Methods and Devices for Delivering Drugs Using Drug-Delivery or Drug-Coated Guidewires

Abstract

The present invention relates to a method of delivering drugs having e.g., anti-proliferative activity in the vascular, preferably, the cardiovascular, system locally or systematically using an at least partially drug-coated guidewire. The drug-coated guidewire, particularly an expansion member or portion thereof, is brought into contact with the target tissue or in circulation and the drugs are quickly released into the area surrounding the device in a short time after the contact step. Once the therapeutic drugs are released, they are quickly and effectively absorbed by the surrounding cells or circulation.

1 . A method of delivering an agent to vascular tissue using a guidewire, the method comprising:
 contacting the tissue with an agent-delivering surface of a guidewire the surface having an agent disposed thereon; and   permitting the agent to be delivered to the tissue by maintaining contact between the agent-delivery surface and the tissue a sufficient time for agent delivery to occur.   
     
     
         2 . A method according to  claim 1  wherein the guidewire surface comprises a portion of a guidewire expansion member. 
     
     
         3 . A method according to  claim 1  wherein the agent is a drug. 
     
     
         4 . A method according to  claim 1  wherein the agent is a biological substance. 
     
     
         5 . A method according to  claim 1  wherein contact between the agent-delivery surface and the tissue is maintained for less than or equal to one minute. 
     
     
         6 . A method according to  claim 1  wherein the agent-delivering surface is the outside surface of a guidewire expansion member. 
     
     
         7 . A method according to  claim 6  wherein the expansion member comprises a radially-expandable, interwound cooperating series of struts. 
     
     
         8 . An agent-delivery guidewire, the guidewire having distal and proximal portions, and a core wire which defines a guidewire axis, the distal portion including an expansion member, the expansion member having an agent coated on an outside surface thereof and being coupled to the core wire. 
     
     
         9 . An agent-delivery guidewire according to  claim 8  which further includes a proximally located expansion means, said means coupled to said expansion member so that when activated the expansion means causes the expansion member to expand radially outward from the axis of the guidewire. 
     
     
         10 . An agent-delivery guidewire according to  claim 9  wherein the expansion means in a hypotube which is slideably disposed over the core wire and coupled to the expansion member on its proximal end. 
     
     
         11 . A guidewire of  claim 10  wherein the expansion member comprises radially expandable interwound struts. 
     
     
         12 . An agent-delivery guidewire according to  claim 10  wherein the expansion means is a counter-wound coil disposed over the core wire proximal to the expansion member, the counter-wound coil providing approximately 1:1 torque transmission to the proximal end of the expansion member permitting radial expansion of the expansion member by proximal application of radial torque. 
     
     
         13 . A guidewire method of endovascular agent delivery comprising the steps of:
 advancing a guidewire through a vessel to a site of treatment to which the agent is to be delivered, the guidewire including an expansion member having agent coated thereon;   applying opposing forces to the expansion member to cause it to expand radially outwardly, from the axis of the guidewire to the site of treatment;   permitting the expansion member endovascularly to deliver the agent to the site of treatment by maintaining the expansion member at the site of treatment for a time sufficient to deliver the agent;   removing the opposing forces applied to the expansion member to permit the expansion member to return to its radial dimension during the advancing step withdrawing the guidewire from the vessel.   
     
     
         14 . A method according to  claim 13  wherein the expansion member is maintained at the site of treatment for less than 5 minutes. 
     
     
         15 . A method according to  claim 13  wherein the expansion member is maintained at the site of treatment for less than 1 minute. 
     
     
         16 . A method according to  claim 13  wherein vessel dilation occurs simultaneously with agent delivery by the radial expansion of the expansion member. 
     
     
         17 . Guidewire for delivering a medicament to an obstruction within guidewire apparatus, a vascular segment or a body passageway which comprises:
 a guidewire having a distal end and a proximal end;   a substantially cylindrical shaped expansion member located on the distal end of the guidewire, the expansion member including first and second ends and comprising a plurality of flexible elongate elements, the flexible elongate elements comprising:
 a first set of elements having a first common direction of rotation crossing a second set of elements having a second common direction of rotation opposite to that of the first direction of rotation to form a mesh, the mesh having on its outward most surface an agent coated thereon. 
 a movement mechanism which causes the expansion member to change configuration between a first configuration wherein the expansion member is characterized by a first diameter and a second configuration wherein the expansion member is characterized by a second diameter, the second diameter being greater than the first diameter.