Bifurcatable trabecular shunt for glaucoma treatment

• US 20020165478A1
• Filed: 05/02/2001
• Published: 11/07/2002
• Est. Priority Date: 05/02/2001
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Gharib, Morteza, Tu, Hosheng, Bergheim, Olav
• Granted Patent: US 6,666,841 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

A trabecular shunt and methods for treating glaucoma are disclosed. The method comprises placing a trabecular shunt through diseased trabecular meshwork, between the anterior chamber and Schlemm'"'"'s canal. The trabecular shunt includes a hollow, elongated tubular element having an inlet section and an outlet section. The outlet section includes two bifurcatable elements adapted to be positioned and stabilized inside Schlemm'"'"'s canal.

Claims

1. A trabecular shunt for transporting aqueous humor in an eye, comprising:

an elongate tubular element having an inlet section and an outlet section;

wherein the outlet section comprises two bifurcatable elements, the bifurcatable elements configured to be positioned within a Schlemm'"'"'s canal of the eye.

2. The shunt of claim 1, wherein the tubular element is hollow.

3. The shunt of claim 1, wherein said shunt is configured to attach to a delivery apparatus.

4. The shunt of claim 1, wherein the a distal end of a first of the two bifurcatable elements is adapted to move away from a distal end of a second of the two bifurcatable elements.

5. The delivery apparatus of claim 3, wherein said delivery apparatus comprises a deployment mechanism for releasing the shunt from the delivery apparatus.

6. The delivery apparatus of claim 4, wherein the deployment mechanism comprises a plunger.

7. The shunt of claim 1, wherein said two bifurcatable elements are attached to said inlet section at a joint.

8. The shunt of claim 7, further comprising a slit in at least one of the bifurcatable elements near the joint.

9. The shunt of claim 1, comprising material selected from the group consisting of polyvinyl alcohol, polyvinyl pyrolidone, collagen, heparinized collagen, polytetrafluoroethylene, expanded polytetrafluoroethylene, fluorinated polymer, fluorinated elastomer, flexible fused silica, polyolefin, polyester, polyimide, polysilison, silicone, polyurethane, Nylon, polypropylene, hydroxyapetite, precious metal, Nitinol, and stainless steel.

10. The shunt of claim 1, comprising biocompatible material.

11. The shunt of claim 1, wherein the outlet section comprises a form selected from the group consisting of a coil, a mesh, a spiral, a fishbone, a porous form, a semi-permeable form, and a continuous solid form.

12. The shunt of claim 1, wherein the outlet section comprises a cross-sectional shape selected from the group consisting of an ellipse, a circle, a semi-circle, and an asymmetric shape.

13. The shunt of claim 12, wherein the asymmetric shape comprises a D-shape.

14. A delivery applicator, a portion of said delivery applicator configured to be placed within a lumen of the elongate tubular element of claim 1, wherein the delivery applicator comprises a mechanism for permitting the two bifurcatable elements of said outlet section to move away from each other.

15. A delivery applicator according to claim 14, wherein the delivery applicator is selected from the group consisting of a guidewire, an expandable basket, and an inflatable balloon.

16. The shunt of claim 1, wherein at least one of said two bifurcatable elements comprises a shape-memory material, the shape-memory material having a preshape and a shape-transition temperature, wherein the shape-memory material conforms to its preshape when the shape-memory material is heated to above the shape-transition temperature.

17. The shunt of claim 16, wherein a longitudinal axis of the preshape of the shape-memory material is at an angle with respect to a longitudinal axis of the inlet section.

18. The shunt of claim 17, wherein the angle is between about 70 degrees and about 110 degrees.

19. The shunt of claim 16, wherein said shape-memory material comprises Nitinol.

20. The shunt of claim 16, wherein the shape-transition temperature of said shape-memory material is between about 39°

C. and about 90°

C.

21. The shunt of claim 16, further comprising an external heat source that is adapted to heat the shape-memory material to above the shape-transition temperature.

22. The shunt of claim 16, wherein said shape-memory material further comprises a biocompatible material selected from the group consisting of silicone, polyurethane, and expanded polytetrafluoroethylene.

23. The shunt of claim 16, wherein said shape-memory material further comprises a material selected from the group consisting of a porous material and an elastomer.

24. The shunt of claim 16, wherein at least one of said two bifurcatable elements further comprises a semi-permeable membrane.

25. The shunt of claim 1, wherein at least one of the two bifurcatable elements has a tapered distal end.

26. The shunt of claim 1, wherein said trabecular shunt comprises a surface coating comprising a material selected from the group consisting of polytetrafluoroethylene, polyimide, hydrogel, heparin, an anti-angiogenic factor, an anti-proliferative factor, and a therapeutic drug.

27. The shunt of claim 1, wherein said trabecular shunt comprises a surface coating comprising a hydrophilic material.

28. The shunt of claim 1, wherein said inlet section further comprises a flow-restricting element for restricting at least one component in blood, wherein said flow-restricting element is a filter comprising a material selected from the group consisting of expanded polytetrafluoroethylene, cellulose, ceramic, glass, Nylon, plastic, and fluorinated hydrocarbon.

29. The shunt of claim 1, wherein said inlet section further comprises a flow-restricting element for restricting at least one component in blood, wherein said flow-restricting element is a filter selected from the group of filter types consisting of hydrophobic filter, hydrophilic filter, membrane filter, microporous filter, and nonwoven filter.

30. The shunt of claim 29, wherein one of said at least one component is selected from the group consisting of platelets, red blood cells, white blood cells, a virus, a bacterium, an antigen, a serum protein, and a toxin.

31. The shunt of claim 1, wherein said inlet section further comprises a pressure sensor for measuring an intraocular pressure of said eye.

32. The shunt of claim 31, wherein the pressure sensor further comprises a transmitter for wirelessly transmitting said intraocular pressure to a receiver located outside said eye.

33. The shunt of claim 31, wherein the transmitter transmits radiofrequency signals.

36. The method of claim 35, the method further comprising transmitting a measured intraocular pressure to a receiver outside of said eye.

38. The method of claim 37, further comprising:

releasing said trabecular shunt from a delivery apparatus into said eye.

39. A method according to claim 38, wherein the delivery apparatus comprises a plunger, the method comprising advancing the plunger to deploy the trabecular shunt from said delivery apparatus.

40. A method according to claim 37, further comprising placing a delivery applicator inside a lumen of the hollow elongated tubular element, wherein the delivery applicator comprises a deployment mechanism for permitting the first bifurcatable element to move away from the second bifurcatable element.

41. A method according to claim 40, comprising advancing a guidewire to place the trabecular shunt inside said eye.

42. A method according to claim 40, wherein the delivery applicator comprises an expandable basket.

43. A method according to claim 40, wherein the delivery applicator comprises an inflatable balloon.

44. A method according to claim 37, further comprising measuring a pressure of an anterior chamber of the eye, wherein said trabecular shunt comprises a pressure sensor for measuring said pressure.

45. A method according to claim 44, further comprising transmitting said pressure to a receiver located outside said eye.

34. A method of placing a trabecular shunt into a trabecular meshwork of an eye, the method comprising:

advancing a trabecular shunt having two distal bifurcatable elements through an opening in said trabecular meshwork.; and

placing the bifurcatable elements in a Schlemm'"'"'s canal of said eye.

35. A method of placing a trabecular shunt into a trabecular meshwork of an eye, the method comprising advancing a trabecular shunt having a pressure sensor through an opening in said trabecular meshwork.

37. A method for inserting a trabecular shunt into an eye of a patient, the method comprising:

creating an opening in a trabecular meshwork of said eye;

inserting the trabecular shunt into the opening, wherein the trabecular shunt comprises an elongate tubular element having an inlet section and an outlet section, and wherein the outlet section comprises a first bifurcatable element and a second bifurcatable element;

positioning the first and second bifurcatable elements inside a Schlemm'"'"'s canal of said eye; and

permitting the first bifurcatable element to move away from the second bifurcatable element.

46. A method for measuring and transmitting intraocular pressure of an eye to an external receiver comprising:

placing a pressure sensor within an anterior chamber of the eye;

measuring a pressure within said anterior chamber with said pressure sensor; and

transmitting said pressure to a receiver located outside said eye.