Transcatheter Flexible Capsule Delivery for Reduced Ventricle Depth
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Solution Overview
Problem
Existing transcatheter delivery devices face challenges in delivering and deploying prosthetic heart valves due to limitations in device design, particularly in reducing ventricle depth during deployment, which restricts the patient population and valve locations suitable for prosthesis delivery.
Innovation Solution
The use of a flexible capsule system, including a distal and optional proximal capsule, that can transition between curved and straightened states, combined with a rigid distal portion of the outer sheath, allows for reduced ventricle depth during deployment, enabling wider applicability of the delivery device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a conventional delivery device with a straight capsule is used, then the device structure is simple, but the ventricle depth required during deployment is large, limiting patient population and valve locations
Solution Approach 1:
The capsule is designed to dynamically change its configuration from a curved delivery state to a straightened deployed state. The distal portion of the capsule can deflect or straighten upon contact with the anatomy or upon deployment, allowing the device to adapt its shape during the procedure. This dynamic transformation reduces the ventricle depth required during delivery while maintaining structural integrity during deployment.
Solution Approach 2:
The physical parameters of the capsule, specifically its curvature and rigidity, are changed during the delivery process. The capsule transitions from a curved configuration with lower rigidity during delivery to a straightened configuration with increased rigidity during deployment. This parameter change allows the device to fit within smaller ventricle spaces during delivery while providing sufficient structural support during valve deployment.
2Reliability
If the capsule is made rigid to maintain structural integrity during deployment, then deployment stability is improved, but the device cannot deflect or reduce ventricle depth, limiting applicability
Solution Approach 1:
The capsule is segmented into different portions with different mechanical properties. The distal portion is designed to be more flexible and capable of deflection, while the proximal portion maintains greater rigidity for structural support. This segmentation allows the device to achieve both deflection capability for ease of operation and structural integrity for reliable deployment.
Solution Approach 2:
Different portions of the capsule have different local qualities in terms of rigidity and flexibility. The distal portion is designed with local quality characteristics that allow deflection and curvature, while maintaining overall structural integrity. This localized variation in material or structural properties enables the capsule to deflect when needed while maintaining deployment stability.
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
This design enhances the flexibility and adaptability of the delivery device, increasing the patient population and valve locations suitable for prosthesis delivery by minimizing the depth required in the ventricle, thus expanding the applicability of transcatheter procedures.
Implementation Method 1
The flexible capsule can be forced into a generally straightened state and transition to a generally curved or first state to provide clearance during delivery and deployment of the prosthesis
Data Source
AI summary
Aspects of the disclosure include transcatheter delivery devices for delivery and deployment of a cardiac prosthesis, such as a prosthetic heart valve. Various embodiments include a one or two part capsule for maintaining the prosthesis during delivery. Embodiments include a flexible capsule that can deflect, either automatically or in response to contact with the anatomy, to reduce a delivery depth within a ventricle necessary to fully unsheathe the prosthesis, which increases the patient population and valve locations suitable for prosthesis delivery with the delivery device.