Methods and devices for increasing aqueous drainage of the eye
A device for disrupting tissue in an eye including a distal portion sized and configured for ab interno insertion into an anterior chamber of the eye having an elongate, flexible shaft of super-elastic memory-shape material. A distal end region is shaped into a curve having a radially inner surface connected to a radially outer surface by two lateral sides. The device has a tissue disruptor proximal of a distal-most end formed on at least one of the inner surface and the outer surface. The distal face of the tissue disruptor is a blunt tissue-engaging surface without any cutting element. Related methods and devices are provided.
1. A device for disrupting tissue in an eye, the device comprising:
a distal portion sized and configured for ab interno insertion into an anterior chamber of the eye, the distal portion comprising:
an elongate, flexible shaft of super-elastic memory-shape material comprising:
a distal end region shaped into a curve having a central plane, wherein a radially inner surface is connected to a radially outer surface by two lateral sides;
a distal-most end; and
a tissue disruptor proximal of the distal-most end formed on at least one of the inner surface and the outer surface, wherein the tissue disruptor has a distal face, a proximal face, and a maximum thickness, the distal face sloping from a first thickness of the shaft distal to the tissue disruptor towards the maximum thickness and the proximal face tapering down from the maximum thickness to a second thickness of the shaft proximal to the tissue disruptor, wherein the first thickness, the maximum thickness, and the second thickness are each between the inner and outer surfaces, and
wherein the distal face of the tissue disruptor is a blunt tissue-engaging surface without any cutting element.
2. The device of claim 1 , wherein the distal-most end is a smooth ball tip.
3. The device of claim 2 , wherein the smooth ball tip is configured for circumferential gonio-traction.
4. The device of claim 2 , wherein the smooth ball tip on the shaft is located 1 mm-3 mm away from the distal face.
5. The device of claim 1 , wherein the tissue disruptor comprises a first tissue disruptor formed on the inner surface and a second tissue disruptor formed on or adjacent to the outer surface opposite the first tissue disruptor.
6. The device of claim 1 , further comprising a proximal housing having an introducer tube projecting from a distal end region of the housing, at least a portion of the shaft extending through a lumen of the introducer tube.
7. The device of claim 6 , wherein the shaft is configured to be advanced from the introducer tube.
8. The device of claim 7 , wherein the shaft develops a spring-load as the shaft extends from the introducer tube.
9. The device of claim 7 , wherein the shaft applies a radially outward force as the shaft extends from the introducer tube.
10. The device of claim 6 , wherein the introducer tube is a substantially rigid tube having a proximal end region that extends away from the proximal housing along a longitudinal axis and a distal end region that curves relative to the longitudinal axis.
11. The device of claim 10 , wherein the distal end region of the introducer tube has a first curved region and a second curved region, wherein the first curved region curves in a first direction at a first radius of curvature and the second curved region curves in a second direction at a second radius of curvature.
12. The device of claim 11 , wherein the first radius of curvature is greater than the second radius of curvature.
13. The device of claim 1 , wherein the first thickness of the shaft between the inner and outer surfaces proximal to the disruptor is 100-2000 microns and the second thickness of the shaft between the inner and outer surfaces distal to the disruptor is 100-550 microns.
14. The device of claim 13 , wherein the maximum thickness of the tissue disruptor between the inner and the outer surfaces is about 450-600 microns.
15. The device of claim 1 , wherein the shaft has a cross-sectional shape taken transverse to a length of the shaft between that is non-circular.
16. The device of claim 15 , wherein the cross-sectional shape is square or rectangular.
17. The device of claim 1 , wherein the curve of the distal end region of the shaft has a radial curvature of 5-20 mm.
18. The device of claim 1 , wherein the shaft has a length sufficient to be advanced around 30-360 degrees of a circumference of an eye.