Delivery system and method of use for the eye

• US 9,603,741 B2
• Filed: 09/16/2013
• Issued: 03/28/2017
• Est. Priority Date: 05/19/2000
• Status: Expired due to Term

• Current Assignee: Ivantis Inc.
• Original Assignee: Michael S. Berlin
• Inventors: Berlin, Michael S.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US14/028,460
• Publication Number:
  US 20150080783A1
• Time in Patent Office: 1,289 Days
• Field of Search: 604 8- 10, 604/27, 604/294, 604/264, 604/284, 604/523, 606107-109, 606/151, 606/167, 600/398, 623/1.1, 623/4.1, 623/11.1, 623/1.35
• US Class Current: 1/1
• CPC Class Codes: A61F 2009/00868 Ciliary muscles or trabecular meshwork
• CPC Class Codes: A61F 2009/00891 Glaucoma
• 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 9/00802 for photoablation

Abstract

A method and delivery system are disclosed for creating an aqueous flow pathway in the trabecular meshwork, juxtacanalicular trabecular meshwork and Schlemm'"'"'s canal of an eye for reducing elevated intraocular pressure. Pulsed laser radiation is delivered from the distal end of a fiber-optic probe sufficient to cause photoablation of selected portions of the trabecular meshwork, the juxtacanalicular trabecular meshwork and an inner wall of Schlemm'"'"'s canal in the target site. The fiber-optic probe may be advanced so as to create an aperture in the inner wall of Schlemm'"'"'s canal in which fluid from the anterior chamber of the eye flows. The method and delivery system may further be used on any tissue types in the body.

Claims

1. A method, of maintaining an opening in a trabecular meshwork of a patient'"'"'s eye to conduct fluid from an anterior chamber to Schlemm'"'"'s canal of the eye, comprising:

positioning an intraocular implant through an opening in the trabecular meshwork of the eye, the implant having a proximal portion configured to reside in the anterior chamber of the eye, a distal portion configured to reside in Schlemm'"'"'s canal of the eye, a middle portion having an outer cross-sectional dimension that is less than a cross-sectional dimension of the distal portion and a cross-sectional dimension of the proximal portion, and a passageway extending from a proximal end of the implant to a distal end of the implant, the middle portion dimensioned to extend across the inner wall of Schlemm'"'"'s canal and the trabecular meshwork, the distal portion comprising a contact surface to contact an inner wall of Schlemm'"'"'s canal, the distal portion configured to substantially inhibit contact with the outer wall of Schlemm'"'"'s canal when the contact surface of the distal portion engages the inner wall of Schlemm'"'"'s canal and self-retains the implant with the inner wall of Schlemm'"'"'s canal; and

wherein fluid is conducted through the passageway from an opening on the proximal portion of the implant to an opening on the distal portion of the implant, such that fluid flows from the anterior chamber into Schlemm'"'"'s canal through the implant.

2. The method of claim 1, wherein the middle portion outer cross-sectional dimension comprises an outer cross-section diameter.

3. The method of claim 1, further comprising providing an inserter device that is configured to carry the intraocular implant and puncture the trabecular meshwork and position the distal portion of the implant within Schlemm'"'"'s canal.

4. The method of claim 3, wherein positioning the intraocular implant comprises advancing the intraocular implant relative to inserter device.

5. The method of claim 1, further comprising abutting a portion of the distal portion to an internal surface of the inner wall of Schlemm'"'"'s canal.

6. The method of claim 1, further comprising inserting the intraocular implant through a corneal incision.

7. The method of claim 1, further comprising inserting the intraocular implant through a self-sealing incision in the eye.

8. The method of claim 1,

wherein the middle portion comprises a substantially straight passageway extending from the proximal portion of the implant to the distal portion of the implant, the middle portion having a substantially uniform outer diameter between the proximal portion and the distal portion.

9. The method of claim 8, wherein a natural aqueous outflow space comprises Schlemm'"'"'s canal.

10. The method of claim 1,

wherein the distal portion of the implant has an outer cross-sectional dimension that is greater than a cross-sectional dimension of the opening on the distal portion.

11. The method of claim 10, wherein the outer cross-sectional dimension comprises an outer diameter.

12. The method of claim 10, wherein the opening extends within a corneoscleral angle of the eye.

13. The method of claim 10, wherein the natural aqueous outflow space comprises Schlemm'"'"'s canal of the eye.

14. An intraocular implant for placement in an eye to conduct fluid from the eye, the eye having a trabecular meshwork, an anterior chamber and a Schlemm'"'"'s canal, the implant comprising:

a proximal portion, sized and shaped to reside in an anterior chamber of an eye, the proximal portion comprising a flange having a surface oriented to contact the trabecular meshwork and an opening to receive fluid from the anterior chamber when placed;

a distal portion, sized and shaped to reside in Schlemm'"'"'s canal of the eye, the distal portion comprising a contact surface to contact an inner wall of Schlemm'"'"'s canal and retain the implant with the inner wall of Schlemm'"'"'s canal, the distal portion comprising an opening to release fluid into Schlemm'"'"'s canal, the distal portion configured to substantially inhibit contact with the outer wall of Schlemm'"'"'s canal when the contact surface of the distal portion engages the inner wall of Schlemm'"'"'s canal and self-retains the implant with the inner wall of Schlemm'"'"'s canal;

a middle portion, extending from the proximal portion to the distal portion, the middle portion sized and shaped to extend through a trabecular meshwork of an eye when the proximal portion resides in the anterior chamber and the distal portion resides in Schlemm'"'"'s canal; and

a substantially straight passageway, extending through the intraocular implant between a proximal end and a distal end of the intraocular implant, the passageway being configured such that when the implant is positioned in the eye, the passageway conducts fluid from the anterior chamber, through the implant, and to Schlemm'"'"'s canal.

15. The implant of claim 14, wherein the outer cross-sectional dimension comprises an outer diameter.

16. The implant of claim 14, wherein a cross-sectional dimension of the passageway is between 10 and 200 microns.

17. The implant of claim 14, further comprising an expandable member coupled to the intraocular implant, the expandable member engaging the inner wall of Schlemm'"'"'s canal when the implant is positioned in the eye.

18. The implant of claim 17, wherein the expandable member comprises a foldable leg configured to unfold.

19. The implant of claim 14,

wherein, when the implant is positioned within the eye, an outer cross-sectional dimension of the distal portion is greater than an outer cross-sectional dimension of the middle portion.

20. The implant of claim 19, wherein, when the implant is positioned in the eye, the proximal portion is configured to engage the trabecular meshwork on a first end of the implant and the distal portion is configured to engage an inner wall of Schlemm'"'"'s canal on a second end.

21. The implant of claim 19, wherein the distal portion outer cross-sectional dimension comprises a distal portion outer diameter.

22. The implant of claim 19, wherein the distal portion outer cross-sectional dimension is between 10 and 100 microns greater than the middle portion outer cross-sectional dimension.

23. The implant of claim 19, wherein the implant comprises at least one of stainless steel, thermoplastic, polymethylmethacrylate, nylon, and polypropylene.

24. The implant of claim 19, further comprising an anchor, coupled to the proximal portion of the implant, that engages the trabecular meshwork.

25. An intraocular implant for placement in an eye having a Schlemm'"'"'s canal with an inner wall, the implant comprising:

a proximal portion, sized and shaped to reside in an anterior chamber of an eye;

a distal portion, sized and shaped to reside in Schlemm'"'"'s canal of the eye, the distal portion having an expandable portion that, upon positioning of the implant within the eye and expansion of the expandable portion, increases an outer cross-sectional dimension of the distal portion, wherein the expandable portion engages the inner wall of Schlemm'"'"'s canal when the implant is positioned with the expandable portion expanded and wherein the distal portion is configured to substantially inhibit contact with an outer wall of Schlemm'"'"'s canal when placed;

a middle portion, sized and shaped to extend through a trabecular meshwork of the eye when the proximal portion resides in the anterior chamber and the distal portion resides in Schlemm'"'"'s canal; and

a passageway, extending through the implant between a proximal end and a distal end of the implant, the passageway being configured such that when the implant is positioned in the eye, the passageway conducts fluid from the anterior chamber, through the implant, and to Schlemm'"'"'s canal.

26. The implant of claim 25, wherein the expandable portion comprises a foldable leg.

27. The implant of claim 25, wherein the outer cross-sectional dimension comprises an outer diameter.

28. The implant of claim 25, wherein a cross-sectional dimension of the passageway is between 10 and 200 microns.

29. A system, for reducing intraocular pressure of an eye having a Schlemm'"'"'s canal, comprising:

an intraocular implant, having a proximal portion sized and shaped to reside within an anterior chamber of an eye, a middle portion, a distal portion sized and shaped to reside within a natural aqueous outflow space of the eye, the distal portion having an outer cross-sectional dimension that, when implanted within the eye, is greater than an outer cross-sectional dimension of the middle portion; and

an inserter device that is configured to carry the intraocular implant, the intraocular implant being configured to be movable with respect to the inserter device;

wherein, when the intraocular implant is implanted within the eye, the inserter device guides the intraocular implant into position such that fluid is conducted through the intraocular implant from the anterior chamber to Schlemm'"'"'s canal and wherein the distal portion is sized and shaped to engage a wall of Schlemm'"'"'s canal and wherein engagement of the wall of Sclemm'"'"'s canal is limited to engagement of an inner wall of Schlemm'"'"'s canal.

30. The system of claim 29, further comprising an expandable member coupled to the intraocular implant, the expandable member engaging a wall of the natural aqueous outflow space when the implant is positioned in the eye.

31. The system of claim 30, wherein the expandable member comprises a foldable leg.

32. The system of claim 29, wherein the distal portion outer cross-sectional dimension comprises a distal portion outer diameter.

33. A method, of treating glaucoma of an eye having a Schlemm'"'"'s canal, the method comprising:

advancing a distal portion of an inserter device through an anterior chamber of an eye toward a trabecular meshwork of the eye; and

advancing an intraocular implant along the inserter device and into position within the trabecular meshwork;

wherein, when positioned in the trabecular meshwork, the implant conducts fluid from the anterior chamber through a substantially straight passageway of the implant, the substantially straight passageway extending from a proximal end of the implant to a distal end of the implant, and wherein a distal portion of the implant engages a wall of Schlemm'"'"'s canal and wherein engagement of the wall of Schlemm'"'"'s canal is limited to an inner wall of Schlemm'"'"'s canal.

34. The method of claim 33, wherein a sharp distal tip of the inserter device extends beyond the implant and cuts the trabecular meshwork to position the distal portion of the implant in Schlemm'"'"'s canal.

35. The method of claim 33, wherein the implant is straight between the proximal opening and the distal opening and wherein the distal portion fits within a cannula of the inserter device.