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-11179557-B2
Publication Date
2021-11-23
Expiration Date
Abstract
Modular mammalian body implantable fluid flow influencing device, comprising: docking unit having receiving surface, distal and proximal ends, proximal guide hole. Functional unit having docking surface shaped to mate with receiving surface, distal and proximal ends. Control wire extends from proximal end of functional unit then goes through guide hold then extends proximally away from docking unit. Functional and docking units are dimensioned and shaped to be deliverable to an implantation site via catheter. Functional unit has docked configuration in which docking surface mates with receiving surface of docking unit and undocked configuration in which docking surface is unmated with and spaced apart from receiving surface of docking unit. Functional unit moveable at implantation site between undocked and docked configurations via movement of control wire. Functional unit moveable into docked configuration by pulling control wire, and moveable from into undocked configuration by pushing control wire. Multiple functional units also disclosed.
Core Innovation
The patent describes a modular mammalian body implantable fluid flow influencing device including a docking unit and one or more elongated functional units. The docking unit has an elongated body with a longitudinal axis, at least one receiving surface extending parallel to the longitudinal axis, and at least one proximal guide hole, and 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.
Each functional unit has an elongated body with a longitudinal axis and a docking surface extending parallel to the longitudinal axis, where the docking surface is shaped to mate with an associated receiving surface of the docking unit. The functional unit includes a control wire extending proximally from the proximal end of the functional unit, through the proximal guide hole associated with the receiving surface, and then extending proximally away from the docking unit.
The functional unit is unable to pass through the proximal guide hole associated with the receiving surface and is moveable at the implantation site between an undocked configuration and a docked configuration via movement of the control wire. The described implementations further disclose modular docking and deployment options for multiple pumping units, including retaining elements biasing the functional units in docked configuration, anchor assembly conversion to an anchored state when released from a delivery sheath, and barrier assemblies for blocking recirculation and optionally anchoring.
Claims Coverage
The independent claim coverage centers on a modular transcatheter implantable architecture with a docking unit and a first functional unit, where docking and undocking are controlled by a proximal control wire routed through a proximal guide hole. The claim centers on the structure of the docking interface, the guide-hole constraint on the functional unit’s size and movement, and the ability to move between docked and undocked configurations by pulling or pushing the control wire. The independent claim coverage includes 4 inventive features.
Docking unit deliverable via catheter with proximal guide hole
A docking unit having an elongated body with a longitudinal axis, at least one receiving surface extending parallel to the longitudinal axis, and at least one proximal guide hole associated with each receiving surface; 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.
Functional unit docking surface mates with receiving surface
A first functional unit having an elongated body with a longitudinal axis and a docking surface extending parallel to the longitudinal axis, where the docking surface is shaped to mate with a first one of the at least one receiving surface of the docking unit.
Guide-hole constraint and control wire routed through proximal guide hole
The elongated body of the first functional unit is sized, shaped, and structured to be unable to pass through a corresponding one of the at least one proximal guide holes of the docking unit associated with the receiving surface; a control wire extends proximally from the proximal end of the first functional unit, goes through the associated proximal guide hole, and extends proximally away from the docking unit.
Move between undocked and docked configuration using pulling and pushing
The first functional unit has a docked configuration in which the docking surface mates with the associated receiving surface, and an undocked configuration in which the docking surface is unmated and spaced apart from the receiving surface; the first functional unit is moveable between the undocked and docked configurations via movement of the control wire, including move into the docked configuration by pulling the control wire and move into the undocked configuration by pushing the control wire.
Across the independent claim, the main inventive coverage is the combination of a catheter-deliverable docking unit with proximal guide holes, a functional unit whose docking surface mates with a receiving surface, a structural constraint preventing passage through the proximal guide hole, and a control-wire mechanism that moves the functional unit between docked and undocked configurations by pulling or pushing.
Stated Advantages
Animal trial outcomes indicate successful implantation/operation/explantation in a pig.
No significant elevation in blood damage markers LDH and plasma-free Hb was reported in the pig trial outcomes.
No reduction in vWF activity was reported in the pig trial outcomes.
Shear-stress/CFD analyses indicate reduced shear/hemolysis risk for comparable flow versus modular multi-pump compared to single-pump VADs.
Shear-stress/CFD analyses indicate improved throughput at a given hemolysis threshold versus modular multi-pump compared to single-pump VADs.
Documented Applications
Modular multi-pump VAD docking and implantation in a mammalian subject, including pig outcomes reporting successful implantation/operation/explantation.
Use of fluid-blocking functional units enabling fluid withdrawal and delivery within the modular implantable fluid flow influencing device.
Use of barrier assembly to block recirculation in alternative embodiments of the modular implantable device.
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