Expandable member formed of a fibrous matrix for intraluminal drug delivery

• US 8,076,529 B2
• Filed: 09/26/2008
• Issued: 12/13/2011
• Est. Priority Date: 09/26/2008
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Ehrenreich, Kevin J., Newhauser, Richard R., von Oepen, Randolf, Stankus, John
• Primary Examiner(s): Lucchesi, Nicholas D
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US12/238,627
• Publication Number:
  US 20100081992A1
• Time in Patent Office: 1,173 Days
• Field of Search: 604/103.08, 604/96.01, 604/103.06, 604/101.01, 604/101.04, 604/286, 604365-368
• US Class Current: 604/367
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• 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 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 25/1029 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 25/104 used for angioplasty
• CPC Class Codes: D01D 5/0076 characterised by the collecting device, e.g. drum, wheel, endless belt, plate or grid D01D5/0046 takes precedence

Abstract

An intraluminal catheter device having an expandable member formed of a matrix of fiber elements with a therapeutic agent incorporated therein. The therapeutic agent can be coated on the fiber elements in a co-axial configuration. The fiber elements may also have a second coating including a protective substance surrounding the therapeutic agent. The matrix of fiber elements can be formed by electrospinning. A process of delivering a therapeutic agent to a target site includes providing an intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member having a therapeutic agent dispersed therein, and advancing the catheter device at a desired treatment site. Once at the desired treatment site, fluid is introduced into the inflation lumen to expand the expandable member from a first profile to a second profile, and the therapeutic agent is delivered to the desired treatment site.

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; and

an expandable member formed essentially of an electrospun matrix of fiber elements and disposed proximate to the distal end portion of the catheter shaft to define an inner chamber fluidly coupled to the inflation lumen, wherein individual fiber elements of the matrix carry at least one therapeutic agent.

2. The device of claim 1, wherein the fiber elements comprise a polymer.

3. The device of claim 2, wherein the at least one therapeutic agent is incorporated into the polymer of the individual fiber elements.

4. The device of claim 3, wherein the at least one therapeutic agent is dispersed and encapsulated in the polymer of the individual fiber elements.

5. The device of claim 2, wherein the polymer is selected from the group consisting of polyamides, polyurethanes, fluoropolymers, polyolefins, polyimides, polyimines, (methyl)acrylic polymers, polyesters, and co-polymers thereof.

6. The device of claim 1, wherein the individual fiber elements each include at least one coating.

7. The device of claim 6, wherein the at least one coating includes the at least therapeutic agent.

8. The device of claim 7, wherein the individual fiber elements include a second coating surrounding the first coating, the second coating-comprising a protective substance.

9. The device of claim 8, wherein the protective substance is selected from the group consisting of glucose, hydrophilic coatings, mediums which are dissolvable in blood or aqueous mediums, and other mediums which will crack under expansion.

10. The device of claim 6, wherein the at least one coating comprises a protective substance.

11. 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, antithrombotic, antimitotic, antibiotic, antiallergic and antioxidant compounds and combinations thereof.

12. The device of claim 1, wherein the expandable member is expandable from a first profile to a second profile.

13. The device of claim 1, wherein the expandable member is essentially fluid-tight and can maintain an expanded profile.

14. The device of claim 1, the expandable member defining an outer surface, and further comprising a coating on at least one portion of the outer surface of the expandable member.

15. The device of claim 14, wherein the coating comprises a protective substance.

16. The device of claim 14, wherein the coating comprises at least one therapeutic agent.

17. The device of claim 16, further comprising a second coating surrounding the first coating on at least one portion of the outer surface of the expandable member, the second coating comprising a protective substance.

18. The device of claim 1, wherein the matrix of fiber elements defines a plurality of gaps between the fibers.

19. The device of claim 1, wherein the at least one therapeutic agent is released from the individual fiber elements upon radial expansion of the expandable member.

20. The device of claim 1, wherein the at least one therapeutic agent is released from the individual fiber elements by diffusion upon expansion of the expandable member against a target area.

21. An intraluminal catheter device made by:

forming an expandable member a essentially of an electrospun matrix of fiber elements to define an inner chamber, individual fiber elements of the matrix carrying at least one therapeutic agent;

providing 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; and

attaching the expandable member to the distal end portion of the elongated catheter shaft with the inner chamber of the expandable member fluidly coupled to the inflation lumen.

22. The device of claim 21, wherein the fiber elements comprise a polymer.

23. The device of claim 22, wherein the at least one therapeutic agent is incorporated into the polymer of the individual fiber elements.

24. The device of claim 23, wherein the at least one therapeutic agent is dispersed and encapsulated in the polymer of the individual fiber elements.

25. The device of claim 22, wherein the polymer is selected from the group consisting of polyamides, polyurethanes, fluoropolymers, polyolefins, polyimides, polyimines, (methyl)acrylic polymers, polyesters, and co-polymers thereof.

26. The device of claim 21, wherein the individual fiber elements each include at least one coating.

27. The device of claim 26, wherein the at least one coating includes the at least one therapeutic agent.

28. The device of claim 27, wherein the individual fiber elements include a second coating surrounding the first coating, the second coating comprising a protective substance.

29. The device of claim 26, wherein the at least one coating comprises a protective substance.

30. The device of claim 21, wherein the at least one therapeutic agent is released from the individual fiber elements upon radial expansion of the expandable member.

31. The device of claim 21, wherein the at least one therapeutic agent is released from the individual fiber elements by diffusion upon expansion of the expandable member against a target area.