Vascular filter system

• US 6,391,044 B1
• Filed: 02/12/1999
• Issued: 05/21/2002
• 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: Raatikka, Amy, Yadav, Jay S., Borillo, Thomas, Sutton, Gregg S.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/249,377
• Time in Patent Office: 1,194 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 2/011 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 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A removable vascular filter system for blocking micro- and macro-emboli while allowing the continued perfusion of blood comprises a filter membrane positioned on a guidewire, wherein a free end of the membrane sits tightly against the guidewire when the filter membrane is in a collapsed state and wherein the filter has a means for deploying the filter membrane to assume a position substantially normal to the longitudinal axis of the guidewire. The filter membrane is comprised of a fine mesh material which has a pore size capable of blocking emboli while allowing continued blood flow, a preferred embodiment of which comprises regularly spaced, laser-formed holes.

Claims

1. A removable percutaneous vascular filter system for blocking micro- and macro-emboli in a vessel while allowing continued perfusion of blood, comprising:

a guidewire having distal and proximal ends,

a filter comprising (a) a non-metallic, porous, flexible filter membrane having a distal portion and a proximal free 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 and wherein the filter membrane proximal free end portion is substantially parallel to the guidewire in its collapsed state, and

deploying means operatively connected to the filter to cause the filter membrane proximal free end portion to move from a position substantially parallel to the guidewire to a position removed from the longitudinal axis of the guidewire to cause the flexible filter membrane to form a substantially conical shape to form a generally sealing relationship with the wall of said vessel.

2. The vascular filter system of claim 1, whereby the deploying means comprises a control mechanism at the proximal end of the guidewire operatively connected to the filter.

3. The vascular filter system of claim 1, wherein the pore size of the filter membrane is from about 20 to about 300 microns.

4. The vascular filter system of claim 1, wherein the deploying means comprises a moveable core, the moveable core being slidably positioned in the interior of the guidewire.

5. The vascular filter system of claim 4, 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.

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

7. The vascular filter system of claim 6, wherein the collapsing means further comprises collapsing wires each having first and second ends, wherein said collapsing wires 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.

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

9. The vascular filter system 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.

10. A removable percutaneous vascular filter system for blocking micro- and macro-emboli while allowing continued perfusion of blood, comprising:

a guidewire having distal and proximal portions, wherein there is a recess in the distal portion, the recess having distal and proximal ends,

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 the flexible membrane distal portion is pivotally attached to the guidewire near the distal end of the guidewire recess and wherein the flexible membrane proximal free end portion is positioned in the recess when the filter membrane is in a collapsed state, and

deploying means operatively connected to the filter to cause the filter membrane proximal free end portion to move from a position substantially parallel to the guidewire to a position removed from the longitudinal axis of the guidewire to cause the flexible filter membrane to form a substantially conical shape to form a generally sealing relationship with the wall of said vessel.

11. The vascular filter system of claim 10, wherein the deploying means is a handle or shaft that can be used to release or collapse the filter membrane.

12. The vascular filter system of claim 10, wherein the filter membrane comprises a set of inflatable spines, said spines being hollow plastic tubes.

13. The vascular filter system of claim 12 which further comprises an inflator for inflating the spines, wherein said spines become rigid upon inflation.

14. The vascular filter system of claim 13, where the inflator is an endoflator.

15. A method of treating diseased corporeal blood vessels in a patient, comprising the steps of:

(a) percutaneously inserting a removable vascular filter system comprising;

a guidewire having distal and proximal ends,

a filter comprising (1) 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 and wherein the filter membrane proximal free end portion is substantially parallel to the guidewire in its collapsed state, and

deploying means operatively connected to the filter to cause the filter membrane proximal free end portion to move from a position substantially parallel to the guidewire to a position removed from the longitudinal axis of the guidewire to cause the flexible filter membrane to form a substantially conical shape to form a generally sealing relationship with the wall of said vessel, into a diseased blood vessel to position the filter distal to a diseased segment of the vessel;

(b) deploying the filter;

(c) advancing a therapeutic catheter distally over the guidewire to the diseased segment;

(d) treating the diseased segment with the therapeutic catheter, whereby any loosened fragments from the diseased segment are carried distally by blood flow and are captured by the deployed filter;

(e) withdrawing the therapeutic catheter from the blood vessel;

(f) collapsing the filter with any trapped fragments; and

(g) withdrawing the vascular filter system from the blood vessel.

16. The method of claim 15, wherein the therapeutic catheter has a stent arranged thereon or comprises a dilatation balloon.

17. The method of claim 15, wherein the therapeutic catheter comprises a surgical device.

18. A method of percutaneously capturing emboli after a surgical or interventional procedure in a patient, comprising the steps of:

(a) percutaneously inserting a removable vascular filter system comprising;

a guidewire having distal and proximal ends,

a filter comprising (1) 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 pivotably attached to the guidewire near said distal end of the guidewire and wherein the filter membrane proximal free end portion is substantially parallel to the guidewire in its collapsed state, and

deploying means operatively connected to the filter to cause the filter membrane proximal free end portion to move from a position substantially parallel to the guidewire to a position removed from the longitudinal axis of the guidewire to cause the flexible filter membrane to form a substantially conical shape to form a generally sealing relationship with the wall of said vessel, into a diseased blood vessel to position the filter distal to a diseased segment of the vessel;

(b) deploying the filter;

(c) collapsing the filter with any trapped emboli; and

(d) withdrawing the guidewire from the blood vessel.

19. The method of claim 18 which comprises the additional steps after step (b) of:

advancing a therapeutic catheter distally over the guidewire to a diseased segment,

treating the diseased segment with the therapeutic catheter, whereby any loosened fragments from the diseased segment are carried distally by blood flow and are captured by the deployed filter, and withdrawing the therapeutic catheter from the blood vessel.

20. A removable percutaneous vascular filter system for blocking micro- and macro-emboli while allowing continued perfusion of blood, comprising:

a guidewire having distal and proximal ends,

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 flexible filter membrane distal portion is pivotally attached to the guidewire near said distal end of the guidewire and wherein the filter membrane proximal free end portion is substantially parallel to the guidewire in its collapsed state; and

a control handle at the distal end of the guidewire, the control handle being operatively connected to the filter to cause the filter membrane proximal free end portion to move from a position substantially parallel to the guidewire to a position removed from the longitudinal axis of the guidewire to cause the flexible filter membrane to form a substantially conical shape to form a generally sealing relationship with the wall of said vessel.

21. A percutaneous vascular filter system comprising:

a guidewire having proximal and distal ends,

a filter concentrically arranged around said guidewire, said filter comprising (a) a non-metallic, porous, flexible 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 membrane proximal portion, wherein the flexible membrane distal portion is pivotally attached to the guidewire adjacent its distal end and the proximal end of the filter is attached to the guidewire, and

a sheath concentrically arranged around the guidewire and having proximal and distal ends, the distal end of the sheath having a lumen of sufficient diameter to slide over the proximal portion of the filter.

22. The vascular filter system of claim 21, wherein the proximal end of the filter is slidably attached to the guidewire by a radiopaque marker or crimp band and the distal end of the filter is fixedly attached to the guidewire by a radiopaque marker or crimp band.

23. The vascular filter system of claim 21, wherein the proximal end of the filter is fixedly attached to the guidewire by a radiopaque marker or crimp band and the distal end of the filter is slidably attached to the guidewire by a radiopaque marker or crimp band.

24. The vascular filter system of claim 21, wherein the filter membrane is attached to only the distal portion of the filter membrane support structure.

25. The vascular filter system of claim 21, wherein the distal end of the guidewire comprises a floppy tip.

26. The vascular filter system of claim 21, wherein the proximal end of the sheath is attached to a handle.

27. The vascular filter system of claim 21, wherein the proximal end of the filter membrane is slidably attached to the guidewire by a grommet.

28. A percutaneous vascular filter system comprising:

a guidewire having proximal and distal ends, and

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, the filter concentrically arranged around said guidewire, the distal end of the filter being attached to the guidewire adjacent its distal end and the proximal end of the filter being attached to the guidewire.

29. The vascular filter system of claim 28 which also comprises a sheath concentrically arranged around the guidewire and having proximal and distal ends, the distal end of the sheath having a lumen of sufficient diameter to slide over the proximal portion of the filter.

30. The vascular filter system of claim 28, wherein the filter membrane is attached to only the distal portion of the wire structure.

31. The vascular filter system of claim 28, wherein the proximal end of the filter is fixedly attached to the guidewire by a radiopaque marker or crimp band and the distal end of the filter is slidably attached to the guidewire by a radiopaque marker or crimp band.

32. The vascular filter system of claim 28, wherein the proximal end of the filter is slidably attached to the guidewire by a radiopaque marker or crimp band and the distal end of the filter is fixedly attached to the guidewire by a radiopaque marker or crimp band.

33. The vascular filter system of claim 32, wherein the distal end of the filter is inverted proximally.

34. The vascular filter system of claim 33, which also comprises a member slidable over the guidewire to collapse the filter to trap debris or emboli.