Abstract: A kit for coronary treatment comprising a pressure sensing guidewire that includes a pressure sensor for measuring pressure within a patient's vasculature. A sheath comprising a tube having a proximal end and a distal end and defining an internal lumen sized for receiving the pressure sensing guidewire; a hemostasis valve positioned over the proximal end of the tube; a cylindrical element attached to the distal end of the tube, the cylindrical element having an internal lumen sized for receiving a conventional guidewire; wherein the pressure sensing guidewire is configured to be slideably insertable into the tube from the proximal end of the tube; and further wherein, the tube is configured to permit the pressure sensing guidewire, including the pressure sensor, to freely slide distally and proximally within the tube at the election of a user.

Abstract: Systems, devices and methods for eluting an agent at a treatment site are disclosed. The devices include an expandable frame and at least one membrane. The membrane may carry an agent to elute at the treatment site. The membrane may allow blood flow at the treatment site during agent delivery.

Abstract: A controlled pressure inflation-deflation device inflates a balloon to occlude a blood vessel by moving a large plunger to provide incremental pressure increases within a syringe. A releasable latch moves a second plunger, positioned within a syringe formed by an inner columnar opening in the large plunger, between an occlusion position and a perfusion position. A three-position switch has a release position to allow the large plunger to move freely, an adjust position to provide the incremental pressure increases, and a lock position to lock the location of the plunger. Pressures at which various balloons (e.g., folded balloons) achieve or nearly achieve a substantially circular cross-section may be extrapolated by inflating balloons with pressures equal and/or greater than the first occlusion pressure. Balloons may be pre-inflated up to or below the first occlusion pressure to achieve a substantially circular cross-section, prior to increasing the balloon to an occlusion pressure.

Abstract: A method is provided including introducing a delivery device through a vessel wall to a treatment site within one of a peri-adventitial space or a pericardium adjacent a coronary blood vessel and delivering a treatment agent through the delivery device. The treatment agent is delivered through the delivery device according to conditions that hydraulically dissect tissue planes within the peri-adventitial space. A kit is provided including a delivery device having a needle to be advanced through one of an epicardium of a heart and a wall of a coronary blood vessel into a peri-adventitial space and a treatment agent comprising particles having an average diameter on the order of 15 microns or more to be delivered through the delivery device into the peri-adventitial space.

Abstract: A kit for coronary treatment comprising a pressure sensing guidewire that includes a pressure sensor for measuring pressure within a patient's vasculature. A sheath comprising a tube having a proximal end and a distal end and defining an internal lumen sized for receiving the pressure sensing guidewire; a hemostasis valve positioned over the proximal end of the tube; a cylindrical element attached to the distal end of the tube, the cylindrical element having an internal lumen sized for receiving a conventional guidewire; wherein the pressure sensing guidewire is configured to be slideably insertable into the tube from the proximal end of the tube; and further wherein, the tube is configured to permit the pressure sensing guidewire, including the pressure sensor, to freely slide distally and proximally within the tube at the election of a user.

Abstract: Systems, devices and methods for eluting an agent at a treatment site are disclosed. The devices include an expandable frame and at least one membrane. The membrane may carry an agent to elute at the treatment site. The membrane may allow blood flow at the treatment site during agent delivery.

Abstract: A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device.

Abstract: Systems, devices and methods for eluting an agent at a treatment site are disclosed. The devices include an expandable frame and at least one membrane. The membrane may carry an agent to elute at the treatment site. The membrane may allow blood flow at the treatment site during agent delivery.

Abstract: A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device.

Abstract: Systems and methods for electropolishing devices are disclosed. The electropolishing system includes electropolishing fixtures configured to reposition the devices during the electropolishing process.

Abstract: Methods and apparatuses for positioning medical devices onto (or close to) a desired portion of the interior wall of an internal channel, such as for scan imaging, for photodynamic therapy and/or for optical temperature measurement. In one embodiment, a catheter assembly has a distal portion that can be changed from a configuration suitable for traversing the internal channel to another configuration suitable for scan at least a spiral section of the interior wall of an internal channel, such as an artery. In one example, the distal portion spirals into gentle contact with (or close to) a spiral section of the artery wall for Optical Coherence Tomography (OCT) scanning. The spiral radius may be changed through the use of a guidewire, a tendon, a spiral balloon, a tube, or other ways.

Abstract: An electropolishing system that includes electropolishing fixtures. The electropolishing fixtures include pendulum assemblies configured to establish electrical contact between a device being electropolished and an anode and to reposition the device during the electropolishing process.

Abstract: Embodiments include an infusion-occlusion system having a delivery catheter, a guide catheter adapted to receive the delivery catheter, and a guidewire with an occlusion device adapted to be received within the guide catheter. The guide catheter of the catheter kit may be provided with an occlusion device at the distal end of the guide catheter. The delivery catheter may have an accessory lumen, coaxial or co-linear lumen, a supporting mandrel, or an occlusion device at its distal end. Moreover, according to some embodiments, occlusion devices may be a single material or a composite balloon having an inner liner and an outer layer of different materials, a high compliance low pressure balloon, or a filter device that restricts particles from passing through but does not restrict fluid, such as blood. An inflation device with a large volume and low volume syringe can be used to inflate the balloon.

Abstract: A medical system utilizes a guide wire with a fluid filled internal lumen and a pressure measurement system to measure blood pressure in a body vessel. The guide wire includes an internal lumen with a distal opening for admitting fluid flow. The internal lumen is filled with a fluid or other media which can transmit pressure along the guide wire. The pressure measurement system includes a pressure transducer in fluid communication with the internal lumen of the guide wire. Pressure waveform in the body vessel are transmitted through the fluid or media from the distal opening of the internal lumen to the pressure transducer. The pressure transducer is in communication with a processor (with display) for determining the pressure acting on the pressure transducer. A pump with a fluid reservoir in fluid communication with the internal lumen of the guide wire is controlled by the processor. The pump introduces additional fluid into the guide wire lumen.

Abstract: Methods and apparatuses for positioning medical devices onto (or close to) a desired portion of the interior wall of an internal channel, such as for scan imaging, for photodynamic therapy and/or for optical temperature measurement. In one embodiment, a catheter assembly has a distal portion that can be changed from a configuration suitable for traversing the internal channel to another configuration suitable for scan at least a spiral section of the interior wall of an internal channel, such as an artery. In one example, the distal portion spirals into gentle contact with (or close to) a spiral section of the artery wall for Optical Coherence Tomography (OCT) scanning. The spiral radius may be changed through the use of a guidewire, a tendon, a spiral balloon, a tube, or other ways.

Abstract: A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device.

Abstract: The invention is directed to devices and methods for passing optical radiation into and out of a body lumen. In particular, the invention is directed to a rotatable ferrule for use in an optical guidewire and methods for using a rotatable ferrule. The rotatable ferrule may be either rotatably captured by and free to rotate within a guidewire, or may rotate upon release from a releasable, mechanically stable friction-fit engagement with a guidewire. The invention is further directed to sterile interfaces for readily connecting and disconnecting an optical guidewire with and from other optical instrumentation while maintaining the sterility of the guidewire, and methods for using a sterile interface device. The invention is also directed to interface devices that provide either direct or indirect optical and mechanical connection between an optical guidewire and peripheral instrumentation.

Abstract: Devices and methods for passing optical radiation into and out of a body lumen may include a rotatable ferrule for use in an optical guidewire and methods for using a rotatable ferrule. The rotatable ferrule may be either rotatably captured by and free to rotate within a guidewire, or may rotate upon release from a releasable, mechanically stable friction-fit engagement with a guidewire. Sterile interfaces for readily connecting and disconnecting an optical guidewire with and from other optical instrumentation while maintaining the sterility of the guidewire, and methods for using a sterile interface device are disclosed. Interface devices can be used to provide either direct or indirect optical and mechanical connection between an optical guidewire and peripheral instrumentation.

Abstract: An agent delivery catheter that includes an anti-whipping feature, improved assembly of distal parts and/or accuracy/repeatability of needle delivery to a target tissue. Additional features include fitting a catheter with a pneumatic delivery device for delivery of a therapeutic agent without using a needle.

Abstract: An electropolishing system that includes electropolishing fixtures. The electropolishing fixtures include pendulum assemblies configured to establish electrical contact between a device being electropolished and an anode and to reposition the device during the electropolishing process.