DISTAL PROTECTION FILTER

• US 20130238010A1
• Filed: 05/15/2012
• Published: 09/12/2013
• Est. Priority Date: 03/06/2012
• Status: Active Grant

• Current Assignee: Crux Biomedical, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Crux Biomedical, Inc. (Koninklijke Philips N.V.)
• Inventors: Johnson, Eric, Do, Paul, Laroya, Gilbert
• Granted Patent: US 10,213,288 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2002/015 Stop means therefor
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes

Abstract

Embodiments of the invention relate generally to devices and methods for providing filtration of debris within a body lumen. More particularly, embodiments of the invention related to devices and methods for providing distal protection to a medical procedure by filtration of debris generated by the medical procedure using filters having a frame with a slidable crossover point.

Claims

1. A system for providing embolic protection, the system comprising:

a first sheath having a proximal end, a distal end and a lumen, the lumen configured to receive a guidewire;

a first distal protection filter attached to a distal portion of the first sheath, the first distal protection filter comprising a self-expanding frame with a slidable crossover point that defines a proximal loop and a distal loop, and a filter element attached to one of the proximal loop or distal loop of the self-expanding frame of the first distal protection filter, wherein the crossover point is proximate to the filter element;

a second sheath having a proximal end, a distal end and a lumen, the second sheath disposed over the first sheath, wherein the distal end of the second sheath is located proximally the first distal protection filter;

a second distal protection filter attached to a distal portion of the second sheath, the second distal protection filter comprising a self-expanding frame with a slidable crossover point that defines a proximal loop and a distal loop, and a filter element attached to the proximal loop of the self-expanding frame of the second distal protection filter, wherein the crossover point is proximal to the filter element; and

an outer sheath disposed over both the first sheath and the second sheath.

2. The system of claim 1, wherein the filter element of the second distal protection filter has a mouth and an apex, wherein the mouth of the filter element is attached to the proximal loop and the apex is unattached to the sheath.

3. The system of claim 1, wherein the first sheath includes a stop portion proximal the first distal protection filter, wherein the stop portion is configured to stop advancement of the second sheath proximal to the stop portion.

4. The system of claim 1, wherein in a stowed configuration within the outer sheath, the filter element of the first distal protection filter has a mouth facing the second distal protection filter and the filter element of the second distal protection filter has a mouth facing the first distal protection filter.

5. The system of claim 1, wherein the distance between the first distal protection filter and the second distal protection filter is adjustable.

6. They system of claim 5, wherein the position of the first sheath and the position of the second sheath are independently lockable, allowing one of the first sheath and the second sheath to be locked in position while the position of the other sheath adjusted.

7. The system of claim 1, wherein the self-expanding frame of the first distal protection filter includes at least one anchor element.

8. The system of claim 1, wherein the self-expanding frame of the second distal protection filter includes at least one anchor element.

9. The system of claim 6, wherein the at least one anchor element of the first distal protection filter is configured to partially penetrate through the vessel wall.

10. The system of claim 1, wherein the first sheath includes at least one anchor proximal the first distal protection filter.

11. The system of claim 10, wherein the at least one anchor is located on a side of the first sheath opposite the crossover point of the first distal protection filter.

12. The system of claim 10, wherein the at least one anchor is configured to be located within the aortic arch of a patient when the first distal protection filter is deployed from the outer sheath.

13. The system of claim 10, wherein the at least one anchor of the first sheath is configured to partially penetrate through the vessel wall.

14. The system of claim 1, wherein the filter elements of both the first distal protection filter and the second distal protection filter include a plurality of pores with a diameter of less than about 200 microns.

15. The system of claim 14, wherein the pores of the filter elements of both the first distal protection filter and the second distal protection filter are distributed more densely in the peripheral portion of the filter elements.

16. The system of claim 14, wherein the pores of the filter elements of both the first distal protection filter and the second distal protection filter are larger in the peripheral portion of the filter elements than in the central portion of the filter elements.

17. The system of claim 14, wherein the pores of the filter elements are oblong shaped.

18. The system of claim 1, wherein the filter elements comprises filter membranes with laser drilled holes.

19. The system of claim 1, wherein the filter elements comprise polymer fibers that are selected from the group consisting of electrospun fibers, knitted fibers, braided fibers, and woven fibers.

21. The system of claim 1, wherein the filter elements are made from a polymer selected from the group consisting of polyurethane, polyethylene, and nylon.

22. The system of claim 1, wherein the filter elements of both the first distal protection filter and the second distal protection filter have an open area between about 25 to 75 percent.

23. The system of claim 1, wherein the outer sheath is 9 Fr or less.

24. The system of claim 1, wherein the self-expanding frames of both the first distal protection filter and the second distal protection filter include a radiopaque marker.

25. The system of claim 24, wherein the radiopaque marker is a radiopaque coil of wire wrapped around a superelastic core.

26. The system of claim 1, the distal loops of both the first distal protection filter and the second distal protection filter are unattached to either the first sheath or second sheath.

27. The system of claim 1, wherein the outer sheath includes a curved distal portion with a curvature between about 15 to 45 degrees.

28. The system of claim 1, wherein the first distal protection filter and second distal protection filter are coated with a drug.

29. The system of claim 28, wherein the drug is heparin.

30. The system of claim 1, wherein the proximal loop of the first distal protection filter is attached to first sheath, and the proximal loop of the second distal protection filter is attached to the second sheath.

31. The system of claim 1, wherein the distal loop of the first distal protection filter is attached to first sheath, and the proximal loop of the second distal protection filter is attached to the second sheath.

32. The system of claim 1, wherein the self-expanding frame comprises a single wire element shaped in a figure eight configuration.

33. The system of claim 1, further comprising a hub, the hub having a first hub portion that is engaged with the proximal portion of the first sheath, a second hub portion that is engaged with the proximal portion of the second sheath, and a third hub portion that is engaged with the proximal portion of the outer sheath, wherein the hub allows the first sheath, the second sheath, and the outer sheath to be independently manipulated.

34. The system of claim 33, wherein the third hub portion is removable and configured to allow the outer sheath to be swapped for another sheath.

35. The system of claim 33, wherein each of the first hub portion, the second hub portion and the third hub portion are configured to receive the guidewire.

36. The system of claim 1, further comprising a deflection mechanism attached to the first sheath at a location between the first distal protection filter and the second distal protection filter after deployment of both distal protection filters.

37. The system of claim 36, wherein the deflection mechanism is an inflatable balloon.

38. The system of claim 36, wherein the deflection mechanism is a flat shield.

39. A method of providing embolic protection to at least two blood vessels, the method comprising:

advancing a first distal protection filter to a first location in a first blood vessel, wherein the first distal protection filter includes a first self-expanding frame, and a first filter element having a mouth and an apex with the mouth attached to the first self-expanding frame;

deploying the first distal protection filter at the first location;

manipulating a second distal protection filter to a second location in a second blood vessel, wherein the second distal protection filter includes a second self-expanding frame and a second filter element having a mouth and an apex with the mouth attached to the second self-expanding frame;

deploying the second distal protection filter at the second location;

performing a procedure in a portion of the vasculature that releases or generates particulate debris; and

capturing the particulate debris with one or more of the first distal protection filter and the second distal protection filter.

40. The method of claim 39, further comprising advancing an outer sheath over the mouth of the second filter element to close the mouth of the second filter element before advancing the outer sheath over the apex of the second filter element;

and

advancing the outer sheath over the mouth of the first filter element to close the mouth of the first filter element before advancing the outer sheath over the apex of the first filter element.

41. The method of claim 39, wherein the first distal protection filter is deployed in the left common carotid artery and the second distal protection filter is deployed in the brachiocephalic trunk.

42. The method of claim 39, further comprising adjusting the length between the first distal protection filter and the second distal protection filter.

43. The method of claim 42, wherein the length is adjusted by fixing the location of the first distal protection filter, and then manipulating the position of the second distal protection filter.

44. The method of claim 39, further comprising conforming a sheath attached to the first distal protection filter to the upper surface of the aortic arch between the left common carotid artery and the brachiocephalic trunk.

45. The method of claim 39, further comprising conforming a sheath attached to the first distal protection filter along the inner wall of the aortic arch from the outer radius of the aortic arch proximate the left common carotid artery to the inner radius of the aortic arch and to the outer radius of the aortic arch proximate the brachiocephalic trunk.

46. The method of claim 39, wherein the first self-expanding frame includes a slidable crossover point that defines a proximal loop and a distal loop, and wherein the second self-expanding frame includes a slidable crossover point that defines a proximal loop and a distal loop with the mouth of the second filter element attached to the proximal loop of the second self-expanding frame.

47. The method of claim 46, wherein the apex of the second filter element is unattached to the second self-expanding frame.

48. The method of claim 46, wherein the distal loop of first self-expanding frame moves proximally as the mouth of the first filter element is closed such that the distal loop of the first self-expanding frame is proximal the crossover point of the first self-expanding frame during a part of the mouth closure process.

49. The method of claim 46, wherein the distal loop of second self-expanding frame moves proximally as the mouth of the second filter element is closed such that the distal loop of the second self-expanding frame is proximal the crossover point of the second self-expanding frame during a part of the mouth closure process.

50. The method of claim 39, wherein the apex of the second filter is unattached to a structure on which the second distal protection filter is attached.

51. The method of claim 39, further comprising aspirating the debris trapped in either the first distal protection filter or the second distal protection filter.

52. The method of claim 39, further comprising deploying a deflection mechanism between the first distal protection filter and the second distal protection filter.

53. The method claim 39, wherein manipulating a second distal protection filter to a second location includes withdrawing the second distal protection filter to the second location.

54. The method claim 39, wherein manipulating a second distal protection filter to a second location includes advancing the second distal protection filter to the second location.