Prosthetic Valve Delivery System with Retrograde and Antegrade Access

Solution Overview

Problem

Minimally-invasive percutaneous valve replacement procedures face challenges due to limited access within the vasculature, making it difficult to introduce and maneuver tools and prosthetic devices to heart valves, especially with lesions present in the vasculature.

Innovation Solution

The valve access system provides an antegrade and retrograde approach using an implantation device that establishes a continuous pathway from the aorta to the apex of the heart, allowing for larger devices and tools to be delivered through a transthoracic port, enabling greater flexibility and ease of access to heart valves.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a minimally-invasive percutaneous approach is used, then patient trauma and recovery time are reduced, but access to heart valves is limited and device delivery becomes challenging

Engineering Contradiction:

Improvepatient traumaVSAvoidaccess to heart valves

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The delivery system is divided into multiple segments: a first delivery system accessed through a first site (e.g., femoral artery) and a second delivery system accessed through a second site (e.g., transapical approach). Each segment can be independently navigated and positioned, allowing complex valve replacement procedures to be performed through multiple access points rather than requiring a single large access route, thus maintaining minimally-invasive benefits while improving access to heart valves

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention transitions from a single-dimensional access approach (either retrograde through femoral artery or antegrade through apex) to a multi-dimensional access strategy by combining both retrograde and antegrade approaches simultaneously. This dimensional expansion in terms of access pathways enables better visualization, manipulation, and delivery of devices to heart valves while maintaining small incision sites

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

2Ease of operation

If the device is dimensioned to fit within the vasculature, then it can be introduced through small incisions, but the device size and maneuverability are restricted

Engineering Contradiction:

Improvedevice delivery through vasculatureVSAvoiddevice size and configuration

Core Design Contradiction:

Ease of operationVSAdaptability or versatility

Solution Approach 1:

The delivery system is divided into multiple segments: a first delivery system accessed through a first site (e.g., femoral artery) and a second delivery system accessed through a second site (e.g., transapical approach). Each segment can be independently navigated and positioned, allowing complex valve replacement procedures to be performed through multiple access points rather than requiring a single large access route, thus maintaining minimally-invasive benefits while improving access to heart valves

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The delivery systems are designed with dynamic characteristics that allow them to adapt to different vascular pathways. The systems can be collapsed or expanded, adjusted in diameter, and reconfigured during navigation through different access routes, enabling the same basic device to be delivered through various sizes of incisions while maintaining the ability to accommodate different valve sizes and configurations

Inventive Principle:

Principle #15Dynamics

3Ease of operation

If lesions are present in the vasculature, then access pathways are blocked, but certain delivery systems become contraindicated

Engineering Contradiction:

Improveaccess to heart valvesVSAvoiddelivery system options

Core Design Contradiction:

Ease of operationVSAdaptability or versatility

Solution Approach 1:

The delivery system is divided into multiple segments: a first delivery system accessed through a first site (e.g., femoral artery) and a second delivery system accessed through a second site (e.g., transapical approach). Each segment can be independently navigated and positioned, allowing complex valve replacement procedures to be performed through multiple access points rather than requiring a single large access route, thus maintaining minimally-invasive benefits while improving access to heart valves

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

When a lesion blocks a conventional retrograde access pathway, the system can invert the approach by using the antegrade transapical pathway instead. This inversion of the traditional access sequence allows delivery of devices through the apex of the heart rather than through the aorta, bypassing blocked vascular lesions and maintaining surgical access to heart valves

Inventive Principle:

Principle #13The other way round (Inversion)

Data Source

PatentUS8808367B2Prosthetic valve delivery system including retrograde/antegrade approach

Publication Date: 2014.08.19 CORCYM SRL

AI summary

A device for implanting an expandable heart valve prosthesis at a valve annulus in a patient's heart includes an implantation device configured to extend from a first opening in the patient's body, through the patient's aorta, through a valve annulus, through an opening in a ventricle, and to exit through the patient's thoracic region. The device further includes a port having a hemostasis valve for providing access through the patient's thoracic region and into the ventricle and at least two interchangeable modules configured for delivery using the implantation device.