# US 2019/0167476 A1 · Method and device for treating and managing diseased ocular tissue

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- Number: US 2019/0167476 A1
- Document ID: US20190167476A1
- Status: Published application
- Kind: A1
- Application number: 16/273,711
- Filed: 2019-02-12
- Published: 2019-06-06
- Earliest claimed: 2017-10-02
- Inventors: Sara Heikali; Moossa Heikali
- Web page: https://patentgrep.com/patent/US20190167476A1

## CPC

- A61F 9/007: Methods or devices for eye surgery
- A61F 9/00736: {Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments (A61F9/008 takes precedence)}
- A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 9/0051: {Ocular inserts or implants}
- A61F 9/0017: {implantable in, or in contact with, the eye, e.g. ocular inserts}
- A61F 9/00781: {Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment (drainage implants in general A61M27/002)}
- A61F 2210/0004: bioabsorbable
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2250/0031: made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61L 2430/16: for reconstruction of eye parts, e.g. intraocular lens, cornea
- 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 (dental prosthetics A61C)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A method of treating and managing diseased ocular tissue in the bulbar conjunctiva comprises providing a device comprising a plurality of microneedles arranged on a substrate contacting the device with a diseased ocular tissue region formed in the bulbar conjunctiva stroma to form a plurality of micro-injury sites therein. A device comprises a contact lens substrate comprising a substantially elliptical corneal portion and a limbus portion located radially about the corneal portion. A scleral portion is located radially about the substrate. The device is at least partially degradable and comprises a therapeutic compound. At least a portion of the scleral portion is configured to overlay, and deliver the therapeutic compound to, a diseased ocular tissue located adjacent to the cornea of a patient.

## Claims

### Claim 1

A method of treating and managing diseased ocular tissue in the bulbar conjunctiva comprising:
providing a device comprising a plurality of microneedles arranged on a substrate; and
contacting the device with a diseased ocular tissue region formed in the bulbar conjunctival stroma to form a plurality of micro-injury sites within the diseased bulbar conjunctival stroma, and cause release of growth factors and formation of new collagen fibrils.

### Claim 2 (depends on 1)

The method of claim 1, comprising contacting the microneedles with the vasculature located in the bulbar conjunctival stroma to initiate bleeding and release of growth factors.

### Claim 3 (depends on 1)

The method of claim 1, comprising contacting the microneedles in bulbar conjunctival stroma to cause formation of aligned collagen and elastin fibrils.

### Claim 4 (depends on 1)

The method of claim 1, comprising penetrating the microneedles into the bulbar conjunctival stroma without penetrating through the scleral tissue located below the bulbar conjunctiva.

### Claim 5 (depends on 1)

The method of claim 1, wherein the diseased ocular tissue region comprises a pinguecula or pterygium.

### Claim 6 (depends on 1)

The method of claim 1, further comprising the step of determining the dimensions of the diseased ocular tissue region and determining the arrangement and dimensions of the microneedles based on the diseased tissue dimensions.

### Claim 7 (depends on 1)

The method of claim 1, wherein the device microneedles are arranged and dimensioned to penetrate a curved surface on the diseased tissue around the cornea as substantially the same depth.

### Claim 8 (depends on 1)

The method of claim 1, wherein the microneedles are degradable and comprise a therapeutic compound.

### Claim 9

A method of treating and managing diseased ocular tissue in the bulbar conjunctiva comprising:
providing a device comprising:
a contact lens substrate comprising:
a substantially elliptical corneal portion;
a limbus portion located radially about the corneal portion; and
a scleral portion located radially about the substrate;
wherein the device is at least partially degradable and comprises a therapeutic compound, and wherein at least a portion of the scleral portion is configured to overlay, and deliver the therapeutic compound to, a diseased ocular tissue located adjacent to the cornea of a patient; and
contacting the device with the diseased ocular tissue.

### Claim 10 (depends on 9)

The method of claim 9, wherein the scleral portion of the device is at least partially degradable.

### Claim 11 (depends on 9)

The method of claim 9, wherein the scleral portion of the device comprises at least one lateral extension portion configured to overlay a Pinguecula located on the nasal or temporal bulbar conjunctiva.

### Claim 12 (depends on 9)

The method of claim 9, wherein the scleral portion of the device comprises at least one vertical extension portion configured to contact the interior eyelid wall.

### Claim 13 (depends on 9)

The method of claim 9, the contact lens substrate comprises an optical material and is configured to correct a patient's visual acuity.

### Claim 14 (depends on 9)

The method of claim 9, wherein the device has a top side opposite an underside, and at least one degradable layer of a therapeutic compound on the top side or underside of the device.

### Claim 15 (depends on 9)

Method of claim 9, wherein the contact lens substrate comprises an open central pupil portion, the corneal portion comprises a colored portion, and wherein both the substrate and scleral portions comprise a therapeutic compound and are degradable.

### Claim 16

A method of treating and managing diseased ocular tissue comprising:
providing a device comprising a plurality of microneedles arranged on a substrate; and
contacting the device with a diseased ocular tissue to form a plurality of micro-injury sites within the diseased tissue, and cause release of growth factors and formation of new collagen fibrils.
