Modular Transcatheter Valve Device Segmentation

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Solution Overview

Problem

Transcatheter valve replacement devices face challenges in positioning due to required minimum length, which increases metal presence in the body, leading to complications like thrombus formation.

Innovation Solution

A modular transcatheter valve replacement device comprising a top module for optimal positioning and a bottom module for permanent placement, where the top module is detachable or bio-absorbable, minimizing hardware left in the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the TAVR device length is increased to optimize positioning in the aortic canal, then ease of operation is improved, but the quantity of metal remaining in the body increases leading to complications

Engineering Contradiction:

Improveease of device positioningVSAvoidmetal presence in body

Core Design Contradiction:

Ease of operationVSQuantity of substance

Solution Approach 1:

The TAVR device is divided into two separate modules: a bottom module containing the replacement valve that remains permanently in the body, and a top module that provides positioning assistance during deployment but is then detached and removed. This segmentation allows the device to achieve optimal positioning (requiring greater length) while minimizing the permanent metal burden in the patient's body.

Inventive Principle:

Principle #1Segmentation

2Stability of the object's composition

If the TAVR device length is increased to optimize positioning, then device orientation is improved, but harmful factors increase due to more metal remaining in the body

Engineering Contradiction:

Improvedevice orientationVSAvoidthrombus formation

Core Design Contradiction:

Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

By segmenting the device into a permanent bottom module and a temporary top module, the invention achieves stable device orientation during the critical positioning phase while eliminating the source of long-term harmful effects (excess metal) through removal of the top module after deployment.

Inventive Principle:

Principle #1Segmentation

3Quantity of substance

If the TAVR device is made shorter to reduce metal presence in the body, then harmful factors are reduced, but ease of operation deteriorates due to difficulty in positioning

Engineering Contradiction:

Improvemetal presence in bodyVSAvoidease of device positioning

Core Design Contradiction:

Quantity of substanceVSEase of operation

Solution Approach 1:

The segmentation strategy allows the bottom module to be optimally sized for minimal permanent metal presence, while the temporary top module provides the additional length needed for easy positioning and orientation during the procedure. This resolves the contradiction by providing both short-term operational ease and long-term minimal metal burden.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS10543078B2Modular dis-assembly of transcatheter valve replacement devices and uses thereof

Publication Date: 2020.01.28 CEDARS SINAI MEDICAL CENT

AI summary

The present invention provides modular transcatheter valve replacement devices and methods of using the same to treat valvular heart diseases. Disclosed is a bottom module that contains a heart valve replacement, and a top module connected to the bottom module. The top module may be bio-absorbable, or may contain one or more severable joints that allow the top module to be removed after implantation. The removable or absorbable top portion serves to add additional length the structure to add in orientation during implantation, but is removed or absorbed to minimize the metal and other foreign material in a patient's body that could cause thrombosis or other reactions.