JP2008539033A - Epithelial stripping device (V) and blade useful in the device - Google Patents

Abstract

The described device is useful in the field of ophthalmology. Blades, devices, and methods of their use involve separation or lifting of the corneal epithelium from a substantially continuous layer of the eye to form an epithelial tissue that normally remains attached to the cornea. The epithelial tissue is often in the shape of a flap or pocket. Specifically, the device, for example, structurally and lubricates the epithelium between the natural cut surface of the eye, specifically the epithelium that is specifically separated at the transparent layer portion and the corneal stroma (Bomann membrane). A non-corneal oscillating blade that functions as a separating or cutting instrument configured to separate is used.

Description

  The described device is useful in the field of ophthalmology. Blades, devices, and methods of their use involve separation or lifting of the corneal epithelium from a substantially continuous layer of the eye to form an epithelial tissue that normally remains attached to the cornea. The epithelial tissue is often in the shape of a flap or pocket. Specifically, the device, for example, structurally and lubricates the epithelium between the natural cut surface of the eye, specifically the epithelium that is specifically separated at the transparent layer portion and the corneal stroma (Bomann membrane). A non-corneal oscillating blade that functions as a separating or cutting instrument configured to separate is used. The blade may be blunt and have an opening away from the dissector edge to provide a low frictional force against the separated epithelium. The blade first forms a sharp enough edge to cut the epithelium, then electropolished that edge, and a substantially dull edge suitable for separating the epithelium from the cornea without cutting the cornea You may have a blunt dissector that can be created by The blade may be at least partially covered by one or more lubricating materials, desirably on the surface that will be in close proximity to the epithelium during use. The separated epithelium may be lifted off the surface of the eye or detached to form an epithelial flap or pocket. The epithelium may subsequently be returned on the cornea after refraction treatment or may be returned on the intraocular lens after placement of the intraocular lens in the eye.

  Refractive surgery refers to a series of surgical procedures that alter the visual acuity or focusing power of the natural eye. These changes reduce the need for glasses or contact lenses that an individual may otherwise rely on to obtain a clear vision. Most of the focusing power in the human eye is determined by the curvature of the gas-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 light that creates the image we see passes through the cornea, the anterior chamber, the lens, and the vitreous humor before focusing on the retina to form an image. It is this ability to expand the curved air-cornea interface that has provided an opportunity in the field of refractive surgery to surgically correct vision defects.

  Early refractive surgery procedures corrected myopia by flattening the curvature of the cornea. The first highly successful treatment was named radial keratotomy (RK). In RK, radially oriented incisions were made around the cornea, which were widely used in the 1970s and early 1980s. These incisions allowed the outward curvature of the peripheral cornea, thereby flattening the central optical area of the cornea. This was very easy and was therefore popular, but it rarely worked beyond reducing the dependence on eyeglasses or contact lenses.

  A treatment that had great deficiencies and was unsuccessful, superficial corneal transplantation, was developed during the RK era. This is now a fundamentally impractical exception. Superficial corneal transplantation gave a new curvature to the curvature outside the cornea by implanting a thin layer of preserved corneal tissue in the cornea. Lyophilization is a preservation method used in superficial corneal transplantation in which the cornea is lyophilized. The tissue is not acellularized, but is non-living. During the lyophilization process, the cornea is also shaved to a specific curvature.

  The lens of the superficial keratoplasty is surgically placed in the eye. An annular 360 ° incision is provided in the cornea after complete removal of the epithelium from where the superficial corneal transplant lens is placed. The periphery of this lens is inserted into an annular incision and maintained in place by continuous stitching. There were several problems with superficial corneal transplantation. 1) The lens remained cloudy until host stromal fibroblasts established the lens, which could take several months 2) The transitional epithelium was on the surface of the lens above the incision site The split epithelium was the site of infection until it could grow into 3), and the epithelium that recovered on the surgical site could migrate to the gap between the lens and the host cornea. Currently, superficial corneal transplantation has limited uses. Today it is used in pediatric aphakic patients who cannot tolerate very strong contact lenses.

  A large-scale industrial research effort attempted to produce an artificial superficial corneal transplant graft called an artificial onlay in an artificial epilens. Other synthetic polymers have also been used (hydroxyethyl methacrylate, polyethylene oxide, lidofilcon, polyvinyl alcohol). Hydrogels of these materials usually did not have a surface that immediately promotes epithelial cells that grow and settle onto these artificial surfaces. This was one of the main factors hindering artificial onlays. Epithelial cells could not fully recover on these lenses.

  Another problem with these artificial lenses was that they did not stick well to the eye surface. Conventional suturing is difficult and there is a problem with the use of biological glue. The glue was not ideally biocompatible in the cornea.

  Finally, the permeability of these hydrogels is quite limited. Surface live epithelial cells were difficult to obtain adequate nutrition. The nutrient flow of the corneal epithelium passes from the aqueous humor through the cornea and out of the epithelial cells. In the end, industrial efforts failed to develop a suitable artificial surface corneal transplant lens.

  Around the mid-1990s, the procedure of shaping the cornea with a laser was successful enough to replace radial keratotomy. The first generation of laser ablation was termed optical keratotomy (PRK). In PRK, an ablation laser (such as an excimer laser) focuses on the cornea and forms a new curvature on the surface. In PRK, the epithelium is destroyed when a new outer curved surface is obtained. Over the days after surgery, the epithelium grows or recovers and returns to place. This epithelial recovery period was mostly problematic for patients because the cornea, which had been detached and removed, was painful. It is also difficult to see early and this “recovery period” can range from a few days to over a week.

  LASIK, a subsequent modification of PRK corneal laser ablation, has become very common. LASIK, also known as laser in situ corneal curvature, is synonymous with laser vision correction. In LASIK, the outer part of the cornea (tendon-like lens part) (thickness 80-150 microns) is surgically cut from the corneal surface. This is performed by a device called a microkeratome. A microkeratome is a device that cuts out a circular flap that remains hinged at one end from the corneal surface. The flap is folded and an ablation (excimer) laser is used to remove or improve a portion of the exposed surgical site. The flap is brought down to a predetermined position. When this flap is tilted into place, the cornea achieves a new curvature because the flap matches the laser modified surface. This treatment does not remove or damage the epithelial cells. The epithelial cells were simply incised at the end of this flap. When the flap is returned onto the corneal bed, the epithelium recovers at the original incision site. There is basically no recovery period and results are almost immediate. LASLK is now the primary method of performing refractive surgery because of the very short surgery time (15 minutes per eye) and the very accurate results that continue.

  The latest technique that has been evaluated in the practice of numerous refractive operations and in several academic centers is a procedure called laser subepithelial refractive surgery (LASEK). In LASEK, “flaps” are made only from the epithelium. This layer of epithelium is lifted from the cornea in a manner similar to LASIK. The ablation laser is focused only on the surface of the detached cornea (similar method as done with PRK). However, this epithelial flap remains intact, ie the epithelium is not destroyed. This is simply pushed back into place after the formation of the curved anterior cornea, resulting in a much shorter recovery period than PRK. The current method of LASEK is not as good as LASIK, but the results are better than PRK.

  The corneal epithelium is a multi-layered epithelial structure, usually about 50 μm thick. This is not keratogenic. The outer cells are alive, but are essentially flat. Epithelial basal cells are cubic and are located on a structural substrate surface known as the Bowman membrane. The basal cell layer is usually about 1 mil (0.001 ″) thick. The basal cells produce keratin as they are produced in the outer skin such as skin. Epithelial basal cells express keratins 5 and 14. And has the ability to differentiate into squamous epithelial cells of the corneal epithelium that produce keratins 6 and 9. The corneal epithelium has a number of important features: 1) transparent, 2) impermeable, 3 4) A nerve-distributed organ, which is a barrier to external substances, and nerves from the cornea directly enter the epithelium, so this organ failure causes pain.

  Epithelial cells are attached to each other by transmembrane molecules called desmosomes. Another transmembrane protein, hemidesmosome, is linked to type 7 collagen and is present on the basolateral surface of epithelial basal cells. The hemidesmosome anchors the epithelium to the collagenous portion of the underlying matrix. The junction between the epithelium and the corneal stroma is called the basement membrane region (BMZ).

  When LASEK is performed, physical holes are placed or formed in the epithelium and filled with a selection from 20 percent ethanol and balanced salt solution. Contact with the solution loses the adhesion of epithelial cells in the BMZ, most often by destroying part of the cell population. The epithelium is then pushed up with, for example, a Weck sponge to remove the paint on the wall. The exposed collagenous portion of the corneal stroma is then removed to reshape its surface. The weakened epithelium is put back in place and acts as a bandage. However, this “bandage” does not return the epithelium to its original state, ie, does not maintain the integrity of the epithelium, thus reducing its transparency, water impermeability, and barrier function. Furthermore, the ability to adhere to the epithelial corneal stroma is impaired.

  U.S. Patent Nos. 5,099,028 and 5,037,094 to Klopotek describe a method of cutting a corneal epithelial layer to prepare an eye for a microkeratome device and LASIK or other remodeling procedure. If the epithelium is returned, it is attached using surgical techniques.

  All references cited do not illustrate or suggest the invention described herein.

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

  The description is a blunt, separating, or dissecting instrument that is dull enough to not cut the corneal matrix (such as Bowman's layer) but passes through the epithelium along the epidermal surface without cutting the cornea. Including. The non-cutting blade forms an epithelial tissue section generally in at least one end connected to the cornea, possibly as a flap or pocket, in the form of a substantially continuous layer of epithelium separated or lifted from its supporting substructure. The formed epithelial tissue part may be used in combination with refractive surgery or the installation of a refractive lens.

  The blade may have an opening in the blade body that reduces friction between the blade body and the epithelium or cornea when forming the epithelial tissue section or when pulled back after formation of the element. The blade may additionally or alternatively have an edge originally formed by electropolishing a sharp edge.

  The epithelial stripping device may comprise one or more lubricating materials on the surface of the stripping device that contacts the epithelium at least during the delamination and retrieval steps.

  The stripping blade may comprise a composite blade that is also configured to receive an optical device, such as a lens, for implantation during the procedure.

  Epithelial stripping devices including these blades are inherently mechanical separation instruments. These are mechanical ablation devices that may normally vibrate or vibrate the blade and provide translational movement of the blade during formation of the epithelial tissue.

  Furthermore, the methods of the present invention may be used in a variety of ways to remove the corneal epithelium in preparation for a remodeling procedure such as LASEK or for the formation of a pocket for encapsulating a contact lens.

  FIG. 1 shows one version of a corneal epithelial insertion / exfoliation blade 8. The blade 10 includes a main body 12. As shown in FIG. 1, the body 12 has a first surface 14, a first end 16, and a second end 18. Again, when used in conjunction with a cutting device used to place an implant or lens on the surface of an epithelial removal cornea ("anlay") rather than below the surface of the cornea, An effective “cutting” ability of the body 12 may be described as being able to penetrate the epithelium, separate the epithelium from the Bowman membrane, and form a pocket opening. Usually, the contour or shape of the tip edge, blunting of the body or “lack of sharpness” determines its functional parameters, but it need not be the sole determinant of its capabilities. For example, the motion applied to the body 10 may be selected to enhance or reduce the scope of the device's “cut” function associated with the various components of the eye. When this device is used to ultimately penetrate the Bowman layer to place an inlay-type implant, the effective “cutting” capability of the device is significantly enhanced.

  In connection with the figures and only when the cutting system penetrates the epithelium and is used to separate it from the cornea, it will be understood that the first surface 14 is the back or bottom or back of the body 12. It's okay. This first or back surface 14 faces the patient or cornea during use. Further, the first or distal end 16 may be understood to be the distal end of the body 12, and the second end 18 may be understood to be the proximal end of the body 12. The distal end 16 first contacts the eye surface during the surgical procedure.

  The blade 10 may include a plurality of openings 20 located at the distal end 22 of the body 12. As described in detail herein, the opening 20 may be understood to be a port, such as a vacuum and / or fluid supply port. The opening 20 may extend through the body 12 from the first surface 14 to the opposing second surface 30 (shown in FIG. 3). Although the openings 20 are illustrated arranged in two concentric circles, other cutting devices may have more or fewer openings arranged in other configurations.

  As shown, the groove 24 extends through an extension of the body 12 and provides a fluid supply path to the opening 20. As shown in FIG. 1, the groove 24 extends from the distal end 22 to the proximal end 18 where the groove 24 terminates at a port 26. Port 26 may be understood to be a vacuum or exhaust fluid port or a cooling fluid port. Obviously, one or more grooves such as groove 24 may be used.

  2 shows the face of the blade 10 similar to FIG. 1, but with a cover 28 defined on the groove 24 (not shown) and in this form covers the various openings 20 seen in FIG. ing. A cover 28 is placed over the groove 24 to effectively seal the groove 24 so that a vacuum can be created near the opening 20 as seen on the opposite side (30 in FIG. 3). For example, a vacuum device or suction source may be connected to port 26 to create a vacuum in groove 24 and distal end 22. Although the cover 28 is illustrated as a separate element attached to the body, such groove or grooves may be integrated or formed in such an extension 13 during the production of the blade 10, for example by drilling or injection. . In such a configuration, a cover would not be required because the groove may be a perforation or lumen through the body extension 13.

  FIG. 3 shows an upper or second surface 30 having a corneal onlay 32 in preparation for subepithelial implantation. In the form shown, vacuum, negative pressure, or reduced pressure relative to atmospheric pressure is provided, and the corneal onlay 32 is held on the blade 12 while passing through the corneal epithelium and to the installation site separating from the Bowman layer. As shown in FIG. 3, the body 12 has a second surface 30 that can be understood to be the top, front, or front of the blade 12. The corneal onlay 32 is illustrated as being held on the second surface 30.

  In the other form shown here, the corneal onlay 32 is held on the first or bottom surface 14, ie, the corneal proximate surface, during the delamination step.

  The corneal onlay 32 is shown located at the distal end 22 of the blade 12. In this illustrated form, the distal end 22 has a maximum diameter that is slightly larger than the maximum diameter of the corneal onlay. For example, the maximum diameter of the distal end 22 may be about 1% to about 30% larger than the maximum diameter of the corneal onlay 32. In this configuration, the maximum diameter or width of the distal end 22 is substantially similar to the maximum diameter of the corneal onlay so that the maximum diameter or width of the pocket opening substantially matches the maximum diameter of the corneal onlay. To do. This sizing results in a reduction in onlay movement or dispersion within the pocket.

  FIG. 4A shows a side view of the distal end 22 of the body 12. The distal end 22 includes a beveled edge 34 that extends around the onlay support 35. For example, the distal end includes a chamfered edge surface 34 that extends around the side of the distal end 22 and the distal end 18, and an inclined edge surface 36 that extends around the proximal portion of the onlay 32. In the form shown in FIG. 4A, the chamfered edge surface 34 terminates at a close distance from the first surface 14. This distance from the outermost end of the chamfered surface 34 to the first surface 14 is reflected in the surface 38. The inclined edge surface 36 holds the corneal onlay in place at the distal end 22 of the blade 10 during the implantation procedure. The inclined edge 36 also serves to reduce the operation of the corneal onlay 32 if the vacuum pressure is disturbed or insufficient to hold the onlay.

  FIG. 4B shows a cross-sectional side view of the distal end 22 shown in FIG. 4A. The positioning of the onlay 32 on the onlay support 35 is clearly shown. The relationship between the vacuum / fluid opening / fluid / cooling fluid access hole 20 and their onlay 32 is apparent from the drawings. The position of the sealing plate 28 is also shown. Optional chamfer 29 is shown supporting sealing plate 28. Also shown is a lubricating layer 31 which will be described in more detail below.

  Another design of the blade 10 is described below. In a form having a dual function of a corneal epithelial peeling device and an intraocular device insertion device, such a component can be replaced by a “cutting device”, “peeling device”, “applicator”, or “intraocular device applicator”. May also be called.

  As described elsewhere in this document, the continuous layer of corneal epithelium varies from the front of the eye to the front, or the basal cell layer, or the junction between the basal cell layer and Bowman's membrane ("transparent layer"). It may be separated or lifted by applying mechanical force. As used herein, the term “continuous” means “uninterrupted”. More or less epithelium may be separated from the cornea. Various devices and methods disclosed herein, for example, provide loose flaps of the corneal epithelium where 50% or less (often about 10% to about 50%) of the delaminated epithelial edges remain attached to the cornea. Although used for making, it is generally desirable that the device be used to provide a corneal epithelial pocket that leaves 50% to 75% of the delaminated epithelial edges attached to the cornea. . The delaminated corneal epithelium half-flaps or tight pockets may also be formed by leaving 50% to 95% of the delaminated epithelial edge attached to the cornea.

  In particular, the applicator described herein allows an intraocular device to be inserted subcutaneously separated from the cornea on the delaminated cornea. The separated epithelium can then be returned over the inserted intraocular device.

  Another form of applicator, a composite stripping / insertion instrument, comprises a blunt instrument 40 as seen in FIG. 5A. Generally, these applicators have an elongated shape that terminates at an edge 42. In general, this version of the applicator may be substantially flat, as shown in the outline of the applicator in FIG. 5B. The applicator includes an upper or upper surface 54 and a lower or bottom surface 56. The bottom surface 56 is shown in FIG. 5C. The part of the applicator that faces the delaminated corneal surface is the bottom 56 face of the applicator 40, and the part of the applicator that faces the delaminated corneal epithelium (or near the back of the epithelium during the insertion step) is , 44 upper surfaces. The applicator is shown to be substantially flat and have a uniform thickness 50 over its entire length, although other shapes (such as a non-uniform thickness “wedge” type) are also included in this description. Shall. FIG. 5C also illustrates an intraocular device holder (or retainer), shown as a cavity 60 at the bottom, in which at least a portion of the intraocular device fits.

  During operation, the applicator 40 may be controlled by the user by being attached to an applicator fixture or handle. As will be described below, such an applicator fixture has a drive motor such that the edge or blunt end 42 operates in a repetitive oscillating motion that separates the corneal epithelium from the underlying tissue without cutting the corneal tissue. May be included or connected to it. The edge 42 may be configured to operate in at least one of a left-right motion and a vertical motion. The edge may operate, for example, in a circular or semi-circular motion that follows a radius smaller than the diameter of the tip.

  The edge 42 of the applicator 40 is a portion that mechanically interacts with the cornea to peel the epithelium from the surface of the cornea. The edge portion may therefore have a shape that facilitates this interaction. In the cross-sectional contour, the edge portion is shown as a wedge-shaped corner in FIG. 5B, but the edge 42 may be another contour such as a peak, a plane, or a curved surface. The cross-sectional profile of the edge can be any degree of dullness, from very dull to very sharp (close to the edge of the knife). The cross-sectional profile of the edge may vary over the entire length of the edge. Such choice is left to the designer when this teaching is adopted and applied to the design of instruments to accomplish a particular task or procedure. For example, selecting a wide applicator 40 having a blunt end will create a large epithelial pocket, for example for attaching a large contact lens to the pocket.

  If the cross-sectional profile of the edge is substantially wedge-shaped, the angle of the edge profile may vary over a suitable range. For example, in FIG. 5B, the edges are shown having an angle of 20 ° from the horizontal plane (70 ° from the vertical plane). In one version, the edge contour ranges from 5 ° to over 45 °. This angle may be constant or vary across the cross-sectional profile. For example, in one version, the portion of the edge closest to the bottom surface is about 20 °, and the angle may decrease as the edge approaches the upper surface. The angle may be changed and reduced so that there is no visible transition from the edge to the upper surface. The strength of the edge contour gradient may increase as it approaches the upper surface. The transition between the edge portion and the lower and upper portions may be dull (such as smooth) or sharp (such as angled).

  Functionally, the edge (in this form, and in other forms described below) separates the epithelium from the cornea and creates a delaminated epithelial layer that does not have any (or very little) corneal tissue attached. If it is possible to do so, it may be considered to have an appropriate dullness. In some cases, primarily dealing with the specific physiology of a particular eye, such as the presence of a scar site, the created delaminated epithelial layer has only a small amount of attached corneal tissue. Ideally, the delaminated epithelium has no attached corneal tissue.

  The size and shape of the edge (such as that shown at 42 in FIG. 5A) may also vary. For example, the size and shape of the edge may be selected based on the intended use of the applicator and the desired flap or pocket size. In FIG. 5A, the edge portion is shown as a semicircle. Virtually any shape that can achieve the objectives described herein may be used. For example, the edge portion may be a shovel shape, a heart shape, a rectangular shape, or may be simply flat. The size (width, etc.) of the edge portion may vary. Finally, although the edge is shown to be substantially flat in most figures, the edge may be molded to match, for example, a slight curvature of the cornea. Other examples of edge shapes that may be used with the insertion instruments described herein are US patent application Ser. No. 10 / 346,664 (filed 1/17/2003) and US Provisional Application No. 60/505. No. 219 (9/22/2003 application), which are incorporated herein by reference in their entirety.

  Although the insertion tool is illustrated or described as flat or planar, these terms are suitable for facilitating mechanical separation of the epithelium from the corneal surface if one axis (such as left and right) and another It should be understood that it specifically includes a shape with curvature on the axis (such as front and back).

  The edge of the insertion instrument may penetrate the epithelium with or without further epithelial surface preparation or manipulation. For example, the epithelium may be scored or broken (punctured, torn, etc.) before the applicator is used. In general, the applicator may be used on an initially intact epithelium.

  The edge of the insertion tool may be made of any material sufficient to withstand the force applied by the edge when peeling the epithelial layer from the cornea. Specifically, the edge may be made of metal, ceramic, or polymer, and may be painted with another similar or different material. The material and coating may be selected to enhance the ability of the edge to delaminate the epithelium from the cornea without damaging the cornea or epithelial cells. For example, the edge may be made of polished (such as electropolished) or painted stainless steel. The material of the edge may be made from the same material as the applicator shaft or from a different material. Applicators intended for use in biological tissue are preferably made from a sterilizable material. The edge may also include materials containing therapeutic features (drugs, growth factors, etc.) to aid the recovery process, reduce pain, or assist the cornea to accept ocular implants. For example, the edge (or any portion of the applicator) may be configured to release the drug from the polymer matrix while in contact with the eye.

  In one version of the applicator, the delamination edge comprises at least a portion of the intraocular device to be implanted. For example, the edge may be part of a lens made from a relatively hard material or a hydrophilic lens that has not yet been fully hydrated. The lens is maintained in an intraocular device holder, and at least a portion of the lens protrudes from the applicator and is used to peel the epithelial layer from the corneal surface. After delamination and positioning of the lens on the corneal stroma, the lens is released from the applicator and secured in place. The applicator is then removed and the lens is left in place (and the lens is rehydrated if necessary).

  The top surface 44 and bottom surface 46 (including the shaft portion 64) of the applicator 40 may also affect the performance of the applicator. The upper surface 44 of the applicator contacts the newly delaminated corneal epithelium when the applicator is used. The surface properties of the applicator top surface may be configured to reduce friction between the applicator and the delaminated corneal epithelial layer. For example, the upper surface of the applicator may be smoothed by polishing and at least partially painted with a material that reduces friction (such as a biocompatible lubricant).

  The upper portion 44 may also comprise a material that has a low coefficient of friction against the epithelial layer. Biocompatible lubricants such as silicon and hyaluronic acid may be used.

  Suitable polymeric materials having a low coefficient of friction include polyethylene, polypropylene, polyvinyl chloride (PVC), ethyl vinyl acetate (EVA), polyurethanes, polyimides, polyamides (such as nylon), polyethylene terephthalate (PET), and Mixtures and copolymers thereof are included. Particularly lubricious polymers include polysulfone, polyxylene (such as paralene), fluoropolymers such as polytetrafluoroethylene (PTFE or TFE), ethylene-chlorofluoroethylene (ECTFE), fluorinated ethylene propylene (FEP), Polychlorotrifluoroethylene (PCTFE), polyvinyl fluoride (PVF), polyvinylidene fluoride (PVDF), mixtures thereof, alloys, copolymers, block copolymers, and the like are included.

  Suitable hydrophilic polymers having a low coefficient of friction include ethylene oxide and its higher homologs; 2-vinyl pyridine; N-vinyl pyrrolidone; monomethoxytriethylene glycol mono (meth) acrylate, monomethoxytetraethylene glycol mono (meth) Acrylates, polyethylene glycol acrylates such as monoalkoxyl polyethylene glycol mono (meth) acrylates including polyethylene glycol mono (meth) acrylate; 2-hydrophilic acrylates such as 2-hydroxyethyl methacrylate and glyceryl methacrylate; acrylic acid and its salts; Acrylamide and acrylonitrile; Acrylamide methylpropane sulfonic acid and its salts; Cellulose, methylcellulose ethylcellulose, carboxymethylcellulose, Include those made from monomers such as aldehydes; maleic anhydride; Ano ethylcellulose, cellulose derivatives such as cellulose acetate, amylose, pectin, amylopectin, alginic acid, and polysaccharides such as cross-linked heparin. These monomers may form homopolymers or block or random copolymers. The use of oligomers of these monomers in the coating of the device for further polymerization is also an option.

  Other suitable lubricating materials include diamond, carbon nitride, silicon carbide, diamond-like carbon (DLC), and other inorganic materials such as various deposited or pyrolytic carbon films.

  In general, the applicator may also include an incorporated therapeutic material (such as a drug) for release during use, for example. All applicators, or portions of applicators, may be made from a material having therapeutic properties, or may be painted (or injected) with a material having therapeutic properties.

  Friction between the applicator and the delaminated epithelium may also be reduced by reducing the overall volume, volume, or size of the surface area in contact with the delaminated epithelium. 6A and 6B show an applicator with an edge comprising a ring 121. In this version, the presence of the opening 123 reduces the surface area of the top of the applicator 100, thus reducing friction.

  6A and 6B also show an attachment site 65 that may connect the applicator to the applicator fixture. Applicator 40 may be attached to the tip of the applicator furthest from the delamination edge of the applicator of the applicator fixture. In this version, the drive is connected to an attachment site 65 on the applicator. The drive is configured to vibrate the entire applicator or primarily the edges of the applicator.

  The intraocular device applicator also includes an intraocular device holder (“holder”) for maintaining an implantable intraocular device. FIG. 7A shows one version of the applicator holder, but the intraocular device resides in a recess in the bottom surface of the applicator 42. Generally, the holder releasably secures the intraocular device on (inside) the applicator. The holder releases the fixed intraocular device when the applicator sufficiently separates the epithelium from the cornea, so that the intraocular device fits within the delaminated site.

  Similar to the arrangement seen in FIGS. 1-4B, the intraocular device holder of FIG. 7A matches at least a portion of the site of the intraocular device. The intraocular device holder may coincide with at least one outer surface of the intraocular device or may completely enclose the intraocular device. The device shown in FIG. 7A is configured such that the lens does not protrude beyond the surface of the bottom side 46 by fitting the lens within the cavity formed by the holder portion 60. In the devices shown in FIGS. 5A-5C and 6A-6C, the intraocular device holder 60 forms a cavity in the bottom of the applicator in which the intraocular device is housed. The holder is shown to be near the delamination edge of the applicator 42, and the holder is surrounded by this edge on at least three sides. The holder need not necessarily be a recess in the bottom of the applicator. The holder may protrude from the bottom surface of the applicator. By placing the holder on or near the applicator, the applicator can place the intraocular device after delamination of the appropriate size of the cornea.

  The holder or retainer may include cavities in both the top and bottom of the applicator (see, eg, FIGS. 6A, 6B, and 6C). In particular, FIG. 6C shows a lens 47 that is defined in the retainer under the blade 42 but extends through the blade 42 and extends from the top of the ring 61.

  The intraocular device holder maintains the intraocular device before and during delamination and releases the intraocular device after delamination is substantially complete. The intraocular device may be maintained and / or released from the holder and by applying a force to the intraocular device or by using a releasable adhesive, or a combination thereof.

  As described above, the intraocular device may be maintained in the intraocular device holder by applying a vacuum. One or more grooves 67 are connected to the holder as shown in FIG. 7A. Through this groove 67, a restraining force may be applied to the intraocular device in the holder. A negative force may be applied to secure the intraocular device within the holder (eg, by pulling a vacuum) and a positive force may be applied to release the intraocular device from the holder. For example, air pressure (or any other gas) may be applied through the groove to release the intraocular device. Fluid pressure (such as water pushed through the groove or saline) may be applied to release the intraocular device. Any fluid can be used to controllably hold and release the intraocular lens in the applicator. In addition, the grooves may be used to add other useful materials (eg, saline, liquids such as drugs) to the eye and may be used to provide a cooling fluid.

  The intraocular device may be maintained on the holder by a releasable adhesive. In particular, a soluble adhesive may be used. For example, in one version, the water soluble material secures the intraocular device in the holder until ready to be released after insertion. Then water or saline or other fluid may be added to dissolve the adhesive. Examples of water soluble materials include, but are not limited to, polymers such as polyvinyl alcohol (PVA), biopolymers such as hyaluronic acid (HA), and polysaccharides. The addition of a fluid that releases the adhesive (eg, saline, water, or other beneficial fluid) dissolves or releases the adhesive and allows implantation of the intraocular device. Such a solution may be applied locally (eg, through groove 67) or over a wide area of the cornea.

  8A, 8B, and 8C show a spatula-like applicator similar to that shown in FIGS. 7A and 7B. In FIG. 8B, the groove 67 is a vacuum source or air or liquid adjusted to apply force to maintain or release the intraocular device in the holder 60 at the distal end of the intraocular device holder portion 60. Connected to a source (not shown). The inner portion of the holder 60 includes additional grooves 69 to distribute the force across the intraocular device maintained within the intraocular device holder 60. The groove 67 shown in FIG. 8B is shown open, but is usually enclosed to allow pressure to be transferred to the holder.

  FIG. 8C shows a holder 60 that holds the intraocular device 71 (lens). The groove 67 connected to the holder is sealed with an outer surface coating (tape or the like) 73. The groove may be incorporated inside the applicator.

  In operation, the applicator can be variously adapted to help the applicator fitting, handle, or user move the blade or applicator across the cornea and place the selected implant at the desired site. It may be attached to a configured system.

  The applicator may be processed and assembled as separate parts (eg, edges, holders, etc.) or may be processed as a single piece. For example, the applicator may be injection molded or molded with a micro stamp. The size of the applicator may be selected by the designer, and is determined mainly by the intended use of the applicator, centering on the resulting device. Applicator dimensions are usually selected such that the edge has a thickness similar to that of the basal cell layer, eg, about 1/2 mil to 3.5 mil (0.0005 to 0.0035 ″), but many In the case of about 1.0 mil to 3.0 mil (0.001 to 0.003 ″). For example, the applicator edge may have a thickness of approximately 2.0 mils.

  FIG. 9A shows a top view of the dissection instrument 80 described. As described below, the lancing device 80 also described herein as a blunt blade or separation device comprises a blade body 82 having a blunt body edge 84 that surrounds a substantial portion of the blade body 82. This form of the dissection instrument 80 described includes a blunt edge 84 that is substantially curved in shape. This may be part of an ellipse or a circle. Since the blade body 82 is often oscillated left and right during the separation step, some of the sides of the blade edge 84 may be configured to separate the epithelium from the cornea.

  In this form of blade 80, the blade body 82 includes a wide opening 86. Because the opening 86 is positioned in the blade body 82, the dissecting instrument will pass between the blade body 82 and the epithelium as it passes through the epidermis across the cornea rather than with a blade that does not have such an opening. Generates a fairly low level of friction. If the opening 86 is circular, the diameter of the opening may have a diameter as high as 75 to 85% of the diameter 88 of the blade edge 84. The opening is beneficial even if it is as small as 10-15% of the blade diameter 88.

  The form of blade body 82 described in FIGS. 9A-9C includes a portion configured to be attached to a vibrator or vibrator. Such portions may include an extension 90 or neck and opening 91 for fasteners. Other fixed arrangements may be used. The blade body 82 may alternatively be integrated into the epithelial removal assembly as described below.

  FIG. 9B1 presents a cross-sectional side view of a configuration comprising a blade body 82 having a corneal side 92 and an epithelial side 94. In this configuration, the corneal side 92 is concave and has a shape that probably matches or resembles the shape of the cornea to be treated.

  FIG. 9B2 shows a cross-sectional side view of another form of the corneal side 92 when the corneal side 92 is substantially flat. The appropriate curvature of the corneal side 96 ranges from a radius of the cornea to an infinite theoretical radius formed by a straight line.

  FIG. 9C shows a cross-sectional front view of the blade body 82, showing a blunt edge 84 and a central opening 86. FIG.

  FIGS. 10A-10D show another form of cutting instrument or blunt blade 98 having a flat portion 100 located on the epithelial side 102. The flat area or portion 100 serves as a friction reducer that is similar in function to the opening 86 of the blade body 82 in FIG. 9A.

  FIG. 10B shows the side of a blunt blade 98 having a flat portion 100. The blade edge 104 is positioned similarly to the blunt edge 82 in FIG. 9A.

  FIG. 10C shows the end of the blunt separating blade 98 showing the flat part 100.

  Finally, FIG. 10D shows an enlarged cross-sectional view of the junction of the flat portion 100 on the epithelial side 102 and the curved surface on the corneal side 98.

  Other designs for reducing incidental friction between the dissector blade and the isolated epithelium are also suitable. For example, the epithelial side of the blade may be attached to a physical structure designed to reduce friction.

  11A-11D illustrate another form of blade 60 or blunt dissector blade having features that include a physical friction reduction design. The illustrated blade configuration 60 is shown in many of the other drawings and includes a blunt cutting edge 132 similar to that of the general type described herein, which further includes an epithelial surface 138 of the blade 60. And a friction reducing portion 134 having a number of long ridges 136 intended to have a very small contact surface with the epithelium when slid along the longitudinal direction. In general, the illustrated blade 60 is shown as having no openings through the blade body 140, but it is of course acceptable to include one or more openings between the ridge structures 136.

  FIG. 11B shows the cutting blade 60 again. This figure is a cross-sectional view of the portion shown in FIG. 11A. FIG. 6 is a view showing a ridge 136 extending from the epithelial side 138 of the blade body 40. In general, it is contemplated from FIG. 11B that the blade body 140 may or may not be flattened at the ridge 136 site.

  FIG. 11C shows the part 142 circled in FIG. 11B. 11C also shows that the corneal side 144 of the blade is slightly concave in the depicted form.

  FIG. 11D presents a cross-sectional end view of the enlarged portion 142 shown in FIG. 11C.

  FIG. 11D again shows the corneal side 144, the epithelial side 138, and the gentle ridge 136.

  The blade edges of the blades described (and other blade configurations described here when the blade is only used for epithelial delamination) may instead be described as “epithelial incision edges” and those edges May be characterized as “dull”. In more detail, the term “dull” means that when the edge passes axially (relative to the arrival of the blade) at an angle of 25 ° or less to the contact surface of the cornea, This means that the Bowman membrane cannot be cut. At the same time, however, the blade edge penetrates and passes through the epithelial layer, separating the epithelial tissue as the blade passes over the cornea into a separated or lifted epithelium. This separation is usually done in a transparent layer unless the structure of the eye contains any unusual features. For example, scar tissue, in certain cases, causes the cutting instrument to take different or subcutaneous pathways in the subepithelium.

  The particular shape or contour of the blade is not critical to the physical friction reduction function of the dull blade described above.

  However, in order to form the blade edge, not only simply polishing the blade edge, which may otherwise be sharp enough to cut corneal tissue such as Bowman's membrane, but especially the electropolishing step In use, it has been found that very useful blade edges can be produced. Electropolishing is the electrolytic removal of metals in a highly ionic solution using current. This may be considered “reverse electroplating”. Electropolishing often creates a microscopically smooth reflective surface. Current density found at sharper points or edges in any electropolishing process desirably removes or polishes those sites, burrs, or edges and is used to produce blunt blades when used with the described blade The blade material is dulled to provide a consistent edge that functionally separates epithelial tissue from the cornea without cutting the corneal tissue. The temperatures used for electropolishing the blade material used in the dull blades described are well known and can easily be found in the published description of this process. The temperature may be raised slightly above room temperature, for example 110 ° to 160 ° Fahrenheit. The voltage applied to the stainless steel metal blade material is usually in the range of 6 to 30 volts, but the lower end voltage in that range is often used. The amperage may be between 5 and 30 amperes per square foot of material blade area. Acidic additives such as sulfuric acid or phosphoric acid may be employed.

  FIG. 12A shows a cross-sectional view of an edge 150 of a typical stainless steel blade blank 152. The blade edge 150 is shown to be fairly sharp, and in this example is sharp enough to cut the corneal tissue. Various arrows 154 shown in FIG. 12A are schematic indicators of current density in the process. The current density 154 is shown high at the blade blank edge 150 and low elsewhere. The sharpness of the edge 150 is desirably removed during the process of manufacturing the blunted edge 156 seen in FIG. 12B. There are other blade edges that are suitable for reaching the functional outcomes identified here. Some of the other shapes are described below.

  The various cutting, insertion, and disector blades may be used for a variety of operations unless stated above. In some instances, it may be desirable to supply fluid to the epithelium or cornea during the process of separating the epithelium from the cornea. A chilled fluid, such as a saline solution, often serves to provide predictable viability to the created isolated epithelial tissue.

  FIG. 13A shows a top view of a cutting blade 160 having a water channel for fluid 162 defined on the epithelial side 164 of the blade 160. FIG. 13B shows a cross-sectional view of the blade of FIG. 13A with a water channel 166. The external water channel 166 is shown externally but comprises one or more openings placed underneath the epithelium (or openings) or on the cornea, during the separation step or blade removal, or It may be an enclosed passage that allows the passage of fluid during any period in between.

  FIG. 14A shows a similar configuration 168 having a passage 170, but in this case the passage or groove 170 is positioned on the corneal side 172 of the blunt blade 160, as shown in FIG. 14B.

  15A-15D illustrate various “blunt” blade edges that are generally suitable for use with the described cutting blade. FIG. 15A shows a blade 180 having an edge 182, but the edge has a slightly convex contour 184 on the cornea side. FIG. 15B shows a dull blade 180 having a slightly concave shape on the corneal side 186. FIG. 15C shows a blunt blade with a corneal bead or ridge 188. FIG. 15D shows a blade 180 having a substantially flat corneal side 190.

  Forming an enclosed pocket or at least a partially enclosed pocket, and the end of the element may form a hinge or other point of rotation about the corneal surface, eg forming the end of the pocket In the form of a cutter or a dissector blade used to create an epithelial tissue portion that is incapable of location and type, it may have a separate edge on the side of the blade, or at least off the axis of the blade.

  Since the blade body may vibrate in a left-right motion, or other motion that is not strictly axial in nature, the blade's separation edge may have a “separation shape” that divides a substantial portion of the blade's tip edge. . For example, FIG. 16A shows a blade 200 having a blade edge 202 that divides an angle 204 that is approximately 180 °. FIG. 16B shows another form of blade 206 in which the leading edge 208 includes a separation surface that divides an angle 210 between 210 ° and 225 °. FIG. 16C shows a blade body having a separating edge 214 that divides the blade body 212, perhaps 270 ° -280 ° 216.

  The dull blade may be made from a variety of suitable materials. While various stainless steels and spring steels are very suitable as blade materials, polymer materials such as polymethylmethacrylate (PMMA) and polycarbonate are suitable for the chosen design or configuration of the dull blades described.

  As described above, the described epithelial detachment blade may employ a lubricating material on one or more surfaces. Lubricating materials can be variously permanent (lasting at a substantially uniform thickness throughout the epithelial delamination step), temporarily (suspended in a fluid, possibly decreasing in volume or thickness during the epithelial delamination step) Solid, gel, or particulate material), reactivity (hydrogel or other polymeric material that reacts with water to form a slippery material during or immediately prior to the epithelial delamination step), and fluid lubricant (exfoliation) There may be several different forms, such as a fluid introduced with the instrument. The stripping device may be completely covered with the lubricating material or partially covered with the lubricating material during the procedure. In particular, the part of the peeling blade that contacts the epithelium during peeling of the epithelial layer is at least partially provided with a lubricating material, and the corneal side may be less lubricious in comparison.

  17A to 17D show a form 240 of the peeling and cutting blade 10 shown in FIGS. This configuration is also useful for simultaneously placing an implanted lens (or other onlay or implant). These figures also show the subcomponent parts and the contained lens 242.

  FIG. 17A is a cross-sectional view showing the peeling device 240 and the lens 242 accommodated therein. The lens 242 is shown slightly away from the surface of the stripping tool 240 for clarity of explanation and depiction. The stripping tool 240 shown comprises a dome 244 and a sealing plate 246. The top and bottom views of the dome 244 are shown in FIGS. 17B and 17E, respectively, with the lens 242 removed in the first view and the sealing plate 246 removed in the later views. Lens 242 is shown isolated in the top view of FIG. 17C. Sealing plate 246 is shown isolated in the top view of FIG. 17D.

  Returning to the dome portion 244 of FIG. 17A, this configuration is configured to house the lens in the upper surface 248. The upper surface 248 may be formed to approximate at least the lower surface 250 of the lens 242. Various sizes and locations of the passages 252 are shown to allow vacuum conduction from the lower surface 254 to the upper surface 248 and the lens 242. A vacuum may be used to maintain the lens 242 in place until delivery. As will be shown in more detail below, the upper surface 248 allows the end of the lens 242 to more easily pass across the back surface of the epithelium during the entry portion of the lens insertion procedure. May include an inlet having Furthermore, the upper surface 248 includes a lubricious coating or coating 253 on at least the surface that contacts the lens 242 and the surface that contacts the epithelium during introduction of the release device 240 and during recovery after installation of the lens 242. Good. Although the remaining portion of the stripping device 240 may be treated to be lubricious, the benefits added by such treatment appear to be limited. FIG. 4B shows a part of the lubrication range 31 with a very similar configuration.

  FIGS. 17A, 17B, and 17E respectively show a tip edge 262 that has the function of first penetrating the epithelium and subsequently separating the epithelium from the cornea and Bowman's layer. Acceptable edge shapes, cross-sections, and proximity slopes are described below and elsewhere in this document.

  Returning again to FIG. 17A, the chamber 256 formed between the sealing plate 246 and the back surface 254 of the dome 240 also provides saline or water to push the lens 242 away from the upper surface 248 as part of the release step. (And drugs if desired) may be used to allow the passage of fluids.

  As shown in FIGS. 17F and 17G, chamber 256 may be divided into a number of independent chambers if desired and reached by an independent path through drive legs 260. The independent paths (262, 264) in the drive leg 260 may be installed by machining or casting. Similarly, the chamber 256 may be divided into independent chambers (266, 268) by one or more walls 270 projecting upward from the sealing plate 246. FIGS. 17F and 17G show top and end views of such a configuration with split channels for independent chambers. In this configuration, a single bent wall 270 provides two chambers (266, 268), in this example reaching individual sets of passages through the dome. One chamber 268 reaches the outer circle of the opening 252 and the central opening 251. Another chamber reaches the four openings 253 in the dome 244 shown in FIGS. 17B and 17E. The passages and chambers are isolated and may allow separate access of the dome 244 to the separate passages 250, such as by vacuum or saline. Such a separate reach may sometimes be desirable. The vacuum distributed at the end of the lens, provided by a number of small passages or openings 252 at the end of the dome 244, is believed to help the stability of the lens during insertion of the insertion / extraction instrument 240. . A wide direct passage or opening 250 in the center of the dome 244 for passing water or saline is believed to assist in releasing the lens when desired.

  FIG. 17B shows a top view of the dome portion 244 of FIG. 17A. Inlet end 253 and various open passages (251, 252, 255) may be seen.

  FIG. 17C shows a top view of the selected lens 242. Lenses suitable for use with this device are not limited in any way. As mentioned above, the lens may be a soft, flexible, or hard lens in terms used in ophthalmology. The lens may be a hydrophilic or hydrophobic polymer, or a mixture thereof, their materials, composites, multi-layered blocks or random copolymers.

  FIG. 17D shows a top view of the sealing plate 246.

  FIG. 17E shows a bottom view of the dome 244 with the sealing plate (246 in FIG. 17D) removed. A ravet 267 for supporting the end of the sealing plate 246 may be seen. Various passages or openings (251, 252, 255) may also be seen through the dome 244.

  The various passages configured to conduct the maintenance vacuum and release fluid to the various open passages (251, 252, 255) are one or more of these various open passages (251, 252, 255). May be used to pass cooling fluid through and cool the epithelium or cornea in the pocket.

  18A-18E show another form of stripping instrument / blade 290, in particular a dome 292 and its associated lens 294. FIG. This configuration houses the implant lens 294 below the dome 292.

  FIG. 18A shows a side cross-sectional view of the peeler 290, dome 292, sealing plate 306, and its associated lens 294. The chamber 298 below the dome 292 may be adapted or configured to hold the lens 294 during delivery and to controllably release the lens 294 when the desired placement site is reached.

  One way to hold the lens 294 to the dome 292 during delivery is illustrated in the bottom view of FIG. 18B. Various recesses 300 may be installed on the back surface 302 of the dome 292. The recess 300 may be connected to a passage 304 for vacuum passing through the recess, as seen in the arm 308 below the sealing plate 306. These similar passages and recesses may be used to add a fluid, such as water or saline, to release the lens 294 in FIGS. 18A and 18C.

  FIGS. 18A and 18B show the distal edge 310 of a peeling device 290 that has the function of first penetrating the epithelium and subsequently separating the epithelium from the cornea, Bowman's layer. The appropriate shape, cross section, and proximity slope of the edges are described elsewhere.

  FIG. 18C shows a top view of the lens 294.

  FIG. 18D shows a top view of the dome 292.

  FIG. 18E shows a partially enlarged cross-sectional view of the epithelial stripping device 290 shown in FIG. 18A. In particular, FIG. 18E shows the presence of the lubricious coating 318 at the site where the peeling blade contacts the epithelium during the delamination procedure on the upper surface of the peeling device.

  Again, each of the various epithelial stripping devices described herein may be adapted or configured to secure the graft during the implantation and delamination steps and to release the graft utilizing the teachings described herein.

  The following figures show various stripping device shapes, the placement of the lubricating material, and in some examples, the partial shape of the formed epithelium. In some examples, the peeling device may be configured to include an implant for co-positioning the implant during the delamination step.

  FIG. 19A shows a top view of the spatula peeler 340. The peeling device 340 may vibrate in the left-right or axial direction, back and forth, and a combination of the two.

  FIG. 19B shows a side cross-sectional view of a peeling device 340 having a substantially flat bottom 342 that is defined in proximity to the eye and cornea during use. An uncut tip edge 344 of the rounded top surface 346 is also seen.

  FIG. 19C shows a front cross-section of the stripper 340 and the top surface 346 with an inclined rounded shape. The top surface 346 is in close proximity to the epithelium during the step of delamination of the epithelium.

  FIG. 19D shows a partial cross-section of the peeling device 340 and, in particular, a blade substrate 348 with a lubrication layer 350 defined on the side of the peeling device 340 that is in close proximity to the epithelium during use.

  FIG. 19E shows a partial cross-section of a stripping tool 340 that includes a blade substrate 348 having a lubrication layer 350 on both sides of the substrate 348.

  FIG. 20A shows an epithelial stripping device 360 having a substantially circular active end. As in the case of the stripper shown in FIG. 19A, this configuration may be vibrated from side to side or axially back and forth, or a combination of the two movements. The leading edge 362 needs to be configured to have a separation shape only at the marked portion 364.

  FIG. 20B shows a side cutaway view of a stripping tool 360 with a tip edge 364. In this shape, the main body or substrate 366 of the peeling device 360 is shown in a slightly dome shape.

  FIG. 20C shows a cross-sectional front view of the peeling device 360 and the dome-shaped substrate 366.

  FIG. 20D shows a partial cross-section of the stripper 360 and, in particular, the blade substrate 366. Lubricating layer 368 is shown defined on the side or site that will be in close proximity to the epithelium during use of stripping device 360.

  FIG. 20E shows a partial cross-section of a stripping tool 360 having a lubrication layer 368 on both sides of the stripping device substrate 366.

  FIG. 21A shows a top view of a peeling device 380 having a tip 382 with a protruding feature. The stripping device may be used to create a substantially hinged epithelial flap, rather than the epithelial pocket described elsewhere herein. The peeling device 380 may be vibrated back and forth in the left-right direction or the axial direction during use, but is usually used only with front-rear vibration. FIG. 21B shows a side view of a stripping tool 380 with a tip edge 382.

  FIG. 21C shows a partial side cross-sectional view of an exfoliating device 380 having a blade substrate 384 and a layer of lubricating material 386 only where it is likely to contact the epithelium during the delamination step.

  FIG. 21D shows a peeling device 380 that includes a substrate 384 and a lubricious coating 386 on all sides that contact the eye during use.

  FIG. 22A shows a top view of a release device 390 that is somewhat spatula shaped but includes a dome shaped portion 392 on the front side and includes a recessed portion 394 on the bottom side 396, as seen in FIG. 22B. Epithelial stripper dome 392 has a tip with an edge configured to separate the epithelium from the Bowman layer without cutting the cornea or leaving a significant portion of the epithelial tissue in the cornea or corneal tissue on the back of the epithelium. Includes an edge 396.

  FIG. 22B shows a front cross-sectional view of the peeling device 390 showing both the dome 392 and the recessed portion 394.

  FIG. 22C shows a side view of the peeling device 390 and the presence of the dome 392.

  FIG. 22D shows a partial side cross-sectional view of a release device 390 comprising a dome 392 and a concave portion 394 on the bottom side 396.

  FIG. 22E shows the peeler 390 blade substrate 398 and the lubrication layer 400 in the dome shape. The dome portion of the peeling device 390 contacts the backside of the epithelium during the delamination step.

  FIG. 22F shows a partial cross-sectional side view of the peeler 390, which in this example shows the lubricating layer 400 on both sides of the blade substrate 398. FIG.

  FIG. 23A shows a simple wire whip peeling element 401 that is vibrated back and forth as shown in FIG. 23B to form a separated epithelium.

  FIG. 23C shows one shape of the isolated epithelium 402 that may be created by changing the “whipped point” position 404 as the wire moves axially below the epithelium 406.

  FIG. 23D illustrates the substrate wire 408 and the portion of the wire that acts as the delamination element 401 and the partially lubricious coating 410 at the site that contacts the cornea and epithelium.

  FIG. 23E shows a delaminated wire element 401 with a wire substrate 408 and a lubricious coating 410 that substantially covers the entire substrate 408.

  FIG. 23F shows a delamination wire element 401 comprising a substrate 408 and a lubricious coating 410 covering the portion of the substrate wire 408 that contacts the epithelium.

  FIG. 24A shows an epithelial stripping device 411 having a substantially elliptical cross section. The left and right dimensions of the ellipse in this configuration are usually substantially relatively small, for example, less than 10% of the epithelial diameter in the eye where the isolated epithelium is desired.

  FIG. 24B shows the limited rotational motion 412 of the epithelial detachment element 411.

  FIG. 24C shows the left-right motion 414 of the epithelial detachment element 411.

  FIG. 24D shows the combined motion of the epithelial delaminating member 411, in which a left-right rotational motion is combined with an axial motion to create a lifted epithelial site having a connecting end 416 and subepithelial opening 418. Yes. This configuration may be used to create a pocket with a wide opening.

  FIG. 24E introduces the peeling device 411 subepithelially, rotates it about a pivotal portion near the mouth 422, and collects the peeling device 411 at the maximum angle to form the illustrated portion. FIG. 5 shows an epithelial pocket made by, having an attached end 420 and a small opening 422. This combination of rotational movement and axial movement of the peeling device 411 is useful for creating a pocket having a small opening and a large closed portion in the subepithelium.

  FIG. 24F depicts a cross section of a delamination element 411 comprising a blade substrate 430 and a lubricant coating 432 on the surface of the delamination element that contacts the epithelium during the delamination step.

  FIG. 24G shows a cross section of a delamination element 411 with a substrate 430 and a lubricious coating 432 that covers all surfaces of the delamination element 411 in contact with the eye.

  The ablation / cutting device described in connection with FIGS. 23A-24G is not a physical shape that readily adapts to accommodate the implant during the epithelial layer ablation step. However, because they provide an epithelial pocket with a relatively small opening, for use with an implant that may be folded for introduction into the pocket, and for an implant formed in situ, the reactive agent or It is particularly suitable to provide for the introduction of shapes and the like. In such use, the folded lens or reactant may be transported over another system element that may or may not be simultaneously introduced into the epithelial pocket.

  In many cases, an ablation device is used to insert an intraocular device under a substantially intact epithelial layer (ie, the portion of the epithelium passing in front of the dissecting device is continuous). However, the peeling device may be used in a less precise manner. For example, a peeling instrument may be used to move or remove selected portions of the membrane. In fact, when this device is used in conjunction with a LASEK procedure, the epithelium is removed in the form of a soft flap, facilitating epithelial repositioning or repositioning after any corneal laser remodeling is complete.

  In some cases, heat may be applied to the front of the eye to improve mechanical epithelial detachment, or cooling fluid may be added to the device and the epithelium to improve epithelial viability after treatment is complete. desirable.

  The blunt dissector blade described may be used with a device having only a handle, i.e. without mechanical vibration or a drive for advancing the blade across the cornea. More often, as shown in FIGS. 25A and 25B, a blunt blade dissector 450 is used in conjunction with a vibrator 452 that is used to oscillate the blade 450 as indicated by arrow 454.

  In addition to the vibration drive, the handle 452 is a drive that allows axial movement 456 of the dull blade 450 by manual movement by pushing the dull blade 454 with a thumb, or the vibration 454 causes the blade to axially move the cornea. An electric or motor-type drive unit that operates across the vehicle may be employed. This axial movement 456 occurs, for example, with the use of alignment rails 458 to facilitate passage across the cornea.

  An outline of a procedure for providing epithelial tissue using a blunt blade as described herein is shown in FIGS. FIG. 26A shows an eye 460 having a cornea 462. A blunt blade 464 having both left-right vibration 466 and axial motion 468 reaches the eye 460.

  FIG. 26B shows the blade 464 entering with vibration 466 by penetrating the epithelial layer and forming an opening 468.

  FIG. 26C shows the axial motion of blade 464 and possibly the vibrational motion both stopping. Blade 464 is located within epithelial tissue portion 470 having an opening 468. In this example, epithelial tissue portion 470 is a general type of circular pocket. The described device is best for creating an epithelial tissue portion where some portion of the epithelial tissue portion 470 remains attached to the cornea. In some examples, the epithelial tissue portion 470 has an attachment that allows the epithelium to be shaped, for example, a flag shape, and to rotate or move away from near the front of the cornea. You can do it.

  FIG. 26D shows the removal of blade 464 from eye 460 in all cases, but below epithelial element 470 for any additional treatment of the eye, such as a LASEK procedure, other laser therapy procedure, or placement of an intraocular lens. The epithelial tissue portion 470 and the opening 468 are left to allow entry into the. In each instance, the epithelial tissue may be left on any therapeutic outcome of the ocular surface, but these are intrinsically guided therapeutic lasers or implants. Mechanical or surgical eye treatment, or repositioning of epithelial tissue at any other treatment site is also appropriate.

  Similarly, the described blades may be further treated or covered with a temporary, temporary, or permanent coating to enhance the friction improving capabilities of the dull blades described. The coating film may be as described above.

  The described mechanical epithelial stripping device may be considered a blunt dissection device. A blunt dissection instrument has an uncut surface suitable for placement between the epithelium and collagenous matrix tissue. The term “non-cut” as used herein means that a blunt dissection instrument does not have the ability to dissect the corneal matrix when used with normal force. The inventor believes that this blunt dissecting instrument separates the epithelium from the corneal matrix layer with a basement membrane that is inherently the least adherent, the transparent layer. The isolated epithelium does not contain a significant amount of corneal parenchyma or, for the purposes of the present invention, has a “normal” eye for treatment (having no artificial consequences due to a disorder or disease) ) Does not contain very little amount of matrix tissue. The isolated epithelium does not contain type I or type III collagen that may be found in matrix tissue.

  The described procedure may be used to dissociate a substantially intact epithelial layer (ie, the portion of the epithelium passing through the front of the dissecting instrument is continuous), while the device is used to create other epithelial tissue May be used. For example, a cutting instrument may be used to remove only selected portions of the membrane. Indeed, when the device is used in conjunction with a LASEK procedure, the epithelium is removed in the form of a soft flap to facilitate repositioning or repositioning after any corneal laser remodeling is complete. This cutting instrument may be used to form an epithelial pocket.

  The epithelial layer detachment method described herein may be used in conjunction with a corneal regeneration procedure or a procedure involving placement of an intraocular lens device on the surface of the eye. Specifically, the disclosed procedure may be used to prepare a flap having an epithelial pocket or often an attached hinge. A suitable intraocular lens is then placed on the substrate surface and the epithelial flap is returned onto the lens. One such suitable intraocular lens device for use with the present invention is described in US Pat. No. 6,544,286, which is hereby incorporated by reference in its entirety.

  Similarly, a corneal regeneration procedure may be performed to return the corneal flap to its original position.

  The structure and physiological properties of the present invention and certain benefits unique to the specific form of the epithelial delamination device have been described. However, this description of the invention should not be viewed as limiting the scope of the invention in any way.

FIG. 1 is a perspective view of the back or bottom of a corneal blade and graft applicator. FIG. 2 is a perspective view similar to FIG. 1 in which the corneal blade includes a cover on the rear surface. FIG. 3 is a perspective view of the front or top surface of the corneal blade in FIG. 1, with the implant placed on that surface. 4A is an enlarged side view of the distal end of the blade of FIG. FIG. 4B shows an enlarged cut side view of the distal end of the blade of FIG. 4A. FIG. 5A is a top view of another version of an intraocular device applicator useful for separating the corneal epithelium and inserting the intraocular device between the cornea and the corneal epithelium. FIG. 5B is a side view of the intraocular device applicator of FIG. 5A. FIG. 5C is a bottom view of the intraocular device applicator of FIG. 5A. FIG. 6A is a top view of another version of an intraocular device applicator having a central opening and a graft below the applicator in the opening. 6B is a bottom view of the intraocular device applicator of FIG. 6A. FIG. 6C is a side view of the applicator of FIG. 6A showing the implanted lens being installed. FIG. 7A is a bottom view of another intraocular device applicator. FIG. 7B is a perspective sectional view taken along line LL ′ of FIG. 7A. FIG. 8A shows a perspective view of the top of the applicator similar to the applicator of FIG. 7A. FIG. 8B shows a perspective view of the applicator bottom of FIG. 8A. FIG. 8C shows a perspective view of the applicator bottom of FIG. 8A with the cover plate attached. FIG. 9A is a top view of one form of a blunt blade useful for separating corneal epithelium. 9B1 and 9B2 are side (or axial) cross-sectional views of the apparatus of FIG. 9A. FIG. 9C is a cross-sectional end view of the apparatus of FIG. 9A. FIG. 10A is a top view of a second configuration of a blunt blade epithelial separation device. 10B is a side or axial cross-sectional view of the apparatus of FIG. 10A. 10C is a cross-sectional end view of the apparatus of FIG. 10A. FIG. 10D is an enlarged side cross-sectional view of a portion of the apparatus of FIG. 10A. 11A, 11B, 11C, and 11D show a top view, a cross-sectional side view, a partially enlarged side view, and a partially enlarged side view, respectively, of one form of a peeling blade having a physical friction reducing function. 12A and 12B schematically illustrate the production of a blunt edge of a cutting blade that uses electropolishing to provide a blade suitable for exfoliating the epithelium without entering the corneal stroma. 13A and 13B show a schematic top and cross-sectional front view of one form of a cutting blade having a passage for fluid introduction during use. 14A and 14B show a schematic bottom and cross-sectional front view of another form of cutting blade having a passage for fluid introduction during use. 15A to 15D show cross sections of the contours of the leading edges of various blades. 16A to 16C show top views of the dividing angles of various tip edges. 17A-17G illustrate one embodiment of the peel-cut blade and its components and lens shown in FIGS. 1-4B, a side cross-sectional view of the blade, a top view of the blade, a top view of the implantation onlay, a sealing / fluid routing plate , Bottom view of blade without cover plate installed, top view of sealing / fluid routing plate, and end view of sealing / fluid routing plate, respectively. FIGS. 18A to 18E show one embodiment of a peeling cutting blade whose components are attached to the bottom surface at the time of installation, its constituent parts, and the lens. The figures show a side cross-sectional view of the blade and lens, a bottom view of the blade, a top view of the implantation onlay, a top view of the blade, and an enlarged side cross-sectional view of the blade and lens, respectively. 19A-19E show a top view, a cut side view, a cut end view, a partially cut side view showing a single lubricious surface, and a partial side cut view showing one or more lubricious surfaces, respectively. All are of the spatula type epithelial layer peeling member. FIG. 20A shows a top view of the circular epithelial stripping device. FIG. 20B shows a cross-sectional side view. FIG. 20C shows a cross-sectional end view. 20D and 20E show partial side cutaway views depicting single and multiple lubricious surfaces of the delamination element of FIG. 20A. FIG. 21A shows a top view of another form of block epithelial stripping device. FIG. 21B shows a side view of the delamination member. FIGS. 21C and 21D show partial cross-sectional side views of the stripping device with a lubricious coating, with the epithelial contact portion and the entire stripping device, respectively. FIG. 22A shows a top view of a corneal epithelial stripping device having a dome-shaped portion and a recess opposite the dome portion. FIG. 22B shows a cross-sectional end view. FIG. 22C shows a side view of the delamination member of FIG. 22A. FIG. 22D shows a side cross-sectional view of the delamination member of FIG. 22A. 22E and 22F show the stripping device of FIG. 22A having a single lubricious surface and multiple lubricious surfaces, respectively. FIG. 23A shows a top view of the wire whip epithelial layer peeling member. FIG. 23B shows the free movement of the whip of the delamination member. FIG. 23C illustrates the shape of one raised epithelial portion created using the restraining motion of the whip layer release member of FIG. 23A and the moving restraint point. FIG. 23D shows a wire layer strip with a lubricant material in proximity to the epithelium. FIG. 23E shows a wire release member with a lubricious coating on the surface. FIG. 23F shows a cross-sectional view when the wire release member is partially provided with a lubricious coating on the surface. FIG. 24A shows a small oval delaminating member. FIGS. 24B, 24C, 24D, and 24E illustrate particular lifted epithelial sites that have been created utilizing various operations and combinations of operations suitable for use with the delamination member of FIG. 24A. 24F and 24G respectively show cross-sectional views of the delamination member of FIG. 24A in which the epithelial surface is coated with a lubricating material and all surfaces coated with a lubricating material. 25A and 25B show a vibrator or cutting instrument assembly, respectively, with a blunt blade in a generally unextended and extended position. Figures 26A, 26B, 26C, and 26D generally illustrate the steps of using the blunt blade and lancing instrument assembly described herein.

Claims (21)

  The epithelial tissue part attached at least partially to the cornea is formed by cutting the epithelium and separating the epithelium from the eye having the epithelium attached to the cornea, but forming the epithelial tissue part A low-friction dissector blade configured to not cut the cornea while the blade oscillates across the eye and passes laterally, the blade comprising at least one cornea A blade body having a blunt edge for non-cutting epithelial tissue separation; an epithelial surface configured to pass near the epithelium during the lateral passage; and near the cornea from which the epithelium has been removed during the lateral passage A low friction dissector blade comprising a corneal surface configured to pass through and a lubricious coating on at least a portion of the epithelial surface rather than the corneal surface.   The dissector blade of claim 1, wherein the lubricious coating comprises a liquid lubricant comprising an element selected from silicones and hyaluronic acid.   The lubricious coating is a group consisting of polyethylene, polypropylene, polyvinyl chloride (PVC), ethyl vinyl acetate (EVA), polyurethanes, polyimides, polyamides, polyethylene terephthalate (PET), and mixtures and copolymers thereof. The disector blade of claim 1, comprising one or more elements selected from:   The lubricious coating comprises one or more elements selected from the group consisting of polysulfones, fluoropolymers, and mixtures thereof, alloys, random copolymers, and block copolymers. Dissector blades.   The lubricity coating is composed of polytetrafluoroethylene (PTFE or TFE), ethylene-chlorofluoroethylene (ECTFE), fluorinated ethylene propylene (FEP), polychlorotrifluoroethylene (PCTFE), polyvinyl fluoride (PVF), polyfluoride. The disector blade of claim 1 comprising one or more elements selected from the group consisting of vinylidene fluoride (PVDF), and mixtures, alloys, random copolymers, and block copolymers thereof.   The lubricating coating comprises ethylene oxide and its higher homologues, 2-vinyl pyridine, N-vinyl pyrrolidone, polyethylene glycol acrylate, monoalkoxy polyethylene glycol mono (meth) acrylate, acrylic acid and its salts, acrylamide, acrylonitrile, acrylamidomethyl Claims comprising one or more elements selected from the group consisting of propanesulfonic acid and its salts, cellulose, cellulose derivatives, polysaccharides, maleic anhydride, and hydrophilic polymers made from monomers including aldehydes. The dissector blade according to 1.   The lubricious coating comprises hydrophilic polymers made from monomers including monomethoxytriethylene glycol mono (meth) acrylate, monomethoxytetraethylene glycol mono (meth) acrylate, and polyethylene glycol mono (meth) acrylate, 2- The disector blade of claim 1 comprising one or more elements selected from the group consisting of hydroxyethyl methacrylate and glyceryl methacrylate.   The lubricity coating comprises one or more elements selected from the group consisting of hydrophilic polymers made from monomers including methylcellulose ethylcellulose, carboxymethylcellulose, cyanoethylcellulose, and cellulose acetate. Dissector blade.   The lubricious coating of claim 1, comprising one or more elements selected from the group consisting of hydrophilic polymers made from monomers including amylose, pectin, amylopectin, alginic acid, cross-linked heparin, and the like. Dissector blade.   The die of claim 1, wherein the lubricious coating comprises one or more elements selected from the group consisting of diamond, carbon nitride, silicon carbide, diamond-like carbon (DLC), and vapor deposited or pyrolytic carbon films. Sector blade.   The blade of claim 1, wherein the dull edge comprises a shape formed by electropolishing a sharp edge capable of cutting corneal tissue.   The blade according to claim 1, further comprising a vibrator driving unit.   The blade of claim 1, further comprising a lateral motion drive.   The blade of claim 1, further configured to hold an intraocular implant during the lateral passage.   The blade of claim 1, further comprising a coolant path.   An epithelial tissue part that is at least partially attached to the cornea is configured to be formed by cutting the epithelium and separating the epithelium from an eye having an epithelium attached to the cornea, but forming the epithelial tissue part A low-friction dissector blade configured to not cut the cornea while the blade oscillates across the eye and passes laterally, the blade being at least one corneal uncut A low-friction dissector blade comprising a blade body having a blunt edge for separating a type epithelial tissue and an opening through the blade body.   The blade of claim 16, wherein the blade body comprises a corneal side and an epithelial side.   The blade of claim 17, wherein the blunt edge comprises a shape formed by electropolishing a sharp edge capable of incising corneal tissue.   The blade according to claim 17, further comprising a lubricating coating applied to at least a portion of the blade body on the epithelial side.   The blade of claim 16, further comprising a coolant path.   An epithelial tissue part that is at least partially attached to the cornea is configured to be formed by cutting the epithelium and separating the epithelium from an eye having an epithelium attached to the cornea, but forming the epithelial tissue part A dissector blade configured to not cut the cornea while the blade oscillates across the eye and passes laterally, the blade comprising at least one non-corneal epithelial tissue A dissector blade comprising a blade body with a blunt edge having a shape formed by electropolishing a blunt edge for separation and sharp edges capable of cutting corneal tissue.

Images