Automated Vascular Closure Deployment Mechanism

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Solution Overview

Problem

Current vascular closure devices require manual deployment, leading to subjective tactile manipulation, multiple procedural steps, low precision, and a long learning curve, which hampers ease of use, precision, and adoption in cardiac catheterization laboratories, resulting in prolonged patient recovery and increased complications.

Innovation Solution

A closure device with an automated deployment mechanism, comprising a footplate, plug, and wire, designed to minimize tactile manipulation and user-induced steps, featuring a monolithic footplate that can plastically deform and a biodegradable material for secure early ambulation, with a deployment device that uses elastic members and release mechanisms for precise placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If manual deployment of closure device is used, then device complexity is reduced, but manufacturing precision and placement accuracy deteriorate due to subjective tactile manipulation

Engineering Contradiction:
Improvedeployment mechanism complexityVSAvoidclosure device placement precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The patent replaces manual tactile manipulation with an automated deployment mechanism that uses mechanical components (pusher, sheath, expansion elements) to precisely position and deploy the closure device. The system substitutes human sensory-based control with mechanical guidance structures including rails, slots, and interlocking components that objectively ensure accurate placement.

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

Solution Approach 2:

The closure device incorporates self-aligning and self-positioning features where the expansion elements automatically engage with the vessel wall and the pusher mechanism self-regulates deployment depth through mechanical constraints. The device serves itself by using the vessel anatomy and pre-configured mechanical guides to achieve precise placement without continuous manual adjustment.

Inventive Principle:
Principle #25Self-service

2Manufacturing precision

If automated deployment mechanism is implemented, then placement precision improves, but device complexity increases

Engineering Contradiction:
Improveclosure device placement precisionVSAvoiddeployment mechanism complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The deployment device is divided into distinct functional modules: a sheath for delivery, a pusher for advancement, expansion elements for deployment, and a release mechanism for activation. Each segment performs a specific function, allowing the complex overall system to be managed through modular components that can be independently manufactured and assembled.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs nested structures where the pusher is contained within the sheath, expansion elements are folded within the pusher, and the entire assembly is delivered through a catheter. This nesting minimizes the profile during delivery while allowing sequential deployment of each component, managing complexity through compact integration.

Inventive Principle:
Principle #7Nested doll (Nesting)

3Ease of operation

If multiple procedural steps are required for deployment, then ease of operation deteriorates, but device reliability improves through controlled sequential actions

Engineering Contradiction:
Improvedeployment procedure easeVSAvoidclosure device deployment reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The closure device is pre-configured with expansion elements folded in specific orientations, the pusher is pre-positioned within the sheath, and mechanical constraints are pre-set to guide deployment. This preliminary preparation ensures that when deployment is initiated, the device follows a predetermined reliable sequence without requiring complex real-time adjustments by the operator.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces a release mechanism as an intermediary that translates a simple operator action (pulling or releasing a tab) into a coordinated sequence of deployment events. This intermediary component mediates between the simple user input and the complex multi-step deployment process, maintaining reliability while improving ease of operation.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 solution provides a more precise, user-friendly, and efficient vascular closure with reduced procedural complexity, enabling faster patient recovery and lower complication rates by ensuring a secure and stable closure resistant to physiologic motion.

Implementation Method 1

at least one bias member adapted to exert a bias force

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

a closure device (100) for sealing an opening (402) formed through biological tissue

Methodology Applied
Scientific EffectOcclusion:

Implementation Method 3

featuring a monolithic footplate that can plastically deform

Methodology Applied
Scientific EffectPlastic deformation: Plasticity

Data Source

PatentEP2635197B1Deployment apparatus for deploying a closure device
Publication Date: 2019.01.09 TRANSLUMINAL TECH INC
  • EP2635197B1 patent drawingFigure 1a
  • EP2635197B1 patent drawingFigure 1b
  • EP2635197B1 patent drawingFigure 1c

AI summary

The present invention relates a closure device implant for sealing an opening formed through biological tissue including a plug, a rigid wire including a plastically deformable portion configurable between an unrestrained position and a restrained position relative to the plug, wherein a distal end of the wire is substantially spherically shaped, and a footplate attached to the wire, wherein the footplate comprises an elongated plate portion including a wire channel. The present invention also relates to a closure device deployment device including an elongated housing, a sheath assembly connected to the housing, and at least two sliding members slidably connected to the housing.