Abstract: A medical system includes an introducer device having an elongate shaft defining a shaft lumen and a hub secured to a proximal region of the elongate shaft. The hub includes a primary channel extending through the hub and fluidly coupled with the shaft lumen and a secondary channel extending through the hub and fluidly coupled with the shaft lumen. A guide catheter is adapted to be advanced through the secondary channel and into the shaft lumen. A guidewire is adapted to be advanced through the secondary channel and into the shaft lumen. A working catheter is adapted to be advanced through the primary channel and into the shaft lumen when the guide catheter is positioned with a distal end of the guide catheter within the secondary channel, the working catheter including a catheter shaft including a distal region that is adapted to releasably engage the guidewire.

Abstract: Tissue puncture devices, and systems and methods for accessing tissue (e.g., cardiovascular tissue) according to the present disclosure may include a tubular sheath extending along a longitudinal axis, the tubular sheath having a proximal end and a distal end, a needle disposed coaxially in the sheath, the needle having a proximal end and a distal end and being movable along the longitudinal axis of sheath, and a needle control mechanism disposed at the proximal end of the needle, the needle control mechanism being configured to lock the distal end of the needle in a first position retracted within the distal end of the sheath, and release the needle to an unlocked second position such that the distal end of the needle is extendable beyond the distal end of the sheath.

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: 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: 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: The present disclosure relates generally to the field of medical devices for delivering artificial chordae tendineae in a patient. In an embodiment, an anchor is movable between a delivery configuration and a deployed configuration, the anchor being in the delivery configuration when disposed within a delivery catheter, the anchor being in the deployed configuration when the anchor is moved beyond a distal end of the delivery catheter. When the anchor is in the delivery configuration it has a first outer dimension and when the anchor is in the deployed configuration it has a second outer dimension, the first outer dimension being smaller than the second outer dimension. The anchor is engageable with a papillary muscle or a heart wall when the anchor is in the deployed configuration and is also coupleable to an artificial chordae tendineae to anchor the artificial chordae tendineae to the papillary muscle or heart wall.

Abstract: A catheter configured to dynamically compensate for the impact of internal and external forces that act upon the catheter during use is disclosed. The catheter may include sensors configured to measure received forces on control cables that extend within the catheter. A controller, coupled to the sensors, may record received force measurements associated with a working position of a distal end of the catheter. The controller may monitor subsequently received forces to identify force variances that may deflect the distal end of the catheter from its working position and may apply a driving force to one or more of the control cables to minimize the force variances. Monitoring received forces during use and applying compensating drive forces may reduce deflection of the distal end of the catheter, increasing the accuracy and precision of an annuloplasty procedure while minimizing potential damage to cardiac tissue.

Abstract: The present disclosure relates generally to the field of medical devices for treating heart disease. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae tendineae in a patient. A system for delivering a chordae tendineae into a heart may include a delivery catheter. A clamp catheter may be configured to translate through the delivery catheter. A spreader may be disposed on the clamp catheter. A first clamp may be at least partially contained in the spreader in a closed configuration and may be attached to the chordae tendineae. An anchor catheter may be configured to translate through the delivery catheter and may have an anchor attached to the chordae tendineae. A sheath may be extended over the anchor catheter and anchor and may be configured to restrain an arm of the anchor.

Abstract: The present disclosure relates generally to the field of medical devices for delivering artificial chordae tendineae in a patient. In an embodiment, an anchor is movable between a delivery configuration and a deployed configuration, the anchor being in the delivery configuration when disposed within a delivery catheter, the anchor being in the deployed configuration when the anchor is moved beyond a distal end of the delivery catheter. When the anchor is in the delivery configuration it has a first outer dimension and when the anchor is in the deployed configuration it has a second outer dimension, the first outer dimension being smaller than the second outer dimension. The anchor is engageable with a papillary muscle or a heart wall when the anchor is in the deployed configuration and is also coupleable to an artificial chordae tendineae to anchor the artificial chordae tendineae to the papillary muscle or heart wall.

Abstract: The present disclosure relates generally to the field of medical devices for treating heart disease. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae tendineae in a patient. A system for delivering a chordae tendineae into a heart may include a delivery catheter. A clamp catheter may be configured to translate through the delivery catheter. A spreader may be disposed on the clamp catheter. A first clamp may be at least partially contained in the spreader in a closed configuration and may be attached to the chordae tendineae. An anchor catheter may be configured to translate through the delivery catheter and may have an anchor attached to the chordae tendineae. A sheath may be extended over the anchor catheter and anchor and may be configured to restrain an arm of the anchor.

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 the field of medical devices for delivering artificial chordae tendineae in a patient. A system for adjusting tension in an artificial chordae tendineae includes an artificial chordae tendineae coupleable between a clip and an anchor. The clip is engageable with a leaflet of a heart valve while the anchor is engageable with a papillary muscle or heart wall. The anchor includes a body portion, and a locking portion coupleable with the artificial chordae tendineae and configured to allow movement of the artificial chordae tendineae in a first direction while preventing movement of the artificial chordae tendineae in a second direction opposite the first direction. An actuator is coupled to the locking portion for selectively releasing the locking portion to enable selective movement of the artificial chordae tendineae in the second direction.

Abstract: According to one aspect, a visualization device may include an image sensor, a lens for focusing light onto the image sensor, a first end, a second end opposite the first end, a lateral wall surface extending between the first end and the second end, and a coating on the lateral wall surface. The coating may include at least one of an electrically-insulating layer and a light-blocking layer, and may be deposited on the lateral wall surface using, for example, physical vapor deposition (PVD).

Abstract: The present disclosure relates generally to the field of medical devices for delivering artificial chordae tendineae in a patient. A system for adjusting tension in an artificial chordae tendineae includes an artificial chordae tendineae coupleable between a clip and an anchor. The clip is engageable with a leaflet of a heart valve while the anchor is engageable with a papillary muscle or heart wall. The anchor includes a body portion, and a locking portion coupleable with the artificial chordae tendineae and configured to allow movement of the artificial chordae tendineae in a first direction while preventing movement of the artificial chordae tendineae in a second direction opposite the first direction. An actuator is coupled to the locking portion for selectively releasing the locking portion to enable selective movement of the artificial chordae tendineae in the second direction.

Abstract: The present disclosure relates generally to the field of medical devices for clamping a leaflet of a heart valve. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae tendineae in a patient. In an embodiment, a system may include a clamp having a plurality of arms at a first end. The plurality of arms may have a closed configuration in which the arms are oriented toward each other, and an open configuration in which the arms are oriented away from each other. A spring portion may be coupled to the plurality of arms at a second end that is configured to bias the arms to the closed configuration. The arms of the clamp may be configured to fixedly engage with a leaflet of the heart valve. The second end of the clamp may be configured to couple to an artificial chordae tendineae.

Abstract: According to one aspect, a visualization device may include an image sensor, a lens for focusing light onto the image sensor, a first end, a second end opposite the first end, a lateral wall surface extending between the first end and the second end, and a coating on the lateral wall surface. The coating may include at least one of an electrically-insulating layer and a light-blocking layer, and may be deposited on the lateral wall surface using, for example, physical vapor deposition (PVD).

Abstract: A heart valve anchor apparatus may include a body having a proximal portion and a distal portion. The body may include a first radially expandable portion at the proximal portion of the body, a second radially expandable portion at the distal portion of the body, and a root portion extending from the first radially expandable portion to the second radially expandable portion, the root portion having an outer extent. The first radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. The second radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. In an unstressed configuration, the body may define a longitudinal centerline that extends away from a plane tangent to the root portion.

Abstract: The present disclosure relates generally to the field of medical devices for clamping a leaflet of a heart valve. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae tendineae in a patient. In an embodiment, a system may include a clamp having a plurality of arms at a first end. The plurality of arms may have a closed configuration in which the arms are oriented toward each other, and an open configuration in which the arms are oriented away from each other. A spring portion may be coupled to the plurality of arms at a second end that is configured to bias the arms to the closed configuration. The arms of the clamp may be configured to fixedly engage with a leaflet of the heart valve. The second end of the clamp may be configured to couple to an artificial chordae tendineae.

Abstract: A clip and a clip deployment and delivery system. The clip may be engaged with a clip spreader such that simple relative movement, such as sliding movement, between the clip and clip spreader causes the clip and clip spreader to disengage from each other. A clip spreader actuator may be coupled to one arm of the clip spreader, extend distally around a distal end of the clip spreader, proximally along the other clip spreader arm, and to a proximal end at which the actuator may be controlled to open or close the clip spreader. The clips may be leaflet clips having teeth on one arm thereof and bumps on another arm thereof. The arms of the leaflet clip may be biased into a closed configuration by a flex zone which has an expanded portion extending laterally away from only one of the clip arms.

Abstract: A heart valve anchor apparatus may include a body having a proximal portion and a distal portion. The body may include a first radially expandable portion at the proximal portion of the body, a second radially expandable portion at the distal portion of the body, and a root portion extending from the first radially expandable portion to the second radially expandable portion, the root portion having an outer extent. The first radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. The second radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. In an unstressed configuration, the body may define a longitudinal centerline that extends away from a plane tangent to the root portion.