Transcatheter heart valve prosthesis assembled inside heart chambers or blood vessels
Some embodiments described herein include a heart valve replacement system that may be delivered to the targeted heart valve site via a delivery catheter. In some embodiments, the heart valve replacement system can assemble a valve device after the valve device is delivered to the heart. In some embodiments, heart valve replacement system includes two anterior flaps that are separate but overlap each other.
1 . A method for deploying a prosthetic heart valve at a native heart valve site, the method comprising:
attaching the prosthetic heart valve to one or more delivery catheters using removable sutures, wherein the prosthetic heart valve comprises:
an occluder frame;
an occluder disposed in the occluder frame and comprising valve leaflets; and
one or more anchoring flaps extending from the occluder frame,
wherein the occluder frame and the one or more anchoring flaps are: (i) collapsible to a low-profile delivery configuration and (ii) expandable to a deployed configuration;
navigating, using the one or more delivery catheters, the prosthetic heart valve in the low-profiled delivery configuration to the native heart valve site;
at the native heart valve site, causing the prosthetic heart valve to emerge from a sheath catheter while holding the removable sutures in tension to thereby maintain the occluder frame and the one or more anchoring flaps in the low-profile delivery configuration after the emergence of the prosthetic heart valve from the sheath catheter;
after the emergence of the prosthetic heart valve from the sheath catheter, slacking tension of at least a first one of the removable sutures to allow the one or more anchoring flaps to expand to a deployed natural shape that extends radially away from the occluder frame and into contact with ventricular wall anatomical areas near the native heart valve site;
controllably expanding the occluder frame into contract with an annulus of the native heart valve site by slacking tension of at least a second one of the removable sutures; and
after controllably expanding the occluder frame, detaching the prosthetic heart valve from the one or more delivery catheters by releasing the removable sutures from the prosthetic heart valve.
2 . The method of claim 1 , wherein the one or more anchoring flaps comprise a posterior anchoring flap and one or more anterior anchoring flaps.
3 . The method of claim 2 , wherein the one or more anterior anchoring flaps are controllably deployed to extend into a right ventricular outflow tract (RVOT).
4 . The method of claim 3 , wherein the one or more anterior anchoring flaps comprise two anterior anchoring flaps.
5 . The method of claim 2 , wherein the posterior anchoring flap is controllably deployed into contact with the ventricular wall below the native heart valve site.
6 . The method of claim 2 , wherein the posterior flap extends from the occluder frame directionally opposite of the one or more anterior anchoring flaps.
7 . The method of claim 2 , wherein the one or more anterior anchoring flaps and/or the posterior anchoring flap occlude a portion of an opening defined by the annulus of the native heart valve site.
8 . The method of claim 1 , wherein the occluder frame and the anchoring flaps are self-expandable.
9 . The method of claim 1 , wherein the prosthetic heart valve is navigated, using the one or more delivery catheters, to the native heart valve site via a transjugular access route.
10 . The method of claim 1 , wherein the prosthetic heart valve is navigated, using the one or more delivery catheters, to the native heart valve site via a transfemoral access route.
11 . The method of claim 1 , wherein, when the prosthetic heart valve is implanted at the native heart valve site, an inlet end portion of the prosthetic heart valve is positioned in an atrium and an outlet end portion of the prosthetic heart valve is positioned in a ventricle.
12 . A method for deploying a prosthetic heart valve at a native tricuspid heart valve site, the method comprising:
navigating, using one or more delivery catheters, the prosthetic heart valve in a low-profile delivery configuration to the native tricuspid heart valve site, wherein the prosthetic heart valve is attached to the one or more delivery catheters, and held in the low-profile delivery configuration, by removable sutures, wherein the prosthetic heart valve comprises:
an occluder frame;
an occluder disposed in the occluder frame and comprising valve leaflets; and
anchoring flaps extending from the occluder frame,
wherein the occluder frame and the anchoring flaps are collapsible to the low-profile delivery configuration and self-expandable to a deployed configuration;
at the native tricuspid heart valve site, slacking tension of at least a first one of the removable sutures to allow a first anchoring flap of the anchoring flaps to expand to a deployed natural shape that extends radially away from the occluder frame and into contact with first right ventricle wall areas near the native tricuspid heart valve site;
after controllably deploying the first anchoring flap, controllably deploying a second anchoring flap of the anchoring flaps from attachment to the one or more delivery catheters, wherein the second anchoring flap is controllably deployed into contact with second right ventricle wall areas near the native tricuspid heart valve site; and
controllably expanding the occluder frame within an annulus of the native tricuspid heart valve site by slacking tension of at least a second one of the removable sutures.
13 . The method of claim 12 , wherein the anchoring flaps comprise a posterior anchoring flap and one or more anterior anchoring flaps.
14 . The method of claim 13 , wherein the one or more anterior anchoring flaps comprise two anterior anchoring flaps.
15 . The method of claim 14 , wherein the two anterior anchoring flaps are controllably deployed to extend into a right ventricular outflow tract (RVOT).
16 . The method of claim 13 , wherein the posterior anchoring flap is controllably deployed into contact with the first right ventricle wall.
17 . The method of claim 13 , wherein the posterior flap extends from the occluder frame directionally opposite of the one or more anterior anchoring flaps.
18 . The method of claim 13 , wherein the one or more anterior anchoring flaps and/or the posterior anchoring flap occlude a portion of an opening defined by the annulus of the native tricuspid heart valve site.
19 . The method of claim 12 , wherein, wherein the prosthetic tricuspid heart valve is navigated, using the one or more delivery catheters, to the native heart valve site via a transjugular access route.
20 . The method of claim 12 , wherein, wherein the prosthetic tricuspid heart valve is navigated, using the one or more delivery catheters, to the native heart valve site via a transfemoral access route.