Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the vascular system of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's vascular system. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: A transfer device usable in a system for intraluminal treatment of a selected site in a body of a patient in which the transfer device comprises an integral pump for pressurizing and circulating fluid through a fluid path defined by the transfer device and associated catheter. A removable fluid cartridge is provided including a reservoir from which fluid is drawn by the pump and into which fluid is returned after being circulated through the fluid path. The pump may be a peristaltic pump and the fluid cartridge may include an elongated fluid pick-up having an inlet through which fluid is introduced into the transfer device. The fluid pick-up is sized in length so that the inlet is always submerged in the fluid regardless of the orientation of the transfer device.

Abstract: A transfer device and catheter assembly for the delivery of treatment elements to a selected location within the intraluminal passageways of a patient as part of an intraluminal radiation system. The transfer device includes a gate member that permits the treatment elements to have the transfer device only if the catheter is attached thereto. A pressure indicator provides a visual indication of the fluid pressure within the transfer device, and provides for a release of the fluid if the pressure exceeds a predetermined pressure. The catheter also includes detents to secure it to the transfer device and which must be manually activated to remove the catheter from the transfer device. The transfer device includes circuiting that determines whether the treating elements reside within the transfer device based upon the reflectivity of the treating elements. A method for determining whether treating elements reside in the catheter is also disclosed.

Abstract: A hydraulically actuated medical instrument includes an elongated shaft having proximal and distal ends, a hydraulically actuated end effector at the distal end of the shaft and a fluid flow path extending through the shaft to the end effector. The shaft may be capable of an angled configuration where at least a portion of the shaft is manually movable to a direction in which it extends at an angle to another portion of the shaft. The end effector is not limited to a linear configuration and at least a portion of an elongated end effector extends at an angle relative to another portion of the end effector as is needed or desirable for the particular procedure to be performed.

Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the vascular system of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's vascular system. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the vascular system of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's vascular system. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: A hydraulically actuated medical instrument includes an elongated shaft having proximal and distal ends, a hydraulically actuated end effector at the distal end of the shaft and a fluid flow path extending through the shaft to the end effector. The end effector may be directly manually operated by way of a handle located at the proximal end of the shaft or remotely, for example, via robotic controller. Articulation joints may be provided along the shaft, between the shaft and end effector or handle, or elsewhere. The hydraulic actuation of the present invention permits multiple axis instrument articulation, miniaturization and simplified instrument fabrication.

Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the intraluminal passageways of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's intraluminal passageways. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: This invention is a transfer device and catheter assembly for the delivery of treatment elements to a selected location within the intraluminal passageways of a patient as part of an intraluminal radiation system. The transfer device includes a gate member that permits the treatment elements to leave the transfer device only if the catheter is attached thereto. A pressure indicator provides a visual indication of the fluid pressure within the transfer device, and a pressure relief valve provides for a release of the fluid if the pressure exceeds a predetermined pressure. Transfer device also includes a treatment element detection system, low power indicator, a counter system, and an electromagnetic locking mechanism to prevent the opening or closing of the gate member when less than all of the treatment elements are in the transfer device.

Abstract: A transfer device and catheter assembly for the delivery of treatment elements to a selected location within the intraluminal passageways of a patient as part of an intraluminal radiation system. The transfer device includes a gate member that permits the treatment elements to have the transfer device only if the catheter is attached thereto. A pressure indicator provides a visual indication of the fluid pressure within the transfer device, and provides for a release of the fluid if the pressure exceeds a predetermined pressure. The catheter also includes detents to secure it to the transfer device and which must be manually activated to remove the catheter from the transfer device. The transfer device includes circuiting that determines whether the treating elements reside within the transfer device based upon the reflectivity of the treating elements. A method for determining whether treating elements reside in the catheter is also disclosed.

Abstract: A blood containment, visualization and tactile confirmation device is provided for use with a vascular entry needle. The device includes a visualization channel and/or a compliant outer wall portion which indicates whether a needle connected to the device has entered a selected blood vessel. The visualization channel is optionally vented to the outside to allow displaced air to escape, but has a gas permeable member to prevent blood from escaping. Alternatively, the visualization channel is substantially sealed such that it is not significantly vented. Preferably, a compliant outer wall portion defining the visualization channel pulses with changes in blood pressure, thereby providing a tactile indication that the needle tip is properly positioned. The device has a guideway with a barrier of elastomeric material which prevents blood from passing therethrough, but which allows passage of an elongated medical instrument such as catheterization apparatus.

Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the intraluminal passageways of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's intraluminal passageways. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: A blood containment, visualization and tactile confirmation device is provided for use with a vascular entry needle. The device includes a visualization channel and/or a compliant outer wall portion which indicates whether a needle connected to the device has entered a selected blood vessel. The visualization channel is vented to the outside to allow displaced air to escape, but has a gas permeable member to prevent blood from escaping. The visualization channel may have one, two, or more stages, with a first stage chamber which indicates initial penetration of a selected blood vessel, and a second stage chamber which fills more slowly and indicates that the needle remains positioned within the blood vessel. A third stage chamber with entrapped air which compresses slightly due to the heartbeat may also be used. Preferably, a compliant outer wall portion pulses with changes in blood pressure, thereby providing a tactile indication that the needle tip is properly positioned.

Abstract: A sheath introducer for a catheterization or similar procedure comprises a main body having an exterior tapered sidewall, an interior lumen, a beveled top surface and an annular boss extending from the top surface; a rotating section having an exterior sidewall, an interior lumen, a beveled bottom surface having a recessed portion dimensioned so as to be received within the main body annular boss, and a top surface having an annular shoulder extending therefrom creating a recess; a cannula extending from the bottom end of the main body; and, a hemostatic valve having an access port and a fluid tight slit opening and seated within the upper portion and maintained by a cap, the valve being maintained within the rotating section recess and preferably slightly compressed when the rotating section and main body are assembled. When assembled, the rotating section can rotate up to approximately 180.degree., affording approximately a 45.degree.

Abstract: Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the vascular system of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient's vascular system. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.

Abstract: A sheath introducer for a catheterization or similar procedure comprises a body having a upper portion and a lower portion, the lower portion being angled with respect to the upper portion; a curved tapering channel extending through the upper and lower portions; a cannula with a tapered distal end extending at an angle with respect to the upper portion a hemostatic valve having an access port and a fluid tight slit opening and seated within the upper portion and maintained by a cap; and an angled sideport in fluid communication with the channel. Optionally, a wiper flange extends inward within the valve access port which provide an additional fluid tight seal when a catheter is slidingly inserted, removed or maintained within the valve. A dilator can be adapted for use with the introducer by having a bend in the tube portion of the dilator.

Abstract: A blood containment, visualization and tactile confirmation device is provided for use with a vascular entry needle. The device includes a visualization channel and/or a complaint outer wall portion which indicates whether a needle connected to the device has entered a selected blood vessel. The visualization channel is vented to the outside to allow displaced air to escape, but has a gas permeable member to prevent blood from escaping. The visualization channel may have one, two, or more stages, with a first stage chamber which indicates initial penetration of a selected blood vessel, and a second stage chamber which fills more slowly and indicates that the needle remains positioned within the blood vessel. A third stage chamber with entrapped air which compresses slightly due to the heartbeat may also be used. Preferably, a compliant outer wall portion pulses with changes in blood pressure, thereby providing a tactile indication that the needle tip is properly positioned.

Abstract: The stent placement dilation balloon assembly comprises a catheter having a distal end, a distal end portion, and a proximal end, a balloon mounted to, about, and around the distal end portion of the catheter which has at least on opening therein communicating with the interior of the balloon, and, an elastic sleeve positioned about and around the balloon. The sleeve has an at rest diameter which is less than the width of the collapsed balloon if the collapsed balloon was allowed, when deflated, to assume a flat shape. A stent is mounted on the sleeve for placement in a vessel in a human body.

Abstract: A catheter sheath introducer comprises: a tubular body portion having opposed ends; a catheter sheath tube which is optionally replaceably carried on one of the body portion ends; and a slit, elastomeric hemostasis valve partition which is optionally replaceably carried on the other of the body portion ends.