Mitral Valve Prosthesis Annular Flap Paravalvular Leakage
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Solution Overview
Problem
Existing prostheses for heart valves face challenges in preventing paravalvular leakage and securely anchoring within the body cavity without causing trauma to intralumenal tissue, particularly during minimally invasive procedures for replacing impaired mitral valves.
Innovation Solution
A prosthesis with an expandable frame, distal and proximal anchors, an annular flap, and a valve body designed to radially expand and contract, featuring cushions on anchors to reduce trauma and an annular flap to prevent fluid flow around the exterior, ensuring secure anchoring and minimizing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If an expandable frame with anchors is used to secure the prosthesis, then anchoring strength is improved, but trauma to intralumenal tissue increases
Solution Approach 1:
Cushions are provided on the anchors before deployment to reduce trauma to intralumenal tissue. The cushions act as protective elements that are already in place before the anchors contact the tissue, preventing direct mechanical trauma while maintaining anchoring capability.
Solution Approach 2:
The prosthesis includes an annular flap that acts as a flexible barrier to prevent paravalvular leakage. This thin film structure creates a seal around the expandable frame without requiring rigid fixation that would cause tissue trauma.
2Reliability
If an annular flap is added to prevent paravalvular leakage, then sealing effectiveness is improved, but device complexity increases
Solution Approach 1:
The annular flap is integrated with the expandable frame structure, combining the sealing function with the existing prosthesis design. This merging approach adds the sealing capability while minimizing the increase in overall device complexity by sharing structural elements.
3Object-affected harmful factors
If the prosthesis is designed for minimally invasive delivery, then patient trauma is reduced, but difficulty of secure anchoring increases
Solution Approach 1:
The prosthesis is divided into separable components including the expandable frame, anchors, cushions, and annular flap. This segmentation allows the components to be delivered through minimally invasive approaches and then assembled or deployed at the target site, reducing patient trauma while maintaining anchoring capability.
Data Source
Figure 1A
Figure 1B
Figure 2
AI summary
A prosthesis (10) can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis comprises an expandable frame (20) configured to radially expand and contract for deployment within the body cavity and an annular flap (50) positioned around and secured to an exterior of the expandable frame, the annular flap having a distal edge secured at or near the distal end (14) of the frame and extending to a proximal edge secured at an intermediate location on the frame between the proximal (12) and distal (14) ends. The prosthesis also comprises a valve body positioned within an interior of the expandable frame, wherein the valve body comprises: an inner skirt (62) secured to the interior of the expandable frame (20); and a plurality of leaflets (64) configured to allow flow in a first direction and prevent flow in a second opposite direction. An opening is defined at or near the distal end of the frame between the annular flap and the valve body to provide access for fluid to flow into a space (59) between the annular flap and the valve body, and wherein fluid flow into the space causes the annular flap to move from a first configuration wherein the flap is closer to the frame to a second configuration wherein the flap is spaced further away from the frame to increase the surface area of the prosthesis and create a barrier to fluid flow exterior to the frame when deployed within the body cavity.