Implantable drug delivery device and a system & method for deployment of such devices

Abstract

A drug delivery device is formed from an elastic sleeve deployed around a core, with first and second edge portions inwardly inverted. When a fluid is introduced between the core and the sleeve, the sleeve inflates to form a reservoir with a pressure of the fluid pressing the inwardly-inverted extremities portions against the core. The device is preferably anchored by providing a stem of conformable material which is depressed by pressure applied by adjacent edges of a layer of tissue to achieve tissue-wedged anchoring of the device.

What is claimed is: 
     
         1 . A method for deploying an implant anchored in a layer of tissue, the method comprising the steps of:
 (a) providing an implant having a distal portion, a stem and a proximal end, the implant being located within a canula;   (b) inserting the canula through an incision in the layer of tissue so as to penetrate through at least part of the layer of tissue;   (c) advancing the implant so that the distal portion extends beyond the layer of tissue, at least part of the stem is exposed, and at least the proximal end remains within the canula; and   (d) withdrawing the canula so that contact of the tissue layer with the stem grips the stem and anchors the implant in the layer of tissue with the proximal end proximal to the layer of tissue.   
     
     
         2 . The method of  claim 1 , wherein the incision is an arcuate incision forming a flap of the layer of tissue. 
     
     
         3 . The method of  claim 1 , wherein the canula is a beveled insertion needle, and wherein the incision is formed by advancing the beveled insertion needle into the tissue. 
     
     
         4 . The method of  claim 1 , wherein a non-penetrating stopper at least partially surrounds the canula so as to define a fully-inserted position of the canula relative to the layer of tissue. 
     
     
         5 . The method of  claim 1 , wherein advancing the implant is performed by a plunger selectively advanceable within the canula, the plunger having a limited range of motion defining a partially-projecting position of the implant. 
     
     
         6 . The method of  claim 1 , wherein the distal portion of the implant comprises a gradual release drug delivery arrangement. 
     
     
         7 . The method of  claim 1 , wherein the distal portion of the implant comprises an inflatable reservoir for receiving a volume of a liquid drug. 
     
     
         8 . The method of  claim 7 , wherein said steps of inserting and advancing are performed with the inflatable reservoir in an uninflated state, the method further comprising filling the inflatable reservoir with a volume of a liquid drug prior to said withdrawing. 
     
     
         9 . The method of  claim 8 , wherein said filing is performed via a filling needle that extends along said canula. 
     
     
         10 . The method of  claim 1 , wherein at least the stem of the implant is formed from a material having a Shore-A hardness in the range 20-70. 
     
     
         11 . The method of  claim 1 , wherein at least the stem of the implant is formed from a material having a Shore-A hardness in the range 30-45. 
     
     
         12 . The method of  claim 1 , wherein the tissue layer is the ocular sclera.