Direct Visualization Lead Placement in Heart Cavities
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Solution Overview
Problem
Current medical procedures for delivering leads into a patient's body, particularly within heart lumens and epicardial locations, face challenges in visualization and securing leads due to opaque fluids like blood, limiting the effectiveness of existing imaging and delivery methods.
Innovation Solution
A system comprising an imaging device, an elongate rail with fixation elements, and a lead that can be advanced over or through the rail, allowing for direct visualization and secure placement of leads within body cavities and lumens, using a guidewire or sheath for navigation and fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional imaging methods (x-ray, fluoroscopy) are used to visualize leads during delivery, then lead delivery can be performed, but the visualization is insufficient due to opaque fluids like blood obscuring the optical path
Solution Approach 1:
The patent extracts and removes the harmful opaque fluid (blood) from the optical path by introducing a clear fluid that displaces the blood away from the imaging region, allowing direct optical visualization of the lead delivery site
Solution Approach 2:
A clear fluid acts as an intermediary substance between the imaging device and the target site, replacing the opaque blood and enabling light transmission for direct visualization while maintaining a sterile environment
2Manufacturing precision
If leads are delivered without direct visualization, then the procedure can be completed, but the placement accuracy and precision are reduced
Solution Approach 1:
The patent combines the imaging device and lead delivery system into an integrated apparatus, allowing direct visualization of the lead placement process while maintaining a coordinated and streamlined system architecture
Solution Approach 2:
The imaging device serves multiple functions: visualizing the delivery path, identifying the target site, and confirming lead placement, thereby reducing the need for separate imaging and delivery systems
3Stability of the object's composition
If fixation elements are used to secure the lead, then the lead remains stable at the target site, but the complexity of the delivery system increases
Solution Approach 1:
The fixation elements are applied locally at the distal end of the lead where stabilization is needed, rather than throughout the entire lead, allowing targeted anchoring with minimal additional complexity
Solution Approach 2:
The fixation elements are pre-positioned on the lead before delivery, allowing for simple deployment at the target site without requiring complex assembly or activation mechanisms during the procedure
Data Source
AI summary
An apparatus for imaging a body structure within a body cavity includes a catheter including proximal and distal ends, an imaging element on the distal end, and an extension extending distally from the distal end for contacting a surface of a body cavity into which the catheter is introduced. The extension has a length to maintain the optical imaging element away from the surface. Optionally, a transparent member, e.g., an expandable balloon, may be attached to the distal end of the tubular member and the extension to isolate the imaging element from contact with fluid within the body cavity. During use, the catheter is inserted into a chamber of a beating heart, and the extension and/or balloon is placed against the wall of the chamber. Sufficient force is applied to stabilize the imaging element relative to the wall while the heart is beating.