Shape Memory Mitral Valve Implant Anchoring

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Solution Overview

Problem

Current treatments for mitral valve regurgitation are invasive, costly, and often require exceptional surgical skills, with existing implants facing challenges in long-term durability and accurate positioning due to significant movement of valve tissues and contraction issues.

Innovation Solution

A shape memory structure-based implant with a biocompatible membrane, ventricular projection, and anchoring device, deployable via a steerable catheter, which can be folded for percutaneous delivery and anchored using active or passive microhooks, providing enhanced leaflet coaptation without disrupting anatomy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open-heart surgery with mechanical annuloplasty rings is used, then mitral valve regurgitation is treated effectively, but the procedure is invasive, costly, and requires exceptional surgical skills

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidsurgical complexity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces the mechanical annuloplasty ring system with a shape memory polymer implant that uses shape memory effect to provide structural support and coaptation assistance. The polymer material transforms from a compressed delivery state to an expanded functional state, eliminating the need for complex mechanical rings and sutures, thereby reducing surgical complexity while maintaining treatment effectiveness

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

Solution Approach 2:

The implant utilizes shape memory polymer properties to change its physical state in response to temperature or other stimuli. The material transitions from a compressed low-volume delivery configuration to an expanded functional configuration within the heart, enabling minimally invasive delivery while providing sustained mechanical support without requiring exceptional surgical skills

Inventive Principle:
Principle #35Parameter changes

2Reliability

If conventional implants are used, then valve replacement is achieved, but long-term durability is compromised due to significant movement of valve tissues and contraction issues

Engineering Contradiction:
Improveimplant durabilityVSAvoidtissue stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent employs a flexible shape memory polymer implant that can accommodate the dynamic movement and contraction of heart tissues. The polymer's inherent flexibility allows it to deform with the cardiac cycle while maintaining its structural integrity and coaptation function, thereby improving long-term durability without compromising tissue stability

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The implant utilizes shape memory polymer materials that combine the benefits of flexibility and memory. The polymer structure allows it to be compressed for delivery and then automatically expand to its functional shape, providing consistent support throughout the cardiac cycle and improving durability compared to conventional rigid implants

Inventive Principle:
Principle #40Composite materials

3Ease of operation

If minimally invasive delivery is implemented, then surgical trauma is reduced, but accurate positioning becomes difficult due to significant movement of valve tissues

Engineering Contradiction:
Improvedelivery minimalityVSAvoidpositioning accuracy
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The implant is pre-compressed into a small delivery configuration that can be easily positioned through minimally invasive access. Upon deployment, the shape memory effect automatically expands the implant to its functional size and shape, ensuring accurate positioning and engagement with the valve tissues without requiring complex real-time adjustment procedures

Inventive Principle:
Principle #10Preliminary action

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 enables minimally invasive, reliable, and cost-effective treatment of mitral valve regurgitation by enhancing leaflet coaptation, reducing the need for open-heart surgery and skilled surgeons, while maintaining implant stability through shape memory materials and precise anchoring.

Implementation Method 1

A shape memory structure-based implant with a biocompatible membrane, ventricular projection, and anchoring device, deployable via a steerable catheter, which can be folded for percutaneous delivery

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS20240341957A1Mitral valve implants for the treatment of valvular regurgitation
Publication Date: 2024.10.17 POLARES MEDICAL INC
  • US20240341957A1 patent drawing
  • US20240341957A1 patent drawing
  • US20240341957A1 patent drawing

AI summary

The invention relates in some aspects to a device for use in the transcatheter treatment of mitral valve regurgitation, including steerable guidewires, implantable coaptation assistance devices, anchoring systems for attaching a ventricular projection of an implantable coaptation device, a kit, and methods of using an implantable coaptation assistance device among other methods.