Method and assembly for distal embolic protection

• US 7,604,650 B2
• Filed: 09/10/2004
• Issued: 10/20/2009
• 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
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Lang; Amy T
• Application Number:
  US10/938,410
• Publication Number:
  US 20050119688A1
• Time in Patent Office: 1,866 Days
• Field of Search: 606/200, 606/113, 606/114, 623 11- 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 distal embolic protection assembly structured for introduction into a blood vessel, the 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, a collapsible and expandable frame comprising a stent made of a shape memory alloy coupled to the open proximal end of the bag;

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; and

further 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 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.

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 substantially circular and is configured to have a diameter that conforms to or is slightly larger than the diameter of a blood vessel.

5. The distal embolic protection assembly of claim 4, wherein the frame and the actuating member is formed from a single piece of shape memory metal.

6. The distal embolic protection assembly of claim 5, 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.

7. The distal embolic protection assembly of claim 1, wherein the frame includes a cloth covering the open proximal end of the filter assembly.

8. The distal embolic protection assembly of claim 1, 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.