Abstract: Described herein are catheters for use with Optical Coherence Tomography (OCT) that include an optical fiber core having a first refractive index and an interface medium having a second refractive index, where the first and second refractive indexes are mismatched such that receiving electronics configured to receive optical radiation reflected from the reference interface and the target operate in a total noise range that is within 5dB of the shot noise limit. These OCT catheters may include a silicon die mirror having a reflective coating that is embedded in the interface medium. The optical fiber can be fixed at just the distal end of the catheter, and may be managed within a handle that is attached to the proximal end of the catheter body, and is configured to allow rotation of both the catheter body and the optical fiber relative to the handle.

Abstract: A catheter device for crossing occlusions includes an elongate body, a central lumen extending within the elongate body from the proximal end to the distal end, a rotatable tip at the distal end of the elongate body, and an OCT imaging sensor. The rotatable tip is configured to rotate relative to the elongate body. The OCT imaging sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. A distal end of the elongate body includes one or more markers configured to occlude the OCT imaging sensor as it rotates. A fixed jog in the elongate body proximal to the distal end of the catheter positions the distal end of the catheter at an angle relative to the region of the catheter proximal to the fixed jog and is aligned with the one or more markers on the elongate body.

Abstract: A fire suppressant mixture comprising: an organic or supplemental organic fire suppressant compound; a halogen element, and an organic compound, wherein the organic fire suppressant compound, the halogen element and the organic compound are combined such that a boiling point of the mixture is lower than the boiling point of the organic fire suppressant. In some embodiments, the organic fire suppressant compound is FK 5-1-12 and the organic compound is carbon dioxide. In other embodiments, the mixture is supplemented with an additional organic compound such as CF3I or 2,2-Dichloro-1,1,1-trifluoroethane (R123), or an halogen element. In some embodiments an inorganic pressurizing gas, such as nitrogen, is also added.

Abstract: Described herein are atherectomy catheters, systems and methods that include a distal tip region that may be moved laterally so that its long axis is parallel with the long axis of the main catheter body axis. Displacing the distal tip region laterally out of the main catheter body axis exposes an annular blade and opens a passageway for cut tissue to enter a storage region within the catheter. The annular blade may be internally coupled to a drive shaft that rotates the blade, and thus the exposed blade edge may have the same crossing profile (OD) as the rest of the distal end region of the catheter. Also described herein are gear-driven atherectomy devices that may use a cable drive shaft to actuate the annular blade. Both push-to-cut and pull-to-cut variations are described, as are methods for cutting tissue and systems including these atherectomy catheters.

Abstract: A catheter device for crossing occlusions includes an elongate body, a central lumen extending within the elongate body from the proximal end to the distal end, a rotatable tip at the distal end of the elongate body, and an OCT imaging sensor. The rotatable tip is configured to rotate relative to the elongate body. The OCT imaging sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. A distal end of the elongate body includes one or more markers configured to occlude the OCT imaging sensor as it rotates. A fixed jog in the elongate body proximal to the distal end of the catheter positions the distal end of the catheter at an angle relative to the region of the catheter proximal to the fixed jog and is aligned with the one or more markers on the elongate body.

Abstract: Described herein are atherectomy catheters, systems and methods that include a distal tip region that may be moved laterally so that its long axis is parallel with the long axis of the main catheter body axis. Displacing the distal tip region laterally out of the main catheter body axis exposes an annular blade and opens a passageway for cut tissue to enter a storage region within the catheter. The annular blade may be internally coupled to a drive shaft that rotates the blade, and thus the exposed blade edge may have the same crossing profile (OD) as the rest of the distal end region of the catheter. Also described herein are gear-driven atherectomy devices that may use a cable drive shaft to actuate the annular blade. Both push-to-cut and pull-to-cut variations are described, as are methods for cutting tissue and systems including these atherectomy catheters.

Abstract: Catheter-based Optical Coherence Tomography (OCT) systems utilizing an optical fiber that is positioned off-axis of the central longitudinal axis of the catheter have many advantage over catheter-based OCT systems, particularly those having centrally-positioned optical fibers or fibers that rotate independently of the elongate body of the catheter. An OCT system having an off-axis optical fiber for visualizing the inside of a body lumen may be rotated with the body of the elongate catheter, relative to a handle portion. The handle may include a fiber management pathway for the optical fiber that permits the off-axis optical fiber to rotate with the catheter body relative to the handle. The system may also include optical processing elements adapted to prepare and process the OCT image collected by the off-axis catheter systems described herein.

Abstract: A fire suppressant mixture comprising: an organic or supplemental organic fire suppressant compound having a boiling point; and an organic compound with a boiling point lower than the boiling point of the organic fire suppressant compound, wherein the organic fire suppressant compound and the organic compound are combined such that a boiling point of the mixture is lower than the boiling point of the organic fire suppressant. In some embodiments, the organic fire suppressant compound is FK 5-1-12 and the organic compound is carbon dioxide. In other embodiments, the mixture is supplemented with an additional organic compound CF3I and an inorganic pressurizing gas, such as nitrogen.

Abstract: A fire suppressant mixture comprising: an organic or supplemental organic fire suppressant compound; a halogen element, and an organic compound, wherein the organic fire suppressant compound, the halogen element and the organic compound are combined such that a boiling point of the mixture is lower than the boiling point of the organic fire suppressant. In some embodiments, the organic fire suppressant compound is FK 5-1-12 and the organic compound is carbon dioxide. In other embodiments, the mixture is supplemented with an additional organic compound such as CF3I or 2,2-Di-chloro-1,1,1-trifluoroethane (R123), or an halogen element. In some embodiments an inorganic pressurizing gas, such as nitrogen, is also added.

Abstract: A fire suppressant mixture comprising: an organic or supplemental organic fire suppressant compound; a halogen element, and an organic compound, wherein the organic fire suppressant compound, the halogen element and the organic compound are combined such that a boiling point of the mixture is lower than the boiling point of the organic fire suppressant. In some embodiments, the organic fire suppressant compound is FK 5-1-12 and the organic compound is carbon dioxide. In other embodiments, the mixture is supplemented with an additional organic compound such as CF3I or 2,2-Dichloro-1,1,1-trifluoroethane (R123), or an halogen element. In some embodiments an inorganic pressurizing gas, such as nitrogen, is also added.

Abstract: A catheter device for crossing occlusions includes an elongate body, a central lumen extending within the elongate body from the proximal end to the distal end, a rotatable tip at the distal end of the elongate body, and an OCT imaging sensor. The rotatable tip is configured to rotate relative to the elongate body. The OCT imaging sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. A distal end of the elongate body includes one or more markers configured to occlude the OCT imaging sensor as it rotates. A fixed jog in the elongate body proximal to the distal end of the catheter positions the distal end of the catheter at an angle relative to the region of the catheter proximal to the fixed jog and is aligned with the one or more markers on the elongate body.

Abstract: The present invention relates to: (1) guidewire support/placement catheters; (2) support/placement catheters with imaging; (3) atherectomy catheters, (4) atherectomy catheters with imaging, (5) occlusion crossing catheters, and (6) occlusion crossing catheters with imaging as well as methods for using them to treat disorders (and particularly peripheral artery disease) and systems including them.

Abstract: The present invention relates to methods and devices for predicting restenosis, and for treating atherosclerosis to prevent or reduce the incidence of restenosis. Methods of predicting restenosis in a stenosed peripheral artery may include quantitative histology of the vessel. For example, a method of treating a stenosed artery (and particularly a peripheral artery) may include the steps of determining a level of hypercellularity and one or more of the lipid-richness and extent of inflammatory cell inclusion in the tissue. An index of restenosis based on the hypercellularity and lipid richness and/or extent of inflammatory cell inclusion in the tissue may be determined. Systems for treating or preventing restenosis may include one or more imaging modalities for imaging tissue regions and determining the level of hypercellularity and one or more of the degree of lipid-richness and the extent of inflammatory cell inclusion in the tissue region.

Abstract: A system for imaging a body lumen includes a controller and a display. The controller is configured to connect to a proximal end of a catheter having an optical fiber extending along the length of an elongate catheter body. The controller is further configured to rotate a distal end of the optical fiber from a location near a proximal end of the elongate catheter body, acquire optical coherence tomography (OCT) images using the optical fiber as the distal end of the optical fiber rotates, and determine a rotational lag of the distal end of the optical fiber. The display is configured to display one or more OCT images corrected for the rotational lag.

Abstract: The present invention relates to methods and devices for predicting restenosis, and for treating atherosclerosis to prevent or reduce the incidence of restenosis. Methods of predicting restenosis in a stenosed peripheral artery may include quantitative histology of the vessel. For example, a method of treating a stenosed artery (and particularly a peripheral artery) may include the steps of determining a level of hypercellularity and one or more of the lipid-richness and extent of inflammatory cell inclusion in the tissue. An index of restenosis based on the hypercellularity and lipid richness and/or extent of inflammatory cell inclusion in the tissue may be determined. Systems for treating or preventing restenosis may include one or more imaging modalities for imaging tissue regions and determining the level of hypercellularity and one or more of the degree of lipid-richness and the extent of inflammatory cell inclusion in the tissue region.

Abstract: A fire suppressant mixture comprising: an organic or supplemental organic fire suppressant compound; a halogen element, and an organic compound, wherein the organic fire suppressant compound, the halogen element and the organic compound are combined such that a boiling point of the mixture is lower than the boiling point of the organic fire suppressant. In some embodiments, the organic fire suppressant compound is FK 5-1-12 and the organic compound is carbon dioxide. In other embodiments, the mixture is supplemented with an additional organic compound such as CF3I or 2,2-Dichloro-1,1,1-trifluoroethane (R123), or an halogen element. In some embodiments an inorganic pressurizing gas, such as nitrogen, is also added.

Abstract: A fire suppressant mixture comprising: an organic or supplemental organic fire suppressant compound having a boiling point; and an organic compound with a boiling point lower than the boiling point of the organic fire suppressant compound, wherein the organic fire suppressant compound and the organic compound are combined such that a boiling point of the mixture is lower than the boiling point of the organic fire suppressant. In some embodiments, the organic fire suppressant compound is FK 5-1-12 and the organic compound is carbon dioxide. In other embodiments, the mixture is supplemented with an additional organic compound CF3I and an inorganic pressurizing gas, such as nitrogen.

Abstract: An apparatus and method are provided for very precise and efficient delivery of e.g. viscous nutritive cell matrices and/or drugs into an exact point in the human body using minimally-invasive surgical techniques. Embodiments are compatible with modern catheter access and endoscopic techniques and a disposable-plus-capital-equipment business model separating the cost of the procedure between a reusable and a disposable component. It also represents a substantial step forward in terms of safety with no high voltage or high pressure components present in the body. The inherent risk of using this design to deliver substances into the human body is significantly reduced compared to standard hydraulic methods. Mechanical trauma associated with needles is avoided with this invention, and the method is also compatible with tortuous anatomy such as the coronary or brain arteries.

Abstract: The present invention relates to methods and devices for predicting restenosis, and for treating atherosclerosis to prevent or reduce the incidence of restenosis. Methods of predicting restenosis in a stenosed peripheral artery may include quantitative histology of the vessel. For example, a method of treating a stenosed artery (and particularly a peripheral artery) may include the steps of determining a level of hypercellularity and one or more of the lipid-richness and extent of inflammatory cell inclusion in the tissue. An index of restenosis based on the hypercellularity and lipid richness and/or extent of inflammatory cell inclusion in the tissue may be determined. Systems for treating or preventing restenosis may include one or more imaging modalities for imaging tissue regions and determining the level of hypercellularity and one or more of the degree of lipid-richness and the extent of inflammatory cell inclusion in the tissue region.

Abstract: Catheter-based Optical Coherence Tomography (OCT) systems utilizing an optical fiber that is positioned off-axis of the central longitudinal axis of the catheter have many advantage over catheter-based OCT systems, particularly those having centrally-positioned optical fibers or fibers that rotate independently of the elongate body of the catheter. An OCT system having an off-axis optical fiber for visualizing the inside of a body lumen may be rotated with the body of the elongate catheter, relative to a handle portion. The handle may include a fiber management pathway for the optical fiber that permits the off-axis optical fiber to rotate with the catheter body relative to the handle. The system may also include optical processing elements adapted to prepare and process the OCT image collected by the off-axis catheter systems described herein.