Method and device for subretinal drug delivery

Abstract

Devices and methods for the treatment of the eye are disclosed. Preferred devices of the invention include a piercing member that is inserted into the eye to create a pathway for a cannula. The cannula is slidably mounted to the piercing member and is adapted to reach a treatment site within the eye at which material is injected into and/or withdrawn from the eye. The outer diameter of the piercing member is small enough to allow for self-sealing of the insertion site of the device upon the device's withdrawal therefrom. Also disclosed are methods for the utilizing the devices to treat the eye.

1 . A device for treating an eye comprising:
 a piercing member having a length, an outer diameter, a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end being of sufficient sharpness to cause a penetration of the eye conjunctiva and sclera; and   a cannula having a proximal end, a distal end, a lumen extending between the proximal and distal ends, and an outer diameter, wherein the cannula is slidably disposed within the lumen of the piercing member and wherein the distal end of the cannula is extendable beyond the distal end of the piercing member;   wherein the outer diameter of the piercing member is sized to allow the length of the piercing member to be advanced through the penetration, and for self sealing of the penetration upon removal of the piercing member from the eye.   
   
   
       2 . The device of  claim 1  wherein the length of the piercing member is such that the distal end of the piercing member is capable of accessing any treatment site within the eye when the length of the piercing member is inserted in the eye. 
   
   
       3 . The device of  claim 2  wherein the length of the piercing member is in the range of 22 mm to 30 mm. 
   
   
       4 . The device of  claim 1  wherein the outer diameter of the piercing member is 0.5 mm or less. 
   
   
       5 . The device of  claim 1  wherein a proximal portion of the device is provided to remain outside of the eye after penetration by the piercing member, and wherein angling of the proximal portion of the device outside of the eye provides the distal end of the cannula with access to multiple treatment sites via the penetration. 
   
   
       6 . The device of  claim 5  wherein the proximal portion of the device comprises a handle having a length, a proximal end, a distal end, and a substantially hollow portion, the distal end of the handle being mounted to the piercing member. 
   
   
       7 . The device of  claim 1  wherein the cannula has a length such that when the cannula is advanced through the lumen of the piercing member, the proximal end of the cannula is capable of accessing any treatment site within the eye. 
   
   
       8 . The device of  claim 1  wherein the outer diameter of the cannula is in the range of 0.128 mm to 0.0457 mm. 
   
   
       9 . The device of  claim 1  wherein the cannula comprises polyimide. 
   
   
       10 . The device of  claim 6  further comprising a quantity of tubing having a proximal end, a distal end, and a lumen extending therebetween, the distal end of the tubing being disposed within the substantially hollow portion of the handle. 
   
   
       11 . The device of  claim 10  wherein the quantity of tubing is in fluid connection with the cannula. 
   
   
       12 . The device of  claim 10  wherein the proximal end of the tubing is adapted to be connected to a supply device. 
   
   
       13 . The device of  claim 10  wherein the proximal end of the tubing is adapted to be connected to a syringe. 
   
   
       14 . The device of  claim 1  further comprising a rigid member having a proximal end, a distal end, and a lumen therebetween, wherein the rigid member is in connection with the cannula such that distal-to-proximal movement and proximal-to-distal movement of the rigid member affects movement of the cannula correspondingly. 
   
   
       15 . The device of  claim 14  wherein the cannula comprises polyimide tubing. 
   
   
       16 . The device of  claim 14  wherein the proximal end of the rigid member is connected to the distal end of the tubing, 
   
   
       17 . The device of  claim 16  wherein an epoxy is used to connect the proximal end of the rigid member to the distal end of the tubing, and the distal end of the rigid member to the proximal end of the cannula. 
   
   
       18 . The device of  claim 1  further comprising a housing disposed in the substantially hollow portion of the handle, the housing movable in distal-to-proximal and proximal-to-distal directions. 
   
   
       19 . The device of  claim 18  wherein the housing that is movable in distal-to-proximal and proximal-to-distal directions causes corresponding movement of the cannula in distal-to-proximal and proximal-to-distal directions. 
   
   
       20 . The device of  claim 19  wherein the housing is connected to an actuating element, which can be manipulated by an operator to cause corresponding movement of the housing. 
   
   
       21 . A device for treating an eye comprising:
 a piercing member having a length, an outer diameter, a proximal end, a distal end, the distal end being of sufficient sharpness to cause a penetration in the eye conjunctiva and sclera;   a handle having a length, a proximal end, a distal end, and a substantially hollow portion, the distal end of the handle being mounted to the piercing member, wherein the piercing member and the handle have a lumen therebetween, defining a pathway between the proximal end of the handle and distal end of the piercing member; a rigid member and cannula slidably disposed within the lumen of the piercing member and the handle, wherein rigid member has a proximal end, a distal end, and a lumen therebetween, and the cannula has a proximal end, a distal end, and a lumen therebetween, and the distal end of the rigid member is connected to the proximal end of the cannula; and   a quantity of tubing having a proximal end, a distal end, and a lumen extending therebetween, the distal end of the tubing being disposed within the lumen of the handle and being connected to the proximal end of the rigid member.   
   
   
       22 . A device for treating an eye comprising:
 a piercing member having a length, an outer diameter, a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end being of sufficient sharpness to cause a penetration in the eye conjunctiva and sclera wherein the outer diameter of the piercing member is sized to allow the length of the piercing member to be advanced through the penetration, and for self sealing of the penetration upon removal of the piercing member from the eye;   a fluid conduit comprising a cannula having a proximal end, a distal end, a lumen extending between the proximal and distal ends, and an outer diameter; and a rigid member having a proximal end, a distal end, and a lumen therebetween, wherein the cannula is disposed within the lumen of the rigid member, and wherein the rigid member and cannula are both slidably disposed within the lumen of the piercing member, and wherein the distal end of the cannula is extendable beyond the distal end of the piercing member and the distal end of the rigid member;   wherein distal-to-proximal movement and proximal-to-distal movement of the rigid member affects movement of the cannula correspondingly.