Drug delivery and dilatation-drug delivery catheters in a rapid exchange configuration

• US 5,514,092 A
• Filed: 08/08/1994
• Issued: 05/07/1996
• Est. Priority Date: 08/08/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Stowell, Lori L., Forman, Michael R.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/287,121
• Time in Patent Office: 638 Days
• Field of Search: 604/96-103, 604/265-266, 604/269, 604/280, 606/194
• US Class Current: 604/101.03
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Catheters for drug delivery or for both dilatation and drug delivery are provided with a guide wire lumen terminating within the catheter shaft and having an opening through the catheter shaft to enable a guide wire to exit the catheter shaft substantially distal to the proximal end of the catheter. In one embodiment, drug delivery ports are provided between occlusion balloons. In another embodiment, a dilatation balloon is also provided between the occlusion balloons. In another embodiment, a double layered balloon is provided to simultaneously dilatate the stenosis and deliver medication to the site. Alternatively, a balloon can be provided which only delivers medication.

Claims

1. A drug delivery catheter comprising:

a catheter shaft comprising a proximal end, a distal end, at least one drug delivery port proximate the distal end and at least one drug delivery lumen for providing a drug to the drug delivery port, the at least one drug delivery lumen in fluid communication with the proximal end,

the catheter shaft further comprising a guide wire lumen extending from the distal end of the catheter shaft to a terminus within the catheter shaft, the terminus being proximal to the drug delivery port, and defining an opening proximate the terminus for the guide wire to exit the catheter shaft.

2. The drug delivery catheter of claim 1, further comprising a first occlusion balloon distal to the drug delivery port, and an inflation lumen in fluid communication with the first occlusion balloon.

3. The drug delivery catheter of claim 2, further comprising a second occlusion balloon proximal to the drug delivery port, wherein the terminus of the guide wire lumen is proximal to the second occlusion balloon.

4. The drug delivery catheter of claim 3, wherein the inflation lumen is in fluid communication with the first and second occlusion balloons.

5. The drug delivery catheter of claim 1, wherein there are a plurality of drug delivery ports in fluid communication with the drug delivery lumen.

6. The drug delivery catheter of claim 1, further comprising a lubricous coating on the catheter shaft.

7. The drug delivery catheter of claim 3, further comprising a lubricous coating on the catheter shaft and the occlusion balloons.

8. The drug delivery catheter of claim 3, wherein the occlusion balloons comprise inflatable plastic tubes.

9. The drug delivery catheter of claim 3, wherein the occlusion balloons are blow molded.

10. The drug delivery catheter of claim 2, further comprising perfusion means for allowing blood to flow through at least a portion of the catheter shaft.

11. The drug delivery catheter of claim 3, further comprising an additional lumen in the catheter shaft for perfusion.

12. The drug delivery catheter of claim 11, further comprising at least one opening in a wall of the catheter shaft, proximal the occlusion balloons, in fluid communication with the additional lumen.

13. The drug delivery catheter of claim 1, further comprising a dilatation balloon and a dilatation lumen in fluid communication with the dilatation balloon.

14. The drug delivery catheter of claim 3, further comprising a dilatation balloon and a dilatation lumen in fluid communication with the dilatation balloon, wherein the dilatation balloon is located between the occlusion balloons.

15. The drug delivery catheter of claim 1, wherein the guide wire lumen is proximate the periphery of the catheter shaft.

16. The drug delivery catheter of claim 12, wherein the additional lumen has a tapered distal end.

17. The drug delivery catheter of claim 2, further comprising at least one port through the catheter shaft to the guide wire lumen, to enable perfusion of blood through the guide wire lumen.

18. A catheter comprising:

a catheter shaft having a distal portion, a distal end, and a proximal end;

means for conveying a drug to an exterior of the catheter;

means for delivering the drug from the proximal end to the means for conveying; and

means for receiving a guide wire within the distal portion of the catheter shaft, the means for receiving including a means for the guide wire to exit the distal portion of the catheter shaft to the exterior of the catheter shaft.

19. The catheter of claim 18, wherein the means for conveying comprises at least one port in the distal portion of the catheter shaft, in fluid communication with the means for delivering.

20. The catheter of claim 18, wherein the means for conveying is a balloon attached to the distal portion of the catheter shaft, wherein the balloon defines a plurality of openings for enabling the drug to exit the balloon to the exterior of the catheter, the balloon being in fluid communication with the means for delivering.

21. The catheter of claim 20, wherein the balloon is adapted to dilatate a stenosis while conveying drugs.

22. The catheter of claim 21, wherein the balloon comprises an outer and an inner layer, the plurality of openings being in the outer layer, the outer and inner layer defining a region in fluid communication with the means for delivering, and the inner layer having an interior region, the catheter shaft further comprising a means for delivering inflation fluid to the interior region.

23. The catheter of claim 18, wherein the catheter shaft has a proximal end and the means for receiving the guide wire comprises a lumen within the distal portion of the catheter shaft, the lumen having a first end proximate the distal end of the catheter shaft and open to the exterior of the catheter, the lumen terminating at its proximal end substantially distal of the proximal end of the catheter shaft in a aperture open to the exterior of the catheter, the aperture being proximal to the means for conveying.

24. The catheter of claim 18, further comprising perfusion means.

25. The catheter of claim 18, further comprising occlusion means.

26. A dilatation-drug delivery catheter comprising:

a catheter shaft comprising a distal portion, a distal end and a proximal end;

a dilatation balloon attached to the distal portion of the catheter shaft;

a first occlusion balloon attached to the catheter shaft at a location distal to the dilatation balloon and a second occlusion balloon attached to the catheter shaft at a location proximal to the dilatation balloon;

the catheter shaft further comprising at least one drug delivery port in the distal portion of the catheter shaft, between the dilatation balloon and at least one of the occlusion balloons,

at least one dilatation lumen in fluid communication with the dilatation balloon,

at least one inflation lumen in fluid communication with the occlusion balloons,

at least one drug delivery lumen fluidly communicating between the drug delivery port and the proximal end, and

a guide wire lumen in the distal portion of the catheter shaft, the guide wire lumen having a first opening to an exterior of the catheter shaft at the distal end of the catheter shaft and a second opening to the exterior of the catheter shaft in the distal portion of the catheter shaft, proximal to the second occlusion balloon and substantially distal to the proximal end of the catheter shaft, such that a guide wire can enter the catheter shaft through the first opening and exit the catheter shaft through the second opening.

27. The catheter of claim 26, wherein the catheter shaft is integral.

28. The catheter of claim 26, wherein the catheter shaft comprises tubes which define the lumens.

29. A dilatation-drug delivery catheter comprising:

a catheter shaft comprising a distal portion, a distal end and a proximal end;

a dilatation balloon attached to the distal portion of the catheter shaft, the dilatation balloon having an outer and an inner layer wherein the inner layer defines an inner region proximate the catheter shaft and the outer and inner layers define an outer region, and the outer layer comprises a plurality of openings;

the catheter shaft further comprising a first lumen fluidly communicating between the outer region and the proximal end, and a second lumen in fluid communication with the inner region, and

a third lumen in the distal portion of the catheter shaft for receiving a guide wire, the third lumen having a first opening to an exterior of the catheter shaft at the distal end of the catheter shaft and a second opening to the exterior of the catheter shaft in the distal portion of the catheter shaft, proximal to the dilatation balloon and substantially distal to the proximal end of the catheter shaft, such that the guide wire can enter the catheter shaft through the first opening and can exit the catheter shaft through the second opening.

30. The catheter of claim 29, wherein the first lumen is adapted to deliver a drug and the second lumen is adapted to deliver inflation fluid.

31. A drug delivery catheter comprising:

a catheter shaft having a distal portion, a distal end and a proximal end;

a drug delivery balloon attached to the distal portion of the catheter shaft, the drug delivery balloon including a plurality of ports extending through the balloon;

the catheter shaft further comprising at least one delivery lumen fluidly communicating between the drug delivery balloon and the proximal end, and a lumen in the distal portion of the catheter shaft for receiving a guide wire, the lumen having a first opening to the exterior of the catheter shaft at the distal end of the catheter shaft and a second opening to the exterior of the catheter shaft in the distal portion of the catheter shaft, proximal to the drug delivery balloon and substantially distal to the proximal end of the catheter shaft, such that the guide wire can enter the catheter shaft through the first opening and exit the catheter shaft through the second opening.

32. The catheter of claim 31, further comprising a perfusion lumen.

33. The catheter of claim 32, wherein the perfusion lumen extends from the distal end of the catheter shaft to the proximal end of the catheter shaft.

34. The catheter of claim 32, wherein the perfusion lumen extends from the distal end of the catheter shaft to a terminus proximal to the drug delivery balloon, the catheter shaft further comprising at least one port proximate the terminus of the perfusion lumen and extending through the catheter shaft to the perfusion lumen, to enable blood to enter the perfusion lumen.

35. The catheter of claim 34, wherein the perfusion lumen has a tapered distal end.