Implantable biologic stent and system for biologic material shaping and preparation in the treatment of glaucoma
A system for preparation of an implant and ab interno insertion of the implant into an eye including a handle having one or more actuators and an elongated shaft having an outer sheath and an elongate member positioned within a lumen of the tubular outer sheath. The system includes a recess sized for holding a patch of material fixed relative to the handle and a cutting member movable relative to the handle and to the recess. The cutting member cuts the patch of material into an implant as the cutting member moves towards a cutting configuration. The implant, once cut, is axially aligned with the lumen of the tubular outer sheath. The inner elongate member is movable relative to the tubular outer sheath to advance the implant into a deployment position in the lumen of the tubular outer sheath for delivery into the eye. Related devices and methods are provided.
1 . An implant for minimally-invasive implantation into an eye, the implant being a piece of a biologically-derived material comprising corneal tissue or scleral tissue, the piece having a length between a first end and a second, opposite end of the piece that is greater than a width of the piece, the implant being contained within a distal end region of an elongate tubular member sized for insertion through a minimally-invasive penetration of the eye,
wherein the biologically-derived material is porous and has a hydrophilic permeability that allows fluid to move from the first end towards the second, opposite end and a structure that reinforces a treatment location between internal eye tissue layers to maintain aqueous outflow from an anterior chamber of the eye via the treatment location so as to provide intraocular pressure regulation.
2 . The implant of claim 1 , wherein the treatment location is within or near Schlemm's canal or a cyclodialysis cleft.
3 . The implant of claim 1 , wherein the hydrophilic permeability provides for fluid filtration through the biologically-derived material.
4 . The implant of claim 1 , wherein, upon implantation in the eye, fluid passes along outside surfaces of the biologically-derived material in a direction from the first end towards the second, opposite end.
5 . The implant of claim 1 , wherein the biologically-derived material is conformable to an internal wall of a sclera of the eye.
6 . The implant of claim 1 , wherein the biologically-derived material comprises tissue harvested from a donor or a patient being treated by the implant.
7 . The implant of claim 1 , wherein the length of the implant is 1-10 mm, the width of the implant is 100-1500 microns, and a thickness of the implant is 100-800 microns.
8 . The implant of claim 1 , wherein the implant further comprises one or more therapeutic agents deliverable from the biologically-derived material.
9 . The implant of claim 1 , wherein the implant comprises a longitudinal axis between the first end and the second, opposite end, wherein the longitudinal axis of the implant is aligned with a longitudinal axis of a lumen of the elongate tubular member and the first end is arranged nearer to a distal opening from the elongate tubular member than the second, opposite end.
10 . A system for treating glaucoma, the system comprising:
an elongate tubular member sized for insertion through a minimally-invasive penetration of an eye; and
an implant for minimally-invasive implantation into the eye, the implant being a piece of a biologically-derived material comprising corneal tissue or scleral tissue, the piece having a length between a first end and a second, opposite end of the piece that is greater than a width of the piece, wherein the implant is contained within a distal end region of the elongate tubular member,
wherein, upon implantation in the eye, the biologically-derived material has a structure that reinforces a treatment location within or near Schlemm's canal and allows fluid to move from the first end towards the second, opposite end to maintain aqueous outflow from an anterior chamber of the eye into Schlemm's canal so as to provide intraocular pressure regulation.
11 . The system of claim 10 , wherein, upon implantation in the eye, fluid passes along outside surfaces of the biologically-derived material in a direction from the first end towards the second, opposite end.
12 . The system of claim 10 , wherein the biologically-derived material is porous and has a hydrophilic permeability that provides for fluid filtration through the biologically-derived material.
13 . The system of claim 10 , wherein the biologically-derived material comprises tissue harvested from a donor or a patient being treated by the system.
14 . The system of claim 10 , wherein the length of the implant is 1-10 mm, the width of the implant is 100-1500 microns, and a thickness of the implant is 100-800 microns.
15 . The system of claim 10 , wherein the implant further comprises one or more therapeutic agents deliverable from the biologically-derived tissue-material.
16 . The system of claim 10 , wherein the implant comprises a longitudinal axis between the first end and the second, opposite end, wherein the longitudinal axis of the implant is aligned with a longitudinal axis of a lumen of the elongate tubular member and the first end is arranged nearer to a distal opening from the elongate tubular member than the second, opposite end.
17 . The system of claim 10 , wherein the distal end region of the elongate tubular member is angled or curved.
18 . The system of claim 10 , wherein the distal end region of the elongate tubular member is capable of flexing from being straight to being curved.