Vascular device for emboli and thrombi removal and methods of use

• US 20020161393A1
• Filed: 03/21/2002
• Published: 10/31/2002
• Est. Priority Date: 07/30/1999
• Status: Active Grant

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Demond, Jackson F., Khosravi, Farhad, Renati, Richard J., Ramee, Stephen, Salahieh, Amr, Young, Kirk Hsueh-kai, Krolik, Jeff A.
• Granted Patent: US 7,306,618 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• 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 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 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 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

Abstract

Apparatus and methods are provided for use in filtering emboli from a vessel and/or performing thrombectomy and embolectomy, wherein a vascular device disposed on a guidewire comprises a support hoop disposed from a suspension strut. Alternately, a support hoop having an articulation region may be directly connected to a region proximate the distal end of the guidewire. A blood permeable sac is affixed to the support hoop to form a mouth of the blood permeable sac. The support hoop is disposed obliquely relative to the longitudinal axis of the guidewire and is capable of being properly used in a wide range of vessel diameters. The vascular device collapses during removal to prevent material from escaping from the sac. A delivery sheath and introducer sheath for use with the vascular device of the present invention are also provided.

Claims

1. Apparatus suitable for filtering emboli or performing thrombectomy comprising:

an elongated member having a distal region;

a support hoop attached to the distal region, the support hoop having one or more articulation regions; and

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

2. The apparatus of claim 1 further comprising a thrombus removal element disposed proximal of the support hoop.

3. The apparatus of claim 2, wherein the thrombus removal element is adapted to be movable in a proximal direction independent of the elongated member.

4. The apparatus of claim 2, wherein the thrombus removal element comprises a second support hoop with blood permeable sac.

5. The apparatus of claim 4, wherein the second support hoop is slidably disposed on the elongated member.

6. The apparatus of claim 1, wherein the blood permeable sac comprises a plurality of pores dimensioned to allow passage of blood cells therethrough.

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

8. The apparatus of claim 1, wherein the support hoop comprises a wire having a thickness that tapers to a minimum thickness at the one or more articulation regions.

9. The apparatus of claim 1, wherein the apparatus has a deployed state, wherein the 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.

10. The apparatus of claim 1, wherein the support hoop folds at the one or more articulation regions when the apparatus is contracted to the delivery state.

11. The apparatus of claim 2, wherein thrombus is excised or ablated by the thrombus removal element.

12. The apparatus of claim 9, 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.

13. The apparatus of claim 10 wherein opposite sides of the support hoop close towards one another when the apparatus is contracted to its contracted configuration.

14. The apparatus of claim 1, wherein the support hoop comprises a radiopaque feature.

15. The apparatus of claim 1 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, support hoop and blood permeable sac.

16. The apparatus of claim 1, wherein the support hoop and blood permeable sac comprise a thrombus removal element.

17. The apparatus of claim 1 further comprising a spinner tube coaxially disposed about the distal region of the elongated member, the blood permeable sac coupled to the spinner tube.

18. The apparatus of claim 17, wherein the elongated member further comprises proximal and distal stops, the spinner tube disposed between the proximal and distal stops.

19. The apparatus of claim 17 further comprising a nose cone disposed on a distal end of the spinner tube.

20. The apparatus of claim 1, further comprising a delivery sheath for accepting the elongated member, support hoop and blood permeable sac, and wherein the delivery sheath further comprises a distal end having a positive locking feature.

21. The apparatus of claim 20, wherein the positive locking feature is configured to selectively maintain the support hoop in an expanded deployed configuration.

22. The apparatus of claim 21, wherein the positive locking feature comprises a wedge.

23. The apparatus of claim 1 further comprising a positive locking feature in communication with the support hoop, the positive locking feature configured to selectively maintain the support hoop in an expanded deployed configuration.

24. The apparatus of claim 1, further comprising a delivery sheath for accepting the elongated member, support hoop and blood permeable sac, and wherein the delivery sheath further comprises a distal section having the lumen, a proximal section having a second lumen, and a bridge section disposed between the proximal and distal sections.

25. The apparatus of claim 16, wherein the thrombus removal element further comprises an arch support coupled to the support hoop to form a filter frame.

26. The apparatus of claim 25, wherein the arch support comprises a hinge articulation region disposed between first and second support struts, the first and second support struts coupled to the support hoop.

27. The apparatus of claim 26, wherein the first support strut is further coupled to the elongated member.

28. The apparatus of claim 25 wherein the blood permeable sac is coupled to the filter frame.

29. The apparatus of claim 25 further comprising a delivery sheath having a distal section and a bridge section disposed proximal of the distal section, the distal section comprising a lumen for accepting the elongated member and thrombus removal element.

30. The apparatus of claim 16, wherein the thrombus removal element further comprises a tension thread, the tension thread coupled to the support hoop and to the elongated member proximal of the support hoop.

31. The apparatus of claim 30, wherein the tension thread is taut when the thrombectomy element is in an expanded deployed configuration and is lax when the thrombectomy element is in a collapsed delivery configuration.

32. The apparatus of claim 31, wherein the tension thread is configured to maintain the thrombectomy element in the deployed configuration during proximal retraction through thrombus.

33. The apparatus of claim 31 further comprising a delivery sheath having a distal section and a bridge section disposed proximal of the distal section, the distal section comprising a lumen for accepting the elongated member and thrombus removal element.

35. The apparatus of claim 34, wherein the blood permeable sac comprises a biocompatible material.

36. The apparatus of claim 35, wherein the biocompatible material comprises a material chosen from a group consisting of polyethylene, polypropylene, polyurethane, polyester, polyethylene tetraphlalate, nylon and polytetrafluoroethylene.

37. The apparatus of claim 34, 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.

38. The apparatus of claim 37, wherein each one of the plurality of pores has a diameter in a range of 20 to 400 microns.

39. The apparatus of claim 34, wherein the support hoop comprises a super-elastic material.

40. The apparatus of claim 34, wherein the support hoop comprises stainless steel.

41. The apparatus of claim 34, wherein the support hoop includes an articulation region.

42. The apparatus of claim 34, 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 a delivery sheath.

43. The apparatus of claim 34, further comprising a single-use delivery sheath.

44. The apparatus of claim 42, wherein the mouth of the blood permeable sac is closed when the apparatus is in the contracted configuration to prevent emboli from escaping from the blood permeable sac.

45. The apparatus of claim 44 wherein opposite sides of the first support hoop close towards one another when the apparatus is contracted to its contracted configuration.

46. The apparatus of claim 34, wherein the first support hoop comprises a radiopaque feature.

47. The apparatus of claim 34, further comprising a tube disposed in the distal region, and the suspension strut and blood permeable sac are affixed to the tube.

48. The apparatus of claim 47 wherein the distal region has a reduced diameter to accept the tube.

49. The apparatus of claim 34 wherein the suspension strut further includes one or more side turns to stabilize and orient the apparatus in the deployed state.

50. The apparatus of claim 34 wherein the elongated member is a guide wire.

51. The apparatus of claim 47 further comprising a nose cone disposed on the tube.

52. The apparatus of claim 34, wherein the blood permeable sac has a length and a diameter that tapers along the length.

53. The apparatus of claim 34, wherein the blood permeable sac comprises a plurality of pores formed by laser drilling.

54. The apparatus of claim 34 further comprising a delivery sheath having a longitudinal perforation, the delivery sheath retaining the vascular filter in a contracted delivery state.

55. The apparatus of claim 54 further comprising an introducer sheath having a longitudinal slit, the introducer sheath facilitating insertion of the vascular filter into a guide catheter.

57. The apparatus of claim 56, wherein the blood permeable sac comprises a biocompatible material.

58. The apparatus of claim 56, wherein the blood permeable sac comprises a plurality of pores having diameters in a range of 20 to 400 microns.

59. The apparatus of claim 56, wherein the support hoop includes an articulation region.

60. The apparatus of claim 56, 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 a delivery sheath.

61. The apparatus of claim 56, further comprising a single-use delivery sheath.

62. The apparatus of claim 56, wherein the mouth of the blood permeable sac is closed when the apparatus is in the contracted configuration to prevent emboli from escaping from the blood permeable sac.

63. The apparatus of claim 56, further comprising a tube disposed in the distal region, and the suspension strut and blood permeable sac are affixed to the tube.

64. The apparatus of claim 63 wherein the distal region has a reduced diameter to accept the tube.

65. The apparatus of claim 56 wherein the elongated member is a guide wire and the guide wire further comprises an articulation region.

34. Apparatus suitable for filtering emboli comprising:

an elongated member having a distal region having a longitudinal axis;

a support hoop;

a suspension member coupling the support hoop to the distal region so that the support hoop may be eccentrically laterally displaced relative to the longitudinal axis; and

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

56. Apparatus suitable for filtering emboli comprising:

an elongated member having a distal region having a longitudinal axis;

a support hoop;

a suspension member coupling the support hoop to the distal region so that the support is disposed obliquely relative to the longitudinal axis; and

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