Actively Controllable Heart Valve Implant and Method of Controlling Same
First Claim
1. A mitral valve implant, comprising:
- a force-expanding mitral valve lattice having an interior orifice; and
a self-expanding valve trampoline attached at the interior orifice of the force-expanding mitral valve lattice.
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Accused Products
Abstract
A mitral valve implant includes a force-expanding mitral valve lattice having an interior orifice and a self-expanding valve trampoline attached at the interior orifice of the force-expanding mitral valve lattice. The mitral valve lattice is self-expandable to a first configuration and force expandable from the first configuration to a second configuration. The configurations can be circular or D-shaped. The mitral valve lattice comprises jack screws adjusting configurations of the mitral valve lattice. The valve trampoline has a cylindrical central region comprising valve leaflets. An outwardly flaring implant skirt is attached to the mitral valve lattice exterior. Wall-retaining wires are attached to the mitral valve lattice, are petal-shaped, and have a pre-set, radially outward, memory shape. The wires and skirt impart a force on a respective side of the native mitral valve when the mitral valve lattice is expanded within an annulus of the native mitral valve.
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Citations
21 Claims
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1. A mitral valve implant, comprising:
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a force-expanding mitral valve lattice having an interior orifice; and a self-expanding valve trampoline attached at the interior orifice of the force-expanding mitral valve lattice. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A mitral heart valve implant system, comprising:
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a valve delivery system comprising; a controller; a guidewire lumen connected to the controller and having a distal nosecone; a hollow external sheath surrounding the guidewire lumen, having a proximal end connected to the controller, and configured to retract proximally from an extended, valve-installed position; a given number of implant drive wires each having a distal drive wire connector; and hollow connector lumens equal in number to the given number and each; respectively threaded on one of the drive wires; and having a distal hollow connector sleeve; a self-expanding and forcibly expanding mitral valve frame defining a central axis and comprising; proximal and distal jack screw strut pairs equal in number to the given number and disposed parallel to the central axis; intermediate struts equal in number to the given number and disposed parallel to the central axis, each intermediate strut disposed between two adjacent ones of the jack screw strut pairs; arms respectively connecting adjacent ones of the jack screw strut pairs and the intermediate struts; and a plurality of jack screws; each rotatably connected to one jack screw strut pair; forming, together with the jack screw strut pairs, the intermediate struts, and the arms, an adjustable stent lattice having a ventricle side and an atrial side; configured to reversibly forcibly expand and contract the adjustable stent lattice between a compressed state and an enlarged state for implantation of the mitral valve frame into a native mitral valve; and each having a driving connector shaped to removably mate and connect to the distal drive wire connector of one of the drive wires and be held connected thereto when the hollow connector sleeve is disposed about the mated driving connector and distal drive wire connector such that rotation of the drive wires correspondingly rotates the jack screws to forcibly expand or contract the adjustable stent lattice; a self-expanding implant skirt attached to the ventricle side of the adjustable stent lattice, the implant skirt configured to compress and be stored inside the external sheath and, when released from the external sheath at a native mitral valve, to self-expand and sealably position on tissue at a ventricular side of the native mitral valve; wall-retaining wires attached to the atrium side of the adjustable stent lattice and configured to compress and be stored inside the external sheath and, when released from the external sheath at a native mitral valve, to self-expand on tissue at an atrial side of the native mitral valve; a self-expanding valve trampoline lattice disposed inside and connected to the adjustable stent lattice and comprising; an expandable outer trampoline portion having a circumferential exterior connected to the interior of the adjustable stent lattice and a circumferential interior; and an inner circumferential valve portion; connected to the circumferential interior and extending inwardly from the circumferential interior to define an interior cylindrical portion; and having a circular valve with internal valve leaflets disposed at the interior cylindrical portion. - View Dependent Claims (18, 19)
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20. A mitral heart valve implant system, comprising:
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a mitral valve lattice having a pre-set D-shaped cross-sectional configuration, defining an internal orifice, and comprising a plurality of jack screws configured to forcibly expand and contract the mitral valve lattice reversibly between a compressed configuration and an enlarged configuration; an outwardly flaring, self-expanding implant skirt attached to an exterior of the mitral valve lattice, the implant skirt shaped to be positioned on a ventricular side of a native mitral valve to secure the mitral valve lattice in the annulus of the native mitral valve; radially outwardly biased wall-retaining wires attached to the mitral valve lattice and shaped to be positioned on an atrial side of the native mitral valve to secure the mitral valve lattice in the annulus of the native mitral valve; a self-expanding valve trampoline lattice containing interior valve leaflets, the valve trampoline lattice disposed within the internal orifice of the mitral valve lattice and having a D-shape portion attached to the mitral valve lattice and a substantially cylindrical interior portion, wherein the valve leaflets are attached to the substantially cylindrical interior portion; and a delivery system comprising a plurality of implant drive wires temporarily connectable to the jack screws such that, when connected, rotation of the drive wires in one direction forcibly expands the mitral valve lattice towards the enlarged configuration and rotation of the drive wires in a direction opposite the one direction forcibly contracts the mitral valve lattice towards the compressed configuration.
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21. A method for implanting a mitral heart valve, which comprises:
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contracting a self-expanding and forcibly-expanding mitral valve of a shape-memory material set to a given shape to a reduced implantation size with a delivery system having drive wires, the mitral valve having an adjustable assembly with adjustable elements operatively connected to the drive wires such that, when the adjustable elements are adjusted by the drive wires, a configuration change in at least a portion of the mitral valve occurs; inserting the contracted mitral valve into a native mitral valve annulus in which the mitral valve is to be implanted; rotating the drive wires with the delivery system to forcibly expand the mitral valve into the native annulus; while rotating the drive wires, determining with the delivery system a torque applied to the drive wires; and stopping rotation of the drive wires based upon a value of the determined torque.
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Specification