Vascular Occlusion Device Additive Manufacturing

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Solution Overview

Problem

There is a need for alternative methods and devices for vascular occlusion that can effectively treat conditions like arterial venous malformations and other cardiovascular diseases by restricting blood flow, as existing technologies may not adequately address the growth and spread of these conditions.

Innovation Solution

A vascular occlusion device is manufactured using a method that involves cutting a tubular member to form an expandable frame, heat-setting it, and securing a constrainment member using additive manufacturing technology, with internal teeth and a centering rod to guide and secure the struts, allowing the device to expand and occlude blood flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional manufacturing methods are used for vascular occlusion devices, then manufacturing processes are well-established, but device complexity and limitations in treating cardiovascular conditions persist

Engineering Contradiction:

Improveeffectiveness in treating cardiovascular conditionsVSAvoiddevice structure complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The device is divided into multiple functional segments: an expandable frame with struts, a constrainment member with teeth, and a centering rod. This segmentation allows each component to perform a specific function (structural support, strut engagement, alignment) while collectively achieving effective vascular occlusion, resolving the contradiction between adaptability and complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The centering rod is nested within the expandable frame structure, and the constrainment member engages with the struts. This nesting approach allows multiple components to occupy the same spatial envelope, reducing overall device complexity while maintaining the adaptability needed for effective treatment of various cardiovascular conditions.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Manufacturing precision

If additive manufacturing technology is used for the constrainment member, then manufacturing precision and customization are improved, but manufacturing complexity increases

Engineering Contradiction:

Improveconstrainment member precisionVSAvoidmanufacturing process simplicity

Core Design Contradiction:

Manufacturing precisionVSEase of manufacture

Solution Approach 1:

Additive manufacturing is applied specifically to the constrainment member where complex geometry (teeth structure) is required for precise strut engagement, rather than manufacturing the entire device additively. This localized application of advanced manufacturing achieves the necessary precision while keeping the overall manufacturing process manageable by using conventional methods for simpler components.

Inventive Principle:

Principle #3Local quality

3Strength

If the expandable frame is cut from a tubular member, then structural integrity is maintained, but manufacturing flexibility is reduced

Engineering Contradiction:

Improveexpandable frame strengthVSAvoiddevice configuration flexibility

Core Design Contradiction:

StrengthVSAdaptability or versatility

Solution Approach 1:

The tubular member is cut and formed into segmented struts that maintain structural integrity through their connected framework design. This segmentation allows the frame to be configured in different geometries to suit various vascular conditions while the continuous material structure preserves strength, resolving the contradiction between strength and adaptability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The expandable frame transitions from a compressed delivery configuration to an expanded treatment configuration. This dynamic transformation allows the same structurally-intact frame to adapt to different vessel sizes and conditions, maintaining strength while achieving the flexibility needed for various cardiovascular applications.

Inventive Principle:

Principle #15Dynamics

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

The device effectively expands to occlude blood flow, potentially starving malformations of oxygen and nutrients, thereby limiting their growth and spread, and can be used in various cardiovascular applications.

Implementation Method 1

heat-setting the expandable frame to define an expanded configuration of the expandable frame

Methodology Applied

Scientific EffectHeat-setting: Heat Treatment

Data Source

PatentUS11284902B2Method of making a vascular occlusion device

Publication Date: 2022.03.29 BOSTON SCIENTIFIC SCIMED INC

AI summary

A method of making a vascular occlusion device may include cutting a tubular member to form an expandable frame including a first hub integrally formed with the expandable frame adjacent a first end of the expandable frame, and a plurality of longitudinally-oriented struts extending in a direction opposite the first end; heat-setting the expandable frame to define an expanded configuration of the expandable frame; sliding a constrainment member over the plurality of longitudinally-oriented struts, the constrainment member being formed using additive manufacturing technology; fixedly securing the constrainment member to the plurality of longitudinally-oriented struts to define a second hub of the expandable frame; and cutting the plurality of longitudinally-oriented struts adjacent the constrainment member and opposite the first end relative to the constrainment member.