Percutaneous Suture Anchor for Mitral Valve Repair

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Solution Overview

Problem

Conventional methods for repairing heart structures, such as attaching artificial chordae tendinae, are cumbersome and often inaccurate due to difficulties in accessing the mitral valve area during open-heart surgery, leading to inefficient and time-consuming procedures.

Innovation Solution

A suture device comprising a thread, an anchor, and a delivery system that allows for secure attachment to heart tissue without the need for needles and forceps, using memory materials like Nitinol for the anchor to expand and deploy within the heart, facilitating percutaneous or minimally invasive procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional needle and thread suturing is used to attach artificial chordae tendinae to papillary muscle, then the procedure can be performed with standard surgical instruments, but the process becomes time-consuming and inaccurate due to limited visual access and difficult angles

Engineering Contradiction:

Improveaccuracy of attachmentVSAvoidtime required for attachment

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces the conventional mechanical needle and thread suturing system with a suture anchor system that uses a delivery catheter to directly implant the anchor into the papillary muscle. This eliminates the need for needle holders and forceps, and allows for more precise and faster attachment without the limitations of traditional mechanical suturing in the constrained surgical field of view.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Ease of operation

If open-heart surgery with sternal split is used to access the mitral valve area, then direct visual access is achieved, but the procedure creates significant trauma to the patient and has limited visual access due to narrow space between leaflets

Engineering Contradiction:

Improvevisual access to mitral valveVSAvoidtrauma to patient

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a delivery catheter as an intermediary device that can be advanced through the heart to the mitral valve area without requiring open-heart surgery. The catheter serves as a mediator to deliver the suture anchor through the septum and into the papillary muscle, providing access to the constrained surgical field without creating significant trauma to the patient.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent transitions from a two-dimensional open chest approach to a three-dimensional percutaneous delivery system. The delivery catheter can be advanced through the septum and positioned at the mitral valve area from a different spatial dimension, allowing access to the narrow space between leaflets without requiring sternal split and providing better visual access through the catheter-based approach.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

3Device complexity

If traditional suturing techniques are used to attach suture to tissue, then the method is simple and requires minimal equipment, but it is cumbersome and difficult to perform in the constrained space between mitral valve leaflets

Engineering Contradiction:

Improvesimplicity of suture attachmentVSAvoidease of attaching suture to tissue

Core Design Contradiction:

Device complexityVSEase of operation

Solution Approach 1:

The patent divides the suture attachment system into separate functional components: a delivery catheter for positioning, a suture anchor for tissue engagement, and a suture thread for connection. This segmentation allows each component to be optimized for its specific function and simplifies the overall operation by eliminating the need for complex needle manipulation in the constrained mitral valve space.

Inventive Principle:

Principle #1Segmentation

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 precise and efficient attachment of artificial chordae tendinae and heart defect repairs, reducing trauma to the patient and improving the accuracy of procedures through minimally invasive techniques.

Implementation Method 1

The anchor may be formed of a memory material, such as Nitinol, or other materials having shape memory properties. The anchor may be biased toward the deployed state so that the anchor is configured to expand from a delivered state to a deployed state when ejected from a distal end of a sheath on the delivery catheter.

Methodology Applied

Scientific EffectMemory material: Shape Memory Alloy

Data Source

PatentUS10154838B2Suture and method for repairing a heart

Publication Date: 2018.12.18 EDWARDS LIFESCIENCES CORP

AI summary

Devices and methods for treating or repairing a heart are disclosed. The device includes at least one radially expandable tissue-engaging element, an elongate member (e.g., suture) coupled to the expandable element, and a locking mechanism (e.g., locking clip, suture knot). The expandable element may be anchored to heart tissue within the heart, such as in the left ventricle, with the elongate member extending from the expandable element and across a heart chamber to a second location such as the heart apex where the elongate member is held by the locking mechanism.