Apparatus and Methods for Filling a Drug Eluting Medical Device Via Capillary Action

摘要

Methods and apparatus are disclosed for filling a therapeutic substance or drug within a hollow wire that forms a stent. The stent is placed within a chamber housing a fluid drug formulation. During filling, the chamber is maintained at or near the vapor-liquid equilibrium of the solvent of the fluid drug formulation. To fill the stent, a portion of the stent is placed into contact with the fluid drug formulation until a lumenal space defined by the hollow wire is filled with the fluid drug formulation via capillary action. After filling is complete, the stent is retracted such that the stent is no longer in contact with the fluid drug formulation. The solvent vapor pressure within the chamber is reduced to evaporate a solvent of the fluid drug formulation. A wicking means may control transfer of the fluid drug formulation into the stent.

主权项

1. An apparatus for filling a fluid drug formulation within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a stent, the apparatus comprising:
a first chamber including a reservoir filled with a solvent; a stent suspension means housed within the first chamber and operable to suspend a plurality of stents; a second chamber having a fluid drug formulation therein, wherein the fluid drug formulation is composed of the same solvent that fills the reservoir in the first chamber; a wicking means housed within the second chamber and in contact with the fluid drug formulation, wherein the wicking means is operable to assist in the movement of the fluid drug formulation from the second chamber into the lumenal spaces of the stents by capillary action; and a valve positioned between the first and second chambers, wherein the valve is operable to alternate between an open configuration in which the first chamber and second chamber are in fluid communication and a closed configuration in which the first chamber and second chamber are not in fluid communication and wherein the stent suspension means is operable to move the plurality of stents between the chambers, and into and out of contact with the fluid drug formulation via the wicking means.