US20200170786A1 - Corneal implant with peripheral skirt - Google Patents

Corneal implant with peripheral skirt Download PDF

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Publication number
US20200170786A1
US20200170786A1 US16/207,142 US201816207142A US2020170786A1 US 20200170786 A1 US20200170786 A1 US 20200170786A1 US 201816207142 A US201816207142 A US 201816207142A US 2020170786 A1 US2020170786 A1 US 2020170786A1
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US
United States
Prior art keywords
central portion
peripheral skirt
implant
mesh
corneal implant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US16/207,142
Inventor
Ofer Daphna
Nahum Ferera
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
EyeYon Medical Ltd
Original Assignee
EyeYon Medical Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by EyeYon Medical Ltd filed Critical EyeYon Medical Ltd
Priority to US16/207,142 priority Critical patent/US20200170786A1/en
Priority to PCT/IB2019/060122 priority patent/WO2020115605A1/en
Priority to US17/299,037 priority patent/US11890183B2/en
Publication of US20200170786A1 publication Critical patent/US20200170786A1/en
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/142—Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/145—Corneal inlays, onlays, or lenses for refractive correction
    • A61F2/1453—Corneal lenses connected to distinct attachment means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/15—Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/0081—Special surfaces of prostheses, e.g. for improving ingrowth directly machined on the prosthetic surface, e.g. holes, grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • A61F2250/0024—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity made from both porous and non-porous parts, e.g. adjacent parts

Definitions

  • the present invention relates generally to corneal implants, such as for treating an over-hydrated, edematous cornea, and particularly to a corneal implant with a peripheral skirt that improves adhesion of the implant to the corneal tissue.
  • U.S. Pat. Nos. 8,109,997 and 8,500,803 to Daphna describe bonding a hydrophobic pseudo-endothelial implant to a posterior portion of the cornea adjacent the aqueous humor with a binding agent.
  • the implant serves as a water barrier enabling dehydration of the cornea, and may be used in the treatment of an edematous cornea.
  • the adhesion of an implant to corneal tissue without sutures or mechanical fasteners poses a challenge.
  • the adhesive materials must be compatible with the ocular environment and yet must provide good adhesion for a long time without degradation in the ocular quality of the eye.
  • the present invention relates to a corneal implant with a peripheral skirt that improves adhesion of the implant to the corneal tissue, as is described more in detail hereinbelow.
  • the corneal implant has a central portion of about 4 mm in diameter (“about” is ⁇ 10%) and the peripheral skirt is outwards of the central portion.
  • the central portion is transparent and may or may not have optical properties, such as positive or negative magnification, astigmatism correction, refraction adjustment and others.
  • the peripheral skirt may be transparent but can instead be opaque.
  • the peripheral skirt includes a mesh that enables cell growth in and through the mesh to enhance adhesion of the implant to the cornea.
  • the peripheral skirt may be thinner or thicker than the central portion.
  • a corneal implant including a central portion and a peripheral skirt extending outwards from the central portion, wherein at least a portion of the peripheral skirt includes a mesh.
  • FIGS. 1 and 2 are simplified planar-view and edgewise-view illustrations, respectively, of a corneal implant, constructed and operative in accordance with a non-limiting embodiment of the present invention.
  • FIGS. 1 and 2 illustrate a corneal implant 10 , constructed and operative in accordance with an embodiment of the present invention.
  • the implant 10 may be a pseudo-endothelial implant, which can be used instead of an implant from a donor in a DSEK (Descemet Stripping Endothelial Keratoplasty) or DMEK (Descemet Membrane Endothelial Keratoplasty) surgery.
  • Implant 10 serves as a water barrier enabling the dehydration of the cornea.
  • Implant 10 may be constructed of a clear, transparent, biologically compatible material, such as but not limited to, polymethylmethacrylate (PMMA), silicone, silicone rubber, collagen, hyaluronic acid (including the sodium, potassium and other salts thereof), hydrogel, such as acrylic or methacrylic hydrogels, e.g., hydroxyethyl methacrylate or methacrylic acid copolymer/partially hydrolyzed poly(2-hydroxyethyl methacrylate) (known as PolyHEMA), polysulfones, thermolabile materials and other relatively hard or relatively soft and flexible biologically inert optical materials, or any combination of such materials, such as a gel encapsulated in a polymer. Implant 10 may thus be rigid, semi-rigid or foldable, for example.
  • PMMA polymethylmethacrylate
  • silicone silicone
  • silicone rubber collagen
  • hyaluronic acid including the sodium, potassium and other salts thereof
  • hydrogel such as acrylic or methacrylic hydrogels, e
  • implant 10 may be hydrophilic or hydrophobic.
  • corneal implant 10 has a central portion 12 of about 4 mm in diameter (“about” is ⁇ 10%) and a peripheral skirt 14 extending outwards from the central portion 12 .
  • the central portion 12 may be transparent and may or may not have optical properties, such as positive or negative magnification, astigmatism correction, refraction adjustment and others.
  • peripheral skirt 14 may be made of the same material as central portion 12 .
  • peripheral skirt 14 may be made of a different material than central portion 12 and bonded or otherwise attached to central portion 12 .
  • the peripheral skirt 14 may be transparent but can instead be opaque.
  • At least a portion of the peripheral skirt 14 includes a mesh 16 that enables cell growth in and through the mesh to enhance adhesion of the implant to the cornea.
  • the mesh 16 may have openings of equal or different sizes
  • Non-limiting dimensions of the implant are as follows, using the nomenclature shown in FIG. 2 :
  • Peripheral width of peripheral skirt 14 (PS): 0.1-1.5 mm
  • peripheral skirt 14 may have a different thickness than the central portion 12 or may be the same thickness.
  • peripheral skirt 14 may be formed with one or more radial slits 33 , which may extend the entire width of peripheral skirt 14 or just a portion of the width.
  • peripheral skirt 14 may include one or more radially extending portions 40 or 42 (shown in broken lines), which may be curved or straight with pointed on non-pointed ends.
  • peripheral skirt 14 may create a bond between the implant and the corneal tissue without the need for application of an external adhesive substance.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Transplantation (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

A corneal implant includes a central portion and a peripheral skirt extending outwards from the central portion, and at least a portion of the peripheral skirt includes a mesh.

Description

    FIELD OF THE INVENTION
  • The present invention relates generally to corneal implants, such as for treating an over-hydrated, edematous cornea, and particularly to a corneal implant with a peripheral skirt that improves adhesion of the implant to the corneal tissue.
    • BACKGROUND OF THE INVENTION
  • U.S. Pat. Nos. 8,109,997 and 8,500,803 to Daphna describe bonding a hydrophobic pseudo-endothelial implant to a posterior portion of the cornea adjacent the aqueous humor with a binding agent. The implant serves as a water barrier enabling dehydration of the cornea, and may be used in the treatment of an edematous cornea.
  • The adhesion of an implant to corneal tissue without sutures or mechanical fasteners poses a challenge. The adhesive materials must be compatible with the ocular environment and yet must provide good adhesion for a long time without degradation in the ocular quality of the eye.
    • SUMMARY OF THE INVENTION
  • The present invention relates to a corneal implant with a peripheral skirt that improves adhesion of the implant to the corneal tissue, as is described more in detail hereinbelow.
  • In one aspect of the invention, the corneal implant has a central portion of about 4 mm in diameter (“about” is ±10%) and the peripheral skirt is outwards of the central portion. The central portion is transparent and may or may not have optical properties, such as positive or negative magnification, astigmatism correction, refraction adjustment and others. The peripheral skirt may be transparent but can instead be opaque. In one aspect of the invention, the peripheral skirt includes a mesh that enables cell growth in and through the mesh to enhance adhesion of the implant to the cornea. The peripheral skirt may be thinner or thicker than the central portion.
  • There is provided in accordance with an embodiment of the present invention a corneal implant including a central portion and a peripheral skirt extending outwards from the central portion, wherein at least a portion of the peripheral skirt includes a mesh.
    • BRIEF DESCRIPTION OF THE DRAWINGS
  • The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:
  • FIGS. 1 and 2 are simplified planar-view and edgewise-view illustrations, respectively, of a corneal implant, constructed and operative in accordance with a non-limiting embodiment of the present invention.
    •  DETAILED DESCRIPTION OF EMBODIMENTS
  • Reference is now made to FIGS. 1 and 2, which illustrate a corneal implant 10, constructed and operative in accordance with an embodiment of the present invention. The implant 10 may be a pseudo-endothelial implant, which can be used instead of an implant from a donor in a DSEK (Descemet Stripping Endothelial Keratoplasty) or DMEK (Descemet Membrane Endothelial Keratoplasty) surgery. Implant 10 serves as a water barrier enabling the dehydration of the cornea.
  • Implant 10 may be constructed of a clear, transparent, biologically compatible material, such as but not limited to, polymethylmethacrylate (PMMA), silicone, silicone rubber, collagen, hyaluronic acid (including the sodium, potassium and other salts thereof), hydrogel, such as acrylic or methacrylic hydrogels, e.g., hydroxyethyl methacrylate or methacrylic acid copolymer/partially hydrolyzed poly(2-hydroxyethyl methacrylate) (known as PolyHEMA), polysulfones, thermolabile materials and other relatively hard or relatively soft and flexible biologically inert optical materials, or any combination of such materials, such as a gel encapsulated in a polymer. Implant 10 may thus be rigid, semi-rigid or foldable, for example.
  • Some or all of implant 10 may be hydrophilic or hydrophobic. In one aspect of the invention, corneal implant 10 has a central portion 12 of about 4 mm in diameter (“about” is ±10%) and a peripheral skirt 14 extending outwards from the central portion 12. The central portion 12 may be transparent and may or may not have optical properties, such as positive or negative magnification, astigmatism correction, refraction adjustment and others.
  • The peripheral skirt 14 may be made of the same material as central portion 12. Alternatively, peripheral skirt 14 may be made of a different material than central portion 12 and bonded or otherwise attached to central portion 12. The peripheral skirt 14 may be transparent but can instead be opaque.
  • In one aspect of the invention, at least a portion of the peripheral skirt 14 includes a mesh 16 that enables cell growth in and through the mesh to enhance adhesion of the implant to the cornea. The mesh 16 may have openings of equal or different sizes
  • Non-limiting dimensions of the implant are as follows, using the nomenclature shown in FIG. 2:
  • Outer diameter of implant 10 (OD): 4.2-7.0 mm
  • Maximum thickness of central portion 12 (CPT): 25-75 μm
  • Peripheral width of peripheral skirt 14 (PS): 0.1-1.5 mm
  • Minimum thickness of peripheral skirt 14 (PST): 0-25 μm
  • Extra thickness of central portion 12 more than skirt 14 (CPE): 0-75 μm
  • Radius of curvature (RC) of implant from radius origin O: 6-10 mm
  • Accordingly, peripheral skirt 14 may have a different thickness than the central portion 12 or may be the same thickness.
  • As another alternative, peripheral skirt 14 may be formed with one or more radial slits 33, which may extend the entire width of peripheral skirt 14 or just a portion of the width.
  • As another alternative, peripheral skirt 14 may include one or more radially extending portions 40 or 42 (shown in broken lines), which may be curved or straight with pointed on non-pointed ends.
  • The increased adhesion of peripheral skirt 14 may create a bond between the implant and the corneal tissue without the need for application of an external adhesive substance.

Claims (12)

What is claimed is:
1. Apparatus comprising:
a corneal implant comprising a central portion and a peripheral skirt extending outwards from said central portion, wherein at least a portion of said peripheral skirt comprises a mesh.
2. The apparatus according to claim 1, wherein said mesh is configured to enable cell growth in and through said mesh to enhance adhesiveness of the implant to a cornea.
3. The apparatus according to claim 1, wherein said central portion is 4 mm ±10% in diameter.
4. The apparatus according to claim 1, wherein said central portion is transparent.
5. The apparatus according to claim 1, wherein said central portion has optical magnification.
6. The apparatus according to claim 1, wherein said central portion has astigmatism correction.
7. The apparatus according to claim 1, wherein said central portion has refraction adjustment.
8. The apparatus according to claim 1, wherein said peripheral skirt and said central portion are made of identical materials.
9. The apparatus according to claim 1, wherein said peripheral skirt and said central portion are made of different materials.
10. The apparatus according to claim 1, wherein said peripheral skirt is opaque.
11. The apparatus according to claim 1, wherein said mesh has openings of different sizes.
12. The apparatus according to claim 1, wherein said peripheral skirt comprises one or more radially extending portions.
US16/207,142 2018-12-02 2018-12-02 Corneal implant with peripheral skirt Abandoned US20200170786A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US16/207,142 US20200170786A1 (en) 2018-12-02 2018-12-02 Corneal implant with peripheral skirt
PCT/IB2019/060122 WO2020115605A1 (en) 2018-12-02 2019-11-25 Corneal implant with peripheral skirt
US17/299,037 US11890183B2 (en) 2018-12-02 2019-11-25 Corneal implant with peripheral skirt

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US16/207,142 US20200170786A1 (en) 2018-12-02 2018-12-02 Corneal implant with peripheral skirt

Related Child Applications (1)

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US17/299,037 Continuation US11890183B2 (en) 2018-12-02 2019-11-25 Corneal implant with peripheral skirt

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US17/299,037 Active 2039-07-09 US11890183B2 (en) 2018-12-02 2019-11-25 Corneal implant with peripheral skirt

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220401262A1 (en) * 2021-06-17 2022-12-22 EyeYon Medical Ltd. Endothelial ocular implant
DE102021130009A1 (en) 2021-11-17 2023-05-17 Universität Rostock, Körperschaft des öffentlichen Rechts Support membrane and method for producing a support membrane

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US20170319330A1 (en) * 2014-11-06 2017-11-09 Ophta Innovations Inc. Cosmetic corneal inlay and implantation method thereof
US20170319339A9 (en) * 2003-04-28 2017-11-09 C. R. Bard, Inc. Loading and delivery of self-expanding stents

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220401262A1 (en) * 2021-06-17 2022-12-22 EyeYon Medical Ltd. Endothelial ocular implant
US11737919B2 (en) * 2021-06-17 2023-08-29 EyeYon Medical Ltd. Endothelial ocular implant
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JP7506839B1 (en) 2021-06-17 2024-06-26 アイヨン メディカル リミテッド Endothelial Ocular Implant
DE102021130009A1 (en) 2021-11-17 2023-05-17 Universität Rostock, Körperschaft des öffentlichen Rechts Support membrane and method for producing a support membrane
WO2023088729A1 (en) 2021-11-17 2023-05-25 Universität Rostock Supporting membrane and method for producing a supporting membrane

Also Published As

Publication number Publication date
WO2020115605A1 (en) 2020-06-11
US11890183B2 (en) 2024-02-06
US20220023030A1 (en) 2022-01-27

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