Patent Publication Number: US-7901421-B2

Title: System for cutting the cornea of an eye

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. patent application Ser. No. 10/445,065, filed May 27, 2003, now U.S. Pat. No. 7,223,275, the full disclosure of which is incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to surgical systems for cutting the cornea of a patient&#39;s eye. 
     The cornea is the clear cover of the eye and is also the main focusing lens in the eye. Disorders of the cornea, which adversely affect its shape or clarity, can cause loss of vision. Such disorders include Fuchs&#39; endothelial dystrophy, pseudophakic bullous keratopathy, keratoconus, and herpes virus infection. When these conditions are severe the most common treatment is a full thickness corneal transplant which is also known as penetrating keratoplasty. 
     Penetrating keratoplasty is the removal of a full-thickness disk of diseased corneal tissue followed by the replacement of the diseased full-thickness disk of tissue by a full thickness disk of donated healthy corneal tissue. Currently, the diseased tissue is removed by the use of a non-automated or automated corneal trephine combined with manual excision using scalpels and or micro-surgical scissors. The disk of donated healthy corneal tissue is then secured to the recipient cornea by the means of sutures using micro-surgical techniques. Penetrating keratoplasty can provide dramatic improvements in vision in patients who have opacified or irregularly shaped corneas. Approximately, 40,000 corneal transplants are performed annually in the United States. 
     However, there are distinct disadvantages of penetrating keratoplasty. For example, penetrating keratoplasty has a long recovery time and typically takes between 6 to 12 months to achieve good vision. Moreover, because the donor corneal tissue is sutured manually, even in the hands of an experienced corneal surgeon, irregularities in the shape of the cornea frequently occur and can produce decreased vision because of induced astigmatism. The donated corneal tissue can also be rejected by the recipient&#39;s immune system with resulting loss of transparency of the donated cornea. Penetrating keratoplasty also has the potential for a devastating complication called expulsive suprachoroidal hemorrhage. In this complication, a spontaneous hemorrhage from the choroidal blood vessels behind the retina can occur during penetrating keratoplasty surgery after the diseased cornea has been removed and before the donor cornea has been sutured securely in place. Because the eye is open to atmospheric pressure in this situation, there is no normal intraocular pressure to stop the choroidal vessels from bleeding. The terrible result is that the retina, vitreous, and crystalline lens may be expulsed from the opening in the cornea resulting in blindness. This complication is estimated to occur approximately 1 in 500 cases with penetrating keratoplasty. Endophthalmitis (i.e. infection of the inside of the eye) is another serious complication that can occur and can also cause blindness if treatment is unsuccessful. Finally, after penetrating keratoplasty, the eye is very sensitive to injury, since the junction of the transplanted cornea and the recipient cornea can be easily disrupted with even mild trauma. 
     Because of the disadvantages of penetrating keratoplasty other methods of corneal surgery have recently been developed, as follows. 
     Lamellar keratoplasty is the general term for corneal surgeries that involve cutting within the layers (lamellae) of the cornea. Lamellar keratoplasty techniques allow removal and replacement of specific layers of the cornea. It is useful to be able to remove and transplant specific layers of the cornea because there are common corneal conditions that involve only certain layers of the cornea. 
     For example, a scar in the cornea from a herpes virus infection may affect only the superficial layers of the cornea. Removal and transplantation of the superficial layers of the cornea may be all that is necessary to restore sight to an eye that has a superficial scar and avoids many of the complications that can be associated with penetrating keratoplasty including endophthalmitis and expulsive suprachoroidal hemorrhage. 
     Another example would be Fuchs&#39; endothelial dystrophy. The endothelium is the innermost layer of the cornea, which is responsible for pumping fluid out of the corneal tissues. This removal of fluid prevents the cornea from swelling and becoming opaque. In Fuchs&#39; endothelial dystrophy, the endothelium is damaged and is unable to adequately pump fluid out of the cornea, which results in swelling and opacification of the cornea. Removal of the diseased inner layers of the cornea and transplantation with a layer of healthy tissue can restore clarity to the cornea and vision to the eye. By only exchanging the inner layers of tissue, the front surface of the cornea is essentially undisturbed. This decreases the likelihood of post-surgical astigmatism and may also result in less risk of rejection of the transplanted tissue. 
     A particular technique of lamellar keratoplasty is anterior lamellar keratoplasty. Anterior lamellar keratoplasty is a procedure where the superficial layers of the cornea are separated from the deeper layers with a hand held scalpel or an automated corneal surgical device called a microkeratome. Using this technique, a cap of the superficial layers of the cornea is removed and then replaced with a healthy cap from the superficial layers of the donor cornea. 
     Unfortunately, corneal tissue removal and replacement by the free hand method is extremely difficult to perform. Under the best of circumstances, it usually results in irregular astigmatism that is caused by irregularities in the thickness of the corneal tissue removed as well as in the thickness of the transplanted tissue. The irregular astigmatism typically limits the best spectacle corrected vision to no better than 20/40. 
     As stated above, automated anterior lamellar keratoplasty involves the excision of a cap of superficial corneal tissue by the use of a microkeratome. Similarly, the same apparatus can be used to prepare a cap of superficial donor corneal tissue for transplantation. The donor tissue is then sutured to the recipient cornea. The sutures are typically removed within the first few months to minimize astigmatism. Unfortunately, a problem that can occur with this technique is that the transplanted donor disk may be dislodged with relatively minor trauma, even after prolonged periods of time. This can occur because the cap of corneal tissue is only held in place by the relatively weak healing between the layers of donor and recipient tissue and there is no support against lateral or vertical pressure. 
     Another particular technique of lamellar keratoplasty is posterior lamellar keratoplasty. Posterior lamellar keratoplasty is a procedure where the deeper (i.e. rear) layers of the cornea are separated from the superficial layers with a hand held scalpel or an automated microkeratome. A disk of the deeper layers of the cornea is removed and then replaced with a healthy disk from the deeper layers of the donor cornea. 
     In the free hand posterior lamellar keratoplasty technique, a blade is manually used to create a pocket in the deep layers of the cornea. An internal manual trephine is then used to cut a disk of the deepest corneal layers. The disk of the deepest corneal layers is then excised with microsurgical scissors and or scalpels. 
     The donor corneal disk of the deepest corneal layers is then harvested by one of three methods. 
     In a first method a fresh whole donor eye is pressurized with balanced salt solution and a free hand dissection is used to create a pocket within the deep layers of the cornea. The donor disk of the deepest corneal layers is then excised with a trephine, microsurgical scissors, or scalpels. Difficulties with this method include the extremely tedious and difficult nature of the surgical dissection, the potential for inadvertently destroying the donor disk as part of the dissection, and the difficulty with finding a fresh human cadaveric donor eye that is available for surgery within 48 hours of the donor&#39;s time of death. Unlike excised donor corneas, whole donor eyes lose their viability to be used as donor tissue within 48 hours. 
     In a second method, a donor cornea and attached scleral rim is placed within a free standing anterior chamber maintainer. The donor cornea is then pressurized to maintain rigidity of the corneal tissue. A free hand dissection then ensues to create a partial thickness cornea of the deepest layers only. The disk of tissue is then excised using a trephine. Again, a significant problem with this method of harvesting donor tissue is that the free hand dissection is difficult and time consuming. There is also the risk of damaging the donor tissue through the dissection that renders it useless for transplantation. 
     In a third method, the donor cornea and attached scleral rim are placed within a free standing anterior chamber maintainer. The donor cornea is then pressurized to maintain rigidity of the corneal tissue. A separate prior art flap or cap making microkeratome that is adapted for use with the anterior chamber maintainer is used to create a flap or cap in the donor tissue. A disk of tissue is then excised from the partial thickness layers of the cornea that were created by the microkeratome. The primary problem with this method is that a separate prior art expensive flap or cap making microkeratome device is required to harvest the corneal tissue. Moreover, the flap or cap making microkeratome cannot be used to create the corneal pocket. 
     Once the disk of the deepest corneal layers is harvested, it is then placed inside the manually created pocket to fill the space of the excised corneal tissue. The transplanted disk of tissue initially stays in place by the pumping mechanism of the corneal endothelial cells and then gradually heals into place permanently. One significant advantage of this technique is that post-operatively, the eye is much less susceptible to injury than in other methods of corneal transplantation. Moreover, because the transplantation occurs within a pocket of the corneal tissues, the transplant is well protected by the intact boundaries of the corneal pocket. Unfortunately, a disadvantage of such free hand technique is that it is very difficult to manually create a pocket in the corneal tissues, wherein the pocket is of uniform depth. Rather, it is quite possible to either prematurely cut through the deepest layers of the cornea and thus enter the anterior chamber, or to accidentally cut too superficially and thus exit from the superficial cornea. The inability to create a uniform pocket will necessitate the abandonment of posterior lamellar keratoplasty and may require conversion to traditional penetrating keratoplasty. 
     Using a motorized microkeratome for posterior lamellar keratoplasty involves the creation of a flap of corneal tissue with a motorized blade. This is followed by excision of a disk of the deepest layers of the cornea including the endothelium. The excised disk of corneal tissue (including the endothelium) is replaced by the same layers from a donor cornea. The donated corneal disk is then secured in place with sutures. The corneal flap of the recipient cornea is also secured with sutures for up to several months. A disadvantage of this technique is that, like penetrating keratoplasty, the inside of the eye is exposed to atmospheric pressure and therefore there is also a risk of suprachoroidal hemorrhage with this technique. Another disadvantage is that post-operatively the eye is still fairly vulnerable to injury. For example, even minor trauma could result in flap dislocation or rupture of the transplant-recipient junction. 
     Recently anterior lamellar keratoplasty and posterior lamellar keratoplasty have also been performed on an experimental basis where the incisions have been created with a laser. Two disadvantages of this technique are the high cost of lasers and potential difficulty for the laser to create incisions in corneas that are scarred or opacified. See U.S. Pat. No. 6,325,792 to Swinger et al. 
     Ametropia, the incorrect focusing of light rays onto the retina, is the most common cause of decreased vision in humans. Common examples of ametropia include myopia, hyperopia or hypermetropia, and astigmatism. Because the cornea is the primary focusing lens in the eye, modification of the shape of the cornea by surgery has the ability to cause dramatic improvements in vision in patients that have ametropia. 
     LASIK (laser assisted in situ keratomileusis) is a method of laser vision correction that can dramatically improve vision by changing the shape of the cornea to allow the proper focus of light rays onto the retina. In the LASIK technique, a motorized blade is used to cut away a thin flap of tissue from the front of the cornea. The flap of corneal tissue is then lifted to expose the interior surface of the cornea. This exposed interior surface is then reshaped by the application of laser light. The flap of corneal tissue is then repositioned over the reshaped interior portion of the cornea. The flap initially stays in position through the natural pumping mechanism of the corneal endothelial cells and then gradually heals into place permanently. In this procedure, there is considerable variability in the size and shape of the laser treatment. However, with current corneal surgical devices the size and shape of the flap that covers the laser treatment is unfortunately rather limited. Another disadvantage of this procedure is that some corneal tissue is destroyed permanently as part of the vision correction process, due to the vaporization of corneal tissue by the laser. 
     Another vision improvement technique is keratophakia. Keratophakia is the insertion of a lens within the cornea. Keratophakia can also modify the curvature of the cornea for the purpose of improving a patient&#39;s vision. In Keratophakia, a pocket is made within the corneal tissues usually by means of a hand held blade. U.S. patent application Ser. No. 2001/0004702 to Peyman describes a non-motorized apparatus for creating such a pocket within the cornea. In the Peyman device, movement of the blade is created by manually twisting the blade. After the pocket is made within the corneal tissue, an organic or synthetic lens is implanted within the pocket to reshape the cornea in order to change the focus of light rays. The disadvantage of either a manual technique or a non-motorized technique is that the uniformity of the pocket is largely dependent on the surgeon&#39;s skill and experience and therefore there can be a high degree of variability. The Peyman device is designed only for the purpose of creating a pocket within the cornea of a living patient and cannot be used for the purpose of creating a pocket within a donor cornea. 
     U.S. Pat. No. 6,599,305 to Feingold describes a motorized apparatus for creating a pocket within the cornea for the purpose of lens implantation. In this invention, the blade assembly oscillates laterally while extending forward into the cornea to form the pocket, and the amplitude of the lateral oscillation increases as the blade goes beyond an entry incision into the cornea. A disadvantage of this method of automatically creating a pocket within the cornea is that the width of the entry incision will necessarily be relatively large compared to the width of the pocket. The Feingold device cannot create a pocket with an entry incision width that is less than half of the maximum width of the pocket. The Feingold device also cannot create a pocket that is more than twice the width of the cutting blade. Having a larger entry incision will cause slower healing, increase the risk of induced corneal astigmatism, and usually necessitate the need for suture closure. The Feingold device is designed exclusively for the purpose of creating a pocket within the cornea of a living patient and cannot be used for the purpose of creating a pocket within a donor cornea. 
     Because of the apparent difficulties with the current corneal surgical devices there is still a continuing need for an improved apparatus and method to create a pocket, flap, or a cap of corneal tissue in a live or donor cornea, wherein the pocket, flap, or cap is of uniform depth and thickness. In particular, it would be desirable to provide methods and systems for cutting cornea pockets where the ratio of pocket width to width of the entrance channel is maximized. 
     DESCRIPTION OF THE BACKGROUND ART 
     U.S. Pat. Nos. 6,599,305 B1 and 5,964,776, describe methods and apparatus for creating corneal pockets for implanting lenses. Other pertinent patents and published applications include U.S. Pat. Nos. 6,385,260; 6,344,046; 6,332,890; 6,325,792; 6,296,650; 6,277,134; 6,228,099; 6,139,560; 6,045,563; 6,045,562; 6,022,365; 5,944,731; 5,807,380; 5,779,723; and US2002/0,091,401; US2002/0045910; and US2001/0004702. 
     BRIEF SUMMARY OF THE INVENTION 
     Improved systems and methods for cutting the cornea of an eye, particularly for forming internal pockets in the eye, are provided. The systems and methods allow for corneal pocket formation using a relatively small initial incision while providing a pocket having a relatively large width or diameter. 
     Systems for cutting the cornea of an eye in accordance with the present invention comprise a frame, a moveable member having a cutting blade at a distal end thereof, and a driver coupled to the moveable member. The frame can be immobilized relative to the eye and will usually comprise a suction ring and an applanating plate. The driver is adapted to both translate and rotate the moveable member relative to the frame. By having such freedom of movement, motion of the moveable member can be limited within a relatively small entrance incision while motion of the cutting blade is relatively unrestricted. 
     In the exemplary embodiments, the moveable member is linear, but the moveable member could also be non-linear, for example being curved, curved-in-part, angulated, or having other non-linear configurations. 
     The moveable member may be suspended relative to the frame in a variety of ways. Most commonly, the moveable member will be positioned to rotate on a pivot, where the pivot can be translated and/or moved over a two-dimensional plane. Alternatively, the moveable member may be mounted a fixed pivot, where the moveable member can translate and/or rotate over the pivot. When the pivot translates, the path of translation may be linear or non-linear, typically being linear and aligned with a centerline through the frame. The pivot itself may comprise a pin or other protrusion to support the moveable member. In other embodiments, however, the “pivot” may comprise lateral restraints which allow the moveable member to translate while limiting lateral movement of the moveable arm at the point of the restraints, i.e., mimicking a pivotal support where the arm translates and rotates over the pivot. 
     In other embodiments, the moveable member will be manipulated on a “pivotless” system. Such pivotless systems may provide for essentially unlimited freedom of motion in a two-dimensional plane. Such drivers may comprise parallelogram linkages, cable supports, and other known mechanical drive systems. 
     In all cases, the moveable arm may be manually positioned, often using a template or other motion guide. In the presently preferred embodiments, however, the moveable arm will be driven by a powered system, typically a motor, which is automatically controlled using a computer, programmable controller, or other control system which can be programmed to achieve a precise and selectable pocket size. 
     The systems of the present invention will be particularly useful for performing corneal transplants. In such cases, the systems will frequently further comprise an anterior chamber maintainer which can be used to hold a donor cornea prior to harvesting the corneal implant. In particular, the anterior chamber maintainer will be adapted for use together with the moveable member, cutting blade, and driver in place of the corneal frame. In that way, the implant which is cut from the donor cornea will precisely match the thickness of the hole which is cut by the same system when used on the cornea with the frame. The peripheral dimensions of the implant will, of course, be determined by the separate cutting blade which is used for both the donor cornea and the recipient cornea. 
     The present invention further provides methods for forming a pocket in a cornea. The methods comprise advancing a cutting element at a distal end of a moveable member through an entry incision in the cornea. Movement of the movable member is controlled to cause the cutting element to create a pocket having a width in at least one direction through a center of the cornea which is greater than twice a width of the entry incision. Usually, the entry incision has a width which is no greater than 4 mm and the pocket has a width which is greater than 8 mm. Preferably, the pocket will have a width of at least 8 mm, and in some cases the width will be at least 10 mm. 
     The ratio of the pocket width or diameter relative to the entry incision width can be maximized by using a moveable member having a relatively narrow width, at least at a region through which the member passes through the entry incision. Usually, the width will be no greater than 1 mm over this region. 
     Controlling the moveable member typically comprises both translating and rotating the moveable member relative to the cornea. Such translating and rotating can be achieved in a number of ways, generally as described above in connection with the systems of the present invention. Briefly, the moveable member may be rotated on a pivot point, where the pivot point is capable of being translated and/or the moveable member may translate over the pivot point. In other embodiments, the pivot point may be fixed relative to the cornea and the moveable member translated over or under the pivot point. In addition to being useful for performing corneal transplantation, the methods of the present invention can be used for implanting a lens in the pocket which is formed. Frequently, the lens will restrained to pass through the narrow width entry incision and released to its expanded configuration within the pocket. The methods, of course, are also useful for implanting a corneal graft in the pocket as generally described above. 
     In yet another aspect of the present invention, a method for cutting a pocket in a cornea comprises advancing a cutting element at the distal end of a moveable member through an entry incision into the cornea. Movement of the moveable member is controlled to cause the cutting element to create a pocket, where the moveable member is both rotated and translated relative to the cornea. The rotation and translation of the moveable member may be achieved by any of the techniques described above using a pivot point or using a pivotless driver. Preferred dimensions of the entry incision and ratios between the width of the entry incision and dimensions of the corneal pocket have also been described previously. 
     In a still further aspect of the present invention, methods for transplanting a cornea comprise creating a pocket in the cornea of the patient, where the pocket has an entry incision with a width less than that of the pocket. A cylinder of tissue is removed from over or under the pocket while the remaining portions of the corneal tissue remain intact to limit exposure of the interior of the eye to atmospheric pressure. The removed cylinder of tissue may then be replaced with donor tissue, where the interior of the cornea remains protected from exposure to the atmospheric pressure. The procedure is useful for both anterior lamellar keratoplasty and posterior lamellar keratoplasty. The pocket is typically created by advancing a blade into the cornea while flattening the cornea with an applanator. Optionally, the donor tissue may be harvested with the same pocket making device that was used to create the pocket in the recipient cornea. In such instances, the donor cornea may be supported on an anterior chamber maintainer which the cornea is cut with the cutting element. 
     In an additional aspect of the system of the present invention, an anterior chamber maintainer for harvesting a donor cornea comprises a support for the donor cornea useful while a pocket forming device creates a pocket within the donor cornea. 
     The inventions described above provide a number of advantages and benefits. In preferred aspects, the present invention provides a system for cutting the cornea of an eye, comprising a moveable member that may be translated or rotated within a plane in a non-manual or manual fashion, a cutting element at one end of the moveable member, a suction ring for stabilizing the cornea, and an applanator for flattening the cornea. 
     In preferred aspects, the moveable member has a cutting blade at one end, a pivot element disposed thereon, a cutting guide restraint disposed thereon, a mechanism for oscillating the moveable member around the pivot element, a cutting guide software program which controls a programmable motor that engages the cutting guide restraint on the moveable member and thereby limits the degree of angular movement of the cutting blade as the moveable member rotates about the pivot element, and a cutting guide software controlled positioning system configured to advance the moveable member with respect to the cornea 
     In further preferred aspects of the invention, the moveable member, cutting element, suction ring, and applanator are all disposable. 
     In still further preferred aspects, the cutting element may be a solid blade or any other cutting mechanism appropriate to cut the cornea e.g. electromagnetic energy such as a laser or plasma field. 
     In alternate preferred aspects of the invention, the pivot element of the moveable member may be adjustably or selectively positioned relative to the cutting path. Adjusting the position of the pivot element allows the cutting blade to move within a pocket that has a small opening. 
     In one embodiment, the position of the pivot element is determined by a cutting guide software program that commands a programmable motor to move the pivot element along a specified path. The path of the pivot element of the moveable member may be either linear or non-linear. 
     Other embodiments can be envisioned where the movement of the pivot element is controlled by wires, pistons, pneumatics, or magnetism, these are all within the scope of the present invention. In additional preferred aspects, the angles of the cutting guide restraint and the cutting blade are determined by the relative position of the pivot element of the moveable member and a restraining element engaged to the cutting restraint. 
     In preferred aspects the cutting blade is able to create a pocket with an internal maximum width that is larger than twice the entry incision width. 
     In further preferred aspects of the invention, the moveable member may have a fixed pivot point relative to the cornea. The moveable member may translate over or under the pivot point as well as rotate around the pivot point while a cutting element attached to one end of the moveable member creates a cut in the cornea. 
     In alternative preferred aspects, the moveable member may have a fixed pivot point relative to the cornea and the moveable member is able to shorten and lengthen its portion that is proximal to the cornea while a cutting element attached to one end of the moveable member creates a cut in the cornea. 
     In other alternate preferred aspects of the invention, the moveable member may have no pivot element. The angular position of the moveable may be determined by applying a pushing or pulling force to at least one point on each side of the moveable member. Angular and translational positioning of the moveable member may be achieved by any form of a mechanical, electrical, magnetic or pneumatic system, but the present invention is not so limited. 
     In yet other preferred aspects, the cutting element may be deformable in shape and size. This advantageously allows a larger pocket to be created through a relatively small opening. 
     In still more preferred aspects of the invention, one or all of the following components are disposable: the cutting guide, the mechanism for oscillating the moveable member, the applantor, and the suction ring. 
     In yet more preferred aspects, the cutting guide software determines the shape of a cut made by the cutting blade by simultaneously controlling the angle of the cutting blade and the relative position of the cutting blade to the cornea. The cutting guide software program controls the angle and position of the blade by giving commands to one or more programmable motors such as a stepper or servo motor to change the angle of the blade as the blade is advanced into the cornea by a programmable drive motor. 
     In additional alternate preferred aspects, the mechanism for oscillating the moveable member around the pivot element may comprise any form of a mechanical, electrical, magnetic or pneumatic system, but the present invention is not so limited. 
     In yet additional alternate preferred aspects, the positioning system that moves the moveable member relative to the cutting guide may comprise any form of a mechanical, electrical, magnetic or pneumatic system, but the present invention is not so limited. 
     In specific aspects of the invention, the present invention also provides a method of cutting a cornea, including: penetrating a cornea with a cutting element at one end of a moveable member; non-manually moving or rotating a moveable within a plane; and advancing the moveable member with respect to the cornea, thereby cutting the cornea with the cutting blade. 
     In preferred aspects, a pivot point of the moveable member is advanced with respect to the cornea in order to advance the blade into the cornea. In one embodiment, the position of the pivot point may be adjusted in a controlled fashion by a linkage to a programmable motor. In another embodiment, no pivot element is used and the angle and position of the moveable member is not limited by a pivot point. In further preferred aspects, the cornea is stabilized with a suction ring; and the front surface of the cornea is flattened with an applanator prior to penetrating the cornea with the cutting blade. In alternate preferred aspects, a donor cornea is stabilized prior to cutting by an optional anterior chamber maintainer that attaches to the present invention. 
     In preferred aspects, the path of the moveable member may either be linear or non-linear as it cuts the cornea. An example of a non-linear path would be an arcuate path. In one embodiment of the device, the moveable member is rotated into the cornea as it oscillates to create the pocket. 
     In different embodiments, the applanator may be held at a fixed position as the cutting blade cuts through the cornea, or the applanator may be advanced across the cornea as the cutting blade cuts through the cornea. The applanator may be in the form of a plate that can flatten the majority of the cornea or it may be an applanator that is only sufficiently large to flatten the portion of the cornea that is being cut. The applanator may also move in conjunction with the cutting blade, so that the portion of the cornea that is to be cut will be flattened in advance of the cutting blade. 
     Accordingly, the present invention provides a system and method of creating a pocket of uniform depth in the cornea. The pocket can be made of various shapes and sizes, between various layers of a live or donor cornea. 
     One advantage of the present system is that it is able to create a pocket of uniform depth within the cornea. Another advantage of the present system is that it is able to create a cut into the cornea wherein the cut has an external opening that is smaller than the internal dimensions of the pocket. In particular, the present system is able to automatically or manually create a pocket with an external incision width that is smaller than half of the maximum pocket width, e.g., larger than twice the width of the cutting blade. 
     Accordingly, the present invention may be used to transplant a portion of the inner layer of the cornea with a number of advantages. A significant safety advantage is that the transplantation may occur in a relatively closed system protected from atmospheric pressure. This reduces the risk of expulsive suprachoroidal hemorrhage. Being able to create a relatively large pocket also has the advantage of being able to transplant a larger section of the donor cornea with a corresponding larger number of healthy corneal endothelial cells. Additionally, having the external opening smaller than the internal dimensions of the pocket will also make the eye much more resistant to trauma than would be the case in penetrating keratoplasty. Moreover, the ability to make a small external opening will increase the speed of healing, decrease surgically induced astigmatism, and allows sealing of the wound without the use of sutures. 
     The present invention also allows the convenient harvesting of a donor graft for both anterior and posterior lamellar keratoplasty. The optional anterior chamber maintainer device allows the creation of a pocket within a donor cornea. A disk of donor tissue from above or below the pocket can then be excised with scissors or a trephine for the purpose of anterior or posterior lamellar keratoplasty. Advantageously, the same pocket making device that is used to create a pocket within the layers of the recipient cornea may be used to harvest the donor corneal tissue, thus increasing the ease of the procedure and eliminating the expense of purchasing a separate device to harvest the donor corneal tissue. 
     The present invention also describes an anterior chamber maintainer that may be adapted to function with any pocket forming device such as those described by Peyman in U.S. Pat. Application 20010004702 and Feingold in U.S. Pat. No. 6,599,305 to allow harvesting of donor corneal tissue . 
     The present invention may also be used to insert a reversibly deformable lens into the cornea. Having an external opening that is smaller than the internal dimensions of the pocket will help protect against extrusion of the lens. Having a larger pocket area also has the advantage of being able to insert a larger lens, which can result in improved vision especially for patients that have large pupils. Specifically, a pocket which has a width that is larger than at least 5 mm will be able to contain a lens that is at least 5 mm in diameter. A lens inserted within the cornea with a diameter of at least 5 mm is more likely to be compatible with acceptable vision than a lens smaller than 5 mm. Moreover, the ability to make a small external opening will increase the speed of healing, decrease surgically induced astigmatism, and allows sealing of the wound without the use of sutures. 
     The reversibly deformable lens may be folded or squeezed by forceps to allow entry through the small external opening. The deformable lens may also be composed of a thermally reactive polymer that allows the implant to be in a shape that easily fits through the small external opening at room temperature (e.g. a rod) and then allows the implant to change into a final shape (e.g. a disk) that is well retained within the pocket. In preferred aspects the deformable intracorneal lens should be bio-compatible with the cornea and will allow diffusion of oxygen, carbon dioxide, other gases, glucose and other nutrients through the implanted lens and cornea. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a top plan view of the moveable member and associated cutting guide. 
         FIG. 2  is a side elevation view corresponding to  FIG. 1 . 
         FIG. 3  is a view similar to  FIG. 1 , but additionally showing (in dotted lines) the moveable member moved to a second position at which a cutting guide restraint on the moveable member contacts a side of the cutting guide. 
         FIG. 4  is a side elevation view corresponding to  FIG. 3 . 
         FIG. 5A  is a top plan view showing the moveable member moved from a first position at which the cutting guide restraint contacts one side of the cutting guide (shown in solid lines) to a second position at which the cutting guide restraint contacts the other side of the cutting guide (showing in dotted lines). 
         FIG. 5B  is a top plan view showing the linkage of the moveable member to a motor as consisting of two links connected by a joint. 
         FIG. 5C  is a schematic side elevation view showing that the presence of two sequential links connected by a joint can minimize vertical up and down motion of the moveable member. 
         FIG. 6A  is a schematic side elevation view of an embodiment of the invention in which a non-moving applanating plate flattens the surface of the cornea prior to cutting. 
         FIG. 6B  is a schematic side elevation view of an embodiment of the invention in which a non-moving applanating plate flattens the surface of the cornea during cutting. 
         FIGS. 7A and 7B  are sequential schematic side elevation views of an embodiment of the invention in which an applanating plate advances across the surface of the cornea simultaneously with the cutting blade cutting through the cornea. 
         FIG. 7C  is a front elevation view of the embodiment of the invention shown in  FIGS. 7A and 7B . 
         FIG. 8A  is a side elevation view of an optional anterior chamber maintainer that may be affixed to the suction ring of the present invention. 
         FIG. 8B  is a sectional side elevation view corresponding to  FIG. 8A , showing inner workings of the anterior chamber maintainer. 
         FIG. 9  is a sectional side elevation view of an embodiment of the invention in which an operator manually depresses a plunger to advance the cutting blade. 
         FIG. 10  is a top plan view of an embodiment of the invention in which the cutting blade is advanced through a curved path into the cornea. 
         FIG. 11  is corresponding side and top views of anterior lamellar keratoplasty procedure performed with prior art techniques. 
         FIG. 12  is corresponding side and top views of anterior lamellar keratoplasty procedure performed with a technique in accordance with the present invention. 
         FIG. 13  is corresponding side and top views of a posterior keratoplasty procedure performed with prior art techniques. 
         FIG. 14  is corresponding side and top views of a posterior keratoplasty procedure performed with a technique in accordance with the present invention. 
         FIG. 15A  is a top plan view of a mechanical system for moving a moveable member and cutting blade in accordance with the principles of the present invention. 
         FIG. 15B  is a side view of a system employing the mechanism of  FIG. 15A . 
         FIG. 16  illustrates an alternative mechanical system for manipulating a moveable member and cutting blade. 
         FIG. 17  illustrates a system where the moveable member is mounted on a pivot point which moves over a circular path. 
         FIGS. 18A-18D  provide an example of the motion of the cutting system of  FIG. 17 . 
         FIG. 19  is yet another embodiment of a mechanism for manipulating a moveable member and cutting blade in accordance with the principles of the present invention. 
         FIGS. 20A-20D  illustrate how a large pocket can be made through a small incision over a fixed pivot point. 
         FIG. 21  illustrates a pivotless driver for manipulating a moveable member and cutting blade in accordance with the principles of the present invention. 
         FIGS. 22A-22D  illustrate a prior art cutting system which lacks the advantages of the present invention. 
         FIGS. 23A and 23B  illustrate a system constructed in accordance with the principles of the present invention having an applanator slightly larger than the cutting element. 
         FIGS. 23C-23F  illustrate movement of the cutting blade in the systems of  FIGS. 23A and 23B  as illustrated. 
         FIGS. 24A-24C  illustrate methods in accordance with the principles of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In preferred aspects, the present invention provides a corneal surgery system that can be used to cut a live or donor cornea to form a pocket, flap or cap by separating the layers of the cornea. Specifically, the present invention provides a system for automatically creating a pocket of uniform depth, which can be of various shapes and sizes, between the layers of a live or donor cornea. The present invention may also be used to create a flap or cap of corneal tissue in a live or donor cornea. 
     In accordance with the present invention, a system for cutting a cornea is provided. The system comprises a cutting blade that is moved back and forth in an arcuate path while simultaneously being advanced to cut through a cornea. As will be explained, the degree of angular movement of the cutting blade is limited by contacts between a moveable member (to which the cutting blade is attached) and a cutting guide. 
     Operation of the present invention can be understood by reference to  FIGS. 1 to 5  which illustrate the movement of the moveable member with respect to the cutting guide. 
       FIGS. 6A to 7C  and  9  and  10  show further details of various embodiments of the present invention. 
       FIGS. 8A and 8B  show an optional attachment device that can be used with various embodiments of the present invention. 
     Lastly,  FIGS. 11 and 13  show surgical cutting procedures performed by pre-existing techniques.  FIGS. 12 and 14  show comparable surgical cutting procedures performed with the system of the present invention. 
     Referring first to  FIGS. 1 and 2 , a moveable member  10  is provided. Moveable member  10  has a cutting blade  12  at one end. In optional aspects, cutting blade  12  may be made of steel, stainless steel, sapphire, diamond, plastic or ceramic, but is not so limited. Rather, any material suitable for cutting the cornea may be used. Moveable member  10  has a pivot  14  thereon. As will be shown, moveable member  10  is oscillated such that it sweeps back and forth in an angular path of direction O about its pivot  14 . Moveable member  10  further includes a cutting guide restraint  16  projecting therefrom. Cutting guide restraint  16  is received with a hole  22  of a cutting guide  20 . 
     As shown in  FIGS. 2 and 4 , cutting guide restraint  16  projects from the bottom of moveable member  10  and cutting guide  20  is positioned below moveable member  10 . The present invention is not so limited. Alternate embodiments are possible, all keeping within the scope of the present invention. For example, cutting guide restraint  16  may instead project from the top of the moveable member with cutting guide  20  being placed above moveable member  10 . Other designs are also possible. 
     In accordance with the present invention, corneal cutting is performed by angular back and forth movement (i.e.: oscillation in direction O) of moveable member  10  about pivot  14  at the same time that pivot  14  is advanced in direction D with respect to cutting guide  20 . As moveable member  10  is advanced in direction D, cutting guide restraint  16  will contact successive locations around the sides of hole  22  in cutting guide  20 . The novel shape of hole  22  in cutting guide  20  will have the effect of limiting the degree of angular (i.e., side to side) motion of cutting blade  12 . Accordingly, as cutting blade  12  is advanced in direction D with respect to cutting guide  20  (by advancing pivot  14  of moveable member  10  in direction D), the novel shape of hole  20  will cause cutting blade  12  to cut a preferred shape of cut in the cornea. 
     This can be seen as follows. Referring to  FIG. 3 , moveable member  10  is rotated in direction R about pivot  14  to the position shown in dotted lines as  10 A. At such location, cutting guide restraint reaches the position shown in dotted lines as  16 A (at which time it contacts the side of hole  22 , as shown). Blade  12  is thus not able to rotate further in direction R than to the position shown in dotted lines as  12 A. Thereafter, moveable member  10  will be rotated in the opposite direction such that cutting guide restraint  16  will instead contact the opposite side of hole  22  (thus limiting maximum angular movement in the opposite direction). 
     Concurrently, moveable member  10  will be moved in direction D with respect to cutting guide  20 . This movement is shown by referring first to  FIG. 4  and then to  FIG. 2 . ( FIG. 4  shows the position of the moveable member with respect to the cutting guide when cutting is first commenced, and  FIG. 2  shows the position of the moveable member with respect to the cutting guide after cutting has been carried out for some time.) 
       FIG. 5A  illustrates a mechanical system for oscillating moveable member  10  back and forth in direction O. Specifically,  FIG. 5A  shows moveable member  10  at a first maximum angular extension (shown in solid lines) and moveable member  10  at an opposite maximum angular extension (shown in dotted lines). In preferred aspects of the invention, moveable member  10  includes a flexible portion  18 . Flexible portion  18  may optionally comprise a spring or a flexible piece of plastic or rubber. As can be seen, an advantage of having portion  18  flexible is that it bends when cutting guide restraint  16  is stopped from further angular movement by its contact with the sides of hole  22 . A system  30  for oscillating moveable member  10  may include a motorized mechanical linkage for rotating moveable member  10  back and forth by alternatingly moving flexible portion  18  back and forth in a direction generally perpendicular to direction D. For example, system  30  may include a motor  32  that rotates a wheel  34  (by rotating shaft  35 ). A pin  33  is eccentrically mounted to wheel  34  such that as wheel  34  rotates, the movement of pin  33  causes link  36  to move back and forth, thereby repetitively moving moveable member  10  back and forth between positions (shown as  10  and  10 A). 
     In preferred aspects, link  36  may include more than one link member connected together in series. An advantage of having link  36  include more than one link member is that this can minimize up and down movement of the flexible portion  18  and moveable member  10  as pin  33  moves around shaft  35 .  FIG. 5B  shows link  36  consisting of portions  36 A,  36 B, and  36 C. Portion  36 C is a joint which connects portion  36 A and  36 B.  FIG. 5C  shows how joint  36 C allows portion  36 A to move in a vertical up and down motion while portion  36 B moves predominantly in a transverse horizontal motion relative to pivot  14 . Portion  36 B, therefore transmits predominantly horizontal back and forth motion to flexible portion  18  and moveable member  10  around pivot  14  and minimizes up and down motion. 
     As can be seen in  FIGS. 1 ,  3  and  5 , hole  22  in cutting guide has a novel shape. In particular, hole  22  has a “gourd” or a “bowling pin” shape. The present inventor has determined that such “gourd” or a “bowling pin” shaped hole will result in a corneal cut that is roughly shaped like an “ice cream cone” (i.e. a triangular section with a convexly-curved end). Preferably, hole  22  will have a symmetrical shape. As will be shown, a particular advantage of this shape of cut is that it will create a pocket in the cornea wherein the opening through the surface of the cornea is smaller in width than the internal dimensions of the pocket. 
     In accordance with the present invention, an applanating plate is positioned against the front surface the cornea and the intraocular pressure is elevated by a suction ring during the time the cornea is cut by the movement of the cutting blade. The applanating plate presses down against the front surface of the cornea and the intraocular pressure presses up against the back surface of the cornea, thereby uniformly flattening a portion of the cornea. This has the advantage of ensuring a uniform thickness of the cornea is cut by the cutting blade when forming a pocket, flap, or cap. 
     In one embodiment, the applanating plate is positioned at a fixed location on the surface of the cornea prior to commencing cutting of the cornea with the cutting blade. An example of such system is shown in  FIGS. 6A and 6B . In an alternate embodiment of the invention, the applanating plate is advanced over the surface of the cornea concurrently with the cutting blade penetrating and cutting across the cornea. An example of such system is shown in  FIGS. 7A to 7C . Additionally,  FIGS. 7A to 7C  show an optional anterior chamber maintainer  60  which is especially useful when cutting a donor cornea. It is to be understood that anterior chamber maintainer  60  is an optional attachment that may or may not be used with the various embodiments of the invention shown in  FIGS. 6A to 7C , as desired. 
     Referring first to  FIG. 6A , when vacuum pump  59  connected to suction ring  50  by tubing  57  via tubing connector  55 , creates a vacuum to a predetermined level, suction ring  50  holds cornea C (positioned therearound) in a fixed position. The vacuum transmitted by suction ring  50  also raises the pressure against the rearward surface of cornea C because the vacuum causes the eyeball to partially squeeze into the suction ring. The applanating plate  52  pushes down against the front surface of the cornea, thereby flattening the cornea. As illustrated, a member  42  is used to advance pivot  14  in direction D from the position shown in  FIG. 6A  to the position shown in  FIG. 6B . (The relative movement of cutting guide restraint  16  within cutting guide  20  can be seen.) In accordance with the present invention, member  42  may include any form of mechanical linkage, guide rails or even simply a portion of the housing of the device. 
       FIGS. 7A to 7C  show an alternate embodiment of the invention in which applanating plate  52  is moved across cornea C concurrently with blade  12  advancing (i.e. cutting through the cornea) in direction D. Moveable member  10 , cutting guide  20  and system  30  are all positioned inside housing  40 . As was explained above, system  30  causes moveable member  10  to rotate back and forth around pivot  14 , with cutting guide restraint  16  is received within cutting guide  20 . (In contrast to the embodiment of  FIGS. 6A and 6B ; however, pivot  14  instead projects from the bottom of moveable member  10 , and cutting guide  20  is positioned above moveable member  10 .) Member  42  is advanced in direction D within housing  40 , thereby moving moveable member  10  in direction D. Cutting guide  20  is connected to housing  40  such that cutting guide restraint  16  moves along through hole  22  therein. Further details can be seen in  FIG. 7C  in which supports  45  hold applanating plate  52  within housing  40  such that moveable member  10  is free to move side-to-side therebetween. 
       FIGS. 7A and 7B  show an optional anterior chamber maintainer  60  that may be used as an attachment to the present invention. Further details of the anterior chamber maintainer  60  are shown in  FIGS. 8A and 8B . Anterior chamber maintainer  60  is specifically used when cutting tissue in a donor cornea. The donor corneal tissue is usually provided to the surgeon in the form of an excised cornea with a small rim of surrounding scleral tissue. As stated above, the present invention is designed to cut the cornea of a living complete eyeball. However, it is also necessary to have an attachment that will also enable the invention to cut a donated cornea that has been excised from the donor eyeball. 
     In accordance with the present invention, an optional anterior chamber maintainer  60  is provided to hold a donor cornea stable after the donor cornea has been cut away from the donor eyeball. As shown in the exploded view of  FIGS. 8A and 8B , a cut away donor cornea C is placed on top of anterior chamber maintainer  60 . In this preferred embodiment, suction ring  50  has an inner threading  63 . The body of the anterior chamber maintainer  61  has an outer threading  62 . The outer threading  62  is received into the inner threading  63  of suction ring  50 . The inner threading  63  of suction ring  50  connects to outer threading of body  61 , thereby firmly holding cornea C in place by trapping cornea C between suction ring  50  and body  61 . The front surface of the cornea protrudes through the opening  51  of the suction ring. The body  61  has an interior chamber  66  that is filled with fluid or gas. A bottom portion  68  screws into the bottom end of interior chamber  66 . By rotating bottom portion  68 , the volume of interior chamber  66  can be adjusted. The top end  69  of fluid chamber  66  is open such that the fluid or gas within interior chamber  66  provides pressure against the rear surface of the donor cornea C. By providing pressure against the rear surface of donor cornea C, anterior chamber maintainer  60  simulates the pressures that would exist behind cornea C in a living eyeball. Moreover, the pressures produced in interior chamber  66  applied to the rear surface of cornea C allows the donor corneal tissue to be pressed flat against applanating plate  52  so that a cut of uniform depth can be made by blade  12 . The amount of pressure inside the interior chamber may be measured by a pressure gauge or sensor connected to opening  67 . 
       FIGS. 8A and 8B  illustrate the tubing connector  55  on the top surface of the suction ring  50 . This is an alternate location for tubing connector  55 . In  FIGS. 6A ,  6 B,  7 A,  7 B, and  9  the tubing connector  55  is shown on the side surface of the suction ring  50 .  FIG. 8B  illustrates that there is a hollow space  56  inside tubing connector  55  which communicates with the inside of suction ring  50  that allows the vacuum pump  59  to generate vacuum inside suction ring  50 . Advantageously, the generation of vacuum by vacuum pump  59  is not necessary for a cut to be made in the donor cornea C, because the cornea is already fixed in position by the anterior chamber maintainer  60  and the pressure on the rear surface of the cornea can also be sufficiently elevated by the anterior chamber maintainer  60 . 
       FIG. 9  shows another embodiment of the present invention in which the cutting blade is manually advanced by an operator. Within housing  70  are provided a guide rail or track  72  along which a cutting mechanism  74  moves. Cutting mechanism  74  may be a self-contained unit that includes moveable member  10 , cutting guide restraint  16 , a system for oscillating moveable member  10  about a pivot  14  thereon. A plunger  78  is connected to cutting mechanism  74 . A spring  76  is connected at one end to housing  70  and at the other end to cutting mechanism  74 . Spring  76  is a tension spring that tends to move cutting mechanism  74  so that blade  12  is retracted (as shown). When the operator depresses plunger  78 , spring  76  will lengthen, and cutting mechanism  74  will move forward along track  72  such that blade  12  on moveable member  10  will advance between applanating plate  52  and suction ring  50 , cutting through the cornea C. The interaction of cutting guide restraint  16  and cutting guide  20  will cause the cut to be of a preferred shape as was described above. Spring  76  will provide resistance to the forward motion of cutting mechanism  74  along track  72 , thus , limiting uncontrolled forward motion of moveable member  10 &#39;s cutting blade  12 . Optionally, a liquid dispensing system  71  to spray fluid to cool the cutting blade and the cornea during cutting. Such a liquid dispensing system may be incorporated into any of the various other embodiments of the invention, as desired. 
       FIG. 10  illustrates yet another embodiment of the invention in which a blade holder  80  having a blade  82  at one end is connected to moveable member  83  which pivots about a pivot point  84 . As shown herein, blade  82  may be wider than the bladeholder  80 , if desired. (Similarly, blade  12  may be wider than moveable member  10  in  FIG. 1 , if desired.) A motor  90  moves a linkage  88  back and forth. Linkage  88  is connected to moveable member  83  by flexible member  86  such that moveable member  83  is made to oscillate back and forth about pivot point  84 . Thus, blade holder  80  and blade  82  oscillates back and forth in direction O. Blade holder  80  has a cutting guide restraint  87  disposed thereon. Cutting guide restraint  87  mates with a cutting guide (not shown) the shape of which limits maximum angular movement of blade  82 , in the manner previously described above. The various components of the invention are mounted to a plate  92  that is connected to a rotatable member  94  that is rotated in direction R such that plate  92  is moved in direction R such that blade  82  and blade holder  80  will advance between applanating plate  52  (thereabove) and suction ring  50  (therebelow) to cut the flattened cornea. 
     As illustrated in various figures herein, pivot  14  and cutting guide restraint  16  may each comprise protrusions extending from moveable member  10 . Moreover, in various figures herein, cutting guide  20  is illustrated as comprising a hole  22 . The present invention is not so limited. For example, the pivot  14  on moveable member  10  may instead comprise a hole dimensioned to receive a protrusion therein. Moreover, the cutting guide restraint may instead comprise a slot with the cutting guide comprising some form of protrusion interacting therewith. 
     As stated above, the present invention may be used to for cutting a cornea on a living patient, or for cutting a donor cornea. Due to the accuracy of the present invention&#39;s system of cutting, the present invention may be used for removing diseased or damaged sections of a living patient&#39;s cornea, and then replacing these sections with similar shaped sections cut from a donor cornea. 
     In various aspects of performing the method of the present invention, the “section” of the cornea that is transplanted may be the front portion or the rear portion of the cornea. Cutting away a section of the front of the cornea and replacing the excised section with a donor graft is known as “anterior lamellar keratoplasty”. Cutting away a section of the rear of the cornea and replacing the excised section with a donor graft is known as “posterior lamellar keratoplasty”. 
       FIG. 11  illustrates an anterior lamellar keratoplasty procedure performed with prior art techniques; and  FIG. 12  illustrates an anterior lamellar keratoplasty procedure performed with a technique in accordance with the present invention.  FIG. 13  illustrates an posterior keratoplasty procedure performed with prior art techniques; and  FIG. 14  illustrates a posterior lamellar keratoplasty procedure performed with a technique in accordance with the present invention. In each of  FIGS. 11 to 14 , a cut passing through the exterior of the cornea is shown in solid lines and a cut passing only through the interior of the cornea is shown in dotted lines. 
     Turning first to  FIG. 11 , a standard anterior lamellar keratoplasty procedure is shown. Specifically, a cut  100  is made through cornea C such that a frontal “cap” CA of tissue is removed for transplantation. A disadvantage of transplanting a frontal cap CA formed by cut  100  is that it s rather fragile, and prone to dislocation after surgery. 
     By instead using the present invention to form a cut  102  ( FIG. 12 ), a pocket can be made in the cornea. A particular advantage of forming a pocket by cut  102  is that the pocket will have an opening  103  that is smaller than the interior width of the pocket. After the cutting blade forms cut  102 , a trephine can be used to cut straight downwards into cornea in a cylindrical shaped cut  104 . When cut  104  reaches cut  102 , a cylindrical shaped portion CY of the cornea will be formed. This cylindrical shaped portion CY of the cornea of the donor cornea can then be transplanted into a similar cylindrical shaped hole cut into the living patient&#39;s cornea. A particular advantage of transplanting such a cylindrical shaped section (as opposed to transplanting a simple cap CA as shown in  FIG. 11 ) is that a cylindrical shaped cornea section received into a cylindrical shaped hole will be much more stable and resistant to injury. Specifically, the donated corneal tissue would be much less likely to dislocate with vertical or lateral pressure following transplantation. After healing, the donor recipient disk would be much more resistant to vertical and or lateral displacement from mild trauma than superficial corneal tissue transplanted without the physical support of a rim of surrounding recipient corneal tissue. 
     Turning to  FIG. 13 , a standard posterior lamellar keratoplasty procedure is shown. A cut  110  is made in cornea C, as shown. Cut  110  does not pass fully across the cornea. Rather, a flap F of corneal tissue is formed by cut  110 . After flap F is pulled back, a trephine or trephine section is then used to cut straight downwards, thus cutting a circular shaped cut  112  forming a cylindrical shaped portion CYR of the rear of the cornea. 
     By instead using the present invention to form a cut  120 , ( FIG. 14 ) a pocket can be made in the cornea. A particular advantage of forming a pocket by cut  120  is that the pocket will have an opening  123  that is smaller than the interior width of the pocket. After the cutting blade forms cut  120 , a thin profile trephine (preferably mounted on a ring) or microsurgical scissors can be used to cut straight downwards into the deep layers of the cornea in a cylindrical shaped cut  124 , thus forming a cylindrical shaped portion CYR of the rear of the cornea. An advantage of performing the operation in this manner is that it is not necessary to form and pull back a “flap” of tissue from the front of the cornea. Instead, the entire operation is performed without a large portion of the cornea being “open” to the external environment. Rather, the only opening into the cornea is through opening  123 . This dramatically reduces the possibility for suprachoroidal hemorrhages. 
     In preferred aspects of the resent invention, openings  103  or  123  have a width of about 4 or 5 mm and interior pockets  102  and  120  have a maximum internal diameter of about 9 or 10 mm. Cylindrical corneal sections CY and CYR typically are about 7 to 8 mm in diameter in the patient&#39;s eye, and about 7 to 8 mm in diameter in the donor cornea. 
     In various aspects, the portion CYR of the donor cornea can be completely excised with the use of microsurgical scalpels and or scissors, and portion CY can be manually separated from the superficial layers of the cornea using microsurgical forceps. 
     In various aspects, viscoelastic can be injected onto the inside surface (relative to the center of tine eyeball) of the CYR portion of the donor cornea to protect the corneal endothelium. The inner layer of the cornea is then partly folded in half with microsurgical forceps, with a cushion of viscoelastic preventing the endothelium on each half of the donor disk CYR from touching together. Viscoelastic can also be used to position the donor corneal disk into the space previously occupied by the excised recipient corneal disk CYR. 
     The opening  103  or  123  of the corneal pocket may optionally be closed with sutures or tissue glue to make the wound water tight. Possible tissue glues which could be used include cyanoacrylate, fibrinogen tissue adhesives, or dendrimers. Viscoelastic can be removed from the anterior chamber using irrigation of balanced salt solution and aspiration. 
     It is to be understood that the dimensions for the size and shape of cuts made in the recipient and donor corneal tissues are merely representative of the type of surgery which can be done. Thus, variations in the dimensions and shape of the pocket, flap, cap, and corneal donor or recipient disks are expected, all keeping within the scope of the present invention. 
     Referring to  FIG. 15A  a top view of a mechanical system for oscillating moveable member  210  along non-linear path O around pivot element  214 . Specifically,  FIG. 15A  shows moveable member  210  at a first position (shown in solid lines) and moveable member  210  in a second position (shown in dotted lines). Moveable member  210  is moved from the first position to the second position along a non-linear path O, by the movement of restraining element  221  within hollow slot  216  in a cutting guide restraint  222 . Restraining element  221  in this embodiment is a protrusion, but in alternative embodiments may be a hole designed to receive a protrusion. In preferred aspects, restraining element  221  is mounted eccentrically on a wheel  235  which is connected to a programmable oscillating motor  232  ( FIG. 15B ) such as a stepper or servo motor. The programmable oscillating motor turns wheel  235  around pivot element  215  in direction O′. In this embodiment, the cutting guide comprises a software program which limits the angular motion of programmable oscillating motor  232 . Programmable oscillating motor  232  is engaged to cutting guide restraint  216  by restraining element  221 . The cutting guide software program thereby limits the degree of angular movement of cutting element  212  around pivot element  214 . Cutting element  212  may be a solid cutting blade, but may also be any other cutting mechanism appropriate to cut the cornea e.g. electromagnetic energy such as a laser or plasma field. In alternate preferred aspects, cutting element  212  is deformable in shape and size, such as in the case of a sharp wire loop that can be extended or retracted to increase or decrease the cutting surface. The deformability of the blade advantageously allows the size of the blade to increase once it is beyond the entry incision which helps to enable the creation of a large pocket through a small incision. 
       FIG. 15B  illustrates a side view of the above described mechanical system. Restraining element  221  is located within a hollow slot  216  (shown in dotted lines) of the cutting guide restraint  222 . When programmable oscillating motor  232  turns wheel  235 , moveable member  210  pivots around pivot element  214 . In preferred aspects, the movements of the programmable oscillating motor are controlled by a cutting guide (software program) encoded within encoder  237  or computer  238 . In one embodiment, the cutting mechanism including moveable arm  210 , cutting element  212 , pivot element  214 , cutting guide restraint  216 , wheel  234 , and programmable oscillating motor  232  are all mounted on a platform  242 . The cutting mechanism components can be driven forward by a programmable drive motor  239 . In preferred aspects, when programmable drive motor  239  turns a lead screw  275  that is engaged to threads  244  on platform  242 , the platform and the cutting mechanism will move forward or back. Alternative methods of moving the cutting mechanism forward and back (e.g. with motors, pneumatics, and the like) can also be used and are all within the scope of the described invention. In preferred aspects, movements of the programmable drive motor  239  are controlled by the cutting pattern guide software program that is encoded within encoder  237  and/or computer  238 . 
       FIG. 16  illustrates an embodiment where the cutting pattern guide comprises a software program that controls the movements of a programmable oscillating motor (not shown) and a programmable drive motor (not shown). The programmable oscillating motor is connected to wheel  235 . The angular movement θ 2  of blade  212 , moveable member  210 , and cutting guide restraint  216  around pivot point  214  is controlled by the movement of restraining element  221  within hollow slot  216  of cutting guide restraint  222 . Restraining element  221  is mounted on wheel  235  of radius R which rotates around center point  215 . When wheel  235  rotates, an angle θ 1  is formed between the X axis and the line through pivot point  215  and restraining element  221 . The distance between pivot point  214  and center point  215  is L. Using trigonometry the relationship between an angle θ 2  and θ 1  can be determined. The cutting guide software program thereby controls the path of the cut into cornea C by controlling the rotation of wheel  235  through the programmable oscillating motor and the movement of the moveable member along the X-axis through the programmable drive motor. Please note, during the creation of the pocket P through incision I, cornea C is temporarily flattened by the use of an applanator (not shown). The cornea C may be part of a living eyeball or may be a donor cornea that has been excised from a cadaveric (donor) eyeball. 
     As shown in  FIG. 17 , if the position of pivot point  214  is adjustable in both the X axis and the Y axis, such additional freedom of movement allows the cutting element to create a relatively large pocket P′ through a small external opening I. Specifically the maximal width W of pocket P′ may be more than twice the width of incision I. The internal boundary B of Pocket P′ is shown in dotted lines. In this  FIG. 17 , width of entry incision I is 4 mm and the maximum width W of pocket P′ is 10 mm. This can be created with a 2 mm wide blade  12 , with a moveable member  10  of 1 mm width, and a pivot element  214  which is 12 mm behind the tip of the cutting element  212 . 
     In the embodiment of  FIG. 17 , the position of pivot point  214  is made adjustable by mounting pivot point  214  on a wheel  237 . Wheel  237  turns around pivot point  215 . Restraining element  221  is mounted on a gear G′ and is located within hollow slot  216  cutting guide restraint  222 . Gear G′ is concentric to wheel  237  and is also centered on pivot  215 . Moveable member  210  and cutting guide restraint  222  are shown in dotted lines to indicate that they are beneath wheel  37  and gear G′. Gear G′ is rotated by a second gear (not shown) that is engaged to a programmable motor (not shown). The angles of the cutting element  212 , moveable member  210 , and cutting restraint  216  are determined by the relative positions of pivot point  214  and restraining element  221 . The positions of pivot point  214  and restraining element  221  are determined by two separate programmable motors (not shown) which control the rotational angles of wheel  37  and gear G′. Angle θ 3  represents the angle between the X-axis and the line drawn through pivot point  214  and center point  215  and the X axis. Angle θ 4  represents the angle between the X-axis and the line drawn through restraining element  221  and center point  215 . Angle θ 5  represents the angle between the X-axis and the line drawn through restraining element  221  and pivot point  214 . Angle θ 5  also represents the angle between the cutting element  212  and the X axis. In order to create a pocket within the cornea, cutting element  212 , moveable member  210 , cutting restraint  222 , wheel  237  are all moved toward cornea C along the X axis by a programmable drive motor (not shown), while the positions of the pivot point  214  and restraining element  221  are determined by programmable motors that are controlled by cutting guide software. 
     Table I shows a sample set of parameters for D′, θ 5 , θ 3 , Θ 4  that can be used to cut a pocket within the cornea which has a 4 mm entry incision I and an internal width W of 10 mm. The blade  12  is 2 mm wide with a moveable member  10  of 1 mm width, and a pivot element  14  which is 12 mm behind the tip of the cutting blade  12 . Positive values indicate clockwise rotation from the X-axis. Negative values indicated counterclockwise rotation from the X-axis. The following parameters can be incorporated into cutting guide software that controls programmable motors. 
     The cutting path derived from the parameters in Table I is shown in  FIGS. 18A-18D . For each distance D′ of pivot point  215  away from cornea C, the positions of blade  212 , pivot element  214 , and restraining element  221  are shown in relation to pocket P′ and incision  1 . 
     
       
         
           
               
               
               
               
             
               
                 TABLE 1 
               
               
                   
               
               
                   
                   
                   
                 Angle of 
               
               
                 Distance of Center 
                   
                   
                 Restraining 
               
               
                 of Wheel from the 
                 Angle of Blade 
                 Angle of Pivot 
                 Element 
               
               
                 Cornea D′ 
                 in degrees θ 5   
                 in degrees θ 3   
                 in degrees θ 4   
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 19 
                 0 
                 0 
                 0 
               
               
                 19 
                 −5 
                 0 
                 −9 
               
               
                 19 
                 0 
                 0 
                 0 
               
               
                 19 
                 +5 
                 0 
                 +9 
               
               
                 18 
                 0 
                 0 
                 0 
               
               
                 18 
                 −5 
                 0 
                 −9 
               
               
                 18 
                 0 
                 0 
                 0 
               
               
                 18 
                 +5 
                 0 
                 +9 
               
               
                 17 
                 0 
                 0 
                 0 
               
               
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     An alternative embodiment is shown in  FIG. 19  where the pivot point  214  is mounted on a platform  247  and restraining element  221  is mounted on platform  243 . Gear G rotates around center point  215  and gear G″ rotates around center point  217 . The rotation of gears G and G″ determines the angle of blade  212  relative to axis A. Through the use of trigonometry, a table can be created and then used to program the cutting guide software to create a corneal pocket. Combinations of rotatable wheels and platforms that move along linear paths may also be used to position pivot point  214  and restraining element  221 . 
     Another way that a relatively large pocket can be made through a small incision is to fixate pivot point  214  relative to the cornea, but to allow the moveable member  210  to translate and rotate over or under the pivot point  214 .  FIGS. 20A-20D  show the moveable member  210  translating and rotating over or under pivot point  214  to allow cutting element  212  to create a relatively large pocket P′ through a small incision I′. Usually, the mechanism (not shown) to translate or rotate the moveable member  210  over or under pivot point  214  will be mounted on translatable or otherwise positionable table to allow axial movement of the moveable member  210  relative to the cornea (not shown). 
     An example of a cutting mechanism that does not contain a pivot element is shown in  FIG. 21 . Moveable member  210  is shown having two cutting guide restraints on each side, e.g., protrusions  218 . Wires  220  are attached to protrusions  218  and programmable motors  233  that can either wind the wires to a shorter length or unwind the wires to a longer length. The programmable motors are controlled by cutting guide software. The winding and unwinding of the wires  220  applies force to the moveable member in the directions of the arrows adjacent to the wires and move the moveable member in an angular or translational way to create a cut by cutting element  212 . In this embodiment, force is applied via wires, but any form of mechanical, pneumatic, electrical, or magnetic force could be used to create the same effect. 
       FIGS. 23A and 23B  show an alternate embodiment of the present invention in which an applanator  254  is only slightly larger than the cutting element  212  and moveable member  210 . In  FIGS. 23C-23F  Applanator  254  is shown in solid lines overlying the cornea C. Blade  212  and moveable member  210  are shown in dashed lines moving within pocket P. Applantor  254  moves concurrently with moveable member  210  and blade  212  to flatten cornea C in advance of blade  212  and moveable member  210 . 
       FIGS. 23A and 23B  also show an optional anterior chamber maintainer  60  that may be used as an attachment to the present embodiment. Details of the anterior chamber maintainer  60  were previously shown in  FIGS. 7A and 8B . Anterior chamber maintainer  60  is specifically used when cutting tissue in a donor cornea. The donor corneal tissue is usually provided to the surgeon in the form of an excised cornea with a small rim of surrounding scleral tissue. As stated above, the present invention is designed to cut the cornea of a living complete eyeball. However, in order to harvest a donor cornea, it is also necessary to have an apparatus that will also enable the invention to cut a donated cornea that has been excised from the donor eyeball. The use of anterior chamber maintainers with prior art pocket forming devices has not been described. However, anterior chamber maintainers of the present invention may be adapted for use with other pocket forming devices such as such as those described by Peyman in U.S. Pat. Application 20010004702 and Feingold in U.S. Pat. No. 6,599,305 to allow harvesting of donor corneal tissue. The anterior chamber maintainer may be used for harvesting a donor cornea for any pocket forming device that requires stabilization of the donor cornea during the pocket forming process 
     The sizes, distances, positions, and angles of the components of the present embodiments are merely representative of the types of mechanical devices and software which can be created. It is to be expected that other sizes, distances, positions, and angles of components can be used, all of which are in keeping within the scope of the present invention. Although, the described embodiments of the invention describe primarily non-manual methods of translating and rotating the cutting element, it is to be understood that manual translation and rotation of the cutting element is also within the scope of the invention. 
     The present invention provides a method for creating a corneal pocket that may have a small external incision and a relatively large pocket. The corneal pocket created by the present invention may be advantageously used to retain an intracorneal lens that is reversibly deformable in shape. Once the lens is within the pocket, the small external opening prevents inadvertent dislocation or extrusion.  FIG. 24  A shows a cross-section of a human eyeball which shows the relative location of cornea C.  FIG. 24B  shows a cross-sectional view of the cornea with a pocket  330  shown in broken lines and a small external opening  333 .  FIG. 37C  shows a cross-sectional view of the cornea with a lens implant  334  within the pocket. The reversibly deformable lens may be folded or squeezed to allow entry through opening  333 . The deformable lens may also be composed of a thermally reactive polymer that allows the implant to be in a shape that easily fits through opening  333  at room temperature (e.g. a rod) and then allows the implant to change into a final well fitting shape (e.g. a disk) when it is exposed to body temperature (not shown). Once the deformable lens is implanted into pocket  330 , small external opening  333  may spontaneously self seal. Alternatively small external opening  333  can be closed with sutures or tissue adhesives. 
     Comparison between the pocket size achievable with the present invention and that achievable with a prior art device is shown in  FIGS. 22A-22B . A prior art corneal cutting device by Feingold is shown in  FIG. 22A . In this apparatus, the blade assembly  240  oscillates the blade  244  laterally via blade assembly stem  242  while extending forward into the cornea to form the pocket P″, and the amplitude of the lateral oscillation increases as the blade goes beyond an entry incision I′ into the cornea C. The inner dotted lines indicate the boundary of pocket P″. The outer dotted lines B′ indicate the boundary of a pocket created by the present invention. As shown in  FIG. 22B , the smallest theoretical possible size of the entry incision would be the maximal width BW of the cutting blade  244 . This type of entry incision would be created in the case that the blade  244  does not oscillate laterally during the entry cut. In this  FIG. 22B  the width BW of the blade is the same size as incision I′. 
     Once the blade is inside of the cornea as shown in  FIG. 22C , the limit of lateral travel of the blade is governed by the width of the entry incision I′ and the width of the blade assembly stem  242  that moves the blade. The stem of the blade assembly may not move more lateral than the lateral limit of the entry incision I′ . When the blade moves to the right, the width of the pocket is extended to the right one half of the maximal width of the blade BW minus one half the width of the blade assembly stem  242 . 
     When the blade moves to the left as shown in  FIG. 22D , the width of the pocket is extended to the left one half of the maximal width of the blade BW minus one half the width of the blade assembly stem  242 . Therefore, the maximal width of the pocket W′ is twice the maximal width of the blade minus the width of the blade assembly stem. The inner set of dotted lines F is the boundary of the pocket that can be created with Feingold&#39;s device. In the case that the width of the stem of the blade assembly approaches zero (not shown), the maximum width of the pocket is simply twice the blade width. Therefore, if the minimum width of the entry incision is the width of the blade and the maximum width of the pocket can only be twice the width of the blade, the ratio of the maximum pocket width to the entry incision width will always be less than the number two. From a practical standpoint, the ratio of the maximum pocket width to the entry incision will be significantly less than two because the blade assembly will usually need to oscillate to create the entry incision and the stem of the blade assembly cannot be zero. In this scaled drawing the maximal width of pocket P″ is equal to 7 mm, the width of the incision I′ is equal to 4 mm and the blade width BW is also equal to 4 mm. The ratio of the maximum pocket width W′ to the incision width I′ in this case is 1.75. The boundary B′ is the boundary of a pocket using the present invention. Note that boundary B′ is larger than boundary F for the same size incision I. The width of W in this scaled drawing is 10 mm and the incision width I′ is 4 mm. Please also note that the ratio of the width of the pocket for the present invention W to the width of I′ is 2.5, which is greater than the number two. 
     While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.