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Publication Number
US-10743987-B2
Publication Date
2020-08-18
Expiration Date
Abstract
Methods for delivering a pulmonary or mitral valve prosthesis using a transcatheter approach are provided. The implantation devices can utilize movable claspers for both positioning and anchoring the valve prostheses within the native cardiac valve, minimizing the extent of imaging necessary.
Core Innovation
The invention relates to minimally invasive, sutureless transcatheter heart valve prostheses for deployment within a native heart valve annulus. The prostheses include a radially expandable support frame having an outer surface and a longitudinal axis, flexible leaflets attached to the support frame, and a valve clasper movably coupled to the support frame.
The valve clasper is movable relative to the support frame along the longitudinal axis from an engagement position in which the valve clasper and the support frame are collapsed against the delivery device, to a nesting position in which the support frame is positioned within the valve clasper. The valve clasper is used to engage and anchor against the native valve annulus.
During delivery, the implantation device includes a control unit, a track wire, and first and second sheaths where at least portions of the prosthesis and clasper are encased in a compact condition. Deployment includes exposing and engaging the valve clasper, allowing expansion of the radially expandable support frame, and removing the delivery device after deployment.
Claims Coverage
The partial content provides two independent claims (clm-00001 and clm-00010) covering deployment methods for a sutureless transcatheter heart valve prosthesis within a native heart valve annulus. Across the independent claims, there are five main inventive feature groups.
Radially expandable support frame with flexible leaflets and movable valve clasper
A valve prosthesis having a radially expandable support frame with an outer surface and a longitudinal axis; a plurality of flexible leaflets attached to the support frame; and a valve clasper movably coupled to the support frame such that the valve clasper is movable relative to the support frame along the longitudinal axis from an engagement position to a nesting position.
Delivery device with control unit, track wire, and first and second sheaths encasing prosthesis and clasper
A delivery device having a control unit, a track wire, and first and second sheaths, the track wire having a proximal end attached to the control unit and a distal end for contact with the valve clasper, the first sheath encasing at least a portion of the valve prosthesis in a compact condition, and the second sheath encasing at least a portion of the valve clasper.
Advancing implantation device toward the heart through the vena cava
Inserting at least the distal end of the implantation device into a patient and advancing the implantation device toward the heart through the vena cava.
Anchor sheath exposes and engages a movably coupled valve clasper with the native annulus
Moving an anchor sheath of the delivery device longitudinally relative to the valve clasper to expose at least a portion of the valve clasper and engaging the valve clasper with the native valve annulus.
Frame sheath permits expansion of the radially expandable support frame and removal of delivery device
Moving a frame sheath longitudinally relative to the support frame to permit expansion of the support frame and removing the delivery device from the patient.
Claim coverage centers on deploying a heart valve prosthesis within a native heart valve annulus using a delivery system that exposes and engages a movably coupled valve clasper and then permits expansion of a radially expandable support frame, with deployment performed by advancing a delivery/implantation device through the vena cava and concluding by removing the delivery device.
Stated Advantages
Improved positioning and anti-migration by clasper anchoring.
Reduced reliance on imaging.
Documented Applications
Deploying a heart valve prosthesis within a native heart valve annulus using minimally invasive, sutureless transcatheter delivery.
Advancing the implantation device toward the heart through the vena cava during transcatheter deployment.
Deploying in a pulmonary valve annulus setting and anchoring the valve clasper beyond the native pulmonary valve annulus.
Deploying in a mitral valve annulus setting via transeptal puncture with the valve clasper anchored in a sinus of the native mitral valve.
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