Modular mammalian body implantable fluid flow influencing device and related methods
Inventors
GEORGES, Gabriel • Trudeau, François • DOUCET-MARTINEAU, Jade
Assignees
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Publication Number
US-12053623-B2
Publication Date
2024-08-06
Expiration Date
Abstract
A docking unit for use in a modular mammalian body implantable device. The docketing unit comprising an elongated body. The body has: a longitudinal axis, at least one receiving surface extending parallel to the longitudinal axis, a distal end and a proximal end, and at least one proximal guide hole. Each receiving surface has at least one proximal guide hole associated therewith. The docking unit is dimensioned and shaped to be deliverable to an implantation site within a conduit of a conduit system of the mammalian body via a catheter.
Core Innovation
The invention relates to a modular medical device for implantation in a subject's body that includes a functional unit, a wire configured to attach to and extend from the functional unit, and a docking unit. The wire and the docking unit are movable relative to each other so the functional unit and the docking unit dock together into a docked configuration and undock into an undocked configuration. In the docked configuration the functional unit and the docking unit are substantially transversally arranged one next another, and in the undocked configuration the functional unit and the docking unit are substantially longitudinally arranged one after another.
The modular medical device is transcatheterly deliverable to a conduit of a subject's body when the functional unit and the docking unit are in the undocked configuration. The modular arrangement supports in vivo assembly and delivery concepts in which one configuration is used for transcatheter delivery and a different configuration is used for a docked state in which the functional unit is associated with the docking unit. Multiple functional units can be provided in modular form and associated with the docking unit and corresponding wire(s).
The invention also describes a docking and control arrangement that manages a control cable carrying a control wire assembly with containment features. Docking surfaces and receiving surfaces with proximal guide holes are provided so the functional units with pumping structures can mate with the receiving surfaces and cannot pass through the guide holes. In addition, non-expandable impellers are described for pumping structures, and optional anchoring and an expandable barrier assembly are described to prevent recirculation and/or to block fluid flow around the device.
Claims Coverage
The independent claims cover a modular medical device with a functional unit coupled to a docking unit via a movable wire, where relative movement produces docked and undocked configurations and enables transcatheter delivery in the undocked state. Across the independent claims, the inventive features focus on the configuration-dependent relative arrangement, docking and undocking via movable wire, and, where recited, an anchor assembly that switches conformation based on docking state.
Configuration-dependent docking and undocking arrangement
The wire and the docking unit are movable relative to each other to cause the functional unit and the docking unit to dock together and have a docked configuration and to undock from each other and have an undocked configuration, wherein the functional unit and the docking unit are substantially transversally arranged one next another when in the docked configuration, and substantially longitudinally arranged one after another when in the undocked configuration.
Transcatheter deliverability in undocked configuration
The modular medical device is transcatheterly deliverable to a conduit of a subject's body when the functional unit and the docking unit are in the undocked configuration.
Anchor assembly switching conformation based on docking state
An anchor assembly configured to attach to the docking unit, with an unanchored configuration for transcatheter implantation and an anchored conformation for intraluminally anchoring the modular device, wherein the anchor assembly is capable of being in the unanchored configuration only when the functional unit and the docking unit are in the undocked configuration, and is capable of being in the anchored configuration when the functional unit and the docking unit are in the undocked configuration and the docked configuration.
Collectively, the independent claims define a modular implantable device in which docking state controls the relative transverse versus longitudinal arrangement of the functional unit and docking unit and whether the device is delivered in an undocked condition via transcatheter delivery. In the claims that include an anchor assembly, the anchor conformation capability is tied to the undocked versus docked configurations for transcatheter implantation and intraluminal anchoring.
Stated Advantages
Animal trial outcomes described as successful pig implantation with no significant elevation in blood damage markers and supporting analyses to argue reduced hemolysis risk.
No significant elevation in blood damage markers (LDH, plasma-free Hb) in the described pig animal trial.
No reduction in vWF activity in the described pig animal trial.
Documented Applications
Transcatheter implantation and delivery to a conduit of a subject's body when the functional unit and the docking unit are in the undocked configuration.
In vivo assembly and delivery concepts for the modular device, including an example modular blood pump implementation (e.g., a triple pump modular assembly).
Animal trial in pig reporting successful implantation and operation and subsequent explant.
Transcatheter delivery and implantation of a modular ventricular assist device including a docking unit and multiple pumping units, with docking and undocking of functional units to form a docked configuration or an undocked configuration during delivery and implantation.
Use of an anchor assembly for intraluminal anchoring in the context of transcatheter implantation when the device transitions between undocked and docked configurations.
Blocking recirculation using a fluid-blocking functional unit and an expandable barrier assembly within the modular system.
Animal trial context described as pig implantation with measurement of blood damage markers and supporting shear-stress and CFD analyses.
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