. In particular, a base member, optionally together with a vacuum forming device, and optionally together with an epithelial delamination tool, is exemplary of the described system or kit.

Claims (22)

1. A corneal stabilizing device configured to be placed on an eye, comprising:

(a) at least one outer radial surface adapted to contact the surface of the eye and cooperate with the inner radial surface to form a vacuum seal with the surface of the eye;

(b) an inner radial surface adapted to contact the surface of the eye by deformation of the eye, but which is not in contact with the eye at the time of initial placement;

(c) an annular vacuum volume formed on the rim by the inner and outer radial surfaces; and

(d) an aperture within the inner radial surface that allows the inner corneal surface to extend through the aperture when the stabilization device is in contact with the eye with the inner radial surface and at least one of the outer radial surfaces.

2. The apparatus of claim 1, further comprising a vacuum source.

3. The device of claim 1, further comprising a handle adapted to be manipulated by a user.

4. The device of claim 1, further comprising a guide configured to engage at least one auxiliary device.

5. The device of claim 1, wherein the auxiliary device comprises an epithelial delamination device.

6. The device of claim 1, further comprising a vacuum forming device configured to close the opening through which the cornea extends and thereby deform that eye such that the cornea extends or protrudes.

7. The device of claim 1, wherein said inner radial surface is positioned to be spaced apart from said eye when the outer radial surface is in contact with said eye without application of a vacuum.

8. The device of claim 7, wherein the inner radial surface is positioned to be spaced apart from the eye by a distance of 0.0625 inches +/-0.030 inches when the outer radial surface is in contact with the eye without the application of vacuum.

9. The device of claim 1 wherein said outer radial surface is at least partially compliant.

10. The device of claim 1 wherein said outer radial surface is substantially rigid.

11. The device of claim 1 wherein there is exactly one said outer radial surface.

12. The device of claim 1 wherein there is more than one of said outer radial surfaces.

13. A kit comprising a device according to any of claims 1-12 in combination with a vacuum forming device for closing the open area.

14. A kit comprising a device according to any of claims 1 to 12 and further comprising a lens.

15. A kit comprising a device according to any one of claims 1 to 12 and further comprising an epithelial delaminating device.

16. The device of claim 15, wherein the epithelial delamination device is adapted to form an epithelial flap.

17. The device of claim 15, wherein the epithelial delamination device is adapted to form an epithelial pocket.

18. A method for stabilizing the cornea of a selected eye comprising the steps of: a) providing a stabilization device selected from the devices of claims 1-12, b) applying a vacuum to the annular vacuum volume, and c) deforming the eye such that the inner radial surface contacts the eye and seals the stabilization device against the eye and stabilizes the cornea.

19. The method of claim 18, further comprising the step of separating at least a portion of the epithelium of the selected eye.

20. The method of claim 19, wherein the step of separating the epithelium includes forming a member selected from the group consisting of: a divided epithelium, an epithelial flap with a hinge, and an epithelial pocket with one or more openings.

21. The method of claim 20, further comprising the step of performing a subtractive procedure on the corneal surface and repositioning the epithelium on said surface.

22. The method of claim 20, further comprising the step of introducing a lens onto the corneal surface and covering the lens with separated epithelium.