Method and assembly for distal embolic protection
First Claim
1. An embolic protection assembly for introduction into a blood vessel, the assembly comprising:
- a sleeve having a lumen with a groove;
an actuator having proximal and distal ends, wherein the actuator is movably disposed;
a filter assembly coupled to the actuator, the filter assembly comprising;
a porous bag having an open proximal end;
a collapsible and expandable frame made of a shape memory alloy coupled to the open proximal end of the bag;
the frame comprising a proximal end, a distal end, and a projection protruding in a radial direction;
the distal end of the frame being coupled to and supporting the open proximal end of the porous bag; and
longitudinal arms joining the proximal end of the frame and the distal end of the frame, the longitudinal arms being biased to expand radially;
wherein the actuator is configured to be moved in a first direction to compress and retract the frame within the lumen of the sleeve,wherein the actuator is configured to be moved in a second direction to expand the distal end of the frame to an expanded state,wherein the sleeve and filter assembly are configured such that the proximal end of the frame remains within the lumen when the distal end of the frame is expanded at the expanded state, andwherein the projection is adapted to mate with the groove when the frame is expanded at the expanded state.
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Accused Products
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.
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Citations
19 Claims
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1. An embolic protection assembly for introduction into a blood vessel, the assembly comprising:
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a sleeve having a lumen with a groove; an actuator having proximal and distal ends, wherein the actuator is movably disposed; a filter assembly coupled to the actuator, the filter assembly comprising; a porous bag having an open proximal end; a collapsible and expandable frame made of a shape memory alloy coupled to the open proximal end of the bag; the frame comprising a proximal end, a distal end, and a projection protruding in a radial direction; the distal end of the frame being coupled to and supporting the open proximal end of the porous bag; and longitudinal arms joining the proximal end of the frame and the distal end of the frame, the longitudinal arms being biased to expand radially; wherein the actuator is configured to be moved in a first direction to compress and retract the frame within the lumen of the sleeve, wherein the actuator is configured to be moved in a second direction to expand the distal end of the frame to an expanded state, wherein the sleeve and filter assembly are configured such that the proximal end of the frame remains within the lumen when the distal end of the frame is expanded at the expanded state, and wherein the projection is adapted to mate with the groove when the frame is expanded at the expanded state. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for providing embolic protection during cardiovascular surgery, the method comprising:
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collapsibly introducing an embolic protection assembly through an apex of a patient'"'"'s heart, the embolic protection assembly comprising; a sleeve having a lumen with a groove; an actuator having proximal and distal ends, wherein the actuator is movably disposed; and a filter assembly coupled to the actuator, the filter assembly comprising; a porous bag having an open proximal end; a frame coupled to the open proximal end of the bag, the frame comprising a proximal end, a distal end, and a projection protruding in a radial direction, the distal end being coupled to and supporting the open proximal end of the porous bag; and longitudinal arms joining the proximal end and the distal end, the longitudinal arms being biased to expand radially; wherein collapsibly introducing the embolic protection assembly into the apex of the heart comprises; actuating the actuator to compress and retract the frame of the embolic protection assembly within the lumen of the sleeve and retain the frame in a collapsed state; and advancing the sleeve through the apex of the heart; advancing the sleeve to a target location downstream of an area in which valve repair or replacement surgery is to be performed; actuating the actuator such that the distal end of the frame expands to a deployed state at the target location and the projection mates with the groove while the proximal end of the frame remains within the lumen. - View Dependent Claims (9, 10, 11, 12, 13)
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14. A method for providing embolic protection during cardiovascular surgery, the method comprising:
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collapsibly introducing an embolic protection assembly through an apex of a patient'"'"'s heart, the embolic protection assembly comprising; a sleeve having a sleeve lumen with a channel; an actuating member having proximal and distal ends, wherein the actuating member is movably disposed within the sleeve; and a filter assembly coupled to 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 moved in a first direction to compress and retract the frame within the sleeve lumen and retain the frame in a collapsed state therein; and wherein the actuating member is configured to be moved in a second direction to expand the frame to a deployed condition; wherein the frame comprises; a proximal collapsed end that remains within the sleeve lumen when the frame is deployed; a projection extending in a distal direction, the projection being adapted to contact the channel of the sleeve when the frame is expanded to the deployed condition; 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 sleeve lumen at the target location. - View Dependent Claims (15, 16, 17, 18, 19)
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Specification