JP2008539052A - Epithelial pocket expansion tool and epithelial delaminating device and corneal remodeler combination - Google Patents

Abstract

The described device is useful in the field of ophthalmology. The device and methods of using the device may separate or lift the corneal epithelium from the eye in a substantially continuous layer to form a flap or pocket. In particular, the device generally isolates the epithelium, especially in the region of lamina lucida, between the incision surface that naturally occurs in the eye, in particular between the epithelium and the corneal stroma (Bowman's membrane). Utilize a configured non-incision type separator or dissector. The dissector can oscillate during the separation. The separator or dissector also has a structure that expands the epithelial pocket after formation. Independently, the separator or dissector can also include structures that reshape the underlying cornea alone or in combination with various energy sources in the treatment of refractive surgery or other diseases.

Description

  The described device is useful in the field of ophthalmology. The device and method for using the device form a flap or pocket by separating or lifting the corneal epithelium from the eye in a substantially continuous layer. In particular, the device utilizes a non-cutting separator or dissector that is epithelial at the incision plane that occurs naturally in the eye, particularly between the epithelium and the corneal stroma (Bowman's membrane). And in particular in the region of lamina lucida. The dissector can oscillate during the separation. The separator or dissector can also have a structure that expands the epithelial pocket after formation. Independently, the separator or dissector can also include a structure that alone or in combination with various energy sources reshapes the underlying cornea in a refractive procedure or treats other illnesses. Then, after such a step, epithelial tissue members can be exchanged on the cornea or can be exchanged on the eyepiece after placement of the eyepiece on the eye.

  Refractive surgery refers to a set of surgical procedures that alter the eye's natural optical or focusing ability. These changes alleviate the need for glasses or contact lenses that individuals can rely on for clear visibility if they do not undergo the surgery. Most of the focusing ability in the human eye is defined by the curvature of the air-liquid interface, where there is a maximum change in refractive index. This curved interface is the outer surface of the cornea. The refractive power of this interface accounts for about 70% of the total magnification of the eye. The rays that make up the image we see pass through the cornea, the anterior chamber, the lens, and the vitreous humor before the rays are focused on the retina and form an image. It is this ability to focus the curved air-cornea interface that has provided the opportunity for surgical correction of visual defects in the field of refractive surgery.

  The first refractive surgery procedure corrected myopia by flattening the curvature of the cornea. The first successful procedure was called radial keratotomy (RK). RK was widely used in the 1970s and early 1980s, and in RK, a radially oriented incision was made around the cornea. These incisions allow the surrounding cornea to bend outwardly, resulting in a flattened central optical zone of the cornea. This was fairly easy and thus gained popularity, but rarely did more than reduce reliance on glasses or contact lenses.

  A highly flawed and failed treatment called epikeratofakia developed in the RK era. Epikeratofakia is now an essentially academic exception. Epikeratophakia provided a new curvature to the outer curvature of the cornea by implanting a thin layer of preserved corneal tissue over the cornea. Freeze-drying is a storage method used in epikeratophakia, in which the cornea is freeze-dried. The tissue is decellularized but is not considered non-viable. During the lyophilization process, the cornea is also shaved to a specific curvature.

  The epikeratophakia lens was surgically placed in the eye. An annular 360 ° incision was placed in the cornea after completely removing the epithelium from where the epikeratophakia lens was placed. The outer periphery of the lens is inserted into the annular incision and held in place by running the suture. There were some problems with epikeratofakia. These issues are: 1) The lens remains cloudy until the host matrix fibroblasts colonize the lens, which can take several months to colonize. 2) The interrupted epithelium is the starting point for infection until the moving epithelium can grow over the incision and onto the lens surface, and 3) the epithelium healing the surgical site is occasionally Moving to the space between the corneas. At present, epikeratofacia is limited in its use. Currently, the epikeratophakia is used for pediatric aphakic patients who cannot tolerate very steep contact lenses.

  A major industrial research effort has worked to produce synthetic versions of epikeratophakian grafts called synthetic onlays in synthetic epilens. Various synthetic polymers (hydroxyethyl methacrylate, polyethylene oxide, lidofilcon, polyvinyl alcohol) were used. The hydrogels of these materials usually did not have a surface that readily aids epithelial cells that grow and adhere on these composite surfaces. This was one of the major failures of the synthetic onlay. Epithelial cells failed to heal properly on these lenses.

  Another problem with these synthetic lenses is that they do not adhere well to the eye surface. Conventional suturing is difficult and the use of biological glue is also defective. The biocompatibility in the glue cornea was not ideal.

  Finally, the water permeability of these hydrogels was severely limited. It was difficult for epithelial cells that survived on the surface to obtain adequate nutrition. Corneal epithelial nutrient flow exits the epithelial cells from the aqueous humor through the cornea. Ultimately, industrial efforts failed to develop a suitable synthetic epikeratophakia lens.

  Laser-sharpened corneas, about the mid-1990s, were sufficiently successful that they began to replace radial keratotomy. The first generation of corneal laser ablation was called laser refractive keratotomy (PRK). In PRK, a stripping laser (eg, an excimer laser) is focused on the cornea to scrape a new curvature to the surface. In PRK, the epithelium is destroyed when it achieves a new outer surface curve. In the following days after surgery, the epithelium needs to grow or heal to its original location. This epithelial healing phase has been a problem for many patients. This is because the epithelium was deprived and the cut cornea had pain. Initially, it is also difficult to see and this “recovery time” can last from a few days to over a week.

  LASIK, a variant that follows PRK corneal laser ablation, has become very popular. The LASIK procedure, also known as laser corneal cutting, is also synonymous with laser vision correction in general memory. In LASIK, the outer part of the cornea (or the cord-like lens-shaped part) (80-150 micrometers thick) is cut from the corneal surface by surgery. This is done by a device called a microkeratome. A microkeratome is a device that cuts a circular flap from the surface of the cornea. This flap remains hinged at one edge. This flap is flipped and an ablation (excimer) laser is used to remove or reshape a portion of the exposed surgical foundation. The flap is returned to its original position. When this flap is returned to its original position, the cornea gains a new curvature. This is because the flap coincides with the laser modified surface. In this procedure, epithelial cells are not removed or damaged. The epithelial cells can simply be cut at the edge of this flap. When the flap is placed back on the corneal foundation, the epithelium heals the cut site. In essence, there is no recovery time and the result is almost immediate. LASIK is now considered the first method of performing refractive surgery because of its very short surgical time (15 minutes per eye), persistence, and very accurate results.

  The newest technique is evaluated in high-volume refractive surgery, and in some academic centers, is a procedure called Laser-Assisted Subepithelial Keratomileesis (LASEK). In LASEK, a “flap” consists only of the epithelium. This layer of epithelium is lifted from the cornea in a manner similar to LASIK. The ablation laser is just focused on the exposed cornea surface (in the same way as done with PRK). However, this epithelial flap remains intact. That is, the epithelium is not destroyed. The epithelium is simply rolled back to its original position after formation of the anterior portion bent behind the cornea, resulting in a much less recovery time compared to PRK. The current method of LASEK is not as good as LASIK, but the result is better than PRK.

  The corneal epithelium is a multilayered epithelial structure typically about 50 μm thick. The corneal epithelium is not keratinized. The outer cells survive, but the cells are essentially flat. Basal epithelial cells are cubic and are on the surface of a structural substrate known as the Bowman membrane. The basal cell layer is typically about 1 mil (0.001 ″) thick. The basal cells produce the same keratin as the keratin produced in the outer skin, ie the skin. It expresses 5 and keratin 14 and has the potential to differentiate into squamous epithelial cells of the corneal epithelium, which produce keratin 6 and keratin 9. The corneal epithelium has several important properties. The properties are: 1) the corneal epithelium is transparent; 2) the corneal epithelium is impermeable; 3) the corneal epithelium is a barrier to external agents; 4) the corneal epithelium is highly innervated tissue This nerve defect causes pain because nerves from the cornea are sent directly to the epithelium.

  Epithelial cells are attached laterally by transmembrane molecules called adhesion plaques. Another transmembrane protein, semi-adhesive plaque, is connected to type 7 collagen and is present on the basal outer surface of basal epithelial cells. Semi-adhesive plaques anchor the epithelium to the collagen portion of the underlying matrix. The connection between the epithelium and the corneal stroma is called the basement membrane zone (BMZ).

  When LATEK is performed, a physical wall is placed or formed on the epithelium and filled by selection of 20% ethanol and a stable salt solution. Contact with the solution most likely causes the epithelial cells to lose adhesion of the epithelial cells to the BMZ by destroying a portion of the cell population. The epithelium is then lifted by pushing the epithelium in a manner similar to peeling a painted wall using, for example, a Weck sponge. The exposed collagenous portion of the corneal stroma is then stripped to reshape its surface. The weakened epithelium is then rolled back to its original position and serves as a bandage. However, this “bandage” fails to restore the epithelium to its original state. That is, a “bandage” does not preserve epithelial integrity and therefore reduces its transparency, water impermeability, and barrier function. In addition, the ability of the epithelium to adhere to the corneal stroma is impaired.

  U.S. Patent Nos. 5,057,028 and 2,028 to Klopotek describe a microkeratome device and a method of cutting the corneal epithelial layer and preparing it for the LASIK or other remodeling procedure. When replaced, the epithelium is attached using surgical techniques.

  The cited references do not indicate or suggest the device described by the inventor.

US Pat. No. 6,099,541 US Pat. No. 6,030,398

  The description includes a mechanical non-cutting device and a method for forming a separation of the epithelium from the eye or a method for lifting a generally continuous layer of epithelium from the underlying supporting structure. Epithelial delaminators are used to generate epithelial flaps or pockets. The flaps or pockets can be used with refractive surgery or refractive lens placement.

  The epithelial delaminator can be mechanical in nature. Such mechanical delaminators lift the epithelium from the anterior surface of the eye in a generally continuous layer by application of an incision, non-cutting, mechanical force. Mechanical delaminators include, among other things, non-pointed dissectors and wire-based dissectors with wires that are passive or active when applied to the eye.

  In addition, the devices and methods described can be used in various ways to form epithelial tissue members such as pockets or flaps, and to reshape the underlying corneal surface without removing the device, In preparation for such a reshape or reform procedure, the cornea reduces epithelialization, forms a pocket for contact lens insertion, or as desired Extend the pocket formed.

  For any epidermal surface such as skin, respiratory epithelium, visceral epithelium and cornea, there is an epithelial cell layer attached to the underlying basement membrane. When the epithelium is separated from its basement membrane and underlying collagen tissue, subepithelial vesicles are formed. Usually, a total separation less than 1 mm in diameter is known as vesicle formation, and a separation greater than 1 mm in diameter is known as a true vesicle.

  A continuous layer of corneal epithelium is applied by applying various mechanical forces to the front of the eye, or to the basal cell layer, or between the basal cell layer and the Bowman layer or Bowman membrane ("lamina lucida"). It can be separated from the front of the eye or lifted. As used herein, the term “continuous” means “not interrupted”. As used herein, the term “mechanical force” refers to any physical force generated by a person, instrument or device. Examples of mechanical forces include suction forces, shear forces and blunt forces.

  A mechanical force is applied to the epithelium, such as the corneal epithelium, by the epithelial delaminator. As used herein, the term “epithelial delaminator” refers to any instrument or device that separates the epithelium from the basement membrane by applying mechanical force. The epithelium can also be separated or lifted from the front of the eye by contacting the front of the eye with a chemical composition that leads to separation of the epithelium from the underlying matrix.

(Combination of disector and corneal remodeling device)
1A-1D generally illustrate a process for using a combination of the described disector and corneal remodeling device.

  FIG. 1A provides access to a side view (200) of the eye and a disector-corneal remodeler combination (202) as described below. When the tip edge (204) and other suitable edges of the combined dissector (202) pass along the axis to the corneal surface after penetrating the epithelium, the epithelium is not cut or the front of the cornea, ie Bowman It is configured to be blunt enough to remove tissue from the membrane. The disector-reformer (202) can vibrate side to side or axially as desired by the designer. Generally, the device provides an epithelial tissue membrane that remains attached to the cornea, possibly in the form of a pocket, at at least a portion of the separated epithelial tissue edge.

  FIG. 1B shows in cross section the dissector's body (208) placement under the epithelium (210), and in this variation forms a pocket-shaped epithelial tissue member (206).

  FIG. 1C shows a blade body (208) placed over an eye having an opening (200) to an epithelial pocket or epithelial tissue member (206) with the disector-corneal remodeler combination still in place. Show.

  With the disector-corneal reformer (202) arranged in FIG. 1C, the device can be used to apply energy to the corneal surface to reshape its shape in a very special way. Appropriate device variations for such changes in the shape of the corneal surface are discussed below. Alternatively, if the device is a suitable device for expansion of the epithelial pocket (206), the expansion step can occur simultaneously. Variations that extend the inventors' devices are also found below.

  FIG. 1D shows the step of pulling the combination device (202) out of the eye (200), whatever the practiced steps left. The epithelial member (206) closes over the eye and by its nature provides some healing for the cornea.

  2A-2E illustrate one variation of a combined disector and corneal remodeling device.

  FIG. 2A shows a perspective view of a generalized version of a combination device (220) having a blade body (222) and a blade edge (224). Further, the blades can vibrate from side to side, or axially, or any combination of the two directions. The edge (224) is also sharp enough because the edge (224) first penetrates the epithelial layer of the eye but does not cut tissue from the underlying cornea.

  FIG. 2B shows the device shown in FIG. 2A in cross section. Visible on the corneal side (226) of the disector body (222) are several or arrays of energy emission points (228) (which are better seen in the bottom view (FIG. 2D)).

  These energy release sites (228) can be of any type. For example, the site can be a laser diode (eg, a laser diode as manufactured by Tyco Electronics, Laser Diode Incorporated, Sanyo or Sony), resulting in remodeling with or near corneal collagen or corneal tissue. In the described or desired site arrangement of the diodes in the device to the radiation of the wavelength interacting with the dye introduced to generate or provide sufficient heat Can be selected.

  The reshaping light source may alternatively be located away from the light directed to the exit point (228) via the blade body (222) and the optical fiber. An energy conduit (230) is shown in support (232). As shown in the cross section of support (232), conduit (230) is electrically conductive when the energy source is a light emitting source or a thermal resistance source and is located within blade body (222). Wire or ribbon, or essentially optical fiber if the energy source is remote from the blade body (222). In fact, energy conduits can be fluid in nature, and the path of heated, cooled or reactive fluids allows the passage of those fluids to the eye surface. .

  FIG. 2C shows a top view of the device shown in FIG. 2A.

  3A and 3B show one variation of the inventor's combination device in which the laser diode (228) is mounted on the blade body (222), in particular the blade is located below the epithelium. Sometimes light is emitted from the side (229) of the blade body (222) proximate the epithelium. The laser emitting diode (228) emits directly from the position of the diode, illuminates directly on the cornea and directly hits the cornea for remodeling of the cornea. Opaque fluids or fluids containing heat-absorbing and heat-conducting materials, such as slurries of biocompatible metals such as platinum or gold small particles, can absorb light and heat during use. Can be guided to the lower eye of the blade body to enhance the conversion. In this variation, the energy conduit (232) is simply an electrical conductor that powers the diode (228).

  It should be clear that once a correction to the eye that is needed is determined, the series number and position of the diodes that are activated is a routine decision. The diodes can be turned on independently for proper modification as needed. They can be lit continuously in some positions more than others, thereby achieving the desired correction, for example for various eye abnormalities, e.g. myopia, astigmatism or even presbyopia . Furthermore, depending on the nature of the energy source selected, this arrangement generates light for corneal remodeling or heat for corneal remodeling or heat for corneal remodeling. Can be used either for light.

  FIG. 4 shows a variation of the inventor's described device (230), in which the laser diode (232) is placed behind a light-absorbing thermally conductive member (234). In the variation shown in FIG. 4, the conductor (234) may be substantially continuous in an area intended to cover a particular area of the cornea that the user desires to reshape. In this variation, the member selected from the laser diode integration is activated and provides light to the conductor (234). The absorber-conductor (234) absorbs light and is thereby heated in the region of the diode. Apparently, the warmed or heated region of the conductor (234) then heats the cornea for re-formation of adjacent corneal tissue. The device operates similarly when the light source is located remotely and energy is directed onto the conductor (234) via the optical fiber.

  FIG. 5 provides a cross section of the blade body (240) similar in design and construction to that seen in FIG. In this variation, the conductor (larger (242), smaller (244)) is heated by the laser diode (232). 6 and 7 show two variations of the design found in FIG. As shown in FIGS. 6 and 7, these separate absorber-conductors (244, 246) are various suitable for the user to treat the cornea to modify vision as desired. Can be positioned or arranged in the blade body in a simple pattern. Further, the pattern can be selected to treat a particular type of eye abnormality, or the pattern can be selected while the application of heat is while the disector body is in contact with the cornea and under the epithelium. Or it can be generalized so that it can be recognized. In other words, myopia can be treated by heating only the corneal region around the cornea. The size of the various absorber-conductors (244, 246) and their separation depends only on the need for isolation of the various individual absorber-conductors from each other and the size of the corneal region to be treated. Can be provided by a skilled designer. Furthermore, materials with high absorbency and high thermal conductivity are quite suitable. A trouble-free choice for such material candidates includes members of the noble metals of the Mendeleev table, such as platinum, rhodium, etc. and gold and various alloys of these materials. The absorption of the absorber-conductor can of course be adjusted by surface treatment, for example by painting a surface that is otherwise a reflective surface, in order to enhance the absorption of light.

  8A, 8B and 8C provide a depiction of another variation of the disector-corneal remodeler combination. In this variation, the device utilizes radio frequency (RF) to achieve corneal remodeling or modification. Essential to understanding this variant is the knowledge that there are two cooperating devices. One is an RF transmitter provided out of the eye, and the other device, the dissector, receives one or more susceptors or RF receivers or RF and is heated locally during reception. Includes members of an "antenna array". The heated susceptor is heated by RF, and the heat is conducted to the front surface of the reshaped cornea.

  FIG. 8A shows the arrangement of various components in use. FIG. 8A is a cross section of various components. The front region (300) of the eye with its various layered components is depicted. A dissector blade body (304) having various individual energy receiving areas or susceptors (306) is also shown. Each of these susceptors (306) is made of a material such as a ferromagnetic metal or alloy that becomes heated, for example, when placed at a site for receiving RF. The material can be moderately heated or controlled by mixing with other materials such as, for example, phase change materials such as paraffin or salts that are designed to absorb significant heat at a particular temperature. Can be selected and engineered in such a way as to provide an increase in temperature, or physically to provide a smooth temperature gradient across the device by granulation and mixing of crystalline particulate materials each having a different melting point Can be processed. Where separation of effects on the cornea is desired, it may be preferable to thermally separate each separated member from the neighboring members. Similarly, separation of the RF radiation region on the antenna wand (310) (FIGS. 8A and 8C) may be preferred.

  Referring to FIG. 8A, an antenna component (310) having a plurality of separate antenna sections (312) is shown to be outside the epithelium (314). A dissector with an RF receiving element or susceptor (306) is shown to be placed between the epithelium (314) and the cornea (300).

  In operation, this variation can operate in the following manner. The mode is that one separate antenna, eg (310a), is activated and begins transmitting RF. Due to its relative proximity, the susceptor (306a) is heated. Heat from the susceptor (306a) is induced near the cornea, causing the region (316) to contract, thereby further modifying the shape of the cornea and changing its refractive properties. As in LASIK or LASEK or PRK, careful planning of the light and heat load on the cornea changes the refractive properties of the corneal rim for the purpose of improving eye visibility.

  FIG. 9A shows another partial cross-section of a blade body (350) having an integrated separated RF radiating member combined with a separated susceptor (354) in the same body (350).

  FIG. 9B shows another variation of the blade body (360) that utilizes an RF emitter (362) that passes RF energy directly to the cornea for reshaping. Each of the RF radiation regions in each of these variations can either radiate RF energy independently, or can be used in harmony or in both spatial and temporal patterns to achieve the desired refraction in the cornea. Achieve rate change.

  FIG. 10 shows another variation in which the blade body (370) is provided with a separate electrically resistive heating element (372). In this variation, each single addressable lead (374) goes to a resistive heating element (372). The return line for the current occurs through the common bus (376).

  In a similar concept, FIG. 11 depicts a blade body (380) having several resistive heating elements (372), where each element is in close proximity to a thermal conductor (374) and heat The conductor (374) makes it possible to concentrate or diffuse the application of heat to the adjacent cornea.

  In summary, a generic combination device is here capable of separating the epithelium from the cornea and providing or performing refractive surgery prior to withdrawing the device from beneath the epithelial tissue. It is a device that can.

(Epithelial tissue member expansion device)
In some examples, the volume of the epithelial tissue member or pocket that is formed is not sufficient to allow the introduction of other treatment devices into the pocket. Some types of larger devices may simply be needed.

  FIG. 12A provides a general depiction of the functionality of the device. Generally, the dilator (400) includes a non-pointed tip (402) that allows the epithelium to be separated from the cornea without penetrating the epithelium and without cutting the corneal tissue. Further, the blade body region (404) is at least partially expandable, as shown by arrow (406) in FIG. 12B. This movement can be caused by hydraulic actuation, electrical movement (heating of the motor or preformed shape memory Nitinol member) or other power actuators.

  FIG. 13A shows one of the variants comprising an inflatable balloon (408) located in an internal space between two members: a movable epithelial member (410) and a stationary corneal member (412). (406) is shown.

  FIG. 13B provides a cross-sectional side view of the blade body (406) with the inner balloon (408) expanded.

  FIG. 14A shows a similar deformation (430) in which the inflatable balloon (432) contacts the epithelium during introduction of the blade body (430) and subsequent expansion thereof. FIG. 14B shows an expanded balloon (432). Constructing a balloon from NYLON or TEFLON®, which is not required, but made of a hard and slippery material, for example, a type often used for cardiovascular balloons of constant diameter, offers several advantages Can do.

  Finally, FIGS. 15A and 15B show a cross-sectional view of another variation (440) in which the epithelial surface of the blade body (442) is as in the case shown in FIGS. 12A-14B. It extends from the center rather than through the leading hinge. FIG. 15A shows the blade (440) before expansion, and FIG. 15B shows the blade (440) after expansion.

1A-1D show a schematic version of the outlined method using the generic device described herein. 2A-2E show various directional views and cross-sectional views of a combination device for forming an epithelial tissue member and re-forming the cornea under the member. FIG. 3A shows a cross-section of a combined corneal remodeling device in a schematic arrangement of laser emission sites. FIG. 3B shows a bottom view of the device of FIG. 3A. FIG. 4 shows a cross section of a corneal remodeling device utilizing a laser and a heat absorbing contact layer and a heat conducting contact layer. FIG. 5 shows a device similar to FIG. 4, but instead includes a separate heat conducting member. FIG. 6 depicts an example of the formation of a separate heat transfer site suitable for use with the variation shown in FIG. FIG. 7 depicts an example of the formation of a separate heat transfer site suitable for use with the variation shown in FIG. FIG. 8A depicts an RF device in which the dissector (shown in FIG. 8B) cooperates with several RF receivers that are heated during RF application and a receiver located above the dissector. A selectable RF transmitter for dynamic heating. The antenna source is shown in the bottom view of FIG. 8C. 9A and 9B show a further variation of the combined RF source dissector. FIG. 10 shows a combined dissector that includes several heat sources. FIG. 11 shows a side cross-sectional view of a device similar to FIG. 10, but with a further isolated thermal conduction site. 12A and 12B provide a side view of a dissector configured to form and expand an epithelial pocket. FIGS. 13A and 13B show cross-sectional views of a dissector as found in FIGS. 12A and 12B with hinged rotating members. 14A and 14B show side cross-sectional views of a dissector having a member that is expandable by hydraulic pressure. 15A and 15B show side cross-sectional views of an expandable disector that extends in the middle of the device.

Claims (19)

A device for opening and expanding an epithelial pocket,
An edge providing an opening in the epithelium, separating at least a portion of the epithelium from the cornea without cutting the cornea;
A first surface located adjacent to the epithelium and a second surface located adjacent to the cornea when the edge has already separated the epithelium from the cornea, The surface and the second surface comprise a first surface and a second surface that are movable away from each other after first separating at least a portion of the epithelium from the cornea; device.   The device of claim 1, further comprising an actuator configured to move the first surface from the second surface.   The device of claim 2, wherein the actuator comprises an inflatable balloon.   The device of claim 2, wherein the actuator comprises the first surface, the second surface, or the first surface and the second surface.   The device of claim 2, wherein the actuator is disposed by hydraulic pressure.   The device of claim 2, wherein the actuator is electrically actuated.   The device of claim 2, wherein the actuator is mechanically actuated.   The device of claim 1, wherein at least one of the first surface, second surface or edge is at least partially smooth. A corneal remodeling device that changes the shape of the cornea on an eye having a cornea and an epithelium,
Configured to provide an opening in the epithelium and further configured to separate at least a portion of the epithelium from the cornea and form an epithelial tissue member without severing the cornea Edge,
A corneal reshaper member configured to reshape the cornea adjacent to the cornea and at least partially positioned under the separated epithelial tissue member.   The device of claim 9, wherein the cornea remodeler comprises one or more light sources.   The device of claim 9, wherein the corneal remodeler comprises one or more heat sources.   The device of claim 9, wherein the cornea reformer comprises one or more heat sources and one or more light sources.   The cornea remodeler is positionable adjacent to the cornea during remodeling and is configured to increase the temperature during remodeling to reshape the cornea The device according to claim 9, comprising the above energy absorbing conductive member.   The cornea remodeler is positionable adjacent to the cornea during remodeling and is configured to absorb light and increase temperature during reshaping to reshape the cornea 11. The device of claim 10, comprising one or more energy absorbing conductive members that are attached.   The cornea remodeler is positionable adjacent to the cornea during remodeling and is configured to absorb heat and increase temperature during remodeling to reshape the cornea The device of claim 11, comprising one or more energy absorbing conductive members.   The cornea remodeler can be positioned adjacent to the cornea during remodeling and absorbs heat and light and increases the temperature during remodeling to reshape the cornea 13. The device of claim 12, comprising one or more energy absorbing conductive members configured in   The cornea remodeler further comprises one or more fluid sources and is configured to absorb light and heat and increase the temperature during remodeling to reshape the cornea. Item 10. The device according to Item 9.   The cornea remodeler can be positioned adjacent to the cornea during remodeling and absorbs RF energy from an RF energy source during remodeling and reshapes the cornea 10. The device of claim 9, comprising one or more RF susceptors that are configured to increase the temperature during.   19. The RF energy source configured to cooperatively direct RF energy to one or more RF susceptors of the cornea reformer to reshape the cornea. Devices.

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