Abstract: The invention provides optical switching-based systems and methods for catheter-based optical diagnosis which are particularly well suited to determining the condition of blood vessels, including the state of the vessels with respect to atherosclerosis and its development. Various embodiments provide catheter-based spectroscopic systems that are configured to cycle between different optical interrogation techniques such as Raman spectroscopy, optical coherence tomography and time-resolved laser-induced fluorescence spectroscopy. One embodiment of the invention provides an intravascular catheter-based diagnostic system that cycles between fingerprint region (200-2,500 cm?1) Raman spectroscopy and high-wavenumber region (2,500-4,000 cm?1) Raman spectroscopy.

Abstract: The invention provides expandable tubular prostheses that are designed for the treatment of atherosclerotic lesions, such as vulnerable plaques, and that are characterized by no foreshortening, optimal radial force and accuracy of deployment. In the treatment of vulnerable plaque, the device may be expanded in a blood vessel so that its central section at least partially contacts a vulnerable plaque lesion and/or the blood vessel wall in close proximity to the vulnerable plaque lesion. The invention also provides more general methods of treating atherosclerosis and promoting endothelialization using the prostheses of the invention.

Abstract: A novel treatment for atherosclerotic vascular disease is described utilizing the implantation of a thin, conformable biocompatible prosthesis constructed from a composite of various structural and therapeutic scaffolds in combination with one or more bioactive agents. This prosthesis can be delivered into position over a lesion in order to passivate atherosclerotic plaques with minimal remodeling of the artery, or alternatively can be applied with a balloon to passivate the remodeled site. The composite prosthesis itself provides mild structural reinforcement of the vessel wall and an evenly distributed platform for the introduction of bioactive therapeutic agents.

Abstract: The invention provides expandable tubular endoluminal prostheses for the treatment of atherosclerotic lesions of blood vessels, including vulnerable plaque lesions, and methods of treatment using the prostheses. Various prostheses of the invention are characterized by hoop strength suitable for treating vulnerable plaque lesions, good conformability and good apposition to vessel walls, as well as minimal coverage areas in order to minimize the inflammatory response to the implanted prostheses.

Abstract: The invention provides unitary optics modules that integrate several light management functions for performing optical spectroscopy, such as Raman spectroscopy, and optical spectroscopy systems that include one or more of the unitary optics modules. Methods of using the modules and systems are also provided.

Abstract: The present invention provides apparatuses and methods for sample analysis, such as tissue analysis, that integrate high wavenumber (HW) Raman spectroscopy for chemical composition analysis and optical coherence tomography (OCT) to provide depth and morphological information. The invention also provides side-viewing optical probes that are based on a single double clad optical fiber for performing the combined HW Raman spectroscopy and OCT. Intravascular catheter embodiments and related vascular diagnostic methods are also provided.

Abstract: The present invention provides apparatuses and methods for sample analysis, such as tissue analysis, that integrate high wavenumber (HW) Raman spectroscopy for chemical composition analysis and spectral-domain optical coherence tomography (SD-OCT) to provide depth and morphological information. Intravascular catheter embodiments and related vascular diagnostic methods are also provided.

Abstract: The invention provides balloon-expandable intravascular basket-style catheters optimized for efficient interrogation of blood vessel walls. Related diagnostic systems and methods are also provided.

Abstract: Spectroscopic systems and methods are disclosed for determining levels of at least one analyte in blood undergoing hemodialysis. In one aspect, the invention employs Raman spectroscopy to monitor and/or control hemodialysis. In one embodiment, the system uses a laser light directed to circulating blood from a patient undergoing dialysis to make Raman spectral measurements. For example, the laser light can be directed into a segment of the dialysis tubing. The system can utilize unique Raman spectroscopic signature of one or more analytes, e.g., urea, to identify and quantify such analytes against a whole blood background. Based on the spectral response, the concentration of the analytes can be monitored and/or used to control hemodialysis.

Abstract: The invention provides hybrid basket-type intravascular catheter probes designed to optimize blood vessel wall contact or close proximity while traversing tortuous curves. Related diagnostic systems and methods are also provided.

Abstract: The invention provides diagnostic apparatuses that are advantageously adapted for the Raman spectroscopic analysis of fluid samples, such as biological fluid samples, deposited on test strip substrates. The tests strips may be include a surface-enhanced Raman spectroscopy (SERS) surface for deposition and analysis of a sample and/or may be lateral flow binding assay type test strips.

Abstract: Methods and apparatus for in vitro detection of an analyte in a body fluid sample using low resolution Raman spectroscopy are disclosed. The body fluid analyzer includes a disposable strip for receiving a sample of body fluid on a target region, the target region including gold sol-gel to provide surface enhanced Raman scattering. A light source irradiates the target region to produce a Raman spectrum consisting of scattered electromagnetic radiation that is separated into different wavelength components by a dispersion element. A detection array detects at least some of the wavelength components of the scattered light and provides data to a processor for processing the data. The results of the processed data are displayed on a screen to inform a user about an analyte within the body fluid sample.

Abstract: The invention provides miniature side-viewing fiber optic probes that achieve high collection efficiency by maximizing the overlap of a laser delivery fiber's illumination and a collection fiber's collection cone. The probes can be made with as few as one optical piece, in addition to the optical fibers. In one embodiment of the invention, the probes are configured for performing Raman spectroscopy. Spectroscopy systems utilizing the probes of the invention are also provided.

Abstract: Novel approaches for a conformable vascular prosthesis delivery system are provided which overcome the limitations of existing high pressure balloons for delivering intravascular prostheses to the site of high-risk plaques. One embodiment involves a short balloon segment which is inflated at one end of the prosthesis and then pulled to traverse the length of the prosthesis, dilating the surrounding prosthesis and securing it to the vessel wall as it traverses the length of the prosthesis. The short balloon segment causes less local trauma to the vessel relative to a full length balloon. Another embodiment involves use of a self-expandable mesh to expand the surrounding prosthesis and secure it to the vessel wall. The self expandable mesh is less traumatic than a typical angioplasty balloon because of the lower radial forces applied and the relatively higher transverse flexibility of the mesh.

Abstract: Methods and apparatus for in vitro detection of an analyte in a blood sample using low resolution Raman spectroscopy are disclosed. The blood analyzer includes a disposable strip for receiving a sample of blood on a target region, the target region including gold sol-gel to provide surface enhanced Raman scattering. A light source irradiates the target region to produce a Raman spectrum consisting of scattered electromagnetic radiation that is separated into different wavelength components by a dispersion element. A detection array detects a least some of the wavelength components of the scattered light and provides data to a processor for processing the data. The results of the processed data are displayed on a screen to inform a user about an analyte within the blood sample.

Abstract: A novel treatment for atherosclerotic vascular disease is described utilizing the implantation of a thin, conformable biocompatible prosthesis constructed from a composite of various structural and therapeutic scaffolds in combination with one or more bioactive agents. This prosthesis can be delivered into position over a lesion in order to passivate atherosclerotic plaques with minimal remodeling of the artery, or alternatively can be applied with a balloon to passivate the remodeled site. The composite prosthesis itself provides mild structural reinforcement of the vessel wall and an evenly distributed platform for the introduction of bioactive therapeutic agents.

Abstract: The present invention provides intravascular diagnostic catheters that include a centrally disposed intravascular ultrasound (IVUS) imaging element and radially extendable, wall-contacting optical probe arms of a novel design for improving the IVUS imaging aspect of combined IVUS and optical analysis. In one embodiment, the dimension of the portion of the probe arm(s) that is in the field-of-view of the IVUS imaging element is minimized. In another embodiment, thin tethers are disposed in the field-of-view of the IVUS imaging element, rather than a continuation of the probe arm itself into the IVUS field. In still another embodiment, the probe arms at least substantially do not impinge on the field-of-view of the IVUS imaging element and tethers that are not within the field-of-view of the IVUS imaging element are used to control the probe arms, thereby providing a clear field-of-view for the IVUS imaging element.

Abstract: One aspect of the invention provides catheter pullback apparatuses in which a reusable drive component is enclosed in a sterile disposable barrier enclosure, such as a polymeric sheath/bag. In one embodiment, the reusable drive component includes a pullback carriage that is magnetically coupled, through the sterile barrier, to a slideable catheter shuttle adapted to retain a catheter hub of a catheter. In another embodiment, a sterile barrier-enclosed drive component is inserted into a housing, in which process a piercing tip provided on the catheter shuttle pierces the enclosure and mechanically mates the slideable catheter shuttle and pullback carriage. In this manner, non-sterility of the operating environment is minimized.

Abstract: The invention provides expandable tubular prostheses that are designed for the treatment of atherosclerotic lesions, such as vulnerable plaques, and that are characterized by no foreshortening, optimal radial force and accuracy of deployment. In the treatment of vulnerable plaque, the device may be expanded in a blood vessel so that its central section at least partially contacts a vulnerable plaque lesion and/or the blood vessel wall in close proximity to the vulnerable plaque lesion. The invention also provides more general methods of treating atherosclerosis and promoting endothelialization using the prostheses of the invention.

Abstract: The present invention provides intravascular diagnostic catheters that include one or more wall-contacting/wall-approaching probes including IVUS probe elements and diagnostic systems including such catheters, for the evaluation and diagnosis of blood vessels. Also provided are intravascular catheters in which the wall-contacting/wall-approaching probes further include an optical probe element and systems including such catheters, for combined IVUS and optical analysis of a blood vessel wall.