Abstract: The present invention is directed to an apparatus and method for delivering a drug to a selected site in the vascular system of a patient. More specifically, the apparatus is a balloon catheter comprising an expandable balloon with a pouch around at least a portion of the balloon. When the balloon is not expanded, an agent can be located in the area between the pouch and the balloon. The agent is released through the pouch when the balloon is expanded.

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: 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 includes an elongated flexible catheter having proximal and distal end portions, with fluidly connected coaxial lumens extending therebetween, and a diameter sufficiently small for insertion into a patient's intraluminal passageways. One or more treating elements are positionable within one of the lumens and movable between the proximal and distal portions by fluid flowing through the lumens. The distal portion includes a distal guide wire lumen having a proximal exit port distally located relative to the treatment elements positioned at the distal portion. To simultaneously achieve stiffness along the proximal portion and flexibility along the distal portion, the inner and/or outer coaxial members may be of more than one-piece construction. The inner and/or outer members may also be stepped or bumped in diameter to decrease the pressure and fluid transit times within the catheter. A balloon may be added to the distal portion for positioning the catheter or performing angioplasty.

Abstract: A system comprising a microprocessor-controlled transfer device and a separate catheter for intraluminal treatment of a selected site in a body of a patient by at least one treating element advanced from a removable treating element cartridge received in the transfer device into a lumen of the separate catheter by means of pressurized fluid controlled by a fluid control switch moveable between send and return positions, and a safety interlock for use with the system.

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: The present invention is directed to a method and apparatus for maintaining the patency of vascular catheter lumens so as to keep such lumens open and unobstructed when an indwelling catheter is not being used to administer treatment.

Abstract: The present invention is directed to an apparatus and method for delivering a drug to a selected site in the vascular system of a patient. More specifically, the apparatus is a balloon catheter comprising an expandable balloon with a pouch around at least a portion of the balloon. When the balloon is not expanded, an agent can be located in the area between the pouch and the balloon. The agent is released through the pouch when the balloon is expanded.

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. A removable treatment cartridge having a lumen forming part of the fluid path may also be provided, and a storage sleeve for the treatment cartridge may be of a radiation-blocking material, such as quartz.

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. A removable treatment cartridge having a lumen forming part of the fluid path may also be provided, and a storage sleeve for the treatment cartridge may be of a radiation-blocking material, such as quartz.

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. A removable treatment cartridge having a lumen forming part of the fluid path may also be provided, and a storage sleeve for the treatment cartridge may be of a radiation-blocking material, such as quartz.

Abstract: Methods and apparatus are disclosed for treating body tissue whereby a section of tissue is drawn into contact with the open distal end of the first passageway of the apparatus. A tissue treatment fluid is introduced into the second passageway for treating the desired section of tissue retained within the first passageway. Methods and apparatus are also disclosed for positioning a medical device at a desired location within the heart. A portion of the apparatus is retained at a desired location of the heart and a medical device is extended through a passageway of the apparatus for contacting the heart at the desired location.

Abstract: A system comprising a microprocessor-controlled transfer device and a separate catheter for intraluminal treatment of a selected site in a body of a patient by at least one treating element advanced from a removable treating element cartridge received in the transfer device into a lumen of the separate catheter by means of pressurized fluid controlled by a fluid control switch moveable between send and return positions. A safety interlock is provided for preventing both (1) the disassembly of the system unless the treating element resides in the treating element cartridge and (2) the actuation of the fluid control switch unless the system is assembled. The safety interlock comprises a first lock moveable from a first position to a second position only if both the catheter and the treating element cartridge are secured to 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: 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 system comprising a microprocessor-controlled transfer device and a separate catheter for intraluminal treatment of a selected site in a body of a patient by at least one treating element advanced from a removable treating element cartridge received in the transfer device into a lumen of the separate catheter by means of pressurized fluid controlled by a fluid control switch moveable between send and return positions. A safety interlock is provided for preventing both (1) the disassembly of the system unless the treating element resides in the treating element cartridge and (2) the actuation of the fluid control switch unless the system is assembled. The safety interlock comprises a first lock moveable from a first position to a second position only if both the catheter and the treating element cartridge are secured to the transfer device.

Abstract: A treating element source train that comprises a plurality of treating elements, with each treating element comprising a hollow outer housing closed on each end and a radiation emitting substance encapsulated therein. The treating elements are aligned end-to-end, and a wire is wound around the exterior of the treating elements to maintain the treating elements in their end-to-end relationship. The wire may be helically coiled about the treating elements, or braided around them. Also, the wire may be secured to the proximal and distal treating elements, or to each individual treating element. Preferably, the wire is made of a radiopaque material such as gold, platinum, platinum iridium, tungsten and tantalum. In an alternate embodiment, the source train may be provided with an end cap at either end, with the wire jacket being secured to each endcap.