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Title:
TRI-POD CORNEAL DONOR VACUUM PUNCH
Document Type and Number:
WIPO Patent Application WO/2023/229984
Kind Code:
A1
Abstract:
Disclosed herein is a corneal punch including a cylindrical body and a plurality of protrusions extending radially outward from the cylindrical body and extending along the length of the cylindrical body. The cylindrical body has a longitudinal axis, defines a proximal end and a distal end, and contains a central opening along the longitudinal axis. The plurality of protrusions contain channels that are in communication with the central opening. The distal end of the cylindrical body contains a cutting edge.

Inventors:
GHAFFARIEH ALIREZA (US)
WARNER DAVID (US)
Application Number:
PCT/US2023/023082
Publication Date:
November 30, 2023
Filing Date:
May 22, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
BIOVENTURES LLC (US)
International Classes:
A61F9/013; A61B17/32; A61F2/14; A61F9/007
Domestic Patent References:
WO2014187435A12014-11-27
Foreign References:
US20190060054A12019-02-28
US20140155871A12014-06-05
US20190380868A12019-12-19
US5755785A1998-05-26
Attorney, Agent or Firm:
KREPEL, Allison N. et al. (US)
Download PDF:
Claims:
CLAIMS

What is claimed is:

1 . A corneal punch, comprising: a cylindrical body having a longitudinal axis and defining a proximal end and a distal end, wherein the cylindrical body contains a central opening along the longitudinal axis; a plurality of protrusions extending radially outward from the cylindrical body, wherein the plurality of protrusions each define a channel that is in communication with the central opening; and a cutting edge at the distal end of the cylindrical body and the distal end of the plurality of protrusions, wherein the plurality of protrusions each include radial walls and an outer wall that connects the radial walls.

2. The corneal punch of claim 1 , wherein each channel is a rectangular cross- sectional shape.

3. The corneal punch of claim 1 , wherein the plurality of protrusions includes three protrusions uniformly spaced approximately 120-degrees around the longitudinal axis of the cylindrical body.

4. The corneal punch of claim 1 , wherein the central opening of the cylindrical body defines an inner surface that has a radius between 2.0 millimeters and 6.0 millimeters with respect to the longitudinal axis of the cylindrical body.

5. The corneal punch of claim 1 , wherein the outer wall of each of the plurality of protrusions defines an inner surface that has a radius between 5.0 millimeters and 9.0 millimeters with respect to the longitudinal axis of the cylindrical body.

6. The corneal punch of claim 1 , wherein the cylindrical body and the radial walls of each of the plurality of protrusions intersect at a radius between 0.25 millimeters and 1 .25 millimeters.

7. The corneal punch of claim 1 , wherein the radial walls of each of the plurality of protrusions and the outer wall of each of the plurality of protrusions intersect at a radius between 0.25 millimeters and 1 .25 millimeters.

8. The corneal punch of claim 1 , wherein the distal end of each of the plurality of protrusions are configured to form a convex shape, wherein the convex shape forms a radius between 6.0 millimeters and 10.0 millimeters.

9. The corneal punch of claim 1 , wherein the cylindrical body is between 15.0 millimeters and 35.0 millimeters in length.

10. The corneal punch of claim 1 , wherein the cylindrical body and the plurality of protrusions are made of surgical-grade stainless steel.

11. A method of using a corneal punch having a longitudinal axis, a proximal end, a distal end, and a cutting edge at the distal end, the method comprising: applying the cutting edge of the corneal punch to a donor cornea with the longitudinal axis of the corneal punch generally aligned with an optical axis of the donor cornea, wherein the corneal punch contains a cylindrical body with a central opening along the longitudinal axis and a plurality of protrusions extending radially outward from the cylindrical body, wherein the plurality of protrusions contain channels that are in communication with the central opening, wherein the plurality of protrusions each include radial walls extending radially outward from the cylindrical body and an outer wall that connects the radial walls; advancing the corneal punch through the donor cornea with the longitudinal axis of the corneal punch remaining generally aligned with the optical axis of the donor cornea; and removing the corneal punch from the donor cornea, thereby creating a corneal graft in a shape corresponding to a cross-sectional shape of the corneal punch.

12. The method of claim 11 , wherein each channel is a rectangular cross-sectional shape.

13. The method of claim 11 , wherein the plurality of protrusions includes three protrusions uniformly spaced approximately 120-degrees about the longitudinal axis of the cylindrical body.

14. The method of claim 11 , wherein the central opening of the cylindrical body defines an inner surface that has a radius between 2.0 millimeters and 6.0 millimeters with respect to the longitudinal axis of the cylindrical body.

15. The method of claim 11 , wherein the outer wall of each of the plurality of protrusions defines an inner surface that has a radius between 5.0 millimeters and 9.0 millimeters with respect to the longitudinal axis of the cylindrical body.

16. The method of claim 11 , wherein the cylindrical body and the radial walls of each of the plurality of protrusions intersect at a radius between 0.25 millimeters and 1.25 millimeters.

17. The method of claim 11 , wherein the radial walls of each of the plurality of protrusions and the outer wall of each of the plurality of protrusions intersect at a radius between 0.25 millimeters and 1 .25 millimeters.

18. The method of claim 11 , wherein the distal end of each of the plurality of protrusions are configured to form a convex shape, wherein the convex shape forms a radius between 6.0 millimeters and 10.0 millimeters.

19. The method of claim 11 , wherein the cylindrical body is between 15.0 millimeters and 35.0 millimeters in length.

20. The method of claim 11 , wherein the cylindrical body and the plurality of protrusions are made of surgical-grade stainless steel.

Description:
TRI-POD CORNEAL DONOR VACUUM PUNCH

FIELD

[0001] The present invention relates to corneal lamellar transplants in ophthalmology and, in particular, to a tri-pod corneal donor vacuum punch and methods of use thereof.

BACKGROUND

[0002] Lamellar keratoplasty involves the removal of diseased corneal tissue and replacement with donor lamellar corneal tissue. In some cases, a partial thickness of the posterior cornea is transplanted. For example, both Descemet’s Membrane Endothelial Keratoplasty (DMEK) and Descemet’s Stripping Automated Endothelial Keratoplasty (DSEAK) involve removing the endothelium and the Descemet’s membrane from the cornea of the patient (i.e., recipient). In DMEK, a graft comprising the endothelium and Descemet’s membrane from a donor cornea are transplanted onto the posterior cornea of the recipient. In DSEAK, graft comprising the endothelium, the Descemet’s membrane, and a layer of stroma from the donor cornea are transplanted onto the posterior cornea of the recipient. In these procedures, the corneal graft from the donor cornea is injected into the anterior chamber of the eye of the recipient.

[0003] However, current surgical methods for lamellar keratoplasty are technically challenging because the methods require air management, handling and opening the graft inside the eye, head positioning for the elderly for 3-5 days after surgery, and laser peripheral iridotomy (PI). Moreover, the main risk with the current surgical methods is that the thin graft of endothelium donor tissue can become displaced within the first few days or weeks after surgery.

[0004] Therefore, there is a need for a tri-pod corneal donor vacuum punch that simplifies corneal transplantations by eliminating preoperative laser peripheral iridotomy (PI), complicated course of tissue opening and air management during and after surgery, and precise head positioning of the recipient. Moreover, there is a need for a tri-pod corneal donor vacuum punch that increases the rate of success for corneal transplantations by reducing the rate of graft displacement and reducing the rate of endothelial cell loss.

SUMMARY

[0005] This disclosure provides a tri-pod corneal donor vacuum punch and methods of use thereof. One aspect of the present disclosure encompasses a corneal punch that includes a cylindrical body and a plurality of protrusions extending radially outward from the cylindrical body. The cylindrical body has a longitudinal axis, defines a proximal end and a distal end, and contains a central opening along the longitudinal axis. The plurality of protrusions each define a channel that is in communication with the central opening. The plurality of protrusions may each include radial walls and an outer wall that connects the radial walls. The distal end of the cylindrical body and the distal end of the plurality of protrusions may contain a cutting edge.

[0006] The corneal punch may include channels that are rectangular in cross-sectional shape. The corneal punch may include three protrusions uniformly spaced approximately 120-degrees around the longitudinal axis of the cylindrical body. The central opening of the cylindrical body may define an inner surface that has a radius between 2.0 millimeters and 6.0 millimeters with respect to the longitudinal axis of the cylindrical body. The outer wall of each of the plurality of protrusions may define an inner surface that has a radius between 5.0 millimeters and 9.0 millimeters with respect to the longitudinal axis of the cylindrical body.

[0007] The cylindrical body and the radial walls of each of the plurality of protrusions may intersect at a radius between 0.25 millimeters and 1.25 millimeters. Similarly, the radial walls of each of the plurality of protrusions and the outer wall of each of the plurality of protrusions may intersect at a radius between 0.25 millimeters and 1.25 millimeters. The distal end of each of the plurality of protrusions may be configured to form a convex shape and the convex shape may define a radius between 6.0 millimeters and 10.0 millimeters. The cylindrical body may be between 15.0 millimeters and 35.0 millimeters in length. The corneal punch may be made of surgical-grade stainless steel. [0008] Also disclosed herein is a method for using the corneal punch. The method may include applying the cutting edge of the corneal punch to a donor cornea with the longitudinal axis of the corneal punch generally aligned with an optical axis of the donor cornea. Additionally, the method may further include advancing the corneal punch through the donor cornea with the longitudinal axis of the corneal punch remaining generally aligned with the optical axis of the donor cornea. Finally, the method may include removing the corneal punch from the donor cornea, thereby creating a corneal graft in a shape corresponding to the cross-sectional shape of the corneal punch.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The description will be more fully understood with reference to the following figures and data graphs, which are presented as various embodiments of the disclosure and should not be construed as a complete recitation of the scope of the disclosure. It is noted that, for purposes of illustrative clarity, certain elements in various drawings may not be drawn to scale. Understanding that these drawings depict only exemplary embodiments of the disclosure and are not therefore to be considered to be limiting of its scope, the principles herein are described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0010] FIG. 1 is a perspective view of a tri-pod corneal donor vacuum punch.

[0011] FIG. 2A is a side plan view of a tri-pod corneal donor vacuum punch.

[0012] FIG. 2B is a top plan view of the corneal punch.

[0013] FIG. 2C is the top plan view of the corneal punch.

[0014] FIG. 3A is a perspective view photograph of a tri-pod corneal donor vacuum punch.

[0015] FIG. 3B is another perspective view photograph of the corneal punch.

[0016] FIG. 3C is another perspective view photograph of the corneal punch.

[0017] FIG. 3D is a top view photograph of the corneal punch. [0018] FIG. 4A is a photograph of a donor cornea on a cutting block and the distal end of a tri-pod corneal donor vacuum punch.

[0019] FIG. 4B is a photograph of the corneal punch cutting through the donor cornea to harvest corneal tissue.

[0020] FIG. 4C is a photograph of a graft that was harvested from the donor cornea.

[0021] FIG. 4D is a photograph of an eyeball, which represents the eyeball of the patient (i.e., recipient), with markings prior to the injection of the graft from the donor.

[0022] FIG. 4E is a photograph of the graft being injected into the anterior chamber of the eyeball.

[0023] FIG. 4F is a photograph of the graft being injected into the anterior chamber of the eyeball.

[0024] FIG. 4G is a photograph of the graft in the anterior chamber of the eyeball of the recipient.

[0025] FIG. 5A is an image captured during an optical coherence tomography (OCT) scan after the injection of the graft into the anterior chamber of the eyeball.

[0026] FIG. 5B is an image captured during the OCT scan.

[0027] FIG. 5C is an image captured during the OCT scan.

[0028] FIG. 5D is an image captured during the OCT scan.

[0029] FIG. 5E is an image captured during the OCT scan.

[0030] FIG. 5F is an image captured during the OCT scan.

[0031] FIG. 5G is an image captured during the OCT scan.

[0032] FIG. 5H is an image captured during the OCT scan.

DETAILED DESCRIPTION

[0033] Various embodiments of the disclosure are discussed in detail below. While specific implementations are discussed, it should be understood that this is done for illustration purposes only. A person skilled in the relevant art will recognize that other components and configurations may be used without parting from the spirit and scope of the disclosure. Thus, the following description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, well-known or conventional details are not described in order to avoid obscuring the description. References to one or an embodiment in the present disclosure can be references to the same embodiment or any embodiment; and, such references mean at least one of the embodiments.

[0034] Reference to “one embodiment”, “an embodiment”, or “an aspect” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrase “in one embodiment” or “in one aspect” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others.

[0035] The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Alternative language and synonyms may be used for any one or more of the terms discussed herein, and no special significance should be placed upon whether or not a term is elaborated or discussed herein. In some cases, synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and is not intended to further limit the scope and meaning of the disclosure or of any example term. Likewise, the disclosure is not limited to various embodiments given in this specification.

[0036] Additional features and advantages of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or can be learned by practice of the herein disclosed principles. The features and advantages of the disclosure can be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the disclosure will become more fully apparent from the following description and appended claims, or can be learned by the practice of the principles set forth herein.

[0037] Provided herein is a tri-pod corneal donor vacuum punch and methods of use thereof to simplify lamellar keratoplasty. As illustrated in FIG. 1 , the corneal punch comprises a cylindrical body, a plurality of protrusions extending radially outward from the cylindrical body, and cutting edges at the distal end of the corneal punch. In some embodiments, as seen in FIGS. 2A-B, the intersections between the walls of the cylindrical body and the radial walls of the protrusions may be curved. Moreover, the intersections between the radial walls of the protrusions and the outer walls of the protrusions may be curved. FIGS. 3A-3D are photographs of a corneal punch. The corneal punch may be used to harvest corneal tissue from a donor cornea, as illustrated in FIGS. 4A-G. Finally, FIGS. 5A-H illustrate images captured during an optical coherence tomography (OCT) scan after the injection of the graft into the anterior chamber of the eyeball.

[0038] The tri-pod corneal donor vacuum punch and methods of use may have significant advantages over traditional lamellar keratoplasty. First, the corneal punch may simplify corneal transplantation. For example, the corneal punch may eliminate preoperative laser peripheral iridotomy (PI), complicated course of tissue opening and air management during and after surgery, and patient (i.e., recipient) head positioning. Second, the corneal punch may increase the rate of success of corneal transplantation. For example, the corneal punch may reduce the rate of graft detachment and/or displacement and may reduce the rate of endothelial cell loss. Additionally, the corneal punch may improve the ability to place the graft and may provide improved fixing or attachment of the graft to the cornea of the recipient.

[0039] FIG. 1 illustrates one aspect of the corneal punch 100 in a perspective view. The corneal punch 100 may be made of surgical-grade stainless steel. The corneal punch 100 has a proximal end 102 and a distal end 104. The corneal punch 100 comprises a cylindrical body 106 defining a longitudinal axis and extending from the proximal end 102 to the distal end 104 of the corneal punch 100. In one embodiment, the cross-section of the cylindrical body 106 is a circular shape. In other embodiments, the cross-section of the cylindrical body 106 may be a substantially circular shape or an ovular shape. The length of the cylindrical body 106 extends from the proximal end 102 to the distal end 104 of the corneal punch 100. The length of the cylindrical body 106 may be between 15.0 and 35.0 millimeters. In one example, the length of the cylindrical body 106 is approximately 25.0 millimeters.

[0040] A central opening 108 (i.e., void) extends along the longitudinal axis of the cylindrical body 106. In one embodiment, the cross-section of the central opening 108 is a circular shape. In other embodiments, the cross-section of the central opening 108 may be a substantially circular shape or an ovular shape. In one embodiment, the central opening 108 extends from the proximal end 102 to the distal end 104 of the corneal punch 100 (i.e., through the entire length of the cylindrical body 106).

[0041] The cylindrical body 106 contains an inner surface 110, which defines the central opening 108, and an outer surface 112. In one embodiment, the cross-sections of the inner surface 110 and the outer surface 112 are circular in shape and are concentric. In other embodiments, the cross-sections of the inner surface 110 and the outer surface 112 may be a substantially circular shape or an ovular shape and may be concentric. The inner surface 110 of the cylindrical body 106 defines a radius, measured from the longitudinal axis of the cylindrical body 106 to the inner surface 110, which may be between 2.0 and 6.0 millimeters. In one example, this radius may be approximately 3.75 millimeters. The distance between the inner surface 110 of the cylindrical body 106 and the outer surface 112 of the cylindrical body 106 defines the wall thickness of the cylindrical body 106.

[0042] A cutting edge 114 may be formed at the distal end 104 of the cylindrical body 106. In one example, the wall thickness of the cylindrical body 106 (i.e., the distance between the inner surface 110 and the outer surface 112) is reduced at the distal end 104. For example, material may be removed from the outer surface 112 and/or inner surface 110 at the distal end 104, such as by grinding. In other embodiments, the wall thickness of the cylindrical body 106 may be generally uniform along the entire length of the cylindrical body 106. In an example, the cutting edge 114 may be sharp. In some examples, the cutting edge 114 may be configured to cut tissue in an eyeball (e.g., tissue from a cornea).

[0043] A plurality of protrusions 116 are integrated into the cylindrical body 106. The protrusions 116 extend radially outward from the cylindrical body 106. The protrusions 116 may extend along the length of the cylindrical body 106, from the proximal end 102 to the distal end 104. The longitudinal axis of each protrusion 116 may be parallel to the longitudinal axis of the cylindrical body 106. In one embodiment, the cylindrical body 106 contains three protrusions 116 that are spaced uniformly spaced around the longitudinal axis of the cylindrical body 106. Thus, the angle between the centerline of each protrusion 116 around the longitudinal axis of the cylindrical body 106 is approximately 120-degrees. In other embodiments, the cylindrical body 106 may contain two, three, four, or five protrusions 116. In some examples, the protrusions 116 may be uniformly or symmetrically distributed around the longitudinal axis of the cylindrical body 106. In other examples, the protrusions 116 may be non-uniformly or asymmetrically distributed around the longitudinal axis of the cylindrical body 106.

[0044] Channels 118 (i.e., voids) are defined by the protrusions 116, extending along the longitudinal axis of the protrusions 116. The channels 118 are in communication with the central opening 108 through the cylindrical body 106. In one embodiment, the crosssection of each protrusion 116 and related channel 118 is generally rectangular in shape. In other embodiments, the cross-section of each protrusion 116 and related channel 118 may be generally circular, ovular, triangular, or square. In some embodiments, the edges of the protrusions 116 may be rounded. In other embodiments, the edges of the protrusions 116 may be square.

[0045] Radial walls 120 of the protrusions 116 extends radially outward from the cylindrical body 106. The radial walls 120 include an inner surface 122, which defines the channel 118, and an outer surface 124. The distance between the inner surface 122 and outer surface 124 defines the thickness of the radial walls 120 of the protrusion 116. In one embodiment, the thickness of the radial walls 120 is the same as the wall thickness of the cylindrical body 106. In some embodiments, the intersection between the cylindrical body 106 and the radial walls 120 of the protrusions 116 may be curved. This curve defines a radius, measured from the arc of the curve to the center point of the arc, which may be between 0.25 millimeters and 1.25 millimeters. In one example, this radius may be approximately 0.75 millimeters.

[0046] A cutting edge 126 may be formed at the distal end 104 of the radial walls 120 of the protrusions 116. In one embodiment, the thickness of the radial walls 120 (i.e. , the distance between the inner surface 122 and the outer surface 124) is reduced at the distal end 104. For example, material may be removed from the outer surface 124 and/or inner surface 122 of the radial walls 120 at the distal end 104, such as by grinding. In other embodiments, the thickness of the radial walls 120 may be generally uniform along the entire length of the radial walls 120. In an example, the cutting edge 126 may be sharp. In some examples, the cutting edge 126 may be configured to cut tissue in an eyeball (e.g., tissue from a cornea). In some examples, each protrusion 116 may have a cutting edge 126.

[0047] An outer wall 128 of the protrusion 116 extends tangentially with respect to a radius around the longitudinal axis of the cylindrical body 106. The outer wall 128 includes an inner surface 130, which defines the channel 118, and an outer surface 132. In one embodiment, the outer wall 128 is straight, tangential to a radius around the longitudinal axis of the cylindrical body 106. In other embodiments, the outer wall 128 may be curved (i.e., an arc) to form a discontinuous circular shape or discontinuous oval shape around the longitudinal axis of the cylindrical body 106. The distance between the inner surface 130 and outer surface 132 defines the thickness of the outer wall 128 of the protrusion 116. In one embodiment, the thickness of the outer wall 128 is the same as the thickness of the radial walls 120 and/or the same as the wall thickness of the cylindrical body 106. The inner surface 130 of the outer wall 128 of the protrusion 116 defines a radius, measured from the longitudinal axis of the cylindrical body 106 to the inner surface 130, which may be between may be between 5.0 and 9.0 millimeters. In one example, this radius may be approximately 6.75 millimeters. In some embodiments, the intersection between the radial walls 120 of the protrusions 116 and the outer wall 128 of the protrusion 116 may be curved. This curve defines a radius, measured from the arc of the curve to the center point of the arc, which may be between 0.25 millimeters and 1.25 millimeters. In one example, this radius may be approximately 0.75 millimeters.

[0048] A cutting edge 134 may be formed at the distal end 104 of the outer wall 128 of the protrusions 116. In one embodiment, the thickness of the outer walls 128 (i.e., the distance between the inner surface 130 and the outer surface 132) is reduced at the distal end 104. For example, material may be removed from the outer surface 132 and/or inner surface 130 of the outer walls 128 at the distal end 104, such as by grinding. In other embodiments, the thickness of the outer walls 128 may be generally uniform along the entire length of the outer walls 128. In an example, the cutting edge 134 may be sharp. In some examples, the cutting edge 134 may be configured to cut tissue in an eyeball (e.g., tissue from a cornea). In some examples, each protrusion 116 may have a cutting edge 134.

[0049] The profile of the distal end 104 of the corneal punch 100 may be configured to match the cutting surface of a cutting block. In one example, when the corneal punch 100 is used to harvest corneal tissue from a donor cornea, the donor cornea may be positioned within the concave surface (i.e., well) of the cutting surface of a cutting block. Then, the corneal punch 100 may be used to cut through the donor cornea and create a graft. The corneal punch 100 may cut through the donor cornea using the cutting edges 114, 126, 134. Thus, the profile of the distal end 104 of the corneal punch 100 may be configured as a generally convex, spherical shape to match the concave surface of the well of the cutting block.

[0050] The distal ends 104 of the protrusions 116 (i.e., the profile of cutting edges 126 and cutting edges 134) may be curved with respect to a point along the longitudinal axis of the cylindrical body 106. In one embodiment, the distal ends 104 of the protrusions 116 may be curved along the entire distance extending radially outward from the longitudinal axis. This curve defines a radius, measured from the distal end 104 of the protrusions 116 to a point along the longitudinal axis of the cylindrical body 106, which may be between 6.0 millimeters and 10.0 millimeters. In one example, this radius may be approximately 7.80 millimeters. This curve also defines a length, measured along the longitudinal axis of the cylindrical body 106 from a plane defining the distal end 104 of the cylindrical body 106 to a continuation of the radius (i.e., if the discontinuous curve was continuous), which may be between 0.25 and 1.75 millimeters. In one example, this distance may be approximately 0.97 millimeters.

[0051] FIGS. 2A-C illustrate another aspect of the corneal punch 200 in a side plan view, a top plan view, and another top plan view. The corneal punch 200 in FIGS. 2A-C is similar to the corneal punch 100 in FIG. 1 . The corneal punch 200 has a proximal end 202 and a distal end 204. The corneal punch 200 comprises a cylindrical body 206 defining a longitudinal axis, extending from the proximal end 202 of the corneal punch 200 to the distal end 204 of the corneal punch 200, and including a central opening 208 (i.e., void). The cylindrical body 206 contains an inner surface 210, which defines the central opening 208, and an outer surface 212. A plurality of protrusions 216, extending radially outward, are integrated into the cylindrical body 206. The protrusions 216 define channels 218 (i.e., voids) that are in communication with the central opening 208. Radial walls 220 of the protrusions 216 include an inner surface 222, which defines the channel 218, and an outer surface 224. Outer walls 228 of the protrusions 216 include an inner surface 230, which defines the channel 218, and an outer surface 232.

[0052] The length (L) of the cylindrical body 206 extends from the proximal end 202 to the distal end 204 of the corneal punch 200. The length of the cylindrical body 206 may be between 15.0 and 35.0 millimeters. In one example, the length (L) of the cylindrical body 206 is approximately 25.0 millimeters.

[0053] The radius (R), which is defined by inner surface 210 of the cylindrical body 206, is measured from the longitudinal axis of the cylindrical body 206 to the inner surface 210. This radius (R) may be between 2.0 and 6.0 millimeters. In one example, this radius (R) may be approximately 3.75 millimeters.

[0054] The radius (R’), which is defined by the inner surface 230 of the outer wall 228 of the protrusion 216, is measured from the longitudinal axis of the cylindrical body 206 to the inner surface 230. This radius (R’) may be between may be between 5.0 and 9.0 millimeters. In one example, this radius (R’) may be approximately 6.75 millimeters.

[0055] The radius (R”), which is defined by a curve at the intersection between the cylindrical body 206 and the radial walls 220 of the protrusions 216, is measured from the arc of the curve to the center point of the arc. This radius (R”) may be between 0.25 millimeters and 1.25 millimeters. In one example, this radius (R”) may be approximately 0.75 millimeters.

[0056] The radius (R’”), which is defined by a curve at the intersection between the radial walls 220 of the protrusions 216 and the outer wall 228 of the protrusion 216, is measured from the arc of the curve to the center point of the arc. This radius (R’”) may be between 0.25 millimeters and 1.25 millimeters. In one example, this radius (R’”) may be approximately 0.75 millimeters.

[0057] The radius (R””), which is defined by a curve (i.e. , cross-sectional profile) of the distal end 204 of the corneal punch 200, is measured from the distal ends 204 of the protrusions 216 to a center point along the longitudinal axis of the cylindrical body 206. This radius (R””) may be between 6.0 millimeters and 10.0 millimeters. In one example, this radius (R””) may be approximately 7.80 millimeters.

[0058] The length (L’), is measured along the longitudinal axis of the cylindrical body 206 from a plane defining the distal end 204 of the cylindrical body 206 to a continuation of the radius (R””) (i.e., if the discontinuous curve was continuous), which may be between 0.25 and 1.75 millimeters. In one example, this distance may be approximately 0.97 millimeters.

[0059] FIGS. 3A-D illustrate additional exemplary embodiments of the corneal punch. FIGS. 3A-C illustrate perspective views of the corneal punch. FIG. 3D illustrates a top view of the corneal punch. The corneal punch 300 may be made of surgical-grade stainless steel.

[0060] FIGS. 4A-G illustrate a method of using the corneal punch. The corneal punch may be used to harvest corneal tissue from a donor cornea. The harvested corneal tissue (i.e., the graft) may be used in a corneal transplantation. The corneal punch may include a generally cylindrical body with protrusions extending radially outward, which results in the graft containing a generally cylindrical shape with extensions or tabs extending radially outward. In other words, the shape of the graft corresponds to the cross-section of the inner walls of the corneal punch. The extensions or tabs of the graft may improve the ability to place the graft and may provide improved fixing or attachment of the graft to the cornea of the recipient.

[0061] The donor cornea may be placed onto a cutting block, as shown in FIG. 4A. The cutting block may contain a cutting surface and arms extending radially outward from the cutting surface. The arms of the cutting block may contain circular apertures, which may be used to align a punch top of a blade assembly while cutting the donor cornea. The cutting surface may be a concave surface (i.e., a well), which may be generally spherically shaped. The well of the cutting block may include one central positioning hole, four additional holes spaced around the central positioning hole, and/or a trough that is oriented in a circular shape around the central positioning hole. A vacuum may be applied through the holes and/or trough in the well of the cutting block. The vacuum prevents movement of the donor cornea during the application of the corneal punch to cut the donor cornea and maintains the graft in the well of the cutting block after cutting. In other words, during and after cutting, the graft does not remain in the corneal punch.

[0062] The distal end of the corneal punch (i.e., the cutting edge) may be applied to the upward facing surface of the donor cornea. In some embodiments, the endothelial surface may face upward. The longitudinal axis of the corneal punch is generally aligned perpendicular to the donor cornea and centered on the donor cornea, as shown in FIG. 4B. In other words, the longitudinal axis of the corneal punch is generally aligned with the optical axis of the donor cornea. The corneal punch may then be pressed downward, with the longitudinal axis of the corneal punch remaining generally aligned with the center of the donor cornea, and advanced through the donor cornea. Then, the corneal punch may be moved upward, away from the donor cornea.

[0063] In some embodiments, the corneal punch may be integrated with a punch top (not shown in FIG. 4B). The punch top may be coupled to the proximal end of the corneal punch, whereby the punch top and the corneal punch comprise a blade assembly. The punch top may contain arms extending radially outward from the body of the punch top, whereby the arms of the punch top correspond to the arms extending radially outward from the body of the cutting block. Each arm of the punch top may contain a metal rod coupled to the arm, whereby each metal rod extends generally perpendicular to each arm. The metal rods may be configured to align with and fit into the circular apertures of the arms extending radially outward from the body of the cutting block, thereby aligning the punch top with the cutting block and aligning the corneal punch with the well of the cutting block. In other words, the metal rods function as guideposts to align the blade assembly with the cutting block, thereby centering the corneal punch with respect to the donor cornea while advancing the blade assembly through the donor cornea. In some embodiments, use of the blade assembly (i.e. , the corneal punch integrated into a punch top) in combination with the cutting block may provide automatic alignment of the corneal punch with the donor cornea without depending on the surgeon to align or hold the donor cornea and/or corneal punch.

[0064] After cutting the donor cornea, the donor cornea is separated into an outer section and the graft. The outer section may include the scleral rim, in whole or in part, and may also include a portion of the cornea. The graft includes a portion of the donor cornea in the shape of the inner walls of the corneal punch, as shown in FIG. 4C. In other words, the graft contains a generally circular shape with three extensions or tabs extending radially outward. Forceps may be used to separate the graft from the outer section of the donor cornea. The graft may include at least a portion of the endothelium, Descemet’s membrane, and/or a layer of stroma from the donor cornea.

[0065] The anterior surface of the cornea of the recipient may be marked with a surgical marking pen, as shown by the markings on the eyeball representing the eyeball of the recipient in FIG. 4D. The markings may be in general accordance with the shape of the graft. A needle may be inserted into the anterior chamber of the eye of the recipient, as shown in FIG. 4E. The needle may be inserted through a corneal paracentesis. The graft may be injected into the anterior chamber of the recipient, as shown in FIG. 4F. This process transplants the graft from the donor cornea into the anterior chamber of the eye of the recipient, as shown in FIG. 4G. The extensions or tabs of the graft, which correspond to the protrusions of the corneal punch, may improve the ability to place the graft and may provide improved fixing or attachment of the graft to the cornea of the recipient. [0066] FIGS. 5A-H are images captured of an optical coherence tomography (OCT) scan performed after the graft was injected into the anterior chamber of the eyeball.