Abstract: Embodiments of the present disclosure are configured to assess the severity of a blockage in a vessel and, in particular, a stenosis in a blood vessel. In some particular embodiments, the devices, systems, and methods of the present disclosure are configured to assess the severity of a stenosis in the coronary arteries without the administration of a hyperemic agent. In some embodiments, the devices, systems, and methods of the present disclosure are configured to optimize proximal and distal pressure measurements utilized to assess the vessel.

Abstract: Systems, methods, and apparatus for providing a fluid and reduced-toxicity optical media with optical analysis and therapeutic energy delivery. An aspect of the invention provides an aqueous solution of increased-salinity of between about 1% and 35%. An increasing salinity in accordance with the invention provides improved transmissive efficiency at many wavelengths and less toxicity than many existing systems and methods. A catheter having integrated fibers for probing or treating internal lumens or other tissues can include a liquid-inflatable balloon or flushing mechanism using the solution for displacing blood or other obstructions in an optical path between the fiber and targeted tissue. Methods including spectroscopy can be employed with the solution for diagnosing medical conditions associated with diseased vessels or other tissues while reducing the risk of permanent damage resulting from the diagnosis.

Abstract: Embodiments of the present disclosure are configured to assess the severity of a blockage in a vessel and, in particular, a stenosis in a blood vessel. In some particular embodiments, the devices, systems, and methods of the present disclosure are configured to assess the severity of a stenosis in the coronary arteries without the administration of a hyperemic agent. In some embodiments, the devices, systems, and methods of the present disclosure are configured to optimize proximal and distal pressure measurements utilized to assess the vessel.

Abstract: A system for analyzing a body lumen including a flexible conduit that is elongated along a longitudinal axis, the flexible conduit having a proximal end and a distal end; at least one delivery waveguide and at least one collection waveguide extending along the flexible conduit, a transmission output of the at least one delivery waveguide and a transmission input of the at least one collection waveguide located along a distal portion of the conduit; a spectrometer connected to the at least one delivery waveguide and the at least one collection waveguide, the spectrometer configured to perform diffuse reflectance spectroscopy, wherein the spectrometer emits at least one primary radiation signal of a wavelength having an absorption coefficient of between about 8 cm?1 and about 10 cm?1 when transmitted through a highly aqueous media; a controller system configured to calculate at least one of an extent, area, and volume of highly aqueous media based on the amount of absorption of the at least one primary radiatio

Abstract: A system is provided for probing a body lumen that includes a flexible conduit that is elongated along a longitudinal axis, the flexible conduit having a proximal end and a distal end, at least one delivery waveguide and at least one collection waveguide extending along the flexible conduit, a transmission output of the at least one delivery waveguide and a transmission input of the at least one collection waveguide located along a distal portion of the conduit. A spectrometer is connected to the at least one delivery waveguide and the at least one collection waveguide, the spectrometer configured to perform spectroscopy. A controller system is configured to calculate a distance between the flexible conduit and the wall of the body lumen based on a spectroscopic measurement of the at least one primary radiation signal that traveled between the flexible conduit and body lumen.

Abstract: A catheter for placement within a body lumen, the catheter including a flexible conduit that is elongated along a longitudinal axis, the flexible conduit having a proximal end and a distal end, at least one delivery waveguide and at least one collection waveguide extending along the flexible conduit, a lumen-expanding inflatable balloon disposed about a portion of the conduit, a transmission output of the at least one delivery waveguide and a transmission input of the at least one collection waveguide located within the balloon; and, at least one elongate arm connected to the conduit and positioned within the balloon, the at least one elongate arm radially translatable with respect to the conduit, and wherein at least one of the transmission output and transmission input is coupled to the elongate arm.

Abstract: A system for analyzing a body lumen including a flexible conduit that is elongated along a longitudinal axis, the flexible conduit having a proximal end and a distal end; at least one delivery waveguide and at least one collection waveguide extending along the flexible conduit, a transmission output of the at least one delivery waveguide and a transmission input of the at least one collection waveguide located along a distal portion of the conduit; a spectrometer connected to the at least one delivery waveguide and the at least one collection waveguide, the spectrometer configured to perform diffuse reflectance spectroscopy, wherein the spectrometer emits at least one primary radiation signal of a wavelength having an absorption coefficient of between about 8 cm?1 and about 10 cm?1 when transmitted through a highly aqueous media; a controller system configured to calculate at least one of an extent, area, and volume of highly aqueous media based on the amount of absorption of the at least one primary radiatio

Abstract: A system for treating a body lumen comprises a catheter including a flexible conduit that is elongated along a longitudinal axis and suitable for insertion into a body lumen, the conduit having a proximal end and a distal end, one or more waveguides integrated with the flexible conduit, the one or more waveguides constructed and arranged to deliver and collect radiation concentrated along a predetermined radial axis of the conduit, the predetermined radial axis of the conduit substantially aligned with respect to at least one therapy delivery component of the catheter, at least one radiation source connected to a transmission input of the one or more waveguides integrated with the flexible conduit, and at least one optical detector connected to a transmission output of the one or more waveguides integrated with the flexible conduit.

Abstract: Systems, methods, and apparatus for providing a fluid and reduced-toxicity optical media with optical analysis and therapeutic energy delivery. An aspect of the invention provides an aqueous solution of increased-salinity of between about 1% and 35%. An increasing salinity in accordance with the invention provides improved transmissive efficiency at many wavelengths and less toxicity than many existing systems and methods. A catheter having integrated fibers for probing or treating internal lumens or other tissues can include a liquid-inflatable balloon or flushing mechanism using the solution for displacing blood or other obstructions in an optical path between the fiber and targeted tissue. Methods including spectroscopy can be employed with the solution for diagnosing medical conditions associated with diseased vessels or other tissues while reducing the risk of permanent damage resulting from the diagnosis.

Abstract: A catheter is provided for placement within a body lumen, the catheter including a flexible conduit that is elongated along a longitudinal axis, the flexible conduit having a proximal end and a distal end. The catheter further includes at least one delivery waveguide and at least one collection waveguide positioned along the flexible conduit, the at least one delivery waveguide and the at least one collection waveguide constructed and arranged to transmit radiation at a wavelength in a range of about 250 to 2500 nanometers.

Abstract: Textured coatings for implantable medical devices can be provided in metallic or polymer surface layers having surface texture factors down to nanometer and sub-nanometer levels. Implantable devices having such textured surfaces and methods of coating such devices comprises providing a substrate surface of an implantable device and forming a coating layer of the substrate surface by directing a mixture of atoms of a first type of material and a second type of material toward the substrate surface while simultaneously and collinearly bombarding the substrate surface with ions, wherein the first type of material is substantially resistant to a removal process and the second type of material is substantially susceptible to a removal process.

Abstract: An implantable device and method of forming the same comprises a substrate, an adhesion layer, and a capping layer. The adhesion layer comprises a portion with a predominant proportion of palladium, the portion of the predominant proportion of palladium directly on the substrate. The capping layer comprises a capping layer material, and is on the adhesion layer.

Abstract: A method and apparatus for analyzing and treating internal tissues and, in particular, tissues affected by myocardial infarct. The apparatus includes a catheterized device integrating an optical probe and treatment delivery system. The probe component includes fiber optic lines that can be used in conjunction with infrared spectroscopy to analyze various characteristics of tissues, including chemical, blood, and oxygen content, in order to locate those tissues associated with myocardial infarct, to determine the best location for applying treatment, and to monitor treatment and its effects. Physically integrated with the probe component is a treatment component for delivering treatments including stem cell and gene therapy, known for having beneficial effects on tissues associated with myocardial infarct. A control system coordinates operation of the catheter, including performing chemometric analysis with the use of model data, and for providing control and visual feedback to an operator.

Abstract: An apparatus includes a feedback loop for controlling an extent of a gap between a wall of a balloon mounted on a catheter and a wall of a lumen into which the catheter is inserted. The apparatus includes a radiation detector mounted within the balloon for generating a feedback signal having information indicative of whether the extent of the gap is greater than or less than a desired value. The feedback loop receives the feedback signal and controls a size of the balloon to cause the extent of the gap to approach the desired value.

Abstract: First and second optical-redirectors mounted on a catheter couple radiation to a target along separate first and second paths. Either the first or second optical-redirectors, or both, can include a steering mechanism for selecting the first and/or second path.

Abstract: A catheter based optical system for generating data as to the condition of a tissue sample of a mammalian vessel. The system includes an elongated catheter shaft having a tissue engaging distal end and a coupled proximal end and an elongated optical delivery fiber arrangement disposed through a lumen of said catheter, said optical delivery fiber arrangement having a distal end and a proximal end. The distal end of the delivery fiber arrangement has a re-director light emitter thereon for directing light against mammalian tissues. An elongated optical collection fiber arrangement is disposed through a lumen of the catheter, the optical collection fiber arrangement having a distal end and a proximal most end. The distal end of the collection fiber arrangement has a re-director light receiver thereon for receiving light reflected from the mammalian tissue by the light emitter. The light emitter and the light receiver are longitudinally spaced apart from one another in the distal end of the catheter.

Abstract: The invention provides methods and apparatus to reference or normalize optical measurements, by removing or accounting for background factors and artifacts, such as motion artifacts, that arise during use of optical catheters.

Abstract: The invention provides methods and apparatus to reference or normalize optical measurements, by removing or accounting for background factors and artifacts, such as motion artifacts, that arise during use of optical catheters.

Abstract: A catheter based optical system for generating data as to the condition of a tissue sample of a mammalian vessel. The system includes an elongated catheter shaft having a tissue engaging distal end and a coupled proximal end and an elongated optical delivery fiber arrangement disposed through a lumen of said catheter, said optical delivery fiber arrangement having a distal end and a proximal end. The distal end of the delivery fiber arrangement has a re-director light emitter thereon for directing light against mammalian tissues. An elongated optical collection fiber arrangement is disposed through a lumen of the catheter, the optical collection fiber arrangement having a distal end and a proximal most end. The distal end of the collection fiber arrangement has a re-director light receiver thereon for receiving light reflected from the mammalian tissue by the light emitter. The light emitter and the light receiver are longitudinally spaced apart from one another in the distal end of the catheter.

Abstract: First and second optical-redirectors mounted on a catheter couple radiation to a target along separate first and second paths. Either the first or second optical-redirectors, or both, can include a steering mechanism for selecting the first and/or second path.