CATHETER WITH LAMINAR FLOW DRUG DELIVERY PROPERTIES

• US 20080287911A1
• Filed: 05/16/2007
• Published: 11/20/2008
• Est. Priority Date: 05/16/2007
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Hossainy, Syed F.A., Ludwig, Florian N., Consigny, Paul, El-Nounou, Fozan O.
• Granted Patent: US 8,641,666 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
• CPC Class Codes: A61M 2206/11 Laminar flow
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

Catheters with laminar flow bioactive agent delivery properties and methods of using for treating or preventing vascular disease are disclosed.

Claims

1. A catheter comprising:

an elongate tubular member comprising a proximal end, a distal end and a lumen extending from the proximal end to the distal end; and

an elongate cylindrical member disposed at least partially within the lumen of the elongate tubular member along the longitudinal axis of symmetry and having a proximal end, a distal end and a delivery assembly extending from the distal end, wherein the delivery assembly is capable of producing a laminar flow of a bioactive agent formulation at or near a blood vessel wall in which the catheter is disposed.

2. The catheter according to claim 1, wherein the elongate cylindrical member is extendable and retractable such that in its retracted position the delivery assembly is disposed within the lumen of the tubular member and in its extendable position the delivery assembly extends beyond the distal end of the tubular member.

3. The catheter according to claim 2, wherein the delivery assembly comprises a flared conical shaped solid member when the elongate cylindrical member is in its extendable position.

4. The catheter according to claim 2, wherein the elongate cylindrical member comprises a lumen extending from the proximal end to the distal end of the elongate cylindrical member.

5. The catheter according to claim 4, wherein the lumen opens to a plurality of tubular channels radiating outward from the distal end of the elongate cylindrical member through the delivery assembly where they open to the blood vessel.

6. The catheter according to claim 5, wherein the delivery assembly comprises a flared conical shaped member, within which the plurality of tubular channels are disposed, when the elongate cylindrical member is in its extendable position.

7. The catheter according to claim 4, wherein the lumen opens to the delivery assembly comprising a plurality of tubular extensions open to the blood vessel.

8. The catheter according to claim 7, wherein each tubular extension is positioned near or in contact with the wall of a blood vessel when the elongate cylindrical member is in its extendable position.

9. The catheter according to claim 4, wherein the lumen opens to a delivery assembly comprising a ring element oriented perpendicular to the lumen when the elongate cylindrical member is in its extendable position.

10. The catheter according to claim 9, wherein the ring element comprises a plurality of holes positioned along the down-stream side of the ring element.

11. The catheter according to claim 9, wherein the ring element comprises an air foil-shaped configuration comprising a plurality of holes positioned along the abluminal side of the ring element.

12. The catheter according to claim 9, wherein the ring element is self-expanding.

13. The catheter according to claim 2, wherein the delivery assembly comprises a flared sieve when the elongate cylindrical member is in its extendable position.

14. The catheter according to claim 13, wherein the sieve is self-expanding.

15. The catheter according to claim 13, wherein the sieve is balloon-expandable.

16. The catheter according to claim 2, wherein the delivery assembly comprises a shape memory polymer or a shape memory metal.

17. A method for treating or preventing a vascular disease comprising:

providing a catheter according to claim 1;

inserting the catheter into the blood vessel of a patient;

providing a bioactive agent formulation; and

introducing the bioactive agent formulation into the blood vessel of a patient through the catheter.

18. The method according to claim 17, wherein the viscosity of the bioactive agent formulation is modified by an excipient comprising a polymer, a protein, a sugar or an alcohol.

19. The method according to claim 17, wherein introducing the bioactive agent formulation into the blood vessel of a patient does not impede the flow of blood through the vessel.

20. The method according to claim 17, wherein the bioactive agent formulation comprises a corticosteroid, everolimus, zotarolimus, sirolimus, a sirolimus derivative, paclitaxel, a bisphosphonate, ApoA1, a mutated ApoA1, ApoA1 milano, an ApoA1 mimetic peptide, an ABC A1 agonist, an anti-inflammatory agent, an anti-proliferative agent, an anti-angiogenic agent, an antifibrotic agent, a profibrotic agent, an antithrombotic agent, a matrix metalloproteinase inhibitor or a tissue inhibitor of metalloproteinase.

21. The method according to claim 17, wherein the bioactive agent formulation has a viscosity higher than that of blood.