Prosthetic heart valve delivery system: paddle attachment feature
Inventors
BENSON, THOMAS • Diedering, Jason S.
Assignees
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Publication Number
US-12133797-B2
Publication Date
2024-11-05
Expiration Date
Abstract
Systems, devices and methods for attaching an operator-manipulatable tether(s) to the stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stent to, and within, the subject heart chamber.
Core Innovation
The invention relates to a prosthetic heart valve delivery system for delivering an expandable prosthetic heart valve using a self-expanding stent frame. The delivery system includes an operating handle having push/pull and release mechanisms, and three tether assemblies operatively connected at their distal ends to corresponding push/pull and release mechanisms. Each tether assembly includes an outer tube defining a lumen therethrough and a notched wire slidingly received within the lumen, with a distal T-shaped engagement channel formed at the distal end of the notched wire.
The self-expanding stent frame includes three attachment features extending from an end of the stent frame. Each T-shaped engagement channel is configured to releasably engage a corresponding attachment feature, and when engaged, the outer tube is configured to be advanced over the entire T-shaped engagement channel to secure the attachment feature within the engagement channel. Each attachment feature includes a wire portion and an enlarged proximal end portion having a circular shape configured to engage a T-shaped engagement channel corresponding to the attachment feature.
The described delivery concept includes loading/collapsing with multiple tether assemblies into a catheter sheath, distal translation, and self-expansion of the expandable stent frame with repositioning in the heart. The tether assemblies support selective tether lengthening via an operating handle with lever-based locked/unlocked release, and provide detachment for recapture/resheathing and withdrawal from the heart. Preference is indicated for transapical access and for using delivery catheter or sheath/trackable transcatheter access routes.
Claims Coverage
The independent claim (and its dependent refinements) cover a delivery system for an expandable prosthetic heart valve that uses three tether assemblies actuated by an operating handle and releasably coupled to a self-expanding stent frame via distal T-shaped engagement channels and an outer tube that can advance over the engaged channel to secure attachment features. The refinements further define self-expanding stent frame sub-structures, lever-based locked/unlocked actuation, catheter-lumen positioning constraints, and additional treatment and transcatheter access routes in related method claims.
Operating handle with push/pull and release mechanisms for multiple tether assemblies
An operating handle comprising push/pull and release mechanisms, wherein each of three tether assemblies is operatively connected at its distal end to a corresponding one of the push/pull and release mechanisms.
Outer tube and notched wire with distal T-shaped engagement channel
Each tether assembly comprises an outer tube defining a lumen therethrough and a notched wire slidingly received within the lumen, wherein the notched wire defines a T-shaped engagement channel at a distal end and the T-shaped engagement channel is configured to be distally extended from the lumen of the outer tube.
Releasable engagement of stent attachment features via T-shaped engagement channels
The self-expanding stent frame comprises three attachment features extending from an end of the stent frame, and each T-shaped engagement channel is configured to releasably engage a corresponding attachment feature.
Outer tube advancement over engagement channel to secure attachment feature
When a corresponding attachment feature is engaged with the T-shaped engagement channel, the outer tube is configured to be advanced over the entire T-shaped engagement channel, securing the corresponding attachment feature within the engagement channel.
Attachment feature geometry with wire portion and enlarged circular proximal end portion
Each attachment feature includes a wire portion and an enlarged proximal end portion having a circular shape configured to engage a T-shaped engagement channel corresponding to the attachment feature.
Across the independent claim and refinements, the inventive coverage centers on three tether assemblies that use an outer tube and a notched wire with a distal T-shaped engagement channel to releasably engage and secure corresponding stent attachment features on a self-expanding stent frame, with actuation via an operating handle. Additional dependent refinements further specify stent-frame sub-structure, catheter-lumen constraints for actuation, and related method delivery targets and transcatheter access routes.
Stated Advantages
Documented Applications
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