Abstract: Systems and methods for monitoring oxygenator performance in extracorporeal circuit systems or the like. More particularly, the disclosure relates to systems and methods including a controller programmed to determine oxygenator apparatus flow impedance as a function of an inlet pressure measurement, an outlet pressure measurement and a blood flow rate measurement. The systems and methods may include a communication device that receives signals from the controller to communicate information regarding oxygenator apparatus performance.

Abstract: In some examples, a catheter defines a longitudinal axis and includes an inner member, a retaining member, and a support member. The inner member has an outer wall, and a portion of the inner member has a first stiffness. The retaining member defines a pocket configured to receive a connecting member of an expandable medical device. The retaining member has a second stiffness that is different from the first stiffness. The support member extends distally from the retaining member. In some examples, the support member is configured to be received radially within the expandable medical device when the connecting member is received within the pocket. The support member is configured to provide a gradual transition between the first stiffness of the inner member and the second stiffness of the retaining member.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body sized and shaped to be received in the body lumen. A handle is mounted at a proximal end portion of the catheter and is operable to cause rotation of the elongate body. A tissue-removing element is mounted on a distal end portion of the elongate body. The tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen. A guidewire lumen extends through the elongate body from a distal end of the catheter to an intermediate location on the catheter spaced distally from the proximal end portion of the catheter. The guidewire lumen is configured to receive a guidewire such the catheter can be removed from the body lumen by pulling the catheter along the guidewire without removing the guidewire from the body lumen.

Abstract: Example articles coated with tissue layers and techniques for forming articles with tissue layers. An example article may include a tubular frame extending along a longitudinal axis. The tubular frame includes a plurality of struts joined at apices to define a plurality of cells including a group of struts. The example article includes a tissue layer coating each strut and extending across each cell. The tissue layer defines a plurality of defects, each cell including a respective defect.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Certain disclosed delivery devices include a handle assembly including an actuator, a shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a torque shaft that is configured to apply and adjust the amount of tension in the each tension member. For example, the torque shaft can be configured to wind and unwind each elongate tension member around the torque shaft to correspondingly compress and expand the stented prosthesis. The torque shaft can be controlled with an actuator provided in the handle assembly, for example. In some embodiments, the actuator is further configured to axially move the torque shaft.

Abstract: The techniques of this disclosure generally relate to a variable permeability layered prosthesis including an impermeable outer layer and a permeable inner layer. The impermeable outer layer is well suited to seal a dissection opening of a dissection. The permeable inner layer allows fluid to enter into a dead space between the impermeable outer layer and the permeable inner layer. The fluid in the dead space coagulates in the dead space providing a media for tissue growth into the prosthesis. The ability of tissue to integrate into the prosthesis provides biological fixation of the prosthesis in vessels and prevents endoleaks and migration of the prosthesis.

Abstract: A telescoping catheter including an elongated tubular member having a proximal end, a distal end, and a passageway extending between the proximal end and the distal end. The tubular member includes a first tubular segment and a second tubular segment. The first tubular segment and the second tubular segment are slidable relative to one another to vary a length of the tubular member. The first tubular segment includes a first connector mateable with a second connector of the second tubular segment to selectively maintain the first and second tubular segments in an extended position. The second tubular segment includes a second proximal end that is mateable with a handle.

Abstract: A delivery device for implanting a prosthetic heart valve. The device includes an inner shaft assembly, an outer sheath and a connector assembly. The inner shaft assembly defines a guide wire lumen. The outer sheath is slidably received over the inner shaft assembly, and forms an exit port proximate a distal end thereof. The connector assembly establishes a guide wire passageway between the guide wire lumen and the exit port. The connector assembly is configured to permit sliding movement of the outer sheath relative to the inner shaft assembly when deploying the prosthetic heart valve. The connector assembly can include first and second tubes that are slidable relative to one another in facilitating movement of the outer sheath relative to the inner shaft assembly.

Abstract: A delivery device for delivery and deployment of a heart valve prosthesis with a torque anchoring mechanism includes a balloon having a shaped surface configured to engage a corresponding shaped surface of the heart valve prosthesis. The balloon is configured to rotate about a central longitudinal axis of the delivery device to rotate the heart valve prosthesis.

Abstract: Numerous delivery devices for delivery of a stented prosthesis, such as a stented prosthetic heart valve. Various delivery devices include a capsule that is advanced proximally to retain the stented prosthesis, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper or bumper assembly to provide a smooth transition of the capsule over the stented prosthesis. In some alternate disclosed embodiments, the bumper further serves to connect various elements of the inner shaft assembly. Additional embodiments include a bumper assembly arranged and configured to longitudinally expand and contract to substantially fill any open space as the capsule is retracted from the stented prosthesis, which prevents kinking in the capsule. Additional embodiments include proximal and/or distal bumpers for temporarily covering and smoothing the ends of the stented prosthesis as part of a delivery device that does not include a capsule.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: Stented prosthetic heart valves comprising a stent frame having a compressed arrangement for delivery within a patient's vasculature and an expanded arrangement for deployment within a native heart valve. The stented prosthetic heart valves including a paravalvular leakage prevention or mitigation wrap that encircles a stent frame and is formed of a flexible material having a variable diameter defined by a greatest distance between the wrap and the stent frame. The wrap further includes a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein the wrap can selectively enlarge its diameter in situ via movement of the second end. Devices for and methods of selectively deploying the wrap are also disclosed.

Abstract: A telescoping catheter including an elongated tubular member having a proximal end, a distal end, and a passageway extending between the proximal end and the distal end. The tubular member includes a first tubular segment and a second tubular segment. The first tubular segment and the second tubular segment are slidable relative to one another to vary a length of the tubular member. The first tubular segment includes a first connector mateable with a second connector of the second tubular segment to selectively maintain the first and second tubular segments in an extended position. The second tubular segment includes a second proximal end that is mateable with a handle.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis. The elongate body is sized and shaped to be received in the body lumen. A handle is mounted to the proximal end portion of the elongate body and operable to cause rotation of the elongate body. A tissue-removing element is mounted on the distal end portion of the elongate body. An inner liner is received within the elongate body and coupled to the handle at a proximal end of the inner liner. A sensor is arranged with respect to the elongate body and inner liner and is configured to detect wear of the inner liner caused by the elongate body contacting the inner liner during use.

Abstract: Systems and methods for determining modified fractional flow reserve values of vascular lesions are provided. Patient physiologic data, including coronary vascular information, is measured. According to the physiologic data, a coronary vascular model is generated. Lesions of interest within the coronary vascular system of the patient are identified for modified fractional flow reserve value determination. The coronary vascular model is modified to generate modified blood flow information for determining the modified fractional flow reserve value.

Abstract: A valve delivery system and valve delivery method are disclosed. The valve delivery system includes an inner shaft extending along a longitudinal axis and an elongated tension member to continuously circumferentially coil around a prosthetic valve disposed on the inner shaft to form a sheath portion to releasably contain the prosthetic valve on the inner shaft in a compressed state, the elongated tension member extending from the sheath portion along the longitudinal axis of the inner shaft.

Abstract: A needle lattice is used to form openings within a graft material to selectively enhance permeability of a prosthesis for tissue integration therein. The needle lattice may be disposed on, for example, a surface of a roller or press. The needle lattice precisely places openings in any pattern and location, and on any textile that forms the graft material. The needle lattice can be heated to fuse the surrounding material of the openings of the textile to prevent movement of the textiles and to prevent collapse of the openings. All parameters of the openings, including varying density, patterns, and size of each opening, can be controlled, allowing for the opportunity to selectively enhance and optimize the permeability of the graft material in a vessel. The needle lattice can quickly form multiple openings within a graft material, allowing for quick manufacturing of the prosthesis.

Abstract: A sheath of a delivery system is retracted by winding in cords coupled to the sheath. More particularly, a helical reel is rotated to wind the cords into a helical cord groove and retract the sheath. Rotation of the helical reel simultaneously causes a cord feed ring to slide ensuring that that the cords are correctly fed into the helical cord groove through cord feedthrough apertures of the cord feed ring. Initially, due to a minimal diameter of the helical cord groove, the cords are retracted slowly and with a high amount of torque, e.g., a high mechanical advantage. After retraction of the sheath has begun, the speed of retraction of the sheath is increased with reduced torque as the cords are wound around the increasing diameter of the helical cord groove.

Abstract: A device retention assembly includes a delivery system and a device retention mechanism retaining the delivery system. The device retention mechanism includes a tray, a base coupled to the tray, and retaining flanges pivotally coupled to the base. The delivery system is enclosed within an opening defined by the base and retaining flanges. A key locks the device retention mechanism in the closed position retaining the delivery system. The key must be removed to unlock the device retention mechanism to release the delivery system.