Retrievable Tissue Anchor for Mitral Annuloplasty
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Solution Overview
Problem
Current annulus repair methods for treating mitral valve regurgitation, such as annuloplasty rings, face limitations in effectively stabilizing and resizing the mitral annulus, particularly in degenerative cases, and lack the ability to easily retrieve or reposition anchors once deployed.
Innovation Solution
A system and method utilizing anchors with flanges that can be delivered and retrieved, featuring a rod to manipulate the anchors' position, allowing them to transition between a delivery and a natural arrangement for secure engagement and potential repositioning or removal within the tissue, using a delivery device with lumens for anchor deployment and retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If anchors are deployed into tissue to stabilize the mitral annulus, then the stability and anchoring strength are improved, but the ability to retrieve or reposition the anchors is lost
Solution Approach 1:
The anchor system employs a dynamic delivery rod that can be inserted and removed to transform the anchor from a compressed delivery state to an expanded deployed state. The rod acts as a temporary mechanical support that enables controlled deployment while maintaining the possibility of retrieval by re-inserting the rod to compress and withdraw the anchor.
Solution Approach 2:
The delivery rod serves as an intermediary tool between the operator and the anchor. It mediates the deployment process by providing a mechanical interface to compress, position, and release the anchor into tissue. The same rod can be re-inserted to mediate retrieval, thus solving the contradiction between stable anchoring and retrievability.
2Strength
If anchors are firmly anchored in tissue to resist pull-out forces, then the anchoring strength is improved, but the tissue damage increases
Solution Approach 1:
The anchor transitions from a compressed low-profile state during delivery to an expanded state upon deployment. This dynamic transformation allows the anchor to engage tissue with controlled force, achieving secure anchoring while minimizing initial tissue disruption during insertion.
Solution Approach 2:
The delivery rod pre-compresses the anchor into a compact configuration before tissue penetration. This preliminary compression reduces the anchor's cross-sectional area during insertion, minimizing tissue displacement and damage, followed by controlled expansion once positioned.
3Ease of repair
If the anchor structure is made complex to enable retrieval, then the retrievability is improved, but the device complexity increases
Solution Approach 1:
The anchor structure includes self-compressing features when the delivery rod is re-inserted. The radial elements automatically return to their compressed configuration against the rod, enabling retrieval without additional complex mechanisms. The structure serves itself by utilizing the presence of the rod to trigger the compression and withdrawal action.
Data Source
AI summary
Aspects of the disclosure include systems including an anchor including a body having a distal end, a proximal end and an opening extending from the proximal end to the distal end. The distal end includes a plurality of flanges, each flange including a proximal barb and a distal barb; the anchor having a natural arrangement in which the distal barbs of the plurality of flanges converge to form a pointed tip. The system further includes a rod that can be inserted in the opening to force the distal barbs away from a longitudinal axis of the opening into a delivery arrangement. The rod can also be used to retrieve an anchor after deployment. Such anchors can be utilized with annuloplasty implants. Methods of deploying and retrieving anchors of the disclosure are also disclosed.