METHOD AND DEVICE FOR THE TREATMENT OF GLAUCOMA

• US 20110046536A1
• Filed: 08/20/2009
• Published: 02/24/2011
• Est. Priority Date: 08/20/2009
• Status: Active Grant

• Current Assignee: Grieshaber Ophthalmic Research Foundation
• Original Assignee: Grieshaber Ophthalmic Research Foundation
• Inventors: Grieshaber, Hans Rudolf, Grieshaber, Matthias Christian, Stegmann, Robert Christopher
• Granted Patent: US 8,951,221 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2090/3941 Photoluminescent markers
• 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

The invention relates to a method and device for the treatment of glaucoma, though insertion of an implant into the lumen of the Schlemm'"'"'s canal to realize proper drainage of the aqueous humor, which implant is brought into its position in the Schlemm'"'"'s canal by means of a catheter having a distal and a proximate portion and provided with a number of pores through which a gaseous or fluid medium which comes from a pressure source can emerge during insertion of the catheter carrying the implant into the Schlemm'"'"'s canal, and while the catheter is being inserted into the Schlemm'"'"'s canal the gaseous or fluid medium is released under pressure thereby expanding the Schlemm'"'"'s canal and the implant and upon releasing the implant at its determined location, the catheter can be withdrawn from the Schlemm'"'"'s canal.

Claims

1. A method for treatment of glaucoma, comprising the steps of:

sliding a tubular implant over an axial portion of a catheter;

exposing the Schlemm'"'"'s canal through an incision in the sclera and outward bending of a sclera flap;

inserting the catheter with the implant into the lumen of the Schlemm'"'"'s canal in a direction of a target site;

expanding the Schlemm'"'"'s canal and the implant by means of pressure application;

releasing the implant at the target site from the catheter; and

withdrawing the catheter from the lumen of the Schlemm'"'"'s canal.

2. The method of claim 1, wherein after release, the expanded implant reverts to an original shape.

3. The method of claim 1, wherein the implant is placed tightly onto the catheter and wherein pressure acting on the implant is effected by means of a pressurized medium, wherein during the insertion, a first pressure is applied and thereafter increasing the pressure for releasing the implant at the target location and withdrawing the catheter.

4. The method of claim 3, wherein the medium is a gaseous or fluid medium.

5. The method of claim 3, wherein during insertion of the catheter with the implant into the lumen of the Schlemm'"'"'s canal, the catheter is connected to a pressure source which generates pressure for the pressure medium acting on the implant such that the implant expands and upon releasing the implant at the target site, the catheter is withdrawn from the lumen.

6. The method of claim 1, wherein the catheter has a light-reflecting head piece for the detection of a position of the catheter upon insertion into and release of the implant into the lumen of the circular Schlemm'"'"'s canal.

7. The method of claim 6, wherein the head piece is also reflecting light upon withdrawal of the distal portion from the lumen of the Schlemm'"'"'s canal.

8. The method of claim 7, wherein a present position of the head piece is visually detectable by means of reflecting light coming from a light source.

9. The method of claim 7, wherein the present position of the head piece is visually detectable by means of a fluorescent coating of the head piece reflecting light from a light source of a surgical microscope.

10. A device for treatment of glaucoma, comprising:

a catheter having proximal and distal portions;

a tubular implant placed over the distal portion of the catheter for insertion into the Schlemm'"'"'s canal in a direction of a target site,

wherein the distal portion has spaced-apart bores in communication with an interior space of the catheter for injecting a medium under pressure at the target site to expand the implant and thereby release the implant from the catheter at the target site and allow withdrawal of the catheter.

11. The device of claim 10, wherein the proximate portion is connected to a pressure source and the distal portion is removably connected to the proximate portion by means of a coupling.

12. The device of claim 10, wherein the distal portion and the implant each have a length dimension corresponding to a circumferential length of the Schlemm'"'"'s canal from a point of insertion of the distal portion into the exposed Schlemm'"'"'s canal to a point where the exposed Schlemm'"'"'s canal ended.

13. The device of claim 11, wherein the coupling has a diameter corresponding to the outer diameter of the implant and includes a circular bearing surface at a side facing the implant.

14. The device of claim 10, wherein the distal portion includes a head piece configured as a cap of semi-circular shape with at least one bore in communication with the interior of the catheter.

15. The device of claim 14, wherein the head piece, beginning from the outer diameter of the distal portion is tapered into a tip having a bore in communication with the interior of the catheter.

16. The device of claim 14, wherein the head piece is made of a light-reflecting and biocompatible material.

17. The device of claim 14, wherein the head piece is coated with a light reflecting and biocompatible foil.

18. The device of claim 10, wherein the bores are distributed circumferentially and along an entire axial length of the distal portion.

19. The device of claim 18, wherein the bores are configured as pores which act as nozzles having a diameter from 10 μ

m to 25 μ

m.

20. The device of claim 19, wherein the bores are laser cut into the distal portion by an Excimer laser.

21. The device of claim 10, wherein the implant has a cross section of a shape selected from the group of circular ring-shaped, ring-shaped oval, double symmetrical ring-shaped oval, ring-shaped elliptical, square and trapezoidal and includes a connecting part extending along an axial extension of the implant for bearing at an inner wall at the Schlemm'"'"'s canal, and ring parts arranged in axial direction at the connecting part and spaced-apart from each other by recesses.

22. The device of claim 21, wherein the ring parts are divided into two ring members by an axially oriented gap, wherein the two ring members are movable relative to each other such that the gap can be increased for removal of the catheter.

23. The device of claim 22, wherein the gap is at a location on the ring part approximately opposite the connecting part.

24. The device of claim 23, wherein the two ring members are movable relative to each other upon an increase or decrease of pressure from the pressure medium.

25. The device of claim 24, wherein the gap between the ring member is approximately U-shaped or approximately Z-shaped with the ring members shaped in correspondence to the shape of the gap.

26. The device of claim 21, wherein the recesses between the ring parts have an opening angle (W) from 90°

to 105°

.

27. The device of claim 21, wherein the recesses between the ring parts have an opening angle (W) from 280°

to 290°

.

28. The device of claim 10, wherein the implant having a generally circular cross section includes two axially extending connecting parts disposed opposite from each other in circumferential direction and ring members arranged at the connection parts spaced-apart from each other by recesses, wherein one of the connecting parts is provided with a slot-shaped gap extending in axial direction and another one of the connecting parts has a surface of a shape for supporting an inner wall of the Schlemm'"'"'s canal.

29. The device of claim 28, wherein the shape of the other one of the connecting parts has a circular arced surface.

30. The device of claim 28, wherein the recesses between the ring members have an opening angle from 90°

to 105°

.

31. The device of claim 21, wherein the implant is made of a material selected from the group consisting of biocompatible material, plastic, stainless steel, special steel, silver, gold, platinum and nitinol.

32. The device of claim 31, wherein the implant is made from polymeric material having thermal or mechanical shape memory.

33. The device of claim 31, wherein the implant is provided with a biocompatible coating.

34. The device of claim 33, wherein the coating is heparin.

35. An implant for use in the surgical treatment of glaucoma comprising:

An elongated generally tubular-shaped flexible device including at least one connecting part,

a plurality of ring parts disposed at the connecting part and spaced-apart by recesses;

wherein the ring parts are each separated by a gap which under application of pressure through a pressure medium opens wider to radially expand the implant and when the pressure is withdrawn the gap is closed and the implant is reverted to an original shape.