Double Baffle Vascular Occluder for Stable Occlusion

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Solution Overview

Problem

Existing vascular occlusion methods, such as wire coils and thrombogenic agents, face challenges like prolonged occlusion time, risk of recanalization, and migration, especially in complex vessel anatomies and short vessel lengths, requiring improved solutions for reliable and stable occlusion.

Innovation Solution

A vascular occluder assembly featuring first and second baffle members with annular expansion devices and membranes, along with spacer elements to maintain distance and create a chamber for thrombogenic agent delivery, providing enhanced stability and immediate occlusion, and optionally permeable membranes to slow blood flow and promote clotting.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If wire coils are implanted to achieve vascular occlusion, then occlusion can be achieved, but the procedure takes time and the occluding barrier length varies and can be significant

Engineering Contradiction:
Improveocclusion effectivenessVSAvoidtime to attain adequate occlusion
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The device divides the occlusion function into two segments: a first baffle member with a membrane that provides immediate occlusion, and a second baffle member that creates a chamber for thrombogenic agent delivery. This segmentation allows immediate occlusion while enabling controlled thrombus formation, reducing the time to achieve adequate occlusion compared to sequential coil implantation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The first baffle member with its membrane performs preliminary occlusion action immediately upon deployment, blocking blood flow before thrombus formation. This preliminary action ensures that occlusion is achieved from the start, eliminating the time delay associated with waiting for thrombus formation alone to occur.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If wire coils are implanted to achieve vascular occlusion, then occlusion can be achieved, but the overall length of the implanted coils will vary and can be significant

Engineering Contradiction:
Improveocclusion effectivenessVSAvoidlength of occluding barrier
Core Design Contradiction:
ReliabilityVSLength of moving object

Solution Approach 1:

The device segments the occlusion function into two distinct baffle members spaced apart by a defined distance. This creates a compact, predetermined length occluding barrier that is shorter than the variable-length coil assemblies required to achieve similar occlusion, while maintaining effectiveness through the combination of membrane barrier and chamber-based thrombus formation.

Inventive Principle:
Principle #1Segmentation

3Length of moving object

If thrombogenic agent is injected between two spaced balloons to create occlusion, then an occluding barrier of set length can be generated, but occlusions of this nature can be liable to recanalization

Engineering Contradiction:
Improvelength of occluding barrierVSAvoidresistance to recanalization
Core Design Contradiction:
Length of moving objectVSReliability

Solution Approach 1:

The device uses a composite approach combining a membrane material (first baffle member) with thrombogenic agent delivery (second baffle member chamber). This composite structure creates a dual-mechanism occlusion: the membrane provides immediate physical barrier while the thrombogenic agent creates biological occlusion, together providing resistance to recanalization that neither mechanism alone could achieve.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The first baffle member with membrane performs preliminary occlusion action immediately upon deployment, creating a physical barrier before thrombus formation. This preliminary membrane barrier prevents immediate recanalization while the thrombus forms, and the combination provides sustained resistance to recanalization that thrombus alone would not provide.

Inventive Principle:
Principle #10Preliminary action

4Length of moving object

If thrombogenic agent is injected between two spaced balloons to create occlusion, then an occluding barrier of set length can be generated, but the procedure is prone to migration

Engineering Contradiction:
Improvelength of occluding barrierVSAvoidstability of occluder position
Core Design Contradiction:
Length of moving objectVSStability of the object's composition

Solution Approach 1:

The device segments the occlusion structure into two baffle members with a defined chamber between them, creating a stable, predetermined length barrier. This segmented structure with fixed spacing provides positional stability that prevents migration, while maintaining the set length occluding barrier function.

Inventive Principle:
Principle #1Segmentation

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 occluder achieves reliable and stable occlusion with reduced risk of recanalization and migration, allowing for precise control of occlusion length and immediate vessel closure, suitable for various vessel sizes and pressures.

Implementation Method 1

each baffle member including an annular expansion device

Methodology Applied
Scientific EffectRadial expansion:

Implementation Method 2

delivering thrombogenic agent through the delivery catheter into the chamber between the first and second baffle members

Methodology Applied
Scientific EffectCoagulation: Coagulation

Implementation Method 3

optionally permeable membranes to slow blood flow and promote clotting

Methodology Applied
Scientific EffectFlow restriction:

Data Source

PatentEP2856950B1Double baffle vascular occluder
Publication Date: 2018.09.19 COOK MEDICAL TECHNOLOGIES LLC
  • EP2856950B1 patent drawingFigure 1
  • EP2856950B1 patent drawingFigure 2
  • EP2856950B1 patent drawingFigure 3

AI summary

A vascular occluder (10) includes first and second baffle members (14, 16) which are formed of an expansion device such as a stent (18, 20) across which extends an impermeable membrane (22, 24). The baffle members (14, 16) are held at a given separation by spacer elements (28, 30). The separation creates a chamber (26) between the baffle members (14, 16) in which the blood is able to stagnate, thereby creating a second occlusion barrier. One of the baffle members (16) may have an aperture within its membrane (24) for receiving a delivery catheter for delivery of thrombogenic agent into the chamber (26). The occluder (10) has a given length, thereby making it suitable for implantation in difficult vessel sections and is also able to avoid problems of recanalization of the vessel which can occur with prior art occluders.