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Publication Number
US-10751175-B2
Publication Date
2020-08-25
Expiration Date
Abstract
A valve prosthesis and implantation device, and methods for use are provided. The devices described herein may be used for transcatheter delivery of an aortic valve prosthesis or transapical delivery of a mitral valve prosthesis. The implantation device can utilize movable claspers for both positioning and anchoring the valve prosthesis, reducing the extent of imaging needed during the implantation procedure.
Core Innovation
The invention relates to sutureless, self-expanding cardiac valve prostheses that include a radially expandable support frame and a valve clasper that is movable along a longitudinal axis. The support frame carries a plurality of flexible leaflets and provides a central orifice. The valve clasper transitions between a nested position and an engagement position to seat in native valve sinuses and to sandwich native valve leaflets, thereby anchoring the prosthesis without sutures.
The disclosed valve clasper architecture includes a u-shaped member with leg members and detents, and it can include shape-memory material. The detents and engagement geometry support movement from a nested state to an engagement state, in which the clasper seats within a native valve sinus and interacts with native valve leaflets. The prosthesis construction is described as reducing dependence on imaging by providing the structural features that enable seating and anchoring.
The invention also includes delivery device architectures that support deployment of the prosthesis. The delivery device includes a control unit and track wire(s) with locking and release switches, together with first and second sheaths, including a support-frame sheath and a clasper sheath. Deployment concepts describe exposing and deploying the valve clasper and the radially expandable support frame, then releasing the delivery system and removing the delivery device from the patient.
Claims Coverage
The partial content provides five independent methods of deploying a heart valve prosthesis within a native heart valve annulus. Across these independent claims, the inventive structure is consistently based on a radially expandable support frame with flexible leaflets and a valve clasper that is displaceable along a longitudinal axis, combined with sheath-based exposure and engagement steps, followed by delivery-device removal.
Sheath-encased prosthesis with longitudinally displaceable valve clasper
An implantation device having a valve prosthesis with a radially expandable support frame and a plurality of flexible leaflets, and a valve clasper coupled to the support frame and displaceable along a longitudinal axis, wherein a delivery device includes a control unit, a track wire, and first and second sheaths with the first sheath encasing the prosthesis in a compact condition and the second sheath encasing at least a portion of the valve clasper.
Insert-and-remove deploying using track wire and sheaths
A method comprising inserting at least the distal end of the implantation device into a patient to deploy the valve prosthesis and removing the delivery device from the patient.
Expose and engage using anchor sheath and frame sheath for expansion
A method comprising advancing a delivery device carrying the valve prosthesis, moving an anchor sheath longitudinally relative to the valve clasper to expose at least a portion of the valve clasper, engaging the valve clasper with the native valve annulus, 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.
Distally advance anchor sheath to expose clasper, then permit support-frame expansion
A method comprising advancing a delivery device into a patient, distally advancing an anchor sheath longitudinally relative to the valve clasper to expose at least a portion of the valve clasper, engaging the valve clasper with the native valve annulus, 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.
Expose and retract valve clasper to engage native valve leaflets
A method comprising advancing a delivery device into a patient carrying a valve prosthesis with a radially expandable support frame and a valve clasper, moving an anchor sheath longitudinally relative to the valve clasper to expose at least a portion of the valve clasper, proximally retracting the valve clasper to engage valve leaflets of the native heart valve, 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.
Across the independent claims, the coverage centers on deployment of a radially expandable heart valve prosthesis with a longitudinally displaceable valve clasper, using delivery-device components including anchor and frame sheaths, and in one family track wire and sheaths encasing the prosthesis and clasper, to expose the clasper, engage the native valve annulus or native valve leaflets, permit expansion of the support frame, and remove the delivery device.
Stated Advantages
Reduced dependence on imaging.
Documented Applications
Transcatheter and transapical delivery contexts are described for deploying the sutureless, self-expanding cardiac valve prostheses in native aortic, mitral, and pulmonary valve environments.
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