Vascular protection devices and methods of use

• US 20060224180A1
• Filed: 05/31/2006
• Published: 10/05/2006
• Est. Priority Date: 03/08/2002
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: ev3, Inc. (Medtronic Plc)
• Inventors: Anderson, Kent D., Kusleika, Richard S., Adams, Daniel O., Oslund, John
• Granted Patent: US 8,182,507 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22045 fixed to the catheter; guiding tip
• 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 2230/0008 elliptical or oval
• 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
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

An embolic protection device or system for use in a lumen of a vessel in a patient'"'"'s vascular system. The device filters debris and blood clots in a body lumen and/or prevents them from moving distally from a treatment site in a vessel and causing emboli. The device may include a filter placed distally of the treatment site. The device may include an occlusive element placed either distally or proximally of the treatment site.

Claims

1. A protection device for use in a body lumen comprising:

an elongate support member having a proximal elongate segment and a distal elongate segment, the proximal and distal elongate segments each having proximal and distal ends, the proximal elongate segment having a lumen sized to slideably receive a proximal portion of the distal elongate segment; and

a functional element carried by the elongate support member, the functional element being expandable from a delivery configuration to an expanded deployed configuration when the functional element is deployed in the body lumen, the functional element having a proximal end and a distal end, the proximal end of the functional element being connected to the proximal elongate support segment and the distal end of the functional element being connected to the distal elongate support segment at a location distal to the proximal end of the distal elongate support segment such that the proximal end of the distal elongate support segment is contained within the lumen of the proximal elongate segment when the functional element is in the delivery configuration and when the functional element is in the expanded deployed configuration.

2. The protection device of claim 1 wherein the proximal end of the functional element is connected to the proximal elongate support segment at the distal end of the proximal elongate support segment.

3. The protection device of claim 1 wherein the functional element comprises a filter.

4. The protection device of claim 1 wherein the functional element comprises an occlusive element.

5. The protection device of claim 4 wherein the occlusive element comprises a balloon.

6. The protection device of claim 2 wherein the functional element comprises a filter.

7. The protection device of claim 2 wherein the functional element comprises an occlusive element.

8. The protection device of claim 7 wherein the occlusive element comprises a balloon.

9. The protection device of claim 1 wherein the functional element comprises a body defining an interior cavity.

10. The protection device of claim 9 wherein no portion of the proximal elongate support segment lies within the interior cavity.

11. The protection device of claim 9 wherein a portion of the proximal elongate support segment lies within the interior cavity.

12. The protection device of claim 9 wherein the body comprises a plurality of struts.

13. The protection device of claim 12 wherein at least a distal portion of the struts is covered with a filter mesh.

14. The protection device of claim 3 wherein the filter is self-expanding.

15. The protection device of claim 14 wherein the filter comprises self-expanding material.

16. The protection device of claim 15 wherein the self-expanding material is nitinol.

17. A method of filtering emboli from blood flowing through the lumen of a vessel during a percutaneous procedure performed with a treatment device at a treatment site in the vessel comprising:

providing a protection device comprising an elongate support member having a proximal elongate segment and a distal elongate segment, the proximal and distal elongate segments each having proximal and distal ends, the proximal elongate segment having a lumen sized to slideably receive a proximal portion of the distal elongate segment, and a filter carried by the elongate support member, the filter being expandable from a delivery configuration to an expanded deployed configuration when the filter is deployed in the body lumen, the filter having a proximal end and a distal end, the proximal end of the filter being connected to the proximal elongate support segment and the distal end of the filter being connected to the distal elongate support segment at a location distal to the proximal end of the distal elongate support segment such that the proximal end of the distal elongate support segment is contained within the lumen of the proximal elongate segment when the filter is in the delivery configuration and when the filter is in the expanded deployed configuration;

introducing the elongate support member and filter in its delivery configuration into the lumen of the vessel;

advancing the elongate support member through the vessel until the filter is positioned at a desired location distal to the treatment site, at least a proximal portion of the proximal elongate member extending outside of the vessel;

expanding the filter within the lumen of the vessel to its expanded deployed configuration;

advancing the treatment device over the elongate support member to the treatment site while holding the proximal elongate segment;

performing the percutaneous procedure at the treatment site with the treatment device; and

filtering emboli from blood during the percutaneous procedure with the filter.

18. The method of claim 17 wherein the proximal end of the filter is connected to the proximal elongate support segment at the distal end of the proximal elongate support segment.

19. The method of claim 17 wherein the filter comprises a body defining an interior cavity.

20. The method of claim 19 wherein no portion of the proximal elongate support segment lies within the interior cavity.

21. The method of claim 19 wherein a portion of the proximal elongate support segment lies within the interior cavity.

22. The method of claim 19 wherein the body comprises a plurality of struts.

23. The method of claim 22 wherein at least a distal portion of the struts is covered with a filter mesh.

24. The method of claim, 17 wherein the filter is self-expanding.

25. The method of claim 24 wherein the filter comprises self-expanding material.

26. The method of claim 25 wherein the self-expanding material is nitinol.

27. A method of occluding blood flow through the lumen of a vessel of a patient'"'"'s body during a percutaneous procedure performed with a treatment device at a treatment site in the vessel comprising:

providing a protection device comprising an elongate support member having a proximal elongate segment and a distal elongate segment, the proximal and distal elongate segments each having proximal and distal ends, the proximal elongate segment having a lumen sized to slideably receive a proximal portion of the distal elongate segment, and an occlusive element carried by the elongate support member, the occlusive element being expandable from a delivery configuration to an expanded deployed configuration when the occlusive element is deployed in the body lumen, the occlusive element having a proximal end and a distal end, the proximal end of the occlusive element being connected to the proximal elongate support segment and the distal end of the occlusive element being connected to the distal elongate support segment at a location distal to the proximal end of the distal elongate support segment such that the proximal end of the distal elongate support segment is contained within the lumen of the proximal elongate segment when the occlusive element is in the delivery configuration and when the occlusive element is in the expanded deployed configuration;

28. The method of claim 27 wherein the proximal elongate segment includes a lumen having a first port positioned to be outside the patient when the occlusive element is deployed and a second port positioned proximal to the occlusive element, the method further comprising removing emboli from the blood in the occluded vessel through the lumen of the proximal elongate segment.

29. The method of claim 27 wherein the proximal end of the occlusive element is connected to the proximal elongate support segment at the distal end of the proximal elongate support segment.

30. The method of claim 27 wherein the occlusive element comprises a balloon.