Medical Implant Sealing Ring Recesses
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Solution Overview
Problem
Transcatheter heart valve implants experience paravalvular leakage due to the area between the stent and the native heart valve annulus, leading to chronic or acute ventricular decompensation, which is a major adverse event.
Innovation Solution
A medical implant with recesses in its struts to house a sealing member that expands when exposed to fluid or temperature, forming a circumferential seal to prevent leakage, using materials like non-woven fabrics or thermosensitive polymers to ensure effective sealing without being damaged during delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sealing member is sutured to the outer surface of the medical implant, then sealing effectiveness is improved, but the sealing member is at high risk of being destroyed during the delivery procedure
Solution Approach 1:
The sealing member is integrated into recesses formed in the struts of the expandable structure, nesting the sealing component within the structural framework. This integration protects the sealing member during delivery while enabling it to protrude and form an effective seal when the structure is expanded at the implantation site
Solution Approach 2:
The sealing member is pre-positioned within the recesses of the struts in a protected state before delivery. Upon expansion at the target site, the sealing member automatically protrudes from the recesses to engage with the annulus, performing the sealing action preliminarily prepared during the delivery phase
2Reliability
If the sealing member is made to protrude from the struts, then sealing contact with the annulus is improved, but the sealing member becomes vulnerable to damage during delivery
Solution Approach 1:
The sealing member transitions dynamically between two states: a retracted state within the recesses during delivery (protected configuration), and a protruding state when the structure is expanded at the implantation site (sealing configuration). This dynamic transformation allows the sealing member to be protected during delivery while achieving effective contact with the annulus upon deployment
Solution Approach 2:
The sealing member is nested within the recesses of the struts during the delivery phase, protecting it from damage. When the expandable structure is deployed, the sealing member is released from the recesses and protrudes outward to engage with the annulus, providing the necessary sealing contact
3Reliability
If the sealing member expands upon contact with fluid or temperature, then sealing effectiveness is improved, but the material selection and manufacturing complexity increase
Solution Approach 1:
The sealing member is constructed from materials that undergo parameter changes in response to physiological conditions. Specifically, the material changes its physical state (expands) upon contact with blood or body temperature, transforming from a compact state during delivery to an expanded sealing state at the implantation site. This parameter change enables effective sealing while maintaining compatibility with the delivery system
Solution Approach 2:
The sealing member utilizes phase transition properties of specialized materials that expand when exposed to fluid or temperature changes. This phase transition allows the sealing member to remain compact during delivery and automatically expand to form an effective seal upon contact with blood or body heat at the implantation site
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 expanded sealing member significantly reduces paravalvular leakage by forming a tight seal between the implant and the surrounding tissue, minimizing the risk of adverse events and ensuring the implant's stability post-implantation.
Implementation Method 1
the sealing member comprises a material that is fluid-sensitive so that the sealing member expands from the first state into the second state when the sealing member contacts a fluid, particularly blood
Implementation Method 2
the sealing member comprises a material that is thermo-sensitive so that the sealing member expands from the first state into the second state when it reaches a pre-defined temperature, particularly 37°C
Data Source
Figure 1~2
Figure 3~4
AI summary
The invention relates to a medical implant, comprising an expandable structure (100) which is designed to be expanded from a crimped state into an expanded state, wherein the structure (100) forms a tubular scaffolding in the expanded state, and wherein the structure (100) comprises a plurality of first struts (101) arranged along a periphery of the structure in said expanded state. According to the invention, the first struts (101) each comprise a recess (O), wherein the medical implant (1) further comprises a sealing member (200) arranged in said recesses (O), wherein said sealing member (200) is formed annularly in said expanded state.