Expandable Mesh-Balloon Spacer for Transcatheter Tricuspid Repair
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Solution Overview
Problem
Heart valve regurgitation, particularly tricuspid valve regurgitation, is often treated with open-heart surgery, which is invasive and risky, while catheter-based techniques lack effective solutions for proper valve repair.
Innovation Solution
A transcatheter device with a main shaft, distal tail, and spacer body is designed for minimally invasive treatment, featuring a guidewire lumen, nitinol wire lumen, and injection tube lumen, along with a spacer body that can expand to provide a coaptation surface for tricuspid valve leaflets, anchored by a distal tail in the pulmonary artery and intravascular anchor in the vena cava.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery with cardiopulmonary bypass is used to treat tricuspid valve regurgitation, then effective valve repair can be achieved, but the procedure becomes highly invasive and risky
Solution Approach 1:
The device is divided into multiple functional segments: a distal tail for anchoring in the pulmonary artery, a spacer body for creating the coaptation surface, and a proximal portion with an intravascular anchor for stabilization in the vena cava. This segmentation allows the complex valve repair function to be achieved through a minimally invasive catheter-based approach rather than requiring full open-heart surgery with cardiopulmonary bypass.
2Object-affected harmful factors
If catheter-based techniques are used for valve repair, then surgical invasiveness is reduced, but effective solutions for proper valve repair are lacking
Solution Approach 1:
The spacer body acts as an intermediary structure that creates a coaptation surface between the tricuspid valve leaflets. This intermediary element enables proper valve closure and eliminates regurgitation without requiring direct manipulation of the valve apparatus, thus achieving effective repair through a minimally invasive catheter-based approach.
Solution Approach 2:
The device is delivered through a catheter in a compressed state and then expanded at the target site within the heart. This preliminary compression allows the entire repair mechanism to be delivered through a small vascular access point, and the expansion at the destination creates the coaptation surface in the optimal position for valve repair.
3Reliability
If a spacer body is expanded to provide a coaptation surface, then tricuspid regurgitation is effectively treated, but device complexity increases
Solution Approach 1:
The spacer body transitions from a compressed delivery state to an expanded functional state at the target site. This dynamic transformation allows the device to maintain a simple, low-profile configuration during delivery through the catheter, then expand to provide the necessary coaptation surface for effective tricuspid regurgitation treatment.
Solution Approach 2:
The spacer body is nested within the delivery catheter in a compressed state, allowing the entire device to be delivered through a minimally invasive approach. Once positioned, the spacer body expands from its nested configuration to provide the coaptation surface, effectively treating the regurgitation without requiring complex external support structures.
Data Source
Figure 1A
Figure 1B
Figure 1C~1D(c)
AI summary
A transcatheter device includes: a main shaft including a proximal portion, an intermediate portion, and a distal portion, and having a first lumen for insertion of a guidewire, a second lumen for insertion of a nitinol wire, and a third lumen for insertion of an injection tube formed therein; a distal tail comprising a distal portion of the main shaft; a spacer body mounted on the intermediate portion positioned between the distal portion and the proximal portion of the main shaft, in which the proximal portion of the main shaft includes a proximal segment and an intravascular anchor connected to the proximal segment, and wherein the spacer body comprises: a mesh structured body configured contractible or expandable and to be expanded to have a predetermined configuration in the absence of an external force from an environment; and a balloon configured to cover the mesh structured body to maintain an enclosed state, and to be controlled in size depending on an amount of a saline solution injected into an internal space thereof.