Steerable Adapter for Mitral Valve Delivery

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Solution Overview

Problem

Current methods for delivering and securing prostheses, such as replacement heart valves, face challenges in controlled placement and stabilization within the body, particularly due to the need for precise positioning and long-term handling during minimally invasive procedures, which can lead to fatigue and instability.

Innovation Solution

A steerable adapter system with a clamp and actuators providing translational and rotational motions along multiple axes, allowing for precise control and stabilization of the delivery system, which can be attached to a holding arm for reduced physician fatigue and improved precision.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a delivery system is manually held and positioned during prosthesis implantation, then the physician can directly control device placement, but physician fatigue and instability occur leading to reduced precision

Engineering Contradiction:
Improvepositioning precisionVSAvoidphysician fatigue
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

A robotic arm acts as an intermediary between the physician's control inputs and the delivery system. The robotic arm receives commands from the physician and executes precise positioning movements, eliminating the need for the physician to manually hold and position the heavy delivery system throughout the procedure. This mediator enables high positioning precision while keeping the physician's role lightweight and fatigue-free.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If the delivery system is made highly maneuverable for navigation through tortuous vasculature, then access to difficult locations is improved, but stability for precise deployment is reduced

Engineering Contradiction:
Improvenavigation capabilityVSAvoiddeployment stability
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The system is segmented into distinct functional phases: a navigation phase where the delivery system is highly maneuverable for navigating tortuous vasculature, and a deployment phase where the robotic arm provides stable, precise positioning. The robotic arm acts as a stable base that can be engaged once the delivery system reaches the general target area, allowing the system to have both high adaptability during navigation and high stability during deployment.

Inventive Principle:
Principle #1Segmentation

3Productivity

If the delivery system requires continuous manual adjustment during the procedure, then real-time control is maintained, but procedure time increases due to fatigue-related repositioning

Engineering Contradiction:
Improveprocedure efficiencyVSAvoidrepositioning time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The robotic arm provides self-service by automatically maintaining the delivery system's position and making precise adjustments without requiring continuous manual intervention from the physician. Once the robotic arm is engaged and positioned, it autonomously holds the delivery system steady and can make fine adjustments based on control inputs, eliminating the need for the physician to continuously reposition the device due to fatigue or drift.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3370651B1Adapter for prosthesis delivery
Publication Date: 2023.12.27 EDWARDS LIFESCIENCES CORP
  • EP3370651B1 patent drawingFigure 1
  • EP3370651B1 patent drawingFigure 2
  • EP3370651B1 patent drawingFigure 3

AI summary

Disclosed herein are embodiments of adapters that can be used to translate and/or rotate the position of a delivery system, such as for use with a replacement mitral valve. The adapters can allow for three-dimensional motion of the delivery system, thus allow for precise positioning and movement of the delivery system during use by an operator.