Methods and apparatus for distal protection during a medical procedure

• US 6,616,682 B2
• Filed: 09/19/2001
• Issued: 09/09/2003
• Est. Priority Date: 09/19/2001
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Limited (Abbott Laboratories Incorporated)
• Original Assignee: Jomed GmbH
• Inventors: Seibold, Gerd, von Oepen, Randolf, Joergensen, Ib Erling, Michlitsch, Kenneth J., Bremser, Martina, Quint, Bodo Stefan Josef
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/957,482
• Publication Number:
  US 20030055452A1
• Time in Patent Office: 720 Days
• Field of Search: 606/200, 606/114, 606/113, 606/127, 606/159
• US Class Current: 606/200
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Apparatus and methods for providing distal protection during a medical procedure comprising a vascular filter having a self-expanding, porous foam body that conformably seals against a vessel wall and captures emboli within one or more recesses. The filter is coupled to a distal region of an elongated member, such as a guide wire. Delivery systems for use with filters of the present invention and methods of using the apparatus of the present invention also are provided.

Claims

1. Apparatus for distal protection during a medical procedure comprising:

an elongate member having a distal region; and

a vascular filter coupled to the distal region and having a resiliently expandable foam body comprising a substantially annular wall portion having a distal end, an end wall coupled to the distal end, and a plurality of substantially planar partitions extending radially inward from the annular wall portion to the elongate member to define recesses adapted to capture emboli.

2. The apparatus of claim 1, wherein the elongated member comprises a guide wire.

3. The apparatus of claim 1, wherein the foam comprises a sponge-like material having a multiplicity of pores.

4. The apparatus of claim 3, wherein the multiplicity of pores have a diameter greater than about 5 mm.

5. The apparatus of claim 4, wherein the pores have a diameter between 30 and 100 mm.

6. The apparatus of claim 5, wherein the pores have a diameter between 60 and 80 mm.

7. The apparatus of claim 1, wherein the foam comprises a foam fabricated from a material chosen from the group consisting of latex, silicone, polyethylene, polyurethane, polycarbonate, polyvinyl chloride, polystyrene, polypropylene, polyester, and combinations thereof.

8. The apparatus of claim 1, wherein the vascular filter has a length that is greater than or equal to 1½

times a maximum width of the filter.

9. The apparatus of claim 8, wherein the length of the vascular filter is greater than or equal to 2 times the maximum width of the filter.

10. The apparatus of claim 1, wherein the partitions taper proximal of the recesses.

11. The apparatus of claim 1, wherein the filter is longitudinally, but not rotationally, constrained with respect to the elongated member.

12. The apparatus of claim 1, wherein the filter is resiliently expandable from a collapsed delivery configuration adapted for use with a delivery system, to an expanded deployed configuration adapted for engagement with the interior wall of a patient'"'"'s vessel.

13. The apparatus of claim 12 further comprising a delivery system having a delivery sheath, the filter disposed in a collapsed delivery configuration within the delivery sheath.

14. The apparatus of claim 12 further comprising a delivery system having a removable suture, the suture disposed about the filter to maintain the filter in the delivery configuration.

15. The apparatus of claim 12, wherein a proximal end of the one or more recesses is closed when the filter is in the collapsed configuration, thereby preventing emboli captured within the recesses from escaping.

16. The apparatus of claim 1 further comprising a radiopaque feature coupled to the apparatus.

17. The apparatus of claim 1 further comprising an interventional device in communication with the apparatus.

18. The apparatus of claim 17 wherein the interventional device comprises a balloon catheter.

19. The apparatus of claim 1, wherein the filter further comprises a non-stick coating.

20. The apparatus of claim 19, wherein the non-stick coating is chosen from the group consisting of silicone and polytetrafluoroethylene.

21. A method for distal protection during a medical procedure, the method comprising:

providing apparatus comprising an elongate member having a distal region and a resiliently expandable foam body having a substantially annular wall portion with a distal end, an end wall coupled to the distal end, and a plurality of substantially planar partitions extending radially inward from the annular wall portion to the elongate member to define recesses adapted for capturing emboli;

disposing the apparatus in a contracted delivery configuration;

advancing the apparatus to a target site within a patient'"'"'s vessel; and

resiliently expanding the apparatus to an expanded deployed configuration in which the annular wall portion seals against an internal wall of the patient'"'"'s vessel.

22. The method of claim 21, wherein disposing the apparatus in the contracted delivery configuration further comprises constraining the apparatus with a delivery system.

23. The method of claim 22, wherein constraining the apparatus with a delivery system further comprises positioning the apparatus within a delivery sheath.

24. The method of claim 22, wherein constraining the apparatus with a delivery system comprises constraining the apparatus with a removable suture.

25. The method of claim 22 wherein expanding the filter further comprises removing delivery system constraint from the apparatus.

26. The method of claim 21 further comprising:

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

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

performing the medical procedure, the apparatus capturing emboli released during the procedure within the recesses of the vascular filter;

collapsing the apparatus within the guide wire lumen of the interventional device for retrieval; and

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

27. The method of claim 26, wherein the interventional device comprises a balloon catheter.