Heart Valve Delivery System Stabilizer for Precise Placement

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Solution Overview

Problem

Delivering and securing replacement heart valves through minimally invasive procedures poses challenges due to the difficulty in controlling the location and deployment of the prosthesis, particularly in tortuous vasculature, and ensuring atraumatic attachment to intralumenal tissue.

Innovation Solution

A stabilizer system for delivery systems, comprising an elongated main body with angled surfaces and a hub nest, handle carriage, and clamps, which allows for precise control and stabilization of the delivery system, including motorized and electromagnetically controlled components for enhanced maneuverability and attachment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a delivery system is used to deliver replacement heart valves through minimally invasive procedures, then patient trauma is reduced, but control over the location and deployment of the prosthesis becomes difficult

Engineering Contradiction:

Improvepatient traumaVSAvoidcontrol over location and deployment

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

A stabilizer device is introduced as an intermediary between the operator and the delivery system. The stabilizer includes a base plate that can be attached to the patient's body and a positioning mechanism that provides controlled movement of the delivery system, thereby maintaining minimal invasiveness while improving operational control

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The delivery system is divided into separate functional components: the delivery catheter, the prosthesis, and the stabilizer system. This segmentation allows each component to be optimized independently, with the stabilizer providing specialized positioning functions without increasing trauma to the patient

Inventive Principle:

Principle #1Segmentation

2Adaptability or versatility

If the delivery system is made more maneuverable to navigate tortuous vasculature, then access to difficult locations is improved, but stability and precision of prosthesis placement deteriorates

Engineering Contradiction:

Improveability to navigate tortuous vasculatureVSAvoidprecision of prosthesis placement

Core Design Contradiction:

Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The stabilizer system incorporates dynamic positioning capabilities with adjustable components that can be moved between locked and unlocked states. The positioning mechanism allows for controlled maneuverability during navigation, then provides rigid stability during placement, adapting to different operational phases

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system changes physical parameters such as stiffness and positioning constraints based on operational needs. The stabilizer transitions from a more flexible state during navigation to a rigid, precisely constrained state during prosthesis placement, optimizing performance for each phase

Inventive Principle:

Principle #35Parameter changes

3Stability of the object's composition

If clamps are added to secure the delivery system, then stability is improved, but device complexity increases

Engineering Contradiction:

Improvestability of delivery systemVSAvoidnumber of components

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

Multiple stabilization functions are merged into integrated components. The clamps are combined with the base plate and positioning mechanism into a unified stabilizer assembly, providing enhanced stability without proportionally increasing the number of separate components

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS12350446B2Method of using a stabilizer for a delivery system

Publication Date: 2025.07.08 EDWARDS LIFESCIENCES CORP

AI summary

Disclosed herein are embodiments of methods of using stabilizers for use in delivering a replacement heart valve. The stabilizers can receive a portion of a delivery system, such as a handle, to prevent unwanted motion of the delivery system. The stabilizer can include a linear actuator for adjusting a position of the delivery system once held within the stabilizer.