Artificial Chordae Anchor Expansion for Secure Papillary Fixation
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Solution Overview
Problem
Current surgical interventions for mitral valve disease, such as invasive surgeries and valve replacements, are complex and risky, and do not effectively address damaged chordae tendineae, necessitating transluminal solutions for durable repair and replacement.
Innovation Solution
A medical device system for anchoring artificial chordae tendineae to a papillary muscle or heart wall using an anchor that transitions from a delivery configuration to a deployed configuration, with arms that expand radially to securely engage the tissue, allowing for minimally invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive surgical intervention is used to repair mitral valve disease, then the surgeon can directly view and repair the valve, but the procedure becomes complex and risky requiring opening into the chest and heart chamber
Solution Approach 1:
The surgical procedure is segmented into two distinct phases: a minimally invasive delivery phase where the anchor device is introduced through a catheter, and a deployment phase where the anchor expands to engage the papillary muscle. This segmentation allows the complex anchoring function to be achieved without requiring open-heart surgery, thus reducing surgical complexity while maintaining repair effectiveness
Solution Approach 2:
The anchor device is nested within a delivery catheter in a compressed delivery configuration. The anchor contains multiple arms that are initially contained within the catheter lumen, allowing the entire anchoring mechanism to be delivered through a minimally invasive access route. Upon deployment, the arms expand outward from the catheter to engage the heart tissue, achieving reliable fixation without complex open surgery
2Reliability
If the anchor is designed to expand from a small delivery configuration to a larger deployed configuration, then secure engagement with tissue is achieved, but the device must navigate through a narrow catheter
Solution Approach 1:
The anchor device employs dynamic transformation from a static compressed state to an expanded engaged state. The arms are designed to be flexible and movable, transitioning from a radially compressed configuration during delivery to a radially expanded configuration during deployment. This dynamic behavior allows the device to navigate narrow catheters while achieving secure tissue engagement
Solution Approach 2:
The anchor undergoes significant parameter changes during deployment: the outer dimension increases as the arms expand radially outward, and the engagement force increases as the arms penetrate and anchor into the papillary muscle. These parameter changes are controlled and reversible, allowing the device to adapt to different delivery and deployment conditions while maintaining anchoring security
3Reliability
If multiple arms are used to engage the papillary muscle, then secure anchoring is achieved, but the device complexity increases
Solution Approach 1:
Each arm of the anchor serves multiple functions: it acts as a structural support element, a tissue-piercing needle, and an anchoring element. The arms are identical in structure and function, providing redundant anchoring capability while simplifying the overall design. This multi-functionality reduces the need for additional specialized components, thereby limiting the increase in device complexity despite using multiple arms
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
Enables secure anchoring of artificial chordae tendineae to the heart wall, providing a durable solution for mitral valve repair and reducing regurgitation, while minimizing invasive procedures and complications.
Implementation Method 1
The plurality of arms are made from a shape memory material
Data Source
Figure 1
Figure 2A~2B
Figure 2C~2D
AI summary
The present disclosure relates generally to the field of medical devices for delivering artificial chordae tendineae in a patient An anchor for engaging a papillary muscle or heart wall is described, wherein the anchor is movable between a delivery configuration and a deployed configuration. When the anchor is in the delivery configuration the anchor has a first outer dimension and when the anchor is in the deployed configuration the anchor has a second outer dimension. The first outer dimension is smaller than the second outer dimension. The anchor is engageable with a papillary muscle or a heart wall when the anchor is in the deployed configuration. The anchor comprises a plurality of arms coupled at a proximal end thereof to a body portion, at least one arm of the plurality of arms movable between a first position and a second position when the anchor moves from the delivery configuration to the deployed configuration. The plurality of arms each have a distal tip for engaging the papillary muscle or heart wall, wherein as the anchor is moved from the delivery configuration to the deployed configuration, the plurality of arms are movable from an elongated shape to a curved shape.