Abstract: According to aspects of the present disclosure, a system may include a loading device including an exterior surface. The system may also include an expandable member mounted on the exterior surface of the loading device. The expandable member may be configured to selectively transition between a collapsed state and an expanded state. The system may also include a covering mounted on the expandable member. The covering may extend around the expandable member and the loading device. The loading device may be configured to position the expandable member and the covering for mounting on an exterior surface of an elongate introduction sheath.

Abstract: A heart valve anchor has a body that includes a distal portion, a distal end, a proximal portion, and a proximal end. The distal end and the proximal end define a longitudinal axis. The body has an expandable portion that includes a first radially expandable portion at the distal portion of the body, a second radially expandable portion at the proximal portion of the body, and a root portion disposed between the first and second radially expandable portions. The body has a first configuration adapted to be housed at least partially within a tissue penetrating device, and a second configuration in which the first and second radially expandable portions are partially or fully expanded such that the anchor engages tissue in a region between the first and second radially expandable portions.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: The present disclosure relates generally to apparatuses and methods for delivering an occlusion device to a paravalvular leak. In some embodiments, a paravalvular occlusion apparatus includes a catheter having main body including a proximal end and a distal end, a visualization element disposed in the distal end of the main body, and a working channel extending from the distal end of the main body. The catheter further includes an elongate shaft extendable from the working channel, wherein an occlusion device is coupled to the elongate shaft. In some embodiments, an occlusion device includes a leading end including a first section, and a trailing end opposite the leading end, the trailing end including a second section. The first section and the second section of the occlusion device are operable to be positioned along a perimeter of a prosthetic valve for blocking the paravalvular leak.

Abstract: A vascular introducer hub has a body that includes a proximal end, a distal end, and a lumen defined therethrough. The hub includes first and second seals disposed within the body. The first seal includes a first polymeric material and the second seal includes a second polymeric material. The hub is characterized by the first and second polymeric materials having different durometers.

Abstract: Anchor delivery systems and methods for repairing a valve inside a body, such as an atrioventricular valve, may include an anchor delivery device including a sheath for at least partially retaining an anchor in a collapsed form. The anchor delivery device may be configured to deliver the anchor to the atrioventricular valve. The anchor and an adjacent anchor may be connectable to each other in an expanded form, to link a series of anchors implanted at least partially around the atrioventricular valve. In some embodiments, the anchors may be connectable by a connecting member, such as a pledget, or a material disposable on a bulb of the anchor. In other embodiments, a bulb of the anchor and a bulb of the adjacent anchor may be configured to be directly interlocked.

Abstract: An illuminated needle device for performing a heart valve repair includes an outer member and an inner member. The outer member includes a body that has a proximal end and a distal end. The body of the outer member defines a lumen therethrough and the distal end of the body includes a needle. The inner member is slidably disposed within the lumen of the outer member. The inner member includes a distal end that has a radiation emitting element. The illuminated needle device is characterized by the outer and inner members together forming a flexible, elongate shaft, and the inner member being configured to emit radiation from the radiation emitting element from a location proximate to the distal end of the outer member.

Abstract: An introducer catheter device comprising a handle and an elongate shaft coupled to the handle and extending therefrom. The shaft defines a lumen therethrough, a longitudinal axis, and a first aperture in connection with the lumen. The shaft includes a movable deployment element configured for deploying an ancillary device from the first aperture at an angle relative to the longitudinal axis.

Abstract: A visualization catheter includes an elongate shaft, a cap portion, and an offset balloon coupled to the distal end of the shaft. The elongate shaft includes a proximal end, a distal end, and a central axis defined therebetween. The cap portion is coupled to the distal end of the shaft. The cap portion also includes a visualization element and defines an aperture. The offset balloon is coupled to the distal end of the shaft and encapsulates the cap portion. The offset balloon defines a center point offset relative to the central axis of the shaft.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: In various aspects, the present disclosure provides methods for applying ablation therapy to a target tissue region within a patient, which methods include: (a) navigating a catheter to a target tissue region within the patient, the catheter including an elongate body having a proximal portion and a distal portion and a balloon structure positioned at the distal portion of the elongate body, which balloon structure may be permeable to a calcium-ion-containing solution that comprises one or more calcium salts; (b) positioning the balloon structure at the target tissue region; (c) delivering energy to the target tissue region; and (d) eluting the calcium-ion-containing solution from the balloon structure before, during, and/or after delivering the energy to the target tissue region. In various other aspects, the present disclosure provides apparatuses that can be used for performing such methods, among others.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods for assessing electroporation therapy applied to a tissue region of a patient. In certain instances, the apparatuses, systems, and methods may include one or more sensors configured to sense an application of electroporation energy by an electroporation device to determine a location of the electroporation device within the patient.

Abstract: According to aspects of the present disclosure, a retrieval catheter assembly for retrieving an intragastric balloon may include a tubular member configured to pass through a wall of the intragastric balloon. The retrieval catheter assembly may also include a retrieval member coupled to the tubular member and movable between an undeployed configuration and a deployed configuration. In the undeployed configuration the retrieval member may be substantially aligned with the tubular member. In the deployed configuration at least a portion of the retrieval member may diverge from the tubular member and may be configured to engage the wall of the intragastric balloon.

Abstract: A device for collecting a tissue sample includes a needle body extending along a longitudinal axis from a proximal end to a distal end and including a channel extending longitudinally therethrough and a plurality of cut outs extending laterally into the needle body, each of the plurality of cut outs extending at an angle relative to the longitudinal axis from an outer surface of the needle body toward the distal end thereof so that the channel is open to an exterior of the needle body via the plurality of cut outs.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: The present disclosure relates generally to electroporation systems and utilizing algorithms for electroporation pulse delivery including a patient's EKG/EGM monitoring. In some embodiments, an electroporation delivery system may include an electrocardiogram operatively connected to a processing device and a memory. One or more sensors may be operatively connected to the electrocardiogram for measuring electrical activity QRS complex of a patient's heart. One or more electrodes for treatment may be disposed in, at, or near the patient's heart, the one or more electrodes operatively connected to a pulse delivery mechanism. The electroporation delivery system may be configured to determine whether an electroporation pulse is deliverable to a patient based on the electrocardiogram.

Abstract: Anchor delivery systems and methods for repairing a valve inside a body, such as a heart valve, may include a delivery catheter having a distal end comprised of two or more rotatably coupled knuckles. An anchor delivery mechanism is disposed distally of the two or more knuckles, and includes a first pincer arm having a distal end and a proximal end rotatably coupled to a distal end of the anchor delivery mechanism at a first connection point, and a second pincer arm having a distal end and a proximal end rotatably coupled to the distal end of the anchor delivery mechanism at a second connection point opposite the first connection point. In a closed position, the distal ends of the first and second pincer arms are positioned together. In an open position, the distal ends of the first and second pincer arms are rotated apart from each other.

Abstract: The present disclosure relates to medical devices that comprise (a) a balloon structure having a proximal end, a distal end, a porous region, a non-porous region and an interior chamber, and (b) one or more radiopaque markers disposed on the balloon structure, the radiopaque markers including a polymeric material and a radiopaque material. The present disclosure also relates to methods of forming such medical devices, systems that include such medical devices, and methods of using such medical devices and systems.

Abstract: Embodiments of the present disclosure relate to treating diseased tissue with ablation therapy. In an embodiment, an apparatus comprises a catheter having an elongate body extending between a proximal end and a distal end. The apparatus further includes a balloon structure arranged proximal to the distal end of the catheter, wherein the balloon structure has a first portion with a first permeability and a second portion with a second permeability such that the first permeability is different than the second permeability. In addition, the apparatus includes a first electrode arranged on or within the balloon structure and configured to: transmit current through the first portion, receive current transmitted through the first portion or both.

Abstract: The present disclosure relates generally to medical devices and methods for medical devices to be placed within a lumen of a patient, wherein the devices comprise one or more radiopaque filaments arranged with the devices and viewable to assist in placement and orientation of the devices with respect to the lumen.