DEVICES, SYSTEMS, AND METHODS FOR AN IMPLANTABLE HEART-VALVE ADAPTER
Devices, systems, and methods for an implantable heart-valve adapter that enables compact and secure delivery into the heart and allows for convenient control of both the adapter during implantation as well as the expansion and retraction of the valve when implanted, removed, or replaced.
1 . An implantable heart-valve apparatus, comprising:
a tubular body having an inflow end and an outflow end, wherein the tubular body comprises a braided frame;
an atrial sealing skirt extending outwardly from the inflow end to form a flange, wherein the atrial sealing skirt comprises a fabric covering configured to seal against atrial tissue; and
a plurality of engagement attachments extending from the outflow end and comprising a leaflet anchor and a U-shaped stabilization anchor, wherein the U-shaped stabilization anchor extends in a direction toward the inflow end and is configured to be positioned behind one or more native valve leaflets, and wherein at least one of the plurality of engagement attachments and the tubular body define a singular component.
2 . The implantable heart-valve apparatus of claim 1 , wherein at least one of the plurality of engagement attachments is grafted onto the braided frame.
3 . The implantable heart-valve apparatus of claim 1 , wherein at least one of the plurality of engagement attachments is welded onto the braided frame.
4 . The implantable heart-valve apparatus of claim 1 , wherein the braided frame comprises a first wire and at least one of the plurality of engagement attachments comprises a second wire attached to the first wire.
5 . The implantable heart-valve apparatus of claim 2 , wherein the U-shaped stabilization anchor is a first U-shaped stabilization anchor, and wherein the implantable heart-valve apparatus comprises a second U-shaped stabilization anchor position between 120 to 180 degrees apart from the first U-shaped stabilization anchor.
6 . The implantable heart-valve apparatus of claim 1 , wherein the braided frame carries a replacement heart valve.
7 . The implantable heart-valve apparatus of claim 1 , wherein the U-shaped stabilization anchor has a bend in a free end of the U-shaped stabilization member.
8 . An implantable heart valve device, comprising:
a braided frame having an inflow end and an outflow end;
a flange extending radially outward from the inflow end and configured to form a seal against atrial tissue surrounding a native valve annulus; and
a plurality of engagement attachments extending outwardly from the outflow end of the braided frame, the engagement attachments comprising a leaflet clip and a U-shaped stabilization anchor, wherein the U-shaped stabilization anchor extends in a direction toward the inflow end, and wherein at least one of the plurality of engagement attachments is integrally formed with the braided frame.
9 . The implantable heart-valve system of claim 8 , wherein at least one of the plurality of engagement attachments is attached to the braided frame via welding or grafting.
10 . The implantable heart-valve system of claim 8 , wherein the braided frame comprises a first wire and at least one of the plurality of engagement attachments comprises a second wire attached to the first wire.
11 . The implantable heart-valve system of claim 8 , wherein the braided frame and the engagement attachments are integrally formed as a single component.
12 . The implantable heart-valve system of claim 8 , wherein the braided frame is configured to receive a replacement heart valve.
13 . The implantable heart-valve system of claim 8 , further comprising a valve structure varied by the braded frame.
14 . The implantable heart-valve system of claim 8 , wherein the flange comprises a fabric covering configured to fill space around the native valve annulus.
15 . The implantable heart-valve system of claim 8 , further comprising a delivery component having at least one suture line connected to at least one of the plurality of engagement attachments.
16 . A method for percutaneous repairing a native heart valve, the method comprising:
percutaneously inserting a distal end portion of a delivery catheter into one of a vein or an artery, wherein the distal end portion of the delivery catheter carries a heart-valve apparatus in constrained state, and wherein the heart-valve apparatus comprises a tubular body having a braided frame with an inflow end and an outflow end, a flange extending radially outward from the inflow end, and a plurality of engagement attachments extending from the outflow end, wherein the flange, the plurality of engagement attachments, and the braided from together form a single component;
advancing the distal end portion of the delivery catheter to a native heart valve;
positioning the heart-valve apparatus within the native heart valve;
controlling deployment of at least one of the plurality of engagement attachments by applying tension on one or more control lines routed through the heart-valve apparatus, wherein the plurality of engagement attachments comprise a leaflet clip and a plurality of U-shaped stabilization anchors configured to be positioned behind native valve leaflets; and
applying tension to the one or more control lines to allow the braided frame to expand, wherein, when expanded, a fabric covering of the flange seals against tissue proximate a native valve annulus.
17 . The method of claim 16 , wherein the engagement attachments, the flange, and the tubular body are each attached to different control lines of the one or more control lines.
18 . The method of claim 16 , wherein the engagement attachments, the flange, and the tubular body share at least one control line of the one or more control lines.
19 . The method of claim 16 , wherein the vein is a femoral vein and wherein advancing the heart-valve apparatus to the native heart valve comprises advancing the heart-valve apparatus through a vena cava and through a puncture in an atrial septum.
20 . The method of claim 16 , wherein the braided frame contains a replacement heart valve.
21 . The method of claim 16 , wherein at least one of the engagement attachments comprises a wire attached to the braided frame.
22 . The method of claim 16 , further comprising receiving a replacement heart valve within the braided frame.