Abstract: A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent, a plurality of prosthetic valve leaflets each having a belly attached to the cuff between a first location and a second location downstream of the first location in a flow direction, and a sealing structure attached to the annulus section of the stent. The annulus section of the stent may be adjacent the proximal end. The stent may include a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent. The sealing structure may have a deployed condition with a diameter greater than a diameter of the proximal end of the stent when the stent is in an expanded use condition.

Abstract: A system and method for performing a structural heart repair or replacement procedure on a patient includes an augmented reality system, a tracked instrument, a first image acquisition system, and a computer system. The method includes a step of acquiring the first holographic image dataset from the patient. The computer system tracks, in a next step, the tracked instrument using the plurality of sensors to provide a tracked instrument dataset. The method also includes a step of registering the first holographic image dataset and the tracked instrument dataset with the patient. The augmented reality system then renders, in a next step, a first hologram based on the first holographic image dataset from the patient for viewing by a practitioner. The practitioner is thereby permitted to perform the procedure on the patient while viewing the patient and the first hologram with the augmented reality system.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent, a plurality of prosthetic valve leaflets each having a belly attached to the cuff between a first location and a second location downstream of the first location in a flow direction, and a sealing structure attached to the annulus section of the stent. The annulus section of the stent may be adjacent the proximal end. The stent may include a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent. The sealing structure may have a deployed condition with a diameter greater than a diameter of the proximal end of the stent when the stent is in an expanded use condition.

Abstract: A method and a system for image-guided intervention such as a percutaneous treatment or diagnosis of a patient may include at least one of a pre-registration method and a re-registration method. The pre-registration method is configured to permit for an efficient virtual representation of a planned trajectory to target tissue during the intervention, for example, as a holographic light ray shown through an augmented reality system. In turn, this allows the operator to align a physical instrument such as a medical probe for the intervention. The re-registration method is configured to adjust for inaccuracy in the virtual representation generated by the pre-registration method, as determined by live imaging of the patient during the intervention. The re-registration method may employ the use of intersectional contour lines to define the target tissue as viewed through the augmented reality system, which permits for an unobstructed view of the target tissue for the intervention.

Abstract: A holographic augmented reality ultrasound needle guide system and method includes an augmented reality display such as a headset wearable by a user. The augmented reality display is configured to depict a virtual ultrasound image. The augmented reality display is further configured to allow a user to select a desired reference point on the virtual ultrasound image. The system is configured to depict a holographic needle guide based on the selection of the desired reference point. The system is also configured to adjust a trajectory of the holographic needle guide to avoid intersecting undesired anatomical structures. The augmented reality display is further configured to stamp the holographic needle guide into a selectively locked trajectory and position.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end and a distal end. A plurality of commissure attachment features (“CAFs”) is disposed on the stent, with each CAF including a body and a plurality of eyelets. The eyelets may be arranged in a single column or in a plurality of rows and columns. The prosthetic heart valve also includes a collapsible and expandable valve assembly including a plurality of leaflets connected to the plurality of commissure attachment features. The bodies of the CAFs may include a number of other features including, for example, a slot extending between columns of eyelets.

Abstract: A collapsible and expandable stent body includes a generally tubular annulus section, one or more prosthetic valve elements mounted to the stent body, and a cuff attached to the stent body. The prosthetic valve is operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction. The prosthetic heart valve may include paravalvular leak mitigation features in the form of first and second sealing members. The sealing members are attached to the cuff and extend circumferentially around an abluminal surface of the stent body. The sealing members each have an open side facing in a first axial direction and a closed side facing in an opposite second axial direction. Flow of blood in the second axial direction will tend to force blood into the sealing members and cause the sealing members to billow outwardly relative to the stent body, helping to mitigate paravalvular leak.

Abstract: A system for assessing at least one characteristic of a device within a recipient is provided. The system includes a device removably insertable into the recipient where the device includes at least one of a treatment element and implant, and at least one wireless tag positioned within at least one portion of the device. The system includes a tracking device that includes processing circuitry configured to: if the device is inserted into the recipient, interrogate the at least one wireless tag positioned within at least one portion of the device; determine at least one characteristic of at least one portion of the device in three dimensional space based at least in part on the interrogation of the at least one wireless tag; and cause the at least one characteristic of the at least one portion of the device relative to the recipient to be indicated.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end and a distal end. A plurality of commissure attachment features (“CAFs”) is disposed on the stent, with each CAF including a body and a plurality of eyelets. The eyelets may be arranged in a single column or in a plurality of rows and columns. The prosthetic heart valve also includes a collapsible and expandable valve assembly including a plurality of leaflets connected to the plurality of commissure attachment features. The bodies of the CAFs may include a number of other features including, for example, a slot extending between columns of eyelets.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, and a plurality of cells connected to one another in annular rows around the stent, a cuff attached to the stent, and a sealing member attached to the cuff and extending from a proximal end of the cuff to a free edge. The sealing member may be movable between an extended condition in which the free edge is located proximally of the proximal end of the stent, and an inverted condition in which the free edge is located distally of the proximal end of the stent and a first surface of the sealing member confronts an outward-facing surface of the cuff. Various mechanisms for moving the sealing member are also described.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent having a plurality of commissure features, a plurality of first struts and a plurality of second struts. The plurality of first struts define a substantially cylindrical portion and the plurality of second struts have first ends attached to the cylindrical portion and free ends projecting radially outward from the cylindrical portion and configured to couple to adjacent heart tissue to anchor the stent. A collapsible and expandable valve assembly disposed within the stent has a plurality of leaflets coupled to the commissure features.

Abstract: A collapsible and expandable stent body includes a generally tubular annulus section, one or more prosthetic valve elements mounted to the stent body, and a cuff attached to the stent body. The prosthetic valve is operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction. The prosthetic heart valve may include paravalvular leak mitigation features in the form of first and second sealing members. The sealing members are attached to the cuff and extend circumferentially around an abluminal surface of the stent body. The sealing members each have an open side facing in a first axial direction and a closed side facing in an opposite second axial direction. Flow of blood in the second axial direction will tend to force blood into the sealing members and cause the sealing members to billow outwardly relative to the stent body, helping to mitigate paravalvular leak.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The heart valve further includes a plurality of commissure features disposed on the stent, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features, each of the plurality of leaflets having a free edge and being configured to have a tension line aligned near the free edge to prevent backflow.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The heart valve further includes a plurality of commissure features disposed on the stent, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features, each of the plurality of leaflets having a free edge and being configured to have a tension line aligned near the free edge to prevent backflow.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.

Abstract: A method for enhancing a surgical procedure includes providing a three-dimensional model of a patient's organ of a patient based on pre-operative image data of the patient's organ; identifying positional data corresponding to a first position of at least one target treatment anatomy of the patient relative to a second position of an ancillary target anatomy of the patient based on an analysis of the three-dimensional model of the patient's organ of the patient; selecting a puncture location based on the identified positional data; and displaying, by an augmented reality device, a virtual organ object via an augmented reality display system overlaying a real-world environment, the virtual organ object corresponding to the three-dimensional model and visually indicating the selected puncture location.

Abstract: Prosthetic heart devices may be implanted into the heart with a sensor coupled to the device, the sensor being configured to measure physiological data, such as blood pressure, in the heart. Devices that may employ such sensors include prosthetic heart valves and occlusion devices, although sensor systems may be deployed in the heart separate from other implantable devices. The sensors may include a body with different configurations for attaching to the implantable device, such as apertures for sutures or fingers for connecting to structures of the implantable device. The sensors may provide data that allow a determination of aortic regurgitation or other information indicative of function of the implantable device and patient health during and after implantation of the device.

Abstract: A prosthetic heart valve having a cuff attached to a stent provides a seal for preventing paravalvular leakage. The cuff may be constructed from known sealing materials to fill in and around paravalvular leakage gaps, while continuously collapsing down into a low profile volume within the stent. The cuff has a first cuff portion positioned on the luminal surface of the stent and a second cuff portion. The second cuff portion has a deployed configuration in which a region of the second cuff portion is spaced from the abluminal surface of the stent and an initial configuration different from the deployed configuration.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.

Abstract: A device for repairing a native heart valve includes a reinforcing structure configured to couple to a portion of the native heart valve to remodel a geometry of the native heart valve, and at least one supporting member connected to the reinforcing structure.