Preserved corneal plugs and associated systems, devices and methods for fabricating corneal plugs

Abstract

Disclosed here are several implementations directed to a system for precisely and consistently forming corneal plugs from donor corneas for transplantation and various other medical uses. Various implementations use an oscillating blade to ensure consistent incisions, tapered incisions, and / or grooves in the cornea in forming the corneal plugs.

Description

PRESERVED CORNEAL PLUGS AND ASSOCIATED SYSTEMS, DEVICES AND METHODS FOR FABRICATING CORNEAL PLUGSCROSS-REFERENCES & RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 733,305 filed December 12, 2024, and entitled “CORNEA RECOVERY DEVICE AND ASSOCIATED SYSTEMS AND METHODS,” which is hereby incorporated by reference in its entirety.

[0002] This application is related to U.S. Patent Application. No. 18 / 872,698, the various implementations and teachings thereof being incorporated into this disclosure in their entirety.

[0003] This application is related to U.S. Patent Application. No. 18 / 872,159, the various implementations and teachings thereof being incorporated into this disclosure in their entirety.TECHNICAL FIELD

[0004] The disclosure relates to medical devices and systems generally and ocular devices specifically and systems.BACKGROUND

[0005] The disclosure relates to a system, apparatuses, and methods for mechanically cutting a corneal plug. A corneal plug is a circular plug, made of corneal tissue or other materials, with an encircling lamellar groove that renders an anterior and posterior leaflet with a connecting stem; such leaflets may have various profiles including a wedge-shaped or conical profile of the posterior leaflet to facilitate passage through a corneal perforation or other hole requiring plugging.

[0006] When definitive surgical repair is not possible in an operating room, the current standard of care for temporizing a corneal perforation is cyanoacrylate glue with or without a thin layer of reinforcing plastic fashioned ad hoc from a surgical drape. The strength of the perforation repair with cyanoacrylate glue derives from an adhesive bond between the glue and cornea; the patch is applied from outside of the eye onto the#5021115 v.2ocular surface. The intraocular pressure exerts an opposing force against the patch via aqueous fluid in the eye. Once the adhesive bond between the glue and cornea loosens sufficiently, the pressurized intraocular fluid displaces the patch to the point of tectonic failure.

[0007] The corneal plug’s encircling lamellar groove interlocks with the edges of a corneal perforation mechanically. The perforation’s edges act as the ‘tongue’ that fits into the groove of the plug, thereby rendering a circumferential tongue-in-groove interface between the corneal plug and the human recipient’s perforated cornea. The encircling groove can be of various dimensions, depending on the size and excavated contour of the corneal perforation. In certain embodiments, the encircling groove is fashioned into the corneal plug after the tissue has been stored in glycerin, which in addition to preserving the tissue, also has the effect of desiccating it. In such embodiments, when the desiccated plug is placed into the human recipient and it rehydrates, the dimensions of the plug increase in width and height, thereby tightening the mechanical seal of the plug. The mechanical seal is further augmented by tissue adhesive, suture, or in certain embodiments, a central expansile shank that simultaneously compresses the plug in the z-axis and makes it expand in the x-y axis.BRIEF SUMMARY

[0008] The present disclosure relates to various systems, devices, and methods for reliably and efficiently extracting a corneal plug. The various implementations disclosed herein describe devices and techniques for automated or semiautomated incisions in a donor cornea.

[0009] Example 1 relates to a corneal plug extraction device comprising:

[0010] (a) a motor operatively engaged with a blade, the motor constructed and arranged to move the blade as the motor rotates;

[0011] (b) a blade retainer operatively engaged with the blade, the blade retainer constructed and arranged to constrain motions of the blade to oscillations along one axis.

[0012] Example 2 relates to Examples 1 and 3-9, further comprising a plug holder positioned to support a donor cornea in a location that will cause the blade to make an incision in the donor cornea during oscillations along the one axis.

[0013] Example 3 relates to Examples 1 -2 and 4-9, wherein the plug holder comprises a central lumen.

[0014] Example 4 relates to Examples 1 -3 and 5-9, wherein the central lumen is constructed to have vacuum drawn through it

[0015] Example 5 relates to Examples 1 -4 and 6-9, wherein the plug holder is manually rotatable.

[0016] Example 6 relates to Examples 1 -5 and 7-9, wherein the blade is positioned relative to the plug holder such that the incision does not fully cut through the donor cornea.

[0017] Example 7 relates to Examples 1 -6 and 8-9, wherein the blade is positioned relative to the plug holder such that the incision is a full cut through the donor cornea.

[0018] Example 8 relates to Examples 1 -7 and 9, wherein the plug holder is positioned to rotate at an angle relative to the direction of oscillations of the blade.

[0019] Example 9 relates to Examples 1 -8, wherein the angle at which the plug holder rotates is about perpendicular to the direction of oscillations of the blade.

[0020] Example 10 relates to a system for extracting a corneal plug from a donor cornea, comprising a biopsy punch; and a cutting block.

[0021] Example 1 1 relates to Examples 10 and 12-14, wherein the cutting block comprises a central dome shaped to support a donor cornea; and a flange surrounding the central dome.

[0022] Example 12 relates to Examples 10-1 1 and 13-14, wherein the central dome is shaped to support a donor cornea with the endothelium positioned against the central dome.

[0023] Example 13 relates to Examples 10-12 and 14, wherein a user positions the donor cornea onto the cutting block and presses the biopsy punch into the donor cornea, cutting a corneal plug from the donor cornea.

[0024] Example 14 relates to Examples 10-13, wherein the biopsy punch comprises a pushrod that runs coaxially with the biopsy punch, the pushrod shaped and arranged to push a corneal plug from the biopsy punch once extracted from the donor cornea.

[0025] Example 15 relates to a method of extracting a corneal plug comprising positioning a donor cornea into a plug holder; inserting the plug holder into a base of a corneal plug extraction device, the corneal plug extraction device comprising the base configured to support components of the corneal plug extraction device; a motor operatively engaged with a blade, the motor constructed and arranged to move the blade as the motor rotates; a blade retainer operatively engaged with the blade, the blade retainer constructed and arranged to constrain motions of the blade to oscillations along one axis; and rotating the plug holder, causing an incision to be made in the donor cornea, wherein the rotation of the main drive gear causes the oscillation of the pivot fork and the rotation of the plug holder.

[0026] Example 16 relates to Examples 15 and 17-20, further comprising applying vacuum to the plug holder.

[0027] Example 17 relates to Examples 15-16 and 18-20, further comprising inspecting the incision for alignment and completeness.

[0028] Example 18 relates to Examples 15-17 and 19-20, wherein the plug holder is rotated manually.

[0029] Example 19 relates to Examples 15-18 and 20, wherein the incision is a groove that does not fully cut through the donor cornea.

[0030] Example 20 relates to Examples 15-19, wherein the incision is a full cut through the donor cornea.

[0031] While multiple embodiments are disclosed, still other embodiments of the disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the disclosure is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.BRIEF DESCRIPTION OF THE DRAWINGS

[0032] FIG. 1 shows a model of a device for making an incision in a cornea used in the system, according to one implementation and viewed from above.

[0033] FIG. 2 shows an exploded model of a device for making an incision in a cornea used in the system, according to one implementation and viewed isometrically.

[0034] FIG. 3 shows a microscope image of a corneal button, according to one implementation.

[0035] FIG. 4 shows a microscope image of a corneal button, according to one implementation.

[0036] FIG. 5 is a flowchart for a method of using a device for making an incision in a cornea, according to one implementation.

[0037] FIG. 6 shows a model of a device for making a groove in a cornea used in the system, according to one implementation and viewed isometrically.

[0038] FIG. 7 shows an exploded model of a device for making a groove in a cornea used in the system, according to one implementation and viewed from the side.

[0039] FIG. 8 shows an exploded model of a device for making a groove in a cornea used in the system, according to one implementation and viewed in profile.

[0040] FIG. 9 shows an exploded model of a device for making a groove in a cornea used in the system, according to one implementation and viewed from the side.

[0041] FIG. 10 shows an exploded model of a device for making a groove in a cornea used in the system, according to one implementation and viewed in profile.

[0042] FIG. 1 1 is a flowchart for a method of using a device for making a groove in a cornea, according to one implementation.

[0043] FIG. 12 shows a model of a device for making a tapered cut in a cornea used in the system, according to one implementation and viewed from the side.

[0044] FIG. 13 shows a model of a device for making a tapered cut in a cornea used in the system, according to one implementation and viewed in profile.

[0045] FIG. 14 shows a model of a device for making a tapered cut in a cornea used in the system, according to one implementation and viewed from the front.

[0046] FIG. 15 is a flowchart for a method of using a device for making a tapered cut in a cornea, according to one implementation.

[0047] FIG. 16 shows a model of a rotary device for making an incision in a cornea used in the system, according to one implementation.

[0048] FIG. 17 is a flowchart for a method of using a rotary device for making an incision in a cornea, according to one implementation.

[0049] FIG. 18 shows a model of a device for punching out a section of a cornea used in the system, according to one implementation.

[0050] FIG. 19 is a flowchart for a method of using a device for punching out a section of a cornea, according to one implementation.DETAILED DESCRIPTION

[0051] Disclosed herein are devices, systems and methods for the mechanical cutting of a corneal plug.

[0052] Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. When such a range is expressed, a further aspect includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms a further aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “about 10” is also disclosed. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11 , 12, 13, and 14 are also disclosed.

[0053] For the purposes of this disclosure, components said to be “mechanically meshed”, “meshed”, or reasonable variations on those terms will be understood to possess geared teeth that interlock such as to transfer rotation from one component to the other.

[0054] Turning to FIGS. 1 and 2, various implementations include a system 10 for making incisions around the cornea, optionally to create a corneal plug or corneal button. The system 10 may include a device 100, configured to oscillate a blade 12 in asawing motion while processing circumferentially around the plug 1 , shown in FIGS. 3 and 4. Returning to FIGS. 1 and 2, the self-mechanized device 100 may have a base 14 configured to support one or more gears. In various implementations, the device 100 can have a main drive gear 16 mounted onto the base 14. The main drive gear 16, in various implementations, may be mechanically meshed with an oscillator drive 18. In some implementations, the oscillator drive 18 can have geared teeth that may be mechanically meshed with a first set of geared teeth of the main drive gear 16, such that when the main drive gear 16 is rotated, the oscillator drive 18 is rotated. In some implementations, main drive gear 16 and oscillator drive 18 insert into the base 14 in order to keep the main drive gear 16 and oscillator drive 18 spaced consistently and to ensure they remain mechanically meshed.

[0055] The oscillator drive 18 may, in some implementations, possess an offset peg 20 protruding axially from the oscillator drive 18, but offset from the axis of rotation of the oscillator drive 18. As would be understood, the rotation of the oscillator drive 18 about its axis may cause the circular movement of the offset peg 20.

[0056] The offset peg 20, in various implementations, may be inserted into a slot 22 made in a pivot fork 24. In some implementations, the pivot fork 24 can be constructed and arranged to pivot about a fulcrum 26, which may be a peg protruding from the base 14. The pivot fork 24, in various implementations, may have a forked end 28 constructed and arranged to grasp at least some portion of the blade 12. In various implementations, the blade 12 may be held in place by a blade retainer 30.

[0057] In some implementations, the slot 22 and fork end 28 may be on opposite sides of the fulcrum 26, when in its proper, assembled position. In other implementations, the slot 22 and fork end 28 may be on the same side of the fulcrum 26, when in its proper, assembled position.

[0058] In various implementations, when the main drive gear 16 is rotated, the oscillator drive 18 may be driven to rotate due to their mechanical meshing, as discussed above. As the oscillator drive 18 rotates, the offset peg 20 may orbit around the rotational axis of the oscillator drive 18, likewise as discussed above. The orbiting motion of the offset peg 20, which may be inserted into the slot 22 of the pivot fork 24, can cause the pivot fork 24 to pivot in an oscillating pattern about the fulcrum 26. As thepivot fork 24 oscillates about the fulcrum 26, the fork end 28 may push the blade 12 back and forth in a similar oscillating motion. As would be understood, the oscillation of the blade 12 may allow for fine, precise cuts into a cornea, allowing for precise and repeatable incisions in making corneal plugs or corneal buttons.

[0059] Still in FIGS. 1 and 2, the system 10 and device 100 may also use a plug holder 32, which may be rotatably engaged with the base 14. The plug holder 32, in various implementations, may have a central lumen 34 through which a vacuum may be drawn. The donor eye or cornea, in some implementations, can be placed on top of the central lumen 34, where it can be secured in place by the vacuum. The plug holder 32 may be secured to the base 14 by one or more plug holder carriers 36. In some implementations, the plug holder carriers 36 may be arms that fit over the plug holder 32 to prevent wobbling or other erratic motion.

[0060] The plug holder 32 may have a set of geared teeth such that it can mechanically mesh with a rotation drive gear 38. The rotation drive gear 38 may likewise be mechanically meshed with the main drive gear 16 through a second set of geared teeth on the main drive gear 16 (second set of geared teeth are obscured in FIGS. 1 and 2). The mutual meshing of the main drive gear 16 to the rotation drive gear 38 and subsequently to the plug holder 32 may, in various implementations, cause the rotation of the plug holder 32 at a speed proportional to the rotation of the main drive gear 16.

[0061] As would be understood, the adjustment of the radii on which the first and second set of geared teeth on the main drive gear are set can adjust the oscillation frequency of the blade 12 relative to the rotation speed of the plug holder 32, and therefore the donor eye.

[0062] In various implementations, the system 10 can include a method 200 of using the device of FIGS. 1 and 2. FIG. 5 shows a flowchart of one implementation of such a method 200. It should be noted that every step of this method 200 is optional and may be performed, not performed, or performed in a different order. The particular sequence and arrangement of steps presented is meant to be illustrative and not exclusive or restrictive.

[0063] In this method 200, a user may position a cornea or portion of a cornea onto the plug holder 32 (box 202). The user may apply vacuum to the plug holder 32, whereby the cornea portion is secured in place on the plug holder 32 (box 204). The plug holder 32 with cornea portion secured may be placed into the base 14 and secured by the plug holder carriers 36 (box 206). The user may rotate the main drive gear 16 to create a partial thickness incision in the cornea to cut an encircling lamellar groove into a corneal plug or full thickness incision to cut a corneal button (box 208). The user may inspect the incision of the corneal plug to ensure proper alignment and general plug quality (box 210).

[0064] Turning now to FIGS. 6, 7, 8, 9, and 10, various implementations of the system 10 may use a device 100 configured to make incisions around the cornea, optionally to create a corneal plug. The device 100, in some implementations, can be used to make a groove into the cornea, where the groove in the cornea is less than the thickness of the cornea itself. In other implementations the device 100 can be used to cut entirely through the cornea. As would be understood, the type of cut made (full or partial) may be determined through variations in the interfacing profiles of the plug holder 32 and base 14.

[0065] Such implementations can use a base 14 upon which a motor stand 40 configured to support a motor 42, can attach. In various implementations, the motor 42 may be a microkeratome motor 42. The motor 42 can be operatively engaged with the blade 12, which may rest on the base 14. In various implementations, the blade 12 may be secured against the base 14 by a blade retainer 30. The blade retainer 30 may have a channel 44 that allows the blade 12 to be pushed by the motor 42 in an oscillatory manner. In various implementations, the blade 12 can project from the blade retainer 30 to allow the blade 12 to cut a cornea to form a corneal plug or button. In other implementations, the components of the device 100 may be driven manually, such as by a user rotating a crank.

[0066] Still in FIGS. 6, 7, 8, 9, and 10, the cornea from which the corneal button or plug is to be cut, may be held in place on a plug holder 32, which is rotatably engaged with the base 14. In certain embodiments, the cornea may be held in place using a vacuum pulled from the bottom of the plug holder 32. In variousimplementations, the plug holder 32 can rotate in substantially the same plane as the blade 12 oscillates or a plane substantially parallel to the plane in which the blade 12 oscillates.

[0067] In various implementations, the system 10 can include a method 300 of using the device of FIGS. 6, 7, 8, 9, and 10. FIG. 1 1 shows a flowchart of one implementation of such a method 300. It should be noted that every step of this method 300 is optional and may be performed, not performed, or performed in a different order. The particular sequence and arrangement of steps presented is meant to be illustrative and not exclusive or restrictive.

[0068] In this method 300, a user may position a cornea or portion of a cornea onto the plug holder 32 (box 302). The user may apply vacuum to the plug holder 32, whereby the cornea portion is secured in place on the plug holder 32 (box 304). The plug holder 32 with cornea portion secured may be inserted into the base 14 (box 306). The motor 42 may be turned on, whereby the blade 12 will oscillate and create an incision in the cornea (box 308). The user may rotate the plug holder 32 about its axis of rotation to process the incision around the cornea (box 310). The user may inspect the incision of the corneal plug to ensure proper alignment and general plug quality (box 312).

[0069] FIGS. 12, 13, and 14 show an implementation of the system 10 where a device 100 is configured to make a tapered cut into the cornea. The implementations shown can largely reflect the implementations of FIGS. 6, 7, 8, 9, and 10, but the base 14 may position the plug holder 32 at a non-zero angle relative to the plane on which the blade 12 oscillates. As would be understood, the angling of the plug holder 32 relative to the plane on which the blade 12 oscillates allows for a tapered cut to be made in the donor cornea.

[0070] In various implementations, the system 10 can include a method 400 of using the device of FIGS. 12, 13, and 14. FIG. 15 shows a flowchart of one implementation of such a method 400. It should be noted that every step of this method 400 is optional and may be performed, not performed, or performed in a different order. The particular sequence and arrangement of steps presented is meant to be illustrative and not exclusive or restrictive.

[0071] In this method 400, a user may position a cornea or portion of a cornea onto the plug holder 32 (box 402). The user may apply vacuum to the plug holder 32, whereby the cornea portion is secured in place on the plug holder 32 (box 404). The plug holder 32 with cornea portion secured may be inserted into the base 14 (box 406). The motor 42 may be turned on, whereby the blade 12 will oscillate and create a cut in the cornea (box 408). The user may rotate the plug holder 32 about its axis of rotation to process the cut around the cornea (box 410). The user may remove excess material, such as the material removed from the cut by the blade, from the cornea (box 412). The user may inspect the cut cornea to ensure proper alignment and general quality (box 414).

[0072] Turning now to FIG. 16, various implementations of the system 10 use a device 100 having a base 14 with a plug holder 32 configured to engage with the base 14. In some implementations, the plug holder 32 has a central lumen 34 through which vacuum can be pulled. As would be understood, a vacuum present in the central lumen 34 may secure a donor cornea to the plug holder 32. Various implementations of the device 100 may use a rotating blade carrier 46 that may be rotatably engaged with the plug holder 32. The rotating blade carrier 46 may be generally annular in shape, such that the central lumen 34 of the plug holder 32 may be inserted into the center of the rotating blade carrier 46, and so the rotating blade carrier 46 may rotate about the central lumen 34.

[0073] The rotating blade carrier 46 may have one or more front stops 48 and one or more back stops 50, each of which would be a raised portion of material intended to secure a blade 12 in place during use. The front stops 48 may be designed to be pressed against the cutting portion of the blade 12, while the back stops 50 may be designed to secure the non-cutting portion of the blade 12. The rotating blade carrier 46 may have an incline 52 positioned near the front stops 48 and back stops 50 to tilt the blade 12 to a specific angle when in use.

[0074] As would be understood, because the rotating blade carrier 46 is free to rotate about the plug holder 32, and because the blade 12, in some implementations a standard surgical blade, may be secured by the front stops 48, back stops 50, andincline 52, rotation of the rotating blade carrier 46 about the central lumen 34 may result in a precise and repeatable incision in a donor cornea secured to the central lumen 34.

[0075] In various implementations, the system 10 can include a method 500 of using the device of FIG. 16. FIG. 17 shows a flowchart of one implementation of such a method 500. It should be noted that every step of this method 500 is optional and may be performed, not performed, or performed in a different order. The particular sequence and arrangement of steps presented is meant to be illustrative and not exclusive or restrictive.

[0076] In this method 500, a user may position a cornea or portion of a cornea onto the plug holder 32 (box 502). The user may apply vacuum to the plug holder 32, whereby the cornea portion is secured in place on the plug holder 32 (box 504). A blade 12 may be secured onto the rotating blade carrier 46 (box 506). The rotating blade carrier 46 can be rotated about the central lumen 34, causing an incision in the cornea (box 508). The user may inspect the groove of the cornea to ensure proper alignment and general quality (box 510).

[0077] FIG. 18 shows an implementation of the system 10 where a domed cutting block 54 is used in conjunction with a biopsy punch 56 to create corneal plugs or buttons. In various implementations, the domed cutting block 54 may have a central dome 58 surrounded by a flange 60 that a user may grip. In various implementations, the central dome 58 is given a profile similar to that of a cornea. A user may then place a glycerin-preserved or non-preserved cornea onto the central dome 58, endothelium side against the central dome 58, and press the biopsy punch 56 into the cornea to punch out a corneal plug or button. The biopsy punch 56 may have a pushrod 62 running coaxially through the biopsy punch 56 in order to press extracted corneal plugs from the biopsy punch 56.

[0078] In various implementations, the system 10 can include a method 600 of using the device of FIG. 18. FIG. 19 shows a flowchart of one implementation of such a method 600. It should be noted that every step of this method 600 is optional and may be performed, not performed, or performed in a different order. The particular sequence and arrangement of steps presented is meant to be illustrative and not exclusive or restrictive.

[0079] In this method 600, a user may position a cornea or portion of a cornea onto the central dome 58 with the endothelium side against the central dome 58 (box 602). A user may position a biopsy punch 56 above the cornea, centered on the desired portion of the cornea (box 604). The biopsy punch 56 may be pressed firmly into the cornea, keeping the biopsy punch 56 substantially perpendicular to the point at which it contacts the central dome 58 (box 606). The biopsy punch 56 may be rotated slightly while being pressed firmly into the cornea and central dome 58 to assist in severing the corneal plug from the remainder of the cornea (box 608). The corneal plug may then be removed from the biopsy punch 56, such as with a pushrod 62 inserted into the handle of the biopsy punch 56 (box 610). The corneal plug may then be inspected for a clean and complete cut (box 612). These steps may be repeated as necessary and as long as the donor cornea has viable tissue remaining (box 614).

[0080] While the embodiments throughout this disclosure use gears to translate motion and rotation between the various components, other mechanisms may be used, such as but not limited to belts and pulleys or chains and sprockets.

[0081] Although the disclosure has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the disclosed apparatus, systems and methods.

[0082] Although the disclosure has been described with reference to the various embodiments and methods for mechanically cutting a corneal plug or corneal button from glycerin preserved or non-preserved corneal tissue, persons skilled in the art will recognize that these embodiments and methods may be implemented to cut corneal plugs and corneal buttons from tissue other than corneal tissue, including sclera, acellular dermal matrix and other processed tissue grafts derived from human cadaver skin, porcine-derived processed dermal tissue grafts and other animal-derived processed dermal tissue grafts, and synthetic meshes.

[0083] Although the disclosure has been described with reference to the various embodiments and methods for mechanically cutting a corneal plug or corneal button that self-retains itself in a corneal hole, persons skilled in the art will recognize that these embodiments and methods may be implemented to cut plugs that can self-retainthemselves in a tissue wall hole such as a perforation, fistula, communication or gap substantially similar to a corneal hole, such as labral joint tissue, dural tissue, bladder tissue, and gastrointestinal tissue.

[0084] Although the disclosure has been described with reference to the various embodiments and methods for mechanically cutting a corneal plug or corneal button that self-retains itself in a human corneal hole, persons skilled in the art will recognize that the buttons and plugs can be employed in other clinical settings, both human and veterinary.

Claims

CLAIMSWhat is claimed is:1 . A corneal plug extraction device comprising:(a) a motor operatively engaged with a blade, the motor constructed and arranged to move the blade as the motor rotates;(b) a blade retainer operatively engaged with the blade, the blade retainer constructed and arranged to constrain motions of the blade to oscillations along one axis.

2. The corneal plug extraction device of claim 1 , further comprising a plug holder positioned to support a donor cornea in a location that will cause the blade to make an incision in the donor cornea during oscillations along the one axis.

3. The corneal plug extraction device of claim 2, wherein the plug holder comprises a central lumen.

4. The corneal plug extraction device of claim 3, wherein the central lumen is constructed to have vacuum drawn through it5. The corneal plug extraction device of claim 2, wherein the plug holder is manually rotatable.

6. The corneal plug extraction device of claim 2, wherein the blade is positioned relative to the plug holder such that the incision does not fully cut through the donor cornea.

7. The corneal plug extraction device of claim 2, wherein the blade is positioned relative to the plug holder such that the incision is a full cut through the donor cornea.

8. The corneal plug extraction device of claim 2, wherein the plug holder is positioned to rotate at an angle relative to the direction of oscillations of the blade.

9. The corneal plug extraction device of claim 2, wherein the angle at which the plug holder rotates is about perpendicular to the direction of oscillations of the blade.

10. A system for extracting a corneal plug from a donor cornea, comprising:(a) a biopsy punch; and(b) a cutting block.1 1 . The system for extracting a corneal plug from a donor cornea of claim 10, wherein the cutting block comprises:(i) a central dome shaped to support a donor cornea; and(ii) a flange surrounding the central dome.

12. The system for extracting a corneal plug from a donor cornea of claim 11 , wherein the central dome is shaped to support a donor cornea with the endothelium positioned against the central dome.

13. The system for extracting a corneal plug from a donor cornea of claim 10, wherein a user positions the donor cornea onto the cutting block and presses the biopsy punch into the donor cornea, cutting a corneal plug from the donor cornea.

14. The system for extracting a corneal plug from a donor cornea of claim 13, wherein the biopsy punch comprises a pushrod that runs coaxially with the biopsy punch, the pushrod shaped and arranged to push a corneal plug from the biopsy punch once extracted from the donor cornea.

15. A method of extracting a corneal plug comprising: positioning a donor cornea into a plug holder;inserting the plug holder into a base of a corneal plug extraction device, the corneal plug extraction device comprising:(a) the base configured to support components of the corneal plug extraction device;(b) a motor operatively engaged with a blade, the motor constructed and arranged to move the blade as the motor rotates;(c) a blade retainer operatively engaged with the blade, the blade retainer constructed and arranged to constrain motions of the blade to oscillations along one axis; and rotating the plug holder, causing an incision to be made in the donor cornea, wherein the rotation of the main drive gear causes the oscillation of the pivot fork and the rotation of the plug holder.

16. The method of extracting a corneal plug of claim 15, further comprising applying vacuum to the plug holder.

17. The method of extracting a corneal plug of claim 15, further comprising inspecting the incision for alignment and completeness.

18. The method of extracting a corneal plug of claim 15, wherein the plug holder is rotated manually.

19. The method of extracting a corneal plug of claim 15, wherein the incision is a groove that does not fully cut through the donor cornea.

20. The method of extracting a corneal plug of claim 15, wherein the incision is a full cut through the donor cornea.

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