Percutaneous Papillary Muscle Relocation via Nested Sheath Anchoring
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Solution Overview
Problem
Current medical technologies lack effective methods for percutaneously treating mitral regurgitation by relocating the papillary muscles of the heart, which is essential for improving the coaptation of mitral valve leaflets during systole.
Innovation Solution
A system comprising an outer sheath, an intermediate sheath, and an inner sheath, where the inner sheath includes a first anchor configured to penetrate and secure to a papillary muscle. The system uses a tissue grasping mechanism at the distal end of the intermediate sheath to hold and stabilize the papillary muscle for anchor deployment, and a tethering element connects the anchors to reposition the papillary muscles relative to each other.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If percutaneous approach is used to treat mitral regurgitation, then patient trauma and recovery time are reduced, but the complexity of the delivery system increases
Solution Approach 1:
The patent employs a nested sheath configuration where an inner sheath is positioned within an outer sheath, both extending through the aorta and into the left ventricle. This nested structure allows multiple functional components to be delivered through a single percutaneous access point while maintaining individual control and deployment capability for each sheath and its associated anchors.
Solution Approach 2:
The delivery system is divided into distinct functional segments: the outer sheath with first anchors for one papillary muscle, the inner sheath with second anchors for another papillary muscle, and the tissue grasping mechanism. This segmentation allows independent positioning and deployment of each component to achieve precise papillary muscle relocation while simplifying the overall percutaneous delivery process.
2Reliability
If anchors are used to secure papillary muscles, then papillary muscle repositioning effectiveness is improved, but the risk of tissue damage during anchor penetration increases
Solution Approach 1:
The tissue grasping mechanism serves as an intermediary between the anchor and the papillary muscle. It first engages and secures the papillary muscle tissue, then guides the anchor penetration process to ensure precise placement. This intermediary mechanism reduces uncontrolled tissue damage by providing stable tissue engagement before anchor deployment.
Solution Approach 2:
The tissue grasping mechanism performs preliminary engagement and stabilization of the papillary muscle before anchor penetration occurs. This preliminary action ensures the tissue is securely held and properly positioned, allowing for more controlled and precise anchor placement that minimizes collateral tissue damage while maximizing repositioning effectiveness.
3Adaptability or versatility
If multiple sheaths are used to deliver anchors to different papillary muscles, then treatment versatility is improved, but the device complexity and procedural time increase
Solution Approach 1:
The patent merges the functionality of multiple delivery systems into a single integrated apparatus where the inner sheath and outer sheath work cooperatively. Both sheaths are delivered through the same percutaneous access and can be independently controlled, allowing treatment of multiple papillary muscles simultaneously while reducing the overall complexity compared to separate delivery procedures.
Solution Approach 2:
The nested sheath configuration provides universal applicability for treating different papillary muscle arrangements and configurations. The system can adapt to various anatomical scenarios by independently positioning each sheath to target specific papillary muscles, making the device versatile for different patient anatomies without requiring multiple specialized devices.
4Manufacturing precision
If tissue grasping mechanism is used to stabilize papillary muscle, then anchor penetration precision is improved, but the device complexity increases
Solution Approach 1:
The tissue grasping mechanism provides localized stabilization at the specific site where anchor penetration is needed. Rather than requiring complex overall system complexity, the grasping mechanism focuses its function locally at the papillary muscle engagement point, providing precise tissue holding and stabilization exactly where needed for accurate anchor placement.
Data Source
AI summary
A system for treating mitral regurgitation may include an outer sheath having a lumen extending to a distal end of the outer sheath, an intermediate sheath slidably disposed within the lumen of the outer sheath, the intermediate sheath having a lumen extending to a distal end of the intermediate sheath, and an inner sheath slidably disposed within the lumen of the intermediate sheath, wherein the inner sheath includes a first anchor disposed within a lumen of the inner sheath, the first anchor being configured to penetrate and secure to a first papillary muscle. The intermediate sheath may include a tissue grasping mechanism at the distal end of the intermediate sheath, the tissue grasping mechanism being configured to hold and stabilize the first papillary muscle for penetration and securement of the first anchor to the first papillary muscle.