Transparent Balloon Catheter Imaging for Precise Cardiac Device Delivery
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Solution Overview
Problem
Current medical procedures face challenges in accurately identifying important anatomical structures and delivering therapeutic devices to precise locations within the heart while avoiding arteries or veins, and there is a need for improved imaging and delivery methods, particularly for devices with asymmetric cross-sections.
Innovation Solution
A tubular member with a stabilization member and an expandable member carrying an imaging assembly that allows for direct visualization and precise deployment of secondary devices, such as ablation catheters or pacemaker leads, by providing a field of view orthogonal to the longitudinal axis, enabling stable positioning and alignment with anatomical structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopic guidance is used for device delivery, then device delivery precision is improved, but patient radiation exposure increases and procedure complexity increases
Solution Approach 1:
The patent replaces fluoroscopic imaging (radiation-based mechanical system) with direct optical imaging through the transparent balloon wall. The imaging assembly captures images directly through the transparent material, eliminating the need for radiation-based guidance systems while maintaining visualization capability for precise device delivery.
Solution Approach 2:
The transparent balloon material serves as an intermediary that allows optical images to pass through from the interior to the exterior. This intermediary property enables direct visualization without requiring external imaging systems that would expose patients to radiation.
2Measurement precision
If fluoroscopic guidance is used for device delivery, then device delivery precision is improved, but procedure complexity and cost increase
Solution Approach 1:
The patent replaces complex fluoroscopic imaging systems with a simpler integrated optical imaging assembly. The imaging assembly includes basic optical components (light source, imaging element) that are much simpler than fluoroscopy systems, reducing procedural complexity while maintaining delivery precision.
Solution Approach 2:
The imaging assembly is merged with the delivery catheter system, integrating imaging functionality directly into the delivery device. This consolidation eliminates the need for separate fluoroscopy equipment and simplifies the overall procedure while maintaining precise device delivery capability.
3Ease of manufacture
If balloons are made round cross-section, then manufacturing ease is improved, but ability to take asymmetric cross-sections deteriorates
Solution Approach 1:
The patent applies asymmetric shapes to the balloon cross-section to facilitate specific medical procedures. The asymmetric geometry allows the balloon to conform to anatomical structures and provide stable positioning for device delivery, while the manufacturing process accommodates these non-circular shapes through specialized molding techniques.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Facilitates precise delivery and alignment of therapeutic devices by providing direct visualization, reducing the need for fluoroscopic guidance, and allowing for targeted therapy application and evaluation of treatment efficacy.
Implementation Method 1
a substantially transparent expandable member comprising a first end attached to the tubular member distal end and a second end attached adjacent the distal tip
Data Source
AI summary
Systems and methods are provided for injecting one or more agents into tissue within a patient's body that includes a catheter. A needle guide extends from a distal end of the catheter and terminates at a distal tip, e.g., including a foot with an atraumatic contact surface, the needle guide having a cross-section smaller than the distal end and being biased to a curved shape. The needle guide includes a passage communicating from a lumen of the catheter to an outlet at the distal tip, and a needle device is disposed within the passage that may be deployed from the outlet to inject one or more agents into tissue. The catheter also includes an imaging assembly on the distal end configured to acquire images of tissue adjacent the needle guide distal tip.