Abstract: A minimally invasive endoluminal annuloplasty system and method of use includes a guide catheter configured to direct a working catheter to a treatment site within a cardiac cavity. The guide catheter may be translatably disposed within the working catheter which may be translatably disposed within an introducer sheath that extends into the cardiac cavity. The guide catheter may be sized to reduce noise, and/or may be formed from a material that assists with visualization. In one embodiment the guide catheter comprises a distal guidewire anchor. Visualization may be used to embed the distal guidewire anchor into tissue at the target site.

Abstract: A valve fixation device may comprise a unitary elongate member that is biased towards a closed configuration wherein at least a pair of tissue engaging surfaces of the elongate member are held adjacent to each other by a bias force. The bias force is at least equal to a valve leaflet grasping force, enabling the fixation device to grasp and retain leaflets as part of cardiac treatment. A delivery tool including a spreader may independently translate the tissue engaging surfaces to enable cardiac leaflets to be captured and retained by and/or between the tissue engaging surfaces. The valve fixation device may include at least two arms, each of which may be independently controlled to grasp and capture opposing leaflets of a valve, such as the anterior and posterior leaflets of a mitral valve, to reduce the size of the valve opening and improve cardiac performance.

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: A valve fixation device may comprise a unitary elongate member that is biased towards a closed configuration wherein at least a pair of tissue engaging surfaces of the elongate member are held adjacent to each other by a bias force. The bias force is at least equal to a valve leaflet grasping force, enabling the fixation device to grasp and retain leaflets as part of cardiac treatment. A delivery tool including a spreader may independently translate the tissue engaging surfaces to enable cardiac leaflets to be captured and retained by and/or between the tissue engaging surfaces. The valve fixation device may include at least two arms, each of which may be independently controlled to grasp and capture opposing leaflets of a valve, such as the anterior and posterior leaflets of a mitral valve, to reduce the size of the valve opening and improve cardiac performance.

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: 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: 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 medical device for cutting a suture during a minimally invasive procedure includes an elongate shaft, a handle housing disposed at the proximal end of the elongate shaft, and a cutting blade disposed proximate the distal end of the elongate shaft. A proximal portion of the handle housing includes an actuation mechanism including a lever arm having a first portion disposed outside of the handle housing and extending distally from the proximal portion of the handle housing. Translation of the first portion of the lever arm relative to the handle housing axially translates the cutting blade within the elongate shaft. A medical device system may include a stand configured to support at least one medical device and a medical device securable to the stand.

Abstract: Devices, systems, and methods for delivery and deployment of an implantable device. The implantable device may be an anchor. The device includes an anchor garage configured to deliver the anchor, therein, to a target site, and an atraumatic shield movable with respect to the anchor garage. A biasing element biases the atraumatic shield into position with respect to the anchor garage. In some embodiments, the distal end of the anchor garage is a sharp tissue-penetrating end, and the atraumatic shield is biased distally over such sharp end. A limit stop may be provided to limit the extent to which the anchor garage extends distally, thereby limiting tissue penetration by the anchor garage and the depth of deployment of the anchor. An indicator may be positioned and/or configured to provide an indication of the relative positions of the anchor garage and the atraumatic shield.

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 delivery/deployment system having a control handle configured to control delivery and/or deployment of a medical device with arms configured to grasp tissue therebetween. The system may include a device spreader with arms engaging the medical device arms and controlled by an actuator operably coupled with the control handle. The control handle may include a lever pivotable to similarly pivot the device spreader and medical device arms open or closed. A device retention assembly may be provided to retain the medical device with respect to the device spreader. The control handle may include a release element movable to shift the retention assembly into a disengaged configuration allowing release of the medical device from the device spreader. The control handle may axially translate and/or rotate the device spreader into a desired position, and may be fixable in position by a handle lock once in a desired position.

Abstract: A delivery and deployment system having a control handle operable to deliver and/or deploy an implantable device, e.g., transluminally. A steering control system may include a steering control knob rotatable about the longitudinal axis of the handle to axially pull on a steering element to steer a flexible elongate member to deliver an implantable device to a desired site. An implantable device deployment system may include a slider selectively slidable with respect to the control handle to deploy an implantable device, and optionally to retain the implantable device in a delivery position. A tether adjustment system may include a knob rotatable about the handle's longitudinal axis to axially pull on a tether element to adjust the tension and/or length thereof. A tensioning and locking system may include a knob rotatable about the handle's longitudinal axis to shift a tensioning and locking device to set the tether element's tension and/or length.

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 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: 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.