Flexible Multi-Lumen Brachytherapy Catheter with Keyed Stylet
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Solution Overview
Problem
Existing multi-lumen brachytherapy catheters increase rigidity, leading to patient discomfort and balloon movement during treatment, as they do not adequately address the need for flexible and stable radiation delivery in non-uniform resection cavities.
Innovation Solution
A flexible multi-lumen brachytherapy device with a hub that allows independent movement of lumens, combined with a keyed stylet that can selectively increase rigidity for controlled insertion and placement, reducing the device's overall rigidity and enhancing patient comfort by minimizing movement post-placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a multi-lumen design is used to achieve asymmetric dosing profiles, then radiation delivery versatility is improved, but catheter rigidity increases causing patient discomfort and balloon movement
Solution Approach 1:
The catheter is divided into multiple independent lumens (typically 3-5 lumens) that can be positioned separately within the resection cavity. Each lumen can deliver radiation independently, allowing asymmetric dosing profiles while the individual lumens remain flexible rather than forming a rigid bundled structure
Solution Approach 2:
The catheter shaft is designed with varying properties along its length - the distal portion containing lumens is kept flexible for patient comfort, while a proximal rigid section or stylet provides structural support during insertion. This allows different parts of the same catheter to have different rigidity characteristics
2Stability of the object's composition
If catheter rigidity is increased to maintain structural stability, then device stability is improved, but patient discomfort and balloon movement increase
Solution Approach 1:
The catheter system transitions from a static rigid structure to a dynamic system where rigidity can be adjusted. A removable stylet or rigidifying element is inserted during placement to provide temporary structural support, then removed or retracted to allow the catheter to become flexible during the treatment period, adapting to patient movement while maintaining positioning stability
3Ease of operation
If a single lumen design is used to maintain catheter flexibility, then patient comfort is improved, but asymmetric dosing capability is lost
Solution Approach 1:
Instead of a single lumen, the catheter incorporates multiple separate lumens (typically 3-5) that can be independently positioned and loaded with radioactive seeds. This segmentation allows each lumen to contribute to the overall dosing profile, enabling asymmetric radiation delivery while keeping individual lumens flexible enough for patient comfort
Data Source
AI summary
A flexible, multi-lumen brachytherapy device includes a plurality of loose lumens extend through a hub towards a single point of attachment at a distal rigid section. Because the lumens are attached at only a single distal location, the lumens are free to move axially and rotatably, thereby increasing the overall flexibility of the device to thereby decrease intermittent device movement while increasing patient comfort. A novel keyed stylet can be selectively inserted to increase the rigidity of the device as needed. The ability to dynamically modify the rigidity of the brachytherapy device provides a comprehensive brachytherapy solution that satisfies concerns of the patient, the surgeon and the radiologists.