GLAUCOMA DRAINAGE SHUNTS AND METHODS OF USE

• US 20100114006A1
• Filed: 11/05/2008
• Published: 05/06/2010
• Est. Priority Date: 11/05/2008
• Status: Active Grant

• Current Assignee: Johnson & Johnson Surgical Vision, Inc. (Johnson & Johnson)
• Original Assignee: Advanced Medical Optics Incorporated (Johnson & Johnson)
• Inventors: Baerveldt, George
• Granted Patent: US 8,353,856 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 2009/00891 Glaucoma
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• 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: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: Y10S 623/905 Eye

Abstract

A method of treating glaucoma in an eye utilizing an implanted shunt having an elastomeric plate and a non-valved elastomeric drainage tube. The plate is positioned over a sclera of the eye with an outflow end of the elastomeric drainage tube open to an outer surface of the plate. An inflow end of the drainage tube tunnels through the sclera and cornea to the anterior chamber of the eye. The drainage tube collapses upon initial insertion within an incision in the selera and cornea, or at a kink on the outside of the incision, but has sufficient resiliency to restore its patency over time. The effect is a flow restrictor that regulates outflow from the eye until a scar tissue bleb forms around the plate of the slunt. The plate desirably has a peripheral ridge and a large number of fenestrations, and a longer suturing tab extending from one side of the plate to enhance visibility and accessibility when suturing the shunt to the selera.

Claims

1. A glaucoma drainage device, comprising:

a plate;

an elastomeric drainage tube having an open cross-section, an outflow end of the elastomeric drainage tube connected to a part of the plate and an inflow end extending away from the plate, the drainage tube having an open lumen and a tube wall with a hoop strength;

wherein the inflow end of the drainage tube is configured to be inserted through an incision at or near the limbus of an eye and into the anterior chamber of the eye, the hoop strength of the drainage tube being such that the tube wall assumes a collapsed shape within the incision after insertion therein due to the pressure of the incision walls; and

wherein the resiliency of the drainage tube is such that the tube wall will resiliently expand from its collapsed shape to its open cross-section within the incision after a predetermined time after implant.

2. The glaucoma drainage device of claim 1, wherein the plate has a thickness of between about 0.25 to 3.0 mm.

3. The glaucoma drainage device of claim 1, wherein the plate has a concave inner surface and a convex outer surface and wherein the concave inner surface has a radius of curvature between about 12 mm and about 14 mm, and the surface area of the plate is between about 100 mm² and about 600 mm².

4. The glaucoma drainage device of claim 1, the plate further including a peripheral ridge extending outward from the outer surface around the plate, the peripheral ridge having a thickness that is about 150% to about 200% the thickness of the plate.

5. The glaucoma drainage device of claim 4, the plate further including a plurality of cross-beams extending outward from the outer surface around the plate.

6. The glaucoma drainage device of claim 1, wherein the plate has a concave inner surface and a convex outer surface, and further including a plurality of fenestrations extending therethrough from the inner surface to the outer surface and spaced evenly around the inside the periphery of the plate.

7. The glaucoma drainage device of claim 1, wherein the plate has a generally elliptical shape in plane view, and further including an extension thereof from a long side of the plate that has two holes therein for passage of sutures, the extension having a length from the plate of between about 4 and about 8 mm and the two holes being located on an edge of the extension away from the plate.

8. The glaucoma drainage device of claim 1, wherein the drainage tube has an outside diameter of less than about 0.50 mm and a wall thickness of less than about 0.125 mm.

9. A method of treating glaucoma in an eye utilizing an implanted drainage device, the method comprising the steps of:

providing a glaucoma shunt comprising a plate and an elastomeric drainage tube having an open cross-section, an outflow end of the elastomeric drainage tube connected to a part of the plate and an inflow end extending away from the plate, the drainage tube having an open lumen and a tube wall with a hoop strength;

positioning the glaucoma shunt in the eye with the plate positioned on the sclera posterior to the limbus;

forming an incision at or near the limbus;

inserting the inflow end of the drainage tube through the incision and into the anterior chamber of the eye, the hoop strength of the drainage tube being such that the tube wall assumes a collapsed shape within the incision after insertion therein due to the pressure of the incision walls; and

leaving the glaucoma shunt in place for a sufficient amount of time to permit formation of a scar tissue bleb around the plate,

wherein the resiliency of the drainage tube is such that the tube wall will resiliently expand from its collapsed shape to its open cross-section within the incision after a predetermined time after implant.

10. A method of treating glaucoma in an eye utilizing an implanted drainage device, the method comprising the steps of:

providing a glaucoma shunt comprising a plate and an elastomeric drainage tube having an open cross-section, an outflow end of the elastomeric drainage tube connected to a part of the plate and an inflow end extending away from the plate, the drainage tube having an open lumen and a tube wall with a hoop strength;

positioning the glaucoma shunt in the eye with the plate positioned on the sclera posterior to the limbus;

forming an incision at or near the limbus;

inserting the inflow end of the drainage tube through the incision and the inflow end into the anterior chamber of the eye;

bending the drainage tube to extend along the selera close to the incision to create a kink in the drainage tube as it enters the incision, the kink restricting flow through the open lumen;

leaving the glaucoma shunt in place for a sufficient amount of time to permit formation of a scar tissue bleb around the plate; and

causing removal of the kinking suture to permit the drainage tube to resiliently expand to permit fluid flow therethrough.

11. The method of claim 10, further including securing the drainage tube to the selera with a kinking suture close to the incision to facilitate formation of the kink.

12. The method of claim 10, wherein the drainage tube is inserted into the incision at a bend angle of between about 10 degrees and about 90 degrees.