Abstract: Disclosed is a tuvular sheath which is adapted to fit coaxially over an inflatable balloon. The sheath functions to alter the expansion characteristics of the balloon. In one preferred embodiment, the sheath converts the inflation profile of a dilatation balloon from a compliant mode to a noncompliant mode. Advantageously, the balloon sheath may be used in stent placement procedures, to accurately size the stent within a body lumen, while providing protection against balloon rupture. In one embodiment, the balloon sheath comprises a two-layered tubular structure, with an outer elastic layer surrounding an inner inelastic layer. Also disclosed are methods of altering the expansion characteristics of a balloon using the balloon sheath.

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 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 tubular prosthesis formed by rolling a perforated sheet around a longitudinal axis. Preferably, the prosthesis is self expandable under the radially outwardly directed spring bias of the rolled sheet. The perforations in the sheet are configured to provide throughholes in the wall of the multilayer prosthesis, when the prosthesis is in the implanted diameter within a vessel. The throughholes are configured to facilitate neointimal cell growth, and in a preferred embodiment, to minimize roll bias in the prosthesis as it is expanded from its reduced, insertion diameter to its expanded, implanted diameter. The prosthesis may be used as a graft or a stent.

Abstract: An intraluminal graft and method and apparatus for installing an intraluminal graft in relation to a bifurcation of a trunk vessel into two branch vessels to bypass an aneurysm defect or injury, wherein the intraluminal graft is formed of two cooperating graft prostheses. The first graft prosthesis is formed of a flexible tubular member having leg openings and a side, waist opening defined by self-expanding, collapsible stents that may be collapsed under restraint and positioned to bridge the bifurcation and allowed to expand to resemble trousers with the waist opening facing the lumen of trunk vessel and the legs fitting within the branch vessels and defining a first graft lumen therebetween. The second graft prosthesis is formed of a tubular member of sheet material that may be collapsed under restraint and advanced through the first graft lumen and then allowed to self-expand to be seated in the waist opening and against the trunk vessel wall.

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 Low Profile Perfusion Catheter, for use in coronary angioplasty applications. Preferably, the catheter is provided with an inflatable dilatation balloon, and a perfusion lumen extending therethrough. The diameter of the perfusion lumen is enlargable from a first, reduced diameter to a second, enlarged diameter. In one embodiment, an axially movable tubular support is movable within the lumen from a proximal, insertion position to a distal perfusion position. In another embodiment, the support is radially expandable. In a further embodiment, a porus drug delivery balloon is provided.

Abstract: A reinforced lumen catheter body is disclosed, such as for use in a balloon dilatation and/or drug delivery catheter. In one embodiment, the catheter body is provided with a guidewire access port along its length, to permit exchange of catheters during a cardiovascular procedure. Preferably, at least one lumen extending through the catheter body is defined within a tubular metal wall. One or more adjacent lumen are defined within a polymeric wall.

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: Disclosed is a Low Profile Perfusion Catheter, for use in coronary angioplasty applications. Preferably, the catheter is provided with an inflatable dilatation balloon, and a perfusion lumen extending therethrough. The diameter of the perfusion lumen is enlargable from a first, reduced diameter to a second, enlarged diameter. In one embodiment, an axially movable tubular support is movable within the lumen from a proximal, insertion position to a distal perfusion position. In another embodiment, the support is radially expandable. In a further embodiment, a porus drug delivery balloon is provided.

Abstract: Disclosed is a Low Profile Perfusion Catheter, for use in coronary angioplasty applications. Preferably, the catheter is provided with an inflatable dilatation balloon, and a perfusion lumen extending therethrough. The diameter of the perfusion lumen is enlargable from a first, reduced diameter to a second, enlarged diameter. In one embodiment, an axially movable tubular support is movable within the lumen from a proximal, insertion position to a distal perfusion position. In another embodiment, the support is radially expandable. In a further embodiment, a porus drug delivery balloon is provided.

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.

Abstract: An improved drug delivery catheter, for use in the prevention of restenosis of a dilated vascular region, and/or for use in the delivery of a medication to a preselected vascular site. The catheter comprises an elongate body, an inflation balloon disposed about a catheter body. In a drug delivery embodiment, a perforated drug delivery balloon is disposed concentrically about the inflation balloon. In another embodiment, the two balloons are heat sealed together at the distal and proximal ends of the catheter body. A first lumen extends through the catheter body for communicating with the inflation balloon, and a second lumen extends through the body for communicating with the drug delivery balloon. Methods describing the intraluminal delivery of drugs to a site specific location are also disclosed, including the delivery of a drug to a vascular area before, during or after a conventional PTCA procedure.

Abstract: Disclosed in an improved temporary stent and drug delivery catheter, for use in the prevention of restenosis of a dilated vascular region, and/or for use in the delivery of a medication to a preselected vascular site. The catheter comprises an elongate body, a perfusion conduit laterally offset from the axis of the catheter body, and an inflation balloon disposed about the perfusion conduit and at the end of the catheter body. In a drug delivery embodiment, a perforated drug delivery balloon is disposed concentrically about the inflation balloon. A first lumen extends through the catheter body for communicating with the inflation balloon, and a second lumen extends through the body for communicating with the drug delivery balloon. Methods of preventing restenosis during a post procedure observation period and of drug delivery to the vascular intima are also disclosed.

Abstract: Disclosed is a Low Profile Perfusion Catheter, for use in coronary angioplasty applications. Preferably, the catheter is provided with an inflatable dilatation balloon, and a perfusion lumen extending therethrough. The diameter of the perfusion lumen is enlargable from a first, reduced diameter to a second, enlarged diameter. In one embodiment, an axially movable tubular support is movable within the lumen from a proximal, insertion position to a distal perfusion position. In another embodiment, the support is radially expandable. In a further embodiment, a porus drug delivery balloon is provided.

Abstract: An improved drug delivery catheter, for use in the prevention of restenosis of a dilated vascular region, and/or for use in the delivery of a medication to a preselected vascular site. The catheter comprises an elongate body, an inflation balloon disposed about a catheter body. In a drug delivery embodiment, a perforated drug delivery balloon is disposed concentrically about the inflation balloon. In another embodiment, the two balloons are heat sealed together at the distal and proximal ends of the catheter body. A first lumen extends through the catheter body for communicating with the inflation balloon, and a second lumen extends through the body for communicating with the drug delivery balloon. Methods describing the intraluminal delivery of drugs to a site specific location are also disclosed, including the delivery of a drug to a vascular area before, during or after a conventional PTCA procedure.