SYSTEMS AND METHODS FOR DELIVERING AND DEPLOYING AN ARTIFICIAL HEART VALVE WITHIN THE MITRAL ANNULUS
First Claim
1. A delivery system for intravascularly delivering a replacement heart valve to a targeted cardiac valve, the delivery system comprising:
- an expandable replacement heart valve;
a handle assembly; and
an elongated delivery member coupled to the handle assembly and extending distally from the handle assembly, the delivery member having a distal end and being configured to detachably couple to the expandable replacement heart valve at the distal end, the delivery member further including;
an outer sheath having a valve cover configured to constrain the valve in a compressed configuration;
a steering component configured to steer the delivery member to enable intravascular delivery of the delivery member to the targeted cardiac valve;
a delivery catheter configured to longitudinally translate the valve relative to the outer sheath; and
a suture catheter having one or more tethers configured to detachably couple to a proximal section of the valve, the suture catheter being longitudinally translatable relative to the delivery catheter to enable adjustment of tension in the one or more tethers.
1 Assignment
0 Petitions
Accused Products
Abstract
The present disclosure describes devices, systems, and methods for loading, delivering, positioning, and deploying an artificial heart valve device at the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. The valve device is attached at the distal end of the delivery member, and is constrained within a valve cover of an outer sheath. A delivery catheter is configured to advance the valve relative to the outer sheath, and a suture catheter includes sutures/tethers which maintain proximal tension on the valve prior to deployment.
33 Citations
20 Claims
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1. A delivery system for intravascularly delivering a replacement heart valve to a targeted cardiac valve, the delivery system comprising:
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an expandable replacement heart valve; a handle assembly; and an elongated delivery member coupled to the handle assembly and extending distally from the handle assembly, the delivery member having a distal end and being configured to detachably couple to the expandable replacement heart valve at the distal end, the delivery member further including; an outer sheath having a valve cover configured to constrain the valve in a compressed configuration; a steering component configured to steer the delivery member to enable intravascular delivery of the delivery member to the targeted cardiac valve; a delivery catheter configured to longitudinally translate the valve relative to the outer sheath; and a suture catheter having one or more tethers configured to detachably couple to a proximal section of the valve, the suture catheter being longitudinally translatable relative to the delivery catheter to enable adjustment of tension in the one or more tethers. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A delivery system for intravascularly delivering a replacement mitral valve to the mitral annulus, the delivery system comprising:
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a handle assembly; an expandable replacement heart; and an elongated delivery member coupled to the handle assembly and extending distally from the handle assembly, the delivery member having a distal end and being configured to detachably couple to an expandable replacement heart valve at the distal end, the delivery member further including; an outer sheath having a valve cover configured to constrain the valve in a compressed configuration; a steering catheter nested within the outer sheath; a delivery catheter also nested within the outer sheath, the delivery catheter being configured to longitudinally translate the valve relative to the outer sheath and relative to the steering catheter, the delivery catheter including a proximal section and a distal section, wherein the distal section of the delivery catheter is formed as a stacked coil; and a suture catheter nested within the delivery catheter, the suture catheter including a plurality of tethers extending distally from a distal end of the suture catheter, each tether connecting to a corresponding attachment point of an atrial portion of the replacement valve, the suture catheter being longitudinally translatable relative to the delivery catheter to enable adjustment of tension in the tethers. - View Dependent Claims (16, 17)
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18. A method of deploying a replacement heart valve at a targeted mitral valve, the method comprising:
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providing a delivery system, the delivery system including an expandable replacement heart valve, a handle assembly, and an elongated delivery member coupled to the handle assembly and extending distally from the handle assembly, the delivery member having a distal end and being configured to detachably couple to the expandable replacement heart valve at the distal end, the delivery member further including; an outer sheath having a valve cover configured to constrain the valve in a compressed configuration; a delivery catheter configured to longitudinally translate the valve relative to the outer sheath; and a suture catheter having a plurality of tethers configured to detachably couple to a proximal section of the valve, the suture catheter being longitudinally translatable relative to the delivery catheter to enable adjustment of tension in the tethers; intravascularly delivering the elongated delivery member to the targeted mitral valve; retracting the outer sheath relative to the delivery catheter to allow the replacement heart valve to expand, the replacement heart valve being positioned such that a distal portion is disposed on a ventricular side of the mitral valve, a proximal portion is disposed on an atrial side of the mitral valve, and a central portion is interposed between the distal portion and the proximal portion at the annulus of the mitral valve; and translating the suture catheter relative to the delivery catheter to lessen tension in the tethers and allow release of the replacement heart valve from the elongated delivery member. - View Dependent Claims (19, 20)
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Specification