Low profile vascular filter system

• US 20020103501A1
• Filed: 03/12/2002
• Published: 08/01/2002
• Est. Priority Date: 02/12/1999
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Yadav, Jay S., Diaz, Pedro
• Granted Patent: US 6,991,641 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 2230/008 paraboloidal
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body

Abstract

A removable, low profile, vascular filter system for capture and retrieval of emboli while allowing continuous perfusion of blood, comprising a guidewire having proximal and distal markers, a filter delivery and deployment system, having an outer member and an inner member, and a filter removably attached near the distal end of the inner member. The filter comprises proximal and distal basket sleeves which position the filter between the proximal and distal markers on the guidewire, after the guidewire is in position past the vessel occlusion. The guidewire placement prior to filter delivery may facilitate access to the interventional site, especially through tortuous anatomy. Also, retrievability of the filter from the wire may avoid loss of guidewire position, which may occur following removal of filters permanently attached to guidewires.

Claims

1. A vascular filter system comprising:

a) a guidewire having a predetermined diameter, a proximal end, a distal end, a proximal marker having a first diameter and a distal marker having a second diameter, the proximal and distal markers being attached to the distal end of the guidewire;

b) a filter deployment and delivery system including an inner member having a proximal end, a distal end, an inner diameter and an outer diameter, and an outer member having a proximal end, a distal end, an inner diameter and an outer diameter, the inner member being coaxially disposable around the guidewire and the outer member being coaxially disposable around the inner member;

c) a filter removably attached to the distal end of the inner member, the filter including a filter membrane support structure having a proximal portion and a distal portion, a permeable filter membrane attached to the distal portion of the filter membrane support structure, a proximal basket sleeve connected to the proximal portion of the filter membrane support structure, the proximal basket sleeve having a diameter less than or equal to the first diameter of the proximal marker, and a distal basket sleeve connected to the distal portion of the filter membrane support structure having a diameter greater than the first diameter of the proximal marker and less than or equal to the second diameter of the distal marker such that the distal basket sleeve passes over the proximal marker and is stopped at the distal marker, the filter having a diameter for insertion and a diameter for deployment; and

d) a retrieval catheter having a proximal end, a distal end, an inner diameter and an outer diameter, the retrieval catheter being coaxially disposable around the guidewire and the filter.

2. The vascular filter system according to claim 1, wherein the guidewire comprises a Nickel-Titanium alloy.

3. The vascular filter system according to claim 1, wherein the guidewire further comprises a floppy tip connected to the distal end of the guidewire.

4. The vascular filter system according to claim 1, wherein the proximal and distal markers comprise radiopaque material.

5. The vascular filter system according to claim 1, wherein the inner and outer diameter of the outer member of the filter deployment and delivery system is larger at its distal end to accommodate the filter, and the inner diameter of the outer member of the filter deployment and delivery system at its distal end is substantially equal to the diameter for insertion of the filter.

6. The vascular filter system according to claim 1, wherein the filter membrane support structure comprises a plurality of struts connected to the proximal and distal basket sleeves.

7. The vascular filter system according to claim 6, wherein the plurality of struts comprise Nickel-Titanium alloy.

8. The vascular filter system according to claim 6, wherein the filter further comprises at least one marker band attached to at least one strut.

10. The vascular filter system according to claim 1, wherein the permeable filter membrane comprises a flexible polymeric material.

11. The vascular filter system according to claim 10, wherein the permeable filter membrane comprises openings with diameters ranging from twenty to three hundred microns.

12. The vascular filter system according to claim 1, wherein the proximal and distal basket sleeves comprise radiopaque material.

13. The vascular filter system according to claim 1, wherein the proximal basket sleeve and the proximal wire marker comprise interlocking means, the interlocking means limiting longitudinal movement while allowing rotational movement.

14. The vascular filter system according to claim 1, wherein the filter delivery and deployment system and the retrieval catheter are over-the-wire systems.

15. The vascular filter system according to claim 1, wherein the filter deployment and delivery system and the retrieval catheter are rapid exchange systems.

16. The vascular filter system according to claim 1, wherein the outer diameter of the retrieval catheter is larger at its distal end, the outer diameter at its distal end being substantially equal to the diameter for insertion of the filter.

17. The vascular filter system according to claim 1, wherein the retrieval catheter further comprises means to retrieve the filter from the guidewire while the guidewire remains in position within the vasculature.

18. A method for capturing embolic material in the lumen of a vessel utilizing the vascular filter system according to claim 1, comprising the steps of:

a) inserting the distal end of the guidewire into the lumen and advancing it past a target occlusion in the lumen;

b) inserting the proximal end of the guidewire into the distal end of the inner member of the filter delivery and deployment system and advancing the filter delivery and deployment system over the guidewire until the distal basket sleeve is positioned past the proximal marker on the guidewire;

c) retracting the outer member of the filter deployment and delivery system to deploy the filter;

d) retracting and removing the inner and outer member of the filter deployment and delivery system from the guidewire;

e) advancing additional interventional devices over the guidewire to the site of the target occlusion;

f) performing additional procedures to therapeutically treat the occlusion in the vessel;

g) capturing embolic materials generated by the procedures in step (f) utilizing the filter;

h) removing the interventional devices from the guidewire;

i) inserting the proximal end of the guidewire into the distal end of the retrieval catheter and advancing the retrieval catheter to the site of the occlusion; and

j) advancing the distal end of the retrieval catheter over the filter, collapsing the filter and retracting the retrieval catheter, the filter and the guidewire from the lumen.

9. The vascular filter system according to claim 9, wherein the at least one marker band comprises radiopaque material.