DOUBLE BALLOON CATHETER AND METHODS FOR HOMOGENEOUS DRUG DELIVERY USING THE SAME

• US 20100082012A1
• Filed: 09/22/2009
• Published: 04/01/2010
• Est. Priority Date: 09/22/2008
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Foxhollow Technologies Incorporated (Medtronic Plc)
• Inventors: Hattangadi, Neil, Lerner, Daniel, Olivera, Ryan
• Granted Patent: US 8,162,879 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

The invention, in one embodiment, is directed to a catheter for site-specific delivery of a therapeutic agent to a blood vessel of a patient. The catheter further includes an elongated shaft having at least one inner lumen, a distal end and a proximal end and proximal and distal vessel-conforming balloons where each is separately positionable and inflatable, and when inflated, substantially restricts blood flow in the vessel and creates a treatment window of a defined but variable length for delivery of the therapeutic agent. The catheter optionally includes at least one marker band adjacent to the proximal balloon and at least one marker band adjacent to the distal balloon. At least one lateral aperture positioned in the window is in fluid communication with a drug delivery conduit located within either the inner shaft or the outer shaft to provide a homogeneous concentration of the therapeutic agent to the window.

Claims

1. A catheter for site-specific delivery of a therapeutic agent to a blood vessel of a patient comprising:

a. an elongated shaft having at least one inner shaft, at least one outer shaft, a distal end and a proximal end;

b. proximal and distal vessel-conforming balloons, each of which is separately positionable and inflatable which when inflated substantially restricts blood flow in the vessel and creates a treatment window of a defined but variable length for delivery of the therapeutic agent;

c. at least one marker band adjacent to the proximal balloon and at least one marker band adjacent to the distal balloon; and

d. at least one lateral aperture suitable for delivery of the therapeutic agent positioned in the treatment window so as to provide a homogeneous concentration of the therapeutic agent to the treatment window.

2. The catheter of claim 1, wherein the balloons are inflatable at a pressure so as to substantially limit barotrauma to the blood vessel.

3. The catheter of claim 2, wherein the vessel-conforming balloons are inflated at a pressure of less than about 15 psi in the vessel.

4. The catheter of claim 1, wherein the vessel-conforming balloons inhibit the flow of blood through the vessel.

5. The catheter of claim 1, wherein the marker bands are immediately adjacent to the balloons.

6. The catheter of claim 1, wherein at least one marker band is located proximal to the proximal balloon and at least one marker band located distal to the distal balloon.

7. The catheter of claim 6, wherein at least one marker band is located distal to the proximal balloon and at least one marker band located proximal to the distal balloon.

8. The catheter of claim 1, further comprising a balloon inflation port for the distal balloon and a balloon inflation port for the proximal balloon.

9. The catheter of claim 1, further comprising a drug delivery conduit housed in the inner shaft or the outer shaft and in fluid communication with the lateral aperture.

10. The catheter of claim 9, further comprising a drug infusion port in fluid connection with the drug delivery conduit.

11. The catheter of claim 1, wherein the length of the treatment window is variable.

12. The catheter of claim 11, wherein the length of the treatment window is from 2 centimeters to 25 centimeters.

13. The catheter of claim 12, wherein the diameter of the treatment window is from 3 millimeters to 10 millimeters.

14. The catheter of claim 1, further comprising a guidewire.

15. The catheter of claim 14, further comprising a distal leak path.

16. The catheter of claim 1, wherein the number of lateral apertures is from 2 to 20.

17. The catheter of claim 16, wherein the number of lateral apertures is 4, 8 or 16.

18. The catheter of claim 16, wherein the lateral apertures are in a plane and placed at an angle of about 90 to about 180 degrees apart.

19. The catheter of claim 16, wherein the lateral apertures are helically positioned at an angle of about 90 to about 180 degrees apart.

20. The catheter of claim 16, wherein the distance between the lateral apertures is about 1 to about 5 cm.

21. The catheter of claim 16, wherein the distance between the lateral apertures is about 2.8 cm.

22. The catheter of claim 16, wherein the diameter of the lateral apertures is from about 0.001 inches to about 0.050 inches.

23. The catheter of claim 22, wherein the diameter of the lateral apertures is from about 0.001 inches to about 0.018 inches.

24. The catheter of claim 16, wherein the lateral apertures are on the inner shaft of the catheter.

25. The catheter of claim 16, wherein the lateral apertures are on the outer shaft of the catheter.

26. A method of site-specific delivery of a therapeutic agent to a blood vessel of a patient comprising:

a. inserting a catheter into the vessel, wherein said catheter comprises at least one inner shaft, at least one outer shaft;

proximal and distal vessel-conforming balloons; and

at least one lateral aperture;

b. inflating the proximal balloon to substantially restrict blood flow through the vessel;

c. delivering the therapeutic agent through the lateral aperture to provide a homogeneous concentration of the therapeutic agent to the vessel;

d. inflating the distal balloon to form a treatment window for a time sufficient to provide a therapeutically effective amount of the therapeutic agent to the vessel.

27. The method of claim 26, further comprising deflating the proximal and distal balloons.

28. The method of claim 26, wherein the balloons are inflated at pressure so as substantially limit barotrauma to the vessel.

29. The method of claim 26, wherein the balloons are inflated to a pressure of less than about 15 psi in the vessel.

30. The method of claim 26, wherein the amount of therapeutic agent delivered is sufficient to substantially fill the treatment window.

31. The method claim 26, wherein the treatment window has a concentration of therapeutic agent which is substantially homogeneous.

32. The method claim 31, wherein the concentration of therapeutic agent in the treatment window is substantially the same as the original concentration of therapeutic agent infused.

33. The method of claim 26, wherein the number of lateral apertures is from 1 to about 20.

34. The method of claim 33, wherein the number of lateral apertures is 4, 8 or 16.

35. The catheter of claim 33, wherein the lateral apertures are in a plane and placed at an angle of about 90 to about 180 degrees apart.

36. The catheter of claim 33, wherein the lateral apertures are helically positioned at an angle of about 90 to about 180 degrees apart.

37. The method of claim 33, wherein the distance between the lateral apertures is about 1 to about 5 cm.

38. The method of claim 37, wherein the distance between the lateral apertures is about 2.8 cm.

39. The method of claim 33, wherein the diameter of the lateral apertures is from about 0.001 inches to about 0.050 inches.

40. The method of claim 39, wherein the diameter of the lateral apertures is from about 0.001 inches to about 0.018 inches.

41. The method of claim 26, wherein the therapeutic agent is selected from the group consisting of antiproliferative, anti-inflammatory, antineoplastic, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antibiotic, and antioxidant substances.

42. The method of claim 26, wherein the therapeutic agent is paclitaxel.

43. The method of claim 26, wherein the balloons are inflated in less than about 6 seconds.

44. The method of claim 26, wherein the balloons are deflated in less than about 8 seconds.

45. The method of claim 26, wherein the therapeutic agent is delivered at a rate of greater than about 1.0 milliliters/second.

46. The method of claim 26, wherein the length of the treatment window is variable.

47. The method of claim 26, wherein the length of the treatment window is from about 2 centimeters to about 25 centimeters.

48. The method of claim 26, wherein the diameter of the treatment window is from about 3 centimeters to about 10 centimeters.

49. The method of claim 26, wherein the therapeutic agent infusion rate is about 1.0 milliliters/second at a pressure of up to 40 psi.

50. The method of claim 26, wherein the time sufficient to provide a therapeutically effective amount of the therapeutic agent to the vessel is about 5 minutes.

51. The method of claim 26, wherein the lateral apertures are on the inner shaft of the catheter.

52. The method of claim 26, wherein the lateral apertures are on the outer shaft of the catheter.

53. The method of claim 26, wherein the distal balloon is inflated to form a treatment window prior to the delivering of the therapeutic agent through the at least one lateral aperture.

54. The method of claim 53, wherein the therapeutic agent is continuously delivered to the treatment window and is released from the treatment window through a distal leak path.

55. A method for determining homogeneity of drug delivery in vitro comprising:

a. placing a tubular member comprising a liquid of viscosity similar to the viscosity of blood in the path length of an optical sensor;

b. delivering a dye of known concentration to the tubular member; and

c. determining the concentration of dye along a length of the tubular member.