Integral vascular filter system

• US 6,656,203 B2
• Filed: 07/18/2001
• Issued: 12/02/2003
• Est. Priority Date: 07/18/2001
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Wilson, David J., Roth, Noah M., Wiatrowski, Thomas, Johnson, Kirk
• Primary Examiner(s): Truong, Kevin T.
• Application Number:
  US09/907,860
• Publication Number:
  US 20030015206A1
• Time in Patent Office: 867 Days
• Field of Search: 606/159, 606/200, 606/113, 606/114, 606/127
• US Class Current: 606/200
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• 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 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/09191 made of twisted wires
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A integral vascular filter system comprising a guidewire and an integral filter which can be used to capture embolic particulates during medical procedures, while allowing for continuous perfusion of blood, with minimal incremental blood flow turbulence. The vascular filter system addresses the clinical problem of minimizing profile or diameter, so as to enable or facilitate the crossing of a lesion or obstruction in the vessel, while also minimizing incremental blood flow turbulence which may result in thrombus formation.

Claims

1. A vascular filter system for insertion into a lumen of a vessel, said vascular filter system comprising:

a) a guidewire having a distal end and a proximal end, a distal portion and a proximal portion, with said distal portion having a distal end, a midpoint and a proximal end;

b) a prescribed filter shape integral with and placed within said distal portion of said guidewire, said distal portion having a smaller first diameter for insertion into said lumen of said vessel, and a larger second diameter for expanding to substantially equal the diameter of said lumen and to be placed in generally sealing relationship with said lumen;

c) a porous covering having a distal end and a proximal end, with said distal end of said porous covering attached near said distal end of said distal portion of said guidewire, and said proximal end of said porous covering attached near said midpoint of said distal portion of said guidewire, and;

d) actuating means for causing said distal portion of said guidewire to move between said smaller first diameter, and said larger second diameter and said prescribed filter shape wherein said actuating means is a generally solid core wire.

2. The vascular filter system according to claim 1, wherein said guidewire is made from Nickel-titanium alloy.

3. The vascular filter system according to claim 1, wherein said guidewire is made from stainless steel alloy.

4. The vascular filter system according to claim 1, wherein said guidewire is made from polymeric material.

5. The vascular filter system according to claim 1, wherein said distal portion of said guidewire comprises a plurality of slots.

6. The vascular filter system according to claim 5, wherein said plurality of slots comprises a proximal end and a distal end, and at least one articulation point therebetween.

7. The vascular filter system according to claim 6, wherein said at least one articulation point is a hinge.

8. The vascular filter system according to claim 5, wherein said prescribed filter shape comprises said plurality of slots in said distal portion of said guidewire.

9. The vascular filter system according to claim 1, wherein said guidewire is a multi-filament guidewire.

10. The vascular filter system according to claim 9, wherein said prescribed filter shape comprises said multi-filaments of said distal portion of said guidewire.

11. The vascular filter system according to claim 1, wherein said guidewire is a twisted multi-filament guidewire.

12. The vascular filter system according to claim 1, wherein a pore size of said porous covering is from about 20 to about 300 microns.

13. The vascular filter system, according to claim 1, wherein said porous covering is a flexible polymeric material comprising regularly-spaced laser-formed holes therein.

14. The vascular filter system according to claim 13, wherein said flexible polymeric material is chosen from a group consisting of polyurethane, polyethylene, silicone, nylon, polypropylene, PVC, or a co-polymer or mixture thereof.

15. The vascular filter system according to claim 13, wherein said flexible polymeric material is an elastomeric material capable of stretching to achieve said larger second diameter of said filter.

16. The vascular filter system according to claim 13, wherein a pore size of said porous covering is from about 20 to about 300 microns.

17. The vascular filter system according to claim 1, wherein said porous covering is a superelastic metallic mesh.

18. The vascular filter system according to claim 17, wherein said superelastic metallic mesh comprises parallelogram-shaped pores, comprising acute and obtuse angles.

19. The vascular filter system according to claim 17, wherein a pore size of said porous covering is from about 20 to about 300 microns.

20. The vascular filter system according to claim 17, wherein said porous covering is made from Nickel-Titanium alloy.

21. The vascular filter system, according to claim 1, wherein said actuating means is a sheath.

22. The vascular filter system, according to claim 1, wherein said actuating means is a guide catheter.

23. The vascular filter system according to claim 22, wherein a pore size of said parallelogram-shaped pores is from about 20 to about 300 microns.

24. The vascular filter system according to claim 22, wherein said superelastic metallic mesh is made from Nickel-Titanium alloy.

25. A vascular filter system for insertion into a lumen of a vessel, said vascular filter system comprising:

a) a guidewire having a distal end and a proximal end, a distal portion and a proximal portion, with said distal portion having a distal end, a midpoint and a proximal end;

b) a prescribed filter shape integral with and placed within said distal portion of said guidewire, said distal portion having a smaller first diameter for insertion into said lumen of said vessel, and a larger second diameter for expanding to substantially equal the diameter of said lumen and to be placed in generally sealing relationship with said lumen;

c) a porous covering having a distal end and a proximal end with said distal end of said porous covering attached near said distal end of said distal portion of said guidewire, and said proximal end of said porous covering attached near said midpoint of said distal portion of said guidewire, and;

d) actuating means for causing said distal portion of said guidewire to move between said smaller first diameter, and said larger second diameter and said prescribed filter shaped; and

wherein said actuating means is a generally solid core wire having a proximal end and a distal end.

26. The vascular filter system, according to claim 25 wherein said prescribed filter shape attains said larger second diameter when said core wire is slidably retracted through said guidewire.

27. A method for capturing embolic particulates within the lumen of a vessel during a medical procedure, while allowing for continuous perfusion of blood, comprising the steps of:

a) providing a guidewire comprising a distal portion and a proximal portion, with said distal portion having a distal end, a midpoint and a proximal end;

a prescribed filter shape in said distal portion of said guidewire, said distal portion of said guidewire having a smaller first diameter for insertion into a vessel, and a second larger diameter for expanding to substantially equal the diameter of said lumen and to be placed in generally sealing relationship with said lumen;

a porous covering having a distal end and proximal end, with said distal end of said porous covering integral with and placed within near said distal end of said distal portion of said guidewire, and said proximal end of said porous covering attached near said midpoint of said distal portion of said guidewire; and

actuating means for causing said distal portion of said guidewire to move between said smaller first diameter, and said larger second diameter and prescribed filter shape wherein said actuating means a generally solid core wire;

b) inserting said guidewire into said lumen of said vessel until said distal portion of said guidewire is positioned past an occlusion in said vessel;

c) employing said actuating means to cause said distal portion of said guidewire to achieve said larger second diameter and said prescribed shape;

d) advancing additional devices over said guidewire, and positioning said devices at the site of said occlusion in said vessel;

e) performing additional procedures to therapeutically treat said occlusion in said vessel;

f) capturing embolic particulates generated by said procedures, in said porous covering on said distal portion of said guidewire;

g) removing said additional devices from said guidewire;

h) employing said actuating means to cause said distal portion of said guidewire to achieve said smaller first diameter;

i) removing said guidewire from said lumen of said vessel, with said embolic particulates captured in said porous covering.

28. A vascular filter comprising:

a) a guidewire having an outer diameter, a distal portion and proximal portion, with said distal portion having a distal end, a midpoint and proximal end;

b) a filter placed integral with and placed within said distal portion of said guidewire, said filter distal portion having a shape with smaller first diameter for insertion into said lumen of said vessel, and a larger second diameter placed in generally sealing relationship with a body lumen;

c) a porous covering having a distal end and a proximal end, with said distal end of said porous covering attached near said distal end of said distal portion of said guidewire; and

d) actuating means for causing said distal portion of said guidewire to move between said smaller first diameter and said larger second diameter wherein said actuating means is a generally solid core wire.