Method of protecting a patient from embolization during cardiac surgery

• US 6,042,598 A
• Filed: 04/05/1999
• Issued: 03/28/2000
• Est. Priority Date: 05/08/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embolx, Inc.
• Inventors: Tsugita, Ross S., Maahs, Tracy D., Jang, Yue-Teh
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/286,195
• Time in Patent Office: 358 Days
• Field of Search: 606/200, 606/191, 606/159, 606/198, 128/898
• 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 and method for treating stenosed blood vessels is provided, more particularly a percutaneous catheter, including a filter for capturing loose embolic material, used to deliver a stent, preferably within the ascending aorta, the aortic arch, or the carotid arteries. The catheter includes an expandable stent deployed on an inflatable balloon, or alternatively a self-expanding stent. A filter assembly is provided either directly on the catheter, or in a separate sheath or on a guidewire. The filter assembly comprises an expansion frame, having filter mesh attached to it, disposed on a guidewire inserted through the catheter or sheath, or alternatively attached directly on a distal region of the catheter. The expansion frame comprises a structure which is activated from a contracted condition into an enlarged condition in a blood vessel, thereby traversing the vessel with the filter mesh. The expansion frame includes biased struts, a mechanically operated frame, and/or a fluid-operated frame. The catheter is percutaneously introduced into a blood vessel and directed to a target region. The stent is localized across the region, the filter assembly is opened, and the stent is deployed, substantially permanently engaging the walls of the blood vessel, thereby opening the stenosed region and/or containing aortic plaque.

Claims

1. A method of protecting a patient from embolization during cardiac surgery, comprising the steps of:

providing a blood filter device having a filter disposed on a distal region of an elongate member, the filter adapted to operate at a site within the aorta of the patient and to be removed thereafter;

introducing the blood filter device into the femoral artery and advancing the distal region of the elongate member to the site within the aorta upstream of the innominate artery;

deploying the filter at the site within the aorta;

manipulating the aorta in a region upstream of the site within the aorta; and

removing the blood filter device from the aorta,

wherein embolic material is generated and filtered before the blood filter device is removed from the aorta.

2. The method of claim 1, further comprising the steps of introducing a blood bypass cannula into the aorta.

3. The method of claim 2, wherein the cannula is introduced downstream of the site where the filter is deployed.

4. The method of claim 1, wherein the step of manipulating the aorta comprises blocking the aorta.

5. The method of claim 4, wherein the step of blocking the aorta includes cross-clamping the aorta.

6. The method of claim 1, wherein the step of manipulating the aorta comprises unblocking the aorta while the blood filter device is deployed within the aorta.

7. The method of claim 1, wherein said elongate member is a catheter.

8. The method of claim 1, wherein said elongate member is a guidewire.

9. A method of protecting a patient from embolization during cardiac surgery, comprising the steps of:

providing a blood filter device having a filter disposed on a distal region of an elongate member, the filter adapted to operate at a site within the aorta of the patient and to be removed thereafter;

introducing the blood filter device into the left subclavian artery and advancing the distal region of the elongate member to the site within the aorta upstream of the innominate artery;

deploying the filter at the site within the aorta;

manipulating the aorta in a region upstream of the site within the aorta; and

removing the blood filter device from the aorta,

wherein embolic material is generated and filtered before the blood filter device is removed from the aorta.

10. The method of claim 9, further comprising the steps of introducing a blood bypass cannula into the aorta.

11. The method of claim 10, wherein the cannula is introduced downstream of the site where the filter is deployed.

12. The method of claim 9, wherein the step of manipulating the aorta comprises blocking the aorta.

13. The method of claim 12, wherein the step of blocking the aorta includes cross-clamping the aorta.

14. The method of claim 9, wherein the step of manipulating the aorta comprises unblocking the aorta while the blood filter device is deployed within the aorta.

15. The method of claim 9, wherein said elongate member is a catheter.

16. The method of claim 9, wherein said elongate member is a guidewire.

17. A method of protecting a patient from embolization during cardiac surgery, comprising the steps of:

providing a blood filter device having a filter disposed on a distal region of an elongate member, the filter adapted to operate at a site within the aorta of the patient and to be removed thereafter;

introducing the blood filter device into the right subclavian artery and advancing the distal region of the elongate member to the site within the aorta upstream of the innominate artery;

deploying the filter at the site within the aorta;

manipulating the aorta in a region upstream of the site within the aorta; and

removing the blood filter device from the aorta,

wherein embolic material is generated and filtered before the blood filter device is removed from the aorta.

18. The method of claim 17, further comprising the steps of introducing a blood bypass cannula into the aorta.

19. The method of claim 18, wherein the cannula is introduced downstream of the site where the filter is deployed.

20. The method of claim 17, wherein the step of manipulating the aorta comprises blocking the aorta.

21. The method of claim 20, wherein the step of blocking the aorta includes cross-clamping the aorta.

22. The method of claim 17, wherein the step of manipulating the aorta includes unblocking the aorta while the blood filter device is deployed within the aorta.

23. The method of claim 17, wherein said elongate member is a catheter.

24. The method of claim 17, wherein said elongate member is a guidewire.

25. The catheter of claim 17, wherein the expansion frame is activated by inflating an annular balloon at the base of the struts.