Vascular device for emboli, thrombus and foreign body removal and methods of use

• US 6,544,279 B1
• Filed: 08/09/2000
• Issued: 04/08/2003
• Est. Priority Date: 08/09/2000
• Status: Expired

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Renati, Richard, Ramee, Stephen, Lepak, Jonah, Hopkins, L. N., Khosravi, Farhad, Demond, Jackson F., Salahieh, Amr, Krolik, Jeff A.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/636,040
• Time in Patent Office: 972 Days
• Field of Search: 606/159, 606/198, 606/194, 606/200, 604/22, 604/96
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/012 Multiple filtering units
• 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 2230/008 paraboloidal
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/0069 Tip not integral with tube

Abstract

Apparatus and methods are provided for use in filtering emboli from a vessel and/or performing thrombectomy and embolectomy, wherein a vascular device comprises one or more support hoops connected near a distal end of a guide wire, each support hoop having an articulation region, and a blood permeable sac affixed to the support hoop or hoops to form a mouth of the blood permeable sac. The mouth of the sac closes when the apparatus is collapsed for removal to prevent material from escaping from the sac.

Claims

1. Apparatus suitable for filtering emboli or performing thrombectomy, embolectomy or foreign body removal, comprising:

an elongated member having a distal region;

a first support hoop attached to the distal region, the first support hoop having an articulation region interposed between curved regions;

a blood permeable sac affixed to the first support hoop so that the first support hoop forms a mouth of the blood permeable sac;

wherein the apparatus has a deployed state, wherein the first support hoop engages an interior wall of a patient'"'"'s vessel, and a delivery state, wherein the apparatus has a contracted configuration to permit insertion within a delivery sheath; and

wherein the first support hoop is folded at the articulation region when the apparatus is in the delivery state.

2. The apparatus of claim 1, wherein the blood permeable sac comprises a biocompatible material.

3. The apparatus of claim 2, wherein the biocompatible material comprises a material chosen from a group consisting of polyethylene, polypropylene, polyurethane, polyester, polyethylene tetraphlalate, nylon and polytetrafluoroethylene.

4. The apparatus of claim 2, wherein the biocompatible material is substantially non-thrombogenic.

5. The apparatus of claim 2, wherein the biocompatible material is formed into the blood permeable sac by a thermoforming process.

6. The apparatus of claim 1, wherein the blood permeable sac comprises a woven material having a plurality of pores, the pores having a size determined by a weave pattern of the woven material.

7. The apparatus of claim 4, wherein each one of the plurality of pores has a diameter in a range of 20 to 400 microns.

8. The apparatus of claim 4, wherein each one of the plurality of pores has a cross-sectional area, and a sum area of the cross-sectional areas is greater than or equal to a cross-sectional area of a patient'"'"'s vessel.

9. The apparatus of claim 1, wherein the first support hoop comprises a super-elastic material.

10. The apparatus of claim 6, wherein the super-elastic material comprises a nickel-titanium alloy.

11. The apparatus of claim 6, wherein the super-elastic material comprises a spring tempered stainless steel.

12. The apparatus of claim 1, wherein the first support hoop comprises a wire having a thickness that tapers to a minimum thickness at the articulation region.

13. The apparatus of claim 1, wherein the mouth of the blood permeable sac is closed when the apparatus is in the contracted configuration, thereby preventing emboli from escaping from the blood permeable sac.

14. The apparatus of claim 11 wherein opposite sides of the first support hoop close towards one another when the apparatus is contracted to its contracted configuration.

15. The apparatus of claim 1, wherein the first support hoop comprises a radiopaque feature. member.

16. The apparatus of claim 13, wherein the radiopaque feature comprises a radiopaque wire wrapped around the first support hoop.

17. The apparatus of claim 1, wherein the blood permeable sac is affixed to the elongated member along a length of the blood permeable sac.

18. The apparatus of claim 1 wherein the first support hoop includes one or more side turns that stabilize and orient the apparatus in the deployed state.

19. The apparatus of claim 1 wherein the elongated member serves as a guide wire.

20. The apparatus of claim 1 further comprising:

a nose cone disposed on the distal region of the elongated member distal to the first support hoop; and

a delivery sheath having a first lumen for accepting the elongated member, first support hoop and blood permeable sac.

21. The apparatus of claim 17, wherein the delivery sheath further comprises a second lumen for accepting a guide wire.

22. The apparatus of claim 18 wherein the first lumen of the delivery sheath opens to a skive in a lateral wall of the delivery sheath in a distal region of the delivery sheath.

23. The apparatus of claim 18 wherein the second lumen of the delivery sheath opens to a skive in a lateral wall of the delivery sheath in a distal region of the delivery sheath.

24. The apparatus of claim 18, wherein the delivery sheath further comprises a guide tube attached to an exterior surface of the delivery sheath, the guide tube having a portion defining the second lumen.

25. The apparatus of claim 17 further comprising a guide wire in communication with the delivery sheath.

26. The apparatus of claim 23, wherein a distal end of the guide wire is attached to a proximal end of the delivery sheath.

27. The apparatus of claim 1 further comprising a balloon catheter.

28. The apparatus of claim 1, wherein the articulation region comprises a gap, the gap bridged by a portion of the blood permeable sac.

29. The apparatus of claim 25, wherein the proximal end of the blood permeable sac comprises a lumen.

30. The apparatus of claim 29, wherein the lumen is configured to receive the curved regions and bridge the gap.

31. The apparatus of claim 25, wherein the curved regions of the first support hoop comprise an elastic material.

32. The apparatus of claim 1, wherein the blood permeable sac is further affixed to the elongated member.

33. The apparatus of claim 1, wherein the blood permeable sac has a length and a diameter that tapers along the length.

34. The apparatus of claim 29, wherein tapering the blood permeable sac reduces bunching of the sac during retrieval within a delivery sheath.

35. The apparatus of claim 29, wherein tapering the blood permeable sac reduces a delivery profile of the apparatus.

36. The apparatus of claim 29, wherein tapering the blood permeable sac reduces a risk of snagging the sac on a stent during retrieval.

37. The apparatus of claim 1, wherein the first support hoop is attached to a sheath slidably disposed on the elongated member.

38. The apparatus of claim 33 further comprising means for constraining longitudinal motion of the sheath with respect to the elongated member.

39. The apparatus of claim 1 further comprising a second support hoop disposed circumferentially adjacent to the first support hoop, the blood permeable sac further affixed to the second support hoop.

40. The apparatus of claim 1 further comprising:

a second support hoop coupled to the distal region and spaced apart longitudinally from the first support hoop,

the blood permeable sac further affixed to the second support hoop.

41. The apparatus of claim 36, wherein the second support hoop comprises a wire having a thickness that tapers to a minimum thickness at an articulation region.

42. The apparatus of claim 36, wherein the blood permeable sac has a length and a diameter that tapers along the length.

43. The apparatus of claim 36, wherein the second support hoop is smaller than the first support hoop.

44. The apparatus of claim 36, wherein the second support hoop comprises an articulation region having a gap, the gap bridged by a portion of the blood permeable sac.

45. The apparatus of claim 36, wherein the first and second support hoops are attached to a sheath slidably disposed on the elongated member.

46. The apparatus of claim 41 further comprising means for constraining longitudinal motion of the sheath with respect to the elongated member.

47. The apparatus of claim 1 further comprising:

a delivery sheath having a lumen for accepting the elongated member, support hoop and blood permeable sac;

a retrieval sheath having a flared end region and a lumen for accepting the delivery sheath; and

a guide catheter having a lumen for accepting the retrieval sheath.

48. The apparatus of claim 43, wherein the apparatus has a deployed state, wherein the support hoop engages an interior wall of a patient'"'"'s vessel, and a delivery state, wherein the apparatus has a contracted configuration to permit insertion within the delivery sheath.

49. The apparatus of claim 44, wherein the first support hoop folds at the articulation region when the apparatus is contracted to the delivery state.

50. The apparatus of claim 44, wherein the mouth of the blood permeable sac closes when the apparatus is contracted to the delivery state.

51. The apparatus of claim 43, wherein the flared end region comprises a radiopaque feature.

52. The apparatus of claim 43, wherein the retrieval sheath has a deployed state, wherein the flared end region extends distal of the guide catheter and is expanded, and a contracted state, wherein the flared end region is collapsed to fit within the guide catheter lumen.

53. The apparatus of claim 48, wherein the retrieval sheath is retracted from the deployed state to the contracted state when a radiopaque feature on the flared end region is aligned with a radiopaque feature on the blood permeable sac.

54. The apparatus of claim 48, wherein the flared end region contracts the portion of the vascular device remaining in the deployed state within the guide catheter lumen when the retrieval sheath is retracted from the deployed state to the contracted state.

55. The apparatus of claim 43, wherein the flared end region comprises an elastomeric material.

56. The apparatus of claim 1 further comprising:

a delivery sheath having a lumen for accepting the elongated member, support hoop and blood permeable sac, and having an atraumatic expander; and

a retrieval sheath having an expandable end region and a lumen for accepting the delivery sheath.

57. The apparatus of claim 1 further comprising:

a handle having a collet for selectively grasping and releasing the elongated member;

and a lumen flushing section coupled to the handle to allow translation and rotation therebetween, the lumen flushing section having a side port in fluid communication with the lumen of the delivery sheath and configured to allow the elongated member to pass therethrough to the handle.

58. The apparatus of claim 53, wherein the apparatus has a delivery state, wherein the handle is translated longitudinally to a proximal-most position relative to the lumen flushing section, and the first support hoop is retracted within the delivery sheath, and a deployed state wherein the handle is translated longitudinally to a distal-most position adjacent the lumen flushing section, wherein the first support hoop extends beyond a distal end of the delivery sheath and engages an interior wall of a patient'"'"'s vessel.

59. The apparatus of claim 1 further comprising:

a handle configured to selectively grasp and release the elongated member; and

a fluid port section coupled to the handle to allow translation and rotation therebetween, the fluid port section having a side port in fluid communication with the lumen of the delivery sheath and configured to allow the elongated member to pass therethrough to the handle.

60. The apparatus of claim 55, wherein the apparatus has a delivery state, wherein the handle is translated longitudinally to a proximal-most position relative to the fluid port section, and the first support hoop is retracted within the delivery sheath, and a deployed state wherein the handle is translated longitudinally to a distal-most position adjacent the fluid port section, wherein the first support hoop extends beyond a distal end of the delivery sheath and engages an interior wall of a patient'"'"'s vessel.

61. The apparatus of claim 1 further comprising:

a thrombus removal element disposed proximal of the first support hoop, the thrombus removal element movable in a proximal direction independent of the elongated member.

62. The apparatus of claim 57, wherein the thrombus removal element comprises a third support hoop with blood permeable sac.

63. The apparatus of claim 58, wherein the third support hoop is slidably disposed on the elongated member.

64. The apparatus of claim 57, wherein the removal element is configured to excise or ablate thrombus from within a patient'"'"'s vessel.

65. The apparatus of claim 57 further comprising:

a nose cone disposed on the distal region of the elongated member distal to the support hoop;

and a delivery sheath having a lumen for accepting the elongated member, thrombus removal element, first support hoop, and blood permeable sac.

66. The apparatus of claim 1, wherein the blood permeable sac comprises a plurality of pores formed by laser drilling.

67. The apparatus of claim 62, wherein each one of the plurality of pores has a diameter in a range of 20 to 400 microns.

68. The apparatus of claim 1, wherein the blood permeable sac comprises a plurality of elliptical pores.

69. The apparatus of claim 1, wherein the blood permeable sac comprises a plurality of pores provided in sufficient density, such that proximal pores remain open when distal pores become occluded, thereby ensuring continuous blood flow through a patient'"'"'s vessel.