Expandable fluoropolymer device for delivery of therapeutic agents and method of making

An expandable drug delivery device comprising:

• a member constructed a radially inelastic biocompatible fluoropolymer material, the member having a longitudinal axis and a wall having a thickness extending between an inner and an outer surface, the wall being formed of a microstructure of nodes interconnected by fibrils, the member being deployable from a collapsed configuration to an expanded configuration upon application of an expansion force to the lumen, a least a portion of the wall having nodes oriented such that spaces between the nodes form generally aligned micro-channels oriented and extending from the inner surface to the outer surface of the wall, the micro-channels being sized to permit fluid including a therapeutic agent to expand the drug delivery device and permeate from the inner surface to the outer surface of the wall.

A radially expandable fluid delivery device comprising:

• a member constructed of a radially inelastic biocompatible fluoropolymer material, the member having a longitudinal axis and a wall having a thickness extending between an inner and an outer surface, the wall being formed of a microstructure of nodes interconnected by fibrils, the member being deployable from a collapsed configuration to an expanded configuration upon application of an expansion force,
• wherein the wall of the member includes a first microporous portion of micro-channels formed by the microstructure having a porosity sufficient for a fluid to expand the fluid delivery device and permeate through the wall, and a second microporous portion of micro-channels formed by the microstructure spaced apart from the first microporous portion and having a porosity sufficient for a fluid to expand the fluid delivery device and permeate through the wall.

A radially expandable fluid delivery device comprising:

• a member constructed of a radially inelastic biocompatible fluoropolymer material, the tubular member having a longitudinal axis and a wall having a thickness extending between an inner and an outer surface, the wall being formed of a microstructure of nodes interconnected by fibrils, the member being deployable from a collapsed configuration to an expanded diameter configuration upon application of an expansion force from a fluid, the wall including a microporous portion having nodes oriented such that spaces between the nodes form micro-channels extending from the inner surface to the outer surface of the wall, the micro-channels being sized to permit the fluid to permeate from the inner surface to the outer surface of the wall,
• wherein the size of the micro-channels varies circumferentially about the tubular member to provide regions of greater porosity within the microporous portion.

A medical treatment device comprising:

• a catheter having an elongated hollow tube defining an inflation lumen extending from a proximal end to a distal end, and
• a balloon constructed of a radially inelastic biocompatible fluoropolymer material and attached to the distal end of the tube, the balloon having a wall having a thickness extending between an inner and an outer surface and a lumen in fluid communication with the inflation lumen of the catheter, the wall being formed of a microstructure of nodes interconnected by fibrils, the balloon being deployable from a collapsed configuration to an expanded configuration,
• wherein the wall of the balloon includes at least one microporous portion of micro-channels formed by the microstructure having a porosity sufficient for a fluid to expand the medical treatment device and permeate through the wall, substantially all of the nodes within the microporous portion being oriented substantially perpendicular to the longitudinal axis of the balloon.

A radially expandable fluid delivery device having a longitudinal axis and a wall transverse to the longitudinal axis, the fluid delivery device comprising:

• a first layer of biocompatible material being formed of a microstructure of nodes interconnected by fibrils, and
• a second layer of biocompatible material being formed of a microstructure of nodes interconnected by fibrils, the second layer overlying the first layer, the wall of the fluid delivery device extending between an inner surface of the first layer and an outer surface of the second layer, the fluid delivery device being deployable from a first, reduced diameter configuration to a second, increased diameter configuration,
• wherein the wall of the fluid delivery device is formed of at least one microporous portion having a porosity sufficient for a fluid to permeate through the wall, substantially all of the nodes within the microporous portion being oriented such that spaces between the nodes form generally aligned micro-channels oriented and extending from the inner surface of the first layer to the outer surface of the second layer, the micro-channels being sized to permit fluid to expand the fluid delivery device and permeate from the inner surface of the first layer to the outer surface of the second layer.