New ocular device and method for glaucoma treatment

Abstract

An implantable ocular drain includes a body and a compliant portion. The body includes a first end configured to seat in an anterior chamber of an eye. The first end includes an inlet for ingress of aqueous humor into the implantable ocular drain. The body further includes a second end configured to seat in a tear film of the eye. The second end includes an outlet to release a flow of the aqueous humor into the tear film. The body further defines a tortuosity and a fluid conduit. The body includes a lumen having a lumen length and a lumen cross sectional area. The lumen length and the lumen cross sectional area and the tortuosity are configured to control an intraocular pressure (IOP) of the eye by controlling the flow of the aqueous humor through the lumen. The compliant portion is at the second end.

What is claimed is: 
     
         1 . An implantable ocular drain comprising:
 a body comprising a first end configured to seat in an anterior chamber of an eye, the first end including an inlet for ingress of aqueous humor into the implantable ocular drain;   the body further comprising a second end configured to seat in a tear film of the eye, the second end including an outlet to release a flow of the aqueous humor into the tear film;   the body further defining a tortuosity and a fluid conduit, the body including a lumen having a lumen length and a lumen cross sectional area, wherein the lumen length and the lumen cross sectional area and the tortuosity are configured to control an intraocular pressure (IOP) of the eye by controlling the flow of the aqueous humor through the lumen; and   a compliant portion at the second end.   
     
     
         2 . The ocular drain of  claim 1 , wherein the IOP is controlled without a filter, a valve, or a narrowing in the fluid conduit. 
     
     
         3 . The ocular drain of  claim 1 , wherein the lumen includes a lumen cross sectional shape that is circular and the lumen length and the lumen cross sectional area are calculated according to the following equations:
   Δ P= 8μ L Q/πr   4   (Equation 1)
   wherein,   ΔP is a pressure difference between the first end and the second end;   L is the length of the fluid conduit;   μ is a dynamic viscosity of the aqueous humor, μ=7.2×10 −4  Pa·sec at 37° C.;   Q is a volumetric flow rate of the aqueous humor in the fluid conduit; and   r is a radius of the fluid conduit;
     R= 1/ Ct= 8μ L/πr   4   (Equation 2)
 
   wherein,   R is a flow resistance between the first end and the second end; and   Ct is a drain facility of the ocular drain.   
     
     
         4 . The ocular drain of  claim 1 , wherein the inlet has a smaller cross-sectional area than the lumen cross sectional area to reduce clogging of the ocular drain. 
     
     
         5 . The ocular drain of  claim 1 , wherein the first end of the inlet includes a plurality of inlets. 
     
     
         6 . The ocular drain of  claim 1 , wherein the first end of the inlet faces away from the trabecular meshwork. 
     
     
         7 . The ocular drain of  claim 1 , wherein the lumen includes an antimicrobial agent to reduce bacterial ingrowth, wherein the antimicrobial agent is selected from the group consisting of antimicrobial agent/polymer composites, antimicrobial agent/silicone composites, ceramic, glass, stainless steel, metal, metal ion, metal oxide, metal compound, silver, silver oxide, silver nitrate, silver compound, silver nanoparticles, copper, zinc, zinc oxide, platinum, and titanium. 
     
     
         8 . The ocular drain of  claim 1 , wherein the lumen cross sectional area is configured to increase along the lumen length from the first end to the second end. 
     
     
         9 . The ocular drain of  claim 1 , wherein the compliant portion is lubricious to reduce irritation to the eye. 
     
     
         10 . The ocular drain of  claim 1 , wherein the ocular drain further comprises one or more suture holes to anchor the ocular drain in the eye. 
     
     
         11 . The ocular drain of  claim 1 , wherein the ocular drain further comprises one or more retainers to anchor the ocular drain in the eye, wherein the retainers are selected from the group comprising fiber, wire, thread, bump, nodule, ridge, protrusion, mesh, brush, foam, and scaffold. 
     
     
         12 . The ocular drain of  claim 1 , wherein the ocular drain further comprises an adjustable flow restrictor with a distal end and a proximal end, wherein the distal end is configured to seat in the fluid conduit; wherein the proximal end is configured to position in the tear film of the eye, wherein the adjustable flow restrictor is adjustable non-invasively to modify the IOP of the eye and the flow resistance of the ocular drain by controlling one or both of a length of the adjustable flow restrictor and a cross sectional area of the adjustable flow restrictor while the ocular drain is implanted in the eye 
     
     
         13 . The ocular drain of  claim 12 , wherein the adjustable flow restrictor is tapered along the length from the proximal end to the distal end. 
     
     
         14 . The ocular drain of  claim 12 , wherein the adjustable flow restrictor comprises a wire. 
     
     
         15 . The ocular drain of  claim 12 , wherein the adjustable flow restrictor comprises a plurality of wires with various lengths. 
     
     
         16 . The ocular drain of  claim 12 , wherein the adjustable flow restrictor comprises a tube. 
     
     
         17 . The ocular drain of  claim 12 , wherein the adjustable flow restrictor comprises a drug. 
     
     
         18 . The ocular drain of  claim 1 , wherein the ocular drain further comprises a plate or a coating to retain the shape of the ocular drain and protect the ocular drain, wherein the ocular drain is integrated with the plate or the coating. 
     
     
         19 . A method for treating a patient having glaucoma, the method comprising:
 (a) measuring a pre-operative intraocular pressure (IOP) in an eye of the patient;   (b) implanting the ocular drain of  claim 1  into the eye, wherein at least one of the lumen length and the lumen cross sectional area is selected in response to the measured pre-operative TOP; and   (c) measuring a post-operative IOP to confirm treatment of the patient.   
     
     
         20 . The method of  claim 19 , further comprising adjusting an adjustable flow restrictor in response to the post-operative IOP being outside a normal IOP range.