Embolic protection guide wire

• US 7,537,598 B2
• Filed: 04/26/2005
• Issued: 05/26/2009
• Est. Priority Date: 07/13/2000
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Heberer, Joann, Shah, Niraj A.
• Primary Examiner(s): Bui; Vy Q
• Application Number:
  US11/114,932
• Publication Number:
  US 20060095069A1
• Time in Patent Office: 1,491 Days
• Field of Search: 606/108, 606/200, 623/1.11
• US Class Current: 606/108
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A sheath attached to a guide wire, a tubular shaft member slidable on the guide wire and a filtering assembly constricted within the sheath are movable in a vessel to a position distal to a lesion in the direction of fluid flow. The filtering assembly may be formed from a plurality of angularly spaced splines and a mesh disposed on the splines having properties of passing fluid in the vessel while blocking the passage of emboli in the fluid. The splines may be provided with shape memory for expanding against the wall of the vessel when released from constriction by the sheath. The sheath may be moved relative to the filtering assembly and the support member to release the filter for expansion against the vessel wall. An interventional device can be used to treat the lesion. Any emboli released into the vessel as a result of the interventional treatment are blocked by the filter member while fluid is allowed to pass there through.

Claims

1. A device for passing fluid in a vessel while preventing emboli in the fluid from passing through the vessel, comprising:

a guide wire having a proximal end and a distal end;

a tubular shaft member having a proximal and distal end which is movable along the guide wire in a co-axial arrangement;

a filtering assembly including a plurality of splines formed from a portion of the tubular shaft member, the filtering assembly being movable between a collapsed position and expanded position, each spline being movable into a recess formed on the filtering assembly when the filtering assembly is in the collapsed position; and

a sheath, the filtering assembly being constricted within the sheath while in the collapsed position and expanded within the vessel when released from constriction within the sheath to become disposed against the vessel to pass fluid in the vessel while blocking the passage of emboli in the vessel.

2. The filtering device of claim 1, wherein:

the plurality of splines are disposed in annularly spaced relationship to one another and a filter member is attached to the splines.

3. The filtering device of claim 2, wherein:

the splines are formed from a material having shape memory for disposition against the vessel when released from the sheath and

the filter member is formed from a material having properties of passing the fluid in the vessel while blocking the passage of emboli in the vessel.

4. The filtering device of claim 2, wherein:

the splines are self expanding.

5. The filtering device of claim 1, wherein:

the filtering assembly becomes disposed within the sheath when the tubular shaft member becomes disposed within the sheath.

6. The filtering device of claim 1, wherein:

the filtering assembly is self deploying.

7. The filtering device of claim 1, wherein:

the sheath is made from a polymer and has a length to ensure that all of the emboli remain in the sheath when the filtering assembly is moved from the expanded position back into the collapsed position within the sheath.

8. The filtering device of claim 1, wherein:

the filtering assembly has a length to ensure that all of the emboli remain in the filter member when the filtering assembly is moved from the expanded position back into the collapsed position within the sheath.

9. The filtering device of claim 1, wherein:

the filtering assembly has a memory for expanding against the vessel when the tubular shaft member and filtering assembly are displaced relative to the sheath so that they are no longer housed within the sheath.

10. The filtering device of claim 1, wherein:

the tubular shaft member is made from a material having flexible properties and properties of withstanding buckling.

11. The filtering device of claim 1, wherein:

the sheath has a flexibility and shape dependent upon the characteristics of the tortuous anatomy through which the sheath passes.

12. The filtering device of claim 1, wherein:

the sheath has distal and proximal ends, the distal end of the sheath being attached to a guide wire and the proximal end having a opening for receiving the filtering assembly.

13. The filtering device of claim 12, wherein:

the proximal end opening of the sheath is flared outward.

14. The filtering device of claim 1, wherein:

the tubular shaft member is made from hypotube formed from a nickel titanium alloy.

15. A method of passing fluid in a vessel and of preventing emboli in the fluid from passing through the vessel from a lesion in the vessel, including the steps of:

providing a filtering assembly having constricted and expanded positions and having properties in the expanded position of passing fluid while blocking the passage of emboli from the lesion, wherein the filtering assembly includes a plurality of splines formed from a portion of a tubular member, the tubular member including a recess in which the splines may be housed;

disposing the filtering in a sheath to collapse the filtering assembly into the constricted position, the splines being housed within the recesses formed on the tubular member in the constricted position,

positioning the filtering assembly and the sheath in the vessel at a position past the lesion in the direction of the fluid flow in the vessel,

producing relative movement between the sheath and the tubular member in a direction to move the filtering assembly into the expanded position, and

expanding the opening in the vessel at the position of the lesion with an interventional device while the filtering assembly remains in the expanded relationship to provide for the operation of the filtering assembly in passing the fluid while blocking the passage of emboli created during the expansion of the opening in the vessel.

16. A method as set forth in claim 15, including the step of:

withdrawing the sheath and the filtering assembly from the vessel after the disposition of the filtering assembly in the sheath with the emboli disposed within the filtering assembly.

17. A method as set forth in claim 16, wherein:

the filtering assembly is disposed in a fixed relationship on a hypotube,

the hypotube is made from a flexible material having properties of withstanding buckling, and

the distal end of the hypotube becomes disposed within the sheath when the filtering assembly is placed into the sheath.

18. A method as set forth in claim 17, wherein:

the filtering assembly is formed from angularly spaced splines formed from a resilient material capable of withstanding buckling, and

the splines are covered with a filter member made from a material having properties of passing the fluid while blocking the passage of the emboli in the fluid.

19. A method as set forth in claim 15, wherein:

the filtering assembly is disposed in a fixed relationship on a hypotube,

the hypotube is made from a flexible material having properties of withstanding buckling, and

the distal end of the hypotube becomes disposed within the sheath when the filtering assembly is placed into the sheath.