Abstract: Prosthetic heart valve devices with tethered anchors and associated systems and methods are disclosed herein. A heart valve device configured in accordance with embodiments of the present technology can include, for example, a valve support for carrying a prosthetic valve. The valve support can be configured to be implanted at an annulus of a native mitral valve. The device can further include at least one elongated flexible member extending from the valve support in a ventricular direction, and an anchor coupled to the valve support via the elongated flexible member. The anchor can be shaped to wrap around an exterior area of an apical portion of the heart. In addition, the anchor can inhibit retrograde migration of the valve support.

Abstract: In some examples, an introducer apparatus includes an outer elongated member defining a lumen extending therethrough, the lumen having a lumen dimension in cross-section, and a dilator configured to be received within the lumen of the outer elongated member, the dilator may comprise a proximal section, a distal section comprising a distal end of the dilator, and an intermediate section disposed between the proximal section and the tapered distal section. In some examples, the intermediate section may define a through-opening that configures the intermediate section to be collapsible from an expanded configuration to a collapsed configuration. In the collapsed configuration, the intermediate section may have a first dilator dimension in cross-section that is less than a second dilator dimension in cross-section when the intermediate section is in the expanded configuration.

Abstract: A system for treating valvular regurgitation in a heart valve includes a flexible canopy and an elongated tether including an elastic portion and an inelastic portion. When the system is in a deployed configuration, a proximal end of the flexible canopy is coupled to an annulus of the heart valve and a distal end of the elongated tether is coupled to a ventricle. The flexible canopy is configured to overlay a first native leaflet of the heart valve, and tension on the elongated tether is applied and/or adjusted to prevent the first leaflet from prolapsing, to maximize coaptation of the flexible canopy with a second native leaflet of the heart valve, and to minimize regurgitation of the heart valve.

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: 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: A catheter-based system for percutaneously supporting and articulating a septal wall of a heart includes a catheter and a flanged device. The flanged device includes a distal anchor and a proximal anchor, and has a radially collapsed configuration and a radially expanded configuration. When the flanged device is in the radially expanded configuration and disposed through a transseptal puncture in the septal wall, the flanged device is configured to anchor to the septal wall to permit manipulation thereof whereby an angle between an axis through the transseptal puncture and an axis through a native valve is reduced. The proximal anchor and the distal anchor may each be self-expanding or balloon expandable. The flanged device may further include a flanged device shaft. The flanged device shaft may be releasably coupled to the catheter.

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 tissue-removing catheter for removing tissue in a body lumen includes an elongate body and a handle mounted to a proximal end portion of the elongate body. The handle 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. An inner liner is received within the elongate body and is coupled to the handle at a proximal end portion of the inner liner. The inner liner defines a guidewire lumen. The inner liner is coupled to the tissue-removing element at a distal end portion of the inner liner such that translational movement of the inner liner in the body lumen causes a corresponding translational movement of the tissue-removing element.

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: Systems and methods to analyze blood or other fluid sample. The systems and methods utilize bi-directional magnetic forces to push or pull a magnetic object along a post in a chamber housing the fluid sample both before and after clot initiation has been implicated. The magnetic object can be threadably connected to the post. In other embodiments, the chamber is configured such that the magnetic object does not rotate but only slides along the post. Once a clot has been detected, the washer can be moved either up or down to apply either compressive force or strain within the clot, as desired, to evaluate elastic properties or firmness of the clot.

Abstract: A venous valve prosthesis includes a frame and a prosthetic valve coupled to the frame. With the venous valve prosthesis implanted in a vein, the prosthetic valve includes a closed configuration wherein an outer surface of the prosthetic valve is in contact with a wall of the vein around a circumference of the prosthetic valve to prevent blood from flowing past the prosthetic valve between the wall of the vein and the outer surface of the prosthetic valve. The prosthetic valve is configured to move to an open configuration such that at least a portion of an outer wall of the prosthetic valve partially collapses away from the wall of the vein in response to antegrade blood flow through the vein to enable blood flow between the outer surface of the prosthetic valve and the wall of the vein.

Abstract: A flexible, sterilizable pouch includes a first wall coupled to a second wall and a cavity defined between the first wall and the second wall. The cavity is configured to receive a medical device, and the pouch is configured to seal the medical device within the cavity. At least one of the first wall and the second wall of the pouch includes two layers. Each layer is coupled to the adjacent layer such that a breach in any one layer of the multi-layered wall will not breach the seal of the pouch. A pocket may be formed between the layers of the multi-layered wall and may include a gas under pressure to inflate the corresponding wall to an inflated state.

Abstract: A catheter, such as a fractional flow reserve catheter, includes an elongate shaft having a pressure sensing wire extending to the distal portion of the elongate shaft. The wire has a pressure sensor mounted on the distal end for measuring a pressure of a fluid within lumen of vessel. The pressure sensor wire is disposed within a pocket formed adjacent to the pressure sensor thereby minimizing the profile of the catheter. Bending stresses experienced by a pressure sensor mounted to a fractional flow reserve catheter when tracking the catheter through the vasculature creates a distortion of the sensor resulting in an incorrect pressure reading or bend error. In order to isolate the sensor from bending stresses, the sensor is spaced apart from the pressure sensor wire to allow the pressure sensor and the pressure sensor wire to move independently from one another.

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: 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 prosthetic assembly for repairing a target tissue defect within a target vessel region configured includes an exclusion structure sized to substantially bypass target tissue defect, and includes a branch assembly. The branch assembly can include a self-expanding outer branch prosthesis having an inflow region configured to deform to a non-circular cross-sectional-shape when deployed, and a support structure at least partially disposed within the inflow region. The support structure preserves blood flow to the branch vessel while the deformed inflow region inhibits blood leakage between and/or around the prosthetic assembly.

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 balloon catheter includes an elongated catheter shaft, an expandable balloon connected to the elongated catheter shaft, and a sheath that defines a lumen and includes a therapeutic agent disposed within the lumen. The balloon catheter further includes a first configuration and a second configuration. When in the first configuration, the expandable balloon is disposed distally from the sheath such that an outer surface of the expandable balloon does not contact the lumen. Further, when in the second configuration, at least a portion of the outer surface of the expandable balloon is disposed within the lumen of the sheath such that it contacts the therapeutic agent. At least a portion of the therapeutic agent that contacts the outer surface of the expandable balloon is transferred from the lumen of the sheath to the outer surface of the expandable balloon when the balloon catheter is in the second configuration.

Abstract: A laser is used to form openings within a graft material to selectively enhance permeability of a prosthesis for tissue integration therein. A feature of utilizing a laser to create the openings for tissue integration builds from its tunability. More particularly, the laser precisely places openings in any pattern and location, and on any textile that forms the graft material. Further, the power and focus of the laser is precisely adjusted to control the diameter and shape of the openings. All parameters of the openings can be controlled at will, allowing for the opportunity to selectively enhance and optimize the permeability of the graft material in a vessel.