Embolic protection devices
First Claim
1. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:
- a shaft member having distal and proximal ends; and
a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen.
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Accused Products
Abstract
An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. In one embodiment, the filtering assembly is attached to the distal end of a guidewire and is deployed within the patient'"'"'s vasculature as the guidewire is manipulated into the area of treatment. A restraining sheath placed over the filtering assembly in a coaxial arrangement maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Thereafter, the sheath can be retracted to expose the filtering assembly which will then self-expand within the patient'"'"'s vasculature. Interventional devices can be delivered over the guidewire and any embolic debris created during the interventional procedure and released into the blood stream will enter the filtering assembly and be captured therein. Other embodiments include filtering assemblies attached to an outer tubular member and inner shaft member which apply axial force to the distal ends of the assembly to either expand or contract the struts as needed.
192 Citations
100 Claims
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1. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:
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a shaft member having distal and proximal ends; and
a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:
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an inner shaft member having distal and proximal ends;
an outer tubular member having distal and proximal ends coaxially disposed over said inner shaft member; and
a filtering assembly integral with the outer tubular member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position upon application of an axial force, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:
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a shaft member having distal and proximal ends;
a filtering assembly mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of self expanding struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen; and
a dampening element adapted to at least partially absorb vibratory motion which may be transmitted along the shaft member and to at least partially isolate such vibratory motion from acting on the filtering assembly. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39)
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40. An embolic protection system for capturing embolic debris released into a body vessel of a patient, comprising:
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a shaft member having distal and proximal ends;
a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of self expanding struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen; and
a restraining sheath having proximal and distal ends, the restraining sheath being coaxially disposed over the self-expanding struts to maintain the struts in the collapsed position until the filter assembly is to be deployed in the vessel. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48, 49)
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50. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:
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a shaft member having distal and proximal ends; and
a filtering assembly mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position, the filter element comprising a central filter having an inlet opening and defining a storage reservoir for capturing embolic debris, the central filter having a plurality of openings adapted to allow blood to flow therethrough but capture embolic debris larger than the size of the openings and contain the debris within the reservoir, and a proximal cone section integral with the central filter and movable with the struts to the expanded position to contact the wall of the vessel and direct blood and any embolic debris in the blood vessel into the central filter. - View Dependent Claims (51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61)
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62. An expandable strut assembly for moving a filter element between a collapsed and expanded position for capturing embolic debris released into a blood vessel of a patient, comprising:
a segment of tubing having select portions of the tubing removed to form a plurality of expandable struts adapted to move between the collapsed and expanded positions. - View Dependent Claims (63, 64, 65, 66, 67, 68, 69, 70, 71)
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72. A filter element for capturing embolic debris released into the bloodstream of a blood vessel of a patient, comprising:
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a central filter having an inlet opening and defining a storage reservoir for capturing embolic debris, the central filter having a plurality of openings adapted to allow blood to flow therethrough but capture embolic debris larger than the size of the openings and contain the debris within the reservoir; and
a proximal cone section integral with the central filter and an inlet opening, the proximal cone section adapted to move between collapsed and expanded positions, the proximal cone section being adapted to expand to contact the wall of the vessel and direct blood and any embolic debris in the blood vessel into the central filter. - View Dependent Claims (73, 74, 75, 76, 77, 78, 79)
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80. A method of capturing embolic debris released into a blood vessel of a patient during an interventional procedure, in a system comprising an embolic protection device having a shaft member with distal and proximal ends and a filtering assembly rotatably mounted on the shaft member, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly element for capturing embolic debris, the expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position to contact the wall of the vessel to capture embolic debris released into the body lumen, wherein the method comprises of the steps of:
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positioning the filtering assembly while in the collapsed position within the body vessel at a downstream location from the site of the interventional procedure;
expanding the struts of the strut assembly and the filter element to the expanded position to contact the wall of the vessel;
performing the interventional procedure, which may release embolic debris into the blood vessel;
filtering the blood and any embolic debris through the filter element;
collapsing the filter assembly back down to the collapsed position; and
removing the filtering assembly from the blood vessel. - View Dependent Claims (81, 82, 83, 84, 85)
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86. An expandable strut assembly for moving a filter element between a collapsed and expanded position for capturing embolic debris released into a blood vessel of a patient, comprising:
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a first set of struts, each strut having a first and second end;
a second set of struts, each strut having a first and second end; and
a deployment member movable between a collapsed position and an expanded position, wherein each of the first ends of the first and second sets of struts are attached to the deployment member at different locations along the deployment member. - View Dependent Claims (87, 88, 89, 90, 91, 92, 93)
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94. A filter element for capturing embolic debris released into the bloodstream of a blood vessel of a patient, comprising:
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a central region having an inlet opening and defining a storage reservoir for capturing embolic debris, the central region having a plurality of openings adapted to allow blood to flow therethrough but capture embolic debris larger than the size of the openings and contain the debris within the reservoir; and
a filter edge integral with the central region and having an inlet opening, the filter edge having a pattern of alternating peak and valley regions which prevent the filter edge from entering into a restraining sheath all at one time. - View Dependent Claims (95, 96, 97, 98, 99, 100)
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Specification