Atraumatic Prosthesis Anchors for Secure Tissue Engagement
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Solution Overview
Problem
Developing prostheses, particularly replacement heart valves, that can be compactly delivered and controllably expanded for secure placement within body lumens while minimizing trauma and preventing paravalvular leakage has proven challenging, especially in securing the prosthesis to intralumenal tissue without applying significant radial force.
Innovation Solution
The design incorporates an expandable frame with proximal and distal anchors that radially expand and contract, featuring foreshortening cells to decrease longitudinal length and atraumatic looped ends for secure engagement with tissue, along with an outer skirt to prevent leakage, allowing for controlled deployment and positioning within the native mitral valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the prosthesis is designed to radially expand for secure placement within the body lumen, then the anchoring and fixation capability is improved, but the trauma to intralumenal tissue increases due to significant radial force application
Solution Approach 1:
The prosthesis is divided into multiple anchors distributed around the frame, each independently engaging with tissue. This segmentation allows the radial force to be distributed across multiple discrete contact points rather than concentrated, reducing trauma to individual tissue locations while maintaining overall anchoring reliability
Solution Approach 2:
The anchors are designed with differentiated local properties: sharp distal ends for initial tissue penetration and atraumatic looped proximal ends for secure engagement. This local quality variation allows the prosthesis to achieve reliable anchoring through the sharp ends while minimizing tissue trauma through the atraumatic looped configurations that grasp without excessive radial force
2Reliability
If the prosthesis uses traditional anchoring mechanisms that apply significant radial force, then the secure fixation to tissue is improved, but the paravalvular leakage increases due to improper seating
Solution Approach 1:
The distal anchors with sharp ends perform the preliminary action of penetrating and engaging with tissue before the proximal anchors are deployed. This sequential preliminary action ensures proper tissue engagement and seating of the prosthesis, creating a secure foundation that prevents paravalvular leakage while reducing the need for excessive radial force from subsequent anchoring steps
3Ease of operation
If the prosthesis is designed for compact delivery, then the ease of delivery through minimally invasive procedures is improved, but the controllability during expansion and placement deteriorates
Solution Approach 1:
The prosthesis employs dynamically deployable anchors that transition from a compact, constrained state during delivery to an expanded, functional state during implantation. The anchors are initially stored in a low-profile configuration within the delivery catheter, then progressively deployed through controlled mechanisms (balloon expansion, self-expansion, or mechanical actuation) that provide controllable expansion while maintaining ease of delivery through the minimally invasive access route
Data Source
Figure 1A
Figure 1B
Figure 2~3
AI summary
A prosthesis (10) comprising an expandable frame (20) with a plurality of distal anchors (24) and a plurality of proximal anchors (22). The anchors extend outwardly from the frame. The frame is configured to radially expand and contract for deployment within a body cavity. When the frame is in an expanded configuration, the proximal anchors extend a significant distance away from the exterior of the frame, such as a length equal to or greater than about one half the diameter of the frame. The anchors can have looped ends. Proximal anchors extend proximally away from a proximal end of the frame and then turn to extend distally, and distal anchors extend distally away from a distal end of the frame and then turn to extend proximally.