Cardiac Tissue Anchor Delivery With Depth Indicator and Penetration Limit
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Solution Overview
Problem
Existing technologies face challenges in precisely visualizing and delivering tissue anchors to cardiac tissue in a beating heart due to limitations in resolution, contrast-induced nephropathy, fluid overload, and difficulty in obtaining absolute orientation, especially in hearts with conditions like heart failure or mitral valve regurgitation, which complicates procedures requiring precise tissue penetration.
Innovation Solution
The development of an anchor delivery device with a tissue depth indicator and limiter that allows for real-time visualization of cardiac tissue boundaries and limits penetration depth, using a tissue depth indicator that transitions configurations based on tissue contact to indicate precise anchor deployment, and a limiter that prevents excessive penetration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Illumination intensity
If transesophageal echo (TEE) is used for visualization, then real-time imaging of cardiac tissue is improved, but resolution is insufficient
Solution Approach 1:
The patent combines multiple visualization modalities (fluoroscopy with contrast injection and echocardiography) into a single integrated system, allowing simultaneous acquisition of both real-time imaging and high-resolution anatomical detail, thereby resolving the contradiction between real-time capability and resolution
2Illumination intensity
If contrast injection is used to enhance fluoroscopic imaging, then visualization of cardiac tissue is improved, but contrast-induced nephropathy (CIN) occurs
Solution Approach 1:
The system uses echocardiographic imaging as a feedback mechanism to guide contrast injection timing and dosage, allowing optimization of contrast usage to achieve adequate visualization while minimizing nephrotoxic exposure through real-time monitoring of cardiac chamber opacification
3Illumination intensity
If fluoroscopic contrast injection is used for imaging, then cardiac tissue visualization is improved, but fluid overload occurs
Solution Approach 1:
The system employs selective contrast injection into specific cardiac chambers only when and where needed for visualization, rather than systematic contrast administration, thereby achieving adequate imaging with reduced total contrast volume and minimizing fluid overload risk
4Reliability
If electrical sensors are used to detect tissue contact, then contact detection is improved, but depth of penetration determination is inaccurate
Solution Approach 1:
The patent introduces a delivery catheter with marked depth indicators as an intermediary measurement tool that provides direct visual correlation between catheter insertion distance and actual penetration depth into cardiac tissue, eliminating the indirect and inaccurate estimation required when using electrical sensors alone
5Productivity
If procedures are performed in beating heart conditions, then real-time treatment is improved, but precision of tissue anchor delivery is reduced due to tissue movement
Solution Approach 1:
The system performs preliminary visualization and positioning of the delivery catheter using integrated imaging before tissue anchor deployment, establishing accurate spatial coordinates and depth markers in advance, which compensates for subsequent tissue movement during the actual anchor delivery process in beating heart conditions
6Strength
If deeper penetration into cardiac tissue is attempted to ensure anchor placement, then anchor security is improved, but risk of excessive penetration and tissue damage increases
Solution Approach 1:
The delivery catheter incorporates visual depth markers and integrated imaging feedback that provide real-time information on penetration depth, allowing the operator to stop advancement at the optimal depth for secure anchor placement without exceeding safe limits and causing tissue damage
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.