Vascular device having articulation region and methods of use

• US 6,530,939 B1
• Filed: 07/30/1999
• Issued: 03/11/2003
• Est. Priority Date: 07/30/1999
• Status: Expired due to Term

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Demond, Jackson F., Krolik, Jeff A., Hopkins, Leo N., Khosravi, Farhad, Salahieh, Amr
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/364,064
• Time in Patent Office: 1,320 Days
• Field of Search: 606/200, 606/194, 606/198, 604/22, 604/96.01, 604/104
• US Class Current: 606/200
• 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 2/013 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 2230/008 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 performing thrombectomy and embolectomy, wherein a vascular device comprises a support hoop having an articulation region 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. The articulation region comprises a reduced thickness region of the support hoop that prevents kinks from forming in the support hoop when the apparatus is contracted to its delivery state, and curved regions that close the mouth of the sac to prevent material escaping from the sac when the apparatus is collapsed for removal.

Claims

1. Apparatus suitable for filter emboli or performing thrombectomy or embolectomy comprising:

an elongated member having a distal region;

a support structure attached to the distal region, the support structure having an articulation region interposed between curved regions that orient the articulation region relative to a vessel wall when the support structure is deployed within a vessel; and

a blood permeable sac affixed to the support structure so that the support structure forms a mouth of the blood permeable sac,

wherein the opposite sides of the support structure close towards one another when the apparatus is contracted to a contracted configuration.

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 list consisting of polyethylene, polypropylene, polyester, polyurethane and nylon.

4. 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.

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

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

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

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

9. The apparatus of claim 1, wherein the apparatus has a deployed state, wherein the support structure engages an interior wall of a patient'"'"'s vessel, and a delivery state, wherein the apparatus has the contracted configuration to permit insertion within a delivery sheath.

10. The apparatus of claim 9, wherein the support structure is folded at the articulation region when the apparatus is in the delivery state.

11. 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.

12. The apparatus of claim 1, wherein the support structure comprises a radiopaque band.

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

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

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

16. The apparatus of claim 1 further comprising:

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

a delivery sheath having a first lumen for accepting the elongated member, support structure and blood permeable sac, and a second lumen for accepting a guide wire.

17. The apparatus of claim 16 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.

18. The apparatus of claim 16 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.

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

20. A method of trapping emboli or thrombus during a medical procedure, the method comprising:

providing apparatus comprising an elongated member, a support structure having an articulation region coupled to the elongated member, and a blood permeable sac affixed to the support structure so that the support structure 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;

withdrawing the delivery sheath to expand the apparatus to a deployed state wherein the support structure seals against the vessel wall;

providing an interventional device for performing a medical procedure, the interventional device comprising a guide wire lumen;

percutaneously and transluminally advancing the interventional device along the elongated member to position the interventional device within the patient'"'"'s vessel at a location proximal of the apparatus; and

performing the medical procedure, the apparatus catching emboli released when the medical procedure is performed.

21. The method of claim 20 further comprising:

retracting the apparatus into a collapsed configuration within the guide lumen of the interventional device; and

removing the interventional device and apparatus from the patient'"'"'s vessel.

22. The method of claim 21, wherein retracting the apparatus within the guide wire lumen comprises folding the support structure at the articulation region to close the mouth of the blood permeable sac.

23. The method of claim 20, further comprising, prior to advancing the delivery sheath to a desired location within a patient'"'"'s vessel:

providing a catheter having a balloon in a distal region;

inserting the catheter so that the balloon is disposed proximally of a lesion; and

inflating the balloon to arrest antegrade flow through the vessel,

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

24. The method of claim 23, further comprising, after withdrawing the delivery sheath to expand the apparatus, deflating the balloon to re-establish antegrade flow through the vessel.

25. The method of claim 20 further comprising:

partially retracting the apparatus into a collapsed configuration within the guide lumen of the interventional device; and

removing the interventional device and apparatus from the patient'"'"'s vessel.

26. Apparatus suitable for filtering emboli or performing thrombectomy or embolectomy comprising:

an elongated member having a distal region;

a support structure comprising a super-elastic material attached to the distal region, the support structure having an articulation region interposed between curved regions that orient the articulation region relative to a vessel wall when the support structure is deployed within a vessel; and

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

27. The apparatus of claim 26, wherein the blood permeable sac comprises a biocompatible material.

28. The apparatus of claim 27, wherein the biocompatible material comprises a material chosen from a list consisting of polyethylene, polypropylene, polyester, polyurethane and nylon.

29. The apparatus of claim 26, 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.

30. The apparatus of claim 29, wherein each one of the plurality of pores has a diameter in a range of 20 to 400 microns.

31. The apparatus of claim 26, wherein the super-elastic material comprises a nickel-titanium alloy.

32. The apparatus of claim 26, wherein the support structure comprises a wire having a thickness that tapers to a minimum thickness at the articulation region.

33. The apparatus of claim 26, wherein the apparatus has a deployed state, wherein the support structure 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.

34. The apparatus of claim 33, wherein the support structure is folded at the articulation region when the apparatus is in the delivery state.

35. The apparatus of claim 33, 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.

36. The apparatus of claim 26, wherein the support structure further comprises a radiopaque band.

37. The apparatus of claim 27, wherein the blood permeable sac is affixed to the elongated member along a length of the blood permeable sac.

38. The apparatus of claim 26 wherein the support structure includes one or more side turns that stabilize and orient the apparatus in the deployed state.

39. The apparatus of claim 26 wherein the elongated member serves as a guide wire.

40. The apparatus of claim 26 further comprising:

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

a delivery sheath having a first lumen for accepting the elongated member, support structure and blood permeable sac, and a second lumen for accepting a guide wire.

41. The apparatus of claim 40 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.

42. The apparatus of claim 40 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.

43. The apparatus of claim 26 further comprising a balloon catheter.