Intraocular implant, delivery device, and method of implantation

Abstract

An ophthalmic implant for treatment of glaucoma, a delivery device for implanting such an implant, and a method of implanting such an implant. The implant includes a tube having an inlet end, an outlet end, and a tube passage therebetween, and a disk connected to the tube at the outlet end of the tube. The tube passage has a cross-sectional area sufficiently small to inhibit the flow of aqueous humor through the tube passage. The implant provides a bleb of aqueous humor under the conjunctiva so that the bleb and the elasticity of the conjunctiva assist in regulating the flow of aqueous humor through the tube as a function of the IOP. The tube at its inlet end has a beveled surface facing away from the iris and one or more circumferential holes. One or more retention projections are provided for anchoring and may be extended outwardly when the implant is implanted in the eyeball. The disk has an outer rim and one or more inner uprights. The implant is implanted by use of a delivery device comprising a handle and a rodlike instrument, with a tip for insertion into the tube passage of the implant and a retention mechanism for retaining the implant. During implantation, the implant is inserted through a slit in a portion of the conjunctiva which normally lies at a distance away from the intended implantation site.

What is claimed is:  
     
         1 . An intraocular implant for implantation in an eyeball comprising: 
 a tube for implanting into the eyeball comprising an inlet end, an outlet end, and a tube passage extending between the inlet end and the outlet end for permitting aqueous humor to flow out of the eyeball; and    a flanged disk connected to the tube at the outlet end of the tube for placing on a surface of the eyeball;    wherein the tube passage has a cross-sectional area sufficiently small to inhibit the flow of aqueous humor through the tube passage when an intraocular pressure of the eyeball is below a threshold amount.    
     
     
         2 . An intraocular implant according to  claim 1  wherein the tube passage is cylindrical, and wherein a diameter of the tube passage is substantially smaller than a length of the tube passage.  
     
     
         3 . An intraocular implant according to  claim 2  wherein the diameter of the tube passage is about 300 micrometers or less.  
     
     
         4 . An intraocular implant for implantation in an eyeball comprising: 
 a tube for implanting into the eyeball comprising an inlet end with a beveled surface at the inlet end, an outlet end, and a tube passage extending between the inlet end and the outlet end for permitting aqueous humor to flow out of the eyeball; and    a flanged disk connected to the tube at the outlet end of the tube for placing on a surface of the eyeball;    wherein the beveled surface at the inlet end of the tube lies in a first plane forming an angle with the longitudinal axis of the tube and the flanged disk lies in a second plane which is angled opposite to the first plane.    
     
     
         5 . An intraocular implant for implantation in an eyeball comprising: 
 a tube for implanting into the eyeball comprising an inlet end, an outlet end, and a tube passage extending between the inlet end and the outlet end for permitting aqueous humor to flow out of the eyeball; and    a flanged disk connected to the tube at the outlet end of the tube for placing on a surface of the eyeball;    wherein the tube has at least one circumferential hole which opens into the tube passage proximate the inlet end of the tube.    
     
     
         6 . An intraocular implant for implantation in an eyeball comprising: 
 a tube for implanting into the eyeball comprising an inlet end, an outlet end, and a tube passage extending between the inlet end and the outlet end for permitting aqueous humor to flow out of the eyeball; and    a flanged disk connected to the tube at the outlet end of the tube for placing on a surface of the eyeball;    wherein the flanged disk comprises a base, an outer rim, and at least one inner upright, and wherein the base and outer rim form a reservoir having a larger cross-sectional area than the tube passage.    
     
     
         7 . An intraocular implant according to  claim 6  wherein at least one inner upright is curved to form an inner rim proximate an axial outlet opening of the tube and substantially bounding the axial outlet opening of the tube, the flanged disk further comprising at least one passageway in the inner rim for enabling flow of aqueous humor from the axial outlet opening through the passageway.  
     
     
         8 . An intraocular implant according to  claim 6  wherein the flanged disk has an elliptical shape.  
     
     
         9 . An intraocular implant for implantation in an eyeball comprising: 
 a tube for implanting into the eyeball comprising an inlet end, an outlet end, and a tube passage extending between the inlet end and the outlet end for permitting aqueous humor to flow out of the eyeball; and    a flanged disk connected to the tube at the outlet end of the tube for placing on a surface of the eyeball;    wherein the implant has at least one retention projection for anchoring the implant in the eyeball, said retention projection being extended outwardly when the implant is implanted in the eyeball.    
     
     
         10 . An intraocular implant according to  claim 9  wherein at least one retention projection is extended outwardly by an expansion tool when the implant is implanted in the eyeball.  
     
     
         11 . An intraocular implant according to  claim 9  wherein at least one retention projection is constructed of a shape memory alloy and is extended outwardly when subjected to the heat of the eyeball when the implant is implanted in the eyeball.  
     
     
         12 . A method of regulating an intraocular pressure of an eyeball comprising the steps of: 
 providing an intraocular implant comprising (a) a tube for implanting into the eyeball, said tube comprising an inlet end, an outlet end, and a tube passage extending between the inlet end and the outlet end for permitting aqueous humor to flow out of the eyeball, said tube passage having a cross-sectional area sufficiently small to inhibit the flow of aqueous humor through the tube passage when an intraocular pressure of the eyeball is below a threshold amount, and (b) a flanged disk connected to the tube at the outlet end of the tube for placing on a surface of the eyeball; and    implanting the intraocular implant in the eyeball including implanting the tube into the eyeball and placing the flanged disk on a surface of the eyeball.    
     
     
         13 . A delivery device for implanting an intraocular implant into an eyeball, the delivery device comprising: 
 a handle; and    a rodlike instrument;    wherein the rodlike instrument comprises a tip for penetrating a tube passage of the implant and a retention mechanism for retaining the implant on the delivery device.    
     
     
         14 . A delivery device according to  claim 13  wherein the rodlike instrument comprises a probe.  
     
     
         15 . A delivery device according to  claim 13  wherein the rodlike instrument comprises a needle.  
     
     
         16 . A delivery device according to  claim 15  wherein the tip of the rodlike instrument for penetrating a cube passage of the implant comprises a plug inserted in a bore of the needle.  
     
     
         17 . A delivery device according to  claim 13  wherein the retention mechanism comprises an abutment surface for abutting a flanged disk of the implant, wherein the abutment surface has an angle generally corresponding to an angle of the flanged disk.  
     
     
         18 . A method of implanting an intraocular implant into an eyeball comprising the steps of: 
 attaching the implant to a delivery device;    cutting a slit in a portion of the conjunctiva of the eyeball which normally lies at a distance away from an intended implantation site;    placing the implant by the delivery device through the slit in the conjunctiva;    directing the implant by the delivery device to the implantation site;    inserting the implant through the sclera at the implantation site;    withdrawing the delivery device; and    allowing the slit in the conjunctiva to be lie at the distance away from the implantation size.    
     
     
         19 . A method of implanting an intraocular implant according to  claim 18  wherein the distance between the slit in the conjunctiva and the implantation site is about 5 millimeters or more.  
     
     
         20 . A method of implanting an intraocular implant according to  claim 18  wherein the slit has a length of about 2 millimeters or less.  
     
     
         21 . A method of implanting an intraocular implant according to  claim 18  wherein, in the step of inserting the implant through the sclera, the sclera is penetrated by a tip of the tube of the implant.  
     
     
         22 . A method of implanting an intraocular implant according to  claim 18  wherein, in the step of inserting the implant through the sclera, the sclera is penetrated by a needle tip of the delivery device.  
     
     
         23 . A method of implanting an intraocular implant into an eyeball comprising the steps of: 
 attaching the implant to a delivery device;    directing the implant by the delivery device to the implantation site;    inserting the implant through the sclera at the implantation site such that a beveled surface at an inlet end of the implant faces away from the iris; and    withdrawing the delivery device.    
     
     
         24 . A method of implanting an intraocular implant into an eyeball comprising the steps of: 
 attaching the implant to a delivery device;    directing the implant by the delivery device to the implantation site;    inserting the implant through the sclera at the implantation site such that a marker is visible upon penetration through the sclera; and    withdrawing the delivery device.    
     
     
         25 . A method of implanting an intraocular implant according to  claim 24  wherein the marker comprises a circumferential hole.  
     
     
         26 . A method of implanting an intraocular implant into an eyeball comprising the steps of: 
 attaching the implant to a delivery device;    directing the implant by the delivery device to the implantation site;    inserting the implant through the sclera at the implantation site;    extending outwardly at least one retention projection for anchoring the implant in the eyeball; and    withdrawing the delivery device.    
     
     
         27 . A method of implanting an intraocular implant according to  claim 26  wherein, in the step of extending outwardly at least one retention projection, at least one retention projection is extended outwardly by an expansion tool when the implant is implanted in the eyeball.  
     
     
         28 . A method of implanting an intraocular implant according to  claim 26  wherein, in the step of extending outwardly at least one retention projection, at least one retention projection is extended outwardly by the action of a shape memory alloy from which it is constructed when subjected to the heat of the eyeball when the implant is implanted in the eyeball.  
     
     
         29 . A method of implanting an intraocular implant into an eyeball comprising the steps of: 
 attaching the implant to a delivery device comprising a handle and a rodlike instrument comprising a tip for penetrating a tube passage of the implant and a retention mechanism for retaining the implant on the delivery device;    directing the implant by the delivery device to the implantation site;    inserting the implant through the sclera at the implantation site; and    withdrawing the delivery device.    
     
     
         30 . A method of implanting an intraocular implant according to  claim 29  wherein the retention mechanism comprises an abutment surface for abutting a flanged disk of the implant, wherein the abutment surface has an angle generally corresponding to an angle of the flanged disk.  
     
     
         31 . A method of implanting an intraocular implant according to  claim 29  further comprising the step of vibrating the delivery device during the step of inserting the implant through the sclera at the implantation site.