Aortic occluder with associated filter and methods of use during cardiac surgery

• US 7,306,575 B2
• Filed: 07/14/2003
• Issued: 12/11/2007
• Est. Priority Date: 05/14/1996
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Barbut, Denise, Root, Jonathan D., Pastrone, Giovanni, Maahs, Tracy D., Tsugita, Ross S.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US10/619,760
• Publication Number:
  US 20040158276A1
• Time in Patent Office: 1,611 Days
• Field of Search: 604/104, 604/508, 604/509, 604/164.01
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2/013 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 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/127 Aorta

Abstract

A balloon arterial cannula and methods for filtering blood. The devices generally include a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Claims

1. A method for removing embolic material during an open surgical procedure, comprising the steps of:

making an incision in an aorta;

introducing a distal end of a cannula into the aorta through the incision, wherein the cannula has an outer surface, a distal end adapted to enter an artery, a proximal end, a filter disposed about the distal end of the cannula which is expandable and contractable between a contracted condition and an enlarged condition, and an occluder which is expandable and contractable between a contracted condition and an expanded condition, and wherein the filter is in the contracted condition;

expanding the filter;

expanding the occluder to occlude the aorta in a region upstream of the filter, and thereafter contracting the occluder;

contracting the filter with embolic material from the aorta captured therein; and

removing the cannula and the captured embolic material from the aorta.

2. The method of claim 1, wherein th proximal end of the cannula is adapted to receive blood from a bypass-oxygenator machine.

3. The method of claim 2, wherein the step of expanding the occluder is followed by the steps of:

supplying blood to the aorta from the bypass-oxygenator machine by way of the cannula; and

performing a surgical procedure on at least one of the heart, the aorta upstream of the occluder, and vasculature associated with the heart and/or aorta.

4. The method of claim 1, wherein the pressurizing cannula further includes an inflation system comprising a first lumen adapted to receive pressurized fluid and a second lumen adapted to evacuate gas, and wherein the inflation seal further includes an entry port in fluid communication with the first lumen of the pressurizing cannula and an exit port in fluid communication with the second lumen of the pressurizing cannula, so that when fluid is advanced through the first lumen, the fluid enters the inflation seal and forces gas from the inflation seal through the second lumen, thereby purging the system of gas.

5. The method of claim 1, wherein the cannula further comprises a handle slideably disposed about the cannula and enclosing the filter and occluder when the filter and the occluder are in the contracted condition, and wherein the method of further comprises the step of moving the handle in a proximal direction to release the filter and occluder and allow same to be activated to an expanded condition.

6. The method of claim 1, wherein the occluder is disposed circumferentially about the cannula.

7. The method of claim 1, wherein the occluder is disposed at a radial position along the side of the cannula.

8. A method for removing embolic material during an open surgical procedure, comprising the steps of:

providing a blood cannula having a distal end and comprising disposed a filter disposed about the distal end and including an inflation seal that is controllaby inflatable and deflatable to change the filter between a contracted condition and an expanded condition the cannula further comprising an occluder configured to be controllable inflatable and deflatable to change the occluder between a contracted condition and an expanded condition;

introducing the distal end of the blood cannula into the aorta through an incision with the inflation seal and the occluder in their respective contracted conditions,

inflating the inflation seal to change the filter to its enlarged condition;

inflating the occluder to change the occluder to its expanded condition so as to occlude the aorta in a region upstream of the filter;

deflating the occluder to change the occluder to its contracted condition;

deflating the inflation seal of the filter so as to change the filter to its contracted condition with embolic material from the aorta captured therein; and

removing the blood cannula and the captured embolic material from the aorta.

9. The method of claim 8, wherein the blood cannula includes pressurizing cannula, and wherein the inflation seal and the occluder are inflatable and deflatable through the pressurizing cannula.

10. The method of claim 8, wherein the occluder is disposed circumferentially about the blood cannula.

11. The method of claim 8, wherein the occluder is disposed at a radial position along the side of the blood cannula.

12. A method for removing embolic material during an open surgical procedure, comprising the steps of:

making an incision in an aorta;

introducing a distal end of a cannula into the aorta through the incision, wherein the cannula has an outer surface, a distal end adapted to enter an artery, a proximal end a filter disposed about the distal end of the cannula which is expandable and contractable between a contracted condition and an enlarged condition, and an occluder disposed circumferentially about the cannula and that is expandable and contractable between a contracted condition and an expanded condition, and wherein the filter is in the contracted condition;

expanding the filter to its enlarged condition;

expanding the occluder to its expanded condition so as to occlude th aorta in a region upstream of the filter, and thereafter contracting the occluder to its contracted position;

contracting the filter to its contracted position with embolic material from the aorta

captured therein; and

removing the cannula and the captured embolic material from the aorta.

13. The method of claim 12, wherein the filter and the occluder are expandable and contractable by inflation and deflation through a pressurizing cannula carried on the cannula.

14. A method for removing embolic material during an open surgical procedure comprising the steps of:

making an incision in an aorta;

introducing a distal end of a cannula into the aorta through the incision, wherein the cannula has an outer surface, a distal end adapted to enter an artery, a proximal end, a filter disposed about the distal end of the cannula which is expandable and contractable between a contracted condition and an enlarged condition, and an occluder disposed radially along the side of the cannula and that is expandable and contractable between a contracted condition and an expanded condition, and wherein the filter is in the contracted condition;

expanding the filter to its enlarged condition;

expanding the occluder to its expanded condition so as to occlude the aorta in a region upstream of the filter, and thereafter contracting the occluder;

contracting the filter to its contracted condition with embolic material from the aorta

captured therein; and

removing the cannula and the captured embolic material from the aorta.

15. The method of claim 14, wherein the filter and the occluder are expandable and contractable by inflation and deflation through a pressurizing cannula carried on the cannula.