Abstract: The invention provides a rotational atherectomy system, device and method comprising a flexible, elongated, rotatable drive shaft with a pre-curved abrasive section disposed within a catheter that deforms the abrasive section to a substantially straight profile and, when the abrasive section is moved distally out of the catheter, the abrasive section resumes its pre-curved profile. Directional ablation is achieved by rotation of the drive shaft along its pre-curved axis as the abrasive section is urged against a portion of the lumen wall.

Abstract: The invention provides a rotational atherectomy device having, in various embodiments, a flexible, elongated, rotatable drive shaft with at least one flexible or inflexible eccentric enlarged abrading and cutting head attached thereto which comprises an abrasive surface. When placed against stenotic tissue and rotated at high speed, the eccentric nature of the abrading and cutting head moves along an orbital path, opening the lesion to a diameter larger than the resting diameter of the enlarged abrading and cutting head. Preferably the abrading and cutting head has a center of mass spaced radially from the rotational axis of the drive shaft, facilitating the ability of the device to travel along an orbital path. The abrading and cutting head comprises proximal and/or distal radiused surfaces that facilitate cutting difficult stenosis material while minimizing trauma to the vessel.

Abstract: The invention provides a rotational atherectomy device having, in various embodiments, a flexible, elongated, rotatable drive shaft with at least one asymmetric and at least partially spherical abrading element attached thereto, which comprises an abrasive surface. The abrading element comprises more mass above the drive shaft than below and comprises a flattened side or transverse surface which creates hard cutting edges and spaces the center of mass radially from the rotational axis of the drive shaft. Thus the center of mass is moved vertically and transversely by the structure of the abrading element, conferring geometric and mass eccentricity upon the element. When placed against stenotic tissue and rotated at high speed, the eccentric nature of the abrading element moves along an orbital path, opening the lesion to a diameter larger than the resting diameter of the abrading element.

Abstract: The invention provides a rotational atherectomy system, device and method comprising a flexible, elongated, rotatable drive shaft with a pre-curved abrasive section disposed within a catheter that deforms the abrasive section to a substantially straight profile and, when the abrasive section is moved distally out of the catheter, the abrasive section resumes its pre-curved profile. Directional ablation is achieved by rotation of the drive shaft along its pre-curved axis as the abrasive section is urged against a portion of the lumen wall.

Abstract: An rotational atherectomy apparatus for abrading tissue, comprising: a flexible, elongated, rotatable drive shaft having a proximal end and a distal end opposite the proximal end; a nose cone operatively attached proximate the distal end of the drive shaft comprising a distal tapered section and a plurality of elongate, flexible members adjacent to the distal tapered section of the drive shaft, each member in the plurality being fixed at both a proximal end and a distal end opposite the proximal end; a proximal mount rotatable with the drive shaft and fixedly connected to the proximal ends of all the flexible members in the plurality; and a distal mount axially separated from the proximal mount and fixedly connected to the distal ends of all the flexible members in the plurality.

Abstract: The invention provides a rotational atherectomy device having, in various embodiments, a flexible, elongated, rotatable drive shaft with at least one flexible or inflexible eccentric enlarged abrading and cutting head attached thereto which comprises an abrasive surface. When placed against stenotic tissue and rotated at high speed, the eccentric nature of the abrading and cutting head moves along an orbital path, opening the lesion to a diameter larger than the resting diameter of the enlarged abrading and cutting head. Preferably the abrading and cutting head has a center of mass spaced radially from the rotational axis of the drive shaft, facilitating the ability of the device to travel along an orbital path. The abrading and cutting head comprises proximal and/or distal radiused surfaces that facilitate cutting difficult stenosis material while minimizing trauma to the vessel.

Abstract: The invention provides a rotational atherectomy device having, in various embodiments, a flexible, elongated, rotatable drive shaft with at least one asymmetric and at least partially spherical abrading element attached thereto, which comprises an abrasive surface. The abrading element comprises more mass above the drive shaft than below and comprises a flattened side or transverse surface which creates hard cutting edges and spaces the center of mass radially from the rotational axis of the drive shaft. Thus the center of mass is moved vertically and transversely by the structure of the abrading element, conferring geometric and mass eccentricity upon the element. When placed against stenotic tissue and rotated at high speed, the eccentric nature of the abrading element moves along an orbital path, opening the lesion to a diameter larger than the resting diameter of the abrading element.

Abstract: A method for tightening a cardiac support device includes forming offsets in excess material in the cardiac support device and inserting a fastener through the offsets. A device for tightening a cardiac support device includes first and second clamp members moveable into and out of mateable engagement. Each of the first and second clamp members includes offset-forming structure.

Abstract: A method for tightening a cardiac support device includes forming offsets in excess material in the cardiac support device and inserting a fastener through the offsets. A device for tightening a cardiac support device includes first and second clamp members moveable into and out of mateable engagement. Each of the first and second clamp members includes offset-forming structure.

Abstract: A method for applying a cardiac support device to a heart of a mammal includes surgically accessing a heart, providing a cardiac support device including a jacket, and positioning the jacket around at least a portion of the heart by applying a pulling force to the jacket. The step of positioning the jacket can include using a tool from a position superior to the heart to pull the jacket onto the heart. One device for placing a cardiac support jacket onto the heart includes first and second tubular walls. The second tubular wall is oriented within the first tubular wall and against an internal surface of the first tubular wall. The second tubular wall includes a plurality of grooves and has an open interior volume to hold the cardiac support jacket. Another device for placing a cardiac support jacket onto the heart includes a tubular wall having a plurality of lumens extending between opposite ends of the tubular wall.

Abstract: A method for applying a cardiac support device to a heart of a mammal includes surgically accessing a heart, providing a cardiac support device including a jacket, and positioning the jacket around at least a portion of the heart by applying a pulling force to the jacket. The step of positioning the jacket can include using a tool from a position superior to the heart to pull the jacket onto the heart. One device for placing a cardiac support jacket onto the heart includes first and second tubular walls. The second tubular wall is oriented within the first tubular wall and against an internal surface of the first tubular wall. The second tubular wall includes a plurality of grooves and has an open interior volume to hold the cardiac support jacket. Another device for placing a cardiac support jacket onto the heart includes a tubular wall having a plurality of lumens extending between opposite ends of the tubular wall.

Abstract: A cardiac constraint jacket is formed of flexible material defining a volume between an open upper end and a lower end. The jacket is dimensioned for an apex of a patient's heart to be inserted into the volume through the open upper end and for the jacket to be slipped over the heart. A delivery device is used to place the jacket on the heart. The delivery device includes a plurality of attachment locations. Each of the attachment locations is releasably secured to separate positions surrounding a periphery of the open upper end of the jacket. The delivery device also includes a control arrangement which is selectively movable between an open position and a closed position. The control arrangement is connected to the attachment locations such that the attachment locations are in a compact array urging the open upper end of the jacket into a collapsed configuration when the control member is in the closed position.

Abstract: A cardiac constraint jacket is formed of flexible material defining a volume between an open upper end and a lower end. The jacket is dimensioned for an apex of a patient's heart to be inserted into the volume through the open upper end and for the jacket to be slipped over the heart. A delivery device is used to place the jacket on the heart. The delivery device includes a plurality of attachment locations. Each of the attachment locations is releasably secured to separate positions surrounding a periphery of the open upper end of the jacket. The delivery device also includes a control arrangement which is selectively movable between an open position and a closed position. The control arrangement is connected to the attachment locations such that the attachment locations are in a compact array urging the open upper end of the jacket into a collapsed configuration when the control member is in the closed position.

Abstract: A method for tightening a cardiac support device includes forming offsets in excess material in the cardiac support device and inserting a fastener through the offsets. A device for tightening a cardiac support device includes first and second clamp members moveable into and out of mateable engagement. Each of the first and second clamp members includes offset-forming structure.

Abstract: A method for applying a cardiac support device to a heart of a mammal includes surgically accessing a heart, providing a cardiac support device including a jacket, and positioning the jacket around at least a portion of the heart by applying a pulling force to the jacket. The step of positioning the jacket can include using a tool from a position superior to the heart to pull the jacket onto the heart. One device for placing a cardiac support jacket onto the heart includes first and second tubular walls. The second tubular wall is oriented within the first tubular wall and against an internal surface of the first tubular wall. The second tubular wall includes a plurality of grooves and has an open interior volume to hold the cardiac support jacket. Another device for placing a cardiac support jacket onto the heart includes a tubular wall having a plurality of lumens extending between opposite ends of the tubular wall.

Abstract: A cardiac constraint jacket is formed of flexible material defining a volume between an open upper end and a lower end. The jacket is dimensioned for an apex of a patient's heart to be inserted into the volume through the open upper end and for the jacket to be slipped over the heart. The jacket includes a receiving member along its upper end for engagement to a delivery apparatus, the apparatus used in positioning the jacket on the heart. The delivery apparatus includes a handle and a band. The band is generally hoop shaped having a first end and a second end attached to the handle, the first end fixedly attached to the handle and the second end releasably attached to the handle. Alternatively, the first end can be attached to a releasable end cap of the handle. In use, the second end of the band is released from the handle and inserted into the jacket receiving member. The jacket is threaded onto the band and the band end re-attached to the handle.

Abstract: A tension indicator and a method for treating cardiac disease using the tension indicator is provided. The tension indicator is configured for placement between a cardiac support device and the epicardial surface to determine the pressure exerted by the device on the epicardial surface.

Abstract: An adjustment clamp suitable for adjusting the tension of a material such as a cardiac support device. The adjustment clamp comprises a pair of interconnected, intersecting arms capable of rotating around a common axis. The arms each comprise a handle, a jaw and a shaft between the handle and jaw. The clamp also includes a latch operably mounted to the handle, wherein the latches of the two arms are capable of engaging each other to secure the clamp at a desired position. In one embodiment, the jaw comprises a flat contact surface. In another embodiment, at least one jaw of one arm comprises a roller assembly. Preferably, the clamp also includes a turning mechanism operably mounted to at least one roller assembly. Methods for using the adjustment claim to increase tension in a material are also described. In a preferred embodiment, the clamp is used to adjust the tension of a cardiac support device.

Abstract: A tension indicator and a method for treating cardiac disease using the tension indicator is provided. The tension indicator is configured for placement between a cardiac support device and the epicardial surface to determine the pressure exerted by the device on the epicardial surface.

Abstract: A surgical tool for measuring a heart that includes a first and second handle member having proximal and distal ends and internal passageways that run lengthwise from the proximal end to the distal end, a flexible member that is cylindrically shaped with a marked proximal end that is larger in diameter than the unmarked distal end, a hinged region with a connection receiving portion on the first handle member and a connection portion on the second handle member, wherein the distal end of the flexible member passes through the internal passageway of the first handle member from the proximal end of the first handle member to the distal end of the first handle member, extends out, then enters into the distal end of the second handle member, passes through the internal passageway of the second handle member from the proximal end to the distal end of the second handle member.