Embolic filtering method and apparatus

• US 20060009799A1
• Filed: 07/19/2005
• Published: 01/12/2006
• Est. Priority Date: 05/19/2003
• Status: Active Grant

• Current Assignee: SeptRx, Inc.
• Original Assignee: SeptRx, Inc.
• Inventors: Kleshinski, Stephen J., Russell, Scott M.
• Granted Patent: US 8,758,395 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2250/0039 : differing in diameter

Abstract

The present invention relates generally to a device and method for preventing the undesired passage of emboli from a venous blood pool to an arterial blood pool. The invention relates especially to a device and method for treating certain cardiac defects, especially patent foramen ovales and other septal defects, through the use of an embolic filtering device capable of instantaneously deterring the passage of emboli from the moment of implantation. The device consists of a frame, and a braided mesh of sufficient dimensions to prevent passage of emboli through the mesh. The device is preferably composed of shape memory allow, such as nitinol, which conforms to the shape and dimension of the defect to be treated.

Claims

1. An embolic filtering device, comprising:

a frame, wherein said frame comprises at least one base and at least two arms coupled to said base, and further wherein each of said at least two arms comprise at least one anchor extending laterally from said arms; and

a mesh, wherein said mesh is coupled to said frame.

2. The embolic filtering device of claim 1, comprising a first base and a second base, wherein said at least two arms connect said first base to said second base.

3. The embolic filtering device of claim 1 or 2, wherein said at least two arms are positioned opposite one another.

4. The embolic filtering device of claim 1 or 2, wherein said at least two arms are biased apart from another.

5. The embolic filtering device of claim 1 or 2, wherein the length of said frame is elongated when said at least two arms are compressed perpendicularly to the longitudinal axis of said frame.

6. The embolic filtering device of claim 1 or 2, wherein said at least one anchor is pliable.

7. The embolic filtering device of claim 1 or 2, wherein said at least anchor is rigid.

8. The embolic filtering device of claim 1 or 2, wherein said at least one anchor is arcuate.

9. The embolic filtering device of claim 1 or 2, wherein at least one anchor is linear.

10. The embolic filtering device of claim 1 or 2, wherein at least a portion of said frame is comprised of a radiopaque material.

11. The embolic filtering device of claim 10, wherein said radiopaque material is tantalum.

12. The embolic filtering device of claim 1 or 2, said frame and said mesh are comprised of at least one of metal, fabric, and polymer.

13. The embolic filtering device of claim 12, wherein said metal is a shape memory metal.

14. The embolic filtering device of claim 13, wherein said shape memory metal is nitinol.

15. The embolic filtering device of claim 11, wherein said metal is a non-shape memory metal.

16. The embolic filtering device of claim 14, wherein said non-shape memory metal

is selected from the group consisting of elgiloy, cobalt chromium, stainless steel,

17. The embolic filtering device of claim 1 or 2, wherein said device is collapsible into a catheter and capable of expanding to a relaxed state as said device is released from said catheter.

18. The embolic filtering device of claim 1 or 2, wherein a first portion of said mesh is secured by a first fastener, a second portion of the mesh overlaps said first portion of said mesh and is secured by a second fastener, and a third portion of said mesh overlaps said first and second portions of said mesh and is secured by a third fastener

19. The embolic filtering device of claim 1 or 2, wherein said mesh is coupled to at least one of said bases.

20. The embolic filtering device of claim 18, wherein one of said first and second base is secured to said third fastener.

21. The embolic filtering device of claim 1 or 2, wherein said mesh is at least partially disposed between the two arms of said frame.

22. The embolic filtering device of claim 1 or 2, wherein said mesh is at least partially disposed between said first base and said second base.

23. The embolic filtering device of claim 1 or 2, wherein said at least one base comprises a collar, the lumen of said collar being aligned along a common axis.

24. The embolic filtering device of claim 18, wherein said fasteners are collars, the lumen of said collars being aligned along a common axis.

25. The embolic filtering device of claim 23, wherein a guide wire is insertable through the lumen of said collars.

26. The embolic filtering device of claim 24, wherein a guide wire is insertable through the lumen of said collars.

27. The embolic filtering device of claim 1 or 2, wherein said embolic filtering device is deliverable to within, proximate to, and/or adjacent to the passage between a venous blood pool and an arterial blood pool.

28. The embolic filtering device of claim 27, wherein said passage is a passage defined by a septal defect.

29. The embolic filtering device of claim 28, wherein said septal defect is a patent foramen ovale.

32. The embolic filtering device of claim 18, wherein at least a portion of said first fastener, second fastener, and/or said third fastener is radiopaque.

33. The embolic filtering device of claim 1, wherein said mesh is composed of foam.

34. The embolic filtering device of claim 1, wherein at least one of frame and/or said mesh are coated with an anticoagulant.

35. The embolic filtering device of claim 1, wherein at least one of said frame and mesh are coated with at least one of thrombin, collagen, hyluron or a host growth factor.

36. The mesh of claim 1 or 2, wherein said mesh if formed of a plurality strands, the density of said strands being sufficient to prevent the passage of emboli through said mesh.

37. The embolic filtering device of claim 1 or 2, wherein said at least one base is attachable to a delivery device.

39. The embolic filtering device of claim 1 or 2, comprising a plug disposed within the interior of said mesh.

40. The embolic filtering device of claim 39, wherein is comprised of at least one of collagen, fabric, an adhesive, polymer, or foam.

44. The embolic filtering device of claim 1, wherein said frame and mesh are comprised of at least one of metal, fabric, and polymer.

45. The embolic filtering device of claim 44, wherein said metal is at shape memory metal.

46. The embolic filtering device of claim 45, wherein said shape memory metal is nitinol.

47. The embolic filtering device of claim 44, wherein said metal is a non-shape memory metal.

48. The embolic filtering device of claim 47, wherein said non-shape memory metal

is selected from the group consisting of elgiloy, cobalt chromium, and stainless steel.

49. The embolic filtering device of claim 1, wherein said device is collapsible into a catheter and capable of expanding to a relaxed state as said device is released from said catheter.

50. The embolic filtering device of claim 1, wherein a first portion of said mesh is secured by a first fastener, a second portion of the mesh overlaps said first portion of said mesh and secured by a second fastener to form, and a third portion of said mesh is extended over said first and second portions of said mesh and secured by a third fastener.

51. The embolic filtering device of claim 1, wherein said mesh is secured to said frame.

52. The embolic filtering device of claim 1, wherein said embolic filtering device is deliverable to within, proximate to, and/or adjacent to the passage between a venous blood pool and an arterial blood pool.

53. The embolic filtering device of claim 52, wherein said passage is a passage defined by a septal defect.

54. The embolic filtering device of claim 53, wherein said septal defect is selected from the group consisting of:

a patent foramen ovale.

55. The embolic filtering device of claim 15, wherein at least a portion of at least one of said frame and mesh is radiopaque.

56. The embolic filtering device of claim 1, wherein said mesh is comprised of foam.

57. The embolic filtering device of claim 1, wherein at least one of said frame and said mesh are coated with an anticoagulant.

58. The embolic filtering device of claim 1, wherein at least one of said frame and mesh are coated with at least one of thrombin, collagen, hyluron or a host growth factor.

59. The embolic filtering device of claim 1, wherein said mesh if formed of a plurality of strands, said plurality of strands being impermeable to emboli.

60. The embolic filtering device of claim 1, wherein at least one said first base and said second base is attachable to a delivery device.

61. The embolic filtering device of claim 1, comprising a plug within the interior of said mesh, said plug being comprised of at least one of collagen, fabric, an adhesive, polymer, or foam.

62. A method of preventing passage of emboli between a venous blood pool and an arterial blood pool comprising the steps of:

delivering the embolic filtering device of claim 1 to within, proximate to, and/or adjacent to a passage between a venous blood pool and an arterial blood pool;

securing said embolic filtering device within, proximate to, and/or adjacent to said passage.

63. The method of claim 62, wherein said embolic filtering device is delivered by means of a catheter to within and/or adjacent to said passage.

64. The method of claim 62, wherein said embolic filtering device is secured within and/or adjacent to said passage by said at least two anchors.

65. The method of claim 62, wherein said passage is within the lungs.

66. The method of claim 62, wherein said passage is within the heart

67. The method of claim 62, wherein said passage is a passage defined by a septal defect.

68. The method of claim 62, wherein said septal defect is a patent foramen ovale.

69. The embolic filtering device of claim 1 or 2, wherein said mesh comprises polyester, nylon, polytetrafluoroethylene (PTFE), polyurethane, polyaryletheretherketone (PEEK), and polyglycolic acid (PGA), polylactide (PLA), polyepsilon-caprolactone, polyethylacrylate (PEA).

70. The embolic filtering device of claim 12, wherein said mesh is co-braided with at least one of platinum or a platinum alloy.

41. The embolic filtering device of claim 1 or 2, wherein said mesh comprises a first diameter portion and a second diameter portion, said second diameter portion being disposed within said first diameter portion.

42. The embolic filtering device of claim 41, wherein said mesh is spherical, with an open interior.

43. The embolic filtering device of claim 41, wherein said mesh comprises a first diameter portion and a second diameter portion, said second diameter portion being disposed within the first diameter portion.

41-1. An embolic filtering device, comprising:

a frame,

a mesh, said mesh comprised of a plurality of braided strands, wherein the density of said strands is sufficient to prevent the passage of emboli through said mesh.