Expandable member having a covering formed of a fibrous matrix for intraluminal drug delivery
The present invention generally relates to an intraluminal catheter device for use in angioplasty and delivery of a therapeutic agent. Particularly, the present invention is directed to a catheter having an expandable member having a therapeutic agent disposed thereon and a fibrous matrix covering for delivering a therapeutic agent and methods of using the same.
1. An intraluminal catheter device comprising:
an elongated catheter shaft having a proximal end portion and a distal end portion, the shaft having an inflation lumen disposed between the proximal end portion and the distal end portion;
an expandable member having an outer surface and an inner surface disposed proximate to the distal end portion of the catheter shaft, the expandable member having a coating of at least one therapeutic agent disposed on at least a portion of the outer surface; and
a covering having a proximal end portion and a distal end portion, the covering positioned over at least a portion of the therapeutic agent coating on the outer surface of the expandable member, the covering formed of a matrix of fiber elements and attached to the catheter device by an attachment consisting of a bond at one of either the proximal end portion to a portion of the expandable member that is generally cylindrical after expansion of the expandable member or the distal end portion of the covering to a portion of the expandable member that is generally cylindrical after expansion of the expandable member.
2. The device of claim 1 , wherein the matrix of fiber elements of the covering is formed of electrospun fiber elements.
3. The device of claim 1 , wherein the fiber elements comprise a polymer selected from the group consisting of polyamides, polyurethanes, fluoropolymers, polyolefins, polyimides, polyimines, (methyl)acrylic polymers, polyesters, and co-polymers thereof.
4. The device of claim 1 , wherein the attachment consists of the bond at the proximal end portion of the covering.
5. The device of claim 1 , wherein the attachment consists of a bond at the distal end portion of the covering.
6. The device of claim 1 , wherein the bond attaches the covering to the catheter shaft.
7. The device of claim 1 , wherein the bond is selected from the group consisting of adhesion, thermal welding, heat shrink bands and direct solvent bonding.
8. The device of claim 1 , wherein at least one of the proximal or distal end portions of the covering has a tapered end.
9. The device of claim 1 , wherein the covering is essentially free of the at least one therapeutic agent.
10. The device of claim 1 , wherein the matrix of fibers of the covering is relatively tightly woven to prevent the at least one therapeutic agent from entering between the fibers.
11. The device of claim 1 , wherein the outer surface of the expandable member is textured to include a plurality of voids.
12. The device of claim 11 , wherein the size of the voids ranges from 1 nanometer to 1 micron.
13. The device of claim 11 , wherein the therapeutic agent of the therapeutic agent coating is loaded within the plurality of voids.
14. The device of claim 1 , wherein the at least one therapeutic agent is selected from the group consisting of anti-proliferative, anti-inflammatory, antineoplastic, antiplatelet, anti-coagulant, anti-fibrin, antithrombonic, antimitotic, antibiotic, antiallergic and antioxidant compounds and combinations thereof.
15. The device of claim 1 , wherein the expandable member is expandable from a first profile to a second profile.
16. The device of claim 1 , wherein the matrix of fiber elements defines a plurality of gaps between the fibers.
17. The device of claim 1 , wherein the covering formed of a matrix of fiber elements is separately formed and is slipped over the therapeutic agent coating on the outer surface of the expandable member.
18. The device of claim 1 , wherein the covering formed of a matrix of fiber elements is formed directly over the therapeutic agent coating on the outer surface of the expandable member.