Methods and devices for increasing aqueous humor outflow

Abstract

An ocular implant having an inlet portion and a Schlemm's canal portion distal to the inlet portion, the inlet portion being disposed at a proximal end of the implant and sized and configured to be placed within an anterior chamber of a human eye, the Schlemm's canal portion being arranged and configured to be disposed within Schlemm's canal of the eye when the inlet portion is disposed in the anterior chamber.

What is claimed is: 
     
         1 . An ocular implant comprising:
 a longitudinally extending body having an inlet portion and a Schlemm's canal portion distal to the inlet portion, the inlet portion being configured to extend into and be in fluid communication with an anterior chamber of a human eye and the Schlemm's canal portion being configured to be inserted into Schlemm's canal adjacent to collector channels of the eye;   a plurality of alternating spines and frames positioned longitudinally along at least a portion of the Schlemm's canal portion wherein the plurality of alternating spines and frames define a central channel extending therethrough, with the central channel being in fluid communication with the inlet portion;   each of the spines having edges partially defining an opening across from the central channel and in fluid communication with the central channel; and   each of the frames including first and second struts, the first and second struts each having an edge contiguous with an edge of an adjacent spine, the edges defining the opening in fluid communication with the central channel;   wherein the ocular implant is configured to provide at least a 121% increase in average outflow facility of aqueous humor from the anterior chamber through the collector channels of the eye.   
     
     
         2 . The ocular implant of  claim 1 , wherein the implant comprises at least three openings across from the central channel. 
     
     
         3 . The ocular implant of  claim 2 , wherein the average outflow facility comprises 0.438 μl/min/mmHg. 
     
     
         4 . The ocular implant of  claim 2 , wherein a peak circumferential flow rate through the ocular implant comprises 3.2 μl/min. 
     
     
         5 . The ocular implant of  claim 1 , wherein the implant comprises at least six openings across from the central channel. 
     
     
         6 . The ocular implant of  claim 5 , wherein the average outflow facility comprises 0.638 μl/min/mmHg. 
     
     
         7 . The ocular implant of  claim 5 , wherein a peak circumferential flow rate through the ocular implant comprises 5.7 μl/min. 
     
     
         8 . The ocular implant of  claim 1 , wherein the average outflow facility of the eye prior to implantation of the ocular implant comprises 0.138 μl/min/mmHg. 
     
     
         9 . An ocular implant adapted to reside at least partially in a portion of Schlemm's canal of an eye adjacent to collector channels of the eye, the implant comprising:
 a longitudinally extending curved body including a proximal portion and a distal portion;   the distal portion of the curved body defining a longitudinal channel including a channel opening; and   the curved body being adapted and configured such that the distal portion of the curved body resides in Schlemm's canal and the proximal portion extends into the anterior space of the eye while the ocular implant assumes an orientation in which the channel opening is adjacent a major side of Schlemm's canal when the ocular implant is implanted;   wherein the ocular implant is configured to provide a 121%-222% increase in average outflow facility of aqueous humor from the anterior chamber through the collector channels of the eye.   
     
     
         10 . The ocular implant of  claim 9 , wherein the implant comprises at least three openings across from the central channel. 
     
     
         11 . The ocular implant of  claim 10 , wherein the average outflow facility comprises 0.438 μl/min/mmHg. 
     
     
         12 . The ocular implant of  claim 10 , wherein a peak circumferential flow rate through the ocular implant comprises 3.2 μl/min. 
     
     
         13 . The ocular implant of  claim 9 , wherein the implant comprises at least six openings across from the central channel. 
     
     
         14 . The ocular implant of  claim 13 , wherein the average outflow facility comprises 0.638 μl/min/mmHg. 
     
     
         15 . The ocular implant of  claim 13 , wherein a peak circumferential flow rate through the ocular implant comprises 5.70 min. 
     
     
         16 . The ocular implant of  claim 9 , wherein the average outflow facility of the eye prior to implantation of the ocular implant comprises 0.138 μl/min/mmHg. 
     
     
         17 . The ocular implant of  claim 10 , wherein the distal portion of the curved body occupies up to 20% of Schlemm's canal but accounts for up to 54.5% of total outflow in the eye. 
     
     
         18 . The ocular implant of  claim 13 , wherein the distal portion of the curved body occupies up to 40% of Schlemm's canal but accounts for up to 74.6% of total outflow in the eye. 
     
     
         19 . An ocular implant comprising an inlet portion and a Schlemm's canal portion distal to the inlet portion, the inlet portion being disposed at a proximal end of the implant and sized and configured to be placed within an anterior chamber of a human eye, the inlet portion having an inlet adapted to be in fluid communication with the anterior chamber, the Schlemm's canal portion comprising:
 a central channel in fluid communication with the inlet, the central channel extending longitudinally in the Schlemm's canal portion;   a first element disposed along the central channel;   a second element disposed along the central channel distal to the first element;   a third element disposed along the central channel distal to the first element and proximal to the second;   a fourth element disposed along the central channel distal to the second element;   the first, second, third and fourth elements each comprising two edges partially defining an elongate opening in fluid communication with the central channel, each of the first, second, third and fourth elements having circumferential extents less than 360 degrees so that the elongate opening extends continuously along the first, second, third and fourth elements, the circumferential extents of the first and second elements being less than the circumferential extents of the third and fourth elements;   the Schlemm's canal portion being arranged and configured to be disposed within Schlemm's canal of the eye when the inlet portion is disposed in the anterior chamber, wherein the ocular implant is configured to provide a 121%-222% increase in average outflow facility of aqueous humor from the anterior chamber through the collector channels of the eye.   
     
     
         20 . The ocular implant of  claim 19 , wherein the implant comprises at least three openings across from the central channel. 
     
     
         21 . The ocular implant of  claim 20 , wherein the average outflow facility comprises 0.438 μl/min/mmHg. 
     
     
         22 . The ocular implant of  claim 20 , wherein a peak circumferential flow rate through the ocular implant comprises 3.2 μl/min. 
     
     
         23 . The ocular implant of  claim 19 , wherein the implant comprises at least six openings across from the central channel. 
     
     
         24 . The ocular implant of  claim 23 , wherein the average outflow facility comprises 0.638 μl/min/mmHg. 
     
     
         25 . The ocular implant of  claim 23 , wherein a peak circumferential flow rate through the ocular implant comprises 5.7 μl/min. 
     
     
         26 . The ocular implant of  claim 19 , wherein the average outflow facility of the eye prior to implantation of the ocular implant comprises 0.138 μl/min/mmHg. 
     
     
         27 . The ocular implant of  claim 20 , wherein the Schlemm's canal portion occupies up to 20% of Schlemm's canal but accounts for up to 54.5% of total outflow in the eye. 
     
     
         28 . The ocular implant of  claim 23 , wherein the Schlemm's canal portion occupies up to 40% of Schlemm's canal but accounts for up to 74.6% of total outflow in the eye. 
     
     
         29 . A method of treating glaucoma comprising:
 supporting tissue forming Schlemm's canal in an eye with an implant extending at least partially in the canal along an axial length within the canal;   contacting with the implant less than 50% of the tissue forming the canal along the axial length   disposing an inlet portion of the implant in an anterior chamber of the eye; and   providing fluid communication between the anterior chamber and the canal axially through the inlet into a channel of the implant such that an average outflow facility between the anterior chamber and the canal is increased by 121%-222%; and   wherein the implant comprises open areas separated by spine areas along a first longitudinal section, the spine areas partially defining the channel, the supporting step comprising orienting the first longitudinal section openings towards a trabecular mesh portion of the canal.   
     
     
         30 . An ocular implant adapted to reside at least partially in a portion of Schlemm's canal of a human eye, the implant comprising:
 a body configured to extend within Schlemm's canal in a curved volume having a large radius side and a short radius side, the body having a circumferential extent within the curved volume that varies along the length of the body between sections having a lesser circumferential extent and sections having a greater circumferential extent, wherein the body defines a channel extending longitudinally through the body, the channel having a substantially open side disposed on the large radius side at one of the sections of lesser circumferential extent and an adjacent section of greater circumferential extent and a plurality of openings along the length of the body on the short radius side, the openings being in fluid communication with the channel; and,   an inlet portion configured to be disposed in an anterior chamber of the eye when the body is in Schlemm's canal, the inlet portion disposed on a proximal end of the body in fluid communication with the channel, the inlet portion defining one or more openings in fluid communication with the anterior chamber of the eye;   wherein the ocular implant is configured to provide a 121%-222% increase in average outflow facility of aqueous humor from the anterior chamber through the collector channels of the eye.   
     
     
         31 . An ocular implant adapted to reside at least partially in a portion of Schlemm's canal of an eye, the eye having an iris defining a pupil, the implant comprising:
 a longitudinally extending curved body including a proximal portion and a distal portion, the distal portion of the curved body having a central longitudinal axis defined by a radius of curvature and a lateral cross section having a first lateral extent and a second lateral extent, an aspect ratio of the first lateral extent to the second lateral extent being greater than or equal to about two;   the distal portion of the curved body defining a longitudinal channel including a channel opening, the channel opening included in defining the first lateral extent;   the curved body being adapted and configured such that the distal portion of the curved body resides in Schlemm's canal and the proximal portion extends into the anterior space of the eye while the ocular implant assumes an orientation in which the channel opening is adjacent a major side of Schlemm's canal when the ocular implant is implanted; and   wherein the ocular implant is configured to provide a 121%-222% increase in average outflow facility of aqueous humor from the anterior chamber through the collector channels of the eye.