Expandable member having a covering formed of a fibrous matrix for intraluminal drug delivery

• US 8,226,603 B2
• Filed: 09/25/2008
• Issued: 07/24/2012
• Est. Priority Date: 09/25/2008
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Von Oepen, Randolf, Stankus, John, Stamberg, Barbara, Yribarren, Travis R., Newhauser, Richard R.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Wilson, Larry R
• Application Number:
  US12/237,998
• Publication Number:
  US 20100076401A1
• Time in Patent Office: 1,398 Days
• Field of Search: 604/96.01, 604/103.01, 604/103.02, 604/103.05, 604/103.06, 604/103.08, 604/101.01, 604/101.02, 604/509
• US Class Current: 604/103.05
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

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.

Claims

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.