Heart Valve Chordae Replacement Apparatus

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Solution Overview

Problem

Current methods for repairing heart valves, such as the thorascopic heart valve repair method, are invasive and require external equipment, and there is a need for a more efficient and less invasive approach to attach artificial chordae to heart valve leaflets without stopping the heart.

Innovation Solution

A hand-held apparatus with an elongated shaft and movable jaw surfaces for clamping tissue, along with a leaflet stabilization structure like a resiliently expandable wire mesh or inflatable balloon, is used to attach a tether between a heart valve leaflet and the ventricle wall, reducing blood leakage and allowing for adjustable tether length during the procedure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a thorascopic heart valve repair method is used to attach artificial chordae, then the valve repair can be performed on a beating heart with less invasive access, but external equipment is required and the procedure complexity increases

Engineering Contradiction:
Improveinvasiveness of accessVSAvoidexternal equipment requirements
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent combines multiple functions (leaflet stabilization, tissue clamping, tether attachment) into a single integrated apparatus that can be inserted through the apex of the heart. This eliminates the need for external equipment and reduces procedural complexity while maintaining the benefit of performing repair on a beating heart.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The apparatus employs nested structures where the stabilizing element, jaw surfaces, and tether attachment mechanism are contained within a single insertable shaft. The stabilizing element can be deployed from within the shaft, similar to nested dolls, allowing compact delivery through minimal access while providing full functionality once deployed.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Device complexity

If traditional suture methods are used to attach artificial chordae, then the procedure is simpler, but the heart must be stopped and full sternotomy is required

Engineering Contradiction:
Improveprocedural simplicityVSAvoidinvasiveness of access and heart stopping
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The procedure is segmented into distinct functional components: a stabilizing element to restrain leaflet movement, jaw surfaces to clamp tissue, and a tether attachment mechanism. This segmentation allows each component to perform its specific function efficiently, enabling minimally invasive repair on a beating heart while maintaining procedural simplicity through modular design.

Inventive Principle:
Principle #1Segmentation

3Ease of operation

If the leaflet is allowed to move freely during tether attachment, then the procedure is easier, but accurate tether placement and length adjustment become difficult

Engineering Contradiction:
Improvetether attachment easeVSAvoidtether placement precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The stabilizing element is deployed before tether attachment to counteract and restrain leaflet movement. This preliminary action prevents the leaflet from moving during the tether attachment process, ensuring accurate placement and length adjustment while keeping the procedure straightforward for the operator.

Inventive Principle:
Principle #9Preliminary anti-action

4Ease of operation

If an insertable apparatus with stabilizing structure is used, then minimally invasive repair on beating heart is enabled, but blood leakage through the access aperture occurs

Engineering Contradiction:
Improveminimally invasive capabilityVSAvoidblood leakage
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The apparatus employs a sealing structure as an intermediary element between the insertable shaft and the heart wall at the access aperture. This sealing structure prevents blood leakage through the aperture while allowing the shaft to remain in place for tether attachment, thus maintaining minimally invasive benefits without the harmful effect of blood loss.

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 apparatus enables minimally invasive attachment of artificial chordae to heart valve leaflets, improving valve performance by reducing prolapsing and enhancing coaptation, while allowing for real-time adjustment of tether length during the procedure without the need for external equipment or stopping the heart.

Implementation Method 1

The leaflet stabilization structure may include a resiliently expandable wire mesh structure

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

The leaflet stabilization structure may include an inflatable balloon

Methodology Applied
Scientific EffectPressure: Pressure Increase

Data Source

PatentUS11357625B2Heart valve chordae replacement methods and apparatus
Publication Date: 2022.06.14 ST JUDE MEDICAL LLC
  • US11357625B2 patent drawing
  • US11357625B2 patent drawing
  • US11357625B2 patent drawing

AI summary

Apparatus for attaching a prosthetic tether between a leaflet of a patient's heart valve and another portion of the patient's heart to help prevent prolapse of the leaflet and/or to otherwise improve leaflet function. The apparatus can be used with relatively low invasiveness of the patient's body. The apparatus releasably clamps the leaflet during attachment of the tether to the leaflet. The apparatus may include an integrated display for indicating how extensively the leaflet is being clamped, as well as structure for stabilizing the leaflet for better clamping. The apparatus may enter the heart through an aperture in the wall of the heart, and may include structure for helping to reduce blood leakage from that aperture. The apparatus may be able to enter the heart by following a guide wire. The apparatus may include various means for attaching the tether to the leaflet.