Systems and methods for intra-procedural cardiac pressure monitoring

A delivery device for delivering an interventional device to a targeted treatment area within a body, the delivery device comprising:

• a steerable outer guide catheter having a proximal end and a distal end;
• a steerable inner sleeve positioned radially within the outer guide catheter and configured to be translatable within the outer guide catheter;
• a delivery catheter positioned radially within the inner sleeve and configured to be translatable within the inner sleeve, the delivery catheter being configured to enable delivery of an interventional device through the inner sleeve and outer guide catheter to a targeted treatment area within a body;
• and
• at least one pressure sensor coupled to one or more of the outer guide catheter, inner sleeve, or delivery catheter, the at least one pressure sensor being configured to enable monitoring of blood pressure at the targeted treatment area during deployment of an interventional device using the delivery device.

A delivery device for delivering an interventional device to a mitral valve, the delivery device comprising:

• a steerable outer guide catheter having a proximal end and a distal end;
• a steerable inner sleeve positioned radially within the outer guide catheter and configured to be translatable within the outer guide catheter;
• a delivery catheter positioned radially within the inner sleeve and configured to be translatable within the inner sleeve, the delivery catheter being configured to enable delivery of an interventional device through the inner sleeve and outer guide catheter to a targeted treatment area within a body;
• and
• a plurality of pressure sensors coupled to one or more of the outer guide catheter, inner sleeve, or delivery catheter, the plurality of pressure sensors being arranged so as to enable monitoring of blood pressure at different areas near the mitral valve during deployment of an interventional device.

An interventional spacer assembly configured for delivery to a targeted treatment area within a body, the spacer assembly comprising:

• a spacer device having a proximal end and a distal end, the spacer device being configured for placement within a heart valve to provide a surface for coaptation of valve leaflets;
• an anchoring trackwire attached to the distal end of the spacer device and extending distally therefrom, the anchoring trackwire being configured to enable anchoring into a section of myocardium when the spacer device is deployed in the valve in order to orient the spacer device relative to the valve;
• and
• one or more sensors associated with the spacer device to enable monitoring of hemodynamic properties near the heart valve during and after deployment of the spacer device.

An interventional spacer assembly configured for delivery to a mitral valve, the spacer assembly comprising:

• a spacer device having a proximal end and a distal end, the spacer device being configured for placement within a mitral valve to provide a surface for coaptation of mitral valve leaflets;
• a trackwire attached to the spacer device and extending at least distally therefrom, the trackwire being configured to enable anchoring into a section of myocardium of a left ventricle when the spacer device is deployed in the mitral valve in order to properly orient the spacer device relative to the mitral valve;
• and
• a pair of pressure sensors associated with the spacer device and positioned on opposite sides of the spacer device to enable monitoring of pressure on either side of the mitral valve during and after deployment of the spacer device.

A method for delivering a spacer device to a mitral valve for deployment of the spacer device at the mitral valve, comprising:

• delivering a tracking wire to the mitral valve by passing the tracking wire through a septum to cross into a left atrium;
• passing the tracking wire through the mitral valve and anchoring the tracking wire in myocardium of a left ventricle;
• and
• using the tracking wire to guide a spacer assembly to deploy the spacer assembly within the mitral valve, the spacer assembly including a spacer device configured to allow coaptation of mitral valve leaflets against the spacer device, and one or more sensors enabling monitoring of one or more hemodynamic properties in the vicinity of the spacer device.

An interventional chord replacement assembly configured for attachment to a targeted heart valve, the chord replacement assembly comprising:

• a chord replacement device having a proximal end and a distal end, the chord replacement device being configured for attachment to a heart valve to tether the heart valve to a section of myocardium of the heart;
• one or more sensors coupled to the chord replacement device to enable monitoring of hemodynamic properties associated with the heart valve during and after deployment of the chord replacement device;
• and
• an access component configured to be positioned outside the heart and configured to enable adjustment of the length of the cord replacement device.

A method for attaching a chord replacement device to a mitral valve, the method comprising:

• delivering a chord replacement device to the mitral valve;
• attaching a proximal end of the chord replacement device to a leaflet of the mitral valve;
• anchoring a distal end of the chord replacement device to myocardium located at an apex of a left ventricle, the distal end of the chord replacement device extending through the myocardium to couple to an access component disposed on an exterior of the myocardium, the access component being coupled to the chord replacement device so as to enable adjustment to the length of the chord replacement device;
• receiving hemodynamic information from one or more sensors coupled to the chord replacement device;
• and
• based on the received hemodynamic information, adjusting the length of the chord replacement device.

An interventional assembly configured for deployment at a targeted heart valve, the interventional assembly comprising:

• an adjustable interventional device configured for deployment at the targeted heart valve to reduce a level of regurgitation at the heart valve, the adjustable interventional device including a connector that extends, when the interventional device is deployed at the heart valve, into a ventricular area to attach to myocardium in the ventricular area;
• an actuator component disposed external to the myocardium and opposite the connector, the connector extending through the myocardium to couple with the actuator component;
• one or more sensors coupled to the adjustable interventional device, the one or more sensors being configured to gather hemodynamic information;
• and
• a controller communicatively associated with the one or more sensors and with the actuator component, the controller being configured to receive hemodynamic information from the one or more sensors and, in response, direct the actuator component to adjust the adjustable interventional device according to the hemodynamic information.

An interventional occluder assembly configured for deployment at a targeted treatment site, the occluder assembly comprising:

• an occluder device configured to occlude a defect at the treatment site;
• one or more sensors extending from the occluder device, the one or more sensors being configured to measure one or more hemodynamic properties;
• and
• a connector disposed between the occluder device and the one or more sensors, the connector being configured in size and shape to direct the one or more sensors from the occluder device to one or more desired hemodynamic measurement areas when the occluder device is deployed.

An interventional tissue fixation assembly, comprising:

• a tissue fixation clip including a pair of distal elements rotatably joined to a coupling member and a pair of proximal elements resiliently biased toward the distal elements, the distal elements being configured to receive the proximal elements so as to enable the grasping of tissue therebetween;
• one or more mounts configured to be attachable to the clip;
• and
• one or more sensors configured to be attachable to the one or more mounts, the one or more sensors being configured to measure one or more hemodynamic properties.

An interventional mitral valve fixation assembly, comprising:

• a mitral valve fixation clip including a pair of distal elements rotatably joined to a coupling member and a pair of proximal elements resiliently biased toward the distal elements, the distal elements being configured to receive the proximal elements so as to enable the grasping of mitral valve leaflets therebetween;
• a distal mount coupled to the coupling member and extending distally from the coupling member;
• a proximal mount joined to the clip member and extending proximally from the clip;
• and
• one or more pressure sensors mounted in each of the distal mount and the proximal mount, the one or more sensors being configured to measure left atrial and left ventricular pressure during and/or after deployment of the fixation clip.

A method for deploying a tissue fixation device at a heart valve, the method comprising:

• using a delivery catheter, delivering a tissue fixation clip to the heart valve and passing the tissue fixation clip from a proximal side through the heart valve to a distal side;
• positioning a pair of distal elements on a distal side of heart valve tissue;
• lowering a pair of proximal elements onto a proximal side of the heart valve tissue so as to grasp the heart valve tissue between the distal elements and the proximal elements;
• decoupling the delivery catheter from the tissue fixation clip;
• and
• delivering a proximal mount to the proximal side of the deployed clip and attaching the proximal mount to the clip, the proximal mount including one or more sensors for measuring one or more hemodynamic properties.

An interventional annuloplasty assembly configured for deployment at a targeted treatment site, the annuloplasty assembly comprising:

• an annuloplasty device having a lumen;
• a plurality of anchors positionable within the lumen so as to anchor the annuloplasty device along a plurality of corresponding positions;
• a connecting wire connecting the plurality of anchors such that tensioning of the connecting wire brings the plurality of anchors closer together to tighten the annuloplasty device;
• and
• one or more sensors coupled to the connecting wire of the annuloplasty device, the one or more sensors being configured to measure one or more hemodynamic properties at a targeted treatment site upon deployment of the annuloplasty assembly at the targeted treatment site.