Fluid infusion methods for glaucoma treatment

• US 7,186,232 B1
• Filed: 03/07/2003
• Issued: 03/06/2007
• Est. Priority Date: 03/07/2002
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukoa Corporation
• Inventors: Tu, Hosheng, Haffner, David, Smedley, Gregory
• Primary Examiner(s): Bianco; Patricia
• Application Number:
  US10/384,912
• Time in Patent Office: 1,460 Days
• Field of Search: 604 8- 10, 604/540, 604/289, 604/294, 604/521, 604264- 6, 604/275, 604/523, 604533- 4, 604/284, 604/541, 600398-399, 128/898, 606107- 8, 606 1- 6, 424422- 8, 424/400, 424/DIG.7, 623/4.1, 623/11.11, 623/23.64, 623 237- 2371, 623 2375- 2376, 623/902, 623/905, 623/1.1, 623/1.13
• US Class Current: 604/8
• CPC Class Codes: A61F 2009/00891 Glaucoma
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00745 using mechanical vibrations, e.g. ultrasonic
• 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: 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
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor

Abstract

The invention relates to methods of treating glaucoma, such as a method that includes inserting a stent through an incision in an eye; the stent having an inflow portion that is in fluid communication with an outflow portion of the stent; transporting the stent from the incision through the anterior chamber of the eye to an aqueous cavity of the eye, such that the inflow portion of the stent is positioned in the anterior chamber and the outflow portion of the stent is positioned at the aqueous cavity; and infusing fluid from the inflow portion to the outflow portion of the stent.

Claims

1. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication through a stent lumen with an outflow portion of the stent;

transporting the stent from the incision through the anterior chamber of the eye to an aqueous cavity of the eye such that the inflow portion of the stent is positioned in the anterior chamber and the outflow portion of the stent is positioned at the aqueous cavity;

providing a delivery element having a delivery lumen;

coupling the delivery element to the stent, such that the stent lumen is coextensive and in fluid communication with the delivery lumen; and

infusing fluid external to the eye through the delivery lumen to the stent lumen, such that fluid flows from the inflow portion to the outflow portion of the stent, and such that the fluid flows into the aqueous cavity;

wherein the aqueous cavity is selected from the group consisting of Schlemm'"'"'s canal, an aqueous collector channel, and an episcleral vein of the eye.

2. The method of claim 1, wherein said infusing of fluid is at a pressure sufficient to cause plastic deformation of at least a portion of the aqueous cavity.

3. The method of claim 2, wherein a temperature of said fluid is raised sufficiently to enhance said plastic deformation.

4. The method of claim 2, wherein a pH of said fluid is adjusted sufficiently to enhance said plastic deformation.

5. The method of claim 1, further comprising positioning the stent such that fluid communicating from the inflow portion to the outflow portion of the stent bypasses the trabecular meshwork of the eye.

6. The method of claim 1, wherein said infusing further comprises injecting said fluid in at least one of a pulsed mode, an intermittent mode, and a programmed mode.

7. The method of claim 1, wherein said fluid is at least one of salt solution or viscoelastic fluid.

8. The method of claim 1, wherein the coupling further comprises coupling the inflow portion of the stent with the delivery element that transmits the fluid to the stent.

9. The method of claim 1, wherein the fluid comprises a therapeutic substance selected from the group consisting of a pharmaceutical, a gene, a growth factor, and an enzyme.

10. The method of claim 1, wherein the fluid comprises a therapeutic substance selected from the group consisting of an antiglaucoma drug, a beta-adrenergic antagonist, a TGF-beta compound, and an antibiotic.

11. The method of claim 1, further comprising closing the incision, leaving the stent in the eye such that the inflow portion of the stent is positioned in the anterior chamber of the eye and the outflow portion of the stent is positioned in the aqueous cavity.

12. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication with an outflow portion of the stent;

transporting the stent from the incision through the anterior chamber of the eye to an aqueous cavity of the eye such that the inflow portion of the stent is positioned in the anterior chamber and the outflow portion of the stent is positioned at the aqueous cavity;

infusing fluid external to the eye from the inflow portion to the outflow portion of the stent, such that the fluid flows into the aqueous cavity;

wherein the infusing further comprises coupling the inflow portion of the stent with a fluid the delivery element that transmits the fluid to the stent; and

wherein the coupling comprises securing a screw thread arrangement of the fluid delivery element with a receiving thread arrangement of the stent.

13. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication through a stent lumen with an outflow portion of the stent;

positioning the stent such that the inflow portion of the stent is positioned in the anterior chamber of the eye and the outflow portion of the stent is positioned at an aqueous cavity;

providing a delivery element having a delivery lumen;

coupling the delivery element to the stent, such that the stent lumen is coextensive and in fluid communication with the delivery lumen; and

infusing fluid through the delivery lumen to the stent lumen, such that fluid flows from the inflow portion to the outflow portion of the stent, and such that the fluid flows into the aqueous cavity;

wherein the aqueous cavity is selected from the group consisting of Schlemm'"'"'s canal, an aqueous collector channel, and an episcleral vein of the eye.

14. The method of claim 13, further comprising positioning the stent such that the fluid communicating from the inflow portion to outflow portion of the stent bypasses the trabecular meshwork of the eye.

15. The method of claim 13, further comprising closing the incision, leaving the stent in the eye such that the inflow portion of the stent is positioned in the anterior chamber of the eye and the outflow portion of the stent is positioned in the aqueous cavity.

16. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication with an outflow portion of the stent;

transporting the stent from the incision through the anterior chamber of the eye to an aqueous cavity of the eye, such that the inflow portion of the stent is positioned in the anterior chamber and the outflow portion of the stent is positioned at the aqueous cavity; and

infusing fluid from the inflow portion to the outflow portion of the stent, the infusing further comprising coupling the inflow portion of the stent with a fluid delivery element that transmits the fluid to the stent, the coupling comprising securing a screw thread arrangement of the fluid delivery element with a receiving thread arrangement of the stent.

17. The method of claim 16, further comprising positioning the stent such that fluid communicating from the inflow portion to the outflow portion of the stent bypasses the trabecular meshwork of the eye.

18. The method of claim 16, wherein said fluid is infused through a lumen of the stent.

19. The method of claim 16, wherein said aqueous cavity is Schlemm'"'"'s canal.

20. The method of claim 16, wherein said aqueous cavity is an aqueous collector channel.

21. The method of claim 16, wherein said infusing further comprises injecting said fluid in at least one of a pulsed mode, an intermittent mode, and a programmed mode.

22. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication through a stent lumen with an outflow portion of the stent;

transporting the stent from the incision through the anterior chamber of the eye to an aqueous cavity of the eye, such that the inflow portion of the stent is positioned in the anterior chamber and the outflow portion of the stent is positioned at the aqueous cavity; and

infusing fluid through a delivery element having a delivery lumen, said delivery lumen being coupled to and in fluid communication with the stent, the fluid flowing from the inflow portion to the outflow portion of the stent into the aqueous cavity, said infusing of fluid being at a pressure sufficient to cause plastic deformation of at least a portion of the aqueous cavity;

wherein the aqueous cavity is selected from the group consisting of Schlemm'"'"'s canal, an aqueous collector channel, and an episcleral vein of the eye.

23. The method of claim 22, wherein a temperature of said fluid is raised sufficiently to enhance said plastic deformation.

24. The method of claim 22, wherein a pH of said fluid is adjusted sufficiently to enhance said plastic deformation.

25. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication with an outflow portion of the stent;

positioning the stent such that the inflow portion of the stent is positioned in the anterior chamber of the eye and the outflow portion of the stent is positioned in Schlemm'"'"'s canal of the eye; and

applying pressure to a fluid such that the fluid flows through a delivery element having a lumen, said lumen being coupled to and in fluid communication with the stent, such that the fluid flows from the inflow portion to the outflow portion of the stent and into Schlemm'"'"'s canal.

26. The method of claim 25, wherein the fluid is other than aqueous humor.

27. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication with an outflow portion of the stent;

positioning the stent such that the inflow portion of the stent is positioned in the anterior chamber of the eye and the outflow portion of the stent is positioned in Schlemm'"'"'s canal of the eye; and

infusing fluid through a delivery element having a lumen, said lumen being coupled to and in fluid communication with the stent, the fluid flowing from the inflow portion to the outflow portion of the stent such that the fluid flows into Schlemm'"'"'s canal.

28. A method of treating glaucoma, comprising:

providing an implant that is positioned in a patients'"'"' eye, the implant having an inflow portion that is in fluid communication with an outflow portion of the implant;

wherein the inflow portion of the implant is positioned in the anterior chamber of the eye and the outflow portion of the stent is positioned in Schlemm'"'"'s canal of the eye; and

infusing fluid through a delivery element having a lumen, said lumen being coupled to and in fluid communication with the implant, the fluid flowing from the inflow portion to the outflow portion of the implant, such that the fluid flows into Schlemm'"'"'s canal.

29. A method of treating glaucoma, comprising:

providing an implant having an inflow portion that is in fluid communication with an outflow portion of the implant;

inserting the implant through an incision in an eye;

positioning the implant such that the inflow portion of the implant is positioned in the anterior chamber of the eye and the outflow portion of the implant is positioned in Schlemm'"'"'s canal of the eye;

providing a delivery element having a lumen;

positioning an end of the delivery element in Schlemm'"'"'s canal such that the lumen in the delivery element extends into Schlemm'"'"'s canal; and

applying pressure to a fluid contained in the lumen in the delivery element, such that the fluid flows through the lumen in the delivery element, and such that the fluid flows into Schlemm'"'"'s canal.

30. The method of claim 29, wherein the delivery element comprises the implant.

31. The method of claim 29, wherein said positioning of the end of the delivery element further comprises:

inserting the delivery element through the incision in the eye;

transporting the delivery element from the incision through the anterior chamber of the eye to Schlemm'"'"'s canal of the eye.

32. A method of treating glaucoma, comprising:

providing an eye that has an implant positioned in the eye, the implant having an inflow portion that is in fluid communication with an outflow portion of the implant, the implant positioned such that the inflow portion of the implant is positioned in the anterior chamber of the eye and the outflow portion of the implant is positioned in Schlemm'"'"'s canal of the eye;

providing a delivery element having a lumen;

positioning an end of the delivery element in Schlemm'"'"'s canal such that the lumen in the delivery element extends into Schlemm'"'"'s canal; and

applying pressure to a fluid contained in the lumen in the delivery element, such that the fluid flows through the lumen in the delivery element, and such that the fluid flows into Schlemm'"'"'s canal.

33. The method of claim 32, wherein the delivery element comprises the implant.

34. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication through a stent lumen with an outflow portion of the stent;

transporting the stent from the incision through the anterior chamber of the eye to an aqueous cavity of the eye, such that the inflow portion of the stent is positioned in the anterior chamber and the outflow portion of the stent is positioned at Schlemm'"'"'s canal of the eye;

providing a delivery element having a delivery lumen;

coupling the delivery element to the stent, such that the stent lumen is coextensive and in fluid communication with the delivery lumen; and

infusing fluid external to the eye through the delivery lumen to the stent lumen, such that fluid flows from the inflow portion to the outflow portion of the stent, and such that the fluid flows into Schlemm'"'"'s canal.

35. A method of treating glaucoma, comprising:

inserting an implant through an incision in an eye;

the implant having an inflow portion that is in fluid communication, through an implant lumen, with an outflow portion of the implant;

transporting the implant from the incision through the anterior chamber of the eye to an aqueous cavity of the eye, such that the inflow portion of the implant is positioned in the anterior chamber and the outflow portion of the implant is positioned at the aqueous cavity;

providing a delivery element having a delivery lumen;

coupling the delivery element to the implant, such that the implant lumen is in fluid communication with the delivery lumen; and

infusing fluid through the delivery lumen and through the inflow portion of the implant to the implant lumen, such that fluid flows through a fluid path that is sealed along some of its length from aqueous humor, and such that the fluid flows into the aqueous cavity;

wherein the aqueous cavity is selected from the group consisting of Schlemm'"'"'s canal, an aqueous collector channel, and an episcleral vein of the eye.

36. The method of claim 35, wherein the implant lumen is at an end of the fluid pathway.

37. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication through a stent lumen with an outflow portion of the stent;

transporting the stent from the incision through the anterior chamber of the eye to an aqueous cavity of the eye, such that the inflow portion of the stent is positioned in the anterior chamber and the outflow portion of the stent is positioned at the aqueous cavity;

providing a delivery element having a delivery lumen;

coupling the delivery element to the stent, such that the stent lumen is confluent with the delivery lumen; and

infusing fluid external to the eye through the delivery lumen to the stent lumen, such that fluid flows from the inflow portion to the outflow portion of the stent, and such that the fluid flows into the aqueous cavity;

wherein the aqueous cavity is selected from the group consisting of Schlemm'"'"'s canal, an aqueous collector channel, and an episcleral vein of the eye.

38. The method of claim 37, further comprising positioning the stent such that fluid communicating from the inflow portion to the outflow portion of the stent bypasses the trabecular meshwork of the eye.

39. The method of claim 37, wherein said aqueous cavity is Schlemm'"'"'s canal.

40. The method of claim 37, wherein said aqueous cavity is an aqeous collector channel.

41. The method of claim 37, wherein said infusing of fluid is at a pressure sufficient to cause plastic deformation of at least a portion of the aqueous cavity.

42. The method of claim 37, wherein said fluid is at least one of salt solution or viscoelastic fluid.

43. The method of claim 37, wherein the coupling further comprises coupling the inflow portion of the stent with the delivery element that transmits the fluid to the stent.

44. The method of claim 37, wherein said infusing further comprises injecting said fluid in at least one of a pulsed mode, an intermittent mode, and a programmed mode.

45. The method of claim 37, wherein the infusing further comprises coupling the inflow portion of the stent with a fluid delivery element that transmits the fluid to the stent.

46. The method of claim 45, wherein a temperature of said fluid is raised sufficiently to enhance said plastic deformation.

47. The method of claim 45, wherein a pH of said fluid is adjusted sufficiently to enhance said plastic deformation.

48. The method of claim 37, wherein the fluid comprises a therapeutic substance selected from the group consisting of a pharmaceutical, a gene, a growth factor, and an enzyme.

49. The method of claim 37, wherein the fluid comprises a therapeutic substance selected from the group consisting of an antiglaucoma drug, a beta-adrenergic antagonist, a TGF-beta compound, and an antibiotic.

50. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication through a stent lumen with an outflow portion of the stent;

positioning the stent such that the inflow portion of the stent is positioned in the anterior chamber of the eye and the outflow portion of the stent is positioned at an aqueous cavity;

providing a delivery element having a delivery lumen;

coupling the delivery element to the stent, such that the stent lumen is confluent with the delivery lumen; and

infusing fluid through the delivery lumen to the stent lumen, such that fluid flows from the inflow portion to the outflow portion of the stent, and such that the fluid flows into the aqueous cavity;

wherein the aqueous cavity is selected from the group consisting of Schlemm'"'"'s canal, an aqueous collector channel, and an episcleral vein of the eye.

51. The method of claim 50, further comprising positioning the stent such that the fluid communicating from the inflow portion to outflow portion of the stent bypasses the trabecular meshwork of the eye.

52. The method of claim 50, further comprising closing the incision, leaving the stent in the eye such that the inflow portion of the stent is positioned in the anterior chamber of the eye and the outflow portion of the stent is positioned in the aqueous cavity.

53. A method of treating glaucoma, comprising:

inserting a stent through an incision in an eye;

the stent having an inflow portion that is in fluid communication through a stent lumen with an outflow portion of the stent;

transporting the stent from the incision through the anterior chamber of the eye to an aqueous cavity of the eye, such that the inflow portion of the stent is positioned in the anterior chamber and the outflow portion of the stent is positioned at Schlemm'"'"'s canal of the eye;

providing a delivery element having a delivery lumen;

coupling the delivery element to the stent, such that the stent lumen is confluent with the delivery lumen; and

infusing fluid external to the eye through the delivery lumen to the stent lumen;

such that fluid flows from the inflow portion to the outflow portion of the stent, and such that the fluid flows into Schlemm'"'"'s canal.

54. The method of claim 53, wherein said infusing of fluid is at a pressure sufficient to cause plastic deformation of at least a portion of the aqueous cavity.