Abstract: A prosthetic heart valve includes (a) a stent body including a generally tubular annulus region having a tubular wall and a proximal-to-distal axis, the stent body having a radially expanded condition when the stent body is implanted, (b one or more prosthetic valve elements mounted to the stent body and operative to allow blood flow in a distal direction through the annulus region but to substantially block blood flow in a proximal direction through the annulus region, (c) a cuff coupled to the stent body, and (d) one or more biasing elements connected to the stent body and to the cuff, the biasing elements being adapted to bias at least a portion of the cuff outwardly with respect to the stent body.

Abstract: A method of assembling a prosthetic heart valve includes providing a collapsible and expandable stent having an annulus section and an aortic section. The annulus section has a first diameter in a relaxed condition and a second diameter less than the first diameter in a collapsed condition. A constraint is applied to the stent to constrain the annulus section to a predetermined diameter between the first and second diameters. Applying a cuff and/or a plurality of leaflets to the stent in the constrained condition enables less material to be used. The resultant prosthetic valve is therefore able to be collapsed to a smaller diameter for introduction into a patient.

Abstract: A prosthetic heart valve for replacement of a native heart valve having a native valve annulus includes a stent body having a proximal end adjacent an inflow end and a distal end adjacent an outflow end and including an annulus section, the stent body having a radially collapsed condition and a radially expanded condition, one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end, a cuff coupled to the stent body, the cuff having a mobile portion that is moveable relative to the stent body, and at least one engagement element remote from the stent body.

Abstract: A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient's native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Abstract: A prosthetic heart valve includes a stent having a collapsed condition and an expanded condition. The stent includes a plurality of cells, each cell being formed by a plurality of struts, and a plurality of commissure features.

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 prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Abstract: Novel tools and techniques are provided for implementing intelligent assistance (“IA”) or extended intelligence (“EI”) ecosystem to placement procedures for cardiac implantable electronic device (“CIED”). In various embodiments, a computing system might analyze received one or more first layer input data (i.e., room content-based data) and received one or more second layer input data (i.e., patient and/or tool-based data), and might generate one or more recommendations for guiding a medical professional in performing a CIED placement procedure in a heart of the patient, based at least in part on the analysis, the generated one or more recommendations comprising 3D or 4D mapped guides toward, in, and around the heart of the patient. The computing system might then generate one or more XR images, based at least in part on the generated one or more recommendations, and might present the generated one or more XR images using a UX 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 is coupled circumferentially about the stent by members which may be in the nature of dimension and/or shape memory material having a tensioned and relaxed state. The members may be in the form of elongated elastic members or coiled members. When in the tensioned state, the cuff is located within the stent volume to provide a low profile prosthetic heart valve. Upon relaxing of the members, the cuff is pulled over the abluminal surface of the stent to form a cuff seal circumscribing the stent for preventing paravalvular leakage.

Abstract: A prosthetic heart valve includes a stent having a collapsed condition and an expanded condition. The stent includes a plurality of cells, each cell being formed by a plurality of struts, and a plurality of commissure features. The heart valve further includes a valve assembly secured to the stent and including a cuff and a plurality of leaflets, each leaflet being attached to adjacent commissure features and to the stent struts and/or the cuff.

Abstract: A collapsible prosthetic heart valve includes a collapsible and expandable stent and a collapsible and expandable valve assembly. The stent has a proximal end and a distal end. A plurality of commissure points is disposed on the stent. The valve assembly is disposed within the stent and includes a plurality of leaflets. Each leaflet has a free edge. An end portion of the free edge of each leaflet is folded and sutured to a corresponding one of the plurality of the commissure points.

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 collapsible prosthetic heart valve includes a stent and a valve assembly. The stent includes an annulus section and at least one foldable section. The stent is movable between an unfolded condition in which the foldable section is longitudinally spaced from the annulus section, and a folded condition in which the foldable section is at least partially positioned radially adjacent the annulus section. The valve assembly is positioned within the annulus section of the stent in the folded condition of the stent.

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 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 is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient's native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Abstract: A loading tool for loading a collapsible prosthetic heart valve into a delivery device may include a body extending in a longitudinal direction between a proximal end and a distal end, an extension on the distal end of the body, and a slot extending through the extension from a free end of the extension toward the distal end of the body. The body may include a lumen extending between the proximal end and the distal end, the body lumen having a first diameter. The extension may have a lumen coaxial with the body lumen, the extension lumen having a second diameter less than the first diameter so as to define a shelf surface between the proximal end of the body and the free end of the extension.

Abstract: According to one aspect of the invention, 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 (e.g., a prosthetic aortic valve) is designed to be somewhat circumferentially collapsible and then re-expandable. The collapsed condition may be used for less invasive delivery of the valve into a patient. When the valve reaches the implant site in the patient, it re-expands to normal operating size, and also to engage surrounding tissue of the patient. The valve includes a stent portion and a ring portion that is substantially concentric with the stent portion but downstream from the stent portion in the direction of blood flow through the implanted valve. When the valve is implanted, the stent portion engages the patient's tissue at or near the native valve annulus, while the ring portion engages tissue downstream from the native valve site (e.g., the aorta).

Abstract: A collapsible prosthetic heart valve includes a collapsible and expandable stent and a collapsible and expandable valve assembly. The stent has a proximal end and a distal end. A plurality of commissure points is disposed on the stent. The valve assembly is disposed within the stent and includes a plurality of leaflets. Each leaflet has a free edge. An end portion of the free edge of each leaflet is folded and sutured to a corresponding one of the plurality of the commissure points.