GLAUCOMA TREATMENT DEVICE

• US 20100010416A1
• Filed: 09/17/2009
• Published: 01/14/2010
• Est. Priority Date: 01/17/2006
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Gifford, Hanson S. III, Deem, Mark E., Juan, Eugene De JR., Boyd, Stephen, Rosenman, Dan
• Granted Patent: US 8,734,378 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 11/00 Methods or devices for treatment of the ears or hearing sense implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/142 Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• 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: A61F 9/0133 Knives or scalpels specially adapted therefor
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 2202/04 Liquids
• 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

Abstract

Methods and devices are adapted for implanting into the eye. An incision is formed in the cornea of the eye and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid passageway. The shunt is passed along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

Claims

1. An ocular implant, comprising:

a substantially straight, rigid, generally cylindrical body of a length no greater than 5 mm, the body having a tip that narrows toward an end, at least one inlet communicating with at least one inner lumen that terminates at one or more outlets, the lumen having a sufficient length to extend from an anterior chamber to a suprachoroidal space of an eye; and

means for regulating fluid flow through the lumen.

2. The implant of claim 1, wherein the tip is sufficiently sharp to pierce eye tissue near the scleral spur of the eye.

3. The implant of claim 2, wherein the tip is sufficiently blunt so as not to substantially penetrate scleral tissue of the eye.

4. The implant of claim 1, wherein the generally cylindrical body includes at least one surface irregularity.

5. The implant of claim 4, wherein the surface irregularity comprises an annular groove

6. The implant of claim 1, wherein the cylindrical body has an outer surface of which at least a portion is porous.

7. The implant of claim 1, wherein the cylindrical body comprises material that includes a drug.

8. The implant of claim 1, wherein the cylindrical body includes a coating which includes a therapeutic agent.

9. The implant of claim 8, wherein the therapeutic agent is selected from the group consisting of:

heparin, TGF-beta, an intraocular pressure-lowering drug, and an anti-proliferative agent.

10. The implant of claim 1, further comprising a biodegradable material in or on the implant.

11. The implant of claim 10, wherein the biodegradable material is selected from the group consisting of poly(lactic acid), polyethylene-vinyl acetate, poly(latic-co-glycolic acid), poly(D,L-lactide), poly(D,L-lactide-co-trimethylene carbonate), collagen, heparinized collagen, poly(caprolactone), poly(glycolic acid), and a copolymer.

12. A method for reducing intraocular pressure in an eye of a mammal, comprising:

introducing an ocular implant into the anterior chamber of the eye, the ocular implant having proximal and distal ends;

cutting eye tissue using a distal portion of the implant at a location posterior of a scleral spur;

advancing the implant from the anterior chamber into the cut eye tissue such that the distal end is located in the suprachoroidal space and the proximal end is located in the anterior chamber; and

conducting aqueous humor between the proximal and distal ends of the implant.

13. The method of claim 12, further comprising transocularly advancing the implant from the site of introduction across the anterior chamber to a location proximate a scleral spur of the eye.

14. The method of claim 12, wherein advancing involves moving the implant having a distal portion that is rigid in at least an axial direction through eye tissue.

15. The method of claim 12, further comprising regulating flow of aqueous humor conducted through the implant.

16. The method of claim 15, wherein regulating flow of aqueous humor comprises varying between at least first and second operational states in which flow through of aqueous humor is more restricted in a first state and less restricted in a second state.

17. The method of claim 12, wherein advancing involves passing a distal end of the implant between scleral tissue and ciliary body tissue to position the distal end in the uveoscleral outflow pathway.

18. The method of claim 17, the distal end of the implant is located in the supraciliary space.

19. The method of claim 17, the distal end of the implant is located in the suprachoroidal space.

20. The method of claim 12, additionally comprising injecting a viscoelastic material through the ciliary muscle attachment.

21. The method of claim 12, additionally comprising introducing an agent into the suprachoroidal space.

22. A method of performing surgery to lower intraocular pressure of an eye, comprising:

providing an opening into an anterior chamber of the eye;

inserting an instrument into the anterior chamber through said opening to perform a cataract extraction from the eye;

providing an ocular implant having an inflow portion in fluid communication with an outflow portion;

transporting the ocular implant from the opening through the anterior chamber of the eye to the anterior chamber angle of the eye;

positioning the ocular implant such that the inflow portion of the ocular implant is positioned in the anterior chamber and the outflow portion of the ocular implant is positioned in the suprachoroidal space; and

permitting aqueous humor to flow from the anterior chamber of the eye through the inflow portion of the ocular implant to the outflow portion of the ocular implant and into the suprachoroidal space of the eye.

23. A method for lowering intraocular pressure in a patient having at least one ocular shunt implanted in the trabecular meshwork to drain aqueous humor from the anterior chamber towards Schlemm'"'"'s canal, comprising:

introducing a drainage device through tissue adjacent the limbus into the anterior chamber;

advancing the drainage device across the anterior chamber to a location near the scleral spur; and

implanting the drainage device in eye tissue at a location spaced from the at least one ocular shunt and the trabecular meshwork to establish a flow path from the anterior chamber towards the suprachoroidal space.

24. An ocular device, comprising:

a substantially straight, tubular body having a predetermined stiffness, the tubular body having a length of 0.2 inches, the body having a tip that is tapered moving along its length in the distal direction, at least one opening for ingress of fluid communicating with at least one internal lumen having a distal end that communicates with at least one or more openings for egress of fluid, the internal lumen having a length sufficient such that fluid can flow from an anterior chamber to a suprachoroidal space; and

means for regulating fluid flow through the lumen.

25. The device of claim 24, wherein the tip is sufficiently sharp to facilitate penetration of the body through eye tissue near the scleral spur of the eye.

26. The device of claim 25, wherein the tip is blunt.

27. The device of claim 24, wherein the tubular body includes at least one surface irregularity.

28. The device of claim 27, wherein the surface irregularity comprises a groove.

29. The device of claim 24, wherein at least a portion of the tubular body comprises a porous material.

30. The device of claim 24, wherein the tubular body comprises material that includes a drug.

31. The device of claim 24, wherein the tubular body includes a coating that includes a therapeutic agent.

32. The device of claim 31, wherein the therapeutic agent is selected from the group consisting of:

an anticoagulant, an antiglaucomatous agent, and an antiproliferative agent.

33. The device of claim 24, further comprising a biodegradable material in or on the device.

34. The device of claim 33, wherein the biodegradable material is selected from the group consisting of poly(lactic acid), polyglycolic acid, polylactic glycolic acid, collagen, non-inflammatory collagen, poly(caprolactone), polyester, homopolymer, and a copolymer.

35. A method for reducing intraocular pressure in an eye, comprising:

introducing an ocular device into the anterior chamber of the eye, the ocular device having proximal and distal ends;

cutting eye tissue using a distal end of the ocular device at a location posterior of the scleral spur;

advancing the ocular device from the anterior chamber through the cut eye tissue such that the proximal end is located in the anterior chamber; and

flowing aqueous humor between the proximal and distal ends of the ocular device.

36. The method of claim 35, further comprising advancing the ocular device from a site of introduction across the anterior chamber to a location proximate a scleral spur of the eye.

37. The method of claim 35, wherein the ocular device has a distal portion that is rigid in at least an axial direction, and wherein advancing includes moving the distal portion through eye tissue.

38. The method of claim 35, further comprising regulating flow of aqueous humor through the ocular device.

39. The method of claim 38, wherein regulating flow of aqueous humor comprises varying a state of the ocular device between a first state of less restricted flow and a second state of more restricted flow.

40. The method of claim 35, wherein advancing involves passing the distal end of the ocular device between scleral tissue and the ciliary body tissue to position the distal end in communication with a uveoscleral outflow route.

41. The method of claim 35, wherein the distal end of the ocular device is located in the supraciliary space.

42. The method of claim 35, wherein the distal end of the implant is located in the suprachoroidal space.

43. The method of claim 35, additionally comprising injecting a viscoelastic material through the ciliary muscle attachment.

44. The method of claim 35, additionally comprising introducing a liquid into the suprachoroidal space.

45. A method of treating glaucoma, comprising:

creating an incision in the cornea through to the anterior chamber;

removing a cataract through the incision;

deploying an ocular shunt having an inflow port in a proximal end in fluid communication with an outflow port in a distal end;

advancing the ocular shunt from the incision through the anterior chamber of the eye toward an anterior chamber angle of the eye;

positioning the ocular implant such that the inflow port in the proximal end is positioned in the anterior chamber and the outflow port in the distal end is positioned in the suprachoroidal space; and

permitting flow of aqueous humor from the anterior chamber of the eye through the inflow port of the ocular shunt to the outflow port of the ocular shunt and into the suprachoroidal space of the eye.

46. A method for reducing intraocular pressure, comprising:

implanting a first shunt in the trabecular meshwork to drain aqueous humor into Schlemm'"'"'s canal;

introducing a second shunt through eye tissue adjacent the limbus into the anterior chamber;

advancing the second shunt across the anterior chamber to a location near the scleral spur; and

positioning the second shunt into the eye tissue at a location adjacent the first shunt to form a fluid pathway from the anterior chamber toward the suprachoroidal space.