Side-Delivered Transcatheter Heart Valve with Flow Control
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Solution Overview
Problem
Current transcatheter heart valve replacement technologies face challenges with regurgitation and material durability issues, requiring expensive materials to withstand the mechanical stresses of heart function, and often necessitate open heart surgery for implantation.
Innovation Solution
A side-delivered transcatheter prosthetic valve with a tubular frame that is compressible and expandable along a long-axis parallel to the delivery catheter, featuring a flow control component and tension arms for secure anchoring, allowing for minimally invasive implantation without open heart surgery, using biocompatible materials like pericardial tissue and synthetic polyester.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transcatheter valves are delivered by perforating the apex of the heart to access the ventricle, then minimally invasive procedure is achieved, but the perforation is often used to anchor an annular valve replacement which complicates the procedure
Solution Approach 1:
The delivery system is divided into separate functional components: the catheter for access, the compression device for valve preparation, and the deployment mechanism for valve installation. This segmentation allows each component to perform its specific function independently, simplifying the overall procedure while maintaining minimal invasiveness
Solution Approach 2:
The valve is designed with self-compression capabilities through its frame structure that can be compressed by the catheter itself without requiring external compression devices. The valve also features self-deployment mechanisms that allow it to expand and anchor automatically upon release from the catheter, reducing procedural complexity
2Ease of operation
If stent-style replacement valves are used, then transcatheter delivery is enabled, but regurgitation or leakage problems persist and expensive materials engineering is required
Solution Approach 1:
The valve combines a flexible frame structure made of shape-memory alloy (such as nitinol) with biological tissue leaflets. This composite construction allows the frame to provide structural support and compression resistance while the biological tissue provides natural valve function with minimal regurgitation, eliminating the need for expensive mechanical materials
Solution Approach 2:
The valve utilizes phase transition properties of shape-memory alloys that change from austenite to martensite phases during compression and deployment. This parameter change allows the valve to be compressed to small dimensions for catheter delivery, then automatically return to its original expanded configuration upon release, providing reliable sealing without expensive materials
3Reliability
If expensive materials engineering is used to cope with mechanical stresses, then valve durability is improved, but cost increases
Solution Approach 1:
The valve employs phase transition properties of shape-memory alloys that change from austenite to martensite phases during compression and deployment. This parameter change allows the valve to be compressed to small dimensions for catheter delivery, then automatically return to its original expanded configuration upon release, providing reliable sealing without expensive materials
Solution Approach 2:
The valve uses biocompatible materials that are cost-effective and sufficiently durable for the required service life. The biological tissue leaflets and shape-memory alloy frame provide adequate durability for typical valve replacement needs without requiring expensive mechanical materials designed for indefinite service life
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
Enables effective blood flow regulation with reduced regurgitation and improved durability, facilitating minimally invasive procedures that reduce patient trauma and surgical costs while enhancing valve longevity.
Implementation Method 1
the tubular frame is compressible and expandable along a long-axis substantially parallel to a cylindrical axis of the delivery catheter
Data Source
AI summary
The invention relates to a transcatheter heart valve replacement (A61F2/2412), and in particular a side delivered transcatheter prosthetic valve having a tubular frame with a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter, and wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.