Intravascular blood filters and methods of use

• US 9,326,843 B2
• Filed: 08/30/2010
• Issued: 05/03/2016
• 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.
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US12/871,708
• Publication Number:
  US 20110282379A1
• Time in Patent Office: 2,073 Days
• Field of Search: 606/200, 600/146, 600/149, 604/534, 604/525
• US Class Current: 1/1
• 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. 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, the distal articulatable sheath comprising a first proximal articulatable section, a second distal articulatable section, and a lumen extending through the first proximal articulatable section and the second distal articulatable section, the first proximal articulatable section configured to curve in a first direction and the second distal articulatable section configured to curve in a second direction that is different than the first direction, wherein the first proximal articulatable section comprises a slotted tube and the second distal articulatable section comprises a braided tube;

a pull wire having a length with a proximal end and a distal section coupled to the distal articulatable sheath, the pull wire crossing from a side of the lumen within the first proximal articulatable section to an opposite side of the lumen within the second distal articulatable section, wherein retraction of the pull wire causes the first proximal articulatable section to curve in the first direction and the second distal articulatable section to curve in the second direction; 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, wherein the first proximal articulatable section and the second distal articulatable section are separate constructions with different types of articulable structures.

2. The filter system of claim 1 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.

3. The filter system of claim 2 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.

4. The filter system of claim 1 wherein the distal articulatable sheath is adapted to bend relative to the proximal sheath and the proximal filter.

5. The filter system of claim 4 wherein the distal articulatable sheath has a preset bent configuration.

6. The filter system of claim 1 wherein the distal articulatable sheath is adapted to be axially translated relative to the proximal sheath and the proximal filter.

7. The filter system of claim 1 wherein the distal articulatable sheath is adapted to be rotated relative to the proximal sheath and the proximal filter.

8. The filter system of claim 1 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.

9. The filter system of claim 1 further comprising a guiding member carrying the distal filter.

10. The system of claim 9 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.

11. The system of claim 9 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.

12. The system of claim 11 wherein the distal shaft is co-axial with the proximal sheath.

13. The filter system of claim 1, 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.

14. The filter system of claim 1 wherein the distal and proximal sheaths have substantially the same outer diameter.

15. The filter system of claim 1 wherein the distal articulatable sheath is configured with a preset S-bend configuration.

40. The filter system of claim 1 wherein retraction of the pull wire causes the first proximal articulatable section to bend out of plane.

41. The filter system of claim 1 wherein retraction of the pull wire causes the second distal articulatable section to continue to curve in the second different direction after the first proximal articulatable section has stopped bending.

42. The filter system of claim 41 wherein the first proximal articular section stops bending as slots in the first proximal articulatable section narrow and touch one another.

16. An intravascular blood filter system, comprising:

a proximal sheath;

a proximal shaft extending through proximal sheath,

an expandable proximal filter carried by the proximal shaft collapsed within the proximal sheath;

a distal shaft extending through the proximal shaft and the expandable proximal filter;

a distal articulatable sheath carried by the distal shaft and positioned distal to a distal end of the proximal sheath and the expandable proximal filter;

a guiding member extending through the distal articulatable sheath;

an expandable distal filter carried by the guiding member and collapsed within the distal articulatable sheath and distal to the distal end of the proximal sheath,

wherein the proximal sheath and the proximal filter allow 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 as the proximal sheath is withdrawn with respect to the proximal filter, and

wherein the guiding member and the distal sheath allow 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 as the guiding member and the expandable distal filter is advanced with respect to the distal sheath;

wherein the distal articulatable sheath comprises a first proximal articulatable section, a second distal articulatable section, and a lumen extending through the first proximal articulatable section and the second distal articulatable section, the first proximal articulatable section comprising an articulable hypotube with a plurality of slots formed therein and the second distal articulatable section not including a hypotube with a plurality of slots formed therein and a pull wire having a length with a proximal end and a distal section coupled to the distal articulatable sheath, the pull wire crossing from a side of the lumen within the first proximal articulatable section to an opposite side of the lumen within the second distal articulatable section, wherein retraction of the pull wire causes the first proximal articulatable section and the second distal articulatable section to curve, wherein the first proximal articulatable section comprises a slotted tube and the second distal articulatable section comprises a braided tube.

17. The filter system of claim 16 wherein the proximal filter is secured to the proximal shaft radially disposed within the proximal sheath.

18. The filter system of claim 16 wherein the distal articulatable sheath has a preset S-bend configuration.

19. 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, the distal articulatable sheath comprising a first proximal articulatable section, a second distal articulatable section, and a lumen extending through the first proximal articulatable section and the second distal articulatable section, the first proximal articulatable section configured to curve in a first direction and the second distal articulatable section configured to curve in a second direction that is different than the first direction, wherein the first proximal articulatable section comprises a first type of articulable structure and the second distal articulatable section comprises a separate type of articulable structure that is different from the first type of articulable structure, wherein the first proximal articulatable section comprises a slotted tube and the second distal articulatable section comprises a braided tube;

a distal filter shaft;

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

a single actuation member extending between the handle and the distal articulatable sheath wherein actuation of the single actuation member causes the first proximal articulatable section to curve in the first direction and the second distal articulatable section to curve in the second direction, the single actuation member crossing from a side of the lumen within the first proximal articulatable section to an opposite side of the lumen within the second distal articulatable section.

20. The intravascular blood filter system of claim 19 wherein the single actuation member comprises:

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.

21. The intravascular blood filter system of claim 19 wherein the handle comprises a first handle section secured to the proximal sheath and a second handle section secured to the distal shaft.

22. The intravascular blood filter system of claim 21 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.

23. The intravascular blood filter system of claim 21 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.

24. The intravascular blood filter system of claim 23 wherein the single actuation member comprises:

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.

25. The intravascular blood filter system of claim 19 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.

26. The intravascular blood filter system of claim 25 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.

27. The intravascular blood filter system of claim 26 wherein the single actuation member comprises:

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.

28. The intravascular blood filter system of claim 27 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.

29. The intravascular blood filter system of claim 19 wherein the slotted tube is metal.

30. The intravascular blood filter system of claim 29 wherein the slotted tube is comprised of a plurality of transverse slots.

31. The intravascular blood filter system of claim 19 wherein the single actuation member comprises:

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.

32. The intravascular blood filter system of claim 31 wherein the distal articulatable sheath is adapted to be articulated into a configuration substantially similar to a shepherd'"'"'s staff or crook.

33. The intravascular blood filter system of claim 19 wherein the proximal filter is expandable and adapted to be collapsed within the proximal sheath.

34. The intravascular blood filter system of claim 33 wherein the proximal filter is configured as an oblique truncated cone.

35. The intravascular blood filter system of claim 34 wherein the proximal filter comprises an expandable frame comprising a stiffening element extending at least partially along the length of the proximal filter.

36. The intravascular blood filter system of claim 33 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.

37. The intravascular blood filter system of claim 19 wherein the proximal filter has a plurality of holes formed therein to allow blood to be filtered therethrough.

38. The intravascular blood filter system of claim 37 wherein the plurality of holes are triangular in shape.

43. The intravascular blood filter system of claim 19 wherein actuation of the single actuation member causes the first proximal articulatable section to bend out of plane.

44. The intravascular blood filter system of claim 19 wherein actuation of the single actuation member causes the second distal articulatable section to continue to curve in the second different direction after the first proximal articulatable section has stopped bending.

45. The intravascular blood filter system of claim 44 wherein the first proximal articulatable section stops bending as slots in the first proximal articulatable section narrow and touch one another.

39. 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 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, a second distal articulatable section, and a lumen extending through the first proximal articulatable section and the second distal articulatable section, wherein the first proximal articulatable section comprises a first type of articulable structure where bending is limited and the second distal articulatable section comprises a separate type of articulable structure where the bending is not limited, wherein the first proximal articulatable section comprises a slotted tube and the second distal articulatable section comprises a braided tube;

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, the pull wire crossing from a side of the lumen within the first proximal articulatable section to an opposite side of the lumen within the second distal articulatable section, wherein retraction of the pull wire causes the first proximal articulatable section to curve in a first direction and the second distal articulatable section to curve in a second different direction;

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.

46. The intravascular blood filter system of claim 39 wherein retraction of the pull wire causes the first proximal articulatable section to bend out of plane.

47. The intravascular blood filter system of claim 39 wherein retraction of the pull wire causes the second distal articulatable section to continue to curve in the second different direction after the first proximal articulatable section has stopped bending.

48. The intravascular blood filter system of claim 47 wherein the first proximal articulatable section stops bending as slots in the first proximal articulatable section narrow and touch one another.