Method and assembly for distal embolic protection

• US 8,430,902 B2
• Filed: 10/16/2009
• Issued: 04/30/2013
• Est. Priority Date: 10/06/2003
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Inventors: Bergheim, Bjarne
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US12/580,525
• Publication Number:
  US 20100036474A1
• Time in Patent Office: 1,292 Days
• Field of Search: 606/200, 606/113, 606/114, 623 111- 121
• 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 method for providing distal embolic protection during cardiovascular surgery, the method comprising:

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

collapsibly introducing a distal embolic protection assembly into the apex of the heart, the distal embolic protection assembly comprising

a sleeve having a sleeve lumen with a stop latch matching groove;

an actuating member having proximal and distal ends, wherein the actuating member is movably disposed within the sleeve lumen; 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 comprising a stent coupled to the open proximal end of the bag;

wherein the actuating member is configured to 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 is configured to be pushed in a distal direction out of the lumen to a deployed expanded state; and

wherein the stent comprises

a proximal collapsed end that remains within the sleeve lumen;

a stop latch protruding from and biased in a distal direction, the stop latch being adapted to mate with the stop latch matching groove when the stent is expanded to a deployed condition;

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, the longitudinal arms being biased to expand radially to a deployed state;

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 at the target location.

2. The method of claim 1, wherein the incision is created by inserting a trocar having a diameter of approximately 12 mm through the apex of the heart.

3. The method of claim 2, 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.

4. The method of claim 3, wherein the target location for deployment of the distal embolic protection assembly is in the ascending aorta between the aortic valve and the brachiocephalic artery.

5. The method of claim 2, 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.

6. The method of claim 5, wherein the target location for deployment is the area between the pulmonary valve and the pulmonary trunk.

7. The method of claim 1, wherein the porous bag comprises at least one support spine disposed along at least a part of a longitudinal axis of the porous bag.

8. The method of claim 7, wherein the porous bag comprises a plurality of support spines.

9. The method of claim 1, wherein the stent is made of a shape memory metal.

10. The method of claim 1, wherein the collapsible and expandable frame is configured to have a diameter that conforms to or is slightly larger than the diameter of a blood vessel.

11. The method claim 1, wherein the collapsible and expandable frame and the actuating member are formed from a single piece of shape memory metal.

12. The method of claim 11, wherein a kink is pre-shaped at the junction of the frame and the distal end of the actuating member so as to urge the frame at an angle from the axis of the actuating member.

13. The method of claim 11, wherein the frame further comprises a cloth covering the open proximal end of the filter assembly.

14. The method claim 1, wherein the distal embolic protection assembly further comprises 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. A method for providing distal embolic protection during cardiovascular surgery, the method comprising:

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

collapsibly introducing a distal embolic protection assembly into the apex of the heart, the distal embolic protection assembly comprising

an actuating member having proximal and distal ends; 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, a collapsible and expandable frame comprising an inflatable balloon member, the collapsible and expandable frame being coupled to the open proximal end of the bag, the inflatable balloon member being configured to be inflated from a collapsed state to a deployed expanded state;

advancing the distal embolic protection assembly 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; and

deploying the filter assembly by inflating the inflatable balloon member at the target location.

16. The method of claim 15, wherein the inflatable balloon member is substantially donut-shaped in the inflated and deployed state.

17. The method of claim 15, wherein:

the distal embolic protection assembly further comprises a sleeve having a sleeve lumen;

the actuating member is movably disposed within the sleeve lumen; and

deploying the filter assembly further comprises removing the frame from the lumen of the sleeve at the target location.

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

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

collapsibly introducing a distal embolic protection assembly into the apex of the heart, the distal embolic protection assembly comprising

a sleeve having a sleeve lumen;

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

wherein the actuating member is configured to 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 is configured to be pushed in a distal direction out of the lumen to a deployed expanded state;

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 at the target location.

19. The method of claim 18, wherein the expandable and collapsible frame comprises a stent.

20. The method of claim 18, wherein the expandable and collapsible frame is made of a shape memory metal.

21. The method of claim 18, 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.

22. The method of claim 18, 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.