Radioembolization Vial with Inclined Base for Uniform Microsphere Delivery

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Solution Overview

Problem

Current devices for radioembolization are cumbersome to use, requiring manual positioning of stopcocks and relying on manual disturbance to deliver radioactive microspheres uniformly, which can lead to incorrect fluid delivery and non-uniform pulsing, posing challenges in managing radioactive contamination and ensuring effective delivery of microspheres during procedures.

Innovation Solution

The system includes vials with inclined or domed bases and controlled inlet angles to facilitate rotational flow, combined with a tubing configuration featuring one-way valves and a three-way fluid connector, simplifying the operation and ensuring uniform dispersion and delivery of microspheres by creating a vortex that lifts settled particles into solution for easy ejection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If manual positioning of stopcocks and manual disturbance are used to deliver microspheres, then the procedure can be performed with simple device structure, but the ease of operation deteriorates and delivery uniformity worsens

Engineering Contradiction:
Improveease of operationVSAvoiddevice complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The vial is designed with an inclined base that automatically causes microspheres to roll toward the outlet aperture due to gravity, eliminating the need for manual disturbance. The system serves itself by using gravitational force to maintain microsphere movement and delivery without requiring operator intervention to reposition components.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The vial incorporates a curved or inclined base surface instead of a flat bottom, which geometrically directs microspheres toward the outlet aperture. This curved geometry passively guides the flow of microspheres and carrier fluid, improving delivery uniformity without adding complex mechanical controls.

Inventive Principle:
Principle #14Spheroidality (Curvature)

2Productivity

If energetic bursts of delivery solution are used to loft particles, then particle delivery can be achieved, but the productivity deteriorates due to trial and error positioning and non-uniform pulsing

Engineering Contradiction:
ImproveproductivityVSAvoidloss of time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The vial is pre-configured with an inclined base and outlet aperture positioned to receive microspheres as they naturally roll down the incline. The carrier fluid inlet is positioned to enter near the apex of the incline, pre-establishing the flow path before delivery begins. This preliminary arrangement eliminates the need for trial-and-error positioning during the procedure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The design enables continuous, uniform delivery of microspheres through the inclined base geometry that maintains constant gravitational force on the particles. The carrier fluid flows continuously down the incline, carrying microspheres steadily to the outlet without requiring intermittent pulsing or bursts, thereby maintaining productive continuous action.

Inventive Principle:
Principle #20Continuity of useful action

3Ease of operation

If multiple tubes, syringes, connectors are used to manage delivery, then the reliability can be maintained through controlled fluid paths, but the device complexity worsens and ease of operation deteriorates

Engineering Contradiction:
Improveease of operationVSAvoiddevice complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The system merges the vial, carrier fluid delivery path, and microsphere outlet into a single integrated assembly. The inclined base vial combines the containment vessel and delivery mechanism, while the outlet aperture integrates the exit path for both carrier fluid and microspheres. This consolidation reduces the number of separate components that must be managed during the procedure.

Inventive Principle:
Principle #5Merging (Combining)

4Reliability

If manual stopcock positioning is used to alternate between radioactive particles and imaging solution, then the device structure remains simple, but the reliability deteriorates due to human error in remembering position changes

Engineering Contradiction:
ImprovereliabilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system uses the inherent physical properties of the inclined base and gravitational force to automatically direct both imaging solution and radioactive microspheres through the same passive delivery path. The design does not require active control or repositioning to handle different fluid types, as the geometry naturally guides all materials to the outlet aperture without human intervention.

Inventive Principle:
Principle #25Self-service

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 configuration enhances the ease of operation, improves the uniformity of microsphere delivery, reduces the risk of radioactive contamination, and ensures efficient delivery of microspheres during radioembolization procedures, addressing the challenges of existing devices.

Implementation Method 1

the inlet channel defining a direction vector of fluid flow, wherein the direction vector is oriented at a first predefined angle with respect to a horizontal plane and oriented at a second predefined angle with respect to a line tangent to the cylindrical interior wall such that fluid flowing in through the inlet channel causes a rotational flow or an upwardly moving fluid vortex to be created in the vial

Methodology Applied
Scientific EffectVortex flow: Vortex Ring

Implementation Method 2

vials with inclined or domed bases and controlled inlet angles to facilitate rotational flow, combined with a tubing configuration featuring one-way valves and a three-way fluid connector, simplifying the operation and ensuring uniform dispersion and delivery of microspheres by creating a vortex that lifts settled particles into solution for easy ejection

Methodology Applied
Scientific EffectRotational flow: Vortex Ring

Implementation Method 3

the particles tend to be denser than the delivery solution (e.g., DI water) and tend to quickly settle at the bottom of the delivery vial

Methodology Applied
Scientific EffectSedimentation: Sedimentation

Data Source

PatentEP3890677B1Apparatus for delivery of radioembolization microspheres
Publication Date: 2023.01.04 SIRTEX MEDICAL INC
  • EP3890677B1 patent drawingFigure 1
  • EP3890677B1 patent drawingFigure 2
  • EP3890677B1 patent drawingFigure 3A~3B

AI summary

An apparatus and methods for embolization of a patient includes vials for containing radiomicrospheres including inclined and domed base are described. Apparatus for delivering the microspheres from the vials to a patient for radioembolization are also described.