Off-Center Tissue Anchor Rotational Adjustment
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Solution Overview
Problem
Existing tissue anchors may inadvertently compress blood vessels during implantation in soft tissue, such as cardiac tissue, leading to cardiac complications.
Innovation Solution
A tissue anchor with an off-centered tissue-coupling element that can be rotated during implantation to avoid contact with sensitive anatomic structures like blood vessels, allowing for selection of an anchoring site without relocating the exit site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tissue anchor with a centered tissue-coupling element is used, then the implantation process is simple, but the tissue-coupling element may inadvertently compress blood vessels leading to cardiac complications
Solution Approach 1:
The tissue-coupling element is positioned off-center relative to the shaft, creating an asymmetric configuration that allows rotational adjustment during implantation. This asymmetry enables the surgeon to orient the tissue-coupling element away from blood vessels while maintaining the same exit site, thereby avoiding vascular compression without requiring additional punctures or complex repositioning procedures.
2Object-affected harmful factors
If the tissue-coupling element is positioned off-center, then blood vessels can be avoided during implantation, but the device structure becomes more complex
Solution Approach 1:
The off-centered tissue-coupling element configuration provides dynamic adjustability during the implantation process. The element can be rotated to different angular positions around the shaft, allowing real-time adaptation to the anatomical landscape and avoidance of critical structures like blood vessels, while the overall device structure remains relatively simple.
3Reliability
If the exit site is relocated to avoid blood vessels, then safe implantation is achieved, but the implantation time and complexity increase
Solution Approach 1:
The off-centered tissue-coupling element is pre-configured on the shaft before implantation, anticipating the need for angular adjustment. This preliminary configuration allows the surgeon to simply rotate the element to the appropriate angle after penetration, avoiding the time-consuming process of removing the device and performing a second puncture at a different site.
Data Source
AI summary
A tissue anchor (200, 258, 300) includes a shaft (122), a tissue-coupling element (128), and a flexible elongate tension member (202). The tissue-coupling element (128) includes a wire (150), which is shaped as an open loop (154) having more than one turn when the tissue anchor (200, 258, 300) is unconstrained. The tension member (202) includes a distal portion (204) that is fixed to a site (206) on the open loop (154), a proximal portion (208), which has a longitudinal segment (209) that runs alongside at least a portion (210) of the shaft (122), and a crossing portion (212), which (i) is disposed between the distal and the proximal portions (204, 208) along the tension member (202), and (ii) crosses at least a portion of the open loop (154) when the tissue anchor (200, 258, 300) is unconstrained. The tissue anchor (200, 258, 300) is configured to allow relative axial motion between the at least a portion (210) of the shaft (122) and the longitudinal segment (209) of the proximal portion (208) of the tension member (202) when the tissue anchor (200, 258, 300) is unconstrained.