Apparatus and methods for intravascular embolic protection

• US 20060287668A1
• Filed: 06/16/2005
• Published: 12/21/2006
• Est. Priority Date: 06/16/2005
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Morejohn, Dwight P., Salahieh, Amr, Fawzi, Natalie V.
• Application Number:
  US11/155,309
• Publication Number:
  US 20060287668A1
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

The present invention provides intravascular embolic protection apparatus including a blood filter element having an accommodating passageway adapted to permit passage of a procedure device therethrough and to substantially seal against passage of particles between the embolic protection apparatus and the procedure device by accommodating to a size and shape of the procedure device. Furthermore, the present invention provides a method of performing an endovascular procedure on a patient including the steps of delivering an embolic protection apparatus to a location within a vascular lumen of the patient; passing a procedure device through an accommodating passageway of the apparatus, the accommodating passageway accommodating to a size and shape of the procedure device; performing the endovascular procedure; and removing the procedure device from the patient.

Claims

42. A method of performing an endovascular procedure on a patient with a procedure device, the method comprising:

delivering an embolic protection apparatus to a location within a vascular lumen of the patient, the embolic protection apparatus comprising an accommodating passageway;

passing the procedure device through the accommodating passageway from a point proximal to the embolic protection apparatus to a point distal to the embolic protection apparatus after the delivering step, the accommodating passageway accommodating to a size and shape of the procedure device;

performing the endovascular procedure; and

removing the procedure device from the patient.

1. An intravascular embolic protection apparatus comprising:

a blood filter element adapted to capture particles and to allow blood to flow therethrough;

an opening adapted to face blood flow;

a closed portion adapted to retain captured particles; and

an accommodating passageway adapted to permit passage of a procedure device therethrough from a position proximal to the closed portion to a position distal to the opening and to substantially seal against passage of particles between the embolic protection apparatus and the procedure device by accommodating to a size and shape of the procedure device.

2. The intravascular embolic protection apparatus of claim 1, wherein the passageway is sealable to substantially prevent passage of particles through the passageway when a procedure device is not disposed in the passageway.

3. The intravascular embolic protection apparatus of claim 2, wherein the passageway is self-sealing.

4. The intravascular embolic protection apparatus of claim 3, wherein the passageway is biased toward a sealed position.

5. The intravascular embolic protection apparatus of claim 1, wherein the passageway has a tapered opening for catheter guidance.

6. The intravascular embolic protection apparatus of claim 1, wherein the passageway is expandable to permit devices of different sizes to pass through the passageway.

7. The intravascular embolic protection apparatus of claim 1, wherein the passageway is a lumen in the apparatus.

8. The intravascular embolic protection apparatus of claim 1, wherein the passageway is a fold in the apparatus.

9. The intravascular embolic protection apparatus of claim 1, wherein the apparatus is self-expanding from a delivery configuration to a deployed configuration.

10. The intravascular embolic protection apparatus of claim 9, wherein the passageway is expandable independent of the rest of the apparatus.

11. The intravascular embolic protection apparatus of claim 1, wherein the apparatus is radially symmetrical.

12. The intravascular embolic protection apparatus of claim 1, wherein the apparatus is bilaterally symmetrical.

13. The intravascular embolic protection apparatus of claim 1, wherein the passageway is located in a center of the apparatus.

14. The intravascular embolic protection apparatus of claim 1, wherein the passageway is located off-center of the apparatus.

15. The intravascular embolic protection apparatus of claim 1, wherein the closed portion defines a plurality of pockets adapted to trap and retain particles.

16. The intravascular embolic protection apparatus of claim 1, wherein the closed portion is tapered to facilitate recapture of the apparatus.

17. The intravascular embolic protection apparatus of claim 1, wherein the blood filter element defines the opening and the closed portion.

18. The intravascular embolic protection apparatus of claim 17, wherein the blood filter element defines the passageway.

19. The intravascular embolic protection apparatus of claim 18, wherein the opening surrounds the passageway.

20. The intravascular embolic protection apparatus of claim 18, wherein the closed portion surrounds the passageway.

21. The intravascular embolic protection apparatus of claim 18, wherein the blood filter element provides a bias force to substantially seal the passageway, and wherein the bias force may be overcome to permit passage of the procedure device through the passageway.

22. The intravascular embolic protection apparatus of claim 1, wherein the blood filter element comprises a mesh material.

23. The intravascular embolic protection apparatus of claim 22, wherein the mesh material is formed from a single wire.

24. The intravascular embolic protection apparatus of claim 22, wherein the mesh-material is formed from multiple wires.

25. The intravascular embolic protection apparatus of claim 22, wherein the mesh material is formed from multiple meshes.

26. The intravascular embolic protection apparatus of claim 22, wherein the mesh material is covered at least in part by filter material.

27. The intravascular embolic protection apparatus of claim 22, wherein the mesh material defines the passageway.

28. The intravascular embolic protection apparatus of claim 27, wherein the mesh material provides a bias force to substantially seal the passageway, and wherein the bias force may be overcome to permit passage of the procedure device through the passageway.

29. The intravascular embolic protection apparatus of claim 1, wherein the apparatus is adapted to be delivered via a catheter.

30. The intravascular embolic protection apparatus of claim 29, wherein the apparatus is further adapted to be delivered over a guidewire.

31. The intravascular embolic protection apparatus of claim 30 further comprising a guidewire tube.

32. The intravascular embolic protection apparatus of claim 29, wherein the apparatus further comprises an anchor element.

33. The intravascular embolic protection apparatus of claim 29, wherein the apparatus further comprises multiple attachment wires.

34. The intravascular embolic protection apparatus of claim 33, wherein the multiple attachment wires can be independently controlled.

35. The intravascular embolic protection apparatus of claim 29, wherein the apparatus is configured for delivery against blood flow.

36. The intravascular embolic protection apparatus of claim 1, wherein the apparatus is further adapted to be recaptured into a catheter.

37. The intravascular embolic protection apparatus of claim 36, wherein the blood filter element is further adapted to retain captured particles during recapture of the apparatus into the catheter.

38. The intravascular embolic protection apparatus of claim 36 further comprising a recapture guide element attached to the blood filter element.

39. The intravascular embolic protection apparatus of claim 38, wherein the recapture guide element comprises longitudinal recapture wires.

40. The intravascular embolic protection apparatus of claim 38, wherein the recapture guide element comprises spiral recapture wires.

41. The intravascular embolic protection apparatus of claim 36 further comprising a lasso for recapturing the apparatus within the catheter.

43. The method of claim 42, wherein the embolic protection device comprises a filter, the method further comprising filtering blood flowing in the vascular lumen.

44. The method of claim 42, wherein delivering the embolic protection apparatus further comprises delivering the embolic protection device in a direction against the vascular lumen'"'"'s blood flow direction.

45. The method of claim 42 further comprising removing the embolic protection apparatus from the patient.

46. The method of claim 45 further comprising retaining captured particles in the apparatus during the removing step.

47. The method of claim 45, wherein removing the embolic protection apparatus further comprises capturing the embolic protection apparatus in a catheter.

48. The method of claim 47, wherein capturing the embolic protection apparatus further comprises capturing the embolic protection apparatus with a capture tool.

49. The method of claim 42, wherein delivering the embolic protection apparatus further comprises permitting the embolic protection apparatus to self-expand.

51. The method of claim 42, wherein delivering the embolic protection apparatus further comprises delivering the embolic protection apparatus over a guidewire.

52. The method of claim 51, wherein the embolic protection apparatus further comprises a guidewire tube, the method further comprising removing the guidewire tube prior to the passing step.

53. The method of claim 42 further comprising anchoring the embolic protection apparatus with. an anchor element.

54. The method of claim 42, wherein passing the procedure device through the accommodating passageway further comprises opening the passageway.

55. The method of claim 54, wherein opening the passageway further comprises causing the passageway to self-seal against the procedure device.

56. The method of claim 54, wherein opening the passageway further comprises overcoming the passageway'"'"'s sealing bias.

57. The method of claim 42, wherein the passageway comprises a lumen in the embolic protection apparatus, and wherein passing the procedure device through the accommodating passageway further comprises passing the procedure device through the lumen.

58. The method of claim 57, wherein passing the procedure device through the accommodating passageway further comprises using the passageway to guide the procedure device.

59. The method of claim 58, wherein the lumen of the accommodating passageway of the embolic protection apparatus is off-center.

60. The method of claim 42 further comprising substantially sealing the accommodating passageway after the removing step.

59-1. The method of claim 42, wherein the passageway comprises a fold in the embolic protection apparatus, and wherein passing the procedure device through the accommodating passageway further comprises passing the procedure device through the fold.