Intravascular Blood Filters and Methods of Use

• US 20110282379A1
• Filed: 08/30/2010
• Published: 11/17/2011
• Est. Priority Date: 01/16/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Claret Medical, Inc. (Boston Scientific Corporation)
• Inventors: Lee, Michael, Fifer, Daniel W., Lashinski, Randall T.
• Granted Patent: US 9,326,843 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• 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 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

Multi-filter endolumenal methods and systems for filtering fluids within the body. In some embodiments a multi-filter blood filtering system captures and removes particulates dislodge or generated during a surgical procedure and circulating in a patient'"'"'s vasculature. In some embodiments a dual filter system protects the cerebral vasculature during a cardiac valve repair or replacement procedure.

Claims

1. A method of intravascular blood filtration, comprising:

a filter system comprising an expandable proximal filter and an expandable distal filter;

translating a proximal sheath proximally relative to the proximal filter to expand the proximal filter from a collapsed configuration within the proximal sheath to an expanded configuration within a first vessel;

articulating a distal articulatable sheath independently of the proximal sheath and of the proximal filter from a first configuration to a second configuration to position the distal sheath towards a second vessel; and

advancing a guiding member carrying the expandable distal filter thereon distally from the distal articulatable sheath to expand the distal filter from a collapsed configuration within the distal sheath to an expanded configuration within the second vessel.

2. The method of claim 1 wherein translating the proximal sheath relative to the proximal filter comprises translating the proximal sheath proximally relative to the distal sheath.

3. The method of claim 1 wherein articulating the distal articulatable sheath independently of the proximal sheath comprises bending the distal sheath from a first configuration to a second configuration.

4. The method of claim 3 wherein bending the distal sheath comprises orienting the distal end of the distal sheath towards an opening of the second vessel.

5. The method of claim 1 wherein articulating the distal articulatable sheath independently of the proximal sheath comprises axially translating the distal sheath relative to the proximal filter and the proximal sheath.

6. The method of claim 1 wherein articulating the distal articulatable sheath independently of the proximal sheath comprises rotating the distal sheath relative to the proximal sheath and the proximal filter.

7. The method of claim 1 wherein the articulating step is performed after the proximal filter is expanded from the collapsed configuration to the expanded configuration.

8. The method of claim 7 wherein expanding the distal filter is performed after the articulating step.

9. The method of claim 1 wherein the articulating step comprises positioning a distal end of the articulatable distal sheath within the second vessel.

10. The method of claim 1 wherein the articulating step comprises bending an intermediate portion of the distal sheath without bending a distal portion of the distal sheath.

11. The method of claim 1 further comprising seating the distal articulatable sheath snugly against tissue between the opening of the first vessel and the opening of the second vessel to minimize the amount of the distal sheath present in the space between the opening of the first vessel and the opening of the second vessel.

12. The method of claim 1 where the articulating step comprises protecting the guiding member by positioning the distal sheath between the opening of the first vessel and the opening of the second vessel such that the guiding member is not exposed between the two openings.

13. The method of claim 1 wherein expanding the proximal filter comprises allowing the proximal filter to self-expand.

14. The method of claim 1 wherein expanding the distal filter comprises allowing the distal anchor to self-expand.

15. A method of protecting the cerebral vasculature, comprising:

a filter system comprising an expandable proximal filter and an expandable distal filter;

translating a proximal sheath proximally relative to the proximal filter to expand the proximal filter from a collapsed configuration within the proximal sheath to an expanded configuration within a brachiocephalic trunk;

articulating a distal articulatable sheath independently of the proximal sheath and of the proximal filter from a first configuration to a second configuration to position the distal sheath towards a left common carotid artery; and

advancing a guiding member carrying the expandable distal filter thereon distally from the distal articulatable sheath to expand the distal filter from a collapsed configuration within the distal sheath to an expanded configuration within the left common carotid artery.

16. The method of claim 15 wherein the articulating step comprises bending the distal sheath from a first configuration to a second configuration.

17. The method of claim 15 wherein the articulating step comprises positioning the distal end of the distal sheath within the left common carotid artery.

18. The method of claim 17 wherein the articulating step comprises bending the distal sheath from a first configuration to a second configuration.

19. The method of claim 15 further comprising positioning a portion of the distal sheath within the aortic arch.

20. The method of claim 15 wherein articulating the distal articulatable sheath independently of the proximal sheath comprises axially translating the distal sheath relative to the proximal filter and the proximal sheath.

21. The method of claim 15 wherein articulating the distal articulatable sheath independently of the proximal sheath comprises rotating the distal sheath relative to the proximal sheath and the proximal filter.

22. The method of claim 15 wherein the articulating step is performed after the proximal filter is expanded from the collapsed configuration to the expanded configuration in the brachiocephalic trunk.

23. The method of claim 22 wherein expanding the distal filter in the left common carotid artery is performed after the articulating step.

24. The method of claim 15 further comprising seating the distal articulatable sheath snugly against the tissue between the opening of the brachiocephalic trunk and the opening of the left common carotid artery to minimize the amount of the distal sheath present in the aorta.

25. The method of claim 15 wherein the articulating step comprises protecting the guiding member by positioning the distal sheath in the aorta such that the guiding member is not exposed in the aorta.

26. An intravascular blood filter system, comprising:

an expandable proximal filter adapted to be collapsed within a proximal sheath;

a distal articulatable sheath disposed distal to the proximal sheath; and

an expandable distal filter adapted to be collapsed within the distal articulatable sheath,

wherein the distal articulatable sheath is adapted to be independently articulated relative to the proximal sheath and the proximal filter.

27. The filter system of claim 26 wherein the proximal sheath is adapted to be proximally retracted relative to the proximal filter to allow the expandable proximal filter to expand from a collapsed configuration within the proximal sheath to an expanded configuration outside of the proximal sheath.

28. The filter system of claim 27 wherein the proximal filter is secured to a proximal shaft disposed within the proximal sheath, and wherein the proximal sheath is adapted to be proximally retracted relative to the proximal shaft.

29. The filter system of claim 26 wherein the distal articulatable sheath is adapted to bend relative to the proximal sheath and the proximal filter.

30. The filter system of claim 29 wherein the distal articulatable sheath has a preset bent configuration.

31. The filter system of claim 26 wherein the distal articulatable sheath is adapted to be axially translated relative to the proximal sheath and the proximal filter.

32. The filter system of claim 26 wherein the distal articulatable sheath is adapted to be rotated relative to the proximal sheath and the proximal filter.

33. The filter system of claim 26 wherein the distal articulatable sheath is adapted to be bent, to be axially translated, and to be rotated, relative to the proximal sheath and the proximal filter.

34. The filter system of claim 26 further comprising a guiding member carrying the distal filter.

35. The system of claim 34 wherein the guiding member is adapted to be moved distally relative to the distal sheath to expand the distal filter from a collapsed configuration within the distal sheath to an expanded configuration outside of the distal sheath.

36. The system of claim 34 wherein the distal sheath is secured to a distal shaft, and wherein the guiding member is disposed with the distal shaft and adapted to be axially movable relative to the distal shaft.

37. The system of claim 36 wherein the distal shaft is co-axial with the proximal sheath.

38. The filter system of claim 26,

wherein the proximal filter is secured to a proximal shaft disposed radially within the proximal sheath,

wherein the distal sheath is secured to a distal shaft,

wherein the distal filter is carried by a guiding member, and

wherein the proximal sheath is adapted to be axially moved relative to the proximal filter, the distal sheath, and the distal filter, and wherein the distal filter is adapted to be independently axially moved relative to the proximal sheath, proximal filter, and the distal sheath.

39. The filter system of claim 26 wherein the distal and proximal sheaths have substantially the same outer diameter.

40. The filter system of claim 26 wherein the distal articulatable sheath is configured with a preset S-bend configuration.

41. An intravascular blood filter system, comprising:

an expandable proximal filter adapted to be collapsed within a proximal sheath;

an expandable distal filter carried by a guiding member and adapted to be collapsed within a distal articulatable sheath,

wherein the proximal sheath and the proximal filter are adapted for relative axial translation to allow the proximal filter to expand from a collapsed configuration within the proximal sheath to an expanded configuration outside of the proximal sheath, and

wherein the guiding member and the distal sheath are adapted for relative axial translation to allow the expandable distal filter to expand from a collapsed configuration within the distal articulatable sheath to an expanded configuration outside of the distal articulatable sheath.

42. The filter system of claim 41 wherein the proximal sheath and the distal sheath are separate sheaths.

43. The filter system of claim 41 wherein the proximal filter is secured to a proximal shaft radially disposed within the proximal sheath.

44. The filter system of claim 43 wherein a portion of the guiding member is disposed radially within the proximal shaft.

45. The filter system of claim 44 wherein the distal sheath is secured to a distal shaft, and wherein the guiding member is axially movable within the distal shaft.

46. The filter system of claim 45 wherein the distal shaft has an outer diameter less than an outer diameter of the distal sheath.

47. The filter system of claim 41 wherein the distal articulatable sheath has a preset S-bend configuration.

48. An intravascular blood filter system comprising:

a handle;

a proximal shaft secured to the handle;

a proximal sheath secured to the handle and axially movable with respect to the proximal shaft;

a proximal filter secured to the proximal shaft, wherein the proximal sheath is axially movable with respect to the proximal filter;

a distal shaft secured to the handle;

a distal articulatable sheath secured to the distal shaft and axially movable with respect to the proximal sheath;

a distal filter shaft; and

a distal filter secured to the distal filter shaft and axially movable with respect to the proximal sheath and the distal articulatable sheath.

49. The intravascular blood filter system of claim 48 further comprising:

a pull wire having a length with a proximal end and a distal section; and

wherein the pull wire proximal end is secured to the handle and the pull wire distal section is secured to the distal articulatable sheath.

50. The intravascular blood filter system of claim 48 wherein the handle comprises a first handle section secured to the proximal sheath and a second handle section secured to the distal shaft.

51. The intravascular blood filter system of claim 50 wherein the first handle section houses a proximal hub secured to the proximal sheath, and wherein the proximal hub is adapted to be slideable within the first handle section to cause axial movement of the proximal sheath.

52. The intravascular blood filter system of claim 50 wherein the second handle section further comprises a deflection knob which is adapted to be slideable within and movable with respect to the second handle section.

53. The intravascular blood filter system of claim 52 further comprising:

a pull wire having a length with a proximal end and a distal section;

wherein the pull wire proximal end is secured to the second handle section and the pull wire distal section is secured to the distal articulatable sheath;

wherein the distal shaft is secured to the deflection knob; and

whereby movement of either the deflection knob or the second handle section relative to and in a direction away from each other tensions the pull wire thereby causing deflection of the distal articulatable sheath.

54. The intravascular blood filter system of claim 48 wherein the handle comprises a first handle section secured to the proximal sheath, a second handle section secured to the proximal shaft, and a third handle section secured to the distal shaft.

55. The intravascular blood filter system of claim 54 wherein the second handle section is disposed between the first handle section and the third handle section and wherein the first and third handle sections are movable relative to each other and relative to the second handle section.

56. The intravascular blood filter system of claim 55 further comprising:

a pull wire having a length with a proximal end and a distal section;

wherein the pull wire proximal end is secured to the third handle section and the pull wire distal section is secured to the distal articulatable sheath.

57. The intravascular blood filter system of claim 56 wherein:

the third handle section further comprises a deflection knob which is slideable within and movable with respect to the third handle section;

wherein the pull wire is secured to the third handle section;

wherein the distal shaft is secured to the deflection knob; and

whereby movement of either the deflection knob or the third handle section relative to and in a direction away from each other tensions the pull wire thereby causing deflection of the distal articulatable sheath.

58. The intravascular blood filter system of claim 48 wherein the distal articulatable sheath further comprises a first proximal articulatable section and a second distal articulatable section.

59. The intravascular blood filter system of claim 58 wherein the first proximal articulatable section is formed of a tubular metal member with at least one slot formed therein.

60. The intravascular blood filter system of claim 59 further comprising a plurality of transverse slots formed in the tubular metal member.

61. The intravascular blood filter system of claim 58 further comprising:

a pull wire having a length with a proximal end and a distal section;

wherein the pull wire proximal end is secured to the handle and the pull wire distal section is secured to the first proximal articulatable section of the distal articulatable sheath and the second distal articulatable section of the distal articulatable sheath;

wherein the handle is configured such that movement of the handle tensions or relieves tension on the pull wire; and

whereby initial tensioning of the pull wire causes the first proximal articulatable section to deflect in a first direction having a first radius of curvature and further tensioning of the pull wire causes the second distal articulatable section to deflect in a second direction with a second radius of curvature.

62. The intravascular blood filter system of claim 61 wherein the distal articulatable sheath is adapted to be articulated into a configuration substantially similar to a shepherd'"'"'s staff or crook.

63. The intravascular blood filter system of claim 48 wherein the proximal filter is expandable and adapted to be collapsed within the proximal sheath.

64. The intravascular blood filter system of claim 63 wherein the proximal filter is configured as an oblique truncated cone.

65. The intravascular blood filter system of claim 64 wherein the proximal filter comprises an expandable frame comprising a stiffening element extending at least partially along the length of the proximal filter.

66. The intravascular blood filter system of claim 63 wherein the proximal filter comprises an oblique truncated conical filter with an expandable frame and a stiffening element extending along a length thereof from a point proximate the proximal shaft to a point proximate the shorter length of the oblique truncated conical filter.

67. The intravascular blood filter system of claim 48 wherein the proximal filter has a plurality of holes formed therein to allow blood to be filtered therethrough.

68. The intravascular blood filter system of claim 67 wherein the plurality of holes are triangular in shape.

69. An intravascular blood filter system comprising:

A handle comprising a first handle section and a second handle section;

a proximal shaft secured to the first handle section;

a proximal sheath secured to the first handle section and axially movable with respect to the proximal shaft;

an expandable proximal filter secured to the proximal shaft and collapsible within the proximal sheath and wherein the proximal sheath is axially movable with respect to the proximal filter;

a distal shaft secured to the second handle section;

a distal articulatable sheath a secured to the distal shaft and axially movable with respect to the proximal sheath wherein the distal articulatable sheath comprises a first proximal articulatable section and a second distal articulatable section;

a pull wire having a length with a proximal end and a distal section wherein the pull wire proximal end is secured to the second handle section and the pull wire distal section is secured to the distal articulatable sheath;

a distal filter shaft; and

an expandable distal filter secured to the distal filter shaft and collapsible within the distal shaft and distal articulatable sheath and wherein the distal filter is axially movable with respect to the proximal sheath, the distal shaft and the distal articulatable sheath.

70. A method for protecting the cerebral vasculature during a heart valve procedure, comprising the steps of:

providing a dual filter assembly comprising a handle, an expandable proximal filter, an expandable distal filter, a proximal sheath and a distal articulatable sheath;

percutaneously accessing the right radial artery or the right brachial artery;

advancing the expandable proximal filter, the expandable distal filter, the proximal sheath and the distal articulatable sheath through the percutaneous access to the brachiocephalic artery;

actuating the handle to translate the proximal sheath proximally relative to the expandable proximal filter to expand the expandable proximal filter from a collapsed configuration within the proximal sheath to an expanded configuration within the brachiocephalic artery at a position between the aortic arch and the ostium of the right common carotid artery;

accessing the aortic arch by further actuating the handle to advance the distal articulatable sheath past the expanded expandable proximal filter toward the aortic arch;

accessing the left common carotid artery by further actuating the handle to articulate the distal articulatable sheath from the aortic arch toward and into the left common carotid artery; and

advancing the expandable distal filter distally from the distal articulatable sheath to expand the expandable distal filter from a collapsed configuration within the distal articulatable sheath to an expanded configuration within the left common carotid artery.

71. The method according to claim 70 wherein the steps of advancing and articulating the distal articulatable sheath positions the distal articulatable sheath in the aortic arch and the left common carotid artery.

72. The method according to claim 70 wherein the step of articulating the distal articulatable sheath articulates the distal articulatable sheath from a first configuration to a second configuration to position the distal articulatable sheath towards and accessing the left common carotid artery.

73. The method according to claim 72 wherein in the second configuration the distal articulatable sheath has a configuration substantially similar to a shepherd'"'"'s staff or crook with a distal portion of the distal articulatable sheath positioned in the ostium of the left common carotid artery.

74. The method according to claim 70 wherein the steps of advancing and articulating the distal articulatable sheath are performed without the use of a guide wire or guiding member to position the distal articulatable sheath in the ostium of the left common carotid artery.