Closure Implant Tension Element for Controlled Release

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Solution Overview

Problem

Current devices for closing the left atrial appendage face challenges in controlled and precise release of closure implants due to uncontrolled expansion and difficulty in assessing proper placement, risking tissue injury and inadequate fixation.

Innovation Solution

A device featuring a self-expanding stent framework with a flexible material layer and a longitudinally extending tension element allows for controlled expansion and retraction, using a catheter to deploy and retract the closure implant, ensuring precise placement and secure anchoring within the atrial appendage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the pull-back principle is used to release the closure implant, then the implant can be deployed from the catheter, but the release becomes uncontrolled and the implant may jump out suddenly causing tissue injury

Engineering Contradiction:
Improverelease controlVSAvoidtissue injury risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the passive pull-back mechanism with an active tension element system that dynamically controls implant release. The tension element runs through the implant and catheter, allowing the operator to control expansion by adjusting tension rather than relying on sudden geometric release. This dynamic control prevents uncontrolled jumping out and tissue injury.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The tension element acts as an intermediary between the operator and the closure implant, providing fine-grained control over the release process. By pulling or releasing the tension element, the operator can control the timing and speed of implant deployment, preventing sudden release and tissue damage.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the closure implant is firmly connected to the catheter by screw and guide wire, then the implant can be securely transported, but it becomes difficult to control successful placement and test fixation

Engineering Contradiction:
Improvetransport securityVSAvoidplacement control
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent extracts the fixation testing function from the catheter connection by using the tension element as a separate, dedicated mechanism. The tension element can be independently manipulated to test implant fixation by applying controlled forces, while the catheter connection remains simple for transport. This separation allows placement verification without compromising transport security.

Inventive Principle:
Principle #2Taking out (Extraction)

3Object-affected harmful factors

If the closure implant has a barrel shape, then it can effectively close the atrial appendage, but the release control is less precise due to sudden expansion behavior

Engineering Contradiction:
Improveclosure effectivenessVSAvoidrelease precision
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The tension element serves as an intermediary that decouples the implant geometry from the release control mechanism. Even with a barrel-shaped implant, the tension element provides gradual, controlled expansion by distributing force along the implant length, preventing sudden release and improving precision.

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

Enables controlled and precise deployment and retrieval of the closure implant, reducing the risk of tissue injury and improving the assessment of implant fixation, thereby enhancing the safety and effectiveness of the procedure.

Implementation Method 1

The ability for self-expansion of the stent framework can, for. B. by a material property of the stent framework, such. B. be due to an elastic restoring force

Methodology Applied
Scientific EffectElastic restoring force: Elasticity

Implementation Method 2

The ability for self-expansion of the stent framework can, for. B. by a material property of the stent framework, such. B. be due to an elastic restoring force or superelasticity

Methodology Applied
Scientific EffectSuperelasticity: Pseudoelasticity

Implementation Method 3

The configuration of the stent structure from a shape memory alloy, in particular nitinol, is preferred

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Data Source

PatentEP3320862B1Device for positioning and release of a closure implant for closing the left atrial auricle
Publication Date: 2020.09.30 BIOTRONIK AG
  • EP3320862B1 patent drawingFigure 1
  • EP3320862B1 patent drawingFigure 2
  • EP3320862B1 patent drawingFigure 3

AI summary

The invention relates to a device (10) for closing the left atrial appendage (HO), comprising: a closure implant (200) for closing the left atrial appendage (HO), wherein the closure implant (200) has a self-expanding stent frame (2b) that can be automatically expanded from a compressed state to an expanded state, and wherein the closure implant (200) has a flexible material layer (2d) fixed to the stent frame (2b), wherein the material layer (2d) is stretched in the expanded state of the stent frame (2b), and a catheter (K) with a lumen (L) for receiving the closure implant (200) in the compressed state of the stent frame (2b), wherein the closure implant (200) can be released by pushing it out of the lumen (L) and the stent frame (2b) can be brought into the expanded state.According to the invention, the device (10) has a flexible and longitudinally extended traction element (2c) fixed to the flexible material layer, so that the closure implant (200) can be retracted into the lumen (L) of the catheter (K) by means of the traction element (2c) and the stent frame (2b) can be brought into the compressed state.