WO1996013215A1

WO1996013215A1 - Sutureless corneal transplantation apparatus and method

Info

Publication number: WO1996013215A1
Application number: PCT/US1995/013932
Authority: WO
Inventors: James J. Rowsey; Joseph Patrick Collins
Original assignee: University Of South Florida
Priority date: 1994-08-12
Filing date: 1995-10-26
Publication date: 1996-05-09
Also published as: AU4014495A

Abstract

This invention is an apparatus and method for preparing a cornea of a donor eye and transplanting it into a recipient eye with minimal or no sutures. The donor material is outlined and cut to a circular extent with symmetrically positioned tabs (24), preferably diamond shaped, extending radially from the periphery (18) of the central extent (16) and with the tabs being composed of only the Bowman's membrane (28) as a continuation of the Bowman's membrane of the central extent. The recipient eye (10) is cut with a trephine to form a circular aperture (38) in the cornea at its central portion, the circular aperture being of a size and shape essentially that of the periphery of the central extent of the donor material, the aperture being of a common thickness at the periphery of the aperture, the central portion having a corresponding number of symmetrically positioned pockets (46). The central extent of the donor material is positioned within the aperture of the recipient eye, and then the tabs of the central extent are imbricated into the respective pockets of the recipient eye, thereby securing the transplanted donor cornea into the recipient eye.

Description

SUTURELESS CORNEAL TRANSPLANTATION APPARATUS AND METHOD The United States Government has rights in this invention pursuant to contract no. DE-AC0-4-92AL73000 between the United States Department of Energy and Martin Marietta Speciality Components, Inc.

BACKGROUND OF THE INVENTION Field of the Invention

This invention relates to sutureless corneal transplantation and, more particularly, to a method and apparatus for transplanting corneas with minimal or no sutures . This also invention relates to the preparation of donor material for a sutureless corneal transplantation, and more particularly, to a method and apparatus for precisely cutting and preparing the donor material including tabs used for transplanting corneas without the use of sutures. Description of the Background Art

Corneal transplantation occurs in approximately 37,000 patients in the United States per year. Each of these patients has delayed wound healing because of the avascular nature of the cornea. The stromal wound healing is facilitated by sutures. The sutures, however, induce astigmatism. The current trephine cutting techniques also produce tissue addition or tissue removal asymmetrically around the corneal periphery. These tissue aberrations further increase astigmatism.

Continuing efforts are being made to improve eye surgery methods and apparatus. Consider background patents which illustrate, for example, the large number of corneal transplant techniques such as in U.S. Patent Number 3,945,054 to Fedorov and U.S. Patent Numbers 4,772,283; 5,030,230 and 5,139,518 all to White.

In addition, apparatus including punches for preparing donor material for corneal transplants are disclosed in another large number of patents. By way of example, note U.S. Patent Number 4,236,519 to La Russa; U.S. Patent Number 4,824,066 to Smith; U.S. Patent Number 4,718,420 to Lemp; U.S. Patent Number 4,429,696 to Hanna; and U.S. Patent Number 4,190,050 to Bailey.

Another grouping of background patents are those which disclose corneal layers used in association with eye surgery. By way of example, note U.S. Patent Number 4,662,881 to Nordan; U.S. Patent Number 3,454,966 to Rosen; and U.S. Patent Number 4,810,082 to Abel .

Lastly, U.S. Patent Number 4,127,903 to Schachar discloses an intraocular lens.

Efforts to improve eye surgery techniques continue. Accordingly, it is an object of the invention to provide an improvement which overcomes inadequacies of the prior art devices and provides an improvement which is a significant contribution to the advancement of the art .

Another object of the invention is to provide a new device that allows for penetrating keratoplasty with attendant corneal tabs .

A further object of the invention is to use corneal tabs from the donor material into the recipient rim.

A further object of the invention is to transplant corneas without sutures.

A further object of the invention is a more rapid completion of a corneal transplant.

A further object of the invention is reduced corneal astigmatism.

A further object of the invention is to improve wound healing following corneal transplant .

A further object of the invention is to reduce incidences of graft rejection following corneal transplants.

A further object of the invention is to improve wound coaptation following corneal transplants.

A further object of the invention is to transplant a cornea without sutures comprising (1) a donor material in the shape of a partial sphere having a central extent, the central extent being of the size and shape of the central portion of the cornea of the eye, the central extent having a periphery and an exterior surface in a convex configuration and an interior surface in a concave configuration and with an essentially common thickness throughout, the central extent having a plurality of corneal tabs extending radially from the periphery of the central extent, the tabs having exterior surfaces as a continuation of the exterior surface of the central extent and (2) a recipient eye in the shape of a partial sphere having an aperture in the cornea at its central portion, the aperture in the cornea being of a size and shape essentially that of the periphery of the central extent of the donor material, the central portion having pockets equal in number to the plurality of tabs of the donor material and aligned therewith, and with the central extent of the donor material located within the aperture of the recipient eye and with the tabs of the central extent being located within the respective pockets of the recipient eye.

A further object of the present invention is to provide an apparatus and method for repairing a cornea of an eye, comprising the steps of providing a donor material in the shape of a partial sphere, the donor material having an exterior Bowman's membrane; die cutting the donor material to define an outline configuration including a central extent and a plurality of tabs extending outwardly therefrom; shaving the Bowman's membrane of the tabs to remove donor material therefrom leaving the Bowman's membrane of the tabs intact with the Bowman's membrane of the central exten ; forming a central aperture in the cornea to be repaired, the central aperture having a size and shape essentially that of the central extent of the donor material; incising a plurality of pockets from the central aperture into the cornea, the pockets being positioned and sized and shaped to receive the respective tabs when the central extent is positioned within the central aperture; and positioning the central extent within the central aperture and imbricating the tabs into the respective pockets.

The foregoing has outlined some of the pertinent objects of the invention. These objects should be construed to merely illustrative of some of the more prominent features and applications of the intended invention. Many other beneficial results can be attained by applying the disclosed invention in a different manner or modifying the invention within the scope of the disclosure. Accordingly, other objects and a fuller understanding of the invention and the detailed description of the preferred embodiment in addition to the scope of the invention defined by the claims taken in conjunction with the accompanying drawings.

SUMMARY OF THE INVENTION For the purpose of summarizing the invention, the invention comprises an eye with a cornea repaired with minimal or no sutures including, in combination, a donor material and a recipient eye. The donor material is of living tissue in the shape of a partial sphere and is cut in a generally circular central extent, the central extent being of the size and shape of the central portion of a cornea of an eye, the central extent having a periphery of a fixed diameter of between about 7.0 and 7.5 millimeters with an exterior surface in a convex configuration and an interior surface in a concave configuration and with an essentially common thickness throughout, the central extent having four to sixteen, preferably six, symmetrically positioned corneal tabs, preferably diamond- shaped, extending radially from the periphery of the central extent, the tabs having exterior surfaces as a continuation of the exterior surface of the central extent, and the exterior surfaces of the central extent and the tabs being of a common Bowman's membrane of about 100 microns thickness. Preferably, the tabs have a thickness of about 10 percent of the thickness of the central extent with the area of juncture between the tabs and the central extent constituting between about 10 percent and 100 percent (i.e., one continuous tab) of the circumference of the central extent, with the radial dimension of each tab being between about 25 and 75 percent of the diameter of the central extent, with the side edges of the tabs being radii of the central extent, and with the radially exterior edge of each tab being curved concentric with the curvature of the central extent. The recipient eye is in the shape of a partial sphere having a circular aperture in the cornea at its central portion, the circular aperture being of a size and shape essentially that of the periphery of the central extent of the donor material, the aperture being of a common thickness at the periphery of the aperture, the central portion having four to sixteen, preferably six, symmetrically positioned pockets, with the pockets being at the area adjacent to the periphery of the aperture and constituting between about 10 percent and 100 percent (i.e., one continuous tab) of the periphery of the aperture, and with the radial dimension of each pocket being between about 25 and 75 percent of the diameter of the aperture. The central extent of the donor material is positioned within the aperture of the recipient eye, and then the tabs of the central extent are imbricated into the respective pockets of the recipient eye.

Advantageously, corneal transplantation according to the invention permits elevated intraocular pressure without tissue movement. Further, the imbrication of the tabs into the pockets reduces astigmatism in the postoperative period.

The invention is also directed to an outline cutter assembly comprising male and female dies for die-cutting the outline of the donor material inclusive of the central extent and the tabs when the donor material is placed therebetween and the dies are mated. The outline cutter assembly further includes a tab incisor punch for annularly cutting through the donor material about the periphery of the central extent from the interior surface thereof to a depth proximate of the common Bowman's membrane such that the Bowman's membrane of the central extent and the tabs remains intact.

The invention is also directed to a tab shaver assembly comprising male and female dies for folding the tabs of the die-cut and incised donor material along the length of the male die when the die-cut and incised donor material is placed therebetween and the dies are mated. The tab shaver assembly further includes a tab shaver punch for inserting between the mated dies to annularly shave the donor material from the Bowman's membrane of the folded- back tabs. The Bowman's membrane of the tabs therefore remains intact with the Bowman's membrane of the central extent. The die- cut and shaved donor material may now be utilized in the transplantation method of the invention as described above.

The foregoing has outlined rather broadly the more pertinent and important features of the present invention in order that the detailed description of the invention that follows may be better understood so that the present contribution to the art can be more fully appreciated. Additional features of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and the specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS For a fuller understanding of the nature and objects of the invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which:

Fig. 1 is a perspective illustration of the preferred embodiment of a sutureless corneal transplant effected in accordance with the principles of the present invention;

Fig. 2 is an exploded perspective view of the eye illustrated in Fig. 1;

Fig. 3 is a cross-sectional view of the repaired eye of Fig. 1;

Fig. 3A is a cross-sectional view of the repaired eye of Fig. 1 but with the pockets in the recipient eye being positioned further interiorly;

Fig. 4 is a perspective illustration of a trephine for use in association with the sutureless corneal transplant technique of the present inven ion;

Fig. 5 is a side elevational view of the trephine of Fig. 4 and an associated block;

Fig. 6 is a side elevational view similar to Fig. 5 but showing the trephine during the cut;

Fig. 7 is a side elevational view similar to Figs. 5 and 6 but showing the trephine in the retracted position after the cut;

Fig. 8 is an exploded view of the outline cutter assembly of the invention illustrating the base support, hand support, tab incisor punch, and spring-loaded medical syringe;

Fig. 9A is a longitudinal cross-sectional view of the male die of the outline cutter assembly illustrating the longitudinal cross- sectional configuration of the male die;

Fig. 9B is a longitudinal cross-sectional view of Fig. 9A taken within the longitudinal slots thereof illustrating the longitudinal cross-sectional configuration of the male die;

Fig. 9C is a transverse cross-sectional view of the upper portion of the male die illustrating the transverse cross-sectional configuration of the male die;

Fig. 9D is a perspective view of the upper portion of the male die with the die-cut donor material shown in phantom therein;

Fig. 10A is a longitudinal cross-sectional view of the female die of the outline cutter assembly of the invention taken through the cutting teeth thereof;

Fig. 10B is a longitudinal cross-sectional view of the female die taken between the cutting teeth thereof;

Fig. 11 is a longitudinal cross-sectional view of Fig. 8 illustrating the spring-loaded medical syringe rigidly connected to the access and vacuum holes of the boss of the base support for creating vacuum within the male die;

Fig. 12 is a transverse cross-sectional view of Fig. 8 illustrating the guide pins that axially guide the hand support containing the female die in axial engagement with the male die extending from the base support;

Fig. 13 is a longitudinal cross-sectional view of the male die of the outline cutter assembly with the spreader tool of the donor material support assembly positioned thereon for facilitating positioning of the O-ring about the male die;

Fig. 14 is a cross-sectional view of the male die of the outline cutter assembly with the donor material supporter of the donor material support assembly held into position about the upper end of the male die by means of the O-ring;

Fig. 15 is an exploded diagram of the tab shaver assembly of the invention illustrating the base support, hand support, the tab shaver punch and the spring-loaded medical syringe thereof;

Fig. 16 is a longitudinal cross-sectional view of Fig. 15; Fig. 17 is a transverse cross-sectional view of Fig. 15; Fig. 18A is a cross-sectional view of the male die of the tab shaver assembly taken through the upstanding arms thereof; Figs. 18B-18E illustrate the operation of the tab shaver; Figs. 19A-19C illustrate a tool for carrying out the preparation of the donor material according to an embodiment of the instant invention;

Fig. 20 illustrates the cooperation of the various elements depicted in Figures 3A-3C when the tool is being used;

Figs. 21A-21D illustrate sequentially the appearance of the donor material during the corneal preparation according to a method of the instant invention;

Figs. 22A-22C illustrate a tweezer punch according to the present invention utilized for punching a hole in the tabs of the donor material so as to form barbs extending outwardly from the upper or lower surface of the tab; and

Figs. 23A and 23B illustrate the preferred configuration of the tabs formed in the tabs by the tweezer punch of Figs. 22A-22C. Similar reference characters refer to similar parts throughout the several views of the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Eye With Transplanted Cornea

The present invention as illustrated in Figs. 1 and 2 relates to an eye 10 with a cornea 12 repaired with minimal or no sutures. The repaired cornea 12 includes two major components, the donor material 14 of living tissue and the recipient eye 10.

With regard to the donor material 14, such material is cut to a particular shape prior to being coupled with the recipient eye 10. The shape is that of a partial sphere. Such sphere has a generally circular central extent 16. The central extent 16 is of the size and shape of the central portion of the cornea of an eye. The central extent 16 has a periphery 18 of a fixed diameter of about 7.0 and 7.5 millimeters. It has an exterior surface 20 in a convex configuration. It also has an interior surface 22 in a concave configuration. The central extent 16 also has an essentially common thickness throughout.

Formed as part of the central extent 16 are a plurality of symmetrically positioned diamond-shaped corneal tabs 24. Four to sixteen of such tabs is the preferred number and six is the most preferred. Such tabs 24 extend radially from the periphery 18 of the central extent 16. The tabs 24 have exterior surfaces 26 as a continuation of the exterior surface 20 of the central extent 16. The exterior surfaces 20 and 26 of the central extent 16 and tabs 24, respectively, are preferably of a common Bowman's membrane 28 typically having a thickness of about 100 microns.

The tabs 24 typically have a thickness of about 10 percent of the thickness of the central extent 16 of the donor material. The radial dimension of each tab 24 is between about 25 and 75 percent of the diameter of the central extent 16. The side edges 32 of the tabs 24 are preferably formed as radii of the central extent 16. In addition, the radially exterior edges 34 are preferably curved essentially concentric with the curvature of the central extent 16. The next component of the repaired cornea is the recipient eye 10. Such eye 10 is in the shape of a partial sphere. The recipient eye 10 is formed with a circular central aperture 38 at its central portion 40. The circular central aperture 38 is of a size and shape essentially that of the periphery 18 of the central extent 16 of the donor material 14 for the receipt thereof. The periphery 42 of the aperture 38 is of a common thickness. The central portion 40 has a plurality (four illustrated) of symmetrically positioned pockets 46. The pockets 46 are simply incisions made into the thickness of the cornea, preferably just under the Bowman's membrane 28 into the periphery 42 of the aperture 38. The pockets 46 each constitute between about 10 and 100 percent of the periphery 42 of the aperture 38. The radial dimension of each pocket 46 is between about 25 and 75 percent of the diameter of the aperture 38. In operation and use, the central extent 16 of the donor material 14 is positioned within the aperture 38 of the recipient eye 10. The tabs 24 of the central extent 16 are imbricated into the pockets 46 of the recipient eye 10. Forceps are preferably used for the positioning of the central extent 16 and the imbrication of each of the tabs 24 into their respective pockets 46. Transplantation Method

The invention, in addition to the combination of the donor material 14 and recipient eye 10, also includes the method of repairing the recipient eye 10. Such method includes the step of providing donor material 14 of the type as described above. The method also includes the step of providing a recipient eye 10 as described above. The method then includes a step of positioning the donor material 14 with its central extent 16 within the aperture 38 of the recipient eye 10 and imbricating the tabs 24 of the donor material 14 into the pockets 46 of the recipient eye 10.

The invention further comprises a method for preparing the donor material 14 and for preparing the recipient eye 10. More particularly, the central extent 16 and the tabs 24 are preferably cut out of the donor material 14 obtained from a donor's eye (not shown) . Such cuts are preferably made by first inverting the donor material 14 and resting its convex exterior surface 20 onto a suitable support and then holding it into position by means of vacuum or the like. The cuts are then made through the donor material 14 in an outline configuration to produce the central extent 16 with the plurality of tabs 24. Preferably, such cuts are made parallel to the axis of the partial sphere of the central extent 16. Additional cuts are then made at the juncture between the central extent 16 and the tabs 24 to a depth of about 90 percent of the thickness of the central extent 16, thereby leaving intact the common Bowman's membrane 48 of the central extent 16 and the tabs 24 that constitutes the convex exterior surfaces 20 and 26 of the central extent 16 and the tabs 24, respectively. Finally, additional cuts are made parallel along the Bowman's membrane 28 constituting the exterior surface 26 of the tabs 24 so as to remove the corneal material from the tabs 24 while leaving intact the Bowman's membrane 28 of the tabs 24 and the central extent 16.

The recipient eye 10 is prepared according to the method of this invention by first marking the intended location of the pockets 46 with a conventional corneal marking tool (not shown) . The circular aperture 38 is then cut into the central portion 40 of the recipient eye 10 by means of a conventional trephine or the like (not shown) which makes a circular cut through the central portion 40 whereupon the central portion 40 of the recipient eye 10 is removed and discarded. The pockets 46 are then formed into the periphery 42 of the central aperture 38 and the recipient eye 10 by means of a conventional diamond knife (not shown) having a width equal to the proximal width of the openings of the pockets 46 intended to be formed in the periphery 42 of the circular aperture 38. Each pocket 46 is then formed by inserting the diamond knife into the periphery 42 of the central aperture 38 of the recipient eye 10 in alignment with the respective corneal markings previously made. As shown in Fig. 3, the knife is preferably positioned just under the Bowman's membrane and then advanced inwardly to a depth equal to the intended depth of the pocket 46. The diamond knife is then moved in both directions sideways so as to cut a diamond-shaped pocket corresponding to the size and shape of the tabs 24. It is noted, however, that the width of the diamond knife and hence the width of the opening into the pockets 46 may be appreciably smaller than the corresponding width of the tabs 24 at its juncture with the central extent 16 so as to more securely retain the tabs 24 in the pockets 46.

After preparing the donor material 14 and the recipient eye

10 in the manner described above, the donor material 14 may then be coupled with the recipient eye 10 by positioning the central extent 16 of the donor material 14 into the central aperture 38 of the recipient eye 10. Each of the tabs 24 are imbricated into the respective pockets 46 by means of forceps which, when pressed upon each of the tabs 24, cause the tabs 24 to fold, thereby facilitating the insertion of the tabs 24 into their respective pockets 46. After all of the tabs 24 are positioned within their respective pockets 46, the central extent 16 is securely retained within the central aperture 38 of the recipient eye 10 in such a manner that postoperative astigmatism is minimized while permitting increased intraocular pressure without tissue movement.

It is noted that if the width of the openings of the pockets 46 were incised appreciably smaller than the width of the tabs 24 at their juncture with the central extent 16, as described above, the tabs 24 may be more securely retained therein by forming a notch or otherwise nicking the tabs 24 at their juncture with the central extent 16 thereby allowing the narrower-width edges of the pocket openings to engage therein. It is also noted that to minimize astigmitation due to swelling, the pockets 46 may be cut further interiorally as shown in Fig. 3A. Without departing from the spirit of the invention, in the event that the donor material 14 shifts post operatively due to trauma or otherwise, the tabs 24 may be temporarily secured in the respective pockets 46 by means of sutures .

It is noted that the transplantation method of this invention is not limited to corneal transplantation and may be implemented in other transplantations without departing from the spirit and scope of this invention. Transplantation Trephine and Method of Use In addition to the eye with a repaired cornea and the method of repairing a cornea as set forth above, the present invention also includes a trephine 52.

The trephine 52 of the invention is particularly useful in cutting and forming the donor material 14 as described above. The trephine 52 of the invention is for the cutting of donor material 14 and is adapted to be used in corneal transplants. The trephine 52 comprises, in combination, a cylindrical support 56, a plurality of circular cutting blades 58 and 60, radially extending blades 62 and an associated block 64.

More specifically, the cylindrical support 56 of the invention is adapted to be held by a surgeon in the cutting of the donor material 14. The trephine 52 includes a cylindrical central portion 68 with an upper edge 70 and a lower edge 72. A central axis 73 extends along the length of the cylindrical support 56.

The plurality of circular cutting blades 58 and 60 are formed in the lower edge 72 of the cylindrical support 56. The circular cutting blades 58 and 60 include an exterior continuous cutting blade 74 having a diameter between about 11 and 12 millimeters. The cutting blades 58 and 60 also include an interior discontinuous cutting blade 76 having a diameter of about between 7 and 7 1/2 millimeters.

The radially extending blades 62 are located between the circular blades 58 and 60. The exterior circular blade 60 is located closer to the upper edge 70 of the cylindrical support 56 than the interior circular blade 58 by a distance of about 100 microns equal to the thickness of the Bowman's membrane 28. The radial blades 62 thus extend at an acute angle with respect to the upper edge 70 of the support 56. For producing four tabs 24, the radial blades 62 are eight in number and arranged for cutting diamond shaped tabs 24. The tabs 24 together constitute between about 10 and 100 percent of the circumvents of the inner and outer circular blades 58 and 60. The radially interior edge 96 of the interior cutting blade 76 is blunt to preclude cutting of donor material 14 at the location of the tabs 24.

In association with the above trephine 52, there is provided a block 64. Such block 64 has a pocketed, generally spherical surface 80. Such spherical surface has a radius of curvature of about 7.5 millimeters. The purpose of such surface is for constituting a support for the donor material 14 during the cutting thereof by the trephine 52.

The use of the trephine 52 as described above constitutes an inventive method of the invention in addition to the trephine 52 itself. In practicing the method of cutting donor material 14 with the trephine 52 as described above, the steps include providing a cylindrical support 56 of the type as described above. The method then includes the step of providing a plurality of circular cutting blades 58 and 60 in the cylindrical support 56 as described above. The method also includes the step of providing radially extending blades 62 between the circular blades 58 and 60 as described above. The invention also includes the step of providing an associated block 64 as described above . The method of the invention then includes the step of positioning donor material 14 adapted to be used in corneal transplants on the support surface 80 of the block 64 and cutting such supported donor material 14 with the trephine 52 as described above.

In the fabrication of the pockets 46 in the recipient eye 10, the incisions which extend generally parallel with the upper and lower surfaces of the eye 10 beneath the Bowman's membrane 28 are preferably done by a conventional diamond knife in the manner described above.

The specifics of the trephine 52 as described above are as follows:

A trephine blade which punches out the donor material to 90 percent of the corneal thickness;

A trephine blade which punches out the donor material at a rim of 10-12 millimeters;

A diamond incision of the superficial Bowman's membrane which fashions corneal tabs for insertion into the recipient rim;

A recipient rim formation beneath the Bowman's membrane of a pocket through which the donor tab is transferred;

The method of securing the donor tab in the recipient rim is with forceps that allow manipulation of the tabs in the postoperative period to reduce the astigmatism and to allow for a spherical surface;

The lack of sutures at the time of corneal transplantation reduces the need for suture adjustment and the attendant micro abscesses and wound compression that occur with all sutures;

The recipient bed is incised in a step fashion to coapt the stroma;

A diamond knife is provided which produces an undermined tab of Bowman's membrane;

A corneal punch which produces donor tabs of Bowman's membrane; and

Forceps for insertion of the Bowman's membrane tabs beneath the recipient rim. Outline Cutter Assembly, Tab Shaver Assembly and Method of Use

The invention also comprises an outline cutter assembly 100 as shown in Figs. 8-14 for cutting the outline of the donor material 14 inclusive of the central extent 16 and the tabs 24 and a tab shaver assembly 102 as shown in Figs. 15-18 for shaving the tabs 24 to remove the corneal material from the tabs 24 leaving the Bowman's membrane 28 of the tabs 24 intact with the Bowman's membrane 28 of the central extent 16.

More particularly, the outline cutter assembly 100 shown in Figs. 8-14 comprises a male die 104 rigidly extending vertically from a generally-rectangular base support 106, a female die 108 rigidly supported within a hand support 110 and a tab incisor punch 112. As best shown in Figs. 9A-9D, the male die 104 comprises a generally circular cylindrical member 114 having an increased diameter upper portion 116 and a reduced diameter lower portion 118. Equally-spaced slots 120 are machined longitudinally along the length of the upper portion 116 to form a castellated configuration. Slots 120 are configured and dimensioned such that the cross-sectional configuration (see Fig. 9C) of the upper portion 116 of the male die 104 is the same as the desired outline configuration of the donor material 14 inclusive of its central extent 16 and tabs 24.

For example, when desired to produce a six-tabbed donor material 14, the upper portion 116 of the cylindrical member 114 is machined with six equally-spaced slots 120. Furthermore, when desiring to produce tabs 24 having radial side edges 32 as described above, the sides 122 of slots 120 may be machined as radii of the cylindrical member 114. Finally, with the outer diameter of the upper portion 116 of the cylindrical member 114 being determined to equal the desired outer diameter of the donor material 14, the depth at which the slots 120 are machined into such upper portion 116 determines the outer diameter of the central extent 16 of the donor material 14 and thus, the relative size of its tabs 24.

The upper end 126 of the upper portion 116 of the cylindrical member 114 is machined concavely to a partially-spherical configuration having a radius substantially equal to the spherical radius of the exterior surface 20 of the donor material 14. It is noted that the spherical machining of the upper end 126 creates upwardly extending sharp edges 128 in an outlined configuration of the slotted upper end 126 of the upper portion 116 of the cylindrical member 114. As will become apparent below, the sharp edges 128 serve to cut the donor material 114 in an outline configuration inclusive of its central extent 116 and tabs 24.

The male die 104 preferably includes a central blind hole 104B extending from its lower portion 118 and into its upper portion 116, and a plurality of suction holes 104S extending from the blind hole 104B to the surface of its upper end 126. When a source of vacuum is fluidly connected to the blind hole 104B and the donor material 14 is positioned on the upper end 126, the vacuum in the suction holes 104S assures that the donor material 14 will remain securely seated.

Corresponding to the male die 104, as best shown in Figs. 10A and 10B, the female die 108 comprises a generally circular cylindrical member 130 having an annular cutting rim 132 with cutting teeth 134 extending downwardly therefrom. The radially outward surfaces of the annular cutting rim 132 and the cutting teeth 134 are frustro-conically shaped such that the lowermost edge 136 of the cutting rim 132 and the lowermost edges 138, as well as side edges 140, of the cutting teeth 134 define sharp cutting edges.

It is noted that the cutting teeth 134 of the female die 108 are appropriately configured and dimensioned to axially mate with and slide into the slots 120 formed in the upper portion 116 of the male die 104 such that when the donor material 14 is positioned therebetween and the dies 104 and 106 are axially mated together, the donor material 14 is precisely die-cut into the desired outline configuration.

Notably, the frustro-conical shape of the cutting teeth 134 as well as the cutting rim 132 assures that the donor material 14 is cylindrically cut even though the donor material 14 (and the upper end 26 of the male die 104) are partially spherically shaped.

Notably, as best shown in Fig. 8 in combination with Figs. 11 and 12, in order to assure exact axial mating of the male and female dies 104 and 108, the male die 104 is supported by the base support 106, female die 108 is supported by the hand support 110 and the supports 106 and 108 are axially movable relative to one another by means of guide pins 141A and 14IB.

More particularly, base support 106 comprises a generally hollow rectangular configuration defined by rim 106R and a flat top surface 106S from which a boss 106B interiorly extends. The lower portion 118 of the cylindrical member 114 of the male die 104 is rigidly positioned into a cylindrical blind hole 142 in the boss 106B of the base support 106. Blind hole 142 is formed at a right angle to the flat upper surface 106S of the base support 106 such that the upper portion 116 of the male die 104 extends perpendicularly therefrom. The guide pins 141A and 141B, preferably of different diameters and heights, are rigidly mounted into guide holes 143A and 143B in the boss 106B of the base support 106 so as to extend parallel to each other and to the male die 104. A vacuum hole 144 extends from the exterior of the boss 106B to the blind hole 142. Its opened end 144E is dimensioned to be fitted with a source of vacuum, such as a spring-loaded medical syringe 146. It is noted that the spring 146S of such a spring- loaded medical syringe 146 preferably includes a spring constant that creates the desired vacuum within the blind and vacuum holes 142 and 144 (and correspondingly the male die 104) so as to assure that the donor material 14 is held in its seated position within the spherical upper end 126 of the male die 104. Conveniently, access hole 148 formed in the rim 106R of the base support 106 supports the syringe 146 in collinear alignment with the vacuum hole 144.

The hand support 110 in which is positioned the female die 108 (or formed integrally therewith as shown) , comprises a central bore 150 for receiving the female die 108 and a pair of side bores 152A and 152B for slideably receiving the guide pins 141A and 141B of the base support 106. The central bore 150 is positioned relative to the side bores 152A and 152B such that the female die 108 is positioned in precise axial alignment with the male die 104 when the guide pins 141A and 141B are positioned into the respective side bores 152A and 152B, thereby permitting the female die 108 to axially engage the male die 104 as shown in Figs. 11 and 12 with the hand support 110 eventually being seated on the upper surface 106S of the base support 106.

Indeed, it should be appreciated that the longitudinal positioning of the female die 108 within the central bore 150 determines the extent by which the female die 106 mates with and extends along the length of the upper portion 116 of the male die 104. Finally, it should be appreciated that the hand support 110 comprises a substantially oblong configuration that can be easily grasped by the physician performing the corneal transplantation and then conveniently oriented and aligned with the base support 106 such that the guide pins 141A and 141B engage into the side bores 152A and 152B, respectively. As shown, the outer exterior surfaces of the hand support 110 may be knurled 154 to facilitate better grasping of the hand support 110 by the physician.

As best shown in Figs. 13 and 14 in combination with Fig. 8, a donor material support assembly 156 is preferably provided to provide additional support to the donor material 14 when it is positioned onto the upper end 126 of the male die 104 prior to cutting. More particularly, as shown in Fig. 13, the donor material support assembly 156 comprises a generally frustro-conical spreader tool 158 having a recess 160 formed at its wide, lower end. The spreader tool 158 facilitates the positioning of an O- ring 162 onto the male die 104 by simply positioning the recessed end 160 of the spreader tool 158 onto the upper end 126 of the male die 104 and then positioning an O-ring 162 about the tip 164 of the spreader tool 158. By sliding the O-ring 162 along the length of the spreader tool 158 (as shown in phantom in Fig. 13) , it is forced to expand. Once the O-ring 162 is slid past the recessed end 160 of the spreader tool 158, it resiliently grasps around the male die 104.

As shown in Fig. 14, an annular-shaped donor material supporter 166 with central hole 168 may then be positioned about the male die 104 and rested upon the O-ring 162. It is noted that the upper portion of the central hole 168 may be spherically recessed 170. In this manner, the depth of the recessed end 160 of the spreader tool 158 may be dimensioned such that the O-ring 162 is positioned about the male die 104 at a location that aligns the spherical recess 170 of the supporter 166 with the spherical upper end 126 of the male die 104. Importantly, the donor material supporter 166 assures that the donor material 14 retains its spherical shape while it is being die cut by the male and female dies 104 and 108. However, it is also noted that as the female die 108 is moved along the male die 104, the O-ring 162 and the donor material supporter 166 are easily pushed downwardly further along the length of the male die 104. Indeed, as best shown in Figs. 11 and 12, central bore 150 of the hand support 110 may include a step portion 172 substantially equal in diameter to the diameter of the supporter 166. Step portion 172 is preferably positioned within the central bore 150 at a position slightly below the sharp edges 138 of the cutting teeth 134 of the female die 108 such that the supporter 166 is forced downwardly by means of the step portion 172 without actually engaging the sharp edges 138 and possibly dulling the same.

As best shown in Figs. 11 and 12, the tab incisor punch 112 of the outline cutter assembly 100 functions to incise the circular configuration of the central extent 16 from the concave interior surface 22 thereof up to the Bowman's membrane 28 constituting the convex exterior surface 20 thereof. More particularly, the tab incisor punch 112 comprises a generally circular cylindrical configuration having an increased diameter portion 174 and a reduced diameter portion 176 that form a step 178 therebetween. A knurl 180 is formed about the outer surface of the increased diameter portion 174 to facilitate it functioning as a handle for easy grasping by the physician. The reduced diameter portion 176 is dimensioned to slideably engage into the upper portion of the central bore 150 of the hand support 110.

An annular cutter 182 extends concentrically from the bottom 184 of the reduced diameter portion 176. Preferably, the annular cutter 182 is frustro-conically shaped such that its cylindrical lumen is positioned parallel and concentrically with the axis of the punch 112. Finally, it is noted that the relative lengths of the annular cutter 182, the reduced diameter portion 176, the central bore 150 are such that the sharp edge of the annular cutter 182 is positioned away from the spherical recess of the end 126 of the male die 104 by thickness of the Bowman's membrane 28 (e.g., 100 microns) when the hand support 110 is seated on the surface 106S of the base support 106 and when the step portion 172 is engaged with the upper edge of the central bore 150. Consequently, after the outline of the donor material 14 is die cut by means of the male and female dies 104 and 108, the incisor punch 112 can be easily inserted into the central bore 150 of the hand support 110 and moved downwardly until seated. When seated, a precise cut is made about the periphery of the central extent 16 through the thickness thereof up to the Bowman's membrane 28 thereof. The Bowman's membrane 28 of the central extent 16 and the tabs 24 therefore remains intact. The donor material 14 may then be removed from the outline cutter assembly 100 by removing the incisor punch 112 and the hand support 110 and releasing the vacuum. The donor material 14, now outlined die-cut, may then be positioned within the tab shaver assembly 102 of the invention to shave off the excess donor material proximate to the Bowman's membrane 28 of the tabs 24.

The tab shaver assembly 102 of the invention is illustrated in Figs. 15-18 and comprises a vertically-disposed male die 190 that supports the outline die-cut donor material 14, a female die 192 that bends the tabs 24 of the donor material 14 downwardly along the length of the male die 190 when the dies 190 and 192 are engaged, and a tab shaver punch 194 that shaves the excess donor material from the tabs 24 while leaving the Bowman's membrane 28 intact. As shown in Figs. 15, 16 and 17, many components of the tab shaver assembly 102 are similar to the corresponding components of the outline cutter assembly 100. Therefore, the similar components of the tab shaver assembly 102 are referenced by primed reference numerals and are not individually described in detail again.

Now referring to Fig. 18A, the male die 190 of the tab shaver assembly 102 comprises a generally cylindrical castellated configuration with an increased diameter step 196 that functions to locate the male die 190 in the blind hole 142' in the boss 106B' of the base support 106' (see Fig. 16) . The upper end 126' is machined to a spherical configuration having a radius substantially equal to the spherical radius of the donor material 14. A plurality of arms 198 extend longitudinally from the outer circumferential surface of the male die 190. Arms 198 are preferably spaced equidistantly and each include a width substantially equal to the distance between the tabs 24 of the die- cut donor material 14. In this manner, as shown in Fig. 18B, when the die cut donor material 14 is removed from the outline cutter assembly 100 of the invention, it can be seated upon the upper end 126' of the male die 190 with the tabs 24 thereof extending radially outwardly between the respective arms 198. The donor material 14 may be secured into position by means of the vacuum hole 144', blind holes 142' and 104B', suction holes 104S, and a vacuum source such as the spring-loaded medical syringe 146'.

The female die 192 is positioned within, or formed integrally with (as shown), the central bore 150' of the hand support 110'. As best shown in Figs. 16 and 17, the female die 192 simply comprises a central hole 200 that has a diameter appreciably greater than the diameter of the male die 190. The female die 192 is positioned vertically within the central bore 150 ' of the hand support 110' such that the central hole 200 bends over the tabs 24 of the donor material 14 along the length of the male die 190 as the hand support 110 is seated onto the upper surface 106S' of the base support 106' . Most preferably, the diameter of central hole 200 is marginally greater than the diameter of the male die 190 (equal to the diameter of the central extent 16) plus twice the thickness of the Bowman's membrane 28 (e.g. 2 x 100 microns) . Being marginally greater in diameter than the combined width of the central extent 16 and two layers of Bowman's membrane 28, it can be appreciated that tabs 24 would be forced to bend over the upper end 126' of the male die 190 and lay down along the length of the male die 190 as the central hole 200 of the female die 192 is moved downwardly into its seated position (see Fig. 18C) .

The tab shaver punch 194 is similar in design to the tab incisor punch 112 described above. Consequently, primed reference numerals are used in the drawings to refer to the similar components of the tab shaver punch 194 and are not discussed separately.

The annular cutter 182' of the tab shaver punch 194 includes an extended length (greater than that of the annular cutter 182 of the tab incisor punch 112) . Furthermore, the diameter of the lumen of the annular cutter 182 ' is slightly enlarged to be substantially equal to the diameter of the central extent 16 plus twice the thickness of the Bowman's membrane 28 (e.g. 2 x 100 microns) . With the increased diameter and increased length of the annular cutter 182', it should be appreciated that as the tab shaver punch 194 is inserted into the central bore 150' of the hand support 110' and is moved downwardly, the annular cutter 182 ' simply shaves off the excess donor material 193 from the tabs 24 while leaving the Bowman's membrane 28 of the tabs 24 intact with the Bowman's membrane 28 of the central extent 16 (see Figs. 18D and 18E) . Once the excess material 193 is shaved off, the hand support 110' together with the tab shaver punch 194 may be removed from the base support 106' . When the vacuum is released, the die-cut, and shaved, donor material 14 may be removed from the male die 190, and is ready for transplantation according to the surgical method of the invention described above.

Figures 19A-19C illustrate an apparatus (or tool) used for preparation of the donor material 102 (Figure 2) according to an embodiment of the instant invention. As illustrated in Figure 19A, a base 201 is provided to support the tool. Guide pins 207 extending up from the base 201 support a punch base 202. A punch 208 (similar in design to the male die of the out cutter assembly 104 of Figs. 9A-9C) is held in place within the punch base 202. The punch 208 (shown in greater detail in Figure 19C) has a shape corresponding to that of the top surface of the donor material to be prepared. That is, the surface on the top end of the punch has a concave spherical radius at its center portion 806 and tabbed portions 802 extending radially from a central axis of the system and the punch corresponding to the tabbed portions of the donor material. A nest 203 having a centrally located nest hole 310, also having a shape corresponding substantially to the desired axis end is adapted to receive the punch 208 in the next hole 310. The nest 203 has guide holes 312 located on the periphery of the nest in order that the periphery of the punch 208 fits closely within the nest hole 310 .

A die 204 is aligned along the central axis to be positioned above the nest 203 and guided by guide pins 207. The die also has a hole 410 centrally located which corresponds to the shape of the donor material. The die 204 (similar in design to the female die of the outline cutter assembly 104 of Figs. 10 and 10B) is provided to cut through the donor material to prepare a donor blank as more fully described below. The central portion 411 of the die 204 is illustrated in greater detail in Figure 19B. Portions of an upper surface of the central portion 411 of the die 204 act as a lower scalpel guide 401. The operation of the scalpel guide will be more fully explained below. The die 204 is adapted to receive the punch 208 such that the extending tabbed portions 802 (Figure 19C) of the punch 208 are received by the recessed portions 402 of the die 204. The die 204 also includes guide holes 412 (Figure 19A) which are adapted to receive the guide pins 207 for alignment. A bottom portion of die 204 which defines the periphery where it intersects the hole 410 acts as a cutting edge 422 in combination with a cutting edge 822 of the punch 208 which is defined by the intersection of the surfaces 802 and 806 and the vertical outside surface 824 of the punch 208. The peripheral clearance between the punch 208 and the die 204 at the recessed portions 402 should not exceed 0.0001" .

A hollow guide member 205 is adapted to be aligned by the guide pins 207 via guide holes 513. A downwardly extending cylindrical portion 514 of the hollow guide member 205 includes a bottom end 510 adapted to engage and rest on a portion of the top surface of the die 204. The hollow guide 205 also includes lateral slots 520 through a portion of_ the bottom end 510 which serve to form an upper scalpel guide. The lateral slots 520 in the guide member 205 are aligned with the lower scalpel guide 401 (Figure 19B) of the die 204. A round trephine 206 having a round cutting edge 601 on a bottom end thereof is received by the guide member 205. The guide member 205 serves to guide the punch 208 after the die 204 has been used to prepare the donor blank. The trephine 6 is used to make a circular cut into the donor blank as more fully described below. In other words, the cutting edge of the round trephine 206 extends through the guide member 205 and out the bottom end 510 of the guide member 205, which is in contact with the die 204, and cuts into the donor material.

The operation of the device illustrated in Figures 19A-19C will now be more fully described in connection with Figures 3A-3C, 20 and 21A-21D. Prior to use, all the instruments should be sterile. Moreover, the corneal issue should not be exposed to any instrument parts which are not at room temperature. In operation, the nest 203 is placed on the guide pins 207 and lowered until its upper surface 330 is coincident with the periphery of the punch 208. This provides a place to rest the donor cornea material in preparation for the upcoming operation. The donor material 1020 (in the shape shown in Figure 21A) is placed centrally on the nest

203 with the endothelium facing upward. The donor material 102 is secured in place by generating a vacuum beneath the material on the punch 108. The vacuum may be produced, for example, using a syringe (not shown) connected to produce a vacuum at the surface 806 (Figure 19C) of the punch via holes 804. It is noted that during the process, the corneal end thelium cell layer should only be touched in those areas which are eventually removed and discarded.

Once the donor material is in place on the nest 203, the die

204 is installed on the guide pins 207 and brought downward until the donor material 1020 is cut to produce a donor blank 1021 having the tabbed shape depicted in Figure 21B. The scrap portion 162 (Figure 20) goes down around punch 208 in the nest 203 and is discarded later. The die 204 descends until the surface of the lower scalpel guide 401 is higher than the punch cutting edge 832 by the thickness of the Bowman's membrane, 100 μm (0.004") . In the configuration illustrated in Figure 19A, the die should be gripped at the guide pins 207 in order to avoid cooking.

Once the tabbed blank 1021 is produced and inspected to insure correct peripheral cutting, the hollow guide member 205 is assembled onto the guide pins 207. The hollow guide member 205 is lowered until it bottoms out (i.e., comes into contact with the top of die 204) . At this point the tabbed blank 1021 is resting on the punch 208 with a portion of the tabbed blank 1021 extending upward above the top surface of lower scalpel guide 401 of the die 204. The guide 205 and the die 204 are now completely enclosed on 4 planes by the tool. Specifically, the lower surface 1032 of the tabs 1060 is supported by the punch 208. The radially extending sides 1034 of the tabs 1060 are surrounded by the die 204. The top portion 1036 of the tabs 1060 is enclosed by the guide member 205. A round trephine 206 is inserted into the hollow guide member 205. The round trephine is lowered using an oscillating motion until it reaches its lowest point just above the Bowman's membrane 108a, 1062. At its lowest point, the trephine 206 cuts into the stroma between the tabs 106 and the central portion 103 of the donor tabbed blank 201 down to the Bowman's membrane 108a as illustrated in Figures 20 and 21C. Specifically, an incision (or slit) 1061 is made into the tabbed blank 1021 leaving a portion 1062 of the donor material beneath the incision intact. The thickness of the intact portion 1062 is equal to the desired thickness of the tabs 106 (Figure 21D) . The trephine 6 is left in place such that the tab stroma is now confined on a fifth of the six possible planes by the blade of the trephine as illustrated in Figure 20.

Using a scalpel 209, positioned by the lateral slots 520 of the guide 205 forming the upper scalpel guide and the lower scalpel guide 401 of the die 204, the stroma of the tab is cut away from the Bowman's membrane 108a of the donor blank 1021. In this manner, the scalpel 209 is used to trim the undesired portion of the donor blank 1021 using the scalpel guide and trephone 206 lend as support for the donor material as illustrated in Figure 20. The resultant donor material now has the desired shape as illustrated in Figure 21D including thin tabbed portions 106.

Once the donor material is trimmed using the scalpel 209 to produce the donor material as illustrated in Figure 21D, the scalpel 209, the round trephine 206 and the guide 205 are removed. The donor material 102 may then be removed from the die 204 and has the shape illustrated in Figure and 21D. The donor material is placed into the recipient's eye as illustrated in Figure 18.

Experience has indicated that additional mechanical means for securing the tabs 24 into the pockets 46 of the recipient eye 10 is desired. Accordingly, the various methods of the invention as described above preferably include the step of forming a barb 1010 in the tabs 24 by means of a tweezer punch 1001 or other tool (see Figs. 22A-22C and 23A-23B) . More particularly, a preferred embodiment of a tweezer punch 1001 includes a conventional tweezer design with handle 1002 and opposing tongs 1003 and 1004 biased apart from each other as shown in Fig. 22A. As best shown in Figs. 22B and 22C, the distal end of one of the tongs such as 1003 includes an inwardly protruding punch 105 having a generally triangular configuration in cross-section as well as in planar view. Correspondingly, the other tong such as 1004 includes die hole 1006 having a generally triangular planar configuration. In view of the sloped configuration of the punch 1005, cutting action is created along the cutting edges 1007 of the die hole 1006 but not along fold edge 1008. Accordingly, it should be appreciated that upon placement of material between the tongs 1003 and 1004 of the tweezer 1001 and squeezing of the tweezer 1001, the punch 1005 will form an outwardly extending barb 1010 in the material defined by cutting edges 1007 and fold edge 1008.

As shown in Figs. 23A and 23B, the tweezer punch 1001 may be used to form barbs 1010 on the outer or inner surfaces of one or more or all of the tabs 24 of the donor material 14. Importantly, it should be appreciated that barb 1010 is composed of the Bowman's membrane 28 and therefore serves to more securely retain the tabs 24 into their respective pockets 46 once they are imbricated therein. Additionally, it should be appreciated that due to the squeezing action of the tweezer punch 1001, the Bowman's membrane 28 constituting the barb 1010 is squeezed of a certain amount of moisture and dries to a certain degree, thereby desirably becoming more rigid and thus functioning even better as a barb 1010.

As shown in Fig. 23B, the pockets 46 of the recipient eye 10 are preferably formed further interiorly to provide sufficient room for the barbs 1010 once imbricated therein without causing bulging of the Bowman's membrane 28 of the recipient eye 10 as could occur if the pockets 46 were formed immediately under the Bowman's membrane as illustrated in Fig. 3. Finally, without departing from the spirit and scope of this invention, the barbs 1010 may be formed to extend outwardly from the outer surface of the Bowman's membrane, from the inner surface of the Bowman's membrane, or a mixed combination thereof as shown in Figs. 23A and 23B.

The present disclosure includes that contained in the appended claims, as well as that of the foregoing description. Although this invention has been described in its preferred form with a certain degree of particularity, it is understood that the present disclosure of the preferred form has been made only by way of example and that numerous changes in the details of construction and methods and the combination and arrangement of parts and method steps may be resorted to without departing from the spirit and scope of the invention.

Now that the invention has been described, WHAT IS CLAIMED IS:

1. A method of repairing a cornea of an eye, comprising the steps of: providing a donor material in the shape of a partial sphere, the donor material having an exterior Bowman's membrane; die cutting the donor material to define an outline configuration including a central extent and a plurality of tabs extending outwardly therefrom; shaving the Bowman's membrane of the tabs to remove donor material therefrom leaving the Bowman's membrane of the tabs intact with the Bowman's membrane of the central extent; forming a central aperture in the cornea to be repaired, the central aperture having a size and shape essentially that of the central extent of the donor material; incising a plurality of pockets from the central aperture into the cornea, the pockets being positioned and sized and shaped to receive the respective tabs when the central extent is positioned within the central aperture; and positioning the central extent within the central aperture and imbricating the tabs into the respective pockets.

2. The method as set forth in Claim 1, wherein the step of die cutting the donor material comprises the step of positioning the donor material between male and female dies, the dies including the outline configuration such that the donor material is die-cut to the outline configuration as the male and female dies are mated.

3. The method as set forth in Claim 2 further including the step of vertically supporting one of the dies allowing the donor material to be seated thereon prior to being die cut by the mating of the dies.

4. The method as set forth in Claim 3, wherein the step of

Claims

vertically supporting one of the dies comprises the step of vertically supporting the male die and wherein the female die is aligned and moved vertically downwardly toward the male die during mating thereby die cutting the donor material seated thereon into the outline configuration.

5. The method as set forth in Claim 4, wherein the step of vertically moving the female die downwardly toward the male die comprises the step of coupling the female die with the male die by means of at least one guide pin.

6. The method as set forth in Claim 5, further comprises the step of incising the central extent to the exterior Bowman's membrane thereof thereby leaving intact the exterior Bowman membrane of the central extent and the tabs.

7. The method as set forth in Claim 6, wherein the step of incising the central extent comprises the step of aligning an annular cutter above the male die having the donor material seated thereon and then moving the annular cutter downwardly toward the male die to a depth no deeper than the height of the Bowman's membrane of the donor material seated on the male die.

8. The method as set forth in Claim 7, further comprising the step of positioning an annular supporter about the male die for providing additional support to the donor material when seated thereon.

9. The method as set forth in Claim 8, wherein the step of positioning the supporter about the male die comprises positioning an elastomeric ring about the male die to support the supporter rested thereon.

10. The method as set forth in Claim 1, wherein the method of shaving the donor material from the exterior Bowman's membrane of the tabs comprises the steps of : positioning the die-cut donor material between a male die and a female die, the dies being respectively configured to fold the tabs along the length of the male die when the dies are mated; mating the dies to fold the tabs along the length of the male die; and longitudinally shaving the donor material from the Bowman's membrane of the tabs.

11. The method as set forth in Claim 10 further including the step of vertically supporting one of the dies allowing the donor material to be seated thereon prior to the tabs being shaved by the mating of the dies.

12. The method as set forth in Claim 11, wherein the step of vertically supporting one of the dies comprises the step of vertically supporting the male die and wherein the female die is aligned and moved vertically downwardly toward the male die during mating thereby folding the tabs of the donor material seated thereon along the sides of the male die.

13. The method as set forth in Claim 12, wherein the step of vertically moving the female die downwardly toward the male die comprises the step of coupling the female die with the male die by means of at least one guide pin.

14. The method as set forth in Claim 1 , wherein the step of shaving the donor material from the exterior Bowman's membrane of the tabs comprises the step of aligning an annular cutter above the male die having the donor material seated thereon and then moving the annular cutter downwardly between the mated dies to shave the donor material from the Bowman's membrane of the tabs folded along the side of the male die.

15. An apparatus for transplanting a donor material in the shape of a partial sphere into a central aperture of an eye, the donor material having an exterior Bowman's membrane, comprising in combination: means for die cutting the donor material to define an outline configuration including a central extent and a plurality of tabs extending outwardly therefrom, the central extent having a size and shape essentially that of the central aperture; means for shaving the Bowman's membrane of the tabs to remove donor material therefrom leaving the Bowman's membrane of the tabs intact with the Bowman's membrane of the central extent; and means for incising a plurality of pockets from the central aperture into the cornea, the pockets being positioned and sized and shaped to receive the respective tabs when the central extent is positioned within the central aperture, whereby the central extent may be positioned within the central aperture and the tabs imbricated into the respective pockets thereby securing the donor material in the central aperture.

16. The apparatus as set forth in Claim 15, wherein the means for die cutting the donor material comprises male and female dies, the dies having the outline configuration such that the donor material is die-cut to the outline configuration when positioned between the dies and the male and female dies are mated.

17. The apparatus as set forth in Claim 16, further including means for vertically supporting one of the dies allowing the donor material to be seated thereon prior to being die cut by the mating of the dies.

18. The apparatus as set forth in Claim 17, wherein the means for vertically supporting one of the dies comprises means for vertically supporting the male die and wherein the female die is aligned and moved vertically downwardly toward the male die during mating thereby die cutting the donor material seated thereon into the outline configuration.

19. The apparatus as set forth in Claim 18, wherein the means for vertically moving the female die downwardly toward the male die comprises coupling the female die with the male die by means of at least one guide pin.

20. The apparatus as set forth in Claim 19, further comprising means for incising the central extent to the exterior Bowman's membrane thereof thereby leaving intact the exterior Bowman membrane of the central extent and the tabs.

21. The apparatus as set forth in Claim 20, wherein the means for incising the central extent comprises means for aligning an annular cutter above the male die having the donor material seated thereon and then moving the annular cutter downwardly toward the male die to a depth no deeper than the height of the Bowman's membrane of the donor material seated on the male die.

22. The apparatus as set forth in Claim 21, further comprising and annular supporter and means for positioning the annular supporter about the male die thereby providing additional support to the donor material when seated thereon.

23. The apparatus as set forth in Claim 22, wherein the means for positioning the supporter about the male die comprises an elastomeric ring positioned about the male die to support the annular supporter rested thereon.

24. The apparatus as set forth in Claim 15, wherein the means for shaving the donor material from the exterior Bowman's membrane of the tabs comprises in combination: means for positioning the die-cut donor material between a male die and a female die, the dies being respectively configured to fold the tabs along the length of the male die when the dies are mated; means for mating the dies to fold the tabs along the length of the male die; and means for longitudinally shaving the donor material from the Bowman's membrane of the tabs.

25. The apparatus as set forth in Claim 24, further including means for vertically supporting one of the dies allowing the donor material to be seated thereon prior to the tabs being shaved by the mating of the dies.

26. The apparatus as set forth in Claim 25, wherein the means for vertically supporting one of the dies comprises means for vertically supporting the male die such that as the female die is aligned and moved vertically downwardly toward the male die during mating, the tabs of the donor material seated thereon are folded along the sides of the male die.

27. The apparatus as set forth in Claim 26, wherein the means for vertically moving the female die downwardly toward the male die comprises means for coupling the female die with the male die by means of at least one guide pin.

28. The apparatus as set forth in Claim 27, wherein the means for shaving the donor material from the exterior Bowman's membrane of the tabs comprises means for aligning an annular cutter above the male die having the donor material seated thereon such that as the annular cutter is moved downwardly between the mated dies, the donor material is shaved from the Bowman's membrane of the tabs folded along the side of the male die.

29. An apparatus for preparing donor material for transplantation into a central aperture of an eye, the eye having a plurality of pockets incised about the periphery of the central aperture and the donor material having an exterior Bowman's membrane, comprising in combination: means for die cutting the donor material to define an outline configuration including a central extent and a plurality of tabs extending outwardly therefrom, the central extent having a size and shape essentially that of the central aperture; and means for shaving the Bowman's membrane of the tabs to remove donor material therefrom leaving the Bowman's membrane of the tabs intact with the Bowman's membrane of the central extent, whereby the central extent may be positioned within the central aperture and the tabs imbricated into the respective pockets thereby securing the donor material in the central aperture.

30. The apparatus as set forth in Claim 29, wherein the means for die cutting the donor material comprises male and female dies, the dies having the outline configuration such that the donor material is die-cut to the outline configuration when positioned between the dies and the male and female dies are mated.

31. The apparatus as set forth in Claim 30, further including means for vertically supporting one of the dies allowing the donor material to be seated thereon prior to being die cut by the mating of the dies.

32. The apparatus as set forth in Claim 31, wherein the means for vertically supporting one of the dies comprises means for vertically supporting the male die and wherein the female die is aligned and moved vertically downwardly toward the male die during mating thereby die cutting the donor material seated thereon into the outline configuration.

33. The apparatus as set forth in Claim 32, wherein the means for vertically moving the female die downwardly toward the male die comprises coupling the female die with the male die by means of at least one guide pin.

34. The apparatus as set forth in Claim 33, further comprising means for incising the central extent to the exterior Bowman's membrane thereof thereby leaving intact the exterior Bowman membrane of the central extent and the tabs.

35. The apparatus as set forth in Claim 34, wherein the means for incising the central extent comprises means for aligning an annular cutter above the male die having the donor material seated thereon and then moving the annular cutter downwardly toward the male die to a depth no deeper than the height of the Bowman's membrane of the donor material seated on the male die. 36. The apparatus as set forth in Claim 35, further comprising and annular supporter and means for positioning the annular supporter about the male die thereby providing additional support to the donor material when seated thereon.

37. The apparatus as set forth in Claim 36, wherein the means for positioning the supporter about the male die comprises an elastomeric ring positioned about the male die to support the annular supporter rested thereon.

38. The apparatus as set forth in Claim 29, wherein the means for shaving the donor material from the exterior Bowman's membrane of the tabs comprises in combination: means for positioning the die-cut donor material between a male die and a female die, the dies being respectively configured to fold of the tabs along the length of the male die when the dies are mated; means for mating the dies to fold the tabs along the length of the male die; and means for longitudinally shaving the donor material from the Bowman's membrane of the tabs.

39. The apparatus as set forth in Claim 38, further including means for vertically supporting one of the dies allowing the donor material to be seated thereon prior to the tabs being shaved by the mating of the dies.

40. The apparatus as set forth in Claim 39, wherein the means for vertically supporting one of the dies comprises means for vertically supporting the male die such that as the female die is aligned and moved vertically downwardly toward the male die during mating, the tabs of the donor material seated thereon are folded along the sides of the male die.

41. The apparatus as set forth in Claim 40, wherein the means for vertically moving the female die downwardly toward the male die comprises means for coupling the female die with the male die by means of at least one guide pin.

42. The apparatus as set forth in Claim 41, wherein the means for shaving the donor material from the exterior Bowman's membrane of the tabs comprises means for aligning an annular cutter above the male die having the donor material seated thereon such that as the annular cutter is moved downwardly between the mated dies, the donor material is shaved from the Bowman's membrane of the tabs folded along the side of the male die.

43. An eye with a repaired cornea comprising, in combination: a donor material in the shape of a partial sphere having a generally circular central extent, the central extent being of the size and shape of the central portion of a cornea of an eye, the central extent having a periphery of a fixed diameter of between about 7.0 and 7.5 millimeters with an exterior surface in a convex configuration and an interior surface in a concave configuration and with an essentially common thickness throughout, the central extent having four symmetrically positioned diamond shaped corneal flaps extending radially from the periphery of the central extent, the flaps having exterior surfaces as a continuation of the exterior surface of the central extent, the exterior surface of the central extent and flaps being of a common Bowman's membrane, the flaps having a thickness of about 10 percent of the thickness of the central extent, the area of coupling between the flaps and the central extent constituting between about 10 and 100 percent of the circumference of the central extent, and with the radial dimension of each flap being between about 25 and 75 percent of the diameter of the central extent, and with the side edges of the flaps being radii of the central extent, and with the radially exterior edge of each flap being curved concentric with the curvature of the central extent; and a recipient eye in the shape of a partial sphere having a circular aperture in the corner at its central portion, the central aperture being of a size and shape essentially that of the periphery of the central extent of the donor material, the aperture being of a common thickness at the periphery of the aperture, the central portion having four symmetrically positioned pockets, the pockets having a thickness of about 10 percent of the thickness of the cornea, the pockets being at the area adjacent to the periphery of the aperture and constituting between about 10 and 100 percent of the periphery of the aperture, with the radial dimension of each pocket being between about 25 and 75 percent of the diameter of the aperture, and with the central extent of the donor material located within the aperture of the recipient eye, and with the flaps of the central extent being located within the pockets of the recipient eye.

44. An eye with a repaired cornea comprising: a donor material in the shape of a partial sphere having a central extent, the central extent being of the size and shape of the central portion of a cornea of an eye, the central extent having a periphery and an exterior surface in a convex configuration and an interior surface in a concave configuration and with an essentially common thickness throughout, the central extent having at least one corneal flap extending radially from the periphery of the central extent, the flap having an exterior surface as a continuation of the exterior surface of the central extent; and a recipient eye in the shape of a partial sphere having an aperture in the cornea at its central portion, the aperture in the cornea being of a size and shape essentially that of the periphery of the central extent of the donor material, the central portion having at least one pocket aligned with the flap, and with the central extent of the donor material located within the aperture of the recipient eye and with the flap of the central extent being located within the pocket of the recipient eye.

45. The eye as set forth in Claim 44, wherein the flap has a thickness of about 10 percent of the thickness of the central extent, the juncture between the flap and the central extent constituting between about 10 to 100 percent of the circumference of the central extent, with the radial dimension of the flap being between about 25 and 75 percent of the diameter of the central extent, and with the side edges of the flap being radii of the central extent, and with the radially exterior edge of the flap being curved concentric with the curvature of the central extent. 46. The eye as set forth in Claim 44, wherein the pocket has a thickness of about 10 percent of the thickness of the cornea, the pocket at the area adjacent to the periphery of the aperture constituting between about 10 and 100 percent of the periphery of the aperture, with the radial dimension of the pocket being between about 25 and 75 percent of the diameter of the aperture. 47. A method of repairing a cornea comprising: providing a donor material in the shape of a partial sphere having a generally central extent, the central extent being of the size and shape of the central portion of a cornea of an eye, the central extent having a periphery with an exterior surface in a convex configuration and an interior surface in a concave configuration and with an essentially common thickness throughout, the central extent having one or more corneal flaps extending radially from the periphery of the central extent, the flaps having exterior surfaces as a continuation of the exterior surface of the central extent; and providing a recipient eye in the shape of a partial sphere having a central aperture in the cornea, the central aperture being of a size and shape essentially that of the periphery of the central extent of the donor material, the central portion having pockets and with the central extent of the donor material located within the central aperture of the recipient eye and with the flaps of the central extent being located within the pockets of the recipient eye; and positioning the central extent of the donor material within the aperture of the recipient eye with the flaps of the central extent being located within the pockets of the recipient eye.

48. A trephine for the cutting of donor material adapted to be used in corneal transplants comprising, in combination: a cylindrical support adapted to be held by a surgeon in the cutting of donor material, the trephine including a cylindrical central portion with an upper edge and a lower edge with a central axis along the length thereof; a plurality of circular cutting blades formed in the lower edge of the support, the circular cutting blades including an exterior continuous circular blade with a diameter of between about 11 and 12 millimeters, and an interior discontinuous circular blade; a plurality of linear radially extending blades between the circular blades, the exterior circular blade being closer to the upper edge of the support than the interior circular blade by about 100 microns, and with the radial blades extending at an angle with respect to the upper edge of the support, the radial blades being eight in number and arranged as four diamond shaped components constituting between about 10 and 100 percent of the circumference of the inner and outer circular blades, and with the radially interior edge of the diamond shaped components being blunt; and an associated block with a pocketed, generally spherical surface for constituting a support for the donor material during the cutting thereof by the trephine.

49. A trephine for cutting of donor material adapted to be used in corneal transplants comprising, in combination: a cylindrical support adapted to be held by a surgeon in the cutting of donor material, the trephine including a cylindrical central portion with an upper edge and a lower edge with a central axis along the length thereof; a plurality of circular cutting blades formed in the lower edge of the support, the circular cutting blades including an exterior continuous circular blade, and an interior discontinuous circular blade; and a plurality of linear radially extending blades between the circular blades, the exterior circular blade being closer to the upper edge of the support than the interior circular blade with the radial blades extending at an angle from the upper edge of the support .

50. The trephine as set forth in Claim 49 and further including: an associated block with a generally spherical surface for constituting a support for the donor material during the cutting thereof by the trephine.

51. The trephine as set forth in Claim 49, wherein the exterior circular blade as a diameter of between about 11 and 12 m i l l i m e t e r s . 5 2 .

The trephine as set forth in Claim 49, wherein the radial blades are eight in number and arranged as four diamond shaped components constituting between about 10 and 100 percent of the circumference of the inner and outer circular blades and with the radially interior edge of the diamond shaped components being blunt .

53. A method of cutting donor material adapted to be used in corneal transplants with a trephine comprising, in combination: providing a cylindrical support adapted to be held by a surgeon in the cutting of donor material, the trephine including a cylindrical central portion with an upper edge and a lower edge with a central axis along the length thereof; providing a plurality of circular cutting blades formed in the lower edge of the support, the circular cutting blades including an exterior continuous circular blade, and an interior discontinuous circular blade; providing a plurality of linear radially extending blades between the circular blades, the exterior circular blade being closer to the upper edge of the support than the interior circular blade with the radial blades extending at an angle from the upper edge of the support; providing an associated block with a recessed, generally spherical surface for constituting a support for the donor material during the cutting thereof by the trephine; positioning donor material on the block; and moving the trephine into contact with the donor material to cut the donor material into a shape for insertion into an aperture in an eye for the repair thereof.

54. A segment of tissue having a repaired central portion comprising: a donor material having a central extent, the central extent being of the size and shape of the central portion of the segment of tissue, the central extent having a periphery and at least one flap extending radially from the periphery, the flap having an exterior surface as a continuation of an exterior surface of the central extent; and the segment of tissue having an aperture at its central portion, the aperture being of a size and shape essentially that of the periphery of the central extent of the donor material, the central portion having at least one pocket aligned with the flap, and with the central extent of the donor material located within the aperture and with the flap of the central extent being imbricated within the pocket of the segment of tissue.

55. A method of thinning a tabbed portion of donor material having a predetermined shape, the tabbed portion extending outward radially from a center portion of the donor material, said method comprising the steps of: holding the donor material in a thinning tool such that the tabbed portion is held between a first and second surface of the tool; inserting a cutting device between the first and second surface of the thinning tool and cutting away a portion of the tabbed portion while the donor material is held in place by the tool.

56. A method as recited in Claim 55, wherein the cutting device is a round trephine.

57. A method as recited in Claim 56, wherein a portion from each of a plurality of tabbed portions of the donor material is cut away simultaneously.

58. A method as recited in Claim 55, wherein the cutting device is a scalpel.

59. A method as recited in Claim 55, further comprising the steps of: holding the donor material in a first tool; cutting a first incision into the center portion of the donor material guided by the first tool in a first direction substantially perpendicular to a surface of the center portion to a desired depth, the desired depth being selected such that a portion of the donor material is left intact at an end of the first incision; placing the donor material in the thinning tool such that the center portion rests on a surface of an inner portion of the thinning tool, and the tabbed portion is held between an outer wall of the inner portion of the thinning tool and an inner wall of an outer portion of the thinning tool; and inserting the cutting device between the outer wall of the inner portion of the thinning tool and the inner wall of the outer portion of the thinning tool such that a portion of the tabbed portion adjacent the inner wall of the outer portion of the thinning tool is cut away.

60. A tool for thinning a tabbed portion of donor material having a predetermined shape, the tabbed portion extending outward radially from a center portion of the donor material, said tool comprising: a nest having a top surface and outer wall extending downward from said top surface, the nest being adapted to hold the donor material, the nest having a shape such that the tabbed portions of the donor material extend beyond a periphery of the top surface of the nest defined by the outer wall; a tab bender adapted to be inserted over the nest a distance between an inside wall of the tab bender and the outer wall of the nest being approximately equal to a thickness of the tabbed portions, wherein the inside wall of the tab bender bends the tabbed portions and presses the tabbed portions against a part of the outer wall of the nest when the tab bender is inserted over the nest; and a cutting tool inserted between the inside wall of the tab bender and the outer wall of the nest, the cutting tool cutting a part of the tabbed portion adjacent to the outer wall of the tab bender away from the tabbed portions.

61. An apparatus as recited in Claim 60, further comprising a suction device operable to hold the donor material in place when the tab bender is inserted over the nest.

62. An apparatus for preparing donor material for corneal transplantation, comprising: a first cutting means for cutting the donor material into a donor blank having a predetermined shape, the predetermined shape including a center portion and at least one tab extending radially outward from the center portion; a second cutting means for cutting into the center portion of the donor blank to a set depth leaving a portion of the donor blank having a predetermined thickness intact; and a guide means for guiding the second cutting means as the second cutting means cuts into the donor blank, the guide means including lateral slots aligned with the tabs to receive a third cutting means for thinning the tabs to the predetermined thickness. 63. A method for preparing donor material for corneal transplantation, the method comprising the steps of: holding in a tool a donor material having a predetermined shape including a center portion and at least one tabbed portion extending outward radially from a first axis of the central portion; cutting a first incision into the center portion of the donor material guided by the tool in a direction substantially parallel to the first axis to a desired depth, the desired depth being selected such that a portion of the donor material is left intact at an end of the first incision having a predetermined thickness; and cutting a second incision guided by the tool into the donor material in a direction along a second axis to a point where the second incision joins the end of the first incision.

64. An apparatus for preparing donor material for corneal transplantation comprising: a stationary punch extending along a first axis, a cross section of the punch taken along a second axis perpendicular to the first axis having a predetermined shape, the predetermined shape including at least one tab extending outward radially from the first axis; a nest having a nest hole defined therethrough, the nest hole having the predetermined shape and being adapted to receive the punch through the nest hole, the nest being movably mounted so as to move in the direction of the first axis; a die having a die hole defined therethrough, the die hole also having the predetermined shape, the die being movably mounted above the nest so as to be moved along the first axis between a first position and a second position, the die hole being adapted to receive the punch when the die is moved along the first axis such that the punch substantially fills the die hole; a hollow guide member mounted along the first axis when the die is moved to the second position, a first end of the hollow guide member being in contact with a top surface of the die, the first end of the hollow guide member having lateral slots which correspond to and are aligned with tabs of the predetermined shape of the die hole; and a round cutting device having a cutting end, the cutting device being adapted to be received through a second end of the hollow guide member and extending through the hollow guide member, the cutting end extending out of the first end of the hollow guide member.

65. A method of preparing donor material for corneal transplantation, the method comprising the steps of: placing the donor material on a supporting member, the supporting member including a punch having a predetermined shape including at least one tabbed portion and a nest having a nest hole of the predetermined shape defined therethrough, the punch having aligned along a first axis with a top portion thereof being received by the nest hole such that an upper surface of the nest is coincident with a periphery of the punch; aligning a die member including a die hole having the predetermined shape such that the die hole aligns with the nest hole along the first axis; moving the die member along the first axis so as to cut the donor material with the die member to produce a donor blank having the predetermined shape including at least one donor blank tab, the donor blank having a bottom surface resting on the top surface of the die, the top surface of the punch being recessed from the top surface of the die member; positioning a hollow guide member along the first axis such that a bottom end of said guide member rests on a top surface of said die member, said bottom end of said guide member having lateral slots defined therethrough, the lateral slots being aligned with the donor blank tabs; inserting a round cutting member within the hollow guide member and moving the cutting member downward along the first axis so as to cut into the donor blank material to a predetermined depth; and inserting a thinning scalpel into the lateral slots to a point where a tip of the scalpel reaches the cutting member so as to thin the donor blank tab to a desired thickness.

66. A method of repairing a cornea of an eye, comprising the steps of: providing a donor material in the shape of a partial sphere, the donor material having an exterior Bowman's membrane; die cutting the donor material to define an outline configuration including a central extent and a plurality of tabs extending outwardly therefrom; shaving the Bowman's membrane of the tabs to remove donor material therefrom leaving the Bowman's membrane of the tabs intact with the Bowman's membrane of the central extent; forming a barb extending from the Bowman's membrane of one or more of the t .θs; forming a central aperture in the cornea to be reDairec the central aperture having a size and shape essentially that of the central extent of the donor material; incising a plurality of pockets from the central aperture into the cornea, the pockets being positioned and sized and shaped to receive the respective tabs when the central extent is positioned within the central aperture; and positioning the central extent within the central aperture and imbricating the tabs into the respective pockets.

ABSTRACT OF THE DISCLOSURE An apparatus and method for preparing a cornea of a donor eye and transplanting it into a recipient eye with minimal or no sutures. The donor material is outlined cut to a circular extent with symmetrically positioned tabs, preferably diamond-shaped, extending radially from the periphery of the central extent and with the tabs being composed of only the Bowman's membrane as a continuation of the of the Bowman's membrane of the central extent. The recipient eye is cut with a trephine to form a circular aperture in the cornea at its central portion, the circular aperture being of a size and shape essentially that of the periphery of the central extent of the donor material, the aperture being of a common thickness at the periphery of the aperture, the central portion having a corresponding number of symmetrically positioned pockets. The central extent of the donor material is positioned within the aperture of the recipient eye, and then the tabs of the central extent are imbricated into the respective pockets of the recipient eye, thereby securing the transplanted donor cornea into the recipient eye.