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 . A method of treating an eye, the method comprising:
inserting an implant into the eye ab interno, the implant being a biologically-derived tissue comprising corneal tissue or scleral tissue cut to have a length between a first end and a second, opposite end of the implant that is greater than a width of the implant, 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;
positioning the implant into a treatment location between internal eye tissue layers;
structurally reinforcing the treatment location with the implant; and
increasing aqueous outflow from an anterior chamber of the eye via the treatment location.
2 . The method of claim 1 , wherein increasing aqueous outflow treats glaucoma.
3 . The method of claim 1 , further comprising passing fluid along outside surfaces of the biologically-derived tissue.
4 . The method of claim 1 , wherein the biologically-derived tissue serves as a structural spacer and creates a gap along the implant.
5 . The method of claim 1 , wherein the biologically-derived tissue is porous and has a hydrophilic permeability.
6 . The method of claim 5 , wherein the hydrophilic permeability provides for fluid filtration through the biologically-derived tissue from the first end towards the second, opposite end so as to provide intraocular pressure regulation.
7 . The method of claim 1 , wherein the biologically-derived tissue is biocompatible and conformable to an internal wall of a sclera of the eye.
8 . The method of claim 1 , wherein the biologically-derived tissue comprises tissue harvested from a donor or a patient being treated by the method.
9 . The method 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.
10 . The method of claim 1 , wherein the implant further comprises one or more therapeutic agents deliverable from the biologically-derived tissue.
11 . The method of claim 1 , wherein one of the internal eye tissue layers comprises sclera.
12 . The method of claim 11 , wherein another one of the internal eye tissue layers comprises ciliary tissue and/or choroidal tissue.
13 . The method of claim 1 , wherein positioning the implant into the treatment location positions at least one surface of the implant adjacent an internal wall of a sclera of the eye.
14 . The method of claim 1 , wherein positioning the implant into the treatment location positions at least one surface of the implant adjacent an internal wall of a sclera of the eye within or near Schlemm's canal or a cyclodialysis cleft.
15 . The method of claim 1 , wherein positioning the implant into the treatment location comprises positioning at least the first end of the implant to reside at least in part between a ciliary body and a sclera of the eye.
16 . The method of claim 1 , wherein positioning the implant into the treatment location comprises positioning at least the second, opposite end of the implant to reside at least in part between a ciliary body and a sclera within a cyclodialysis cleft of the eye.
17 . The method of claim 1 , wherein positioning the implant into the treatment location comprises positioning at least the first end of the implant to reside at least in part within or near Schlemm's canal.
18 . The method of claim 1 , wherein the positioning the implant into the treatment location results in the first end residing at least in part within or near Schlemm's canal and the second end residing at least in part within the anterior chamber.
19 . The method of claim 1 , wherein positioning the implant into the treatment location comprises positioning the first end of the implant between a ciliary body and a sclera of the eye or between a choroid and the sclera of the eye and the second end within an anterior chamber of the eye.
20 . The method of claim 1 , wherein inserting the implant into the eye ab interno comprises:
inserting at least the distal end region of the elongate tubular member into the anterior chamber of the eye; and
positioning the distal end region adjacent the treatment location.
21 . The method of claim 20 , wherein inserting at least the distal end region of the elongate tubular member into the anterior chamber comprises inserting the implant ab interno through a corneal incision.
22 . The method of claim 1 , wherein positioning the implant into the treatment location comprises deploying the implant contained within a lumen of the elongate tubular member through at least a portion of the lumen such that the implant engages the treatment location.
23 . The method of claim 22 , wherein positioning the implant into the treatment location comprises positioning the implant at least in part between a ciliary body and a sclera of the eye while the implant is at least partially inside the lumen of the distal end region.
24 . The method of claim 22 , wherein deploying the implant comprises retracting the elongate tubular member proximally from the implant and preventing the implant from moving proximally relative to the treatment location.
25 . The method of claim 22 , wherein deploying the implant comprises pushing the implant out of the elongate tubular member and into the treatment location.
26 . The method of claim 1 , wherein the implant comprises a longitudinal axis between the first end and the second 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 end.
27 . The method of claim 1 , wherein the distal end region of the elongate tubular member is angled or curved.
28 . The method of claim 1 , wherein the distal end region of the elongate tubular member is capable of flexing from being straight to being curved.
29 . The method of claim 1 , wherein inserting the implant into the eye ab interno comprises:
inserting at least the distal end region of the elongate tubular member into the anterior chamber of the eye; and
positioning the distal end region adjacent the treatment location.
30 . The method of claim 29 , wherein inserting at least the distal end region of the elongate tubular member into the anterior chamber comprises inserting the implant ab interno through a corneal incision.
31 . A method of treating an eye, the method comprising:
inserting an implant into the eye ab interno, the implant being a biologically-derived tissue cut to have a length between a first end and a second, opposite end of the implant that is greater than a width of the implant, wherein the biologically-derived tissue comprises tissue harvested from a donor or a patient being treated by the method, and wherein the implant is contained within a distal end region of an elongate tubular member sized for insertion through a minimally-invasive penetration of the eye;
positioning the implant into a treatment location between internal eye tissue layers;
structurally reinforcing the treatment location with the implant; and
increasing aqueous outflow from an anterior chamber of the eye via the treatment location.
32 . The method of claim 31 , wherein increasing aqueous outflow treats glaucoma.
33 . The method of claim 31 , further comprising passing fluid along outside surfaces of the biologically-derived tissue.
34 . The method of claim 31 , wherein the biologically-derived tissue comprises corneal tissue or scleral tissue.
35 . The method of claim 31 , wherein the biologically-derived tissue serves as a structural spacer and creates a gap along the implant.
36 . The method of claim 31 , wherein the biologically-derived tissue is porous and has a hydrophilic permeability.
37 . The method of claim 36 , wherein the hydrophilic permeability provides for fluid filtration through the biologically-derived tissue from the first end towards the second, opposite end so as to provide intraocular pressure regulation.
38 . The method of claim 31 , wherein the biologically-derived tissue is biocompatible and conformable to an internal wall of a sclera of the eye.
39 . The method of claim 31 , 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.
40 . The method of claim 31 , wherein the implant further comprises one or more therapeutic agents deliverable from the biologically-derived tissue.
41 . The method of claim 31 , wherein one of the internal eye tissue layers comprises sclera.
42 . The method of claim 41 , wherein another one of the internal eye tissue layers comprises ciliary tissue and/or choroidal tissue.
43 . The method of claim 31 , wherein positioning the implant into the treatment location positions at least one surface of the implant adjacent an internal wall of a sclera of the eye.
44 . The method of claim 31 , wherein positioning the implant into the treatment location positions at least one surface of the implant adjacent an internal wall of a sclera of the eye within or near Schlemm's canal or a cyclodialysis cleft.
45 . The method of claim 31 , wherein positioning the implant into the treatment location comprises positioning at least the first end of the implant to reside at least in part between a ciliary body and a sclera of the eye.
46 . The method of claim 31 , wherein positioning the implant into the treatment location comprises positioning at least the second, opposite end of the implant to reside at least in part between a ciliary body and a sclera within a cyclodialysis cleft of the eye.
47 . The method of claim 31 , wherein positioning the implant into the treatment location comprises positioning at least the first end of the implant to reside at least in part within or near Schlemm's canal.
48 . The method of claim 31 , wherein the positioning the implant into the treatment location results in the first end residing at least in part within or near Schlemm's canal and the second end residing at least in part within the anterior chamber.
49 . The method of claim 31 , wherein positioning the implant into the treatment location comprises positioning the first end of the implant between a ciliary body and a sclera of the eye or between a choroid and the sclera of the eye and the second end within an anterior chamber of the eye.
50 . The method of claim 31 , wherein the implant comprises a longitudinal axis between the first end and the second 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 end.
51 . The method of claim 31 , wherein the distal end region of the elongate tubular member is angled or curved.
52 . The method of claim 31 , wherein the distal end region of the elongate tubular member is capable of flexing from being straight to being curved.
53 . The method of claim 31 , wherein positioning the implant into the treatment location comprises deploying the implant contained within a lumen of the elongate tubular member through at least a portion of the lumen such that the implant engages the treatment location.
54 . The method of claim 53 , wherein positioning the implant into the treatment location comprises positioning the implant at least in part between a ciliary body and a sclera of the eye while the implant is at least partially inside the lumen of the distal end region.
55 . The method of claim 53 , wherein deploying the implant comprises retracting the elongate tubular member proximally from the implant and preventing the implant from moving proximally relative to the treatment location.
56 . The method of claim 53 , wherein deploying the implant comprises pushing the implant out of the elongate tubular member and into the treatment location.