Attachable Implement for Sheath Migration Tracking

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Solution Overview

Problem

The introduction of vascular devices, such as vena cava filters, under ultrasound guidance is challenging due to difficulties in confirming the positioning of the device before deployment, leading to potential misplacement and increased risk of device failure, as localized imaging devices often need to be removed from the sheath, making it hard to verify the device's position within the vessel.

Innovation Solution

An attachable implement with a coupling surface and adherent material is used to securely attach to the medical device and the skin, allowing for precise tracking of the device's position, preventing migration and ensuring accurate deployment by maintaining the sheath's position relative to the target site using external markers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If ultrasound imaging is used to guide vascular device introduction, then the procedure can be performed without fluoroscopy and contrast agents, but the images are more difficult to interpret for implant guidance

Engineering Contradiction:
Improveexposure to fluoroscopy and contrast agentsVSAvoiddifficulty of interpreting ultrasound images
Core Design Contradiction:
Object-affected harmful factorsVSDifficulty of detecting and measuring

Solution Approach 1:

The patent applies visual enhancement techniques to ultrasound images, using different grayscale levels and contrast mechanisms to make anatomical structures and device positions more distinguishable. This resolves the contradiction by maintaining the safety benefits of ultrasound while improving image interpretability through visual processing.

Inventive Principle:
Principle #32Color changes

2Measurement precision

If localized imaging devices are removed from the sheath for positioning verification, then the device position can be checked, but it becomes hard to confirm accurate placement and increases risk of misplacement

Engineering Contradiction:
Improvedevice position verificationVSAvoidrisk of device misplacement
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent uses external markers that create visible references on the skin surface corresponding to the sheath position. These markers serve as copies or representations of the internal device position, allowing verification without removing the imaging device from the sheath, thus maintaining reliability while achieving measurement precision.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

External skin markers act as intermediaries between the internal sheath position and the external observation. These markers transfer position information from the internal device to the external surface, enabling position verification without direct access to the internal device, thereby reducing misplacement risk while maintaining verification capability.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Manufacturing precision

If external markers are used to track sheath position, then device placement accuracy is improved, but the complexity of the procedure increases

Engineering Contradiction:
Improvedevice placement accuracyVSAvoidprocedure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The positioning system is segmented into simple, separate components: skin markers placed on the surface and corresponding references on the sheath. This segmentation allows each component to be simple and easy to apply, while their combination provides accurate positioning, resolving the contradiction between precision and complexity.

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

This solution enables accurate and precise deployment of vascular devices by ensuring the sheath remains aligned with the target site, reducing the risk of misplacement and device failure, and allows for real-time monitoring of the device's position during procedures.

Implementation Method 1

the adherent material positioned on the coupling surface and arranged to adhere the coupling surface to the surface of the medical device

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentEP2914327B1Implements for identifying sheath migration
Publication Date: 2021.08.04 MUFFIN INC
  • EP2914327B1 patent drawingFigure 1~2
  • EP2914327B1 patent drawingFigure 3~5
  • EP2914327B1 patent drawingFigure 6~8

AI summary

Attachable implements, systems, and methods for identifying the migration of a medical device extending through a percutaneous insertion site of a patient's skin are disclosed. In one embodiment, an attachable implement for identifying migration comprises a attachable implement body having a coupling surface and a skin contacting surface, the coupling surface arranged to couple to a surface of the medical device, and the skin contacting surface arranged to contact the skin of the patient; wherein the attachable implement body is arranged to be side mountable on the medical device and wherein the attachable implement is configured to move from a first position adjacent to the patient's skin to a second position remote from the patient's skin. Systems, methods, and other embodiments are disclosed.