Abstract: Disclosed is a thin film radiation source, which may be used to deliver a radioactive dose to a site in a body lumen. The source comprises a thin flexible substrate, and a layer of radioisotope attached thereto. The source may further comprise additional layers such as one or more tie layers disposed between the substrate and the radioisotope layer and one or more outer coating layers. In one embodiment, the source is wrapped around an inflatable balloon. Inflation of the balloon at a treatment site positions the source directly adjacent to the vessel wall, and allows irradiation of the site following or simultaneously with a balloon angioplasty, stent implantation, or stent sizing procedure.

Abstract: Disclosed is a radioactive tubular prosthesis formed by rolling a flexible sheet around a longitudinal axis. Preferably, the prosthesis is self expandable under the radially outwardly directed spring bias of the rolled sheet. At least a portion of the sheet is provided with a coating comprising at least one radioisotope.

Abstract: Disclosed is a balloon catheter having an inflatable balloon having a radiation carrier such as a radiation delivery layer thereon. In one embodiment, the radiation delivery layer comprises one or more layers of metal foil, such as gold. The foil is irradiated, and the balloon is thereafter positioned at a treatment site in a vessel and expanded to bring the metal foil layer into close proximity with the vessel wall. In another embodiment, the radiation carrier is in the form of a dopant in the balloon material. Methods of using the balloon include radiation dosing a site following a balloon dilatation or other procedure, and simultaneously performing balloon angioplasty and radiation dosing.

Abstract: Disclosed is a dual catheter radiation delivery system, for delivering a dose of radiation to a treatment site, typically in a body lumen. The system comprises an outer sheath catheter, having an inflatable balloon thereon. The system further comprises an inner radiation delivery catheter, having a radially expandable structure such as a balloon with a radiation source thereon. The sheath catheter is positioned such that the sheath balloon is at the treatment site, and the radiation delivery catheter is transluminally advanced through the sheath catheter such that the radiation source is positioned within the sheath balloon. The radiation delivery balloon is inflated within the sheath balloon, to position the radioactive source near the vessel wall. The source may comprise a thin film carried by the radiation delivery balloon, having a radioactive isotope implanted therein or chemically bonded thereto. Alternatively, the radioactive isotope may be implanted within or adhered to the radiation delivery balloon.

Abstract: Disclosed is a focal balloon having at least one reference zone and a focal zone. In one embodiment, the reference zone and focal zone are inflatable to a first generally cylindrical profile at a first pressure. At a second, greater pressure, the focal section expands to a second, greater diameter, while the reference zone remains substantially at the first diameter. In an alternate embodiment, the focal zone and the reference zone are inflatable to their respective predetermined diameters at the inflation pressure, in the absence of constricting lesions or anatomical structures. Multiple lobed and drug delivery embodiments are also disclosed.

Abstract: Disclosed is a tubular microporous prosthesis formed by rolling a flexible sheet around a longitudinal axis. Preferably, the prosthesis is self expandable under the radially outwardly directed spring bias of the rolled sheet. At least a portion of the sheet may be provided with a coating to affect the physical and/or biological properties of the prosthesis.

Abstract: Disclosed is a tubular prosthesis formed by rolling a flexible sheet around a longitudinal axis. Preferably, the prosthesis is self expandable under the radially outwardly directed spring bias of the rolled sheet. Also disclosed are catheters for delivering two or more of the tubular prostheses at a site within a body lumen. Multiple prostheses may be deployed directly against a vessel wall in a single procedure, or may be deployed within a vascular graft to provide support throughout the length of the graft.

Abstract: Disclosed is a delivery catheter adapted for delivery of a dose of radiation to a vessel wall. A radiation source is enlargeable from a first, reduced cross-sectional profile to a second, enlarged cross-sectional profile by unwinding around a central core. Following delivery of a radiation dose to the vessel wall, the source is reduced in profile by wrapping around the core and removed from the treatment site.

Abstract: Disclosed is a low profile infusion catheter for medical use. The catheter comprises a proximal infusion lumen, which, in one embodiment, branches into two or more distal infusion lumen. Each of the distal fluid lumen is provided with at least one effluent flow port for infusion into the patient. Construction of the catheter provides a series of discrete flexibility zones.

Abstract: A dilatation catheter includes an inflation balloon having a variable diameter inflation profile. The balloon has a first inflation profile, in which it exhibits a substantially cylindrical central working profile. The first inflation profile of the balloon is achieved by inflating the balloon to a first inflation pressure. The balloon has a second inflation profile which is achieved by increasing the inflation pressure to a second, higher pressure. In the second inflation profile, a proximal segment and a distal segment of the balloon have a first inflated diameter and a central focal segment, separating the proximal and distal segments, has a second inflated diameter, such that the second inflated diameter is greater than the first inflated diameter. Methods of using the catheter are also disclosed.

Abstract: Disclosed is a focal balloon having at least one reference zone and a focal zone. In one embodiment, the reference zone and focal zone are inflatable to a first generally cylindrical profile at a first pressure. At a second, greater pressure, the focal section expands to a second, greater diameter, while the reference zone remains substantially at the first diameter. In an alternate embodiment, the focal zone and the reference zone are inflatable to their respective predetermined diameters at the inflation pressure, in the absence of constricting lesions or anatomical structures. Both balloons may be utilized to conduct interactive angioplasty to provide real-time feedback about the morphology of the lesion, and both balloons may be utilized to implant or size intravascular stents.

Abstract: Disclosed is a site specific microcapsule delivery system and microcapsules for delivering one or more active agents to a preselected site. The system includes a catheter and microcapsules. A preferred embodiment of the catheter includes an inner inflatable balloon having an outer perforated delivery balloon concentrically disposed thereon. The microcapsule preferably comprises a water dissolvable core, and at least one outer protective shell. In a preferred embodiment, the core comprises phosphorous 31 and the outer shell comprises PGLA or other water soluble material. Neutron beam activation of the core produces phosphorous 32, for emitting therapeutic radiation to the treatment site. The outer protective shell dissipates over time, and, following a predetermined delivery period, the outer shell is removed and the central core dissipates to leave only biologically compatible break down products.