Tissue Shaping Device with Variable Thickness Connector
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Solution Overview
Problem
Existing methods for treating mitral valve regurgitation, such as surgical replacement or ring implantation, are invasive and carry significant risks, while less invasive tissue shaping devices face challenges in adapting to varying patient anatomy, particularly in avoiding constriction of coronary arteries like the circumflex artery.
Innovation Solution
A tissue shaping device with adjustable anchors and connectors, designed to be deployed in the coronary sinus, which includes flexible wire crimps and actuatable anchors to minimize constriction risks and maximize therapeutic effect by reshaping the mitral valve annulus, allowing for precise anchoring and reshaping forces to reduce regurgitation without compromising cardiac perfusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tissue shaping device is deployed in the coronary sinus to reshape the mitral valve annulus, then mitral valve regurgitation is reduced, but there is a risk of constricting nearby coronary arteries such as the circumflex artery
Solution Approach 1:
The connector is designed with non-uniform thickness, being thicker at the anchor attachment locations and thinner at the midsection. This local variation in structural properties allows the connector to provide stronger support where anchors are attached while being more flexible in the midsection, reducing the risk of constricting the coronary artery that may pass through this region.
Solution Approach 2:
The connector incorporates a hinge that allows relative movement between the proximal and distal anchors. This dynamic capability enables the device to adapt to anatomical variations and physiological movements of the heart, maintaining therapeutic effect while accommodating changes in the position of coronary arteries during cardiac cycles.
2Reliability
If surgical replacement or ring implantation is used to treat mitral valve regurgitation, then valve function is restored, but the procedure is highly invasive with significant risks
Solution Approach 1:
The tissue shaping device is divided into separate components including proximal and distal anchors connected by a connector. This segmentation allows the device to be delivered through a catheter in a collapsed state and then expanded to its functional configuration within the coronary sinus, enabling percutaneous implantation without open chest surgery.
Solution Approach 2:
The device components are designed to nest within each other during delivery, with the connector and anchors collapsed into a compact configuration that can pass through the catheter. Once positioned, the device expands from this nested state to its functional configuration, achieving valve repair through minimally invasive access.
3Ease of manufacture
If the connector has uniform thickness, then manufacturing is simplified, but the device cannot adequately adapt to varying patient anatomy and anchor attachment requirements
Solution Approach 1:
The connector features variable thickness with thicker regions at the anchor attachment sites providing structural strength for anchor integration, and thinner regions in the midsection providing flexibility to accommodate coronary artery passage and anatomical variations. This non-uniform geometry balances manufacturing feasibility with anatomical adaptability.
Data Source
AI summary
A tissue shaping device adapted to be deployed in a vessel to reshape tissue adjacent to the vessel. In some embodiments the device includes first and second anchors and a connector disposed between the first and second anchors, with the connector being integral with at least a portion of the first anchor. The invention is also a method of making a tissue shaping device including the steps of removing material from a blank to form a connector and an integral anchor portion; and attaching a non-integral anchor portion to the integral anchor portion.