Nested Helical Tissue Anchors for Secure Valve Attachment
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Solution Overview
Problem
Current tissue anchors face challenges in achieving optimal anchoring strength and ease of placement, particularly in hemodynamic stress conditions, such as those encountered in heart valve treatments, due to the complexity of anchor placement and the need for multiple anchors.
Innovation Solution
The development of tissue anchors with multiple tissue-engaging elements, including helical and supplementary elements, such as hooks, barbs, and expandable portions, designed to provide enhanced stability and force distribution, along with mechanisms like torque limiters and radiopaque contrast agents for verification of placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If multiple tissue anchors are used to achieve sufficient anchoring strength, then the anchoring strength is improved, but the device complexity and difficulty of placement increase
Solution Approach 1:
The patent combines multiple tissue-engaging elements (helical element, expandable element, and supplementary elements like hooks or barbs) into a single integrated anchor device. This merging allows the anchor to achieve the anchoring strength of multiple separate anchors while simplifying the placement procedure to a single insertion operation, thereby resolving the contradiction between anchoring strength and placement complexity.
Solution Approach 2:
The anchor is divided into multiple functional segments including a helical tissue-engaging element for initial insertion, an expandable element for securing, and supplementary tissue-engaging elements for additional stability. Each segment performs a specific function that contributes to the overall anchoring strength, allowing the device to achieve multi-anchor equivalent strength through a unified structure.
2Reliability
If multiple tissue anchors are used to ensure secure attachment, then the reliability is improved, but the ease of operation deteriorates
Solution Approach 1:
By merging multiple tissue-engaging mechanisms into one anchor device, the patent maintains the reliability of multiple anchors for secure attachment while significantly improving ease of operation. The single-anchor design with multiple functional elements can be deployed in one operation, eliminating the need to place multiple separate anchors and thereby simplifying the surgical procedure while ensuring reliable attachment.
3Strength
If additional tissue-engaging elements are added to enhance stability, then the anchoring strength is improved, but the device complexity increases
Solution Approach 1:
The patent employs a nested structure where the supplementary tissue-engaging elements are positioned within or around the helical and expandable elements. This nesting arrangement allows multiple functional elements to be integrated in a compact configuration, enhancing anchoring strength through multiple engagement mechanisms while minimizing the overall structural complexity and maintaining a streamlined device design.
Data Source
AI summary
A system comprises an anchor (20) comprising an inner helical tissue-engaging element (24); an outer helical tissue-engaging element (22); and a head assembly (29). The head assembly comprises a first head (25), fixed to a proximal end of the inner tissue-engaging element, and a second head (26), fixed to a proximal end of the outer tissue-engaging element. The system further comprises a driver (28), reversibly interfacing with and engaging the first head and the second head, in order to anchor the anchor in the target tissue. Other applications are also described.