Catheter-Assembled Modular Impeller for Larger, Lower-Shear VAD Pumping
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Solution Overview
Problem
Current ventricular assist devices (VADs) require invasive open surgery and are limited by the size of the device due to peripheral vascular access, leading to high impeller rotation speeds that cause shear stress and complications such as embolic strokes and thrombosis, while expandable impeller pumps face issues with mechanical joints, inflation requirements, and material flexibility affecting hydraulic efficiency and durability.
Innovation Solution
A modular impeller design with interchangeable hub and vane modules that can be assembled in vivo via a catheter, allowing for a larger operating diameter without the need for expansion mechanisms, reducing the risk of complications and improving hydraulic efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a larger impeller is used to reduce rotation speed and shear stress, then blood compatibility and safety are improved, but the device cannot be delivered through peripheral vascular access
Solution Approach 1:
The impeller is divided into separate modular components (hub module and vane modules) that can be delivered individually through the catheter and then assembled at the implantation site. This segmentation allows the delivery of compact components through peripheral vessels while enabling the formation of a larger assembled impeller that reduces shear stress and improves blood compatibility.
Solution Approach 2:
The modular impeller components are delivered nested within the catheter in a compact configuration, then assembled at the implantation site to form a larger impeller structure. This nesting approach allows the components to pass through narrow vascular access points while achieving the desired larger operating diameter at the implantation location.
2Productivity
If expandable impeller pumps are used to achieve larger diameter, then hydraulic efficiency is improved, but mechanical joints and inflation requirements complicate the device
Solution Approach 1:
Instead of using a complex expandable impeller with mechanical joints and inflation mechanisms, the invention segments the impeller into separate modular components that are assembled without requiring expansion. This eliminates the complexity of joints and inflation systems while still achieving the hydraulic efficiency of a larger impeller diameter through the assembled modular structure.
Solution Approach 2:
Rather than delivering a compact impeller and then expanding it to a larger size (the conventional approach), the invention delivers separate modular components that are assembled into the final larger configuration at the implantation site. This inverts the traditional expandable impeller approach, eliminating the need for expansion mechanisms while achieving the same hydraulic efficiency.
3Reliability
If a larger impeller is implanted to reduce rotation speed, then complications such as thrombosis are reduced, but the implantation requires more invasive surgery
Solution Approach 1:
The impeller is segmented into modular components that can be delivered through a catheter via percutaneous access, eliminating the need for open surgical implantation. This modular delivery approach allows a larger impeller to be implanted with minimal invasiveness, reducing thrombosis risk through lower rotation speeds while avoiding the complications of open surgery.
Solution Approach 2:
A catheter serves as an intermediary delivery mechanism that enables the transport of modular impeller components through the vascular system to the implantation site. This intermediary approach allows minimally invasive implantation of a larger impeller, reducing both the invasiveness of the procedure and the risk of thrombosis through reduced rotation speeds.
Data Source
AI summary
Mammalian body implantable fluid flow influencing device, comprising a modular impeller having: An impeller hub module dimensioned and shaped to be deliverable to a delivery site within a conduit of a conduit system of the mammalian body via a catheter. An impeller vane module having at least a portion of an impeller vane; having, with respect to the impeller hub module, an assembled configuration in which the impeller vane module mates with the impeller hub module, and an unassembled configuration, in which the impeller vane module is unmated with the impeller hub module and being dimensioned and shaped to be deliverable to the delivery site via the catheter when in the unassembled configuration. The modular impeller being formed when the impeller vane module is retained in its assembled configuration, and dimensioned and shaped to be operable within at least one conduit of the conduit system. Method of implantation disclosed.