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Publication Number

US-12303389-B2

Patent

Publication Date

2025-05-20

Expiration Date


Abstract

Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valves are implanted using catheter-based deployment systems that include multiple control wires. In particular implementations, the deployment systems can include a retrieval catheter that can be used to recapture the prosthetic heart valve back into a delivery sheath after being expressed from the delivery sheath. The prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved control catheter and/or a deflectable catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.

Core Innovation

The invention is a prosthetic heart valve system having a main body with an inflow end portion and an outflow end portion defining a central axis. The outflow end portion extends one or more anterior flaps in a first direction transverse to the central axis and a posterior flap in a second direction transverse to the central axis.

The valve is deployed using a valve deployment system including an elongate control catheter that defines one or more lumens and carries multiple slidably disposed control wires. The deployment system releasably couples different control wires to different valve portions so the prosthetic heart valve is deployed through coordinated wire actuation.

A first control wire is slidably disposed in the lumens and releasably coupled to the inflow end portion, and a second control wire is slidably disposed in the lumens and releasably coupled to the outflow end portion. Additional control wires are configured to releasably couple to the one or more anterior flaps and the posterior flap.

The system further includes selectively deflectable deployment components that support deployment and retrieval behavior. A deflectable catheter defines a lumen in which a portion of the control catheter is slidably disposable, with a distal end portion selectively deflectable by manipulating a user control mechanism coupled to the proximal end of the valve deployment system, and in some configurations a fifth control wire is slidably coupled with the deflectable catheter and releasably coupled to a posterior arm of the prosthetic heart valve.

Claims Coverage

The independent claims define four coordinated valve portions and a valve deployment system with an elongate control catheter carrying multiple slidably disposed control wires. The inventive features further include wire-loop or single-wire-segment configurations and a selectively deflectable catheter, and in some configurations an additional fifth control wire coupled to a posterior arm.

Transverse anterior and posterior flaps on an outflow end portion

A prosthetic heart valve main body including an inflow end portion and an outflow end portion, defining a central axis, with one or more anterior flaps extending from the outflow end portion transverse to the central axis and a posterior flap extending from the outflow end portion transverse to the central axis.

Elongate control catheter with lumens carrying multiple slidably disposed releasably coupled control wires

A valve deployment system comprising an elongate control catheter defining one or more lumens; a first control wire slidably disposed in the one or more lumens and releasably coupled to the inflow end portion; a second control wire slidably disposed in the one or more lumens and releasably coupled to the outflow end portion; a third control wire slidably disposed in the one or more lumens and releasably coupled to the one or more anterior flaps; and a fourth control wire slidably disposed in the one or more lumens and releasably coupled to the posterior flap.

Wire-loop couplings for specific valve portions

At least one of the control wires is configured as a wire loop extending out of the one or more lumens and releasably coupled to a specified valve portion, including configurations where the first control wire comprises a first wire loop coupled to the inflow end portion, or where the second or fourth control wire comprises a wire loop coupled to the outflow end portion.

Single wire segment with distal tip releasable engagement for anterior flaps

A control wire comprises a single wire segment that extends out of the one or more lumens, releasably couples to the one or more anterior flaps, and terminates in releasable engagement with a distal tip portion of the control catheter.

Deflectable catheter with selectively deflectable distal end controlled by a proximal user control mechanism

A deflectable catheter defining a lumen, wherein a portion of the control catheter is slidably disposable within the lumen of the deflectable catheter, and wherein a distal end portion of the deflectable catheter is selectively deflectable by manipulating a user control mechanism coupled to a proximal end of the valve deployment system.

Posterior arm with additional fifth control wire coupled via deflectable catheter distal tip

The prosthetic heart valve includes a posterior arm, and a fifth control wire slidably coupled with the deflectable catheter releasably couples to the posterior arm and engages a distal tip portion of the deflectable catheter.

Overall, the independent claim set covers a prosthetic heart valve having transverse anterior flaps and a transverse posterior flap at an outflow end portion, combined with an elongate control catheter carrying multiple slidably disposed control wires that are releasably coupled to inflow, outflow, anterior flap, and posterior flap structures. The dependent structures constrain the control wires into wire-loop or single-wire-segment forms and, in additional configurations, add a deflectable catheter with a selectively deflectable distal end controlled by a proximal user mechanism, plus an additional fifth control wire interacting with a posterior arm and engaging a distal tip portion.

Stated Advantages

Documented Applications

No documented applications found

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