Abstract: A guide wire including a lubricous distal portion and a less lubricous intermediate portion proximal of said distal portion. One guide wire provides a highly lubricous distal portion with a hydrophilic layer and a less lubricous intermediate portion with a hydrophobic layer. Another guide wire provides a lubricous distal portion with a polymer tip that is itself hydrophilic. Yet another guide wire provides a less lubricous intermediate portion using a stainless steel coil helically wound around the tapering intermediate portion. The coil is preferably coated with a hydrophobic coating such as PTFE or silicone. The coil can either abut the distal portion proximal end or extend into the distal portion interior.

Abstract: An inflation device such as a syringe is preloaded with gas (other than air) for inflation of balloon catheters. The syringe is lined with, or is packaged within, a low gas-permeability membrane to keep the stored gas from becoming contaminated with air. The physician using the syringe is able to determine whether air has infiltrated the syringe and contaminated the gas stored in the syringe.

Abstract: Devices and methods for detecting vulnerable plaque within a blood vessel are disclosed. A system in accordance with the present invention includes a first wire having a distal end coupled to a voltage source and a proximal end coupled to an instrument capable of measuring voltage. A distal end of a second wire is also coupled to the voltage source and a proximal end of the second wire is coupled to the instrument. The amplitude of the electromotive force produced by the voltage source preferably varies with the temperature of a tissue proximate the voltage source.

Abstract: A system for intravascular ionizing radiation therapy including a radiation device and a guide wire having radiopaque markers to facilitate precise repositioning of the radiation source along the length of the treatment site. The radiopaque markers are separated by a distance L, which corresponds to the distance between the 50% dose points in the dose fall-off regions. This produces partial dose overlap when the radioactive source is positioned in tandem adjacent each radiopaque marker. Preferably, only the dose fall-off regions overlap thereby providing more uniform and complete radiation exposure along the length of the treatment site.

Abstract: A catheter capable of irradiating blood vessel walls to inhibit restenosis after angioplasty. Catheters are capable of simultaneous irradiation, angioplasty, and in some devices, drug infusion. Preferred catheters include a helical perfusion balloon having strand windings spaced apart when inflated and defining a perfusion lumen within. A tubular sheath over the helical strands and distal shaft region is used in some embodiments and defines an outer wall for the perfusion lumen. A spiral, inter-strand space is defined between the sheath outer wall and the blood vessel inner wall, providing a confined volume for controlled delivery of drugs to the vessel wall in conjunction with irradiation. A device having a radiation wire, distally closed-end tube is provided. A device having a radiation wire open ended tube terminating proximally of the perfusion lumen is also provided.

Abstract: A radioactive source for use in intravascular treatment includes an elongated wire having a first diameter and an integral distal end having a second diameter. The second diameter is less than the first diameter. A plurality of spaced apart toroidal elements are disposed on the distal end of the wire. The toroidal elements include radioactive material.

Abstract: A guide wire including a lubricous distal portion and a less lubricous intermediate portion proximal of said distal portion. One guide wire provides a highly lubricous distal portion with a hydrophilic layer and a less lubricous intermediate portion with a hydrophobic layer. Another guide wire provides a lubricous distal portion with a polymer tip that is itself hydrophilic. Yet another guide wire provides a less lubricous intermediate portion using a stainless steel coil helically wound around the tapering intermediate portion. The coil is preferably coated with a hydrophobic coating such as PTFE or silicone. The coil can either abut the distal portion proximal end or extend into the distal portion interior.

Abstract: An intravascular medical device including an elongate shaft and a variable-length ionizing radiation source disposed on the distal end thereof. The present invention may be manifested as a source wire, a guide wire, a catheter or other suitable intravascular device with an adjustable length radiation source. For example, the adjustable source may be implemented on a wire having a variable-length radioactive tip, on a balloon catheter having a variable-length balloon inflated with a radioactive fluid, or on a catheter having means for advancing and retracting radioactive seeds of variable number and/or spacing.

Abstract: A guidewire for use in combination with a balloon catheter having a guidewire lumen disposed distal of the balloon, wherein the guidewire defines a perfusion lumen extending from a point proximal of the balloon to a point distal of the balloon such that blood may perfuse across the balloon when inflated. The guidewire may be used in an intravascular balloon angioplasty system, an intravascular system for the administration of ionizing radiation utilizing a centering balloon catheter, or any other intravascular system utilizing a balloon catheter and a guidewire. The guidewire includes an elongate shaft wherein a distal a portion of the shaft defines the perfusion lumen. Alternatively, the perfusion lumen may be defined by a tubular member carried by the shaft. The tubular member may be fixed to the shaft or may be movable relative thereto. As a further alternative, the shaft may include an expandable portion which defines the perfusion lumen.

Abstract: A guide wire including a lubricous distal portion and a less lubricous intermediate portion proximal of said distal portion. One guide wire provides a highly lubricous distal portion with a hydrophilic layer and a less lubricous intermediate portion with a hydrophobic layer. Another guide wire provides a lubricous distal portion with a polymer tip that is itself hydrophilic. Yet another guide wire provides a less lubricous intermediate portion using a stainless steel coil helically wound around the tapering intermediate portion. The coil is preferably coated with a hydrophobic coating such as PTFE or silicone. The coil can either abut the distal portion proximal end or extend into the distal portion interior.

Abstract: A low attenuation guide wire for use in combination with a radiation device for intravascular ionizing radiation therapy. The distal region of the guide wire is less attenuating to ionizing radiation than the proximal region and may be disposed adjacent the radiation emitting portion of the radiation device without significantly compromising the emission of radiation. Thus, the guide wire does not need to be removed or retracted in order to effectively deliver ionizing radiation to the vascular target site.

Abstract: A device for irradiating human vessel interior walls including a perfusion balloon catheter having a radioactive perfusion tube affixed therein. Preferably, the balloon is helical, having adjacent helical strand windings closely spaced in contact upon inflation to minimize trapped blood and reduce attenuation. The perfusion tube can be made radioactive by inclusion of a helical, radioactive metal coil in the perfusion tube wall. In use, the catheter can be advanced over a guide wire to a stenosis, inflated to dilate the site, with beta radiation from the coil passing through the device to the vessel walls, relatively unhindered by blood.

Abstract: A device for irradiating human vessel interior walls including a perfusion balloon catheter having a radioactive perfusion tube affixed therein. Preferably, the balloon is helical, having adjacent helical strand windings closely spaced in contact upon inflation to minimize trapped blood and reduce attenuation. The perfusion tube can be made radioactive by inclusion of a helical, radioactive metal coil in the perfusion tube wall. In use, the catheter can be advanced over a guide wire to a stenosis, inflated to dilate the site, with beta radiation from the coil passing through the device to the vessel walls, relatively unhindered by blood.

Abstract: A catheter capable of irradiating blood vessel walls to inhibit restenosis after angioplasty. Catheters are capable of simultaneous irradiation and angioplasty. Preferred catheters include a helical perfusion balloon having closely spaced or contacting adjacent windings when inflated. A helical balloon with strand windings having little space therebetween decreases the amount of blood between the balloon exterior surface and vessel walls. A removable, sheathed, elongate radiation source is used with some embodiments. A fixed, flexible sheath partitioning the catheter lumen into sterile and non-sterile portions is included in another embodiment. Internal rather than external perfusion and use of gas to inflate the balloon decrease the absorption of beta radiation by blood, and liquid inflation fluid, respectively.

Abstract: A radiation source for inhibiting restenosis including a radiation delivery tube having a radioactive distal region, the tube being adapted to slide over a core wire within a radiation delivery catheter. The core wire is preferably in a slidable relation with the radiation delivery catheter. By withdrawing the core wire to a proximal position, the flexibility of a distal region of the radiation delivery catheter may be increased, thereby allowing the radiation delivery catheter to navigate more tortuous paths and reach more distal sites. Before the radiation delivery tube is advanced into the catheter distal region, the core wire is preferably slid distally to a distal position. With the core wire in the distal position, the core wire may provide a structure that can be used to rapidly advance the radiation source to the lesion site.

Abstract: A method for inhibiting restenosis including local application of an oxidizing agent to blood vessel walls. Preferred oxidizing agents include peroxides, most preferably hydrogen peroxide. Oxidizing agents can be delivered utilizing drug delivery balloon catheters. Preferred delivery catheters include an inflatable balloon having a perfusion lumen therethrough to allow for longer application periods. Oxidizing agents can be delivered either alone or in conjunction with radiation or stent delivery. One method includes local delivery of 0.1% hydrogen peroxide to a dilated stenosis wall for a period of 10 minutes at a rate of 0.5 cc per minute.

Abstract: A guide wire including a lubricous distal portion and a less lubricous intermediate portion proximal of said distal portion. One guide wire provides a highly lubricous distal portion with a hydrophilic layer and a less lubricous intermediate portion with a hydrophobic layer. Another guide wire provides a lubricous distal portion with a polymer tip that is itself hydrophilic. Yet another guide wire provides a less lubricous intermediate portion using a stainless steel coil helically wound around the tapering intermediate portion. The coil is preferably coated with a hydrophobic coating such as PTFE or silicone. The coil can either abut the distal portion proximal end or extend into the distal portion interior.

Abstract: A device and method for irradiating human body vessel interior walls. One device includes a beta radiation emitting segmented metal tube disposed at the distal end of an elongate shaft. Another device includes a radioactive elastic sleeve mounted on a shaft. The device can be used to inhibit restenosis following angioplasty in coronary arteries. In use, the device can be advanced distally over the balloon portion of a positioned and deflated angioplasty balloon catheter, whereupon the balloon is inflated, pressing the radiation device into close contact with vessel walls. After a desired exposure period, the balloon is deflated, and the device, biased to contract, contracts with the balloon, allowing for ease of withdrawal from the patient.

Abstract: A catheter capable of irradiating blood vessel walls to inhibit restenosis after angioplasty. Catheters are capable of simultaneous irradiation, angioplasty, and in some devices, drug infusion. Preferred catheters include a helical perfusion balloon having strand windings spaced apart when inflated and defining a perfusion lumen within. A tubular sheath over the helical strands and distal shaft region is used in some embodiments and defines an outer wall for the perfusion lumen. A spiral, inter-strand space is defined between the sheath outer wall and the blood vessel inner wall, providing a confined volume for controlled delivery of drugs to the vessel wall in conjunction with irradiation. A device having a radiation wire, distally closed-end tube is provided. A device having a radiation wire open ended tube terminating proximally of the perfusion lumen is also provided.

Abstract: An intravascular guidewire providing enhanced steerability and radioscopic visibility. The guidewire has an elongated selectively formable core and a plastic jacket including proximal and distal jacket portions, where the distal jacket portion is further divided into a proximal jacket section and a distal jacket section. The distal jacket portion incorporates means for enhancing the radiopaque properties of the distal jacket portion relative to the proximal jacket portion. The distal jacket section has a different radiopacity than the proximal jacket section, making the distal jacket section more easily viewable under radioscopy. One embodiment provides enhanced steerability with a distal jacket section made of softer material than the proximal jacket section. Another embodiment provides enhanced steerability with a distal jacket cross-section smaller than the proximal jacket cross-section.