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 method of treating glaucoma of an eye comprising:
inserting a first implant in a treatment site in an eye, wherein the implant comprises dehydrated, biologically-derived tissue having a first size;
opening a space within the treatment site with the implant due to the dehydrated, biologically-derived tissue of the implant rehydrating in the eye and expanding from the first size to a second size; and
inserting a second implant near the treatment site of the first implant,
wherein the first implant and the second implant are both formed and cut of dehydrated, biologically-derived tissue, wherein the biologically-derived tissue of the first implant is the same as or different from the biologically-derived tissue of the second implant,
wherein the second implant creates a scaffold with the first implant and a reservoir within a target site between the first implant and the second implant, and
wherein the treatment site is between internal eye tissue layers, and wherein opening the space within the treatment site increases outflow of aqueous from an anterior chamber of the eye through the treatment site between the internal eye tissue layers.
2. The method of claim 1 , wherein the dehydrated, biologically-derived tissue is cornea, sclera, or amniotic membrane.
3. The method of claim 1 , further comprising inserting the first implant into the treatment site ab externo via a scleral flap.
4. The method of claim 1 , further comprising inserting the first implant into the treatment site ab interno.
5. The method of claim 4 , wherein inserting the first implant ab interno comprises advancing a delivery cannula through a cornea of the eye and advancing the delivery cannula towards the treatment site, the first implant having the first size contained within a lumen of the delivery cannula for deploying the first implant in the treatment site.
6. The method of claim 1 , wherein the first size of the first implant comprises a width of 400-800 microns.
7. The method of claim 1 , wherein the second size of the first implant following rehydration is at least 50% up to about 200% greater than the first size of the first implant.
8. The method of claim 1 , wherein the second size of the first implant is at least 1.2× up to about 3× the first size of the first implant.
9. The method of claim 1 , wherein the first implant has a dehydrated maximum thickness of about 600 microns and a hydrated maximum thickness of about 1000 microns.
10. The method of claim 1 , wherein the dehydrated, biologically-derived tissue is dehydrated using ethyl alcohol or by lyophilizing.
11. The method of claim 1 , wherein the treatment site in the eye comprises a suprachoroidal space, a supraciliary space, a Schlemm's canal, or an anterior chamber.
12. The method of claim 1 , wherein the first implant deployed in the treatment site provides aqueous communication between an anterior chamber of the eye and at least one of a supraciliary space, a suprachoroidal space, a Schlemm's Canal, and a sub-conjunctival space.
13. The method of claim 1 , wherein the treatment site includes a sub-conjunctival space of the eye and the first implant extends trans-sclerally from a sub-scleral location to a supra-scleral location.
14. The method of claim 1 , wherein the first implant provides sub-scleral, trans-scleral, or supra-scleral occlusion, stenting, and/or tissue reinforcement.
15. The method of claim 1 , further comprising compressing the first implant into a plug prior to deploying in the treatment site.
16. The method of claim 15 , further comprising stenting the treatment site with the plug.
17. The method of claim 15 , further comprising occluding the treatment site with the plug, the treatment site being a wall rupture or over-filtering bleb.
18. The method of claim 1 , 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.
19. The method of claim 18 , wherein the first implant and the second implant are positioned about 5 degrees to about 20 degrees apart on a 12 mm diameter circle of the eye.