Abstract: Methods and products for diagnosing, treating and/or delaying onset of chronic allograft rejection, including cardiac allograft vasculopathy. In an exemplary embodiment of a noninvasive method of screening a cardiac allograft recipient for being at-risk for developing cardiac allograft vasculopathy of the present disclosure, the method comprises the steps of withdrawing at least one biological sample from a cardiac allograft recipient; and analyzing the at least one biological sample for one or more biomarkers indicative of the presence of fibrin deposits within the cardiac allograft microvasculature; wherein detection of the one or more biomarkers indicates that the cardiac allograft recipient is at-risk for or developing cardiac allograft vasculopathy.

Abstract: Devices and systems for tissue engagement and methods of using the same.

Abstract: Devices, systems, and methods for delivering a substance within a mammalian luminal organ or area adjacent thereto. In at least one exemplary embodiment of a system of the present disclosure, the system comprises an inner delivery device, comprising an inner portion configured to receive a substance therein, a pock tip at or near a distal end of the inner delivery device, the pock tip configured to deliver the substance from the inner portion, through a pock tip aperture defined within the pock tip, and into a mammalian tissue and/or luminal organ, and an embolus positioned within the inner portion, the embolus configured so that the substance remains distal to the embolus when the substance is positioned within the inner portion.

Abstract: Systems, devices, and methods for organ Retroperfusion along with regional mild hypothermia. One such system includes a hypothermia system including a hypothermia system outlet and a hypothermia system inlet; and a connector comprising a coolant inlet, a coolant outlet, a coolant reservoir, and a blood lumen, whereby the coolant inlet is configured to couple to the hypothermia system outlet and whereby the coolant outlet is configured to couple to the hypothermia system inlet; whereby a cooling product, when the hypothermia system is connected to the connector, can flow from the hypothermia system, through the hypothermia system outlet, into the coolant inlet, through the coolant reservoir, into the coolant outlet, and into the hypothermia system inlet, so that the cooling product can cool blood flowing through the blood lumen.

Abstract: Systems and methods for locally engaging tissue using suction. In at least one catheter device embodiment, the catheter device comprises an engagement catheter having a proximal end, a distal end, and a vacuum lumen therethrough operably coupling the proximal and distal ends; an elongated tube of a shape memory material having a plurality of elongated strips removed from a length of the elongated tube to form elongated shape memory tines at a distal end of the tube, wherein the shape memory tines flare outward away from a central axis to form a fluted distal end; and an elastomeric coating disposed over the elongated shape memory material tines to form a suction cup shape.

Abstract: Engagement catheter devices, systems, and methods to use the same under suctional tissue engagement. A method of the present disclosure comprises the steps of engaging a targeted tissue under suction/vacuum using an engagement catheter, delivering a substance into or through the targeted tissue using a needle positioned within a first lumen of the engagement catheter, injecting a fluid within the first lumen of the engagement catheter to flush at least part of the first lumen with the fluid, and suctionally removing the injected fluid from within the first lumen of the engagement catheter.

Abstract: A microneedle device comprising a membrane having an adhesive thereon and a microneedle substrate adhered to the membrane via the adhesive. The microneedle substrate may have a plurality of microneedles coupled thereto, or the microneedle substrate can comprise the plurality of microneedles. The microneedle device can be mated with a reagent container and the microneedles aligned with wells on the reagent container said wells configured to hold reagents thus comprising a system for detecting opioids or other drugs. In another embodiment, the device comprises a sweat-absorbent swatch adhered to a membrane. This embodiment can be mated to a screening pad comprising blisters of reagents on the base layer of the screening pad. Upon mating, a needle device can be used to pierce the blisters such that the reagents are released and react with the sweat absorbent swatch to indicate the presence of opioids or other drugs.

Abstract: Methods and uses of biological tissues for various stent and other medical applications. In an exemplary embodiment of a method of processing a tissue of the present disclosure, the method comprises the steps of acquiring a mammalian tissue comprising at least a portion of a pulmonary region tissue, selecting a sample of pulmonary region tissue from the at least a portion of a pulmonary region tissue, and fixing the sample of pulmonary region tissue using a fixative, resulting in a fixed sample. In at least one embodiment, the step of selecting a sample of pulmonary region tissue comprises selecting a sample of pulmonary ligament tissue from the mammalian tissue.

Abstract: Steering engagement catheter devices, systems, and methods of using the same for accessing a tissue, including internal and external tissues of a heart, are disclosed. In at least one embodiment, a steering engagement catheter is provided, comprising an elongated tube having a proximal end, a distal end, and a first wall positioned circumferentially along a length of the elongated tube, the elongated tube configured such that a delivery catheter is capable of at least partial insertion into the elongated tube, at least one steering wire having a proximal end and a distal end, the distal end of the at least one steering wire coupled to the first wall of the elongated tube at or near the distal end of the elongated tube, and a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire.

Abstract: Devices and systems for navigation and positioning a central venous catheter within a patient. In an exemplary embodiment of a system of the present disclosure, the system comprises a first pole and a second pole, the first pole and the second pole configured to generate an electric field within a mammalian body sufficient to obtain a plurality of field measurements therein, and an elongated body configured for at least partial insertion into a blood vessel of the mammalian body and advancement through a vasculature, said advancement dependent upon the plurality of field measurements indicative of one or more locations of a portion of the elongated body within the vasculature. In at least one embodiment, the elongated body is configured as a stylet.

Abstract: Luminal grafts and methods of making and using the same. An exemplary luminal graft of the present disclosure is configured as a generally tubular element configured for nerve cells to grow therethrough and comprises at least one sheet of biological tissue having elastin fibers and collagen fibers, with the elastin fibers being a dominant component thereof; and a plurality of microchannels formed on a surface of the at least one sheet of biological tissue, each of the microchannels extending longitudinally between a first end and a second end of the at least one sheet of biological tissue and configured to provide intraluminal structural guidance to nerve cells proliferating therethrough.

Abstract: Devices and systems for tissue engagement and methods of using the same. In at least one embodiment of a device of the present disclosure, the device comprises an elongated body having a proximal end, a distal end, and at least one lumen extending from the proximal end to the distal end; an engagement portion at the distal end of the elongated body, the engagement portion configured to engage a tissue adjacent thereto when the engagement portion contacts the tissue while suction is applied through the device; and at least one electrode present along the engagement portion and configured to contact the tissue when the engagement portion contacts the tissue and to obtain bioimpedance data from the tissue while suction is applied through the device.

Abstract: Devices and methods for assisting cardiac function. In an exemplary embodiment of a device for assisting heart function of the present disclosure, the device includes a first plate and an opposing second plate, each plate having an inner surface, a cardiac processor coupled to at least one of the first plate and the second plate, a bladder having an inner chamber and disposed between the inner surfaces, and a first catheter having a proximal end in communication with the inner chamber of the bladder and a distal end having a first pericardial balloon coupled thereto, wherein a gas and/or a liquid within the inner chamber of the bladder can be injected into the first pericardial balloon upon compression of the first plate relative to the second plate, and wherein the gas and/or the liquid can be removed from the first pericardial balloon upon retraction of the first plate relative to the second plate.

Abstract: Methods and uses of biological tissues for various stent and other medical applications. In an exemplary embodiment of a method of processing a tissue of the present disclosure, the method comprises the steps of acquiring a mammalian tissue comprising at least a portion of a pulmonary region tissue, selecting a sample of pulmonary region tissue from the at least a portion of a pulmonary region tissue, and fixing the sample of pulmonary region tissue using a fixative, resulting in a fixed sample. In at least one embodiment, the step of selecting a sample of pulmonary region tissue comprises selecting a sample of pulmonary ligament tissue from the mammalian tissue.

Abstract: Devices, systems, and methods for remotely monitoring physiologic cardiovascular data are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for the delivery of the sensor to the epicardial surface of the heart. In addition, various disclosed embodiments provide for a memory device capable of receiving the physiologic cardiovascular data collected by the sensors and transmitting such data wirelessly to a remote location.

Abstract: Devices, systems, and methods to determine fractional flow reserve. At least one method for determining fractional flow reserve of the present disclosure comprises the steps positioning a device comprising at least two sensors within a luminal organ at or near a stenosis, wherein the at least two sensors are separated a predetermined distance from one another, operating the device to determine flow velocity of a second fluid introduced into me luminal organ to temporarily displace a first fluid present within the luminal organ, and determining fractional flow reserve at or near the stenosis based upon the flow velocity, a mean aortic pressure within the luminal organ, and at least one cross-sectional area at or near the stenosis. Devices and systems useful for performing such exemplary methods are also disclosed herein.

Abstract: Deflection devices, systems, and methods for the prevention of stroke. Devices hereof comprise an extension portion and an anchor portion, both of which are configured to prevent the device from advancing into the artery extending from the aortic arch in which the device may be positioned. Additionally, a retrieval system is provided, the system comprising a sleeve catheter and a retrieval device slidably disposed therein. The distal end of the retrieval device comprises one or more attachment portions configured to engage at least a portion of the anchor portion of a device positioned within an artery extending from the aortic arch.

Abstract: Devices and systems for obtaining conductance data and methods of manufacturing and using the same. In at least one embodiment of a device of the present disclosure, the device is an elongated body with at least one groove defined therein, the at least one groove configured to receive one or more conductor wires therein. In another embodiment, the device is an elongated core body having a plurality of conductive elements positioned thereon and a coating to result in a device having an overall round-cross section.

Abstract: Methods and devices for controlling blood perfusion pressure along with regional mild hypothermia. In at least one embodiment of a device for controlling blood perfusion pressure within a vessel of the present disclosure, the device comprises an elongated body having a lumen, a proximal end configured for placement in a first area having a first blood pressure, and a distal end configured for placement in a second area having a second blood pressure, a partial occluder positioned within the lumen of the elongated body between the proximal end and the distal end, the partial occluder configured so not to fully occlude a blood vessel and to equalize the first blood pressure at the first area with the second blood pressure at the second area, and a regional hypothermia system operably coupled thereto, the regional hypothermia system operable to reduce and/or regulate a temperature of a bodily fluid flowing therethrough.

Abstract: Blood filter devices, systems, and methods of using the same to detect the presence of a thrombus within said filter devices. A device of the present disclosure for detecting a thrombus or other blood particulate matter of a threshold size within a vessel can comprise a filter having a head and a plurality of legs extending distally therefrom, configured to capture the thrombus or other blood particulate matter of at least a threshold size, and at least one impedance element positioned distal to the head and configured to detect a presence of the thrombus or other blood particulate matter of at least a threshold size within the filter by obtaining data within a bloodstream when the filter is positioned within the bloodstream.