Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: A crimper includes a top iris shell defining a top iris channel. The crimper also includes a base iris shell coupled to the top iris shell at a pivot connection, the base iris shell defining a base iris channel. The top iris shell is configured to rotate about the pivot connection relative to the base shell from an open state to a closed state. When in the open state, the base iris channel is exposed for loading the expandable medical device. When in the closed state, the top iris channel and the base iris channel define a crimper chamber. The crimper also includes a handle configured to operate the clamshell crimper. The actuation of the handle decreases a volume of the crimper chamber to transition the expandable medical device from the uncompressed state to the compressed state.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: A crimper configured to radially compress a transcatheter valve prosthesis into a crimped configuration for delivery within a vasculature. The transcatheter valve prosthesis includes a frame and at least one leaflet secured within the frame. The crimper is configured to apply pressurized fluid to the at least one leaflet of the transcatheter valve prosthesis during the crimping process to prevent protrusion of the leaflet into the frame of the transcatheter valve prosthesis that may cause leaflet pinching and damage. The crimper includes a plurality of crimper elements that collectively define a crimper chamber of the crimper, and at least one crimper element of the plurality of crimper elements includes an integral channel extending therethrough for applying the pressurized fluid to the at least one leaflet.

Abstract: A crimper includes a top iris shell defining a top iris channel. The crimper also includes a base iris shell coupled to the top iris shell at a pivot connection, the base iris shell defining a base iris channel. The top iris shell is configured to rotate about the pivot connection relative to the base shell from an open state to a closed state. When in the open state, the base iris channel is exposed for loading the expandable medical device. When in the closed state, the top iris channel and the base iris channel define a crimper chamber. The crimper also includes a handle configured to operate the clamshell crimper. The actuation of the handle decreases a volume of the crimper chamber to transition the expandable medical device from the uncompressed state to the compressed state.

Abstract: A crimper includes atop iris shell defining atop iris channel. The crimper also includes abase iris shell coupled to the top iris shell at a pivot connection, the base iris shell defining a base iris channel. The top iris shell is configured to rotate about the pivot connection relative to the base shell from an open state to a closed state. When in the open state, the base iris channel is exposed for loading the expandable medical device. When in the closed state, the top iris channel and the base iris channel define a crimper chamber. The crimper also includes a handle configured to operate the clamshell crimper. The actuation of the handle decreases a volume of the crimper chamber to transition the expandable medical device from the uncompressed state to the compressed state.

Abstract: In some examples, a tissue compression device includes a base including a major surface configured to engage a dorsal surface of a hand of a patient, a flexible backing adjustably mechanically connected to the base and configured to engage a palmar surface of the hand when the dorsal surface of the hand is engaged with the base, and an expandable member mechanically connected to the flexible backing. The expandable member is configured to be positioned over an ulnar region of the patient when the palmar surface of the hand is engaged with the flexible backing and the dorsal surface of the hand is engaged with the base, such that inflation of the expandable member may apply pressure to tissue near the ulnar artery of the patient.

Abstract: A crimper for altering an implantable medical device from an uncompressed state to a compressed state. The crimper includes a plurality of crimper elements that define a crimper channel, each of the crimper elements including a non-planar surface that forms a portion of the crimper channel. Each non-planar surface is configured to apply non-uniform radial compression along a length of the implantable medical device during operation of the crimper when altering the implantable medical device from the uncompressed state to the compressed state. The crimper also includes handle configured to operate the crimper. Actuation of the handle decreases a volume of the crimper chamber to transition the implantable medical device from the uncompressed state to the compressed state.

Abstract: An assembly including a transcatheter valve prosthesis and a leaflet folding accessory configured for use when compressing the transcatheter valve prosthesis into the crimped configuration. The transcatheter valve prosthesis includes a frame and a prosthetic valve component including at least one leaflet disposed within and secured to the frame. The leaflet folding accessory includes a plurality of guide fingers. A leaflet contact portion of each guide finger is configured to be disposed radially within the frame and contact an inner surface of a leaflet of the at least one leaflet. During crimping of the transcatheter valve prosthesis, the plurality of guide fingers remain disposed radially within the frame such that the at least one leaflet preferentially folds around the plurality of guide fingers.

Abstract: A crimper includes atop iris shell defining atop iris channel. The crimper also includes abase iris shell coupled to the top iris shell at a pivot connection, the base iris shell defining a base iris channel. The top iris shell is configured to rotate about the pivot connection relative to the base shell from an open state to a closed state. When in the open state, the base iris channel is exposed for loading the expandable medical device. When in the closed state, the top iris channel and the base iris channel define a crimper chamber. The crimper also includes a handle configured to operate the clamshell crimper. The actuation of the handle decreases a volume of the crimper chamber to transition the expandable medical device from the uncompressed state to the compressed state.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: A crimper includes a first arm that includes a first crimper die that defines a first tapered channel. The crimper also includes a second arm coupled to the first arm at a pivot connection. The second arm includes a second crimper die that defines a second tapered channel. The pivot connection enables the first arm and the second arm to rotate about the pivot connection from an open state to a closed state. The first arm and second arm rotate at an angle relative to one another to allow loading of the expandable medical device into the first tapered channel or the second tapered channel and to allow positioning of the expandable medical device relative to a delivery device. When transitioning, the first tapered channel and the second tapered channel form a chamber that is configured to crimp the expandable medical device from the uncompressed state to the compressed state.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: In some examples, a tissue compression device includes a base including a major surface configured to engage a dorsal surface of a hand of a patient, a flexible backing adjustably mechanically connected to the base and configured to engage a palmar surface of the hand when the dorsal surface of the hand is engaged with the base, and an expandable member mechanically connected to the flexible backing. The expandable member is configured to be positioned over an ulnar region of the patient when the palmar surface of the hand is engaged with the flexible backing and the dorsal surface of the hand is engaged with the base, such that inflation of the expandable member may apply pressure to tissue near the ulnar artery of the patient.

Abstract: In some examples, a tissue compression device includes a base including a major surface configured to engage a dorsal surface of a hand of a patient, a flexible backing adjustably mechanically connected to the base and configured to engage a palmar surface of the hand when the dorsal surface of the hand is engaged with the base, and an expandable member mechanically connected to the flexible backing. The expandable member is configured to be positioned over an ulnar region of the patient when the palmar surface of the hand is engaged with the flexible backing and the dorsal surface of the hand is engaged with the base, such that inflation of the expandable member may apply pressure to tissue near the ulnar artery of the patient.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: A crimper for altering an implantable medical device from an uncompressed state to a compressed state. The crimper includes a plurality of crimper elements that define a crimper channel, each of the crimper elements including a non-planar surface that forms a portion of the crimper channel. Each non-planar surface is configured to apply non-uniform radial compression along a length of the implantable medical device during operation of the crimper when altering the implantable medical device from the uncompressed state to the compressed state. The crimper also includes handle configured to operate the crimper. Actuation of the handle decreases a volume of the crimper chamber to transition the implantable medical device from the uncompressed state to the compressed state.

Abstract: In some examples, a tissue compression device configured to apply pressure at the snuffbox includes a flexible backing adjustably mechanically connected to a base, and an expandable member mechanically connected to the flexible backing. The base includes a major surface configured to engage a palmar surface of a hand of a patient, for example, to position the hand of the patient in a predetermined configuration, and a plurality of base attachment structures extending from the major surface. The flexible backing is adjustably mechanically connected to the base via the plurality of base attachment structures. The expandable member is configured to be positioned over the snuffbox of the hand of the patient and apply pressure to tissue at the snuffbox when the palmar surface of the hand is engaged with the major surface of the base.

Abstract: In some examples, an introducer apparatus includes an outer elongated member defining a lumen extending therethrough, the lumen having a lumen dimension in cross-section, and a dilator configured to be received within the lumen of the outer elongated member, the dilator may comprise a proximal section, a distal section comprising a distal end of the dilator, and an intermediate section disposed between the proximal section and the tapered distal section. In some examples, the intermediate section may define a through-opening that configures the intermediate section to be collapsible from an expanded configuration to a collapsed configuration. In the collapsed configuration, the intermediate section may have a first dilator dimension in cross-section that is less than a second dilator dimension in cross-section when the intermediate section is in the expanded configuration.