Embolic protection devices

• US 6,695,813 B1
• Filed: 12/30/1999
• Issued: 02/24/2004
• Est. Priority Date: 12/30/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Huter, Scott J., Burkett, David H., Stalker, Kent C. B., Whitfield, John D., Kokish, Arkady, Wang, Chicheng, Boyle, William J., Huter, Benjamin C., Denison, Andy E.
• Primary Examiner(s): Mendez, Manuel
• Assistant Examiner(s): Han, Mark K.
• Application Number:
  US09/476,159
• Time in Patent Office: 1,517 Days
• Field of Search: 604/22, 604/28, 604/36, 604/500, 604/75, 604/106, 604/107, 604/108, 604/264, 604/266, 604/267, 604/327, 604/104, 604/105, 604/109, 604/523, 606/108, 606/191, 606/198, 606/200, 623/1.15
• US Class Current: 604/106
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

An embolic protection device includes a filtering assembly having a self-expanding strut assembly and a filter element. The filtering assembly can be attached to a guidewire and deployed within the patient'"'"'s vasculature into an area of treatment. A restraining sheath maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Interventional devices can be delivered over the guidewire and any embolic debris created and released into the blood stream will enter the filtering assembly. The filtering assembly can be rotatably mounted on the guide wire and may include a dampening element which helps to prevent some shock force that may be transmitted along the guide to the deployed filtering assembly.

Claims

1. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:

a shaft member having distal and proximal ends; and

a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen, wherein the strut assembly is made from a segment of tubing having selectively removed portions and selectively remaining portions forming the struts of the strut assembly and further including a dampening element attached to the segment of tubing for at least partially absorbing vibratory motion which may be transmitted along the shaft member and to at least partially isolate such vibratory motion from the filtering assembly.

2. The embolic protection device of claim 1 wherein the expandable struts are self-expanding.

3. The embolic protection device of claim 1 wherein the strut assembly has proximal and distal ends, the proximal end being rotatably affixed to the shaft member and the distal end being movable longitudinally along the shaft member and being rotatable as well.

4. The embolic protection device of claim 1 wherein the segment of tubing is hypotubing made from a self-expanding material.

5. The embolic protection device of claim 1 wherein the portions of the tubing which are selectively removed are shaped in a desired pattern to form struts having particular size and shape.

6. The embolic protection device of claim 1 wherein the dampening element is a helical coil.

7. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:

a shaft member having distal and proximal ends; and

a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen, wherein the proximal end is mounted between a pair of stop elements which prevent any longitudinal motion of the proximal end relative to the shaft member while permitting the filtering assembly to be rotatable on the shaft member.

8. The embolic protection device of claim 7 wherein at least one of the stop elements is made from a radiopaque material.

9. The embolic protection device of claim 7 wherein the dampening element is disposed between the pair of stop elements.

10. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:

a shaft member having distal and proximal ends; and

a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen; and

a dampening element attached to the strut assembly which is adapted to at least partially absorb vibratory motion which may be transmitted along the shaft member and to at least partially isolate such vibratory motion from the filtering assembly.

11. The embolic protection device of claim 10 wherein the dampening element is a helical coil.

12. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:

a shaft member having distal and proximal ends;

a filtering assembly mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of self expanding struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen; and

a dampening element adapted to at least partially absorb vibratory motion which may be transmitted along the shaft member and to at least partially isolate such vibratory motion from acting on the filtering assembly.

13. The embolic protection device of claim 12 wherein the expandable struts are self-expanding.

14. The embolic protection device of claim 12 wherein the strut assembly has proximal and distal ends, the proximal end being rotatably affixed to the shaft member and the distal end being movable longitudinally along the shaft member and being rotatable as well.

15. The embolic protection device of claim 14 wherein the proximal end is mounted between a pair of stop elements which prevent any longitudinal motion of the proximal end relative to the shaft member while permitting the filtering assembly to be rotatable on the shaft member.

16. The embolic protection device of claim 15 wherein the dampening element is disposed between the pair of stop elements.

17. The embolic protection device of claim 12 wherein the dampening element is a helical coil.

18. The embolic protection device of claim 12 wherein the strut assembly is made from a segment of tubing which has portions of the tubing selectively removed to form each of the struts of the assembly.

19. The embolic protection device of claim 18 wherein the segment of tubing is hypotubing made from a self-expanding material.

20. An embolic protection system for capturing embolic debris released into a body vessel of a patient, comprising:

a shaft member having distal and proximal ends;

a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of self expanding struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen;

a restraining sheath having proximal and distal ends, the restraining sheath being coaxially disposed over the self-expanding struts to maintain the struts in the collapsed position until the filter assembly is to be deployed in the vessel; and

a dampening element attached to the strut assembly for at least partially absorbing vibratory motion which may be transmitted along the shaft member and to at least partially isolate such vibratory motion from the filtering assembly.

21. An expandable strut assembly for moving a filter element between a collapsed and expanded position for capturing embolic debris released into a blood vessel of a patient, comprising:

a segment of tubing having select portions of the tubing removed to form a plurality of expandable struts adapted to move between the collapsed and expanded positions, and a dampening element attached to the tubing for at least partially absorbing vibratory motion which may be transmitted to the strut assembly.

22. The expandable strut assembly of claim 21 wherein the dampening element is a helical coil.

23. An expandable strut assembly for moving a filter element between a collapsed and expanded position for capturing embolic debris released into a blood vessel of a patient, comprising:

a segment of tubing having select portions of the tubing removed to form a plurality of expandable struts adapted to move between the collapsed and expanded positions, wherein a dampening element is cut into the tubing and is adapted to at least partially absorbed vibratory motion which may be transmitted to the strut assembly.

24. The expandable strut assembly of claim 23 wherein the dampening element is a helical coil.

25. A method of capturing embolic debris released into a blood vessel of a patient during an interventional procedure, in a system comprising an embolic protection device having a shaft member with distal and proximal ends and a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen, the filtering assembly including a dampening element adapted to at least partially absorb vibratory motion which may be transmitted along the shaft member and to at least partially isolate such vibratory motion from the filtering assembly, wherein the method comprises of the steps of:

positioning the filtering assembly while in the collapsed position within the body vessel at a downstream location from the site of the interventional procedure;

expanding the struts of the strut assembly and the filter element to the expanded position to contact the wall of the vessel;

performing the interventional procedure, which may release embolic debris into the blood vessel;

filtering the blood and any embolic debris through the filter element;

collapsing the filter assembly back down to the collapsed position; and

removing the filtering assembly from the blood vessel.

26. The method of claim 25 further including the steps, prior to the positioning of the filtering assembly, of:

placing a restraining sheath over the filtering assembly to maintain the filtering assembly in the collapsed position.

27. The method of claim 26 further including the steps, after the step of positioning the filtering assembly, of:

retracting the restraining sheath to expose the struts of the strut assembly.

28. The method of claim 27 wherein the struts of the strut assembly are self-expanding.

29. The method of claim 25 further including the step of:

at least partially absorbing vibratory motion which may be transmitted along the shaft member.

30. An embolic protection system for capturing embolic debris released into a body vessel of a patient, comprising:

a shaft member having distal and proximal ends;

a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of self expanding struts adapted to move between a collapsed position and an expanded position, the strut assembly having a proximal end and a distal end, the proximal end being rotatably affixed to the shaft member and the distal end being movable longitudinally along the shaft member and rotatable, the proximal end being mounted between a pair of stop elements which prevent any longitudinal motion of the proximal end relative to the shaft member, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen; and

a restraining sheath having proximal and distal ends, the restraining sheath being coaxially disposed over the self-expanding struts to maintain the struts in the collapsed position until the filter assembly is to be deployed in the vessel.

31. The embolic protection system of claim 30 further including a dampening element attached to the strut assembly and disposed between the pair of stop elements for at least partially absorbing vibratory motion which may be transmitted along the shaft member and to at least partially isolate such vibratory motion from the filtering assembly.

32. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:

a shaft member having distal and proximal ends; and

a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen, wherein the strut assembly is made from a segment of tubing having selectively removed portions and selectively remaining portions forming the struts of the strut assembly and a dampening element is cut into the tubing which is adapted to at least partially absorbed vibratory motion which may be transmitted along the shaft member and to at least partially isolate such vibratory motion from the filtering assembly.

33. An embolic protection device for capturing embolic debris released into a blood vessel of a patient, comprising:

a guide wire;

an expandable strut assembly rotatably mounted on the guide wire and formed from a segment of tubing having select portions removed to form a plurality of expandable struts adapted to move between a collapsed position and an expanded position and a collar attached to the plurality of expandable struts, wherein the struts are heat set to the expanded position, the strut assembly having a proximal end and a distal end, the proximal end being mounted between a pair of stop elements which prevent any longitudinal motion of the proximal end relative to the guide wire while permitting the strut assembly to be rotatable on the guide wire; and

a filter element made from a different material than the tubing attached to the expandable struts.

34. An embolic protection device for capturing embolic debris released into a blood vessel of a patient, comprising:

a guide wire;

an expandable strut assembly rotatably mounted on the guide wire and formed from a segment of tubing having select portions removed to form a plurality of expandable struts adapted to move between a collapsed position and an expanded position and a collar attached to the plurality of expandable struts, wherein the struts are mechanically set to the expanded position, the strut assembly having a proximal end and a distal end, the proximal end being mounted between a pair of stop elements which prevent any longitudinal motion of the proximal end relative to the guide wire while permitting the strut assembly to be rotatable on the guide wire; and

a filter element made from a different material than the tubing attached to the expandable struts.

35. An embolic protection device for capturing embolic debris released into a blood vessel of a patient, comprising:

a guide wire;

an expandable strut assembly rotatably mounted on the guide wire and formed from a segment of tubing having select portions removed to form a plurality of expandable struts adapted to move between a collapsed position and an expanded position and a collar attached to the plurality of expandable struts, wherein the struts are set to the expanded position and the segment of tubing is laser cut to selectively remove portions of the tubing, the strut assembly having a proximal end and a distal end, the proximal end being mounted between a pair of stop elements which prevent any longitudinal motion of the proximal end relative to the guide wire while permitting the strut assembly to be rotatable on the guide wire; and

a filter element made from a different material than the tubing attached to the expandable struts.