Apparatus, systems and methods for cornea recovery

Abstract

Disclosed herein are various implementations directed to a corneal recovery system comprising a dome-shaped cup, comprising a central section, a medial section and an outer section, wherein the outer section comprises a cuttable skirt and a template marking. In some implementations, a vacuum may be pulled through the dome-shaped cup to secure the cornea.

Description

APPARATUS, SYSTEMS AND METHODS FOR CORNEA RECOVERYCROSS-REFERENCES & RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 733,275 filed December 12, 2024, and entitled “CORNEA RECOVERY DEVICE AND ASSOCIATED SYSTEMS AND METHODS,” which is hereby incorporated by reference in its entirety under 35 U.S.C. § 119(e).

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

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

[0004] The disclosure relates to medical procedures, generally, and optical surgery, specifically.BACKGROUND

[0005] The disclosure relates to apparatus, systems, and methods for cornea recovery. The current approach to corneal recovery yields inconsistent quality and requires significant resources to train the proper technique. The current approach involves manually excising the cornea from its cadaveric donor by a trained eye bank technician with a pair of scissors and forceps. In the current procedure, the eye - a hollow, pressurized organ - is punctured with a scalpel through the sclera (the white of the eye), and a circumferential cut is made to render a corneoscleral rim that is approximately 16 mm in diameter, comprising approximately a 2 mm scleral rim that encompasses a 12 mm diameter cornea. Two challenges arise from this approach:

[0006] First, when making the circular cut through the sclera, it is difficult to maintain a constant radius to cut a circular corneoscleral rim of the optimal dimensions for subsequent corneal transplant-related procedures such as certain forms of endothelialkeratoplasty that require specific diameters to fit into preset machinery tolerances (i.e. microkeratome) - too small of a corneoscleral ring diameter or too big of a diameter encumbers such processing and furthermore, too small of a diameter subjects the corneal tissue to excessive distortion from the compressive shearing actions of the scissor blades.

[0007] Second, when separating the scleral tissue from the iris after the scleral wall has been punctured and the eyeball has lost its shape and rigidity, it is difficult to manipulate the cornea without distorting its natural shape because corneal tissue is not rigid - this permanently damages the endothelial cell layer, whose health after the recovery is a surrogate for procedural success or failure.

[0008] Most recovery technicians have surgical dexterity and surgical judgment that are much less developed than experienced corneal surgeons. Thus, there is a need in the art for a system, device and method to improve the accuracy of cornea removal and speed of training.BRIEF SUMMARY

[0009] This disclosure relates to systems, devices, and methods to standardize recovery of corneal tissue from cadaveric donors. Various implementations of these system use a dome-shaped suction cup integrated with a transparent, cuttable skirt bearing a circular template. The system may apply vacuum through a central connection point and / or distributed perforations arranged in configurable pressure zones to immobilize the cornea while allowing peripheral flexion at the sclera, thereby reducing tissue distortion during circumferential incision.

[0010] Example 1 relates to a corneal recovery system comprising a dome-shaped cup, comprising a central section, a medial section and an outer section, wherein the outer section comprises a cuttable skirt and a template marking.

[0011] Example 2 relates to Examples 1 and 3-7, further comprising a connection point in the central section.

[0012] Example 3 relates to Examples 1 -2 and 4-7, wherein the connection point is constructed to allow air flow through the connection point.

[0013] Example 4 relates to Examples 1 -3 and 5-7, wherein a vacuum is pulled on the connection point.

[0014] Example 5 relates to Examples 1 -4 and 6-7, wherein the connection point has a Luer-lock fitting.

[0015] Example 6 relates to Examples 1 -5 and 7, wherein the cuttable skirt is transparent.

[0016] Example 7 relates to Examples 1 -6, wherein the dome-shaped cup is transparent.

[0017] Example 8 relates to a corneal recovery system comprising a dome-shaped cup comprising a cuttable skirt; and one or more perforations in the dome-shaped cup.

[0018] Example 9 relates to Examples 8 and 10-15, wherein the one or more perforations are separated into one or more pressure zones.

[0019] Example 10 relates to Examples 8-9 and 11 -15, wherein one of the one or more pressure zones is a central zone and one or more of the one or more pressure zones is a peripheral zone.

[0020] Example 1 1 relates to Examples 8-10 and 12-15, further comprising an outer shroud attached to the dome-shaped cup, wherein the outer shroud forms a void between the outer shroud and the dome-shaped cup.

[0021] Example 12 relates to Examples 8-11 and 13-15, wherein the outer shroud comprises one or more connection points.

[0022] Example 13 relates to Examples 8-12 and 14-15, wherein vacuum may be applied through the one or more perforations by way of applying vacuum to the one or more connection points.

[0023] Example 14 relates to Examples 8-13 and 15, wherein the one or more perforations are separated into one or more pressure zones, and wherein some of the one or more connection points correspond to some of the one or more pressure zones to allow varying vacuum to be applied to the one or more pressure zones.

[0024] Example 15 relates to Examples 8-14, wherein the outer shroud is extended away from the dome-shaped cup.

[0025] Example 16 relates to a method of corneal recovery, comprising positioning a dome-shaped suction cup over a cornea; attaching a vacuum source; apply a vacuum; making an incision in the cornea; removing the cornea.

[0026] Example 17 relates to Examples 16 and 18-20, wherein the vacuum source is attached through a connection point.

[0027] Example 18 relates to Examples 16-17 and 19-20, wherein the dome-shaped suction cup comprises one or more zones, each comprising one or more perforations.

[0028] Example 19 relates to Examples 16-18 and 20, the vacuum is applied in varying degree for the one or more zones.

[0029] Example 20 relates to Examples 16-19, wherein the dome-shaped suction cup is transparent, and where the dome-shaped suction cup is positioned using visual cues seen through the dome-shaped suction cup.

[0030] While multiple embodiments are disclosed, still other embodiments of the disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the disclosure is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.BRIEF DESCRIPTION OF DRAWINGS

[0031] FIG. 1 is a diagram of a corneal recovery system, according to one implementation.

[0032] FIG. 2A is a cut-away diagram of the corneal recovery system positioned over a donor cornea, according to one implementation.

[0033] FIG. 2B is a front view of the corneal recovery system positioned over a donor cornea, according to one implementation.

[0034] FIG. 3 is a diagram of corneal recovery system with various sections projected across cut-away and front views, according to one implementation.

[0035] FIG. 4 is a flowchart of a method of use of the system, according to one implementation.

[0036] FIG. 5 is a diagram of a corneal recovery system perfusions separated into zones, according to one implementation.

[0037] FIG. 6 is a front view of a corneal recovery system perfusions separated into zones, according to one implementation.

[0038] FIG. 7 is a suction ring, according to one implementation.

[0039] FIG. 8 is a cut-away diagram of the corneal recovery system with an outer shroud, according to one implementation.

[0040] FIG. 9 is a cut-away diagram of the corneal recovery system with a rigid outer shroud, according to one implementation.

[0041] FIG. 10 is a close-up image of a dome-shaped cup viewed from underneath, according to one implementation.

[0042] FIG. 1 1 is an image of a dome-shaped cup viewed from the side, according to one implementation.

[0043] FIG. 12 is an image of a dome-shaped cup viewed from underneath, according to one implementation.

[0044] FIG. 13 is an image of a dome-shaped cup viewed from above, according to one implementation.

[0045] FIG. 13 is an image of a dome-shaped cup viewed from above, according to one implementation.

[0046] FIG. 14 is an image of the corneal recovery system with an extended outer shroud, according to one implementation.DETAILED DESCRIPTION

[0047] Disclosed herein are devices, systems and methods for the recovery of cornea tissue from cadavers. In various implementations, the disclosed recovery system 10 comprises a suction cup 12 operationally integrated to a transparent cuttable skirt 14 configured for placement on the eye 1 for cutting and recovery of the cornea.

[0048] According to certain embodiments, the devices, systems and methods standardize current recovery technique of manually excising the cornea from its cadaveric donor by a trained eye bank technician with a pair of scissors and forceps. That is, the devices, systems and methods standardize current technique by 1 ) affixinga cuttable circular template around the circumference of the cornea, and 2) stabilizing the cornea with suction to prevent distortion during the cut and during separation of the sclera from the iris.

[0049] Most recovery technicians lack the surgical dexterity and surgical judgment of experienced corneal surgeons. Accordingly, the recovery system 10 is configured to facilitate corneal tissue recovery by standardizing critical elements of the current process for novice operators.

[0050] As shown variously in FIGS. 1 -3, various implementations of the recovery system 10 can include a multi-piece system 10, such as is shown in FIG. 1 , which comprises a cuttable skirt 14 joined to the peripheral edge of a separate suction cup 12 having a device body 12A and outer edge 13 that adjoins the skirt 14. As shown in the implementations of FIGS. 2A-2B and 3, a single-piece, unitary system 10 may comprise a flexible suction cup 12 that is contiguous with a cuttable skirt 14. In these implementations, the cuttable skirt 14 is operationally integrated into the suction cup 12 and the suction cup 12 is operationally integrated into a vacuum source through a connection point 22, such as a rigid Luer-lock connection 22.

[0051] As shown in FIGS. 2A-2B, the recovery system 10 according to certain implementations reduces potential for scleral cuts that are not circular and / or too large or too small in diameter by providing a cuttable skirt 14 having a template 16 with a circular line 18 that the technician can follow by direct visualization. FIG. 2A shows a cross-section of the system 10 comprising the transparent suction cup 12 operationally integrated to the transparent cuttable skirt 14 configured for placement on the eye 1 .

[0052] These implementations reduce the potential for corneal tissue damage during excision by statically fixating the cornea 2 so that it does not substantially bend during scleral manipulation and scleral cutting. Additionally, the recovery system 10 may also facilitate excision of the corneoscleral rim and iris together to enable ex vivo tissue dissection under a laboratory microscope, avoiding the current practice of in-the-field in situ tissue dissection without the benefit of magnification and en face visualization of the underside of the corneoscleral rim.

[0053] As is shown in the preferred embodiments of FIGS. 2A-2B and 3, the recovery system 10 comprises a dome-shaped suction cup 12 made of flexible,transparent material, with three distinct sections: a central section 20, a medial section 30, and an outer section 40. In these various sections 20, 30, 40, the flexible material varies in thickness to enable the suction cup 12 to be structurally rigid at its thicker sections, flexible at its thinner sections, and easily cuttable with scissors at its thinnest sections, as will be appreciated.

[0054] In certain implementations, the material is transparent to permit visualization of the tissue structures beneath it (i.e. the cornea 2 and sclera 4).

[0055] As shown in FIGS. 2A-2B and 3, in certain implementations the rigid central section 20 comprises a Luer-lock connection 22 located at the apical center of the dome-shaped suction cup 12. The Luer-lock connection 22 according to these implementations attaches to a commercially available Luer-lock-fitted tubing that in-turn connects to a Luer-lock fitted spring-loaded syringe static vacuum source or other source of continuous vacuum such as a pump, which pulls suction on the suction cup 12.

[0056] As shown in FIG. 3, the medial section 30 transitions from semi-rigid to flexible in certain implementations, and, as shown in FIGS. 1 -3 comprises a hollow vacuum cavity 15 comprised of an outer wall 24 that is contiguous with the Luer-lock connection 22, and an inner wall 26 that has with one or more perforations 28 and shaped to mimic the average corneal curvature of a normal cornea (ranging from approximately 7.6-8.6 mm base curve).

[0057] Further, according to certain implementations, the medial section 30 is wider in diameter than the average horizontal corneal diameter of 12-13 mm and extends onto the limbus 3 (the anatomic junction between the cornea and sclera) such that the inner wall’s perforations 28 enable suction of both the corneal and the scleral surfaces adjacent to the limbus 3 in addition to elsewhere on the cornea; the thickness of the medial section 30 tapers from an appropriate thickness to be rigid to secure a Luer-lock fitting at its apex, to an appropriate thickness to be semi-rigid to prevent substantial corneal tissue distortion, to appropriate thickness to flex with the sclera 4 without separating its points of suction and thereby prevent suction-breakage due to the tissue flexion typical of a corneal recovery procedure.

[0058] Continuing with the outer section 40, in certain implementations the outer section 40 is a very thin, contiguous extension of the medial section 30 comprised of a single wall that drapes over the surface of the sclera 4 and provides the cuttable skirt 14, template 16 and any template markings 18 such as a circular, dashed line 18. The outer section 40 according to certain implementations is wider in diameter than the 16 mm targeted corneoscleral cut and has template markings 18 in the form of an indicator line to guide the technician’s placement of the scissors.

[0059] The variable degrees of flexibility of the medial section 30 enable it to be configured to substantially immobilize the cornea 2 by preventing the corneal tissue from flexing under the central aspects of the suction cup 12, and to maintain the suction’s seal under the peripheral aspects of the suction cup by substantially flexing with the scleral tissue to prevent suction-breakage. A uniformly rigid suction cup that approximated the modulus of elasticity of a standard scleral contact lens would only transiently enable immobilizing the cornea 2, but because it was rigid at the periphery of the suction cup 12 would also enable the tissue to flex away from the points of suction thereby breaking suction of the entire device if coupled to a static vacuum source such as a spring-loaded syringe and losing central corneal tissue immobilization. A uniformly flexible suction cup that approximated the modulus of elasticity of human cornea would maintain suction during tissue flexion but be insufficiently rigid to immobilize the cornea 2 to prevent tissue damage.

[0060] Turning now to FIG. 4, the system 10 may include a method 100 of use. The particular method 100 described herein is merely exemplary and is not intended to provide a limiting and exhaustive recitation of steps and their order. The steps described may be reordered, modified, or omitted as those of skill in the art would understand possible.

[0061] A user of the system 10 may begin by positioning the dome-shaped cup 12 over the cornea to be recovered (box 102). The user may then attach a vacuum source, such as a syringe or vacuum tube, to the connection 22 (box 104). In other implementations, the user may attach the vacuum source (box 104) and subsequently position the dome-shaped cup 12 (box 102).

[0062] The user may then apply vacuum through the dome-shaped cup 12, securing it to the cornea (box 106). The user may then make an incision around cornea (box 108) and recover the cornea by removing it from the donor site (box 1 10).

[0063] Alternative implementations of the system 10 may use various other designs to apply vacuum. Turning to FIGS. 5-9, various embodiments of the system 10 may use multiple pressure zones, allowing for vacuums of varying strength to be applied. FIG. 5 shows an implementation of the dome-shaped cup 12 with a central zone 42 and various peripheral zones 44. FIG. 6 shows a top-view of the same. The central zone 42 and peripheral zones 44 may each have one or more perforations 28, that allow pressure or vacuum to be applied to a cornea held by the dome-shaped cup 12.

[0064] In various implementations, the system 10 may apply vacuum across the peripheral zones 44 with a single vacuum source by linking the peripheral zones 44 with a suction ring 48, such as is shown in FIG. 7. In alternative implementations, such as in FIGS. 8 and 9, vacuum may be applied to the dome-shaped cup 12 using an outer shroud 50 or cap 50. The outer shroud 50 may connect the various perforations 28 to one or more connection points 22. The outer shroud 50 may connect the perforations 28 and connection points 22 through one or more voids 52 kept open between the outer shroud and dome-shaped cup 12. In some implementations, the voids 52 may be kept open due to the fact that the outer shroud 50 may be made of a rigid material. In various implementations, the dome-shaped cup 12 may be made of flexible materials, such as but not limited to silicone.

[0065] In various implementations, the outer shroud 50 may separate or compartmentalize different peripheral zones 44 or central zones 42 to allow different amounts of vacuum to be applied. In some implementations, compartmentalized peripheral zones 44 or central zones 42 may share one or more connection points 22 that are not used by peripheral zones 44 or central zones 42 intended to receive different levels of vacuum.

[0066] FIGS. 10-13 show images of an implementation of the dome-shaped cup 12 in line with those diagrammed in FIGS. 5-9. The perforations 28 are visible in these images. FIG. 14 shows an implementation of the system 10 where the outer shroud 50is extended away from the dome-shaped cup 12 to allow for a user to more easily grasp the system 10.

[0067] The system will increase the rate of success of corneal excision, providing important economic benefits. Of the 85,000 corneas recovered annually in the US, at least 30% are not suitable for transplant. One-third to half of the unsuitable recoveries are lost due to damage caused during the recovery procedure. Medicare, Medicaid, and private insurers in the United States reimburse between $3500 and $5500 for each corneal tissue transplanted. Thus, conservatively, 8,500 corneas worth $29.75 million to $46.75 million in revenue are lost by U.S. eye banks annually.

[0068] In various implementations, the system is a single piece that can be manufactured with injection molding from silicone or silicone-like materials. Other embodiments may function as a single piece but be manufactured from multiple pieces, such as an inner and outer piece. Yet other embodiments may be manufactured from multiple variants of silicone-like materials. Yet other embodiments may be manufactured from distinct materials, such as various forms of plastic and rubber.

[0069] Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. When such a range is expressed, a further aspect includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms a further aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “about 10” is also disclosed. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 1 1 , 12, 13, and 14 are also disclosed.

[0070] Although the disclosure has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the disclosed apparatus, systems and methods.

Claims

CLAIMSWhat is claimed is:1 . A corneal recovery system comprising a dome-shaped cup, comprising a central section, a medial section and an outer section, wherein the outer section comprises a cuttable skirt and a template marking.

2. The corneal recovery system of claim 1 , further comprising a connection point in the central section.

3. The corneal recovery system of claim 2, wherein the connection point is constructed to allow air flow through the connection point.

4. The corneal recovery system of claim 3, wherein a vacuum is pulled on the connection point.

5. The corneal recovery system of claim 1 , wherein the connection point has a Luer-lock fitting.

6. The corneal recovery system of claim 1 , wherein the cuttable skirt is transparent.

7. The corneal recovery system of claim 1 , wherein the dome-shaped cup is transparent.

8. A corneal recovery system comprising: a dome-shaped cup comprising a cuttable skirt; and one or more perforations in the dome-shaped cup.

9. The corneal recovery system of claim 8, wherein the one or more perforations are separated into one or more pressure zones.

10. The corneal recovery system of claim 9, wherein one of the one or more pressure zones is a central zone and one or more of the one or more pressure zones is a peripheral zone.1 1 . The corneal recovery system of claim 8, further comprising an outer shroud attached to the dome-shaped cup, wherein the outer shroud forms a void between the outer shroud and the dome-shaped cup.

12. The corneal recovery system of claim 1 1 , wherein the outer shroud comprises one or more connection points.

13. The corneal recovery system of claim 12, wherein vacuum may be applied through the one or more perforations by way of applying vacuum to the one or more connection points.

14. The corneal recovery system of claim 12, wherein the one or more perforations are separated into one or more pressure zones, and wherein some of the one or more connection points correspond to some of the one or more pressure zones to allow varying vacuum to be applied to the one or more pressure zones.

15. The corneal recovery system of claim 1 1 , wherein the outer shroud is extended away from the dome-shaped cup.

16. A method of corneal recovery, comprising: positioning a dome-shaped suction cup over a cornea; attaching a vacuum source; apply a vacuum; making an incision in the cornea; removing the cornea.

17. The method of claim 16, wherein the vacuum source is attached through a connection point.

18. The method of claim 16, wherein the dome-shaped suction cup comprises one or more zones, each comprising one or more perforations.

19. The method of claim 18, the vacuum is applied in varying degree for the one or more zones.

20. The method of claim 16, wherein the dome-shaped suction cup is transparent, and where the dome-shaped suction cup is positioned using visual cues seen through the dome-shaped suction cup.

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