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 method of improving aqueous drainage of an eye, the method comprising:
introducing a distal portion of a tissue disruption device into an anterior chamber of an eye through an ab interno insertion location towards an anterior angle of the eye, the distal portion comprising:
an elongate, flexible shaft of super-elastic memory-shape material comprising a radially inner surface that 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 the radially outer surface, wherein the tissue disruptor has a maximum thickness between the radially inner surface and the radially outer surface;
positioning the tissue disruptor against a wall of the anterior angle of the eye outside of Schlemm's canal; and
moving the tissue disruptor relative to the wall to reduce a thickness of the wall with the tissue disruptor.
2 . The method of claim 1 , wherein the wall comprises a scleral wall.
3 . The method of claim 2 , wherein the thickness of the wall is reduced by partial thickness cutting, debriding, abrading, shaving, or ablating the wall with the tissue disruptor.
4 . The method of claim 1 , wherein moving the tissue disruptor comprises retracting the tissue disruptor relative to the insertion location.
5 . The method of claim 4 , wherein retracting the tissue disruptor comprises retracting the shaft around at least a portion of a circumference of the eye.
6 . The method of claim 5 , wherein the portion is about 30-120 degrees of the circumference.
7 . The method of claim 1 , wherein the maximum thickness of the tissue disruptor is at least 150 microns up to about 2 mm.
8 . The method of claim 1 , wherein the shaft has a cross-sectional shape taken transverse to a length of the shaft between that is non-circular.
9 . The method of claim 8 , wherein the cross-sectional shape is square or rectangular.
10 . The method of claim 1 , further comprising modifying a second wall of the anterior angle of the eye using a second tissue disruptor.
11 . The method of claim 10 , wherein the second tissue disruptor is located on the radially inner surface proximal of the distal-most end of the shaft.
12 . The method of claim 10 , wherein the second wall comprises a trabecular meshwork.
13 . The method of claim 10 , wherein modifying the second wall is performed prior to moving the tissue disruptor to reduce the thickness of the wall.
14 . The method of claim 10 , wherein modifying the second wall comprises advancing the second tissue disruptor relative to the insertion location.
15 . The method of claim 14 , wherein advancing the second tissue disruptor comprises advancing the shaft longitudinally around at least a portion of a circumference of the eye.
16 . The method of claim 15 , wherein the portion is about 30-120 degrees of the circumference.
17 . The method of claim 1 , wherein the ab interno insertion location is a corneal incision having a size less than about 2.75 mm.
18 . The method of claim 1 , further comprising performing phacoemulsification of a cataract.
19 . The method of claim 1 , wherein the tissue disruptor has a distal face and a proximal face, 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.
20 . The method of claim 19 , wherein the distal-most end is a smooth ball tip configured for circumferential gonio-traction.
21 . The method of claim 20 , wherein the smooth ball tip on the shaft is located 1 mm-3 mm away from the distal face.
22 . The method of claim 1 , wherein introducing the distal portion further comprises introducing an introducer tube projecting from a distal end region of a proximal housing, wherein at least a portion of the shaft extends through a lumen of the introducer tube.
23 . The method of claim 22 , wherein the shaft is configured to be advanced from the introducer tube and retracted into the introducer tube.
24 . The method of claim 23 , wherein the shaft develops a spring-load as the shaft extends from the introducer tube.
25 . The method of claim 23 , further comprising applying a radially outward force with the shaft as the shaft extends from the introducer tube.