Glaucoma implant device

• US 7,837,644 B2
• Filed: 11/21/2006
• Issued: 11/23/2010
• Est. Priority Date: 12/03/2004
• Status: Active Grant

• Current Assignee: InnFocus, Inc. (Santen Pharmaceutical Company Limited)
• Original Assignee: Innfocus, LLC
• Inventors: Pinchuk, Leonard, Fantes, Francisco, Parel, Jean-Marie A.
• Primary Examiner(s): Deak; Leslie R
• Assistant Examiner(s): Wiest; Philip R
• Application Number:
  US11/561,956
• Publication Number:
  US 20070118066A1
• Time in Patent Office: 1,463 Days
• Field of Search: 604 8- 10, 604/19, 604 27- 30, 604/48, 604/264, 604/93.01, 604/94.01, 128/898, 600/561, 600/573, 600/579, 606/6, 606/100, 606/108
• US Class Current: 604/8
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

An aqueous humor drainage device having an elongate structure that provides a fluid passageway for diverting aqueous humor from the anterior chamber of the eye. The device is formed from a biocompatible soft polymeric material with a hardness less than Shore 80A. Preferably, the polymeric material includes polyisobutylene and a glassy segment. The device preferably includes at least one fixation member that extends from the elongate structure. In one embodiment, the fixation member is realized by a tab that is spaced apart from the two ends of the elongate structure. In another embodiment, the fixation member is realized by a pair of tines that extend in traverse directions relative to the central axis of the elongate structure. The tines are spaced apart for positioning on opposite sides of the sclera of the eye during use.

Claims

1. An aqueous humor drainage device comprising:

an elongate duct structured to provide a fluid passageway for diverting aqueous humor from the anterior chamber of the eye, said elongate duct having a proximal end opposite a distal end, said proximal end operably disposed within the anterior chamber of the eye and said distal end operably disposed posterior to the limbus of the eye for outlet to a drainage bleb that forms adjacent thereto, said elongate duct formed of a polymeric material comprising polyisobutylene and a glassy segment, said polymeric material having a hardness less than Shore 80A, wherein said elongate duct defines a lumen channel having a diameter between 0.002 in and 0.006 in, and wherein said polymeric material resists obstruction of the elongate duct by tissue encapsulation.

2. An aqueous humor drainage device according to claim 1, wherein:

said polymeric material is loaded with at least one therapeutic agent that minimizes fibrosis of ocular tissue.

3. An aqueous humor drainage device according to claim 2, wherein:

said at least one therapeutic agent is selected from the group including an agent containing verteporfin, an agent containing ranibizumab, an agent containing combretastatin, an agent containing tin ethyl etiopurpurin, an agent containing hydrochlorothiazide and telmisartan, an agent that binds or inhibits Vascular Endothelial Growth Factor, an agent containing Taporfin Sodium, an agent carrying the Pigment Epithelium-Derived Factor (PEDF) gene, an agent carrying endostatin and angiostatin, Integrin, an agent containing 2-methoxyestradiol, Anecortave Acetate, an agent that inhibits Angiotensin II, an agent containing isotretinoin, an agent containing PEGylated aptamer, an agent containing Motexafin, lutetium, mitomycin C, 5-fluorouracil, corticosteroids, modified toxins, methotrexate, adriamycin, radionuclides, protein kinase inhibitors, nitric oxide releasing compounds or analogs or functional equivalents thereof, paclitaxel or analogs or functional equivalents, inhibitors of specific enzymes, superoxide dismutase inhibitors, terminal deoxynucleotidyl-transferas, reverse transcriptase, antisense oligonucleotides that suppress cell proliferation, angiogenesis inhibitors, rapamycin, cerivastatin, and flavopiridol and suramin and the like, peptidic or mimetic inhibitors, pericytes, growth factors, homing receptors, extracellular matrix receptors, subfragments of heparin, triazolopyrimidine, lovastatin, and prostaglandins E1 or I2.

4. An aqueous humor drainage device according to claim 1, wherein:

said glassy segment does not contain any cleavable group which will release in the presence of body fluid inside the human eye and cause toxic side effects and cell encapsulation.

5. An aqueous humor drainage device according to claim 1, wherein:

said glassy segment comprises a vinyl aromatic polymer.

6. An aqueous humor drainage device according to claim 5, wherein:

said vinyl aromatic polymer comprises at least one of styrene and α

-methylstyrene.

7. An aqueous humor drainage device according to claim 1, wherein:

said glassy segment comprises a methacrylate polymer.

8. An aqueous humor drainage device according to claim 7, wherein:

said methactylate polymer comprises at least one of methylmethacrylate, ethylmethacrylate, and hydroxymethalcrylate.

9. An aqueous humor drainage device according to claim 1, wherein:

said polymeric material has a general block structure with a central elastomeric polyolefinic block and thermoplastic end blocks.

10. An aqueous humor drainage device according to claim 9, wherein:

said polymeric material comprises a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene.

11. An aqueous humor drainage device according to claim 1, wherein:

said polymeric material has a general block structure selected from one of the following;

a) BAB or ABA,

b) B(AB)n or a(BA)n, and

c) X-(AB)n or X-(BA)n;

where A is an elastomeric polyolefinic block, B is a thermoplastic block, n is a positive whole number and X is a starting seed molecule.

12. An aqueous drainage device according to claim 11, wherein:

said material comprises one of a star-shaped block copolymer (where n=3 or more) and multi-dendrite-shaped block copolymer.

13. An aqueous humor drainage device according to claim 1, wherein:

said elongate duct has an outside diameter less than 0.02 inches.