One-piece minicapsulorhexis valve

Abstract

A one-piece capsulorhexis device is presented comprising a membrane having a curved, flexible substantially discoid flap-valve member shaped to align with an ocular lens capsular bag inner surface, and at least one integral, flexible retainer shaped to align with an ocular lens capsular bag outer surface.

1 . A one-piece capsulorhexis device for insertion in a lens capsule, comprising:  
     a unitary flexible discoid section having a peripheral region and a central region; and  
     a plurality of integral retainers, each having proximal and distal ends, said distal end extending radially outward from the central region of the discoid portion,  
     wherein the peripheral region of the discoid section is positioned along an interior surface of a lens capsule and said retainers are positioned along an outer surface of the lens capsule such that a wall of a lens capsule is fixedly positioned between the peripheral region of the discoid section and the retainers; and 
 wherein the device is made from a polymer.  
 
   
   
       2 - 5 . (canceled)  
   
   
       6 . The device according to  claim 1 , wherein the discoid portion comprises a peripheral region and a central region, wherein the thickness of the peripheral region is greater than the thickness of the central region.  
   
   
       7 - 10 . (canceled)  
   
   
       11 . The device according to  claim 1 , further comprising a rectangular aperture in the distal end.  
   
   
       12 - 15 . (canceled)  
   
   
       16 . The device according to  claim 1 , wherein the device is made from a synthetic polymer.  
   
   
       17 . The device according to  claim 1 , wherein the device is made from an organic polymer.  
   
   
       18 . The device according to  claim 1 , wherein the device is made from a sterilizable material.  
   
   
       19 . The device according to  claim 1 , wherein the device is impregnated with a therapeutic agent.  
   
   
       20 . The device according to  claim 19 , wherein the therapeutic agent is dispersed from the device.  
   
   
       21 . The device according to  claim 19 , wherein the therapeutic agent is time-released.  
   
   
       22 . The device according to  claim 19 , wherein the therapeutic agent is released by photo-activation.  
   
   
       23 . The device according to  claim 1 , wherein the polymer comprises a biocompatible elastomer, which is selected from the group consisting of: urethanes, silicones, cross-linkable polydimethylsiloxanes, cross-linkable dimethyldiphenylsiloxanes, polyacrylamides, poly-N-vinylpyrrolidones, hydroxyalkylacrylates, hydroxyethylmethacrylate, poly-tetrafluoroethylene, polyethylene, and polyethyleneglycol diacrylate.  
   
   
       24 . The device according to  claim 1 , wherein the polymer comprises a biocompatible elastomer, which comprises a biodegradable material capable of biodegradation upon photo-activation.  
   
   
       25 . The device according to  claim 1 , wherein the polymer comprises a biocompatible elastomer, which is selected from the group consisting of collagen, collagen derivatives, processed amniotic membrane material, cross-linked sodium hyaluronate, cross-linked polysaccharides and mixtures thereof.  
   
   
       26 . The device according to  claim 1 , wherein the polymer comprises a biocompatible elastomer, which comprises a 10 to 80 Shore A durometer medical grade crosslinkable trimethyl polydimethylsiloxane.  
   
   
       27 . The device according to  claim 1 , wherein the polymer comprises an elastomer, which is transparent to radiation of a wavelength of from about 300 nm to about 1100 nm  
   
   
       28 . The device according to  claim 1 , wherein the polymer comprises an elastomer, which is transparent to radiation of a wavelength of from about 300 nm to about 400 nm.  
   
   
       29 . The device according to  claim 1 , wherein the polymer comprises an elastomer, which is transparent to radiation of a wavelength of from about 400 nm to about 700 nm.  
   
   
       30 . The device according to  claim 1 , wherein the polymer comprises an elastomer, which is transparent to radiation of a wavelength of from about 700 nm to about 1100 nm.  
   
   
       31 . The device according to  claim 1 , wherein the discoid portion has a central region and a peripheral flange.  
   
   
       32 . The device according to  claim 31 , wherein the peripheral flange has a greater thickness than the central region.  
   
   
       33 . The device according to  claim 31 , wherein the central region has a greater thickness than the peripheral flange.  
   
   
       34 . (canceled)  
   
   
       35 . (canceled)  
   
   
       36 . The device according to  claim 1 , wherein the device further comprises an alignment indicia.  
   
   
       37 . A unitary capsulorhexis valve device comprising: a membrane made from a material transparent to radiation, said membrane having a wavelength transmission of from about 300 nm to about 1100 nm, said material made from a biocompatible elastomer selected from the group consisting of urethanes, silicones, cross-linkable polydimethylsiloxanes, cross-linkable dimethyldiphenylsiloxanes, poly-acrylamides, poly-N-vinylpyrrolidones, hydroxyalkylacrylates, hydroxyethylmethacrylate, poly-tetrafluoroethylene, polyethylene, poly-ethyleneglycol diacrylate, collagen, collagen derivatives and mixtures thereof, said membrane having a discoid portion and at least one integral retainer, said retainer extending radially outward from the discoid portion.  
   
   
       38 . A method of accessing an ocular lens comprising the steps of: making a limbus incision to open an anterior chamber of an eye; filling the anterior chamber with a viscoelastic solution; creating an anterior capsulorhexis opening in a lens capsule; and inserting into the opening a unitary flexible capsulorhexis valve device comprising a discoid portion having a periphery, and at least one integral flexible retainer such that the periphery of the device is positioned along an interior surface of the lens capsule and said flexible retainer is positioned along an outer surface of the lens capsule, positioning a wall of the lens capsule therebetween.  
   
   
       39 . A method of accessing an ocular lens comprising the steps of: making a limbus incision to open an anterior chamber of an eye; filling the anterior chamber with a viscoelastic solution; creating an anterior capsulorhexis opening in a lens capsule; inserting into the opening a unitary flexible capsulorhexis valve device comprising a discoid portion having a periphery, and at least one integral flexible retainer such that the periphery of the device is positioned along an interior surface of the lens capsule and said flexible retainer is positioned along an outer surface of the lens capsule, positioning a wall of the lens capsule therebetween, said device impregnated with a therapeutic agent; and dispersing the therapeutic agent from the device to the eye.