Expandable Valve Support for Beating Heart Repair
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Solution Overview
Problem
Current heart valve repair devices are inflexible and unable to address patient-specific valve defects, leading to sub-optimal durability and recurrent regurgitation, as they do not conform to the beating heart's anatomy and require invasive procedures.
Innovation Solution
Development of adjustable valve repair devices with expandable valve supports and mounting structures that can be implanted on a beating heart, using materials like permeable membranes and shape memory alloys, to provide a coaptation surface for leaflets and eliminate regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional valve repair devices are used, then the procedure can be performed with current technology, but the devices lack flexibility and cannot address patient-specific valve defects, leading to sub-optimal durability and recurrent regurgitation
Solution Approach 1:
The valve support is designed as an expandable structure that can be adjusted after implantation to accommodate the beating heart's anatomy. The expandable nature allows the device to adapt dynamically to physiological conditions, resolving the contradiction between adaptability and reliability by enabling post-implantation adjustments based on actual cardiac function.
Solution Approach 2:
The device utilizes shape memory alloys that can change their physical properties (shape, rigidity) in response to temperature or other stimuli. This parameter change capability allows the valve support to transform from a compact delivery state to an expanded functional state, providing both adaptability to different patient anatomies and reliable structural support for durable repair.
2Ease of operation
If valve repair is performed on a flaccid heart during surgery, then the device can be implanted, but the heart must be arrested and the procedure cannot account for the beating heart's anatomy, leading to persistent regurgitation after recovery
Solution Approach 1:
The valve support is pre-configured in a compressed state within the delivery device, allowing for simplified implantation procedures. The preliminary preparation of the device in a ready-to-deploy state enables ease of operation during surgery, while the subsequent expansion and adjustment capabilities ensure reliable elimination of regurgitation by adapting to the beating heart's anatomy.
Solution Approach 2:
The expandable valve support transitions from a static implantation state to a dynamic adjusted state after deployment. This dynamic capability allows the device to accommodate the living, beating heart's movements and anatomical variations, ensuring reliable regurgitation elimination while maintaining surgical simplicity through the initial straightforward implantation process.
3Productivity
If current valve repair devices are used, then the procedure can be completed, but the devices cannot be adjusted after implantation, requiring repeated invasive surgeries when regurgitation persists
Solution Approach 1:
The valve support is designed with adjustable expansion capabilities that can be modified after implantation. This dynamic adjustability allows clinicians to optimize the device's performance in the living patient without requiring repeated invasive surgeries, thereby improving both the efficiency of the initial procedure and the ease of post-implantation repairs through non-invasive adjustments.
Solution Approach 2:
The device incorporates features that allow for self-adjustment or easy re-adjustment after implantation, reducing the need for additional surgical interventions. This self-service capability enables the valve support to maintain optimal function over time, improving procedural efficiency and making repairs easier through adjustable rather than fixed design.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The devices reduce or eliminate regurgitation by enabling proper coaptation of native valve leaflets onto an artificial surface, supporting flail or prolapsing leaflets, and can be adjusted post-implantation, reducing the need for repeated invasive surgeries.
Implementation Method 1
The valve support may be made of a hydrophilic material, such as a hydrophilic protein or a biocompatible gelatin, and may be structured to expand when exposed to bodily fluid such as blood
Implementation Method 2
The mounting structure may include a shape memory alloy
Data Source
AI summary
The systems and devices and methods relate to surgical and percutaneous repair of heart valve regions. The systems and devices are structured to conform to the desired shape of a specific patient. The devices may include a mounting structure and a valve support onto which leaflets of the valve may coapt or rest. The devices may be structured to be mounted directly onto a leaflet of the valve.