Distal embolic protection devices with a variable thickness microguidewire and methods for their use

• US 9,034,007 B2
• Filed: 09/21/2007
• Issued: 05/19/2015
• Est. Priority Date: 09/21/2007
• Status: Active Grant

• Current Assignee: Insera Therapeutics, Inc.
• Original Assignee: Insera Therapeutics, Inc.
• Inventors: Janardhan, Vikram
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): Kapoor, Sidharth
• Application Number:
  US11/859,272
• Publication Number:
  US 20090082800A1
• Time in Patent Office: 2,797 Days
• Field of Search: 606/200, 606/114, 606/108, 604/104, 623/1.11, 623/1.12, 600/585, 600434-435
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• 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 2230/008 paraboloidal
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A distal embolic protection device for dedicated use in cerebral arterial blood vessels is described. The distal embolic protection device comprises a variable-thickness micro-guidewire and a collapsible filtering device mounted on the microguidewire over two mobile attachment points so that in its collapsed configuration, the thickness of the microguidewire and the filtering device at this region is less than or equal to 0.017 inch (0.432 mm) in thickness to be able to pass through existing conventional microcatheters. The mobile attachment points allow for rotatory and longitudinal mobility of the microguidewire while the filtering device is stable thereby decreasing the risk of trauma to the fragile cerebral arterial blood vessels. Preferably, the filtering device comprises an expansion assembly, e.g., a plurality of struts attached to a filter membrane that are in a folded position which self expand to the desired dimensions within the cerebral blood vessels. Also described are methods of using the distal embolic protection devices of this invention.

Claims

1. A distal embolic protection device for filtering thrombo-embolic material, debris or clots released during percutaneous neurovascular interventional procedures specifically performed in cerebral arterial blood vessels of a human, not attached to a balloon or a stent, and comprising:

a variable thickness microguidewire comprising a thinner segment bordered by thicker segments,

wherein said thinner segment is about 0.008 to 0.010 inch in thickness and has a length,

wherein the thicker segments are no more than about 0.017 inch in thickness,

a filtering device movable between an expanded configuration and a collapsed configuration, the filtering device configured to be deployed beyond an area of blockage or clot in a cerebral arterial blood vessel, the filtering device configured to be tracked uncovered through a microcatheter having an inner diameter of 0.017 inches from a proximal end of the microcatheter to a distal end of the microcatheter, the filtering device comprising;

an expansion assembly,

a filter membrane, and

two mobile attachment points, one of the mobile attachment points on each end of the filtering device, the mobile attachment points each having a length that covers a portion of the length of the thinner segment of the microguidewire, the lengths of the mobile attachment points together being less than the length of the thinner segment of the microguidewire,

a first coil between one of the mobile attachment points and one of the thicker segments;

a second coil between the other of the mobile attachment points and the other of the thicker segments;

wherein the thinner segment of the microguidewire where the filtering device is mounted comprises a core microguidewire, and

wherein each of the thicker segments of the microguidewire comprises the core microguidewire coated by a flexible hypotube,

wherein the filtering device is rotatably mounted on the thinner segment of the variable thickness microguidewire between the thicker segments via the mobile attachment points, the filtering device rotationally and longitudinally displaceable relative to and independently of the microguidewire,

wherein the thickness of the distal embolic protection device in the collapsed configuration measures no more than about 0.017 inch,

wherein the length of the thinner segment of the variable thickness microguidewire is longer than a length of the filtering device in the collapsed configuration,

wherein the filtering device is configured to float along the length of the thinner segment of the variable thickness microguidewire.

2. The distal embolic protection device of claim 1, wherein:

the expansion assembly comprises;

a plurality of struts,

a single ring, or

both a plurality of struts and a single ring,

wherein said plurality of struts or said ring or said both plurality of struts and single ring comprise a biocompatible material, said biocompatible material comprising platinum, stainless steel, or nickel-titanium, and

the filtering device is no more than about 0.017 inch in thickness in the collapsed configuration, and in the expanded configuration the filtering device has diameter of from about 1.5 mm to 4.5 mm, and

the filter membrane has a hemispherical or conical shape.

3. The distal embolic protection device of claim 1, wherein:

the thicker segments of the microguidewire are no more than about 0.014 inch in thickness, and

the microguidewire has a length ranging from about 190 cm to about 300 cm.

4. The distal embolic protection device of claim 1, wherein:

the core microguidewire comprises a metal or alloy, said metal being stainless steel and said alloy being nickel-titanium, and

the flexible hypotube comprises platinum, tantalum, gold, palladium, tungsten, tin, silver, titanium, nickel, zirconium, rhenium, bismuth, molybdenum or a combination thereof.

5. The distal embolic protection device of claim 1, wherein:

the microguidewire comprises a proximal stop and a distal stop where the thinner segment of the microguidewire meets the thicker segments of the microguidewire, wherein the thickness of the stops is about 0.014 inch to about 0.017 inch, and

the two mobile attachment points of the filtering device comprises;

a distal mobile attachment point, and

a proximal mobile attachment point,

wherein each of the two mobile attachment points is between the proximal and distal stops, such that there is rotatory as well as longitudinal mobility of the microguidewire through, and independently of, the filtering device between the proximal and distal stops.

6. The distal embolic protection device of claim 1, wherein:

the filter membrane comprises a biopolymer having pores large enough to allow blood cells to pass through the filter but small enough to capture debris and clots that are released during percutaneous neurovascular interventional procedures in the cerebral arterial blood vessels.

7. The distal embolic protection device of claim 6, wherein the pore openings are about 50-150 microns in diameter.

8. The distal embolic protection device of claim 1, wherein:

the distal portion of the filtering device is covered by the filter membrane, and wherein the filter membrane comprises;

a biomedical polymer selected from the group consisting of polyethylene, polyester, polypropylene, poly tetra fluoro-ethylene, polyamides, polycarbonate and polyethylene-terephthalate, or

a membrane comprising;

a biomedical polymer, and

radio-opaque particles or agents,

wherein the membrane is visible during fluoroscopic neurovascular interventional procedures.

9. The distal embolic protection device of claim 8, wherein the radio-opaque particles in the membrane comprise tantalum or gold and the radio-opaque agents comprise barium sulfate, tungsten powder, bismuth subcarbonate, bismuth oxychloride, or iodine containing compounds.

10. The distal embolic protection device of claim 1, wherein:

the expansion assembly comprises;

a plurality of struts,

a single ring, or

a plurality of struts and a single ring.

11. The distal embolic protection device of claim 10, wherein the expansion assembly comprises:

a biocompatible metal or alloy, or

a radio-opaque material.

12. The distal embolic protection device of claim 11, wherein the biocompatible metal or alloy comprises stainless steel, platinum or nickel-titanium and the radio-opaque material comprises tantalum, platinum, tungsten or gold.

13. The distal embolic protection device of claim 1, wherein the microguidewire comprises:

a shapeable tip coated with a hypotube, and

proximal and distal stops,

wherein the shapeable tip of the microguidewire coated with the hypotube, the two mobile attachment points, and the proximal and distal stops are covered by a radio-opaque material, metal or alloy.

14. The distal embolic protection device of claim 13, wherein the metal or alloy comprises stainless steel or nickel-titanium, and the radio-opaque material comprises tantalum, platinum, tungsten or gold.

19. The distal embolic protection device of claim 1, wherein the expansion assembly comprises a plurality of struts.

20. The distal embolic protection device of claim 1, wherein the expansion assembly comprises a ring.

21. The distal embolic protection device of claim 1, wherein the expansion assembly comprises a plurality of struts coupled to a ring.

22. The distal embolic protection device of claim 1, wherein the filter membrane has a hemispherical or conical shape.

23. The distal embolic protection device of claim 1, wherein the thicker segments of the microguidewire are no more than about 0.014 inch in thickness.

24. The distal embolic protection device of claim 1, wherein the microguidewire has a length ranging from about 190 cm to about 300 cm.

25. The distal embolic protection device of claim 1, wherein the filter membrane comprises:

a biomedical polymer, and

radio-opaque particles or agents.

26. The distal embolic protection device of claim 1, wherein the microguidewire comprises a shapeable tip.

15. A distal embolic protection device for filtering thrombo-embolic material, debris or clots released during percutaneous neurovascular interventional procedures specifically performed in cerebral arterial blood vessels, not attached to a balloon or a stent, and comprising:

a variable thickness microguidewire comprising;

a thinner segment having a thickness of about 0.008 to 0.010 inch,

a first thicker segment distal to the thinner segment, the first thicker segment coated with a distal hypotube,

a second thicker segment proximal to the thinner segment, the second thicker segment coated with a proximal hypotube, and

a shapeable distal tip,

a filtering device movable between an expanded configuration and a collapsed configuration, the filtering device configured to be deployed beyond an area of blockage or clot in a cerebral arterial blood vessel, the filtering device configured to be tracked uncovered through a microcatheter having an inner diameter of 0.017 inches from a proximal end of the microcatheter to a distal end of the microcatheter, the filtering device comprising;

an expansion assembly,

a filter membrane,

a distal mobile attachment point on a distal end of the filtering device, and

a proximal mobile attachment point on a proximal end of the filtering device,

wherein the expansion assembly is attached to both the proximal and distal mobile attachment points, and

wherein the filter membrane is attached to at least the distal mobile attachment point,

wherein the filtering device is rotatably mounted on the thinner segment of the variable thickness microguidewire between the first thicker segment and the second thicker segment via the proximal and distal mobile attachment points, the filtering device rotationally and longitudinally displaceable relative to and independently of the microguidewire,

wherein the thickness of the distal embolic protection device in the collapsed configuration measures no more than about 0.017 inch,

wherein the variable thickness microguidewire is configured to float along the thinner segment of the variable thickness microguidewire, and

wherein the shapeable tip of the microguidewire, the expansion assembly and the filter membrane all comprise a radio-opaque material, metal or alloy.

16. The distal embolic protection device of claim 15, wherein a distal-most 30 cm or less of the microguidewire is coated by a flexible hypotube, and wherein the proximal and distal mobile attachment points are covered by a radio-opaque material, metal or alloy.

27. The distal embolic protection device of claim 15, wherein the filter membrane comprises a biomedical polymer and radio-opaque particles.

28. The distal embolic protection device of claim 15, further comprising:

a first coil between the proximal mobile attachment points and the first thicker segment; and

a second coil between the distal mobile attachment points and the second thicker segment.

17. A distal embolic protection device, not attached to a balloon or a stent, for filtering thrombo-embolic material, debris or clots released during percutaneous neurovascular interventional procedures specifically performed in cerebral arterial blood vessels of a human, and comprising:

a core microguidewire having a diameter of about 0.008 to 0.010 inch,

a filtering device movable between an expanded configuration and a collapsed configuration, the filtering device configured to be deployed beyond an area of blockage or clot in a cerebral arterial blood vessel, the filtering device configured to be tracked through a microcatheter having an inner diameter of 0.017 inches uncovered, the filtering device comprising;

an expansion assembly,

a filter membrane, and

a proximal mobile attachment point on a proximal end of the filtering device, and

a distal mobile attachment point on a distal end of the filtering device,

wherein a first portion of the microguidewire is coated with a proximal flexible hypotube and a second portion of the microguidewire is coated with a distal flexible hypotube, the first portion longitudinally spaced from the second portion, the coated portions being no more than about 0.017 inch thick, and

wherein the filtering device is rotatably mounted on the microguidewire between the hypotubes via the mobile attachment points, such that the filtering device may be rotationally and longitudinally displaced relative to and independently of the microguidewire and hypotubes,

wherein the thickness of the distal embolic protection device in the collapsed configuration measures no more than about 0.017 inch,

wherein a length of the microguidewire not covered by the hypotubes is longer than a length of the filtering device in the collapsed configuration.

18. The distal embolic protection device of claim 17, wherein the metal or alloy comprises platinum, tantalum, gold, palladium, tungsten, tin, silver, titanium, nickel, zirconium, rhenium, bismuth, molybdenum, or combinations thereof.

29. The distal embolic protection device of claim 17, wherein the filter membrane comprises a biomedical polymer and radio-opaque particles.

30. The distal embolic protection device of claim 17, further comprising:

a first coil between the proximal mobile attachment points and the proximal flexible hypotube; and

a second coil between the distal mobile attachment points and the distal flexible hypotube.

31. A distal embolic protection device comprising:

a core wire having a diameter of about 0.008 to 0.010 inch, at least a portion of the core wire comprising a thinner segment;

a proximal hypotube coating around the core wire and proximal to the thinner segment;

a distal hypotube coating around the core wire and distal to the thinner segment, wherein at least one of the proximal coating and the distal coating comprises a coil;

a filtering device around the thinner segment and between the proximal hypotube coating and the distal hypotube coating, the filtering device rotatably and longitudinally movable relative to the thinner segment, the filtering device transformable between a collapsed configuration and an expanded configuration, the filtering device having a thickness of no more than about 0.017 inches in the collapsed configuration, the filtering device comprising;

a proximal attachment point, a distal attachment point,

a plurality of struts between the proximal attachment point and the distal attachment point, and

a porous filter membrane coupled to the plurality of struts.

32. The distal embolic protection device of claim 31, wherein at least each of the proximal hypotube coating, the distal hypotube coating, and the plurality of struts comprises radio-opaque material.

33. The distal embolic protection device of claim 32, wherein at least each of the proximal attachment point and the distal attachment point comprises radio-opaque material.

34. The distal embolic protection device of claim 31, wherein the filter membrane comprises a biomedical polymer and radio-opaque particles.

35. The distal embolic protection device of claim 31, further comprising:

a proximal coil between the proximal attachment point and the proximal coating; and

a distal coil between the distal attachment point and the distal coating.

36. The distal embolic protection device of claim 31, wherein the filter membrane is hemispherical.

37. The distal embolic protection device of claim 31, wherein the filter membrane is conical.

38. The distal embolic protection device of claim 31, wherein each of the plurality of struts is in a plane parallel with the core wire.

39. The distal embolic protection device of claim 31, wherein each of the plurality of struts is helical about the core wire.

40. The distal embolic protection device of claim 31, further comprising a ring, wherein the plurality of struts extend from the distal attachment point to the ring and wherein the ring is coupled to the proximal attachment point.

41. The distal embolic protection device of claim 31, wherein each of the proximal hypotube coating and the distal hypotube coating is no more than about 0.017 inch thick.