Rapid exchange vascular device for emboli and thrombus removal and methods of use

• US 6,616,679 B1
• Filed: 07/07/2000
• Issued: 09/09/2003
• Est. Priority Date: 07/30/1999
• Status: Expired due to Term

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Khosravi, Farhad, Renati, Richard
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): PHANIJPHAND, GWEN G
• Application Number:
  US09/611,428
• Time in Patent Office: 1,159 Days
• Field of Search: 606/200, 606/159, 606/151, 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 2/013 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, and a delivery sheath that permits the vascular device to be deployed in a “rapid exchange” mode. 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 rapid delivery for filtering emboli or performing thrombectomy or embolectomy comprising:

an elongated member having a distal region;

a support hoop attached to the distal region;

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

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

a delivery sheath having an exterior surface, a distal end, a first lumen for accepting the elongated member, support hoop and blood permeable sac; and

a guide wire in communication with the delivery sheath.

2. The apparatus of claim 1, wherein the delivery sheath further comprises a second lumen for accepting the guide wire.

3. The apparatus of claim 2, wherein the second lumen opens to the exterior surface through a skive disposed proximally of the distal end.

4. The apparatus of claim 3, wherein the first lumen opens to the exterior surface through a skive disposed proximally of the distal end.

5. The apparatus of claim 2, wherein the delivery sheath further comprises a guide tube attached to the exterior surface proximal of the distal end, the guide tube having a portion defining the second lumen.

6. The apparatus of claim 1, wherein a distal end of the guide wire is attached to a proximal end of the delivery sheath.

7. The apparatus of claim 1, wherein the support hoop further comprises at least one articulation region.

8. The apparatus of claim 1, wherein the blood permeable sac comprises a biocompatible material chosen from a group consisting of polyethylene, polypropylene, polyester, polyurethane and nylon.

9. The apparatus of claim 1, wherein the blood permeable sac comprises a plurality of pores, and each one of the plurality of pores has a diameter in a range of 20 to 400 microns.

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

11. The apparatus of claim 7, wherein the support hoop comprises a wire having a thickness that tapers to a minimum thickness at the articulation region.

12. The apparatus of claim 7, 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.

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

14. The apparatus of claim 12, wherein the mouth of the blood permeable sac closes when the apparatus is contracted to the delivery state.

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

providing apparatus comprising an elongated member, a support hoop directly connected to the elongated member, and a blood permeable sac affixed to the support hoop so that the support hoop forms a mouth of the blood permeable sac;

providing a delivery sheath having a distal endface, an exterior surface, a first lumen, and a second lumen;

positioning the apparatus in a contracted delivery state within the first lumen;

providing a guide wire having proximal and distal ends;

advancing a distal end of the guide wire to a desired position in a patient'"'"'s vessel;

loading the delivery sheath on the proximal end of the guide wire via the second lumen;

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

withdrawing the guide wire from the 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.

16. The method of claim 15 further comprising withdrawing the delivery sheath from the patient'"'"'s vessel.

17. The method of claim 16 further comprising:

providing an interventional device having 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;

performing a medical procedure, the apparatus catching emboli released while the medical procedure is being performed;

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

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

18. The method of claim 17, wherein the support hoop of the apparatus includes an articulation region, and retracting the apparatus within the guide wire lumen comprises folding the support hoop at the articulation region to close the mouth of the blood permeable sac.

19. The method of claim 15, wherein providing a delivery sheath having a second lumen further comprises the second lumen extending between an opening in the distal endface and a skive disposed proximally of the distal endface.

20. The method of claim 19, wherein providing a delivery sheath having a first lumen further comprises the first lumen extending between an opening in the distal endface and a skive disposed proximally of the distal endface.

21. The method of claim 15, wherein the delivery sheath further comprises a guide tube attached to the exterior surface proximally of the distal endface, the second lumen passing through the guide tube.

22. The method of claim 15 further comprising:

performing a medical procedure, the apparatus catching emboli released while the medical procedure is being performed;

retracting the apparatus into a collapsed configuration within the first lumen of the delivery sheath; and

removing the delivery sheath and apparatus from the patient'"'"'s vessel.

23. The method of claim 22, wherein the support hoop of the apparatus includes an articulation region, and retracting the apparatus within the first lumen comprises folding the support hoop at the articulation region to close the mouth of the blood permeable sac.

24. The method of claim 15 further comprising:

retracting the apparatus to scrape the support hoop against the vessel wall and excise thrombus; and

capturing the thrombus in the blood permeable sac.

25. The method of claim 24 further comprising:

retracting the apparatus into a collapsed configuration within the first lumen of the delivery sheath; and

removing the delivery sheath and apparatus from the patient'"'"'s vessel.

26. The method of claim 25, wherein the support hoop of the apparatus includes an articulation region, and retracting the apparatus within the first lumen comprises folding the support hoop at the articulation region to close the mouth of the blood permeable sac.

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

providing apparatus comprising an elongated member, a support hoop coupled to the elongated member, and a blood permeable sac affixed to the support hoop so that the support hoop forms a mouth of the blood permeable sac;

providing a delivery sheath having a distal endface, an exterior surface, a lumen, and a proximal end;

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

providing a guide wire having a distal end, the distal end of the guide wire attached to the proximal end of the delivery sheath;

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

withdrawing the delivery sheath, via the guide wire, to expand the apparatus to a deployed state wherein the support hoop seals against the vessel wall.

28. The method of claim 27 further comprising withdrawing the delivery sheath and attached guide wire from the patient'"'"'s vessel.

29. The method of claim 28 further comprising:

providing an interventional device having 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;

performing a medical procedure, the apparatus catching emboli released while the medical procedure is being performed;

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

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

30. The method of claim 29, wherein the support hoop of the apparatus includes an articulation region, and retracting the apparatus within the guide wire lumen comprises folding the support hoop at the articulation region to close the mouth of the blood permeable sac.

31. The method of claim 27 further comprising:

performing a medical procedure, the apparatus catching emboli released while the medical procedure is being performed;

retracting the apparatus into a collapsed configuration within the lumen of the delivery sheath; and

removing the delivery sheath and apparatus from the patient'"'"'s vessel.

32. The method of claim 31, wherein the support hoop of the apparatus includes an articulation region, and retracting the apparatus within the lumen comprises folding the support hoop at the articulation region to close the mouth of the blood permeable sac.

33. The method of claim 27 further comprising:

retracting the apparatus to scrape the support hoop against the vessel wall and excise thrombus; and

capturing the thrombus in the blood permeable sac.

34. The method of claim 33 further comprising:

retracting the apparatus into a collapsed configuration within the lumen of the delivery sheath; and

removing the delivery sheath and apparatus from the patient'"'"'s vessel.

35. The method of claim 34, wherein the support hoop of the appartatus includes an articulation region, and retracting the apparatus within the lumen comprises folding the support hoop at the articulation region to close the mouth of the blood permeable sac.