Integrated vascular device having thrombectomy element and vascular filter and methods of use

• US 6,203,561 B1
• Filed: 12/23/1999
• Issued: 03/20/2001
• Est. Priority Date: 07/30/1999
• Status: Expired due to Term

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Khosravi, Farhad, Ramee, Stephen, Hopkins, L. N.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/470,681
• Time in Patent Office: 453 Days
• Field of Search: 606/200, 606/191, 606/194
• 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 2/012 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 2230/008 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 removing thrombus from a vessel, wherein a vascular device comprises an thrombectomy element for excising or ablating thrombus and a vascular filter for capturing emboli generated during removal of the thrombus. The vascular filter 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. In a preferred embodiment, the thrombectomy element comprises a second support hoop and blood permeable sac attached to the guide wire proximal of the vascular filter support hoop.

Claims

1. Apparatus suitable for performing thrombectomy comprising:

an elongated member having a distal region;

a support hoop attached to the distal region, the support hoop having a reduced-thickness articulation region, the hoop attached to the elongated member;

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

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

2. The apparatus of claim 1, wherein the thrombus removal element comprises a second support hoop with blood permeable sac.

3. The apparatus of claim 2, wherein the second support hoop is slidably disposed on the elongated member.

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

5. The apparatus of claim 4, wherein the biocompatible material comprises a material chosen from a list consisting of polyethylene, polypropylene, polyester, polyurethane and nylon.

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 6, wherein each one of the plurality of pores has a diameter in a range of 20 to 400 microns.

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

9. The apparatus of claim 8, wherein the super-elastic material comprises a nickel-titanium alloy.

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

11. 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.

12. The apparatus of claim 11, wherein the support hoop folds at the articulation region when the apparatus is contracted to the delivery state.

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

14. The apparatus of claim 11, 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.

15. The apparatus of claim 12 wherein opposite sides of the support hoop close towards one another when the apparatus is contracted to its contracted configuration.

16. The apparatus of claim 1, wherein the support hoop comprises a radiopaque band.

17. 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, thrombus removal element, support hoop and blood permeable sac.

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

providing apparatus comprising an elongated member having a distal region, a support hoop having an articulation region coupled to the distal region of the elongated member, a blood permeable sac affixed to the support hoop so that the hoop forms a mouth of the blood permeable sac, and a thrombus removal element disposed proximal to the support hoop;

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 delivery sheath to expand the apparatus to a deployed state wherein the support hoop seals against the vessel wall, and the thrombus removal element is configured to excise or ablate the thrombus.

19. The method of claim 18, 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.

20. The method of claim 18 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.

21. The method of claim 20, wherein the thrombus removal element comprises an additional support hoop and blood permeable sac.

22. The method of claim 21, wherein the additional support hoop is slidably disposed on the elongated member, the method further comprising sliding the additional support hoop proximally to excise thrombus from the vessel by scraping against the vessel wall.