Magnetically Coupled Cinching Valve Annulus Reduction

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Solution Overview

Problem

Current methods for reducing the diameter of a valve annulus in a patient's body are inefficient, as they lack a reliable and minimally invasive mechanism for actuating a cinching loop post-implantation to effectively reduce the annulus diameter.

Innovation Solution

An apparatus and method involving a tissue engaging member with anchors and a cinching loop, where an actuator is implanted to pull cinching wires, reducing the cinching loop's diameter by using a hydraulic or magnetic pump or electric motor activated externally, with a cord lock mechanism to secure the wires, promoting tissue ingrowth and minimizing external intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a cinching loop is implanted to reduce valve annulus diameter, then the annulus diameter can be reduced, but the mechanism for actuating the cinching loop post-implantation is complex and requires significant external intervention

Engineering Contradiction:
Improvereliability of cinching mechanismVSAvoidcomplexity of actuation mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The actuator is extracted from external devices and implanted within the patient's body, eliminating the need for complex external intervention mechanisms. The actuator is delivered via catheter through venous access and positioned at the implant site, where it directly engages with the cinching loop wires to provide controlled cinching action.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The actuator is nested within a delivery catheter system, allowing minimally invasive implantation. The catheter provides a conduit for delivering the actuator to the target site, and the actuator itself contains nested components including the hydraulic cylinder, pump, and magnetic coupling mechanisms within a compact housing.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Ease of operation

If external actuation devices are used to pull cinching wires, then the cinching loop can be actuated, but the procedure requires significant external intervention and is not minimally invasive

Engineering Contradiction:
Improveease of post-implantation actuationVSAvoidcomplexity of external intervention
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

A magnetic coupling mechanism serves as an intermediary between the external controller and the implanted actuator. The external controller generates magnetic fields that pass through the patient's body to actuate the magnetic pump or hydraulic system within the actuator, eliminating the need for direct mechanical connection or electrical wires through the skin.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

Traditional mechanical or electrical actuation systems are replaced with a magnetically actuated hydraulic system. The magnetic field from an external controller drives the magnetic pump, which delivers hydraulic fluid to the actuator's hydraulic cylinder, converting magnetic energy to mechanical motion without direct mechanical contact.

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

3Ease of operation

If the actuator is implanted within the patient's body, then minimal external intervention is required, but the actuator must be sufficiently small to fit within the body while maintaining functionality

Engineering Contradiction:
Improveminimally invasive implantationVSAvoidsize of actuator
Core Design Contradiction:
Ease of operationVSWeight of moving object

Solution Approach 1:

The actuator uses a hydraulic system where a small-volume hydraulic cylinder provides high force output. The magnetic pump delivers hydraulic fluid through narrow-bore tubing to the cylinder, enabling compact actuator design. The hydraulic system allows small actuator dimensions while maintaining sufficient cinching force capability.

Inventive Principle:
Principle #29Pneumatics and hydraulics

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 allows for a controlled and minimally invasive reduction of the valve annulus diameter, enhancing the efficacy of the procedure by ensuring secure anchoring and tissue integration, thereby providing a durable and effective reduction in annulus size.

Implementation Method 1

the pump may be rotary magnetic pump configured for implantation beneath the patient's skin, and this pump is configured to pump when a rotating magnetic field is coupled into the rotary magnetic pump

Methodology Applied
Scientific EffectRotating magnetic field: Magnetic Field

Implementation Method 2

the actuator comprises a hydraulic cylinder having an inlet port and a pump configured to, when actuated, pump hydraulic fluid into the inlet port

Methodology Applied
Scientific EffectHydraulic pressure: Hydraulic Press

Data Source

PatentUS10398555B2Magnetically coupled cinching of a loop installed in a valve annulus
Publication Date: 2019.09.03 EDWARDS LIFESCIENCES CORP
  • US10398555B2 patent drawing
  • US10398555B2 patent drawing
  • US10398555B2 patent drawing

AI summary

The diameter of an annulus in a patient (e.g., the mitral valve annulus) can be reduced using a tissue engaging member that is installed on the annulus and an actuator that is implanted into the patient's body. The tissue engaging member has anchors used to implant the tissue engaging member into the annulus, and a cinching loop runs through the tissue engaging member. The cinching loop terminates onto cinching wires. Preferably, tissue healing is used to enhance the bond between the tissue engaging member and the annulus. The actuator, which can be actuated from outside the patient's body, pulls the cinching wires in a proximal direction while holding the distal end of the cinching wires in close proximity to each other, so as to cause a reduction in the diameter of the cinching loop. This will cause a corresponding reduction in the diameter of the annulus.