DEVICES AND SYSTEMS FOR CUTTING, LOADING, AND DELIVERING BIOLOGIC INTRAOCULAR IMPLANTS FOR INCREASED AQUEOUS OUTFLOW AND LOWERING OF INTRAOCULAR PRESSURE
A system for treating an eye comprising a tissue stored within a lumen of an elongated cannula, the tissue comprises scleral, amniotic membrane, or acellular biomatrix tissue and having an elongated form factor. Related devices, systems, and methods are provided.
1 . A system of treating glaucoma of an eye comprising:
a first implant;
a second implant; and
at least one delivery cannula,
wherein the first implant and the second implant are each formed of dehydrated, biologically-derived tissue cut to have a first size for being received within a lumen of the at least one delivery cannula,
wherein the dehydrated, biologically-derived tissue of each of the first implant and the second implant rehydrates upon deployment in the eye and expands from the first size to a second, larger size thereby opening a space between internal eye tissue layers of a treatment site to facilitate aqueous outflow from an anterior chamber of the eye through the treatment site.
2 . The system of claim 1 , wherein the biologically-derived tissue of the first implant is the same as the biologically-derived tissue of the second implant.
3 . The system of claim 1 , wherein the dehydrated, biologically-derived tissue is corneal tissue, scleral tissue, or amniotic membrane tissue.
4 . The system of claim 1 , wherein the at least one delivery cannula is sized and shaped for ab interno insertion through an incision.
5 . The system of claim 1 , wherein the first size of at least one of the first implant and the second implant comprises a width of 400-800 microns.
6 . The system of claim 1 , wherein the second size of at least one of the first implant and the second implant following rehydration is at least 50% up to about 200% greater than the first size.
7 . The system of claim 1 , wherein the second size of at least one of the first implant and the second implant is at least 1.2× up to about 3× the first size.
8 . The system of claim 1 , wherein at least one of the first implant and the second implant has a dehydrated maximum thickness of about 600 microns and a hydrated maximum thickness of about 1000 microns.
9 . The system of claim 1 , wherein the treatment site in the eye comprises a suprachoroidal space, a supraciliary space, or Schlemm's canal.
10 . The system of claim 1 , wherein a scaffold and a reservoir are created within the treatment site upon inserting the second implant near the first implant.
11 . The system of claim 10 , wherein a distance between the first implant and the second implant is about 0.5 mm-2.0 mm around a circumference of the eye.
12 . The system of claim 11 , wherein the first implant and the second implant are positionable about 5 degrees to about 20 degrees apart on a 12 mm diameter circle of the eye.
13 . The system of claim 1 , wherein the first implant and/or the second implant has a form factor of a disk, pellet, plug, rod, strip, or an angular wedge.
14 . The system of claim 1 , wherein a first implant is scleral tissue and the second implant is amniotic membrane tissue, wherein the second implant acts as an adjunct treatment for the first implant by releasing one or more healing factors derived from the amniotic membrane tissue.
15 . The system of claim 1 , wherein the at least one delivery cannula comprises an elongate shaft and an outer tube member that extends over at least a distal end region of the elongate shaft forming a distal end of the at least one delivery cannula.
16 . The system of claim 15 , wherein the outer tube member is a polymeric material that is translucent or transparent.
17 . The system of claim 15 , wherein the distal end of the at least one delivery cannula curves or bends away from a longitudinal axis of a proximal end region of the at least one delivery cannula.
18 . The system of claim 15 , wherein the distal end of the at least one delivery cannula comprises a beveled distal tip at a distal opening from the lumen.
19 . The system of claim 1 , wherein the first implant and the second implant create a scaffold within the treatment site to facilitate aqueous outflow from the anterior chamber through the treatment site.
20 . The system of claim 1 , wherein the at least one delivery cannula is a single delivery cannula containing at least the first implant and the second implant.