WO2018094371A1 - Dispositifs cornéens dotés de structures et de cellules ouvertes - Google Patents

Dispositifs cornéens dotés de structures et de cellules ouvertes Download PDF

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Publication number
WO2018094371A1
WO2018094371A1 PCT/US2017/062672 US2017062672W WO2018094371A1 WO 2018094371 A1 WO2018094371 A1 WO 2018094371A1 US 2017062672 W US2017062672 W US 2017062672W WO 2018094371 A1 WO2018094371 A1 WO 2018094371A1
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WO
WIPO (PCT)
Prior art keywords
open cells
implant
corneal
corneal implant
cells
Prior art date
Application number
PCT/US2017/062672
Other languages
English (en)
Inventor
Joseph Anthony COLLINS
John Kilcoyne
Ross Tsukashima
Original Assignee
Revision Optics, Inc.
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 Revision Optics, Inc. filed Critical Revision Optics, Inc.
Publication of WO2018094371A1 publication Critical patent/WO2018094371A1/fr

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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
    • A61F2/145—Corneal inlays, onlays, or lenses for refractive correction

Definitions

  • Corneal implants such as corneal inlays can be implanted within the corneal tissue to correct one or more visual errors.
  • small diameter inlays e.g., 1 mm - 3mm
  • Some embodiments in these disclosures include hydrogel inlays with meniscus-shaped bodies with diameters between 1 mm and 3mm, and with indexes of refraction that are substantially the same as stromal tissue (e.g., 1.36-1.39, such as 1.360, 1.365, 1.370, 1.375, 1.380, 1 .385, or 1.390).
  • U.S. Pat. No. 6,102,946 to Nigam describes hydrogel inlays with micropores with diameters as large as 10 microns.
  • the micropores are a property of the material itself, and are not created in the implant in a separate manufacturing step. These micropores are not described as trying to remove a significant portion of the body of the implant.
  • the disclosure relates generally to corneal devices that have an interconnected framework that defines a plurality of open cells.
  • Corneal devices as described herein, include corneal onlays, inlays, or any other type of corneal implant or device.
  • a corneal implant comprising: a body made from a hydrogel material and having an index of refractive that is substantially the same as the refractive index of a stromal layer of a human cornea, the body comprising a plurality of open cells defined by an interconnected framework of the body, the plurality of open cells each extending through an anterior surface and a posterior surface of the body.
  • the plurality of open cells can have the same configuration.
  • Each of the plurality of open cells can be defined by a plurality of linear sides, each optionally at least five sides.
  • the plurality of open cells can each have a configuration that is selected from the group consisting of a pentagon, a hexagon, a heptagon, and an octagon.
  • the plurality of open cells can each have a hexagon configuration.
  • the implant body can have an area defined by an outer perimeter of the implant body in a top view, and wherein the plurality of open hexagon cells cover at least 80% of that area.
  • the implant body can have an area defined by an outer perimeter of the implant body in a top view, and wherein the plurality of open cells extend over at least 80% of the area, optionally at least 85%, and optionally at least 90% of the area.
  • Each of the plurality of open cells can have a dimension between .1 mm and 1 .0mm, defined as a diameter of an inscribed circle within the open cell.
  • Each of the plurality of open cells can have a dimension between .2mm and 1 .0mm, defined as a diameter of an inscribed circle within the open cell.
  • Each of the plurality of open cells can have a dimension between .3mm and 1.0mm, defined as a diameter of an inscribed circle within the open cell.
  • the interconnected framework can comprise a plurality of linear body elements that define sides of the plurality of open cells.
  • Each of the plurality of open cells can be defined by at least five linear body elements.
  • the body can have, in a top view, a total area defined by the outer perimeter of the body, and wherein a region that includes the plurality of open cells and the interconnected framework extends over at least 80% of the total area.
  • the body can have, in a top view, a total area defined by the outer perimeter of the body, and wherein an area defined by the interconnected framework is between 20% and 90% of the total area.
  • the body can have, in a top view, a total area defined by the outer perimeter of the body, and wherein an area defined by all of the plurality of open cells is between 20% and 90% of the total area.
  • One aspect of the disclosure includes methods of forming corneal devices (such as any of the devices described herein), wherein the corneal device includes an interconnected framework that defines a plurality of open cells.
  • One example is a method of forming a corneal device, comprising: providing a cornea device body made from a hydrogel material that has a refractive index substantially the same as the cornea; and selectively removing a plurality of regions of the device body to thereby form an interconnected framework of the body defining plurality of open cells in the body.
  • the selectively removing step can form an interconnected framework of linear body elements, the linear body elements defining a plurality of polygonal open cells.
  • the selectively removing step can form a plurality of open cells that have the same configuration, all of which are optionally polygonal.
  • the selectively removing step can form a plurality of open cells that have hexagon configurations.
  • Figure 1 is a top view of an exemplary corneal device comprising an interconnected framework defining a plurality of open cells.
  • Figure 2 is a perspective view of the exemplary corneal device from figure 1.
  • Figure 3A is a side sectional view of the exemplary corneal device from figure 1.
  • Figure 3B is a perspective sectional view of the exemplary corneal device from figure 1
  • Figure 4 is a top view of an exemplary corneal device that includes an interconnected framework defining a plurality of open cells, illustrating merely exemplary dimensions.
  • Figure 5 is a top view of an exemplary corneal device that includes an interconnected framework defining a plurality of open cells, illustrating merely exemplary dimensions.
  • Figure 6 is a top view of an exemplary corneal device that includes an interconnected framework defining a plurality of open cells, illustrating merely exemplary dimensions.
  • This disclosure relates generally to a corneal device that has one or more openings therein.
  • This disclosure includes corneal devices (e.g., corneal inlays) with a body that includes an interconnected framework, or scaffolding, that defines a plurality of open cells.
  • the body of the implant prior to the interconnected scaffolding formation can be manufactured using known techniques.
  • the scaffolding can then be created by removing select regions of the body, such as with a laser. The removal of the select regions of the body creates the implant body scaffolding, or framework, which defines a plurality of open cells. Removing the select regions of the body is considered a step that is separate from the implant body formation, and generally occurs at a time after the body has been formed. It is conceivable, however, that the interconnected framework could be created in the device at the time of the body is formed.
  • nutrient transport includes oxygen permeability and glucose permeability to support the health of the cornea tissue.
  • An additional exemplary benefit of removing select regions of the body can be that less implant body material will be present (compared to the implant body before material removal), which can reduce a negative bodily reaction to the implant. In some embodiments, as much implant body material as possible is removed, to either increase nutrient transport and/or minimize the likelihood of bodily reaction to the implant.
  • the implant is a corneal inlay, is positioned within stromal tissue (e.g., under a flap or in a pocket), and causes a deformation of at least a portion of the anterior surface of the cornea to provide vision correction (e.g., presbyopia).
  • vision correction e.g., presbyopia
  • the framework that is created after removal of the one or more select regions of material still provides enough support to modify the anterior corneal surface curvature to provide the desired vision correction. If too much material is removed, for example, the implant may be unable to provide enough support to correctly reshape the anterior surface.
  • an aspect of this disclosure is creating implants such as inlays with as much body material removed as possible (e.g., to reduce bodily reaction to the implant and/or increase nutrient transport) while still providing enough support to provide the desired vision correction.
  • FIG. 1 illustrates an exemplary corneal device 10 that includes interconnected framework, or scaffolding, 12.
  • framework 12 includes a plurality of interconnected central elements 18 and peripheral element 16.
  • Voids, or open cells, 14 are defined by the framework structure and are the spaces between the body material.
  • the device interconnected framework can have a wide variety of shapes and sizes, and the description herein provides some examples.
  • interconnected framework 12 includes a plurality of hexagon-shaped cells defined by a plurality of central elements 18.
  • One hexagon "cell” in this embodiment is defined by six linear central elements 18 forming a hexagon configuration.
  • the six elements 18 are all part of the original implant body material, but can be thought of as six different elements that together form a hexagon shape.
  • Scaffolding 12 also includes a plurality of triangular-shaped peripheral cells defined by central elements 18 and peripheral portion 16.
  • the implant scaffolding has a general honeycomb configuration, at least in the central region.
  • the scaffolding including one or more cells thereof, can have a wide variety of shapes and sizes, and all cells need not be the same as other cells.
  • the one or more cells can be round, polygonal, or can have other curvilinear configurations, or any other combination thereof.
  • Cells can also vary in shape throughout the interconnected framework. For example, any number of cells might be hexagonal, while other cells are triangular, or round, or triangular, or square.
  • the configuration of the scaffolding can impact whether the implant body provides enough support to modify the corneal surface curvature as desired.
  • Figure 2 is a perspective view of cornea device 10 from Figure 1.
  • the original device body had a meniscus shape, but the implant body can have any other suitable optical shape, from which the framework can be formed.
  • Figures 3A and 3B are sectional side and perspective views of Section A-A taken from Figure 2.
  • the dimensions of the plurality of open cells can also vary throughout the framework.
  • the open cell "dimension" (unless a different dimension of the cell is called out herein) may be measured as the diameter of an inscribed circle within the shape of the individual cell. If the shape is a circle, the open cell dimension would be the diameter of the circle.
  • one or more open cells have a dimension of about .025mm to about 1 ,0mm of an inscribed circle within the shape of the individual cell.
  • the open cell dimension is between about .050mm and about 1.0mm, between about .075mm and about 1 .0mm, between about .10 mm and about 1.0mm, between about .125mm and about 1 .0mm, between about .150mm and about 1.0mm, between about .175mm and about 1.0mm, between about .200mm and about 1.0mm, between about .225mm and about 1.0mm, between about .250mm and about 1.0mm, between about .275mm and about 1.0mm, between about .300mm and about 1.0mm, between about .325mm and about 1.0mm, between about ,350mm and about 1.0mm, between about .375mm and about 1.0mm, between about .400mm and about 1.0mm, between about .425mm and about 1.0mm, between about .450mm and about 1 .0mm, between about .475mm and about 1.0mm, between about .500mm and about 1.0mm, between about .5
  • the one or more open cells have a dimension between about .250mm and about .750mm, such as between .275 and about .725mm, or between about .300mm and about ,700mm, or about .325mm and about .675mm, such as between about .350mm and about .650mm, such as between about .375mm and about .625mm, such as between about
  • .400mm and about .600mm such as between about .425mm and about .600mm, such as between about .450mm and about ,600mm.
  • the plurality of open cells with any of the above dimensions are located within a central region of the implant that occupies more than 50% of the area of the original implant body in a top view.
  • the area is generally defined by the outer perimeter of the device, in a top view (whether there is body material or an open cell).
  • the hexagonal cells are located in a central region that extends over almost the entire area of the original implant body (except for the triangular cells).
  • Figures 4 and 5 illustrate top views of exemplary corneal devices 20 and 30 (e.g., inlays), respectively, showing merely exemplary dimensions of the inlay, cells, and scaffolding.
  • the listed dimensions are in millimeters.
  • the hexagonal cells in the central portion of inlay 20 have dimensions of .545mm (the diameter of the inscribed circle). This dimension can be also considered the distance between parallel sides of a hexagon shape, or any other shape with linear sides.
  • the thickness of each element 28 is about .10mm.
  • one or more of the one or more open cells have a dimension between about .300mm and about .900mm, such as between about .325mm and about .875mm, such as between about .350mm and about .850mm, such as between about .375mm and about .825mm, such as between about .400mm and about .800mm, such as between about .425mm and about .775mm, such as between about .450mm and about ,750mm, such as between about
  • ,475mm and about ,725mm such as between about ,500mm and about ,700mm, such as between about ,525mm and about ,675mm, such as between about ,550mm and about ,675mm, or between about ,575mm and about ,675mm.
  • Figure 5 illustrates an exemplary corneal device 30 with a plurality of open cells defined by central elements 38 of framework 32.
  • the dimensions of the optional hexagonal cells is about .63mm.
  • the thickness of each element 38 is about .02mm.
  • Figure 6 illustrates another exemplary corneal device 40 with an interconnected network 42 that defines a plurality of open cells 44 (only three are indicated).
  • Figure 6 illustrates exemplary dimensions, and the entire description herein can apply to the embodiment in figure 6 as well.
  • the volume of removed material from the implant is relatively large compared to the volume of the original implant body, as can be seen generally in Figures 4 and 5. This is in contrast to some previous implants that have relatively small holes that may be formed for nutrient transport, but for which there is a general desire to keep the holes as small as possible.
  • the implant has a refractive index that is substantially the same as the cornea, and thus removal of implant body material does not create any intrinsic power change due to the absence of the material. This is in contrast to, for example, a pin-hole design with an opaque outer region, wherein the central aperture does have intrinsic power.
  • the implant diameter is 4mm or less (e.g., 1mm - 3mm).
  • Implants of this size may be generally referred to herein as "small diameter implants," examples of which are described in more detail in some of the references incorporated by reference herein.
  • Some of the exemplary cell dimensions herein e.g., greater than 200 microns are, compared to the overall outermost diameter of the implant (in a top view) larger than cell dimensions compared to larger diameter implants (e.g., 4mm, 5mm, 6mm).
  • the dimensions of scaffolding between polygonal cells is between about 10 microns and about 300 microns.
  • the thickness of the scaffolding between parallel sides of adjacent hexagonal cells is about 100 microns, and in Figure 5 it is about 20 microns.
  • the exemplary dimensions can occur with any sized cells described herein.
  • the framework thickness is about 10 microns to 250 microns, 10 microns to 200 microns, or 10 microns to 150 microns. These dimensions may also apply to a shortest dimension between adjacent cells even if they are not polygonal. For example, if adjacent cells have circular dimensions, the thickness above may be the shortest linear distance between the sides of circular adjacent cells.
  • any of the thicknesses described herein can be used in combination with any of the cell dimensions herein, or cell shapes herein (including a variety of cell shapes within a given framework).
  • the overall shape of the original implant body herein can be any suitable shape, but in Figures 1 -5 the implants are shown with a meniscus shape.
  • the device has, in a top view, a "total area” that is defined as the total area within the outer perimeter of the device. This "total area” includes regions of open cells as well as regions of the interconnected framework.
  • the area of the interconnected framework body (in a top view) is between 10% and 95% of the "total area" of the device, such as between 20% and 90%, or 30% to 90%, or 40%) to 80%.
  • the area of the voids can be determined as a percentage of the area of the total implant area (in a top view).
  • the aggregate area of the plurality of open cells is between 10% and 95% of the "total area" of the device, such as between 20% and 90%, or 30% to 90%, or 40% to 80%.
  • the region of the device over which the interconnected framework and plurality of cells extends is at least 80%> of the total area of the device, such as at least 85%, or even at least 90%.
  • the interconnected framework extends over virtually the entire device body,
  • peripheral voids, or cells have different configurations than cells that are centrally located.
  • the implant includes peripheral triangular cells, and central hexagonal cells.
  • the cells do not provide intrinsic power, unlike pin-hole design implants, for example.
  • Implants herein can be made of hydrogel material with at least 50% water content, such as about 70% or higher.
  • the implants can have an index of refraction that is substantially the same as the index of refraction of stromal tissue, which is generally regarded in the art as between 1 .36 and about 1.39, such as about 1.376.
  • One difference between some implants herein that are optically transparent and opaque implants is that with opaque lenses, there will be a desire that any holes in the implant for nutrient flow be as small as possible to minimize visual disturbances. That is unlike some embodiments herein, where as much material as possible can be removed, while still providing enough support to create the desired vision correction.
  • the one or more select region(s) of the implant body to be removed can be removed with a laser.
  • the implant can be molded with the one or more voids.
  • the implant voids may be able to be created as part of the lathing process that forms the implant body.
  • the plurality of open cells extend all the way through the anterior and posterior surfaces of the device.
  • a hydrogel is adapted to utilize one or more properties of the hydrogel to administer drugs directly into the cornea.
  • the unique physical properties of hydrogels have sparked particular interest in their use in drug delivery applications.
  • Their highly porous structure can easily be tuned by controlling the density of cross- links in the gel matrix and the affinity of the hydrogels for the aqueous environment in which they are swollen.
  • Their porosity also permits loading of drugs into the gel matrix and subsequent drug release at a rate dependent on the diffusion coefficient of the small molecule or macromolecule through the gel network.
  • hydrogels for drug delivery may be largely pharmacokinetic in that a depot formulation can be created from which drugs slowly elute, maintaining a high local concentration of drug in the surrounding tissues over an extended period, although they can also be used for systemic delivery. Any of the implants herein can be adapted to be used in this manner for drug delivery.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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)

Abstract

La présente invention concerne des dispositifs cornéens qui ont une pluralité de cellules ouvertes à l'intérieur de ceux-ci. La pluralité de cellules ouvertes peut être définie par une structure interconnectée formée par élimination de parties sélectionnées du corps de dispositif. Les dispositifs cornéens peuvent être des onlays cornéens, des inlays cornéens ou d'autres types d'implants et de dispositifs cornéens.
PCT/US2017/062672 2016-11-21 2017-11-21 Dispositifs cornéens dotés de structures et de cellules ouvertes WO2018094371A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662425003P 2016-11-21 2016-11-21
US62/425,003 2016-11-21

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WO2018094371A1 true WO2018094371A1 (fr) 2018-05-24

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080255663A1 (en) * 2007-04-13 2008-10-16 Akpek Esen K Artificial Cornea and Method of Making Same
US20150223930A1 (en) * 2010-09-30 2015-08-13 KeraMed, Inc. Corneal implants
WO2016150652A1 (fr) * 2015-03-26 2016-09-29 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Membrane de descemet artificielle

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080255663A1 (en) * 2007-04-13 2008-10-16 Akpek Esen K Artificial Cornea and Method of Making Same
US20150223930A1 (en) * 2010-09-30 2015-08-13 KeraMed, Inc. Corneal implants
WO2016150652A1 (fr) * 2015-03-26 2016-09-29 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Membrane de descemet artificielle

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