Method and assembly for distal embolic protection

• US 20050119688A1
• Filed: 09/10/2004
• Published: 06/02/2005
• Est. Priority Date: 10/06/2003
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: Bergheim, Bjarne
• Granted Patent: US 7,604,650 B2
• Time in Patent Office: Days
• 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 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• 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 2230/0008 elliptical or oval
• 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

Abstract

Methods and assemblies are described for capturing embolic material in a blood vessel or other body cavity during cardiovascular or valve replacement and repair surgery, wherein access is provided through the apical area of the patient'"'"'s heart. The distal embolic protection assembly generally comprises a sleeve having a lumen, an actuating member having proximal and distal ends, wherein the actuating member is movably disposed within the lumen, and a filter assembly coupled to the distal end of the actuating member. The filter assembly generally comprises a porous bag having an open proximal end, a collapsible and expandable frame that is coupled to the open proximal end of the porous bag, and at least one support spine disposed at least a part of the longitudinal axis of the porous bag. The porous bag is configured such that it permits blood to perfuse freely through while capturing embolic material and other debris.

Claims

1. A distal embolic protection assembly adapted to be introduced through the apex of the heart of a patient, the assembly comprising:

a sleeve having a lumen;

an actuating member having proximal and distal ends, wherein the actuating member is movably disposed within the lumen of the sleeve; and

a filter assembly coupled to the distal end of the actuating member, the filter assembly comprising a porous bag having an open proximal end and a collapsible and expandable frame coupled to the open proximal end;

wherein the actuating member may be pulled in a proximal direction to compress and retract the frame within the lumen of the sleeve and retain the frame in a collapsed state and wherein the actuating member may be pushed in a distal direction out of the lumen to a deployed expanded state.

2. The distal embolic protection assembly of claim 1, wherein the porous bag comprises at least one support spine disposed along at least a part of the longitudinal axis of the porous bag.

3. The distal embolic protection assembly of claim 2, wherein the porous bag comprises a plurality of support spines.

4. The distal embolic protection assembly of claim 1, wherein the collapsible and expandable frame is made of shape memory metal.

5. The distal embolic protection assembly of claim 4, wherein the collapsible and expandable frame is substantially circular and is configured to have a diameter that conforms to or is slightly larger than the diameter of a blood vessel.

6. The distal embolic protection assembly of claim 5, wherein the frame and the actuation member is formed from a single piece of shape memory metal.

7. The distal embolic protection assembly of claim 6, wherein a kink is pre-shaped at the junction of the frame and the distal end of the actuation member so as to urge the frame at an angle from the axis of the actuation member.

8. The distal embolic protection assembly of claim 5, wherein the frame comprises a cloth covering open proximal end of the filter assembly.

9. The distal embolic protection assembly of claim 5, further comprising a one-way valve and at least one support rod disposed on the porous bag to support the one-way valve along a longitudinal axis of the porous bag.

10. The distal embolic protection assembly of claim 4, wherein the expandable and collapsible frame comprises a stent.

11. The distal embolic protection assembly of claim 10, wherein the stent comprising a proximal collapsed end that remains within the lumen, an expanded distal end that is coupled to and supports the open proximal end of the porous bag, and longitudinal arms joining the proximal collapsed end and the expanded distal end, wherein the longitudinal arms are biased to expand radially to a deployed state.

12. The distal embolic protection assembly of claim 11, wherein the proximal collapsed end further comprises a stop latch protruding from and biased in a distal direction and wherein the lumen further comprises a matching groove adapted to mate with the stop latch when the stent is expanded to a deployed condition.

13. The distal embolic protection assembly of claim 12, wherein the frame comprises a cloth covering open proximal end of the filter assembly.

14. The distal embolic protection assembly of claim 12, further comprising a one-way valve and at least one support rod disposed on the porous bag to support the one-way valve along a longitudinal axis of the porous bag.

15. The distal embolic protection assembly of claim 4, wherein the expandable and collapsible frame comprises a plurality of arms, the plurality of arms converging and coupled to the distal end of the actuating member and extending radially outward and coupled to the open proximal end of the porous bag.

16. The distal embolic protection assembly of claim 15, wherein the frame comprises a cloth covering open proximal end of the filter assembly.

17. The distal embolic protection assembly of claim 15, further comprising a one-way valve and at least one support rod disposed on the porous bag to support the one-way valve along a longitudinal axis of the porous bag.

18. The distal embolic protection assembly of claim 1, wherein the collapsible and expandable frame is an inflatable balloon member, wherein the inflatable balloon member is in fluid communication with a saline reservoir through a conduit.

19. The distal embolic protection assembly of claim 18, wherein the inflatable balloon member is substantially donut-shaped in the expanded and deployed state.

20. A method for providing distal embolic protection during cardiovascular surgery, the method comprising:

creating an incision in the at or near the apex of a patient'"'"'s heart;

introducing the sleeve of the distal embolic protection assembly of claim 1, wherein the frame of the filter assembly is collapsed within the lumen of the sleeve;

advancing the sleeve through the apex of the heart and to a target location downstream of an area in which valve repair or replacement surgery is to be performed;

positioning the sleeve at or near the target location; and

deploying the filter assembly by removing the frame from the lumen of the catheter at the target location.

21. The method of claim 20, wherein the incision is created by a inserting a trocar having a diameter of approximately 12 mm through the apex of the heart.

22. The method of claim 21 wherein the sleeve is advanced through the apex of the heart via the trocar, through the left ventricle and across the aortic valve and into the ascending aorta.

23. The method of claim 22 wherein the target location is in the ascending aorta between the aortic valve and the brachiocephalic artery.

24. The method of claim 21 wherein the sleeve is advanced through the apex of the heart via the trocar, through the right ventricle and downstream of the pulmonary valve and before the pulmonary trunk.

25. The method of claim 24 wherein the target location is the area between the pulmonary valve and the pulmonary trunk.