Delivery apparatus for a prosthetic valve

Inventors

Rupp, Kevin D.Gross, Alyssa JoyLiu, JunRafi, HamidChhe, ChamboryTrinh, Uy D.Nguyen, Duc Hong

Assignees

Edwards Lifesciences Corp

Interested in licensing this patent?

MTEC can help explore whether this patent might be available for licensing for your application.

Publication Number

US-12440334-B2

Patent

Publication Date

2025-10-14

Expiration Date


Abstract

A delivery assembly comprises a delivery apparatus and a prosthetic valve releasably connected to a cord-retaining device of the delivery apparatus by a plurality of cords or tethers. The cords desirably have a multi-stranded construction formed from a plurality of strands of material. The multi-stranded construction can be, for example, a braided construction, a twisted construction, or a whip-stitch construction. The multi-stranded construction can include integral openings along opposing end portions of each cord. Each cord can extend through an aperture in an apex of the frame of the prosthetic valve or around an apex with one end portion of the cord being retained on the cord-retaining device and another end portion of the cord being retained on a slideable release member of the delivery apparatus.

Core Innovation

The invention relates to a prosthetic valve delivery assembly for transcatheter prosthetic heart valve delivery in which an expandable frame having a plurality of apices at one end of the frame is retained in a radially compressed state by a sheath advanceable over the prosthetic valve and retractable relative to the prosthetic valve to permit radial expansion to a radially expanded state. The delivery assembly uses separate cords that releasably connect the prosthetic valve to a cord-retaining device of the delivery apparatus while keeping the valve attached during deployment and expansion.

A cord-retaining device comprising an annular body and circumferentially spaced tabs is provided, with one or more slideable release members extending through the cord-retaining device. Each separate cord includes a first end portion having a first loop with a first opening and a second end portion having a second loop with a second opening; each cord extends through an aperture in one of the apices or extends around one of the apices. The first loop is retained on tabs, and the second end portion is retained by one of the slideable release members extending through the second opening.

Deployment is achieved by retracting the sheath to deploy the prosthetic valve from the sheath, allowing a distal end of the prosthetic valve to radially expand while a proximal end remains connected to the cord-retaining device by the cords. After radial expansion, the one or more slideable release members can be moved axially relative to the second end portions of the cords to release the second end portions from the slideable release members, thereby allowing the prosthetic valve to be released from the delivery apparatus. The cords are described as multi-stranded and, in further refinements, as braided constructions including first and second separately braided sections on opposite sides of the first opening and braided sections on opposite sides of the second opening.

Claims Coverage

The partial content includes three independent claims, collectively covering a prosthetic valve delivery assembly and a method for delivering a prosthetic heart valve. Across the independent claims, the core inventive elements are the expandable-frame prosthetic valve retained by a retractable sheath, the loop-and-aperture cord retention on a cord-retaining device with tabs, and axial release using one or more slideable release members, with additional cord multi-stranded/locally braided structure in further independent/dependent definition.

Looped cords through apices and releasable slideable release members

A prosthetic valve delivery assembly including a prosthetic valve comprising an expandable frame having a plurality of apices at one end of the frame, and a delivery apparatus with a cord-retaining device having circumferentially spaced tabs and one or more slideable release members, where a plurality of separate cords each has a first loop with a first opening and a second loop with a second opening, each cord extends through an aperture in one of the apices or extends around one of the apices, the first loop extends around one of the tabs, and the second end portion is retained by a slideable release member extending through the second opening of the second loop, with the slideable release members movable axially relative to the second end portions to release the second end portions and allow the prosthetic valve to be released from the delivery apparatus.

Separately braided loop sections retained and axially released

A prosthetic valve delivery assembly where the cords comprise a multi-stranded construction formed from a plurality of strands of material, the first loop comprises first and second separately braided sections on opposite sides of the first opening, and the second loop comprises first and second separately braided sections on opposite sides of the second opening, with the first loop retained on the cord-retaining device and the second loop retained by one of the slideable release members extending through the opening in the second end portion of the cord, and where the one or more slideable release members can be moved axially relative to the second end portions of the cords to release the second end portions from the slideable release members to allow the prosthetic valve to be released from the delivery apparatus.

Deploying valve while proximal end remains cord-connected then releasing

A method for delivering a prosthetic heart valve comprising inserting a distal end portion of a delivery apparatus into a patient’s vasculature with the prosthetic heart valve retained in a radially compressed state within a sheath and releasably connected to a cord-retaining device by a plurality of separate cords, positioning the apparatus at or adjacent a selected implantation location by advancing the distal end portion, retracting the sheath to deploy the prosthetic heart valve from the sheath, and wherein deploying the prosthetic heart valve allows a distal end of the prosthetic heart valve to radially expand while a proximal end remains connected to the cord-retaining device by the cords such that the distal end expands to a larger diameter than the proximal end.

Across the independent claims, the inventive subject matter is a prosthetic valve delivery assembly and method that retains an expandable-frame prosthetic valve in a radially compressed state using a retractable sheath while separately connecting the valve to a cord-retaining device via looped, multi-stranded cords that extend through apices or around apices, with cord retention/release controlled by slideable release members that move axially to release cord second end portions after sheath-based deployment.

Stated Advantages

Improved controlled implantation, based on reducing entanglement by releasing the cords after the valve is positioned.

Documented Applications

Transcatheter/minimally invasive delivery of a prosthetic heart valve using a delivery apparatus with a sheath, cords, a cord-retaining device, and slideable release members.

Delivery of a prosthetic heart valve at or adjacent a selected implantation location via insertion of the delivery apparatus into a patient’s vasculature and sheath retraction to deploy the valve.

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.