Vascular device having emboli and thrombus removal element and methods of use

• US 20020026211A1
• Filed: 01/16/2001
• Published: 02/28/2002
• Est. Priority Date: 12/23/1999
• Status: Abandoned Application

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Khosravi, Farhad, Ramee, Stephen, Salahieh, Amr, Krolik, Jeff A.
• Application Number:
  US09/764,777
• Publication Number:
  US 20020026211A1
• 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 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 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

Apparatus and methods are provided for use in filtering emboli or removing thrombus from a vessel, wherein a vascular device comprises a vascular filter for capturing emboli and optionally, a thrombectomy element for excising or ablating thrombus. The vascular filter comprises a support hoop having one or more articulation regions connected near a distal end of a guide wire, and a blood permeable sac affixed to the support hoop so that the support hoop forms a mouth of the blood permeable sac. In a preferred embodiment, the thrombectomy element also comprises a vascular filter support hoop, and may include filter frame, locking feature or tensioning thread.

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 method of claim 34, wherein the filter comprises a thrombus removal element, the method further comprising moving the thrombus removal element relative to the vessel wall to excise thrombus from the vessel.

36. The method of claim 34, wherein advancing the delivery sheath to a desired location within a patient'"'"'s vessel comprises advancing the delivery sheath through an interior lumen of a catheter so that a distal region of the delivery sheath is disposed distal to the lesion.

37. The method of claim 34 further comprising retracting the apparatus within the delivery sheath by folding the support hoop at the articulation region to close the mouth of the blood permeable sac.

38. The method of claim 34, wherein advancing the delivery sheath to the desired location within the patient'"'"'s vessel comprises advancing the delivery sheath through tortuous anatomy to the desired location within the patient'"'"'s vessel.

39. The method of claim 34 further comprising reversibly locking the support hoop in the deployed state.

40. The method of claim 34 further comprising applying tension to the support hoop in the deployed state with a tension thread.

34. A method of trapping thrombus and/or filtering emboli during a medical procedure, the method comprising:

providing apparatus comprising an elongated member having a distal region and a filter, the filter comprising a support hoop having one or more articulation regions and coupled to the distal region of the elongated member, and a blood permeable sac affixed to the support hoop so that the hoop forms a mouth of the blood permeable sac;

positioning the apparatus in a contracted delivery state within a delivery sheath;

advancing the delivery sheath to a desired location within a patient'"'"'s vessel; and

withdrawing the apparatus from the delivery sheath to expand the apparatus to a deployed state wherein the support hoop of the filter seals against the vessel wall.