Intraluminal Delivery Device with Radiopaque Marker Alignment

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Solution Overview

Problem

Current stent and stent delivery systems have limitations in effectively treating atherosclerotic occlusive disease, particularly in providing precise and efficient deployment of intraluminal devices like tacks for maintaining vessel patency and stabilizing plaque.

Innovation Solution

A delivery device with a unique shape, featuring a sleeve of flexible material surrounding a harder inner shaft and annular pusher bands, allows for sequential deployment of intraluminal devices by aligning radiopaque markers for precise placement and deployment, utilizing a mechanism with an outer sheath that can be withdrawn to release the devices at specific treatment areas.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a traditional stent delivery system is used, then the device can be deployed in the vessel, but precise placement and control during deployment are limited

Engineering Contradiction:
Improveplacement precisionVSAvoiddelivery system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The delivery device employs a nested structure where the inner shaft is surrounded by the outer sheath, and multiple delivery platforms are positioned along the inner shaft. The outer sheath can be withdrawn to expose the compressed intraluminal devices on the delivery platforms, enabling precise deployment while maintaining a compact deliverable profile.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent replaces traditional mechanical deployment mechanisms with a radiopaque marker alignment system. Radiopaque markers on the outer sheath and delivery platforms allow visualization and precise alignment under imaging guidance, substituting complex mechanical positioning systems with a visual alignment approach.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Adaptability or versatility

If multiple intraluminal devices are delivered sequentially, then treatment coverage is improved, but deployment time and procedural complexity increase

Engineering Contradiction:
Improvetreatment coverageVSAvoiddeployment time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

Multiple intraluminal devices are pre-loaded onto delivery platforms along the inner shaft before insertion into the vessel. The devices are compressed and positioned in advance, allowing sequential deployment as the outer sheath is withdrawn, eliminating the need for separate delivery procedures for each device.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The delivery device is designed as a multi-functional system capable of delivering multiple different types of intraluminal devices (stents, tacks, grafts) from a single platform. The standardized delivery platforms can accommodate various device types, enabling versatile treatment options without requiring multiple specialized delivery systems.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Manufacturing precision

If radiopaque markers are used for alignment, then placement accuracy is improved, but the device structure becomes more complex

Engineering Contradiction:
Improvealignment accuracyVSAvoidmarker system complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

Radiopaque markers are incorporated into the outer sheath and delivery platforms to enable visualization under fluoroscopic or X-ray imaging. These markers appear as distinct radiopaque features that allow real-time tracking and precise alignment of the delivery device with the target vessel segment during the procedure.

Inventive Principle:
Principle #32Color changes

4Ease of operation

If the outer sheath is withdrawn to deploy devices, then deployment control is improved, but the risk of premature deployment increases

Engineering Contradiction:
Improvedeployment controlVSAvoiddeployment safety
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The outer sheath is designed to be dynamically withdrawable, allowing the operator to control the exposure of delivery platforms in real-time. The sheath can be retracted incrementally to expose only the specific delivery platform needed for current deployment, while remaining platforms stay protected, enabling controlled sequential deployment.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP3735943B1Delivery device
Publication Date: 2022.03.09 INTACT VASCULAR
  • EP3735943B1 patent drawingFigure 1~2
  • EP3735943B1 patent drawingFigure 3~3A
  • EP3735943B1 patent drawingFigure 4

AI summary

A delivery device can include several different features including, at least: a shuttle and trigger retraction of an outer sheath; an interlock device to prevent actuation of the trigger; a retraction override switch and lock; and an inner shaft adjuster to ensure correct alignment of the inner shaft and the outer sheath prior to device deployment. The inner shaft adjuster may include, at least: a proximal portion of the handle housing having slots therethrough: pins operatively fixed to the inner shaft and extending through and slidable within the slots: and a cap having an inner helical groove that mates with the pins. Rotation of the cap may push the pins and the inner shaft in a proximal-distal direction. The cap may have a distal lip configured to accept a proximal extension of the interlock and retain it in a locked position until the inner shaft has been adjusted or moved.