Abstract: An expandable frame for an embolic filtering device used to capture embolic debris in a body vessel includes a first half frame having a first control arm connected to a second control arm by a partial loop and a second half frame having a first control arm connected to a second control arm by a partial loop. The partial loops cooperatively form a composite loop for attachment of a filtering element which will expand in the body vessel to capture embolic debris entrained in the fluid of the vessel. The lengths and positioning of the first and second control arms of each half frame can be varied to create an expandable frame which conforms to the size and shape of the body vessel in which the filtering device is deployed. Additionally, the radius of the partial loops, along with the length of the arc of the partial loops, can be varied on each of the frames to create a composite filtering assembly that can easily adapt to the size and shape of the body vessel.

Abstract: A self-expanding cage for use in conjunction with an embolic filtering device includes one or more circumferential members adapted to expand from an unexpanded position to a expanded position within the patient's body vessel. At least one proximal strut and at least one distal strut are attached to the circumferential member to form the basket. The circumferential member may include a plurality of bending regions which enhance the ability of the circumferential member to move between the unexpanded and expanded positions. The proximal and distal struts can be attached to one of the bending regions. When two or more circumferential members are utilized, each member may be connected by a connecting strut which may be connected at a bending region. The connecting strut can be a straight segment or may have a non-linear shape to provide additional flexibility. The expandable cage can be mounted to a elongated member, such as a guide wire, and can be either permanently mounted or rotatably mounted thereto.

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 guide wire and is deployed within the patient's vasculature as the guide wire 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.

Abstract: A system for enabling the insertion and removal of an embolic protection device, for capturing and retaining embolic debris which may be created during the performance of a therapeutic interventional procedure in a stenosed or occluded region of a blood vessel. The system, in an embodiment thereof, is capable of enabling at least one operator to control the delivery and removal of an embolic protection device to a position in a patient's vasculature distal to an interventional procedure site, to enable the exchange of the delivery and recovery system. The system, in another embodiment thereof, includes a delivery system and a recovery system which are capable of enabling the delivery and recovery of an embolic protection device so as to maintain a clinically acceptable profile and flexibility through the patient's vasculature.

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 guide wire and is deployed within the patient's vasculature as the guide wire 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.

Abstract: Nickel-titanium alloys that have been deep drawn in a cold working process have linear pseudoelastic behavior without a phase transformation or onset of stress-induced martensite. A medical device made from a structural element which has been deep drawn and subsequently formed into a desired medical device geometry will experience such linear pseudoelastic behavior.

Abstract: An expandable frame for an embolic filtering device used to capture embolic debris in a body vessel includes a first half frame having a first control arm connected to a second control arm by a partial loop and a second half frame having a first control arm connected to a second control arm by a partial loop. The partial loops cooperatively form a composite loop for attachment of a filtering element which will expand in the body vessel to capture embolic debris entrained in the fluid of the vessel. The expandable frame and filtering element can be mounted on a filter support structure, such as a coiled wire, and mounted on a guide wire. The expandable frames includes an articulation region which helps to distribute the strain which can be developed when the frame moves between an expanded and deployed position. The expandable frame may include further strain distributing bends which help distribute strain and increase the bendability of the frame.

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.

Abstract: An embolic protection device that employs a superelastic alloy self-expanding strut assembly with a small profile delivery system for use with interventional procedures is disclosed. The expandable strut assembly is covered with a filter element and both are compressed into a restraining sheath for delivery to a deployment site downstream and distal to the interventional procedure. Once at the desired site, the restraining sheath is retracted to deploy the embolic protection device, which captures flowing emboli generated during the interventional procedure. The expandable strut assembly is made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element in order to minimize the stress hysteresis of the superelastic material. The stress hysteresis is defined by the difference between the loading plateau stress and the unloading plateau stress of the superelastic material. The resulting delivery system including the restraining sheath has a small profile and has a thin wall.

Abstract: A separate deliverable embolic protection device filter that attaches to a helical coil at a distal end of a conventional guide, for use in a blood vessel when an interventional procedure is being performed to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filter assembly with a proximal end and a distal end, and a guide wire connector attached to the distal end of the filter assembly. The guide wire connector is able to couple with the helical coil of the guide wire. A restraining sheath placed over the filter assembly in a coaxial arrangement maintains the filter assembly in a collapsed position and delivers the filter assembly separately to the helical coil of the guide wire, and then the guide wire connector is joined to the helical coil. Alternatively, the guide wire can include a rotatable coil section forming a portion of the distal tip coil on the guide wire which is adapted to be coupled to the filter assembly.

Abstract: An expandable frame for an embolic filtering device used to capture embolic debris in a body vessel includes a first half frame having a first control arm connected to a second control arm by a partial loop and a second half frame having a first control arm connected to a second control arm by a partial loop. The partial loops cooperatively form a composite loop for attachment of a filtering element which will expand in the body vessel to capture embolic debris entrained in the fluid of the vessel. The lengths and positioning of the first and second control arms of each half frame can be varied to create an expandable frame which conforms to the size and shape of the body vessel in which the filtering device is deployed. Additionally, the radius of the partial loops, along with the length of the arc of the partial loops, can be varied on each of the frames to create a composite filtering assembly that can easily adapt to the size and shape of the body vessel.

Abstract: An embolic protection device that employs a superelastic alloy self-expanding strut assembly with a small profile delivery system for use with interventional procedures is disclosed. The expandable strut assembly is covered with a filter element and both are compressed into a restraining sheath for delivery to a deployment site downstream and distal to the interventional procedure. Once at the desired site, the restraining sheath is retracted to deploy the embolic protection device, which captures flowing emboli generated during the interventional procedure. The expandable strut assembly is made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element in order to minimize the stress hysteresis of the superelastic material. The stress hysteresis is defined by the difference between the loading plateau stress and the unloading plateau stress of the superelastic material. The resulting delivery system including the restraining sheath has a small profile and has a thin wall.

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 guide wire and is deployed within the patient's vasculature as the guide wire 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.

Abstract: An embolic protection device includes a filtering assembly having a self-expanding strut assembly and a filter element. The filtering assembly can be attached to a guidewire and deployed within the patient's vasculature into an area of treatment. A restraining sheath maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Interventional devices can be delivered over the guidewire and any embolic debris created and released into the blood stream will enter the filtering assembly. The filtering assembly can be rotatably mounted on the guide wire and may include a dampening element which helps to prevent some shock force that may be transmitted along the guide to the deployed filtering assembly.

Abstract: Nickel-titanium alloys that have been deep drawn in a cold working process have linear pseudoelastic behavior without a phase transformation or onset of stress-induced martensite. A medical device made from a structural element which has been deep drawn and subsequently formed into a desired medical device geometry will experience such linear pseudoelastic behavior.

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 guide wire and is deployed within the patient's vasculature as the guide wire 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.

Abstract: A system used 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 system includes an emboli-capturing filter which is capable of occluding a blood vessel distal to an interventional procedure site, passing the blood to enable blood to flow past the occlusion, and filtering the blood to capture and retain embolic material which may be released into the blood during a therapeutic interventional procedure. The emboli-capturing filter includes an expandable member which is capable of projecting from a guiding catheter so as to be deployed distal to the interventional procedure site to filter the blood. The expandable member is also capable of being retracted into the guiding catheter to capture and retain any released embolic material.

Abstract: A delivery system for an expandable filter device includes a dual lumen delivery sheath which has a lumen for receiving the expandable filter device and a lumen for receiving a primary guide wire. The primary guide wire is utilized to place the delivery sheath and expandable filter into the desired region of the patient's vasculature via an over-the-wire or rapid-exchange arrangement. The delivery sheath can be protracted over the expandable filter device to allow the filter to be deployed within the patient's vasculature at the desired location. The delivery system can be embodied in an alternative design in which the primary guide wire extends through a guide wire lumen located in an obturator which forms part of the expandable filter device. Again, the primary guide wire is utilized to maneuver the filter device into the desired area via an over-the-wire arrangement.

Abstract: A self-expanding cage for use in conjunction with an embolic filtering device includes a circumferential member adapted to expand from an unexpanded position to a expanded position within the patient's body vessel. A proximal strut and distal strut are attached to the circumferential member to form the cage. A plurality of proximal and distal struts may be attached the circumferential member. Additionally, a second circumferential member can be attached to the first circumferential member. Each circumferential member can be connected by a single or a plurality of connecting struts. One embodiment of the cage utilizes a single wire to form to the cage. A delivery system attached to the single wire cage moves the cage and its associated filter element between the expanded and unexpanded positions through relative movement of the distal delivery system.

Abstract: A self-expanding cage for use in conjunction with an embolic filtering device includes one or more circumferential members adapted to expand from an unexpanded position to a expanded position within the patient's body vessel. At least one proximal strut and at least one distal strut are attached to the circumferential member to form the basket. The circumferential member may include a plurality of bending regions which enhance the ability of the circumferential member to move between the unexpanded and expanded positions. The proximal and distal struts can be attached to one of the bending regions. When two or more circumferential members are utilized, each member may be connected by a connecting strut which may be connected at a bending region. The connecting strut can be a straight segment or may have a non-linear shape to provide additional flexibility. The expandable cage can be mounted to a elongated member, such as a guide wire, and can be either permanently mounted or rotatably mounted thereto.