Abstract: Devices and methods for crimping a prosthetic heart valve onto a delivery device are described. In some embodiments, valves are crimped over an inflatable balloon and between proximal and distal shoulders mounted on a shaft inside the balloon. Crimping methods can include multiple compression steps with the valve located in different axial positions relative to the crimping jaws at each different step. In some methods, the valve may extend partially outside of the crimping jaws during certain crimping steps, such that the crimping force is only applied to the part of the valve that is inside the jaws. Exemplary crimping devices can include two or more adjacent sets of jaws that close down to different inner diameters, such that different parts of a valve get compressed to different outer diameters at the same time during a single crimping step.

Abstract: A system includes at least one electrode configured for transcutaneous stimulation of a pudendal nerve or surrounding perianal tissue or both. The at least one electrode is coupled to a substrate that includes a rectal portion and a buttocks support portion. The rectal portion includes a fecal blocking element. A control module is coupled to the at least one electrode, and includes a microprocessor for controlling operational parameters of the system.

Abstract: Methods and systems for attaching a radiopaque marker to a prosthetic heart valve to indicate a location of a commissure of the prosthetic heart valve are disclosed. As one example, a prosthetic heart valve includes a frame including a plurality of struts forming a plurality of cells of the frame arranged between an inflow end and an outflow end of the frame, a plurality of leaflets arranged within the frame, and at least one commissure comprising an attachment member arranged across a selected cell of the plurality of cells of the frame and commissure tabs of two adjacent leaflets coupled to the attachment member. The valve further includes a radiopaque marker arranged on the attachment member of the commissure within the selected cell.

Abstract: A delivery apparatus for a medical device can include a handle, a shaft, a plurality of sleeves, and a suture. The shaft includes a proximal end portion coupled to the handle and is configured to be disposed outside of a patient's body during an implantation procedure and a distal end portion configured to be disposed inside a patient's body during the implantation procedure. Each of the sleeves includes a connection portion coupled to the distal end portion of the shaft and a receiving portion configured to receive an apex of a stent or a prosthetic heart valve. The suture extends through the shaft and the sleeves and is configured for releasably securing the stent or the prosthetic heart valve to the receiving portions of the sleeves.

Abstract: A medical balloon sensing assembly constituted of: a handle; a first catheter extending distally from the handle; an inflatable medical balloon, the inflatable medical balloon secured by the first catheter; at least one sensor position member; and at least one sensor secured to the at least one sensor position member, wherein the at least one sensor position member is arranged to contact an outer face of the inflatable medical balloon.

Abstract: A multiple location pressure sensing device for use with a prosthetic heart valve delivery assembly is disclosed in several examples. As one example, a prosthetic heart valve delivery assembly with a multiple location pressure sensing device can include a delivery apparatus, a guidewire, and a delivery apparatus. The example also includes a first pressure sensor configured to be positioned near an inlet end of a prosthetic heart valve and a second pressure sensor configured to be positioned near an outlet end of the prosthetic heart valve, wherein the first and second sensor are configured to measure a pressure gradient across the prosthetic heart valve.

Abstract: A method of implanting a prosthetic heart valve includes determining from a set of expandable prosthetic heart valves a first prosthetic heart valve. The first prosthetic heart valve has a first nominal diameter less than a native annulus diameter. The method further includes determining a first suggested expanded diameter for the first prosthetic heart valve based on the native annulus diameter, wherein the first suggested expanded diameter is greater than the first nominal diameter, and determining a pressure gradient across the first prosthetic heart valve at the first suggested expanded diameter based at least in part on pressure values from hemodynamic data of the first prosthetic heart valve. The method further includes selecting the prosthetic heart valve from the set of expandable prosthetic heart valves with the suggested expanded diameter resulting in the lowest pressure gradient for implantation from the set of prosthetic heart valves.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising first, second, and third rows of angled struts that define two circumferentially extending rows of diamond-shaped cells that extend continuously around the frame, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is connected to and disposed between the frame and the cusp edge portions of the leaflets, the skirt being connected to consecutive struts in the first, second, and third rows of struts with sutures. The compressed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body.

Abstract: Methods and assemblies for attaching leaflets to a frame of a prosthetic heart valve using a connecting skirt are disclosed. As one example, a prosthetic heart valve can include a frame, a valvular structure mounted within the frame and comprising a plurality of leaflets, each leaflet comprising tabs on opposite sides of the leaflet and a cusp edge portion, and a plurality of connecting skirts. Each connecting skirt comprises side base portions and a central portion connected to each of the cusp edge portion of a corresponding leaflet and struts of the frame, each connecting skirt further comprising side extension portions that extend away from the cusp edge portion along a length of the frame, where each side extension portion of each connecting skirt extends across struts of the frame, between cusp edge portions of adjacent leaflets and connects to an adjacent side extension portion of an adjacent connecting skirt.

Abstract: Methods and systems for attaching a radiopaque marker to a prosthetic heart valve to indicate a location of a commissure of the prosthetic heart valve are disclosed. As one embodiment, a prosthetic heart valve can include a frame including a plurality of struts forming a plurality of cells of the frame arranged between an inflow end and an outflow end of the frame, a plurality of leaflets arranged within the frame, at least one commissure comprising an attachment member arranged across a selected cell of the plurality of cells of the frame and attached to struts of the frame forming the selected cell, and commissure tabs of two adjacent leaflets coupled to the attachment member, and a radiopaque marker arranged on the attachment member of the commissure. The marker is configured to indicate a location of the commissure of the prosthetic heart valve.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising a plurality of circumferentially extending rows of angled struts, including first, second, and third rows of angled struts forming rows of diamond-shaped cells, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is disposed between the frame and the cusp edge portions, the skirt being sutured to selected struts of the frame along diagonal paths extending from an inflow end portion toward an outflow end portion. Each diagonal path along which the skirt is sutured to the frame extends along the first, second, and third rows of angled struts.

Abstract: A method for delivering a prosthetic valve to a native annulus of a heart can include inserting a delivery apparatus into a patient's body, advancing the delivery apparatus to an implantation location within the native annulus, retracting a delivery sheath of the delivery apparatus relative to the prosthetic valve to expose the prosthetic valve from a distal end of the delivery sheath, and after the prosthetic valve is exposed from the delivery sheath, expanding the prosthetic valve from a radially compressed state to a radially expanded state by reducing axial tension on a first end and a second end of the prosthetic valve.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end, an outflow end, and a plurality of struts. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. The cusp edge portion of each leaflet can be folded toward the outflow end of the frame along a bending axis and a reinforcing member extends along an outflow surface of the cusp edge portion along the bending axis. The prosthetic heart valve can include a plurality of connecting skirts, each disposed between the cusp edge portion of an adjacent leaflet and the frame. First stitching secures the reinforcing member and the connecting skirts to the cusp edge portions and second stitching secures the connecting skirts to selected struts of the frame.

Abstract: A prosthetic heart valve including a frame, leaflet structure, and sealing member disposed around an outer surface of the frame is disclosed. As one example, the sealing member includes a knitted fabric layer, the knitted fabric layer comprising a base layer forming an inner surface of the knitted fabric layer, where the base layer has a mesh-like structure. The knitted fabric layer further comprises a plush outer surface comprising a plurality of pile yarns knit into loops and that extend outward from the base layer.

Abstract: Methods and systems for attaching a radiopaque marker to a prosthetic heart valve to indicate a location of a commissure of the prosthetic heart valve are disclosed. As one embodiment, a prosthetic heart valve can include a frame including a plurality of struts forming a plurality of cells of the frame arranged between an inflow end and an outflow end of the frame, a plurality of leaflets arranged within the frame, at least one commissure comprising an attachment member arranged across a selected cell of the plurality of cells of the frame and attached to struts of the frame forming the selected cell, and commissure tabs of two adjacent leaflets coupled to the attachment member, and a radiopaque marker arranged on the attachment member of the commissure. The marker is configured to indicate a location of the commissure of the prosthetic heart valve.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon. The distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion, and a radiopaque marker is disposed on the flared portion.

Abstract: Devices and methods for crimping a prosthetic heart valve onto a delivery device are described. In some embodiments, valves are crimped over an inflatable balloon and between proximal and distal shoulders mounted on a shaft inside the balloon. Crimping methods can include multiple compression steps with the valve located in different axial positions relative to the crimping jaws at each different step. In some methods, the valve may extend partially outside of the crimping jaws during certain crimping steps, such that the crimping force is only applied to the part of the valve that is inside the jaws. Exemplary crimping devices can include two or more adjacent sets of jaws that close down to different inner diameters, such that different parts of a valve get compressed to different outer diameters at the same time during a single crimping step.

Abstract: A prosthetic heart valve including a frame, leaflet structure, and sealing member disposed around an outer surface of the frame is disclosed. As one example, the sealing member includes an inner layer and a plush outer layer comprising a plush outer surface. The inner layer is arranged against the outer surface of the frame and the outer layer is arranged against and attached to the inner layer. The inner layer is folded over at inflow and outflow ends, in an axial direction relative to a central longitudinal axis of the frame, to overlap respective ends of the outer layer and form tapered folds at opposite ends of the sealing member, each tapered fold including a narrower, first portion where the inner layer folds over and contacts itself and a wider, second portion where the inner layer overlaps an outer surface of an end portion of the outer layer.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising first, second, and third rows of angled struts that define two circumferentially extending rows of diamond-shaped cells that extend continuously around the frame, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is connected to and disposed between the frame and the cusp edge portions of the leaflets, the skirt being connected to consecutive struts in the first, second, and third rows of struts with sutures. The compressed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising a plurality of circumferentially extending rows of angled struts, including first, second, and third rows of angled struts forming rows of diamond-shaped cells, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is disposed between the frame and the cusp edge portions, the skirt being sutured to selected struts of the frame along diagonal paths extending from an inflow end portion toward an outflow end portion. Each diagonal path along which the skirt is sutured to the frame extends along the first, second, and third rows of angled struts.