METHOD AND DEVICE FOR THE TREATMENT OF GLAUCOMA

• US 20110118649A1
• Filed: 11/13/2009
• Published: 05/19/2011
• Est. Priority Date: 11/13/2009
• Status: Active Grant

• Current Assignee: Grieshaber Ophthalmic Research Foundation
• Original Assignee: Grieshaber Ophthalmic Research Foundation
• Inventors: Stegmann, Robert, Grieshaber, Matthias, Grieshaber, Hans
• Granted Patent: US 8,845,572 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61B 2090/3937 Visible 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 a device for treatment of glaucoma, wherein by means of an elongated catheter provided with a distal portion and a proximal portion, a tube-shaped implant is inserted and released in a Schlemm'"'"'s canal with two opposite openings exposed by an incision and a folded up scleral flap. In a first phase, the distal portion inserted into the Schlemm'"'"'s canal through the first opening, while a fluid or gaseous medium is injected at the same time, and exited through the second opening, which is, in circumferential direction, oppositely located. The implant detachably disposed at the protruding distal portion and, in a second phase, inserted, in circumferential direction, into the expanded Schlemm'"'"'s canal up to the first opening. Subsequently, the distal portion, which protrudes from the first opening, is detached from the implant and, together with the catheter, removed.

Claims

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

exposing the Schlemm'"'"'s canal through an incision in the sclera and

outward bending of a scleral flap thereby providing access to two openings in the Schlemm'"'"'s canal which are, in circumferential direction, located opposite each other;

inserting a catheter through one of the two openings into a lumen of the Schlemm'"'"'s canal;

simultaneously injecting a fluid or gaseous medium into the Schlemm'"'"'s canal through the one opening, wherein the Schlemm'"'"'s canal is expanded;

exiting the catheter from another one of the openings, which at least partially protrudes from the other one of the openings;

detachably disposing an implant at the exiting catheter and inserting the catheter with the implant circumferentially from the other one of the openings through the expanded Schlemm'"'"'s canal until the implant reaches the one opening;

releasing the implant from the catheter and the catheter from the Schlemm'"'"'s canal.

2. The method according to claim 1, wherein, during insertion of the implant disposed at the distal portion, which is oriented in circumferential direction from the second opening to the first opening, the fluid or gaseous medium is injected into the Schlemm'"'"'s canal.

3. The method according to claim 1, wherein a hydrophilic fluid is injected into a lumen of the Schlemm'"'"'s canal for expanding the Schlemm'"'"'s canal and for inserting the implant disposed at the distal portion.

4. The method according to claim 1, wherein the implant, which is detachable from the distal portion, is positively inserted in circumferential direction into the Schlemm'"'"'s canal, from the second opening to the first opening, and wherein the exited distal portion is detached from the implant and, together with the catheter, removed.

5. The method according to claim 1, wherein the implant, which is positively connected to the distal portion, is positively inserted into the Schlemm'"'"'s canal in circumferential direction and wherein the exited distal portion is detached from the implant and, together with the catheter, removed.

6. The method according to claim 1, wherein the implant, which is detachably disposed at the distal portion, is inserted into the Schlemm'"'"'s canal while facing a trabecular tissue, and wherein recesses, which are spaced apart in axial direction, and ring members are disposed at the implant.

7. The method according to claim 1, wherein, during insertion of the implant, which is detachably disposed at the distal portion, a surgical thread is additionally inserted, which penetrates an inner space of the implant in axial direction and is held with one end of the surgical thread at the distal portion and whose other end protrudes from the tube-like implant.

8. The method according to claim 7, wherein the thread, which is exited from the released implant with the two ends of the thread, is loaded against an inner side of the implant and knotted in the area of the incision in order to achieve an expansion of a trabecular tissue, which is located upstream of the Schlemm'"'"'s canal.

9. The method according to claim 1, wherein, during a first phase, which circularly expands the Schlemm'"'"'s canal, and during a second phase, which inserts the implant into the Schlemm'"'"'s canal, a current position of the distal portion is illuminated by light that is reflected so that the current position of the distal portion is visually recognized.

10. The method according to claim 9, wherein at least one of the distal portion and a head piece disposed at the distal portion has a fluorescence coating, by means of which the reflection is ended within one millionth of a second after the light illumination.

11. A system for treating glaucoma, comprising:

a catheter having proximal and distal portions;

a pressure source connected to the catheter; and

a tubular implant insertable into Schlemm'"'"'s canal that has been exposed by an incision to provide access to two openings located opposite each other, said implant provided with spaced-apart recesses and ring members and configured for detachable disposition at the distal portion for release in the Schlemm'"'"'s canal;

wherein the distal portion has spaced-apart bores in communication with an interior space of the catheter for injecting a fluid or gaseous medium under pressure from the pressure source into the Schlemm'"'"'s canal and having at least a length which is oriented, in circumferential direction of the Schlemm'"'"'s canal, from one of the two openings to the other of the two openings and to partially protrude from the Schlemm'"'"'s canal;

wherein the distal portion has, at its front distal end, a head piece at which the implant is disposed and positively connected.

12. The system according to claim 11, further comprising a surgical thread that is tied as a sling or loop, by which the tube-like implant is detachably disposed at at least one of the distal portion and the head piece of the distal portion.

13. The system according to claim 11, further comprising a detachable rapid connection, in which the head piece, which is disposed at the distal portion, has a ring groove, and in which the tube-like implant, which is coaxially slideable, has at least two latch cams, which are arranged opposite of each other at the circumference of an inner space of the tube-like plant and configured to positively and detachably engage during sliding into the ring groove.

14. The system according to claim 13, wherein the latch cams, which are arranged in the inner space of the implant and which engage the ring groove, are configured as circular rings.

15. The system according to claim 11, wherein the tube-like implant has, on a side that is opposite of an arc-shaped connection member which is oriented in axial direction, a slit-shaped crack that is oriented in axial direction and wherein separated sides of the ring members are spread in radial direction in relation to each other.

16. The system according to claim 11, wherein the tube-like implant is slid with at least one of the ring members onto the distal portion in a jammed manner and wherein the at least one of the ring members, which is provided with a slit-shaped crack, is spread in radial direction for detachment and removal of the distal portion.

17. The system according to claim 11, wherein the tube-like implant is slid with at least one of the ring members onto the head piece of the distal portion in a jammed manner and wherein the at least one of the ring members, which is provided with a slit-shaped crack, is spread in radial direction for detachment and removal of the distal portion.

18. The system according to claim 16, wherein the at least one of the ring members, which is provided with the slit-shaped crack, is spread in radial direction by a pressurized injected medium for detachment and removal of the distal portion.

19. The system according to claim 11, wherein a surgical thread is arranged in the tube-like implant that penetrates an inner space of the tube-like implant in axial direction, and wherein, after removal of the distal portion and the catheter, the surgical thread is loaded against an inner wall of the tube-like implant so as to expand a trabecular tissue.

20. The system according to claim 11, wherein the distal portion of the catheter has a length that is 1.5 to 2 times the circumference of a circular Schlemm'"'"'s canal and wherein the bores of the distal portion are distributed in axial and circumferential direction.

21. The system according to claim 20, wherein the bores, which are arranged at the distal portion and the head piece, have a diameter of 10 μ

m to 25 μ

m and operate as nozzles, and wherein the bores are bored with a laser.

22. The system according to claim 21, wherein the laser is an excimer laser.

23. The system according to claim 11, wherein the head piece is configured as a semicircular cap and wherein the head piece has at least one bore that is connected to an inner space of the distal portion and the catheter.

24. The system according to claim 11, wherein the head piece is tapered, starting from an outer diameter of the distal portion in the direction of a distal tip, and wherein the head piece has at least one bore that is connected to an inner space of the distal portion and the catheter.

25. The system according to claim 11, wherein one of the distal portion is coated at a distal end with a light-reflecting and biocompatible foil and the distal portion has a front portion made of light-reflecting and biocompatible material.

26. The system according to claim 11, wherein the head piece disposed at the distal portion is one of made of light-reflecting and biocompatible material and coated with a light-reflecting and biocompatible foil.

27. The system according to claim 11, wherein the cross-section of the implant is circular and wherein the implant has a connection member, which is oriented in axial direction and approximately circular, and the recesses, which are arranged between individual ones of the ring members, each of which having an opening angle between 280°

and 290°

.

28. The system according to claim 11, wherein the cross-section of the implant is circular and wherein the implant has two circular connection members, which are diametrically opposite of each other and oriented in axial direction, and wherein the implant has the recesses, which are arranged between individual ones of the ring members, each of which having an opening angle of 90°

to 105°

.

29. The system according to claim 11, wherein the cross-section of the implant is in the shape of an oval ring and wherein the implant has a connection member, which is oriented in axial direction and arc-shaped, and the recesses arranged between individual ones of the ring members, each of which having an opening angle of 280°

to 290°

.

30. The system according to claim 29, wherein the cross-section of the implant is in the shape of a double-symmetric oval.

31. The system according to claim 27, wherein the implant, which has the ring members and the recesses, has on the opposite side of the connection member a slit-shaped crack, which is oriented in axial direction.

32. The system according to claim 11, wherein the tube-like implant is made of biocompatible flexible material.

33. The system according to claim 32, wherein the biocompatible flexible material is polymeric material having one of a thermal and mechanical shape memory effect.

34. The system according to claim 11, wherein the implant is made of biocompatible material, including one of plastic, non-corroding steel and stainless steel selected from the group consisting of silver, gold, platinum, and nitonol.

35. The system according to claim 11, wherein the implant has a biologically active coating.

36. The system according to claim 35, wherein the biologically active coating is a heparin coating.