Radiopaque Depth Indicators for Cardiac Tissue Anchor Delivery
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Solution Overview
Problem
Existing technologies face challenges in accurately visualizing and delivering tissue anchors to a precise depth within cardiac tissue due to limitations such as insufficient resolution, fluid overload, and transient contrast injection, making it difficult to perform precise procedures in beating hearts with anatomical irregularities.
Innovation Solution
A tissue anchor delivery device equipped with a tissue depth indicator and optional depth limiter, which includes a tissue depth indicator within a longitudinal lumen to delineate the tissue surface and a depth limiter to prevent excessive penetration, allowing for precise anchor deployment by visual and tactile cues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If fluoroscopic contrast injection is used to visualize cardiac tissue, then tissue visualization is achieved, but the image quality deteriorates due to transient contrast and heart chamber shape making interpretation difficult
Solution Approach 1:
A depth indicator wire is introduced as an intermediary element between the delivery catheter and the tissue. The wire extends beyond the catheter tip and provides a visual reference that mediates the measurement of penetration depth, making it easier to interpret fluoroscopic images and determine when the desired depth is reached.
Solution Approach 2:
The depth indicator wire incorporates radiopaque segments that appear distinct under fluoroscopy, creating visual contrast changes that help operators track the position and depth of penetration in real-time, improving measurement precision despite the transient nature of contrast injection.
2Reliability
If electrical sensors are used to signal contact with tissue, then contact detection is achieved, but depth of penetration determination becomes unreliable
Solution Approach 1:
The depth measurement function is segmented from the electrical contact sensor. The depth indicator wire provides a separate, dedicated visual measurement system that operates independently from the electrical contact detection, allowing each function to perform its specialized role without interference.
Solution Approach 2:
The radiopaque depth indicator wire serves as an intermediary visual reference that translates the physical penetration depth into observable fluoroscopic markers, enabling precise depth determination without relying on electrical sensor interpretations.
3Duration of action of moving object
If transesophageal echo is used for tissue visualization, then real-time imaging is achieved, but resolution is insufficient for precise procedures
Solution Approach 1:
The fluoroscopic imaging system is enhanced to serve multiple functions: it provides both the real-time imaging capability needed for dynamic procedures and the high resolution required for precise depth measurement, by incorporating the radiopaque depth indicator wire that appears clearly on fluoroscopic images.
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 1E~1F
AI summary
Disclosed herein are devices and methods for assessing the surface of a target cardiac tissue and for delivering a tissue anchor to cardiac tissue at a preselected depth within the myocardium in a beating heart procedure. In one variation, an anchor delivery device comprises an elongate body, a tissue anchor disposed within a first longitudinal lumen of the elongate body, and a tissue depth indicator slidable within a second longitudinal lumen of the elongate body. The tissue depth indicator has a first configuration that indicates the boundary of the surface of the target tissue and a second configuration that indicates when the distal tip of the elongate body has been advanced to a preselected depth into the target tissue. In some variations, a tissue depth indicator may also be configured to resist or limit the penetration of the delivery device into tissue after a preselected depth has been reached.