Methods of protecting a patient from embolization during surgery

• US 20030065356A1
• Filed: 11/12/2002
• Published: 04/03/2003
• Est. Priority Date: 05/08/1997
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embol X Inc (Edwards Lifesciences Corporation)
• Inventors: Tsugita, Ross S., Maahs, Tracy D., Jang, Yue-Teh
• Application Number:
  US10/293,533
• Publication Number:
  US 20030065356A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• 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 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

An apparatus suitable for filtering emboli in an open surgical procedure. The apparatus comprises an elongated member having a distal region and a support hoop attached to the distal region. A blood permeable sac is affixed to the support hoop so that the support hoop forms a distally-facing mouth of the blood permeable sac. A guidewire is slideably attached to the elongated member. A delivery sheath is provided having a cavity for accepting the elongated member, support hoop and blood permeable sac, and a lumen extending through the cavity to permit the guidewire to pass therethrough. Methods of use are also described.

Claims

1. An apparatus suitable for filtering emboli in an open surgical procedure, comprising:

an elongated member having a distal region;

a support hoop attached to the distal region; and

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

a guidewire slideably attached to the elongated member; and

a delivery sheath having a cavity for accepting the elongated member, support hoop and blood permeable sac, and a lumen extending through the cavity to permit the guidewire to pass therethrough.

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 3, wherein the blood permeable sac comprises a plurality of pores, each one of the plurality of pores having a diameter in a range of 20 to 400 microns.

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

6. The apparatus of claim 1, wherein the support hoop comprises a wire.

7. The apparatus of claim 1, wherein the elongated member abuts against an interior surface of the cavity so that distal translation of the elongated member is transmitted to the delivery sheath.

8. The apparatus of claim 1, 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 of the elongated member, support hoop, and blood permeable sac within the delivery sheath.

9. The apparatus of claim 8, wherein the support hoop folds when the apparatus is contracted to the delivery state.

10. The apparatus of claim 8, 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.

11. 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.

12. The apparatus of claim 1, wherein the delivery sheath further comprises a radiopaque band.

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

14. A method of trapping emboli or thrombus during an open surgical procedure, the method comprising:

providing apparatus comprising an elongated member, a support hoop coupled to the elongated member, a blood permeable sac affixed to the support hoop so that the support hoop forms a distally-facing mouth of the blood permeable sac, a guidewire slideably attached to the elongated member and having a distal region, and a delivery sheath having a cavity for accepting the elongated member, the support hoop, and the blood permeable sac;

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

positioning the elongated member, support hoop, and blood permeable sac in a contracted delivery state within the delivery sheath;

advancing the elongated member and delivery sheath over the guidewire; and

withdrawing the elongated member with the guidewire held stationary to release the support hoop from the cavity so that the apparatus expands to a deployed state wherein the support hoop seals against the vessel wall.

15. The method of claim 14, further comprising:

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

advancing the elongated member over the guidewire to return the apparatus to a collapsed configuration within the cavity of the delivery sheath; and

removing the apparatus from the patient'"'"'s vessel.

16. The method of claim 14, wherein advancing the elongated member and delivery sheath further comprises advancing the elongated member and delivery sheath to a location within the patient'"'"'s ascending aorta proximal of the aortic valve, so that the apparatus is upstream of the brachiocephalic trunk in the deployed state.

17. The method of claim 14, wherein advancing the elongated member and delivery sheath further comprises advancing the elongated member and delivery sheath against a direction of blood flow through the patient'"'"'s vessel.

18. The method of claim 15, wherein returning the apparatus to a collapsed configuration within the delivery sheath channel comprises folding the support hoop to close the mouth of the blood permeable sac.

19. An apparatus suitable for filtering emboli in an open surgical procedure, 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 distally-facing mouth of the blood permeable sac;

a guidewire slideably attached to the elongated member; and

a delivery sheath having a proximally-facing cavity for accepting the elongated member, the support hoop and the blood permeable sac.

20. The apparatus of claim 19 further comprising a lumen extending through the cavity to permit the guidewire to pass therethrough.

21. A method for open surgery on a patient, comprising the steps of:

introducing a flexible elongate member into a peripheral artery, the flexible elongate member having a filter on a distal region thereof, the filter comprising a support hoop and a mesh carried by the support hoop, the support hoop having a circumference, the support hoop being coupled to the flexible elongate member at a single point on the circumference of the support hoop;

advancing the filter to a site within the aorta upstream of a branch vessel from the aorta;

deploying the filter at the site;

manipulating the aorta by direct access upstream of the site; and

removing the filter from the aorta.

22. The method of claim 21, wherein the site is in the ascending aorta.

23. The method of claim 21, wherein the peripheral artery is a femoral artery.

24. The method of claim 21, wherein the step of manipulating the aorta by direct access further comprises the steps of blocking the aorta upstream of the site and placing the patient on cardiopulmonary bypass.

25. The method of claim 21, wherein the branch vessel is the brachiocephalic trunk.

26. The method of claim 21, wherein the flexible elongate member, support hoop, and filter are carried within an elongate tubular member, and wherein the step of deploying the filter at the site comprises sliding the support hoop and filter outside the elongate tubular member.