Annulus Patch Mitigates Migration and Tissue Damage in Valve Repair

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Solution Overview

Problem

Current surgical and endoluminal annuloplasty techniques face challenges in securely positioning and preventing migration of implantable devices in the mitral valve annulus, leading to potential tissue damage and reduced cardiac output due to mitral insufficiency.

Innovation Solution

A heart valve implant device with a frame and patch system that secures to the valve annulus, featuring distal apices and anchors, which can move between collapsed and expanded configurations to modify the valve annulus shape, and an annulus patch to prevent migration and promote tissue growth, ensuring secure implantation and reducing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If an implantable device is secured to the valve annulus using conventional annuloplasty techniques, then the valve annulus shape can be modified, but the device may migrate or loosen over time causing tissue damage

Engineering Contradiction:
Improvedevice positioning stabilityVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A patch is implanted into the valve annulus tissue before the implantable device is secured. This preliminary patch creates a reinforced interface that prevents device migration and reduces tissue damage when the device is cinched to modify the valve annulus configuration.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patch acts as a cushioning layer between the implantable device and the valve annulus tissue. This beforehand cushioning protects the tissue from damage caused by the device securing process and prevents migration, thereby improving long-term reliability.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

2Reliability

If the frame is cinched to modify the valve annulus configuration, then mitral insufficiency is treated, but tissue damage may occur at the treatment site

Engineering Contradiction:
Improvevalve function restorationVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patch is implanted beforehand to cushion and protect the valve annulus tissue during the frame cinching process. This protective layer allows the frame to be tightened to restore valve function while minimizing direct contact between the frame and vulnerable tissue.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If the implantable device is secured tightly to prevent regurgitation, then valve function is improved, but the device may loosen or migrate later

Engineering Contradiction:
Improvevalve sealing effectivenessVSAvoiddevice position stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patch is implanted beforehand to create a stable, reinforced interface between the implantable device and the valve annulus. This preliminary reinforcement ensures that when the device is secured tightly to prevent regurgitation, it remains stable and does not migrate or loosen over time.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS12127940B2Predisposed annulus patch for valve repair implant
Publication Date: 2024.10.29 BOSTON SCIENTIFIC SCIMED INC
  • US12127940B2 patent drawing
  • US12127940B2 patent drawing
  • US12127940B2 patent drawing

AI summary

A patch for interposing between an implantable device and a treatment site, such as to inhibit migration (e.g., lateral shifting) of the implantable device with respect to the treatment site without interfering with contact of the implantable device with the treatment site, and/or to reduce (and preferably inhibit or prevent) damage to tissue at the treatment site and/or movement of the anchor element (used to anchor the implantable device) with respect to the treatment site. The patch may extend continuously around the perimeter of the device, or discontinuously as more than one patch. The patch may be delivered on the implantable device to the treatment site, or separately delivered and deployed before the implantable device is delivered and deployed, the implantable device being implanted over the patch and the treatment site.