Intraocular implants and methods and kits therefor

• US 9,370,443 B2
• Filed: 02/10/2011
• Issued: 06/21/2016
• Est. Priority Date: 06/26/2006
• Status: Active Grant

• Current Assignee: Sight Sciences, Inc.
• Original Assignee: Sight Sciences, Inc.
• Inventors: Badawi, David Y., Badawi, Paul
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/025,112
• Publication Number:
  US 20110130831A1
• Time in Patent Office: 1,958 Days
• Field of Search: 604/8, 604/9, 604/264, 623/23.64, 623/23.7
• US Class Current: 1/1
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

Devices, methods and kits are described for reducing intraocular pressure. The devices include a support that is implantable within Schlemm'"'"'s canal and maintains the patency of the canal without substantially interfering with transmural fluid flow across the canal. The devices utilize the natural drainage process of the eye and can be implanted with minimal trauma to the eye. Kits include a support and an introducer for implanting the support within Schlemm'"'"'s canal. Methods include implanting a support within Schlemm'"'"'s canal, wherein the support is capable of maintaining the patency of the canal without substantial interference with transmural fluid flow across the canal.

Claims

1. A device for reducing intraocular pressure in an eye having a Schlemm'"'"'s canal and a trabecular meshwork, comprising:

a support implantable circumferentially within Schlemm'"'"'s canal and configured to maintain the patency of at least a portion thereof, wherein the support comprises an arcuate member, wherein at least a portion of the arcuate member has a radius of curvature smaller than the radius of curvature of Schlemm'"'"'s canal so that at least a portion of the arcuate member is configured to extend out of Schlemm'"'"'s canal and into the trabecular meshwork and wherein the support does not substantially interfere with transmural flow across Schlemm'"'"'s canal, and wherein when the support is disposed within a cylindrical section of the lumen of the canal having an internal wall surface area C, the support contacts less than 30% of C.

2. The device of claim 1 wherein the support comprises an active agent.

3. The device of claim 2 wherein the support is coated or impregnated with the active agent.

4. The device of claim 2 wherein the active agent is dispersed within the support.

5. The device of claim 2 wherein the active agent is selected from the group consisting of prostaglandins, prostaglandin analogs, beta blockers, alpha-2 agonists, calcium channel blockers, carbonic anhydrase inhibitors, growth factors, anti-metabolites, chemotherapeutic agents, steroids, antagonists of growth factors, and combinations thereof.

6. The device of claim 2 wherein the active agent is capable of release using electromagnetic radiation.

7. The device of claim 2 wherein release of the active agent is controllable using a time release system.

8. The device of claim 1 wherein the support has at least one fenestration.

9. The device of claim 1 wherein the shape of the support is capable of alteration using electromagnetic radiation.

10. The device of claim 9 wherein the electromagnetic radiation comprises a laser having a wavelength absorbable by at least one localized portion of the support.

11. The device of claim 1 wherein the support has a circumference equal to about half or less than half of the circumference of Schlemm'"'"'s canal.

12. The device of claim 1 wherein the support has a circumference equal to about a quarter or less than a quarter of the circumference of Schlemm'"'"'s canal.

13. The device of claim 1 wherein at least a portion of the support is made from a biocompatible polymer.

14. The device of claim 13 wherein the biocompatible polymer is selected from the group consisting of acrylics and silicones.

15. The device of claim 13 wherein the biocompatible polymer comprises a biodegradable polymer.

16. The device of claim 15 wherein the biodegradable polymer is selected from the group consisting of collagen, a collagen derivative, a poly(lactide);

a poly(glycolide);

a poly(lactide-co-glycolide);

a poly(lactic acid);

a poly(glycolic acid);

a poly(lactic acid-co-glycolic acid);

a poly(lactide)/poly(ethylene glycol) copolymer;

a poly(glycolide)/poly(ethylene glycol) copolymer;

a poly(lactide-co-glycolide)/poly(ethylene glycol) copolymer;

a poly(lactic acid)/poly(ethylene glycol) copolymer;

a poly(glycolic acid)/poly(ethylene glycol) copolymer;

a poly(lactic acid-co-glycolic acid)/poly(ethylene glycol) copolymer;

a poly(caprolactone);

poly(caprolactone)/poly(ethylene glycol) copolymer;

a poly(orthoester);

a poly(phosphazene);

a poly(hydroxybutyrate) or a copolymer including a poly(hydroxybutyrate);

a poly(lactide-co-caprolactone);

a polycarbonate;

a poly(esteramide);

a polyanhydride;

a poly(dioxanone);

a poly(alkylene alkylate);

a copolymer of polyethylene glycol and a polyorthoester;

a biodegradable polyurethane;

a poly(amino acid);

a polyetherester;

a polyacetal;

a polycyanoacrylate;

a poly(oxyethylene)/poly(oxypropylene) copolymer; and

blends and copolymers thereof.

17. The device of claim 13 wherein at least a portion of the support is made from polymethylmethacrylate.

18. The device of claim 1 wherein the support is capable of visual enhancement using fluorescence or phosphorescence emission.

19. The device of claim 18 wherein the support comprises a chromophore that fluoresces or phosphoresces upon excitation with a light source.

20. The device of claim 18 wherein the emitted fluorescence or phosphorescence is in the wavelength range of about 300 nm to about 800 nm.

21. The device of claim 1 wherein at least a portion of the support is made from a shape memory material.

22. The device of claim 21 wherein the shape memory material comprises a shape memory polymer.

23. The device of claim 21 wherein the shape memory material comprises a shape memory alloy.

24. The device of claim 23 wherein the shape memory alloy comprises a nickel titanium alloy.

25. The device of claim 21 wherein the support has a compressed state prior to and during implantation and an expanded state following implantation.

26. The device of claim 1 wherein at least a portion of the support is made from a hydrogel.

27. The device of claim 1 wherein at least a portion of the support is made from a biocompatible metal.

28. The device of claim 27 wherein the metal is gold.

29. The device of claim 1 wherein the support comprises at least two adjacent beads.

30. The device of claim 29 wherein the at least two adjacent beads are of different sizes.

31. The device of claim 29 wherein the at least two adjacent beads are of different shapes.

32. The device of claim 29 wherein the shapes of the at least two adjacent beads are independently selected from the group consisting of a sphere, a spheroid, an ovoid, a cylinder, a cuboid, a cube, a cone, a discoid, a coil, and combinations and segments thereof.

33. The device of claim 29 further comprising a connector linking the at least two adjacent beads.

34. The device of claim 33 wherein the connector is flexible.

35. The device of claim 33 further comprising at least three adjacent beads, wherein each bead is linked to its adjacent bead by a connector.

36. The device of claim 35 wherein each connector has a different length.

37. The device of claim 33 wherein the connector comprises the same material as the beads.

38. The device of claim 33 wherein the connector comprises a different material than the beads.

39. The device of claim 33 wherein the connector is also a spacer configured to provide a space between adjacent beads.

40. The device of claim 1 wherein the support comprises at least two discs separated by, and connected with, a connector.

41. The device of claim 40 wherein at least one of the discs has at least one fenestration.

42. The device of claim 1 wherein the support is configured to contact a wall of Schlemm'"'"'s canal at least at two points.

43. The device of claim 42 wherein the support is configured to contact a wall of Schlemm'"'"'s canal at least at three points.

44. The device of claim 1 wherein the support is solid.

45. The device of claim 1 wherein at least a portion of the support is hollow.

46. The device of claim 1 wherein at least a portion of the support is porous.

47. The device of claim 1 wherein at least a portion of the support is made of a mesh.

48. The device of claim 1 wherein the support comprises one or more rod-like members.

49. The device of claim 1 wherein the support is capable of being attached to tissue.

50. The device of claim 1 wherein the support contacts less than 10% of C.

51. The device of claim 1 wherein the support contacts less than 1% of C.

52. The device of claim 1 wherein the support is flexible.

53. The device of claim 1 wherein the support is rigid.

54. The device of claim 1 wherein the support has a cross-sectional diameter of about 50 microns to about 500 microns.

55. The device of claim 1 wherein the support has a cross-sectional diameter of about 190 microns to about 370 microns.

56. The device of claim 1 wherein the support does not substantially interfere with longitudinal flow along Schlemm'"'"'s canal.

57. The device of claim 1 wherein the support does not substantially interfere with transmural flow into and out of Schlemm'"'"'s canal.

58. A kit for reducing intraocular pressure in an eye having a Schlemm'"'"'s canal and a trabecular meshwork comprising:

a support implantable circumferentially within Schlemm'"'"'s canal and configured to maintain the patency of at least a portion thereof, wherein the support comprises an arcuate member, wherein at least a portion of the arcuate member has a radius of curvature smaller than the radius of curvature of curvature of Schlemm'"'"'s canal so that at least a portion of the arcuate member is configured to extend out of Schlemm'"'"'s canal and into the trabecular meshwork and wherein the support does not substantially interfere with transmural flow across Schlemm'"'"'s canal, and wherein when the support is disposed within a cylindrical section of the lumen of the canal having an internal wall surface area C, the support contacts less than 30% of C; and

an introducer for delivering the support.

59. The kit of claim 58 further comprising instructions on using the kit.

60. The kit of claim 58 further comprising an active agent.

61. The kit of claim 58 comprising at least two supports.

62. The kit of claim 61 comprising at least two introducers for delivering the at least two supports.

63. The kit of claim 61 wherein the at least two supports are of different shapes.

64. The kit of claim 61 wherein the at least two supports are of different sizes.

65. The kit of claim 61 wherein the at least two supports comprise different materials.

66. The kit of claim 61 wherein the at least two supports are connected together.

67. The kit of claim 58 further comprising a fixation device for attaching the support to tissue.

68. The kit of claim 58 further comprising a system for visually enhancing the support.

69. The kit of claim 58 further comprising a positioning device for positioning the support.

70. The kit of claim 58 wherein the support is preloaded into the introducer.

71. The kit of claim 58 wherein the introducer comprises a pusher.