Conduction Tissue Protector for TAVI Valve Implantation
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Solution Overview
Problem
During transcatheter aortic valve implantation (TAVI) procedures, the metal frame of the valve prosthesis often interferes with conduction tissue, leading to heart block, bradycardia, and paravalvular leakage due to improper implantation depth, necessitating temporary or permanent pacemaker implantation and increasing the risk of mechanical trauma.
Innovation Solution
A valve-delivery-assist tool comprising a delivery catheter, an aortic-valve cusp guide, and a conduction-tissue protector with a sheet that expands to shield the conduction tissue, along with a landing-support stabilizer to ensure precise implantation depth and reduce trauma, is used to protect the conduction tissue and facilitate proper valve placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the valve prosthesis is deployed to treat aortic valve stenosis, then the aortic valve function is improved, but the conduction tissue is damaged causing heart block
Solution Approach 1:
A conduction tissue protector is introduced as an intermediary element between the valve prosthesis and the conduction tissue. The protector is deployed first to shield the vulnerable conduction tissue, then the valve prosthesis is deployed over it. The protector acts as a barrier that prevents direct contact and damage between the metal frame of the valve and the conduction tissue below the aortic valve cusps.
Solution Approach 2:
The conduction tissue protector is deployed in advance before the valve prosthesis is released. This preliminary deployment ensures that the protective barrier is already in place to prevent damage when the valve prosthesis expands and its metal frame interacts with surrounding tissues during the TAVI procedure.
2Reliability
If the valve implantation depth is increased to prevent paravalvular leakage, then sealing is improved, but the risk of conduction tissue impingement increases
Solution Approach 1:
The conduction tissue protector serves as a mediator that allows the valve to be implanted at the optimal depth for sealing while preventing direct impingement on the conduction tissue. The protector absorbs the mechanical interaction, enabling deeper implantation without increasing conduction tissue damage risk.
Data Source
AI summary
A valve-delivery-assist tool (20, 120, 220, 320) is provided for use during a transcatheter aortic valve implantation (TAVI) procedure on a native aortic valve. The valve-delivery-assist tool (20, 120, 220, 320) includes a delivery catheter (22); an aortic-valve cusp guide (24), which deflects laterally upon being released from the delivery catheter (22); and a conduction-tissue protector (26, 126), which includes a sheet (28,128) and expands upon being released from a distal end (29) of the delivery catheter (22). The valve-delivery-assist tool (20, 120, 220, 320) is configured such that after lateral deflection of the aortic-valve cusp guide (24) and expansion of the conduction-tissue protector (26, 126), the released conduction-tissue protector (26, 126) and the released aortic-valve cusp guide (24) are axially stationary with respect to each other such that a distal-most point (30) of the released conduction-tissue protector (26, 126) is disposed distal to a distal-most point (32) of the released aortic-valve cusp guide (24). Other embodiments are also described.