Deflectable Anchor Balloon Catheter for Vascular Navigation
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Solution Overview
Problem
Current catheter technologies face challenges in navigating tortuous vascular paths, particularly in patients with difficult anatomy, as they are not flexible enough to make necessary bends and maintain position during procedures, leading to high complication rates and limited treatment options for conditions like PAD and DVT.
Innovation Solution
A multidirectional balloon tipped catheter system with a flexible catheter body and an anchor balloon that can be inflated to occlude vascular channels, allowing for multidirectional deflections and stabilization, enabling the use of a stiff guide wire to route therapeutic catheters through complex arterial pathways.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a stiff catheter is used to maintain position during procedures, then stability is improved, but the ability to navigate tortuous vascular paths deteriorates
Solution Approach 1:
The catheter is divided into multiple segments with different flexibility characteristics. The proximal portion is stiffer for stability and control, while the distal portion is more flexible for navigation. This segmentation allows each part to perform its optimal function without compromising the other.
Solution Approach 2:
The catheter incorporates dynamic elements such as shape memory alloys or superelastic materials that can change their mechanical properties in response to temperature or stress. This allows the catheter to be stiff during insertion and stabilization, then become flexible when thermal energy is applied for navigation through tortuous paths.
2Adaptability or versatility
If a flexible catheter is used to navigate tortuous paths, then navigation capability is improved, but the ability to maintain stable position deteriorates
Solution Approach 1:
Different portions of the catheter are designed with different mechanical properties. The distal tip is made highly flexible with multiple articulation points for navigation, while the proximal shaft maintains higher stiffness for stable positioning and control. This local differentiation resolves the contradiction between flexibility and stability.
Solution Approach 2:
The catheter is pre-formed with specific curvature and flexibility characteristics that enable it to navigate tortuous vascular paths before reaching the target site. Once positioned, the catheter's distal tip can be selectively articulated or heated to achieve final positioning, while the proximal portion maintains stable anchoring.
3Adaptability or versatility
If a multidirectional deflectable catheter is used, then navigation capability is improved, but device complexity increases
Solution Approach 1:
The catheter incorporates pre-formed curves and articulation points that enable multidirectional deflection without requiring complex mechanical mechanisms. The catheter body includes sections with different radii of curvature that can be selectively engaged to navigate various vascular geometries, achieving complexity reduction through geometric design.
Solution Approach 2:
The catheter's flexibility and deflection characteristics are controlled by changing physical parameters such as temperature (via shape memory materials) or mechanical pre-stress. This allows a single catheter structure to provide multiple deflection states and navigation capabilities without requiring multiple discrete components or complex control mechanisms.
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
This solution simplifies procedures by allowing for reliable navigation through complex vascular anatomy, reducing complications and enabling effective treatment of conditions such as PAD and DVT with improved precision and safety.
Implementation Method 1
The anchor balloon is in fluid communication with the balloon port and overhangs the distal end of the catheter body by a predetermined distance when the anchor balloon is inflated
Data Source
AI summary
A deflectable multidirectional balloon tipped catheter system for conducting peripheral vascular procedures in a remote entry point such as an opposite extremity or other branch point in the arterial system is provided. The catheter system includes a multidirectional catheter body, which includes a wire lumen and a balloon lumen with a control port for connecting to a balloon control and a balloon inflation port, and a compliant or non-compliant anchor balloon connected near the flexible catheter distal end. A method for treating peripheral vascular disease, administration of pharmaceutical and chemotherapeutic agents to the local vascular system, and therapeutic embolization of vascular territories by using the catheter system is provided.