Modular transcatheter heart valve and implantation method
First Claim
1. A heart valve replacement system, comprising:
- a delivery catheter having a proximal end, a central lumen, and a distal end;
a scaffold stent configured to fit over a portion of the delivery catheter proximate the distal end of the delivery catheter, the scaffold stent having a reduced delivery configuration and an expanded configuration;
a valve support comprising a frame and a plurality of leaflets attached to the frame, the frame comprising a downstream end, an upstream end, and a plurality of struts extending axially from the frame, each strut having a retaining structure at the downstream end, the valve support having a reduced delivery configuration wherein the valve support is housed within the central lumen of the delivery catheter, wherein the valve support is located distal of the scaffold stent, and wherein the valve support is configured to be delivered independent of the scaffold stent; and
a grasping member configured to operably attach to the retaining structures of the plurality of struts to compress the valve leaflets, and wherein the retaining structures couple together to form a spherical shape.
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Accused Products
Abstract
Disclosed herein are valves, such as an aortic valve replacement can be delivered via a transcatheter approach can be deployed by a single operator through a lower profile (e.g., 8-12 French, or even less) delivery system. Lower profile delivery systems can advantageously potentially expedite procedures and reduce complications, as they tend to be easier to navigate through the vascular anatomy. In some embodiments, the valve system can be deployed in a multiple stage approach as two separate components, rather than a single unified component; first a stent, followed by a discrete structure such as a valve support that includes the valve leaflets. The components can be positioned separately during delivery at different locations in and over the catheter. The stent can include a pair of rows of hooks directed in directions opposite to one another. The valve support can include struts having retaining structures that form a spherical configuration when retained together by a grasping member to keep the valve folded and conical during delivery thereof inside the catheter.
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Citations
21 Claims
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1. A heart valve replacement system, comprising:
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a delivery catheter having a proximal end, a central lumen, and a distal end; a scaffold stent configured to fit over a portion of the delivery catheter proximate the distal end of the delivery catheter, the scaffold stent having a reduced delivery configuration and an expanded configuration; a valve support comprising a frame and a plurality of leaflets attached to the frame, the frame comprising a downstream end, an upstream end, and a plurality of struts extending axially from the frame, each strut having a retaining structure at the downstream end, the valve support having a reduced delivery configuration wherein the valve support is housed within the central lumen of the delivery catheter, wherein the valve support is located distal of the scaffold stent, and wherein the valve support is configured to be delivered independent of the scaffold stent; and a grasping member configured to operably attach to the retaining structures of the plurality of struts to compress the valve leaflets, and wherein the retaining structures couple together to form a spherical shape. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A transluminal method of delivering an aortic valve replacement, comprising the steps of:
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providing a delivery catheter carrying a scaffold stent over a distal portion of the delivery catheter, the scaffold stent having an upstream end and a downstream end, the delivery catheter also comprising a central lumen and a valve support having a frame, a plurality of valve leaflets, and a distal flap portion, the valve support further having a plurality of struts extending axially from the frame, each strut having a retaining structure at the downstream end, wherein the retaining structures couple together to form a spherical shape, wherein the retaining structures are releasably connected to a delivery cable, the valve support not connected to the scaffold stent, and wherein the valve support is positioned inside the lumen of the delivery catheter and distal of the scaffold stent; positioning the distal end of the delivery catheter in the left ventricle, to position the scaffold stent at the level of the native aortic valve annulus; expanding the scaffold stent within the native aortic valve annulus; partially moving the valve support out of the delivery catheter, thereby expanding the distal flap portion; retracting the valve support such that the distal flap contacts the downstream end of the scaffold stent; disconnecting the valve support from the delivery cable; and withdrawing the delivery catheter and the delivery cable. - View Dependent Claims (16, 17, 18, 19, 20, 21)
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Specification