Intravascular dilatation infusion catheter

• US 20050288632A1
• Filed: 06/23/2004
• Published: 12/29/2005
• Est. Priority Date: 06/23/2004
• Status: Active Grant

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Willard, Martin R.
• Granted Patent: US 7,537,580 B2
• Time in Patent Office: Days
• US Class Current: 604/103.01
• 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 2025/1093 having particular tip characteristics
• 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 25/104 used for angioplasty

Abstract

A medical device comprises a catheter having at least one catheter shaft, which defines an inflation lumen for transport of an inflation fluid therethrough. The inflation fluid comprises a coolant. An expandable balloon, which has a proximal cone, distal cone, and a body region therebetween, is engaged to a distal region of the at least one catheter shaft. The balloon interior is in fluid communication with the inflation lumen. A portion of the catheter distal of the balloon body defines at least one port that is in fluid communication with the inflation lumen and the balloon interior.

Claims

1. A medical device comprising:

a catheter, the catheter having at least one catheter shaft, the at least one catheter shaft defining an inflation lumen for transport of an inflation fluid therethrough, the inflation fluid comprising a coolant; and

an expandable balloon, the balloon having a proximal cone, a distal cone and a body region therebetween, the balloon being engaged to a distal region of the at least one catheter shaft, the balloon defining an exterior and an interior, the interior being in fluid communication with the inflation lumen, a portion of the catheter distal of the balloon body defining at least one port in fluid communication with the inflation lumen and the balloon interior.

2. The medical device of claim 1 wherein the at least one port is defined by the distal cone of the balloon.

3. The medical device of claim 2 wherein the distal cone of the balloon defines a plurality of ports.

4. The medical device of claim 3 further comprising a flexible baffle, the baffle positioned adjacent to the distal cone, the baffle constructed and arrange to permit the inflation fluid to pass from the balloon interior, through the plurality of ports, to the balloon exterior and to limit flow from the balloon exterior to the balloon interior.

5. The medical device of claim 4 wherein the baffle is positioned in the balloon interior proximal to the distal cone.

6. The medical device of claim 5 wherein the baffle is actuatable from a collapsed state to an occluded state, in the occluded state the baffle at least partially occluding the plurality of ports.

7. The medical device of claim 6 wherein the baffle is disposed about the at least one catheter shaft, a first end portion of the baffle being engaged to the at least one catheter shaft, a second end portion of the baffle being moveable relative to the at least one catheter shaft.

8. The medical device of claim 7 wherein the second end portion is operatively engaged to at least one actuation member, the at least one actuation member extending proximally along the at least one catheter shaft and is moveable relative thereto, such that moving the at least one actuation member in a distal direction actuates the baffle from the collapsed state to the occluded state, and moving the at least one actuation member in the proximal direction actuates the baffle from the occluded state to the collapsed state.

9. The medical device of claim 8 wherein the actuation member is a bellows.

10. The medical device of claim 4 wherein the baffle is positioned on the balloon exterior distal to the distal cone.

11. The medical device of claim 10 wherein a first end portion of the baffle is fixedly engaged to the catheter and a second end portion of the baffle is moveable relative to the catheter.

12. The medical device of claim 11 wherein the first end portion of the baffle is engaged to the balloon.

13. The medical device of claim 11 wherein the first end portion of the baffle is engaged to the at least one catheter shaft distally of the distal cone of the balloon.

14. The medical device of claim 3 further comprising a baffle, the baffle positioned adjacent to the distal cone of the balloon, wherein the baffle comprises a first end portion and a second end portion, the first end portion of the baffle being engaged to at least a portion the distal cone and the second end portion being engaged to the at least one catheter shaft, the baffle defining a plurality of baffle openings therethrough.

15. The medical device of claim 14 wherein each of the plurality of ports is radially offset from each of the plurality of baffle openings.

16. The medical device of claim 1 wherein the catheter comprises at least one valve mechanism.

17. The medical device of claim 16 wherein the at least one valve mechanism is positioned in the inflation lumen.

18. The medical device of claim 17 wherein the at least one valve mechanism permits the inflation fluid to flow freely through the inflation lumen in only one direction.

19. The medical device of claim 16 wherein the at least one valve mechanism permits the inflation fluid to flow freely through the at least one port in only one direction.

26. The medical device of claim 1 further comprising a guidewire, the guidewire having a guidewire diameter, the guidewire moveable through the inflation lumen.

27. The medical device of claim 26 wherein the inflation lumen comprises a proximal portion and a distal portion, the proximal portion having a diameter greater than that of the distal portion, the distal portion having a diameter approximately the same as the guidewire diameter.

28. The medical device of claim 27 wherein the distal region of the at least one catheter shaft which underlies the balloon defines at least one shaft entrance port, which provides the fluid communication between the balloon interior and the inflation lumen.

29. The medical device of claim 28 wherein the at least one shaft distal of the balloon defines at least one shaft exit port, which provides fluid communication between the inflation lumen and the balloon exterior.

30. The medical device of claim 1 wherein the coolant has a temperature of about 37 degrees Celsius or less.

32. The medical device of claim 1 wherein the inflation fluid comprises at least one therapeutic agent.

33. The medical device of claim 1 further comprising an expandable stent, prior to expansion the stent being disposed about at least a portion of the body region of the balloon.

34. The medical device of claim 33 further comprising at least one therapeutic agent applied thereto.

35. The medical device of claim 34 wherein the at least one therapeutic agent is a coating, the coating being applied to at least one surface selected from the group consisting of a surface of the balloon, a surface of the stent and any combination thereof.

36. The medical device of claim 34 wherein the at least one therapeutic agent selected from at least one member of the group consisting of:

at least one non-genetic therapeutic agent, at least one genetic therapeutic agent, at least one type of cellular material, and any combination thereof

37. The medical device of claim 34 wherein the at least one therapeutic agent comprises at least one polymer agent.

20. The medical device of claim I wherein the at least one catheter shaft comprises an inner shaft and an outer shaft, the outer shaft disposed about a proximal portion of the inner shaft, a distal portion of the inner shaft extending distally therefrom;

the balloon further comprises a proximal waist proximal of the proximal cone and a distal waist distal of the distal cone, the proximal waist being engaged to the outer shaft, the distal waist being engaged to the distal portion of the inner shaft, the inflation lumen being defined by the proximal portion of the inner shaft and the outer shaft disposed thereabout.

21. The medical device of claim 20 wherein the inner shaft defines a guidewire lumen for passage of a guidewire therethrough.

22. The medical device of claim 21 wherein the distal portion of the inner shaft which underlies the balloon defines at least one shaft entrance port, the at least one shaft entrance port providing fluid communication between the interior of the balloon and the guidewire lumen.

23. The medical device of claim 22 wherein the inner shaft distal of the balloon defines at least one shaft exit port, the at least one shaft exit port providing fluid communication between the guidewire lumen and the balloon exterior.

24. The medical device of claim 21 further comprising at least one valve mechanism, the at least one valve mechanism positioned in the guidewire lumen proximal of the balloon, the at least one valve mechanism permitting passage of only the guidewire therethrough.

25. The medical device of claim 21 wherein the guidewire has an advanced position and a withdrawn position, in the advanced position a portion of the guidewire at least partially occludes the at least one shaft entrance port to limit the flow of fluid therethrough, in the withdrawn position the guidewire is positioned proximal to the at least one shaft entrance port.

31. The medical device of claim I wherein the inflation fluid is selected from at least one member of the group consisting of:

saline, Ringers Lactate, a therapeutic agent and any combinations thereof

38. A medical device comprising:

a catheter, the catheter having at least one catheter shaft, the at least one catheter shaft defining an inflation lumen for transport of an inflation fluid therethrough, and a separate infusate lumen for transport of an infusate fluid therethrough; and

an expandable balloon, the balloon having a proximal cone, a distal cone and a body region therebetween, the balloon being engaged to a distal region of the at least one catheter shaft, the balloon defining an exterior and an interior, the interior being in fluid communication with the inflation lumen, a portion of the catheter distal of the balloon body defining at least one port in fluid communication with the infusate lumen.

39. The medical device of claim 38 wherein the infusate lumen is positioned radially external to the inflation lumen.

40. The medical device of claim 38 wherein the infusate fluid and the inflation fluid have substantially the same composition.

41. The medical device of claim 38 wherein the infusate fluid and the inflation fluid have different compositions.

42. The medical device of claim 38 wherein the infusate fluid comprises a coolant, the coolant having a temperature of about 37 degrees Celsius or less.