Intravascular blood filters and methods of use

• US 9,636,205 B2
• Filed: 08/30/2010
• Issued: 05/02/2017
• 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): Nguyen, Victor
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US13/497,235
• Publication Number:
  US 20120289996A1
• Time in Patent Office: 2,437 Days
• Field of Search: 606 1, 606191-200
• CPC Class Codes: A61F 2/012 Multiple filtering units
• 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 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 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes

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:

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

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

pulling a single pull wire to deflect a distal articulatable sheath independently of the proximal sheath and of the proximal filter and from a first configuration to a second configuration to position the distal articulatable sheath towards a second vessel, wherein in the second configuration, a distal section of the distal articulable sheath curves in a first plane and a proximal section of the distal articulatable sheath curves in a second plane, wherein the first plane is out-of-plane from the second plane, wherein pulling the single pull wire deflects a proximal section of the distal articulatable sheath and deflects a distal section of the distal articulatable sheath, and wherein the distal section of the distal articulatable sheath is configured to continue to bend without further bending the proximal section of the distal articulatable sheath when the distal section of the articulatable sheath is articulated by the single pull wire; and

advancing a tubular member carrying the expandable distal filter thereon distally from the distal articulatable sheath to permit the distal filter to expand from a collapsed configuration within the distal articulatable 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 articulatable sheath.

3. The method of claim 1, further comprising translating the distal articulatable sheath relative to the proximal filter and the proximal sheath.

4. The method of claim 1, further comprising rotating the distal articulatable sheath relative to the proximal sheath and the proximal filter.

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

6. The method of claim 5 wherein expanding the distal filter is performed after the deflecting step.

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

8. The method of claim 1 wherein the deflecting step comprises bending the proximal section of the distal articulatable sheath without bending the distal section of the distal articulatable sheath.

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

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

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

12. 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 distal section and a proximal section, the distal section being configured to curve in a first plane, the proximal section being configured to curve in a second plane, wherein the first plane is out-of-plane from the second plane;

a single pull wire configured to articulate the proximal section of the distal articulatable sheath and articulate the distal section of the distal articulatable 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 deflected relative to the proximal sheath and the proximal filter, and

wherein the distal section of the distal articulatable sheath is configured to continue bending without further bending of the proximal section of the distal articulatable sheath when the distal section of the articulatable sheath is articulated by the single pull wire.

13. The filter system of claim 12 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.

14. The filter system of claim 13 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.

15. The filter system of claim 12 wherein the distal articulatable sheath is adapted to be axially translated relative to the proximal sheath and the proximal filter.

16. The filter system of claim 12 wherein the distal articulatable sheath is adapted to be rotated relative to the proximal sheath and the proximal filter.

17. The filter system of claim 12 further comprising a tubular member carrying the distal filter.

18. The system of claim 17 wherein the tubular member is adapted to be moved distally relative to the distal articulatable sheath to permit expansion of the distal filter from a collapsed configuration within the distal articulatable sheath to an expanded configuration outside of the distal articulatable sheath.

19. The system of claim 17 wherein the distal articulatable sheath is secured to a distal shaft, and wherein the tubular member is disposed within the distal shaft and adapted to be axially movable relative to the distal shaft.

20. The filter system of claim 12 wherein the distal and proximal sheaths have substantially the same outer diameter.

21. 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 distal section and a proximal section, the distal section being configured to curve in a first plane, the proximal section being configured to curve in a second plane, wherein the first plane is out-of-plane from the second plane;

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

the pull wire proximal end being secured to the handle and the pull wire distal section being secured to the distal articulatable sheath, the single pull wire configured to articulate the proximal section of the distal articulatable sheath and to articulate the distal section of the distal articulatable sheath, the distal section of the distal articulatable sheath being configured to continue bending without further bending of the proximal section of the distal articulatable sheath when the distal section of the articulatable sheath is articulated by the single pull wire;

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.

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

23. The intravascular blood filter system of claim 22 wherein the first handle section houses a proximal hub secured to the proximal sheath, and wherein the proximal hub is adapted to cause axial movement of the proximal sheath.

24. The intravascular blood filter system of claim 22 wherein the second handle section further comprises a deflection control.

25. The intravascular blood filter system of claim 24 further comprising:

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

whereby movement of either the deflection control 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.

26. The intravascular blood filter system of claim 21 wherein the proximal filter is configured as an oblique truncated cone.

27. The intravascular blood filter system of claim 26 wherein the proximal filter comprises an expandable frame comprising a stiffening element extending at least partially along a length of the proximal filter.

28. The intravascular blood filter system of claim 21 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.