Filter device for embolic protection systems

• US 20030225435A1
• Filed: 06/19/2003
• Published: 12/04/2003
• Est. Priority Date: 06/29/2001
• Status: Active Grant

• Current Assignee: Anuja Patel, Benjamin C. Huter, John D. Whitfield, John E. Papp
• Original Assignee: Anuja Patel, Benjamin C. Huter, John D. Whitfield, John E. Papp
• Inventors: Whitfield, John D., Papp, John E., Huter, Benjamin C., Patel, Anuja
• Granted Patent: US 7,244,267 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 2002/015 Stop means therefor
• 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 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A system for enabling the insertion and removal of an embolic protection device, for capturing and retaining embolic debris which may be created during the performance of a therapeutic interventional procedure in a stenosed or occluded region of a blood vessel. The system, in an embodiment thereof, enables the device to be snap-fitted so as to engage the distal end of a guide wire, to provide a reference for positioning the device at a location distal to the interventional procedure site, and to enable an end of the device to be in tension to assist in the tracking and deploying of the system.

Claims

1. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to an interventional procedure site; and

a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an engaging element, for enabling the filter device to be snap fitted so as to engage the distal end of the guide wire;

wherein the guide wire further includes engageable elements, adapted to enable engagement therewith of the engaging element of the filter device, and comprised of radiopaque material, for providing a reference for positioning the filter device in the patient'"'"'s vasculature.

2. The system of claim 1, wherein the filter device, upon being snap-fitted to the distal end of the guide wire, is adapted to enable rotational movement of the filter device independent of rotational movement of the guide wire, and to inhibit translational movement of the filter device relative to the guide wire.

3. The system of claim 1, wherein the engageable elements in the guide wire include a proximal stop and a distal stop, adapted to be secured to the distal end of the guide wire, and having a space between the proximal stop and the distal stop, and adapted to enable the engaging element of the filter device to be engaged with the proximal stop and the distal stop in the space between the proximal stop and the distal stop.

4. The system of claim 1, wherein the filter device includes a cage, adapted to be engaged with the distal end of the guide wire, and filter material, for filtering embolic material, secured to the cage.

5. The system of claim 1, wherein the guide wire includes a tip coil, at the distal end of the guide wire, the tip coil includes a proximal portion, and the system further comprises an obturator, which includes a distal portion, wherein the distal portion of the obturator is adapted to extend over the proximal portion of the tip coil.

6. The system of claim 1, wherein the filter device is adapted to be formed from a hypotube of expandable material.

7. The system of claim 3, wherein the proximal stop and the distal stop comprise a pair of bushings.

8. The system of claim 3, wherein the engaging element of the filter device comprises at least one tab, adapted to engage the proximal stop and the distal stop in the space between the proximal stop and the distal stop.

9. The system of claim 4, wherein the cage includes a plurality of struts.

10. The system of claim 4, wherein the cage includes a proximal end, and the engaging element is located at the proximal end of the cage.

11. The system of claim 5, wherein the cage includes a distal end, the obturator further includes a proximal portion, and the proximal portion of the obturator is adapted to extend over the distal portion of the cage.

12. The system of claim 5, wherein the filter device includes a cage, adapted to be snap fitted onto the distal end of the guide wire, and filter material, for filtering embolic material, and the filter material includes a proximal end, secured to the cage, and a distal portion, and the proximal portion of the obturator extends over the distal portion of the filter material.

13. The system of claim 6, wherein the hypotube includes a plurality of ends, and the system further comprises a spring, adapted to be connected to an end of the hypotube, to enable a portion of the cage, to be formed from the hypotube by the system, to be in tension, so as to aid in the tracking and deploying of the cage in tortuous vasculature.

14. The system of claim 13, wherein the hypotube includes at least one tab, formed at the end thereof at which the spring is adapted to be connected and which is adapted to be in tension.

15. A method of enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, in a system which comprises a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to an interventional procedure site, and a filter device, adapted to be positioned and deployed at a location in the patient'"'"'s vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an engaging element, for enabling the filter device to be snap fitted so as to engage the distal end of the guide wire, wherein the guide wire further includes engageable elements, adapted to enable engagement therewith of the engaging element of the filter device, and comprised of radiopaque material, for providing a reference for positioning the filter device in the patient'"'"'s vasculature, wherein the method comprises:

snap fitting the filter device so as to engage the distal end of the guide wire;

inserting the filter device and the guide wire to the location in the patient'"'"'s vasculature distal to the interventional procedure site, such that the radiopaque engaging element provides a reference for positioning the filter device; and

expanding the filter device for deployment thereof.

16. The method of claim 15, wherein the system further includes a proximal stop and a distal stop, comprising a pair of bushings adapted to be secured to the distal end of the guide wire, and having a space between the proximal stop and distal stop, and adapted to enable the engaging element of the filter device to be engaged with the proximal stop and the distal stop in the space between the proximal stop and the distal stop, and the engaging element of the filter device comprises at least one tab, and wherein snap fitting comprises engaging the at least one tab in the space between the pair of bushings.

17. The method of claim 15, wherein the filter device is adapted to be formed from a hypotube of expandable material, the hypotube includes a plurality of ends and at least one tab formed at an end thereof, and the system further comprises a spring, adapted to be connected to the tab end of the hypotube at which the at least one tab is formed, to enable a portion of the cage, to be formed from the hypotube by the system, to be in tension, so as to aid in the tracking and deploying of the cage in tortuous vasculature, further comprising forming the filter device from the hypotube, forming the at least tab at the tab end of the hypotube, and connecting the spring to the tab end of the hypotube such that the tab end of the hypotube is in tension.