Glaucoma treatment devices and methods

• US 10,736,778 B2
• Filed: 12/30/2015
• Issued: 08/11/2020
• Est. Priority Date: 12/31/2014
• Status: Active Grant

• Current Assignee: Innomedex LLC
• Original Assignee: MicroOptx, Inc.
• Inventors: Brown, J. David
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/540,904
• Publication Number:
  US 20170367888A1
• Time in Patent Office: 1,686 Days
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/28 Materials for coating prostheses

Abstract

Devices can be implanted in an eye to treat glaucoma. The devices described herein include a body defining a lumen and having first and second ends and external and lumenal surfaces. The body has a length sufficient to provide fluid communication between the anterior chamber and tear film of the eye through the lumen when the device is implanted in the sclera. By the strategic selection of particular materials of construction, and/or by controlling the configuration and size of the lumen, in some embodiments, the device is a filterless construct. In some embodiments, a filter is included. The glaucoma treatment devices as provided herein are designed to prevent bacterial ingress and to provide the required level of outflow resistance to achieve a desired intraocular pressure. Methods of treating glaucoma wherein the device is implanted in the sclera of an afflicted eye are also described.

Claims

1. A device for treating glaucoma in an eye, the device comprising:

a body defining a lumen and having first and second ends and external and lumenal surfaces, said body having a length sufficient to provide fluid communication between an anterior chamber and a tear film of the eye through said lumen when said device is implanted in the eye such that;

(i) the first end is in the anterior chamber, (ii) the second end is exterior to the eye, and (iii) a portion of the external surface of the body is in contract with a sclera of the eye,

wherein the lumen is circular and open from the first end to the second end and configured to maintain a desired intraocular pressure without having a porous element inside the lumen,

wherein the portion of the external surface of the body that is in contact with the sclera of the eye while the device is implanted in the eye is chemically etched to provide increased friction with the sclera and includes two pairs of barbs extending in opposite lateral directions from the body,

wherein a portion of the body including the second end is laterally flared and includes a surface shaped to follow an outer contour of the eye, and

wherein the first end is beveled.

2. The device of claim 1, wherein the body includes one or more ribs that extend longitudinally through at least a portion of the lumen, and wherein the one or more ribs define open channels for aqueous humor outflow.

3. The device of claim 1, wherein the lumenal surface of the device comprises a hydrophilic material.

4. The device of claim 3, wherein the hydrophilic material comprises polyethylene glycol.

5. The device of claim 1, wherein the external surface of the device is coated with a hetero-bifunctional crosslinker.

6. The device of claim 5, wherein the hetero-bifunctional crosslinker is 5-azido-2-nitrobenzoic acid N-hydroxysuccinimide.

7. The device of claim 1, further comprising a bolster portion configured to couple with the body, wherein the bolster portion is configured to stabilize the body in relation to the eye when said device is implanted in the eye.

8. The device of claim 1, wherein the laterally flared portion of the body including the second end is laterally wider than the two pairs of barbs.

9. The device of claim 1, wherein the second end is radiused.

10. A method for treating an eye, the method comprising:

implanting a device in the eye, wherein the device comprises;

a body defining a lumen and having first and second ends and external and lumenal surfaces, wherein the lumen is circular and open from the first end to the second end and configured to maintain a desired intraocular pressure without having a porous element inside the lumen, wherein a portion of the external surface of the body is chemically etched to provide increased friction with a sclera of the eye and includes two pairs of barbs extending in opposite lateral directions that engage the sclera to provide migration resistance,

wherein, while the device is implanted in the eye;

(i) the first end is in an anterior chamber of the eye, (ii) the second end is exterior to the eye, (iii) the portion of the external surface of the body is in contract with the sclera, and (iv) aqueous humor flows from the anterior chamber of the eye to a tear film of the eye through the lumen.

11. The method of claim 10, wherein, after implanting the device, the second end protrudes from the eye by a distance in the range from about 50 μ

m to about 1000 μ

m.

12. The method of claim 11, wherein a portion of the body including the second end is laterally extended and a surface of the laterally extended portion is in contact with the eye and follows a contour of the eye while the device is implanted in the eye.

13. The method of claim 10, wherein the aqueous humor flowing from the anterior chamber to the tear film of the eye increases moisture and lubrication of a surface of the eye.

14. The method of claim 10, wherein the first end is beveled, and wherein implanting the device in the eye includes making an incision through the sclera and inserting the beveled first end through the incision.