Heart Valve Annulus Reshaping via Expandable Implant Contraction

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Solution Overview

Problem

Current methods for addressing heart valve incompetency, such as surgical implantation of an annuloplasty ring, are invasive and carry risks like morbidity, mortality, and extended recovery times due to the need for open chest surgery and cardiopulmonary bypass.

Innovation Solution

A minimally invasive percutaneous delivery system for a heart valve implant with a tubular frame and moveable struts that engages the heart valve annulus, allowing for expansion to match the dilated annulus diameter and subsequent contraction to reduce the annulus size, utilizing a delivery catheter with imaging and positioning features for precise placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical implantation of an annuloplasty ring is performed, then the valve annulus is restored to its native configuration, but the procedure is invasive and carries risks of morbidity and mortality

Engineering Contradiction:
Improvevalve function restorationVSAvoidmorbidity and mortality risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The implant is divided into multiple struts that can be independently positioned and engaged with the annulus tissue, allowing for staged deployment and reduced procedural risk while achieving the same annular restoration effect

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The implant acts as an intermediary device that can be delivered percutaneously through the femoral vein and positioned in the left atrium, avoiding direct surgical access to the heart while still achieving annular restoration through the mediating implant structure

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If open chest surgery with cardiopulmonary bypass is performed, then the annuloplasty ring can be implanted, but the procedure time and recovery period are extended

Engineering Contradiction:
Improveannuloplasty implantationVSAvoidprocedure duration and recovery time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The implant is pre-assembled in a compressed configuration within the delivery system, allowing for rapid deployment once positioned in the target site, thereby reducing procedure time while maintaining implantation reliability

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The traditional mechanical surgical approach involving sternotomy and cardiopulmonary bypass is replaced with a percutaneous delivery system that uses catheter-based navigation and imaging guidance, dramatically reducing procedure time and recovery period

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

3Object-affected harmful factors

If a percutaneous delivery system is used, then the procedure is less invasive, but precise positioning and engagement with the annulus requires advanced imaging and positioning features

Engineering Contradiction:
ImproveinvasivenessVSAvoidimaging and positioning system
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The delivery system merges multiple functions including catheter-based delivery, real-time imaging guidance, positioning control, and implant deployment into a single integrated system, reducing invasiveness while managing complexity through functional integration

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The delivery system is designed with multi-functionality to handle various imaging modes, positioning adjustments, and implant deployment scenarios, allowing a single complex system to address multiple requirements simultaneously rather than requiring separate specialized devices

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentUS20230157823A1Implantable device and delivery system for reshaping a heart valve annulus
Publication Date: 2023.05.25 BOSTON SCIENTIFIC SCIMED INC
  • US20230157823A1 patent drawing
  • US20230157823A1 patent drawing
  • US20230157823A1 patent drawing

AI summary

Systems, devices and methods related to various heart valve implants and for delivery of those heart valve implants are described. The implants may be used to re-size a native valve annulus or to replace a native heart valve. The implants include a re-sizable frame having angled struts. Anchors secure the implant to tissue and collars are used to decrease the angle between the struts and contract the frame. The implant thus expands from a first size inside of a delivery catheter, to a second and larger deployed size inside the heart to engage and anchor with the tissue, and then to a third and contracted size to re-size the annulus and/or provide a secure fit for a replacement heart valve. Various delivery systems including imaging capabilities for precise delivery, positioning and anchoring of the various implants are further described.