Sutureless Flow Cannula for Co-Pulsatile Ventricular Support
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Solution Overview
Problem
Current mechanical circulatory support systems, such as LVADs, are ineffective for treating heart failure with preserved ejection fraction (HFpEF) due to their design being suited for systolic heart failure, and they often cause right heart failure in recipients, lacking a suitable mechanism for addressing the pathophysiology of HFpEF.
Innovation Solution
A flow cannula assembly for an implantable co-pulsatile epi-ventricular circulatory support system with a seamless conduit body, bellmouth, and fasteners for sutureless attachment to the heart, coupled with a valveless displacement blood pump that operates in sync with the cardiac cycle to address diastolic heart failure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional LVAD systems are used for heart failure treatment, then mechanical circulatory support is provided, but the system is ineffective for HFpEF patients and causes device-induced right heart failure
Solution Approach 1:
The cannula system employs dynamic elements including a compressible seal that adapts to the beating heart surface, and a flexible conduit body that can accommodate cardiac motion. The male and female fasteners create a dynamic sealing interface that maintains reliability during cardiac cycles, enabling the system to effectively treat HFpEF while adapting to heart movement.
Solution Approach 2:
The invention changes the operational parameters of circulatory support by using a pulsatile pump system rather than continuous flow, and by implementing a sutureless fastening mechanism that alters the mechanical interface parameters between device and heart tissue. This enables effective treatment of HFpEF patients who previously responded poorly to conventional LVAD therapy.
2Reliability
If suture-based cannula fixation is used, then the cannula can be anchored to the heart, but surgical trauma increases and leak risk rises
Solution Approach 1:
The invention extracts and eliminates the sutures from the fixation system, replacing them with a direct mechanical fastening mechanism. The male fastener on the conduit body engages with the female fastener on the pump housing, creating a sutureless connection that anchors the cannula without requiring needle penetration or thread anchoring, thereby reducing surgical trauma while maintaining connection integrity.
Solution Approach 2:
The fastener assembly acts as an intermediary mechanism between the conduit body and pump housing, providing a standardized mechanical interface that eliminates the need for surgical sutures. This intermediary coupling system reduces direct tissue manipulation while ensuring reliable, leak-proof connection through standardized engagement features.
3Reliability
If conventional cannula design is used, then connection to pump is possible, but thrombosis risk increases due to flow disturbances
Solution Approach 1:
The conduit body features a curved, bell-shaped inlet that smoothly transitions blood flow from the ventricle into the pump. This curved geometry eliminates sharp angles and abrupt transitions that would create flow separation and eddies, thereby reducing thrombosis risk while maintaining reliable connection to the pump system.
4Reliability
If complex fastening mechanism is used to ensure leak-proof connection, then connection reliability improves, but device complexity increases
Solution Approach 1:
The fastening mechanism is segmented into distinct male and female components that independently attach to the conduit body and pump housing respectively. This segmentation allows each component to be optimized for its specific function while simplifying the overall assembly process, achieving leak-proof connection through modular, standardized interfaces rather than complex integrated mechanisms.
Data Source
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AI summary
An implantable circulatory support system, configured to connect a ventricular chamber of a heart, including a valveless displacement blood pump, a deformable polymeric flow cannula, a pair of male and female fasteners, a coupler, a driveline assembly, and a co-pulsatile driver. Forward and backward flow communication between the blood pump and the heart chamber is accomplished using the present flow cannula invention which is anastomosed to the heart chamber in a sutureless manner. When providing circulatory support, the co-pulsatile driver ejects blood out of the blood pump during systolic ventricular contraction and fills the blood pump with blood during diastolic ventricular relaxation.