Embolic protection devices

• US 20030212361A1
• Filed: 03/10/2003
• Published: 11/13/2003
• Est. Priority Date: 12/30/1999
• Status: Active Grant

• Current Assignee: Andy E. Denison, Benjamin C. Huter, Christopher Tarapata, John D. Whitfield, Kent C.B. Stalker, Richard S. Stack, Scott J. Huter, William J. Boyle
• Original Assignee: Andy E. Denison, Benjamin C. Huter, Christopher Tarapata, John D. Whitfield, Kent C.B. Stalker, Richard S. Stack, Scott J. Huter, William J. Boyle
• Inventors: Huter, Scott J., Boyle, William J., Huter, Benjamin C., Stack, Richard S., Whitfield, John D., Denison, Andy E., Tarapata, Christopher, Stalker, Kent C.B.
• Granted Patent: US 7,217,255 B2
• Time in Patent Office: Days
• US Class Current: 604/104
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. In one embodiment, the filtering assembly is attached to the distal end of a guide wire and is deployed within the patient'"'"'s vasculature as the guide wire is manipulated into the area of treatment. A restraining sheath placed over the filtering assembly in a coaxial arrangement maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Thereafter, the sheath can be retracted to expose the filtering assembly which will then self-expand within the patient'"'"'s vasculature. Interventional devices can be delivered over the guide wire and any embolic debris created during the interventional procedure and released into the blood stream will enter the filtering assembly and be captured therein. Other embodiments include filtering assemblies attached to an outer tubular member and inner shaft member which apply axial force to the distal ends of the assembly to either expand or contract the struts as needed.

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 element for capturing embolic debris, the expandable strut assembly having a first set of struts, each strut having a first and second end;

a second set of struts, each strut having a first and second end; and

a deployment member movable between a collapsed position and an expanded position, wherein first end of the first set of struts and the first end of the second set of struts each are attached to the deployment member at different locations along the deployment member and the set of expandable struts are movable between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position so that at least a portion thereof contacts the wall of the vessel to capture embolic debris released into the body lumen.

2. The embolic protection device of claim 1, wherein the 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 3, 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.

5. The embolic protection device of claim 4, wherein at least one of the stop elements is made from a radiopaque material.

6. The embolic protection device of claim 1, 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.

7. The embolic protection device of claim 6, wherein the segment of tubing is hypotubing made from a self-expanding material.

8. The embolic protection device of claim 6, wherein the portions of the tubing which are selectively removed are shaped in a desired pattern to form struts having particular size and shape.

9. The embolic protection device of claim 1, further including 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.

10. The embolic protection device of claim 9, wherein the dampening element is a helical coil.

11. The embolic protection device of claim 9, wherein the dampening element is disposed between a pair of stop fittings.

12. The embolic protection device of claim 1, wherein the deployment member is self-expanding.

13. The embolic protection device of claim 12, wherein the deployment member has a pattern of alternating peaks and valleys in a wave pattern, each of the first ends of the first set of struts being attached to the valley portions of the deployment member and each of the first ends of the second set of struts being attached to the peak portions of the deployment member.

14. The embolic protection device of claim 1, wherein the first set of struts and second set of struts are arranged in a staggered pattern along the deployment member.

15. The embolic protection device of claim 1, wherein each of the struts of the first set are arranged in a staggered pattern with each of the struts of the second set of struts along the deployment member.

16. The embolic protection device of claim 1, wherein each of the second ends of the first and second set of struts are attached to a collar which is movable axially along the shaft member.

17. The embolic protection device of claim 1, wherein the deployment member is integral with each of the struts of the first and second sets of struts.

18. The embolic protection device of claim 1, wherein the deployment member provides vessel wall opposition.

19. The embolic protection device of claim 1, wherein the filter element includes a central region having an inlet opening and defining a storage reservoir for capturing embolic debris, the central region having a plurality of openings adapted to allow blood to flow therethrough but capture embolic debris larger than the size of the openings and contain the debris within the reservoir;

and

a filter edge integral with the central region and having an inlet opening, the filter edge having a pattern of alternating peak and valley regions which prevent the filter edge from entering into a restraining sheath all at one time.

20. The embolic protection device of claim 19, wherein the filter edge has a wave configuration which includes peak and valley regions.

21. The embolic protection device of claim 19, wherein the peak portions are attachable to the deployment member of the strut assembly.

22. The embolic protection device of claim 13, wherein the peak and valley regions have a substantially V-shaped configuration.

23. The embolic protection device of claim 1, further including an obturator attached to the distal end of the filtering assembly which has a tapered configuration which facilitates the insertion of the embolic protection device through the body vessels of the patient.

24. The embolic protection device of claim 23, further including a restraining sheath which is adapted to be placed over the shaft member and filtering assembly in a coaxial arrangement to collapse the expandable strut assembly into its collapsed position.

25. The embolic protection device of claim 24, wherein the obturator and restraining sheath abut against each other when the restraining sheath is placed over the filtering assembly for position within the blood vessel of the patient to create a composite catheter which facilitates the delivery of the embolic protection device through the body vessels of the patient.

26. The embolic protection device of claim 25, wherein the restraining sheath has a lumen defined therein for receiving fluids for eliminating any air bubbles trapped within the lumen and the obturator.

27. 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 element for capturing embolic debris, the expandable strut assembly having a set of struts, each strut having a first and second end, a deployment member movable between a collapsed position and an expanded position, wherein each of the first ends of the struts are attached to the deployment member at different locations along the deployment member and the struts are movable between a collapsed position and an expanded position, the filter element being movable with the struts and expandable member to the expanded position so that at least a portion thereof contacts the wall of the vessel to capture embolic debris released into the body lumen.

28. The embolic protection device of claim 27, wherein the struts are self-expanding.

29. The embolic protection device of claim 28, 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.

30. The embolic protection device of claim 27, wherein the deployment member is self-expanding.

31. The embolic protection device of claim 30, wherein the deployment member has a pattern of alternating peaks and valleys in a wave pattern, each of the first ends of the struts being attached to being attached to the peak portions of the deployment member.

32. The embolic protection device of claim 31, wherein the struts are arranged in a staggered pattern along the deployment member.

33. The embolic protection device of claim 27, wherein the deployment member is integral with each of the struts.

34. The embolic protection device of claim 27, wherein the deployment member provides vessel wall opposition.

35. The embolic protection device of claim 27, wherein the filter element includes a central region having an inlet opening and defining a storage reservoir for capturing embolic debris, the central region having a plurality of openings adapted to allow blood to flow therethrough but capture embolic debris larger than the size of the openings and contain the debris within the reservoir;

and

a filter edge integral with the central region and having an inlet opening, the filter edge having a pattern of alternating peak and valley regions which prevent the filter edge from entering into a restraining sheath all at one time.

36. The embolic protection device of claim 35, wherein the filter edge has a wave configuration which includes peak and valley regions.

37. The embolic protection device of claim 35, wherein the peak portions are attachable to the deployment member of the strut assembly.

38. The embolic protection device of claim 27, further including a tubular member attached to each of the seconds ends of the struts and wherein the filter element has a tapered distal end which is attached to the tubular member, the tubular member being rotatably mounted on the shaft member.

39. The embolic protection device of claim 38, wherein the filter element a proximal opening which is attached to the deployment member.

40. The embolic protection device of claim 38, wherein the tubular member is disposed between two stop elements located on the shaft member.

41. The embolic protection device of claim 40, wherein the shaft member is a guide wire and one of the stop fittings is coils forming part of the guide wire.