Apparatus And Method For Surgical Enhancement Of Aqueous Humor Drainage

• US 20090043321A1
• Filed: 04/29/2005
• Published: 02/12/2009
• Est. Priority Date: 04/29/2004
• Status: Abandoned Application

• Current Assignee: iScience Interventional Corporation
• Original Assignee: iScience Interventional Corporation
• Inventors: Hee, Michael, Conston, Stanley R., McKenzie, John R., Kupiecki, David J., Yamamoto, Ronald
• Application Number:
  US11/587,785
• Publication Number:
  US 20090043321A1
• Time in Patent Office: Days
• US Class Current: 606/166
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• 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 9/008 using laser

Abstract

An apparatus is provided for forming a tissue tract (8, 11A, 17A) from within a first passageway of an eye (11, 17) connecting to a second passageway in the eye (12, 16) comprising an elongated tool with a proximal end and distal end. The tool has an outer diameter in the range of about 50 to about 1000 microns. Methods of using the tool are provided for creating a fluid path for aqueous humor of an eye from a first passageway of the eye, such as the Schlemm'"'"'s Canal, to a second passageway, such as the suprachoroidal space

Claims

1. An apparatus for forming a tissue tract from within a first passageway of an eye connecting to a second passageway in the eye comprising an elongated tool with a proximal end and distal end, said tool having an outer diameter in the range of about 50 to about 1000 microns.

2. The apparatus according to claim 1 where the tool comprises a flexible microcannula.

3. The apparatus according to claim 2 wherein said flexible microcannula is located proximal to said distal end.

4. The apparatus according to claim 1 wherein said tool comprises an outer sheath and inner member.

5. The apparatus according to claim 4 wherein said outer sheath is flexible and said inner member has a higher flexural rigidity than said outer sheath.

6. The apparatus according to claim 5 wherein said inner member may be removed and exchanged with another inner member during use of said apparatus in the eye.

7. The apparatus according to claim 3 wherein said flexible microcannula comprises a rounded atraumatic distal terminus which forms said distal end of said tool.

8. The apparatus according to claim 1 wherein said flexible microcannula additionally comprises a lubricious outer surface coating.

9. The apparatus according to claim 1 wherein said tool comprises a mechanically cutting tip at said distal end.

10. The apparatus of according to claim 1 where said tool has the capacity to direct tissue ablative energy from said distal end.

11. The apparatus according to claim 10 wherein said energy comprises laser light, radio frequency energy or thermal energy.

12. The apparatus according to claim 1 wherein said distal tip is visible by imaging to enable image guidance during formation of said tract.

13. The apparatus according to claim 12 wherein said imaging comprises ultrasound or optical coherence topography.

14. The apparatus according to claim 1 wherein said distal tip comprises an optical beacon visible under direct observation through scleral tissues.

15. The apparatus according to claim 1 further comprising a space-maintaining material or implant for placement within said tract.

16. The apparatus according to claim 1 wherein said tool comprises means for blunt dissection, viscoelestic dissection or tissue penetration.

17. The apparatus according to claim 15 wherein said space-maintaining material comprises. hyaluronic acid.

18. The apparatus according to claim 15 wherein said space-maintaining material comprises an anti-fibrotic agent.

19. The apparatus according to claim 18 wherein said anti-fibrotic agent comprises methotrexate, paclitaxel, 5 fluoro uracil or sirolimus.

20. The apparatus of according to claim 15 wherein said space-maintaining material comprises an anti-thrombotic agent.

21. The apparatus according to claim 20 wherein said anti-thrombotic agent comprises heparin or tissue plasminogen activator.

22. The apparatus according to claim 15 wherein said implant comprises a tube or stent-like device.

23. The apparatus according to claim 15 wherein said implant comprises stainless steel, titanium, nickel titanium alloy, cobalt chrome alloy, ceramic, carbon, or polymeric material.

24. The apparatus according to claim 15 wherein said implant is capable of changing configurations when delivered in the eye from said apparatus.

25. An implant for placement in a surgically formed tissue tract in the eye between the suprachoroidal space and Schlemm'"'"'s Canal, wherein said implant maintains the space of said tissue tract and provides a path for aqueous humor flow through said tissue tract.

27. The implant according to claim 25 or 26 comprising microspheres, microparticles, microfibers, open or closed cell matrices, foam, gel, a tubular device, or a stent-like device.

28. The implant according to claim 25 or 26 comprising a suture, a flange, or a tissue ingrowth surface to provide tissue fixation of said implant in said tract.

29. The implant according to claim 25 or 26 comprises stainless steel, titanium, titanium alloy, cobalt chrome alloy, ceramic, carbon or polymeric material.

30. The implant according to claim 25 or 26 comprising a biodegradable or bioerodable material.

31. The implant according to claim 25 or 26 comprising an anti-fibrotic material.

26. An implant for placement in a surgically formed tissue tract between the suprachoroidal space and the anterior chamber, wherein said implant maintains the space of said tissue tract and provides a path for aqueous humor flow through said tissue tract.

32. A method for creating a fluid path for aqueous humor of an eye from a first passageway of the eye comprising Schlemm'"'"'s Canal to a second passageway comprising the suprachoroidal space, the method comprising:

a) inserting a microsurgical tool from a surgical access site into said first passageway;

b) advancing said tool along said first passageway to a desired site for formation of a tissue tract for said fluid path;

c) actuating said tool to form said tissue tract from said first passageway to said second passageway;

d) removing said tool and

e) closing said surgical access site.

34. The method according to claim 32 or 33 wherein the advancing of said tool and the actuating of said tool to form said tract is directed by imaging.

35. The method according to claim 32 or 33 wherein said tool comprises a flexible microcannula.

36. The method according to claim 32 or 33 further comprising placing a space-maintaining material or implant within said tract.

37. The method according to claim 32 or 33 wherein said space-maintaining material comprises hyaluronic acid.

38. The method according to claim 32 or 33 wherein said implant comprises a tube-like or stent-like device.

39. The implant according to claim 32 or 33 wherein said implant a suture, a flange, or a tissue ingrowth surface to provide tissue fixation of said implant in said tract.

40. The method according to claim 32 or 33 wherein the advancing of said tool and actuating of said tool is performed a plurality of times to form multiple tissue tracts from said first passageway to said second passageway using a single surgical access site.

33. A method for creating a fluid path for aqueous humor of an eye from a first passageway of the eye comprising the suprachoroidal space to a second passageway selected from Schlemm'"'"'s Canal or the anterior chamber, the method comprising:

a) inserting a microsurgical tool from a surgical access site into said first passageway;

b) advancing said tool along said first passageway to a desired site for formation of a tissue tract for said fluid path;

c) actuating said tool to form said tissue tract from said first passageway to said second passageway;

d) removing said tool and

e) closing said surgical access site.