Mitral Valve Leaflet Repair via Percutaneous Anchor Securing

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Solution Overview

Problem

Current methods for treating degenerative mitral regurgitation, such as surgical resection and annuloplasty, are invasive and unsuitable for frail patients, and there is a need for minimally invasive techniques to address redundant tissue in mitral valve leaflets without tissue removal.

Innovation Solution

A mitral valve leaflet repair system using a delivery catheter with anchor elements and a securing element to isolate redundant tissue percutaneously, forming folds in the mitral valve leaflet tissue to facilitate proper closure without removing any tissue, employing suction lumens, anchor lumens, and various types of anchor elements like rivets, expanding frames, and screw-type fasteners.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical resection and annuloplasty are used to treat degenerative mitral regurgitation, then the mitral valve function is restored, but the invasiveness of the procedure increases and patient eligibility decreases

Engineering Contradiction:
Improvemitral valve function restorationVSAvoidinvasiveness
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and removes the problematic redundant tissue from the mitral valve leaflet through a percutaneous approach. The delivery catheter is advanced through the venous system to the mitral valve, and the cutting element selectively removes the redundant tissue portion that causes prolapse, leaving the healthy tissue intact. This extraction approach restores valve function while avoiding the invasiveness of open surgical resection.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces a delivery catheter as an intermediary device that mediates between the operator and the mitral valve tissue. The catheter serves as a conduit to deliver cutting, grasping, and remodeling elements to the target site through minimally invasive percutaneous access. This intermediary approach enables complex tissue manipulation without requiring open surgical exposure.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If traditional surgical methods are avoided to treat frail patients, then patient eligibility for treatment increases, but the ability to effectively address redundant tissue decreases

Engineering Contradiction:
Improvepatient eligibilityVSAvoidredundant tissue management
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent segments the treatment process into distinct functional modules delivered through the catheter system. The cutting element is separated from the grasping element, which is separated from the remodeling element. This segmentation allows each function to be optimized independently and delivered through a single percutaneous access point, making the procedure adaptable to frail patients who cannot tolerate open surgery.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent replaces the mechanical system of open surgical exposure and manual tissue manipulation with a catheter-based system that delivers specialized elements through the bloodstream. Instead of requiring direct surgical access to the heart, the system uses fluid dynamics and catheter mechanics to navigate to the mitral valve and perform tissue modification, thereby expanding eligibility to include frail patients.

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

3Reliability

If tissue removal is performed to address redundant tissue, then mitral valve function improves, but the complexity of the procedure and risk of complications increases

Engineering Contradiction:
Improvemitral valve functionVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple functions (cutting, grasping, remodeling) into a single integrated delivery catheter system. All necessary elements are delivered through one percutaneous access point, and the procedure is completed through a single vascular puncture. This merging approach reduces procedural complexity compared to multiple separate interventions while maintaining effective redundant tissue management.

Inventive Principle:
Principle #5Merging (Combining)

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 minimally invasive treatment of degenerative mitral regurgitation by isolating redundant tissue, allowing the mitral valve leaflets to close properly, thereby reducing blood backflow without the need for invasive surgery, suitable for patients who are not candidates for traditional surgical methods.

Implementation Method 1

The at least one lumen may comprise a suction lumen configured to grasp a mitral valve leaflet prior to extending the plurality of anchor elements through one layer of mitral valve leaflet tissue

Methodology Applied
Scientific EffectSuction: Suction

Implementation Method 2

the securing element comprises a shape memory material

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Implementation Method 3

the securing element comprises a magnetic attraction between each of the at least two of the plurality of anchor elements

Methodology Applied
Scientific EffectMagnetic attraction: Magnetism

Data Source

PatentUS11918470B2Percutaneous repair of mitral prolapse
Publication Date: 2024.03.05 BOSTON SCIENTIFIC SCIMED INC
  • US11918470B2 patent drawing
  • US11918470B2 patent drawing
  • US11918470B2 patent drawing

AI summary

A mitral valve leaflet repair system may include a delivery catheter having at least one lumen extending proximally from a distal end of the delivery catheter, a plurality of anchor elements disposed within the at least one lumen, each of the plurality of anchor elements being configured to extend through one layer of mitral valve leaflet tissue, and a securing element configured to secure at least two of the plurality of anchor elements together on one side of the mitral valve leaflet tissue. The at least one lumen may include a suction lumen configured to grasp a mitral valve leaflet prior to extending the plurality of anchor elements through one layer of mitral valve leaflet tissue.