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: A deployment control system provides controlled deployment of an embolic protection device which may include a guide wire, an expandable filter attached to the guide wire near its distal end, and a restraining sheath that maintains the expanded filter in a collapsed position. The deployment control system includes a torque control device which allows the physician to torque the guide wire into the patient's anatomy and a mechanism for preventing the guide wire from buckling as the restraining sheath is being retracted to deploy the expandable filter. A recovery control system for recovering the embolic protection device includes an inner catheter which extends within a lumen of an outer recovery sheath in a coaxial arrangement. A distal portion of the inner catheter extends beyond another recovery sheath during advancement of the recovery system into the vasculature. The recovery sheath can be advanced over the inner catheter to collapse the expandable filter.

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: 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: 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, enables the device to be snap-fitted so as to engage the distal end of a guide wire, to provide a reference for positioning the device at a location distal to the interventional procedure site, and to enable an end of the device to be in tension, enabling a portion of the device to be in tension and another portion to be in compression, so as to assist in bending thereof in tortuous vasculature.

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: A filtering device for capturing and removing embolic debris from a body vessel and a system for insertion and removal of the filtering device to facilitate an interventional procedure in a stenosed or occluded region of a body vessel. The filtering device is adapted to be expandable in the body vessel, allowing blood to pass therethrough while maintaining apposition with the body vessel wall and capturing embolic material released into the bloodstream during the interventional procedure, and to be collapsible to remove the captured embolic material from the body vessel. The filtering device includes a guidewire, an expandable cage assembly secured to the guide wire, filter material secured to the expandable cage assembly, and at least one hinge, the hinge allowing the expandable cage assembly to bend independent from the guide wire.

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: A deployment control system provides controlled deployment of an embolic protection device which may include a guide wire, an expandable filter attached to the guide wire near its distal end, and a restraining sheath that maintains the expanded filter in a collapsed position. The deployment control system includes a torque control device which allows the physician to torque the guide wire into the patient's anatomy and a mechanism for preventing the guide wire from buckling as the restraining sheath is being retracted to deploy the expandable filter. A recovery control system for recovering the embolic protection device includes an inner catheter which extends within a lumen of an outer recovery sheath in a coaxial arrangement. A distal portion of the inner catheter extends beyond another recovery sheath during advancement of the recovery system into the vasculature. The recovery sheath can be advanced over the inner catheter to collapse the expandable filter.

Abstract: A deployment control system provides controlled deployment of an embolic protection device which may include a guide wire, an expandable filter attached to the guide wire near its distal end, and a restraining sheath that maintains the expanded filter in a collapsed position. The deployment control system includes a torque control device which allows the physician to torque the guide wire into the patient's anatomy and a mechanism for preventing the guide wire from buckling as the restraining sheath is being retracted to deploy the expandable filter. A recovery control system for recovering the embolic protection device includes an inner catheter which extends within a lumen of an outer recovery sheath in a coaxial arrangement. A distal portion of the inner catheter extends beyond another recovery sheath during advancement of the recovery system into the vasculature. The recovery sheath can be advanced over the inner catheter to collapse the expandable filter.

Abstract: A delivery system for a medical device or other devices to be deployed within a biological body including a sheath having a longitudinal joint. The joint can be either resealable or non-resealable. The joint remains intact during delivery of the medical device, thereby facilitating accurate delivery of the medical device. During removal of the sheath, the joint is separated, thereby permitting the sheath to be peeled from the medical device while maintaining the position of the device. The delivery system allows a single operator to deploy the medical device and remove the sheath.

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: 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 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 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 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: 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, enables the device to be snap-fitted so as to engage the distal end of a guide wire, to provide a reference for positioning the device at a location distal to the interventional procedure site, and to enable an end of the device to be in tension, enabling a portion of the device to be in tension and another portion to be in compression, so as to assist in bending thereof in tortuous vasculature.