Abstract: A delivery system for prosthetic heart valves are provided. The delivery system includes a flexible shaft, a distal sheath capsule configured to contain the prosthetic heart valve, an inner steerable catheter including an inner distal flex component, and an outer steerable catheter including an outer distal flex component. The inner distal flex component includes a first cut pattern and a second cut pattern distal to the first cut pattern. The outer distal flex component includes a third cut pattern. The inner steerable catheter is rotatable at least 90 degrees relative to the outer steerable catheter when the third cut pattern of the outer distal flex component is disposed over at least a portion of the first cut pattern of the inner distal flex component and each of the inner steerable catheter and the outer steerable catheter is in the flexed configuration.

Abstract: A device for percutaneously deploying a stented prosthetic heart valve includes a distal portion, a spacing collar, and an outer collar. The distal portion provides a coupling structure configured to selectively engage the stented prosthetic heart valve. The spacing collar is located proximal to the distal portion. The spacing collar is transitionable from a loaded state to an activated state. The spacing collar in the loaded state has a radial dimension less than the spacing collar in the activated state. The outer collar is configured to be movable relative to the distal portion and the spacing collar. The outer collar is slidably disposed over the spacing collar to provide the loaded state and is slidably retracted from the spacing collar when in the activated state.

Abstract: A device for percutaneously repairing a heart valve of a patient including a self-expanding, stented prosthetic heart valve and a delivery system. The delivery system includes delivery sheath slidably receiving an inner shaft forming a coupling structure. A capsule of the delivery sheath includes a distal segment and a proximal segment. An outer diameter of the distal segment is greater than that of the proximal segment. An area moment of inertia of the distal segment can be greater than an area moment of inertia of the proximal segment. Regardless, an axial length of the distal segment is less than the axial length of the prosthesis. In a loaded state, the prosthesis engages the coupling structure and is compressively retained within the capsule. The capsule is unlikely to kink when traversing the patient's vasculature, such as when tracking around the aortic arch, promoting recapturing of the prosthesis.

Abstract: A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal portion and an intermediate portion, and an inner lumen extending through the shaft assembly. The delivery system includes a sheath assembly defining an outer lumen sized to slidably receive the shaft assembly. At least one flush port is formed in the intermediate portion. The at least one flush port is in fluid communication with the inner lumen and the outer lumen. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve.

Abstract: A device for percutaneously repairing a heart valve of a patient including a self-expanding, stented prosthetic heart valve and a delivery system. The delivery system includes delivery sheath slidably receiving an inner shaft forming a coupling structure. A capsule of the delivery sheath includes a distal segment and a proximal segment. An outer diameter of the distal segment is greater than that of the proximal segment. An area moment of inertia of the distal segment can be greater than an area moment of inertia of the proximal segment. Regardless, an axial length of the distal segment is less than the axial length of the prosthesis. In a loaded state, the prosthesis engages the coupling structure and is compressively retained within the capsule. The capsule is unlikely to kink when traversing the patient's vasculature, such as when tracking around the aortic arch, promoting recapturing of the prosthesis.

Abstract: A device for percutaneously repairing a heart valve of a patient including a self-expanding, stented prosthetic heart valve and a delivery system. The delivery system includes delivery sheath slidably receiving an inner shaft forming a coupling structure. A capsule of the delivery sheath includes a distal segment and a proximal segment. An outer diameter of the distal segment is greater than that of the proximal segment. An area moment of inertia of the distal segment can be greater than an area moment of inertia of the proximal segment. Regardless, an axial length of the distal segment is less than the axial length of the prosthesis. In a loaded state, the prosthesis engages the coupling structure and is compressively retained within the capsule. The capsule is unlikely to kink when traversing the patient's vasculature, such as when tracking around the aortic arch, promoting recapturing of the prosthesis.

Abstract: A device for percutaneously delivering a stented prosthetic heart valve. The device includes an inner shaft, a delivery sheath, stability tube, and a handle. The delivery sheath is slidably disposed over the inner shaft, and includes a capsule compressively containing the prosthesis over the inner shaft. The stability tube is coaxially received over the delivery sheath, and includes a distal region. A circumferential rigidity of the capsule is greater than a circumferential rigidity of the distal region. In transitioning from a delivery state to a deployed state, the capsule is withdrawn from the prosthetic heart valve and at least partially into the distal region to permit the prosthesis to self-deploy. The capsule forces the distal region to stretch and expand in diameter.

Abstract: A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal portion and an intermediate portion, and an inner lumen extending through the shaft assembly. The delivery system includes a sheath assembly defining an outer lumen sized to slidably receive the shaft assembly. At least one flush port is formed in the intermediate portion. The at least one flush port is in fluid communication with the inner lumen and the outer lumen. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve.

Abstract: A device for percutaneously deploying a stented prosthetic heart valve includes a distal portion, a spacing collar, and an outer collar. The distal portion provides a coupling structure configured to selectively engage the stented prosthetic heart valve. The spacing collar is located proximal to the distal portion. The spacing collar is transitionable from a loaded state to an activated state. The spacing collar in the loaded state has a radial dimension less than the spacing collar in the activated state. The outer collar is configured to be movable relative to the distal portion and the spacing collar. The outer collar is slidably disposed over the spacing collar to provide the loaded state and is slidably retracted from the spacing collar when in the activated state.

Abstract: A device for percutaneously repairing a heart valve of a patient including a self-expanding, stented prosthetic heart valve and a delivery system. The delivery system includes delivery sheath slidably receiving an inner shaft forming a coupling structure. A capsule of the delivery sheath includes a distal segment and a proximal segment. An outer diameter of the distal segment is greater than that of the proximal segment. An area moment of inertia of the distal segment can be greater than an area moment of inertia of the proximal segment. Regardless, an axial length of the distal segment is less than the axial length of the prosthesis. In a loaded state, the prosthesis engages the coupling structure and is compressively retained within the capsule. The capsule is unlikely to kink when traversing the patient's vasculature, such as when tracking around the aortic arch, promoting recapturing of the prosthesis.

Abstract: A device for percutaneously delivering a stented prosthetic heart valve. The device includes an inner shaft, a delivery sheath, stability tube, and a handle. The delivery sheath is slidably disposed over the inner shaft, and includes a capsule compressively containing the prosthesis over the inner shaft. The stability tube is coaxially received over the delivery sheath, and includes a distal region. A circumferential rigidity of the capsule is greater than a circumferential rigidity of the distal region. In transitioning from a delivery state to a deployed state, the capsule is withdrawn from the prosthetic heart valve and at least partially into the distal region to permit the prosthesis to self-deploy. The capsule forces the distal region to stretch and expand in diameter.