Medical device coating apparatus and methods of use

Abstract

Apparatus and methods are configured to coat a medical device, such as a stent, with a beneficial medicinal agent using one or more liquid feeds and one or more micromist nozzles. In one implementation, an agent coating rig includes a vertical adjustment means, a rotation means, and a traverse adjustment means for moving a medical device along virtually any point on an x or y axis. In additional or alternative implementations, the agent coating rig can further include a secondary horizontal adjustment means that allows adjustment along virtually any point on a z axis. Furthermore, methods and apparatus are provided for distributing the beneficial agent on the medical device, including delivering the beneficial agent efficiently over time.

1 . An agent coating rig configured for coating a medical device with a micromist form of a beneficial agent, comprising:
 a base;   vertical adjustment means positioned on the base, the vertical adjustment means configured to hold one or more micromist nozzles;   rotation means configured to rotate one or more medical devices with respect to the one or more micromist nozzles; and   traverse adjustment means positioned on the base;   wherein the traverse adjustment means and the vertical adjustment means are configured to move the one or more micromist nozzles in a corresponding x axis or y axis direction relative to the base.   
   
   
       2 . The rig as recited in  claim 1 , further comprising secondary horizontal adjustment means mounted to the base, the secondary horizontal adjustment means being configured to move the one or more micromist nozzles in a z axis direction relative to the base. 
   
   
       3 . The rig as recited in  claim 2 , wherein one or both of the secondary horizontal adjustment means and the vertical adjustment means are automated. 
   
   
       4 . The rig as recited in  claim 1 , wherein one or both of the rotation means and the traverse adjustment means are automated. 
   
   
       5 . The rig as recited in  claim 1 , further comprising a first key coupled to the rotation means and a second key coupled to the traverse adjustment means, wherein the first and second key are configured to be coupled to the rotation means or the traverse adjustment means to a motor. 
   
   
       6 . The rig as recited in  claim 1 , further comprising at least one liquid agent feed line coupled adjacent at least one micromist nozzle, and at least one cleaning solution feed line, wherein the at least one liquid agent feed line and the at least one cleaning solution feed line are coupled to deliver out of the same liquid nozzle. 
   
   
       7 . The rig as recited in  claim 1 , wherein the vertical adjustment means further comprises an extension for receiving a plurality of different detachable micromist nozzle adaptors. 
   
   
       8 . The rig as recited in  claim 7 , further comprising a detachable micromist nozzle adaptor coupled to the vertical adjustment means. 
   
   
       9 . A system configured to coat a beneficial agent on one or more medical devices in a single pass, comprising:
 a base;   a vertical member slidably coupled to the base, the vertical member further being detachably coupled to one or more micromist nozzle adaptors having corresponding one or more micromist nozzles inserted therein;   first and second holding members configured to rotate a medical device relative to the one or more micromist nozzles, wherein at least one of the first and second holding members is coupled to a first motor; and   a traverse adjustment means coupled to a second motor.   
   
   
       10 . The system as recited in  claim 9 , further comprising a first feed line positioned adjacent the corresponding one or more micromist nozzles, wherein:
 the one or more micromist nozzles are configured to deliver air at a pressure of about 20 psi or greater along a y axis;   the first feed line is configured to deliver the beneficial agent at a flow rate of about 100 ml/min. or greater; and   the traverse adjustment means is configured to move a medical device about 0.5 mm/sec or greater along an x axis.   
   
   
       11 . The system as recited in  claim 9 , further comprising a first feed line and a second feed line positioned adjacent the corresponding one or more micromist nozzles, the first feed line and second feed lines being coupled to different liquid feed nozzles. 
   
   
       12 . The system as recited in  claim 9 , further comprising a second feed line coupled to the first feed line via a coupling member, wherein the first feed line carries the beneficial agent, and the second feed line carries a cleaning solution. 
   
   
       13 . The system as recited in  claim 12 , wherein:
 (i) the coupling member receives both the first feed line and the second feed line; and   (ii) the coupling member delivers the beneficial agent or the cleaning solution to a single liquid feed nozzle, depending on a setting of the coupling member.   
   
   
       14 . A method of coating a medical device with a beneficial agent in a single pass, comprising the steps of:
 receiving a medical device in a rotation means of an agent coating rig;   receiving a micromist nozzle about the medical device;   receiving a first liquid feed line about the micromist nozzle;   rotating the medical device in the rotation means;   adjusting a y coordinate of the micromist nozzle and an x coordinate of the medical device; and   providing a beneficial agent through the first liquid feed line, wherein the beneficial agent is atomized upon encountering air from the micromist nozzle.   
   
   
       15 . The method as recited in  claim 14 , further comprising a step of adjusting a z coordinate of the micromist nozzle through secondary horizontal adjustment means. 
   
   
       16 . The method as recited in  claim 14 , further comprising providing the beneficial agent through a second liquid feed line at the same time as the first liquid feed line, wherein the beneficial agent is atomized when exiting both of the first and second liquid feed lines upon encountering air from the micromist nozzle. 
   
   
       17 . The method as recited in  claim 14 , further comprising a step of delivering a cleaning solution through first liquid feed line. 
   
   
       18 . The method as recited in  claim 14 , further comprising a step of creating secondary atomization of the beneficial agent. 
   
   
       19 . The method as recited in  claim 18 , wherein the step of creating secondary atomization comprises applying air out of the micromist nozzle at about 20 psi or greater. 
   
   
       20 . The method as recited in  claim 19 , further comprising the steps of:
 setting a rotation speed of the medical device at about 120 rpm or greater;   setting a flow rate of the beneficial agent through the first liquid feed line at about 100 ml/min. or greater; and   setting a traverse adjustment means to adjust an x coordinate for the medical device at a speed of about 0.5 mm/sec or greater.