Offset cardiac leaflet coaptation element
First Claim
1. A heart valve coaptation system for reducing regurgitation through the valve, comprising:
- a flexible rail having a ventricular anchor on a distal end thereof adapted to anchor into tissue within a ventricle;
a delivery catheter having a lumen defining a central axis through which the flexible rail passes and including a locking mechanism for fixing relative axial positions of the delivery catheter and flexible rail; and
a coaptation member fixed on a distal end of the delivery catheter having an outer cover surrounding a compressible inner filler member and a generally cylindrical shape, the compressible inner filler member being mounted on the delivery catheter so that a majority of the filler member is radially offset from the central axis of the delivery catheter and the delivery catheter lies along one radial side thereof to form an offset spine of the coaptation member, whereinthe compressible inner filler member is an open cell foam that fills the space between the delivery catheter and the outer cover, and whereinthere are two types of open cell foam, with a majority being a first foam and a significantly stiffer second foam positioned in a thin region along the one radial side between the delivery catheter and outer cover.
1 Assignment
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Accused Products
Abstract
Systems, devices, and methods for reducing regurgitation through an atrioventricular heart valve: i.e., the mitral valve and the tricuspid valve. The device includes a flexible anchor rail anchored in the tissue of the ventricle and an offset coaptation element on a catheter that rides over the anchor rail and is positionable between the valve leaflets. The proximal end of the coaptation catheter is fixed subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering over a foam interior, and is radially offset on the catheter so that the foam body projects away from the septal side of the valve to reduce or minimize deformation from contact with the septal wall of the ventricle. Markers on the coaptation element facilitate positioning in the desired rotational orientation during delivery and implant.
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Citations
18 Claims
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1. A heart valve coaptation system for reducing regurgitation through the valve, comprising:
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a flexible rail having a ventricular anchor on a distal end thereof adapted to anchor into tissue within a ventricle; a delivery catheter having a lumen defining a central axis through which the flexible rail passes and including a locking mechanism for fixing relative axial positions of the delivery catheter and flexible rail; and a coaptation member fixed on a distal end of the delivery catheter having an outer cover surrounding a compressible inner filler member and a generally cylindrical shape, the compressible inner filler member being mounted on the delivery catheter so that a majority of the filler member is radially offset from the central axis of the delivery catheter and the delivery catheter lies along one radial side thereof to form an offset spine of the coaptation member, wherein the compressible inner filler member is an open cell foam that fills the space between the delivery catheter and the outer cover, and wherein there are two types of open cell foam, with a majority being a first foam and a significantly stiffer second foam positioned in a thin region along the one radial side between the delivery catheter and outer cover. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A heart valve coaptation system for reducing regurgitation through the valve, comprising:
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a flexible rail having a ventricular anchor on a distal end thereof adapted to anchor into tissue within a ventricle; a delivery catheter having a lumen defining a central axis through which the flexible rail passes and including a locking mechanism for fixing relative axial positions of the delivery catheter and flexible rail; and a coaptation member fixed on a distal end of the delivery catheter comprising a compressible member having a radial cross-sectional shape larger than a cross-section of the delivery catheter, the compressible member extending across a radial cross-section of the coaptation member and being configured to enable passive expansion of the coaptation member from a compressed state, the delivery catheter being mounted within the cross-sectional shape so as to lie along one diametric side thereof so that a majority of the compressible member is axially offset from a central axis of the delivery catheter, the delivery catheter being formed of a material that is relatively stiffer than the compressible member to form a spine while the compressible member forms a belly, wherein the coaptation member has an outer cover surrounding a compressible inner filler member, wherein the compressible inner filler member is an open cell foam that fills the space between the delivery catheter and the outer cover, and wherein there are two types of open cell foam, with a majority being a first foam and a significantly stiffer second foam positioned in a thin region along the one diametric side between the delivery catheter and outer cover. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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Specification