Device for draining aqueous humor in cases of glaucoma

• US 7,811,268 B2
• Filed: 02/15/2006
• Issued: 10/12/2010
• Est. Priority Date: 02/21/2005
• Status: Expired due to Fees

• Current Assignee: Artom SA
• Original Assignee: Artom SA
• Inventors: Maldon Ado Bas, Arturo
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): Chapman; Ginger T
• Application Number:
  US11/354,529
• Publication Number:
  US 20060189916A1
• Time in Patent Office: 1,700 Days
• Field of Search: 604/361, 604/362, 604/294, 604/8, 604/9
• US Class Current: 604/294
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

A device is made up of one piece, or two independent pieces, that can be linked with each other to make a unit. The anterior end of a drainage tube is introduced 2 mm into the anterior chamber of the eye while the rear end of the tube is placed in the scleral lake. A cover is a plane body slight in height and oval or oblong in format that is provided with four parallel cuts that create two girths. The said girths are used to retain the drainage tube below the cover, thus creating a curvature in it to form a concave inner surface and a convex outer surface.

Claims

1. A drainage device for implanting into a sclera of a patient'"'"'s eye to drain aqueous humor from an anterior chamber of the eye into an intrascleral space the device comprising:

a tube having a free anterior end at the anterior chamber of the eye and a free rear end at the intrascleral space; and

a cover having a plurality of cuts forming girths, wherein the tube passes through the girths and is retained between the girths and a lower face of the cover, in a manner that the cover bends around the tube to leave an inner concave surface, whereby, with the tube passing through the girths, the anterior and rear ends of the tube remain free and the cuts in the cover are open to enable circulation of aqueous humor from a lower part to an upper part of the cover.

2. The device, according to claim 1, wherein the cover has a surface within a radius of between 2 mm and 3 mm, a thickness of approximately 0.2 to 0.5 mm and a maximum height of a vault defined between a supporting plane and a highest point of the inner surface of between 0.4 mm and 0.7 mm.

3. The device, according to claim 1, wherein the tube has an outer diameter of between 0.5 mm and 1 mm;

an inner diameter of between 0.3 mm and 0.4 mm and sufficient length to position the anterior end in the anterior chamber of the eye and the rear end having a size which fits within an area covered by a perimeter of the cover, located in the intrascleral space for drainage of the aqueous humor.

4. The device, according to claim 1, wherein the tube has two lateral orifices in a zone next to the rear end, each orifice having a diameter of approximately 0.3 mm.

5. The device, according to claim 1, wherein lateral zones of the cover have a number of orifices suitable for passing sutures.

6. The device, according to claim 1, wherein at least one of said tube and cover is made of at least one non-degradable and biocompatible material.

7. The device according to claim 6, wherein the at least one non-degradable and biocompatible material is selected from the group consisting of silicon, hydroxyethylmetacrylate, and hydrophobic acrylic.

8. The device, according to claim 1, wherein the cover is fixed with four non-reabsorbable suture stitches of polypropylene or polyester fiber suture 9 or 10-0, the scleral flap is replaced with sutures of nylon 9-0, and the conjunctiva is sutured with silk 8-0.

9. The device, according to claim 1, wherein the device is fixed at less than 10 mm from the limbus.

10. A method of treating glaucoma by implanting a drainage device for aqueous humor in a patient'"'"'s eye, the method comprising the steps of:

providing a drainage device comprising a tube having a free anterior end and a free rear end, and a cover having cuts forming girths, wherein the tube passes through the girths and is retained between the girths and a lower face of the cover, in a manner that the cover bends around the tube to leave an inner concave surface, whereby, with the tube passing through the girths, the anterior and rear ends of the tube remain free and the cuts in the cover are open to enable circulation of aqueous humor from a lower part to an upper part of the cover;

making a fornix-based conjunctival incision, and a limbus-based laminar scleral flap;

inserting the cover with the tube into a sclera of the eye in a manner that the free end of the tube is placed into an anterior chamber of the eye and the free rear end into the sclera of the eye, ending into an intrascleral space,

suturing the cover to the sclera, and

closing and suturing the scleral flap.

11. The method of claim 10, wherein the step of making comprises making a 7 mm fornix-based conjunctival incision, and a limbus-based laminar scleral flap of about 6 mm by 8 mm and 350 micras in depth.

12. The method of claim 10, further comprising the step of making a paracentesis in front of Schwalbe'"'"'s line, through which the device is introduced.

13. The method of claim 12, further comprising the step of taking a length of 2 mm of the free anterior end of the tube and introducing the end, parallel to the iris, into the anterior chamber of the eye while the cover, that is displaced and covering the free rear end of the tube, is situated next to a limbus of the eye and fixed with sutures, and replacing and suturing the scleral flap.

14. The method of claim 13, further comprising the step of performing a cyclodialysis, introducing 2 mm of the free anterior end of the tube into an uveoscleral space, and 2 mm into the anterior chamber of the eye, parallel to the iris.

15. The method of claim 10, wherein the step of making comprises making a 1.5 mm vertical incision, extending it to the supraciliary space, 2 mm from a limbus of the eye.