Deformable Wire Valve Clip for Mitral Regurgitation Repair

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Solution Overview

Problem

Current methods for treating mitral valve regurgitation, such as open heart surgery, are invasive and have long recovery times, while minimally invasive techniques like clip-based fasteners may not adequately address the issue of valve leaflet coaptation in all cases.

Innovation Solution

A medical system comprising a deformable wire valve clip with a catheter delivery system that allows for transcatheter deployment, enabling the clip to be extended and contracted to engage and secure valve leaflets, potentially reducing regurgitation through edge-to-edge repair without the need for open surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open heart surgery is used to treat mitral valve regurgitation, then effective valve repair can be achieved, but the procedure is invasive and requires long recovery time

Engineering Contradiction:
Improvevalve repair effectivenessVSAvoidinvasiveness and recovery time
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A catheter serves as an intermediary device to deliver the valve clip to the mitral valve through blood vessels, eliminating the need for open heart surgery. The catheter navigates through the femoral vein, crosses into the left atrium, and positions the clip at the mitral valve, providing a minimally invasive pathway for effective valve repair.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical open surgery approach with a transcatheter delivery system. The valve clip is loaded into a catheter in a compressed state, then deployed at the target site through controlled expansion, substituting the need for surgical incisions and direct mechanical manipulation of the valve.

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

2Reliability

If a valve clip is deployed to engage mitral valve leaflets, then regurgitation can be reduced, but the clip must be precisely positioned to ensure proper coaptation

Engineering Contradiction:
Improveregurgitation reductionVSAvoidclip positioning accuracy
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The system incorporates imaging guidance (fluoroscopy, echocardiography, or angiography) to provide real-time feedback on catheter and clip positioning. This allows the operator to visualize the clip's location relative to the mitral valve leaflets and make adjustments to ensure proper engagement and coaptation before final deployment.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The valve clip is pre-loaded into the catheter in a compressed, constrained state that maintains its integrity during delivery. The catheter system is prepared in advance with the clip secured, and the delivery pathway is established before reaching the target site, ensuring that the clip is ready for precise deployment when the catheter is positioned correctly.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If a deformable wire valve clip is used to engage valve leaflets, then the clip can be extended and contracted for deployment, but the delivery system requires multiple control members and delivery devices

Engineering Contradiction:
Improveclip configuration flexibilityVSAvoiddelivery system structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The valve clip is divided into two separate wire portions (first and second wire portions) that can be independently controlled by separate delivery devices. This segmentation allows each wire portion to be manipulated independently for engagement with the valve leaflets, providing flexibility in deployment while simplifying the control mechanism compared to a single complex wire system.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The valve clip utilizes a deformable wire structure that can dynamically change between compressed and expanded configurations. The wire portions are designed to be flexible and responsive to control forces, allowing the clip to transition from a compact delivery state to an expanded engagement state, and potentially back to a compressed state for retrieval or repositioning.

Inventive Principle:
Principle #15Dynamics

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

This approach provides a less invasive method for treating mitral valve regurgitation, allowing for effective engagement and stabilization of valve leaflets, potentially reducing regurgitation and the progression to heart failure, with the ability to assess and reposition the clip for improved treatment efficacy.

Implementation Method 1

a deformable wire configured to engage valve leaflets of a patient, where the deformable wire extends from a first wire portion to a second wire portion

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP4013353B1Heart valve repair
Publication Date: 2023.09.27 MEDTRONIC VASCULAR INC
  • EP4013353B1 patent drawingFigure 1A
  • EP4013353B1 patent drawingFigure 1B
  • EP4013353B1 patent drawingFigure 2A

AI summary

A medical system includes a catheter navigable through vasculature of patient to introduce a valve clip configured to join the edges of heart valve leaflets. The valve clip includes a deformable wire configured to engage valve leaflets, the wire extending from a first wire portion to a second wire portion. The catheter includes a handle having control members, an elongate body defining a lumen extending from the handle to a distal opening, and first and second delivery devices operatively coupled to a control member and extending through the lumen to the distal opening. Each delivery device is configured to releasably couple to a portion of the wire and moveable relative to the distal opening. The delivery devices are controllable at the handle to move the valve clip between an extended configuration and a contracted configuration to engage the valve leaflets.