Abstract: Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

Abstract: Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Abstract: Described herein are devices and methods for improving the hemodynamic function of a patient. In particular, a first device adapted to reshape an atrio-ventricular valve is used in combination with a second device configured to further alter the blood flow through the valve. The first device is typically an implant positioned in the subvalvular space of a ventricle. The second device may be an annuloplasty implant, a non-annulus valve apparatus implant, a ventriculoplasty implant, or a cardiac rhythm management device.

Abstract: Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

Abstract: Methods and devices for successively advancing a plurality of catheters over a guide element to a body tissue are described. In some of the methods, the guide element may be attached to the body tissue, which may be accessible minimally invasively. In certain variations, the guide element may not be detached from the body tissue after the catheters have been advanced over the guide element. The methods may further comprise deploying at least one implant from at least one of the plurality of catheters. In some variations, a method may comprise advancing a first delivery catheter to a first region of a body tissue, deploying a first anchor from the first delivery catheter, where the first anchor is attached to a guide element, proximally withdrawing the first delivery catheter, advancing a second delivery catheter over the guide element, and deploying a second anchor from the second delivery catheter.

Abstract: Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

Abstract: Devices and methods used in termination of a tissue tightening procedure are described. Termination includes the cinching of a tether to tighten the tissue, locking the tether to maintain tension, and cutting excess tether. In procedures involving anchors secured to the tissue, the tether is coupled to the anchors and the tissue is tightened via tension applied to the anchors by cinching the tether. In general, the devices and methods can be used in minimally invasive surgical procedures, and can be applied through small incisions or intravascularly. A method for tightening tissue by fixedly coupling a first anchor to a tether and slidably coupling a second anchor to the tether, securing both anchors to the tissue, applying tension to the tether intravascularly, fixedly coupling the tether to the second anchor, and cutting the tether is described. The tissue to be tightened can comprise heart tissue, in particular heart valve annulus tissue.

Abstract: Devices and methods generally provide enhanced stabilization, exposure and/or treatment of a cardiac valve annulus. Methods generally involve introducing a stabilizing member beneath one or more leaflets of a heart valve to engage the annulus at an intersection between the leaflets and the interior ventricular wall of the heart. Force is then applied to the stabilizing member to stabilize and/or expose the valve annulus. In some embodiments, the stabilizing member may include a series of hydraulically driven tethered anchors, such as hooks or clips, for engaging and cinching valve annulus tissue to decrease the diameter of a regurgitant valve. Alternatively, other treatments may be delivered by a stabilizing member, such as radiofrequency energy, drugs, bulking agents or shape memory stents. A second stabilizing member may also be introduced above the leaflets for further stabilization.

Abstract: Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Abstract: Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Abstract: Devices and methods generally provide enhanced stabilization, exposure and/or treatment of a cardiac valve annulus. Methods generally involve introducing a stabilizing member beneath one or more leaflets of a heart valve to engage the annulus at an intersection between the leaflets and the interior ventricular wall of the heart. Force is then applied to the stabilizing member to stabilize and/or expose the valve annulus. In some embodiments, the stabilizing member may include a series of hydraulically driven tethered anchors, such as hooks or clips, for engaging and cinching valve annulus tissue to decrease the diameter of a regurgitant valve. Alternatively, other treatments may be delivered by a stabilizing member, such as radiofrequency energy, drugs, bulking agents or shape memory stents. A second stabilizing member may also be introduced above the leaflets for further stabilization.

Abstract: Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Abstract: Described herein are devices and methods for improving the hemodynamic function of a patient. In particular, a first device adapted to reshape an atrio-ventricular valve is used in combination with a second device configured to further alter the blood flow through the valve. The first device is typically an implant positioned in the subvalvular space of a ventricle. The second device may be an annuloplasty implant, a non-annulus valve apparatus implant, a ventriculoplasty implant, or a cardiac rhythm management device.

Abstract: Devices and methods for facilitating transvascular, minimally invasive and other “less invasive” surgical procedures generally include a sheath with an expandable balloon at the distal end, an inflation lumen for expanding the balloon, and a device passage lumen for allowing passage of one or more surgical instruments. The sheath is configured to house at least one visualization device such that an optical element of the device is positioned to view the surgical site. In some embodiments, instruments may be passed through the sheath, with the distal balloon partially or fully circumscribing or encircling the instruments. Any suitable instrument(s) may be passed through sheaths of the invention, such as a surgical clip applier for repairing a heart valve, an ablation member for treating atrial fibrillation, one or more pacemaker leads, a coronary sinus access device or the like.

Abstract: Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Abstract: Methods and devices provide constriction of a heart valve annulus to treat cardiac valve regurgitation and other conditions. Embodiments typically include a device for attaching a cinching or tightening apparatus to a heart valve annulus to reduce the circumference of the annulus, thus reducing valve regurgitation. Tightening devices may include multiple tethered clips, multiple untethered crimping clips, stabilizing devices, visualization devices, and the like. In one embodiment, a plurality of tethered clips is secured circumferentially to a valve annulus, and the tether coupling the clips is cinched to reduce the circumference of at least a portion of the annulus. Methods and devices may be used in open heart surgical procedures, minimally invasive procedures, catheter-based procedures, and/or procedures on beating hearts or stopped hearts.

Abstract: Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

Abstract: Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Abstract: Devices and methods generally provide enhanced stabilization, exposure and/or treatment of a cardiac valve annulus. Methods generally involve introducing a stabilizing member beneath one or more leaflets of a heart valve to engage the annulus at an intersection between the leaflets and the interior ventricular wall of the heart. Force is then applied to the stabilizing member to stabilize and/or expose the valve annulus. In some embodiments, the stabilizing member may include a series of hydraulically driven tethered anchors, such as hooks or clips, for engaging and cinching valve annulus tissue to decrease the diameter of a regurgitant valve. Alternatively, other treatments may be delivered by a stabilizing member, such as radiofrequency energy, drugs, bulking agents or shape memory stents. A second stabilizing member may also be introduced above the leaflets for further stabilization.

Abstract: Methods and devices provide constriction of a heart valve annulus to treat cardiac valve regurgitation and other conditions. Embodiments typically include a device for attaching a cinching or tightening apparatus to a heart valve annulus to reduce the circumference of the annulus, thus reducing valve regurgitation. Tightening devices may include multiple tethered clips, multiple untethered crimping clips, stabilizing devices, visualization devices, and the like. In one embodiment, a plurality of tethered clips is secured circumferentially to a valve annulus, and the tether coupling the clips is cinched to reduce the circumference of at least a portion of the annulus. Methods and devices may be used in open heart surgical procedures, minimally invasive procedures, catheter-based procedures, and/or procedures on beating hearts or stopped hearts.