Abstract:
A device for percutaneously delivering a stented prosthetic heart valve. The device includes an inner shaft assembly, a delivery sheath assembly, an outer stability tube, and a handle. The sheath assembly is slidably disposed over the inner shaft, and includes a capsule and a shaft. The capsule compressively contains the prosthesis over the inner shaft. The stability tube is slidably disposed over the delivery sheath, and includes a distal region configured to be radially expandable from a first shape having a first diameter to a second shape having a larger, second diameter. In a first delivery state, the distal region assumes the first shape, providing a low profile appropriate for traversing a patient's vasculature. In a second delivery state, the distal region has the expanded diameter second shape, sized to receive the capsule, such as when retracting the capsule to implant the prosthesis.
Abstract:
A heart valve prosthesis and delivery systems are provided for replacing a cardiac valve. The heart valve prosthesis includes a self-expanding frame includes a portion having a crimp that provides additional flexibility to the self-expanding frame in the collapsed configuration.
Abstract:
A delivery device for percutaneously deploying a prosthetic valve includes a sheath, an inner shaft, and a release assembly. The release assembly is disposed between the sheath and the inner shaft, and includes a retraction member, a release member, and a retention member. The retraction member can self-retract in length from an extended condition to a retracted condition. The release member can self-expand from a compressed condition to an expanded condition. The retention member is distal the release member. In a delivery state, the sheath end is distal the retention member, the release member is in the compressed condition and the retraction member in the extended condition to retain the prosthesis. In a deployment state, the sheath end is positioned to permit the release member to self-transition to the expanded condition, allowing the retraction member to self-transition to the retracted condition and release the prosthesis.
Abstract:
A tray for loading a medical device on a catheter assembly includes a reservoir and a temperature sensing and indicating device disposed in the reservoir. The reservoir is defined by a bottom surface, a first wall, a second wall, a third wall, and a fourth wall, and includes an open top opposite the bottom surface. The reservoir configured to receive a liquid such that a medical device may be loaded onto a catheter assembly while submerged in the liquid. The temperature sensing and indicating device senses the temperature of the liquid in the reservoir and indicates to the user when the liquid is at a desired temperature for loading the medical device onto the catheter assembly.
Abstract:
A heart valve prosthesis and delivery systems are provided for replacing a cardiac valve. The heart valve prosthesis includes a self-expanding frame includes a portion having a crimp that provides additional flexibility to the self-expanding frame in the collapsed configuration.
Abstract:
Delivery devices and methods for percutaneously delivering a prosthetic valve to the heart of a patient. These prosthetic valves may be configured to provide complimentary features that promote optimal placement of the prosthetic valve in a native heart valve, such as the aortic valve, mitral valve, pulmonic valve, and/or tricuspid valve. The delivery device includes a release sheath assembly housed within an outer delivery sheath. A release sheath component of the assembly captures a portion of the prosthetic valve to the delivery device, and effectuates complete release of the prosthetic valve with retraction of the outer sheath.
Abstract:
A prosthesis having a radially expanded configuration and a radially compressed configuration includes a frame with a plurality of infolding longitudinal segments. Each of the infolding longitudinal segments of the frame extend an entire length of the frame and is configured to deform radially inward when the prosthesis is in the radially compressed configuration such that a series of longitudinally aligned apices of each infolding longitudinal segment is disposed radially inward of the remainder of the prosthesis. In an embodiment, the frame also includes a plurality of outfolding longitudinal segments. Each of the outfolding longitudinal segments of the frame extend an entire length of the frame and is configured to deform radially outward when the prosthesis is in the radially compressed configuration such that a series of longitudinally aligned apices of each outfolding longitudinal segment is disposed radially outward of the remainder of the prosthesis.
Abstract:
Prosthetic heart valve devices and associated methods for percutaneous or transcatheter heart valve replacement are disclosed herein. A heart valve prosthesis configured in accordance herewith includes a frame having a valve support and a plurality of support arms extending therefrom. The plurality of support arms may include a main support arm configured to extend from the valve support for capturing at least a portion of a valve leaflet of a native heart valve therebetween when the valve prosthesis is in an expanded configuration and deployed within the native heart valve. In addition, the plurality of support arms may include multiple supplemental support arms disposed about the circumference of the valve support that when deployed in the expanded configuration are configured to at least partially engage subannular tissue at the native heart valve.
Abstract:
An attachment mechanism for coupling a stent to a delivery system is disclosed. The attachment mechanism is configured to pivot relative to an inner shaft assembly of the delivery system in order to release the stent from the delivery system. Methods of deploying the stent with the delivery system are also disclosed.
Abstract:
A delivery device for percutaneously deploying a prosthetic valve includes a sheath, an inner shaft, and a release assembly. The release assembly is disposed between the sheath and the inner shaft, and includes a retraction member, a release member, and a retention member. The retraction member can self-retract in length from an extended condition to a retracted condition. The release member can self-expand from a compressed condition to an expanded condition. The retention member is distal the release member. In a delivery state, the sheath end is distal the retention member, the release member is in the compressed condition and the retraction member in the extended condition to retain the prosthesis. In a deployment state, the sheath end is positioned to permit the release member to self-transition to the expanded condition, allowing the retraction member to self-transition to the retracted condition and release the prosthesis.