Abstract: A delivery apparatus can include a handle, a first shaft extending from the handle and having a proximal end portion coupled to the handle and a distal end portion and a second shaft extending coaxially over the first shaft and having a proximal end portion coupled to the handle and a distal end portion. The delivery apparatus can further include a shoulder coupled to the distal end portion of the second shaft and having a flared end portion configured to abut a prosthetic valve positioned around the first shaft in a radially compressed state, an extension portion extending from the shoulder, and at least one radiopaque marker disposed on the extension portion at a location within the prosthetic valve when the prosthetic valve is in a radially compressed configuration on the first shaft.

Abstract: Disclosed herein are embodiments of a balloon shaped to have one or more enlarged regions to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve's tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon—reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.

Abstract: Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each of the first and second shell members including a first portion and a second portion, the second portion having a larger width than the first portion. The first portions of the first and second shell members define a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery apparatus. The second portions of the first and second shell members define a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery apparatus, proximal to a valve mounting portion of the distal end portion of the delivery apparatus.

Abstract: Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each of the first and second shell members including a first portion and a second portion, the second portion having a larger width than the first portion. The first portions of the first and second shell members define a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery apparatus. The second portions of the first and second shell members define a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery apparatus, proximal to a valve mounting portion of the distal end portion of the delivery apparatus.

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: A steerable medical apparatus includes a shaft, a steering mechanism, and an actuation mechanism. The shaft has a proximal portion, a distal portion, a first pull wire, and a second pull wire. The distal ends of the first and second pull wires are coupled to the distal portion of the shaft. The steering mechanism has a first wheel and a second wheel coupled by a differential mechanism. The proximal ends of the first and second pull wires are respectively coupled to the first and second wheels. The actuation mechanism is coupled to the steering mechanism. Actuating the actuation mechanism in a first operational mode causes the distal portion of the shaft to curve in a first plane. Actuating the actuation mechanism in a second operational mode causes the distal portion of the shaft to curve away from the first plane.

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 method can comprise advancing a distal end portion of a delivery apparatus toward a native valve; visualizing under fluoroscopy and for a selected imaging view, a position of a radiopaque marker on the distal end portion relative to a guidewire extending through the delivery apparatus, the marker circumferentially offset from a selected commissure of the radially compressed prosthetic valve by a predetermined amount that is determined based on the selected imaging view; rotating the delivery apparatus until the marker is centered along the guidewire; and advancing the distal end portion into the native valve and inflating the balloon to radially expand and implant the prosthetic valve in the native valve such that the selected commissure is aligned with a commissure of the native valve.

Abstract: A method of implanting a prosthetic heart valve includes selecting a prosthetic heart valve. The selected prosthetic heart valve has a nominal diameter that is greater than a native annulus diameter of a native annulus by up to forty percent. The method further comprises compressing the selected prosthetic heart valve to a radially compressed configuration in which the selected prosthetic heart valve has a first diameter that is less than the nominal diameter, positioning the selected prosthetic heart valve within the native annulus, and expanding the selected prosthetic heart valve from the radially compressed configuration to a radially expanded configuration in which the selected prosthetic heart valve has a second diameter which is less than the nominal diameter by up to ten percent and which is greater than the first diameter.

Abstract: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube and a nose cone cap. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. The nose cone cap and the storage tube have mating first and second locking member that can be coupled to selectively secure the nose cone cap to the storage tube.

Abstract: Disclosed herein are embodiments of a balloon shaped to have one or more enlarged regions to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve's tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon—reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.

Abstract: A steerable medical apparatus includes a shaft, a steering mechanism, and an actuation mechanism. The shaft has a proximal portion, a distal portion, a first pull wire, and a second pull wire. The distal ends of the first and second pull wires are coupled to the distal portion of the shaft. The steering mechanism has a first wheel and a second wheel coupled by a differential mechanism. The proximal ends of the first and second pull wires are respectively coupled to the first and second wheels. The actuation mechanism is coupled to the steering mechanism. Actuating the actuation mechanism in a first operational mode causes the distal portion of the shaft to curve in a first plane. Actuating the actuation mechanism in a second operational mode causes the distal portion of the shaft to curve away from the first plane.

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 method can include advancing a distal end portion of an assembly toward a native heart valve, the assembly comprising a delivery apparatus and a prosthetic heart valve, and including one or more radiopaque markers, where one radiopaque marker is suspended within a cell of a frame of the prosthetic heart valve and aligned with a commissure of the prosthetic heart valve. The method further includes receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus, determining, based on the fluoroscopic image and the one or more radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation, and rotating the assembly until the prosthetic heart valve is in the desired rotational orientation.

Abstract: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube and a nose cone cap. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. The nose cone cap and the storage tube have mating first and second locking member that can be coupled to selectively secure the nose cone cap to the storage tube.

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: 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 method can comprise advancing a distal end portion of a delivery apparatus toward a native valve; visualizing under fluoroscopy and for a selected imaging view, a position of a radiopaque marker on the distal end portion relative to a guidewire extending through the delivery apparatus, the marker circumferentially offset from a selected commissure of the radially compressed prosthetic valve by a predetermined amount that is determined based on the selected imaging view; rotating the delivery apparatus until the marker is centered along the guidewire; and advancing the distal end portion into the native valve and inflating the balloon to radially expand and implant the prosthetic valve in the native valve such that the selected commissure is aligned with a commissure of the native valve.

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 volume indicator for a syringe can include an indicator body configured to removably clip onto a syringe body and a window portion extending through a thickness of the indicator body. The volume indicator can include inflation indicia corresponding to a range of expanded diameters for a prosthetic heart valve. The volume indicator can include one or more first engagement elements that correspond to one or more second engagement elements on a syringe.

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 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.