Medical device and method of intravenous filtration

• US 7,722,634 B2
• Filed: 07/02/2004
• Issued: 05/25/2010
• Est. Priority Date: 07/03/2003
• Status: Active Grant

• Current Assignee: Regents of The University of Minnesota (University of Minnesota)
• Original Assignee: Regents of The University of Minnesota (University of Minnesota)
• Inventors: Panetta, Carmelo J., Wilson, Robert F.
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): HORNBERGER, JENNIFER LEA
• Application Number:
  US10/884,600
• Publication Number:
  US 20050038468A1
• Time in Patent Office: 2,153 Days
• Field of Search: 606/191, 606/192, 606/194, 606/200, 606/195, 623/1.11
• US Class Current: 606/200
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A medical catheter having an elongate body, a first expandable balloon and a filter assembly. The filter assembly includes an expandable filter having a first portion coupled to a portion of the medical catheter and a second portion positioned around at least a portion of the first expandable balloon to form a channel between the filter assembly and the first expandable balloon. The filter assembly can further include struts coupled to the second portion of the expandable filter, where the struts tether the second portion of the expandable filter to the elongate body adjacent the proximal end of the first expandable balloon. The first expandable balloon can be used in procedures to dilate blood vessels, including those that deploy stents, where the expandable filter assembly captures particles, including embolic particles, from the blood during the procedure.

Claims

1. A medical catheter, comprising:

an elongate body comprising at least a first lumen extending between an inlet port and an outlet port in the elongate body;

a filter assembly comprising an expandable filter and a plurality of struts, the expandable filter comprising a proximal portion and a distal portion and each strut comprising a proximal end and a distal end, wherein the distal portion of the expandable filter is coupled to a portion of the medical catheter, the proximal ends of the struts are coupled to the elongate body, and the proximal portion of the expandable filter is coupled to the distal ends of the plurality of struts;

a first expandable balloon comprising a proximal end and a distal end, wherein the proximal end and the distal end are coupled to the elongate body and the first expandable balloon is positioned so that, when inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter, and wherein the outlet port is positioned between the proximal end and the distal end so as to be in fluid communication with the first expandable balloon; and

a vascular stent positioned over at least a portion of the first expandable balloon.

2. The medical catheter of claim 1 wherein the distal portion of the expandable filter is coupled to the elongate body.

3. The medical catheter of claim 1 wherein the distal portion of the expandable filter is coupled to a portion of the first expandable balloon.

4. The medical catheter of claim 1 wherein the expandable filter is positioned over at least a portion of both the elongate body and the distal end of the first expandable balloon.

5. The medical catheter of claim 1 wherein the proximal portion of the expandable filter comprises a lip defining an opening into a volume defined by the expandable filter.

6. The medical catheter of claim 5 wherein the lip of the expandable filter comprises a predetermined shape.

7. The medical catheter of claim 6 wherein the predetermined shape is circular.

8. The medical catheter of claim 6 wherein the lip of the expandable filter comprises a diameter no larger than about a diameter of the first expandable balloon.

9. The medical catheter of claim 5 wherein the lip moves along an outer surface of the first expandable balloon as the first expandable balloon inflates to deploy the expandable filter.

10. The medical catheter of claim 5 wherein the proximal portion of the expandable filter to which the distal ends of the plurality of struts are coupled comprises the lip.

11. The medical catheter of claim 1 wherein the plurality of struts are unattached to the first expandable balloon.

12. The medical catheter of claim 1 further comprising a collar positioned around the elongate body adjacent the proximal end of the first expandable balloon, wherein the plurality of struts are coupled to the collar and wherein the collar further comprises a retracting mechanism to move the collar longitudinally along the elongate body and close the expandable filter over at least a portion of the first expandable balloon.

13. The medical catheter of claim 1 wherein the elongate body comprises a second lumen extending from a proximal end of the elongate body to a plurality of surfaces defining openings through the elongate body adjacent the proximal end of the first expandable balloon, wherein the plurality of struts are coupled to a retracting wire in the second lumen through the plurality of surfaces defining the openings, wherein the retracting wire moves to pull the plurality of struts longitudinally along the elongate body so as to draw the expandable filter over and into contact with at least a portion of the first expandable balloon.

14. The medical catheter of claim 1 wherein the struts comprise cables.

15. The medical catheter of claim 1 wherein the struts comprise a mesh.

16. The medical catheter of claim 1 wherein the struts comprise wire.

17. The medical catheter of claim 1 further comprising radial support arms coupled to the proximal portion and the distal portion of the expandable filter, wherein the radial support arms provide a predetermined shape to the expandable filter.

18. The medical catheter of claim 1 wherein the vascular stent is further positioned over at least a portion of the filter assembly.

19. The medical catheter of claim 1 wherein the first lumen of the elongate body further comprises a second outlet port in the elongate body, and wherein the medical catheter further comprising a second expandable balloon coupled to the elongate body and spaced apart from the first expandable balloon, wherein the second outlet portion is in fluid communication with the second expandable balloon.

20. The medical catheter of claim 1 wherein the first expandable balloon is positioned so that, when fully inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter.

21. A medical device system, comprising:

a catheter comprising;

an elongate body comprising at least a first lumen extending between an inlet port and an outlet port in the elongate body;

a filter assembly comprising an expandable filter and a plurality of struts, the expandable filter comprising a proximal portion and a distal portion and each strut comprising a proximal end and a distal end, wherein the distal portion of the expandable filter is coupled to a portion of the medical catheter, the proximal ends of the struts are coupled to the elongate body, and the proximal portion of the expandable filter is coupled to the distal ends of the plurality of struts;

a first expandable balloon comprising a proximal end and a distal end, wherein the proximal end and the distal end are coupled to the elongate body and the first expandable balloon is positioned so that, when inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter, and wherein the outlet port is positioned between the proximal end and the distal end so as to be in fluid communication with the first expandable balloon;

a vascular stent positioned over at least a portion of the first expandable balloon; and

an inflation device comprising a fluid output port to couple to the inlet port of the first lumen, and a fluid pressure generator coupled to the fluid output port to deliver pressurized fluid through the fluid output port to the first expandable balloon.

22. The medical device system of claim 21 wherein the first expandable balloon is positioned so that, when fully inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter.

23. A medical catheter, comprising:

an elongate body comprising at least a first lumen extending between an inlet port and an outlet port in the elongate body;

a first expandable balloon comprising a proximal end and a distal end, wherein the proximal end and the distal end are coupled to the elongate body, and wherein the outlet port is positioned between the proximal end and the distal end so as to be in fluid communication with the first expandable balloon;

a vascular stent positioned over at least a portion of the first expandable balloon; and

a filter assembly comprising an expandable filter and a plurality of struts, wherein the expandable filter comprises a proximal portion and a distal portion and each strut comprises a proximal end and a distal end, wherein the distal portion of the expandable filter is coupled to a portion of the medical catheter, the proximal ends of the struts are coupled to the elongate body, and the proximal portion of the expandable filter is coupled to the distal ends of the plurality of struts, and wherein the first expandable balloon is positioned so that, when inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter and a portion of the expandable filter is positioned around at least a portion of the first expandable balloon to form, when the expandable filter is deployed, a channel between the filter assembly and the first expandable balloon when the first expandable balloon is at least partially deflated after having been inflated.

24. The medical catheter of claim 23 wherein the distal portion of the expandable filter is coupled to the elongate body.

25. The medical catheter of claim 23 wherein the distal portion of the expandable filter is coupled to a portion of the first expandable balloon.

26. The medical catheter of claim 23 wherein the first expandable balloon comprises an outer surface and the expandable filter comprises an inner surface, wherein the outer surface and the inner surface form the channel between the filter assembly and the first expandable balloon.

27. The medical catheter of claim 23 wherein the plurality of struts are unattached to the first expandable balloon.

28. The medical catheter of claim 23 further comprising a collar positioned around the elongate body adjacent the proximal end of the first expandable balloon, wherein the plurality of struts are coupled to the collar and wherein the collar further comprises a retracting mechanism to move the collar longitudinally along the elongate body and close the expandable filter over at least a portion of the first expandable balloon.

29. The medical catheter of claim 23 wherein the elongate body comprises a second lumen extending from a proximal end of the elongate body to a plurality of surfaces defining openings through the elongate body adjacent the proximal end of the first expandable balloon, wherein the plurality of struts are coupled to a retracting wire in the second lumen through the plurality of surfaces defining the openings, wherein the retracting wire moves to pull the plurality of struts longitudinally along the elongate body so as to draw the expandable filter over and into contact with at least a portion of the first expandable balloon.

30. The medical catheter of claim 23 wherein the struts comprise cables.

31. The medical catheter of claim 23 wherein the struts comprise a mesh.

32. The medical catheter of claim 23 wherein the struts comprise wire.

33. The medical catheter of claim 23 wherein the expandable filter is positioned over at least a portion of both the elongate body and the distal end of the first expandable balloon.

34. The medical catheter of claim 23 wherein the proximal portion of the expandable filter comprises a lip defining an opening into a volume of the channel formed by the expandable filter and the first expandable balloon.

35. The medical catheter of claim 34 wherein the lip of the expandable filter comprises a predetermined shape.

36. The medical catheter of claim 35 wherein the predetermined shape is circular.

37. The medical catheter of claim 35 wherein the lip of the expandable filter comprises a diameter no larger than about a diameter of the first expandable balloon.

38. The medical catheter of claim 34 wherein the lip moves along an outer surface of the first expandable balloon as the first expandable balloon inflates to deploy the expandable filter.

39. The medical catheter of claim 34 wherein the proximal portion of the expandable filter to which the distal ends of the plurality of struts are coupled comprises the lip.

40. The medical catheter of claim 23 further comprising radial support arms coupled to the distal portion and the proximal portion of the expandable filter, wherein the radial support arms provide a predetermined shape to the expandable filter.

41. The medical catheter of claim 23 wherein the vascular stent is positioned over at least a portion of the filter assembly and the first expandable balloon.

42. The medical catheter of claim 23 wherein the first lumen of the elongate body further comprises a second outlet port in the elongate body, and wherein the medical catheter further comprising a second expandable balloon coupled to the elongate body and spaced apart from the first expandable balloon, wherein the second outlet portion is in fluid communication with the second expandable balloon.

43. The medical catheter of claim 23 wherein the first expandable balloon is positioned so that, when fully inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter.

44. A method, comprising:

introducing a medical device catheter into a vas, wherein the medical device catheter comprises;

an elongate body comprising at least a first lumen extending between an inlet port and an outlet port in the elongate body;

a filter assembly comprising an expandable filter and a plurality of struts, the expandable filter comprising a proximal portion and a distal portion and each strut comprising a proximal end and a distal end, wherein the distal portion of the expandable filter is coupled to a portion of the medical catheter, the proximal ends of the struts are coupled to the elongate body, and the proximal portion of the expandable filter is coupled to the distal ends of the plurality of struts;

a first expandable balloon comprising a proximal end and a distal end, wherein the proximal end and the distal end are coupled to the elongate body and the first expandable balloon is positioned so that, when inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter, and wherein the outlet port is positioned between the proximal end and the distal end so as to be in fluid communication with the first expandable balloon; and

a vascular stent positioned over at least a portion of the first expandable balloon; and

inflating the expandable balloon to expand the filter assembly.

45. The method of claim 44 further comprising filtering fluid with the filter assembly within the vas.

46. The method of claim 44 wherein introducing the medical device into the vas comprises introducing the medical device into a blood vessel.

47. The method of claim 46 wherein inflating the expandable balloon dilates a lumen of the blood vessel.

48. The method of claim 47 further comprising capturing particles in blood with the filter assembly within the blood vessel.

49. The method of claim 44 wherein inflating the expandable balloon to expand the filter assembly comprises extending a portion of the expandable filter beyond the distal end of the expandable balloon.

50. The method of claim 44 further comprising deploying the stent when inflating the expandable balloon, and capturing particles with the expanded filter assembly.

51. The method of claim 44 further comprising releasing one or more drugs from the filter assembly into the vas.

52. The method of claim 44 wherein inflating the expandable balloon to expand the filter assembly to filter fluid inside the vas comprises capturing particles from the fluid in the filter assembly.

53. The method of claim 44 further comprising drawing the expandable filter over and into contact with at least a portion of the first expandable balloon.

54. A method, comprising:

introducing a medical device catheter into a blood vessel, wherein blood moves through the blood vessel, wherein the medical device catheter comprises;

an elongate body comprising at least a first lumen extending between an inlet port and an outlet port in the elongate body;

a filter assembly comprising an expandable filter and a plurality of struts, the expandable filter comprising a proximal portion and a distal portion and each strut comprising a proximal end and a distal end, wherein the distal portion of the expandable filter is coupled to a portion of the medical catheter, the proximal ends of the struts are coupled to the elongate body, and the proximal portion of the expandable filter is coupled to the distal ends of the plurality of struts;

a first expandable balloon comprising a proximal end and a distal end, wherein the proximal end and the distal end are coupled to the elongate body and the first expandable balloon is positioned so that, when inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter, and wherein the outlet port is positioned between the proximal end and the distal end so as to be in fluid communication with the first expandable balloon; and

a vascular stent positioned over at least a portion of the first expandable balloon;

inflating the expandable balloon in the blood vessel deploying the filter assembly;

at least partially deflating the expandable balloon to form a channel between the filter assembly and the expandable balloon through which the blood moves; and

capturing particles from the blood in the filter assembly moving through the channel.

55. A method of making a medical device catheter, comprising:

providing an elongate body comprising at least a first lumen extending between an inlet port and an outlet port in the elongate body;

coupling a first expandable balloon comprising a proximal end and a distal end to the elongate body, wherein the proximal end and the distal end are coupled to the elongate body, and wherein the outlet port is positioned between the proximal end and the distal end so as to be in fluid communication with the first expandable balloon;

providing a vascular stent positioned over at least a portion of the first expandable balloon; and

providing a filter assembly comprising an expandable filter and a plurality of struts, wherein the expandable filter comprises a proximal portion and a distal portion and each strut comprises a proximal end and a distal end, wherein the distal portion of the expandable filter is coupled to a portion of the medical catheter, the proximal ends of the struts are coupled to the elongate body, and the proximal end of the expandable filter is coupled to the distal ends of the plurality of struts, and wherein the first expandable balloon is positioned so that, when inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter and a portion of the expandable filter is positioned around at least a portion of the first expandable balloon to form, when the expandable filter is deployed, a channel between the filter assembly and the first expandable balloon when the first expandable balloon is at least partially deflated after having been inflated.

56. A medical device system, comprising:

a catheter comprising;

an elongate body comprising at least a first lumen extending between an inlet port and an outlet port in the elongate body;

a first expandable balloon comprising a proximal end and a distal end, wherein the proximal end and the distal end are coupled to the elongate body, and wherein the outlet port is positioned between the proximal end and the distal end so as to be in fluid communication with the first expandable balloon;

a vascular stent positioned over at least a portion of the first expandable balloon; and

a filter assembly comprising an expandable filter and a plurality of struts, wherein the expandable filter comprises a proximal portion and a distal portion and each strut comprises a proximal end and a distal end, wherein the distal portion of the expandable filter is coupled to a portion of the medical catheter, the proximal ends of the struts are coupled to the elongate body, and the proximal end of the expandable filter is coupled to the distal ends of the plurality of struts, and wherein the first expandable balloon is positioned so that, when inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter and a portion of the expandable filter is positioned around at least a portion of the first expandable balloon to form, when the expandable filter is deployed, a channel between the filter assembly and the first expandable balloon when the first expandable balloon is at least partially deflated after having been inflated; and

an inflation device comprising a fluid output port to couple to the inlet port of the first lumen, and a fluid pressure generator coupled to the fluid output port to deliver pressurized fluid through the fluid output port to the first expandable balloon.

57. The medical device system of claim 56 wherein the first expandable balloon is positioned so that, when fully inflated, at least a portion of the first expandable balloon contacts the proximal portion of the expandable filter.