Embolic protection devices having radiopaque markers

• US 20070233175A1
• Filed: 03/28/2007
• Published: 10/04/2007
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Quinn, Christopher G., Sirivong, Sengkham, Zaver, Steven G., Anderson, Linda J., Slee, Earl H.
• Granted Patent: US 9,089,404 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising: a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and an elongate support member, the filter being carried on a portion of the elongate support member, wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and wherein the proximal portion of the filter element comprises a radiopaque element in the form of a discontinuous loop extending around a portion of a perimeter of the proximal facing opening, the discontinuous loop having a gap and the gap being proximate to the elongate support member.

Claims

1. A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising:

a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the proximal portion of the filter element comprises a radiopaque element in the form of a discontinuous loop extending around a portion of a perimeter of the proximal facing opening, the discontinuous loop having a gap and the gap being proximate to the elongate support member.

2. The device of claim 1, wherein radiopaque element is made of metal or metal alloy.

3. The device of claim 2, wherein the radiopaque element is made of gold, platinum, tungsten, tantalum, and alloys thereof.

4. The device of claim 1, wherein the filter element comprises a mesh.

5. The device of claim 4, wherein the radiopaque element is interwoven through the mesh.

6. The device of claim 4, wherein the mesh is braided.

7. The device of claim 1, wherein the filter element is self-expanding.

8. The device of claim 1, wherein the filter element is self-contracting.

9. The device of claim 1, wherein a portion of the elongate support member is disposed within the cavity.

10. The device of claim 1, wherein the radiopaque element is disposed around 50 to 90 percent of the perimeter of the proximal facing opening.

11. The device of claim 1, wherein the radiopaque element is disposed around 70 to 80 percent of the perimeter of the proximal facing opening.

12. The device of claim 1, wherein the radiopaque element is a monofilament.

13. The device of claim 1, wherein the radiopaque element is a wire.

14. The device of claim 1, wherein the radiopaque element is a coiled wire.

15. The device of claim 1, wherein the radiopaque element is a wire comprising coiled segments and uncoiled segments.

16. The device of claim 1, wherein the radiopaque element is a multifilament wire.

17. The device of claim 16, wherein the multifilament wire comprises a wire coiled around a core wire.

18. The device of claim 1, wherein the radiopaque element comprises a tang.

19. The device of claim 18, wherein the radiopaque element comprises two loops, two bands, and one tang.

20. The device of claim 19, wherein the filter element comprises a mesh and each loop encircles a portion of the mesh.

21. The device of claim 1, wherein the filter element comprises a mesh and the radiopaque element comprises a coiled portion, a loop, and a band, the loop encircling a portion of the mesh, and the loop and the band being covered by a protective mass.

22. The device of claim 1, wherein the filter element is attached to slidable proximal and distal markers that are disposed on the elongate support member.

23. The device of claim 18, wherein the radiopaque element comprises two bands and one tang.

24. The device of claim 23, wherein the filter element comprises a mesh and each band encircles a portion of the mesh and a portion of the loop.

25. The device of claim 1, wherein the filter element comprises a mesh and the radiopaque element comprises a first loop encircling a portion of the mesh, a second loop and a first band disposed proximate the second loop, a third loop and a second band disposed proximate the third loop, the second loop and the first band being disposed within the third loop.

26. The device of claim 1, wherein the filter element comprises a mesh and the radiopaque element comprises a coiled portion, a central wire disposed within the coiled portion, a loop, and a band, the loop encircling a portion of the mesh.

27. The device of claim 1, wherein the radiopaque element comprises a protective mass.

28. The device of claim 1, wherein the radiopaque element comprises an enlarged end that prevents it from passing through a band.

29. The device of claim 1, wherein the radiopaque element comprises a wire that has an end portion and the wire comprises a loop, an end portion of the wire being coiled back onto the wire to secure the loop.

30. The device of claim 29, wherein the coiled portion of the wire is covered by a band.

31. The device of claim 29, wherein the coiled portion of the wire is covered by a protective mass.

32. The device of claim 1, wherein the radiopaque element comprises a wire, a loop, a band, the wire having an enlarged diameter portion proximate the band.

33. The device of claim 1, wherein the filter element comprises a mesh, the radiopaque element comprises a wire, a loop, and a band, the loop being attached to the mesh with a flexible strand.

34. A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising:

a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the proximal portion of the filter element comprises a radiopaque element in the form of one or more beads.

35. The device of claim 35, wherein the filter element comprises a mesh comprising strands and wherein the beads are tubular marker bands.

36. A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising:

a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the proximal portion of the filter element comprises a radiopaque element in the form of two or more discontinuous loop segments extending around a portion of a perimeter of the proximal facing opening.

37. The device of claim 36, wherein the discontinuous loop segments are wire.

38. The device of claim 36, wherein the discontinuous loop segments are coiled wire.

39. The device of claim 36, wherein the discontinuous loop segments are stranded wire.

40. The device of claim 36, wherein the filter element comprises a mesh and the discontinuous loop segments are loops of wire interwoven into the mesh.

41. A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising:

a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the proximal portion of the filter element comprises a radiopaque element in the form of two or more discontinuous elongate segments extending around a portion of a perimeter of the proximal facing opening, the elongate segments being oriented in the same general direction as the elongate support member.

42. A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising:

a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the proximal portion of the filter element comprises a radiopaque element comprising a wire having first and second coiled ends, the wire being twisted to form two loops, the filter element comprising a mesh and at least one loop of the radiopaque element encircling a portion of the mesh.

43. A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising:

a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the proximal portion of the filter element comprises a radiopaque element in the form of a discontinuous loop extending around a portion of the perimeter of the proximal facing opening, the discontinuous loop extending around a portion of the perimeter of the proximal facing opening, the filter element comprises a braided, self-expanding mesh, a portion of the elongate support member is disposed within the cavity, the filter element is attached to slidable proximal and distal markers that are disposed on the elongate support member, and the radiopaque element is attached to the proximal marker.

44. A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising:

a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the proximal portion of the filter element comprises a radiopaque element in the form of a loop extending around the perimeter of the proximal facing opening, the filter element comprises a braided, self-expanding mesh, a portion of the elongate support member is disposed within the cavity, the filter element is attached to slidable proximal and distal markers that are disposed on the elongate support member, the radiopaque element is attached to the device at two locations, the first location being the proximal marker and the second location being a region of the mesh that is diametrically opposed to the proximal marker.

45. A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising:

a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the proximal portion of the filter element comprises a radiopaque element in the form of a loop extending around a portion of a perimeter of the proximal facing opening, the loop not extending around the entire perimeter of the proximal facing opening.

46. A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body, comprising:

a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the filter element is attached to slidable proximal and distal markers that are disposed on the elongate support member, the elongate support member comprises a connector that limits the movement of the slidable proximal and distal markers, and the connector comprises a flexibility enhancing structure.

47. The device of claim 46, wherein the flexibility enhancing structure is selected from slots, slits, holes, reduced thickness regions, or annealed regions.

48. A method of deploying a device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient'"'"'s body comprising:

providing the device for filtering emboli, the device comprising a filter element being expandable from a collapsed configuration when the filter element is restrained to an expanded configuration when the filter element is unrestrained, and

an elongate support member, the filter being carried on a portion of the elongate support member,

wherein the filter element has proximal and distal portions and a central portion, the filter element having a shape in the expanded configuration which defines a cavity having a proximal facing opening, and

wherein the proximal portion of the filter element comprises a radiopaque element in the form of a discontinuous loop extending around a portion of a perimeter of the proximal facing opening, the discontinuous loop having a gap and the gap being proximate to the elongate support member;

delivering the device percutaneously to a region of interest in the lumen of the patient'"'"'s body; and

using fluoroscopy to visualize the filter element in the lumen of the patient'"'"'s body.