Tapered Two-Piece Vaginal Brachytherapy Applicator

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Solution Overview

Problem

Current brachytherapy devices for endometrial cancer cause discomfort and suboptimal radiation dosing due to fixed diameters that do not accommodate varying vaginal anatomy, leading to air pockets and reduced radiation effectiveness.

Innovation Solution

A tapered, two-piece vaginal brachytherapy applicator with interlocking hemi-cylindrical bodies allows for a larger diameter at the vaginal apex, minimizing discomfort and ensuring reproducible radiation dosimetry by maintaining a non-deformable, rigid shape, while using 3D printing technology and biocompatible materials for enhanced patient comfort and treatment efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a fixed diameter applicator is used, then the device structure is simple, but it causes discomfort and suboptimal radiation dosing due to not accommodating varying vaginal anatomy

Engineering Contradiction:

Improvepatient comfortVSAvoidapplicator structure

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The applicator is divided into two separate hemi-cylindrical bodies that can be inserted and assembled inside the vagina, allowing the diameter to be adjusted to fit different vaginal anatomies while maintaining structural simplicity through modular design

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The applicator transitions from a static fixed-diameter structure to a dynamic adjustable-diameter structure where the two hemi-cylindrical bodies can be positioned at different alignments to accommodate varying vaginal sizes and shapes

Inventive Principle:

Principle #15Dynamics

2Reliability

If a fixed diameter applicator is used, then manufacturing is simple, but it creates air pockets and reduced radiation effectiveness

Engineering Contradiction:

Improveradiation dosing effectivenessVSAvoidapplicator manufacturing

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

By segmenting the applicator into two hemi-cylindrical bodies, the design allows for a tapered configuration that eliminates air pockets between the applicator and vaginal wall, ensuring uniform radiation dosing while maintaining manufacturing feasibility through separate component production

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The applicator implements a tapered design at specific locations (the distal end) to optimize radiation contact with the target area, providing enhanced dosing effectiveness in the critical treatment zone while maintaining simplicity in other regions

Inventive Principle:

Principle #3Local quality

3Manufacturing precision

If a tapered design is used, then radiation dosimetry is reproducible and uniform, but the device structure becomes more complex

Engineering Contradiction:

Improveradiation dosimetry reproducibilityVSAvoidapplicator geometry

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The tapered geometry is achieved through segmentation into two hemi-cylindrical bodies, where one body is tapered while the other remains cylindrical, allowing precise control over the tapered section's dimensions for reproducible dosimetry while keeping the overall structure manufacturable

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The taper is applied locally to specific portions of the applicator (the distal end) rather than the entire structure, providing the necessary geometric precision for reproducible radiation dosing in the treatment area while maintaining simplicity in the proximal region

Inventive Principle:

Principle #3Local quality

4Adaptability or versatility

If a single-piece applicator is used, then device complexity is low, but it cannot accommodate varying vaginal anatomy as effectively

Engineering Contradiction:

Improveaccommodation of varying vaginal anatomyVSAvoidapplicator structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The applicator is segmented into two hemi-cylindrical bodies that can be independently positioned and aligned, enabling adaptation to varying vaginal anatomies through different configurations while maintaining relatively low structural complexity through modular assembly

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The applicator system transitions from a static single-piece design to a dynamic two-piece configuration where the hemi-cylindrical bodies can be adjusted to different alignments and positions to match diverse vaginal shapes and sizes

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS10905899B2Applicators suitable for brachytherapy and methods using same

Publication Date: 2021.02.02 YALE UNIVERSITY

AI summary

The invention provides a two-step tapered applicator, which can be used to deliver high-dose-rate vaginal brachytherapy to a female patient's vagina post-hysterectomy. In certain embodiments, once inserted through the female patient's vaginal opening (or introitus), the applicator of the invention causes less physical discomfort to the female patient than currently available applicators. In other embodiments, the applicator is used in a female patient whose vaginal apex is larger in diameter than her vaginal introitus.