Vascular filter

• US 6,755,846 B1
• Filed: 10/02/1998
• Issued: 06/29/2004
• Est. Priority Date: 02/03/1997
• Status: Expired due to Term

• Current Assignee: AngioGuard, Inc. (Cardinal Health, Inc.)
• Original Assignee: AngioGuard, Inc. (Cardinal Health, Inc.)
• Inventors: Yadav, Jay S.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/155,753
• Time in Patent Office: 2,097 Days
• Field of Search: 606/200, 606/1, 606/159, 606/198
• US Class Current: 606/200
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A removable vascular filter device for blocking micro-and macro-emboli while allowing continued perfusion of blood, comprises a guidewire having distal and proximal portions, wherein there is a recess in the distal portion and a filter comprising a flexible filter membrane and a filter membrane support structure. The filter membrane has a fixed inner portion and a free outer portion, wherein the filter membrane fixed inner portion is movably attached toward the distal end of the guidewire recess and wherein the filter membrane free outer portion is positioned in the recess when the filter membrane is in a collapsed state. A deploying means causes the filter membrane proximal end portion to assume a position substantially normal to the longitudinal axis of the guidewire.

Claims

1. A removable percutaneous vascular filter device for capturing micro-and macro-emboli while allowing continued perfusion of blood, comprising:

a guidewire comprising an elongate member having distal and proximal portions, the distal portion including a shapeable, tapered soft distal tip, an outside diameter, and a recess in the distal portion immediately adjacent the distal tip, the recess having distal and proximal ends, and a predetermined depth, the guidewire further comprising a central lumen;

a filter comprising (a) a non-metallic, porous, flexible filter membrane having a distal portion and a proximal free end portion and (b) a filter membrane support structure extending from the flexible filter membrane distal portion to at least the flexible filter membrane proximal portion, wherein said filter membrane distal portion is pivotally attached to the guidewire near said distal end of the guidewire recess and wherein the filter membrane proximal free end portion is positioned in the recess substantially parallel to the guidewire when the filter membrane is in a collapsed state, the predetermined depth of the recess providing a space wherein the filter membrance lies adjacent to an inner portion of the elongate member when the filter membrane is in the collapsed state and has an outside diameter that is less than the outside diameter any portion of of the elongate member except for said recess and the distal portion of said distal tip; and

deploying means operatively connected to the filter to cause filter membrane proximal free end portion to move from a position substantially parallel to the elongate member to a position removed from the longitudinal axis of the elongate member to cause the flexible filter membrane to form a substantially conical shape to form a generally sealing relationship with the wall of said vessel, the deploying means including a moveable core being slidably positioned in the central lumen and extending beyond the flexible filter membrane distal position and into the shapeable, tapered soft distal tip.

2. The vascular filter of claim 1, wherein the pore size of the filter membrane is from about 40 to about 300 microns.

3. The vascular filter of claim 1, wherein the deploying means further comprises deploying fibers each having first and second ends and said filter membrane further comprises an outer edge, and wherein said deploying fibers are each attached at a first end to the moveable core and are attached at a second end to the outer edge of the filter membrane.

4. The vascular filter of claim 3, wherein the moveable core creates a tension in the deploying fibers when it slides proximally in relation to the guidewire, and said tension causes the filter membrane to expand outwardly until the outer edge of the filter membrane is in firm contact with a lumen wall.

5. The vascular filter of claim 3 further comprising a means for collapsing the filter membrane from a deployed state to a collapsed state.

6. The vascular filter of claim 5, wherein the collapsing means further comprises collapsing fibers each having first and second ends, wherein said collapsing fibers are each attached at a first end to the moveable core and are further attached at a second end to the outer edge of the filter membrane.

7. The vascular filter of claim 6, wherein the moveable core creates a tension in the collapsing fibers when it slides proximally in relation to the guidewire, the said tension causes the filter membrane to collapse tightly against the guidewire.

8. The vascular filter of claim 1, wherein the lumen extends distally from the proximal portion of the guidewire to at least the recess.

9. A removable percutaneous vascular filter device for capturing micro- and macro-emboli while allowing continued perfusion of blood, comprising:

a guidewire comprising an elongate member having distal and proximal portions, the distal portion including a shapeable, tapered soft distal tip, an outside diameter, and a recess in the distal portion immediately adjacent the distal tip, the recess having distal and proximal ends, and a predetermined depth;

a filter comprising a non-metallic, porous, flexible filter membrane and a filter membrane support structure, the filter membrane having a fixed inner portion and a free outer portion, wherein the filter membrane fixed inner portion is attached toward the distal end of the recess and wherein the filter membrane free outer portion is positioned in the recess when the filter membrane is in a collapsed state, the predetermined depth of the recess providing a space, wherein the filter membrane lies adjacent to an inner portion of the elongate member when the filter membrane is in the collapsed state and has an outside diameter that is less than the outside diameter any portion of of the elongate member except for said recess and the distal portion of said distal tip and wherein the filter membrane in an unstressed position assumes a position substantially normal to the longitudinal axis of the elongate member; and

means operatively connected to the filter to collapse the filter membrane from a deployed state to a collapsed state.

10. The vascular filter of claim 9, wherein the filter membrane comprises wires which assume a 90°

angle with respect to the longitudinal axis of the guidewire in an unconstrained state.

11. The vascular filter of claim 9, wherein the filter membrane comprises from 2 to 6 arcing wires.

12. The vascular filter of claim 9, wherein the filter membrane comprises a single spiral wire.

13. The vascular filter of claim 9, wherein the collapsing means comprises collapsing fibers each having first and second ends, wherein said collapsing fibers are each attached at a first end to the outer edge of the filter membrane and the second end of each fiber extends proximally through the guidewire to an actuator.

14. The vascular filter of claim 13, wherein the actuator is a handle or shaft that can be rotated clockwise or counter-clockwise to release or collapse the filter membrane.

15. The vascular filter of claim 9, wherein the filter membrane comprises a set of inflatable spines, said spines being hollow plastic tubes.

16. The vascular filter of claim 15 which further comprises an inflator for inflating the spines, wherein said inflator is in fluid communication with said spines, which become rigid upon inflation.

17. The vascular filter of claim 16, where the means of inflation is an endoflator.

18. The vascular filter of claim 9, wherein the guidewire has a lumen extending distally from the proximal portion of the guidewire to at least the recess.

19. The vascular filter of claim 9, which also comprises a sheath positioned concentric to the collapsed filter membrane, wherein said membrane causes the filter member to be in a collapsed state but can be moved distally to allow the filter member to extend radially.

20. The vascular filter of claim 19, wherein the sheath has proximal and distal portions and is attached at its distal end to a distal guidewire tip that is affixed to a moveable core extending proximally through the guidewire.