Abstract:
A system and method for restoring (e.g., replacing) a defective heart valve of a patient. A delivery system is manipulated to percutaneously deliver and implant a stented prosthetic heart valve to a native heart valve. A post-dilatation balloon is percutaneously delivered to the implantation site, and a compliant segment thereof is arranged within a region of the implanted prosthesis. The balloon is inflated such that the compliant segment expands and contacts the prosthesis, expanding a remodeling region of the prosthesis to a remodeled state. With these and related techniques, remodeling of an implanted, stented prosthetic heart valve to better match the native valve shape is possible, providing many benefits such as reducing the risk of paravalvular leaks.
Abstract:
Distal tips for use with delivery catheters are disclosed that are configured to maintain complete engagement between the distal tip and a distal opening of a sheath component of the delivery catheter so as to prevent separation therebetween and/or to prevent fish-mouthing of a distal leading edge of the sheath component during in vivo use. Distal tips so configured realize one or more of the objectives of safer tracking of the delivery catheter through the vasculature, safe crossing of the delivery catheter through structural components of the vasculature and heart, such as through native valves, and safe removal of the delivery catheter post deployment.
Abstract:
A delivery device for percutaneously deploying a stented prosthetic heart valve. The device includes a delivery capsule and a recapture sheath. The capsule is configured to compressively retain the prosthesis. The recapture sheath includes a funnel segment having a plurality of circumferentially spaced runners and a polymer overlay. The runners are attached to a shaft and terminate at a distal tip. The overlay surrounds the runners, and is bonded to the shaft but not to at least the tips. The funnel segment is transitionable from a normal condition to an expanded condition forming a funnel shape with a distally increasing diameter, and self-transitionable back toward the normal condition. The funnel segment facilitates sliding of the capsule over a partially deployed region of the prosthesis as part of a recapturing operation. The runners provide columnar strength, with the overlay controlling a shape of the funnel segment.
Abstract:
Distal tips for use with delivery catheters are disclosed that are configured to maintain complete engagement between the distal tip and a distal opening of a sheath component of the delivery catheter so as to prevent separation therebetween and/or to prevent fish-mouthing of a distal leading edge of the sheath component during in vivo use. Distal tips so configured realize one or more of the objectives of safer tracking of the delivery catheter through the vasculature, safe crossing of the delivery catheter through structural components of the vasculature and heart, such as through native valves, and safe removal of the delivery catheter post deployment.
Abstract:
A system and method for restoring (e.g., replacing) a defective heart valve of a patient. A delivery system is manipulated to percutaneously deliver and implant a stented prosthetic heart valve to a native heart valve. A post-dilatation balloon is percutaneously delivered to the implantation site, and a compliant segment thereof is arranged within a region of the implanted prosthesis. The balloon is inflated such that the compliant segment expands and contacts the prosthesis, expanding a remodeling region of the prosthesis to a remodeled state. With these and related techniques, remodeling of an implanted, stented prosthetic heart valve to better match the native valve shape is possible, providing many benefits such as reducing the risk of paravalvular leaks.
Abstract:
A delivery device for percutaneously deploying a stented prosthetic heart valve. The device includes a delivery capsule and a recapture sheath. The capsule is configured to compressively retain the prosthesis. The recapture sheath includes a funnel segment having a plurality of circumferentially spaced runners and a polymer overlay. The runners are attached to a shaft and terminate at a distal tip. The overlay surrounds the runners, and is bonded to the shaft but not to at least the tips. The funnel segment is transitionable from a normal condition to an expanded condition forming a funnel shape with a distally increasing diameter, and self-transitionable back toward the normal condition. The funnel segment facilitates sliding of the capsule over a partially deployed region of the prosthesis as part of a recapturing operation. The runners provide columnar strength, with the overlay controlling a shape of the funnel segment.
Abstract:
A percutaneous stented valve delivery device including an inner shaft, a sheath, and a delivery capsule. The sheath slidably receives the inner shaft. A capsule proximal zone is attached to the sheath. A capsule distal zone is configured to transition between normal and flared states. A diameter of the distal zone is greater in the flared state, and the capsule includes a shape memory component that naturally assumes the normal state. The device is operable to perform a reversible partial deployment procedure in which a portion of the prosthesis is exposed distal the capsule and allowed to radially expand. Subsequently, with distal advancement of the capsule, the distal zone transitions to the flared state and imparts a collapsing force onto the prosthesis, causing the prosthesis to radially collapse and become recaptured within the delivery capsule. The capsule can include a laser cut tube encapsulated by a polymer.
Abstract:
A percutaneous stented valve delivery device including an inner shaft, a sheath, and a delivery capsule. The sheath slidably receives the inner shaft. A capsule proximal zone is attached to the sheath. A capsule distal zone is configured to transition between normal and flared states. A diameter of the distal zone is greater in the flared state, and the capsule includes a shape memory component that naturally assumes the normal state. The device is operable to perform a reversible partial deployment procedure in which a portion of the prosthesis is exposed distal the capsule and allowed to radially expand. Subsequently, with distal advancement of the capsule, the distal zone transitions to the flared state and imparts a collapsing force onto the prosthesis, causing the prosthesis to radially collapse and become recaptured within the delivery capsule. The capsule can include a laser cut tube encapsulated by a polymer.
Abstract:
A system for percutaneous delivery of a stented prosthetic heart valve. The system includes a delivery device with a self-expanding prosthetic heart valve attached thereto and a delivery sheath with an opening on a distal end thereof. The delivery sheath includes a funnel on a proximal end thereof. The delivery device is inserted into the funnel of the delivery sheath. As the delivery device is advanced into the funnel, the expanded heart valve is compressed by the shape of the funnel into a crimped arrangement. The delivery device further advances the heart valve distally within the delivery sheath past the delivery sheath opening. The delivery device is advanced relative to the delivery sheath in transitioning the heart valve from a crimped arrangement to the expanded and deployed arrangement.
Abstract:
A system and method for restoring (e.g., replacing) a defective heart valve of a patient. A delivery system is manipulated to percutaneously deliver and implant a stented prosthetic heart valve to a native heart valve. A post-dilatation balloon is percutaneously delivered to the implantation site, and a compliant segment thereof is arranged within a region of the implanted prosthesis. The balloon is inflated such that the compliant segment expands and contacts the prosthesis, expanding a remodeling region of the prosthesis to a remodeled state. With these and related techniques, remodeling of an implanted, stented prosthetic heart valve to better match the native valve shape is possible, providing many benefits such as reducing the risk of paravalvular leaks.