Pre-shaped amniotic membranes and contact lens devices including such membranes

Abstract

Devices are provided for treating an ocular condition that include a contact lens comprising an outer surface, an inner surface, a central region and a periphery surrounding the central region including one or more openings; and a sheet of amniotic membrane positioned against the inner surface and at least partially received in the one or more openings to secure the membrane adjacent the inner surface. For example, a plurality of openings may be spaced apart from one another around the periphery of the contact lens, and the sheet may include a plurality of arms, tabs, or other features spaced apart from one another, each feature received in a respective opening of the plurality of openings. The device may be placed against a. patient's eye with the contact lens centering and / or stabilizing the amniotic membrane against the cornea and / or sclera to treat an ocular condition.

Description

PRE-SHAPED AMNIOTIC MEMBRANES AND CON FACT LENS DEVICES INCLUDING SUCH MEMBRANESRELATED APPLICATION DATA

[0001] The present application claims benefit of co-pending U.S. provisional application Serial No. 63 / 698,047, filed September 24, 2024, the entire disclosure of which is expressly incorporated by reference herein.TECHNICAL FIELD

[0002] The present application relates generally to medical devices and, more particularly, to amniotic membranes for use with contact lenses, to contact lens devices including such membranes, and to methods for making and using such membranes and devices.BACKGROUND

[0003] Amniotic membrane (also referred to as “AM” herein) consists of the avascular semi-transparent innermost layer of the placenta. Its thick basement membrane is similar in composition to the basement membrane of the human corneal and conjunctival epithelium. Due to properties, such as its mechanical strength and elasticity, ability to promote epithelial adhesion and migration, and therapeutic advantages (anti-fibrosis, antiinflammation, anti-angiogenesis, and anti -bacteria), AM is an effective therapy for healing ocular surface diseases in a range of pathologies, including comeal epithelial defects, various types of keratopathy and keratitis, neurotrophic keratopathy, limbal stem cell deficiency, chemical burns, and Stevens Johnson Syndrome.

[0004] Presently, there are two main types of sutureless AM products that, are commercially available for in-office use: cryopreserved sutureless amniotic membranes, e.g., the ProKera and CAM360 products (BioTissue, Inc., Miami, FL), and dehydrated sutureless AM, e.g. the AmbioDisk (Katena, Parsippany, NJ), Apollo (Atlas Ocular, Bethesda, MD), and BioDOPTIX (Integra Lifesciences, Cordova, TN) products. In cry opreservation, the AM tissue is placed in a storage medium containing cryoprotectants such as glycerol and frozen to -80°C. The main product, ProKera (Bio-Tissue, Inc., Miami, FL), consists of cryopreserved amniotic membrane held between two clear, flexible polycarbonate rings (outer diameter of 21.6 mm) that conforms to the ocular surface.Logistical considerations include the storage requirement between -80°C to 4°C (-112°F to 39.2°F) and shelf life of two years from the manufacture date.

[0005] Most of the adverse event profil es for the ProKera product are centered around the polycarbonate ring structure. Adverse events include significant pain / ring dysesthesia, perforation, lost ring, and worsened persistent epithelial defects from ring trauma. The main adverse event for the CAM360 product involves scrolling or displacement of the amniotic membrane as it is not actually secured to the contact lens.

[0006] In contrast to cryopreserved amniotic membranes, dehydration preservation methods involve using air or heat to remove the moisture and dehydrate the AM tissue, followed by gamma irradiation to sterilize the tissue. Dehydrated amniotic membranes may lose parts of the extracellular matrix native architecture as well as certain biological components; however, shelf life can be up to five years from the manufacture date. These products are placed over the ocular surface and covered with a bandage contact lens to minimize slippage. In dehydrated sutureless amniotic membranes, encountered adverse events include infectious or sterile infiltrates, scrolled or displaced membranes, and pain.

[0007] FIGS. 1 and 2 show an example of a conventional method for treating an ocular condition of an eye 90, in which an amniotic membrane disk 92 is sandwiched between the cornea of the eye 90 and a contact lens 94. The contact lens 94 is intended to maintain the membrane 92 in place while the membrane 92 helps heal the cornea. .As shown in FIG. 2, the membrane 92 is typically smaller and fully covered by the contact lens 94. The contact lens 94 is intended to settle onto the sclera to maintain its centered position. A common issue arises when the flimsy membrane 92 slips off or is otherwise dislodged from under the contact lens 92, thereby reducing the clinical success of this approach.

[0008] Therefore, improved devices and methods for using amniotic membrane to treat ocular conditions would be useful.SUMMARY

[0009] The present application relates generally to medical devices and, more particularly, to amniotic membranes for use with contact lenses, to contact lens devices including such membranes, and to methods for making and using such membranes and devices.

[0010] As disclosed herein, amniotic membranes may be used for its therapeutic properties to heal the cornea and ocular surface in a variety of conditions. Amnioticmembranes are the innermost, avascular layer of fetal membranes, composed of the epithelium, basement membrane and stroma, which are collected from full-term placental tissue and treated with antibiotics during collection. While the basement layer’s collagen makeup closely resembles that of the cornea and conjunctiva (thereby promoting cellular growth), the stroma contains fetal hyaluronic acid and cytokines, which may be useful to reduce inflammation. As described further elsewhere herein, the collected and treated amniotic membranes may be cut or otherwise formed into sheets, which may be used in cooperation with contact lenses to treat one or more ocular conditions, e.g., injuries, dry eyes, and / or to aid in post-surgeiy recovery.

[0011] There are limiting factors for the current models of sutureless amniotic membrane products including patient tolerability and the ability to maintain the amniotic membrane on the ocular surface (i.e. , slippage and loss of amniotic membrane). To overcome such factors, in various examples herein, a sheet of amniotic membrane is secured or otherwise held with a contact lens, which, in turn, secures the amniotic membrane over the corneal or ocular surface to exert its restorative properties. For example, the devices and systems herein may involve including slits, slots, or other openings within a contact lens to allow7a sheet of amniotic membrane (with or without modification) to be received in or through the openings to secure the amniotic membrane to the contact lens before being applied to a patient’s eye. Variations of the different openings and ways to secure the amniotic membrane to the contact lens are presented as well as other contact lens designs (e.g., thicker periphery to rest on the sclera, different inner contact lens shapes, and the like). In addition, devices and methods are provided for cutting and / or shaping one or both of the amniotic membrane and contact lens. Such devices including an amniotic membranecontact lens combination may improve eye provider use / efficiency as wel 1 as patient comfort while also enhancing healing and patient outcomes.

[0012] Attaching amniotic membrane to a contact lens is unique to all other models that use a contact lens to merely cover the membrane placed over the comea / ocular surface. Securing the membrane may minimize the risk of losing the membrane from slippage and / or may prevent the membrane from scrolling, which may decrease contact time with the ocular surface. The devices and systems herein may allow the membrane to withstand repetitive blinking and delivering drops or other medication that may otherwise dislodge the membrane. The devices and systems herein may also maximize both convenience for the treating eye doctor as well as the comfort for the patient. The method of securing themembrane with a contact lens on the ocular surface may be better tolerated than the polycarbonate ring of the ProKera product for patients, which, in turn, may allow patients to tolerate therapies for a longer duration (e.g., providing a longer contact time between the membrane and ocular surface). Having the membrane and contact lens as a single, deliverable unit may also simplify the application process for treating providers and, optionally, for patients themselves to use. The amniotic membrane-contact lens unit may also improve eye provider use / efficiency as well as patient comfort while also enhancing healing and patient outcomes.

[0013] In accordance with one example, a device is provided for treating an ocular condition that includes a contact lens comprising an outer surface, an inner surface, a central region and a periphery surrounding the central region including one or more openings; and a sheet of amniotic membrane positioned against the inner surface and at least partially received in the one or more openings to secure the membrane adjacent the inner surface. In one example, the contact lens includes a plurality of openings spaced apart from one another around the periphery', and the sheet may include a plurality of arms, tabs, or other features spaced apart from one another, each feature received in a respective opening of the plurality of openings. The device may be placed against a patient’s eye with the contact lens centering and / or stabilizing the amniotic membrane against the cornea and / or sclera to treat an ocular condition.

[0014] In accordance with another example, a device is provided for treating an ocular condition that includes a contact lens comprising an outer surface, an inner surface, a central region and a plurality of features extending radially outwardly from the central region, and a sheet of amniotic membrane positioned against the inner surface and including a plurality of openings, the features at least partially received in respective openings to secure the membrane adjacent the inner surface.

[0015] In accordance with still another example, a method is provided for making a device for treating an ocular condition that includes forming a contact lens comprising an outer surface, an inner surface, a central region and a periphery surrounding the central region; forming a sheet of amniotic membrane; and securing the sheet of amniotic membrane adjacent the inner surface. For example, the contact lens may include one or more openings, e.g., a plurality' of openings spaced apart around the periphery' and the sheet may include one or more features, e.g., a plurality of features received in respective openings of the plurality of openings to secure the sheet adjacent the inner surface.

[0016] In accordance with yet another example, a method is provided for treating an ocular condition that includes providing a device including a contact lens comprising an outer surface, an inner surface, and a sheet of amniotic membrane positioned against the inner surface; and placing the amniotic membrane against a surface of an eye such that the contact lens centers and / or stabilizes the amniotic membrane against the cornea and / or sclera to treat an ocular condition.

[0017] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] It is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0019] FIG. 1 shows an eyeball and a separate sheet of amniotic membrane and contact lens being placed on the eyeball.

[0020] FIG. 2 is a cross-sectional view of the eyeball of FIG. 1.

[0021] FIG. 3 A shows an example of a device for treating an ocular condition .

[0022] FIGS. 3B and 3C show an exemplary contact lens and sheet of amniotic membrane, respectively, that may be assembled to provide the device of FIG. 3 A.

[0023] FIGS. 4A and 4B are front and back views, respectively, of another example of a device for treating an ocular condition.

[0024] FIGS. 4C and 4D show an exemplary' contact lens and sheet of amniotic membrane, respectively, that may be assembled to provide the device of FIGS. 4A and 4B.

[0025] FIG. 5A shows another example of a device for treating an ocular condition including a sheet of amniotic membrane secured to a contact lens.

[0026] FIG. 5B shows the membrane of the device of FIG. 5 A.

[0027] FIG. 6A shows yet another example of a device for treating an ocular condition including a sheet of amniotic membrane secured to a contact lens.

[0028] FIG. 6B shows the membrane of the device of FIG. 6A.

[0029] FIG. 7A shows still another example of a device for treating an ocular condition including a sheet of amniotic membrane secured to a contact lens.

[0030] FIG. 7B shows the membrane of the device of FIG. 7 A.

[0031] FIG. 8A shows another example of a device for treating an ocular condition.

[0032] FIGS. 8B and 8C show an exemplary contact lens and sheet of amniotic membrane, respectively, that may be assembled to provide the device of FIG. 8A.

[0033] FIG. 8D is a detail showing an arm of the amniotic membrane being received in an opening in the contact lens of the devi ce of FIG. 8A.

[0034] FIG. 8E is a cross-sectional view showing the device of FIG. 8 A placed over a cornea of an eye.

[0035] FIGS. 9A and 9B are top and back views, respectively, of yet another example of a device for treating an ocular condition.

[0036] FIG. 9C is a perspective view of an exemplary sheet of amniotic membrane that may be assembled to provide the device of FIG. 9 A.

[0037] FIGS. 9A(1), 9B(1), and 9C(1) are details showing an arm of the amniotic membrane being received in an opening in the contact lens of the device of FIG. 9 A.

[0038] FIGS. 10A-10J show examples of contact lenses including a central region and a periphery surrounding a central region with different opening configurations formed in the periphery'.

[0039] FIGS. 10K-10M show additional examples of contact lenses including openings in a central region of the contact lenses in addition to openings in a periphery.

[0040] FIGS. 11 A-11 G show examples of contact lenses with different orientations of openings formed in the periphery’. Certain opening shapes lend themselves to have an angular orientation with respect to their reference radial line (from the opening location to the center of the contact lens). Using a F-shaped opening (for illustration purpose), the “natural” orientation is defined in FIG. 11 A when the vertical line of the “F” is parallel with the reference (vertical) radial line; FIGS. 1 IB- 11G show’ various rotational orientations of the F-shaped opening with respect to the vertical reference radial line, e.g., having a 30°, 45°, 60°, 90°, 180°, and 270° counter-clockwise rotation, respectively.

[0041] FIGS. 12A and I2B are front and back views, respecti vely, of yet another example of a device for treating an ocular condition including a contact lens that includes features received in respective openings of a sheet of amniotic membrane.

[0042] FIGS. 12C and 12D are perspective views of the device of FIGS. 12A and 12B.

[0043] FIG. 12E show's an exemplary' sheet of amniotic membrane that may be included in the device of FIGS. 12A and 12B.

[0044] FIG. 12F is a detail showing a feature of the contact lens received in an opening in the sheet.

[0045] FIGS. 13 A and 13B are front and perspective views, respectively, of yet another example of a device for treating an ocular condition including a contact lens that includes features received in respective openings of a sheet of amniotic membrane.

[0046] FIG. 13C shows an exemplary sheet of amniotic membrane that may be included in the device of FIGS. 13A and 13B.

[0047] FIG. 13D is a detail showing a feature of the contact lens received in an opening in the sheet.

[0048] FIG. 14A shows another example of a device for treating an ocular condition.

[0049] FIGS. 14B and 14C show an exemplary sheet of amniotic membrane and a contact lens, respectively, that may be assembled to provide the device of FIG. 14A.

[0050] FIGS. 15 A- 15D show different configuration of openings that may be provided in sheets of amniotic membrane that may be included in the devices herein, such as the device shown in FIGS. 14A-14C.

[0051] FIG. 16 is a cross-sectional view showing a device including a sheet of amniotic membrane secured to a contact lens positioned against an eye, the contact lens having a substantially uniform thickness and having a bi-curve or tri-curve base curve radius, e.g., with a central region sized to cover the cornea having a first radius and a periphery surrounding the central region having a larger second radius to seat against the eye around the cornea, as shown.

[0052] FIG. 17 is a cross-sectional view7of a device similar to the device of FIG. 16, with the contact lens having an outer diameter larger than the sheet of amniotic membrane such that a periphery of the contact lens contacts the eye around the membrane.

[0053] FIGS. 18 and 19 are cross-sectional views showing devices including a sheet of amniotic membrane secured to a contact lens positioned against an eye, the contact lens having a periphery that is thicker than a central region thereof.

[0054] FIGS. 20 A and 20B are details showing of the devices of FIGS. 18 and 19, respectively, showing a fluid layer between the amniotic membrane and the surface of the eye.

[0055] FIGS. 21 A and 21 B are perspective and top views, respectively, of an exemplary die that may be used to cut slits to create a sheet of amniotic membrane, such as that shown in FIG. 21 C.

[0056] FIGS. 22A and 22B are perspective and top views, respectively, of another example of a die that may be used to cut slots to create a sheet of amniotic membrane, such as that shown in FIG. 22C.

[0057] FIG. 23 A is a perspective view of a template that may be used to cut slits to create a sheet of amniotic membrane, such as that shown in FIG. 23B, e.g., by directing a blade through the slots of the template.

[0058] FIGS. 24A-24J show additional examples of sheets of amniotic membrane that may be included in the devices herein, including T-shaped cuts or notches to provide a plurality of arms around a central region of the sheets.

[0059] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.DEI AILED DESCRIPTION

[0060] Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0061] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0062] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary' skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[0063] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0064] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0065] The term “substantially” is used throughout this document to indicate variations in the thus qualified terms. These variations are variations that do not materially affect the manner in which the invention works and can be due, for example, to uncertainty in manufacturing processes or to small deviations from a nominal value or ideal shape that do not cause significant changes to the invention. Also, the terminology “proximal” and “distal” refers to a position relative to an operator using the present disclosure on a patient. For example, distal elements are closer to an intervention site, e.g., a patient’s skin, and proximal elements are closer to an operator, for example, a doctor or other caregiver using the devices herein.

[0066] Turning to the drawings, FIGS. 3A-3C show an exemplary device 10 that may be provided for treating an ocular condition that includes a contact lens 20 and a sheet of amniotic membrane 30. As best seen in FIG. 3B, the contact lens 20 includes a central region 22 and a periphery' or skirt 24 at least partially surrounding the central region 24.Generally, the central region 22 corresponds to an optical zone of the contact lens 20, e.g., sized to cover at least the cornea of the eye, while the periphery 24 is located outside the optical zone such that features provided at the periphery 24 will not interfere with the patient’s vision. For example, the central region 22 may have a diameter between about ten and twenty four millimeters (10-24 nun), while the periphery 24 may have an outer diameter between about ten to thirty five millimeters (10-35 mm).

[0067] In the example shown, the periphery 24 extends entirely around the central region 24 and has a substantially uniform radial width. The contact lens 20 may have a substantially uniform thickness, e.g., in both the central region 22 and the periphen,- 24, e.g., as shown in FIGS. 16 and 17. Alternatively, the periphery' 24 may have a thickness greater than the central region 22, e.g., as shown in FIGS. 18 and 19. For example, as shown in FIG. 18, the thickness of the periphery 24’ may transition from the central region 22’ to the periphery- or, alternatively, as shown in FIG. 19, the periphery 24” may have a substantially uniform thickness, thereby providing an edge 25” defining a recess between the central region 22” and the periphery 24”. Thus, in this alternative, an outer edge of the amniotic membrane 30 may be received within the recess, e.g., to minimize any gaps between the contact lens 20” and the membrane 30.

[0068] Optionally, in any of these examples, the central region 22 may include a lens having a predetermined prescription, e.g., for an individual patient, if desired. In this option, one or more weights (not shown) may be provided, e.g., in one side of the periphery to enhance rotational orientation of the contact lens 20 when placed on an eye. In addition or alternatively, at least the central region 22 may include a polarizing layer and / or tinting, if desired.

[0069] With continued reference to FIGS. 3A-3C, the contact lens 20 also includes an outer, e.g., convex, surface 25, and an inner, e.g., concave, surface 23, which may be shaped similar to conventional contact lenses such that the inner surface 23 may be oriented towards a patient’s cornea. For example, the contact lens 20 may have a base curve radius (“BCR” between about five and twelve millimeters (5-12 mm), or between about six and ten millimeters (6-10 mm), and, optionally the inner surface 23 may have a bi-curve or tri-curve shape, e.g., with the periphery 24 having a flatter radius of curvature than the central region 22 to facilitate centering the contact lens 20 on the cornea of an eye.

[0070] Unlike conventional contact lenses, the contact lens 20 includes one or more openings, e.g., a plurality of openings 26 spaced apart from one another in the periphery 24,e.g., a plurality of slits or slots, for receiving features of the membrane 30, as described further elsewhere herein. For example, as best seen in FIG. 3B, the periphery' 24 may include four slots 26 spaced apart equally from one another around the circumference, e.g., about ninety degrees (90°) apart.

[0071] In the example shown, the openings 26 are curved slots that are aligned with one another around a common circumferential line. As shown, each opening 26 includes spaced apart edges that are connected at opposite curved ends. Optionally, the ends may include straight or blunt edges or may include relatively larger circular or otherwise shaped stress-relief regions (not shown), if desired.

[0072] Alternatively, the openings 26 may have other shapes. For example, FIGS. 10A-10J show exemplary contact lenses that include openings 26A-26J having different shapes, which may be included in the contact lens 20 (or any of the other devices herein), e.g., including arcuate openings 26A (FIG. 10A), straight openings 26B (FIG. 10B), chevron openings 26C (FIG. IOC), sawtooth openings 26D (FIG. 10D), curvilinear openings 26E, 26F (FIGS. 10E, 10F), and / or cross or star shapes 26G-26J (FIGS. 10G-10J). The openings 26A-26J may be sized and / or shaped to accommodate receiving and / or securing corresponding features on the membrane 30, as described elsewhere herein. In further alternatives, plain circular holes are also an option, e.g., as shown in FIGS. 10K- 10M.

[0073] Optionally, as shown in FIGS. lOK-lOM, a contact lens may be included in the device that includes one or more openings 23K-23M in the central region 22K-22M, e.g., in addition to openings 26K-26M in the periphery- 24K-24M. For example, the central region 22K may include an opening 23K in the center of the central region 22K, and, optionally, a plurality of additional openings 23K spaced apart from one another between the center and the periphery' 24K. It will be appreciated that any desired number and arrangement of openings 23K-23M may be provided on the central region 22K-22M. Although shown as circular for simplicity, the central openings 23K-23M may have any shape, such as shapes similar to the openings shown in FIGS. 10A-10J. Optionally, the corresponding membrane (not shown) may include one or more flaps, arms, or other features formed in a central region thereof that may be received in corresponding openings 23K-23M of the contact lens.

[0074] The contact lens 20 may be formed from materials similar to conventional contact lenses, e.g., such that at least the central region 22 is transparent to allow' a patientusing the device 10 to continue seeing. For example, the contact lens 20 may be formed from substantially rigid material, e.g., one or more of polymethyl methacrylate (PMMA), polycarbonate (PC), fluorosilicone acrylate, and siloxane acrylate. Alternatively, the contact lens 20 may be formed from flexible material, e.g., one or more of omafilcon, etafilcon, ocufilcon, 2 -Hydroxyethyl methacrylate (HEMA), methacrylic acid (MAA), polyvinylpyrrolidone (PVP), N-vinyl pyrrolidone (NVP), phosphorylcholine (PC), N,N- dimethylacrylamide (DMA), and siloxane. In a further alternative, the central region 22 and periphery 24 may be formed from different materials, e.g., formed as separate elements that are attached together to provide the finished contact lens 20. For example, the contact lens 20 may be formed with a substantially rigid or hard central region 22 and a flexible or soft outer periphery 24, or vice versa, if desired, which maybe integrally formed together or separately and attached together.

[0075] The contact lens 20 may be formed using conventional methods, e.g., one or more of molding, casting, machining, diamond turning, laser cutting, 3D printing, and the like. In one example, the contact lens 20 may be molded similar to methods used to make conventional contact lenses, but including both the central region 22 and the periphery' 24. The openings 26 may be formed when the periphery 24 is formed or may be created subsequent to forming the periphery 24, e.g., by one or more of laser cutting, etching, machining, and the like. For example, the openings 24 may be created slitting the material of the periphery' 24 (i.e., with no material removed to provide “slits”), or by removing some width of material from the periphery 24 along the shape of the opening, e.g., punched-out, waterjet cut, or laser cut, to provide “slots.” Optionally, to avoid the slits or lots from propagating, ends of the openings may be rounded off or stress-relief holes may be added at the ends, e.g., similar to those shown in FIGS. 15C and 15D.

[0076] Returning to FIG. 3C, the sheet of amniotic membrane 30 includes features 36 that are at least partially received in the respective opening(s) 26 in the contact lens 20 to secure the membrane 30 adjacent the inner surface 23. For example, as shown, the membrane 30 has substantially square shape, thereby defining four corners 36, which may be received through respective openings 26 in the periphery of the contact lens, as shown in FIG. 3 A. The membrane 30 may be formed from a larger section of amniotic membrane (not shown), e.g., that has been collected and treated using conventional methods, as described elsewhere herein. In one method, multiple membranes may be formed from a larger section of amniotic membrane, e.g., by one or more of die cutting, stamping, lasercutting, slitting, and the like. Optionally, as described further below, the sheet of amniotic membrane may include one or more features, e.g., arms, tabs, openings, and the like, which may be formed at the same time as the sheet, e.g., by one or more of die cutting, stamping, laser cutting, slitting, and the like.

[0077] To make the device 10, the contact lens 20 may be formed, e.g., using the materials and methods described above, to provide the central region 22, periphery 24, and openings 26. The sheet of amniotic membrane 30 may be formed, e.g., by one or more of cutting, die cutting, stamping, punching, drilling, laser cutting, waterjet cutting, machining, and the like to provide the substantially square shape shown in FIG. 3C. Thus, in this example, the membrane 30 simply includes four straight edges 32 and corners 36, and the comers 36 may be inserted into respective openings 26, thereby securing the membrane 30 adjacent the inner surface 2.3 of the contact lens 20. Although a square shape is shown, alternatively, the membrane may have other geometric shapes, e.g., rectangular or other polygonal shapes that include a plurality of corners and the contact lens may include openings at locations corresponding to the locations of the corners for securing the membrane to the contact lens. In further alternatives, the membrane may have a circular, elliptical or other shape (not shown), and the edge of the membrane may be received in one or more openings of the periphery-' of the contact lens. In addition, or alternatively, the membrane may have an outer diameter or other outer cross-section smaller than the central region of the contact lens, and one or more edges, comers, or other features of the membrane may be received in corresponding openings in the central region of the contact lens, similar to other devices herein. In this alternative, the openings in the periphery / may be omitted.

[0078] With continued reference to FIGS. 3A-3C, the comers 36 and / or other features of the membrane 30 may be held within the corresponding openings 26 by friction. Optionally, the material of the contact lens may have sufficient elasticity' that edge material adjacent the openings may be separated to insert the corners and / or other features and then released to close the edges to enhance engagement between the membrane 30 and the contact lens 20, thereby minimizing the risk of the device 10 subsequently separating. Optionally, if desired an adhesive, fluid, or tacky material may be applied between the membrane and the inner surface 23 of the contact lens 20 to enhance engagement during assembly of the device 10. The assembled device 10 may be packaged and / or otherwiseprepared for delivery to an end user, e.g., an ophthalmologist or other medical professional, using conventional procedures.

[0079] During use, the device 10 may be removed from any packaging (not shown) and prepared for placement against a patient’s eye 90. For example, the device 10 may be rinsed with saline or other fluid and then the exposed surface of the membrane 30 may be placed on the eye 90 to treat an ocular condition. The contact lens 20 may facilitate centering and / or stabilizing the amniotic membrane against the cornea and / or sclera, e.g., as shown in FIG. 16. In addition or alternatively, the shape of the inner surface 23 of the contact lens 20 may ensure the membrane 30 is pressed against the surface of the eye 90 and / or otherwise held in place for an extended period of time, e.g., for several hours or days, which may enhance treatment.

[0080] Alternatively, the sheet of amniotic membrane may include other features that may be received in respective openings in the contact lens to secure the membrane to the contact lens. For example, turning to FIGS. 4A and 4B, another exemplary device 110 is shown that includes a contact lens 120 and a sheet of amniotic membrane 130, which may be generally constructed similar to the device 10. For example, the contact lens 120 includes a central region 122 and a periphery 124 surrounding the central region 122, which includes a plurality of openings 126 spaced apart from one another around the circumference. Unlike the openings 26, however, the openings 126 are straight, e.g., extending tangentially relative to a common circumferential line 127. It will be appreciated that any of the other openings shown and described may be included in the contact lens 120 (or any of the other contact lenses described herein).

[0081] Unlike the square membrane 30 shown in FIG. 3C, the membrane 130 includes a substantially circular central region 132 and a plurality of arms 136 that extend radially outwardly from the central region 132. The central region 132 may be sized to be coextensive with or smaller than the central region 122 of the contact lens 120, e.g., similar to the devices shown in FIGS. 16 and 17. The arms 136 terminate in outer ends 137 and, optionally, as shown, include tabs 138 extending laterally away from one another adjacent the outer ends 137. The arms 136 may be spaced apart circumferentially from one another, e.g., substantially uniformly from one another. For example, in the example shown, the membrane 130 includes six arms 136 spaced apart about sixty degrees (60°) from one another around the circumference. Alternatively, the membrane and contact lens may include other numbers and / or arrangements of arms and openings, which may be spacedapart uniformly or nonuniformly around the circumference, if desired. In various examples, the membrane and contact lens of the device 110 (or any of the other devices herein) may include between one and sixteen (1-16), two and nine (2-9), or three and five (3-5) arms and openings.

[0082] Each arm may have a substantially uniform or variable width along a radial length extending from the sheet central region to an outer end of each arm. For example, the arm 136 may include a uniform width region that transitions outwardly adjacent the outer end 137 to form a pair of tabs 138 that extend laterally opposite one another. In the example shown, the outer end 137 includes a curved shape. Alternatively, as shown in FIG. 4C, each arm 136’ may include a uniform width to the tabs 138’ and the outer end 137’ may have a flat shape.

[0083] FIGS. 5A-7B show other alternatives of arms 236a-236c that may be provided on a sheet of amniotic membrane 230a-23c that may be inserted into respective openings 226 in a contact lens 220. For example, in FIGS. 5A-5B, each arm 236a has a uniform width along its radial length terminating in a rounded outer end, while in FIGS. 6A-6B, each arm 236b has a tapering width with the outer end wider than an inner end adjacent the central region of the sheet 230b, which may resist the arms 236b being pulled back through the openings 226 of the contact lens 220 during use. In FIGS. 7A-7B, each arm 236c has a uniform width and includes a pair of opposing tabs and a rounded outer end, with the tabs resisting pulling the arms 236c back through the openings 226.

[0084] Returning to FIGS. 4 A and 4B, the device 110 may be made similar to the other devices herein, e.g., by forming the contact lens 120 including the central region 122, periphery 124, and openings 126. The sheet 130 may be formed, e.g., by one or more of die cutting, stamping, punching, drilling, machining, laser cutting, waterjet cutting, hand cutting, and the like from a larger section of amniotic membrane, to provide the central region 132 and arms 136. The sheet 130 may then be placed against the inner surface of the contact lens, 120, and the arms 136 inserted through respective openings 126, thereby securing the sheet 130 adjacent the inner surface. Given the flexibility of the amniotic membrane, the tabs 138 may be rolled or folded, as needed, to insert the arms 136 through the openings 126. Once fully inserted, the tabs 138 may lie against the outer surface of the periphery 124, as best seen in FIG. 4 A, which may resist pulling the arms 136 back through the openings 126.

[0085] Turning to FIGS. 8A-8E, another exemplary device 310 is shown that includes a contact lens 320 and a sheet of amniotic membrane 330, which may be generally constructed similar to the other devices herein. For example, the contact lens 320 includes a central region 322 and a periphery 324 surrounding the central region 322, which includes a plurality of openings 326 spaced apart from one another around the circumference. In this example, the openings 326 are curved although, alternatively, any of the other openings shown and described herein may be included in the contact lens 320.

[0086] The membrane 330 includes a substantially circular central region 332 and a periphery 334 surrounding the central region 332. A plurality of arms, i.e., flaps 336, are formed in the periphery' 334, e.g., by a pair of notches 338 extending inwardly from an outer edge 335 of the periphery' 334 such that the flaps 336 terminate in outer ends 337, which may be coextensive with an outer perimeter of the periphery' 334. Alternatively, the outer ends 337 of the flaps 336 may be otherwise shaped or modified, e.g., to facilitate inserting the flaps 336 through the openings 326 in the contact lens 320. Similar to the device 110, the flaps 336 may be spaced apart circumferentially, e.g., substantially uniformly from one another. For example, in the example shown, the membrane 330 includes six arms 336 spaced apart about sixty degrees (60°) from one another around the circumference.

[0087] Alternatively, the membrane and contact lens may include other numbers and / or arrangements of arms and openings, which may be spaced apart uniformly or nonuniformly around the circumference, if desired. For example, FIGS. 24A-24J show alternative examples of sheets of amniotic membranes 630a-630j that may be used in the devices herein that include arms 636a-636j formed from T-shaped cuts or notches 638a- 638j. The resulting arms may extend radially outwardly from and / or surround a central region 632a of the respective sheets. For example, FIG. 24A shows a membrane 630a that includes eight T-shaped notches 638a include a bottom or stem extending radially inwardly towards the central region 632a and a straight top perpendicular to the stem to provide eight arms 636a. Alternatively, as shown in FIG, 24B, the T-shaped notches 638b may be formed as slots, i.e., with material removed to provide spaced apart side edges in the notches 638b, while in FIG. 24C, the notches 638c are formed as slits, i.e., by simply cutting through the membrane without removing material. In FIGS. 24B and 24C, the notches 638b, 638c have curved tops (the horizontal segment of the T), e.g., aligned circumferentially around the central region 632b, 632c and straight bottoms (the vertical segment of the T).

[0088] Optionally, any desired number of notches and arms may be formed in the membranes, similar to the other devices herein. For example, FIG. 24D shows a membrane 630d that includes ten notches 638d arms 636d, while FIG. 24E shows a membrane 630e that includes five notches 638e and arms 636e. In addition, the notches, e.g., formed as slots, may have a substantially uniform widths or may have variable widths. For example, FIG. 24F shows a membrane 63 Of that includes notches 638f that have a uniform width, while FIG. 24G shows a membrane 630g that includes notches 638g where the tops of the Ts have a larger width than the bottoms. Optionally, the notches may have square or rounded edges. For example, FIG. 24H shows a membrane 630h that includes notches 638h with relatively wade tops that include fillets or rounded edges and FIG. 24J shows a membrane 630j that includes 638j that have uniform widths but have fillets or rounded edges.

[0089] Alternatively, as shown in FIGS. 9A-9C, the flaps 336’ may be offset radially inward from the outer edge of the periphery / 334,’ i.e., such that the flaps 336’ are surrounded by other material of the periphery 334.’ For example, in this alternative, one or more notches 338’ may be formed through the material of the periphery 334,’ e.g., a generally “C” or “U” shaped notch 338,’ e.g., as shown in FIG. 9C( 1 ), to provide each flap 336’ having a free end 337’ and an opposite end that remains attached to the periphery / 334.’ In this alternative, the flaps 336’ are oriented radially outwardly, i.e., with the outer ends 337’ adjacent the outer edge of the periphery' 334” although, alternatively, they may be oriented inwardly or laterally within the periphery (not shown). Consequently, the free ends 337’ may be lifted away from the periphery / 334’ to insert the flaps 336’ through the respective openings 326 in the contact lens, e.g., as best seen in FIGS. 9A(1) and 9B( 1). Once the flaps 336’ are received through the openings 326, the flaps 336’ may lie against the outer surface of the contact lens periphery 324, while the sheet central region 332 is maintained adjacent the inner surface of the contact lens 320. The assembled devices 310, 310’ shown in FIGS. 8 A and 9A may be used similar to the other devices herein.

[0090] Alternatively, the location of the openings and features may be reversed, e.g., such that features of the contact lens are received in corresponding openings in a sheet of amniotic membrane. For example, FIGS. 12A-12C shows an exemplary device 410 that includes a contact lens 420 and a sheet of amniotic membrane 430, which may be generally constructed similar to the other devices herein. The contact lens 420 includes a central region 422 and a periphery 424 surrounding the central region 422, generally similar to theother contact lenses herein, expect without any openings through the periphery 424. Instead, the sheet of amniotic membrane 430 includes a plurality of openings 436 in a periphery 434 thereof through which portions of the lens periphery 424 may be received. For example, as best seen in FIGS. 12E and 12F, the membrane 430 may include a plurality, e.g., three, pockets defining the openings 436 that are located adjacent a central region 432 of the membrane 430. The pockets may be positioned and sized such that the outer edge of the lens periphery 424 may be inserted into the openings 436, thereby securing the lens 420 to the membrane 430.

[0091] The device 410 may be manufactured, assembled, and used, similar to the other devices herein. However, in this example, the contact lens 420 may have an outer diameter smaller than the outer diameter of the membrane 430 such that the contact lens 420 does not contact the patient’s eye but merely helps to stabilize and hold the membrane 430 when placed on a patient’s eye.

[0092] In the example shown in FIGS. 12A-12F, the openings 436 are substantially straight, e.g., oriented tangentially relative to a circumferential line around the membrane 430. Alternatively, as shown in FIGS. 13A-13C, a device 410’ is shown that includes a contact lens 420 and sheet of amniotic membrane 430’, with curved openings 436’ provided in the membrane 430’ that may receive the periphery 424 of the contact lens 420, but otherwise similar to the device 410.

[0093] Turning to FIGS. 14A-14C, still another exemplary device 510 is shown that includes a sheet of amniotic membrane 530 secured to a contact lens 520. In this example, as best seen in FIG. 14B, the contact lens 520 includes a central region 522 surrounded by a periphery 524, similar to other devices herein, except that the contact lens 520 includes a plurality of arms, i.e., flaps 526 formed in the periphery 524, e.g., similar to the flaps 336 shown in FIGS. 8A-8E, but provided on the membrane 330 rather than on the contact lens 520. As best seen in FIG. I4C, the membrane 530 includes a central region 532 surrounded by a periphery 534 and includes a plurality of openings 536 formed in the periphery 534 that are configured for receiving the flaps 336, to assemble the final device 510 shown in FIG. 14 A. Otherwise, the device 510 may be manufactured, assembled, and used similar to the other devices herein. Alternatively, the contact lens may include other arms that may be received in the openings 536, e.g., similar to the arms provided on the membranes described elsewhere herein.

[0094] FIGS. 15A-15D show exemplar}' openings that may be provided in the membrane 530 (or other devices herein), e.g., slots 536a, 536d (FIGS. 15A and 15C) or slits 536b, 536c (FIGS. 15B and 15D) that, optionally, may include stress-relief holes 537c, 537d at the ends (FIGS. 15C and 15D). FIGS. 21A and 21B show an exemplar}7tool, i.e., a steel rule die 80, that may be used to create a sheet of amniotic membrane similar to that shown in FIGS. 15B. As shown, the tool 80 includes a base 82 including an outer blade 84a and a plurality of inner blades 84b that may be used to create a sheet of amniotic membrane 520b from a larger section of amniotic membrane. As shown, the outer blade 84a include a circular blade having a diameter corresponding to the outer edge 521b of the membrane 520b. The inner blades 84b include a plurality of curved blades spaced apart circumferentially relative to one another to create slits 536b in the membrane 520b.Optionally, ends of the inner blades 84a, 84b may include pins or other features (not shown) to create stress-relief holes. Alternatively, the stress relief holes may be created after the cuts (slits or slots) have been completed to the membrane or contact lens.

[0095] The tool 80 may be a manual device or may be incorporated into an automated process for making one or more sheets of amniotic membrane 520b from a larger section. For example, a user may place the blades 84a, 84b against a section of amniotic membrane and apply force, e.g., hammering and the like, to cause the blades 84a, 84b to cut through the amniotic membrane in a single action to create the sheet of amniotic membrane 520b for a single device. Slits 536b (without removing internal material) may be formed at the same time the outer edge 510b is cut. The process may be repeated as desired, or multiple dies 80 may be earned on an automated assembly for creating multiple sheets of amniotic membrane simultaneously, as will be appreciated by those skilled in the art.

[0996] Similarly, as shown in FIGS. 22A and 22B, another tool 80’ may be provided to create one or more sheets of amniotic membrane 520a that includes a base 82’ including an outer blade 84a’ and a plurality of inner blades 84b’ generally similar to tool 80. However, the inner blades 84b’ include curved edges and ends such that internal material is removed to create open slots 526a in the membrane 520a, e.g., as shown in FIG. 22C.

[0097] Alternatively, as shown in FIG. 23 A, a template or mask 90 may be provided that includes a plurality of guides or tracks thereby through, which may be used to cut a section of amniotic membrane to create a sheet of amniotic membrane 520b, e.g., as shown in FIG. 23B. As shown, the template 90 includes an outer guide 94a that may be used to cutouter the membrane 520b, e.g., to provide the outer edge, and a plurality of inner guides 94b may be used to cut openings 526b in the membrane 520b, e.g., manually using a knife (not shown), or through other processes, e.g., automated processes such as laser cutting, waterjet cutting, etching, and the like. The resulting membrane 520b may be included in any of the appropriate devices described elsewhere herein.[00098^ While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary', the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

WE CLAIM:

1. A device for treating an ocular condition, comprising: a contact lens comprising an outer surface, an inner surface, a central region and a periphery surrounding the central region including one or more openings; and a sheet of amniotic membrane positioned against the inner surface and at least partially received in the one or more openings to secure the membrane adjacent the inner surface.

2. The device of claim 1, wherein the one or more openings comprise a plurality of openings spaced apart, from one another around the periphery and wherein the sheet comprises a plurality of features spaced apart from one another, each feature received in a respective opening of the plurality of openings.

3. The device of claim 2, wherein the sheet has a polygonal shape and the plurality of features comprise corners of the polygonal shape, each corner received in a respective opening of the plurality of openings.

4. The device of claim 3, wherein the sheet has a square shape defining four comers and the plurality of openings comprise four openings spaced apart equally around the periphery such that each corner is received in a respective opening of the four openings.

5. The device of claim 2, wherein the sheet comprises a central region and a plurality of arms extending outwardly from the central region, each arm received in a respective opening of the plurality of openings.

6. The device of claim 5, wherein each arm extends through the respective opening such that an outer end of each arm is located adjacent the outer surface of the periphery of the contact lens.

7. The device of claim 5, wherein each arm has a substantially uniform width along a radial length extending from the sheet central region to an outer end of each arm.

8. The device of claim 5, wherein each arm has a varying width along a radial length extending from the sheet central region to an outer end of each arm.

9. The device of claim 8, wherein the width of each arm is narrower adjacent the sheet central region than adjacent the outer end.

10. The device of claim 8, further comprising one or more tabs extending from the outer end of each arm defining a width greater than the width adjacent the sheet central region.

11. The device of claim 5, wherein each arm comprises a pair of tabs on an outer end thereof, the tabs extending away from one another.

12. The device of claim 11, wherein each arm has a width smaller than a width of the respective opening and where the pair of tabs define a width larger than the width of the respective opening.

13. The device of claim 2, wherein the sheet comprises a central region and a plurality of flaps, each flap received in a respective opening of the plurality of openings.

14. The device of claim 13, wherein each flap extends through the respective opening such an outer end of each flap is located adjacent the outer edge of the contact lens.

15. The device of claim 13, wherein each flap has a substantially uniform width along a radial length extending from the sheet central region to an outer end of each flap.

16. The device of claim 13, wherein each flap has a varying width along a radial length extending from the sheet central region to an outer free end of each flap.

17. The device of claim 13, wherein each flap is formed by a pair of notches extending inwardly from an outer edge of the periphery.

18. The device of claim 13, wherein each flap is formed by a pair of T-shaped notches extending inwardly from an outer edge of the periphery, wherein the bottom of the T is cut into an outer edge of the periphery.

19. The device of claim 13, wherein each flap is formed in the periphery such that the flap is offset radially inwardly from an outer edge of the periphery'.

20. The device of claim 19, wherein each flap is formed by one or more slits or slots formed in the peripheral region of the sheet such that the flap has a free end that is received through the respective opening of the contact lens.

21. The devi ce of any one of claims 1-20, wherein each opening comprises a slit formed in the peripheral region of the contact lens, through its thickness.

22. The device of claim 21, wherein each slit comprises stress relief features on opposite ends of the slit.

23. The device of any one of claims 1 -20, wherein each opening comprises a slot formed by removing material from the peripheral region of the contact lens.

24. The device of claim 23, wherein each slot comprises stress relief features on opposite ends of the slot.

25. The device of claim 23, wherein each slot defines opposing side edges extending between opposite ends of the slot that, are spaced apart from another by a uniform distance.

26. The device of any' one of claims 1-20, wherein the sheet of amniotic membrane has a substantially uniform thickness.

27. The device of any one of claims 1-20, wherein the sheet of amniotic membrane comprises an avascular layer of fetal membranes.

28. The device of any one of claims 1 -20, wherein the sheet of amniotic membrane comprises epithelium, basement membrane and stroma.

29. The device of any one of claims 2-20, wherein the contact lens includes between two and sixteen openings.

30. The device of any one of claims 2-20, wherein the contact lens includes between two and nine openings.31 . The device of any one of claims 2-20, wherein the contact lens includes between three and five openings.

32. The device of any one of claims 2-20, wherein each of the openings extends partially around a circumference of the periphery.

33. The device of claim 32, wherein each of the openings is one of circular, straight, arcuate, curvilinear, sawtooth, wavy, curved, or star shaped.

34. The device of any one of claims 2-20, wherein each of the openings is one of a circular, elliptical, or polygonal hole through the periphery.

35. The device of any one of claims 1-20, further comprising one or more openings in the central region of the contact lens that frictional ly receive one of more features of the membrane.

36. The device of any one of claims 1-20, wherein the sheet has an outer diameter smaller than an outer diameter of the contact lens.

37. The device of any one of claims 1-20, wherein the contact lens has an outer diameter smaller than an outer diameter of the sheet.

38. The device of any one of claims 1 -20, wherein the contact lens is formed from substantially rigid material.

39. The device of claim 38, wherein the material comprises one or more of polymethyl methacrylate (PMMA), polycarbonate (PC), fluorosilicone acrylate, and siloxane acrylate.

40. The device of any one of claims 1-20, wherein the contact lens is formed from flexible material.

41. The device of claim 40, wherein the material comprises one or more of omafilcon, etafilcon, ocufilcon, 2-Hydroxyethyl methacrylate (HEM A), methacrylic acid (MAA), polyvinylpyrrolidone (PVT), N-vinyl pyrrolidone (NVP), phosphorylcholine (PC), N,N-dimethylaciyl amide (DMA), and siloxane.

42. The device of any one of claims 1 -20, wherein the contact lens has a hybrid construction with a central region having a different material from the periphery.

43. The device of claim 42, wherein the central region is substantially rigid and the periphery is flexible.

44. The device of claim 42, wherein the central region is flexible and the periphery is substantially rigid.

45. The device of any one of claims 1 -20, wherein the periphery of the contact lens has a thickness greater than the central region.

46. The device of claim 45, wherein the sheet is received against the inner surface of the central region without, extending over the inner surface of the periphery / .

47. A device for treating an ocular condition, comprising: a contact, lens comprising an outer surface, an inner surface, and a central region including one or more openings; anda sheet of amniotic membrane positioned against the inner surface and at least partially received in the one or more openings to secure the membrane adjacent the inner surface.

48. The device of claim 47, wherein the one or more openings comprise an opening in a center of the central region.

49. The device of claim 47 or 48, wherein the one or more openings comprise a plurality of openings spaced apart from one another around the central region.

50. The device of claim 47 or 48, wherein the contact lens comprises a periphery surrounding the central region, the periphery comprising one or more additional openings for receiving one or more features of the membrane.51 . A device for treating an ocular condition, comprising: a contact lens comprising an outer surface, an inner surface, a central region and a peripheral region surrounding the central region; a sheet of amniotic membrane positioned against the inner surface, and a plurality of features on one or both of the peripheral region of the contact lens and the sheet to secure the membrane adjacent the inner surface.

52. The device of claim 51, wherein the plurality of features comprises a plurality of openings spaced apart, from one another around the periphery and a plurality of features spaced apart from one another around the sheet, each feature received in a respective opening of the plurality of openings.

53. The device of claim 52, wherein the sheet comprises a central region and a plurality of arms extending outwardly from the central region, each arm received in a respective opening of the plurality of openings.

54. The device of any one of claims 51-53, wherein the plurality of features comprises one or more central openings in the central region and one or more corresponding features on the sheet that are received in the one or more central openings.~ n -55. The device of claim 517, wherein the plurality of features comprises a plurality of openings on the membrane and one or more features on the contact lens received in the plurality of openings to secure the membrane adjacent the inner surface.

56. The device of claim 55, wherein the one or more features comprise an outer edge of the contact lens.

57. The device of claim 55, wherein the one or more features comprise a plurality of features extending radially outwardly from the contact lens, the features received in respective openings to secure the membrane adjacent the inner surface.

58. A device for treating an ocular condition, comprising: a contact lens comprising an outer surface, an inner surface, a central region and one or more features on the central region; and a sheet of amniotic membrane positioned against the inner surface and including a plurality of openings, the one or more features at least partially received in respective openings to secure the membrane adjacent the inner surface.

59. The device of claim 58, wherein the one or more features comprise an outer edge of the contact lens.

60. The device of claim 58, wherein the plurality of openings comprises slots or slits.

61. A method for making a device for treating an ocular condition, comprising: forming a contact lens comprising an outer surface, an inner surface, a central region and a periphery surrounding the central region; forming a sheet of amniotic membrane; and securing the sheet of amniotic membrane adjacent the inner surface.

62. The method of claim 61, wherein the contact lens comprises one or more openings in the periphery and wherein securing the sheet comprises at least partially receiving the sheet in the one or more openings.

63. The method of claim 61, wherein the contact lens comprises a plurality of openings spaced apart from one another around the periphery' and wherein securing the sheet comprises receiving features of the sheet in the openings.

64. The method of claim 63, wherein the features comprise one or more edges or comers of the sheet received in the openings.

65. The method of claim 63, wherein the features comprise a plurality of arms extending radially from the sheet and received in the openings.

66. A method for treating an ocular condition, comprising: providing a device including a contact lens comprising an outer surface, an inner surface, and a sheet of amniotic membrane positioned against the inner surface; and placing the amniotic membrane against a surface of an eye such that the contact lens centers and / or stabilizes the amniotic membrane against the cornea and / or sclera to treat an ocular condition.

67. The method of claim 66, wherein providing the device comprises securing the amniotic membrane to the inner surface of the contact lens.

68. The method of claim 67, wherein securing the amniotic membrane comprises receiving one or more features on the amniotic membrane in respective one or more openings in the contact lens.

69. The method of claim 67, wherein the contact lens comprises a plurality' of openings may be spaced apart from one another around a periphery surrounding the central region, and wherein securing the amniotic membrane comprises receiving a plurality of arms, tabs, or other features spaced apart from one another on the sheet in respective openings of the plurality of openings.

70. The method of claim 67, wherein securing the amniotic membrane comprises receiving one or more features on the contact lens in respective one or more openings in the amniotic membrane.71 . A device for treating an ocular condition, comprising: a contact lens comprising an outer surface, an inner surface, a central region and a periphery surrounding the central region including one or more openings, the periphery defining a recess adjacent the inner surface; and a sheet of amniotic membrane positioned against the inner surface such that an outer edge of the sheet is received adjacent the recess to secure the membrane adjacent the inner surface,72. The device of claim 71, wherein the recess has a depth and the sheet has a thickness that is no more than the depth such that the outer edge is seated within the recess and the sheet is positioned against the inner surface.

73. The device of claim 71, further comprising one or more features on one or both of the contact lens and the sheet to secure the membrane adjacent the inner surface.

74. The device of claim 71, further comprising a plurality of features on one or both of the periphery' of the contact lens and the sheet to secure the membrane adjacent the inner surface.

Images